Transcatheter Aortic Valve Implantation With or Without Preimplantation Balloon Aortic Valvuloplasty: A Systematic Review and Meta‐Analysis

Abstract

BackgroundPreimplantation balloon aortic valvuloplasty (BAV) is considered a routine procedure during transcatheter aortic valve implantation (TAVI) to facilitate prosthesis implantation and expansion; however, it has been speculated that fewer embolic events and/or less hemodynamic instability may occur if TAVI is performed without preimplantation BAV. The aim of this study was to systematically review the clinical outcomes associated with TAVI undertaken without preimplantation BAV.Methods and ResultsWe conducted a search of Medline and Embase to identify studies that evaluated patients who underwent TAVI with or without preimplantation BAV for predilation. Pooled analysis and random‐effects meta‐analyses were used to estimate the rate and risk of adverse outcomes. Sixteen studies involving 1395 patients (674 with and 721 without preimplantation BAV) fulfilled the inclusion criteria. Crude device success was achieved in 94% (1311 of 1395), and 30‐day all‐cause mortality occurred in 6% (72 of 1282) of patients. Meta‐analyses evaluating outcomes of strategies with and without preimplantation BAV showed no statistically significant differences in terms of mortality (relative risk [RR] 0.61, 95% CI 0.32–1.14, P=0.12), safety composite end point (RR 0.85, 95% CI 0.62–1.18, P=0.34), moderate to severe paravalvular leaks (RR 0.68, 95% CI 0.23–1.99, P=0.48), need for postdilation (RR 0.86, 95% CI 0.66–1.13, P=0.58), stroke and/or transient ischemic attack (RR 0.72, 95% CI 0.30–1.71, P=0.45), and permanent pacemaker implantation (RR 0.80, 95% CI 0.49–1.30, P=0.37).ConclusionsOur analysis suggests that TAVI procedures with or without preimplantation BAV were associated with similar outcomes for a number of clinically relevant end points. Further studies including a large number of patients are needed to ascertain the impact of TAVI without preimplantation BAV as a standard practice.

Routine Predeployment Balloon Aortic Valvuloplasty During Transcatheter Aortic Valve Replacement: Time to Move On?

“…Hence, to decrease cerebral emboli during TAVR, emphasis should be made on careful manipulation of catheters in the aortic arch, conscientious anticoagulation, and possibly prophylactic use of an embolic protection device. The present study indicates that BAV during TAVR does not increase the incidence of procedure‐related stroke, which correlates with the bulk of previous evidence . This finding particularly applies to TAVR performed at experienced centers and when third‐generation valves are used.…”

“…These results add to the existing data supporting that TAVR can be performed successfully without routine BAV. Omitting this additional step has been shown to be safe, results in successful valve deployment, and yields similar clinical and hemodynamic outcome at up to 1 year . Additional benefits of direct TAVR are lower contrast use and shorter fluoroscopy and procedural time .…”

“…It has been suggested that direct TAVR can require more frequent postdilation, which is associated with increased cerebral embolic events . However, most trials have not found a difference in the rate of postdilation between direct TAVR and predeployment BAV . Again, BAV does not appear to significantly impact outcomes in TAVR, but its safety and association with stroke using third‐generation valves need to be validated in large randomized trials.…”

Transcatheter aortic valve implantation in the United States: Predictors of early hospital discharge

“…Balloon aortic valvuloplasty performed prior to TAVI was associated with higher likelihood for early discharge. Aortic valvuloplasty prior to TAVI is thought to faciliate optimal sizing and smooth deployment of transcatheter valves potentially reducing paravalvular leaks . However, a recent large meta‐analysis involving 1395 patients showed no significant difference clinical outcomes if TAVI is performed with or without prior valvuloplasty .…”

Permanent pacemaker insertion in patients with conduction abnormalities post transcatheter aortic valve replacement: a review and proposed guidelines

“…The need for pre-dilatation balloon valvuloplasty and post-implant dilatation have not been identified as potential contributing factors as it is believed the impact of the dilatation on the conduction tissue is transient and short lived (38). Access site does not seem to play a role in PPM implantation; there was no significant difference between the transfemoral approaches compared to the transapical approach in a single center study (39).…”