FRANCE 2: Post-TAVR Aortic Regurgitation Doubles Mortality Risk

AMSTERDAM, The Netherlands—After transcatheter aortic valve replacement (TAVR), the strongest predictor of 1-year mortality is post-procedural paravalvular aortic regurgitation (AR). The association holds true no matter whether procedures involved a self- or balloon-expandable device. However, device type does affect AR occurrence, reported researchers in an abstract session on September 2, 2013, at the European Society of Cardiology Congress.

Using data from the FRANCE 2 registry, Eric Van Belle, MD, PhD, of University Hospital (Lille, France), and colleagues evaluated 2,769 patients who underwent successful TAVR and predischarge transthoracic echocardiography (TTE) at 33 French centers. Balloon-expandable devices were implanted in 67.6% of patients and self-expandable in 32.4%. Duration of clinical follow-up was 302 ± 164 days.

Nearly 1 in 6 Patients Affected

Post-procedural TTE identified paravalvular AR grade 2+ (moderate/severe) in 14.9% of cases. Occurrence was almost twice as high in those whose devices were self-expandable rather than balloon-expandable (19.8% vs. 12.2%; P = 0.0001). On multivariate analysis, use of self-expandable devices remained a predictor of AR occurrence (adjusted HR 2.01; P = 0.0001).

At 1 year, mortality was twice as high in patients with AR grade 2+ than in those without AR (24.2% vs. 11.9%; P = 0.0001). The relative difference was similar when looking separately at balloon-expandable (27.1% vs. 12.0%) and self-expandable (20.5% vs. 11.8%) procedures.

Multivariate analysis identified paravalvular AR grade 2+ as the strongest predictor of 1-year mortality (adjusted HR 2.35; 95% CI 1.75-3.15; P = 0.0001). The increase in risk again was similar for both balloon-expandable (adjusted HR 2.68) and self-expandable (adjusted HR 2.10) procedures. Other mortality predictors were use of the non-femoral approach as well as baseline A-fib, renal failure, New York Heart Association class, gradient, and AR grade 0-1.

Predictors of AR varied by device type. For self-expandable devices, the only procedural factor to independently predict AR was use of the femoral approach (HR 2.10; P = 0.008). For balloon-expandable devices, there were 3 predictors:

  • Larger aortic annulus (adjusted HR 1.09 per 1-mm increase; P = 0.001)
  • Smaller device diameter (adjusted HR 2.38 per 3-mm decrease; P = 0.0001)
  • Femoral approach (adjusted HR 1.70; P = 0.006)

Thus, cover index (ratio expressing the difference between prosthesis and aortic annulus diameter) appears to reduce the risk of AR for procedures involving balloon-expandable devices but not those using self-expandable devices, Dr. Van Belle explained.

Results Should Not Guide Device Choice

According to Dr. Van Belle, the registry findings have several clinical implications.

“Post-procedural AR grade 2+ after TAVR is a major issue and should be avoided, especially when there is no significant AR at baseline or when a non-femoral delivery approach is used,” he advised. The association between non-femoral delivery and mortality “suggests that good control of the depth of device delivery and improvement in catheter technology are key to reducing the rate of AR.” Choice of prosthesis diameter matters only for balloon-expandable devices, he added.

“Prevention of AR,” Dr. Van Belle concluded, “remains a major challenge for the development of next-generation device technology.”

Following the presentation, an audience member asked whether the data should encourage clinicians to choose balloon-expandable valves. “No,” Dr. Van Belle replied. While such devices are associated with lower occurrence of AR, overall mortality seems to be equivalent between the 2 designs and therefore other factors must be at work, he explained. “We are not advocating that you must choose 1 device over another.”

Session chair Horst Sievert, MD, PhD, of CardioVascular Center Frankfurt (Frankfurt, Germany), drew attention to fact that the femoral approach is associated with increased aortic insufficiency, which in turn is associated with higher mortality. “But the femoral approach on its own is actually causing less mortality, is that correct?” he asked.

Dr. Van Belle acknowledged that this discrepancy may reflect the inherent limitations of a registry. “What is very difficult to sort out here is what is linked to the approach and what is linked to the severity of the patient you treat,” he said.

Study Details

Patients were aged 83 ± 7 years on average, about half were female, and the average logistic EuroSCORE was 21.5 ± 13.8. The femoral approach was used in three-quarters of cases.

 

Source:

Van Belle E. Procedural predictors of post-TAVR aortic regurgitation for balloon-expandable and self-expandable devices: Insights from the FRANCE 2 registry. Presented at: European Society of Cardiology Congress; September 2, 2013; Amsterdam, The Netherlands.

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Disclosures
  • Dr. Van Belle reports no relevant disclosures.

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