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Pericardial bleeding is a rare but life-threatening complication of atrial fibrillation (AF) ablation. Patients taking uninterrupted oral anticoagulation (AC) may be at increased risk for refractory bleeding despite pericardiocentesis and administration of protamine. In such cases, andexanet alfa can be given to reverse rivaroxaban or apixaban. In this study, we aim to describe the rate of acute hemostasis and thromboembolic complications with andexanet for refractory pericardial bleeding during AF ablation.In this multicenter, case series, participating centers identified patients who received a dose of apixaban or rivaroxaban within 24 hours of AF ablation, developed refractory pericardial bleeding during the procedure despite pericardiocentesis and administration of protamine and received andexanet. Eleven patients met inclusion criteria, with mean age of 73.5 ± 5.3 years and median CHAIn patients on uninterrupted apixaban or rivaroxaban, who develop refractory pericardial bleeding during AF ablation, andexanet can achieve hemostasis thereby avoiding the need for emergent surgery. However, there is a risk of thromboembolism following administration. This article is protected by copyright. All rights reserved.

Advanced heart failure (HF) therapies improve survival in patients with stage D HF. We sought to evaluate differences by race/ethnicity and sex in advanced HF therapy referrals and decision-making across a multicenter survey. We performed a retrospective analysis of patients referred for evaluation for advanced HF therapies at 9 centers (n = 515) across the United States. The median age was 58 years, and 73% were male. White patients comprised 55.7% of referrals, whereas non-White patients comprised 44.3%. Non-ischemic etiology was more common in non-White patients (66.6% vs 47.4% p = 0.0005), and ischemic etiology was more common in men (37.8% vs 20.4% p = 0.0005). The primary reason for referral differed by race/ethnicity but not sex, with ventricular arrhythmias (7.6% vs 3%, p = 0.024) and pulmonary hypertension (3.4% vs 0.4% p = 0.018) being more common in White patients, whereas worsening HF was less common (25.4% vs 35.9%; p = 0.009). White patients were offered left ventricular assist devices (LVADs) (60.3% vs 54.7 p = 0.039) and heart transplants (51.8% vs 33.1% p = 0.0007) more often than non-White patients. The preference not to pursue LVAD therapy was more common in non-White patients (17.6% vs 9.6%; p = 0.049). Men were more often declined for a heart transplant because of psychosocial contraindications (34% vs 15%, p = 0.005). In conclusion, in this multicenter analysis of referrals for advanced HF therapies, we observed significant differences by race, ethnicity, and sex in both referral characteristics and evaluation outcomes. Further investigation is warranted to better understand why rates of LVAD and transplantation may be lower in non-White patients who are referred for advanced therapies.

Background Therapies for advanced heart failure (AHF) improve the likelihood of survival in a growing population of patients with stage D heart failure (HF). Successful implementation of these therapies is dependent upon timely and appropriate referrals to AHF centers. Methods We performed a retrospective analysis of patients referred to 9 AHF centers for evaluation for AHF therapies. Patients’ demographics, referring providers’ characteristics, referral circumstances, and evaluation outcomes were collected. Results The majority of referrals (n = 515) were male (73.4%), and a majority of those were in the advanced state of the disease: very low left ventricular ejection fraction ( Conclusions In this multicenter review of AHF referrals, HF cardiologists referred the most patients despite being a relatively small proportion of the overall clinician population. Late referral was prevalent in this high-risk patient population and correlates with worsened outcomes, suggesting a significant need for broad clinician education regarding the benefits, triggers and appropriate timing of referral to AHF centers for optimal patient outcomes.

Purpose Catheter ablation has become a mainstay therapy for atrial fibrillation (AF) with rapid innovation over the past decade. Variability in ablation techniques may impact efficiency, safety, and efficacy; and the ideal strategy is unknown. Real-world evidence assessing the impact of procedural variations across multiple operators may provide insight into these questions. The Real-world Experience of Catheter Ablation for the Treatment of Symptomatic Paroxysmal (PAF) and Persistent (PsAF) Atrial Fibrillation registry (Real-AF) is a multicenter prospective registry that will enroll patients at high volume centers, including academic institutions and private practices, with operators performing ablations primarily with low fluoroscopy when possible. The study will also evaluate the contribution of advent in technologies and workflows to real-world clinical outcomes. Methods Patients presenting at participating centers are screened for enrollment. Data are collected at the time of procedure, 10–12 weeks, and 12 months post procedure and include patient and detailed procedural characteristics, with short and long-term outcomes. Arrhythmia recurrences are monitored through standard of care practice which includes continuous rhythm monitoring at 6 and 12 months, event monitors as needed for routine care or symptoms suggestive of recurrence, EKG performed at every visit, and interrogation of implanted device or ILR when applicable. Results Enrollment began in January 2018 with a single site. Additional sites began enrollment in October 2019. Through May 2021, 1,243 patients underwent 1,269 procedures at 13 institutions. Our goal is to enroll 4000 patients. Discussion Real-AF’s multiple data sources and detailed procedural information, emphasis on high volume operators, inclusion of low fluoroscopy operators, and use of rigorous standardized follow-up methodology allow systematic documentation of clinical outcomes associated with changes in ablation workflow and technologies over time. Timely data sharing may enable real-time quality improvements in patient care and delivery. Trial registration Clinicaltrials.gov: NCT04088071 (registration date: September 12, 2019) Supplementary Information The online version contains supplementary material available at 10.1007/s10840-021-01031-w.

Objectives The objective of this study was to describe the risk of cardiac implantable electronic devices (CIEDs) complications in patients with left ventricular assist devices (LVADs). Background Patients with LVADs are predisposed to ventricular arrhythmias and frequently have CIEDs before receiving their LVAD. However, the role of CIED procedures such as generator changes (GC) are unclear in this population, given the potential complications of bleeding and infection. Methods This was a retrospective, multicenter study from January 1, 2012, to September 30, 2018. All patients with LVADs were screened and those who had a CIED GC, implantation, or revision were included in the study and followed until December 31, 2018. Results A total of 179 patients across 6 centers had a CIED procedure after LVAD implantation. The mean age was 59.5 ± 13.4, with the cohort comprising mostly men (78%), destination LVAD therapy (53.8%), and GC (66%). The 30-day primary composite endpoint of hematoma or device infection occurred in 34 (19%) patients. The secondary endpoints of rehospitalization within 30 days and appropriate device therapy during follow-up occurred in 40 (22%) and 42 (24%) patients respectively. Of the 126 patients without previous device therapy, 14.3% received appropriate therapy during follow-up. Conclusions In this large, multicenter cohort, we report the incidence of complications for CIED procedures in the LVAD population; specifically, LVAD patients are at increased risk of pocket hematomas, without downstream risk of infection, and do experience a high rate of appropriate device therapies.

In this document, we outline the challenges faced by patients and clinicians in heart failure, specifically centered around the needed coordination of care among the various subspecialties within cardiovascular medicine. We call for a more organized and collaborative effort among clinicians in primary care, general cardiology, electrophysiology, interventional cardiology, cardiothoracic surgery, cardiac imaging, and heart failure—all caring for mutual patients. Care is contextualized within the framework of two phases: a cardiomyopathy phase and an advanced heart failure phase, each of which lends to different considerations in therapy. Ultimately multidisciplinary coordinated care within cardiovascular medicine may lead to greater patient and clinician satisfaction as well as improved outcomes, but this remains to be investigated.

Introduction The utility of accelerometer‐based activity data to identify patients at risk of sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) has not previously been investigated. The aim of the current study was to determine whether physical activity is associated with manifesting spontaneous sustained VT/VF requiring emergent defibrillation in patients with an ejection fraction of ≤35%. Methods Patients consecutively prescribed a wearable cardioverter defibrillator (WCD) from April 2015 to May 2018 were included. Shock data and 4 weeks of physical activity data, beginning with the first week of WCD wear, were analyzed. Results Based on the ROC curve outcome generated from 4057 patients, average daily step count during the first week accurately predicted those patients with sustained VT/VF compared to those without (shocked (n = 81) vs nonshocked (n = 3976) area under the curve, c‐index = 0.71, 95% CI = 0.65‐0.77, P

Background: Significant pulmonary hypertension [PH] is often considered a contraindication for closure of atrial septal defects [ASD]. Treatment of pulmonary arterial hypertension [PAH] with selective pulmonary vasodilators can allow for surgical repair of ASD otherwise considered prohibitive. We describe our experience in the assessment and treatment of adults with ASD and PAH with pulmonary vasodilator therapy who underwent successful surgical repair. Methods: Retrospective case series of patients with atrial level shunts and significant PAH who met clinical criteria for repair. Clinical and demographic data were collected through review of the electronic medical records. Echocardiographic data were analyzed by a single cardiologist. Results: Four patients with ASD and PAH were identified. All four patients experienced a decrease in pulmonary vascular resistance and increase in shunt fraction with institution of PH-directed therapy. Each underwent successful surgical repair with improvements in six-minute walk distance, right ventricular systolic function, and natriuretic peptide levels. All patients remained improved and stable on PH medications at last follow-up. Conclusion: With appropriate selection and application of therapy, patients with atrial level shunts and severe PAH can successfully undergo surgical closure following medical treatment of their pulmonary arterial hypertension.

This study sought to characterize septal substrate in patients with nonischemic left ventricular cardiomyopathy (NILVCM) undergoing ventricular tachycardia (VT) ablation.The interventricular septum is an important site of VT substrate in NILVCM.The authors studied 95 patients with NILVCM and VT. Electroanatomic mapping using standard bipolar (1.5 mV) and unipolar (8.3 mV) low-voltage criteria identified septal scar location and size. Analysis of unipolar voltage was performed and scars quantified using graded unipolar cutoffs from 4 to 8.3 mV were correlated with delayed gadolinium-enhanced cardiac magnetic resonance (DE-CMR), performed in 57 patients.Detailed LV endocardial mapping (mean 262 ± 138 points) showed septal bipolar and unipolar voltage abnormalities (VAs) in 44 (46%) and 79 (83%) patients, most commonly with basal anteroseptal involvement. Of the 59 patients in whom the septum was targeted, bipolar and unipolar septal VAs were seen in 36 (61%) and 54 (92%). Of the 35 with CMR-defined septal scar, bipolar and unipolar septal VAs were seen in 18 (51%) and 31 (89%). In 12 patients without CMR septal scar, 6 (50%) had isolated unipolar septal VAs on electroanatomic mapping, a subset of whom the septum was targeted for ablation (44%). In the graded unipolar analysis, the optimal cutoff associated with magnetic resonance imaging septal scar was 4.8 mV (sensitivity 75%, specificity 70%; area under the curve: 0.75; 95% confidence interval: 0.60 to 0.90).Septal substrate by unipolar or bipolar voltage mapping in patients with NILVCM and VT is common. A unipolar voltage cutoff of 4.8 mV provides the best correlation with DE-CMR. A subset of patients with septal VT had normal DE-CMR or endocardial bipolar voltage with abnormal unipolar voltage.

Wearable cardioverter-defibrillators (WCDs) protect patients from sudden cardiac death (SCD) by detecting and treating life-threatening ventricular tachycardia/fibrillation (VT/VF). Recently, two large studies evaluating WCDs were published. However, the results of older and newer studies have yet to be systematically summarized. The objective of the current study was to conduct a meta-analysis assessing the use and effectiveness of WCDs. We searched MEDLINE and Scopus (January 1998-July 2017) as well as the gray literature. We included registry/observational studies that (1) evaluated adult patients using WCDs; (2) provided data on one or more outcomes of interest; and (3) were full-text studies published in English. We calculated pooled incidence and/or rate [with 95% confidence intervals (CIs)] estimates from nonoverlapping populations using a random-effects meta-analysis model. Statistical heterogeneity was assessed via the I2 statistic. We identified 11 studies (19,882 patients) with nonoverlapping populations/endpoints; seven of them evaluated WCD use across various indications, while the remaining studies restricted their focus to a single indication. Most of the studies were retrospective (82%) and multicenter (64%) in nature, with 45% using manufacturers' registry data. The median duration of WCD use was three or more months in nine (82%) studies, and daily wear time ranged from a mean/median of 17 hours to 24 hours per day across included studies. Seven (64%) studies reported a mean/median daily wear time of more than 20 hours. This meta-analysis showed that the incidences of all-cause and SCD-related mortality among WCD patients were 1.4% (95% CI: 0.7%-2.4%) and 0.2% (95% CI: 0.1%-0.3%), respectively. VT/VF occurred in 2.6% (95% CI: 1.8%-3.5%) of patients. Across patients, 1.7% (95% CI: 1.4%-2.0%) received appropriate WCD treatment, corresponding to a rate of 9.1 patients/100 person-years (95% CI: 6.2-11.9 patients/100 person-years). Successful VT/VF termination following appropriate treatment occurred in 95.5% of patients (95% CI: 92.0%-98.0%) and the incidence of inappropriate treatment was infrequent (0.9%; 95% CI: 0.5%-1.4%). A moderate-to-high degree of statistical heterogeneity was observed in pooled analyses of mortality, VT/VF occurrence, and appropriate/inappropriate treatment (I2 ≥ 41% for all). In conclusion, WCDs appear to be successful in terms of terminating VT/VF in patients with an elevated risk of SCD and are appropriate for use while long-term risk management strategies are being identified.

AIM To examine whether wearable cardioverter defibrillator (WCD) alarms for asystole improve patient outcomes and survival. METHODS All asystole episodes recorded by the WCD in 2013 were retrospectively analyzed from a database of device and medical record documentation and customer call reports. Events were classified as asystole episodes if initial presenting arrhythmia was asystole (< 10 beats/minor ≥ 5 s pause). Survival was defined as recovery at the scene or arrival to a medical facility alive, or not requiring immediate medical attention. Episodes occurring in hospitals, nursing homes, or ambulances were considered to be under medical care. Serious asystole episodes were defined as resulting in unconsciousness, hospital transfer, or death. RESULTS Of the total 51933 patients having worn the WCD in 2013, there were 257 patients (0.5%) who had asystole episodes and comprised the study cohort. Among the 257 patients (74% male, median age 69 years), there were 264 asystole episodes. Overall patient survival was 42%. Most asystoles were considered “serious” (n = 201 in 201 patients, 76%), with a 26% survival rate. All 56 patients with “non-serious” asystole episodes survived. Being under medical care was associated with worse survival of serious asystoles. Among acute survivors, 20% later died during WCD use (a median 4 days post asystole episode). Of the 86 living patients at the end of WCD use period, 48 (56%) received ICD/pacemaker and 17 (20%) improved their condition. CONCLUSION Survival rates after asystole in patients with WCD are higher than historically reported survival rates. Those under medical care at time of asystole exhibited lower survival.

Objectives This study was conceived to determine the safety and efficacy of the subcutaneous implantable cardioverter-defibrillator (S-ICD) in patients with congenital heart disease (CHD). Background The S-ICD is a treatment option for patients with CHD in which a transvenous device is contraindicated due to anatomic considerations. However, efficacy in this group has not been determined. Methods A pooled analysis of 865 patients in the EFFORTLESS (Evaluation of Factors Affecting the Clinical Outcome and Cost-Effectiveness) registry (an international observational database) and a U.S. Investigational Device Exemption study were reviewed. Results Nineteen CHD patients versus 846 non-CHD patients with a median follow-up of 567 days and 639 days, respectively, were included. There were no deaths and no appropriate shocks for ventricular tachycardia/ventricular fibrillation in the CHD cohort, versus 26 deaths (3.1%, p = 0.42) and 111 appropriate shocks in 59 patients (7.1%) in the non-CHD cohort (p = 0.23). There were similar complication rates for the CHD versus non-CHD groups (10.5 vs. 9.6% [p = 0.89]), with inappropriate shocks for T-wave oversensing as the only complication in the CHD group (n = 2). The rate of inappropriate shocks was similar for both groups (10.5% vs. 10.9% [p = 0.96]). Successful defibrillation testing at 80J was comparable for the CHD versus non-CHD groups (100% vs. 98.5%). Conclusions The overall analysis of the CHD cohort from the pooled data of the Investigational Device Exemption study and the EFFORTLESS registry shows that the S-ICD is a safe option in CHD patients deemed to be at high risk for sudden cardiac death who do not have pacing indications. Further research to accurately define sudden cardiac death risk in the diverse anatomic substrates of CHD patients is warranted.

Magnetic resonance imaging (MRI) with late gadolinium enhancement is commonly performed in patients with non-ischemic LV ventricular tachycardia/ventricular premature depolarizations (non-ischemic LV-VT/VPDs) to define VT substrate prior to catheter ablation. We investigated the prevalence of abnormal voltage and VT localized to areas of the myocardium not reported to have late gadolinium enhancement (LGE) on routine pre-procedural MRI and sought to determine if quantitative MRI analysis could reduce this discordance. Patients with non-ischemic LV-VT/VPD who underwent LV endocardial mapping with VT/VPD ablation and either septal or free wall MRI-voltage discordance were studied. Electroanatomic maps were analyzed post-procedure for areas of electrogram-defined scar and VT localized to areas without reported LGE. Discordant segments were then analyzed offline using delayed signal intensity of >2 and >5 standard deviations above normal myocardium. Of 90 consecutive patients, 32 (36%) patients with septal (n = 16), free wall (n = 14) or both (n = 2) MRI-voltage + mismatch were identified. All discordant segments demonstrated unipolar voltage abnormalities with 12 patients (6 septal and 6 free wall) also showing low bipolar voltage but no LGE at signal intensity >5 standard deviations. Eleven patients (5 septum, 6 free wall) had VT localized to discordant areas. Ninety-three percent of patients in the septal group (26/48 segments) and 89% of patients in the free wall group (9/13 segments) had a concordant response established by using a signal intensity cutoff of >2 standard deviations. MRI-voltage discordance was identified in 36% of patients with non-ischemic LV-VT/VPD who underwent VT ablation. In 12% of patients, VT was targeted in areas of abnormal voltage not suggested by routine qualitative MRI. Quantitative MRI analysis using a lower signal intensity threshold increased the sensitivity for detecting areas of clinically relevant VT substrate.

Frequent ventricular premature depolarizations (VPDs) may cause cardiomyopathy (VPDCM), which often improves after VPD suppression. This study aimed to evaluate whether ablation of outflow tract ventricular arrhythmias (OT VAs) in patients with VPDCM improves renal in addition to left ventricular (LV) function. We retrospectively evaluated 153 patients with OT VAs and examined VPD burden and LV ejection fraction (LVEF), as well as estimated glomerular filtration rate (eGFR) pre- and post-ablation. LV dysfunction was defined as LVEF

Long-term outcomes of the Fontan operation include Fontan failure and liver disease. Combined heart-liver transplantation (CHLT) is an option for select patients although limited data exist on this strategy. A retrospective review of Fontan patients 18 years or older referred for cardiac transplant evaluation between 2000 and 2013 at the Hospital of the University of Pennsylvania was performed. All patients were considered for potential CHLT. Clinical variables such as demographics, perioperative factors, and short-term outcomes were reviewed. Of 17 referrals for cardiac transplantation, seven Fontan patients underwent CHLT. All patients who underwent CHLT had either advanced fibrosis or cirrhosis on liver biopsy. There were no perioperative deaths. The most common postoperative morbidity was acute kidney injury. Short-term complications include one episode of acute liver rejection but no cardiac rejection greater than 1R. CHLT is an acceptable therapeutic option for patients with failing Fontan physiology who exhibit concomitant advanced liver fibrosis. However, optimal patient selection is currently undefined, and long-term outcomes are not known.

Maintenance of sinus rhythm by catheter-based ablation of atrial fibrillation (AF) has become a common strategy for symptom control. The cornerstone of AF ablation is pulmonary vein isolation (PVI) with both entrance and exit block. Wide area circumferential ablation (WACA) in the antrum has increasingly replaced pulmonary vein (PV) ostial ablation because of a higher success rate and reduced risk of PV stenosis.1 However, a percentage of patients require a second procedure for AF control.2,3 At repeat ablation, PV reconnection is a common finding, and occasionally, it is difficult to achieve true entrance and exit block, especially for the right pulmonary veins (RPVs). Editor’s Perspective see p 1268 When faced with difficulty in obtaining RPV isolation, we follow a stepwise approach (Figure 1) to successfully identify the area of persistent connection. If WACA fails to achieve RPV entrance and exit block, some alternatives include (1) ablation more ostially and into the carina region, which potentially risks PV stenosis; (2) wider encirclement, which requires a larger ablation region and more radiofrequency application, and may be unsuccessful as a result of anatomic factors (in many cases because of the presence of the phrenic nerve in the septal aspect of the RPVs); or (3) mapping the activation pattern of the persistent connection. Voltage mapping can demonstrate the extent of prior ablation lesions and can also document lesion maturity at the interface of healthy tissue and scar. Activation mapping during pacing from the reconnected PV can reveal the connection pathways, which could be either via the left atrium (gaps in the line of WACA ablation) or connection to adjacent structures (RPV to right atrium). During pacing, if the earliest signal is on the left atrial side of the WACA line, there is a gap in the line, which should be …