Left bundle branch area pacing in heart failure: A systematic review and meta-analysis with meta-regression.

INTRODUCTION: Left bundle branch area pacing is an alternative to biventricular pacing. In this study, we aim to summarize the available evidence on the feasibility, efficacy, and safety of left bundle branch block area pacing (LBBAP). OBJECTIVES: The study summarizes the available evidence on the feasibility, efficacy, and safety of left bundle branch block area pacing (LBBAP). BACKGROUND: Cardiac resynchronization therapy (CRT) reduced mortality and hospitalizations in heart failure (HF) patients with a left ventricular ejection fraction (LVEF) ≤ 35% and concomitant LBBB. Recently LBBAP has been studied as a more physiological alternative to achieve CRT. METHOD: A search of PubMed, EMBASE, and Cochrane databases were performed to identify studies examining the role of LBBAP for CRT in heart failure. Comprehensive meta-analysis version 4 was used for meta-regression to examine variables that contribute to data heterogeneity. RESULT: Eighteen studies, 17 observational and one randomized controlled trial (RCT) were examined. A total of 3906 HF patients who underwent CRT (2036 LBBAP vs. 1870 biventricular pacing [BVP]) were included. LBBAP was performed successfully in 90.4% of patients. Compared to baseline, LBBAP was associated with a reduction in QRS duration (MD: -47.23 ms 95% confidence interval [CI]: -53.45, -41.01), an increase in LVEF (MD: 15.22%, 95% CI: 13.5, 16.94), and a reduction in NYHA class (MD: -1.23, 95% CI: -1.41, -1.05). Compared to BVP, LBBAP was associated with a significant reduction in QRS duration (MD: -20.69 ms, 95% CI: -25.49, -15.88) and improvement in LVEF (MD: 4.78%, 95% CI: 3.30, 6.10). Furthermore, LBBAP was associated with a significant reduction in HF hospitalization (odds ratio [OR]: 0.44, 95% CI: 0.34, 0.56) and all-cause mortality (OR: 0.67, 95% CI: 0.52, 0.86) compared to BVP. CONCLUSION: LBBAP was associated with improved ventricular electrical synchrony compared to BVP, as well as better echocardiographic and clinical outcomes.

Efficacy and Safety of Appropriate Shocks and Antitachycardia Pacing in Transvenous and Subcutaneous Implantable Defibrillators: Analysis of All Appropriate Therapy in the PRAETORIAN Trial.

BACKGROUND: The PRAETORIAN trial (A Prospective, Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) showed noninferiority of subcutaneous implantable cardioverter defibrillator (S-ICD) compared with transvenous implantable cardioverter defibrillator (TV-ICD) with regard to inappropriate shocks and complications. In contrast to TV-ICD, S-ICD cannot provide antitachycardia pacing for monomorphic ventricular tachycardia. This prespecified secondary analysis evaluates appropriate therapy and whether antitachycardia pacing reduces the number of appropriate shocks. METHODS: The PRAETORIAN trial was an international, investigator-initiated randomized trial that included patients with an indication for implantable cardioverter defibrillator (ICD) therapy. Patients with previous ventricular tachycardia <170 bpm or refractory recurrent monomorphic ventricular tachycardia were excluded. In 39 centers, 849 patients were randomized to receive an S-ICD (n=426) or TV-ICD (n=423) and were followed for a median of 49.1 months. ICD programming was mandated by protocol. Appropriate ICD therapy was defined as therapy for ventricular arrhythmias. Arrhythmias were classified as discrete episodes and storm episodes (≥3 episodes within 24 hours). Analyses were performed in the modified intention-to-treat population. RESULTS: In the S-ICD group, 86 of 426 patients received appropriate therapy, versus 78 of 423 patients in the TV-ICD group, during a median follow-up of 52 months (48-month Kaplan-Meier estimates 19.4% and 17.5%; P=0.45). In the S-ICD group, 83 patients received at least 1 shock, versus 57 patients in the TV-ICD group (48-month Kaplan-Meier estimates 19.2% and 11.5%; P=0.02). Patients in the S-ICD group had a total of 254 shocks, compared with 228 shocks in the TV-ICD group (P=0.68). First shock efficacy was 93.8% in the S-ICD group and 91.6% in the TV-ICD group (P=0.40). The first antitachycardia pacing attempt successfully terminated 46% of all monomorphic ventricular tachycardias, but accelerated the arrhythmia in 9.4%. Ten patients with S-ICD experienced 13 electrical storms, versus 18 patients with TV-ICD with 19 electrical storms. Patients with appropriate therapy had an almost 2-fold increased relative risk of electrical storms in the TV-ICD group compared with the S-ICD group (P=0.05). CONCLUSIONS: In this trial, no difference was observed in shock efficacy of S-ICD compared with TV-ICD. Although patients in the S-ICD group were more likely to receive an ICD shock, the total number of appropriate shocks was not different between the 2 groups. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01296022.

Device-related complications in subcutaneous versus transvenous ICD: a secondary analysis of the PRAETORIAN trial.

BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (S-ICD) is developed to overcome lead-related complications and systemic infections, inherent to transvenous ICD (TV-ICD) therapy. The PRAETORIAN trial demonstrated that the S-ICD is non-inferior to the TV-ICD with regard to the combined primary endpoint of inappropriate shocks and complications. This prespecified secondary analysis evaluates all complications in the PRAETORIAN trial. METHODS AND RESULTS: The PRAETORIAN trial is an international, multicentre, randomized trial in which 849 patients with an indication for ICD therapy were randomized to receive an S- ICD (N = 426) or TV-ICD (N = 423) and followed for a median of 49 months. Endpoints were device-related complications, lead-related complications, systemic infections, and the need for invasive interventions. Thirty-six device-related complications occurred in 31 patients in the S-ICD group of which bleedings were the most frequent. In the TV-ICD group, 49 complications occurred in 44 patients of which lead dysfunction was most frequent (HR: 0.69; P = 0.11). In both groups, half of all complications were within 30 days after implantation. Lead-related complications and systemic infections occurred significantly less in the S-ICD group compared with the TV-ICD group (P < 0.001, P = 0.03, respectively). Significantly more complications required invasive interventions in the TV-ICD group compared with the S-ICD group (8.3% vs. 4.3%, HR: 0.59; P = 0.047). CONCLUSION: This secondary analysis shows that lead-related complications and systemic infections are more prevalent in the TV-ICD group compared with the S-ICD group. In addition, complications in the TV-ICD group were more severe as they required significantly more invasive interventions. This data contributes to shared decision-making in clinical practice.

Device-related infection associated with increased mortality risk in de novo transvenous implantable cardioverter-defibrillator medicare patients.

INTRODUCTION: Transvenous implantable cardioverter-defibrillators (TV-ICD) infection is a serious complication that frequently requires complete device removal for attempted cure, which can be associated with patient morbidity and mortality. The objective of this study is to assess mortality risk associated with TV-ICD infection in a large Medicare population with de novo TV-ICD implants. METHODS: A survival analysis was conducted using 100% fee-for-service Medicare facility-level claims data to identify patients who underwent de novo TV-ICD implantation between 7/2016 and 1/2018. TV-ICD infection within 2 years of implantation was identified using International Classification of Disease, 10th Edition and current procedural terminology codes. Baseline patient risk factors associated with mortality were identified using the Charlson Comorbidity Index categories. Infection was treated as a time-dependent variable in a multivariate Cox proportional hazards model to account for immortal time bias. RESULTS: Among 26,742 Medicare patients with de novo TV-ICD, 518 (1.9%) had a device-related infection. The overall number of decedents was 4721 (17.7%) over 2 years, with 4555 (17%) in the noninfection group and 166 (32%) in the infection group. After adjusting for baseline patient demographic characteristics and various comorbidities, the presence of TV-ICD infection was associated with an increase of 2.4 (95% CI: 2.08-2.85) times in the mortality hazard ratio. CONCLUSION: The rate of TV-ICD infection and associated mortality in a large, real-world Medicare population is noteworthy. The positive association between device-related infection and risk of mortality further highlights the need to reduce infections.

Process mapping strategies to prevent subcutaneous implantable cardioverter-defibrillator infections.

BACKGROUND: Infection remains a major complication of cardiac implantable electronic devices and can lead to significant morbidity and mortality. Implantable devices that avoid transvenous leads, such as the subcutaneous implantable cardioverter-defibrillator (S-ICD), can reduce the risk of serious infection-related complications, such as bloodstream infection and infective endocarditis. While the 2017 AHA/ACC/HRS guidelines include recommendations for S-ICD use for patients at high risk of infection, currently, there are no clinical trial data that address best practices for the prevention of S-ICD infections. Therefore, an expert panel was convened to develop a consensus on these topics. METHODS: An expert process mapping methodology was used to achieve consensus on the appropriate steps to minimize or prevent S-ICD infections. Two face-to-face meetings of high-volume S-ICD implanters and an infectious diseases specialist, with expertise in cardiovascular implantable electronic device infections, were conducted to develop consensus on useful strategies pre-, peri-, and postimplant to reduce S-ICD infection risk. RESULTS: Expert panel consensus on recommended steps for patient preparation, S-ICD implantation, and postoperative management was developed to provide guidance in individual patient management. CONCLUSION: Achieving expert panel consensus by process mapping methodology for S-ICD infection prevention was attainable, and the results should be helpful to clinicians in adopting interventions to minimize risks of S-ICD infection.

Esophageal deviation with vacuum suction and mechanical deflection during ablation of atrial fibrillation: First in man evaluation.

Deviation of the esophagus during atrial fibrillation (AF) ablation can reduce esophageal injury. This study reports upon a novel esophageal retractor that utilizes vacuum suction and mechanical deflection to deviate the esophagus. The device was used in seven patients undergoing cryoballoon AF ablation. The esophagus was deviated 31.9 ± 4.4 mm to the right and 28.2 ± 5.9 mm to the left. Endoscopy at 4.4 ± 1.5 days postablation showed no esophageal injury. This study demonstrates the safe and effective deviation of the esophagus without a trailing edge with an esophageal retractor utilizing vacuum suction and mechanical deflection.

A 10 J shock impedance in sinus rhythm correlates with a 65 J defibrillation impedance during subcutaneous defibrillator implantation using an intermuscular technique.

INTRODUCTION: Defibrillation testing (DT) is recommended during the subcutaneous defibrillator (S-ICD) placement. We sought to compare 10 J shock impedance in sinus rhythm (SR) with 65 J defibrillation impedance and evaluate device position on a postimplant chest X-ray (CXR) using an intermuscular (IM) technique. METHODS: Consecutive S-ICD implantations between 12/2019 and 12/2020 at The Ohio State University were reviewed. All implantations were performed using a two-incision IM technique. Standard DT with 65 J shock and 10 J shock in SR were performed unless contraindicated. The PRAETORIAN score was calculated based on CXR. RESULTS: A total of 37 patients (age: 47.2 ± 15.8 years old, male: n = 26 [70.3%], body mass index: 30.1 ± 6.7 kg/m2 ) underwent IM S-ICD implantation, and of those, 27 (73%) underwent both 65 J shock and 10 J shock in SR. The coefficient of determination (R2 ) between 10 J shock impedance and 65 J shock impedance was 0.84. The mean of an impedance difference was 1.6 ± 4.8 Ω (minimum - 11 and maximum 8). Postimplant CXR was available for 33 out of 37 patients (89.2%). The PRAETORIAN score was less than 90 in all patients and the mean score was 32.7 ± 8.8. CONCLUSION: We demonstrated that 10 J shock impedance in SR correlated well with 65 J defibrillation impedance during IM S-ICD implantation. An IM implantation technique provides excellent generator location on postimplant CXR. The IM technique combined with 10 J shock in SR may be sufficient to predict and ensure the defibrillation efficacy of the S-ICD.

Outcomes of two versus three incision techniques: Results from the subcutaneous ICD post-approval study.

BACKGROUND: Traditionally, implantation of the subcutaneous implantable cardioverter defibrillator (S-ICD) requires incisions near the lateral chest wall, the xyphoid, and the superior sternal region (three-incision technique [3IT]). A two-incision technique (2IT) avoids the superior incision and has been shown to be a viable alternative in small studies with limited follow-up. OBJECTIVES: To report on the long-term safety and efficacy of the 2IT compared to the 3IT procedure in a large patient cohort. METHODS: Patients enrolled in the S-ICD post approval study (PAS) were stratified by procedural technique (2IT vs. 3IT). Baseline demographics, comorbidities and procedural outcomes were collected. Complications and S-ICD effectiveness in treating ventricular arrhythmias through an average 3-year follow-up period were compared. RESULTS: Of 1637 patients enrolled in the S-ICD PAS, 854 pts (52.2%) were implanted using the 2IT and 782 were implanted using the 3IT (47.8%). The 2IT became more prevalent over time, increasing from 40% to 69% of implants (Q1-Q4). Mean procedure time was shorter with 2IT (69.0 vs. 86.3 min, p < .0001). No other differences in outcomes were observed between the two groups, including rates of infection, electrode migration, inappropriate shocks and first shock efficacy for treating ventricular arrhythmias. CONCLUSION: In this large cohort of patients implanted with an S-ICD and followed for 3 years the 2IT was as safe and effective as the 3IT while significantly reducing procedure time.

Incidence of pacing-induced cardiomyopathy in pacemaker-dependent patients is lower with leadless pacemakers compared to transvenous pacemakers.

INTRODUCTION: Frequent right AQ4ventricular pacing (≥40%) with a transvenous pacemaker (TVP) is associated with the risk of pacing-induced cardiomyopathy (PICM). Leadless pacemakers (LPs) have distinct physical and mechanical differences from TVP. The risk of PICM with LP is not known. To identify incidence, predictors, and long-term outcomes of PICM in LP and TVP patients. METHODS: The study comprised all pacemaker-dependent patients with LP or TVP who had left ventricular ejection fraction (LVEF) of ≥50 from 2014 to 2019. The incidence of PICM (≥10% LVEF drop) was assessed with an echocardiogram. Predictors for PICM were identified using multivariate analysis. Long-term outcomes after cardiac resynchronization (CRT) were assessed in both groups. RESULTS: A total of 131 patients with TVP and 67 with LP comprised the study. All patients in the TVP group and the majority in the LP group underwent atrioventricular node ablation. The mean follow-up duration in TVP and LP groups was 592 ± 549 and 817 ± 600 days, respectively. A total of 18 (13.7%) patients in TVP and 2 (3%) in LP developed PICM after a median duration of 254 (interquartile range: 470) days. The incidence of PICM was significantly higher with TVP compared with LP (p = .02). TVP as pacing modality was a positive (odds ratio [OR]: 1.07) while age was negative (OR: 0.94) predictor for PICM on multivariable analysis. Both patients in LP and all except two in the TVP group responded to CRT. CONCLUSION: Incidence of PICM is significantly lower with LP compared with TVP in pacemaker-dependent patients. Age and TVP as pacing modality were predictors for PICM.

Trends in anticoagulation management services following incorporation of direct oral anticoagulants at a large academic medical center.

The introduction of direct oral anticoagulants (DOACs) to the market has expanded anticoagulation options for outpatient use. Routine evaluation by health care professionals is recommended as it is with warfarin, therefore requiring adjustments in practices of anticoagulation management services (AMS). This study aims to describe trends that occurred following the incorporation of DOACs into AMS at a large academic medical center. A retrospective chart review of pharmacist-run AMS was used to compare patients on DOAC therapy versus other types of anticoagulation, including warfarin and parenteral agents. Primary outcomes included trends in the number of unique patients, management encounters, and telephone encounters throughout the study period. Secondary outcomes included trends in new encounters, and changes in patient characteristics, resources utilized, and patient satisfaction scores. A total of 2976 unique patients, 74,582 management encounters, and 13,282 telephone encounters were identified. From study beginning to end, results showed stable numbers of unique patients, an increase in management encounters for the DOAC group and decrease in the other anticoagulants group, and stable numbers of telephone encounters. Additionally, the number of new encounters for both groups increased. Throughout the study, pharmacy resources were reallocated within anticoagulation to adapt to the changing trends and patient satisfaction reached targets. Patients' characteristics remained stable, with the DOAC group having fewer comorbid conditions and concomitant medications that could increase bleed risk. This study showed that by reallocating resources within anticoagulation, AMS can maintain stable patient populations while continuing to expand access and satisfy patients following DOAC inclusion.

Evaluation of a novel esophageal retractor utilizing vacuum suction and mechanical force for deviating the esophagus.

BACKGROUND: Deviation of the esophagus prevents esophageal injury during atrial fibrillation ablation. OBJECTIVES: This study is to evaluate, in animals, safety and effectiveness of a novel esophageal retractor that utilizes vacuum suction and mechanical force to deviate the esophagus. METHODS: Following general anesthesia, a radiopaque ruler was placed behind the animal perpendicular to the esophagus. The esophageal retractor was inserted and esophagram was completed. Suction force (280-300 mm Hg) was applied to the distal aspect of the device that resulted in adherence of the esophagus in a circumferential manner. Then movement of a deflecting arm was used to deviate the esophagus. Four animal studies completed: (a) deviation distance and presence of trailing edge; (b) effect of 1 hour continuous suction and deviation upon esophageal cellular architecture; (c) impact on luminal esophageal temperature (LET) during high power ablation; and (d) compatibility of esophageal retractor with electroanatomic mapping system. RESULTS: The distance of deviation to the right (26.6 ± 2.5 mm) was higher than to the left (18.7 ± 2.3 mm; P < .01). There was no esophageal trailing edge in 65/68 deviations (96%). With continuous suction for 1 hour, pathology revealed small, <1mm, circular area of hyperemia in the esophageal mucosa. During high power ablation, the maximum increase in LET was 0.2°C. Finally, there was no interference between the device and electro-anatomical mapping system. CONCLUSION: In animal models, the esophageal retractor utilizing vacuum suction was successful at deviating the esophagus without significant trailing edge and with minor (1 mm) injury with prolonged continuous suction.

BioMonitor 2 in-office setting insertion safety and feasibility evaluation with device functionality assessment: results from the prospective cohort BioInsight study.

BACKGROUND: Insertable cardiac monitors are utilized for the diagnosis of arrhythmias and traditionally have been inserted within hospitals. Recent code updates allow for reimbursement of office-based insertions; however, there is limited information regarding the resources and processes required to support in-office insertions. We sought to determine the safety and feasibility of in-office insertion of the BioMonitor 2 and better understand in-office procedures, including patient selection, pre-insertion protocols, resource availability, and staff support. METHODS: Patients meeting an indication for a rhythm monitor were prospectively enrolled into this single-arm, non-randomized trial. All patients underwent insertion in an office setting. Two follow-up visits at days 7 and 90 were required. Information on adverse events, device performance, office site preparations, and resource utilization were collected. RESULTS: Eighty-two patients were enrolled at six sites. Insertion was successful in all 77 patients with an attempt. Oral anticoagulation was stopped in 20.8% of patients and continued through insertion in 23.4%, while prophylactic antibiotics were infrequently utilized (37.7% of study participants). On average, the procedure required a surgeon plus two support staff and 35 min in an office room to complete the 8.4 min insertion procedure. The mean R-wave amplitude was 0.77 mV at insertion and 0.67 mV at 90-days with low noise burden (2.7%). There were no procedure related complications. Two adverse events were reported (event rate 2.7% [95% CI 0.3, 9.5%]). CONCLUSIONS: In-office insertion of the BioMonitor 2 is safe and feasible. Devices performed well with high R-wave amplitudes and low noise burden. These results further support shifting cardiac monitor insertions to office-based locations. TRIAL REGISTRATION: clinicaltrials.gov, NCT02756338. Registered 29 April 2016.

Perioperative considerations during implantation of the subcutaneous defibrillator: State-of-the-art review.

The subcutaneous implantable cardioverter-defibrillator (S-ICD) is an important tool in the armamentarium of an electrophysiologist. Multiple randomized trials over the last decade have shown that S-ICDs are as efficacious as the transvenous ICDs and eliminate complications related to vascular access. In this review, we highlight issues unique to S-ICD implantation, focusing not only on the surgical implantation procedure, but also the pre- and postimplant management of the patient.

Diagnosis and management of subcutaneous implantable cardioverter-defibrillator infections based on process mapping.

BACKGROUND: Infection is a well-recognized complication of cardiovascular implantable electronic device (CIED) implantation, including the more recently available subcutaneous implantable cardioverter-defibrillator (S-ICD). Although the AHA/ACC/HRS guidelines include recommendations for S-ICD use, currently there are no clinical trial data that address the diagnosis and management of S-ICD infections. Therefore, an expert panel was convened to develop consensus on these topics. METHODS: A process mapping methodology was used to achieve a primary goal - the development of consensus on the diagnosis and management of S-ICD infections. Two face-to-face meetings of panel experts were conducted to recommend useful information to clinicians in individual patient management of S-ICD infections. RESULTS: Panel consensus of a stepwise approach in the diagnosis and management was developed to provide guidance in individual patient management. CONCLUSION: Achieving expert panel consensus by process mapping methodology in S-ICD infection diagnosis and management was attainable, and the results should be helpful in individual patient management.

RIsk Stratification prior to lead Extraction and impact on major intraprocedural complications (RISE protocol).

BACKGROUND: An internal risk stratification algorithm was developed to decrease the risk of major adverse cardiac events (MACEs) during lead extractions (LEs). OBJECTIVE: To report upon the impact of a risk stratification algorithm (RISE [RIsk Stratification prior to lead Extraction] protocol) on outcomes of LEs in a high-volume center. METHODS: A retrospective review of a prospectively maintained LEs database was performed to identify features associated with MACEs. On the basis of the retrospective data, the RISE protocol differentiated LEs procedures into "High" and "Low" risk for occurrence of MACEs. High-risk LEs included dual-coil defibrillator lead (≥3 years), pacemaker and single-coil lead (≥5 years), and any StarFix coronary sinus lead. During the prospective evaluation of the RISE protocol, "High-risk" LEs were performed in an operating room (OR) or hybrid laboratory with the cardiac anesthesiologist, OR nursing team, perfusionist in the room, and a cardiac surgeon on the premises. "Low-risk" LEs were performed in the electrophysiology (EP) laboratory with anesthesia provided by EP nursing team. The preintervention (pre-RISE) and postintervention (post-RISE) group spanned 19 and 40 months and consisted of 449 (632 leads) and 751 patients (1055 leads), respectively. The primary outcome of MACEs in the two groups was compared. RESULTS: Protocol compliance was 100%. The primary outcome of MACEs occurred in 15 patients (3.34%) before and 12 (1.6%) after implementation of the RISE protocol (P = .04). CONCLUSION: RISE identified a low-risk group where minimal resources are needed and allowed for rapid intervention in the high-risk group that reduced the consequences of MACEs.

Type 8 long QT syndrome: pathogenic variants in CACNA1C-encoded Cav1.2 cluster in STAC protein binding site.

AIMS: Pathogenic gain-of-function variants in CACAN1C cause type-8 long QT syndrome (LQT8). We sought to describe the electrocardiographic features in LQT8 and utilize molecular modelling to gain mechanistic insights into its genetic culprits. METHODS AND RESULTS: Rare variants in CACNA1C were identified from genetic testing laboratories. Treating physicians provided clinical information. Variant pathogenicity was independently assessed according to recent guidelines. Pathogenic (P) and likely pathogenic (LP) variants were mapped onto a 3D modelled structure of the Cav1.2 protein. Nine P/LP variants, identified in 23 patients from 19 families with non-syndromic LQTS were identified. Six variants, found in 79% of families, clustered to a 4-residue section in the cytosolic II-III loop region which forms a region capable of binding STAC SH3 domains. Therefore, variants may affect binding of SH3-domain containing proteins. Arrhythmic events occurred in similar proportions of patients with II-III loop variants and with other P/LP variants (53% vs. 48%, P = 0.41) despite shorter QTc intervals (477 ± 31 ms vs. 515 ± 37 ms, P = 0.03). A history of sudden death was reported only in families with II-III loop variants (60% vs. 0%, P = 0.03). The predominant T-wave morphology was a late peaking T wave with a steep descending limb. Exercise testing demonstrated QTc prolongation on standing and at 4 min recovery after exercise. CONCLUSION: The majority of P/LP variants in patients with CACNA1C-mediated LQT8 cluster in an SH3-binding domain of the cytosolic II-III loop. This represents a 'mutation hotspot' in LQT8. A late-peaking T wave with a steep descending limb and QT prolongation on exercise are commonly seen.

Increased risk of hematoma with uninterrupted warfarin in patients undergoing implantation of subcutaneous implantable cardioverter defibrillator.

BACKGROUND: The perioperative management of anticoagulation with the use of subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation is still evolving. OBJECTIVE: The purpose of this study was to assess whether it is safe to perform S-ICD implantation with uninterrupted warfarin. METHODS: This is a multi-center retrospective review of patients undergoing S-ICD implantation between October 1, 2012 and June 30, 2017. Forty-eight patients underwent successful S-ICD implantation during the study period. The most common indication for implantation was primary prevention of sudden cardiac death. In 23 (47.9%) patients, warfarin was continued without any interruption. In 25 (52.1%) patients, warfarin was interrupted prior to implantation. The incidence of clinically significant lateral pocket hematoma was compared in the two groups. RESULTS: The mean international normalized ratio was 2.0 ± 0.4 in the uninterrupted group and 1.4 ± 0.4 for the interrupted group. A total of seven patients developed a hematoma at the lateral pocket. No patient developed a hematoma at the parasternal pockets. Six patients in the uninterrupted group (26.1%) and one patient in the interrupted group (0.04%) developed a significant lateral pocket hematoma (P = .04). The concomitant use of dual antiplatelet therapy did not increase the risk of hematoma. There was no significant difference between HASBLED and CHA2 DS2 VASc scores between the groups. None of the patients with a hematoma developed infection or required hematoma evacuation. CONCLUSIONS: The uninterrupted use of warfarin in the perioperative period of S-ICD implantation is associated with an increased risk of lateral pocket hematoma.

Comprehensive strategy to reduce the incidence of lead dislodgement for cardiac implantable electronic devices.

BACKGROUND: Lead dislodgement (LD) is a well-recognized complication during implantation of cardiac implantable electronic devices (CIEDs). An intraprocedural protocol, referred to as reduction of LD protocol, was developed to reduce the risk of LD. METHODS: The protocol involved (1) inserting a straight stylet down the right atrial lead and applying forward pressure while monitoring for fluoroscopic stability, (2) visualizing all leads during deep inspiration to determine if there is adequate lead redundancy, and (3) having the patient take a deep breath and cough while pacing just at capture threshold to assess for loss of capture in each lead. Any intraprocedural change in the parameters fulfilling the predefined criteria for inadequate lead implantation prompted lead repositioning. Data regarding demographic factors, clinical characteristics, and incidence of LD in the first 30 days after implant was obtained from intramural CIED database. The preintervention (control) group spanned 27 months and consisted of a total of 4,294 leads while the postintervention (intervention) group spanned 17 months and consisted of 2,361 leads implanted. RESULTS: There was no significant difference in the demographic factors and clinical characteristics in the two groups. Protocol compliance was > 90%. There were 44 occurrences of LD (1.02%) before and 10 (0.4%) after implementation of the protocol. The protocol significantly reduced the incidence of LD during the 30 days after implant (P = 0.014). No clinical characteristic predicted the risk of LD. CONCLUSION: Intraprocedural maneuvers performed to assess the adequacy of lead implantation results in reduced risk of LD.

Implantation of subcutaneous defibrillator is feasible and safe with monitored anesthesia care.

BACKGROUND: The perioperative anesthesia care during subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation is still evolving. OBJECTIVE: To assess the feasibility and safety of S-ICD implantation with monitored anesthesia care (MAC) versus general anesthesia (GA) in a tertiary care center. METHODS: This is a single-center retrospective study of patients undergoing S-ICD implantation between October 2012 and May 2019. Patients were categorized into MAC and GA group based on the mode of anesthesia. Procedural success without escalation to GA was the primary endpoint of the study, whereas intraprocedural hemodynamics, need of pharmacological support for hypotension and bradycardia, length of the procedure, stay in the post-anesthesia care unit, and postoperative pain were assessed as secondary endpoints. RESULTS: The study comprises 287 patients with MAC in 111 and GA in 176 patients. Compared to MAC, patients in GA group were younger and had a higher body mass index. All patients had successful S-ICD implantation. Only one patient (0.9%) in the MAC group was converted to GA. Despite a similar baseline heart rate (HR) and mean arterial blood pressure (MAP) in both groups, patients with GA had significantly lower HR and MAP during the procedure and more frequently required pharmacological hemodynamic support. Length of the procedure, stay in the postanesthesia care unit, and postoperative pain was similar in both groups. CONCLUSION: This retrospective experience suggests that implantation of S-ICD is feasible and safe with MAC. Use of GA is associated with more frequent administration of hemodynamic drugs during S-ICD implantation.

Feasibility of concomitant vacuum-assisted removal of lead-related vegetations and cardiac implantable electronic device extraction.

BACKGROUND: Cardiac implantable electronic device (CIED) infections associated with large, mobile vegetation adds to the complexity of lead extraction and is associated with significant patient morbidity and mortality. OBJECTIVE: To show the feasibility of concomitant cardiovascular implantable electronic device extraction and vacuum-assisted removal of lead-related vegetations. METHODS: This is a single-center retrospective case series of consecutive patients with persistent bacteremia, sepsis, or endocarditis despite medical therapy who have vegetations >2 cm and subsequently underwent immediate CIED lead extraction after debulking with vacuum-assisted suction. RESULTS: Eight patients underwent successful removal of 17 leads immediately after debulking of vegetations with vacuum-assisted device suction. Debulking procedure was not successful in 1 patient due to inability to direct the vacuum suction device into proper position. There were no intraprocedure complications related to the vacuum-assisted debulking. One patient required open sternotomy for tear of the coronary sinus ostium related to extraction of a left ventricular pacing electrode. There was no mortality within 30 days of the procedure. CONCLUSIONS: Based upon these clinical results, it is feasible for patients with infected CIED systems that have large right-sided vegetations to undergo vacuum-assisted debulking then immediately followed by percutaneous CIED removal in whom surgical removal is considered high risk.