Avoiding S3 Valve Over-Sizing by Deployment Balloon Over-Filling: Impact on Rates of Permanent Pacemaker and Other Procedural Complications During TAVR.

ABSTRACT

OBJECTIVES: Patients with annular areas just above nominal S3 valve areas are at increased risk of over-sizing if a larger valve is implanted. We therefore evaluated the rate of permanent pacemaker (PPM) implantation associated with avoiding over-sizing by selective deployment balloon over-filling during transcatheter aortic valve replacement (TAVR) with the Sapien 3 (S3) valve. METHODS: We included consecutive patients treated with the S3 valve from January 2016 to May 2017. We identified computed tomography annular areas where the nominally deployed valve would be over-sized by >12%-15% (areas 340-360 mm² for 23 mm valve, 420-450 mm² for 26 mm valve, 530-580 mm² for 29 mm valve) as those at highest risk for valve over-sizing. In these situations, we used the smaller valve and over-filled the deployment balloon to achieve a predicted valve area/annular area ratio of approximately 1. For annular areas >650 mm², we over-filled the 29 mm valve to achieve a similar ratio. RESULTS: We evaluated 102 patients (59 males; mean age, 83.7 ± 6.5 years; mean STS score, 10.2). Over-filling of the deployment balloon was used in 35 cases (34%). We observed a post-TAVR PPM rate of 6.9% overall and 2.7% among the 75 patients without pre-TAVR right bundle-branch block (RBBB). Cases with valve over-filling vs nominal deployment had infrequent need for postdilation (14.3% vs 6.0%, respectively; P=.17) and similar postprocedure gradients (9.9 mm Hg vs 10.3 mm Hg, respectively; P=.59). CONCLUSION: A strategy to avoid S3 valve over-sizing by selective deployment balloon over-filling was associated with a low rate of PPM, especially in patients without pre-existing RBBB.