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Real-world clinical outcomes of percutaneous transluminal septal myocardial ablation for patients with drug-refractory hypertrophic obstructive cardiomyopathy: results from a retrospective multicenter registry of non-high-volume centers

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Abstract

Percutaneous transluminal septal myocardial ablation (PTSMA) is a well-established interventional therapy for drug-refractory hypertrophic obstructive cardiomyopathy (HOCM) as an alternative to surgical myectomy. Although guidelines recommend that PTSMA should be performed in institutions with extensive experience, it is not centralized to such high-volume centers in real-world clinical practice. Thus, this study aimed to assess the feasibility of PTSMA in non-high-volume centers. We retrospectively examined patients with HOCM who underwent PTSMA between August 2012 and May 2020 at four institutions that experienced fewer than 20 cases of PTSMA procedures. The primary clinical endpoint was a composite of safety (all-cause death, electrical defibrillation for ventricular tachycardia or fibrillation, cardiac tamponade, permanent pacemaker implantation, and repeated interventions) and efficacy endpoints (repeated interventions [PTSMA or surgical myectomy]). Fifty-eight consecutive patients were enrolled. During the 30-day follow-up, no major clinical adverse events were noted except three patients (5.2%) requiring permanent pacemaker implantation for complete atrioventricular block. The percentage of patients with New York Heart Association functional class 1 or 2 significantly increased from 8.6 to 100% (p < 0.001). In the Cox proportional hazard model, left ventricular outflow tract pressure gradient at rest ≥ 30 mmHg (hazard ratio [HR] 6.56; 95% confidence interval [CI] 1.44–29.90; p = 0.015) and mitral regurgitation grade ≥ 3 (HR 10.75; 95% CI 1.81–63.79; p = 0.009) at the 30-day follow-up were associated with a composite of major clinical adverse events. The current study demonstrated that 58 patients who underwent PTSMA in non-high-volume centers had favorable 30-day clinical outcomes, with a primary composite endpoint rate of 5.2%. A prospective study with a larger sample size and longer follow-up is warranted to verify the safety and efficacy of PTSMA in non-high-volume centers.

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Authors and Affiliations

  1. Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan

    Koichi Nakamura, Takayoshi Toba, Hiromasa Otake, Shunsuke Kakizaki, Daichi Fujimoto, Yu Takahashi, Yusuke Fukuyama, Hiroyuki Kawamori, Hidekazu Tanaka, Tomofumi Takaya, Hiroya Kawai & Ken-ichi Hirata

  2. Department of Cardiology, Hyogo Prefectural Himeji Cardiovascular Center, Himeji, Japan

    Tomofumi Takaya & Hiroya Kawai

  3. Department of Cardiology, Hyogo Prefectural Awaji Medical Center, Sumoto, Japan

    Masamichi Iwasaki & Takatoshi Hayashi

  4. Department of Cardiology, Osaka Saiseikai Nakatsu Hospital, Osaka, Japan

    Amane Kozuki & Junya Shite

  5. Department of Cardiology, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan

    Takayoshi Toba

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  1. Koichi Nakamura
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Contributions

KN, TT, HK, HO, HT and KH made substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data; or the creation of new software used in the work; KN, TT, TT, MI, AK, HK, TH, JS and KH drafted the work or revised it critically for important intellectual content; KN, TT, SK, DF, YT, YF, HK, HO, HT, TT, MI, AK, HK, TH, JS and KH approved the version to be published; and KN, TT, SK, DF, YT, YF, HK, HO, HT, TT, MI, AK, HK, TH, JS and KH agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Corresponding author

Correspondence to Takayoshi Toba.

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Conflict of interest

The authors declare that there are no relationships regarding the current study with industry or other entities that might constitute competing interests.

Ethics approval

This study was approved by the Ethics Committee of Kobe University Hospital (Kobe University Hospital Clinical and Translational Research Center, ID: B200174) and participating hospitals.

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Patients consented to the use of anonymized clinical data for research purposes using the opt-out method.

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All data generated or analyzed during this study are included in this published article.

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Nakamura, K., Toba, T., Otake, H. et al. Real-world clinical outcomes of percutaneous transluminal septal myocardial ablation for patients with drug-refractory hypertrophic obstructive cardiomyopathy: results from a retrospective multicenter registry of non-high-volume centers. Heart Vessels 37, 1937–1946 (2022). https://doi.org/10.1007/s00380-022-02100-4

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