FRANCE 2 Registry Shows 2011 TAVI Patients Were Older But Less Ill Than 2010 Patients

Reed Miller

August 29, 2012

August 29, 2012 (Munich, Germany) — The latest results of the FRANCE 2 registry, the largest published experience of transcatheter aortic-valve implantation (TAVI) so far, show that French TAVI patients in 2011 were generally older but less ill than the patients who underwent TAVI in France in 2010.

Dr Martine Gilard (Université de Bretagne Occidentale, Brest, France) presented the latest results from the registry, which enrolls all French TAVI patients--3933 patients at 43 centers so far. Data from 3195 patients were recently published in the New England Journal of Medicine [1].

She presented data comparing the 2364 patients treated in 2011 and the 1569 patients treated in 2010. The average age of the 2011 patients was slightly older than the 2010 patients (83.5 vs 82.5, p=0.01), and yet the 2011 patients were also generally less ill than those who came before. The average EuroSCORE in 2011 was 20.7 vs 23.2 in 2010 (p<0.001). Fewer French TAVI patients were given general anesthesia in 2011 vs 2010 (66.1% vs 73.3%, p<0.001) and their hospital stay was generally a bit shorter (11 days vs 11.6 days, p=0.003).

As shown by earlier FRANCE 2 results, patients who underwent TAVI via the transapical approach were more likely to die within a year than those undergoing the more common transfemoral procedure. But as Dr Gerhard Shuler (Herzzentrum Leipzig, Germany) pointed out in his comments on the Gilard's presentation at the European Society of Cardiology 2012 Congress, the early mortality rates are about the same with the transapical and transfemoral approaches, and the curves diverge only beyond the periprocedural period. "It's quite obviously not a procedural problem," he said, noting that this trend also appeared in the seminal PARTNER trial. "So most likely this is a problem of [patient] selection."

Overall, the one-year mortality rate in FRANCE 2 was 24.1%, and the cardiovascular mortality rate was 13.6%. One-month mortality was 9.5%, and one-month cardiovascular mortality was 7.0%. "This registry demonstrated a high success rate with excellent sustained hemodynamic improvements of the patients," Gilard said.

About two-thirds of the patients got an Edwards Sapien valve, and the rest were implanted with the Medtronic CoreValve. The only difference in outcomes between the two devices was that about a quarter of CoreValve patients got a pacemaker while only about half that portion of Sapien recipients got a pacemaker. However, Gilard pointed out that since this was not a randomized trial, the reason for that difference is not clear from the data.

EORP Registry Shows TAVI Differs by Country

Also at the ESC congress today, Dr Carlo Di Mario (Royal Brompton Hospital, London, UK) presented the first results from the Transcatheter Valve Treatment (TCVT) Sentinel Pilot Registry, a multinational registry that is part of ESC's EURObservational Research Programme (EORP).

The registry included 4571 TAVI patients who underwent the TAVI from January 2011 to May 2012 at 137 centers in Israel, the Czech Republic, France, Spain, Switzerland, the UK, Italy, Poland, Belgium, and Germany. Overall, in-hospital mortality was 7.4%, with no significant differences in in-hospital mortality between CoreValve and Sapien patients. But the transfemoral approach yielded much lower in-hospital mortality than the transapical approach (5.9% vs 12.8%; p<0.01).

The average length of hospital stay was 9.3 days, but it ranged from seven days in Switzerland to more than 12 days in Poland. Di Mario said that this difference was often driven by differences in the application of general anesthesia. Patients who received general anesthesia, as is the standard practice with TAVI in the UK and Poland, had an average hospital stay of 10.2 days, vs 7.9 days for those given only local anesthesia (p<0.01), which is more common in Switzerland and Italy, for example. About 44% of patients treated with a transapical approach stayed in the hospital for at least 10 days, compared with only 22% of patients treated transfemorally.

Pharmacological treatment also varied greatly between countries, with generally poor compliance with the recommended combination of aspirin (64.3%) and clopidogrel or other thienopyridines (32.6%) at discharge.

France 2 is sponsored by Medtronic and Edwards.

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