This article is more than 5 years old. Information may no longer be current.
Transfemoral access in transcatheter valve registries linked with lower 30-day mortality
Click Here to Manage Email Alerts
Coverage from the Transcatheter Cardiovascular Therapeutics (TCT) 2010 meeting
Data from three registries indicate better 30-day mortality for transfemoral vs. transapical procedures in patients treated with the Sapien balloon-expandable transcatheter heart valve.
Researchers discussed these data during the Valvular Heart Disease Summit at TCT.
TAVI registry
In the Canadian Edwards TAVI Multicenter Registry, 339 patients received the Sapien device (Edwards Lifesciences) via transfemoral (n=162) or transapical (n=177) approach. The procedural death rate was nearly equal between the groups (transfemoral, 1.8% vs. transapical, 1.7%); however, the 30-day mortality rate favored the transfemoral arm (9.9% vs. 11.3%).
New data from the trial showing similar survival rates between both groups at 24-month follow-up was presented by Josep Rodes-Cabau, MD, of the Quebec Heart and Lung Institute/Laval University in Quebec City.
Additional study data indicated that the predictive factors of cumulative late mortality included chronic obstructive pulmonary disease (HR=2.08; 95% CI, 1.26-3.44), chronic kidney disease (HR=1.74; 95% CI, 1.06-2.85) and peri-procedural sepsis (HR=3.85; 95% CI, 1.06-13.96).
PARTNER EU
The PARTNER EU trial, a prospective, multicenter, non-randomized, observational study, provided further data on the Sapien device in patients undergoing transfemoral (n=61) and transapical (n=69) procedures. According to Olaf Wendler, MD, Kings College Hospital, London, PARTNER EU is the first transcatheter aortic valve implantation (TAVI) trial in which the access approach — transfemoral or transapical — was determined jointly by interventional cardiologists and cardiac surgeons.
The 30-day survival rate in PARTNER EU was higher in the transfemoral group vs. the transapical group (92% vs. 81%). The difference between the two arms was more pronounced by 18 months, with a nearly 30% higher survival rate in the transfemoral group (71% vs. 43%).
SOURCE cohorts
Martyn R. Thomas, MD, of St. Thomas’ Hospital, London, spoke on behalf of the SOURCE investigators, presenting data from two registry cohorts, which he said was the world’s largest and only consecutive patient data on whom 30-day outcomes data on TAVI were available.
The first cohort consisted of 1,123 patients enrolled from November 2007 to January 2009; the second cohort of 1,306 patients was enrolled from February 2009 to December 2009.
Between the two cohorts, 30-day mortality was lowest for transfemoral procedures in the second cohort, but was nearly identical between cohorts for transapical procedures.
“The SOURCE Registry, with more than than 2,300 patients, provides a benchmark against which future device development and patient groups can be assessed,” Thomas said, adding that improved delivery systems could potentially result in lower vascular complications and a further improvement in 30-day and 1-year mortality.
Disclosures:
- Dr. Rodes-Cabau reports acting as a consultant for Edwards Lifesciences and St. Jude Medical.
- Dr. Thomas reports receiving grant and research support, as well as consulting fees and honoraria from Boston Scientific, Cordis and Edwards Lifesciences.
- Dr. Wendler reports receiving grant and research support from Edwards Lifesciences, as well as consulting fees and honoraria from Edwards Lifesciences, Medtronic and St. Jude Medical.