Article preview from Medtech Insight - June, 2010
With innovation as the theme of this year's EuroPCR meeting, emerging technology sessions and innovation presentations sparked lively discussions. While drug-eluting stents remained a key interest area, transcatheter aortic heart valve implantation sessions drew the largest crowds.
Article preview from Medtech Insight - June, 2010
A record attendance of more than 13,100 cardiologists from around the globe gathered in Paris, France, this past May for the 2010 EuroPCR meeting, the official congress of the European Association of Percutaneous Cardiovascular Interventions. The meeting included more than four days of interventional cardiology trial updates, live cases, debates, and training sessions, and with innovation as this year's theme, emerging technology sessions and innovation presentations sparked lively discussions. While drug-eluting stents (DES) remained a key interest area, transcatheter aortic heart valve implantation (TAVI) sessions drew the largest crowds.
SOURCE Registry Shows Positive One-Year Data
The TAVI registry session garnered intense interest, filling the main arena. Both of the currently marketed transcatheter aortic valve replacement devices— Edwards Lifesciences Corp.'s SAPIEN for transapical and transfemoral approaches and Medtronic Inc.'s transfemoral CoreValve—continue to show robust European adoption despite extremely restricted patient qualifying criteria and high device cost (€15,000 to €25,000 versus €2,000 to €4,000 for standard aortic valve replacements). At least 300 new TAVI centers are expected to open in Europe this year, with the estimated worldwide caseload growing from approximately 8,000 in 2009 to about 35,000 by 2013. TAVI accounted for only 2% of all European aortic valve replacement procedures in 2007, but this is anticipated to rise to 28% by year end. ( See Exhibit 1.)
At EuroPCR, Martyn Thomas, MD, director of cardiothoracic services at Guy's & St. Thomas' Hospital NHS Trust (London), presented one-year results from Cohort-1 of Edwards Lifesciences' SAPIEN SOURCE registry. Spanning from November 2007 through January 2009, the registry included 1,038 patients treated in 32 European centers with either a transfemoral or transapical approach and had a 98% one-year follow-up. Baseline severity was based on EuroSCORE, with an average EuroSCORE of 25.8 for the 463 transfemoral patients and an average score of 29 for the 575 transapical patients ( p = 0.007).
At 30 days, survival rates in this very high risk population were 93.7% for transfemoral and 89.2% for transapical patients, averaging 91.2% for both groups. Thomas also reported that at 30 days, 6% of the transfemoral and 7.7% of the transapical groups required permanent pacemaker implantation. Overall one-year survival rate was 81.1% for transfemoral and 72.1% for transapical patients, with an average 76.1% for the entire cohort. ( See Exhibit 2.)
Thomas cautioned that it is inappropriate to compare patient cohorts as the transapical group had higher risk factors at baseline, including higher rates of renal dysfunction, prior coronary artery bypass graft (CABG) surgery, porcelain aorta, mitral valve disease, and peripheral, carotid, and coronary artery disease. Registry follow-up will continue through 2011, with the 1,301-patient SOURCE Cohort-2 results expected to be presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference this September.
- Marie Gethins
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