Citation: J Am Coll Cardiol. 2008;51:865-884.
Author(s): Estes NA, Halperin JL, Calkins H, et al.
Perspective: The following are 10 points to remember from this American College of Cardiology/American Heart Association (ACC/AHA) scientific statement on clinical performance measures for adults with atrial fibrillation (AF) or atrial flutter (AFl).
1. Antithrombotic therapy is indicated for all patients with AF except those with lone AF or contraindications.
2. Assessment of thromboembolic risk factors should include prior stroke/transient ischemic attack (TIA), age ≥75 years, hypertension, diabetes, and heart failure or left ventricular (LV) systolic dysfunction.
3. Prior stroke/TIA is the strongest risk factor and is an indication for anticoagulation with warfarin.
4. Rheumatic mitral stenosis also is a strong risk factor for stroke and is an indication for warfarin even if no other risk factors are present.
5. Warfarin also is indicated for patients with >1 moderate risk factor (age ≥75 years, hypertension, diabetes, and heart failure/LV systolic dysfunction.
6. Aspirin may be used for stroke prevention in patients without any risk factors.
7. Antithrombotic therapy (warfarin or aspirin) should be used on an individualized basis in patients with one moderate risk factor.
8. The international normalized ratio (INR) initially should be measured at least once per week and then once per month after a stable degree of anticoagulation when an INR of 2-3 is achieved.
9. When aspirin is used for stroke prevention, the daily dose should be 81-325 mg/day.
10. Patients with AFl should receive antithrombotic therapy in the same fashion as patients with AF. Fred Morady, M.D., F.A.C.C.
Showing posts with label Atrial Fibrillaton. Show all posts
Showing posts with label Atrial Fibrillaton. Show all posts
Monday, February 18, 2008
Statins Found to Reduce Risk of Recurrent Atrial Fibrillation
TOURS, France, Feb. 18 -- Statin therapy significantly reduces the risk of atrial fibrillation in patients with a history of the condition and other high-risk groups, a meta-analysis has suggested.
Overall, statins reduced the odds ratio for atrial fibrillation by more than 60% compared with patients who did not receive the drugs, Laurent Fauchier, M.D., Ph.D., of Trousseau University Hospital Center, and colleagues reported in the Feb. 26 issue of the Journal of the American College of Cardiology.
Statins appeared to exert a greater impact in secondary prevention of atrial fibrillation rather than new-onset or postoperative atrial fibrillation.
"These results provide some evidence of the benefit of statins beyond their lipid-lowering activity," the authors concluded. "However, large-scale, prospective, randomized clinical trials are still needed to establish whether statins bring a similar benefit and are an appropriate therapeutic option in all subgroups of patients for the management of atrial fibrillation."
Observational studies have provided evidence of a protective effect of statins against atrial fibrillation. However, data were insufficient to provide a basis for recommending statin therapy to prevent the arrhythmia.
In an attempt to bring the potential atrial fibrillation benefit into sharper focus, Dr. Fauchier and colleagues searched for all randomized controlled trials of statins published from January 1980 through June 2007. They identified six trials involving 3,557 patients given statins versus placebo or a control therapy for treatment or prevention of atrial fibrillation.
Three studies examined the use of statins in patients with a history of paroxysmal atrial fibrillation or who were undergoing cardioversion for persistent atrial fibrillation. The remaining three trials evaluated statins in patients undergoing cardiac surgery or after acute coronary syndrome.
Overall, statin therapy was associated with a 61% decrease in the risk of atrial fibrillation (OR 0.39, 95% CI 0.18 to 0.85, P=0.02). Separate analyses suggested a more marked effect in the setting of secondary prevention (OR 0.33, 95% CI 0.10 to 1.03, P=0.06) than for new-onset or postoperative atrial fibrillation (OR 0.60, 95% CI 0.27 to 1.37, P=0.23).
The authors acknowledged they were unable to evaluate the possible impact of statin dose or the degree of LDL-lowering on arrhythmic events. They also noted that atrial fibrillation might arise from different factors in different patient subgroups, potentially making certain patients more responsive to an intervention compared with others.
Despite those limitations, Dr. Fauchier and colleagues concluded, "Use of statins was significantly associated with a decreased risk of incidence or recurrence of AF inpatients in sinus rhythm with a history of previous AF or undergoing cardiac surgery or after acute coronary syndrome."
The authors reported no disclosures.
Primary source: Journal of the American College of CardiologySource reference:Fauchier L, et al "Antiarrhythmic effect of statin therapy and atrial fibrillation: a meta-analysis of randomized controlled trials" J Am Coll Cardiol 2008; 51: DOI:10.1016/j.jacc.2007.09.063.
Overall, statins reduced the odds ratio for atrial fibrillation by more than 60% compared with patients who did not receive the drugs, Laurent Fauchier, M.D., Ph.D., of Trousseau University Hospital Center, and colleagues reported in the Feb. 26 issue of the Journal of the American College of Cardiology.
Statins appeared to exert a greater impact in secondary prevention of atrial fibrillation rather than new-onset or postoperative atrial fibrillation.
"These results provide some evidence of the benefit of statins beyond their lipid-lowering activity," the authors concluded. "However, large-scale, prospective, randomized clinical trials are still needed to establish whether statins bring a similar benefit and are an appropriate therapeutic option in all subgroups of patients for the management of atrial fibrillation."
Observational studies have provided evidence of a protective effect of statins against atrial fibrillation. However, data were insufficient to provide a basis for recommending statin therapy to prevent the arrhythmia.
In an attempt to bring the potential atrial fibrillation benefit into sharper focus, Dr. Fauchier and colleagues searched for all randomized controlled trials of statins published from January 1980 through June 2007. They identified six trials involving 3,557 patients given statins versus placebo or a control therapy for treatment or prevention of atrial fibrillation.
Three studies examined the use of statins in patients with a history of paroxysmal atrial fibrillation or who were undergoing cardioversion for persistent atrial fibrillation. The remaining three trials evaluated statins in patients undergoing cardiac surgery or after acute coronary syndrome.
Overall, statin therapy was associated with a 61% decrease in the risk of atrial fibrillation (OR 0.39, 95% CI 0.18 to 0.85, P=0.02). Separate analyses suggested a more marked effect in the setting of secondary prevention (OR 0.33, 95% CI 0.10 to 1.03, P=0.06) than for new-onset or postoperative atrial fibrillation (OR 0.60, 95% CI 0.27 to 1.37, P=0.23).
The authors acknowledged they were unable to evaluate the possible impact of statin dose or the degree of LDL-lowering on arrhythmic events. They also noted that atrial fibrillation might arise from different factors in different patient subgroups, potentially making certain patients more responsive to an intervention compared with others.
Despite those limitations, Dr. Fauchier and colleagues concluded, "Use of statins was significantly associated with a decreased risk of incidence or recurrence of AF inpatients in sinus rhythm with a history of previous AF or undergoing cardiac surgery or after acute coronary syndrome."
The authors reported no disclosures.
Primary source: Journal of the American College of CardiologySource reference:Fauchier L, et al "Antiarrhythmic effect of statin therapy and atrial fibrillation: a meta-analysis of randomized controlled trials" J Am Coll Cardiol 2008; 51: DOI:10.1016/j.jacc.2007.09.063.
Monday, January 28, 2008
Digitalis: a dangerous drug in atrial fibrillation? An analysis of the SPORTIF III and V data
Commentaries:
In this study patients were not randomized to digitalis use.
Digitalis: a dangerous drug in atrial fibrillation? An analysis of the SPORTIF III and V data
Heart 2008; 94: 191-196
Knut Gjesdal (University of Oslo, Norway) and colleagues
ABSTRACT
Objective: In heart failure, digitalis increases exercise capacity and reduces morbidity, but has no effect on survival. This raises the suspicion that the inotropic benefits of digitalis may be counteracted by serious adverse effects. Patients with atrial fibrillation (AF) were studied to clarify this.
Design: In the Stroke Prevention using an ORal Thrombin Inhibitor in atrial Fibrillation (SPORTIF) III and V studies, 7329 patients with AF at moderate-to-high risk were randomised to preventive treatment of thromboembolism, either with warfarin or the oral direct thrombin inhibitor ximelagatran. The survival of users and non-users of digitalis was investigated.
Results: At baseline, 53.4% of the study population used digitalis, and these patients had a higher mortality than non-users (255/3911 (6.5%) vs 141/3418 (4.1%), p<0.001; hazard ratio (HR) = 1.58 (95% CI 1.29 to 1.94)). Digitalis users also had more baseline risk factors. After multivariate risk factor adjustment, the increased mortality persisted (p<0.001; HR = 1.53 (95% CI 1.22 to 1.92 vs 1.23 to 1.92)).
Conclusions: The results suggest that digitalis, like other inotropic drugs, may increase mortality. This may be concealed in heart failure, but be revealed in patients with AF, who need the rate-reducing effect of digitalis, but do not benefit much from an increased inotropy. Cautious interpretation of the data is mandatory since the patients were not randomised with respect to digitalis use.
In this study patients were not randomized to digitalis use.
Digitalis: a dangerous drug in atrial fibrillation? An analysis of the SPORTIF III and V data
Heart 2008; 94: 191-196
Knut Gjesdal (University of Oslo, Norway) and colleagues
ABSTRACT
Objective: In heart failure, digitalis increases exercise capacity and reduces morbidity, but has no effect on survival. This raises the suspicion that the inotropic benefits of digitalis may be counteracted by serious adverse effects. Patients with atrial fibrillation (AF) were studied to clarify this.
Design: In the Stroke Prevention using an ORal Thrombin Inhibitor in atrial Fibrillation (SPORTIF) III and V studies, 7329 patients with AF at moderate-to-high risk were randomised to preventive treatment of thromboembolism, either with warfarin or the oral direct thrombin inhibitor ximelagatran. The survival of users and non-users of digitalis was investigated.
Results: At baseline, 53.4% of the study population used digitalis, and these patients had a higher mortality than non-users (255/3911 (6.5%) vs 141/3418 (4.1%), p<0.001; hazard ratio (HR) = 1.58 (95% CI 1.29 to 1.94)). Digitalis users also had more baseline risk factors. After multivariate risk factor adjustment, the increased mortality persisted (p<0.001; HR = 1.53 (95% CI 1.22 to 1.92 vs 1.23 to 1.92)).
Conclusions: The results suggest that digitalis, like other inotropic drugs, may increase mortality. This may be concealed in heart failure, but be revealed in patients with AF, who need the rate-reducing effect of digitalis, but do not benefit much from an increased inotropy. Cautious interpretation of the data is mandatory since the patients were not randomised with respect to digitalis use.
Monday, January 21, 2008
Digitalis: a dangerous drug in atrial fibrillation? An analysis of the SPORTIF III and V data
Commentaries:
Patient not randomized to Digitalis
Digitalis: a dangerous drug in atrial fibrillation? An analysis of the SPORTIF III and V data
Heart 2008;94:191-196
K Gjesdal, J Feyzi, S B Olsson
ABSTRACT
Objective: In heart failure, digitalis increases exercise capacity and reduces morbidity, but has no effect on survival. This raises the suspicion that the inotropic benefits of digitalis may be counteracted by serious adverse effects. Patients with atrial fibrillation (AF) were studied to clarify this.
Design: In the Stroke Prevention using an ORal Thrombin Inhibitor in atrial Fibrillation (SPORTIF) III and V studies, 7329 patients with AF at moderate-to-high risk were randomised to preventive treatment of thromboembolism, either with warfarin or the oral direct thrombin inhibitor ximelagatran. The survival of users and non-users of digitalis was investigated.
Results: At baseline, 53.4% of the study population used digitalis, and these patients had a higher mortality than non-users (255/3911 (6.5%) vs 141/3418 (4.1%), p<0.001; hazard ratio (HR) = 1.58 (95% CI 1.29 to 1.94)). Digitalis users also had more baseline risk factors. After multivariate risk factor adjustment, the increased mortality persisted (p<0.001; HR = 1.53 (95% CI 1.22 to 1.92 vs 1.23 to 1.92)).
Conclusions: The results suggest that digitalis, like other inotropic drugs, may increase mortality. This may be concealed in heart failure, but be revealed in patients with AF, who need the rate-reducing effect of digitalis, but do not benefit much from an increased inotropy. Cautious interpretation of the data is mandatory since the patients were not randomised with respect to digitalis use.
Patient not randomized to Digitalis
Digitalis: a dangerous drug in atrial fibrillation? An analysis of the SPORTIF III and V data
Heart 2008;94:191-196
K Gjesdal, J Feyzi, S B Olsson
ABSTRACT
Objective: In heart failure, digitalis increases exercise capacity and reduces morbidity, but has no effect on survival. This raises the suspicion that the inotropic benefits of digitalis may be counteracted by serious adverse effects. Patients with atrial fibrillation (AF) were studied to clarify this.
Design: In the Stroke Prevention using an ORal Thrombin Inhibitor in atrial Fibrillation (SPORTIF) III and V studies, 7329 patients with AF at moderate-to-high risk were randomised to preventive treatment of thromboembolism, either with warfarin or the oral direct thrombin inhibitor ximelagatran. The survival of users and non-users of digitalis was investigated.
Results: At baseline, 53.4% of the study population used digitalis, and these patients had a higher mortality than non-users (255/3911 (6.5%) vs 141/3418 (4.1%), p<0.001; hazard ratio (HR) = 1.58 (95% CI 1.29 to 1.94)). Digitalis users also had more baseline risk factors. After multivariate risk factor adjustment, the increased mortality persisted (p<0.001; HR = 1.53 (95% CI 1.22 to 1.92 vs 1.23 to 1.92)).
Conclusions: The results suggest that digitalis, like other inotropic drugs, may increase mortality. This may be concealed in heart failure, but be revealed in patients with AF, who need the rate-reducing effect of digitalis, but do not benefit much from an increased inotropy. Cautious interpretation of the data is mandatory since the patients were not randomised with respect to digitalis use.
Atral Fibrillation, Inflamation and CPR levels
Commentaries:
There a need for data , well-designed and blinded longitudinal studies.
The role of the post-cardioversion time course of hs-CRP levels in clarifying the relationship between inflammation and persistence of atrial fibrillation
Heart
E M Kallergis, E G Manios, E M Kanoupakis, H E Mavrakis, S G Kolyvaki, G M Lyrarakis, G I Chlouverakis, P E Vardas
Department of Cardiology, University Hospital of Heraklion, Crete, Greece
ABSTRACT
Objectives: Although recent studies suggest that inflammation is involved in the pathogenesis of atrial fibrillation (AF), it remains controversial whether it is a consequence or a cause of the arrhythmia.
Design: Prospective study.
Setting: Tertiary referral centre.
Patients and Interventions: In 52 patients with persistent AF lasting >3 months, high-sensitivity C-reactive protein (hs-CRP) was measured before and after electrical cardioversion.
Measurements and Results: All patients were successfully cardioverted to sinus rhythm (SR), but the recurrence rate was 23% at 1 month. Baseline hs-CRP was higher in patients with AF recurrence than in those who remained in SR (0.5 (SD 0.18) mg/dl vs 0.29 (SD 0.13) mg/dl, respectively, p<0.001). Similarly, arrhythmia recurrence was associated with greater left atrial diameters (45.4 (SD 3.3) mm vs 40.7 (SD 3.1) mm, respectively, p<0.001). However, logistic regression analysis showed that hs-CRP was the only independent predictor for AF recurrence (p<0.001). Additionally, patients who were in SR on final evaluation had significantly lower hs-CRP levels than at baseline (0.10 (SD 0.06) mg/dl vs 0.29 (SD 0.13) mg/dl, respectively, p<0.001), while those who experienced AF recurrence had similar values on final and on initial evaluation (0.56 (SD 0.24) mg/dl vs 0.50 (SD 0.18) mg/dl, respectively, p = 0.42).
Conclusion: High levels of hs-CRP are associated with an increased risk of AF recurrence after cardioversion. The restoration and maintenance of SR result in a gradual decrease of hs-CRP while AF recurrence has a different effect, suggesting that inflammation is a consequence, rather than a cause, of AF.
There a need for data , well-designed and blinded longitudinal studies.
The role of the post-cardioversion time course of hs-CRP levels in clarifying the relationship between inflammation and persistence of atrial fibrillation
Heart
E M Kallergis, E G Manios, E M Kanoupakis, H E Mavrakis, S G Kolyvaki, G M Lyrarakis, G I Chlouverakis, P E Vardas
Department of Cardiology, University Hospital of Heraklion, Crete, Greece
ABSTRACT
Objectives: Although recent studies suggest that inflammation is involved in the pathogenesis of atrial fibrillation (AF), it remains controversial whether it is a consequence or a cause of the arrhythmia.
Design: Prospective study.
Setting: Tertiary referral centre.
Patients and Interventions: In 52 patients with persistent AF lasting >3 months, high-sensitivity C-reactive protein (hs-CRP) was measured before and after electrical cardioversion.
Measurements and Results: All patients were successfully cardioverted to sinus rhythm (SR), but the recurrence rate was 23% at 1 month. Baseline hs-CRP was higher in patients with AF recurrence than in those who remained in SR (0.5 (SD 0.18) mg/dl vs 0.29 (SD 0.13) mg/dl, respectively, p<0.001). Similarly, arrhythmia recurrence was associated with greater left atrial diameters (45.4 (SD 3.3) mm vs 40.7 (SD 3.1) mm, respectively, p<0.001). However, logistic regression analysis showed that hs-CRP was the only independent predictor for AF recurrence (p<0.001). Additionally, patients who were in SR on final evaluation had significantly lower hs-CRP levels than at baseline (0.10 (SD 0.06) mg/dl vs 0.29 (SD 0.13) mg/dl, respectively, p<0.001), while those who experienced AF recurrence had similar values on final and on initial evaluation (0.56 (SD 0.24) mg/dl vs 0.50 (SD 0.18) mg/dl, respectively, p = 0.42).
Conclusion: High levels of hs-CRP are associated with an increased risk of AF recurrence after cardioversion. The restoration and maintenance of SR result in a gradual decrease of hs-CRP while AF recurrence has a different effect, suggesting that inflammation is a consequence, rather than a cause, of AF.
Friday, December 7, 2007
Use of intravenous magnesium to treat acute onset atrial fibrillation: a meta-analysis
Use of intravenous magnesium to treat acute onset atrial fibrillation: a meta-analysis
Kwok M Ho, David J Sheridan, Timothy Paterson
Department of Intensive Care, Royal Perth Hospital, Perth, Australia
ABSTRACT
Objectives: To assess the effects of intravenous magnesium on converting acute onset atrial fibrillation to sinus rhythm, reducing ventricular response and risk of bradycardia.
Design and data sources: Randomised controlled trials evaluating intravenous magnesium to treat acute onset atrial fibrillation from MEDLINE (1966 to 2006), EMBASE (1990 to 2006) and Cochrane Controlled Trials Register without language restrictions.
Review methods: Two researchers independently performed the literature search and data extraction.
Results: 10 randomised controlled trials, including a total of 515 patients with acute onset atrial fibrillation, were considered. Intravenous magnesium was not effective in converting acute onset atrial fibrillation to sinus rhythm when compared to placebo or an alternative antiarrhythmic drug. When compared to placebo, adding intravenous magnesium to digoxin increased the proportion of patients with a ventricular response <100 beats/min (58.8% vs 32.6%; OR 3.2, 95% CI 1.93 to 5.42; p<0.001). When compared to calcium antagonists or amiodarone, intravenous magnesium was less effective in reducing the ventricular response (21.4% vs 58.5%; OR 0.19, 95% CI 0.09 to 0.44; p<0.001) but also less likely to induce significant bradycardia or atrioventricular block (0% vs 9.2%; OR 0.13, 95% CI 0.02 to 0.76; p = 0.02). The use of intravenous magnesium was associated with transient minor symptoms of flushing, tingling and dizziness in about 17% of the patients (OR 14.5, 95% CI 3.7 to 56.7; p<0.001).
Conclusions: Adding intravenous magnesium to digoxin reduces fast ventricular response in acute onset atrial fibrillation. The effect of intravenous magnesium on the ventricular rate and its cardiovascular side effects are less significant than other calcium antagonists or amiodarone. Intravenous magnesium can be considered as a safe adjunct to digoxin in controlling the ventricular response in atrial fibrillation.
Friday, November 23, 2007
UK guidelines for chronic AF called into question
UK guidelines for chronic AF called into question
By Caroline Price
23 November 2007
Br Med J 2007; 335: 1057-1058
MedWire News: The departure from recommending digoxin as the first-line treatment in patients with chronic atrial fibrillation (AF) by current UK guidelines is premature, conclude investigators in a review of available evidence in the British Medical Journal.
The UK National Institute for Clinical Excellence last year published guidelines that replaced digoxin with beta blockers or calcium antagonists as the recommended initial monotherapy for the control of heart rate in patients with chronic AF.
“Digoxin has been the mainstay of treatment for many years, so new recommendations relegating digoxin should be evidence based and safe,” write Theodora Nikolaidou and Kevin Channer, from Royal Hallamshire Hospital in Sheffield, UK.
But the reviewers found little evidence to support replacing digoxin with either of the other treatments as monotherapy. Rather, they found that improvements in both heart rate variability and exercise tolerance have been shown only with the combination of digoxin and a beta blocker or calcium channel blocker. Indeed, they found some evidence that beta blockers used alone may worsen exercise capacity.
Nikolaidou and Channer reviewed a total of 57 studies, including 25 randomized double blind controlled trials, assessing digoxin, beta blockers, calcium antagonists, and combinations for rate control in chronic AF.
They found that beta-blocker monotherapy was better than digoxin alone at controlling heart rate at rest in just one out of 10 studies, although it improved rate control during exercise in four of the studies. Nevertheless, in six other studies, beta blocker use alone did not improve exercise capacity.
Several studies showed that the combination of beta blocker and digoxin gave greater improvements in heart rate control at rest and during exercise compared with digoxin alone.
The combination’s effect on exercise capacity was inconsistent, causing deterioration in some studies, but improvement or no change in others.
The calcium channel blocker diltiazem was found in five studies to be better than digoxin at controlling heart rate during exercise, but not during rest, and it failed to improve exercise capacity. However, most of the eleven studies assessing the combination of diltiazem and digoxin showed that it provided better heart rate control at rest and during exercise than digoxin alone, and two studies showed the combination gave improved exercise tolerance.
Similar results were seen with the calcium antagonist verapamil as monotherapy in comparison with digoxin, although exercise tolerance improved with verapamil in two of three studies that assessed this outcome. Again, the combination of verapamil with digoxin improved rate control at rest and during exercise compared with digoxin alone, but, despite this, exercise tolerance was not consistently improved.
Nikolaidou and Channer note that use of both verapamil and diltiazem is limited by their negative inotropic effects and “considerable” dose-related side effects.
They conclude: “We believe that the combination of digoxin and a beta blocker or calcium antagonist should be recommended as first-line management. We would emphasize that it is safest to start treatment with digoxin first.”
Journal
By Caroline Price
23 November 2007
Br Med J 2007; 335: 1057-1058
MedWire News: The departure from recommending digoxin as the first-line treatment in patients with chronic atrial fibrillation (AF) by current UK guidelines is premature, conclude investigators in a review of available evidence in the British Medical Journal.
The UK National Institute for Clinical Excellence last year published guidelines that replaced digoxin with beta blockers or calcium antagonists as the recommended initial monotherapy for the control of heart rate in patients with chronic AF.
“Digoxin has been the mainstay of treatment for many years, so new recommendations relegating digoxin should be evidence based and safe,” write Theodora Nikolaidou and Kevin Channer, from Royal Hallamshire Hospital in Sheffield, UK.
But the reviewers found little evidence to support replacing digoxin with either of the other treatments as monotherapy. Rather, they found that improvements in both heart rate variability and exercise tolerance have been shown only with the combination of digoxin and a beta blocker or calcium channel blocker. Indeed, they found some evidence that beta blockers used alone may worsen exercise capacity.
Nikolaidou and Channer reviewed a total of 57 studies, including 25 randomized double blind controlled trials, assessing digoxin, beta blockers, calcium antagonists, and combinations for rate control in chronic AF.
They found that beta-blocker monotherapy was better than digoxin alone at controlling heart rate at rest in just one out of 10 studies, although it improved rate control during exercise in four of the studies. Nevertheless, in six other studies, beta blocker use alone did not improve exercise capacity.
Several studies showed that the combination of beta blocker and digoxin gave greater improvements in heart rate control at rest and during exercise compared with digoxin alone.
The combination’s effect on exercise capacity was inconsistent, causing deterioration in some studies, but improvement or no change in others.
The calcium channel blocker diltiazem was found in five studies to be better than digoxin at controlling heart rate during exercise, but not during rest, and it failed to improve exercise capacity. However, most of the eleven studies assessing the combination of diltiazem and digoxin showed that it provided better heart rate control at rest and during exercise than digoxin alone, and two studies showed the combination gave improved exercise tolerance.
Similar results were seen with the calcium antagonist verapamil as monotherapy in comparison with digoxin, although exercise tolerance improved with verapamil in two of three studies that assessed this outcome. Again, the combination of verapamil with digoxin improved rate control at rest and during exercise compared with digoxin alone, but, despite this, exercise tolerance was not consistently improved.
Nikolaidou and Channer note that use of both verapamil and diltiazem is limited by their negative inotropic effects and “considerable” dose-related side effects.
They conclude: “We believe that the combination of digoxin and a beta blocker or calcium antagonist should be recommended as first-line management. We would emphasize that it is safest to start treatment with digoxin first.”
Journal
Wednesday, November 7, 2007
AHA - 2007: Study compares strategies to save heart failure, atrial fibrillation patients
American Heart Association's Scientific Sessions 2007
Late-Breaking Clinical Trials News Release 13
Study compares strategies to save heart failure, atrial fibrillation patients
ORLANDO, Nov. 6 – Final results were presented from a study to determine whether cardiovascular mortality can most effectively be reduced by trying to maintain a normal heart rhythm or by simply controlling the heart rate in people with both heart failure (HF) and atrial fibrillation during the late-breaking clinical trials presented at the American Heart Association’s Scientific Sessions 2007.
The Atrial Fibrillation and Congestive Heart Failure (AF-CHF) trial is a prospective, randomized, multicenter clinical trial with 1,376 patients at 123 sites in Canada, the United States, Brazil, Argentina, Europe, and Israel.
Atrial fibrillation is the most common cardiac arrhythmia, with disorganized electrical activity in the atria, the upper chambers of the heart. Afflicting tens of millions of people worldwide, it is associated with increased risk of death from heart disease and is a major cause of stroke.
HF is a serious heart condition affecting over five million people in the United States. Each year, about 550,000 people are diagnosed for the first time.
In this study, patients randomized to the heart rhythm control group underwent electrical cardioversion combined with antiarrhymic drug therapy, using amiodarone as the initial drug of choice, with sotalol or dofetilide in specific cases. In the heart rate control group, patients received titrated doses of beta-blockers and digoxin or both and pacemaker therapy if needed. Both groups received optimal heart failure management and anticoagulation.
Patients were followed for an average of 37 months. Cardiovascular death (the primary endpoint of the trial) occurred in 26.7 percent of patients in the rhythm-control group compared to 25.2 percent of patients in the rate-control group (p=0.59). Total mortality (31.8 percent vs. 32.9 percent), strokes (2.6 percent vs. 3.6 percent) and worsening HF events (27.6 percent vs. 30.8 percent) were also similar between the rhythm-control versus the rate-control group.
“We found that rhythm control does not improve mortality when compared to rate control,” said Denis Roy, M.D., principal investigator and professor and chair in the department of medicine at the University of Montreal, Quebec, Canada. “The results of the trial do not suggest that a strategy of rhythm control should be advocated for patients with atrial fibrillation and congestive heart failure.”
Support for this study was provided by the Canadian Institutes of Health Research.
Late-Breaking Clinical Trials News Release 13
Study compares strategies to save heart failure, atrial fibrillation patients
ORLANDO, Nov. 6 – Final results were presented from a study to determine whether cardiovascular mortality can most effectively be reduced by trying to maintain a normal heart rhythm or by simply controlling the heart rate in people with both heart failure (HF) and atrial fibrillation during the late-breaking clinical trials presented at the American Heart Association’s Scientific Sessions 2007.
The Atrial Fibrillation and Congestive Heart Failure (AF-CHF) trial is a prospective, randomized, multicenter clinical trial with 1,376 patients at 123 sites in Canada, the United States, Brazil, Argentina, Europe, and Israel.
Atrial fibrillation is the most common cardiac arrhythmia, with disorganized electrical activity in the atria, the upper chambers of the heart. Afflicting tens of millions of people worldwide, it is associated with increased risk of death from heart disease and is a major cause of stroke.
HF is a serious heart condition affecting over five million people in the United States. Each year, about 550,000 people are diagnosed for the first time.
In this study, patients randomized to the heart rhythm control group underwent electrical cardioversion combined with antiarrhymic drug therapy, using amiodarone as the initial drug of choice, with sotalol or dofetilide in specific cases. In the heart rate control group, patients received titrated doses of beta-blockers and digoxin or both and pacemaker therapy if needed. Both groups received optimal heart failure management and anticoagulation.
Patients were followed for an average of 37 months. Cardiovascular death (the primary endpoint of the trial) occurred in 26.7 percent of patients in the rhythm-control group compared to 25.2 percent of patients in the rate-control group (p=0.59). Total mortality (31.8 percent vs. 32.9 percent), strokes (2.6 percent vs. 3.6 percent) and worsening HF events (27.6 percent vs. 30.8 percent) were also similar between the rhythm-control versus the rate-control group.
“We found that rhythm control does not improve mortality when compared to rate control,” said Denis Roy, M.D., principal investigator and professor and chair in the department of medicine at the University of Montreal, Quebec, Canada. “The results of the trial do not suggest that a strategy of rhythm control should be advocated for patients with atrial fibrillation and congestive heart failure.”
Support for this study was provided by the Canadian Institutes of Health Research.
Wednesday, October 17, 2007
Amiodarone raises hypothyroidism in older atrial fibrillation patients
Amiodarone raises hypothyroidism in older atrial fibrillation patients
By Liam Davenport
16 October 2007
Am J Med 2007; 120: 880-885
MedWire News: Older males treated with amiodarone for persistent atrial fibrillation are substantially more likely to develop hypothyroidism than patients with atrial fibrillation who not given the treatment, US study findings indicate.
The majority of patients who are given amiodarone, which has recently been found to have unparalled effectiveness in maintaining sinus rhythm, are male, say Elizabeth Batcher, from West Los Angeles Veterans Affairs Medical Center in California, and colleagues. However, the long-term risk of amiodarone-induced thyroid dysfunction has not been thoroughly investigated.
The team therefore performed a substudy of 612 patients from the Sotalol Amiodarone Atrial Fibrillation Efficacy Trial, of whom 247 were treated with amiodarone and 365 were given sotalol or placebo. Sotalol and placebo patients were combined to form a control group, as neither would be expected to alter thyroid function, the authors note. The average age of the groups was 67.1 years for amiodarone-treated patients and 66.9 years among controls.
Thyroid function was measured at baseline, 3 month, 6 months, and every 6 months for up to 4.5 years by measuring serum thyroid-stimulating hormone (TSH) concentrations. There were no statistical differences in TSH levels at baseline between the groups.
The results indicate that subclinical hypothyroidism, defined as a TSH level of 4.5-10 mU/l, occurred in 25.8% of patients treated with amiodarone, compared with 6.6% of those from the control group, the team reports in the American Journal of Medicine.
In addition, 5.0% of amiodarone patients were found to have overt hypothyroidism, defined as a TSH level of over 10 mU/l, compared with just 0.3% of controls. In both cases, the difference between the amiodarone and control groups was significant.
Of the patients who developed TSH levels of more than 10 mU/l, 93.8% were detected by 6 months. It was also observed that amiodarone patients had a trend towards a greater prevalence of hyperthyroidism, defined as a TSH level of less than 0.35 mU/l, than controls, at 5.3% versus 2.4%.
The researchers write: "In summary, amiodarone-induced hypothyroidism developed in 30.8% of older men treated with amiodarone for chronic atrial fibrillation compared with the control group and presented early during therapy."
They add: "Given the high rate of hypothyroidism among patients taking amiodarone, monitoring of thyroid function is recommended at baseline, 3 months, and every 6 months thereafter during the therapy."
Free abstract
By Liam Davenport
16 October 2007
Am J Med 2007; 120: 880-885
MedWire News: Older males treated with amiodarone for persistent atrial fibrillation are substantially more likely to develop hypothyroidism than patients with atrial fibrillation who not given the treatment, US study findings indicate.
The majority of patients who are given amiodarone, which has recently been found to have unparalled effectiveness in maintaining sinus rhythm, are male, say Elizabeth Batcher, from West Los Angeles Veterans Affairs Medical Center in California, and colleagues. However, the long-term risk of amiodarone-induced thyroid dysfunction has not been thoroughly investigated.
The team therefore performed a substudy of 612 patients from the Sotalol Amiodarone Atrial Fibrillation Efficacy Trial, of whom 247 were treated with amiodarone and 365 were given sotalol or placebo. Sotalol and placebo patients were combined to form a control group, as neither would be expected to alter thyroid function, the authors note. The average age of the groups was 67.1 years for amiodarone-treated patients and 66.9 years among controls.
Thyroid function was measured at baseline, 3 month, 6 months, and every 6 months for up to 4.5 years by measuring serum thyroid-stimulating hormone (TSH) concentrations. There were no statistical differences in TSH levels at baseline between the groups.
The results indicate that subclinical hypothyroidism, defined as a TSH level of 4.5-10 mU/l, occurred in 25.8% of patients treated with amiodarone, compared with 6.6% of those from the control group, the team reports in the American Journal of Medicine.
In addition, 5.0% of amiodarone patients were found to have overt hypothyroidism, defined as a TSH level of over 10 mU/l, compared with just 0.3% of controls. In both cases, the difference between the amiodarone and control groups was significant.
Of the patients who developed TSH levels of more than 10 mU/l, 93.8% were detected by 6 months. It was also observed that amiodarone patients had a trend towards a greater prevalence of hyperthyroidism, defined as a TSH level of less than 0.35 mU/l, than controls, at 5.3% versus 2.4%.
The researchers write: "In summary, amiodarone-induced hypothyroidism developed in 30.8% of older men treated with amiodarone for chronic atrial fibrillation compared with the control group and presented early during therapy."
They add: "Given the high rate of hypothyroidism among patients taking amiodarone, monitoring of thyroid function is recommended at baseline, 3 months, and every 6 months thereafter during the therapy."
Free abstract
Wednesday, September 19, 2007
Atrial Fibrillation: Rhythm or rate control
Atrial Fibrillation: Rhythm or rate control
Prof. J.Y. Le HeuzeyParis, FranceNucleus member of the Working Group on Arrythmias
Therapy for AF is often directed toward the maintenance of sinus rhythm obtained after a cardioversion or by antiarrhythmic agents. The objectives of this rhythm control strategy include relief of symptoms, better exercise tolerance, prevention of embolism and avoidance of cardiomyopathy which together lead to a better quality of life and better survival.
An accepted strategy is to control the ventricular response rate of AF with the depression of conduction across the AV node by pharmacological agents or ablation of the atrioventricular junction and pacemaker implantation. The rationale for using a rate-control strategy is that most symptoms in AF may be caused by an irregular ventricular rate which may be treated by rate-control drugs. Additionally, effective rate-control drugs may prevent tachycardia-induced cardiomyopathy and the adverse effects of drugs.
Strategy trials
Three recent randomized trials compared rhythm and rate control in atrial fibrillation.
In the PIAF trial (1), the two strategies yielded similar clinical results regarding symptoms but exercise tolerance was better in the rhythm-control group.
In the AFFIRM trial (2), 4060 patients with recurrent AF were randomized to one of the two strategies. In this study, there was no survival benefits with the rhythm-control strategy (mortality at 5 years, 23.8% versus 21.3% in the rhythm and rate control group, respectively, p=0.08). The number of hospitalizations [1374 (80.1%) versus 1220 (73.0%), p <0.001] and the proportion of adverse drug effects were greater in the rhythm-control group, especially prolongation of the QT interval, torsade de pointes and bradycardia.
The third randomized trial, Rate control vs electrical cardioversion for persistent atrial fibrillation, RACE (3), compared the two strategies in 522 patients with recurrent persistent AF. The primary end-point was a composite of death from cardiovascular causes, heart failure, bleeding, thrombo-embolic complications, implantation of a pacemaker, and severe adverse effects of drugs.
The primary end-point occurred in 17.2% of the patients in the rate-control group and in 22.6% of the patients in the rhythm-control group which represents a trend in favour of rate control.
These studies show that rate-control is not inferior to rhythm-control strategy and may be an appropriate first choice therapy in patients with recurrent AF. It must be emphasized that most of these studies included patients with structural heart diseases and risk factors of recurrence and thrombo-embolism. Their results cannot be extrapolated to other patients, especially the young patients without underlying cardiopathy.
Management strategies
Patients without symptoms who have experienced at least one cardioversion to restore sinus rhythm can remain in AF with rate-control therapy and prevention of thrombo-embolism.
For patients with disabling symptoms during AF, a drug limiting cardiac rate during the episode can be used. An anti-arrhythmic drug therapy is generally used to maintain the sinus rhythm after the termination of AF.
For patients without heart disease, the first-line therapy includes one of the following drugs : flecainide, propafanone, or sotalol. Second-line therapy includes amiodarone or dofetilide. Third-line therapy includes disopyramide, procainamide, quinidine and non-pharmacological options.
For adrenergic AF, beta-blockers and sotalol are the initial drugs of choice.
For patients experiencing heart failure, solely amiodarone can be used.
For patients with coronary artery disease, sotalol represents the initial drug. In case of recurrence, amiodarone can be used.
In case of hypertension, the choice of antiarrhythmic drugs depends on the importance of left ventricular hypertrophy (LVH). If LVH is <>
Antithrombotic strategies
It has been demonstrated for many years that anticoagulants might be used in permanent atrial fibrillation (AFASAK, BAATAF, SPAF, CAFA, SPINAF…). The AFFIRM trial has clearly demonstrated that this anticoagulation might be pursued in patients for whom the rhythm control strategy is chosen. Even if the sinus rhythm is restored, patients with high risk of thrombo-embolic events must be continuously treated by anticoagulants (age > 65 years, history of stroke or TIA, diabetes, left atrial enlargement, congestive heart failure…).
Conclusion
Atrial fibrillation is characterized by frequent recurrences. Different strategies could be used to maintain sinus rhythm. Rate control is not inferior to rhythm control for the prevention of morbidity and mortality and may be an appropriate strategy in patients with numerous risk factors of recurrence and/or asymptomatic AF episodes. In other patients, especially young patients without structural heart disease and with symptomatic episodes of AF, rhythm control remains the first strategy.
Prof. J.Y. Le HeuzeyParis, FranceNucleus member of the Working Group on Arrythmias
Therapy for AF is often directed toward the maintenance of sinus rhythm obtained after a cardioversion or by antiarrhythmic agents. The objectives of this rhythm control strategy include relief of symptoms, better exercise tolerance, prevention of embolism and avoidance of cardiomyopathy which together lead to a better quality of life and better survival.
An accepted strategy is to control the ventricular response rate of AF with the depression of conduction across the AV node by pharmacological agents or ablation of the atrioventricular junction and pacemaker implantation. The rationale for using a rate-control strategy is that most symptoms in AF may be caused by an irregular ventricular rate which may be treated by rate-control drugs. Additionally, effective rate-control drugs may prevent tachycardia-induced cardiomyopathy and the adverse effects of drugs.
Strategy trials
Three recent randomized trials compared rhythm and rate control in atrial fibrillation.
In the PIAF trial (1), the two strategies yielded similar clinical results regarding symptoms but exercise tolerance was better in the rhythm-control group.
In the AFFIRM trial (2), 4060 patients with recurrent AF were randomized to one of the two strategies. In this study, there was no survival benefits with the rhythm-control strategy (mortality at 5 years, 23.8% versus 21.3% in the rhythm and rate control group, respectively, p=0.08). The number of hospitalizations [1374 (80.1%) versus 1220 (73.0%), p <0.001] and the proportion of adverse drug effects were greater in the rhythm-control group, especially prolongation of the QT interval, torsade de pointes and bradycardia.
The third randomized trial, Rate control vs electrical cardioversion for persistent atrial fibrillation, RACE (3), compared the two strategies in 522 patients with recurrent persistent AF. The primary end-point was a composite of death from cardiovascular causes, heart failure, bleeding, thrombo-embolic complications, implantation of a pacemaker, and severe adverse effects of drugs.
The primary end-point occurred in 17.2% of the patients in the rate-control group and in 22.6% of the patients in the rhythm-control group which represents a trend in favour of rate control.
These studies show that rate-control is not inferior to rhythm-control strategy and may be an appropriate first choice therapy in patients with recurrent AF. It must be emphasized that most of these studies included patients with structural heart diseases and risk factors of recurrence and thrombo-embolism. Their results cannot be extrapolated to other patients, especially the young patients without underlying cardiopathy.
Management strategies
Patients without symptoms who have experienced at least one cardioversion to restore sinus rhythm can remain in AF with rate-control therapy and prevention of thrombo-embolism.
For patients with disabling symptoms during AF, a drug limiting cardiac rate during the episode can be used. An anti-arrhythmic drug therapy is generally used to maintain the sinus rhythm after the termination of AF.
For patients without heart disease, the first-line therapy includes one of the following drugs : flecainide, propafanone, or sotalol. Second-line therapy includes amiodarone or dofetilide. Third-line therapy includes disopyramide, procainamide, quinidine and non-pharmacological options.
For adrenergic AF, beta-blockers and sotalol are the initial drugs of choice.
For patients experiencing heart failure, solely amiodarone can be used.
For patients with coronary artery disease, sotalol represents the initial drug. In case of recurrence, amiodarone can be used.
In case of hypertension, the choice of antiarrhythmic drugs depends on the importance of left ventricular hypertrophy (LVH). If LVH is <>
Antithrombotic strategies
It has been demonstrated for many years that anticoagulants might be used in permanent atrial fibrillation (AFASAK, BAATAF, SPAF, CAFA, SPINAF…). The AFFIRM trial has clearly demonstrated that this anticoagulation might be pursued in patients for whom the rhythm control strategy is chosen. Even if the sinus rhythm is restored, patients with high risk of thrombo-embolic events must be continuously treated by anticoagulants (age > 65 years, history of stroke or TIA, diabetes, left atrial enlargement, congestive heart failure…).
Conclusion
Atrial fibrillation is characterized by frequent recurrences. Different strategies could be used to maintain sinus rhythm. Rate control is not inferior to rhythm control for the prevention of morbidity and mortality and may be an appropriate strategy in patients with numerous risk factors of recurrence and/or asymptomatic AF episodes. In other patients, especially young patients without structural heart disease and with symptomatic episodes of AF, rhythm control remains the first strategy.
Thursday, September 6, 2007
Dronedarone for Maintenance of Sinus Rhythm in Atrial Fibrillation or Flutter
Dronedarone for Maintenance of Sinus Rhythm
in Atrial Fibrillation or Flutter
NEW ENGLAND JOURNAL OF MEDICINE
Volume 357 — September 6, 2007 — Number 10
Bramah N. Singh, M.D., D.Sc., Stuart J. Connolly, M.D., Harry J.G.M. Crijns, M.D., Denis Roy, M.D., Peter R. Kowey, M.D., Alessandro Capucci, M.D., Ph.D., David Radzik, M.D., Etienne M. Aliot, M.D., Stefan H. Hohnloser, M.D., for the EURIDIS and ADONIS Investigators
ABSTRACT
Background Amiodarone is effective in maintaining sinus rhythm in atrial fibrillation but is associated with potentially serious toxic effects. Dronedarone is a new antiarrhythmic agent pharmacologically related to amiodarone but developed to reduce the risk of side effects.
Methods In two identical multicenter, double-blind, randomized trials, one conducted in Europe (ClinicalTrials.gov number, NCT00259428 [ClinicalTrials.gov] ) and one conducted in the United States, Canada, Australia, South Africa, and Argentina (termed the non-European trial, NCT00259376 [ClinicalTrials.gov] ), we evaluated the efficacy of dronedarone, with 828 patients receiving 400 mg of the drug twice daily and 409 patients receiving placebo. Rhythm was monitored transtelephonically on days 2, 3, and 5; at 3, 5, 7, and 10 months; during recurrence of arrhythmia; and at nine scheduled visits during a 12-month period. The primary end point was the time to the first recurrence of atrial fibrillation or flutter.
Results In the European trial, the median times to the recurrence of arrhythmia were 41 days in the placebo group and 96 days in the dronedarone group (P=0.01). The corresponding durations in the non-European trial were 59 and 158 days (P=0.002). At the recurrence of arrhythmia in the European trial, the mean (±SD) ventricular rate was 117.5±29.1 beats per minute in the placebo group and 102.3±24.7 beats per minute in the dronedarone group (P<0.001); the corresponding rates in the non-European trial were 116.6±31.9 and 104.6±27.1 beats per minute (P<0.001). Rates of pulmonary toxic effects and of thyroid and liver dysfunction were not significantly increased in the dronedarone group.
Conclusions Dronedarone was significantly more effective than placebo in maintaining sinus rhythm and in reducing the ventricular rate during recurrence of arrhythmia.
LINK: http://content.nejm.org/cgi/content/short/357/10/987
Thursday, August 30, 2007
Warfarin Versus Aspirin for Stroke Prevention in an Elderly Community Population With Atrial Fibrillation
Title: Warfarin Versus Aspirin for Stroke Prevention in an Elderly Community Population With Atrial Fibrillation (the Birmingham Atrial Fibrillation Treatment of the Aged Study, BAFTA): A Randomised Controlled Trial
Topic: Arrhythmias
Date Posted: 8/28/2007
Author(s): Mant J, Hobbs FD, Fletcher K, et al.
Citation: Lancet. 2007;370:493-503.
Clinical Trial: Yes
Study Question: Does warfarin reduce the risk of major stroke, arterial embolism, or other intracranial hemorrhage, compared with aspirin in elderly patients with atrial fibrillation?
Methods: The authors report the results of the Birmingham Atrial Fibrillation Treatment of the Aged (BAFTA) study, a randomized, open-label trial of aspirin versus warfarin in subjects over age 75 with atrial fibrillation. Patients were excluded if they had increased risk for gastrointestinal bleeding, rheumatic heart disease, intracranial hemorrhage, blood pressure >180/110 mm Hg, or at prohibitive risk for bleeding with warfarin, in their physician’s judgment. Subjects were randomized to warfarin (target INR 2-3), or aspirin 75 mg daily, for a mean of 2.7 years’ follow-up. The primary outcome was fatal or nonfatal stroke, intracranial hemorrhage, or clinically significant arterial embolism. Secondary outcomes were major hemorrhage, other vascular events, and all-cause mortality.
Results: The authors report 973 subjects were randomized from April 2001 to November 2004, among whom there were 24 primary events in the warfarin group (21 strokes, two other intracranial hemorrhages, and one systemic embolus), and 48 events in the aspirin group (44 strokes, one other intracranial hemorrhage, and three systemic emboli), (relative risk, 0.48; 95% confidence interval, 0.28-0.80; p = 0.003). This resulted in a yearly risk for primary event of 1.8% and 3.8% in the two groups, respectively. The yearly risk of extracranial hemorrhage was 1.4% (warfarin) versus 1.6% (aspirin) (relative risk, 0.87; 0.43-1.73).
Conclusions: The authors concluded that the data support the use of warfarin in patients with atrial fibrillation over age 75, unless there are contraindications, or the patient refuses warfarin therapy.
Perspective: There is a common misconception that benefits of medical therapy are fixed, while risks associated with medical therapy vary. This fallacy has led to the belief that greater risk of bleeding with advancing age makes warfarin therapy in the elderly more risky. Forgotten is the fact that risk of thromboembolic stroke from atrial fibrillation also increases with age. This same phenomenon is seen in a number of other medical conditions. Our training to compare ‘risk versus benefits’ leads, I believe, to this error in thinking. Benefits are reported and thought of as fixed (e.g., ‘warfarin lowers risk of stroke in atrial fibrillation x%’), whereas risks of therapy are seen as relative to the patient’s condition, age, and other risk factors. This error of medical decision making is compounded by the exclusion of the elderly from clinical trials—leaving us without adequate data. Ideally, we should assess both the risk of therapy, as well as the risk of not taking therapy, on an individual basis for each patient, based on available data (a ‘risk vs. risk’ comparison, rather than ‘risk vs. benefit’). Clearly, more clinical trial data that include the elderly are crucial. And we should remember that if a treatment is effective, it is logically more effective in groups at higher risk from complications of disease, and that usually means the elderly
Topic: Arrhythmias
Date Posted: 8/28/2007
Author(s): Mant J, Hobbs FD, Fletcher K, et al.
Citation: Lancet. 2007;370:493-503.
Clinical Trial: Yes
Study Question: Does warfarin reduce the risk of major stroke, arterial embolism, or other intracranial hemorrhage, compared with aspirin in elderly patients with atrial fibrillation?
Methods: The authors report the results of the Birmingham Atrial Fibrillation Treatment of the Aged (BAFTA) study, a randomized, open-label trial of aspirin versus warfarin in subjects over age 75 with atrial fibrillation. Patients were excluded if they had increased risk for gastrointestinal bleeding, rheumatic heart disease, intracranial hemorrhage, blood pressure >180/110 mm Hg, or at prohibitive risk for bleeding with warfarin, in their physician’s judgment. Subjects were randomized to warfarin (target INR 2-3), or aspirin 75 mg daily, for a mean of 2.7 years’ follow-up. The primary outcome was fatal or nonfatal stroke, intracranial hemorrhage, or clinically significant arterial embolism. Secondary outcomes were major hemorrhage, other vascular events, and all-cause mortality.
Results: The authors report 973 subjects were randomized from April 2001 to November 2004, among whom there were 24 primary events in the warfarin group (21 strokes, two other intracranial hemorrhages, and one systemic embolus), and 48 events in the aspirin group (44 strokes, one other intracranial hemorrhage, and three systemic emboli), (relative risk, 0.48; 95% confidence interval, 0.28-0.80; p = 0.003). This resulted in a yearly risk for primary event of 1.8% and 3.8% in the two groups, respectively. The yearly risk of extracranial hemorrhage was 1.4% (warfarin) versus 1.6% (aspirin) (relative risk, 0.87; 0.43-1.73).
Conclusions: The authors concluded that the data support the use of warfarin in patients with atrial fibrillation over age 75, unless there are contraindications, or the patient refuses warfarin therapy.
Perspective: There is a common misconception that benefits of medical therapy are fixed, while risks associated with medical therapy vary. This fallacy has led to the belief that greater risk of bleeding with advancing age makes warfarin therapy in the elderly more risky. Forgotten is the fact that risk of thromboembolic stroke from atrial fibrillation also increases with age. This same phenomenon is seen in a number of other medical conditions. Our training to compare ‘risk versus benefits’ leads, I believe, to this error in thinking. Benefits are reported and thought of as fixed (e.g., ‘warfarin lowers risk of stroke in atrial fibrillation x%’), whereas risks of therapy are seen as relative to the patient’s condition, age, and other risk factors. This error of medical decision making is compounded by the exclusion of the elderly from clinical trials—leaving us without adequate data. Ideally, we should assess both the risk of therapy, as well as the risk of not taking therapy, on an individual basis for each patient, based on available data (a ‘risk vs. risk’ comparison, rather than ‘risk vs. benefit’). Clearly, more clinical trial data that include the elderly are crucial. And we should remember that if a treatment is effective, it is logically more effective in groups at higher risk from complications of disease, and that usually means the elderly
Wednesday, August 8, 2007
Warfarin: Prescribe with Care in the Elderly
Journal Watch CardiologyJune 13, 2007
Warfarin: Prescribe with Care in the Elderly
Mark S. Link, MD
Journal Watch. 2007;6(6) ©2007 Massachusetts Medical Society
In a real-world cohort of elderly patients, the hazards of warfarin therapy were found to be greater than previously reported.
Summary
Randomized controlled trials have shown that warfarin significantly reduces the risk for stroke in patients with atrial fibrillation. Therefore, warfarin has become a standard component of the armamentarium for patients with AF and a CHADS2 (congestive heart failure, hypertension, age ≥75, diabetes, previous stroke or transient ischemic attack) score of 1 or 2 (depending on individual patient characteristics) or higher. However, these trials have generally included few individuals older than 80, and the investigators may have preselected, whether by design or unintentionally, participants at a lower risk for bleeding during warfarin treatment. Recently, researchers at an anticoagulation clinic studied a real-world cohort of 472 patients (including 153 aged ≥ 80 years) who were taking warfarin. Prospectively tracked outcomes were major hemorrhage, time to discontinuation of warfarin, and physician-stated reason for warfarin termination.
Within 1 year, 26 patients experienced a major hemorrhage. Patients aged ≥80 years had a markedly increased risk for major hemorrhage (13.10 events per 100 person-years, vs. 4.75 per 100 person-years in patients aged <80>
Comment
Prevention of cerebrovascular accidents in elderly patients with AF is an important and laudable goal. Unfortunately, the hazards of prophylactic warfarin are heightened by advanced age, recent initiation, and higher INRs. Aspirin use, a predisposition to falls, and frailty are also likely to increase the risk for hemorrhage. An accompanying editorial emphasizes the difficulties of treating AF in the elderly and the apparent increase in major bleeding reported in recent trials. Careful analysis of the risks and benefits of anticoagulation is essential in managing such patients.
References:
Hylek EM et al. Major hemorrhage and tolerability of warfarin in the first year of therapy among elderly patients with atrial fibrillation. Circulation 2007 May 29; 115:2689-96.
Wyse DG. Bleeding while starting anticoagulation for thromboembolism prophylaxis in elderly patients with atrial fibrillation: From bad to worse. Circulation 2007 May 29; 115:2684-6.
Warfarin: Prescribe with Care in the Elderly
Mark S. Link, MD
Journal Watch. 2007;6(6) ©2007 Massachusetts Medical Society
In a real-world cohort of elderly patients, the hazards of warfarin therapy were found to be greater than previously reported.
Summary
Randomized controlled trials have shown that warfarin significantly reduces the risk for stroke in patients with atrial fibrillation. Therefore, warfarin has become a standard component of the armamentarium for patients with AF and a CHADS2 (congestive heart failure, hypertension, age ≥75, diabetes, previous stroke or transient ischemic attack) score of 1 or 2 (depending on individual patient characteristics) or higher. However, these trials have generally included few individuals older than 80, and the investigators may have preselected, whether by design or unintentionally, participants at a lower risk for bleeding during warfarin treatment. Recently, researchers at an anticoagulation clinic studied a real-world cohort of 472 patients (including 153 aged ≥ 80 years) who were taking warfarin. Prospectively tracked outcomes were major hemorrhage, time to discontinuation of warfarin, and physician-stated reason for warfarin termination.
Within 1 year, 26 patients experienced a major hemorrhage. Patients aged ≥80 years had a markedly increased risk for major hemorrhage (13.10 events per 100 person-years, vs. 4.75 per 100 person-years in patients aged <80>
Comment
Prevention of cerebrovascular accidents in elderly patients with AF is an important and laudable goal. Unfortunately, the hazards of prophylactic warfarin are heightened by advanced age, recent initiation, and higher INRs. Aspirin use, a predisposition to falls, and frailty are also likely to increase the risk for hemorrhage. An accompanying editorial emphasizes the difficulties of treating AF in the elderly and the apparent increase in major bleeding reported in recent trials. Careful analysis of the risks and benefits of anticoagulation is essential in managing such patients.
References:
Hylek EM et al. Major hemorrhage and tolerability of warfarin in the first year of therapy among elderly patients with atrial fibrillation. Circulation 2007 May 29; 115:2689-96.
Wyse DG. Bleeding while starting anticoagulation for thromboembolism prophylaxis in elderly patients with atrial fibrillation: From bad to worse. Circulation 2007 May 29; 115:2684-6.
Tuesday, August 7, 2007
Routine Pulse Checks Improve Detection of Atrial Fibrillation
Routine Pulse Checks Improve Detection of Atrial Fibrillation
Routine pulse checking in older patients can lead to a substantial increase in the detection of atrial fibrillation, a major risk factor for stroke, according to a study in the British Medical Journal.
The study, conducted in England on nearly 15,000 patients ages 65 and over, compared active screening for atrial fibrillation — in which practice nurses either measured the patients' radial pulses to determine the need for follow-up electrocardiography or simply offered all patients electrocardiography — versus routine care during office visits.
The annual detection rate of new cases was 1.63% during active screening, compared with 1.04% in control practices.
The detection rate for active screening was nearly identical regardless of whether patients were offered electrocardiography routinely or only if they had an irregular pulse.
The authors concluded that routine electrocardiography is unnecessary for finding atrial fibrillation "as long as healthcare professionals are conscientious about feeling the pulse."
Link: BMJ article (Free)
Published in Physician's First Watch August 6, 2007
Thursday, July 19, 2007
Oral anticoagulants versus antiplatelet therapy for preventing stroke in patients with non-valvular atrial fibrillation and no history of stroke or transient ischemic attacks
Cochrane Database of Systematic Reviews 2007 Issue 3 (Status: New) Copyright © 2007 The Cochrane Collaboration.
This version first published online: 18 July 2007 in Issue 3,
This record should be cited as: Aguilar MI, Hart R, Pearce LA.
Abstract
Background
Non-valvular atrial fibrillation (AF) carries an increased risk of stroke mediated by embolism of stasis-precipitated thrombi originating in the left atrial appendage. Both oral anticoagulants and antiplatelet agents have proven effective for stroke prevention in most patients at high risk for vascular events, but primary stroke prevention in patients with non-valvular AF potentially merits separate consideration because of the suspected cardio-embolic mechanism of most strokes in AF patients.
Objectives
To characterize the relative effect of long-term oral anticoagulant treatment compared with antiplatelet therapy on major vascular events in patients with non-valvular AF and no history of stroke or transient ischemic attack (TIA).
Search strategy
We searched the Cochrane Stroke Group Trials Register (June 2006). We also searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 2, 2006), MEDLINE (1966 to June 2006) and EMBASE (1980 to June 2006). We contacted the Atrial Fibrillation Collaboration and experts working in the field to identify unpublished and ongoing trials.
Selection criteria
All unconfounded, randomized trials in which long-term (more than four weeks) adjusted-dose oral anticoagulant treatment was compared with antiplatelet therapy in patients with chronic non-valvular AF.
Data collection and analysis
Two review authors independently selected trials for inclusion, assessed quality and extracted data. The Peto method was used for combining odds ratios after assessing for heterogeneity.
Main results
Eight randomized trials, including 9598 patients, tested adjusted-dose warfarin versus aspirin (in dosages ranging from 75 to 325 mg/day) in AF patients without prior stroke or TIA. The mean overall follow up was 1.9 years/participant. Oral anticoagulants were associated with lower risk of all stroke (odds ratio (OR) 0.68, 95% confidence interval (CI) 0.54 to 0.85), ischemic stroke (OR 0.53, 95% CI 0.41 to 0.68) and systemic emboli (OR 0.48, 95% CI 0.25 to 0.90). All disabling or fatal strokes (OR 0.71, 95% CI 0.59 to 1.04) and myocardial infarction (OR 0.69, 95% CI 0.47 to 1.01) were substantially but not significantly reduced by oral anticoagulants. Vascular death (OR 0.93, 95% CI 0.75 to 1.15) and all cause mortality (OR 0.99, 95% CI 0.83 to 1.18), were similar with these treatments. Intracranial hemorrhages (OR 1.98, 95% CI 1.20 to 3.28) were increased by oral anticoagulant therapy.
Authors' conclusions
Adjusted-dose warfarin and related oral anticoagulants reduce stroke, disabling stroke and other major vascular events for those with non-valvular AF by about one third when compared with antiplatelet therapy.
Plain language summary
Oral anticoagulants versus antiplatelet therapy for preventing stroke in patients with non-valvular atrial fibrillation and no history of stroke or transient ischemic attacksAtrial fibrillation (AF) is an irregularity of the heartbeat that leads to blood clots forming in the upper chambers of the heart (the atria). These clots can break free and travel through the bloodstream to the brain and cause a stroke. Drugs that slow clotting, such as oral anticoagulants (warfarin and other coumarin derivates) and antiplatelet agents (aspirin and others), reduce the risk of stroke in patients with atrial fibrillation. In this review of eight randomized trials, including 9598 patients, oral anticoagulants are shown to reduce the risk of stroke in patients with non-valvular AF and with no prior stroke or transient ischemic attack by one-third when compared with antiplatelet agents alone. Antiplatelet agents reduce stroke by about 20% in AF patients compared with no therapy, offering a less efficacious therapeutic option for those deemed not eligible for anticoagulation therapy. The threshold of absolute benefit that warrants anticoagulation remains controversial and depends on patient's preferences and availability of optimal anticoagulation monitoring.
Cochrane Database of Systematic Reviews 2007 Issue 3 (Status: New) Copyright © 2007 The Cochrane Collaboration.
This version first published online: 18 July 2007 in Issue 3,
This record should be cited as: Aguilar MI, Hart R, Pearce LA.
Abstract
Background
Non-valvular atrial fibrillation (AF) carries an increased risk of stroke mediated by embolism of stasis-precipitated thrombi originating in the left atrial appendage. Both oral anticoagulants and antiplatelet agents have proven effective for stroke prevention in most patients at high risk for vascular events, but primary stroke prevention in patients with non-valvular AF potentially merits separate consideration because of the suspected cardio-embolic mechanism of most strokes in AF patients.
Objectives
To characterize the relative effect of long-term oral anticoagulant treatment compared with antiplatelet therapy on major vascular events in patients with non-valvular AF and no history of stroke or transient ischemic attack (TIA).
Search strategy
We searched the Cochrane Stroke Group Trials Register (June 2006). We also searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 2, 2006), MEDLINE (1966 to June 2006) and EMBASE (1980 to June 2006). We contacted the Atrial Fibrillation Collaboration and experts working in the field to identify unpublished and ongoing trials.
Selection criteria
All unconfounded, randomized trials in which long-term (more than four weeks) adjusted-dose oral anticoagulant treatment was compared with antiplatelet therapy in patients with chronic non-valvular AF.
Data collection and analysis
Two review authors independently selected trials for inclusion, assessed quality and extracted data. The Peto method was used for combining odds ratios after assessing for heterogeneity.
Main results
Eight randomized trials, including 9598 patients, tested adjusted-dose warfarin versus aspirin (in dosages ranging from 75 to 325 mg/day) in AF patients without prior stroke or TIA. The mean overall follow up was 1.9 years/participant. Oral anticoagulants were associated with lower risk of all stroke (odds ratio (OR) 0.68, 95% confidence interval (CI) 0.54 to 0.85), ischemic stroke (OR 0.53, 95% CI 0.41 to 0.68) and systemic emboli (OR 0.48, 95% CI 0.25 to 0.90). All disabling or fatal strokes (OR 0.71, 95% CI 0.59 to 1.04) and myocardial infarction (OR 0.69, 95% CI 0.47 to 1.01) were substantially but not significantly reduced by oral anticoagulants. Vascular death (OR 0.93, 95% CI 0.75 to 1.15) and all cause mortality (OR 0.99, 95% CI 0.83 to 1.18), were similar with these treatments. Intracranial hemorrhages (OR 1.98, 95% CI 1.20 to 3.28) were increased by oral anticoagulant therapy.
Authors' conclusions
Adjusted-dose warfarin and related oral anticoagulants reduce stroke, disabling stroke and other major vascular events for those with non-valvular AF by about one third when compared with antiplatelet therapy.
Plain language summary
Oral anticoagulants versus antiplatelet therapy for preventing stroke in patients with non-valvular atrial fibrillation and no history of stroke or transient ischemic attacksAtrial fibrillation (AF) is an irregularity of the heartbeat that leads to blood clots forming in the upper chambers of the heart (the atria). These clots can break free and travel through the bloodstream to the brain and cause a stroke. Drugs that slow clotting, such as oral anticoagulants (warfarin and other coumarin derivates) and antiplatelet agents (aspirin and others), reduce the risk of stroke in patients with atrial fibrillation. In this review of eight randomized trials, including 9598 patients, oral anticoagulants are shown to reduce the risk of stroke in patients with non-valvular AF and with no prior stroke or transient ischemic attack by one-third when compared with antiplatelet agents alone. Antiplatelet agents reduce stroke by about 20% in AF patients compared with no therapy, offering a less efficacious therapeutic option for those deemed not eligible for anticoagulation therapy. The threshold of absolute benefit that warrants anticoagulation remains controversial and depends on patient's preferences and availability of optimal anticoagulation monitoring.
Wednesday, July 11, 2007
Atrial Fibrilation / Atrial Ablation / Debate
Medical News Today News Article
Debate Over Atrial Ablation Highlights Challenges Posed By Costly Experimental Procedures
11 Jul 2007
An experimental treatment for atrial fibrillation known as ablation, which costs between $25,000 and $50,000, "stands out as another potentially budget-straining medical commitment" for health care payers including the federal government, the New York Times reports. Medicare and private insurers spend billions of dollars per year to treat atrial fibrillation -- which affects at least 2.2 million U.S. residents -- primarily on hospitalizations, tests and off-label prescription drugs.
Atrial ablation involves neutralizing portions of the heart muscle that are the sources of abnormal electrical pulses that set off irregular heart beats. The original atrial ablation procedure included the use of surgical tools, but most of the procedures now are minimally invasive and involve the burning or freezing of heart muscle. Because the procedure has not been approved by FDA, doctors either use experimental equipment or equipment that has been approved for other uses.
Doctors and hospitals can bill Medicare or private insurers using codes for "somewhat similar" procedures, but they say the reimbursements "usually fall far short of full compensation for atrial ablation, which can take four hours or more to perform and requires an overnight stay at the hospital," the Times reports. As a result, the procedures usually are performed at teaching hospitals and other centers where doctors are paid a salary, as well as by some specialty practices.
Debate Over Merits
Advocates for the procedure say that it is more cost-effective over the long run than prescription drugs and improves patient outcomes, but some regulators and doctors say that clinical trials examining the procedure were poorly designed, that the "cure" rate touted by supporters possibly is being exaggerated and that the risks are being minimized. Full-scale clinical trials have not yet demonstrated long-term benefits of minimally invasive atrial ablation, although less-rigorous studies have produced promising results.
Daniel Schultz, head of FDA's Center for Devices and Radiological Health, said, "This is one of those areas where the practice of medicine has moved faster than the approval process," adding, "This is very high on our list of areas that need concerted attention." Schultz said that FDA soon will schedule a public meeting to discuss drugs and devices that are used off-label as treatments for atrial fibrillation.
Carolyn Clancy, director of the Agency for Healthcare Research and Quality, said that any situation where off-label therapies become widespread "spotlights where we lack good evidence of which patients can benefit from which therapies." Clancy said that gathering information on atrial fibrillation is particularly challenging because the severity of the condition varies greatly among patients, most of whom also have other conditions that affect the risks and benefits of competing procedures.
The American Heart Association, the American College of Cardiology and four other major U.S. and European doctors' groups last month recommended that atrial ablation become the standard treatment for patients who do not respond to drugs (Feder [1], New York Times, 7/7).
Additional Coverage
The Times on Saturday also examined how doctors once viewed atrial fibrillation as "relatively benign" but have come to recognize that the condition "allows blood to pool in the atria and form clots, which in turn may explain why such patients are prone to strokes and heart attacks" (Feder [2], New York Times, 7/7).
Another Times article profiles the history of treatments for atrial fibrillation (Feder [3], New York Times, 7/7).
The Times also published FAQ about the condition (New York Times, 7/7).
"Reprinted with permission from http://www.kaisernetwork.org/. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy.
The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Article URL: http://www.medicalnewstoday.com/medicalnews.php?newsid=76326
Debate Over Atrial Ablation Highlights Challenges Posed By Costly Experimental Procedures
11 Jul 2007
An experimental treatment for atrial fibrillation known as ablation, which costs between $25,000 and $50,000, "stands out as another potentially budget-straining medical commitment" for health care payers including the federal government, the New York Times reports. Medicare and private insurers spend billions of dollars per year to treat atrial fibrillation -- which affects at least 2.2 million U.S. residents -- primarily on hospitalizations, tests and off-label prescription drugs.
Atrial ablation involves neutralizing portions of the heart muscle that are the sources of abnormal electrical pulses that set off irregular heart beats. The original atrial ablation procedure included the use of surgical tools, but most of the procedures now are minimally invasive and involve the burning or freezing of heart muscle. Because the procedure has not been approved by FDA, doctors either use experimental equipment or equipment that has been approved for other uses.
Doctors and hospitals can bill Medicare or private insurers using codes for "somewhat similar" procedures, but they say the reimbursements "usually fall far short of full compensation for atrial ablation, which can take four hours or more to perform and requires an overnight stay at the hospital," the Times reports. As a result, the procedures usually are performed at teaching hospitals and other centers where doctors are paid a salary, as well as by some specialty practices.
Debate Over Merits
Advocates for the procedure say that it is more cost-effective over the long run than prescription drugs and improves patient outcomes, but some regulators and doctors say that clinical trials examining the procedure were poorly designed, that the "cure" rate touted by supporters possibly is being exaggerated and that the risks are being minimized. Full-scale clinical trials have not yet demonstrated long-term benefits of minimally invasive atrial ablation, although less-rigorous studies have produced promising results.
Daniel Schultz, head of FDA's Center for Devices and Radiological Health, said, "This is one of those areas where the practice of medicine has moved faster than the approval process," adding, "This is very high on our list of areas that need concerted attention." Schultz said that FDA soon will schedule a public meeting to discuss drugs and devices that are used off-label as treatments for atrial fibrillation.
Carolyn Clancy, director of the Agency for Healthcare Research and Quality, said that any situation where off-label therapies become widespread "spotlights where we lack good evidence of which patients can benefit from which therapies." Clancy said that gathering information on atrial fibrillation is particularly challenging because the severity of the condition varies greatly among patients, most of whom also have other conditions that affect the risks and benefits of competing procedures.
The American Heart Association, the American College of Cardiology and four other major U.S. and European doctors' groups last month recommended that atrial ablation become the standard treatment for patients who do not respond to drugs (Feder [1], New York Times, 7/7).
Additional Coverage
The Times on Saturday also examined how doctors once viewed atrial fibrillation as "relatively benign" but have come to recognize that the condition "allows blood to pool in the atria and form clots, which in turn may explain why such patients are prone to strokes and heart attacks" (Feder [2], New York Times, 7/7).
Another Times article profiles the history of treatments for atrial fibrillation (Feder [3], New York Times, 7/7).
The Times also published FAQ about the condition (New York Times, 7/7).
"Reprinted with permission from http://www.kaisernetwork.org/. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy.
The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Article URL: http://www.medicalnewstoday.com/medicalnews.php?newsid=76326
Tuesday, July 10, 2007
New York Times takes a look at uncertainties in catheter ablation of atrial fibrillation
New York Times takes a look at uncertainties in catheter ablation of atrial fibrillation
July 9, 2007
Michael O'Riordan
New York, NY - Catheter ablation of atrial fibrillation is in the national spotlight this week as a new report in the New York Times (NYT) highlights the rapid growth of the procedure and its associated costs [1]. With limited long-term clinical data and the use of equipment in an off-label manner, coupled with the expected increase in the prevalence of AF as the population ages, the newspaper says catheter ablation is testing "the ability of regulators to keep up with medical treatments being carried out with scant evidence of long-term effectiveness."
Written by Barnaby Feder, the article, which appeared in the July 7, 2007 issue of the NYT, notes that the FDA has not yet approved the devices used in the catheter ablation of AF, and with this, hospital and doctors struggle to be fully reimbursed for the procedure. "This is one of those areas where the practice of medicine has moved faster than the approval process," Dr Daniel G Schultz (Food and Drug Administration, Rockville, MD) told the NYT. "This is very high on our list of areas that need concerted attention."
Dr Carolyn Clancy, director of the Agency for Healthcare Research and Quality, noted that any situation where off-label therapies are used as frequently as they are in AF "spotlights where we lack good evidence of which patients can benefit from which therapies." Although such off-label use is legal, doctors and hospitals often run into roadblocks with reimbursement (payments fall short of full compensation), and insurance companies are sometimes reluctant to cover it, mainly because healthcare providers might have less legal protection should something go wrong, writes Feder.
In addition, although clinical trials have shown ablation to be effective in eliminating AF in the short term, long-term evidence is scant, Feder writes. Still, despite what's missing, a consensus statement, developed by the Heart Rhythm Society, the European Heart Rhythm Association (EHRA), and the European Cardiac Arrhythmia Society (ECAS), in collaboration with the American College of Cardiology, the American Heart Association, and the Society of Thoracic Surgeons, has been drafted to standardize the procedure and define patient indications [2].
Feder reports that estimates of the potential market for AF devices in the next decade range from $1.5 to $5 billion, with projections including the cost of various diagnostic and mapping technologies. The number of ablation procedures would surge if the time needed could be reduced and insurance coverage were easier to obtain, he adds. Even with the uncertainties, many electrophysiologists are not hurting for work. Dr Andrea Natale (Cleveland Clinic, OH) told the NYT that he is booked into 2008 and there is a waiting list of four to six months for other electrophysiologists working at the hospital.
The report goes on to highlight the drawbacks of drug therapy for AF, with Dr Mark Connolly telling the paper that the "medications to control it are nasty drugs. Many patients don't tolerate them well, especially if they are active."
Sources
Feder BJ. Heart therapy strains efforts to limit costs. New York Times, July 7, 2007. Available at http://www.theheart.org/viewDocument.do?document=http%3A%2F%2Fwww.nytimes.com.
Calkins H, Brugada J, Packer DL, et al. HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: Recommendations for personnel, policy, procedures, and follow-up. Heart Rhythm Society 2007. Available at www.hrsonline.org/News/Media/press-releases/upload/HR-and-Euro-Copy-for-Print.pdf.
Related links
Heart rhythm societies develop consensus statement on catheter and surgical ablation of AF [HeartWire > News; May 10, 2007]
Late symptomatic recurrence observed in AF patients "cured" with pulmonary-vein isolation [HeartWire > News; Nov 23, 2006]
ACC/AHA/ESC updates guidelines for AF management [HeartWire > News; Aug 04, 2006]
Ablation superior to drug therapy in patients who have already failed one antiarrhythmic drug [HeartWire > News; May 22, 2006]
Ablation better than drug therapy for restoring sinus rhythm in paroxysmal AF patients [HeartWire > News; Mar 12, 2006]
Experts say time has come for AF ablation RCTs: "Only thing missing is the data" [HeartWire > Features; Sep 01, 2005]
New York Times takes a look at uncertainties in catheter ablation of atrial fibrillation
July 9, 2007
Michael O'Riordan
New York, NY - Catheter ablation of atrial fibrillation is in the national spotlight this week as a new report in the New York Times (NYT) highlights the rapid growth of the procedure and its associated costs [1]. With limited long-term clinical data and the use of equipment in an off-label manner, coupled with the expected increase in the prevalence of AF as the population ages, the newspaper says catheter ablation is testing "the ability of regulators to keep up with medical treatments being carried out with scant evidence of long-term effectiveness."
Written by Barnaby Feder, the article, which appeared in the July 7, 2007 issue of the NYT, notes that the FDA has not yet approved the devices used in the catheter ablation of AF, and with this, hospital and doctors struggle to be fully reimbursed for the procedure. "This is one of those areas where the practice of medicine has moved faster than the approval process," Dr Daniel G Schultz (Food and Drug Administration, Rockville, MD) told the NYT. "This is very high on our list of areas that need concerted attention."
Dr Carolyn Clancy, director of the Agency for Healthcare Research and Quality, noted that any situation where off-label therapies are used as frequently as they are in AF "spotlights where we lack good evidence of which patients can benefit from which therapies." Although such off-label use is legal, doctors and hospitals often run into roadblocks with reimbursement (payments fall short of full compensation), and insurance companies are sometimes reluctant to cover it, mainly because healthcare providers might have less legal protection should something go wrong, writes Feder.
In addition, although clinical trials have shown ablation to be effective in eliminating AF in the short term, long-term evidence is scant, Feder writes. Still, despite what's missing, a consensus statement, developed by the Heart Rhythm Society, the European Heart Rhythm Association (EHRA), and the European Cardiac Arrhythmia Society (ECAS), in collaboration with the American College of Cardiology, the American Heart Association, and the Society of Thoracic Surgeons, has been drafted to standardize the procedure and define patient indications [2].
Feder reports that estimates of the potential market for AF devices in the next decade range from $1.5 to $5 billion, with projections including the cost of various diagnostic and mapping technologies. The number of ablation procedures would surge if the time needed could be reduced and insurance coverage were easier to obtain, he adds. Even with the uncertainties, many electrophysiologists are not hurting for work. Dr Andrea Natale (Cleveland Clinic, OH) told the NYT that he is booked into 2008 and there is a waiting list of four to six months for other electrophysiologists working at the hospital.
The report goes on to highlight the drawbacks of drug therapy for AF, with Dr Mark Connolly telling the paper that the "medications to control it are nasty drugs. Many patients don't tolerate them well, especially if they are active."
Sources
Feder BJ. Heart therapy strains efforts to limit costs. New York Times, July 7, 2007. Available at http://www.theheart.org/viewDocument.do?document=http%3A%2F%2Fwww.nytimes.com.
Calkins H, Brugada J, Packer DL, et al. HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: Recommendations for personnel, policy, procedures, and follow-up. Heart Rhythm Society 2007. Available at www.hrsonline.org/News/Media/press-releases/upload/HR-and-Euro-Copy-for-Print.pdf.
Related links
Heart rhythm societies develop consensus statement on catheter and surgical ablation of AF [HeartWire > News; May 10, 2007]
Late symptomatic recurrence observed in AF patients "cured" with pulmonary-vein isolation [HeartWire > News; Nov 23, 2006]
ACC/AHA/ESC updates guidelines for AF management [HeartWire > News; Aug 04, 2006]
Ablation superior to drug therapy in patients who have already failed one antiarrhythmic drug [HeartWire > News; May 22, 2006]
Ablation better than drug therapy for restoring sinus rhythm in paroxysmal AF patients [HeartWire > News; Mar 12, 2006]
Experts say time has come for AF ablation RCTs: "Only thing missing is the data" [HeartWire > Features; Sep 01, 2005]
New York Times takes a look at uncertainties in catheter ablation of atrial fibrillation
Thursday, May 31, 2007
BAFTA: Warfarin bests aspirin for stroke prevention in elderly AF patients
BAFTA: Warfarin bests aspirin for stroke prevention in elderly AF patients
Glasgow, Scotland - Results of the Birmingham Atrial Fibrillation Treatment of the Aged (BAFTA) trial show that even among elderly patients with atrial fibrillation (AF), anticoagulation with warfarin was superior to aspirin for primary stroke prevention [1].
The benefit of treatment was not at the cost of more major hemorrhage, the rates of which were similar between groups. The results were presented here at the 16th European Stroke Conference.
"Use of anticoagulation rather than aspirin in over-75s in our study will prevent one primary event for every 50 patients treated for a year, or 25 treated for two years," Dr Jonathan W Mant (University of Birmingham, UK) told attendees here. "Our conclusion is that warfarin could be safely used much more widely in the elderly than it is at the moment, and age itself should not be regarded as a contraindication to warfarin therapy."
Glasgow, Scotland - Results of the Birmingham Atrial Fibrillation Treatment of the Aged (BAFTA) trial show that even among elderly patients with atrial fibrillation (AF), anticoagulation with warfarin was superior to aspirin for primary stroke prevention [1].
The benefit of treatment was not at the cost of more major hemorrhage, the rates of which were similar between groups. The results were presented here at the 16th European Stroke Conference.
"Use of anticoagulation rather than aspirin in over-75s in our study will prevent one primary event for every 50 patients treated for a year, or 25 treated for two years," Dr Jonathan W Mant (University of Birmingham, UK) told attendees here. "Our conclusion is that warfarin could be safely used much more widely in the elderly than it is at the moment, and age itself should not be regarded as a contraindication to warfarin therapy."
Sunday, May 20, 2007
ACC/AHA/ESC 2006 Guidelines for the Management of Patients With Atrial Fibrillation
This article has been copublished in the August 15, 2006, issues of Circulation and the Journal of the American College of Cardiology and the August 16, 2006, issue of the European Heart Journal.
ACC/AHA/ESC 2006 Guidelines for the Management of Patients With Atrial Fibrillation—Executive Summary
A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation)
LINK:
http://content.onlinejacc.org/cgi/content/full/48/4/854
OR:
American Family Physician
May 15, 2007 Vol. 75 No. 10
Practice Guidelines
Joint Guideline Released for Atrial Fibrillation
LINK:
http://www.aafp.org/afp/20070515/practice.html
ACC/AHA/ESC 2006 Guidelines for the Management of Patients With Atrial Fibrillation—Executive Summary
A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation)
LINK:
http://content.onlinejacc.org/cgi/content/full/48/4/854
OR:
American Family Physician
May 15, 2007 Vol. 75 No. 10
Practice Guidelines
Joint Guideline Released for Atrial Fibrillation
LINK:
http://www.aafp.org/afp/20070515/practice.html
Thursday, May 17, 2007
The Ottawa Aggressive Protocol for ED Management of Acute Atrial Fibrillation
Acad Emerg Med Volume 14, 5 Supplement 1 9,
The Ottawa Aggressive Protocol for ED Management of Acute Atrial Fibrillation
Ian Stiell, Catherine Clement, Garth Dickinson, Cheryl Symington, Jeffrey Perry and Christian Vaillancourt
University of Ottawa
Objectives
There is no consensus as to the optimal emergency department (ED) management of acute atrial fibrillation (AAF) or atrial flutter (AAFL). Our objective was to examine the efficacy and safety of the Ottawa Aggressive Protocol to convert and discharge ED patients with AAF/AAFL.
Methods
This 5-year cohort study included consecutive visits to a university hospital ED for adults presenting with acute-onset AAF/AAFL and who were managed with the Ottawa Aggressive Protocol. Patients were identified from the National Ambulatory Care Reporting System (NACRS) database. The Aggressive Protocol was overseen by the attending emergency physicians and included: (1) IV procainamide as infusion of 1 gram over 1 hour; (2) electrical cardioversion if necessary, by ED staff; (3) discharge from the ED with outpatient cardiology follow-up. Outcomes included conversion, adverse events, and relapse. The authors conducted descriptive data analyses with 95% CIs.
Results
Characteristics of the 660 eligible patient visits were mean age 64.5 years, mean heart rate 113.4, and mean duration symptoms 8.9 hours, AAF 95.2%, AAFL 4.9%. Overall, 96.8% of patients were discharged home from the ED and 90.3% were discharged in normal sinus rhythm. The respective discharge rates were 97.0% and 93.5% for those in AAF and 93.8% and 87.5% for those in AAFL. All patients received procainamide with a conversion rate of 58.3% (AAF 59.9%, AAFL 28.1%). Electrical cardioversion was attempted in 36.8% of visits with a success rate of 91.7% (AAF 91.0%, AAFL 100%). Adverse events occurred in 7.6% of cases: hypotension 6.7%, bradycardia 0.3%, AAF relapse within 7 days 8.6%, Torsades de Pointes 0%, cerebrovascular accident 0%, mortality 0%.
COMMENTARIES:
Acute atrial fibrillation managed in emergency department
17 May 2007
MedWire News: Over 90% of patients with acute atrial fibrillation (AAF) or atrial flutter (AAFL) can be discharged from the emergency department (ED) with a normal heart rhythm using the Ottawa Aggressive Protocol, a study from Canada shows.
The protocol involves an IV procainamide infusion of 1 g over 1 hour, electrical cardioversion if necessary, by ED staff, and discharge from the ED with outpatient cardiology follow-up. This contrasts with current practice in the USA, for example, where patients with AAF and AAFL are admitted to hospital and treated by cardiologists. Ian Stiell and colleagues from the University of Ottawa in Ontario studied the efficacy and safety of the Ottawa protocol in 660 consecutive patients, whose mean age was 64.5 years, mean heart rate 113.4 beats per minute, and mean duration of symptoms 8.9 hours. AAF was present in 95.2% and AAFL in 4.9%.
Overall, 96.8% of patients were discharged home from the ED and 90.3% were discharged with normal sinus rhythm. The corresponding discharge rates for patients in AAF and AAFL were 97.0% and 93.5%, and 93.8% and 87.5%.
All patients received procainamide with a conversion rate of 58.3% (AAF 59.9%, AAFL 28.1%) and electrical cardioversion was attempted in 36.8% patients, which was successful in 91.7% (AAF 91.0%, AAFL 100%).
Adverse events occurred in 7.6% of cases: hypotension in 6.7%, bradycardia in 0.3%, and AAF relapse within 7 days in 0.6%.
“This is the largest reported study of AAF/AAFL in the ED and demonstrates that the Ottawa Aggressive Protocol is extremely effective for the rapid cardioversion and discharge of patients by ED physicians,” said Stiell.
“This protocol is safe and could lead to a significant decrease in hospital admissions.”
The researchers presented their results at the annual meeting of the Society for Academic Emergency Medicine, held in Chicago, Illinois, USA.
Society for Academic Emergency Medicine Annual Meeting; Chicago, Illinois, USA: 16-19 May, 2007
The Ottawa Aggressive Protocol for ED Management of Acute Atrial Fibrillation
Ian Stiell, Catherine Clement, Garth Dickinson, Cheryl Symington, Jeffrey Perry and Christian Vaillancourt
University of Ottawa
Objectives
There is no consensus as to the optimal emergency department (ED) management of acute atrial fibrillation (AAF) or atrial flutter (AAFL). Our objective was to examine the efficacy and safety of the Ottawa Aggressive Protocol to convert and discharge ED patients with AAF/AAFL.
Methods
This 5-year cohort study included consecutive visits to a university hospital ED for adults presenting with acute-onset AAF/AAFL and who were managed with the Ottawa Aggressive Protocol. Patients were identified from the National Ambulatory Care Reporting System (NACRS) database. The Aggressive Protocol was overseen by the attending emergency physicians and included: (1) IV procainamide as infusion of 1 gram over 1 hour; (2) electrical cardioversion if necessary, by ED staff; (3) discharge from the ED with outpatient cardiology follow-up. Outcomes included conversion, adverse events, and relapse. The authors conducted descriptive data analyses with 95% CIs.
Results
Characteristics of the 660 eligible patient visits were mean age 64.5 years, mean heart rate 113.4, and mean duration symptoms 8.9 hours, AAF 95.2%, AAFL 4.9%. Overall, 96.8% of patients were discharged home from the ED and 90.3% were discharged in normal sinus rhythm. The respective discharge rates were 97.0% and 93.5% for those in AAF and 93.8% and 87.5% for those in AAFL. All patients received procainamide with a conversion rate of 58.3% (AAF 59.9%, AAFL 28.1%). Electrical cardioversion was attempted in 36.8% of visits with a success rate of 91.7% (AAF 91.0%, AAFL 100%). Adverse events occurred in 7.6% of cases: hypotension 6.7%, bradycardia 0.3%, AAF relapse within 7 days 8.6%, Torsades de Pointes 0%, cerebrovascular accident 0%, mortality 0%.
COMMENTARIES:
Acute atrial fibrillation managed in emergency department
17 May 2007
MedWire News: Over 90% of patients with acute atrial fibrillation (AAF) or atrial flutter (AAFL) can be discharged from the emergency department (ED) with a normal heart rhythm using the Ottawa Aggressive Protocol, a study from Canada shows.
The protocol involves an IV procainamide infusion of 1 g over 1 hour, electrical cardioversion if necessary, by ED staff, and discharge from the ED with outpatient cardiology follow-up. This contrasts with current practice in the USA, for example, where patients with AAF and AAFL are admitted to hospital and treated by cardiologists. Ian Stiell and colleagues from the University of Ottawa in Ontario studied the efficacy and safety of the Ottawa protocol in 660 consecutive patients, whose mean age was 64.5 years, mean heart rate 113.4 beats per minute, and mean duration of symptoms 8.9 hours. AAF was present in 95.2% and AAFL in 4.9%.
Overall, 96.8% of patients were discharged home from the ED and 90.3% were discharged with normal sinus rhythm. The corresponding discharge rates for patients in AAF and AAFL were 97.0% and 93.5%, and 93.8% and 87.5%.
All patients received procainamide with a conversion rate of 58.3% (AAF 59.9%, AAFL 28.1%) and electrical cardioversion was attempted in 36.8% patients, which was successful in 91.7% (AAF 91.0%, AAFL 100%).
Adverse events occurred in 7.6% of cases: hypotension in 6.7%, bradycardia in 0.3%, and AAF relapse within 7 days in 0.6%.
“This is the largest reported study of AAF/AAFL in the ED and demonstrates that the Ottawa Aggressive Protocol is extremely effective for the rapid cardioversion and discharge of patients by ED physicians,” said Stiell.
“This protocol is safe and could lead to a significant decrease in hospital admissions.”
The researchers presented their results at the annual meeting of the Society for Academic Emergency Medicine, held in Chicago, Illinois, USA.
Society for Academic Emergency Medicine Annual Meeting; Chicago, Illinois, USA: 16-19 May, 2007
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