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 ... -  《-》

Predictors of Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement With the SAPIEN 3.

The aim of this study was to identify predictors of permanent pacemaker implantation (PPMI) following transcatheter aortic valve replacement (TAVR) with a balloon-expandable transcatheter valve (Edwards SAPIEN 3). New-onset conduction disturbances requiring PPMI remain a major concern following TAVR. Predictors are not yet well defined. The influence of angiographic implantation depth, device landing zone calcium volume, oversizing, pre- and post-dilation, and baseline conduction disturbances on PPMI rate was analyzed in 229 patients undergoing TAVR with the SAPIEN 3 device. PPMI was performed in 14.4% of patients. Patients requiring PPMI had higher left ventricular outflow tract (LVOT) calcium volume in the area below the left coronary cusp (LVOTLC) and the area below right coronary cusp (LVOTRC) (LVOTLC median calcium 23.7 mm3 vs. 3.0 mm3; p < 0.001; LVOTRC median calcium 6.6 mm3 vs. 0.3 mm3; p = 0.014), a higher prevalence of pre-existing right bundle branch block (15% vs. 2%, p = 0.004), and lower implantation depth (ventricular portion of the stent frame 29 ± 12% vs. 21 ± 5%; p < 0.001). On multivariate regression analysis, LVOTLC calcium volume >13.7 mm3, LVOTRC calcium volume >4.8 mm3, pre-existing right bundle branch block, and implantation depth >25.5% emerged as independent predictors of PPMI. Upon modification of the implantation technique, aiming at a high final valve position, implantation depth decreased from 24% ventricular portion to 21% (p = 0.012), accompanied by a decrease in PPMI rate (19.2% vs. 9.2%; p = 0.038). LVOTLC and LVOTRC calcium load, baseline right bundle branch block, and implantation depth were identified as independent predictors of the need for PPMI post-TAVR. Patient groups with different PPMI risk could be stratified using these 4 predictors. A slightly higher valve implantation site may prevent excessive PPMI rates.

Mauri V ，Reimann A ，Stern D ，Scherner M ，Kuhn E ，Rudolph V ，Rosenkranz S ，Eghbalzadeh K ，Friedrichs K ，Wahlers T ，Baldus S ，Madershahian N ，Rudolph TK ... -  《-》

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 ... -  《-》

A Highly Predictive Risk Model for Pacemaker Implantation After TAVR.

This study sought to develop a robust and definitive risk model for new permanent pacemaker implantation (PPMI) after SAPIEN 3 (third generation balloon expandable valve) (Edwards Lifesciences, Irvine, California) transcatheter aortic valve replacement (third generation balloon expandable valve TAVR), including calcification in the aortic-valvular complex (AVC). The association between calcium in the AVC and need for PPMI is poorly delineated after third generation balloon expandable valve TAVR. At Cedars-Sinai Heart Institute in Los Angeles, California, a total of 240 patients with severe aortic stenosis underwent third generation balloon expandable valve TAVR and had contrast computed tomography. AVC was characterized precisely by leaflet sector and region. The total new PPMI rate was 14.6%. On multivariate analysis for predictors of PPMI, pre-procedure third generation balloon expandable valve TAVR, right bundle branch block (RBBB), shorter membranous septum (MS) length, and noncoronary cusp device-landing zone calcium volume (NCC-DLZ CA) were included. Predictive probabilities were generated using this logistic regression model. If 3 pre-procedural risk factors were present, the c-statistic of the model for PPMI was area under the curve of 0.88, sensitivity of 77.1%, and specificity of 87.1%; this risk model had high negative predictive value (95.7%). The addition of the procedural factor of device depth to the model, with the parameter of difference between implantation depth and MS length, combined with RBBB and NCC-DLZ CA increased the c-statistic to 0.92, sensitivity to 94.3%, specificity to 83.8%, and negative predictive value to 98.8% CONCLUSIONS: By using a precise characterization of distribution of calcification in the AVC in a single-center, retrospective study, NCC-DLZ CA was found to be an independent predictor of new PPMI post-third generation balloon expandable valve TAVR. The findings also reinforce the importance of short MS length, pre-existing RBBB, and ventricular implantation depth as important synergistic PPMI risk factors. This risk model will need validation by future prospective multicenter studies.

Maeno Y ，Abramowitz Y ，Kawamori H ，Kazuno Y ，Kubo S ，Takahashi N ，Mangat G ，Okuyama K ，Kashif M ，Chakravarty T ，Nakamura M ，Cheng W ，Friedman J ，Berman D ，Makkar RR ，Jilaihawi H ... -  《-》

1-Year Outcomes With the Evolut R Self-Expanding Transcatheter Aortic Valve: From the International FORWARD Study.

This study sought to report the 1-year safety and efficacy outcomes in the FORWARD (CoreValve Evolut R FORWARD) study following transcatheter aortic valve replacement (TAVR) with the next-generation Evolut R device (Medtronic, Minneapolis, Minnesota) in routine clinical practice. The FORWARD study reported low incidences of mortality, disabling stroke, and significant paravalvular leak following TAVR in routine clinical practice at 30 days. Longer-term results in large patient populations with the Evolut R self-expanding, repositionable transcatheter heart valve (THV) are lacking. This was a prospective, single-arm, multinational, multicenter, observational study investigating efficacy and safety following TAVR with the next-generation self-expanding THV. Between January and December 2016, 1,040 patients underwent attempted implant of the Evolut R self-expanding repositionable valve at 53 sites worldwide. An independent Clinical Events Committee adjudicated safety endpoints based on Valve Academic Research Consortium-2 definitions. An independent echocardiographic core laboratory evaluated all echocardiograms. The mean age was 81.8 ± 6.2 years, 64.8% were women, and patients had a mean Society of Thoracic Surgeons Predicted Risk of Mortality score of 5.5 ± 4.5% and EuroSCORE II of 5.7 ± 5.0%. The 1-year all-cause mortality rate was 8.9%, with a cardiovascular mortality rate of 6.9%. At 1 year, the incidence of disabling stroke was 2.1%, and a pacemaker was implanted in 19.7% of patients. The incidence of more than mild paravalvular leak was 1.2%. The FORWARD study demonstrated good safety and efficacy profiles for the next-generation Evolut R THV up to 1-year follow-up, with very low mortality and adverse events. (CoreValve Evolut R FORWARD Study [FORWARD]; NCT02592369).

Manoharan G ，Van Mieghem NM ，Windecker S ，Bosmans J ，Bleiziffer S ，Modine T ，Linke A ，Scholtz W ，Chevalier B ，Gooley R ，Zeng C ，Oh JK ，Grube E ... -  《-》