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Benchmarking Outcomes of Surgical Aortic Valve Replacement in Patients with Bicuspid Aortic Valves
CONCLUSIONS: In this nationally-representative study, 30-day mortality was similar but risk-adjusted 5-year mortality was significantly lower in bicuspid patients undergoing isolated SAVR compared to tricuspid patients, specifically low-risk and normal left ventricular ejection fraction patients. This analyses provides a much-needed 5-year longitudinal national-level benchmark to better inform the discussion of transcatheter vs SAVR in bicuspid patients.PMID:37454786 | DOI:10.1016/j.athoracsur.2023.06.026
Source: The Annals of Thoracic Surgery - July 16, 2023 Category: Cardiovascular & Thoracic Surgery Authors: Sameer A Hirji Zachary Wegermann Sreekanth Vemulapalli Paige Newell Maria Grau-Sepulveda Sean O'Brien Vinod H Thourani Vinay Badhwar Tsuyoshi Kaneko Source Type: research

Transcatheter vs Surgical Aortic Valve Replacement in Pure Native Aortic Regurgitation
CONCLUSIONS: In Medicare patients with pure native AR, TAVR with the current commercially available transcatheter valves has comparable short-term outcomes. Although long-term outcomes were inferior to SAVR, the possibility of residual confounding, biasing long-term outcomes, given older and frailer TAVR patients, cannot be excluded.PMID:36967709 | DOI:10.1016/j.athoracsur.2022.09.016
Source: The Annals of Thoracic Surgery - March 27, 2023 Category: Cardiovascular & Thoracic Surgery Authors: Amgad Mentias Marwan Saad Venu Menon Grant W Reed Zoran Popovic Douglas Johnston Leonardo Rodriguez Marc Gillinov Brian Griffin Hani Jneid Sidakpal Panaich Samir Kapadia Lars G Svensson Milind Y Desai Source Type: research

Janssen Submits Application to U.S. FDA for New Indication to Expand Use of XARELTO ® (rivaroxaban) in Patients with Peripheral Artery Disease
RARITAN, NJ, October 26, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a new indication to expand the use of XARELTO® (rivaroxaban) in patients with peripheral artery disease (PAD). If approved, this new indication for the XARELTO® vascular dose (2.5 mg twice daily plus aspirin 75-100 mg once daily) would include reducing the risk of major thrombotic vascular events such as heart attack, stroke and amputation in patients after recent lower-extremity revascularization, a c...
Source: Johnson and Johnson - October 26, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Use of Administrative Claims to Assess Outcomes and Treatment Effect in Randomized Clinical Trials for Transcatheter Aortic Valve Replacement: Findings from the Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data (EXTEND) Study.
Conclusions: In the CoreValve HiR and SURTAVI trials, ascertainment of trial primary endpoints using claims reproduced both the magnitude and direction of treatment effect compared with adjudicated event data, but non-fatal and non-procedural secondary outcomes were not as well reproduced. Use of claims to substitute for adjudicated outcomes in traditional trial treatment comparisons may be valid and feasible for all-cause mortality and certain procedural outcomes, but may be less suitable for other endpoints. PMID: 32436390 [PubMed - as supplied by publisher]
Source: Circulation - May 20, 2020 Category: Cardiology Authors: Strom JB, Faridi KF, Butala NM, Zhao Y, Tamez H, Valsdottir LR, Brennan JM, Shen C, Popma JJ, Kazi DS, Yeh RW Tags: Circulation Source Type: research

Use of left atrial appendage occlusion among older cardiac surgery patients with preoperative atrial fibrillation: a national cohort study
ConclusionsSubstantial variability in use of S-LAAO exists. In many instances, the procedure is being deferred in the patients that may be poised to benefit the most (i.e., those with increased CHA2DS2-VASc score-defined stroke risk).
Source: Journal of Interventional Cardiac Electrophysiology - February 2, 2019 Category: Cardiology Source Type: research

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 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

Cardiovascular events and hospital resource utilization pre – and post–transcatheter mitral valve repair in high–surgical risk patients
Conclusions MitraClip was associated with a reduced rate of all-cause and HF hospitalizations and an increased rate of bleeding hospitalizations. One-year Medicare costs were reduced in those who survived a full year after the MitraClip procedure. Payors and providers seeking to reduce HF hospitalizations and associated Medicare costs may consider MitraClip among appropriate patients likely to survive 1 year.
Source: American Heart Journal - May 10, 2017 Category: Cardiology 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