Long-Term Prognostic Value of the Society of Thoracic Surgery Risk Score in Patients Undergoing Transcatheter Aortic Valve Implantation (From the OCEAN-TAVI Registry)

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Highlights

  • The STS score was designed to predict 30-day mortality after cardiac surgery.

  • Lower mortality after transcatheter aortic valve implantation than was predicted.

  • High STS score is associated with an increased risk of long-term mortality.

  • Similar long-term mortality in patients with low and intermediate scores.

The Society of Thoracic Surgeons (STS) risk model, designed to predict operative mortality after cardiac surgery, is often used for the risk assessment of patients considered for transcatheter aortic valve implantation (TAVI). We investigated the long-term prognostic value of the STS score by utilizing the data of 2588 patients undergoing TAVI from the OCEAN (Optimized CathEter vAlvular iNtervention)—TAVI Japanese multicenter registry. The patients were divided into 3 groups according to their pre-procedural STS score as follows: low-risk (STS score <4%, n = 467 [18%]), intermediate-risk (4%≤ STS score <8%, n = 1200 [46.4%]), and high-risk (8%≤ STS score, n = 921 [35.6%]). Low-risk patients were younger and were more frequently male. The prevalence of most of the comorbidities were higher in high-risk patients, while active cancer was more frequent in low-risk patients (p <0.001).The cumulative 4-year all-cause mortality rates were higher in high-risk patients (49.0%) but comparable in low-risk (22.6%) and intermediate-risk patients (28.7%) (hazard ratio [HR] for intermediate-risk versus low-risk, 1.03; 95% confidence interval [CI], 0.77 to 1.37; p = 0.85; HR for high-risk versus low-risk, 2.27; 95% CI 1.72 to 2.99; p = <0.001). Similarly, the cumulative 4-year cardiovascular mortality rates were higher in high-risk patients (20.5%) but comparable in low-risk (9.9%) and intermediate-risk patients (10.3%) (HR for intermediate-risk versus low-risk, 1.10; 95% CI, 0.68 to 1.77; p = 0.69; HR for high-risk versus low-risk, 2.33; 95% CI 1.48 to 3.67; p = <0.001). After adjustment for several confounders, STS score ≥8% was independently associated with increased long-term mortality (HR, 1.35; 95% CI, 1.08 to 1.68). In conclusion, the risk stratification according to STS score demonstrated an increased risk of long-term mortality after TAVI in high-risk patients, albeit with comparable risks in intermediate- and low-risk patients.

Section snippets

Methods

We evaluated the data of 2588 patients with severe AS who underwent TAVI that were available from the OCEAN-TAVI (Optimized CathEter vAlvular iNtervention—Transcatheter Aortic Valve Implantation) registry. The OCEAN-TAVI registry is an ongoing, prospective, multicenter TAVI registry, from which the current data include information from 14 institutions in Japan reported between October 2013 and May 2017. This trial is registered with the University Hospital Medical Information Network

Results

Of the 2588 patients included in the present study, 467 (18.0%) patients were categorized as low-risk (STS score < 4%), 1200 (46.4%) patients as intermediate-risk (4% ≤ STS score < 8%), and 921 (35.6%) as high-risk (8% ≤ STS score) (Figure 1). The baseline patient characteristics are summarized in Table 1. The median age of the included patients was 85 years, 31% of patients were male, and the median STS risk score was 6.6%. Statistically significant group differences in patient demographics

Discussion

The main findings of the study are as follows; 1) the present study showed that a considerable portion of TAVI procedures were performed in patients who were categorized as low- or intermediate-risk according to the STS score but who were considered to be high risk for SAVR; 2) procedural complication rates and in-hospital mortality were lower and comparable in low- and intermediate-risk patients, compared with high-risk patients; 3) the operative (30-day) mortality was quite lower than the

Author's Contributions

Kenichi Ishizu: Conceptualization, Methodology, Formal analysis, Writing - Original Draft. Shinichi Shirai: Writing - Review & Editing, Supervision. Akihiro Isotani: Data Curation. Masaomi Hayashi: Data Curation. Tomohiro Kawaguchi: Data Curation. Tomohiko Taniguhi: Data Curation. Kenji Ando: Supervision. Fumiaki Yashima: Writing - Review & Editing, Resources. Norio Tada: Review & Editing. Masahiro Yamawaki: Review & Editing. Toru Naganuma: Review & Editing. Futoshi Yamanaka: Review & Editing.

Acknowledgments

The authors thank the investigators and institutions that have participated in the OCEAN-TAVI registry.

References (28)

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    Cox proportional hazards models were fitted to estimate hazard ratios with 95% CI for treatment comparison. Hazard ratios (HR) were adjusted for clinical confounders defined a priori based on previous studies [22–25] and clinical significance, including age, sex, baseline glomerular filtration rate, STS score, and left ventricular ejection fraction. Moreover, variable that demonstrated a p-value <0.10 at the univariate Cox analysis were included in the final model.

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The OCEAN-TAVI registry is supported by Edwards Lifesciences, Medtronic, Boston Scientific, Abbott Medical, and Daiichi-Sankyo Company.

Disclosures: Drs. Yamamoto, Tada, Naganuma, Shirai, Mizutani, Tabata, Ueno, and Watanabe are clinical proctors for Edwards Lifesciences and Medtronic. Drs. Takagi and Hayashida are clinical proctors of Edwards Lifesciences. The remaining authors have nothing to disclose.

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