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A nation's health and economic development are inextricably and synergistically connected. Stark differences exist between wealthy and developing nations in the use of cardiac implantable electronic devices (CIEDs). Cardiovascular disease is now the leading cause of death in low- and middle-income countries (LMIC), with a significant burden from rhythm-related diseases. As science, technology, education, and regulatory frameworks have improved, CIED recycling for exportation and reuse in LMIC has become possible and primed for widespread adoption. In our manuscript, we outline the science and regulatory pathways regarding CIED reuse. We propose a pathway to advance this technology that includes creating a task force to establish standards for CIED reuse, leveraging professional organizations in areas of need to foster the professional skills for CIED reuse, collaborating with regulatory agencies to create more efficient regulatory expectations and bring the concept to scale, and establishing a global CIED reuse registry for quality assurance and future science.

Aims No prior study has been adequately powered to evaluate real-world safety outcomes in those receiving adjunctive ablation lesions beyond pulmonary vein isolation (PVI). We sought to evaluate characteristics and in-hospital complications among patients undergoing PVI with and without adjunctive lesions. Methods and results Patients in the National Cardiovascular Data Registry AFib Ablation Registry undergoing first-time atrial fibrillation (AF) ablation between 2016 and 2020 were identified and stratified into paroxysmal (PAF) and persistent AF, and separated into PVI only, PVI + cavotricuspid isthmus (CTI) ablation, and PVI + adjunctive (superior vena cava isolation, coronary sinus, vein of Marshall, atypical atrial flutter lines, other). Adjusted odds of adverse events were calculated using multivariable logistic regression. A total of 50 937 patients [PAF: 30 551 (60%), persistent AF: 20 386 (40%)] were included. Among those with PAF, there were no differences in the adjusted odds of complications between PVI + CTI or PVI + adjunctive when compared with PVI only. Among persistent AF, PVI + adjunctive was associated with a higher risk of any complication [3.0 vs. 4.5%, odds ratio (OR) 1.30, 95% confidence interval (CI) 1.07–1.58] and major complication (0.8 vs. 1.4%, OR 1.56, 95% CI 1.10–2.21), while no differences were observed in PVI + CTI compared with PVI only. Overall, there was high heterogeneity in adjunctive lesion type, and those receiving adjunctive lesions had a higher comorbidity burden. Conclusion Additional CTI ablation was common without an increased risk of complications. Adjunctive lesions other than CTI are commonly performed in those with more comorbidities and were associated with an increased risk of complications in persistent AF, although the current analysis is limited by high heterogeneity in adjunctive lesion set type.

BACKGROUND: Inappropriate sinus tachycardia (IST) is defined as resting heart rate >100 beats/min and average 24-hour heart rate >90 beats/min. It is associated with distressing symptoms and significant loss of quality of life. Drugs are not effective in symptom control of IST in up to 30% of patients. Catheter ablation of the sinus node has a high recurrence rate, and the complications are significant. Recently, a novel hybrid sinus node-sparing ablation approach for IST was described. OBJECTIVE: The objective of the Hybrid Epicardial and Endocardial Sinus Node Sparing Ablation Therapy for Inappropriate Sinus Tachycardia (HEAL-IST) investigational device exemption trial (NCT05280093) is to evaluate safety and effectiveness of the hybrid sinus node-sparing ablation procedure for the treatment of symptomatic, drug-refractory or drug-intolerant IST. METHODS: The HEAL-IST trial is a prospective, multicenter, pivotal, single-arm trial. Up to 142 subjects in up to 40 centers will be treated in the trial with a Bayesian adaptive design. RESULTS: Subjects will be assessed for primary safety through 30 days post-hybrid ablation procedure. The primary effectiveness endpoint will be freedom from IST at 12 months. Freedom from IST will be defined as mean heart rate of ≤90 beats/min or at least a 15% reduction in mean heart rate as compared with baseline, in the absence of new or higher dosage of previously failed medications at a 24-month follow-up assessment. CONCLUSION: The HEAL-IST trial is the first multicenter trial evaluating hybrid IST ablation in patients with symptomatic IST and refractory or intolerant to drugs. The results of this study will help guide decision making regarding the best management in this population.

A significant proportion of patients infected by the severe acute respiratory syndrome-coronavirus (SARS-CoV2) (COVID-19) also have disorders affecting the cardiac rhythm. In this review, we provide an in-depth review of the pathophysiological mechanisms underlying the associated arrhythmic complications of COVID-19 infection and provide pragmatic, evidence-based recommendations for the clinical management of these conditions.Arrhythmic manifestations of COVID-19 include atrial arrhythmias such as atrial fibrillation or atrial flutter, sinus node dysfunction, atrioventricular conduction abnormalities, ventricular tachyarrhythmias, sudden cardiac arrest, and cardiovascular dysautonomias including the so-called long COVID syndrome. Various pathophysiological mechanisms have been implicated, such as direct viral invasion, hypoxemia, local and systemic inflammation, changes in ion channel physiology, immune activation, and autonomic dysregulation. The development of atrial or ventricular arrhythmias in hospitalized COVID-19 patients has been shown to portend a higher risk of in-hospital death.Arrhythmic complications from acute COVID-19 infection are commonly encountered in clinical practice, and COVID-19 patients with cardiac complications tend to have worse clinical outcomes than those without. Management of these arrhythmias should be based on published evidence-based guidelines, with special consideration of the acuity of COVID-19 infection, concomitant use of antimicrobial and anti-inflammatory drugs, and the transient nature of some rhythm disorders. Some manifestations, such as the long COVID syndrome, may lead to residual symptoms several months after acute infection. As the pandemic evolves with the discovery of new SARS-CoV2 variants, development and use of newer anti-viral and immuno-modulator drugs, and the increasing adoption of vaccination, clinicians must remain vigilant for other arrhythmic manifestations that may occur in association with this novel but potentially deadly disease.

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.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.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.

BACKGROUND: Medical treatment of inappropriate sinus tachycardia (IST) remains suboptimal. Radiofrequency sinus node (RF-SN) ablation has poor success and higher complication rates. OBJECTIVE: We aimed to compare clinical outcomes of the novel SN sparing hybrid ablation technique with those of RF-SN modification for IST management. METHODS: This is a multicenter prospective registry comparing the SN sparing hybrid ablation strategy with RF-SN modification. The hybrid procedure was performed using an RF bipolar clamp, isolating superior vena cava/inferior vena cava with the creation of a lateral line across the crista terminalis while sparing the SN region (identified by endocardial 3-dimensional mapping). RF-SN modification was performed by endocardial and/or epicardial mapping and ablation at the site of earliest atrial activation. RESULTS: Of the 100 patients (hybrid ablation group, n = 50; RF-SN group, n = 50), 82% were women, and the mean age was 22.8 years. Normal sinus rhythm and rate were restored in all patients in the hybrid group (vs 84% in the RF-SN group; P = .006). Hybrid ablation was associated with significantly better improvement in mean daily heart rate and peak 6-minute walk heart rate compared with RF-SN ablation. The RF-SN group had a significantly higher rate of redo procedures (100% vs 8%; P < .001), phrenic nerve injury (14% vs 0%; P = .012), lower acute pericarditis (48% vs 92%; P < .0001), permanent pacemaker implantation (50% vs 4%; P < .0001) than did the hybrid ablation group. CONCLUSION: The novel sinus node sparing hybrid ablation procedure appears to be more efficacious and safer in patients with symptomatic drug-resistant IST with long-term durability than RF-SN ablation.

Percutaneous pericardial access is the cornerstone of various procedures in clinical cardiology. The two commonly used methods utilizing large bore (LB) and smaller micropuncture (MP) needles often lead to inadvertent RV punctures. As both of these techniques push the pericardium inward, the novel blunt tip concealed needle device (BTCND) introduces the concept of bringing a small portion of the pericardium into a tube, where needle puncture and guidewire can be passed into the pericardial space all within the safety of the tube.The BTCND (Via One®, CardioVia, Nazareth, Israel) is a tool designed to allow for safe percutaneous subxiphoid pericardial access. In this preclinical study, a total of 18 procedures were performed in 5 female pigs. All procedures were performed under general anesthesia and under fluoroscopic guidance with a team of veterinarians and cardiac electrophysiologists. A laparoscopic camera was used to demonstrate and record the procedure. The Institutional Animal Care and Use Committees approved all preclinical experiments.A total of 18 procedures were performed on five female pigs. In all procedures, the physicians safely introduced guidewire into the pericardial space. Device operation was not associated with any adverse events or bleeding, nor was any damage seen to the pericardium, the heart, or other organs during the procedure.The result of our preclinical report demonstrates that the device is intuitive, easy to use, and effective for its intended use. Large preclinical studies are needed to validate the results of the study.

Artificial intelligence (AI) and machine learning (ML) have significantly impacted the field of cardiovascular medicine, especially cardiac electrophysiology (EP), on multiple fronts. The goal of this review is to familiarize readers with the field of AI and ML and their emerging role in EP. The current review is divided into 3 sections. In the first section, we discuss the definitions and basics of AI, ML, and big data. In the second section, we discuss their application to EP in the context of detection, prediction, and management of arrhythmias. Finally, we discuss the regulatory issues, challenges, and future directions of AI in EP.

BACKGROUND: Device-related thrombus (DRT) following left atrial appendage occlusion (LAAO) can lead to adverse clinical outcomes. DRT rates and outcomes from randomized trials are limited.OBJECTIVES: This analysis investigated the incidence, predictors, and clinical outcomes of DRT following LAAO in the Amulet IDE (AMPLATZER Amulet LAA Occluder Trial) trial.METHODS: Successful implants occurred in 903 patients with an Amulet occluder (dual occlusive mechanism device) and 885 patients with a Watchman device (single occlusive mechanism device). These patients were then followed through 18 months and DRT was assessed by transesophageal echocardiography.RESULTS: The overall incidence of DRT was 3.9% (n = 70) with 3.4% (n = 30) in dual occlusive mechanism device patients and 4.8% (n = 40) in single occlusive mechanism device patients. Most DRTs (n = 19 of 31) were identified early (≤45 days) on the dual occlusive mechanism device, whereas most of the DRTs (n = 31 of 42) were identified late (>45 days) on the single occlusive mechanism device. Strong predictors of DRT included atrial fibrillation at time of procedure (HR: 2.44; 95% CI: 1.42-4.22; P < 0.01), female sex (HR: 1.65; 95% CI: 1.01-2.71; P = 0.04), and older age (HR: 1.04; 95% CI: 1.01-1.08; P = 0.02). There were no stroke events following DRT in the dual occlusive mechanism device group and 3 stroke events following DRT in the single occlusive mechanism device group. Patients with DRT were at a greater risk for cardiovascular mortality compared with non-DRT patients (8.7% vs 3.9%; HR: 2.33; 95% CI: 1.01-5.39; P = 0.04).CONCLUSIONS: Incidence of DRT following LAAO was low. Early DRTs are seen with the dual occlusive mechanism device and late DRTs are seen with the single occlusive mechanism device. Increased cardiovascular mortality risk in patients with DRT should be further investigated. (AMPLATZER Amulet LAA Occluder Trial; NCT02879448).

PURPOSE SharpSense™ technology is an upgradable software enhancement introduced to the Abbott Confirm Rx™ insertable cardiac monitor (ICM). This study aims to characterize the real-world performance of SharpSense algorithms by comparing device detected pause and bradycardia episodes before and after the SharpSense upgrade. METHODS Confirm Rx devices with at least 90 days monitoring each before and after SharpSense upgrade were included in the study. Bradycardia and pause detections and subcutaneous electrocardiograms (SECGs) within 90 days before and after the upgrade were extracted from Merlin.net™ patient care network for evaluation and adjudicated by expert adjudicators. RESULTS A total of 197 devices were included in the analysis. Devices were implanted for syncope (35.0%), atrial fibrillation (32.5%), cryptogenic stroke (16.8%), and other indications including palpitations (15.7%). The SharpSense upgrade significantly reduced the number of bradycardia detections by 86.8% and pause detections by 93.1%. In adjudicated SECGs, the upgrade significantly reduced false positive (FP) bradycardia episodes by 91.5% and FP pause episodes by 82.8%. The percentage of devices with at least one FP episode was reduced from 39 to 20% for bradycardia and from 52 to 35% for pause. The number of devices with FP rate greater than 1 episode per week was reduced from 23 to 8% for bradycardia and from 39 to 20% for pause. CONCLUSIONS In this real-world performance evaluation, the algorithms incorporated in SharpSense software upgrade in Confirm Rx ICMs substantially reduced false positive bradycardia and pause detections and the number of transmitted SECGs for clinic review.

Objectives The aim of this study was to evaluate the efficacy of radiofrequency (RF) energy applications targeting the atrial side of a significant residual leak in patients with acute and chronic evidence of incomplete percutaneous left atrial appendage (LAA) occlusion. Background RF applications have been proved to prevent recanalization of intracranial aneurysms after coil embolization, thereby favoring complete sealing. From a mechanistic standpoint, in vitro and in vivo experiments have demonstrated that RF promotes collagen deposition and tissue retraction. Methods Forty-three patients (mean age 75 ± 7 years mean CHA2DS2-VASc score 4.6 ± 1.4, mean HAS-BLED score 4.0 ± 1.1) with residual leaks ≥4 mm after Watchman implantation were enrolled. Procedural success was defined as complete LAA occlusion or presence of a mild or minimal (1- to 2-mm) peridevice leak on follow-up transesophageal echocardiography (TEE), which was performed approximately 45 days after the procedure. Results RF-based leak closure was performed acutely after Watchman implantation in 19 patients (44.2%) or scheduled after evidence of significant leaks on follow-up TEE in 24 others (55.8%). The median leak size was 5 mm (range: 4-7 mm). On average, 18 ± 7 RF applications per patient (mean maximum contact force 16 ± 3 g, mean power 44 ± 2 W, mean RF time 5.1 ± 2.5 minutes) were performed targeting the atrial edge of the leak. Post-RF median leak size was 0 mm (range: 0-1 mm). A very low rate (2.3% [n = 1]) of major periprocedural complications was observed. Follow-up TEE revealed complete LAA sealing in 23 patients (53.5%) and negligible residual leaks in 15 (34.9%). Conclusions RF applications targeting the atrial edge of a significant peri-Watchman leak may promote LAA sealing via tissue remodeling, without increasing complications. (RF Applications for Residual LAA Leaks [REACT]; NCT04726943 )

Objectives This study evaluated the long-term efficacy of a standard antithrombotic strategy versus half-dose direct oral anticoagulation (DOAC) after Watchman implantation. Background No consensus currently exists on the selection of the most effective antithrombotic strategy to prevent device-related thrombosis (DRT) in patients undergoing endocardial left atrial appendage closure. Methods After successful left atrial appendage closure, consecutive patients were prescribed a standard antithrombotic strategy (SAT) or long-term half-dose DOAC (hdDOAC). The primary composite endpoint was DRT and thromboembolic (TE) and bleeding events. Results Overall, 555 patients (mean age 75 ± 8 years, 63% male; median CHA2DS2-VASc [congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65-74 years, sex category] score 4 [interquartile range (IQR): 3-6]; median HAS-BLED [hypertension, abnormal renal or liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol] score 3 [IQR: 2-4]) were included. Patients were categorized into 2 groups (SAT: n = 357 vs hdDOAC: n = 198). Baseline clinical characteristics were similar between groups. The median follow-up duration was 13 months (IQR: 12-15 months). DRT occurred in 12 (2.1%) patients, all in the SAT group (3.4% vs 0.0%; log-rank P = 0.009). The risk of nonprocedural major bleeding was significantly more favorable in the hdDOAC group (0.5% vs. 3.9%; log-rank P = 0.018). The rate of the primary composite endpoint of DRT and TE and major bleeding events was 9.5% in SAT patients and 1.0% in hdDOAC patients (HR: 9.8; 95% CI: 2.3-40.7; P = 0.002). Conclusions After successful Watchman implantation, long-term half-dose DOAC significantly reduced the risk of the composite endpoint of DRT and TE and major bleeding events compared with a standard, antiplatelet-based, antithrombotic therapy.

We compared the efficacy and safety of cardioneuroablation (CNA) vs. permanent pacing (PM) for recurrent cardioinhibitory vasovagal syncope (CI-VVS).One hundred sixty-two patients (CNA = 61, PM = 101), age 36 + 11 years) with syncope frequency of 6.7 ± 3.9/year were included in this multicenter study. All patients with CNA were provided by a single center, while patients with PM were provided by 4 other centers. In the CNA arm, an electroanatomic mapping guided approach was used to detect and ablate ganglionated plexus sites. Dual chamber rate drop response (RDR) or close loop stimulation (CLS) transvenous and leadless pacemakers were implanted using standard technique. The primary endpoint was freedom from syncope.Of 101 patients in the PM group, 39 received dual-chamber pacemaker implants with the CLS algorithm, 38 received dual-chamber pacemakers with the RDR algorithm, and 24 received a leadless pacemaker. At 1-year follow-up, 97% and 89% in the CNA and PM group met the primary endpoint (adjusted HR = 0.27, 95% CI 0.06-1.24, p = 0.09). No significant differences in adverse events were noted between groups. There was no significant association between age (HR:1.01, 95% CI 0.96-1.06, p = 0.655), sex (HR:1.15, 95% CI 0.38-3.51, p = 0.809), and syncope frequency in the past year (HR:1.10, 95% CI 0.97-1.25, p = 0.122) and the primary outcome in univariable analyses.After adjustment for patient characteristics, the medium-term syncope recurrence risk of CI-VVS patients who underwent CNA was similar to that of a population of patients undergoing pacemaker implantation with a similar safety profile.

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.We aimed to assess clinical outcomes of catheter ablation for VT in HCM patients.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.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%).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.

Subcutaneous implantable cardioverter-defibrillator (S-ICD) is an effective alternative to transvenous implantable cardioverter-defibrillator. General anesthesia (GA) is considered the standard sedation approach because of the pain caused by the manipulation of subcutaneous tissue with S-ICD implantation. However, GA carries several limitations, including additional risk of adverse events, prolonged in-room times, and increased costs.The purpose of this study was to define the effectiveness and safety of tumescent local anesthesia (TLA) in comparison to GA in patients undergoing S-ICD implantation.We performed a prospective, nonrandomized, controlled, multicenter study of patients referred for S-ICD implantation between 2019 and 2020. Patients were allocated to either TLA or GA on the basis of patient's preferences and/or anesthesia service availability. TLA was prepared using lidocaine, epinephrine, sodium bicarbonate, and sodium chloride. All patients provided written informed consent, and the institutional review board at each site provided approval for the study.Sixty patients underwent successful S-ICD implantation from July 2019 to November 2020. Thirty patients (50%) received TLA, and the rest GA. There were no differences between groups with regard to baseline characteristics. In-room and procedural times were significantly shorter with TLA (107.6 minutes vs 186 minutes; P.0001 and 53.2 minutes vs 153.7 minutes; P.0001, respectively). Pain was reported less frequently by patients who received TLA. The use of opioids was significantly reduced in patients who received TLA (23% vs 62%; P = .002).TLA is an effective and safe alternative to GA in S-ICD implantation. The use of TLA is associated with shorter in-room and procedural times, less postprocedural pain, and reduced usage of opioids and acetaminophen for analgesia.