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| Continuing Experience with a Repositionable Inflatable Transcatheter Valve: Direct Flow Medical One Year and Beyond |
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Hendrik Treede1, Thilo Tuebler2, Hermann Reichenspurner1, Eberhard Grube3, Andrea Pascotto2, Olaf Franzen1, Ralf Mueller3, Reginald Low4, Steven F. Bolling5, Thomas Meinertz1, Joachim Schofer2; 1Department of Cardiovascular Surgery and Department of Cardiology, University Heart Center Hamburg, Hamburg, Germany; 2Medical Care Center Prof. Mathey, Prof. Schofer, Hamburg University Cardiovascular Center, Hamburg, Germany; 3Department of Cardiology/Angiology, HELIOS Heart Center Siegburg, Siegburg, Germany; 4Division of Cardiovascular Medicine, University of California Davis Medical Center, Sacramento, CA; 5University of Michigan Cardiovascular Center, Ann Arbor, MI Objective: Transcatheter Valve Replacement is a rapidly emerging alternative for patients at high risk for open surgical repair. The Direct Flow Medical (Santa Rosa, CA) Percutaneous Aortic Valve is a non-metallic tri-leaflet bovine tissue valve that is repositionable and retrievable. The purpose of this study is to assess its safety and function in patients one year post implant and beyond. Methods: Thirty-one patients with severe aortic stenosis demonstrated by baseline mean gradient of 49.1 ± 13.8 mmHg and EOA of 0.54 ± 0.16cm2 were enrolled in the study at 2 centers in Germany. Patients were considered non-surgical candidates with a mean Logistic EuroSCORE of 26.9%, mean age 82.2 years, and increased NYHA Functional Class (71% NYHA Class III). The study valve was successfully implanted with the 22 Fr Direct Flow Medical Delivery System in 22 patients via a transfemoral approach. Of those patients who did not receive a study valve, the catheter could not be inserted (n=2), a successful balloon valvuloplasty was not possible (n=2), or the valve was successfully retrieved (n=5). Results: At one year post implant, mean gradients remain improved at 20.7± 9 mmHg. EOA has decreased slightly from 30 days to 1.22± 0.29cm2, however NYHA functional class has remained greatly improved with all patients reporting NYHA Class I or II. Aortic regurgitation and paravalvular leak also continues to be negligible with all patients exhibiting no or low grade insufficiency. One year risk adjusted survival for the intent to treat population was 72% and early patients are already reaching the 2 year post implant time point. One late death occurred between the 6 month and 1 year time points in an 89 year old patient who suffered from ventricular arrhythmia following a coronary stenting procedure. This death was adjudicated by the CEC as unrelated to the device. All other patients previously reported surviving at 6 months completed a 1 year follow-up visit. Conclusion: Despite multiple comorbidities and a high surgical risk profile, patients implanted with the Direct Flow Valve continue to have positive outcomes at one year post implant. Extended follow-up appears promising as well with 2 year data collection ongoing. Further, the development of an enhanced 18 Fr delivery system will increase patient inclusion and ease of use making this novel technology a formidable option for future patients. Back to 2010 Annual Meeting Back to Program Outline Back to Main Program |
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Copyright © 2012 American Association for Thoracic Surgery
All rights reserved. IMPORTANT REMINDER: The preceding information is intended only to provide
general guidance and not as a definitive basis for diagnosis or treatment in any particular case.
It is very important that you consult a doctor about any specific medical problem or question.
All rights reserved. IMPORTANT REMINDER: The preceding information is intended only to provide
general guidance and not as a definitive basis for diagnosis or treatment in any particular case.
It is very important that you consult a doctor about any specific medical problem or question.