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. 2023 Aug 29;3(5):766-773.
doi: 10.1016/j.jacasi.2023.06.008. eCollection 2023 Oct.

Short-Term Outcomes Following Transcatheter Edge-to-Edge Repair: Insights From the OCEAN-Mitral Registry

Mike Saji  1   2 , Masanori Yamamoto  3   4   5 , Shunsuke Kubo  6 , Masahiko Asami  7 , Yusuke Enta  8 , Shinichi Shirai  9 , Masaki Izumo  10 , Shingo Mizuno  11 , Yusuke Watanabe  12 , Makoto Amaki  13 , Kazuhisa Kodama  14 , Junichi Yamaguchi  15 , Yoshifumi Nakajima  16 , Toru Naganuma  17 , Hiroki Bota  18 , Yohei Ohno  19 , Masahiro Yamawaki  20 , Hiroshi Ueno  21 , Kazuki Mizutani  22 , Yuya Adachi  3   4 , Toshiaki Otsuka  23 , Kentaro Hayashida  24 ; OCEAN-Mitral Investigators
Affiliations

Short-Term Outcomes Following Transcatheter Edge-to-Edge Repair: Insights From the OCEAN-Mitral Registry

Mike Saji et al. JACC Asia. .

Abstract

Background: Transcatheter edge-to-edge repair (TEER) is a less invasive treatment for patients with mitral regurgitation (MR). Limited safety and efficacy data of TEER with MitraClip, including the fourth-generation (G4) system, in a large cohort, are available.

Objectives: This study aimed to summarize the initial experience of the TEER system in patients with MR from a large registry in Japan.

Methods: The OCEAN (Optimized CathEter vAlvular iNtervention)-Mitral Registry is an ongoing, prospective, investigator-initiated, multicenter, observational registry for patients with primary and secondary MR undergoing transcatheter mitral valve therapies. A total of 21 centers participated in the registry. Patients undergoing TEER were enrolled, and their characteristics, procedural details, and clinical outcomes were recorded.

Results: In total, 2,150 patients including 1,605 patients (75.0%) with secondary MR, were enrolled between April 2018 and June 2021. The median age was 80 years, and 43.7% were women. The median device and fluoroscopy times were 60 and 26 minutes, respectively. Those with the G4 system (618/2,150 [28.7%]) were significantly shorter than those with the second generation (G2) system (1,532/2,150 [71.3%]). Overall, 94.6% met acute procedural success without significant differences between the 2 systems (G2 94.7% vs G4 94.6%; P = 0.961).

Conclusions: The OCEAN-Mitral registry has demonstrated the short-term outcomes of TEER systems, including the G4 system, in symptomatic patients with primary and secondary MR. The acute procedural success rate in the G2 system was excellent, and that in the G4 system was expected to improve with the multidisciplinary heart valve team approach. (Japanese Registry study of valvular heart diseases treatment and prognosis; UMIN000023653).

Keywords: G4; OCEAN; mitral regurgitation; transcatheter mitral valve repair.

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Conflict of interest statement

The OCEAN-Mitral registry, which is part of the OCEAN-SHD registry, is supported by Edwards Lifesciences, Medtronic Japan, Boston Scientific, Abbott Medical Japan, and Daiichi Sankyo. Drs Saji, Kubo, Izumo, Watanabe, and Amaki are clinical proctors of transcatheter edge-to-edge repair for Abbott Medical, and have received consultant fees from Abbott Medical. Drs Asami and Kodama have received speaker fees from Abbott Medical. Drs Yamamoto and Nakajima are clinical proctors of transcatheter edge-to-edge repair for Abbott Medical, and have received lecture fees from Abbott Medical. Dr Yamaguchi is clinical proctor of transcatheter edge-to-edge repair for Abbott Medical, and has received a lecture fee and a scholarship donation from Abbott Medical. Dr Ohno has received consultant, advisor, and speaker fees from Abbott Medical. Drs Enta, Shirai, Mizuno, Naganuma, and Bota are clinical proctors of transcatheter edge-to-edge repair for Abbott Medical. All other authors have reported that they have no relationships relevant to the content of this paper to disclose.

Figures

None
Graphical abstract
Figure 1
Figure 1
Cumulative Number of TEER Procedures The cumulative number of TEER procedures at the OCEAN-Mitral investigator sites has been increasing since 2018. TEER = transcatheter edge-to-edge repair.
Figure 2
Figure 2
MR Severity Before and After TEER in Each Etiology Overall, 95.2% achieved MR reduction to 2+ or less, and 71.7% had an MR severity rating of 1+ or less at 30 days. MR significantly decreased from baseline to at discharge (P < 0.001), and baseline to at 30 days (P < 0.001). MR significantly decreased from baseline to at discharge (P < 0.001), and baseline to at 30 days (P < 0.001) in all patient subgroups (PMR, SMR, second generation, and G4). MR = mitral regurgitation; PMR = primary mitral regurgitation; SMR = secondary mitral regurgitation; TEER = transcatheter edge-to-edge repair.
Figure 3
Figure 3
Outcomes in Each MR Etiology There is a significant difference in the acute procedural success rate of G4 system in patients with primary MR, atrial secondary MR, and ventricular secondary MR. Abbreviations as in Figure 2.
Central Illustration
Central Illustration
TEER Outcomes in G4 System in OCEAN-Mitral Registry On upper left, acute procedural success rate in the OCEAN mitral registry was comparable with those in COAPT and CLASP (30-day outcomes) trials. Despite the company regulation for using NT initially regardless of MR etiology/mechanism for safety reasons in G4 system, the figure on lower left shows that XTW (wide and long) devices have been used more in ventricular secondary MR (light blue in the XTW bar), XT (long) devices have been used more in primary MR (dark blue in XT bar), and NTW (wide) devices have been used more in ventricular secondary MR (light blue in NTW bar). With comparison between NTW and XTW bars, there is a larger part of atrial secondary MR (blue) in NTW bar than in XTW bar. In addition on lower right, SLDA, leaflet tear, and device embolization tends to be more frequent in patients who had XT device. MR = mitral regurgitation; PMR = primary mitral regurgitation; SMR = secondary mitral regurgitation; SLDA = single leaflet device attachment; TEER = transcatheter edge-to-edge repair.
See this image and copyright information in PMC

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