Safety and Effectiveness of Pulsed Field Ablation to Treat Atrial Fibrillation: One-Year Outcomes From the MANIFEST-PF Registry.

BACKGROUND: Pulsed field ablation is a novel nonthermal cardiac ablation modality using ultra-rapid electrical pulses to cause cell death by a mechanism of irreversible electroporation. Unlike the traditional ablation energy sources, pulsed field ablation has demonstrated significant preferentiality to myocardial tissue ablation, and thus avoids certain thermally mediated complications. However, its safety and effectiveness remain unknown in usual clinical care. METHODS: MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-Approval Clinical Use of Pulsed Field Ablation) is a retrospective, multinational, patient-level registry wherein patients at each center were prospectively included in their respective center registries. The registry included all patients undergoing postapproval treatment with a multielectrode 5-spline pulsed field ablation catheter to treat atrial fibrillation (AF) between March 1, 2021, and May 30, 2022. The primary effectiveness outcome was freedom from clinical documented atrial arrhythmia (AF/atrial flutter/atrial tachycardia) of ≥30 seconds on the basis of electrocardiographic data after a 3-month blanking period (on or off antiarrhythmic drugs). Safety outcomes included the composite of acute (<7 days postprocedure) and latent (>7 days) major adverse events. RESULTS: At 24 European centers (77 operators) pulsed field ablation was performed in 1568 patients with AF: age 64.5±11.5 years, female 35%, paroxysmal/persistent AF 65%/32%, CHA2DS2-VASc 2.2±1.6, median left ventricular ejection fraction 60%, and left atrial diameter 42 mm. Pulmonary vein isolation was achieved in 99.2% of patients. After a median (interquartile range) follow-up of 367 (289-421) days, the 1-year Kaplan-Meier estimate for freedom from atrial arrhythmia was 78.1% (95% CI, 76.0%-80.0%); clinical effectiveness was more common in patients with paroxysmal AF versus persistent AF (81.6% versus 71.5%; P=0.001). Acute major adverse events occurred in 1.9% of patients. CONCLUSIONS: In this large observational registry of the postapproval clinical use of pulsed field technology to treat AF, catheter ablation using pulsed field energy was clinically effective in 78% of patients with AF.

First-in-human clinical series of a novel conformable large-lattice pulsed field ablation catheter for pulmonary vein isolation.

AIMS: Pulsed field ablation (PFA) has significant advantages over conventional thermal ablation of atrial fibrillation (AF). This first-in-human, single-arm trial to treat paroxysmal AF (PAF) assessed the efficiency, safety, pulmonary vein isolation (PVI) durability and one-year clinical effectiveness of an 8 Fr, large-lattice, conformable single-shot PFA catheter together with a dedicated electroanatomical mapping system. METHODS AND RESULTS: After rendering the PV anatomy, the PFA catheter delivered monopolar, biphasic pulse trains (5-6 s per application; ∼4 applications per PV). Three waveforms were tested: PULSE1, PULSE2, and PULSE3. Follow-up included ECGs, Holters at 6 and 12 months, and symptomatic and scheduled transtelephonic monitoring. The primary and secondary efficacy endpoints were acute PVI and post-blanking atrial arrhythmia recurrence, respectively. Invasive remapping was conducted ∼75 days post-ablation. At three centres, PVI was performed by five operators in 85 patients using PULSE1 (n = 30), PULSE2 (n = 20), and PULSE3 (n = 35). Acute PVI was achieved in 100% of PVs using 3.9 ± 1.4 PFA applications per PV. Overall procedure, transpired ablation, PFA catheter dwell and fluoroscopy times were 56.5 ± 21.6, 10.0 ± 6.0, 19.1 ± 9.3, and 5.7 ± 3.9 min, respectively. No pre-defined primary safety events occurred. Upon remapping, PVI durability was 90% and 99% on a per-vein basis for the total and PULSE3 cohort, respectively. The Kaplan-Meier estimate of one-year freedom from atrial arrhythmias was 81.8% (95% CI 70.2-89.2%) for the total, and 100% (95% CI 80.6-100%) for the PULSE3 cohort. CONCLUSION: Pulmonary vein isolation (PVI) utilizing a conformable single-shot PFA catheter to treat PAF was efficient, safe, and effective, with durable lesions demonstrated upon remapping.

Clinical outcomes of radiofrequency catheter ablation of ventricular tachycardia in patients with hypertrophic cardiomyopathy.

BACKGROUND: Monomorphic ventricular tachycardia (VT) is rare in patients with hypertrophic cardiomyopathy (HCM), management of which is challenging. Limited data exists on the utility of catheter ablation for the treatment of VT in this population. OBJECTIVES: We aimed to assess clinical outcomes of catheter ablation for VT in HCM patients. METHODS: A systematic search, without language restriction, using PubMed, EMBASE, SCOPUS, Google Scholar, and ClinicalTrials.gov was performed. The meta-analysis was performed using a meta-package for R version 4.0/RStudio version 1.2 and Freeman Tukey double arcsine method to establish the variance of raw proportions. Outcomes measured included (1) acute procedure success (defined as noninducible for clinical VT), (2) freedom from VT at follow-up, (3) mortality. RESULTS: This systematic review of six studies (three from the United States and three from Japan) incorporated a total of 68 drug-refractory HCM patients who underwent VT radiofrequency catheter ablation (mean age 57.6 ± 13.3 years, mean LVEF 45.8 ± 15.4%, 85% men, maximum septal wall thickness 17.4 ± 4.6 mm, and 32.3% with an apical aneurysm). Acute procedural success was achieved in 84.5% patients (95% confidence interval [CI]: 70.6%-95.2%) with 27.9% patients had recurrent VT requiring multiple ablations (median 1, IQR 1-3). During the follow-up period (18.3 ± 11.7 months), the pooled incidence of freedom from recurrent VT after index procedure was 70.2% (95% CI: 51.9%-86.2%), while after the last ablation was 82.8% (95% CI: 57%-99.2%). There were two deaths during follow-up, one from heart failure and one from SCD 0.8% (95% CI: 0%-5.8%). CONCLUSION: The results of our pooled analysis demonstrated that catheter ablation for VT in HCM patients was associated with high acute procedural success, and reduced VT recurrence-findings comparable to previously published reports in other disease substrates.

Adverse events associated with amplatzer left atrial appendage occlusion delivery system: A Food and Drug Administration MAUDE database study.

BACKGROUND: Dual occlusive closure mechanism (disc and lobe type), Amulet device (Abbott; a second-generation device that has replaced Amplatzer Cardiac Plug) was approved by the Food and Drug Administration (FDA) in August 2021 for percutaneous left atrial appendage occlusion (LAAO). However, real-world safety data on the delivery system (Amplatzer Cardiac Plug and Amplatzer Amulet device) are lacking. OBJECTIVE: We sought to assess the type of adverse events associated with the Amplatzer LAAO delivery system using the FDA Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: A MAUDE database search was conducted on March 31, 2023, for reports received between February 2013 and March 2023 to capture all adverse events. RESULTS: A total of 59 adverse events were reported, of which 58 were sheath-related events, and one was a wire-related event. The most commonly encountered issue was air embolism (19%, 11 events), followed by sheath thrombosis (13.8%, eight events, two of which were also associated with device thrombosis), kinked sheath (10.3%, six events), and sheath deformation (8.6%, five events). Patient-related adverse events included pericardial effusion requiring pericardiocentesis (22.4%, 13 events), vascular complications (20.7%, 12 events), and device dislodgement (5.2%, three events). CONCLUSION: LAAO-related adverse events are increasingly being reported using the Amplatzer LAAO delivery sheath. It is anticipated that improvements in device technology, the advent of steerable sheaths, and operator experience will minimize these complications.

Adverse events associated with AveirTM VR leadless pacemaker: A Food and Drug Administration MAUDE database study.

BACKGROUND: Leadless pacemaker (LP) offers an innovative approach for treating bradyarrhythmia, thus avoiding pacemaker pocket and lead-related complications. The Food and Drug Administration (FDA) has recently approved the Aveir™ leadless pacing system (screw-in type LP). METHODS: We queried the FDA MAUDE database to study the safety profile and assess the types of complications with this relatively novel device technology. A MAUDE database search was conducted on January 20, 2023, for reports received post-FDA approval to capture all adverse events. RESULTS: A total of 98 medical device report were reported for Aveir™ LP. After excluding duplicate, programmer-related, or introducer-sheath-related entries (n = 34), 64 entries were included. The most commonly encountered problem was high threshold/noncapture (28.1%, 18 events), followed by stretched helix (17.2%, 11 events) and device dislodgement (15.6%, ten events-5 intraprocedural, while 5 in the postoperative Day 1). Other reported events included high impedance (14.1%, nine events), sensing issues (12.5%, eight events), bent/broken helix (7.8%, five events), premature separation (4.7%, three events), interrogation problem (3.1%, two events), low impedance (3.1%, two events), premature battery depletion (1.6%, one event) and inadvertent MRI mode switch (1.6%, one event) and miscellaneous (15.6%, n = 10). There were eight serious patient injury events-pericardial effusion requiring pericardiocentesis (7.8%, five events) due to cardiac perforation that resulted in two deaths (3.1%) followed by sustained ventricular arrhythmias (4.6%, n = 3). CONCLUSION: In our study assessing the real-world safety profile of the Aveir™ LP, serious adverse events have been reported-life-threatening ventricular arrhythmias, pericardial effusion, device explantation/reimplantation, and death.

SGLT2 inhibitors reduce sudden cardiac death risk in heart failure: Meta-analysis of randomized clinical trials.

INTRODUCTION: Multiple randomized controlled trials have demonstrated sodium-glucose cotransporter-2 inhibitors (SGLT2i) decrease the composite endpoint of cardiovascular death or heart failure hospitalizations in all heart failure patients. It is uncertain whether SGLT2i impacts the risk of sudden cardiac death in patients with heart failure. METHODS: A comprehensive search was performed to identify relevant data published before August 28, 2022. Trials were included if: (1) all patients had clinical heart failure (2) SGLT2i and placebo were compared (3) all patients received conventional medical therapy and (4) reported outcomes of interest (sudden cardiac death [SCD], ventricular arrhythmias, atrial arrhythmias). RESULTS: SCD was reported in seven of the eleven trials meeting selection criteria: 10 796 patients received SGLT2i and 10 796 received placebo. SGLT2i therapy was associated with a significant reduction in the risk of SCD (risk ratios [RR]: 0.68; 95% confidence intervals [CI]: 0.48-0.95; p = .03; I2 = 0%). Absent dedicated rhythm monitoring, there were no significant differences in the incidence of sustained ventricular arrhythmias not associated with SCD (RR: 1.03; 95% CI: 0.83-1.29; p = .77; I2 = 0%) or atrial arrhythmias (RR: 0.91; 95% CI: 0.77-1.09; p = .31; I2 = 29%) between patients receiving an SGLT2i versus placebo. CONCLUSION: SGLT2i therapy is associated with a reduced risk of SCD in patients with heart failure receiving contemporary medical therapy. Prospective trials are needed to determine the long-term impact of SGLT2i therapy on atrial and ventricular arrhythmias.

A single-center experience with early adoption of physiologic pacing approaches.

BACKGROUND: Increasing interest in physiological pacing has been countered with challenges such as accurate lead deployment and increasing pacing thresholds with His-bundle pacing (HBP). More recently, left bundle branch area pacing (LBBAP) has emerged as an alternative approach to physiologic pacing. OBJECTIVE: To compare procedural outcomes and pacing parameters at follow-up during initial adoption of HBP and LBBAP at a single center. METHODS: Retrospective review, from September 2016 to January 2020, identified the first 50 patients each who underwent successful HBP or LBBAP. Pacing parameters were then assessed at first follow-up after implantation and after approximately 1 year, evaluating for acceptable pacing parameters defined as sensing R-wave amplitude >5 mV, threshold <2.5 V @ 0.5 ms, and impedance between 400 and 1200 Ω. RESULTS: The HBP group was younger with lower ejection fraction compared to LBBAP (73.2 ± 15.3 vs. 78.2 ± 9.2 years, p = .047; 51.0 ± 15.9% vs. 57.0 ± 13.1%, p = .044). Post-procedural QRS widths were similarly narrow (119.8 ± 21.2 vs. 116.7 ± 15.2 ms; p = .443) in both groups. Significantly fewer patients with HBP met the outcome for acceptable pacing parameters at initial follow-up (56.0% vs. 96.4%, p = .001) and most recent follow-up (60.7% vs. 94.9%, p ≤ .001; at 399 ± 259 vs. 228 ± 124 days, p ≤ .001). More HBP patients required lead revision due to early battery depletion or concern for pacing failure (0% vs. 13.3%, at a mean of 664 days). CONCLUSION: During initial adoption, HBP is associated with a significantly higher frequency of unacceptable pacing parameters, energy consumption, and lead revisions compared with LBBAP.

Periprocedural outcomes of protamine administration after catheter ablation of atrial fibrillation.

BACKGROUND: Perioperative anticoagulation management with uninterrupted or minimally interrupted anticoagulation during atrial fibrillation (AF) ablation is thought to be critical to minimize thromboembolic complications. Protamine is often administered to neutralize the effects of heparin and expedite vascular hemostasis post-procedure. OBJECTIVE: We performed a systematic review and meta-analysis to determine the effectiveness of protamine to expedite vascular hemostasis and ambulation in patients undergoing AF ablation. METHODS: Electronic searches on PubMed, The Cochrane Library, EMBASE, EBSCO, Web of Science, and CINAHL databases from the inception through August 7, 2021, were performed. The primary outcomes included-time to hemostasis (minutes) and time to ambulation (minutes). The secondary outcomes included - any vascular complications (excluding minor hematoma), minor hematoma, or cerebrovascular accidents (CVA). RESULTS: A total of 5 eligible studies (3 retrospective cohort studies and two randomized trials) consisting of 1012 patients (515 patients received protamine group and 497 patients did not receive protamine group) were included in the meta-analysis. There was a significant reduction in time to ambulation [weighted mean difference (WMD) -176.6 minutes, 95% Confidence interval (CI) -266.9 to -86.3; p < 0.01] and time to hemostasis (WMD -13.72 minutes, 95% CI -22 to -5.4, p < 0.01) in the protamine group compared to the contrary. At a follow-up up to 3 months, there was no statistical difference between the two groups with regards to vascular complications (2.9% vs. 7.4%; Risk ratio (RR) 0.46 95% CI 0.17 to 1.24; p = 0.12), minor hematoma (2.1% vs. 5.8%; RR 0.43, 95% CI 0.16 to 1.2; p = 0.11) or CVA (0 vs. 0.3%; RR 0.62, 95% CI 0.08 to 4.98; p = 0.65). CONCLUSION: Protamine administration was associated with reduced time to ambulation (176 minutes reduction) and time to hemostasis (13 minutes reduction) without an increase in any adverse events.

Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF).

AIMS: Pulsed field ablation (PFA) is a novel atrial fibrillation (AF) ablation modality that has demonstrated preferential tissue ablation, including no oesophageal damage, in first-in-human clinical trials. In the MANIFEST-PF survey, we investigated the 'real world' performance of the only approved PFA catheter, including acute effectiveness and safety-in particular, rare oesophageal effects and other unforeseen PFA-related complications. METHODS AND RESULTS: This retrospective survey included all 24 clinical centres using the pentaspline PFA catheter after regulatory approval. Institution-level data were obtained on patient characteristics, procedure parameters, acute efficacy, and adverse events. With an average of 73 patients treated per centre (range 7-291), full cohort included 1758 patients: mean age 61.6 years (range 19-92), female 34%, first-time ablation 94%, paroxysmal/persistent AF 58/35%. Most procedures employed deep sedation without intubation (82.1%), and 15.1% were discharged same day. Pulmonary vein isolation (PVI) was successful in 99.9% (range 98.9-100%). Procedure time was 65 min (38-215). There were no oesophageal complications or phrenic nerve injuries persisting past hospital discharge. Major complications (1.6%) were pericardial tamponade (0.97%) and stroke (0.4%); one stroke resulted in death (0.06%). Minor complications (3.9%) were primarily vascular (3.3%), but also included transient phrenic nerve paresis (0.46%), and TIA (0.11%). Rare complications included coronary artery spasm, haemoptysis, and dry cough persistent for 6 weeks (0.06% each). CONCLUSION: In a large cohort of unselected patients, PFA was efficacious for PVI, and expressed a safety profile consistent with preferential tissue ablation. However, the frequency of 'generic' catheter complications (tamponade, stroke) underscores the need for improvement.

Surgical left atrial appendage occlusion in patients with left ventricular assist device.

BACKGROUND: Thromboembolic (TE) events are among the most common and devastating adverse events in patients with continuous-flow left ventricular assist device (cf-LVAD). Given the high burden of AF among cf-LVAD patients, we sought to evaluate the effect of concomitant surgical LAAO in patients receiving cf-LVAD. METHODS: A systematic search using electronic databases was performed using the keywords: "left atrial appendage occlusion" and "left ventricular assist device." Statistical analysis was performed using metapackage for R version 4.0 and Rstudio version 1.2. Mantel-Haenszel risk ratio (RR) random-effects model was used to summarize data between two groups. The primary outcomes included: (a) stroke; (b) LVAD pump thrombosis; (c) all-cause mortality RESULTS: Three studies with a total of 305 patients (LAAO = 68 and No-LAAO = 237) were included in the analysis. HeartMate II (39%) and Heartware (27.5%) were the two most common cf-LVADs utilized, while only 5% received HeartMate III. At a mean follow up of 1.47 years, LAAO group had a lower risk of stroke (8.8% vs. 15.2%, RR 0.64; 95% CI 0.28-1.49), LVAD pump thrombosis (1.5% vs. 3.8%, RR 0.28; 95% CI 0.05-1.55) and all-cause mortality (5.9% vs. 20.2%, RR 0.69; 95% CI 0.19-2.52) when compared with no-LAAO group, but the difference did not reach statistical significance. CONCLUSION: Concomitant surgical LAAO at the time of cf-LVAD implantation demonstrated a trend toward positive outcomes and was not associated with adverse outcomes during the follow-up period, though the results were not statistically significant.

Guidance for Cardiac Electrophysiology During the COVID-19 Pandemic from the Heart Rhythm Society COVID-19 Task Force; Electrophysiology Section of the American College of Cardiology; and the Electrocardiography and Arrhythmias Committee of the Council on Clinical Cardiology, American Heart Association.

Coronavirus disease 2019 (COVID-19) is a global pandemic that is wreaking havoc on the health and economy of much of human civilization. Electrophysiologists have been impacted personally and professionally by this global catastrophe. In this joint article from representatives of the Heart Rhythm Society, the American College of Cardiology, and the American Heart Association, we identify the potential risks of exposure to patients, allied healthcare staff, industry representatives, and hospital administrators. We also describe the impact of COVID-19 on cardiac arrhythmias and methods of triage based on acuity and patient comorbidities. We provide guidance for managing invasive and noninvasive electrophysiology procedures, clinic visits, and cardiac device interrogations. In addition, we discuss resource conservation and the role of telemedicine in remote patient care along with management strategies for affected patients.

Direct oral anticoagulants to treat left ventricular thrombus-A systematic review and meta-analysis: ELECTRAM investigators.

INTRODUCTION: Though current guidelines currently recommend using warfarin, there is also a growing interest in the utilization of direct oral anticoagulants (DOACs) to treat left ventricular (LV) thrombus. METHODS: We performed a systematic search using PubMed, SCOPUS, EMBASE, Google Scholar, and ClinicalTrials.gov from inception to September 30, 2020, for studies that had reported outcomes in patients with left ventricular thrombus treated with DOACs (PROSPERO registration number CRD42020219761). RESULTS: Twelve studies (n = 867 patients) were included in the analysis. The pooled incidence of the systemic embolic events (SEE) with DOACs was 2.7%, whereas the thrombus resolution rate was 86.6%. The pooled incidence of overall bleeding (composite of major and minor bleeding) and major bleeding with DOACs were 5.6% and 1.1%, respectively. No significant difference was observed in terms of SEE (OR 0.81, 95% confidence interval [CI] 0.44-1.52, p = .54), major bleeding (OR 0.29, 95% CI 0.07-1.26, p = .24), and failure of LV thrombus resolution (OR 0.86, 95% CI 0.28-2.58, p = .68); whereas overall bleeding was significantly low in patients with LV thrombus treated with DOACs compared to vitamin K antagonists (VKAs) (OR 0.33, 95% CI 0.14-0.81, p = .02). CONCLUSION: Our study demonstrates no significant difference in SEE, major bleeding, or failure of LV thrombus resolution between the two groups, thus demonstrating that DOACs are an efficacious and safe alternative for the treatment of LV thrombus compared to VKAs. However, further well-designed prospective trials are needed to answer important clinical questions-optimal dosing/duration of DOACs and its safety in the background of antiplatelet therapy.

Implantable cardioverter-defibrillator in patients with spontaneous coronary artery dissection presenting with sudden cardiac arrest.

INTRODUCTION: The role of secondary prevention implantable cardioverter-defibrillator (ICD) remains uncertain in spontaneous coronary artery dissection (SCAD) patients presenting with sudden cardiac arrest (SCA). METHODS: We aimed at assessing the outcomes following SCA and the role of ICD therapy in SCAD. The meta-analysis was performed using a meta-package for R version 4.0/RStudio version 1.2 and the Freeman-Tukey double arcsine method to establish the variance of raw proportions. Outcomes measured included-(1) incidence of ICD implantation, (2) appropriate and inappropriate ICD therapy, (3) recurrence of SCAD and SCA, and (4) all-cause mortality. RESULTS: Five studies, including 139 SCAD patients with SCA met study inclusion criteria. The mean age was 47.3 ± 12.8 years, mean left ventricular ejection fraction 43.8 ± 10.8%, 88% were female (12% had pregnancy-associated SCAD. Causes of SCA included ventricular arrhythmia (97.9%, n = 136) and pulseless electrical activity (2.1%, n = 3). Overall, 20% patients (95% confidence interval [CI]: 7.1%-36.6%, I2 = 68%) received ICD, of which 1.2% (95% CI: 0%-15.8%, I2 = 0%) and 1% (95% CI: 0%-15.3%, I2 = 0%) patients received appropriate and inappropriate ICD therapies, respectively, during follow-up period (4.1 ± 3.3 years). Incidence of recurrent SCAD was 9% (95% CI: 2.85%-17.5%, I2 = 25%), and recurrent SCA was 3.85% patients (95% CI: 0.65%-8.7%, I2 = 0%; one patient with appropriate ICD therapy). The pooled incidence of all-cause mortality was 6.2% (95% CI: 0.6%-15.1%, I2 = 44%). CONCLUSION: Although ICD therapy is beneficial in patients (all comers) presenting with cardiac arrest; the risk-benefit ratio of secondary prevention ICD arrest remains unclear. Patient-centered shared decision-making and risk-benefit ratio assessment should be performed before consideration for ICD implantation.

Safety and efficacy of left atrial appendage closure using an epicardial suture snaring device: Systematic review and current status.

INTRODUCTION: The LARIAT epicardial suture snaring device has been fraught with technical challenges and procedural complications. Over time, technique modification and improved operator experience have helped overcome many of these challenges. METHODS AND RESULTS: Studies reporting left atrial appendage epicardial closure over a 12-year period from 2009 to 2020 were evaluated. The primary efficacy outcome evaluated was left atrial appendage closure with residual flow ≤1 mm. Safety outcomes evaluated were periprocedural and long term complications after device placement. Nine studies consisting of 1430 patients were included in this analysis, of which 1386 (97%) underwent successful device placement. The mean age was 69.3 years, with a mean CHADS2 -VASC score of 3.78. Primary efficacy end point was achieved in 95.8% patients immediately after device placement, and in 92.8% patients on long term follow-up. Early procedural complications consisted of pericardial effusion 5.6%, cardiac perforation 2.7%, pericarditis 2.6%, and need for open heart surgery 1.5%. Long term complications consisted of all-cause mortality 2.3%, stroke 1.5%, and left atrial appendage thrombus 2.3%. Reduced complications were noted using micropuncture needles (2.20% vs. 10.14%; p < .0001), a longer duration pericardial drainage, and use of anti-inflammatory medications (1.58% vs. 8.4%). Oral anticoagulation use decreased from 44.7% to 22.9% post device implantation, and to 8.5% on last clinical follow up. CONCLUSIONS: The LARIAT device is effective in epicardial closure of the left atrial appendage. Improvement in device techniques such as use of micropuncture needle, prophylactic colchicine, and maintenance of a pericardial drain have helped improve safety over time.

Intracardiac echocardiography-guided implantation of the Watchman FLX left atrial appendage closure device.

BACKGROUND: The next-generation Watchman FLX left atrial appendage closure (LAAC) device has: (1) an atraumatic closed distal end, (2) reduced height, (3) a recessed screw hub to decrease device-related thrombus (DRT), (4) two rows of J-shape anchors so redeployment is possible after full recapture, and (5) ability to treat a greater size range of LAA ostia. OBJECTIVE: To report, for the first time, the feasibility and safety of intracardiac echocardiography (ICE)-guided Watchman FLX implantation. METHODS: A single-center prospective registry of atrial fibrillation patients planned for LAAC with the FLX device underwent ICE-guided implantation with conscious sedation. Transesophageal echocardiography (TEE) imaging was done preprocedure (to assess LAA size and exclude thrombus) and at clinical follow-up at 6-12 weeks. Clinical outcomes were LAA closure success, complications, leak, or DRT on follow-up TEE and major safety events. RESULTS: The study included 30 patients: age 75 ± 8 years, 53% men, CHA2 DS2 -VASc 4.6 ± 1.6, and HAS-BLED 3.4 ± 1.1. The primary indication was prior bleeding in 60% (72% GI bleeding). The LAA orifice width and length were 22.7 ± 3.1 and 25.7 ± 5.7 mm, respectively. Technical success was 100% (the first-choice device was used in 28 of 30). Procedure time was less than 30 min in 27 of 30 cases, with 36 ± 15 ml contrast used. The final device size was 29.2 ± 4.7 mm with 21.6 ± 4.5% compression. There were no procedure-related complications. Follow-up TEE at a median 47 days follow-up showed 100% device success with no DRT or peridevice leak ≥5 mm. Major safety events occurred in 6.6% (2/30). CONCLUSION: The Watchman FLX device can be safely implanted with intraprocedural ICE imaging instead of TEE.

Role of immunosuppressive therapy in the management refractory postprocedural pericarditis.

OBJECTIVE: To assess the safety and efficacy of a novel immunosuppressive regimen-combination Methotrexate/Prednisone (cMtx/P)-in the management of severe refractory rPPP. METHODS: In this multicenter, nonrandomized, retrospective, observational study, 408 consecutive patients diagnosed with persistent rPPP between 2017 and 19 were included. Patients with refractory symptoms despite 3 months of conventional therapy were initiated on a 4-week regimen of oral steroids. Persistence of symptoms at this point, that is, rPPP (n = 25; catheter based = 18, open surgical = 7) prompted therapy with Methotrexate (7.5-15 mg weekly) with folate supplementation along with low dose prednisone (5 mg PO) for a further 3 months. Patients were followed for a total of 11.3 ± 1.8 months. RESULTS: Treatment refractory rPPP occurred in 6.1% of the study population prompting immunosuppressive therapy with cMtx/P. All patients demonstrated complete symptom resolution following 3 months of treatment with an 85% decline in clinically significant pericardial effusions. One patient developed recurrent pericarditis during the 11-month follow-up. Therapy was well tolerated with no significant drug related adverse effects. CONCLUSION: cMtx/P therapy is a safe and effective adjunct in the management of rPPP refractory to standard therapy.

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.

Renal sympathetic denervation for the treatment of recurrent ventricular arrhythmias-ELECTRAM investigators.

INTRODUCTION: Renal sympathetic denervation (RSDN) is an alternate management approach for refractory ventricular arrhythmias (VAs). We aimed to perform a systematic review of clinical outcomes on the impact of RSDN on refractory VA patients. METHODS: A systematic search without language restriction, using PubMed, EMBASE, SCOPUS, Google Scholar, and ClinicalTrials.gov from inception to August 18, 2020, was performed for the studies that reported outcomes in patients who underwent RSDN for VA. The outcomes studied were-(1) recurrent VA; and (2) all-cause mortality. RESULTS: Five studies (from 2014 to 2018) with a total of 51 VA patients met study inclusion criteria. The mean age was 61.92 ± 11.76 years, and 78.4% were men. The pooled incidence of short-term (3 months or less) and long-term (more than 3 months) VA recurrence was 63.85% (95% CI 16.75 to 99.32) and 10.52% (95% CI 0.14 to 28.75), respectively. When stratified by the number of VA episodes, there was a significant reduction in mean VA episodes (SMD -3.79, 95% CI -6.59 to -0.98, p < .01), ICD shocks (SMD -1.71, 95% CI -3.0 to -0.42, p < .01) and anti-tachycardia pacing (SMD -1.21, 95% CI -1.98 to -0.44, p < .01) following RSDN denervation. The pooled incidence of all-cause mortality after RSDN was 10.16% (95% CI 1.08 to 24.12). There were no major vascular complications, one minor vascular complication-small non-flow limiting renal artery dissection (no intervention needed). CONCLUSION: RSDN appears to be a safe and effective treatment strategy in patients with prior failed antiarrhythmic drugs and catheter ablation for recurrent ventricular arrhythmia and electrical storm.

Current practice and future prospects in left atrial appendage occlusion.

The thromboembolic complications of Atrial fibrillation (AF) remain a major problem in contemporary clinical practice. Despite advances and developments in anticoagulation strategies, therapy is complicated by the high risk of bleeding complications and need for meticulous medication compliance. Over the past few decades, the left atrial appendage has emerged as a promising therapeutic target to prevent thromboembolic events while mitigating bleeding complications and compliance issues. Emerging data indicates that it is a safe, effective and feasible alternative to systemic anticoagulation in patients with non-valvular AF. A number of devices have been developed for endocardial or epicardial based isolation of the left atrial appendage. Increasing experience has improved overall procedural safety and ease while simultaneously reducing device related complication rates. Furthermore, increasing recognition of the non-mechanical advantages of this procedure has led to further interest in its utility for further indications beyond the prevention of thromboembolic complications. In this review, we present a comprehensive overview of the evolution of left atrial appendage occlusion, commercially available devices and the role of this modality in the current management of AF. We also provide a brief outline of the landmark trials supporting this approach as well as the ongoing research and future prospects of left atrial appendage occlusion.

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.