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Management: Food and Drug Administration (FDA)
Procedure: Heart Valve Surgery

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Total 20 results found since Jan 2013.

Use of a Dual-Filter Cerebral Embolic Protection Device in Thoracic Endovascular Aortic Repair
We report our initial experience with the off-label use of a dual-filter CEPD in patients undergoing TEVAR.
Source: Annals of Vascular Surgery - January 21, 2020 Category: Surgery Authors: Aamir S. Shah, Akbarshakh Akhmerov, Navyash Gupta, Tarun Chakravarty, Raj R. Makkar, Ali Azizzadeh Tags: Case Report Source Type: research

Stroke After Transcatheter Aortic Valve Replacement
This study reported about a 7% risk of stroke, which was not surprising given the patient population and the likelihood of particulate embolization when expanding a new valve within the annulus of the stenosed and calcified native valve. Nevertheless, even with this stroke risk, there was a clear mortality benefit and quality of life was improved as well. After the PARTNER 1A high-risk cohort demonstrated similar or improved outcomes relative to open surgical aortic valve replacement (SAVR) in patients at high (but not inoperable) surgical risk, the US Food and Drug Administration (FDA) approved TAVR in 2011 and the proced...
Source: JAMA - June 18, 2019 Category: General Medicine Source Type: research

Clinical Pharmacology of Oral Anticoagulants in Patients with Kidney Disease.
This article summarizes the clinical pharmacology of these drugs and identifies knowledge gaps in the literature related to their use. PMID: 29802125 [PubMed - as supplied by publisher]
Source: Clinical Journal of the American Society of Nephrology : CJASN - May 25, 2018 Category: Urology & Nephrology Authors: Jain N, Reilly RF Tags: Clin J Am Soc Nephrol Source Type: research

The Left Atrial Appendage: Target for Stroke Reduction in Atrial Fibrillation.
Abstract A patient with atrial fibrillation (AF) has a greater than 5% annual risk of major stroke, a 5-fold increase compared to the general population. While anticoagulation remains the standard stroke prevention strategy, the nature of lifelong anticoagulation inevitably carries an increased risk of bleeding, increased stroke during periods of interruption, increased cost, and significant lifestyle modification. Many patients with atrial fibrillation have had their left atrial appendage (LAA) ligated or excised by surgeons during cardiac surgery, a decision based largely on intuition and with no clear evidence ...
Source: Methodist DeBakey Cardiovascular Journal - April 1, 2015 Category: Cardiology Authors: Ramlawi B, Abu Saleh WK, Edgerton J Tags: Methodist Debakey Cardiovasc J Source Type: research

Presentation on US Hospital Websites of Risks and Benefits of Transcatheter Aortic Valve Replacement Procedures
Adequate presentation of risks and benefits of medical therapies is essential to informed decision making by patients. Transcatheter aortic valve replacement (TAVR) has been recently approved by the US Food and Drug Administration for the treatment of severe aortic stenosis among carefully selected patients; recent randomized clinical trials have identified important positive and negative outcomes of TAVR in these populations, including twice the risk of stroke for patients undergoing TAVR vs those undergoing open aortic valve replacement. Since 78% of all adults in the United States seek out health information online, we ...
Source: JAMA Internal Medicine - January 12, 2015 Category: Internal Medicine Source Type: research