Real-world data of radiofrequency catheter ablation in paroxysmal atrial fibrillation: Short- and long-term clinical outcomes from the prospective multicenter REAL-AF Registry.

BACKGROUND: The safety and long-term efficacy of radiofrequency (RF) catheter ablation (CA) of paroxysmal atrial fibrillation (PAF) has been well established. Contemporary techniques to optimize ablation delivery, reduce fluoroscopy use, and improve clinical outcomes have been developed. OBJECTIVE: The purpose of this study was to assess the contemporary real-world practice approach and short and long-term outcomes of RF CA for PAF through a prospective multicenter registry. METHODS: Using the REAL-AF (Real-world Experience of Catheter Ablation for the Treatment of Symptomatic Paroxysmal and Persistent Atrial Fibrillation; ClincalTrials.gov Identifier: NCT04088071) Registry, patients undergoing RF CA to treat PAF across 42 high-volume institutions and 79 experienced operators were evaluated. The procedures were performed using zero or reduced fluoroscopy, contact force sensing catheters, wide area circumferential ablation, and ablation index as a guide with a target of 380-420 for posterior and 500-550 for anterior lesions. The primary efficacy outcome was freedom from all-atrial arrhythmia recurrence at 12 months. RESULTS: A total of 2470 patients undergoing CA from January 2018 to December 2022 were included. Mean age was 65.2 ±11.14 years, and 44% were female. Most procedures were performed without fluoroscopy (71.5%), with average procedural and total RF times of 95.4 ± 41.7 minutes and 22.1±11.8 minutes, respectively. At 1-year follow-up, freedom from all-atrial arrhythmias was 81.6% with 89.7% of these patients off antiarrhythmic drugs. No significant difference was identified comparing pulmonary vein isolation vs pulmonary vein isolation plus ablation approaches. The complication rate was 1.9%. CONCLUSION: Refinement of RF CA to treat PAF using contemporary tools, standardized protocols, and electrophysiology laboratory workflows resulted in excellent short- and long-term clinical outcomes.

50-W vs 40-W During High-Power Short-Duration Ablation for Paroxysmal Atrial Fibrillation: A Multicenter Prospective Study.

BACKGROUND: High-power short-duration (HPSD) radiofrequency ablation of atrial fibrillation (AF) increases first-pass pulmonary vein isolation (PVI) and freedom from atrial arrhythmias while decreasing procedural time. However, the optimal power setting in terms of safety and efficacy has not been determined. OBJECTIVES: This study compared the procedural characteristics and clinical outcomes of 50-W vs 40-W during HPSD ablation of paroxysmal AF. METHODS: Patients from the REAL-AF prospective multicenter registry (Real-World Experience of Catheter Ablation for Treatment of Symptomatic Paroxysmal and Persistent Atrial Fibrillation) undergoing HPSD ablation of paroxysmal AF, either using 50-W or 40-W, were included. The primary efficacy outcome was freedom from all-atrial arrhythmias. The primary safety outcome was the occurrence of any procedural complication at 12 months. Secondary outcomes included procedural characteristics, AF-related symptoms, and the occurrence of transient ischemic attack or stroke at 12 months. RESULTS: A total of 383 patients were included. Freedom from all-atrial arrhythmias at 12 months was 80.7% in the 50-W group and 77.3% in the 40-W group (Log-rank P = 0.387). The primary safety outcome occurred in 3.7% of patients in the 50-W group vs 2.8% in the 40-W group (P = 0.646). The 50-W group had a higher rate of first-pass PVI (82.3% vs 76.2%; P = 0.040) as well as shorter procedural (67 minutes [IQR: 54-87.5 minutes] vs 93 minutes [IQR: 80.5-111 minutes]; P < 0.001) and radiofrequency ablation times (15 minutes [IQR: 11.4-20 minutes] vs 27 minutes [IQR: 21.5-34.6 minutes]; P < 0.001) than the 40-W group. CONCLUSIONS: There was no significant difference in freedom from all-atrial arrhythmias or procedural safety outcomes between 50-W and 40-W during HPSD ablation of paroxysmal AF. The use of 50-W was associated with a higher rate of first-pass PVI as well as shorter procedural times.

Impact of Median Sternotomy on Safety and Efficacy of the Subcutaneous Implantable Cardioverter Defibrillator.

BACKGROUND: Subcutaneous implantable cardioverter defibrillators (S-ICDs) are an attractive alternative to transvenous ICDs among those not requiring pacing. However, the risks of damage to the S-ICD electrode during sternotomy and adverse interactions with sternal wires remain unclear. We sought to determine the rates of damage to the S-ICD lead during sternotomy, inappropriate shocks from electrical noise due to interaction with sternal wires, and failure to terminate spontaneous or induced ventricular arrhythmias. METHODS: Retrospective, multicenter study of patients undergoing sternotomy before or after S-ICD implantation. Clinical, procedural, and device-related data were collected by each center and analyzed by the coordinating center. These data were compared with a historical control cohort of nonsternotomy patients. RESULTS: Of 196 identified patients (52±16 years, 47 women), 166 underwent S-ICD implantation after sternotomy and 30 sternotomy after S-ICD. There was no damage to any lead among those who underwent sternotomy after S-ICD. Defibrillation threshold testing was performed in 63% at implant, with 91% first shock success. During a median follow-up of 29 months (range, 1-188), S-ICD first shocks successfully terminated spontaneous ventricular arrhythmias in 31 of 32 patients (97%). Inappropriate shocks occurred in 22 patients, most commonly related to T wave oversensing (n=14). Compared with the nonsternotomy controls, there were no differences in rates of first shock success for induced or spontaneous arrhythmias or rate of inappropriate shocks. CONCLUSIONS: Sternotomy before or after S-ICD does not confer additional risk relative to a historical control group without sternotomy.

High-Frequency Low-Tidal Volume Ventilation Improves Long-Term Outcomes in AF Ablation: A Multicenter Prospective Study.

BACKGROUND: High-frequency, low-tidal-volume (HFLTV) ventilation is a safe and simple strategy to improve catheter stability and first-pass isolation during pulmonary vein (PV) isolation. However, the impact of this technique on long-term clinical outcomes has not been determined. OBJECTIVES: This study sought to assess acute and long-term outcomes of HFLTV ventilation compared with standard ventilation (SV) during radiofrequency (RF) ablation of paroxysmal atrial fibrillation (PAF). METHODS: In this prospective multicenter registry (REAL-AF), patients undergoing PAF ablation using either HFLTV or SV were included. The primary outcome was freedom from all-atrial arrhythmia at 12 months. Secondary outcomes included procedural characteristics, AF-related symptoms, and hospitalizations at 12 months. RESULTS: A total of 661 patients were included. Compared with those in the SV group, patients in the HFLTV group had shorter procedural (66 [IQR: 51-88] minutes vs 80 [IQR: 61-110] minutes; P < 0.001), total RF (13.5 [IQR: 10-19] minutes vs 19.9 [IQR: 14.7-26.9] minutes; P < 0.001), and PV RF (11.1 [IQR: 8.8-14] minutes vs 15.3 [IQR: 12.4-20.4] minutes; P < 0.001) times. First-pass PV isolation was higher in the HFLTV group (66.6% vs 63.8%; P = 0.036). At 12 months, 185 of 216 (85.6%) in the HFLTV group were free from all-atrial arrhythmia, compared with 353 of 445 (79.3%) patients in the SV group (P = 0.041). HLTV was associated with a 6.3% absolute reduction in all-atrial arrhythmia recurrence, lower rate of AF-related symptoms (12.5% vs 18.9%; P = 0.046), and hospitalizations (1.4% vs 4.7%; P = 0.043). There was no significant difference in the rate of complications. CONCLUSIONS: HFLTV ventilation during catheter ablation of PAF improved freedom from all-atrial arrhythmia recurrence, AF-related symptoms, and AF-related hospitalizations with shorter procedural times.

Performance of the REAL-AF Same-Day Discharge Protocol in Patients Undergoing Catheter Ablation of Atrial Fibrillation.

BACKGROUND: Same-day discharge (SDD) after catheter ablation of atrial fibrillation (AF) has been widely adopted. Nevertheless, planned SDD has been performed by using subjective criteria rather than standardized protocols. OBJECTIVES: The goal of this study was to determine the efficacy and safety of the previously described SDD protocol in a prospective multicenter study. METHODS: Using the REAL-AF (Real-world Experience of Catheter Ablation for the Treatment of Paroxysmal and Persistent Atrial Fibrillation) SDD protocol eligibility criteria (stable anticoagulation, no bleeding history, left ventricular ejection fraction >40%, no pulmonary disease, no procedures within 60 days, and body mass index <35 kg/m2), operators prospectively determined whether patients undergoing ablation of AF were candidates for SDD (SDD vs non-SDD groups). Successful SDD was achieved if the patient met the protocol discharge criteria. The primary efficacy endpoint was the success rate of SDD. The primary safety endpoints were readmission rates as well as acute and subacute complications. The secondary endpoints included procedural characteristics and freedom from all-atrial arrhythmias. RESULTS: A total of 2,332 patients were included. The REAL-AF SDD protocol identified 1,982 (85%) patients as potential candidates for SDD. The primary efficacy endpoint was achieved in 1,707 (86.1%) patients. The readmission rate for SDD vs non-SDD group was similar (0.8% vs 0.9%; P = 0.924). The SDD group had a lower acute complication rate than the non-SDD group (0.8% vs 2.9%; P < 0.001), and there was no difference in the subacute complication rate between groups (P = 0.513). Freedom from all-atrial arrhythmias was comparable between groups (P = 0.212). CONCLUSIONS: In this large, multicenter prospective registry, the use of a standardized protocol showed the safety of SDD after catheter ablation of paroxysmal and persistent AF. (Real-world Experience of Catheter Ablation for the Treatment of Paroxysmal and Persistent Atrial Fibrillation [REAL-AF]; NCT04088071).

A novel artificial intelligence based algorithm to reduce wearable cardioverter-defibrillator alarms.

BACKGROUND: The wearable cardioverter defibrillator (WCD) is an important tool in mitigating sudden cardiac death (SCD). The WCD provides patient alarms for detected arrhythmias or electrical noise/artifact. Some patients experience frequent alarms for artifact. We sought to evaluate the effects of a novel artificial intelligence algorithm to reduce alarms related to electrical noise or artifact (advanced arrhythmia discrimination algorithm, AArD). METHODS: A retrospective review of a large commercial database of prescribed WCD. Patients prescribed the WCD during the years 2017 (discrimination algorithm, DA group) or during 2019 (advanced arrhythmia discrimination algorithm, AArD) were analyzed. A total of 96,000 patients were sampled, 48,000 in the control group (using standard direct algorithm, DA) and compared to 48,000 in the intervention AArD (4000 per group per month) for 12 months. The AArD further discriminates ECG signals based on a machine-learning algorithm utilizing intensity and frequency beyond the standard DA. Outcomes regarding alarms, arrhythmias, and safety were analyzed. RESULTS: The AArD algorithm was associated with a significant decrease in frequency of alarms over the course of WCD use; 54% of patients in the AARD versus 27% of DA had 0 alarms (P < .001). In the entire cohort, there was a 56% relative reduction in alarms with the use of AArD. Appropriate arrhythmia treatment time was not significantly different between the groups (44 s DA vs 45 s AArD [p = ns]). CONCLUSIONS: A novel artificial intelligence algorithm reduces alarms without delaying appropriate therapy for VT/VF. These changes may improve compliance and quality of life in patients with a WCD.

Multicenter experience with andexanet alfa for refractory pericardial bleeding during catheter ablation of atrial fibrillation.

INTRODUCTION: 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. METHODS AND RESULTS: In this multicenter, case series, participating centers identified patients who received a dose of apixaban or rivaroxaban within 24 h 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 CHA2 DS2 -VASc score 4 [3-5]. All patients received protamine and pericardiocentesis, and 9 (82%) received blood products. All patients received a bolus of andexanet followed, in all but one, by a 2-h infusion. Acute hemostasis was achieved in eight patients (73%) while three required emergent surgery. One patient (9%) experienced acute ST-elevation myocardial infarction after receiving andexanet. Therapeutic AC was restarted after a mean of 2.2 ± 1.9 days and oral AC was restarted after a mean of 2.9 ± 1.6 days, with no recurrent bleeding. CONCLUSION: In 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.

Disparities in Practice Patterns by Sex, Race, and Ethnicity in Patients Referred for Advanced Heart Failure Therapies.

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.

A prospective multi-site registry of real-world experience of catheter ablation for treatment of symptomatic paroxysmal and persistent atrial fibrillation (Real-AF): design and objectives.

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).

Practices of Referring Patients to Advanced Heart Failure Centers.

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 (<20% in 51.5%); 59.4% inpatient; and high risk Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profiles (74.5% profile 1-3). HF cardiologists (49.1%) were the most common originating referral source; the least common (4.9%) were electrophysiologists. Common clinical triggers for referral included worsening HF (30.0%), inotrope dependence (19.6%), hospitalization (19.4%), and cardiogenic shock (17.8%). Most commonly, AHF therapies were not offered because patients were too sick (38.0%-45.1%) or for psychosocial reasons (20.3%-28.6%). Compared to non-HF cardiologists, patients referred by HF cardiologists were offered an AHF therapy more often (66.8% vs 58.4%, P = 0.0489). Of those not offered any AHF therapy, 28.4% received home inotropic therapy, and 14.5% were referred to hospice. 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.

Incidence of Cardiac Implantable Electronic Device Complications in Patients With Left Ventricular Assist Devices.

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.

A manifesto of collaborative longitudinal cardiovascular care in heart failure.

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.

Physical activity is reduced prior to ventricular arrhythmias in patients with a wearable cardioverter defibrillator.

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 < .001). An average cutoff of 3637 daily steps during week 1 separated the groups. Patients who averaged fewer than 3637 steps per day during the first week of WCD use were 4.3 times more likely to experience a shock than those who walked more than 3637 steps per day (OR = 4.29, 95% CI = 2.58-7.15, P < .001). DISCUSSION: Average daily step counts are lower in WCD patients who manifest spontaneous VT/VF. Whether these findings represent a causal or correlational relationship, future studies to encourage a minimum daily step count in high-risk patients may impact the incidence of sustained VT/VF.

Importance of the Interventricular Septum as Part of the Ventricular Tachycardia Substrate in Nonischemic Cardiomyopathy.

OBJECTIVES: This study sought to characterize septal substrate in patients with nonischemic left ventricular cardiomyopathy (NILVCM) undergoing ventricular tachycardia (VT) ablation. BACKGROUND: The interventricular septum is an important site of VT substrate in NILVCM. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Outcomes after asystole events occurring during wearable defibrillator-cardioverter use.

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.

Wearable Cardioverter-defibrillators for the Prevention of Sudden Cardiac Death: A Meta-analysis.

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.

Cardiac magnetic resonance imaging and electroanatomic voltage discordance in non-ischemic left ventricle ventricular tachycardia and premature ventricular depolarizations.

PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Single-center outcomes of combined heart and liver transplantation in the failing Fontan.

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.