Safety of multi-access site venous closure following catheter ablation of atrial fibrillation and flutter.

BACKGROUND: Following catheter ablation, vascular access management involves potential complications and prolonged recovery. Recently, suture-mediated closure (SMC) devices were approved for venous access procedures. The objective of this study is to evaluate the safety of a commercially available SMC for multiple access site venous closure by duplex ultrasound (DUS) in asymptomatic subjects with non-visible complications. METHODS: Thirty-six subjects (63 ± 10.7 years old, 12 female) were enrolled. Following catheter ablation for atrial fibrillation, all subjects had SMC of every venous access site. Subjects underwent DUS of femoral veins and arteries. DUS was performed at discharge, and again at 30 days. Subjects were evaluated for clinically apparent vascular complications. RESULTS: Mean procedure duration was 138.6 min, and the time to hemostasis was 3.1 min/access site and 9.5 min/subject. Median time to ambulation was 193.5 min, and median time to discharge was 5.95 h, with discharge as early as 2.4 h. A median of 2 sheaths/vein and a median of 2 SMC devices/vein were used. There were no major complications and a 16.7% (6/36) minor complication rate at discharge. All complications resolved at 30 days. The complication rate was not higher in patients with 2 SMC per access site as compared to the patients who just received 1 SMC per access site. CONCLUSIONS: This study demonstrates the safety of multi-access closure using SMC, following catheter ablation procedures, for closure of sites that use sheath sizes from ≤ 8F to ≥ 15F and for those that use 2 or more SMCs per access site.

Early repolarization: Electrocardiographic cues to distinguish benign from malignant variants.

Historically, early repolarization (ER) has been considered a marker of good health as it is more prevalent in athletes, younger persons, and at slower heart rates. However, contemporary reports, largely based on data from resuscitated sudden cardiac arrest patients, suggest an association between ER and an increased risk for sudden cardiac death and the development of malignant ventricular arrhythmias. Therefore, after we present a brief-case presentation, we intend to review a challenging topic in recognition of malignant variants and propose a four-step comprehensive approach to simplify ECG discrimination when assessing ER changes.

An Analysis of Telehealth in the Outpatient Management of Atrial Fibrillation During the COVID-19 Pandemic.

The COVID-19 pandemic accelerated adaption of a telehealth care model. We studied the impact of telehealth on the management of atrial fibrillation (AF) by electrophysiology providers in a large, multisite clinic. Clinical outcomes, quality metrics, and indicators of clinical activity for patients with AF during the 10-week period of March 22, 2020 to May 30, 2020 were compared with those from the 10-week period of March 24, 2019 to June 1, 2019. There were 1946 unique patient visits for AF (1,040 in 2020 and 906 in 2019). During 120 days after each encounter, there was no difference in hospital admissions (11.7% vs 13.5%, p = 0.25) or emergency department visits (10.4% vs 12.5%, p = 0.15) in 2020 compared with 2019. There was a total of 31 deaths within 120 days, with similar rates in 2020 and 2019 (1.8% vs 1.3%, p = 0.38). There was no significant difference in quality metrics. The following clinical activities occurred less frequently in 2020 than in 2019: offering escalation of rhythm control (16.3% vs 23.3%, p <0.001), ambulatory monitoring (29.7% vs 51.7%, p <0.001), and electrocardiogram review for patients on antiarrhythmic drug therapy (22.1% vs 90.2%, p <0.001). Discussions about risk factor modification were more frequent in 2020 compared with 2019 (87.9% vs 74.8%, p <0.001). In conclusion, the use of telehealth in the outpatient management of AF was associated with similar clinical outcomes and quality metrics but differences in clinical activity compared with traditional ambulatory encounters. Longer-term outcomes warrant further investigation.

Experiences Implementing a Suite of Decision Aids for Implantable Cardioverter Defibrillators: Qualitative Insights From the DECIDE-ICD Trial.

BACKGROUND: Shared decision making (SDM) is gaining importance in cardiology, including Centers for Medicare & Medicaid Services (CMS) reimbursement policies requiring documented SDM for patients considering primary prevention implantable cardioverter defibrillators. The DECIDE-ICD Trial (Decision Support Intervention for Patients offered implantable Cardioverter-Defibrillators) assessed the implementation and effectiveness of patient decision aids (DAs) using a stepped-wedge design at 7 sites. The purpose of this subanalysis was to qualitatively describe electrophysiology clinicians' experience implementing and using the DAs. METHODS: This included semi-structured individual interviews with electrophysiology clinicians at participating sites across the US, at least 6 months following conversion into the implementation phase of the trial (from June 2020 through February 2022). The interview guide was structured according to the RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance [implementation evaluation model]) framework, assessing clinician experiences, which can impact implementation domains, and was qualitatively assessed using a mixed inductive/deductive method. RESULTS: We completed 22 interviews post-implementation across all 7 sites. Participants included both physicians (n=16) and other clinicians who counsel patients regarding treatment options (n=6). While perception of SDM and the DA were positive, participants highlighted reasons for uneven delivery of DAs to appropriate patients. The CMS mandate for SDM was not universally viewed as associating with patients receiving DA's, but rather (1) logistics of DA delivery, (2) perceived effectiveness in improving patient decision-making, and (3) match of DA content to current patient populations. Remaining tensions include the specific trial data used in DAs and reconciling timing of delivery with when patients are actively making decisions. CONCLUSIONS: Clinicians charged with delivering DAs to patients considering primary prevention implantable cardioverter defibrillators were generally supportive of the tenets of SDM, and of the DA tools themselves, but noted several opportunities to improve the reach and continued use of them in routine care. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique Identifier: NCT03374891.

Outcome of MRI in Patients with Nonconditional Devices with Mismatch between Manufacturer of Leads and Generator.

In a series of 35 MRI examinations with non-MRI-conditional devices with a mismatch between the manufacturer of the device generators and leads, there were no adverse events.

Prospective evaluation of the effect of smartphone electrocardiogram usage on anticoagulant medication compliance.

PURPOSE: Compliance with anticoagulation treatment for atrial fibrillation is highly variable. Smartphone electrocardiograms that allow patients to have greater insight into their arrhythmia burden may improve anticoagulant compliance. METHODS: Patients were enrolled if they had atrial fibrillation with a CHA2DS2-VASc score of 2 or more, were eligible for anticoagulation and had a smartphone. Participants were randomly assigned to receive a smartphone electrocardiogram (AliveCor Kardia) to record their electrocardiograms 5 times/week or to the control group. All patients received 6 months of anticoagulant (apixaban) dispensed as 1-month pre-loaded pill boxes. RESULTS: A total of 100 patients were enrolled from July 2017 to August 2019, but 5 patients in the monitor arm and 1 in the control arm withdrew prematurely. The monitor and control groups did not differ in age, gender, CHA2DS2-VASc score, or comorbidities. Median medication compliance was 99.7%, with nonsignificantly greater compliance in the monitor group (100%) than in the control group (99.7%) (p-value = 0.247). There was also no significant difference between missing any dose and use/nonuse of the smartphone monitor (48.9% vs. 55.1%; p-value = 0.692). Mean monitor compliance was 86.8% ± 14.0% with an average of 4.34 recorded electrocardiograms per week. Monitor group patients with perfect medication compliance had significantly higher monitor compliance than those patients who missed doses (median 95.3% vs 86.7%; p-value = 0.02). CONCLUSIONS: In a study population with higher-than-expected medication compliance, the use of smartphone electrocardiogram did not demonstrate an improvement in medication compliance as compared to usual care. Greater monitor compliance was associated with greater medication compliance. CLINICAL TRIAL REGISTRATION: BOAT-OAR ClinicalTrials.gov number, NCT03515083.

Comparative outcomes of vascular access closure methods following atrial fibrillation/flutter catheter ablation: insights from VAscular Closure for Cardiac Ablation Registry.

PURPOSE: This registry compared the safety and efficacy of vascular closure device Perclose (PC) with figure-of-eight stitch (Fo8) and manual compression (MC) following catheter ablation of atrial fibrillation/flutter. METHODS: VAscular Closure for Cardiac Ablation Registry (VACCAR) is a prospective, observational registry that assessed the time to hemostasis (TTH), time to ambulation (TTA), length of stay (LOS), complications, patient-reported outcomes, and pain medication use. RESULTS: A total of 434 patients (mean age 64.0±11.0 years; 38% female; 94.9% white) were enrolled between October 2017 and May 2019: 156 in MC, 203 in Fo8, and 75 in the PC group. Median TTH was significantly reduced in the PC and Fo8 group at 7 and 9 min respectively vs. the MC group at 20 min (p<0.001). Median TTA was significantly reduced in both the PC and Fo8 group at 2.2 h vs. the MC group at 6.5 h (p<0.001 for both). Median LOS for the PC group was significantly reduced at 27.5 h compared to the MC and Fo8 group at 29 h (p<0.01). A higher proportion of same-day discharges were noted in the PC and Fo8 groups at 14 (18.7%) and 25 (12.3%), respectively, compared to 5 (3.2%) in the MC group (p<0.01 for all). There was no significant difference in complications between the three groups. CONCLUSIONS: Both PC and Fo8 are safe with improved TTH, TTA, LOS, and a higher number of same-day discharges compared to MC.

Outpatient Management of Heart Failure During the COVID-19 Pandemic After Adoption of a Telehealth Model.

OBJECTIVES: This study sought to determine whether the increased use of telehealth was associated with a difference in outcomes for outpatients with heart failure. BACKGROUND: The COVID-19 pandemic led to dramatic changes in the delivery of outpatient care. It is unclear whether increased use of telehealth affected outcomes for outpatients with heart failure. METHODS: In March 2020, a large Midwestern health care system, encompassing 16 cardiology clinics, 16 emergency departments, and 12 hospitals, initiated a telehealth-based model for outpatient care in the setting of the COVID-19 pandemic. A propensity-matched analysis was performed to compare outcomes between outpatients seen in-person in 2018 and 2019 and via telemedicine in 2020. RESULTS: Among 8,263 unique patients with heart failure with 15,421 clinic visits seen from March 15 to June 15, telehealth was employed in 88.5% of 2020 visits but in none in 2018 or 2019. Despite the pandemic, more outpatients were seen in 2020 (n = 5,224) versus 2018 and 2019 (n = 5,099 per year). Using propensity matching, 4,541 telehealth visits in 2020 were compared with 4,541 in-person visits in 2018 and 2019, and groups were well matched. Mortality was similar for telehealth and in-person visits at both 30 days (0.8% vs 0.7%) and 90 days (2.9% vs 2.4%). Likewise, there was no excess in hospital encounters or need for intensive care with telehealth visits. CONCLUSIONS: A telehealth model for outpatients with heart failure allowed for distanced encounters without increases in subsequent acute care or mortality. As the pressures of the COVID-19 pandemic abate, these data suggest that telehealth outpatient visits in patients with heart failure can be safely incorporated into clinical practice.

Prevention and Treatment of Atrial Fibrillation via Risk Factor Modification.

Atrial fibrillation (AF) is the most common clinically significant arrhythmia, and it increases stroke risk. A preventive approach to AF is needed because virtually all treatments such as cardioversion, antiarrhythmic drugs, ablation, and anticoagulation are associated with high cost and carry significant risk. A systematic review was performed to identify effective lifestyle-based strategies for reducing primary and secondary AF. A PubMed search was performed using articles up to March 1, 2021. Search terms included atrial fibrillation, atrial flutter, exercise, diet, metabolic syndrome, type 2 diabetes mellitus, obesity, hypertension, stress, tobacco smoking, alcohol, Mediterranean diet, sodium, and omega-3 fatty acids. Additional articles were identified from the bibliographies of retrieved articles. The control of hypertension, ideally with a renin-angiotensin-aldosterone system inhibitor, is effective for preventing primary AF and recurrence. Obstructive sleep apnea is a common cause of AF, and treating it effectively reduces AF episodes. Alcohol increases the risk of AF in a dose-dependent manner, and abstinence reduces risk of recurrence. Sedentary behavior and chronic high-intensity endurance exercise are both risk factors for AF; however, moderate physical activity is associated with lower risk of AF. Recently, sodium-glucose cotransporter-2 inhibitors and glucagon-like peptide-1 agonists have been associated with reduced risk of AF. Among overweight/obese patients, weight loss of ≥10% is associated with reduced AF risk. Lifestyle changes and risk factor modification are highly effective for preventing AF.

Successful Subcutaneous Defibrillator Implantation in a Pregnant Patient With Long QT Syndrome.

A 26-year-old woman with recurrent unexplained syncope in the postpartum period was diagnosed with long QT syndrome type 2. Traditional implantation of defibrillator using fluoroscopy became contraindicated after she again became pregnant prior to device implantation. A subcutaneous defibrillator was successfully implanted in the second trimester, after a multidisciplinary evaluation. (Level of Difficulty: Intermediate.).

Coronary Sinus Lead Placement in Patients With Coronary Sinus Ostial Atresia: An Innovative Approach.

This case series demonstrates 2 innovative approaches to successful coronary sinus lead placement in the setting of coronary sinus ostial atresia. Use of venous phase coronary angiography, a computed tomography scan with venous phase, or a left-sided upper extremity venogram may help reveal a variant anatomy and guide tool selection. (Level of Difficulty: Advanced.).

Transvenous Phrenic Nerve Stimulation for Treatment of Central Sleep Apnea: Five-Year Safety and Efficacy Outcomes.

BACKGROUND: The remede System Pivotal Trial was a prospective, multi-center, randomized trial demonstrating transvenous phrenic nerve stimulation (TPNS) therapy is safe and effectively treats central sleep apnea (CSA) and improves sleep architecture and daytime sleepiness. Subsequently, the remede System was approved by FDA in 2017. As a condition of approval, the Post Approval Study (PAS) collected clinical evidence regarding long-term safety and effectiveness in adults with moderate to severe CSA through five years post implant. METHODS: Patients remaining in the Pivotal Trial at the time of FDA approval were invited to enroll in the PAS and consented to undergo sleep studies (scored by a central laboratory), complete the Epworth Sleepiness Scale (ESS) questionnaire to assess daytime sleepiness, and safety assessment. All subjects (treatment and former control group) receiving active therapy were pooled; data from both trials were combined for analysis. RESULTS: Fifty-three of the original 151 Pivotal Trial patients consented to participate in the PAS and 52 completed the 5-year visit. Following TPNS therapy, the apnea-hypopnea index (AHI), central-apnea index (CAI), arousal index, oxygen desaturation index, and sleep architecture showed sustained improvements. Comparing 5 years to baseline, AHI and CAI decreased significantly (AHI baseline median 46 events/hour vs 17 at 5 years; CAI baseline median 23 events/hour vs 1 at 5 years), though residual hypopneas were present. In parallel, the arousal index, oxygen desaturation index and sleep architecture improved. The ESS improved by a statistically significant median reduction of 3 points at 5 years. Serious adverse events related to implant procedure, device or delivered therapy were reported by 14% of patients which include 16 (9%) patients who underwent a pulse generator reposition or lead revision (primarily in the first year). None of the events caused long-term harm. No unanticipated adverse device effects or related deaths occurred through 5 years. CONCLUSION: Long-term TPNS safely improves CSA, sleep architecture and daytime sleepiness through 5 years post implant. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01816776.

Change in hospitalization rates following transcatheter left atrial appendage occlusion.

Introduction: Left atrial appendage occlusion (LAAO) is recommended in patients with non-valvular atrial fibrillation (AF) who have contraindications to or are intolerant of long-term oral anticoagulants (OAC), but its impact on hospitalization rates has not been well described. The objective of our study is to describe the incidence of all-cause, bleeding-related, and thrombosis-related hospitalizations before and after LAAO. Material and methods: We used the Nationwide Readmission Database to include patients aged ≥ 18 years with a diagnosis of AF who underwent transcatheter LAAO during the months of February-November in each year between 2016 and 2018. Patients who died during the index procedure or had missing length of hospital stay or mortality information were excluded. Results: A total of 27,633 patients were included (median age: 77 years, 41% female) with an average pre- and post-LAAO monitoring period of 6.5 and 5.5 months respectively. Of these, 10,808 (39.1%) patients had one or more admissions prior to the procedure compared to 7,196 (26.0%) after the procedure. There was a 26% reduction in incidence of all-cause admissions (rate ratio (RR) = 0.74, 95% confidence interval (CI): 0.71-0.76; p < 0.001), 49% reduction in bleeding-related admissions (RR = 0.51, 95% CI: 0.48-0.55; p < 0.001), and 71% reduction in thrombosis-related readmissions (RR = 0.29, 95% CI: 0.26-0.33; p < 0.001) after LAAO. Conclusions: In a contemporary, nationally representative dataset, we found that LAAO is associated with a significant decrease in all-cause, bleeding-related, and thrombosis-related admissions. These findings lend support to the current use of transcatheter LAAO in clinical practice for patients with contraindications to OAC and/or at high risk of bleeding.

Evolution of Diagnostic and Treatment Patterns of Cardiac Sarcoidosis.

Cardiac sarcoidosis (CS) may impart substantial morbidity and mortality, and novel imaging modalities are now available to aid in early diagnosis of this clinically silent disease. A better understanding of the clinical experience with CS is important. Twenty-eight patients were diagnosed with the aid of multimodality imaging techniques and were treated by a multidisciplinary team. Demographics, symptomatology, imaging, and therapeutic interventions were compiled from our referral center. In patients with CS, nuclear and MR techniques were often the first studies performed. Echocardiographic findings differed widely. Immunosuppressive therapy and cardiac devices were frequently used. Importantly, isolated CS was not an infrequent finding.

A multicenter trial of a shared DECision Support Intervention for Patients offered implantable Cardioverter-DEfibrillators: DECIDE-ICD rationale, design, Medicare changes, and pilot data.

Shared decision making (SDM) facilitates delivery of medical therapies that are in alignment with patients' goals and values. Medicare national coverage decision for several interventions now includes SDM mandates, but few have been evaluated in nationwide studies. Based upon a detailed needs assessment with diverse stakeholders, we developed pamphlet and video patient decision aids (PtDAs) for implantable cardioverter/defibrillator (ICD) implantation, ICD replacement, and cardiac resynchronization therapy with defibrillation to help patients contemplate, forecast, and deliberate their options. These PtDAs are the foundation of the Multicenter Trial of a Shared Decision Support Intervention for Patients Offered Implantable Cardioverter-Defibrillators (DECIDE-ICD), a multicenter, randomized trial sponsored by the National Heart, Lung, and Blood Institute aimed at understanding the effectiveness and implementation of an SDM support intervention for patients considering ICDs. Finalization of a Medicare coverage decision mandating the inclusion of SDM for new ICD implantation occurred shortly after trial initiation, raising novel practical and statistical considerations for evaluating study end points. METHODS/DESIGN: A stepped-wedge randomized controlled trial was designed, guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) planning and evaluation framework using an effectiveness-implementation hybrid type II design. Six electrophysiology programs from across the United States will participate. The primary effectiveness outcome is decision quality (defined by knowledge and values-treatment concordance). Patients with heart failure who are clinically eligible for an ICD are eligible for the study. Target enrollment is 900 participants. DISCUSSION: Study findings will provide a foundation for implementing decision support interventions, including PtDAs, with patients who have chronic progressive illness and are facing decisions involving invasive, preference-sensitive therapy options.

Cryoballoon ablation of pulmonary veins for persistent atrial fibrillation: Results from the multicenter STOP Persistent AF trial.

BACKGROUND: Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation to treat patients with symptomatic drug-refractory atrial fibrillation (AF). OBJECTIVE: The purpose of this study was to assess the safety and efficacy of PVI using the cryoballoon catheter to treat patients with persistent AF. METHODS: STOP Persistent AF (ClinicalTrials.gov Identifier: NCT03012841) was a prospective, multicenter, single-arm, Food and Drug Administration-regulated trial designed to evaluate the safety and efficacy of PVI-only cryoballoon ablation for drug-refractory persistent AF (continuous episodes <6 months). The primary efficacy endpoint was 12-month freedom from ≥30 seconds of AF, atrial flutter (AFL), or atrial tachycardia (AT) after a 90-day blanking period. The prespecified performance goals were set at >40% and <13% for the primary efficacy and safety endpoints, respectively. Secondary endpoints assessed quality of life using the AFEQT (Atrial Fibrillation Effect on Quality of Life) and SF (Short Form)-12 questionnaires. RESULTS: Of 186 total enrollments, 165 subjects (70% male; age 65 ± 9 years; left atrial diameter 4.2 ± 0.6 cm; body mass index 31 ± 6) were treated at 25 sites in the United States, Canada, and Japan. Total procedural, left atrial dwell, and fluoroscopy times were 121 ± 46 minutes, 102 ± 41 minutes, and 19 ± 16 minutes, respectively. At 12 months, the primary efficacy endpoint was 54.8% (95% confidence [CI] 46.7%-62.1%) freedom from AF, AFL, or AT. There was 1 primary safety event, translating to a rate of 0.6% (95% CI 0.1%-4.4%). AFEQT and SF-12 assessments demonstrated significant improvements from baseline to 12 months postablation (P <.001). CONCLUSION: The STOP Persistent AF trial demonstrated cryoballoon ablation to be safe and effective in treating patients with drug-refractory persistent AF characterized by continuous AF episodes <6 months.

Meta-Analysis Comparing Outcomes of Therapies for Patients With Central Sleep Apnea and Heart Failure With Reduced Ejection Fraction.

Patients with heart failure with reduced ejection fraction and predominant central sleep apnea pose treatment challenges. A system review and meta-analysis of randomized controlled trials (RCTs) were undertaken. Electronic searches of digital repositories, journals, specialty society and manufacturer websites, manual searches of reference sections of RCTs, and published clinical guidelines were performed. Studies were graded for bias. Meta-analytic random effects models were used. Outcomes of interest included: sleep, cardiovascular, mortality, and quality of life (QoL). Grading of recommendations assessment, development and evaluation was performed. Nineteen randomized studies were identified that met the inclusion criteria of apnea hypopnea index (AHI) ≥10, predominant central sleep apnea (CSA), and heart failure with reduced ejection fraction (HFrEF) ≤50%. Most trials examined adaptive servo ventilation (ASV) (8 studies) and continuous positive airway pressure (CPAP) (9 studies). Bias existed in that: 15 of 19 (79%) of the trials lacked blinding, 10 of 19 were manufacturer funded, and with attrition in 8 of 19 studies. In meta-analysis, ASV performed better than control on sleep but not on QoL or cardiovascular outcomes, including mortality. CPAP demonstrated positive short-term outcomes on sleep, cardiovascular, and QoL (3 months). Longer-term cardiovascular and mortality data did not show benefit. Drug therapies demonstrated a positive clinical effect short term on sleep outcomes only. Transvenous phrenic nerve stimulation (TPNS) demonstrated positive treatment outcomes on sleep and QoL at 6 months. Evidence suggests improvement in cardiovascular outcomes with TPNS. In conclusion, ASV and CPAP therapies improve sleep, but long-term QoL or cardiovascular benefit was lacking. TPNS exhibited positive outcomes on sleep and QoL at 6 months with positive trends in CV outcomes.