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Incidence and sequelae of prosthesis-patient mismatch in transcatheter versus surgical valve replacement in high-risk patients with severe aortic stenosis: a PARTNER trial cohort--a analysis.

Publication ,  Journal Article
Pibarot, P; Weissman, NJ; Stewart, WJ; Hahn, RT; Lindman, BR; McAndrew, T; Kodali, SK; Mack, MJ; Thourani, VH; Miller, DC; Svensson, LG; Xu, K ...
Published in: J Am Coll Cardiol
September 30, 2014

BACKGROUND: Little is known about the incidence of prosthesis-patient mismatch (PPM) and its impact on outcomes after transcatheter aortic valve replacement (TAVR). OBJECTIVES: The objectives of this study were: 1) to compare the incidence of PPM in the TAVR and surgical aortic valve replacement (SAVR) randomized control trial (RCT) arms of the PARTNER (Placement of AoRTic TraNscathetER Valves) I Trial cohort A; and 2) to assess the impact of PPM on regression of left ventricular (LV) hypertrophy and mortality in these 2 arms and in the TAVR nonrandomized continued access (NRCA) registry cohort. METHODS: The PARTNER Trial cohort A randomized patients 1:1 to TAVR or bioprosthetic SAVR. Postoperative PPM was defined as absent if the indexed effective orifice area (EOA) was >0.85 cm(2)/m(2), moderate if the indexed EOA was ≥0.65 but ≤0.85 cm(2)/m(2), or severe if the indexed EOA was <0.65 cm(2)/m(2). LV mass regression and mortality were analyzed using the SAVR-RCT (n = 270), TAVR-RCT (n = 304), and TAVR-NRCA (n = 1,637) cohorts. RESULTS: The incidence of PPM was 60.0% (severe: 28.1%) in the SAVR-RCT cohort versus 46.4% (severe: 19.7%) in the TAVR-RCT cohort (p < 0.001) and 43.8% (severe: 13.6%) in the TAVR-NRCA cohort. In patients with an aortic annulus diameter <20 mm, severe PPM developed in 33.7% undergoing SAVR compared with 19.0% undergoing TAVR (p = 0.002). PPM was an independent predictor of less LV mass regression at 1 year in the SAVR-RCT (p = 0.017) and TAVR-NRCA (p = 0.012) cohorts but not in the TAVR-RCT cohort (p = 0.35). Severe PPM was an independent predictor of 2-year mortality in the SAVR-RCT cohort (hazard ratio [HR]: 1.78; p = 0.041) but not in the TAVR-RCT cohort (HR: 0.58; p = 0.11). In the TAVR-NRCA cohort, severe PPM was not a predictor of 1-year mortality in all patients (HR: 1.05; p = 0.60) but did independently predict mortality in the subset of patients with no post-procedural aortic regurgitation (HR: 1.88; p = 0.02). CONCLUSIONS: In patients with severe aortic stenosis and high surgical risk, PPM is more frequent and more often severe after SAVR than TAVR. Patients with PPM after SAVR have worse survival and less LV mass regression than those without PPM. Severe PPM also has a significant impact on survival after TAVR in the subset of patients with no post-procedural aortic regurgitation. TAVR may be preferable to SAVR in patients with a small aortic annulus who are susceptible to PPM to avoid its adverse impact on LV mass regression and survival. (The PARTNER Trial: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).

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Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

September 30, 2014

Volume

64

Issue

13

Start / End Page

1323 / 1334

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Time Factors
  • Regression Analysis
  • Prosthesis Failure
  • Middle Aged
  • Male
  • Incidence
  • Hypertrophy, Left Ventricular
  • Humans
  • Heart Valve Prosthesis Implantation
 

Citation

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Pibarot, P., Weissman, N. J., Stewart, W. J., Hahn, R. T., Lindman, B. R., McAndrew, T., … Leon, M. B. (2014). Incidence and sequelae of prosthesis-patient mismatch in transcatheter versus surgical valve replacement in high-risk patients with severe aortic stenosis: a PARTNER trial cohort--a analysis. J Am Coll Cardiol, 64(13), 1323–1334. https://doi.org/10.1016/j.jacc.2014.06.1195
Pibarot, Philippe, Neil J. Weissman, William J. Stewart, Rebecca T. Hahn, Brian R. Lindman, Thomas McAndrew, Susheel K. Kodali, et al. “Incidence and sequelae of prosthesis-patient mismatch in transcatheter versus surgical valve replacement in high-risk patients with severe aortic stenosis: a PARTNER trial cohort--a analysis.J Am Coll Cardiol 64, no. 13 (September 30, 2014): 1323–34. https://doi.org/10.1016/j.jacc.2014.06.1195.
Pibarot, Philippe, et al. “Incidence and sequelae of prosthesis-patient mismatch in transcatheter versus surgical valve replacement in high-risk patients with severe aortic stenosis: a PARTNER trial cohort--a analysis.J Am Coll Cardiol, vol. 64, no. 13, Sept. 2014, pp. 1323–34. Pubmed, doi:10.1016/j.jacc.2014.06.1195.
Pibarot P, Weissman NJ, Stewart WJ, Hahn RT, Lindman BR, McAndrew T, Kodali SK, Mack MJ, Thourani VH, Miller DC, Svensson LG, Herrmann HC, Smith CR, Rodés-Cabau J, Webb J, Lim S, Xu K, Hueter I, Douglas PS, Leon MB. Incidence and sequelae of prosthesis-patient mismatch in transcatheter versus surgical valve replacement in high-risk patients with severe aortic stenosis: a PARTNER trial cohort--a analysis. J Am Coll Cardiol. 2014 Sep 30;64(13):1323–1334.
Journal cover image

Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

September 30, 2014

Volume

64

Issue

13

Start / End Page

1323 / 1334

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Time Factors
  • Regression Analysis
  • Prosthesis Failure
  • Middle Aged
  • Male
  • Incidence
  • Hypertrophy, Left Ventricular
  • Humans
  • Heart Valve Prosthesis Implantation