Correlates and Causes of Death in Patients With Severe Symptomatic Aortic Stenosis Who Are Not Eligible to Participate in a Clinical Trial of Transcatheter Aortic Valve Implantation

Background— Transcatheter aortic valve implantation is currently being evaluated in patients with severe aortic stenosis who are considered high-risk surgical candidates. This study aimed to detect incidences, causes, and correlates of mortality in patients ineligible to participate in transcatheter aortic valve implantation studies. Methods and Results— From April 2007 to July 2009, a cohort of 362 patients with severe aortic stenosis were screened and did not meet the inclusion/exclusion criteria necessary to participate in a transcatheter aortic valve implantation trial. These patients were classified into 2 groups: group 1 (medical): 274 (75.7%): 97 (35.4%) treated medically and 177 (64.6%) treated with balloon aortic valvuloplasty; and group 2 (surgical): 88 (24.3%). The medical/balloon aortic valvuloplasty group had significantly higher clinical risk compared with the surgical group, with significantly higher Society of Thoracic Surgeons score (12.8±7.0 versus 8.5±5.1; P<0.001) and logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) (42.4±22.8 versus 24.4±18.1; P<0.001). The medical/balloon aortic valvuloplasty group had a higher New York Heart Association functional class, incidence of renal failure, and lower ejection fraction. During median follow-up of 377.5 days, mortality in the medical/balloon aortic valvuloplasty group was 102 (37.2%), and during median follow-up of 386 days, mortality in the surgical group was 19 (21.5%). Multivariable adjustment analysis identified renal failure (hazard ratio [HR]: 5.60), New York Heart Association class IV (HR: 5.88), and aortic systolic pressure (HR: 0.99) as independent correlates for mortality in the medical group, whereas renal failure (HR: 7.45), Society of Thoracic Surgeons score (STS; HR: 1.09) and logistic EuroSCORE (HR: 1.45) were correlates of mortality in the in the surgical group. Conclusion— Patients with severe symptomatic aortic stenosis not included in transcatheter aortic valve implantation trials do poorly and have extremely high mortality rates, especially in nonsurgical groups, and loss of quality of life in surgical groups.

[1]  J. Cheatham,et al.  Short-Term Performance of the Transcatheter Melody Valve in High-Pressure Hemodynamic Environments in the Pulmonary and Systemic Circulations , 2011, Circulation. Cardiovascular interventions.

[2]  H. Reichenspurner,et al.  Midterm Stability and Hemodynamic Performance of a Transfemorally Implantable Nonmetallic, Retrievable, and Repositionable Aortic Valve in Patients With Severe Aortic Stenosis: Up to 2-Year Follow-Up of the Direct-Flow Medical Valve: A Pilot Study , 2011, Circulation. Cardiovascular interventions.

[3]  B. Iung,et al.  Transarterial Medtronic CoreValve System Implantation for Degenerated Surgically Implanted Aortic Prostheses , 2011, Circulation. Cardiovascular interventions.

[4]  M. Desai,et al.  Integration of 3D Imaging Data in the Assessment of Aortic Stenosis: Impact on Classification of Disease Severity , 2011, Circulation. Cardiovascular imaging.

[5]  P. Scuffham,et al.  Quality-of-Life Implications of Immediate Surgery and Watchful Waiting in Asymptomatic Aortic Stenosis: A Decision-Analytic Model , 2011, Circulation. Cardiovascular quality and outcomes.

[6]  D. Hagler,et al.  Percutaneous Repair of Paravalvular Prosthetic Regurgitation: Acute and 30-Day Outcomes in 115 Patients , 2011, Circulation. Cardiovascular interventions.

[7]  Á. Cequier,et al.  Atrioventricular Conduction Disturbance Characterization in Transcatheter Aortic Valve Implantation With the CoreValve Prosthesis , 2011, Circulation. Cardiovascular interventions.

[8]  Julio E. Pérez,et al.  The Adverse Impact of Diabetes Mellitus on Left Ventricular Remodeling and Function in Patients With Severe Aortic Stenosis , 2011, Circulation. Heart failure.

[9]  D. Lachance,et al.  Usefulness of Carvedilol in the Treatment of Chronic Aortic Valve Regurgitation , 2011, Circulation. Heart failure.

[10]  F. Maisano,et al.  Incidence and Predictors of Early and Late Mortality After Transcatheter Aortic Valve Implantation in 663 Patients With Severe Aortic Stenosis , 2011, Circulation.

[11]  H. Schäfers,et al.  Valve Configuration Determines Long-Term Results After Repair of the Bicuspid Aortic Valve , 2011, Circulation.

[12]  J. Gummert,et al.  Survival Comparison of the Ross Procedure and Mechanical Valve Replacement With Optimal Self-Management Anticoagulation Therapy: Propensity-Matched Cohort Study , 2011, Circulation.

[13]  R. Lange,et al.  Incidence and Management of CoreValve Dislocation During Transcatheter Aortic Valve Implantation , 2010, Circulation. Cardiovascular interventions.

[14]  H. Baumgartner,et al.  Comparison Between Transcatheter and Surgical Prosthetic Valve Implantation in Patients With Severe Aortic Stenosis and Reduced Left Ventricular Ejection Fraction , 2010, Circulation.

[15]  E. Tay,et al.  Transcatheter Aortic Valve Implantation: Durability of Clinical and Hemodynamic Outcomes Beyond 3 Years in a Large Patient Cohort , 2010, Circulation.

[16]  P. Varadarajan,et al.  Prognostic Implications of Mitral Regurgitation in Patients With Severe Aortic Regurgitation , 2010, Circulation.

[17]  Alexander Kulik,et al.  Long-Term Clinical and Hemodynamic Performance of the Hancock II Versus the Perimount Aortic Bioprostheses , 2010, Circulation.

[18]  A. Colombo,et al.  Safety and Efficacy of the Subclavian Approach for Transcatheter Aortic Valve Implantation With the CoreValve Revalving System , 2010, Circulation. Cardiovascular interventions.

[19]  Thomas Walther,et al.  Thirty-Day Results of the SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry: A European Registry of Transcatheter Aortic Valve Implantation Using the Edwards SAPIEN Valve , 2010, Circulation.

[20]  Bart Meuris,et al.  Prosthesis-Patient Mismatch Predicts Structural Valve Degeneration in Bioprosthetic Heart Valves , 2010, Circulation.

[21]  S. Yun,et al.  Early Surgery Versus Conventional Treatment in Asymptomatic Very Severe Aortic Stenosis , 2010, Circulation.

[22]  M. Forsting,et al.  Silent and Apparent Cerebral Ischemia After Percutaneous Transfemoral Aortic Valve Implantation: A Diffusion-Weighted Magnetic Resonance Imaging Study , 2010, Circulation.

[23]  M. Schemper,et al.  Natural History of Very Severe Aortic Stenosis , 2010, Circulation.

[24]  Jeroen J. Bax,et al.  Comparison of Aortic Root Dimensions and Geometries Before and After Transcatheter Aortic Valve Implantation by 2- and 3-Dimensional Transesophageal Echocardiography and Multislice Computed Tomography , 2010, Circulation. Cardiovascular imaging.

[25]  V. Regitz-Zagrosek,et al.  Regression of Myocardial Hypertrophy After Aortic Valve Replacement: Faster in Women? , 2009, Circulation.

[26]  J. Pepper,et al.  Predictors of survival after aortic valve replacement in patients with low‐flow and high‐gradient aortic stenosis , 2009, European journal of heart failure.

[27]  P. Guéret,et al.  Risk Score for Predicting Outcome in Patients With Asymptomatic Aortic Stenosis , 2009, Circulation.

[28]  Fabian Nietlispach,et al.  Transcatheter Aortic Valve Implantation: Impact on Clinical and Valve-Related Outcomes , 2009, Circulation.

[29]  Patrick Kilgo,et al.  Long-term outcomes after isolated aortic valve replacement in octogenarians: a modern perspective. , 2008, The Annals of thoracic surgery.

[30]  D. Ngaage,et al.  Are initial valve operations in octogenarians still high-risk in the current era? , 2008, The Journal of heart valve disease.

[31]  K. Eagle,et al.  Valve surgery in octogenarians: in-hospital and long-term outcomes. , 2007, The Canadian journal of cardiology.

[32]  J. Gardin,et al.  Burden of valvular heart diseases: a population-based study , 2006, The Lancet.

[33]  Philippe Ravaud,et al.  A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. , 2003, European heart journal.

[34]  Laura P Coombs,et al.  The Society of Thoracic Surgeons: 30-day operative mortality and morbidity risk models. , 2003, The Annals of thoracic surgery.

[35]  Bradley G Hammill,et al.  Validation of European System for Cardiac Operative Risk Evaluation (EuroSCORE) in North American cardiac surgery. , 2002, European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery.

[36]  O. Alfieri,et al.  Inaccuracy of four coronary surgery risk-adjusted models to predict mortality in individual patients. , 2002, European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery.

[37]  M. Schemper,et al.  Predictors of outcome in severe, asymptomatic aortic stenosis. , 2000, The New England journal of medicine.

[38]  B. Bouma,et al.  To operate or not on elderly patients with aortic stenosis: the decision and its consequences , 1999, Heart.

[39]  R. Salamon,et al.  Risk factors and outcome in European cardiac surgery: analysis of the EuroSCORE multinational database of 19030 patients. , 1999, European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery.

[40]  C M Otto,et al.  Prospective study of asymptomatic valvular aortic stenosis. Clinical, echocardiographic, and exercise predictors of outcome. , 1997, Circulation.

[41]  N. Reichek,et al.  Recommendations for quantitation of the left ventricle by two-dimensional echocardiography. American Society of Echocardiography Committee on Standards, Subcommittee on Quantitation of Two-Dimensional Echocardiograms. , 1989, Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography.

[42]  J. Gardin,et al.  Aortic stenosis: can severity be reliably estimated noninvasively? , 1980, Chest.

[43]  M. Cheitlin.  Comparison Between Transcatheter and Surgical Prosthetic Valve Implantation in Patients With Severe Aortic Stenosis and Reduced Left Ventricular Ejection Fraction , 2011 .

[44]  M. Mack,et al.  Reliability of risk algorithms in predicting early and late operative outcomes in high-risk patients undergoing aortic valve replacement. , 2008, The Journal of thoracic and cardiovascular surgery.

[45]  A. Galloway,et al.  High-risk aortic valve replacement: are the outcomes as bad as predicted? , 2008, The Annals of thoracic surgery.

[46]  P. Kolh,et al.  Aortic valve surgery in octogenarians: predictive factors for operative and long-term results. , 2007, European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery.

[47]  D. Shavelle,et al.  Current results of balloon aortic valvuloplasty in high-risk patients. , 2007, The Journal of invasive cardiology.