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TCT-630 Transcatheter and Surgical Repair for Degenerative Mitral Regurgitation In the Elderly: Midterm Results from a Propensity Score Analysis
B256
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 68, NO. 18, SUPPL B, 2016
mortality. The likelihood ratio test for the significance of adding additional variables into the STS-PROM was chi(2) ¼ 35.9 (p<0.001) with a net reclassification improvement of 30.3%. Predictive performance of the revised STS-PROM was confirmed after internal bootstrap resampling (Somer’s Dxy of 0.467, optimism¼0.038). The refined STS-PROM predictive performance was stable at 30-day (C-statistic of 0.846) whilst the STSPROM was persistently miscalibrated (C-statistic of 0.583). CONCLUSION The combination of simple pre-procedural variables into the STS-PROM refines the prediction of mortality both at 30-day and 1-year in patients with severe mitral regurgitation undergoing MitraClip implantation. CATEGORIES STRUCTURAL: Valvular Disease: Mitral TCT-630 Transcatheter and Surgical Repair for Degenerative Mitral Regurgitation In the Elderly: Midterm Results from a Propensity Score Analysis
CONCLUSION Twenty-three years aftersuccessful percutaneous mitral valvuloplasty, over 75% still exhibit sustained results. Prediction of late functional results is multifactorial and strongly determined by age and previous symptoms.
Nicola Buzzatti,1 Mathias Van Hemelrijck,2 Paolo Denti,3 Simon Winther,4 Davide Schiavi,5 Iside Stella Scarfò,6 Diana Reser,7 Alberto Weber,8 Giovanni La Canna,9 Michele De Bonis,10 Francesco Maisano,11 Ottavio Alfieri12 1 San Raffaele University Hospital, Milan, Italy; 2Spital Interlaken, Interlaken, Switzerland; 3San Raffaele University Hospital, Opera (MI), Italy; 4Regionshospitalet, Herning; 5Russian Cardiology Research and Producing Complex; 6Russian Cardiology Research and Producing Complex; 7Mount Sinai Medical Center; 8Baskir State Medical University; 9Medical University of South Carolina; 10Barts Health NHS Trust; 11UniversitätsSpital Zürich, Zürich, Switzerland; 12San Raffaele Hospital, Milan, Italy
CATEGORIES STRUCTURAL: Valvular Disease: Mitral
BACKGROUND MitraClip (Abbott Vascular, Santa Clara, California) recently emerged as a valid option to treat high-risk patients. Elderly represent a growing population at increased risk for surgery.
TCT-629 A simple risk model to refine the predictive ability of the STS score for the estimation of early and mid-term mortality in patients undergoing MitraClip implantation
METHODS To compare the outcomes of MitraClip or surgical repair for degenerative mitral regurgitation (DMR) in the setting of daily practice elderly patients, we retrospectively selected all patients aged 75 years who received mitral repair for DMR at two high-volume centres between 2005-2015. Associated procedures besides left atrial appendage closure, tricuspid regurgitation 3 and Society of Thoracic Surgeons (STS) score 8 were exclusion criteria. 242 (76 MitraClip, 166 surgical) patients were included. MitraClip were older (median 84 vs 78 years) and higher risk (median STS 3.2 vs 1.6) compared to surgical patients. To adjust for baseline imbalances we used a propensity score model, based on 16 variables, for the estimation of the Average Treatment Effect (ATE) on survival.
Carmelo Grasso,1 Buccheri Sergio,2 Marco Barbanti,3 Davide Capodanno,4 Antonio Popolo Rubbio,5 Marilena Di Salvo,6 Salvatore Scandura,7 Sarah Mangiafico,8 sebastiano Imme’,9 Sandra Giaquinta,10 Giuseppe Ronsivalle,11 Antonio Condorelli,12 Piera Capranzano,13 Corrado Tamburino14 1 Ferrarotto Hospital Cardiology Division, Catania, Italy; 2University of Catania, Catania, Catania, Italy; 3Ferrarotto Hospital, University of Catania, Catania, Italy; 4University of Catania, Catania, Catania, Italy; 5 Ferrarotto Hospital, Catania, Catania, Italy; 6Unknown, GIARDINI NAXOS, Italy; 7CRF-Skirball Center for Innovation; 8Fuwai Hospital; 9 Ferrarotto Hospital Catania, Melilli, Palermo, Italy; 10Hull York Medical School; 11S. Chiara Hospital, Cardiology Department, Trento, Italy; 12hopital saint philibert lomme france; 13Ferrarotto Hospital, University of Catania, Catania, Palermo, Italy; 14Ferrarotto Hospital, Catania, Italy BACKGROUND There is a lack of specific tools for risk stratification in patients undergoing MitraClip implantation (Abbott Vascular, Santa Clara, California). The Society of Thoracic Surgeons Predicted Risk of Mortality score (STS-PROM) is one of the most adopted prognostic tool in this context. However, the STS-PROM was derived from surgical series and showed limited adaptability in patients treated with MitraClip. We aimed to refine the predictive ability of the STS-PROM (refined STS-PROM) for the estimation of mortality by combining and introducing variables with prognostic impact that are not considered in the calculation of the score. METHODS A total of 312 consecutive patients undergoing MitraClip implantation were included. A multivariate Cox regression hazard model was used to identify independent predictors of 1-year all cause mortality. Selected variables were combined with the STS-PROM to develop a refined risk model. Validation and calibration was performed using internal bootstrap resampling. RESULTS Forty two deaths were encountered at 1-year follow-up. Cox model identified three additional independent variables (pre-procedural systolic blood pressure and hemoglobin levels, log-transformed N-terminal pro-brain natriuretic peptide) that were simultaneously integrated with the STS-PROM. A clinical nomogram was obtained and a refined STS-PROM score value was calculated for each patient. The refined STS-PROM significantly improved discrimination as compared with conventional STSPROM (C-statistic of 0.762 vs. 0.547, p<0.001) for the prediction of 1-year
RESULTS MitraClip showed lower rate of postoperative complications with shorter lenghts of stay (p<0.05), but with increased residual MR2 (22.4% vs 1.2%, p¼0.001) compared to surgery. Using ATE weights, survival within 1 year was similar between groups (HR 0.3, CI 0.04-2.35, p¼0.252). Beyond 1 year, mortality was increased in MitraClip compared to surgery (38.8% vs 16.2% at 4 years) and it was independently associated with both MitraClip (HR 2.6, CI 1.1-5.9, p¼0.025) and MR3 recurrence (HR 2.8, CI 1.3-6.2, p¼0.009). MR3 recurrence was higher in MitraClip compared to surgery (40.8% vs 5.8% at 3 years, HR 8.2, CI 3.3-20.6, p<0.001), isolated posterior leaflet prolapse being protective (HR 0.4, CI 0.2-0.9, p¼0.030) and residual 2+MR predictive (HR 4.1, CI 1.6-10.4, p¼0.003) factors. CONCLUSION In daily practice elderly patients affected by DMR, the average effect of MitraClip resulted in lower acute morbidity but higher mortality beyond 1 year compared to surgery. Regardless of possible uncaptured confounding factors, higher recurrent MR after MitraClip was a strong independent predictor of mortality. Better MR reduction after MitraClip should be pursuit in the elderly and may be improved through careful anatomical selection. Unless this is achieved, MitraClip should not be considered in patients who can still undergo surgery. CATEGORIES STRUCTURAL: Valvular Disease: Mitral
TCT-631 A Robust Ex-vivo Functional Mitral Valve Model to Test Novel Transcatheter Mitral Valve Devices Daniella Espiritu,1 Kirthana Suresh,2 Qi He,3 Daisuke Onohara,4 Muralidhar Padala5 1 University of California San Francisco; 2Sonogenix; 3Dept. of Cardiology, Aarhus University Hospital; 4Dept. of Cardiology, Aarhus University Hospital; 5Emory University, Atlanta, Georgia, United States
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 68, NO. 18, SUPPL B, 2016
mortality. The likelihood ratio test for the significance of adding additional variables into the STS-PROM was chi(2) ¼ 35.9 (p<0.001) with a net reclassification improvement of 30.3%. Predictive performance of the revised STS-PROM was confirmed after internal bootstrap resampling (Somer’s Dxy of 0.467, optimism¼0.038). The refined STS-PROM predictive performance was stable at 30-day (C-statistic of 0.846) whilst the STSPROM was persistently miscalibrated (C-statistic of 0.583). CONCLUSION The combination of simple pre-procedural variables into the STS-PROM refines the prediction of mortality both at 30-day and 1-year in patients with severe mitral regurgitation undergoing MitraClip implantation. CATEGORIES STRUCTURAL: Valvular Disease: Mitral TCT-630 Transcatheter and Surgical Repair for Degenerative Mitral Regurgitation In the Elderly: Midterm Results from a Propensity Score Analysis
CONCLUSION Twenty-three years aftersuccessful percutaneous mitral valvuloplasty, over 75% still exhibit sustained results. Prediction of late functional results is multifactorial and strongly determined by age and previous symptoms.
Nicola Buzzatti,1 Mathias Van Hemelrijck,2 Paolo Denti,3 Simon Winther,4 Davide Schiavi,5 Iside Stella Scarfò,6 Diana Reser,7 Alberto Weber,8 Giovanni La Canna,9 Michele De Bonis,10 Francesco Maisano,11 Ottavio Alfieri12 1 San Raffaele University Hospital, Milan, Italy; 2Spital Interlaken, Interlaken, Switzerland; 3San Raffaele University Hospital, Opera (MI), Italy; 4Regionshospitalet, Herning; 5Russian Cardiology Research and Producing Complex; 6Russian Cardiology Research and Producing Complex; 7Mount Sinai Medical Center; 8Baskir State Medical University; 9Medical University of South Carolina; 10Barts Health NHS Trust; 11UniversitätsSpital Zürich, Zürich, Switzerland; 12San Raffaele Hospital, Milan, Italy
CATEGORIES STRUCTURAL: Valvular Disease: Mitral
BACKGROUND MitraClip (Abbott Vascular, Santa Clara, California) recently emerged as a valid option to treat high-risk patients. Elderly represent a growing population at increased risk for surgery.
TCT-629 A simple risk model to refine the predictive ability of the STS score for the estimation of early and mid-term mortality in patients undergoing MitraClip implantation
METHODS To compare the outcomes of MitraClip or surgical repair for degenerative mitral regurgitation (DMR) in the setting of daily practice elderly patients, we retrospectively selected all patients aged 75 years who received mitral repair for DMR at two high-volume centres between 2005-2015. Associated procedures besides left atrial appendage closure, tricuspid regurgitation 3 and Society of Thoracic Surgeons (STS) score 8 were exclusion criteria. 242 (76 MitraClip, 166 surgical) patients were included. MitraClip were older (median 84 vs 78 years) and higher risk (median STS 3.2 vs 1.6) compared to surgical patients. To adjust for baseline imbalances we used a propensity score model, based on 16 variables, for the estimation of the Average Treatment Effect (ATE) on survival.
Carmelo Grasso,1 Buccheri Sergio,2 Marco Barbanti,3 Davide Capodanno,4 Antonio Popolo Rubbio,5 Marilena Di Salvo,6 Salvatore Scandura,7 Sarah Mangiafico,8 sebastiano Imme’,9 Sandra Giaquinta,10 Giuseppe Ronsivalle,11 Antonio Condorelli,12 Piera Capranzano,13 Corrado Tamburino14 1 Ferrarotto Hospital Cardiology Division, Catania, Italy; 2University of Catania, Catania, Catania, Italy; 3Ferrarotto Hospital, University of Catania, Catania, Italy; 4University of Catania, Catania, Catania, Italy; 5 Ferrarotto Hospital, Catania, Catania, Italy; 6Unknown, GIARDINI NAXOS, Italy; 7CRF-Skirball Center for Innovation; 8Fuwai Hospital; 9 Ferrarotto Hospital Catania, Melilli, Palermo, Italy; 10Hull York Medical School; 11S. Chiara Hospital, Cardiology Department, Trento, Italy; 12hopital saint philibert lomme france; 13Ferrarotto Hospital, University of Catania, Catania, Palermo, Italy; 14Ferrarotto Hospital, Catania, Italy BACKGROUND There is a lack of specific tools for risk stratification in patients undergoing MitraClip implantation (Abbott Vascular, Santa Clara, California). The Society of Thoracic Surgeons Predicted Risk of Mortality score (STS-PROM) is one of the most adopted prognostic tool in this context. However, the STS-PROM was derived from surgical series and showed limited adaptability in patients treated with MitraClip. We aimed to refine the predictive ability of the STS-PROM (refined STS-PROM) for the estimation of mortality by combining and introducing variables with prognostic impact that are not considered in the calculation of the score. METHODS A total of 312 consecutive patients undergoing MitraClip implantation were included. A multivariate Cox regression hazard model was used to identify independent predictors of 1-year all cause mortality. Selected variables were combined with the STS-PROM to develop a refined risk model. Validation and calibration was performed using internal bootstrap resampling. RESULTS Forty two deaths were encountered at 1-year follow-up. Cox model identified three additional independent variables (pre-procedural systolic blood pressure and hemoglobin levels, log-transformed N-terminal pro-brain natriuretic peptide) that were simultaneously integrated with the STS-PROM. A clinical nomogram was obtained and a refined STS-PROM score value was calculated for each patient. The refined STS-PROM significantly improved discrimination as compared with conventional STSPROM (C-statistic of 0.762 vs. 0.547, p<0.001) for the prediction of 1-year
RESULTS MitraClip showed lower rate of postoperative complications with shorter lenghts of stay (p<0.05), but with increased residual MR2 (22.4% vs 1.2%, p¼0.001) compared to surgery. Using ATE weights, survival within 1 year was similar between groups (HR 0.3, CI 0.04-2.35, p¼0.252). Beyond 1 year, mortality was increased in MitraClip compared to surgery (38.8% vs 16.2% at 4 years) and it was independently associated with both MitraClip (HR 2.6, CI 1.1-5.9, p¼0.025) and MR3 recurrence (HR 2.8, CI 1.3-6.2, p¼0.009). MR3 recurrence was higher in MitraClip compared to surgery (40.8% vs 5.8% at 3 years, HR 8.2, CI 3.3-20.6, p<0.001), isolated posterior leaflet prolapse being protective (HR 0.4, CI 0.2-0.9, p¼0.030) and residual 2+MR predictive (HR 4.1, CI 1.6-10.4, p¼0.003) factors. CONCLUSION In daily practice elderly patients affected by DMR, the average effect of MitraClip resulted in lower acute morbidity but higher mortality beyond 1 year compared to surgery. Regardless of possible uncaptured confounding factors, higher recurrent MR after MitraClip was a strong independent predictor of mortality. Better MR reduction after MitraClip should be pursuit in the elderly and may be improved through careful anatomical selection. Unless this is achieved, MitraClip should not be considered in patients who can still undergo surgery. CATEGORIES STRUCTURAL: Valvular Disease: Mitral
TCT-631 A Robust Ex-vivo Functional Mitral Valve Model to Test Novel Transcatheter Mitral Valve Devices Daniella Espiritu,1 Kirthana Suresh,2 Qi He,3 Daisuke Onohara,4 Muralidhar Padala5 1 University of California San Francisco; 2Sonogenix; 3Dept. of Cardiology, Aarhus University Hospital; 4Dept. of Cardiology, Aarhus University Hospital; 5Emory University, Atlanta, Georgia, United States