Standardized Minimalistic Transfemoral Transcatheter Aortic Valve Replacement (TAVR) Using the SAPIEN 3 Device: Stepwise Description, Feasibility, and Safety from a Large Consecutive Single-Center Single-Operator Cohort

posted on 08.08.2017 by Antonio H. Frangieh, Ilka Ott, Jonathan Michel, Anupama Shivaraju, Michael Joner, N. Patrick Mayr, Christian Hengstenberg, Oliver Husser, Costanza Pellegrini, Heribert Schunkert, Adnan Kastrati, Albert Markus Kasel

Background: To describe our updated minimalist approach (MA) for transfemoral transcatheter aortic valve replacement (TF-TAVR) using the SAPIEN 3 device and its evolution, as well as associated safety and efficacy parameters from a large cohort of patients.

Methods: A stepwise description of the MA technique for TAVR for 300 consecutive patients was detailed. Safety and efficacy parameters were assessed using the VARC-2 criteria at the in-hospital and 30-days follow-up.

Results: A total of 300 consecutive patients (80 ± 7 years; median Logistic EuroSCORE of 11.4% [7.5–17.8]) between January 2014 and May 2016 were evaluated. TF-TAVR was performed under conscious sedation in 247 (82%) patients. Device success was achieved in 286 (95.6%) patients, and intended prosthesis performance in 289 (96.3%) patients. Significant paravalvular leak (PVL) graded more than mild was noted in 7 (2%) patients. No patient had severe PVL. All-cause mortality was noted in one (0.3%) patient in-hospital and in 2 (0.7%) patients at the 30-days follow-up. Major stroke occurred in 4 (1.3%) patients. 9 (3%) patients had major vascular complications at 30-days follow up. MACCE (VARC-2 criteria) were observed in 21 (7%) in-hospital and 25 (8.3%) at 30 days. A new permanent pacemaker implantation was required in 29 (10.7%) patients, and was reduced from 18% to 5.6% (p = 0.001) in a subgroup analysis considering higher implantation position of the valve after the first year of experience.

Conclusion: MA of TF-TAVR, when simplified and standardized, is reproducible, safe and efficient, and should be encouraged to be accepted as the standard method of care.