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Multicenter evaluation of high-risk mitral valve operations: implications for novel transcatheter valve therapies.

ABSTRACT: The MitraClip REALISM (Abbott Vascular, Menlo Park, CA) trial included several inclusion criteria to identify patients at high risk for conventional mitral valve (MV) surgery. This study evaluated contemporary surgical outcomes for high-risk surgical patients who met these defined criteria to serve as a benchmark to evaluate appropriateness in treatment allocation between surgical and percutaneous MV repair.A statewide Society for Thoracic Surgeons (STS) database was queried for patients undergoing isolated mitral valve surgery over a 12-year study period from 17 different hospitals. Patients were stratified into high-risk (HR) versus non-high-risk (non-HR) cohorts based upon clinical criteria similar to those utilized in the REALISM trial. Mixed effects multivariable regression modeling was used to evaluate study endpoints including mortality, morbidity, and resource utilization.Of 2,440 isolated mitral operations, 29% (n = 698) were HR per REALISM criteria. Median STS Predicted Risk of Mortality (PROM) for HR patients was 6.6% compared with 1.6% for non-HR patients (p < 0.001). The HR patients more commonly underwent MV replacement as well as urgent (30% vs 19%, p < 0.001) operations. High-risk patients incurred higher morbidity and mortality (7% vs 1.6%) with longer intensive care unit (48 vs 41 hours) and hospital stays (7 vs 6 days, all p < 0.001). Among REALISM criteria, STS PROM 12% or greater and high-risk STS criteria were the only criteria associated with mortality.Select REALISM criteria, including reoperation with patent grafts and functional MR with ejection fraction less than 0.40, may not identify patients truly at high risk of death with surgery. In addition to conventional STS criteria, risk assessment by surgeons is essential to direct appropriate treatment allocation for high-risk mitral disease.

SUBMITTER: LaPar DJ

PROVIDER: S-EPMC4763607 | biostudies-other | 2014 Dec

REPOSITORIES: biostudies-other

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Multicenter evaluation of high-risk mitral valve operations: implications for novel transcatheter valve therapies.

LaPar Damien J DJ Isbell James M JM Crosby Ivan K IK Kern John J Lim D Scott DS Fonner Edwin E Speir Alan M AM Rich Jeffrey B JB Kron Irving L IL Ailawadi Gorav G

The Annals of thoracic surgery 20141003 6

<h4>Background</h4>The MitraClip REALISM (Abbott Vascular, Menlo Park, CA) trial included several inclusion criteria to identify patients at high risk for conventional mitral valve (MV) surgery. This study evaluated contemporary surgical outcomes for high-risk surgical patients who met these defined criteria to serve as a benchmark to evaluate appropriateness in treatment allocation between surgical and percutaneous MV repair.<h4>Methods</h4>A statewide Society for Thoracic Surgeons (STS) databa ...[more]

PMID: 25282165

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Project description:BackgroundTranscatheter methods have been rapidly evolving to provide an alternative less invasive therapeutic option, mainly because redo patients often present with multiple comorbidities and high operative risk. We sought to evaluate and compare our experience with transapical transcatheter mitral valve replacement (TA-TMVR) to conventional redo mitral valve replacement in patients presenting with degenerated biological mitral valve prostheses or failed valve annuloplasty.Methods and materialBetween March 2012 and November 2020, 74 consecutive high-risk patients underwent surgical redo mitral valve replacement (n = 33) or TA-TMVR (n = 41) at our institution. All patients presented with a history of a surgical mitral valve procedure. All transcatheter procedures were performed using the SAPIEN XT/3™ prostheses. Data collection was prospectively according to MVARC criteria.ResultsThe mean logistic EuroSCORE-II of the whole cohort was 19.9±16.7%, and the median STS-score was 11.1±12.5%. The mean age in the SMVR group was 63.7±12.8 years and in the TMVR group 73.6±9.7 years. Patients undergoing TA-TMVR presented with significantly higher risk scores. Echocardiography at follow up showed no obstruction of the left ventricular outflow tract, no paravalvular leakage and excellent transvalvular gradients in both groups (3.9±1.2 mmHg and 4.2±0.8 mmHg in the surgical and transcatheter arm respectively). There was no difference in postoperative major adverse events between the groups with no strokes in the whole cohort. Both methods showed similar survival rates at one year and a 30-day mortality of 15.2% and 9.8% in SAVR and TMVR group, respectively. Despite using contrast dye in the transcatheter group, the rate of postoperative acute kidney failure was similar between the groups.ConclusionDespite several contraindications for surgery, we showed the non-inferiority of TA-TMVR compared to conventional surgical redo procedures in high-risk patients. With its excellent hemodynamic and similar survival rate, TA-TMVR offers a feasible alternative to the conventional surgical redo procedure in selected patients.

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Multicenter evaluation of high-risk mitral valve operations: implications for novel transcatheter valve therapies.

Publications

Multicenter evaluation of high-risk mitral valve operations: implications for novel transcatheter valve therapies.

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