TCT
TCT
September 25, 2018
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Severe prosthesis-patient mismatch portends risk after TAVR

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Howard C. Herrmann
Howard C. Herrmann

SAN DIEGO — Severe prosthesis-patient mismatch conferred elevated risk for mortality and HF hospitalization at 1 year after transcatheter aortic valve replacement, according to a presentation at TCT 2018.

Howard C. Herrmann, MD, director of the cardiac catheterization laboratories and health system director for interventional cardiology at the Hospital of the University of Pennsylvania and John Winthrop Bryfogle Professor of Cardiovascular Diseases at the Perelman School of Medicine at the University of Pennsylvania, and colleagues analyzed 62,125 patients (mean age, 81 years; 54% men) from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (TVT) registry who underwent TAVR between 2014 and March 2017.

In addition to data from the TVT registry, the researchers were able to acquire additional data on 1-year mortality, stroke and HF hospitalization from a CMS database on patients aged at least 65 years at the time of their procedure who were covered by a Medicare fee-for-service plan.

Herrmann, a member of the Cardiology Today’s Intervention Editorial Board, and colleagues also calculated predictors of severe prosthesis-patient mismatch, which was determined by calculating via the continuity equation the measured echocardiographic effective valve orifice area indexed to body surface area. The researchers defined severe prosthesis-patient mismatch as less than 0.65 cm2/m2, moderate prosthesis-patient mismatch as 0.65 cm2/m2 to 0.85 cm2/m2 and no mismatch as greater than 0.85 cm2/m2.

“TAVR has been shown to result in larger [effective valve orifice area] compared with [surgical AVR], but the associations of [prosthesis-patient mismatch] with outcomes following TAVR have only been studied in small series or with limited follow-up,” Herrmann said during a presentation.

Outcomes of interest at 1 year included all-cause mortality, HF hospitalization, death/HF hospitalization, stroke, Kansas City Cardiomyopathy Questionnaire (KCCQ) score and favorable KCCQ outcome, defined as being alive, having a score of at least 60 and having a score that declined no more than 10 points from baseline.

Mortality rates at 1 year were 17.2% for patients with severe prosthesis-patient mismatch and 15.8% for patients with moderate or no prosthesis-patient mismatch (adjusted HR = 1.19; 95% CI, 1.09-1.31), according to the researchers.

Compared with those without it, patients with severe prosthesis-patient mismatch also had elevated 1-year risk for HF hospitalization (14.7% vs. 12.2%; aHR = 1.12; 95% CI, 1.02-1.24) and death/HF hospitalization (26.8% vs. 24.2%; aHR = 1.13; 95% CI, 1.06-1.22).

However, there was no difference between the groups in 1-year risk for stroke (severe group, 3.8%; nonsevere group, 4.2%; aHR = 0.98; 95% CI, 0.82-1.16).

In multivariable linear regression models, the groups were similar in KCCQ score at 1 year (effect estimate = 0.722; 95% CI, 0.064-8.122) and in favorable KCCQ outcome at 1 year (effect estimate = 0.986; 95% CI, 0.807-1.203).

Herrmann and colleagues also identified factors that in multivariate models were predictors of severe prosthesis-patient mismatch. They were as follows:

  • female sex (OR = 1.463; 95% CI, 1.353-1.583);
  • age (OR per 5-year decrease in patients < 75 years = 1.038; 95% CI, 1.003-1.075; OR per 5-year decrease in patients 75 years = 1.078; 95% CI, 1.046-1.112);
  • nonwhite race or Hispanic ethnicity (OR = 1.233; 95% CI, 1.127-1.348);
  • valve-in-valve procedure (OR = 2.775; 95% CI, 2.53-3.043);
  • valve size 23 mm or less (OR = 2.773; 95% CI, 2.588-2.971);
  • body surface area (OR per 0.2-U increase = 1.71; 95% CI, 1.656-1.765);
  • lower ejection fraction (OR per 5% decrease = 1.097; 95% CI, 1.084-1.111);
  • atrial fibrillation or flutter (OR = 1.119; 95% CI, 1.056-1.186);
  • severe mitral regurgitation (OR = 1.077; 95% CI, 1.009-1.149); and

“Severe [prosthesis-patient mismatch] is associated with increased 1-year mortality and heart failure re-hospitalization when compared with patients with moderate or no [prosthesis-patient mismatch],” Herrmann said during the presentation. “We did not find an association between [prosthesis-patient mismatch] and stroke or quality of life at 1 year. Our findings suggest that efforts should be made to identify and limit the risk for [prosthesis-patient mismatch] after TAVR.” – by Erik Swain

References:

Herrmann HC, et al. Late-Breaking Clinical Science 1. Presented at: TCT Scientific Symposium; Sept. 21-25, 2018; San Diego.

Herrmann HC, et al. J Am Coll Cardiol. 2018;doi:10.1016/j.jacc.2018.09.001.

Disclosure: Herrmann reports he received institutional grants/research support from Abbott Vascular, Bayer, Boston Scientific, Corvia, Edwards Lifesciences, Medtronic and St. Jude Medical, and consultant fees from Edwards Lifesciences, Medtronic and Siemens Healthineers.