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Surgery News
RESCUE: Thoracic stent graft system safe, effective for blunt aortic injury
Thoracic endovascular aneurysm repair with a thoracic stent graft was safe and effective at 5 years in patients with blunt thoracic aortic injury, according to findings from the RESCUE trial presented at the Society of Thoracic Surgeons Annual Meeting.
Autologous blood donation during surgery reduces morbidity, mortality risk
An intraoperative autologous donation protocol used in patients during cardiac surgery was safe and effective in minimizing perioperative morbidity and mortality, according to data presented at The Society for Thoracic Surgeons Annual Meeting.
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COMPASS-CABG
Researchers compared rivaroxaban (Xarelto, Janssen/Bayer), aspirin or both for the prevention of early coronary bypass graft occlusion in patients with recent CABG.
How to improve representation of women in device trials
Underrepresentation of women in clinical trials evaluating CV devices has been a persistent problem, but a multipronged approach coupled with understanding of why women may be more reluctant to enroll in such studies can help overcome this hurdle, according to a new position statement published in JACC: Cardiovascular Interventions.
FDA designates recall of thermodilution catheters as class 1
The FDA has designated Edwards Lifesciences’ product recall of thermodilution catheters used in patients who require intensive monitoring or are undergoing complex surgery such as open heart surgery as a class 1 recall, the most serious kind. The recall affects 1,426 catheters manufactured and distributed between Dec. 26, 2017, and Aug. 20, 2018.
FDA alerts health care providers of mortality concern with right heart pump system
The FDA has issued a letter to health care providers regarding the increased rate of mortality in patients who have received a temporary right heart pump system in a recent interim postapproval study compared with what was previously observed in premarket clinical studies.
CABG no better than PCI in CKD
The presence of chronic kidney disease in patients with diabetes appears to attenuate the benefits of CABG over PCI, although researchers found a nonsignificant trend toward better outcomes with CABG in this patient population, according to new data published in the Journal of the American College of Cardiology.
ZILVER PASS: DES, bypass equally effective at 1 year in long femoropopliteal lesions
HOLLYWOOD, Fla. — A drug-eluting stent conferred similar survival, patency and freedom from target lesion revascularization compared with bypass surgery in patients with long femoropopliteal lesions, according to 12-month results of the ZILVER PASS trial.
Blood flow, perfusion imaging device receives FDA clearance
RFPi announced that a blood flow and perfusion imaging medical device for use during open surgery has received 510(k) clearance from the FDA.
Outcomes similar after PCI regardless of cardiac surgery capabilities at hospitals
Patients with and without STEMI had similar short- and long-term outcomes after PCI regardless of whether a hospital performed surgery on-site, according to a study published in Circulation: Cardiovascular Interventions.