A Highly Predictive Risk Model for Pacemaker Implantation After TAVR

• Published in: JACC. Cardiovascular imaging Vol. 10; no. 10; pp. 1139 - 1147
• Main Authors: Maeno, Yoshio, Abramowitz, Yigal, Kawamori, Hiroyuki, Kazuno, Yoshio, Kubo, Shunsuke, Takahashi, Nobuyuki, Mangat, Geeteshwar, Okuyama, Kazuaki, Kashif, Mohammad, Chakravarty, Tarun, Nakamura, Mamoo, Cheng, Wen, Friedman, John, Berman, Daniel, Makkar, Raj R., Jilaihawi, Hasan
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.10.2017
• Subjects: Aged; Aged, 80 and over; Aortic Valve - diagnostic imaging; Aortic Valve - pathology; Aortic Valve - physiopathology; Aortic Valve - surgery; Aortic Valve Stenosis - diagnostic imaging; Aortic Valve Stenosis - physiopathology; Aortic Valve Stenosis - surgery; Balloon Valvuloplasty - adverse effects; Bundle-Branch Block - diagnosis; Bundle-Branch Block - etiology; Bundle-Branch Block - physiopathology; Bundle-Branch Block - therapy; calcification; Calcinosis - diagnostic imaging; Calcinosis - physiopathology; Calcinosis - surgery; Cardiac Pacing, Artificial; Cardiovascular; Databases, Factual; Decision Support Techniques; Female; Humans; Logistic Models; Los Angeles; Male; Multidetector Computed Tomography; Multivariate Analysis; pacemaker; Pacemaker, Artificial; Predictive Value of Tests; predictors; Retrospective Studies; Risk Factors; Severity of Illness Index; Time Factors; transcatheter aortic valve implantation; transcatheter aortic valve replacement; Transcatheter Aortic Valve Replacement - adverse effects; Treatment Outcome; predictors; transcatheter aortic valve implantation; pacemaker; BE; MS; LVOT; TAVR; NCC; DLZ; Δ MSID; RBBB; transcatheter aortic valve replacement; PPMI; calcification; CA; right bundle branch block; left ventricular outflow tract; calcium volume; noncoronary cusp; balloon-expandable; difference between membranous septum length and implantation depth; permanent pacemaker implantation; device landing zone; membranous septum
• DOI: 10.1016/j.jcmg.2016.11.020
• ISSN: 1936-878X; 1876-7591

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% 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. [Display omitted]