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This study aims to assess the volume-outcome relationship in mitral valve repair or replacement surgeries for primary mitral regurgitation. It analyzes national clinical data from over 1,000 hospitals and 3,000 surgeons to determine the impact of hospital and surgeon volume on 30-day and 1-year outcomes.
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The Mitral Valve Surgery Volume-Outcome Relationship in the United States Vinay Badhwar, MD On behalf of co-investigators: Sreekanth Vemulapalli MD, Michael A. Mack MD, A. Marc Gillinov MD, Joanna Chikwe MD, Joseph A. Dearani MD, Maria V. Grau-Sepulveda MD MPH, Robert Habib MD, J. Scott Rankin MD, Patrick M. McCarthy, MD, Jeffrey P. Jacobs MD, Jordan P. Bloom MD, Paul A. Kurlansky, MD, Moritz C. Wyler von Ballmoos MD, Vinod H. Thourani MD, James R. Edgerton MD, Christina M. Vassileva MD, James S. Gammie, MD, David M. Shahian MD
Disclosure Statement of Financial Interest I, Vinay Badhwar DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.
Management of Primary Mitral Regurgitation • Early surgical correction of severe primary degenerative MR is recommended provided optimal outcomes are achievable. • Durable mitral valve repair is superior to replacement for primary MR • The association of volume to outcome for mitral valve surgery has not been defined by contemporary national clinical data Nishimura RA, et al. J Am CollCardiol2017;70:252-289 Chikwe J, et al. J Am CollCardiol2017;S0735-1097
Objectives • Assess volume of MV repair or replacement (MVRR) • Assess 30-day and 1 year outcomes following isolated MVRR for primary MR using national clinical data • Define the MV surgery volume-outcome relationship at the hospital level and surgeon level
Methods Data Source • The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database (ACSD) • 1,111 hospitals, 3,137 surgeons, 50 states • >95% of all adult operations performed in the US • Routine random annual 3rd party data audits of 10%
Methods Population • Isolated MV Surgery = MVRR ± surgical ablation, TV repair • 30-day Outcomes: STS ACSD 2011 to 2016 • 1-year Outcomes: Linkage to Centers for Medicare and Medicaid Services (CMS)
CONSORT Flow Diagram Isolated MVRR N = 121,405,N = 1,160 sites Outside US, N = 1,359, N = 20 sites Mitral stenosis, N = 20,021, N = 7 sites MR mild to moderate, N = 2,809, N = 0 sites Prior MV Surgery, N = 24, N = 0 sites • Papillary muscle rupture, N = 698, N = 0 sites Endocarditis (treated or active), N=7,346, N = 6 sites No MV disease documented, N = 4,237, N = 0 sites MV Etiology not Annular/Degenerative, N=7,801, N = 9 sites 55,311 patients 1,094 hospitals Reoperations, N = 4237, N = 0 sites Not Elective/Urgent Status, N = 20,021, N = 7 sites Cardiogenic shock, N = 2,809, N = 0 sites Preop Mechanical support, N = 24, N = 0 sites Gender missing, N=7,346, N = 6 sites N = 62,488 N = 1,115 sites Etiology algorithm* Not Primary MR, N = 7,177, N = 21 sites N = 55,311 N = 1,094 sites *Gammie JS, et al. Ann Thorac Surg. 2018;106:716-727
Methods Outcomes • Primary Outcome: • Operative Mortality of isolated MV surgery for primary MR • Secondary Outcomes: • 30-day: Composite Mortality/Morbidity (bleeding, stroke, prolonged ventilation, renal failure, wound infection) • Successful Repair Rate of primary MR (residual MR ≤ mild/1+) • 1-year: Mortality, Reoperation, Heart Failure Re-hospitalization
Methods Statistical Analysis • MVRR volume computed on the entire cohort by quartiles • Multivariable hierarchical volume-outcome models were created to assess the relationship between hospital and surgeon volume of any MVRR to 30-day and 1-year outcomes of isolated MVRR for primary MR • Generalized linear mixed models, logistic regression • Restricted cubic splines between case volumes and outcomes Vemulapalli S, et al. N Engl J Med 2019;380:2541-2550
Overall MV Repair Rate for Primary MR 81% (44,692/55,311)
Operative Characteristics Lowest vs. Highest Volume Quartiles
Primary OutcomeRisk Adjusted Operative MortalityLowest vs. Highest Volume Quartiles
Secondary Outcomes - HospitalLowest vs. Highest Volume Quartiles
Secondary Outcomes - SurgeonLowest vs. Highest Volume Quartiles
Hospital Level Outcomes 30-day Operative Mortality 4 3 Unadjusted Mortality % Adjusted 2 Unadjusted P Adjusted P Association <0.001 <0.001 1 Annual Volume 0 0 100 200 300 400 500
Hospital Level Outcomes 30-day Composite 20 15 Unadjusted Composite % Adjusted 10 Unadjusted P Adjusted P Association <0.001 <0.001 5 Annual Volume 0 0 100 200 300 400 500
Hospital Level Outcomes Successful MV Repair Rate 99 97 100 95 98 Unadjusted MV Repair % 93 Adjusted 96 Unadjusted P Adjusted P Association <0.001 <0.001 94 Annual Volume 92 0 100 200 300 400 500
Hospital Level Outcomes 4 3 Unadjusted Mortality % Adjusted 2 75 Unadjusted P Adjusted P Association <0.001 <0.001 1 Annual Volume 0 0 100 200 300 400 500
Hospital Level Outcomes 20 15 Unadjusted Composite % Adjusted 10 75 Unadjusted P Adjusted P Association <0.001 <0.001 5 Annual Volume 0 0 100 200 300 400 500
Hospital Level Outcomes 99 97 100 148 hospitals (14%) performed ≥ 75 cases/year 95 98 Unadjusted MV Repair % 93 Adjusted 96 75 Unadjusted P Adjusted P Association <0.001 <0.001 94 Annual Volume 92 0 100 200 300 400 500
Surgeon Level Outcomes 30-day Operative Mortality 4 3 Unadjusted Mortality % Adjusted 2 Unadjusted P Adjusted P Association <0.001 <0.001 1 Annual MVRR Volume 0 200 100 0 300
Surgeon Level Outcomes 30-day Composite 20 15 Unadjusted Composite % Adjusted 10 Unadjusted P Adjusted P Association <0.001 <0.001 5 Annual MVRR Volume 0 200 100 0 300
Surgeon Level Outcomes Successful MV Repair Rate 99 97 100 95 98 Unadjusted MV Repair % 93 Adjusted 96 Unadjusted P Adjusted P Association <0.001 <0.001 94 Annual MVRR Volume 92 200 100 0 300
Surgeon Level Outcomes 4 3 Unadjusted Mortality % Adjusted 2 35 Unadjusted P Adjusted P Association <0.001 <0.001 1 Annual MVRR Volume 0 200 100 0 300
Surgeon Level Outcomes 20 15 Unadjusted Composite % Adjusted 10 35 Unadjusted P Adjusted P Association <0.001 <0.001 5 Annual MVRR Volume 0 200 100 0 300
Surgeon Level Outcomes 99 97 100 303 surgeons (13%) performed ≥ 35 cases/year 95 98 Unadjusted MV Repair % 93 Adjusted 96 35 Unadjusted P Adjusted P Association <0.001 <0.001 94 Annual MVRR Volume 92 200 100 0 300
Conclusions National hospital level and surgeon level inverse volume-outcome relationships were identified for: • Successful Repair of Primary MR • 30-day Operative Mortality • 1-year Mortality
Implications These findings may further inform guideline-directed efforts to define access to experienced hospitals and surgeons for primary MR or complex MV disease.