Clinical outcomes in high-risk patients with a severe aortic stenosis: a seven-year follow-up analysis
The aim of this study was to assess the clinical outcomes of high-risk patients with severe aortic stenosis (AS) allocated to medical treatment (MT), transcatheter aortic valve replacement (TAVR), and surgical aortic valve replacement (SAVR) through extended follow-up.
METHODS AND RESULTS
Consecutive patients with severe symptomatic AS included in a prospective single centre registry underwent sweep follow-up between March and August 2016. Clinical outcomes were assessed using a competing risk model. A total of 442 patients (median age 83 years; 52% female) were allocated to MT (n = 78), SAVR (n = 107), or TAVR (n = 257) with a gradient of surgical risk as assessed by logistic EuroSCORE (MT: 27.9 ± 14.5%, TAVR: 24.7 ± 24.9%, SAVR: 12.5 ± 8.2%; p <0.001). Survival after a median duration of follow-up of seven years was 6.4% (MT), 30.4% (TAVR), and 46.7% (SAVR), respectively (p <0.001). One TAVR and one SAVR patient underwent repeat intervention for valvular degeneration between 4.5 and 8.4 years after intervention. Compromised left ventricular function (LVEF <40%) was associated with increased mortality (HR 1.62, 95% CI 1.22–2.15; p <0.0001), whereas female sex was protective (HR 0.68, 95% CI 0.53–0.88; p = 0.0006).
Both TAVR and SAVR reduced mortality compared to MT throughout a median duration of follow-up of seven years. Repeat interventions for valvular degeneration were rare.
- Aronow WS, Kronzon I. Prevalence and severity of valvular aortic stenosis determined by Doppler echocardiography and its association with echocardiographic and electrocardiographic left ventricular hypertrophy and physical signs of aortic stenosis in elderly patients. Am J Cardiol. 1991;67(8):776–7. doi:.https://doi.org/10.1016/0002-9149(91)90542-S
- Kapadia SR, Leon MB, Makkar RR, Tuzcu EM, Svensson LG, Kodali S, et al.; PARTNER trial investigators. 5-year outcomes of transcatheter aortic valve replacement compared with standard treatment for patients with inoperable aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet. 2015;385(9986):2485–91. doi:.https://doi.org/10.1016/S0140-6736(15)60290-2
- Mack MJ, Leon MB, Smith CR, Miller DC, Moses JW, Tuzcu EM, et al.; PARTNER 1 trial investigators. 5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet. 2015;385(9986):2477–84. doi:.https://doi.org/10.1016/S0140-6736(15)60308-7
- Vollenbroich R, Stortecky S, Rothenbuehler M, Roost E, Sakiri E, Franzone A, et al. Very long term outcomes of patients with severe aortic stenosis: the impact of treatment modality. Eur Heart J. 2017;38(suppl.1):482. doi:.https://doi.org/10.1093/eurheartj/ehx501.P482
- Wenaweser P, Pilgrim T, Kadner A, Huber C, Stortecky S, Buellesfeld L, et al. Clinical outcomes of patients with severe aortic stenosis at increased surgical risk according to treatment modality. J Am Coll Cardiol. 2011;58(21):2151–62. doi:.https://doi.org/10.1016/j.jacc.2011.05.063
- Andersen PK, Abildstrom SZ, Rosthøj S. Competing risks as a multi-state model. Stat Methods Med Res. 2002;11(2):203–15. doi:.https://doi.org/10.1191/0962280202sm281ra
- Gray RJ. A class of k-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat. 1988;16(3):1141–54. doi:.https://doi.org/10.1214/aos/1176350951
- Klein JP, Moeschberger ML. Survival analysis: Techniques for censored and truncated data. Springer Science & Business Media; 2006.
- Gray B, Gray MB, Gray R. The cmprsk package. The Comprehensive R Archive network. 2004.
- Pilgrim T, Englberger L, Rothenbühler M, Stortecky S, Ceylan O, O’Sullivan CJ, et al. Long-term outcome of elderly patients with severe aortic stenosis as a function of treatment modality. Heart. 2015;101(1):30–6. doi:.https://doi.org/10.1136/heartjnl-2014-306106
- Foroutan F, Guyatt GH, O’Brien K, Bain E, Stein M, Bhagra S, et al. Prognosis after surgical replacement with a bioprosthetic aortic valve in patients with severe symptomatic aortic stenosis: systematic review of observational studies. BMJ. 2016;354:i5065. doi:.https://doi.org/10.1136/bmj.i5065