Transvenous Lead Extraction in the Left Ventricular Assist Device Patient.

The population of patients with advanced heart failure continues to increase steadily as does the need for mechanical circulatory support. Combination therapy with left ventricular assist devices (LVADs) and cardiovascular implantable electronic devices (CIEDs) is unavoidable. CIED complications in patients with LVADs are common and often necessitate device system revision and transvenous lead extraction. Despite this, management recommendations are limited, and guidelines are lacking.

Improved all-cause mortality with left bundle branch area pacing compared to biventricular pacing in cardiac resynchronization therapy: a meta-analysis.

BACKGROUND: Left bundle branch area pacing (LBBAP) has emerged as a physiological alternative pacing strategy to biventricular pacing (BIVP) in cardiac resynchronization therapy (CRT). We aimed to assess the impact of LBBAP vs. BIVP on all-cause mortality and heart failure (HF)-related hospitalization in patients undergoing CRT. METHODS: Studies comparing LBBAP and BIVP for CRT in patients with HF with reduced left ventricular ejection fraction (LVEF) were included. The coprimary outcomes were all-cause mortality and HF-related hospitalization. Secondary outcomes included procedural and fluoroscopy time, change in QRS duration, and change in LVEF. RESULTS: Thirteen studies (12 observational and 1 RCT, n = 3239; LBBAP = 1338 and BIVP = 1901) with a mean follow-up duration of 25.8 months were included. Compared to BIVP, LBBAP was associated with a significant absolute risk reduction of 3.2% in all-cause mortality (9.3% vs 12.5%, RR 0.7, 95% CI 0.57-0.86, p < 0.001) and an 8.2% reduction in HF-related hospitalization (11.3% vs 19.5%, RR 0.6, 95% CI 0.5-0.71, p < 0.00001). LBBAP also resulted in reductions in procedural time (mean weighted difference- 23.2 min, 95% CI - 42.9 to - 3.6, p = 0.02) and fluoroscopy time (- 8.6 min, 95% CI - 12.5 to - 4.7, p < 0.001) as well as a significant reduction in QRS duration (mean weighted difference:- 25.3 ms, 95% CI - 30.9 to - 19.8, p < 0.00001) and a greater improvement in LVEF of 5.1% (95% CI 4.4-5.8, p < 0.001) compared to BIVP in the studies that reported these outcomes. CONCLUSION: In this meta-analysis, LBBAP was associated with a significant reduction in all-cause mortality as well as HF-related hospitalization when compared to BIVP. Additional data from large RCTs is warranted to corroborate these promising findings.

Left Bundle Branch Pacing vs Left Ventricular Septal Pacing vs Biventricular Pacing for Cardiac Resynchronization Therapy.

BACKGROUND: Left bundle branch pacing (LBBP) and left ventricular septal pacing (LVSP) are considered to be acceptable as LBBAP strategies. Differences in clinical outcomes between LBBP and LVSP are yet to be determined. OBJECTIVES: The purpose of this study was to compare the outcomes of LBBP vs LVSP vs BIVP for CRT. METHODS: In this prospective multicenter observational study, LBBP was compared with LVSP and BIVP in patients undergoing CRT. The primary composite outcome was freedom from heart failure (HF)-related hospitalization and all-cause mortality. Secondary outcomes included individual components of the primary outcome, postprocedural NYHA functional class, and electrocardiographic and echocardiographic parameters. RESULTS: A total of 415 patients were included (LBBP: n = 141; LVSP: n = 31; BIVP: n = 243), with a median follow-up of 399 days (Q1-Q3: 249.5-554.8 days). Freedom from the primary composite outcomes was 76.6% in the LBBP group and 48.4% in the LVSP group (HR: 1.37; 95% CI: 1.143-1.649; P = 0.001), driven by a 31.4% absolute increase in freedom from HF-related hospitalizations (83% vs 51.6%; HR: 3.55; 95% CI: 1.856-6.791; P < 0.001) without differences in all-cause mortality. LBBP was also associated with a higher freedom from the primary composite outcome compared with BIVP (HR: 1.43; 95% CI: 1.175-1.730; P < 0.001), with no difference between LVSP and BIVP. CONCLUSIONS: In patients undergoing CRT, LBBP was associated with improved outcomes compared with LVSP and BIVP, while outcomes between BIVP and LVSP are similar.

Intramyocardial Hematoma During Catheter Ablation for Scar-Related Ventricular Tachycardia.

BACKGROUND: Intramural hematoma during ablation for scar-related ventricular tachycardia (VT) is a rare but life-threatening complication. OBJECTIVES: The goal of this study was to describe the features and outcomes of intramural hematoma during ablation for scar-related VT. METHODS: From 2010 to 2022, >3,514 ablations for ventricular arrhythmias were performed at 2 institutions. Four cases of intramural hematoma complicating VT ablation for scar-related VT were identified. Intraprocedural details, imaging data, and surgical notes were reviewed to create a recognizable pattern of events highlighting this complication. RESULTS: In 3 of 4 cases, intramural hematoma occurred during catheter ablation with an open irrigated 3.5 mm tipped catheter using normal saline for irrigation. In one case, hematoma was noted after ablation using an investigational needle electrode catheter. The occurrence of a steam pop preceded detection of an expanding intramural hematoma in 3 cases. ST-segment elevation on electrocardiography was evident in 3 cases; intracardiac echocardiographic imaging detected the hematoma in all cases. Epicardial rupture and pericardial effusion requiring drainage occurred in 3 cases, whereas 1 hematoma was self-contained and did not require intervention. Surgical intervention was performed in 2 cases, with successful outcomes. One patient who was deemed not a surgical candidate died of progressive cardiogenic shock. CONCLUSIONS: Intramural hematoma during ablation for scar-related VT is a rare but potentially catastrophic complication that requires prompt recognition. Steam pops during ablation frequently precede the hematoma formation. Surgical intervention may be life-saving, although contained hematomas can occasionally be managed conservatively.

Sustained Apnea for Epicardial Access With Right Ventriculography: The SAFER Epicardial Approach.

BACKGROUND: Epicardial access (EA) has emerged as an increasingly important approach for the treatment of ventricular arrhythmias and to perform other interventional cardiology procedures. EA is frequently underutilized because the current approach is challenging and carries a high risk of life-threatening complications. OBJECTIVE: The purpose of this study was to determine the efficacy and safety of the SAFER (Sustained Apnea for Epicardial Access With Right Ventriculography) epicardial approach. METHODS: Consecutive patients who underwent EA with the SAFER technique were included in this multicenter study. The primary efficacy outcome was the successful achievement of EA. The primary safety outcomes included right ventricular (RV) perforation, major hemorrhagic pericardial effusion (HPE), and bleeding requiring surgical intervention. Secondary outcomes included procedural characteristics and any complications. Our results were compared with those from previous studies describing other EA techniques to assess differences in outcomes. RESULTS: A total of 105 patients undergoing EA with the SAFER approach from June 2021 to February 2023 were included. EA was used for ventricular tachycardia ablation in 98 patients (93.4%), left atrial appendage closure in 6 patients (5.7%), and phrenic nerve displacement in 1 patient (0.9%). EA was successful in all subjects (100%). The median time to EA was 7 minutes (IQR: 5-14 minutes). No cases of RV perforation, HPE, or need of surgical intervention were observed in this cohort. Comparing our results with previous studies about EA, the SAFER epicardial approach resulted in a significant reduction in major pericardial bleeding. CONCLUSIONS: The SAFER epicardial approach is a simple, efficient, effective, and low-cost technique easily reproducible across multiple centers. It is associated with lower complication rates than previously reported techniques for EA.

Left Bundle Branch Area Pacing Versus Biventricular Pacing as Initial Strategy for Cardiac Resynchronization.

BACKGROUND: Left bundle branch area pacing (LBBAP) for cardiac resynchronization therapy (CRT) is an alternative to biventricular pacing (BiVp). OBJECTIVES: The purpose of this study was to compare the outcomes between LBBAP and BiVp as an initial implant strategy for CRT. METHODS: In this prospective multicenter, observational, nonrandomized study, first-time CRT implant recipients with LBBAP or BiVp were included. The primary efficacy outcome was a composite of heart failure (HF)-related hospitalization and all-cause mortality. The primary safety outcomes were acute and long-term complications. Secondary outcomes included postprocedural New York Heart Association functional class and electrocardiographic and echocardiographic parameters. RESULTS: A total of 371 patients (median follow-up of 340 days [IQR: 206-477 days]) were included. The primary efficacy outcome occurred in 24.2% in the LBBAP vs 42.4% in the BiVp (HR: 0.621 [95% CI: 0.415-0.93]; P = 0.021) group, driven by a reduction in HF-related hospitalizations (22.6% vs 39.5%; HR: 0.607 [95% CI: 0.397-0.927]; P = 0.021) without significant difference in all-cause mortality (5.5% vs 11.9%; P = 0.19) or differences in long-term complications (LBBAP: 9.4% vs BiVp: 15.2%; P = 0.146). LBBAP resulted in shorter procedural (95 minutes [IQR: 65-120 minutes] vs 129 minutes [IQR: 103-162 minutes]; P < 0.001) and fluoroscopy times (12 minutes [IQR: 7.4-21.1 minutes] vs 21.7 minutes [IQR: 14.3-30 minutes]; P < 0.001), shorter QRS duration (123.7 ± 18 milliseconds vs 149.3 ± 29.1 milliseconds; P < 0.001), and higher postprocedural left ventricular ejection fraction (34.1% ± 12.5% vs 31.4% ± 10.8%; P = 0.041). CONCLUSIONS: LBBAP as an initial CRT strategy resulted in a lower risk of HF-related hospitalizations compared to BiVp. A reduction in procedural and fluoroscopy times, shorter paced QRS duration, and improvements in left ventricular ejection fraction compared with BiVp were observed.

Evaluation of obstructive sleep apnea among consecutive patients with all patterns of atrial fibrillation using WatchPAT home sleep testing.

BACKGROUND: Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice and is associated with significant morbidity, mortality, and financial burden. Obstructive sleep apnea (OSA) is more common in individuals with AF and may impair the efficacy of rhythm control strategies including catheter ablation. However, the prevalence of undiagnosed OSA in all-comers with AF is unknown. DESIGN: This pragmatic, phase IV prospective cohort study will test 250-300 consecutive ambulatory AF patients with all patterns of atrial fibrillation (paroxysmal, persistent, and long-term persistent) and no prior sleep testing for OSA using the WatchPAT system, a disposable home sleep test (HST). The primary outcome of the study is the prevalence of undiagnosed OSA in all-comers with atrial fibrillation. RESULTS: Preliminary results from the initial pilot enrollment of approximately 15% (N = 38) of the planned sample size demonstrate a 79.0% prevalence of at least mild (AHI≥5) OSA or greater in consecutively enrolled patient with all patterns of AF. CONCLUSIONS: We report the design, methodology, and preliminary results of our study to define the prevalence of OSA in AF patients. This study will help inform approaches to OSA screening in patients with AF for which there is currently little practical guidance. CLINICAL TRIAL REGISTRATION: NCT05155813.

10-year single center experience of catheter ablation of focal atrial tachycardia.

BACKGROUND: Focal atrial tachycardias (ATs) represent 5-15% of sustained supraventricular tachycardias (SVTs). Characteristic distribution of sites of origin and detailed electrophysiologic characterization of AT from specific sites of origin (SOO) have been described. Acute success and recurrence are less favorable than for other SVTs. In this series, we present our experience of focal AT ablation over a 10-year period. METHODS: We undertook a retrospective review of an electronically maintained database of all patients undergoing AT ablation at our institution between January 2011 and December 2020. Demographic, procedural, and outcomes data were reviewed. RESULTS: A total of 293 distinct atrial tachycardias were treated during 279 procedures in 256 patients, including 207 first AT ablations. Acutely successful AT suppression was achieved in 91% of first-time ablations. Acute success was dependent on SOO of AT with lowest rates of acute suppression in the para-Hisian region and the crista terminalis (CT). The most common reason for failure to acutely suppress the AT was proximity to a critical structure (phrenic nerve, sinus node, and AV node). 8.9% of patients in this series presented with a tachycardia-mediated cardiomyopathy (TCM). 48% of TCM patients underwent an ablation attempt during an acute medical admission. Among the TCM group, median LV ejection fraction increased from 25% (range 10-50%) to 55% (range 35-65%) with successful treatment of AT. Five patients undergoing a repeat procedure had planned pericardial access for displacement of the phrenic nerve to permit ablation of the AT, which was successful in all cases. Among patients without a pre-existing diagnosis of AF, peri-procedural AF was not associated with a higher incidence of a subsequent diagnosis of AF (odds ratio 1.169, 95% CI 0.4058-3.475, p = 0.7628). Median duration of follow-up was 832 days. By Kaplan-Meier estimate, recurrence-free survival was 78% (95% CI 67-88%). CONCLUSIONS: In this series, focal AT ablation is associated with good acute results and a low rate of complications, but outcomes remain less favorable than previously reported for other forms of SVT.

Left atrial posterior wall isolation in conjunction with pulmonary vein isolation using cryoballoon for treatment of persistent atrial fibrillation (PIVoTAL): study rationale and design.

BACKGROUND: There is growing evidence in support of pulmonary vein isolation (PVI) with concomitant posterior wall isolation (PWI) for the treatment of patients with symptomatic persistent atrial fibrillation (persAF). However, there is limited data on the safety and efficacy of this approach using the cryoballoon. OBJECTIVE: The aim of this multicenter, investigational device exemption trial (G190171) is to prospectively evaluate the acute and long-term outcomes of PVI versus PVI+PWI using the cryoballoon in patients with symptomatic persAF. METHODS: The PIVoTAL is a prospective, randomized controlled study ( ClinicalTrials.gov : NCT04505163) in which patients with symptomatic persAF refractory/intolerant to ≥ 1 class I-IV antiarrhythmic drug, undergoing first-time catheter ablation, will be randomized to PVI (n = 183) versus PVI+PWI (n = 183) using the cryoballoon in a 1:1 fashion. The design will be double-blind until randomization immediately after PVI, beyond which the design will transform into a single-blind. PVI using cryoballoon will be standardized using a pre-specified dosing algorithm. Other empiric ablations aside from documented arrhythmias/arrhythmias spontaneously induced during the procedure will not be permitted. The primary efficacy endpoint is defined as AF recurrence at 12 months, after a single procedure and a 90-day blanking period. Arrhythmia outcomes will be assessed by routine electrocardiograms and 7-14 day ambulatory electrocardiographic monitoring at 3, 6, and 12 months post-ablation. CONCLUSION: The PIVoTAL is a prospective, randomized controlled trial designed to evaluate the outcomes of PVI alone versus PVI+PWI using the cryoballoon, in patients with symptomatic persAF. We hypothesize that PVI+PWI will prove to be superior to PVI alone for prevention of AF recurrence.

Percutaneous management of superior vena cava syndrome in patients with cardiovascular implantable electronic devices.

BACKGROUND: There is no consensus regarding the optimal management of cardiovascular implantable electronic device (CIED)-related superior vena cava (SVC) syndrome. OBJECTIVE: We report our experience with transvenous lead extractions (TLEs) in the setting of symptomatic CIED-related SVC syndrome. METHODS: We reviewed all TLEs performed at a high-volume center over a 14-year period and identified patients in which TLE was performed for symptomatic SVC syndrome. Patient characteristics, extraction details, percutaneous management of SVC occlusions, and clinical follow up data were analyzed. RESULTS: Over a 14-year period, more than 1600 TLEs were performed. Of these, 16 patients underwent TLE for symptomatic SVC syndrome. The mean age was 53.1 ± 12.8 years, and 9 (56.3%) were men. Thirty-seven leads, with a mean dwell time of 5.8 years (range 2-12 years), were extracted. After extraction, 6 patients (37.5%) received an SVC stent. Balloon angioplasty was performed before stenting in 5 cases (31.3%). There was 1 major complication (6.3%) due to an SVC tear that was managed surgically with a favorable outcome. Eleven patients underwent reimplantation of a CIED. Over a median follow-up of 5.5 years (interquartile range 2.0-8.5 years), 12 patients (75%) remained free of symptoms. CONCLUSION: Combining TLE with the percutaneous treatment of symptomatic SVC syndrome is a safe and viable treatment strategy.

Long-term outcomes of secondary atrial fibrillation in the community: the Framingham Heart Study.

BACKGROUND: Guidelines have proposed that atrial fibrillation (AF) can occur as an isolated event, particularly when precipitated by a secondary, or reversible, condition. However, knowledge of long-term AF outcomes after diagnosis during a secondary precipitant is limited. METHODS AND RESULTS: In 1409 Framingham Heart Study participants with new-onset AF, we examined associations between first-detected AF episodes occurring with and without a secondary precipitant and both long-term AF recurrence and morbidity. We selected secondary precipitants based on guidelines (surgery, infection, acute myocardial infarction, thyrotoxicosis, acute alcohol consumption, acute pericardial disease, pulmonary embolism, or other acute pulmonary disease). Among 439 patients (31%) with AF diagnosed during a secondary precipitant, cardiothoracic surgery (n=131 [30%]), infection (n=102 [23%]), noncardiothoracic surgery (n=87 [20%]), and acute myocardial infarction (n=78 [18%]) were most common. AF recurred in 544 of 846 eligible individuals without permanent AF (5-, 10-, and 15-year recurrences of 42%, 56%, and 62% with versus 59%, 69%, and 71% without secondary precipitants; multivariable-adjusted hazard ratio, 0.65 [95% confidence interval, 0.54-0.78]). Stroke risk (n=209/1262 at risk; hazard ratio, 1.13 [95% confidence interval, 0.82-1.57]) and mortality (n=1098/1409 at risk; hazard ratio, 1.00 [95% confidence interval, 0.87-1.15]) were similar between those with and without secondary precipitants, although heart failure risk was reduced (n=294/1107 at risk; hazard ratio, 0.74 [95% confidence interval, 0.56-0.97]). CONCLUSIONS: AF recurs in most individuals, including those diagnosed with secondary precipitants. Long-term AF-related stroke and mortality risks were similar between individuals with and without secondary AF precipitants. Future studies may determine whether increased arrhythmia surveillance or adherence to general AF management principles in patients with reversible AF precipitants will reduce morbidity.

Incidence of nonphysiologic short VV intervals detected by the sensing integrity counter with integrated bipolar compared with true bipolar leads: clinically inconsequential or cause for concern?

INTRODUCTION: The need to detect impending implantable cardiac defibrillator (ICD) lead failure has grown. Automated sensing diagnostics have been developed for this reason. The sensing integrity counter (SIC) is one such oversensing diagnostic, which forms an integral part of the Medtronic™ lead integrity alert (LIA) feature on implantable defibrillators. It records nonphysiologic short VV intervals (NPSVVIs). It is unclear whether SIC data derived from integrated bipolar (IBP) leads need to be interpreted differently when compared to true bipolar (TBP) leads. We hypothesized that IBP ICD leads by virtue of a larger "antennae" may generate more NPSVVIs on than TBP leads, leading to more false-positive SIC counts. METHODS: Equal durations of remote monitoring records of 44 patients (mean age of 65.9 ± 2.2 years, 52 % female) with IBP ICD leads and Medtronic (MDT) generators (IBP group) were compared with those of 44 randomly selected patients (64.0 ± 2.2 years, 24 % female) who had TBP ICD leads and MDT generators (TBP group). Mean surveillance time, defined as the time over which the cumulative SIC count was acquired, was 614 ± 44 days (TBP group) vs. 620 ± 49 days (IBP group, p = ns). The mean time of follow-up following the first documented short VV interval was 115.2 months in the integrated bipolar group and 66.9 months in the true bipolar group. Leads on advisory were excluded from the study. RESULTS: A total of 26/44 patients in the IBP group displayed NPSVVI compared to 11/44 patients in the TBP group (59 vs. 25 %; p = 0.002, Fisher exact test). When adjusted for gender and lead age, the difference was still significant (p = 0.008). When evaluating the clinical consequence of NPSVVI in this cohort, 3/11 TBP leads with NPSVVI of >0 were eventually extracted due to additional abnormalities vs. 0/26 IBP leads with NPSVVI (p = 0.02, Fisher exact test). None of the IBP group patients with NPSVVI have developed inappropriate therapy from lead noise or a need for abandonment or extraction. CONCLUSION: Integrated bipolar ICD leads are more likely to have elevated SIC counts than true bipolar leads despite revealing no other evidence of lead failure. There does not appear to be a need for heightened surveillance in IBP leads with observed elevated SIC counts that have no other findings to suggest lead malfunction.