Importance of Contrast Aortography With Lotus Transcatheter Aortic Valve Replacement: A Post Hoc Analysis From the RESPOND Post-Market Study.

The aim of this post hoc analysis from the RESPOND (Repositionable Lotus Valve System-Post-Market Evaluation of Real World Clinical Outcomes) post-market study was to assess the final implantation depth on the contrast aortogram after Lotus valve (Boston Scientific, Marlborough, Massachusetts) transcatheter aortic valve replacement (TAVR) and to correlate with permanent pacemaker implantation (PPI) and paravalvular leak (PVL). Contrast aortography allows for the assessment of implantation depth and PVL during and after TAVR. Previous reports suggested an association between final device position and rates of PPI and PVL. The RESPOND study was a prospective, open-label, single-arm study in 41 centers evaluating outcomes after Lotus TAVR in routine clinical practice. Aortograms were collected at the Erasmus Medical Center and analyzed by researchers who were blinded to clinical outcomes. The primary analysis correlated implantation depth with PPI and PVL and required aortograms in a coaxial projection. The relation between implantation depth and need for PPI was assessed by multivariate logistic regression, adjusting for pre-defined confounders. A secondary analysis compared PVL analysis by contrast aortography with transthoracic echocardiography (TTE) performed by the independent core laboratory. A total of 724 angiographic studies were included in this analysis. Mean Lotus implantation depth was 6.67 ± 2.19 mm. The overall PPI rate was 35%. PPI rate was lower with shallow implants (<6.5 mm: 21% vs. ≥6.5 mm: 41%; p < 0.001). After adjustment for confounders, implantation depth independently predicted need for PPI (odds ratio per 1-mm increment in depth: 1.200; 95% confidence interval: 1.091 to 1.319; p = 0.002). More than trivial PVL was present in 23% by contrast aortography and in 8% by TTE. Implantation depth was not correlated with PVL by contrast aortography or TTE (p = 0.342 and p = 0.149, respectively). PVL grading by contrast aortography and TTE was concordant in 77%. In this post hoc analysis of the RESPOND study PPI was highly correlated with implantation depth, whereas PVL was not. Higher Lotus implantation may reduce need for PPI.

van Gils L ，Wöhrle J ，Hildick-Smith D ，Bleiziffer S ，Blackman DJ ，Abdel-Wahab M ，Gerckens U ，Brecker S ，Bapat V ，Modine T ，Soliman OI ，Nersesov A ，Allocco D ，Falk V ，Van Mieghem NM ... -  《-》

Use of a Repositionable and Fully Retrievable Aortic Valve in Routine Clinical Practice: The RESPOND Study and RESPOND Extension Cohort.

The authors sought to evaluate 1-year clinical outcomes with the Lotus valve (Boston Scientific, Marlborough, Massachusetts) in a large international, multicenter prospective registry including patients eligible for transcatheter aortic valve replacement (TAVR) based on heart team consensus. TAVR is a safe and effective treatment for severe aortic valve stenosis; however, limited data are available on TAVR with the repositionable and fully retrievable Lotus valve in unrestricted contemporary clinical practice. The RESPOND (Repositionable Lotus Valve System-Post-Market Evaluation of Real World Clinical Outcomes) study enrolled 1,014 patients; 996 patients were implanted with the Lotus valve (mean age 80.8 years, 50.8% female, mean STS score 6.0 ± 6.9%). The primary endpoint was all-cause mortality in the intent-to-treat population at 30 days and 1 year. An Extension cohort of 50 patients was treated with the Lotus valve with Depth Guard including a modified delivery system. Mortality and stroke were independently adjudicated. An independent core laboratory assessed echocardiographic data. One-year clinical follow-up was available for 99.9% of Lotus valve-treated patients. At 1 year, the all-cause mortality rate was 11.7% and 4.1% of patients had experienced a disabling stroke. The permanent pacemaker implantation rate was 32% (37% among pacemaker-naive patients). Echocardiographic data at 1 year were available for core laboratory assessment in 62.6% of patients. Paravalvular leak was absent or trace in 94.5%, mild in 5.1%, and moderate in 0.4% of patients. Data from the Extension cohort confirmed good clinical outcomes at 30 days with an 18% permanent pacemaker rate (20% among pacemaker-naive patients). One-year outcomes from the RESPOND study confirm the safety and efficacy of the Lotus valve when used in routine clinical practice. (Repositionable Lotus Valve System-Post-Market Evaluation of Real World Clinical Outcomes [RESPOND]; NCT02031302).

Van Mieghem NM ，Wöhrle J ，Hildick-Smith D ，Bleiziffer S ，Blackman DJ ，Abdel-Wahab M ，Gerckens U ，Linke A ，Ince H ，Wenaweser P ，Allocco DJ ，Meredith IT ，Falk V ... -  《-》

Long-Term Outcomes in Patients With New Permanent Pacemaker Implantation Following Transcatheter Aortic Valve Replacement.

This study sought to evaluate the long-term clinical impact of permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR). Conduction disturbances leading to PPI are common following TAVR. However, no data exist regarding the impact of PPI on long-term outcomes post-TAVR. This was a multicenter study including a total of 1,629 patients without prior PPI undergoing TAVR (balloon- and self-expandable valves in 45% and 55% of patients, respectively). Follow-up clinical, echocardiographic, and pacing data were obtained at a median of 4 years (interquartile range: 3 to 5 years) post-TAVR. PPI was required in 322 (19.8%) patients within 30 days post-TAVR (26.9% and 10.9% in patients receiving self- and balloon-expandable CoreValve and Edwards systems, respectively). Up to 86% of patients with PPI exhibited pacing >1% of the time during follow-up (>40% pacing in 51% of patients). There were no differences between patients with and without PPI in total mortality (48.5% vs. 42.9%; adjusted hazard ratio [HR]: 1.15; 95% confidence interval [CI]: 0.95 to 1.39; p = 0.15) and cardiovascular mortality (14.9% vs. 15.5%, adjusted HR: 0.93; 95% CI: 0.66 to 1.30; p = 0.66) at follow-up. However, patients with PPI had higher rates of rehospitalization due to heart failure (22.4% vs. 16.1%; adjusted HR: 1.42; 95% CI: 1.06 to 1.89; p = 0.019), and the combined endpoint of mortality or heart failure rehospitalization (59.6% vs. 51.9%; adjusted HR: 1.25; 95% CI: 1.05 to 1.48; p = 0.011). PPI was associated with lesser improvement in LVEF over time (p = 0.051 for changes in LVEF between groups), particularly in patients with reduced LVEF before TAVR (p = 0.005 for changes in LVEF between groups). The need for PPI post-TAVR was frequent and associated with an increased risk of heart failure rehospitalization and lack of LVEF improvement, but not mortality, after a median follow-up of 4 years. Most patients with new PPI post-TAVR exhibited some degree of pacing activity at follow-up.

Chamandi C ，Barbanti M ，Munoz-Garcia A ，Latib A ，Nombela-Franco L ，Gutiérrez-Ibanez E ，Veiga-Fernandez G ，Cheema AN ，Cruz-Gonzalez I ，Serra V ，Tamburino C ，Mangieri A ，Colombo A ，Jiménez-Quevedo P ，Elizaga J ，Laughlin G ，Lee DH ，Garcia Del Blanco B ，Rodriguez-Gabella T ，Marsal JR ，Côté M ，Philippon F ，Rodés-Cabau J ... -  《-》

Optimal Implantation Depth and Adherence to Guidelines on Permanent Pacing to Improve the Results of Transcatheter Aortic Valve Replacement With the Medtronic CoreValve System: The CoreValve Prospective, International, Post-Market ADVANCE-II Study.

The aim of the CoreValve prospective, international, post-market ADVANCE-II study was to define the rates of conduction disturbances and permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement with the Medtronic CoreValve System (Minneapolis, Minnesota) using optimized implantation techniques and application of international guidelines on cardiac pacing. Conduction disturbances are a frequent complication of transcatheter aortic valve replacement. The rates of PPI in the published reports vary according to bioprosthesis type and the indications for PPI. The primary endpoint was the 30-day incidence of PPI with Class I/II indications when the Medtronic CoreValve System was implanted at an optimal depth (≤6 mm below the aortic annulus). The timing and resolution of all new-onset conduction disturbances were analyzed. A total of 194 patients were treated. The overall rate of PPI for Class I/II indications was 18.2%. An optimal depth was reached in 43.2% of patients, with a nonsignificantly lower incidence of PPI in patients with depths ≤6 mm, compared with those with deeper implants (13.3% vs. 21.1%; p = 0.14). In a paired analysis, new-onset left bundle branch block and first-degree atrioventricular block occurred in 45.4% and 39.0% of patients, respectively, and resolved spontaneously within 30 days in 43.2% and 73.9%, respectively. In patients with new PPI, the rate of intrinsic sinus rhythm increased from 25.9% at 7 days to 59.3% at 30 days (p = 0.004). Optimal Medtronic CoreValve System deployment and adherence to international guidelines on cardiac pacing are associated with a lower rate of new PPI after transcatheter aortic valve replacement, compared with results reported in previous studies. (CoreValve Advance-II Study: Prospective International Post-Market Study [ADVANCE II]; NCT01624870).

Petronio AS ，Sinning JM ，Van Mieghem N ，Zucchelli G ，Nickenig G ，Bekeredjian R ，Bosmans J ，Bedogni F ，Branny M ，Stangl K ，Kovac J ，Schiltgen M ，Kraus S ，de Jaegere P ... -  《-》

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 ... -  《-》