TY - JOUR
T1 - A Real-World Comparison of 1-Year Survival and Expenditures for Transcatheter Aortic Valve Replacements
T2 - SAPIEN 3 Versus CoreValve Versus Evolut R
AU - Fukuda, Haruhisa
AU - Kiyohara, Kosuke
AU - Sato, Daisuke
AU - Kitamura, Tetsuhisa
AU - Kodera, Satoshi
N1 - Funding Information:
Funding/Support: This work was supported by a Grant-in-Aid for Health Sciences Research from the Ministry of Health, Labour and Welfare of Japan (Grant Number: H30-Seisaku-Shitei-003 ) and JSPS KAKENHI Grant Number JP 17H04144 and JP 20H00563 .
Funding Information:
Author Contributions: Concept and design: Fukuda, Kiyohara, Sato, Kitamura, Kodera, Acquisition of data: Fukuda, Sato, Kodera, Analysis and interpretation of data: Fukuda, Kiyohara, Kodera, Drafting of the manuscript: Fukuda, Kiyohara, Sato, Kitamura, Kodera, Critical revision of the paper for important intellectual content: Sato, Kitamura, Statistical analysis: Fukuda, Obtaining funding: Fukuda, Supervision: Kitamura, Conflicts of Interest Disclosure: The authors have reported no conflicts of interest. Funding/Support: This work was supported by a Grant-in-Aid for Health Sciences Research from the Ministry of Health, Labour and Welfare of Japan (Grant Number: H30-Seisaku-Shitei-003) and JSPS KAKENHI Grant Number JP17H04144 and JP20H00563. Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Acknowledgment: We are grateful to Messrs Kondo and Yamakawa from Denno Labo Corporation for their support in extracting the study sample from the National Database.
Publisher Copyright:
© 2020 ISPOR–The Professional Society for Health Economics and Outcomes Research
PY - 2021/4
Y1 - 2021/4
N2 - Objectives: New versions of balloon-expandable and self-expandable valves for transcatheter aortic valve replacement (TAVR) have been developed, but few studies have examined the outcomes associated with these devices using national-level data. This study aimed to elucidate the clinical and economic outcomes of TAVR for aortic stenosis in Japan through an analysis of real-world data. Methods: This retrospective cohort study was performed using data from patients with aortic stenosis who had undergone transfemoral TAVR with Edwards SAPIEN 3, Medtronic CoreValve, or Medtronic Evolut R valves throughout Japan from April 2016 to March 2018. Pacemaker implantation, mortality, and health expenditure were examined for each valve type during hospitalization and at 1 month, 3 months, 6 months, and 1 year. Generalized linear regression models and Cox proportional hazards models were used to examine the associations between the valve types and outcomes. Results: We analyzed 7244 TAVR cases (SAPIEN 3: 5276, CoreValve: 418, and Evolut R: 1550) across 145 hospitals. The adjusted 1-year expenditures for SAPIEN 3, CoreValve, and Evolut R were $79 402, $76 125, and $75 527, respectively; SAPIEN 3 was significantly more expensive than the other valves (P < .05). The pacemaker implantation hazard ratios (95% confidence intervals) for CoreValve and Evolut R were significantly higher (P < .001) than SAPIEN 3 at 2.61 (2.07-3.27) and 1.80 (1.53-2.12), respectively. The mortality hazard ratios (95% confidence intervals) for CoreValve and Evolut R were not significant at 1.11 (0.84-1.46) and 1.22 (0.97-1.54), respectively. Conclusions: SAPIEN 3 users had generally lower pacemaker implantation and mortality but higher expenditures than CoreValve and Evolut R users.
AB - Objectives: New versions of balloon-expandable and self-expandable valves for transcatheter aortic valve replacement (TAVR) have been developed, but few studies have examined the outcomes associated with these devices using national-level data. This study aimed to elucidate the clinical and economic outcomes of TAVR for aortic stenosis in Japan through an analysis of real-world data. Methods: This retrospective cohort study was performed using data from patients with aortic stenosis who had undergone transfemoral TAVR with Edwards SAPIEN 3, Medtronic CoreValve, or Medtronic Evolut R valves throughout Japan from April 2016 to March 2018. Pacemaker implantation, mortality, and health expenditure were examined for each valve type during hospitalization and at 1 month, 3 months, 6 months, and 1 year. Generalized linear regression models and Cox proportional hazards models were used to examine the associations between the valve types and outcomes. Results: We analyzed 7244 TAVR cases (SAPIEN 3: 5276, CoreValve: 418, and Evolut R: 1550) across 145 hospitals. The adjusted 1-year expenditures for SAPIEN 3, CoreValve, and Evolut R were $79 402, $76 125, and $75 527, respectively; SAPIEN 3 was significantly more expensive than the other valves (P < .05). The pacemaker implantation hazard ratios (95% confidence intervals) for CoreValve and Evolut R were significantly higher (P < .001) than SAPIEN 3 at 2.61 (2.07-3.27) and 1.80 (1.53-2.12), respectively. The mortality hazard ratios (95% confidence intervals) for CoreValve and Evolut R were not significant at 1.11 (0.84-1.46) and 1.22 (0.97-1.54), respectively. Conclusions: SAPIEN 3 users had generally lower pacemaker implantation and mortality but higher expenditures than CoreValve and Evolut R users.
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U2 - 10.1016/j.jval.2020.10.022
DO - 10.1016/j.jval.2020.10.022
M3 - Article
C2 - 33840427
AN - SCOPUS:85098131331
SN - 1098-3015
VL - 24
SP - 497
EP - 504
JO - Value in Health
JF - Value in Health
IS - 4
ER -
