In the rapidly evolving field of structural heart disease and transcatheter aortic valve replacement (TAVR), great emphasis has been placed on the “heart team” and the TAVR procedure. from Cath Lab Digest. Interdisciplinary care team
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This article features an interview with Vasilis Babaliaros, MD, Associate Director of Structural Heart Disease at Emory University Hospitals in Atlanta, Georgia. It is the fourth in a series of six articles sponsored by Edwards Lifesciences. At Emory, both Dr. Babaliaros and cardiovascular surgeon Dr. Vinod H. Thourani, Associate Director of the Structural Heart Program, are TAVR trainers and proctors for Edwards Lifesciences. from Cath Lab Digest.
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July 26, 2018 — A new multi-societal expert consensus document has been released that summarizes the position of these partnering organizations on the availability, delivery, organization and quality of transcatheter aortic valve replacement (TAVR) cardiovascular care. The document was jointly released from the American Association for Thoracic Surgery (AATS), American College of Cardiology (ACC), Society for Cardiovascular Angiography and Interventions (SCAI), and the Society of Thoracic Surgeons (STS). The "2018 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document: Operator and Institutional Recommendations and Requirements for Transcatheter Aortic Valve Replacement," was also publish online in the Journal of the American College of Cardiology (JACC). With the rapid evolution and spread of TAVR technology, the documents states it is imperative that the cardiovascular community work together to identify the criteria for performing these procedures safely and successfully. Such criteria serve to guide both practitioners and institutions in the development and maintenance of TAVR programs, in the spirit of optimizing quality outcomes. The unique qualifications to participate in this field comprise specific interventional skills, high-tech equipment, collaborative clinical management, evolving approaches for alternative access and multidisciplinary decision making, the authors wrote. The document includes the sections on the following areas: • What Is New in the 2018 TAVR Operator and Institutional Requirements • Structural Program Requirements • Procedural Volume • Multidisciplinary Team (MDT) • Knowledge Base and Skills • Proceduralist Formalized Training • Facilities and Institutional Resources • Process Program Requirements • Patient Selection Requirements • MDT Patient Case Conference Requirements • Operational Details • Patient Selection Considerations • Frailty, Cognition, Quality of Life, Immobility and Disability • Procedural Denial, Futility, QoL, Limited Life Expectancy • Predictive Risk Models • SDM Requirements • Outcome Requirements • Registry Requirements • Criteria for Establishing a TAVR Program and Maintenance of Competence • Requirements and Recommendations for New TAVR Programs • Requirements and Recommendations for Existing TAVR Programs • Requirements for SAVR • SAVR-only Programs • Compliance with Document Recommendations Read through a PDF version of the document. Moving Toward National Coverage for TAVR In addition to releasing the updated consensus document, the ACC—along with AATS, SCAI and STS, is submitting comments to Ceters for Medicare and Medicaid Services (CMS) in response to its request for public comments on a National Coverage Analysis (NCA) to reconsider the national coverage determination (NCD) for TAVR. The comments will use the document as a framework for supporting an updated NCD. CMS convened a panel July 25, of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to discuss procedural volume requirements for hospitals and heart team members to begin and maintain TAVR programs. The ACC participated in the meeting. Lastly, based on the recommendations for external review and accreditation in the Expert Consensus document, as well as the CMS decision to reconsider its current TAVR NCD, the ACC is preparing to offer an external review and accreditation process that would assist hospitals in meeting standards such as multidisciplinary teams, formalized training, shared decision making and registry performance. For more more information: acc.org Related TAVR Content: Length of Stay Impacts TAVR Outcomes VIDEO: Applications in Cardiology for 3-D Printing and Computer Aided Design — Dee Dee Wang, M.D. Hospital Consolidation May Increase Access to TAVR, New Cardiac Technologies VIDEO: Conscious Sedation for TAVR Procedures — Mario Goessl, M.D. Recent Advances in Transcatheter Valve Technology VIDEO: TAVR For Asymptomatic Severe Aortic Stenosis — Philippe Genereux, M.D. How to Perform Transcaval TAVR Access — Adam Greenbaum, M.D. VIDEO: Outcomes Following Urgent TAVR - Results from the TVT Registry — Sammy Elmariah, M.D. TAVR Stands Equal to Surgical Valve Replacement VIDEO: Clinical Outcomes With the Lotus TAVR Valve — Ted Feldman, M.D. How to Build an Integrated Heart Team — Brijeshwar Maini, M.D., Brian Bethea, M.D. VIDEO: TAVR for Degenerated Surgical Valves — Valve-in-Valve TAVR Procedures — Sammy Elmariah, M.D. Advances in Heart Valve Technology in 2017 Reference: 1. Joseph E. Bavaria, Carl L. Tommaso, Ralph G. Brindis, et al. 2018 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document: Operator and Institutional Recommendations and Requirements for Transcatheter Aortic Valve Replacement. Journal of the American College of Cardiology. July 2018. DOI: 10.1016/j.jacc.2018.07.002
March 25, 2020 — CroiValve announced the successful first human use of its Duo Tricuspid Coaptation Valve technology for tricuspid heart valve repair. The procedure was performed by an experienced Heart Team in St. James University Hospital Dublin, led by Stephen O’Connor, M.D., interventional cardiologist, and Michael Tolan, M.D., cardiac surgeon, assisted by doctors Andrew Maree, Charlie McCreery and Caroline Daly. The patient had severe tricuspid regurgitation (TR) with reduced heart function and was at risk of a further deterioration in heart function with treatment of the tricuspid valve. Based on this, the patient had been turned down for open surgical repair. Because the unique, atraumatic approach of the Duo device allows for temporary implantation of the device to restore function without any impact to the native anatomy, the heart team elected to assess the acute effect of tricuspid valve repair on heart function. The procedure was approved by the Irish regulatory body (HPRA) under their compassionate use program. “The unique capability of the Duo Coaptation Valve, to restore tricuspid valve function atraumatically, while facilitating straightforward percutaneous removal, enabled us to determine a strategy to treat the patient," Tolan said. "Considering this patient has had significant suffering from this disease and had no other options, we are extremely proud the physicians and staff at St James University Hospital found an innovative approach to understanding the right treatment approach for this patient.” The procedure, delivery and retrieval were completed fully percutaneously, with the device delivered in five minutes without complications. TR was reduced from torrential to mild and the mean right atrial pressure reduced from 26 to 13 mmHg, with an increase in systolic BP, while the device was in situ. No significant change in right ventricular function was noted during the 30 minutes that the device was in place. The patient is recovering well from the intervention and permanent transcatheter repair of her valve is planned due to the positive cardiac response to treatment. “Early use of the CroíValve system indicates it to be an easy to use, safe and effective intervention for patients with severe tricuspid regurgitation,” O’Connor said. The Duo Tricuspid Coaptation Valve technology provides a simple and atraumatic approach for addressing severe TR in high risk patients. The device is currently being evaluated in a clinical study in Poland to assess the impact of correction of severe tricuspid regurgitation in patients, prior to surgical intervention. The system is also in development for permanent implantation, with clinical studies planned for early next year. For more information: http://www.croivalve.com/
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Diagnostic and Interventional Cardiology (DAIC) reaches more than 25,000 healthcare professionals in cardiology, interventional cardiology and cath labs across the United States.
