Impact of prosthesis‐iteration evolution and sizing practice on the incidence of prosthesis–patient mismatch after transcatheter aortic valve replacement

Abstract

Objectives To investigate the impact of the introduction of the next generation self‐expanding (SE) and balloon‐expandable (BE) transcatheter heart valves (THVs) on the incidence of prosthesis–patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR). Background PPM is a risk factor for accelerated degeneration of bioprosthetic aortic valves. Data on PPM after TAVR are derived mainly from studies of older generation THVs. Methods PPM was assessed at 30 days post‐TAVR with the older generation (Medtronic CoreValve, n = 120 and Edwards Sapien XT, n = 121) and the next generation THVs (Medtronic Evolut R/Pro, n = 136 and Edwards Sapien 3, n = 363). Results The incidence of any and severe PPM was 15.1% and 0.0% for the older generation THVs, and 42.8% and 12.1% for the next generation THVs. The incidence of moderate and severe PPM was 23.3% and 3.5% in patients who received an Evolut R/Pro vs. 33.1% and 14.7% in those who received a Sapien 3 (P < 0.001). On multivariable analysis, TAVR with the Sapien 3 THV was not associated with PPM, while left ventricular ejection fraction (0.97 [0.95–0.99], P = 0.002), history of myocardial infarction (2.09 [1.00–4.34], P = 0.049), annulus maximum diameter (0.84 [0.77–0.92], P < 0.001), and THV oversizing (0.90 [0.87–0.94], P < 0.001) were independently associated with PPM. In Sapien 3, the risk of any and severe PPM was higher in those with no oversizing (odds ratio: 3.25 [1.23–8.53], P = 0.017 and 5.79[2.33–14.36], P < 0.001). Conclusions The incidence of PPM in contemporary TAVR is significant, especially with the next generation BE THV without adequate oversizing.

Accuracy of predicted effective orifice area in determining incidence of patient‐prosthesis mismatch after transcatheter aortic valve replacement

“…While some studies suggest that self‐expanding valves may have lower frequency of PPM as compared with balloon‐expandable valves 20,21 others reported similar rates of PPM between the two valve types 22 . We report similar rates of PPM in patients receiving Sapien 3 and Evolut valves in our study.…”

A match not made in heaven—TAVR prosthesis‐patient mismatch with contemporary valves

“…Concern that PPM may be an underappreciated issue in transcatheter aortic valve replacement (TAVR) has now appeared on center stage, most recently drawing on data in the Transcatheter Valve Therapies Registry . The results, that moderate PPM was present in 25% and severe PPM in 12% are similar to the findings in the current study by Abdelghani et al The authors conclude that the extent of oversizing has an inverse relationship with subsequent PPM, an observation to be expected with the “larger is better” concept implied by the use of the effective orifice area (EOA) to BSA ratio to define the presence of PPM. However, in this study the mean oversizing of the Sapien 3 valves was only 3.8%, well below the standard of those operators who add volume to increase the percent oversizing to 10% or greater (primarily to prevent paravalvular leak) .…”

“…However, in this study the mean oversizing of the Sapien 3 valves was only 3.8%, well below the standard of those operators who add volume to increase the percent oversizing to 10% or greater (primarily to prevent paravalvular leak) . The results of the study by Abdelghani et al suggest that in select patients with low predicted EOA/BSA ratios, greater oversizing may reduce PPM—albeit with the risk of annular damage or valve disruption …”

Predictors and outcomes of patient‐prosthesis mismatch after transcatheter aortic valve replacement

“…In our study, Sapien 3 was associated with a two‐fold higher risk of PPM compared to earlier generation Sapien valve, and a nearly three‐fold higher risk compared with Evolut PRO/R valves. Higher incidence of PPM in the newer Sapien 3 valves has been previously reported . Possible causes of higher PPM risk with Sapien S3 valve include less oversizing compared to Sapien XT and the added outer skirt that may contribute to narrowing of the effective orifice area, relative impedance on the systolic blood flow, and therefore, higher risk of PPM, compared with self‐expandable valves.…”

“…Higher incidence of PPM in the newer Sapien 3 valves has been previously reported . Possible causes of higher PPM risk with Sapien S3 valve include less oversizing compared to Sapien XT and the added outer skirt that may contribute to narrowing of the effective orifice area, relative impedance on the systolic blood flow, and therefore, higher risk of PPM, compared with self‐expandable valves. Evolut PRO/R valves employ a supra‐annular implantation approach rather than intra‐annular as in Edwards Sapien valves, which may lead to better postoperative hemodynamics …”