A Comparison of Semi- and Noncompliant Balloon Systems in Transcatheter Aortic Valve Implantation

Background: The benefit of percutaneous balloon aortic valvuloplasty during transcatheter aortic valve implantation (TAVI) has recently been questioned; however, there has been little focus on the difference in the outcome of compliant (CB) and noncompliant balloon (NCB) use. The aim of this study was the evaluation of possible differences in mortality and complication rates between CB and NCB use during TAVI procedures.

Patients and Methods: Between June 2009 and December 2016, 532 TAVI patients were examined throughout this retrospective single-center cohort study. The primary end point of the study was the grade of residual paravalvular leak (PVL) after TAVI. Secondary end points were 30-day mortality as well as a composite safety end point. Furthermore, complication rates of Valve Academic Research Consortium-2 defined end points had been investigated. NCB (True Dilatation, Bard Inc.) were compared with (semi-) CB, such as Nucleus, Z-MED, or Z-MED II by NuMed Inc., VACS II and III by Ospyka or the standard Edwards Transfemoral Balloon Catheter. Pre- and postdilatation (PreD/PostD), as well as inflation time, had been measured during the implantation.

Results: A postprocedural PVL was not influenced by balloon type or inflation time; however, the overall incidence of PVL was more often observed after PreD (no PreD: 59 [38.1%] vs. PreD: 181 [52.8%]; p = 0.002).

Balloon type nor PreD or PostD had any effect on 30-day mortality; however, during long-term follow-up, the use of PostD had a trend toward impaired long-term survival (log rank: 0.064).

The use of NCBs during PreD led to a higher rate of VIV implantations during index procedure (CB: 2 [0.6%] vs. NCB: 5 [5.7%]; p = 0.005) and conversions to open surgery (CB: 1 [0.3%] vs. NCB: 3 [3.4%]; p = 0.030). Furthermore, a trend toward neurological adverse events had been observed (CB: 6 [1.7%] vs. NCB: 5 [5.5%]; p = 0.058).

Conclusion: The use of NCB systems during PreD must be discouraged in the light of a higher rate of VIV implantations and conversion to open surgery as well as a trend toward neurological adverse events in our study.