Registries Show TAVR Evolution in UK, Internationally

MIAMI BEACH, FLA.—Three registry reports presented at TCT 2012–one international and the other two focusing on Canadian and UK experiences–offer a ‘real-world’ picture of TAVR performance with both Edwards Sapien and Medtronic CoreValve devices.

CoreValve ADVANCE registry

Axel Linke, MDAxel Linke, MD, of the University of Leipzig Heart Center, Leipzig, Germany, presented data on 996 patients implanted with CoreValve at 44 centers in Western Europe, Asia and South America between March 2010 and July 2011. Patients’ mean age was 81 ± 6 years and mean logistic EuroSCORE was 19.2 ± 12.4. Valve implantation was successful in the vast majority of patients (97.8%).

The primary endpoint of MACCE (death, MI, emergent cardiac surgery or reintervention, and stroke) at 30 days occurred in 8.3% of patients, with a 4.5% rate of all-cause mortality, 0.2% rate of MI, and 2.9% rate of stroke. New pacemaker implantation was required in about one-fourth of patients (26.3%).

Linke noted that the presence of left bundle branch block had no impact on 6-month survival. Echocardiography showed a 12% incidence of moderate and 61% incidence of mild regurgitation at 6 months, with most high-grade regurgitation due to paravalvular leakage. Whether patients had no, mild, or moderate-severe regurgitation did not affect Kaplan-Meier 6-month survival (90.9%, 90.8%, and 84%, respectively).

In the latest results, overall 1-year survival free from all-cause mortality was 82.1% and free-from CV mortality was 88.2%.  

Canadian experience

Josep Rodés-Cabau, MD, of the Heart and Lung Institute of Laval University, Quebec City, Canada, provided an update on the Canadian TAVR registry, including 339 patients who received an Edwards valve at six institutions between January 2005 and June 2009. Of these, 167 underwent a transfemoral approach; 172, a transapical approach. Mean follow-up of 42 ± 15 months was available in all but three patients, with rigorous echocardiographic evaluation of most patients.

Mean age was 81 ± 8 years and the mean Society of Thoracic Surgeons score was 9.8 ± 6.4.

At 30 days, the incidence of mortality for all patients was 10.4%; of MI 1.2%; stroke 2.3%; and the need for a new pacemaker 4.9%. Survival declined from 76% at 1 year to 43% at 4 years, with transfemoral and transapical access rates following the same trend. Overall, about one-fourth of the causes of death were cardiac, with noncardiac causes (59%) due mainly to respiratory failure, followed by kidney failure, stroke, major bleeding, and cancer.

In multivariate analyses, predictors of mortality beyond 30 days were chronic atrial fibrillation (HR 1.44; P=.044); COPD (HR 2.18; P<.001); eGFR < 60 ml/min (HR 1.08; P = .009); and frailty (HR 1.52; P=.021), while predictors of cardiac death were pulmonary hypertension (HR 1.98; P=.008) and eGFR < 60 ml/min (HR 1.17; P=.040). Between baseline and last follow-up, the proportion of patients in NYHA class III or IV fell from 91% to about 11% (P<.0001).

In addition, Rodés-Cabau reported, valve function remained stable for up to 4 years, with only mild, non-clinically significant changes in transvalvular gradient and valve areas. No changes were seen in the presence and degree of residual aortic regurgitation. Although regurgitation (mostly paravalvular) was frequent after TAVR, it had no impact on left ventricular diameter or function.

UK TAVI registry

According to Neil E. Moat, MB, BS, of the Royal Brompton Hospital, London, United Kingdom, the UK TAVI registry captures all TAVR implants in the United Kingdom, accounting for 2,732 patients between January 2007 and December 2011. While the registry includes 31 centers, 22 performed fewer than 100 procedures. Use of Edwards Sapien valves and the Medtronic CoreValve was roughly equivalent. Over time, predominant use of the transfemoral route with Medtronic declined; in Sapien patients, the transapical route has declined in favor of the transfemoral, subclavian and other routes of access.

Thirty-day mortality fell from 13.9% in the first year to 5.4% in the third year, and remained fairly stable thereafter.

Overall, mean logistic EuroSCORE tended to be higher in patients treated by transapical or subclavian access compared with transfemoral access. Moreover, logistic EuroSCORE was an important factor in 1-year mortality, with patients with a score of up to 20% having about an 85% survival rate, while those with a logistic EuroSCORE greater than 40% having about a 66% survival rate (P<.00001). This suggests the need to identify those whose comorbidities make them unlikely to benefit from TAVR, Moat said.

Moat pointed out that among aortic patients over age 80 years, the number receiving any intervention nearly doubled between 2006 and 2010. Although 30-day mortality is considerably higher among the very old with surgical valve replacement, for TAVR, the rates are similar for those under and over 80 years.

  • Dr. Linke reports receiving consultant fees/honoraria from Medtronic.
  • Dr. Moat reports receiving consultant fees/honoraria from Abbott Vascular and Medtronic CardioVascular and other support from Edwards Lifesciences.
  • Dr. Rodés-Cabau reports receiving grant/research support from Boston Scientific, Edwards Lifesciences and consultant fees/honoraria from Edwards Lifesciences and St. Jude Medical.