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Condition: Bleeding
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Total 23 results found since Jan 2013.

Boston Scientific dips on Medicare reimbursement hit for Watchman anti-stroke device
Boston Scientific (NYSE:BSX) shares took a hit yesterday after a Centers for Medicare & Medicaid Services proposal that would limit coverage for the Watchman anti-stroke device. Investors also likely reacted to a pair of Class II recalls from the FDA, sending BSX shares down -4.2% to $18.01 apiece yesterday. Watchman, a transcatheter implant designed to seal off the left atrial appendage to prevent the formation of blood clots that could cause stroke, was approved by the FDA in March and asked for a CMS coverage decision in May. The federal health insurer proposed to limit coverage for Watchman to patients in approv...
Source: Mass Device - November 12, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Implants Cardiovascular Recalls Boston Scientific Cardiac Rhythm Management Stroke Source Type: news

Stroke Risk Reduction Outweighed Bleeding Risk Increase from Vitamin K Antagonists Treatment among Nonvalvular Atrial Fibrillation Patients with High Stroke risk and Low Bleeding Risk.
CONCLUSION: In NVAF patients at high risk for stroke and low risk for bleeding, our data confirm the effectiveness of anticoagulation for stroke prevention. The decrease in stroke risk of anticoagulation may outweigh the risk of major bleeding events, particularly among elderly patients. Potential risks of warfarin during initiation warrant attention, especially among patients who stop and start therapy repeatedly. PMID: 28008771 [PubMed - as supplied by publisher]
Source: Current Medical Research and Opinion - December 25, 2016 Category: Research Tags: Curr Med Res Opin Source Type: research

Time to Cost-Effectiveness Following Stroke Reduction Strategies in AF Warfarin Versus NOACs Versus LAA Closure
ConclusionsBoth NOACs and LAAC with the Watchman device were cost-effective relative to warfarin, but LAAC was also found to be cost-effective and to offer better value relative to NOACs. The results of this analysis should be considered when formulating policy and practice guidelines for stroke prevention in AF.
Source: Journal of the American College of Cardiology - December 14, 2015 Category: Cardiology Source Type: research

Study: Boston Scientific’s Watchman cheaper than drugs in reducing afib stroke risk
A study comparing the stroke risk for atrial fibrillation patients treated with Boston Scientific‘s (NYSE:BSX) Watchman device with the anticoagulant drug warfarin and non-warfarin oral anticoagulants found Watchman to be more cost-effective than its counterparts. Watchman is a catheter-delivered cardiac implant designed to close off the left atrial appendage, to prevent blood clots from forming there that could later cause a stroke. The study, published online in the Journal of the American College of Cardiology, showed that the Watchman device was cost-effective at 7 years at a cost of $42,994 per quality-adjust...
Source: Mass Device - December 15, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Wall Street Beat Cardiovascular Cardiac Implants Clinical Trials Boston Scientific Reimbursement Source Type: news

Cost effectiveness of left atrial appendage closure versus Warfarin for stroke risk reduction in non-valvular Atrial Fibrillation in CMS patients
Stroke is the most severe and debilitating consequence of atrial fibrillation (AF), with many patients ranking the resultant disability as worse than death. Warfarin, the established first-line therapy, is effective at reducing ischemic stroke, but is associated with increased bleeding risk and lower quality of life (QoL). Left atrial appendage closure (LAAC) with the Watchman Device has been found to be superior to warfarin at reducing risk of stroke in AF patients. This analysis sought to assess the cost effectiveness of LAAC versus warfarin for stroke prevention in non-valvular AF from the perspective of the US Centers ...
Source: Value in Health - May 1, 2015 Category: Global & Universal Authors: V. Reddy, R. Akehurst, S.L. Amorosi, S. Armstrong, S. Beard, C. Knight, C. Taggart, D. Holmes Source Type: research

Abstract 304: Developing a Patient Registry for Atrial Fibrillation to Improve The Quality of Stroke Prevention in a Safety Net Institution Session Title: Poster Session III
Conclusions: A baseline assessment of stroke prophylaxis among atrial fibrillation patients in a safety net health system demonstrates nonguideline-concordant anticoagulation use among low-risk patients and suboptimal anticoagulation use among high-risk patients, patterns that could not be explained by HAS-BLED score.
Source: Circulation: Cardiovascular Quality and Outcomes - April 29, 2015 Category: Cardiology Authors: Oronce, C. I., Valdez, C., Anderson, S. L., Vlasimsky, T. B., Marrs, J. C., Richesin, S. D., Hanratty, R. Tags: Session Title: Poster Session III Source Type: research

Geographic variation in clinical outcomes and anticoagulation among medicare beneficiaries with non-valvular atrial fibrillation
AbstractOral anticoagulants (OACs) have been used to prevent stroke/systemic embolism (SE) among patients with non-valvular atrial fibrillation (NVAF). To evaluate baseline clinical characteristics, incidence rates of stroke/SE and hospitalization for bleeding, and OAC use among elderly patients with NVAF in the US by geographic region. Patients with NVAF were selected from the US Centers for Medicare& Medicaid Services claims database (01JAN2013-31DEC2016). Twelve months of health plan enrollment was required before and after the NVAF diagnosis to evaluate baseline characteristics and outcomes, respectively. Each pati...
Source: Journal of Thrombosis and Thrombolysis - August 2, 2023 Category: Hematology Source Type: research

Antithrombotic use and bleeding risk in patients with atrial fibrillation: findings from a multipayer analysis.
CONCLUSION: Levels of thromboprophylaxis for high-risk AF patients in real-world data differ significantly from current medical guidelines for stroke prevention. PMID: 26690040 [PubMed - as supplied by publisher]
Source: Journal of Comparative Effectiveness Research - December 23, 2015 Category: Journals (General) Tags: J Comp Eff Res Source Type: research

Long Term Outcomes and Anticoagulation in Mitral Valve Surgery - A Report from the Society of Thoracic Surgeons Database
CONCLUSIONS: Anticoagulation was used in less than half of mitral valve surgery. In MVrep patients, warfarin was associated with increased bleeding and was not protective against either stroke or mortality. In BMVR patients, warfarin was associated with a modest survival benefit, increased bleeding and equivalent stroke risk. NOAC was associated with increased adverse outcomes.PMID:37308066 | DOI:10.1016/j.athoracsur.2023.05.025
Source: The Annals of Thoracic Surgery - June 12, 2023 Category: Cardiovascular & Thoracic Surgery Authors: Thomas A Schwann Andrew M Vekstein Daniel T Engelman Dylan Thibault Joanna Chikwe Milo Engoren Mario Gaudino Sreekanth Vemulapalli Vinod Thourani Gorav Ailawadi Anthony Rousou Robert H Habib Source Type: research

Report: Medicare proposal would broaden coverage for Boston Scientific’s Watchman
The Centers for Medicare & Medicaid Services are reportedly considering broadening the coverage for Boston Scientific‘s (NYSE:BSX) Watchman anti-stroke device, according to an unidentified official with the federal health insurer. Leerink Partners analyst Danielle Antalffy, citing a Bloomberg report, wrote today that the CMS official “clarified that CMS is proposing to pay for Watchman for a subset of the patients who currently would be eligible for the device under the FDA-approved label,” or patients at high risk for stroke and bleeding and/or contraindicated to long-term warfarin use. “Whi...
Source: Mass Device - November 24, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Implants Cardiovascular Wall Street Beat Boston Scientific Centers for Medicare and Medicaid Services (CMS) Reimbursement Source Type: news

Clinical Characteristics, Oral Anticoagulation Patterns, and Outcomes of Medicaid Patients With Atrial Fibrillation: Insights From the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF I) Registry Health Services and Outcomes Research
Conclusions In a contemporary AF cohort, use of OAC overall and use of NOACs were not significantly lower among Medicaid patients relative to others. However, among warfarin users, Medicaid patients spent less time in therapeutic range compared with those with other forms of insurance.
Source: JAHA:Journal of the American Heart Association - May 3, 2016 Category: Cardiology Authors: O'Brien, E. C., Kim, S., Thomas, L., Fonarow, G. C., Kowey, P. R., Mahaffey, K. W., Gersh, B. J., Piccini, J. P., Peterson, E. D. Tags: Atrial Fibrillation, Primary Prevention, Health Services, Quality and Outcomes Health Services and Outcomes Research Source Type: research

Who Should Be Referred for Left Atrial Appendage Occlusion Therapy?
Opinion statementAtrial fibrillation (AF) is the most common cardiac arrhythmia affecting approximately 7 million individuals in USA. It is one of the most significant arrhythmias, which accounts for a majority of embolic strokes, especially in elderly individuals. Although oral anti-coagulation is beneficial in lowering the risk of stroke, 1 in 10 patients have a contra-indication to warfarin therapy. Among patients who do tolerate either warfarin or novel oral anticoagulant (NOAC), major or recurrent bleeding, intracranial bleeds, etc. often lead to interruption of anti-coagulation. Previous studies have reported that>...
Source: Current Treatment Options in Cardiovascular Medicine - May 2, 2017 Category: Cardiology Source Type: research