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Tomohiko Taniguchi, MD Kyoto University Graduate School of Medicine

Evaluation of Initial Surgical Versus Conservative Strategies in Patients With Asymptomatic Severe Aortic Stenosis: - Results from the CURRENT AS registry-. Tomohiko Taniguchi, MD Kyoto University Graduate School of Medicine

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Tomohiko Taniguchi, MD Kyoto University Graduate School of Medicine

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  1. Evaluation of Initial Surgical Versus Conservative Strategies in Patients With Asymptomatic Severe Aortic Stenosis:-Results from the CURRENT AS registry- Tomohiko Taniguchi, MD Kyoto University Graduate School of Medicine Takeshi Morimoto, MD, MPH; Hiroki Shiomi, MD; Kenji Ando, MD; Norio Kanamori, MD; Koichiro Murata, MD; Takeshi Kitai, MD; Yuichi Kawase, MD; Chisato Izumi, MD; Makoto Miyake, MD; Hirokazu Mitsuoka, MD; Masashi Kato, MD; Yutaka Hirano, MD; Shintaro Matsuda, MD; Kazuya Nagao, MD; Tsukasa Inada, MD; Tomoyuki Murakami, MD; Yasuyo Takeuchi, MD; Keiichiro Yamane, MD; Mamoru Toyofuku, MD; Mitsuru Ishii, MD; Eri Minamino-Muta, MD; Takao Kato, MD; Moriaki Inoko, MD; Tomoyuki Ikeda, MD ; Akihiro Komasa, MD; Katsuhisa Ishii, MD; Kozo Hotta, MD; Nobuya Higashitani, MD; Yoshihiro Kato, MD; Yasutaka Inuzuka, MD; Chiyo Maeda, MD: Toshikazu Jinnai, MD; Yuko Morikami, MD; Ryuzo Sakata, MDand Takeshi Kimura, MD On behalf of the CURRENT AS registry Investigators

  2. Disclosure Statement of Financial Interest • I have nothing to declare. • This study was funded by • Kyoto University graduate School of Medicine, • Department of Cardiovascular Medicine.

  3. Current Guidelines Recommendations on Timing of AVR in Asymptomatic Patients with Severe AS Watchful waiting strategy for AVR until symptoms emerge, except for several subgroups of patients such as those with left ventricular dysfunction or very severe AS. Limitations 1. Based on previous small single-center studies evaluating symptoms and/or AVR, but not mortality as the outcome measures. 2. No previous large-scale multicenter study comparing the initial AVR strategy with the conservative strategy.

  4. CURRENT AS registry: Flow ChartMulti-center, retrospective registry • Symptom related to AS • Angina • Syncope • Heart failure including dyspnea Follow-up interval (median): 3.7 years 2-year follow-up: 90%

  5. CURRENT AS registry Baseline Characteristics in the entire cohort

  6. CURRENT AS registry Main Analysis Set: Propensity-score Matched Cohort • Symptom related to AS • Angina • Syncope • Heart failure including dyspnea Propensity-score matched cohort Initial AVR group 291 patients Conservative group 291 patients

  7. CURRENT AS registry Baseline Characteristics in the Propensity-score Matched Cohort

  8. CURRENT AS registry Indications for AVR in the initial AVR group 291 patients in the initial AVR group Very severe AS No formal indication; 37% N=107 Number of patients Formal Indications; 63% N=184 AVR (I) Formal Indications for AVR

  9. CURRENT AS registry Outcome Measures and Analysis • Primary Outcome Measures • All-cause death • Heart failure hospitalization • Secondary Outcome Measures • Cardiovascular death • Non-cardiovascular death • Sudden death • Emerging symptoms related to AS • Analysis was performed in the intention-to-treat principle regardless of the actual performance of AVR.

  10. CURRENT AS registry Surgical AVR or TAVI Initial AVR group 287/291 patients (99%) AVR/TAVI interval: 44 days (median) Conservative group 118/291 patients (41%) AVR/TAVI interval: 780 days (median) 100 97.5% 80 Log-rankP<0.001 60 Cumulative incidence (%) 40 20 3.7% 0 1 2 3 4 5 0.5 0 Years after diagnosis The results from the adjusted analysis conducted as a sensitivity analysis were fully consistent with those from the unadjusted analysis.

  11. CURRENT AS registry Primary outcome measure All-cause death 100 80 Crude HR 0.60 (0.40-0.88), P=0.009 Adjusted HR 0.64 (0.42-0.94), P=0.02 Log-rankP=0.009 60 Cumulative incidence (%) 40 26.4% Conservative group 20 15.4% Initial AVR group 0 1 2 3 4 5 0 Years after diagnosis The results from the adjusted analysis conducted as a sensitivity analysis were fully consistent with those from the unadjusted analysis.

  12. CURRENT AS registry Primary outcome measure Heart failure hospitalization 100 80 Crude HR 0.18 (0.09-0.35), P<0.001 Adjusted HR 0.19 (0.09-0.36), P<0.001 Log-rankP<0.001 60 Cumulative incidence (%) 40 19.9% Conservative group 20 3.8% Initial AVR group 0 1 2 3 4 5 0 Years after diagnosis The results from the adjusted analysis conducted as a sensitivity analysis were fully consistent with those from the unadjusted analysis.

  13. CURRENT AS registry Secondary outcome measures Cumulative 5-Year Incidence Initial AVR Strategy Better Conservative Strategy Better

  14. CURRENT AS registry Adjusted Hazard Ratio for the Primary Outcome Measures Propensity-score matched cohort and Entire cohort Initial AVR Strategy Better Conservative Strategy Better The favorable effect of the initial AVR compared with the conservative strategy was seen in both propensity-score matched cohort and the entire cohort.

  15. CURRENT AS registry Types of emerging symptoms and outcomes in the conservative group Conservative group N=1517 Heart Failure Types of emerging symptoms NYHA unknown No symptom Angina Syncope NYHA class 3 NYHA class 2 NYHA class 4 AVR 71% Proportion of patients who underwent AVR (%) Proportion of patients who died with and without AVR No symptom Angina Syncope NYHA class 2 NYHA class 3 NYHA class 4

  16. CURRENT AS registry Limitations 1. Retrospective study design and variable patient follow-up We were unable to exclude the possibility of ascertainment bias for symptoms related to AS at the baseline. Patient follow-up might have been variable among participating centers. 2. Selection bias and residual confounding Propensity-score matching did not completely eliminate the impact of differences in the two groups. However, the results from the adjusted analysis were fully consistent with those from unadjusted analysis.

  17. CURRENT AS registry Conclusion The long-term outcome of asymptomatic patients with severe AS was dismal when managed conservatively in the real clinical practice, which might be substantially improved by the initial AVR strategy.

  18. CURRENT AS registry 27 Participating Centers • Japanese Red Cross Wakayama Medical Center • National Hospital Organization Kyoto Medical Center • The TazukeKofukai Medical Research Institute, Kitano Hospital • HikoneMunicipal Hospital • Kansai Electric Power Hospital • Hyogo Prefectural Amagasaki General Medical Center • RakuwakaiOtowaHospital • SaiseikaiNoe Hospital • Shiga Medical Center for Adults • Hamamatsu RosaiHospital • Japanese Red Cross Otsu Hospital • Hirakata KohsaiHospital • Kyoto University Hospital • Kokura Memorial Hospital • Shimada Municipal Hospital • Shizuoka City Shizuoka Hospital • Kobe City Medical Center General Hospital • Kurashiki Central Hospital • Tenri Hospital • Nara Hospital, Kinki University Faculty of Medicine • Mitsubishi Kyoto Hospital • Kinki University Hospital • Kishiwada City Hospital • Osaka Red Cross Hospital • Koto Memorial Hospital • Shizuoka General Hospital • Nishikobe Medical Center

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