The objective was to evaluate the safety and efficacy of the Lotus Valve System to treat patients with severe aortic stenosis and high surgical risk. The study included 60 patients who received the device and were followed during 30 days. Mortality from all causes was 1.7% and the incidence of stroke was 8.6%, with half…
BuMA stent: new sirolimus-eluting stent with bio-degradable polymer
Uncovered struts compromise re-endothelization and may induce thrombosis. The new stent approved in China and already used in more than 50,000 patients, is a sirolimus-eluting device with a bio-degradable polymer. Animal studies showed rapid and complete endothelialization. The study included 20 patients with stable angina randomized on a 1:1 ratio to receive, in the same…
EXPAND: expanding the applications of bioresorbable platforms
There is little information about the use of bioresorbable vascular devices in patients with a reference diameter ≥4mm, long, bifurcation, calcified or unstable lesions. The BVS-Expand registry is a single-center study that evaluates the safety and efficacy of this device in past populations (real world).The primary endpoint was the occurrence of MACE (cardiac death, myocardial…
PROTAVI-C: Embolic protection during TAVI
Percutaneous aortic valve replacement (TAVI) is a new treatment option for patients that are inoperable or present a high surgical risk. Some studies have shown that the stroke rate may be higher with TAVI than with medical treatment or surgical replacement. Embolic protection has been used successfully for the carotids, but there is not much…
JUPITER: transapical TAVI device
We evaluated 88 consecutive patients (at this phase) with severe aortic stenosis who received the second-generation device for transapical access. Survival at thirty days was 85.1% with a cardiovascular death rate of 4.8%. No strokes were observed during this period. Average gradient reduction was highly significant, (40.4 to 8.1 mmHg, p <0.001), as well as…
DISCOVER: new low profile valve with little post-implant regurgitation
The objective of the study was to assess events after 30 days with the DirectFLOW Medical Valve device in patients with severe aortic stenosis and high surgical risk. The device is designed to reduce post-implant aortic regurgitation; it has a low profile and high navigability and requires no post-dilatation or rapid pacing. The study included…
DEFLECT I: cerebral protection device in TAVI
Strokes after TAVI occur in between 3.8 and 6.7% of the cases, with new MRI lesions being almost the rule. The TriGuard EDD device is a nitinol filter covering the origin of the vessels of the neck and held in place with stabilizers. It has a diameter of 9 Fr and is implanted by femoral…
HATTRICK-OCT: biodegradable polymer struts coverage versus permanent
Late endothelialization of first generation pharmacological stents may predispose thrombosis. Both the drug and the polymer of the platform may affect the rate at which this occurs. This is a prospective, multicenter study which randomized 44 patients with acute coronary syndrome to receive sirolimus-eluting stent with bio-absorbable polymer versus zotarolimus-eluting stent with permanent polymer. The…
DIRECT: results of drug-eluting stent-on-a-wire after 6 months
This balloon expandable stent is combined with a guide 0.014 in its distal part. The platform is made of cobalt chrome and the polymer is bio-degradable. 30 patients were included prospectively and there was angiographic follow-up with IVUS and OCT after 6 months. The reference vessel diameter was 2.69 mm ± 0.48, with a length…
POLAR ACS: bio-absorbable platform in acute coronary syndromes
Bio-absorbable devices are considered safe and effective for stable patients but there is still little information regarding their use in acute patients. ACS POLAR Register (POLishAbsorb Registry for ACS Patients) is a multicenter study which included 88 patients undergoing acute coronary syndrome without ST elevation who received a bio-absorbable platform. The aim of the study…
PRAGUE 19: bioabsorbable platform for patients with ST segment elevation
Absorbable bioplatforms are considered safe and effective in stable patients but their use in the context of acute myocardial infarction with ST segment elevation has not been reported. Low risk of heart attack with low Killip classification could be the stage for this device. 87 consecutive patients experiencing myocardial infarction with ST elevation underwent primary…
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