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Reply: Stentless versus stented bioprosthetic root replacement in the medicare population and the wisdom of crowds
In our recent analysis of long-term outcomes of aortic root operations in the United States among Medicare beneficiaries using the Society of Thoracic Surgeons Adult Cardiac Surgery Database (STS-ACSD) and Centers for Medicare and Medicaid Services linked data for patients aged 65 years or older undergoing elective aortic root surgery, we concluded that the bioprosthetic Bentall operation should be the procedure of choice in this population due to improved survival and lower stroke risk compared with the use of the mechanical Bentall, and lower risk of aortic valve reintervention compared with valve-sparing aortic root replacement.
Source: The Journal of Thoracic and Cardiovascular Surgery - April 21, 2023 Category: Cardiovascular & Thoracic Surgery Authors: G. Chad Hughes Tags: Letter to the Editor Source Type: research

Reply from the authors: Stentless versus stented bioprosthetic root replacement in the medicare population and the wisdom of crowds
In our recent analysis of long-term outcomes of aortic root operations in the United States among Medicare beneficiaries using the Society of Thoracic Surgeons Adult Cardiac Surgery Database (STS-ACSD) and Centers for Medicare and Medicaid Services linked data for patients aged 65 years or older undergoing elective aortic root surgery, we concluded that the bioprosthetic Bentall operation should be the procedure of choice in this population due to improved survival and lower stroke risk compared with the use of the mechanical Bentall, and lower risk of aortic valve reintervention compared with valve-sparing aortic root replacement.
Source: The Journal of Thoracic and Cardiovascular Surgery - April 21, 2023 Category: Cardiovascular & Thoracic Surgery Authors: G. Chad Hughes Tags: Adult: Aorta: Letters to the Editor Source Type: research

Boston Scientific closes $270m Claret Medical buy
Boston Scientific (NYSE:BSX) said yesterday that it closed the $270 million buyout of Claret Medical and its Sentinel device, including a $50 million earnout pegged to a reimbursement win that just came in. Claret’s Sentinel device is designed to trap and remove debris dislodged during transcatheter aortic valve replacements to prevent stroke and other neurological damage. The deal, announced July 20, originally called for an up-front cash payment of $220 million plus the $50 million reimbursement milestone. That milestone was reached when the Centers for Medicare & Medicaid Services granted a New Technology Add...
Source: Mass Device - August 3, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Mergers & Acquisitions Replacement Heart Valves Wall Street Beat Boston Scientific Claret Medical Inc. Source Type: news

Prevalence and Outcomes of Mitral Stenosis in Patients Undergoing Transcatheter Aortic Valve Replacement: Findings From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry
Conclusions Approximately one-tenth of patients undergoing TAVR have concomitant MS. Severe MS is an independent predictor of 1-year adverse clinical outcomes following TAVR. The higher risk for long-term adverse events must be considered when evaluating patients with combined aortic stenosis and MS for TAVR.
Source: Journal of the American College of Cardiology: Cardiovascular Interventions - April 2, 2018 Category: Cardiology Authors: Joseph, L., Bashir, M., Xiang, Q., Yerokun, B. A., Matsouaka, R. A., Vemulapalli, S., Kapadia, S., Cigarroa, J. E., Zahr, F. Tags: Structural Source Type: research

Claret Medical touts Sentinel data in TAVR study
Claret Medical today released results from a study of its Sentinel cerebral protection system, touting reduced early occurrence of stroke associated with transcatheter aortic valve replacement procedures and lowered mortality rates. The study of the device was recently published in the Journal of the American College of Cardiology: Cardiovascular Interventions, the Santa Rosa, Calif.-based company said. The Sentinel embolic protection device is designed to trap blood clots and prevent stroke during heart valve replacement procedures, which Claret Medical touts as the 1st and only FDA-cleared device to do so. “In pat...
Source: Mass Device - September 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Clinical Trials Neurological Claret Medical Inc. Source Type: news

Early Lessons on Bundled Payment at an Academic Medical Center.
CONCLUSION: Opportunities for savings under bundled payment may be greater for lower extremity joint arthroplasty than for other conditions. PMID: 28837458 [PubMed - in process]
Source: The Journal of the American Academy of Orthopaedic Surgeons - August 25, 2017 Category: Orthopaedics Tags: J Am Acad Orthop Surg Source Type: research

MassDevice.com +5 | The top 5 medtech stories for June 12, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. MassDevice Q&A: Claret Medical’s Azin Parhizgar on trying to make TAVR safer Cerebral protection developer Claret Medical recently won FDA de novo clearance for its Sentinel device designed to trap blood clots and prevent...
Source: Mass Device - June 12, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

MassDevice Q & A: Claret Medical ’ s Azin Parhizgar on trying to make TAVR safer
Cerebral protection developer Claret Medical recently won FDA de novo clearance for its Sentinel device designed to trap blood clots and prevent stroke during heart valve replacement procedures. The Sentinel uses a pair of filters, 1 in the brachiocephalic artery another in the left common carotid artery, to trap debris released during transcatheter aortic valve replacement that could cause a cerebral embolism. The device has seen a rough road to approval, however, after missing the primary efficacy endpoint in its pivotal trial. Despite that, the device saw nearly unanimous support from an FDA advisory panel and was c...
Source: Mass Device - June 12, 2017 Category: Medical Devices Authors: Fink Densford Tags: Neurological Surgical Vascular Claret Medical Inc. Source Type: news

Taking Risk: Early Results From Teaching Hospitals’ Participation in the Center for Medicare and Medicaid Innovation Bundled Payments for Care Improvement Initiative
The authors describe observations from the 27 teaching hospitals constituting the Association of American Medical Colleges (AAMC) cohort in the Center for Medicare and Medicaid Innovation (CMMI) Bundled Payments for Care Improvement (BPCI) initiative. CMMI introduced BPCI in August 2011 and selected the first set of participants in January 2013. BPCI participants enter into Medicare payment arrangements for episodes of care for which they take financial risk. The first round of participants entered risk agreements on October 1, 2013 and January 1, 2014. In April 2014, CMMI selected additional participants who started takin...
Source: Academic Medicine - June 30, 2016 Category: Universities & Medical Training Tags: Articles Source Type: research

Transapical and Transaortic Transcatheter Aortic Valve Replacement in the United States
Conclusions Patients undergoing TAo TAVR are older, more likely female, and have significantly higher STS predicted risk of mortality scores than patients operated on by TA access. There were no risk-adjusted differences between TA and TAo access in mortality, stroke, or readmission rates as long as 1 year after TAVR.
Source: The Annals of Thoracic Surgery - July 30, 2015 Category: Cardiovascular & Thoracic Surgery Source Type: research

Transapical and Transaortic Transcatheter Aortic Valve Replacement in the United States.
CONCLUSIONS: Patients undergoing TAo TAVR are older, more likely female, and have significantly higher STS predicted risk of mortality scores than patients operated on by TA access. There were no risk-adjusted differences between TA and TAo access in mortality, stroke, or readmission rates as long as 1 year after TAVR. PMID: 26233276 [PubMed - as supplied by publisher]
Source: The Annals of Thoracic Surgery - July 29, 2015 Category: Cardiovascular & Thoracic Surgery Authors: Thourani VH, Jensen HA, Babaliaros V, Suri R, Vemulapalli S, Dai D, Brennan JM, Rumsfeld J, Edwards F, Tuzcu EM, Svensson L, Szeto WY, Herrmann H, Kirtane AJ, Kodali S, Cohen DJ, Lerakis S, Devireddy C, Sarin E, Carroll J, Holmes D, Grover FL, Williams M, Tags: Ann Thorac Surg Source Type: research

Clinical Outcomes at 1 Year Following Transcatheter Aortic Valve Replacement
ImportanceIntroducing new medical devices into routine practice raises concerns because patients and outcomes may differ from those in randomized trials.ObjectiveTo update the previous report of 30-day outcomes and present 1-year outcomes following transcatheter aortic valve replacement (TAVR) in the United States.Design, Setting, and ParticipantsData from the Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) Transcatheter Valve Therapies Registry were linked with patient-specific Centers for Medicare & Medicaid Services (CMS) administrative claims data. At 299 US hospitals, 12 182 patients linked wit...
Source: JAMA - March 10, 2015 Category: Journals (General) Source Type: research