Intramural Needle Ablation for Refractory Premature Ventricular Contractions.

BACKGROUND: Frequent premature ventricular contractions (PVCs) are often amenable to catheter ablation. However, a deep intramural focus may lead to failure due to inability of standard ablation techniques to penetrate the focus. We sought to assess the efficacy and safety of infusion needle ablation (INA) for PVCs that are refractory to standard radiofrequency ablation. METHODS: Under 2 Food and Drug Administration approved protocols, INA was evaluated in patients with frequent PVCs that were refractory to standard ablation. Initial targets for ablation were selected by standard mapping techniques. INA was performed with a deflectable catheter equipped with an extendable/retractable needle at the tip that can be extended up to 12 mm into the myocardium and is capable of pacing and recording. After contrast injection for location assessment, radiofrequency ablation was performed with the needle tip using a temperature-controlled mode (maximum temperature 60 °C) with saline infusion from the needle. The primary end point was a decrease in PVC burden to <5000/24 hours at 6 months. The primary safety end point was incidence of procedure- or device-related serious adverse events. RESULTS: At 4 centers, 35 patients (age 55.3±16.9 years, 74.2% male) underwent INA. The baseline median PVC burden was 25.4% (interquartile range, 18.4%-33.9%) and mean left ventricular ejection fraction was 37.7±12.3%. Delivering 10.3±8.0 INA lesions/patient (91% had adjunctive standard radiofrequency ablation also) resulted in acute PVC elimination in 71.4%. After a mean follow-up of 156±109 days, the primary efficacy end point was met in 73.3%. The median PVC burden decreased to 0.8% (interquartile range, 0.1%-6.0%; P<0.001). The primary safety end point occurred in 14.3% consisting of 1 (2.9%) heart block, 1 (2.9%) femoral artery dissection, and 3 (8.6%) pericardial effusions (all treated percutaneously). CONCLUSIONS: INA is effective for the elimination of frequent PVCs that are refractory to conventional ablation and is associated with an acceptable safety profile. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT01791543 and NCT03204981.

Prognostic Value of Electrocardiographic QRS Diminution in Patients Hospitalized With COVID-19 or Influenza.

During the clinical care of hospitalized patients with COVID-19, diminished QRS amplitude on the surface electrocardiogram (ECG) was observed to precede clinical decompensation, culminating in death. This prompted investigation into the prognostic utility and specificity of low QRS complex amplitude (LoQRS) in COVID-19. We retrospectively analyzed consecutive adults admitted to a telemetry service with SARS-CoV-2 (n = 140) or influenza (n = 281) infection with a final disposition-death or discharge. LoQRS was defined as a composite of QRS amplitude <5 mm or <10 mm in the limb or precordial leads, respectively, or a ≥50% decrease in QRS amplitude on follow-up ECG during hospitalization. LoQRS was more prevalent in patients with COVID-19 than influenza (24.3% vs 11.7%, p = 0.001), and in patients who died than survived with either COVID-19 (48.1% vs 10.2%, p <0.001) or influenza (38.9% vs 9.9%, p <0.001). LoQRS was independently associated with mortality in patients with COVID-19 when adjusted for baseline clinical variables (odds ratio [OR] 11.5, 95% confidence interval [CI] 3.9 to 33.8, p <0.001), presenting and peak troponin, D-dimer, C-reactive protein, albumin, intubation, and vasopressor requirement (OR 13.8, 95% CI 1.3 to 145.5, p = 0.029). The median time to death in COVID-19 from the first ECG with LoQRS was 52 hours (interquartile range 18 to 130). Dynamic QRS amplitude diminution is a strong independent predictor of death over not only the course of COVID-19 infection, but also influenza infection. In conclusion, this finding may serve as a pragmatic prognostication tool reflecting evolving clinical changes during hospitalization, over a potentially actionable time interval for clinical reassessment.

How does the level of pulmonary venous isolation compare between pulsed field ablation and thermal energy ablation (radiofrequency, cryo, or laser)?

AIMS: We studied the extent/area of electrical pulmonary vein isolation (PVI) after either pulsed field ablation (PFA) using a pentaspline catheter or thermal ablation technologies. METHODS AND RESULTS: In a clinical trial (NCT03714178), paroxysmal atrial fibrillation (PAF) patients underwent PVI with a multi-electrode pentaspline PFA catheter using a biphasic waveform, and after 75 days, detailed voltage maps were created during protocol-specified remapping studies. Comparative voltage mapping data were retrospectively collected from consecutive PAF patients who (i) underwent PVI using thermal energy, (ii) underwent reablation for recurrence, and (iii) had durably isolated PVs. The left and right PV antral isolation areas and non-ablated posterior wall were quantified. There were 20 patients with durable PVI in the PFA cohort, and 39 in the thermal ablation cohort [29 radiofrequency ablation (RFA), 6 cryoballoon, and 4 visually guided laser balloon]. Pulsed field ablation patients were younger with shorter follow-up. Left atrial diameter and ventricular systolic function were preserved in both cohorts. There was no significant difference between the PFA and thermal ablation cohorts in either the left- and right-sided PV isolation areas, or the non-ablated posterior wall area. The right superior PV isolation area was smaller with PFA than RFA, but this disappeared after propensity score matching. Notch-like normal voltage areas were seen at the posterior aspect of the carina in the balloon sub-cohort, but not the PFA or RFA cohorts. CONCLUSION: Catheter-based PVI with the pentaspline PFA catheter creates chronic PV antral isolation areas as encompassing as thermal energy ablation.

Assessment of Catheter Ablation or Antiarrhythmic Drugs for First-line Therapy of Atrial Fibrillation: A Meta-analysis of Randomized Clinical Trials.

Importance: Early rhythm control of atrial fibrillation (AF) with either antiarrhythmic drugs (AADs) or catheter ablation has been reported to improve cardiovascular outcomes compared with usual care; however, the optimal therapeutic modality to achieve early rhythm control is unclear. Objective: To assess the safety and efficacy of AF ablation as first-line therapy when compared with AADs in patients with paroxysmal AF. Data Sources: PubMed/MEDLINE, Scopus, Google Scholar, and various major scientific conference sessions from January 1, 2000, through November 23, 2020. Study Selection: Randomized clinical trials (RCTs) published in English that had at least 12 months of follow-up and compared clinical outcomes of ablation vs AADs as first-line therapy in adults with AF. The quality of individual studies was assessed using the Cochrane risk of bias tool. Six RCTs met inclusion criteria, including 1212 patients. Data Extraction and Synthesis: Two investigators independently extracted data. Reporting was performed in compliance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analysis) guidelines. Analysis was performed using a random-effects model with the Mantel-Haenszel method, and results are presented as 95% CIs. Main Outcomes and Measures: Main outcomes were safety and efficacy of AF ablation as first-line therapy when compared with AADs. Trials were evaluated as having low risk of selection and attrition biases, high risk of performance bias, and with unclear risk for detection biases due to unblinding and open-label designs. Results: A total of 6 RCTs involving 1212 patients with AF were included (609 were randomized to AF ablation and 603 to drug therapy; mean [SD] age, 56 [11] years). Compared with AADs, catheter ablation use was associated with reductions in recurrent atrial arrhythmia (32.3% vs 53%; risk ratio [RR], 0.62; 95% CI, 0.51-0.74; P < .001; I2 = 40%), with a number needed to treat with ablation to prevent 1 arrhythmia of 5. Use of ablation was also associated with reduced symptomatic atrial arrhythmia (11.8% vs 26.4%; RR, 0.44; 95% CI, 0.27-0.72; P = .001; I2 = 54%) and hospitalization (5.6% vs 18.7%; RR, 0.32; 95% CI, 0.19-0.53; P < .001) with no significant difference in serious adverse events between the groups (4.2% vs 2.8%; RR, 1.52; 95% CI, 0.81-2.85; P = .19). Conclusions and Relevance: In this meta-analysis of randomized clinical trials including first-line therapy of patients with paroxysmal AF, catheter ablation compared with antiarrhythmic drugs was associated with reductions in recurrence of atrial arrhythmias and hospitalizations, with no difference in major adverse events.

Barriers and financial impact of same-day discharge after atrial fibrillation ablation.

BACKGROUND: Same-day discharge (SDD) after atrial fibrillation (AF) ablation is increasingly being considered. This study examined the barriers and financial impact associated with SDD in a contemporary cohort of patients undergoing elective AF ablation. METHODS: A single center retrospective review was conducted of the 249 first case-of-the-day outpatient AF ablations performed in 2019 to evaluate the proportion of patients that could have undergone SDD. Barriers to SDD were defined as any intervention that prevented SDD by 8 p.m. The financial impact of SDD was based on savings from avoidance of the overnight hospital stay and revenue related to management of chest pain facilitated by a vacant hospital bed. RESULTS: SDD could have occurred in 157 patients (63%) without change in management and in up to 200 patients (80%) if avoidable barriers were addressed. Barriers to SDD included non-clinical logistical issues (43%), prolonged post-procedure recovery (42%) and minor procedural complications (15%). On multivariate analysis, factors associated with barriers to SDD included increasing age (P = .01), left ventricular ejection fraction ≤ 35% (P = .04), and severely dilated left atrium (P = .04). The financial gain from SDD would have ranged from $1,110,096 (assuming discharge of 63% of eligible patients) to $1,480,128 (assuming 80% discharge) over the course of a year. CONCLUSIONS: Up to 80% of patients undergoing outpatient AF ablation were amenable to SDD if avoidable delays in care had been anticipated. Based on reduced hospital operating expenses and increased revenue from management of individuals with chest pain, this would translate to a financial savings of ∼$1.5 million.

Malignant Arrhythmias in Patients With COVID-19: Incidence, Mechanisms, and Outcomes.

BACKGROUND: Patients with coronavirus disease 2019 (COVID-19) who develop cardiac injury are reported to experience higher rates of malignant cardiac arrhythmias. However, little is known about these arrhythmias-their frequency, the underlying mechanisms, and their impact on mortality. METHODS: We extracted data from a registry (NCT04358029) regarding consecutive inpatients with confirmed COVID-19 who were receiving continuous telemetric ECG monitoring and had a definitive disposition of hospital discharge or death. Between patients who died versus discharged, we compared a primary composite end point of cardiac arrest from ventricular tachycardia/fibrillation or bradyarrhythmias such as atrioventricular block. RESULTS: Among 800 patients with COVID-19 at Mount Sinai Hospital with definitive dispositions, 140 patients had telemetric monitoring, and either died (52) or were discharged (88). The median (interquartile range) age was 61 years (48-74); 73% men; and ethnicity was White in 34%. Comorbidities included hypertension in 61%, coronary artery disease in 25%, ventricular arrhythmia history in 1.4%, and no significant comorbidities in 16%. Compared with discharged patients, those who died had elevated peak troponin I levels (0.27 versus 0.02 ng/mL) and more primary end point events (17% versus 4%, P=0.01)-a difference driven by tachyarrhythmias. Fatal tachyarrhythmias invariably occurred in the presence of severe metabolic imbalance, while atrioventricular block was largely an independent primary event. CONCLUSIONS: Hospitalized patients with COVID-19 who die experience malignant cardiac arrhythmias more often than those surviving to discharge. However, these events represent a minority of cardiovascular deaths, and ventricular tachyarrhythmias are mainly associated with severe metabolic derangement. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04358029.

Syncope and presyncope in patients with COVID-19.

INTRODUCTION: Recent studies have described several cardiovascular manifestations of COVID-19 including myocardial ischemia, myocarditis, thromboembolism, and malignant arrhythmias. However, to our knowledge, syncope in COVID-19 patients has not been systematically evaluated. We sought to characterize syncope and/or presyncope in COVID-19. METHODS: This is a retrospective analysis of consecutive patients hospitalized with laboratory-confirmed COVID-19 with either syncope or presyncope. This "study" group (n = 37) was compared with an age and gender-matched cohort of patients without syncope ("control") (n = 40). Syncope was attributed to various categories. We compared telemetry data, treatments received, and clinical outcomes between the two groups. RESULTS: Among 1000 COVID-19 patients admitted to the Mount Sinai Hospital, the incidence of syncope/presyncope was 3.7%. The median age of the entire cohort was 69 years (range 26-89+ years) and 55% were men. Major comorbidities included hypertension, diabetes, and coronary artery disease. Syncopal episodes were categorized as (a) unspecified in 59.4% patients, (b) neurocardiogenic in 15.6% patients, (c) hypotensive in 12.5% patients, and (d) cardiopulmonary in 3.1% patients with fall versus syncope and seizure versus syncope in 2 of 32 (6.3%) and 1 of 33 (3.1%) patients, respectively. Compared with the "control" group, there were no significant differences in both admission and peak blood levels of d-dimer, troponin-I, and CRP in the "study" group. Additionally, there were no differences in arrhythmias or death between both groups. CONCLUSIONS: Syncope/presyncope in patients hospitalized with COVID-19 is uncommon and is infrequently associated with a cardiac etiology or associated with adverse outcomes compared to those who do not present with these symptoms.

Follow-up imaging after left atrial appendage closure.

BACKGROUND: Because device-related thrombus (DRT) portends a poor prognosis after left atrial appendage closure with the Watchman device, surveillance transesophageal echocardiography (TEE) is recommended at 45 days and 1 year. However, oral anticoagulants are just discontinued at 45 days, rendering this early TEE unlikely to detect DRT. Indeed, DRT is most likely to occur after instituting aspirin monotherapy. OBJECTIVE: The purpose of this study was to evaluate the alternative strategy of first TEE imaging (or computed tomography) at 4 months post-Watchman implantation. METHODS: After Food and Drug Administration approval, consecutive patients undergoing Watchman implantation at 2 centers received TEE or CT at 4 months and 1 year, along with a truncated drug regimen: 6 weeks of an oral anticoagulant (or clopidogrel in a subset) plus aspirin, then 6 weeks of dual antiplatelet therapy, and finally aspirin monotherapy. RESULTS: Of the 530-patient cohort (mean age 78.7±7.9 years; 65.5% (n = 347) male; CHA2DS2-VASc score 4.5±1.4), 465 patients (87.7%) received 4-month imaging: 83.0% (440 of 530) TEE and 4.7% (25 of 530) computed tomography. Over a median follow-up of 12 months, 16 ischemic strokes (ISs), 8 transient ischemic attacks, and 1 systemic embolization occurred. Importantly, no IS occurred between 45 days and 4 months; the sole transient ischemic attack in this period (at ∼2 months) occurred 1 week after transcatheter aortic valve replacement. DRT was detected in 2.4% (11 of 465) at 4 months and 0.9% (2 of 214) at 1 year. No IS, but 1 leg embolization, was observed after DRT detection. CONCLUSION: Delaying the first imaging post-Watchman implantation to 4 months was associated with no IS between 45 days and 4 months, the "vulnerable" period of this follow-up strategy.

Ostial dimensional changes after pulmonary vein isolation: Pulsed field ablation vs radiofrequency ablation.

BACKGROUND: Pulmonary vein (PV) stenosis is an important potential complication of PV isolation using thermal modalities such as radiofrequency ablation (RFA). Pulsed field ablation (PFA) is an alternative energy that causes nonthermal myocardial cell death. OBJECTIVE: The purpose of this study was to compare the effect of PFA vs RFA on the incidence and severity of PV narrowing or stenosis. METHODS: Data were analyzed from 4 paroxysmal atrial fibrillation ablation trials using either PFA or RFA; because of absent CT scans or poor computed tomography scan quality, 73 of 153 patients (47.7%) were excluded. Baseline and 3-month cardiac computed tomography scans were reconstructed into 3-dimensional images, and the long and short axes of the PV ostia were quantitatively and qualitatively assessed in a randomized blinded manner by 2 physicians. RESULTS: A total of 299 PVs from 80 patients after either PFA (n = 37) or RFA (n = 43) were enrolled. PV ostial diameters decreased significantly less with PFA than with RFA (% change; long axis: 0.9% ± 8.5% vs -11.9% ± 16.3%; P < .001 and short axis: 3.4% ± 12.7% vs -12.9% ± 18.5%; P < .001). After a combined quantitative/qualitative analysis, mild (30%-49%), moderate (50%-69%), or severe (70%-100%) PV narrowing was observed, respectively, in 9.0% (15 of 166), 1.8% (3 of 166), and 1.2% (2 of 166) of PVs in the RFA cohort but in none of the PVs after PFA (P < .001). Overall, PV narrowing/stenosis was present in 0% and 0% vs 12.0% and 32.5% of PVs and patients who underwent PFA and RFA, respectively. CONCLUSION: This study indicates that unlike after RFA, the incidence and severity of PV narrowing/stenosis after PV isolation is virtually eliminated with PFA.

RADAR: A Multicenter Food and Drug Administration Investigational Device Exemption Clinical Trial of Persistent Atrial Fibrillation.

BACKGROUND: Pulmonary vein isolation is insufficient to treat all patients with persistent atrial fibrillation (AF), and effective adjunctive ablation strategies are needed. Ablation of AF drivers holds promise, but current technologies to identify drivers are limited by spatial resolution. In a single-arm, first-in-human, investigator-initiated Food and Drug Administration Investigational Device Exemption study, we used a novel system for real-time, high-resolution identification of AF drivers in persistent AF. METHODS: Patients with persistent or long-standing persistent AF underwent ablation using the RADAR (Real-Time Electrogram Analysis for Drivers of Atrial Fibrillation) system in conjunction with a standard electroanatomical mapping system. After pulmonary vein isolation, electrogram and spatial information was streamed to the RADAR system and analyzed to identify driver domains to target for ablation. RESULTS: Across 4 centers, 64 subjects were enrolled: 73% male, age, 64.7±9.5 years; body mass index, 31.7±6.0 kg/m2; left atrium size, 54±10 mm, with persistent/long-standing persistent AF in 53 (83%)/11 (17%), prior AF ablation (re-do group) in 26 (41%). After 12.6±0.8 months follow-up, 68% remained AF-free off all antiarrhythmics; 74% remained AF-free and 66% remained AF/atrial tachycardia/atrial flutter-free on or off AADs (antiarrhythmic drugs). AF terminated with ablation in 35 patients (55%) overall and in 23/38 (61%) of de novo ablation patients. For patients with AF termination during ablation, 82% remained AF-free and 74% AF/atrial tachycardia/atrial flutter-free during follow-up on or off AADs. Patients undergoing first-time ablation generally had higher rates of freedom from AF than the re-do group. CONCLUSIONS: This novel technology for panoramic mapping of AF drivers showed promising results in a persistent/long-standing persistent AF population. These data provide the scientific basis for a randomized trial. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03263702; IDE#G170049.

The impact of mechanical oesophageal deviation on posterior wall pulmonary vein reconnection.

AIMS: During atrial fibrillation ablation, oesophageal heating typically prompts reduction or termination of radiofrequency energy delivery. We previously demonstrated oesophageal temperature rises are associated with posterior left atrial pulmonary vein reconnection (PVR) during redo procedures. In this study, we assessed whether mechanical oesophageal deviation (MED) during an index procedure minimizes posterior wall PVRs during redo procedures. METHODS AND RESULTS: Patients in whom we performed a first-ever procedure followed by a clinically driven redo procedure were divided based on both the use of MED for oesophageal protection and the ablation catheter employed (force or non-force sensing) in the first procedure. The PVR sites were compared between MED using a force-sensing catheter (MEDForce), or no MED with a non-force (ControlNoForce) or force (ControlForce) sensing catheter. Despite similar clinical characteristics, the MEDForce redo procedure rate (9.2%, 26/282 patients) was significantly less than the ControlNoForce (17.2%, 126/734 patients; P = 0.002) and ControlForce (17.5%, 20/114 patients; P = 0.024) groups. During the redo procedure, the posterior PVR rate with MEDForce (2%, 1/50 PV pairs) was significantly less than with either ControlNoForce (17.7%, 44/249 PV pairs; P = 0.004) or ControlForce (22.5%, 9/40 PV pairs; P = 0.003), or aggregate Controls (18.3%, 53/289 PV pairs; P = 0.006). However, the anterior PVR rate with MEDForce (8%, 4/50 PV pairs) was not significantly different than Controls (aggregate Controls-3.5%, 10/289 PV pairs, P = 0.136; ControlNoForce-2.4%, 6/249 PV pairs, P = 0.067; ControlForce-10%, 4/40 PV pairs, P = 1.0). CONCLUSION: Oesophageal deviation improves the durability of the posterior wall ablation lesion set during AF ablation.

Feasibility of subcutaneous implantable cardioverter-defibrillator implantation with opioid sparing truncal plane blocks and deep sedation.

INTRODUCTION: The subcutaneous implantable cardioverter-defibrillator (S-ICD) is most commonly implanted under general anesthesia (GA), due to the intraoperative discomfort associated with tunneling and dissection. Postoperative pain can be substantial and is often managed with opioids. There is a growing interest in transitioning away from the routine use of GA during S-ICD implantation, while also controlling perioperative discomfort without the use of narcotics. As such, we assessed the feasibility of a multimodal analgesia regimen that included regional anesthesia techniques in patients undergoing S-ICD implantation. METHODS AND RESULTS: Twenty patients received truncal plane block (TBL) immediately before S-ICD implantation. The first 10 patients were implanted under general anesthesia (GA + TBL), and the next 10 patients were implanted under deep sedation (DS + TBL). Additionally, the DS + TBL patients were also prescribed a structured regimen of nonopioid analgesics in the perioperative period. Opioid consumption was calculated as milligram morphine equivalents (MME). In-hospital opioid consumption was significantly lower in the patients implanted with DS + TBL (MME = 0) as compared with patients receiving GA + TBL (MME = 60; P = 0.004). CONCLUSIONS: Subcutaneous ICD implantation with anesthesia-delivered DS and a multimodal anesthetic regimen that includes TBL is feasible and associated with significantly less perioperative opioid consumption.

Catheter Ablation of Atrial Fibrillation in Patients With Heart Failure: A Meta-analysis of Randomized Controlled Trials.

This article has been corrected. The original version (PDF) is appended to this article as a Supplement. Background: Atrial fibrillation (AF) and heart failure (HF) frequently coexist and are associated with increased morbidity and mortality risk. Purpose: To compare benefits and harms between catheter ablation and drug therapy in adult patients with AF and HF. Data Sources: ClinicalTrials.gov, PubMed, Web of Science (Clarivate Analytics), EBSCO Information Services, Cochrane Central Register of Controlled Trials, Google Scholar, and various scientific conference sessions from 1 January 2005 to 1 October 2018. Study Selection: Randomized controlled trials (RCTs) published in English that had at least 6 months of follow-up and compared clinical outcomes of catheter ablation versus drug therapy in adults with AF and HF. Data Extraction: 2 investigators independently extracted data and assessed study quality. Data Synthesis: 6 RCTs involving 775 patients met inclusion criteria. Compared with drug therapy, AF ablation reduced all-cause mortality (9.0% vs. 17.6%; risk ratio [RR], 0.52 [95% CI, 0.33 to 0.81]) and HF hospitalizations (16.4% vs. 27.6%; RR, 0.60 [CI, 0.39 to 0.93]). Ablation improved left ventricular ejection fraction (LVEF) (mean difference, 6.95% [CI, 3.0% to 10.9%]), 6-minute walk test distance (mean difference, 20.93 m [CI, 5.91 to 35.95 m]), peak oxygen consumption (Vo2max) (mean difference, 3.17 mL/kg per minute [CI, 1.26 to 5.07 mL/kg per minute]), and quality of life (mean difference in Minnesota Living with Heart Failure Questionnaire score, -9.02 points [CI, -19.75 to 1.71 points]). Serious adverse events were more common in the ablation groups, although differences between the ablation and drug therapy groups were not statistically significant (7.2% vs. 3.8%; RR, 1.68 [CI, 0.58 to 4.85]). Limitation: Results driven primarily by 1 clinical trial, possible patient selection bias in the ablation group, lack of patient-level data, open-label trial designs, and heterogeneous follow-up length among trials. Conclusion: Catheter ablation was superior to conventional drug therapy in improving all-cause mortality, HF hospitalizations, LVEF, 6-minute walk test distance, Vo2max, and quality of life, with no statistically significant increase in serious adverse events. Primary Funding Source: None.

Esophageal Deviation During Atrial Fibrillation Ablation: Clinical Experience With a Dedicated Esophageal Balloon Retractor.

OBJECTIVES: The goal of this study was to determine the safety and feasibility of a novel esophageal balloon retractor (DV8) for MED during PVI. BACKGROUND: The authors previously showed that mechanical esophageal deviation (MED) is feasible using an off-the-shelf metal stylet to allow uninterrupted ablation along the posterior left atrium during pulmonary vein isolation (PVI). Although it is an attractive strategy to avoid esophageal thermal injury, this technique was hampered by both the propensity for oropharyngeal trauma from the stiff stylet and the limited lateral esophageal displacement. METHODS: In 200 consecutive patients undergoing atrial fibrillation ablation, the DV8 balloon retractor was used for MED; contrast was instilled into the esophagus to accurately delineate the trailing esophageal edge. Deviation was performed to maximize the distance from the trailing esophageal edge to the closest point of the ablation line (MEDEffective) and correlated to occurrences of luminal esophageal temperature elevation. RESULTS: In patients undergoing MED during a first-ever PVI of 304 vein pairs, the MEDEffective during right and left PVI were 21.2 ± 8.7 mm and 15.5 ± 6.8 mm, respectively. Deviation of at least 5 mm of MEDEffective was achievable in 97.7%. Luminal esophageal temperature increases universally occurred (100%) at MEDEffective <5 mm, less often (28%) at MEDEffective 5 to 20 mm, and rarely (1.9%) at MEDEffective >20 mm. There were no esophageal complications, but 2 patients experienced oropharyngeal bleeding due to trauma related to device placement. CONCLUSIONS: MED with the balloon retractor safely moved the esophagus away from the site of energy delivery during atrial fibrillation ablation.

Does Left Atrial Appendage Closure Reduce Mortality? A Vital Status Analysis of the Randomized PROTECT AF and PREVAIL Clinical Trials.

Compared with warfarin, left atrial appendage closure (LAAC) reduced mortality in an analysis of the PROTECTAF and PREVAIL trials. However, these data were limited by patient drop-out.We sought to estimatethe mortality benefit with LAACusing updated vital status information.In PROTECT AF and PREVAIL, 227 of 1114 randomized subjects failed to complete 5-year follow-up. Centers were manually queried for updated vital status on 76 subjects (33%).During median follow-up 5.0 years (interquartile range 3.8, 5.1), 112 of 732 LAAC subjects (15.3%) and 79 of 382 controls (20.7%) died. The hazard ratio for all-cause mortality with LAAC compared with warfarin was 0.70 (95% CI 0.53-0.94, p=0.017).Subgroup analyses suggested that subjects <75 years and those with higher CHA2DS2-VASc score, history of transient ischemic attack or stroke, and permanent AF derived particular benefit, although interaction terms were not significant.The number needed to treat(NNT) with LAAC to prevent one death over 5 years was 16 (95% CI 10-82). Despite competing mortality risks in this elderly cohort, updated vital status data from PROTECT AF and PREVAIL revealed that LAAC was associated with 30% improved survival compared with warfarin, with an NNT of 16.

Catheter Ablation of Ventricular Tachycardia in Structurally Normal Hearts: Indications, Strategies, and Outcomes-Part I.

Catheter ablation of ventricular tachycardia (VT) is being increasingly performed; yet, there is often confusion regarding indications, outcomes, and how to identify those patient populations most likely to benefit. The management strategy differs between those with structural heart disease and those without. For the former, an implantable cardioverter-defibrillator (ICD) is typically required due to an elevated risk for sudden cardiac death, and catheter ablation can be used as adjunctive therapy to treat or prevent repetitive ICD therapies. In contrast, VT or premature ventricular contractions in the setting of a structurally normal heart carries a low risk for sudden cardiac death; accordingly, there is typically no indication for an ICD. In these patients, catheter ablation is considered for symptom management or to treat tachycardiomyopathy and is potentially curative. Here, the authors discuss the pathophysiology, mechanism, and management of VT that occurs in the setting of a structurally normal heart and the role of catheter ablation.

Catheter Ablation of Ventricular Tachycardia in Structural Heart Disease: Indications, Strategies, and Outcomes-Part II.

In contrast to ventricular tachycardia (VT) that occurs in the setting of a structurally normal heart, VT that occurs in patients with structural heart disease carries an elevated risk for sudden cardiac death (SCD), and implantable cardioverter-defibrillators (ICDs) are the mainstay of therapy. In these individuals, catheter ablation may be used as adjunctive therapy to treat or prevent repetitive ICD therapies when antiarrhythmic drugs are ineffective or not desired. However, certain patients with frequent premature ventricular contractions (PVCs) or VT and tachycardiomyopathy should be considered for ablation before ICD implantation because left ventricular function may improve, consequently decreasing the risk of SCD and obviating the need for an ICD. The goal of this paper is to review the pathophysiology, mechanism, and management of VT in the setting of structural heart disease and discuss the evolving role of catheter ablation in decreasing ventricular arrhythmia recurrence.

Outcomes of Ventricular Tachycardia Ablation Using Percutaneous Left Ventricular Assist Devices.

BACKGROUND: Although percutaneous left ventricular assist devices (pLVADs) facilitate mapping and ablation of hemodynamically unstable ventricular tachycardia (VT), there is limited data whether clinical outcomes are improved. We sought to retrospectively compare the outcomes of patients undergoing scar-related VT ablation with and without pLVAD support. METHODS AND RESULTS: The study population comprised 194 patients (109 pLVAD and 85 non-pLVAD). The pLVAD group more often had dilated cardiomyopathy (33% versus 13%; P=0.001), New York Heart Association heart failure class ≥III (51% versus 25%; P<0.001), lower left ventricular ejection fractions (26±10% versus 39±16%; P<0.001), and electrical storm (49% versus 34%; P=0.04). Procedure times (422±112 versus 330±92 minutes; P<0.001), postablation VT inducibility (20% versus 7%; P=0.02), and length of subsequent hospitalization (median 6 versus 4 days; P=0.001) were all higher in the pLVAD group. During median follow-up of 215 days, the primary end point (recurrent VT, heart transplantation, or death) occurred in 36% of the pLVAD versus 26% of the non-pLVAD groups (P=0.14). After propensity matching for differences between groups, no differences were seen between groups for both acute procedural outcomes and the primary end point. CONCLUSIONS: In this large single-center scar-related VT ablation experience, despite the worse clinical status of the patients selected for pLVAD support, clinical outcomes were better than expected and were similar to healthier patients not receiving hemodynamic support. Patients with dilated cardiomyopathy presenting with electrical storm, advanced heart failure, and severe left ventricular dysfunction most frequently received hemodynamic support during VT ablation.