Abstract
CRT 2012, the Cardiovascular Research Technologies conference, has been taking place in Washington this week. During the congress Brazilian cardiologist Dr Valter Lima presented data from 93 of the approximately 150 patients who have been implanted with the Inovare transcatheter aortic valve, a bovine pericardium and cobalt-chromium valve developed by Braile Biomédica. 93% of implants were procedurally successful, with 17% mortality at 1 year and 50% at 2 years being attributed to the extremely sick nature of the patient population.
Background
Brazilian company Braile Biomedica has developed a composite Cobalt chrome metal framed bovine pericardium valve for endovascular replacement of the aortic valve. The lead investigator in its initial implant study, Dr Valter Lima from Hospital São Francisco, Porto Alegre, Brazil, presented initial findings from a clinical implantation study at this week’s CRT conference in Washington DC.
In this initial experience with the device, 93% of the procedures—all transapical implants—were successful. Success was defined as achieving a mean valve gradient under 20 mm Hg with aortic regurgitation less than a grade 2+. The average mean valve gradient for all the patients was reduced from 43 mm Hg to 11 mm Hg after one year.
There were three deaths within 30 days. Mortality was 17% at one year and 50% at two years for the 79 patients for whom data are available.
Clinician comments
Lima explained the relatively high mortality is due to the small sample size and the severe illness of the patients. “It’s self-defensive to say, but I think they were ‘too-sick’ patients,” he said. “But still, 17% at the end of 12 months I think is acceptable. And, of course we need more data.”
Lima explained that 76% of the patients treated so far were considered at high risk for valve surgery while the rest were completely inoperable. Also, 10 of the procedures so far were “valve-in-valve” implants for stenotic or regurgitant prosthetic valves. The patients’ average STS score was 31.
Based on these results, Braile gained regulatory approval to market Inovare in Brazil last November. While the valve is currently available only for transapical implants, with 22F as the smallest size. The company is also developing an 18F transfemoral version.
We say
On the face of it these data, while they look poor, are coloured by the degree of sickness of the patients being operated on. In the PARTNER study in USA, reported here, using Edwards’ Sapien Valve in transapical mode the 12 month figures were higher, close to 30%. The patient populations would have to be much better matched however if the results are to be meaningful. Sapien’s follow-up 822 patient group showed improved 1 year mortality to 23% suggesting of the fact that learning curve, patient cohort and other factors are at play.Two year data from the PARTNER study will be interesting.
Source: theheart.org, medlatest staff
published: February 8, 2012 in: Approval/Clearance, Cardio, Clinical Studies/Trials, Launches / Withdrawals, Regulatory