MUNICH, Germany—Recent data from 2 European registries, one national and the other with a broader European scope, were presented August 29, 2012, at the European Society of Cardiology Congress, providing insight into how TAVR is being applied in contemporary real-world practice.

FRANCE 2 Provides Nationwide Scope

In a presentation focused on France, Martine Gilard, MD, PhD, of Centre Hospitalier Universitaire de Brest (Brest, France), provided an update from the comprehensive national FRANCE 2 (French Aortic National CoreValve and Edwards) Registry. The analysis covered 3,933 consecutive patients enrolled at 34 centers between January 2010 and December 2011. All were deemed by a heart team to be inoperable.  

The primary endpoint for the study was mortality at 30 days, 6 months, and long-term, while secondary endpoints included MACE, hemodynamics, and quality of life.

Average age of the cohort was 82 ± 7 years, with 1.9% of patients having had prior CABG and 9.9% prior stroke. Echocardiographic metrics included a gradient of 48.2 ± 17 mm Hg and an ejection fraction of 53 ± 14%. Logistic EuroSCORE was 21.8 ± 14%, while STS score was 14.1 ± 12%

Overall, 67% of patients received the Sapien valve (Edwards Lifesciences; Irvine, CA) and 33% the CoreValve device (Medtronic; Minneapolis, MN). The transfemoral route was used in 73% of cases, the transapical in 18%, and the subclavian in 6%. General anesthesia was given to 69% of patients, and in 61.3% the anatomy was assessed with transesophageal echocardiography. As a whole, the centers showed a 97% success rate in delivering and implanting the valves.

Post-procedure, 94.4% of patients had only Grade 0-1 central regurgitation, while LVEF increased form an average 53.3% before intervention to 55.6% afterward and 58.1% at 12 months. Kaplan-Meier estimated mortality was 9.5% at 30 days, 18% at 6 months, and 24.1% at 1 year. Mortality rates were very similar between the types of valves.

However, mortality varied widely when nontransfemoral access routes were factored in. While 30-day mortality rates were similar for the Edwards and CoreValve devices used in the transfemoral approach (7.3% and 8.9%, respectively), they were notably higher when the Edwards valve was delivered transapically (14.7%) and the CoreValve via subclavian access (10%).

Major complications were similar between Edwards and CoreValve, except for the expected increased incidence of new pacemaker implantation with CoreValve (table 1).

Table 1. Major Complications

Clinically, New York Heart Association (NYHA) status improved markedly after TAVR, with 75% of patients being in Class III or IV before intervention and about 75% being in Class I or II 12 months afterward.

Comparison between 2010 and 2011 revealed several trends in clinical and procedural characteristics, with logistic EuroSCORE and use of general anesthesia decreasing (table 2).

Table 2. Patient, Procedural Characteristics: Difference Between 2010 and 2011

In multivariate analysis, predictors of 1-year mortality were:

• Logistic EuroSCORE
• Periprosthetic regurgitation score of at least grade 2
• Transapical approach
• NYHA functional class
• Creatinine greater than 200 µmol/L
• Dyslipidemia
• Previous aortic surgery

Commenting on the presentation, Gerhard C. Schuler, MD, of the University of Leipzig (Leipzig, Germany), praised the FRANCE 2 analysis for being the largest registry study to date, with careful selection of centers, use of both valve types, and a very high rate of follow-up (98%). The results are in general agreement with other registries, he said, although the universe of registries is expanding, and comparisons among them would be useful.

In addition, noting that a heart team had judged all patients not to be candidates for surgery, Dr. Schuler wondered how the decision was made and whether it might have affected the registry outcomes.

Europe-Wide Registry Displays Variability in Practice

Providing a broader European perspective, Carlo Di Mario, MD, PhD, of the Royal Brompton Hospital (London, England), reported in-hospital results from the new ESC-sponsored prospective Pilot Sentinel Registry covering 4,571 consecutive patients who underwent TAVR at 137 centers in 10 participating European countries between January 2011 and May 2012. Overall, 57% of patients received the Sapien valve and 43% the CoreValve prosthesis, including the latest iterations of each.

Dr. Di Mario highlighted wide national variations in EuroSCORE, TAVR approach, use of local vs. general anesthesia, and length of hospital stay.

In-hospital outcomes also varied by type of access, with an ‘other’ category for alternative strategies such as the direct approach being a unique feature of this registry, Dr. Di Mario noted (table 3).

Table 3. In-Hospital Outcomes Stratified by Approach

 
Multivariate predictors of in-hospital mortality were:

• Age
• EuroSCORE
• Preprocedural mitral regurgitation of grade 2 or greater
• Success of valve deployment

Dr. Di Mario concluded, “This truly contemporary registry using the most recent valve types and delivery catheters indicates that collecting meaningful transnational data on new procedures is possible outside traditional industry-sponsored registries, allowing comparison of practice and acquisition of large databases in a short time.”

2. Di Mario C. Transcatheter Valve Treatment Pilot Sentinel Registry. Presented at: European Society of Cardiology Congress; August 29, 2012; Munich, Germany.

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