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Surgery News
FDA designates recall of support catheter as class 1
The FDA has designated Cook Medical’s product recall of a support catheter as a class 1 recall, the most serious kind. The recall affects 117 devices manufactured and distributed between Aug. 13 and Sept. 19.
EXCEL trial leadership responds to claims of improper conduct
Editor’s Note: The following is a response written by the EXCEL trial leadership to claims of improper conduct of the trial, as outlined in a Healio article posted on Dec. 12, 2019. The EXCEL trial leadership response was issued on Dec. 12. Healio is posting the response in its entirety at the request of the authors.
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Societies at odds over PCI for left main disease; questions of trial conduct draw response
The European Association for Cardio-Thoracic Surgery has withdrawn its support for the left main disease recommendations of the 2018 European Association for Cardio-Thoracic Surgery/European Society of Cardiology Clinical Guidelines for Myocardial Revascularization, but a portion of the association’s explanation has drawn criticism from the Society for Cardiovascular Angiography and Interventions.
In congenital heart surgery, success is much more than ratings
Breakthroughs in the detection and treatment of congenital heart defects have greatly improved the prognosis for affected children. More than 90% of infants born with congenital heart disease survive into adulthood.
Surgical AVR beneficial in very severe asymptomatic aortic stenosis
PHILADELPHIA — Among patients with very severe but asymptomatic aortic stenosis, surgical aortic valve replacement was linked to lower rates of operative mortality or CV death compared with conservative care, according to the RECOVERY trial.
At Issue: ISCHEMIA trials provoke debate on treatment of stable ischemic heart disease
Healio asked experts for their key takeaways from the ISCHEMIA and ISCHEMIA-CKD trials of invasive vs. conservative strategies in patients with stable ischemic heart disease.
FUEL: Udenafil improves certain exercise performance after Fontan palliation in adolescents
PHILADELPHIA — Udenafil in adolescents after Fontan surgery did not significantly improve oxygen consumption at peak exercise, although it did significantly improve exercise performance at the ventilatory anaerobic threshold, according to data from the FUEL trial presented at the American Heart Association Scientific Sessions.
ISCHEMIA: Invasive strategy, medical therapy yield similar CV outcomes in stable ischemia
PHILADELPHIA — In stable patients with moderate or severe ischemia, an invasive strategy and a conservative strategy of optimal medical therapy yielded similar long-term CV outcomes, according to long-anticipated results of the ISCHEMIA and ISCHEMIA-CKD trials presented at the American Heart Association Scientific Sessions.
Study: RenalGuard system safely reduces AKI after cardiac surgery
WASHINGTON — The RenalGuard System reduced the rate of acute kidney injury by 50% in patients who underwent cardiac surgery, according to data presented at ASN Kidney Week.
Mortality risk increases after elective noncardiac surgery in women with HF
Women with HF have significantly greater odds of mortality after elective noncardiac operations than men with HF; however, both are at greater risk than patients who do not have HF at all, according to findings published in JAMA Network Open.