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 ... -  《-》

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 ... -  《-》

Prosthesis depth and conduction disturbances after last generation balloon-expandable transcatheter aortic valve implantation.

Preliminary data on Sapien 3 valve (S3-THV) use for transcatheter aortic valve implantation have shown an increased permanent pacemaker implantation (PPMI) rate with respect to Sapien XT valve. Aim of this study was to investigate the role of S3-THV position in the left ventricular outflow tract (LVOT) on electrocardiographic changes suggestive of atrioventricular (ΔPR) and/or intraventricular (ΔQRS) conduction abnormalities and 30 days PPMI rate. Eighty-six consecutive patients treated with S3-THV were included in the study. All patients underwent clinical and electrocardiogram evaluation. Left ventricular outflow tract prosthesis depth was assessed by fluoroscopy and expressed quantitatively (mm) and as aorto-ventricular ratio (AVR). Eight patients (9.3%) needed PPMI at 30 days. A low AVR (≤60/40) predicted PPMI (OR = 6.09, 95% CI 1.19-31.01, P = 0.030) and resulted into higher PPMI rate, compared with higher AVR (30.0 vs. 6.6%, P = 0.017). For each millimetre increase in the LVOT prosthesis depth PPMI risk increased by 1.41 times (95% CI 1.06-1.87, P = 0.017). In patients with low AVR, ΔPR was higher than in those with higher AVR (33.4 ± 56.7 vs. 12.1 ± 19.4 ms, P = 0.021) and ΔPR was associated to LVOT prosthesis depth (β = 0.286, P = 0.009). Furthermore, ΔPR was associated with risk of PPMI (OR = 1.03, 95% CI 1.01-1.06, P = 0.024). A low AVR is associated to higher ΔPR and PPMI rates. The correlation between LVOT prosthesis depth with ΔPR and higher PPMI rate suggests the need of a careful S3-THV implantation.

Iacovelli F ，Pignatelli A ，Giugliano G ，Stabile E ，Cicala M ，Salemme L ，Cioppa A ，Popusoi G ，Pucciarelli A ，Verdoliva S ，Bortone AS ，Losi MA ，Coscioni E ，Esposito G ，Contegiacomo G ，Tesorio T ... -  《-》

Computed tomography (CT) assessment of the membranous septal anatomy prior to transcatheter aortic valve replacement (TAVR) with the balloon-expandable SAPIEN 3 valve.

The lower limit of the membranous septum (MS) is considered an anatomic landmark for the emergence of the Bundle of His into the left ventricle. Computed tomography (CT) assessment of MS anatomy may provide useful information about the risk of conduction abnormalities following transcatheter aortic valve replacement (TAVR). The study included 102 consecutive patients undergoing TAVR with the Edwards Sapien 3 (S3) valve. Using pre-TAVR CT and post-procedure angiography we evaluated for the presence of calcium in the left ventricular outflow tract (LVOT), calcium depth (CD), implantation depth (ID) and MS length. The MS length minus the prosthesis ID was calculated (Delta MSID). Outcomes included new left bundle branch block (LBBB) or permanent pacemaker (PPM) within 30days. Seventeen patients (17%) received a PPM and 28 (27%) developed new LBBB following TAVR. Mean (±SD) MS length and delta MSID were 7.5mm (2) and 0.9mm (4.5), respectively. Twenty-one patients (20%) had calcium in the device landing zone and the mean (SD) CD was 6.8mm (±4). Calcium in the device landing zone (37% versus 16%, p=0.02) and implantation depth (6mm (4-8) versus 4mm (4-5), p=0.02) predicted new conduction abnormalities after TAVR. The presence of calcium in the device landing zone is associated with increased risk of conduction abnormalities after TAVR with S3. In such cases, a more aortic deployment of the prosthesis may be warranted.

Oestreich BA ，Mbai M ，Gurevich S ，Nijjar PS ，Adabag S ，Bertog S ，Kelly R ，Garcia S ... -  《-》

Predictors for permanent pacemaker implantation in patients undergoing transfemoral aortic valve implantation with the Edwards Sapien 3 valve.

Gonska B ，Seeger J ，Keßler M ，von Keil A ，Rottbauer W ，Wöhrle J ... -  《-》