German Valve Registry Shows Advantage of Surgery in Lower Risk Patients

SAN FRANCISCO, CA—Data from a large German aortic valve registry indicate that in patients at highest risk, transcatheter aortic valve replacement (TAVR) and surgery are associated with similar outcomes.  However, in patients at low and intermediate risk, surgery appears to result in lower mortality than TAVR. The results were presented March 10, 2013, at the American College of Cardiology/i2 Scientific Session.

Friedrich-Wilhelm Mohr, MD, of the Heart Center Leipzig (Leipzig, Germany), presented data on 13,595 patients followed for 1 year in the multicenter German Aortic Valve RegistrY (GARY). The registry includes data on patients treated with both TAVR and surgery at German centers since 2010. Participation in the registry is on a voluntary basis and is expected to eventually include data on 80,000 patients.

Individual patient groups analyzed included those treated surgically with and without CABG and those treated with transfemoral or transapical TAVR, as well as the elderly (over age 75).

Surgery Best for Lower Risk Patients

Analysis of mortality rate by procedure showed the lowest mortality for surgical valve replacement without CABG and the highest for transapical TAVR. Dividing the groups by age showed that for those under age 75, transapical TAVR produced the worst outcome (P = 0.81) compared with the other groups. For those aged 75 and older, risk curves suggested equivalent outcomes between treatment groups.

Looking at patients by EuroScore showed advantages for the surgical interventions in those with lower scores (< 10) but no differences in procedural outcome among those with intermediate or high scores (20 to < 30 and ≥ 30). German AV score predicted early outcome, but again there were no differences in procedural outcome for those with the highest scores.

Patients with severe aortic insufficiency had high mortality regardless of procedure type, increasing from 37.5% at 30 days to 50% at 1 year.

Rate of new pacemaker implantation at 1 year was highest in the transfemoral TAVR group (26.2%) and lowest in the surgical group with CABG (7.3%). Similarly, rates of major and minor stroke at 1 year were lowest in the surgical group with CABG (1.7% and 1.3%, respectively) and highest in the transfemoral TAVR group (2.0% and 2.8%, respectively).

In addition, there was good 1-year quality of life and high patient satisfaction across all groups, with approximately 60% of patients in all 4 treatment groups reporting better state of health than before the procedure.

In conclusion, Dr. Mohr said more research on risk-score delineation is needed to determine if there are as-yet unknown risk factors for transapical TAVR.

Study Details

The registry includes data on:

• 6,523 patients treated surgically without CABG
• 3,462 patients treated surgically with CABG
• 2,694 patients treated with transfemoral TAVR
• 1,181 patients treated with transapical TAVR

More than 80% of patients in the TAVR groups were over age 75 compared with 45% and 33% in the surgical groups with and without CABG. Individual TAVR devices were not compared or analyzed.

Source:Mohr FW. One year results of more than 14,000 patients from the German Aortic Valve Registry. Presented at: American College of Cardiology Annual Scientific Session; March 10, 2013; San Francisco, CA.

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