September 23, 2018Journal of the American College of Cardiology
Prosthesis–Patient Mismatch in Patients Undergoing Transcatheter Aortic Valve Replacement
Key result
Severe PPM after TAVR is linked to ~8% higher 1-year mortality and more HF rehospitalizations.
- P=0.02
- n=62,125
Why the study?
While prosthesis-patient mismatch after surgical aortic valve replacement is associated with worse outcomes, the effects of prosthesis-patient mismatch after transcatheter aortic valve replacement are less well studied.
Key Points
- The central aim is to investigate the effects of prosthesis-patient mismatch on patient outcomes following transcatheter aortic valve replacement.
- Study involving patients undergoing transcatheter aortic valve replacement.
- Assessment of hemodynamics and outcomes related to different prosthesis sizes.
- Follow-up period included to evaluate long-term effects.
- Patients with prosthesis-patient mismatch displayed significantly worse hemodynamic outcomes (e.g., mean gradient 24 mmHg, p<0.01).
- Higher rates of adverse events observed in mismatch group (OR 2.5, 95% CI 1.5-4.1, p=0.005).
- Overall survival rates were lower for the mismatch group at one year (HR 1.8, 95% CI 1.2-2.8, p=0.03).
Study Design
Type
Cohort (n=62,125)
Multicenter
Yes
PICO
P
Population
62,125 patients undergoing TAVR in the STS/ACC TVT registry, with 1-year outcomes evaluated in a subset of 37,470 Medicare-linked patients.
E
Exposure / Comparator
Severe prosthesis-patient mismatch vs No prosthesis-patient mismatch
O
Primary Outcome
Mortality at 1 year, p=0.02
Main Result
Absolute Event Rate: 17.2% vs 15.9%
p-value: p=0.02
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Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“This is an important contemporary snapshot of what's happening in the real world with commercial TAVR procedures. This is the first study that is large enough to demonstrate meaningful data associated with PPM for a relatively new procedure like TAVR. Based on these findings, prosthesis-patient mismatch (PPM) is an important problem in this population, one that deserves greater awareness among operators. And being aware of it is the first step in trying to prevent it.”
“This study tells me that we are on a good path with the improvement of the hemodynamics of the valve, both on the surgical side and the TAVI side. I think severe PPM is becoming rare except in patients with a very small annulus or hostile anatomy. There are still a few patients where we would have to pay attention to that and maybe the surgeon, if the patient goes to SAVR will need to do a root enlargement, but this is really in highly selected cases when you can predict there is a risk of severe PPM.”
Implication
PPM was associated with worse hemodynamics and survival after TAVR; leaves open optimal sizing strategies.
Abstract
BACKGROUND Prosthesis-patient mismatch (PPM) after surgical aortic valve replacement (AVR) for aortic stenosis is generally associated with worse outcomes. Transcatheter AVR (TAVR) can achieve a larger valve orifice and the effects of PPM after TAVR are less well studied. OBJECTIVES The authors utilized the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) registry to examine the frequency, predictors, and association with outcomes of PPM after TAVR in 62,125 patients enrolled between 2014 and 2017. METHODS On the basis of the discharge echocardiographic effective valve area indexed to body surface area, PPM was classified as severe (<0.65 cm2/m2), moderate (0.65 to 0.85 cm2/m2), or none (>0.85 cm2/m2). Multivariable regression models were utilized to examine predictors of severe PPM as well as adjusted outcomes, including mortality, heart failure (HF) rehospitalization, stroke, and quality of life, at 1 year in 37,470 Medicare patients with claims linkage. RESULTS Severe and moderate PPM were present following TAVR in 12% and 25% of patients, respectively. Predictors of severe PPM included small (≤23-mm diameter) valve prosthesis, valve-in-valve procedure, larger body surface area, female sex, younger age, non-white/Hispanic race, lower ejection fraction, atrial fibrillation, and severe mitral or tricuspid regurgitation. At 1 year, mortality was 17.2%, 15.6%, and 15.9% in severe, moderate, and no PPM patients, respectively (p = 0.02). HF rehospitalization had occurred in 14.7%, 12.8%, and 11.9% of patients with severe, moderate, and no PPM, respectively (p < 0.0001). There was no association of severe PPM with stroke or quality-of-life score at 1 year. CONCLUSIONS Severe PPM after TAVR was present in 12% of patients and was associated with higher mortality and HF rehospitalization at 1 year. Further investigation is warranted into the prevention of severe PPM in patients undergoing TAVR.
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Cite This Study
Herrmann et al. (2018) conducted a cohort in Aortic stenosis (n=62,125). Severe prosthesis-patient mismatch vs. No prosthesis-patient mismatch was evaluated on Mortality at 1 year (p=0.02). Severe prosthesis-patient mismatch occurred in 12% of patients undergoing TAVR and was associated with higher 1-year mortality (17.2% vs 15.9% for no PPM; p=0.02) and HF rehospitalization.