Surgical, Transcatheter Valve Therapies Show Similar Long-term Benefits
Download this article's Factoid (PDF & PPT for Gold Subscribers)
Transcatheter aortic valve replacement (TAVR) lowers mortality and improves symptoms to the same extent as surgery out to 30 months compared with medical therapy in patients with severe aortic stenosis who are at increased surgical risk. The prospective registry study, published in the November 15, 2011, issue of the Journal of the American College of Cardiology, also demonstrates equally low stroke rates among each of the treatment strategies.
The new data come on the heels of the November 2, 2011, US Food and Drug Administration approval of the Edwards Sapien Transcatheter Heart Valve (Edwards Lifesciences, Irvine, CA).
For the study, researchers led by Stephan Windecker, MD, of Bern University Hospital (Bern, Switzerland), focused on 442 elderly patients with severe aortic stenosis (mean logistic EuroScore 22.3 ± 14.6%) allocated to medical therapy (n = 78), TAVR (n = 257), or surgical aortic valve replacement (SAVR; n = 107) at their institution based on a comprehensive evaluation protocol. Transfemoral TAVR was performed with either the CoreValve Revalving System (Medtronic, Minneapolis, MN) or the Sapien valve, whereas only the Sapien prosthesis was used for transapical access.
At 30 months, clinical outcomes including death and MI were lower in both the TAVR and surgery arms than with medical therapy, showing similar rates between the transcatheter and surgical techniques. Stroke rates, meanwhile, were similar in all 3 groups (table 1).
Table 1. Thirty-Month Outcomes
|
Medical |
TAVR |
Surgical |
P Valuea |
Death |
61.5% |
22.6% |
22.4% |
< 0.001 |
CV Death |
59.0% |
15.6% |
11.2% |
< 0.001 |
MI |
2.6% |
1.6% |
0 |
0.25 |
Major Stroke |
3.9% |
4.3% |
4.7% |
0.89 |
TIA |
0 |
0.8% |
2.8% |
0.42 |
Death, Major Stroke, or MI |
64.1% |
25.7% |
24.3% |
< 0.001 |
a P for differences between TAVR and medical therapy, and surgical and medical therapy.
A stratified analysis of 30-month mortality showed consistent results with both TAVR and surgical replacement compared with medical therapy across a wide range of subgroups defined by age (threshold of 90 years), sex, BMI (threshold of 20 kg/m3), logistic EuroScore (threshold of 20%), Society of Thoracic Surgeons (STS) score (threshold of 10), LVEF (threshold of 50%), peripheral disease, prior CABG, and pulmonary artery systolic pressure (threshold of 60 mm Hg). A separate analysis showed no differences between TAVR and surgery across the same subgroups. On multivariable regression analysis, the only predictors of mortality at 30 months were medical treatment, older age (> 80 years), peripheral vascular disease, and atrial fibrillation at baseline.
At 1 year, 92.3% of patients undergoing surgery and 93.2% of patients undergoing TAVR were asymptomatic or had mild symptoms (NYHA class I or II), compared with 70.8% of patients treated medically (P = 0.003 for both groups vs. medical therapy).
Prognosis No Longer Dismal
“Among high-risk patients with severe [aortic stenosis], SAVR and TAVI improve survival and symptoms, compared with [medical therapy],” the authors write. “Clinical outcomes of TAVI and SAVR seem similar among carefully selected high-risk patients with severe [aortic stenosis].”
They add that medical therapy of high-risk patients with severe aortic stenosis “was associated with a dismal prognosis.”
The authors point out the similar patient characteristics and risk scores between the medical therapy and TAVR patients, suggesting that the transcatheter procedure “addresses an unmet clinical need.” However, they add, “the higher rate of paravalvular aortic regurgitation after TAVI and the uncertain long-term durability of percutaneously implanted valve prostheses require further scrutiny.”
In an accompanying editorial, Deeb N. Salem, MD, and Adeeb H. Al-Quthami, MD, both of Tufts Medical Center (Boston, MA), called the study results “striking,” noting similar long-term clinical and symptomatic improvements with TAVR, “which suggests that not only is survival improved but quality of life as well.”
Implications for Younger Patients
Perhaps most intriguing, they write, is the fact that older age and comorbidities were the main predictors of late mortality, “which implies that if TAVI use is expanded to a younger and healthier population the outcomes will also be expected to be very good.”
But a few outstanding issues must be addressed first, Drs. Salem and Al-Quthami caution. One is the stroke rate with TAVR, which though low in the current study can occur in up to 13.5% of transcatheter cases according to previous research. The other is the rate of moderate or severe aortic regurgitation, which was 28.3% with TAVR in the current study, although this did not affect long-term outcomes.
“Further research on the role of moderate and severe aortic insufficiency after TAVI is paramount before recommending its expanded use in patients with longer life expectancies,” the editorial states.
In the meantime, TAVR is expected to emerge as a valuable treatment option in inoperable patients as well as an acceptable alternative to SAVR in select patients at high surgical risk. But until the issues around stroke, aortic regurgitation, and long-term valve durability are addressed by larger randomized trials, nonelderly patients must be told, “You are too young for TAVI,” the editorial concludes.
Study Details
Patients allocated to medical therapy and TAVR showed similar baseline characteristics and risk scores. However, patients receiving SAVR were younger with better LV function and had lower pulmonary arterial pressure and risk by logistic EuroScore and STS score, though they more often received myocardial revascularization. In addition, almost half (48.7%) of the medical therapy patients were only at intermediate surgical risk but refused to undergo surgery or TAVR despite the recommendation of the heart team.
Sources:
1. Wenaweser P, Pilgrim T, Kadner A, et al. Clinical outcomes of patients with severe aortic stenosis at increased surgical risk according to treatment modality. J Am Coll Cardiol. 2011;58:2151-2162.
2. Salem DN, Al-Quthami AH. Are you too young? J Am Coll Cardiol. 2011;58:2163-2164.
Disclosures:
- Dr. Windecker reports receiving lecture and consulting fees from Edwards Lifesciences and Medtronic CoreValve.
- Drs. Salem and Al-Quthami report no relevant conflicts of interest.
Related Stories:
Jason R. Kahn, the former News Editor of TCTMD, worked at CRF for 11 years until his death in 2014…
Read Full Bio
Comments