Safety and efficacy of minimalist approach in transfemoral transcatheter aortic valve replacement: Insights from the Optimized transCathEter vAlvular interventioN-Transcatheter Aortic Valve Implantation (OCEAN-TAVI) registry

Soh Hosoba, Masanori Yamamoto, Kayoko Shioda, Mitsuru Sago, Yutaka Koyama, Tetsuro Shimura, Ai Kagase, Norio Tada, Toru Naganuma, Motoharu Araki, Futoshi Yamanaka, Shinichi Shirai, Yusuke Watanabe, Kentaro Hayashida

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

OBJECTIVES: Favourable results have been reported for monitored anaesthesia care that includes local anaesthesia and conscious sedation [minimalist approach (MA)] for transfemoral transcatheter aortic valve replacement (TAVR). However, the efficacy of MA is still controversial in Japan. We describe our experience from a Japanese multicentre registry. METHODS: Between October 2013 and April 2016, 1215 consecutive Japanese patients with symptomatic, severe aortic stenosis undergoing TAVR with self-expandable or balloon-expandable valves were prospectively included in the Optimized transCathEter vAlvular intervention-Transcatheter Aortic Valve Implantation (OCEAN-TAVI) registry. Of these patients, we retrospectively reviewed 921 consecutive patients who underwent elective transfemoral-TAVR. We evaluated the perioperative results of MA-TAVR and non-minimalist approach (NMA) TAVR using propensity score matching analysis. RESULTS: A total of 118 patients underwent MA-TAVR, and 802 patients underwent NMA-TAVR [median age 84 vs 85 years, P = 0.25; Society of Thoracic Surgeons (STS) score 7.6 vs 6.4, P = 0.01]. One hundred eighteen matched pairs were compared after propensity score matching. In-hospital mortality and stroke/transient ischaemic attack were not significantly different between the MA-TAVR and the NMA-TAVR groups (2.5% vs 0.8%, P = 0.3; 1.7% vs 0.8%, P = 0.6, respectively). Major or life-threatening bleeding and the transfusion rate were significantly lower in the MA-TAVR group (3.4% vs 17%, P = 0.003; 6.8% vs 29%, P = 0.0002, respectively). The total intensive care unit days and length of hospital stay were significantly lower in the MA-TAVR group (P < 0.0002). CONCLUSIONS: MA-TAVR has similar results to NMA-TAVR in terms of mortality and stroke in this Japanese multicentre registry. Shorter procedure time and hospital stays were seen in the MA-TAVR group. MA-TAVR is as safe and effective as NMA-TAVR.

Original languageEnglish
Pages (from-to)420-424
Number of pages5
JournalInteractive Cardiovascular and Thoracic Surgery
Volume26
Issue number3
DOIs
Publication statusPublished - 2018 Mar 1

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Registries
Safety
Length of Stay
Propensity Score
Transcatheter Aortic Valve Replacement
Stroke
Conscious Sedation
Transient Ischemic Attack
Aortic Valve Stenosis
Local Anesthesia
Hospital Mortality
Intensive Care Units
Japan
Anesthesia

Keywords

  • Anaesthesia
  • Aortic valve replacement
  • Cardiac catheterization/intervention
  • OCEAN

ASJC Scopus subject areas

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine

Cite this

Safety and efficacy of minimalist approach in transfemoral transcatheter aortic valve replacement : Insights from the Optimized transCathEter vAlvular interventioN-Transcatheter Aortic Valve Implantation (OCEAN-TAVI) registry. / Hosoba, Soh; Yamamoto, Masanori; Shioda, Kayoko; Sago, Mitsuru; Koyama, Yutaka; Shimura, Tetsuro; Kagase, Ai; Tada, Norio; Naganuma, Toru; Araki, Motoharu; Yamanaka, Futoshi; Shirai, Shinichi; Watanabe, Yusuke; Hayashida, Kentaro.

In: Interactive Cardiovascular and Thoracic Surgery, Vol. 26, No. 3, 01.03.2018, p. 420-424.

Research output: Contribution to journalArticle

Hosoba, Soh ; Yamamoto, Masanori ; Shioda, Kayoko ; Sago, Mitsuru ; Koyama, Yutaka ; Shimura, Tetsuro ; Kagase, Ai ; Tada, Norio ; Naganuma, Toru ; Araki, Motoharu ; Yamanaka, Futoshi ; Shirai, Shinichi ; Watanabe, Yusuke ; Hayashida, Kentaro. / Safety and efficacy of minimalist approach in transfemoral transcatheter aortic valve replacement : Insights from the Optimized transCathEter vAlvular interventioN-Transcatheter Aortic Valve Implantation (OCEAN-TAVI) registry. In: Interactive Cardiovascular and Thoracic Surgery. 2018 ; Vol. 26, No. 3. pp. 420-424.
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abstract = "OBJECTIVES: Favourable results have been reported for monitored anaesthesia care that includes local anaesthesia and conscious sedation [minimalist approach (MA)] for transfemoral transcatheter aortic valve replacement (TAVR). However, the efficacy of MA is still controversial in Japan. We describe our experience from a Japanese multicentre registry. METHODS: Between October 2013 and April 2016, 1215 consecutive Japanese patients with symptomatic, severe aortic stenosis undergoing TAVR with self-expandable or balloon-expandable valves were prospectively included in the Optimized transCathEter vAlvular intervention-Transcatheter Aortic Valve Implantation (OCEAN-TAVI) registry. Of these patients, we retrospectively reviewed 921 consecutive patients who underwent elective transfemoral-TAVR. We evaluated the perioperative results of MA-TAVR and non-minimalist approach (NMA) TAVR using propensity score matching analysis. RESULTS: A total of 118 patients underwent MA-TAVR, and 802 patients underwent NMA-TAVR [median age 84 vs 85 years, P = 0.25; Society of Thoracic Surgeons (STS) score 7.6 vs 6.4, P = 0.01]. One hundred eighteen matched pairs were compared after propensity score matching. In-hospital mortality and stroke/transient ischaemic attack were not significantly different between the MA-TAVR and the NMA-TAVR groups (2.5{\%} vs 0.8{\%}, P = 0.3; 1.7{\%} vs 0.8{\%}, P = 0.6, respectively). Major or life-threatening bleeding and the transfusion rate were significantly lower in the MA-TAVR group (3.4{\%} vs 17{\%}, P = 0.003; 6.8{\%} vs 29{\%}, P = 0.0002, respectively). The total intensive care unit days and length of hospital stay were significantly lower in the MA-TAVR group (P < 0.0002). CONCLUSIONS: MA-TAVR has similar results to NMA-TAVR in terms of mortality and stroke in this Japanese multicentre registry. Shorter procedure time and hospital stays were seen in the MA-TAVR group. MA-TAVR is as safe and effective as NMA-TAVR.",
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T1 - Safety and efficacy of minimalist approach in transfemoral transcatheter aortic valve replacement

T2 - Insights from the Optimized transCathEter vAlvular interventioN-Transcatheter Aortic Valve Implantation (OCEAN-TAVI) registry

AU - Hosoba, Soh

AU - Yamamoto, Masanori

AU - Shioda, Kayoko

AU - Sago, Mitsuru

AU - Koyama, Yutaka

AU - Shimura, Tetsuro

AU - Kagase, Ai

AU - Tada, Norio

AU - Naganuma, Toru

AU - Araki, Motoharu

AU - Yamanaka, Futoshi

AU - Shirai, Shinichi

AU - Watanabe, Yusuke

AU - Hayashida, Kentaro

PY - 2018/3/1

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N2 - OBJECTIVES: Favourable results have been reported for monitored anaesthesia care that includes local anaesthesia and conscious sedation [minimalist approach (MA)] for transfemoral transcatheter aortic valve replacement (TAVR). However, the efficacy of MA is still controversial in Japan. We describe our experience from a Japanese multicentre registry. METHODS: Between October 2013 and April 2016, 1215 consecutive Japanese patients with symptomatic, severe aortic stenosis undergoing TAVR with self-expandable or balloon-expandable valves were prospectively included in the Optimized transCathEter vAlvular intervention-Transcatheter Aortic Valve Implantation (OCEAN-TAVI) registry. Of these patients, we retrospectively reviewed 921 consecutive patients who underwent elective transfemoral-TAVR. We evaluated the perioperative results of MA-TAVR and non-minimalist approach (NMA) TAVR using propensity score matching analysis. RESULTS: A total of 118 patients underwent MA-TAVR, and 802 patients underwent NMA-TAVR [median age 84 vs 85 years, P = 0.25; Society of Thoracic Surgeons (STS) score 7.6 vs 6.4, P = 0.01]. One hundred eighteen matched pairs were compared after propensity score matching. In-hospital mortality and stroke/transient ischaemic attack were not significantly different between the MA-TAVR and the NMA-TAVR groups (2.5% vs 0.8%, P = 0.3; 1.7% vs 0.8%, P = 0.6, respectively). Major or life-threatening bleeding and the transfusion rate were significantly lower in the MA-TAVR group (3.4% vs 17%, P = 0.003; 6.8% vs 29%, P = 0.0002, respectively). The total intensive care unit days and length of hospital stay were significantly lower in the MA-TAVR group (P < 0.0002). CONCLUSIONS: MA-TAVR has similar results to NMA-TAVR in terms of mortality and stroke in this Japanese multicentre registry. Shorter procedure time and hospital stays were seen in the MA-TAVR group. MA-TAVR is as safe and effective as NMA-TAVR.

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