Transcatheter aortic valve implantation (TAVI) with the Evolut system (Medtronic) is as successful as surgical valve replacement in low-risk aortic stenosis patients. Data from the Evolut low risk trial were presented at the American College of Cardiology 68th Annual Scientific Session (ACC 19) and published simultaneously in the New England Journal of Medicine. It compared the minimally invasive Evolut transcatheter aortic valve implantation (TAVI) system to the gold standard of open-heart surgery in characteristically younger, healthier aortic stenosis patients.
Beginning in mid-2019, hospitals performing transcatheter valve repair and replacement will be able to apply for the American College of Cardiology’s (ACC) new Transcatheter Valve Certification. The certification was announced at the ACC Quality Summit in New Orleans.
A subanalysis from the SURTAVI trial has found that transcatheter aortic valve implantation (TAVI) with Evolut R in intermediate-risk patients has lower rates of all-cause mortality or disabling stroke than surgical valve replacement 12 months after implantation. Steven J Yakubov (Riverside Methodist Hospital, Columbus, Ohio, USA) presented data from a propensity-score matched comparison at a late-breaking trial session at Cardiovascular Research Technologies (CRT) 2019 (2–5 March, Washington DC, USA). The findings have also been published in the Journal of American College of Cardiology: Cardiovascular Interventions.
In the last 20 years, there have been major developments in the use of endovascular and hybrid haemorrhage control tools, especially in the treatment of ruptured abdominal aortic aneurysm (rAAA).
Innovative Cardiovascular Solutions (ICS) has announced the first clinical use of its next-generation Emblok embolic protection system in patients undergoing transcatheter aortic valve implantation (TAVI) procedures in its European feasibility study. The cases were successfully performed by primary investigator Federico De Marco (Policlinico San Donato, Milan, Italy).
The Peregrine System infusion catheter (Ablative Solutions) has demonstrated 100% procedural success in the Peregrine post-market clinical trial, new data presented during a late-breaking session at the 2019 Cardiovascular Research Technologies (CRT) meeting (2–5 March, Washington, DC, USA) attests.
A pooled data analysis comparing the Cre8 amphilimus-eluting stent (Alvimedica) and the BioFreedom biolimus-eluting stent (Biosensors) demonstrates similar safety and efficacy for the devices, with possible differences in treatment effect for patients with diabetes mellitus. Describing a combined investigation into two multicentre observational studies in Italy in Circulation: Cardiovascular Interventions, the researchers say: “BioFreedom and Cre8 have favourable and comparable safety and efficacy profiles in real-world all-comer patients undergoing percutaneous coronary revascularisation.” Also, they add: “Cre8 might provide a clinical benefit in diabetic patients.”
Medtronic has issued the following statement regarding revised clinical study data:
On 15 February, 2019, Medtronic issued a statement regarding a programming error in the clinical data reporting isolated to the two and three year follow-up periods in our IN.PACT Global post-market study, part of the IN.PACT Admiral clinical programme for the treatment of femoropopliteal artery disease.
The Sapien 3 device (Edwards Lifesciences) can be safely and effectively used in transcatheter aortic valve implantation (TAVI) via the transcarotid approach in patients for whom the transfemoral route is not suitable, according to 30-day results from a multicentre French registry. The authors of the study, published in the JACC: Cardiovascular Interventions, say: “This descriptive study reports the largest contemporary cohort to date of transcarotid TAVI and demonstrates the safety and efficacy of the transcarotid approach for TAVI with the Edwards Sapien 3 transcatheter heart valve.”
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