Assessment of sex-related differences and outcome in patients who underwent cryoballoon pulmonary vein isolation for atrial fibrillation:an observational cohort study

OBJECTIVES: Pulmonary vein isolation (PVI) is widely accepted as an effective and safe treatment for symptomatic atrial fibrillation (AF). However, data on sex-related differences and associations with clinical outcome and safety of PVI with cryoballoon ablation are limited. We sought to compare sexrelated efficacy and safety of cryoballoon ablation and identify sex-related associations with clinical outcomes. METHODS AND RESULTS: We included 650 consecutive patients with AF undergoing PVI with cryoballoon ablation at our institution between 2013 and 2017. The efficacy outcome was the first documented recurrence (>30 s) of AF, atrial flutter or atrial tachycardia (AF/AT) or repeat ablation during follow-up, after a 90-day blanking period. The safety outcome was the incidence of periprocedural complications. Mean age of the population was 58±10, and 210 (32.3%) patients were women. Women were older, had a higher body mass index, had more renal dysfunction and less coronary artery disease as compared with men. The rate of AF/AT recurrence was similar between women and men at 12-month follow-up (27.6% vs 24.8%, p=0.445). The incidence of periprocedural complications was higher in women (12.9% vs 4.6%; p<0.001), specifically groin haematomas and phrenic nerve palsy. On multivariate analysis, left atrial volume index (adjusted OR 1.05, 95% CI 1.00 to 1.10; p=0.032) was associated with the incidence of procedural complications in women. For men, no relation with complications could be found. CONCLUSION: The efficacy of cryoballoon ablation was similar between women and men; however, women had a higher risk of procedural complications

Identifying patients with atrial fibrillation recurrences after two pulmonary vein isolation procedures

INTRODUCTION: Pulmonary vein isolation (PVI) is an important treatment for atrial fibrillation (AF). However, many patients need more than one procedure to maintain long-term sinus rhythm. Even after two PVIs some may suffer from AF recurrences. We aimed to identify characteristics of patients who fail after two PVI procedures. METHODS AND RESULTS: We included 557 consecutive patients undergoing a first PVI procedure with a second-generation 28 mm cryoballoon. Follow-up procedures were performed using radiofrequency ablation targeting reconnected PVs only. Recurrent AF was defined as any episode of AF lasting >30 s on ECG or 24 hour Holter monitoring performed at 3, 6 and 12 months post procedure. Mean age was 59.1±10.2 years, 383 (68.8%) were male, 448 (80.4%) had paroxysmal AF and the most common underlying condition was hypertension (36.6%). A total of 140/557 (25.1%) patients underwent redo procedure with PVI only. Of these patients 45 (32.4%) had recurrence of AF. These patients were comparable regarding age and sex to those in sinus rhythm after one or two procedures. Multivariate logistic regression showed that non-paroxysmal AF (OR 1.08 (95% CI 1.01 to 1.15), estimated glomerular filtration rate (OR 0.96, 95% CI 0.94 to 0.99), bundle branch block (OR 4.17, 95% CI 1.38 to 12.58), heart failure (OR 4.17, 95% CI 1.38 to 12.58) and Left Atrium Volume Index (OR 1.04, 95% CI 1.01 to 1.08) were associated with AF recurrence after two PVIs. The area under the curve for the identified risk factors was 0.74. CONCLUSIONS: Using a PVI-only approach, recurrence of AF after two AF ablation procedures is associated with more advanced underlying disease and persistent types of AF

Anemia and mortality in heart failure patients - A systematic review and meta-analysis

Objectives The aim of this study was to assess the effect of anemia on mortality in chronic heart failure (CHF). Background Anemia is frequently observed in patients with CHF, and evidence suggests that anemia might be associated with an increased mortality. Methods A systematic literature search in MEDLINE ( through November 2007) for English language articles was performed. In addition, a manual search was performed. We included cohort studies and retrospective secondary analyses of randomized controlled trials whose primary objective was to analyze the association between anemia and mortality in CHF. Of a total of 1,327 initial studies, we included 34 studies, comprising 153,180 patients. Information on study design, patient characteristics, outcome, and potential confounders were extracted. Results Anemia was defined by criteria used in the original articles. Of the 153,180 CHF patients, 37.2% were anemic. After a minimal follow-up of 6 months, 46.8% of anemic patients died compared with 29.5% of nonanemic patients. Crude mortality risk of anemia was odds ratio 1.96 (95% confidence interval: 1.74 to 2.21, p <0.001). Lower baseline hemoglobin values were associated with increased crude mortality rates (r = -0.396, p = 0.025). Adjusted hazard ratios showed an increased adjusted risk for anemia (hazard ratio 1.46 [95% confidence interval: 1.26 to 1.69, p <0.001]). Subgroup analysis showed no significant difference between mortality risk of anemia in diastolic or systolic CHF. Conclusions Anemia is associated with an increased risk of mortality in both systolic and diastolic CHF. Anemia should, therefore, be considered as a useful prognosticator, and therapeutic strategies aimed to increase hemoglobin levels in CHF should be investigated

Sex-related differences in risk factors, outcome, and quality of life in patients with permanent atrial fibrillation:results from the RACE II study

AIMS: Atrial fibrillation (AF) risk factors translate into disease progression. Whether this affects women and men differently is unclear. We aimed to investigate sex differences in risk factors, outcome, and quality of life (QoL) in permanent AF patients. METHODS AND RESULTS: The Rate Control Efficacy in Permanent Atrial Fibrillation (RACE II) randomized 614 patients, 211 women and 403 men, to lenient or strict rate control. In this post hoc analysis risk factors, cardiovascular events during 3-year follow-up (cardiovascular death, heart failure hospitalization, stroke, systemic embolism, bleeding, and life-threatening arrhythmic events), outcome parameters, and QoL were compared between the sexes. Women were older (71 ± 7 vs. 66 ± 8 years, P < 0.001), had more hypertension (70 vs. 57%, P = 0.002), and heart failure with preserved ejection fraction (36 vs. 17%, P < 0.001), but less coronary artery disease (13 vs. 21%, P = 0.02). Women had more risk factors (3.7 ± 1.2 vs. 2.9 ± 1.4, P < 0.001) Cardiovascular events occurred in 46 (22%) women and 59 (15%) men (P = 0.03). Women had a 1.52 times [95% confidence interval (CI) 1.03-2.24] higher yearly cardiovascular event-rate [8.2% (6.0-10.9) vs. 5.4% (4.1-6.9), P = 0.03], but this was no longer significant after adjusting for the number of underlying risk factors. Women had reduced QoL, irrespective of age and heart rate but negatively influenced by their risk factors. CONCLUSION: In this permanent AF population, women had more accumulation of AF risk factors than men. The observed higher cardiovascular event rate in women was no longer significant after adjusting for the number of risk factors. Further, QoL was negatively influenced by the higher number of risk factors in women. This suggests that sex differences may be driven by the greater risk factor burden in women

Does intensity of rate control influence outcome in persistent atrial fibrillation?:Data of the RACE study

Background Large trials have demonstrated that rate control is an acceptable alternative for rhythm control. However, optimal heart rate during atrial fibrillation (AF) remains unknown. Aim of this analysis was to compare outcome between rate control >= 80 and Methods In the RAte Control versus Electrical cardioversion for persistent atrial fibrillation study, 522 patients were included, and 256 were randomized to rate control. This post hoc analysis included patients randomized to rate control. Patients were divided according to their mean resting heart rate during follow-up, = 80 beat/min (n = 139). The end point, a composite of cardiovascular mortality, heart failure, thromboembolic complications, bleeding, pacemaker implantation, and severe drug side effects, was compared between both groups. Results During follow-up (2.3 +/- 0.6 years), a significant difference between both groups in heart rate was observed (72 +/- 5 vs 90 +/- 8 beat/min; P <.001). Rate control drugs were not significantly different between both groups. New York Heart Association class and fractional shortening remained unchanged in both groups. There were 17 (23%) end points in the low heart rate group and 24 (17%) in the higher heart rate group (absolute difference, 5.4 [-7.3 to 8.2]; P = ns). Independent predictors for the primary end point were coronary artery disease, digoxin use, and interrupted anticoagulation, not high heart rate. Quality of life was comparable in both groups during follow-up. Conclusions In patients treated with a rate control strategy, no differences were observed in terms of cardiovascular morbidity, mortality, and quality of life between the observed differences in level of rate control throughout follow-up. (Am Heart J 2009;158:785-91.

Rate Control Efficacy in Permanent Atrial Fibrillation:Successful and Failed Strict Rate Control Against a Background of Lenient Rate Control

<p>Objectives This study sought to investigate differences in outcome between patients treated with successful strict, failed strict, and lenient rate control.</p><p>Background The RACE II (Rate Control Efficacy in Permanent Atrial Fibrillation) study showed no difference in outcome between lenient and strict rate control in patients with permanent atrial fibrillation (AF). However, in the strict group not all patients achieved the pre-defined heart rate target.</p><p>Methods The primary outcome was a composite of cardiovascular morbidity and mortality. For the current analysis outcome events were analyzed from end of the dose-adjustment phase until end of follow-up (median 2.9 years [interquartile range: 2.4 to 3.0 years]). Of 614 patients, 608 completed the dose-adjustment phase-301 in the strict (resting heart rate</p><p>Results Heart rate was different after the dose-adjustment phase between the successful strict (72 +/- 7 beats/min), failed strict (86 +/- 14 beats/min), and lenient (93 +/- 8 beats/min) group (p <0.001) and remained significantly different during follow-up. The primary outcome was reached in 27 of 203 (14.2% KM estimate) in the successful strict versus 14 of 98 (15%) in the failed strict versus 35 of 307 (12.1%) in the lenient group (p = 0.5). The components of the primary outcome and quality of life were similar in the groups.</p><p>Conclusions In patients with permanent AF, successful strict rate control does not improve outcome. Therefore, lenient rate control might be frontline therapy. (J Am Coll Cardiol 2013;61:741-8) (C) 2013 by the American College of Cardiology Foundation</p>