Arrhythmic Risk in Biventricular Pacing Compared With Left Bundle Branch Area Pacing: Results From the I-CLAS Study.

BACKGROUND: Left bundle branch area pacing (LBBAP) may be associated with greater improvement in left ventricular ejection fraction and reduction in death or heart failure hospitalization compared with biventricular pacing (BVP) in patients requiring cardiac resynchronization therapy. We sought to compare the occurrence of sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) and new-onset atrial fibrillation (AF) in patients undergoing BVP and LBBAP. METHODS: The I-CLAS study (International Collaborative LBBAP Study) included patients with left ventricular ejection fraction ≤35% who underwent BVP or LBBAP for cardiac resynchronization therapy between January 2018 and June 2022 at 15 centers. We performed propensity score-matched analysis of LBBAP and BVP in a 1:1 ratio. We assessed the incidence of VT/VF and new-onset AF among patients with no history of AF. Time to sustained VT/VF and time to new-onset AF was analyzed using the Cox proportional hazards survival model. RESULTS: Among 1778 patients undergoing cardiac resynchronization therapy (BVP, 981; LBBAP, 797), there were 1414 propensity score-matched patients (propensity score-matched BVP, 707; propensity score-matched LBBAP, 707). The occurrence of VT/VF was significantly lower with LBBAP compared with BVP (4.2% versus 9.3%; hazard ratio, 0.46 [95% CI, 0.29-0.74]; P<0.001). The incidence of VT storm (>3 episodes in 24 hours) was also significantly lower with LBBAP compared with BVP (0.8% versus 2.5%; P=0.013). Among 299 patients with cardiac resynchronization therapy pacemakers (BVP, 111; LBBAP, 188), VT/VF occurred in 8 patients in the BVP group versus none in the LBBAP group (7.2% versus 0%; P<0.001). In 1194 patients with no history of VT/VF or antiarrhythmic therapy (BVP, 591; LBBAP, 603), the occurrence of VT/VF was significantly lower with LBBAP than with BVP (3.2% versus 7.3%; hazard ratio, 0.46 [95% CI, 0.26-0.81]; P=0.007). Among patients with no history of AF (n=890), the occurrence of new-onset AF >30 s was significantly lower with LBBAP than with BVP (2.8% versus 6.6%; hazard ratio, 0.34 [95% CI, 0.16-0.73]; P=0.008). The incidence of AF lasting >24 hours was also significantly lower with LBBAP than with BVP (0.7% versus 2.9%; P=0.015). CONCLUSIONS: LBBAP was associated with a lower incidence of sustained VT/VF and new-onset AF compared with BVP. This difference remained significant after adjustment for differences in baseline characteristics between patients with BVP and LBBAP. Physiological resynchronization by LBBAP may be associated with lower risk of arrhythmias compared with BVP.

Feasibility and safety of laser balloon pulmonary vein isolation in patients with prior left atrial appendage occlusion device implantation.

INTRODUCTION: With the increasing adoption of left atrial appendage occlusion (LAAO) procedures and the eligibility of patients for pulmonary vein isolation (PVI) post device placement, we examined the feasibility and safety of laser balloon (LB) for PVI in patients with prior LAAO. METHODS: We retrospectively examined consecutive patients with paroxysmal or persistent, drug-resistant atrial fibrillation (AF) who underwent LB PVI, after Watchman FLX device implantation at Rush University Medical Center between January 2020 and December 2021. RESULTS: Seven patients (four persistent and three paroxysmal) with a mean age of 64 ± 11 years, predominantly male sex (86%), were included in the study. Two (29%) patients had prior cryoablation PVI with recurrence of AF. The mean CHA2 DS2 VASc is 2.6 ± 0.5 and the mean HAS-BLED score is 3.4 ± 0.8. The mean follow-up duration was 10 ± 7 months. The mean duration between Watchman FLX device implantation and LB PVI was 592 days. Acute first pass left pulmonary vein (PV) isolation was achieved in 100% of the procedures. There were no periprocedural complications such as death, pericardial tamponade or effusion, phrenic nerve injury, PV stenosis, device perforation or embolization, or worsening peri-device leak in any of the patients. None of the patients had AF recurrence after the blanking period. CONCLUSION: LB PVI was safe and effective with 100% acute isolation of left-sided veins in patients with prior LAAO device.

Comparison of Left Bundle Branch Area Pacing and Biventricular Pacing in Candidates for Resynchronization Therapy.

BACKGROUND: Cardiac resynchronization therapy (CRT) with biventricular pacing (BVP) is a well established therapy in patients with reduced left ventricular ejection fraction (LVEF), heart failure, and wide QRS or expected frequent ventricular pacing. Left bundle branch area pacing (LBBAP) has recently been shown to be a safe alternative to BVP. OBJECTIVES: The aim of this study was to compare the clinical outcomes between BVP and LBBAP among patients undergoing CRT. METHODS: This observational study included patients with LVEF ≤35% who underwent BVP or LBBAP for the first time for Class I or II indications for CRT from January 2018 to June 2022 at 15 international centers. The primary outcome was the composite endpoint of time to death or heart failure hospitalization (HFH). Secondary outcomes included endpoints of death, HFH, and echocardiographic changes. RESULTS: A total of 1,778 patients met inclusion criteria: 981 BVP, 797 LBBAP. The mean age was 69 ± 12 years, 32% were female, 48% had coronary artery disease, and mean LVEF was 27% ± 6%. Paced QRS duration in LBBAP was significantly narrower than baseline (128 ± 19 ms vs 161 ± 28 ms; P < 0.001) and significantly narrower compared to BVP (144 ± 23 ms; P < 0.001). Following CRT, LVEF improved from 27% ± 6% to 41% ± 13% (P < 0.001) with LBBAP compared with an increase from 27% ± 7% to 37% ± 12% (P < 0.001) with BVP, with significantly greater change from baseline with LBBAP (13% ± 12% vs 10% ± 12%; P < 0.001). On multivariable regression analysis, the primary outcome was significantly reduced with LBBAP compared with BVP (20.8% vs 28%; HR: 1.495; 95% CI: 1.213-1.842; P < 0.001). CONCLUSIONS: LBBAP improved clinical outcomes compared with BVP in patients with CRT indications and may be a reasonable alternative to BVP.

Clinical outcomes of conduction system pacing compared to biventricular pacing in patients requiring cardiac resynchronization therapy.

BACKGROUND: Cardiac resynchronization therapy (CRT) with biventricular pacing (BVP) is well-established therapy in patients with reduced left ventricular ejection fraction (LVEF) and bundle branch block or indication for pacing. Conduction system pacing (CSP) using His-bundle pacing (HBP) or left bundle branch area pacing (LBBAP) has been shown to be a safe and more physiological alternative to BVP. OBJECTIVE: The purpose of this study was to compare the clinical outcomes between CSP and BVP among patients undergoing CRT. METHODS: This observational study included consecutive patients with LVEF ≤35% and class I or II indications for CRT who underwent successful BVP or CSP at 2 major health care systems. The primary outcome was the composite endpoint of time to death or heart failure hospitalization (HFH). Secondary outcomes included subgroup analysis in left bundle branch block as well as individual endpoints of death and HFH. RESULTS: A total of 477 patients (32% female) met inclusion criteria (BVP 219; CSP 258 [HBP 87, LBBAP 171]). Mean age was 72 ± 12 years, and mean LVEF was 26% ± 6%. Comorbidities included hypertension 70%, diabetes mellitus 45%, and coronary artery disease 52%. Paced QRS duration in CSP was significantly narrower than BVP (133 ± 21 ms vs 153 ± 24 ms; P <.001). LVEF improved in both groups during mean follow-up of 27 ± 12 months and was greater after CSP compared to BVP (39.7% ± 13% vs 33.1% ± 12%; P <.001). Primary outcome of death or HFH was significantly lower with CSP vs BVP (28.3% vs 38.4%; hazard ratio 1.52; 95% confidence interval 1.082-2.087; P = .013). CONCLUSION: CSP improved clinical outcomes compared to BVP in this large cohort of patients with indications for CRT.

Meta-Analysis of Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in Patients With Low Surgical Risk.

Transcatheter aortic valve implantation (TAVI) is the current standard of care for patients with severe aortic stenosis who are at high risk for surgery. However, several recent studies have demonstrated the comparable safety and efficacy of TAVI in low-risk patients as well. We sought to pool the existing data to further assert its comparability. MEDLINE, Cochrane, and Embase databases were evaluated for relevant articles published from January 2005 to June 2019. Studies comparing outcomes of TAVI versus surgical aortic valve replacement in patients who are at low risk for surgery were included. Twelve studies (5 randomized controlled trials and 7 observational studies) totaling 27,956 patients were included. Follow-up ranged from 3 months to 5 years. Short-term all-cause mortality, short-term, and 1-year cardiac mortality were significantly lower in the TAVI group. One-year all-cause mortality, short-term, and 1-year stroke and myocardial infarction were similar in both groups. Rate of acute kidney injury and new-onset atrial fibrillation were lower in the TAVI group, whereas permanent pacemaker implantation and major vascular complications were higher in the TAVI group. Subgroup analysis of randomized controlled trials showed significantly lower 1-year all-cause mortality in the TAVI group. In conclusion, in severe aortic stenosis patients at low surgical risk, TAVI when compared with surgical aortic valve replacement, demonstrated a lower rate of short-term all-cause mortality, short-term, and 1-year cardiac mortality and similar in terms of 1-year all-cause mortality. TAVI is emerging as a safe and efficacious alternative for low surgical risk patients.

Association Between Body Mass Index and Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement (TAVR) with Edwards SAPIEN™ 3 TAVR Valves: A Single-Center Experience.

BACKGROUND:  Transcatheter aortic valve replacement (TAVR) can be complicated with a high-degree atrioventricular block requiring a permanent pacemaker (PPM) in 5% - 25% of patients. Association between body mass index (BMI) and pacemaker implantation has not been extensively studied. We compared standard BMI classes with the odds of requiring a PPM implantation in patients undergoing TAVR with Edwards SAPIEN™ 3 valves (ESV3) (Edwards Lifesciences, Irvine, CA, USA). METHODS:  Our study involved a single-center retrospective cohort analysis of 449 patients undergoing TAVR from December 2012 to April 2018. First, we excluded patients with a TAVR procedure done with valves other than the ESV3 (127 patients). Second, patients with a prior PPM or an implantable cardioverter-defibrillator (37 patients) were excluded. Finally, patients with an aborted procedure and surgical conversion were excluded (16 patients). The final sample size was 269. The primary outcome was pacemaker implantation. Statistical analysis was done using the Chi-square test, T-test, and adjusted logistic regression. RESULTS:  Of the 269 patients (50.6% males; mean age of 79.5 ± 8.7 years; mean Society of Thoracic Surgeons (STS) score: 6.2), pacemaker implantation was performed in 17 patients (6.3%). Time to pacemaker implantation was 1.3 days. Patients were divided into four categories based on their BMI: as underweight (BMI < 25; 67 patients), normal (BMI: 25 to ≤ 30; 87 patients), overweight (BMI: 30 to ≤ 35; 60 patients), and obese (BMI ≥ 35; 55 patients). Pacemaker implantation was significantly higher in patients with a BMI of > 30 (13 vs. 4, p = 0.037). After logistic linear regression, the odds of getting a PPM after TAVR were significantly higher in patients who were overweight (odds ratio (OR): 12.77, p = 0.024; confidence interval (CI): 1.39 - 17.25) and obese (OR: 15.02, p = 0.036, CI: 1.19 - 19.92). CONCLUSIONS:  Our study demonstrates that increased BMI is a possible risk factor for a high-degree atrioventricular block in patients receiving ESV3.

Conscious Sedation Versus General Anesthesia in Transcatheter Aortic Valve Replacement: A Cost and Outcome Analysis.

Background Transcatheter aortic valve replacement (TAVR) has emerged as an alternative treatment for aortic stenosis in patients who are at moderate to high risk for surgical aortic valve replacement. The use of conscious sedation (CS) as compared with general anesthesia (GA) has shown better clinical outcomes for TAVR patients. Whether CS has any cost-benefit is still unknown. We analyze our local TAVR registry with a focus on the cost comparison between CS and GA for the TAVR population. Methods It is a retrospective chart review of 434 patients who received TAVR at our local center from December 2012 to April 2018. Patients who had their procedure aborted and those requiring a cardiopulmonary bypass or surgical conversion (16 patients) were excluded. The final sample size was 418. Patients were divided into two groups based on whether they received CS or GA. Primary outcomes were intensive care unit (ICU) hours, length of stay in hospital, readmission, or death at 30 days. The secondary outcome was the cost of TAVR admission. The cost was divided into direct and indirect costs. The student's T-test and chi-square tests were used for continuous and categorical variables, respectively. Adjusted logistic regression and multivariate analyses were run for primary and secondary outcomes. Results Of the 418 patients (age: 80.9±8.5, male: 52%) CS was given to 194 patients (46.4%) while GA was given in 224 patients(53.6%). The GA group had comparatively older age (81.8 vs. 80.0; p=0.03) and a higher average Society of Thoracic Surgery (STS) score (8.4 vs 5.7; p<0.001). Patients who received CS had a significantly shorter ICU stay (31.5 vs. 41.6 hours, p<0.001) and total days in the hospital (2.9 vs. 3.8 days, p=0.01). Readmission and mortality at 30 days were not different between the groups. There was no statistical difference in cost between the two groups ($72,809 vs. $71,497: p=0.656). Conclusion Using CS compared with GA improves morbidity for TAVR patients, in the form of ICU stay and the total length of stay in hospital. We did not find a significant difference in the cost of TAVR admission between CS and GA.

Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement: A Cost Analysis.

Background Transcatheter aortic valve replacement (TAVR) can be complicated with a complete atrioventricular block requiring permanent pacemaker (PPM) implantation. The cost of index hospitalization for such patients is higher than usual. However, the magnitude of this increased cost is uncertain. We have looked at our five-year TAVR experience to analyze the detailed cost for PPM implantation in TAVR. Methods This study is a retrospective analysis of patients undergoing TAVR at our tertiary care center from December 2012 to April 2018. The initial sample size was 449. We excluded patients with prior PPM or an implantable cardioverter defibrillator (37). Patients who had their procedure aborted or required a cardiopulmonary bypass (16) and those with missing data variables (14) were excluded. The final sample size was 382. The cost for admission was calculated as the US dollars incurred by the hospital. Cohort costs were categorized as a direct cost, which is patient based, and an indirect cost, which represents overhead costs and is independent of patient volume. Patients were divided into two groups based on the placement of PPM after TAVR. Chi-square test, t-test, and logistic linear regression were used for the statistical analysis. Results Of 382 patients, 19 (4.9%) required PPM after TAVR. Baseline variables, including age, gender, and BMI, were not statistically significant. The PPM group had a significantly longer intensive care unit (ICU) stay (48.6 hours vs. 36.7 hours; p<0.001) and total stay in the hospital (4.2 days vs. 3.4 days; p=0.047). PPM implantation after TAVR increased cost on an average of $10,213 more than a typical TAVR admission (p=0.04). The direct cost was also significantly high for the PPM group ($7,087; p=0.02). On detailed analysis, almost all major cost categories showed a higher cost for pacemaker patients when compared with control. Conclusions PPM implantation adds a significant cost burden to TAVR admissions.