Sana M. Al-Khatib

Pulmonary Vein Isolation for the Maintenance of Sinus Rhythm in Patients with Atrial Fibrillation: a Meta-Analysis of Randomized Controlled Trials

Background—Catheter ablation is an established yet evolving nonpharmacologic intervention for the maintenance of sinus rhythm in patients with atrial fibrillation (AF). The efficacy and safety of pulmonary vein isolation (PVI) compared with medical therapy remain in question. Methods and Results—We conducted a meta-analysis of all randomized, controlled trials comparing PVI and medical therapy for the maintenance of sinus rhythm. The primary end point in this analysis was freedom from recurrent AF at 12 months. The relative efficacy of PVI was estimated using random-effects modeling according to intention to treat. We identified 6 trials that randomized a total of 693 patients with AF to PVI or control. PVI was associated with markedly increased odds of freedom from AF at 12 months of follow-up (n=266/344 [77%] versus n=102/346 [29%]; odds ratio, 9.74; 95% CI, 3.98 to 23.87). When we excluded the trial that only enrolled patients with persistent AF (Q-statistic, 2.485; P=0.647 after exclusion), PVI was associated with even greater odds of AF-free survival (15.78; 95% CI, 10.07 to 24.73). PVI was associated with a decreased hospitalization for cardiovascular causes (14 versus 93 per 100 person-years; rate ratio, 0.15; 95% CI, 0.10 to 0.23). Among those randomly assigned to PVI, 17% required a repeat PVI ablation before 12 months. The rate of major complications was 2.6% (n=9/344) in the catheter ablation group. Conclusions—Compared with a nonablation treatment strategy, PVI results in dramatically increased freedom from AF at 1 year. Although the procedure can be associated with major complications, the risk of these complications is comparable to other interventional procedures.

Cost-Effectiveness of Defibrillator Therapy or Amiodarone in Chronic Stable Heart Failure: Results From the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT)

Background— In the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), implantable cardioverter-defibrillator (ICD) therapy significantly reduced all-cause mortality rates compared with medical therapy alone in patients with stable, moderately symptomatic heart failure, whereas amiodarone had no benefit on mortality rates. We examined long-term economic implications of these results. Methods and Results— Medical costs were estimated by using hospital billing data and the Medicare Fee Schedule. Our base case cost-effectiveness analysis used empirical clinical and cost data to estimate the lifetime incremental cost of saving an extra life-year with ICD therapy relative to medical therapy alone. At 5 years, the amiodarone arm had a survival rate equivalent to that of the placebo arm and higher costs than the placebo arm. For ICD relative to medical therapy alone, the base case lifetime cost-effectiveness and cost-utility ratios (discounted at 3%) were

Combined Heart Failure Device Diagnostics Identify Patients at Higher Risk of Subsequent Heart Failure Hospitalizations: Results From PARTNERS HF (Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure) Study

38 389 per life-year saved (LYS) and

Non-Evidence-Based ICD Implantations in the United States

41 530 per quality-adjusted LYS, respectively. A cost-effectiveness ratio <

Prescription of QT-prolonging drugs in a cohort of about 5 million outpatients

100 000 was obtained in 99% of 1000 bootstrap repetitions. The cost-effectiveness ratio was sensitive to the amount of extrapolation beyond the empirical 5-year trial data:

2015 ACC/AHA/HRS Guideline for the Management of Adult Patients With Supraventricular Tachycardia: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society.

127 503 per LYS at 5 years,

Efficacy and Safety of Apixaban Compared With Warfarin at Different Levels of Predicted International Normalized Ratio Control for Stroke Prevention in Atrial Fibrillation

88 657 per LYS at 8 years, and

Review of the Registry's Fourth Year, Incorporating Lead Data and Pediatric ICD Procedures, and Use as a National Performance Measure

58 510 per LYS at 12 years. Because of a significant interaction between ICD treatment and New York Heart Association class, the cost-effectiveness ratio was

Chronic kidney disease is associated with increased risk of sudden cardiac death among patients with coronary artery disease

29 872 per LYS for class II, whereas there was incremental cost but no incremental benefit in class III. Conclusions— Prophylactic use of single-lead, shock-only ICD therapy is economically attractive in patients with stable, moderately symptomatic heart failure with an ejection fraction ≤35%, particularly those in NYHA class II, as long as the benefits of ICD therapy observed in the SCD-HeFT persist for at least 8 years.

Efficacy and Safety of Apixaban Compared with Warfarin at Different Levels of Predicted INR Control for Stroke Prevention in Atrial Fibrillation

OBJECTIVES We sought to determine the utility of combined heart failure (HF) device diagnostic information to predict clinical deterioration of HF in patients with systolic left ventricular dysfunction. BACKGROUND Some implantable devices continuously monitor HF device diagnostic information, but data are limited on the ability of combined HF device diagnostics to predict HF events. METHODS The PARTNERS HF (Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure) was a prospective, multicenter observational study in patients receiving cardiac resynchronization therapy (CRT) implantable cardioverter-defibrillators. HF events were independently adjudicated. A combined HF device diagnostic algorithm was developed on an independent dataset. The algorithm was considered positive if a patient had 2 of the following abnormal criteria during a 1-month period: long atrial fibrillation duration, rapid ventricular rate during atrial fibrillation, high (> or =60) fluid index, low patient activity, abnormal autonomics (high night heart rate or low heart rate variability), or notable device therapy (low CRT pacing or implantable cardioverter-defibrillator shocks), or if they only had a very high (> or =100) fluid index. We used univariate and multivariable analyses to determine predictors of subsequent HF events within a month. RESULTS We analyzed data from 694 CRT defibrillator patients who were followed for 11.7 +/- 2 months. Ninety patients had 141 adjudicated HF hospitalizations with pulmonary congestion at least 60 days after implantation. Patients with a positive combined HF device diagnostics had a 5.5-fold increased risk of HF hospitalization with pulmonary signs or symptoms within the next month (hazard ratio: 5.5, 95% confidence interval: 3.4 to 8.8, p < 0.0001), and the risk remained high after adjusting for clinical variables (hazard ratio: 4.8, 95% confidence interval: 2.9 to 8.1, p < 0.0001). CONCLUSIONS Monthly review of HF device diagnostic data identifies patients at a higher risk of HF hospitalizations within the subsequent month. (PARTNERS HF: Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure; NCT00279955).