Influence of Predilatation on Stroke, Pacemaker Rate and Paravalvular Leak after Implantation of a Next Generation Self-expandable Transcatheter Aortic Valve Prosthesis

Objectives: The need for aortic balloon valvuloplasty prior to transcatheter aortic valve implantation (TAVR) has been debated. We investigated the influence of predilatation on in-hospital outcomes in patients undergoing TAVR with the latest generation Medtronic Evolut R prosthesis (Evolut R).

Methods: All patients, excluding valve-in-valve patients and patients with pure aortic regurgitation receiving an Evolut R prosthesis were retrospectively analyzed. Patients were assigned to two groups, depending on whether a valvuloplasty of the valve was performed (valvuloplasty versus non-valvuloplasty group). Post-implant pacemaker rate, stroke, other intraprocedural complications, death and postoperative echocardiographic data were analyzed.

Results: We included 230 patients, 92 (40%) without and 138 (60%) with predilatation of the aortic valve. Mean age was 80.1 ± 6.9 with a mean STS-score of 4.3 ± 3.5. The patients without valvuloplasty had a significantly higher rate of postdilatation (non-valvuloplasty 54.3% versus valvuloplasty 38.4%, p = 0.021). There was no significant difference in the malplacement rate (valvuloplasty 1% versus non-valvuloplasty 2.9%, p = 0.651) and the pacemaker rate (valvuloplasty 18.8% versus non-valvuloplasty 13.0%, p = 0.28). After exclusion of the patients who underwent a postdilatation, the pacemaker rate still showed no significant difference (valvuloplasty 21.2% versus non-valvuloplasty 14.3%, p = 0.471). No patient had an in-hospital stroke. There was no significant difference in the postoperative gradients, effective orifice area and indexed orifice area between the groups for each valve size. No patient had more than moderate aortic regurgitation and the degree of aortic regurgitation was not significantly different between the groups (p = 0.346). Non-significance did not change after exclusion of patients who received a postdilatation (p = 0.490). There were three in-hospital deaths, only one was procedure related.

Conclusions: Direct transcatheter aortic valve implantation of an Evolut R prosthesis without prior valvuloplasty is a safe and feasible option. There were no significant differences in malplacement or stroke rates or degree of aortic regurgitation. Although no statistically significant difference was seen, avoidance of predilatation might be beneficial to reduce the pacemaker rate below 15%.

No conflict of interest has been declared by the author(s).