Incidence and predictors of permanent pacemaker implantation following treatment with the repositionable Lotus™ transcatheter aortic valve.

To determine the incidence and predictors of permanent pacemaker (PPM) requirement following transcatheter aortic valve replacement (TAVR) with the mechanically expanded LotusTM Valve System (Boston Scientific). Pacemaker implantation is the most common complication following TAVR. Predictors of pacing following TAVR with the Lotus valve have not been systematically assessed. Consecutive patients with severe aortic stenosis who underwent Lotus valve implantation were prospectively recruited at a single-centre. Patients with a pre-existing PPM were excluded. Baseline ECG, echocardiographic and multiple detector computed tomography as well as procedural telemetry and depth of implantation were independently analyzed in a blinded manner. The primary endpoint was 30-day incidence of pacemaker requirement (PPM implantation or death while pacing-dependent). Multivariate analysis was performed to identify independent predictors of the primary endpoint. A total of 104 consecutive patients underwent TAVR with the Lotus valve with 9/104 (9%) with a pre-existing PPM excluded. New or worsened procedural LBBB occurred in 78%. Thirty-day incidence of the primary pacing endpoint was 28%. The most common indication for PPM implantation was complete heart block (CHB) (69%). Independent predictors of the primary endpoint included pre-existing RBBB (hazard ratio [HR] 2.8, 95% CI 1.1-7.0; P = 0.032) and depth of implantation below the noncoronary cusp (NCC) (HR 2.4, 95% CI 1.0-5.7; P = 0.045). Almost a third of Lotus valve recipients require pacemaker implantation within 30 days. The presence of pre-existing RBBB and the depth of prosthesis implantation below the NCC were significant pacing predictors. © 2016 Wiley Periodicals, Inc.

Zaman S ，McCormick L ，Gooley R ，Rashid H ，Ramkumar S ，Jackson D ，Hui S ，Meredith IT ... -  《-》

Long-term pacemaker dependency and impact of pacing on mortality following transcatheter aortic valve replacement with the LOTUS valve.

To determine permanent pacemaker (PPM) dependency following transcatheter aortic valve replacement (TAVR) with the Lotus™ valve system (Boston Scientific), and the impact of PPM implantation on long-term morbidity and mortality. Conduction abnormalities are among the most common complications following TAVR. Limited studies have assessed pacing dependency following TAVR. Consecutive patients (n = 166) with severe aortic stenosis who underwent TAVR with the Lotus valve system were prospectively recruited from a single-center. PPMs were implanted according to standard clinical criteria. Patients were followed in-hospital and at 1, 3, 6, and 12 months to determine pacemaker dependency and clinical outcomes. Fourteen patients with a pre-existing PPM (8%) were excluded with the remaining 152 patients aged 83.6 ± 5.6 years and 46% male. PPMs were implanted 3.8 ± 4 days post-TAVR in 38/152 patients (25%). Indication for PPM was complete heart block in 29 (76%) of patients. At 30-day and one-year follow up, 57% and 38% of patients were pacemaker dependent, respectively. The mean ventricular pacing percentage decreased in the first three months after PPM implantation and remained relatively stable after that. Only 38% of Lotus recipients who require a PPM following TAVR with the Lotus valve remain pacing dependent at one year.

Alasti M ，Rashid H ，Rangasamy K ，Kotschet E ，Adam D ，Alison J ，Gooley R ，Zaman S ... -  《-》

Minimizing Permanent Pacemaker Following Repositionable Self-Expanding Transcatheter Aortic Valve Replacement.

This study sought to minimize the risk of permanent pacemaker implantation (PPMI) with contemporary repositionable self-expanding transcatheter aortic valve replacement (TAVR). Self-expanding TAVR traditionally carries a high risk of PPMI. Limited data exist on the use of the repositionable devices to minimize this risk. At NYU Langone Health, 248 consecutive patients with severe aortic stenosis underwent TAVR under conscious sedation with repositionable self-expanding TAVR with a standard approach to device implantation. A detailed analysis of multiple factors contributing to PPMI was performed; this was used to generate an anatomically guided MInimizing Depth According to the membranous Septum (MIDAS) approach to device implantation, aiming for pre-release depth in relation to the noncoronary cusp of less than the length of the membranous septum (MS). Right bundle branch block, MS length, largest device size (Evolut 34 XL; Medtronic, Minneapolis, Minnesota), and implant depth > MS length predicted PPMI. On multivariate analysis, only implant depth > MS length (odds ratio: 8.04; 95% confidence interval: 2.58 to 25.04; p < 0.001) and Evolut 34 XL (odds ratio: 4.96; 95% confidence interval: 1.68 to 14.63; p = 0.004) were independent predictors of PPMI. The MIDAS approach was applied prospectively to a consecutive series of 100 patients, with operators aiming to position the device at a depth of < MS length whenever possible; this reduced the new PPMI rate from 9.7% (24 of 248) in the standard cohort to 3.0% (p = 0.035), and the rate of new left bundle branch block from 25.8% to 9% (p < 0.001). Using a patient-specific MIDAS approach to device implantation, repositionable self-expanding TAVR achieved very low and predictable rates of PPMI which are significantly lower than previously reported with self-expanding TAVR.

Jilaihawi H ，Zhao Z ，Du R ，Staniloae C ，Saric M ，Neuburger PJ ，Querijero M ，Vainrib A ，Hisamoto K ，Ibrahim H ，Collins T ，Clark E ，Pushkar I ，Bamira D ，Benenstein R ，Tariq A ，Williams M ... -  《-》

Conduction Abnormalities and Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement Using the Repositionable LOTUS Device: The United Kingdom Experience.

The authors report the incidence of pacemaker implantation up to hospital discharge and the factors influencing pacing rate following implantation of the LOTUS bioprosthesis (Boston Scientific, Natick, Massachusetts) in the United Kingdom. Transcatheter aortic valve replacement (TAVR) is associated with a significant need for permanent pacemaker implantation. Pacing rates vary according to the device used. The REPRISE II (Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System) trial reported a pacing rate of 29% at 30 days after implantation of the LOTUS device. Data were collected retrospectively on 228 patients who had the LOTUS device implanted between March 2013 and February 2015 across 10 centers in the United Kingdom. Twenty-seven patients (12%) had pacemakers implanted pre-procedure and were excluded from the analysis. Patients were aged 81.2 ± 7.7 years; 50.7% were male. The mean pre-procedural QRS duration was 101.7 ± 20.4 ms. More than one-half of the cohort (n = 111, 55%) developed new left bundle branch block (LBBB) following the procedure. Permanent pacemakers were implanted in 64 patients (32%) with a median time to insertion of 3.0 ± 3.4 days. Chief indications for pacing were atrioventricular (AV) block (n = 46, 72%), or LBBB with 1st degree AV block (n = 11, 17%). Amongst those who received a pacemaker following TAVR the pre-procedural electrocardiogram findings included: No conduction disturbance (n = 41, 64%); 1st degree AV block (n = 10, 16%); right bundle branch block (n = 6, 9%) and LBBB (n = 5, 8%). LBBB (but not permanent pacemaker) occurred more frequently in patients who had balloon aortic valvuloplasty before TAVR (odds ratio [OR]: 1.25; p = 0.03). Pre-procedural conduction abnormality (composite of 1st degree AV block, hemiblock, right bundle branch block, LBBB) was independently associated with the need for permanent pacemaker (OR: 2.54; p = 0.048). The absence of aortic valve calcification was also associated with a higher pacing rate (OR: 0.55; p = 0.031). Multivariate regression analysis did not show an independent association between depth of implant, valve oversizing, balloon post-dilatation, and the need for pacing post-procedure. Following implantation of the repositionable LOTUS valve, 55% of patients developed LBBB and 32% of patients required a pacemaker during their index hospital admission. Patients with pre-procedural conduction disturbance and non-calcified aortic valves were more likely to need pacing. No other anatomic features were identified with increased pacing requirement with the LOTUS device.

Rampat R ，Khawaja MZ ，Hilling-Smith R ，Byrne J ，MacCarthy P ，Blackman DJ ，Krishnamurthy A ，Gunarathne A ，Kovac J ，Banning A ，Kharbanda R ，Firoozi S ，Brecker S ，Redwood S ，Bapat V ，Mullen M ，Aggarwal S ，Manoharan G ，Spence MS ，Khogali S ，Dooley M ，Cockburn J ，de Belder A ，Trivedi U ，Hildick-Smith D ... -  《-》

Incidence, Predictors, and Outcomes of Permanent Pacemaker Implantation Following Transcatheter Aortic Valve Replacement: Analysis From the U.S. Society of Thoracic Surgeons/American College of Cardiology TVT Registry.

The purpose of this study was to evaluate the incidence, predictors, and clinical outcomes of permanent pacemaker (PPM) implantation following transcatheter aortic valve replacement (TAVR). Conduction abnormalities leading to PPM implantation are common complications following TAVR. Whether PPM placement can be predicted or is associated with adverse outcomes is unclear. A retrospective cohort study of patients undergoing TAVR in the United States at 229 sites between November 2011 and September 2014 was performed using the Society of Thoracic Surgeons/American College of Cardiology TVT Registry and the Centers for Medicare and Medicaid Services database. PPM placement was required within 30 days of TAVR in 651 of 9,785 patients (6.7%) and varied among those receiving self-expanding valves (25.1%) versus balloon-expanding valves (4.3%). Positive predictors of PPM implantation were age (per 5-year increment, odds ratio: 1.07; 95% confidence interval [CI]: 1.01 to 1.15), prior conduction defect (odds ratio: 1.93; 95% CI: 1.63 to 2.29), and use of self-expanding valve (odds ratio: 7.56; 95% CI: 5.98 to 9.56). PPM implantation was associated with longer median hospital stay (7 days vs. 6 days; p < 0.001) and intensive care unit stay (56.7 h vs. 45.0 h; p < 0.001). PPM implantation was also associated with increased mortality (24.1% vs. 19.6%; hazard ratio [HR]: 1.31; 95% CI: 1.09 to 1.58) and a composite of mortality or heart failure admission (37.3% vs. 28.5%; hazard ratio HR: 1.33; 95% CI: 1.13 to 1.56) at 1 year but not with heart failure admission alone (16.5% vs. 12.9%; HR: 1.23; 95% CI: 0.92 to 1.63). Early PPM implantation is a common complication following TAVR, and it is associated with higher mortality and a composite of mortality or heart failure admission at 1 year.

Fadahunsi OO ，Olowoyeye A ，Ukaigwe A ，Li Z ，Vora AN ，Vemulapalli S ，Elgin E ，Donato A ... -  《-》