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Bioprosthetic Aortic Valve Replacement Prosthesis-Patient Mismatch
Quick Takes
- In a large, observational, population-based cohort study using the SWEDEHEART national registries, severe prosthesis-patient mismatch (PPM) and to a lesser degree moderate PPM both were associated with higher all-cause 10-year mortality compared to no PPM following stented bioprosthetic SAVR.
- There was an association between severe PPM and HF hospitalizations, but no association between PPM and reintervention.
Study Questions:
Is there an association between prosthesis-patient mismatch (PPM) after bioprosthetic surgical aortic valve replacement (SAVR) and all-cause mortality, heart failure (HF) hospitalization, and reintervention?
Methods:
In an observational, nationwide, population-based cohort study, the SWEDEHEART (Swedish Web system for Enhancement and Development of Evidence based care in Heart disease Evaluated According to Recommended Therapies) and other national registries were used to identify patients who underwent stented bioprosthetic SAVR (with or without concomitant ascending aorta surgery or coronary artery bypass grafting) from January 2003–December 2018. Effective orifice area (EOA) data were derived from the model and size of the implanted valve using point estimates in published literature (and substituting the next available valve size when data were unavailable) and the Mosteller method for the calculation of body surface area (BSA). PPM was defined using Valve Academic Research Consortium (VARC)-3 criteria (which includes lower EOA index thresholds for PPM among patients with BSA ≥30 kg/m2 than for those with BSA <30 kg/m2). Outcomes were all-cause mortality, HF hospitalization, and aortic valve reintervention. Regression standardization was used to account for intergroup differences and to estimate cumulative incidence differences.
Results:
After excluding 1,512 patients with missing data on valve model or size, there were 16,423 patients in the study group (mean age 73 years, 63% male), including 7,377 (45%) with no PPM, 8,502 (52%) with moderate PPM, and 544 (3%) with severe PPM. The presence of moderate and severe PPM decreased after 2013. Patients with severe PPM were older (mean age 74 years) and included more women (57%) compared to patients with no PPM (age 71 years, 29% women) or moderate PPM (age 73 years, 43% women). During a follow-up interval of 103,374 person-years (mean 6.3 years, maximum 17.2 years), 6,493 (40%) patients died. After regression standardization, the cumulative incidence of all-cause mortality at 10 years was 43% (95% confidence interval [CI], 24–44%) in the no PPM group, 45% (95% CI, 43–46%) in the moderate PPM group, and 48% (95% CI, 44–51%) in the severe PPM group. The survival difference at 10 years was 4.6% (95% CI, 0.7–8.5%) in the no PPM versus severe PPM groups and 1.7% (95% CI, 0.1–3.3%) in the no PPM versus moderate PPM groups. The difference in HF hospitalization at 10 years was 6.0% (95% CI, 2.2–9.7%) in severe versus no PPM. There was no difference in aortic valve reintervention in patients with or without PPM.
Conclusions:
PPM was common in Sweden, but the incidence decreased after 2013. Increasing grades of PPM were associated with long-term mortality, and severe PPM was associated with increased HF hospitalizations. The authors conclude that moderate PPM was common, but that the clinical significance may be negligible because the absolute risk differences in clinical outcomes were small.
Perspective:
There has been past debate about the clinical implications of PPM, and this study adds additional data supporting that at least severe PPM has a negative clinical impact. This large, observational, population-based cohort study using the SWEDEHEART national registries found that there was a stepwise association with all-cause 10-year mortality between moderate PPM and severe PPM compared to no PPM, and an association between severe PPM with HF hospitalizations. That no association was found between PPM and reintervention could be related to a relatively higher threshold to undergo re-do surgical intervention in the absence of structural valve dysfunction and a variable ability to treat PPM with transcatheter intervention. Findings in this study that a majority of patients had PPM and that only 3% of patients had severe PPM are somewhat surprising. Methodologically, the use of literature values for EOA rather than in vitro hemodynamics in the study patients might have impacted the identification and characterization of patients with PPM.
Clinical Topics: Cardiac Surgery, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Structural Heart Disease
Keywords: Bioprosthesis, Body Surface Area, Cardiac Surgical Procedures, Coronary Artery Bypass, Geriatrics, Heart Failure, Heart Valve Diseases, Heart Valve Prosthesis, Stents, Transcatheter Aortic Valve Replacement
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