Procedure characteristics and outcomes of atrial fibrillation ablation procedures using cryoballoon versus radiofrequency ablation: A report from the GWTG-AFIB registry.

INTRODUCTION: Cryoballoon ablation (CBA) is an alternative to radiofrequency ablation (RFA) for ablation of atrial fibrillation (AF) and real-world comparisons of this strategy are lacking. As such, we sought to compare patient and periprocedural characteristics and outcomes of CBA versus RFA in the Get With the Guidelines AFIB Registry. METHODS: Categorical variables were compared via the χ2 test and continuous variables were compared via the Wilcoxon rank-sum test. Adjusted analyses were performed using overlap weighting of propensity scores. RESULTS: A total of 5247 (1465 CBA, 3782 RFA) ablation procedures were reported from 33 sites. Those undergoing CBA more often had paroxysmal AF (60.0% vs. 48.8%) and no prior AF ablation (87.5% vs. 73.8%). CHA2 DS2 -VASc scores were similar. Among de novo ablations, most ablations involved intracardiac echocardiography and electroanatomic mapping, but both were less common with CBA (87.3% vs. 93.9%, p < .0001, and 87.7% vs. 94.6%, p < .0001, respectively). CBA was associated with shorter procedures (129 vs. 179 min, p < .0001), increased fluoroscopy use (19 vs. 11 min, p < .0001), and similar ablation times (27 vs. 35 min, p = .15). Nonpulmonary vein ablation was common with CBA: roof line 38.6%, floor line 20.4%, cavotricuspid isthmus 27.7%. RFA was associated with more total complications compared to CBA (5.4% vs. 2.3%, p < .0001), due to more volume overload and "other" events, although phrenic nerve injury was more common with CBA (0.9% vs 0.1%, p = .0001). In the adjusted model, any complication was less common among CBA cases (odds ratio, 0.45; confidence interval, 0.25-0.79, p = .0056). CONCLUSION: CBA was associated with fewer complications, and shorter procedure times, and greater fluoroscopy times, compared to RFA. Nonpulmonary vein ablation and electroanatomic mapping system use was common with CBA.

Procedural Patterns and Safety of Atrial Fibrillation Ablation: Findings From Get With The Guidelines-Atrial Fibrillation.

BACKGROUND: Catheter ablation is an increasingly used treatment for symptomatic atrial fibrillation (AF). However, there are limited prospective, nationwide data on patient selection and procedural characteristics. This study describes patient characteristics, techniques, treatment patterns, and safety outcomes of patients undergoing AF ablation. METHODS: A total of 3139 patients undergoing AF ablation between 2016 and 2018 in the Get With The Guidelines-Atrial Fibrillation registry from 24 US centers were included. Patient demographics, medical history, procedural details, and complications were abstracted. Differences between paroxysmal and patients with persistent AF were compared using Pearson χ2 and Wilcoxon rank-sum tests. RESULTS: Patients undergoing AF ablation were predominantly male (63.9%) and White (93.2%) with a median age of 65. Hypertension was the most common comorbidity (67.6%), and patients with persistent AF had more comorbidities than patients with paroxysmal AF. Drug refractory, paroxysmal AF was the most common ablation indication (class I, 53.6%) followed by drug refractory, persistent AF (class I, 41.8%). Radiofrequency ablation with contact force sensing was the most common ablation modality (70.5%); 23.7% of patients underwent cryoballoon ablation. Pulmonary vein isolation was performed in 94.6% of de novo ablations; the most common adjunctive lesions included left atrial roof or posterior/inferior lines, and cavotricuspid isthmus ablation. Complications were uncommon (5.1%) and were life-threatening in 0.7% of cases. CONCLUSIONS: More than 98% of AF ablations among participating sites are performed for class I or class IIA indications. Contact force-guided radiofrequency ablation is the dominant technique and pulmonary vein isolation the principal lesion set. In-hospital complications are uncommon and rarely life-threatening.

Development of an international standard set of outcome measures for patients with atrial fibrillation: a report of the International Consortium for Health Outcomes Measurement (ICHOM) atrial fibrillation working group.

AIMS: As health systems around the world increasingly look to measure and improve the value of care that they provide to patients, being able to measure the outcomes that matter most to patients is vital. To support the shift towards value-based health care in atrial fibrillation (AF), the International Consortium for Health Outcomes Measurement (ICHOM) assembled an international Working Group (WG) of 30 volunteers, including health professionals and patient representatives to develop a standardized minimum set of outcomes for benchmarking care delivery in clinical settings. METHODS AND RESULTS: Using an online-modified Delphi process, outcomes important to patients and health professionals were selected and categorized into (i) long-term consequences of disease outcomes, (ii) complications of treatment outcomes, and (iii) patient-reported outcomes. The WG identified demographic and clinical variables for use as case-mix risk adjusters. These included baseline demographics, comorbidities, cognitive function, date of diagnosis, disease duration, medications prescribed and AF procedures, as well as smoking, body mass index (BMI), alcohol intake, and physical activity. Where appropriate, and for ease of implementation, standardization of outcomes and case-mix variables was achieved using ICD codes. The standard set underwent an open review process in which over 80% of patients surveyed agreed with the outcomes captured by the standard set. CONCLUSION: Implementation of these consensus recommendations could help institutions to monitor, compare and improve the quality and delivery of chronic AF care. Their consistent definition and collection, using ICD codes where applicable, could also broaden the implementation of more patient-centric clinical outcomes research in AF.

Stiff left atrial syndrome after catheter ablation for atrial fibrillation: clinical characterization, prevalence, and predictors.

BACKGROUND: There have been no studies of atrial diastolic function after catheter ablation of atrial fibrillation (AF). We encountered a few patients with symptomatic left atrial (LA) diastolic dysfunction and associated pulmonary hypertension (PH) that developed after catheter ablation for atrial fibrillation. Similar findings were described in patients after cardiac surgery and were referred to as the "stiff left atrial syndrome." OBJECTIVE: The purpose of this study was to prospectively quantify the incidence of patients developing PH associated with diastolic hemodynamic abnormalities of the LA after radiofrequency ablation of AF and to identify the possible predictors. METHODS: Between January 2009 and July 2010, data on 1,380 consecutive patients were prospectively collected. Before ablation and at follow-up, all patients had an echocardiogram to assess for the presence of PH. Patients with no echocardiographic evidence of PH but complaining of unexplained dyspnea with LA diastolic abnormalities were evaluated with right heart catheterization (RHC). Patients were included in the analysis if they developed new or worsening PH postablation with evidence of LA diastolic dysfunction by RHC or direct LA pressure measurement. All patients were evaluated for pulmonary vein stenosis and excluded if this condition was identified. RESULTS: The mean age was 62 ± 11 (75% male), and nonparoxysmal AF was the predominant arrhythmia (71%). New or worsening PH with associated LA diastolic abnormalities was detected in 19 (1.4%) patients after ablation. The prevalence of PH did not differ between AF types (P = .612). Compared with patients who did not develop PH, LA scarring (P <.001), diabetes (P = .026), and obstructive sleep apnea (OSA; P = .006) were more frequently observed among those who developed PH. In a multivariable logistic model, preprocedure LA size ≤45 mm (odds ratio [OR] = 6.13; P = .033), mean LA pressure (OR 1.14; P = .025), severe LA scarring (OR = 4.4; P = .046), diabetes mellitus (OR = 9.5; P = .004), and OSA (OR = 6.2; P = .009) were independently associated with the development of PH postablation. CONCLUSIONS: After radiofrequency catheter ablation of atrial fibrillation (RFCAF), PH with LA diastolic dysfunction or the so-called stiff LA syndrome is a rare but potentially significant complication of AF ablation. Severe LA scarring, LA ≤45 mm, diabetes mellitus, OSA, and high LA pressure are clinical variables that predict the development of this syndrome. The main clinical findings include dyspnea, congestive heart failure, PH, and large V waves on pulmonary capillary wedge pressure (PCWP) or LA pressure tracings in the absence of mitral regurgitation.

Trends in the use of evidence-based treatments for coronary artery disease among women and the elderly: findings from the get with the guidelines quality-improvement program.

BACKGROUND: Significant disparities have been reported in the application of evidence-based guidelines in the treatment of coronary artery disease (CAD) in women and the elderly. We hypothesized that participation in a quality-improvement program could improve care for all patients and thus narrow treatment gaps over time. METHODS AND RESULTS: Treatment of 237 225 patients hospitalized with CAD was evaluated in the Get With the Guidelines-CAD program from 2002 to 2007. Six quality measures were evaluated in eligible patients without contraindications: aspirin on admission and discharge, beta-blockers use at discharge, angiotensin-converting enzyme inhibitor or angiotensin receptor antagonist use, lipid-lowering medication use, and tobacco cessation counseling along with other care metrics. Over time, composite adherence on these 6 measures increased from 86.5% to 97.4% (+10.9%) in men and 84.8% to 96.2% (+11.4%) in women. There was a slight difference in composite adherence by sex that remained significant over time (P<0.0001), but this was confined to patients <75 years. Composite adherence in younger patients (<75 years) increased from 87.1% to 97.7% (+10.6%) and from 83.0% to 95.1% (+12.1%) in the elderly (>or=75 years) over time. CONCLUSIONS: Among hospitals participating in Get With the Guidelines-CAD, guideline adherence has improved substantially over time for both women and men and younger and older CAD patients, with only slight age and sex differences in some measures persisting.

Withdrawing implantable defibrillator shock therapy in terminally ill patients.

PURPOSE: The purpose of this study is to review a multidisciplinary strategy used to identify patients with terminal illnesses and initiate withdrawal of implantable cardioverter defibrillator (ICD) shock therapy as part of a comprehensive comfort care approach. With indications for ICDs increasing, more patients are receiving devices. Once protected from an arrhythmic death, these patients may develop other terminal diseases such as cancer or congestive heart failure. It is appropriate to withdraw defibrillator shock therapy when such patients desire only comfort care. METHODS: The charts of ICD patients who had died were reviewed. Two groups emerged: Group 1 (20) included patients whose defibrillator was turned off through the comprehensive comfort care approach. Group 2 (43) included patients whose clinical course was so rapid that the defibrillator was not turned off. Pacing therapy was not withdrawn in either group. RESULTS: Defibrillator discharges, cause of death, and time from ICD discharge to death were compared. Group 2 patients died more acutely than Group 1. Group 1 experienced fewer shocks prior to death when compared to Group 2. Comparing pacemaker dependent and non-dependent patients, there was no difference in the time between therapy discontinuation and death. CONCLUSION: This is the largest study to date to review the characteristics of patients with ICDs and terminal illness. Only one-third of terminally ill patients with ICDs were able to have shock therapy withdrawn as part of a comfort care strategy. These patients experienced fewer shocks in the final days of their illness.