The aim of this study was to assess the incidence and clinical impact of balloon post-dilation (BPD) after transcatheter aortic valve replacement (TAVR) with the CoreValve prosthesis (Medtronic Inc., Minneapolis, Minnesota).
Background
BPD is a widely adopted strategy to reduce the degree of paraprosthetic regurgitation in case of transcatheter heart valve underexpansion. However, controversies still remain regarding its real effectiveness and safety.
Methods
The ClinicalService (a nation-based data repository and medical care project) dataset was analyzed. All patients were dichotomized according to the need for BPD during the index procedure.
Results
Among 1,376 patients, BPD of the transcatheter heart valve was performed in 272 (19.8%). In 37% of cases, it was unsuccessful at reducing the paravalvular regurgitation to mild or less. No case of valve embolization, new intravalvular regurgitation, coronary occlusion, and aortic root injury occurred during BPD. There were no statistically significant differences between the 2 groups in the incidence of in-hospital all-cause and cardiovascular mortality, neurological events, myocardial infarction, bleeding, conversion to open-chest surgery, and the need for a permanent pacemaker. The need for BPD did not emerge as an independent risk factor for all-cause (adjusted hazard ratio [HR]: 1.33, 95% confidence interval [CI]: 0.81 to 2.19, p = 0.264) and cardiovascular (adjusted HR: 1.48, 95% CI: 0.74 to 2.97, p = 0.265) mortality at 1 year after the procedure. In addition, BPD did not predispose to higher odds of neurological events during 12 months after TAVR (HR: 0.92, 95% CI: 0.45 to 1.88, p = 0.815).
Conclusions
This large study showed that BPD after TAVR was safe and not associated with increased rates of cerebrovascular events, mortality, myocardial infarction, and aortic root injury.
Key Words
post-dilation
TAVR
underexpansion
Abbreviations and Acronyms
BPD
balloon post-dilation
CI
confidence interval
HR
hazard ratio
LBBB
left bundle branch block
PVR
paravalvular regurgitation
TAVR
transcatheter aortic valve replacement
THV
transcatheter heart valve
VASC
Valve Academic Research Consortium
Cited by (0)
Medtronic Italy is the sponsor of the ClinicalService Project. Dr. Latib is on the Advisory Board of Medtronic and a consultant for Direct Flow Medical. Drs. Bedogni, Ettori, Bruschi, and Petronio are consultants for Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.