Contemporary Survival Trends After Transcatheter Aortic Valve Implantation
論文ID: CJ-23-0866
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論文ID: CJ-23-0866
The occurrence of aortic stenosis (AS), which is the most common valve disease and characterized by progressive calcification of the aortic valve,1 is increasing because of population aging. Although surgical aortic valve replacement (SAVR) was the only effective treatment for patients with AS in the past, transcatheter aortic valve implantation (TAVI) is now an established treatment option, as evidenced by sequential randomized clinical trials. TAVI was initially indicated for patients with prohibitive or high estimated risk for death with SAVR, and then indicated for patients at intermediate risk. Currently, TAVI is being used for patients at low risk. According to a recent scientific statement from the Japanese Circulation Society, guidelines offer an index of prioritization of TAVI in patients aged ≥80 years and SAVR in those aged <75 years, regardless of surgical risk.2 Two recent randomized clinical trials comparing TAVI with SAVR in patients at low surgical risk provide strong evidence that TAVI is noninferior and even superior to surgery within 5 years.3,4 Thus, it is now time for a paradigm shift in how to improve the long-term prognosis in patients after TAVI.
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In this issue of the Journal, Sugiyama et al5 describe the results of their real-world registry at 2 international centers (Shonan Kamakura General Hospital in Japan and Helsinki University Central Hospital in Finland), providing useful insights into long-term survival and its trend after TAVI. The study cohort comprised 2,414 consecutive patients who underwent TAVI between December 2008 and December 2021. The indications of TAVI and the selection of the transcatheter heart valve (THV) and its sizing were left to the discretion of the multidisciplinary heart team and operators, based on labeled indications. The operative risk of the patients was evaluated according to the Society of Thoracic Surgeons (STS) score. The results of the study revealed that the overall age at TAVI was 81±6.4 years and the STS score was 4.5±1.7%. The overall survival rate was 67.6% at 5 years and 26.9% at 10 years, with survival improvement over time, and this trend was observed over all age categories. Furthermore, older age and higher STS score were associated with worse prognosis after TAVI. In addition, the incidence of moderate or higher paravalvular leakage, red blood cell transfusion, and acute kidney injury were independently associated with the risk of 5-year death.
Recently, intermediate-term survival within 10 years has been reported in some randomized and nonrandomized clinical trials (Table).3,4,6–14 Most recently, the overall mortality rate of patients at low surgical risk who underwent TAVI was reported to be 10.0% at 5 years in the PARTNER 3 trial,3 and 9.0% at 4 years in the Evolut Low Risk trial.4 In the NOTION trial, which compared clinical outcomes and valve durability after 8 years of follow-up in patients who underwent TAVI or SAVR, the estimated risk for all-cause death was 51.8% and the risk of structural valve deterioration was 13.9% in patients who underwent TAVI.6 However, even now, longer-term survival over 10 years in patients who have undergone TAVI remains questionable. What then is the importance of the study by Sugiyama et al for daily clinical practice?
Mortality Rate of Patients After TAVI (Sorted by STS-PROM Score)
| Study | Enrollment period |
Design | TAVI patients (n) |
Device type | Age at TAVI (years) |
STS-PROM Score (%) |
Follow-up (years) |
Mortality rate after TAVI |
|---|---|---|---|---|---|---|---|---|
| PARTNER 33 | 2016–2017 | Randomized trial (BEV vs. SAVR) | 496 | SAPIEN 3 | 73.3±5.8 | 1.9±0.7 | 5 | 10.0% |
| Evolut Low Risk trial4 | 2016–2019 | Randomized trial (SEV vs. SAVR) | 730 | CoreValve or Evolut-R or Evolut-PRO |
74.1±5.8 | 2.0±0.7 | 4 | 9.0% |
| NOTION6 | 2010–2013 | Randomized trial (SEV vs. SAVR) | 145 | CoreValve | 79.2±4.9 | 2.9±1.6 | 8 | 51.8% |
| SURTAVI7 | 2012–2016 | Randomized trial (SEV vs. SAVR) | 864 | CoreValve (n=724) Evolut R (n=139) |
79.9±6.2 | 4.4±1.5 | 5 | 30.0% |
| PARTNER 28 | 2011–2013 | Randomized trial (BEV vs. SAVR) | 1,011 | SAPIEN XT | 81.5±6.7 | 5.8±2.1 | 5 | 46.0% |
| CHOICE9 | 2012–2013 | Randomized trial (BEV vs. SEV) | 241 | SAPIEN XT (n=121) CoreValve (n=120) |
81.5±6.2 | 5.9±3.5 | 5 | Sapien XT 53.4% CoreValve 47.6% |
| PORTICO IDE10 | 2014–2017 | Randomized trial (SEV vs. Commercially available BEV/SEV*) |
750 | Portico (n=381) BEV/SEV* (n=369) |
83.0±7.0 | 6.5±3.4 | 2 | Portico 22.3% BEV/SEV* 20.2% |
| CoreValve US Pivotal High Risk Trial11 | 2011–2012 | Randomized trial (SEV vs. SAVR) | 391 | CoreValve | 83.2±7.1 | 7.3±3.0 | 5 | 55.3% |
| CoreValve US Extreme Risk Pivotal Trial12 | 2011–2012 | Nonrandomized trial (SEV, single-arm) | 639 | CoreValve | 82.8±8.4 | 10.4±5.6 | 5 | 71.6% |
| PARTNER 1B13 | 2007–2009 | Randomized trial (BEV vs. Standard therapy) | 179 | SAPIEN | 83.1±8.6 | 11.2±5.8 | 5 | 71.8% |
| PARTNER 1A14 | 2007–2009 | Randomized trial (BEV vs. SAVR) | 348 | SAPIEN | 83.6±6.8 | 11.8±3.3 | 5 | 67.8% |
Age at TAVI Procedure and STS-PROM Score are expressed as mean years or %±standard deviation. *Commercially available BEV/SEV; SAPIEN, SAPIEN XT, or SAPIEN 3/CoreValve, Evolut-R, or Evolut-PRO. BEV, balloon-expandable valve; SAVR, surgical aortic valve replacement; SEV, self-expandable valve; STS-PROM, The Society of Thoracic Surgeons Predicted Risk of Mortality; TAVI, transcatheter aortic valve implantation.
First, because the survival rate over 10 years depends on both age and the STS score at the time of the TAVI procedure, adoption of TAVI or SAVR should be based on life expectancy after TAVI in each patient’s case. With regard to lifetime management after TAVI, the durability of bioprosthetic aortic valves is an important issue. Currently, the longevity of THVs probably exceeds the life expectancy of elderly patients. However, patients with a longer life expectancy over 10 years are expected to have a risk of bioprosthetic valve failure. Thus, before the first valve replacement, the possibility of valve-in-valve TAVI should be considered in patients with a longer life expectancy. The authors of this study did not investigate the rate of bioprosthetic valve dysfunction and bioprosthetic valve failure, so the results should be interpreted with caution. Second, to improve long-term outcomes, the possibility of procedural valve-related complications should be assessed in detail before the TAVI procedure. Procedural technique and THV systems have been improved and accordingly, the incidence of moderate or higher paravalvular leakage has been less frequent. However, an excessive amount of asymmetrically distributed calcium in the aortic valve and its extension into the left ventricular outflow tract increase the risk of significant paravalvular leakage, leading to poor long-term prognosis after TAVI. Thus, SAVR is preferred for such patients if the surgical risk is low.
The next step is to examine which type of THV has long-term durability, best hemodynamic state, and improves long-term outcomes, specifically in young and low surgical risk patients, after TAVI. Moreover, treatment strategies following TAVI (e.g., oral anticoagulants, anti-heart failure drugs, cardiac rehabilitation, and dietary modification for frailty) should be investigated to improve the long-term prognosis after TAVI. Informed shared decision making based on the patient’s life expectancy after TAVI should be adapted into daily clinical practice for patients with AS.
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All authors declare that they have no conflicts of interest.
