Prosthesis-patient mismatch (PPM) following TAVR with supra-annular valves may not be associated with increased mortality or valve-related readmissions at one year, according to a study published May 3 in JACC: Cardiovascular Interventions.

Gilbert H.L. Tang, MD, MSc, MBA, FACC, et al., used data from the STS/ACC TVT Registry to assess incidence, predictors and outcomes of severe PPM in patients undergoing supra-annular TAVR for de novo stenosis or transcatheter aortic valve-in-surgical aortic valve (TAV-in-SAV). All patients received an Evolut R, Evolut PRO or Evolut PRO+ valve. The study's primary outcome was correlation of severe PPM with one-year all-cause mortality and valve-related readmissions. Secondary outcomes were predictors of severe PPM and severity of mean aortic valve gradient in patients with PPM by echocardiography after 30 days and one year.

A total of 42,174 patients received TAVR for de novo stenosis and 5,446 underwent TAV-in-SAV. In the de novo group, 34,084 patients (80.8%) did not have PPM, 5,845 (13.9%) had moderate PPM and 2,245 (5.3%) had severe PPM after the procedure. In the TAV-in-SAV group, 2,464 (45.2%) had no PPM, 1,509 (27.7%) had moderate PPM and 1,473 (27%) had severe PPM. There were no significant differences in one-year mortality between patients with severe vs. nonsevere PPM in the de novo TAVR group (13.8% vs. 12.7%; p=0.180) or the TAV-in-SAV group (10.3% vs. 8.7%; p=0.122). In addition, there were no significant differences in valve-related hospital readmissions at one year in the de novo TAVR (1.9% vs. 1.9%; p=0.773) or TAV-in-SAV (1.6% vs. 2.1%; p=0.380) groups.

In both groups, preprocedural variables, including an annular diameter of <20 mm, were good predictors of severe PPM. At baseline, patients in the de novo group with severe PPM were younger; more often male; and more likely to have NYHA Class III or IV symptoms, have insulin-dependent diabetes, serum creatine >2 mg/dl, chronic lung disease, and reduced left ventricular ejection fraction. TAV-in-SAV patients with severe PPM were more likely to have chronic lung disease or prior CABG. Patients with severe PPM in both groups had higher mean aortic valve gradients at all time points.

According to the researchers, there was no association between severe PPM and one-year mortality or valve-related readmissions after de novo supra-annular TAVR or TAV-in-SAV. They note that sever PPM was associated with higher post-procedure gradients at 30 days and one year, concluding that "assessment of long-term valve integrity in patients with elevated transvalvular gradients will require longer-term study."

The findings raise the question of whether "severe PPM become obsolete in the current TAVR era," Julien Ternacle, MD, PhD, et al., write in an accompanying editorial comment. With improved hemodynamic performance in bioprosthetic valves and stringent methods for PPM definition, true severe PPM "has become quasi obsolete," they write. "Further studies are needed to investigate the incidence and impact of PPM defined by the predicted [index effective orifice area] and of high residual gradients following TAVR" in the STS/ACC TVT Registry, they conclude.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Aortic Surgery, Interventions and Imaging, Echocardiography/Ultrasound

Keywords: Patient Readmission, Stroke Volume, Creatine, Aortic Valve, Transcatheter Aortic Valve Replacement, Constriction, Pathologic, Ventricular Function, Left, Hemodynamics, Echocardiography, Registries, Diabetes Mellitus, Lung Diseases, Insulins, Coronary Artery Bypass, National Cardiovascular Data Registries, STS/ACC TVT Registry

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