Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.
Department of Cardiology, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan.
Heart Vessels. 2022 Nov;37(11):1937-1946. doi: 10.1007/s00380-022-02100-4. Epub 2022 May 31.
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.
经皮腔内间隔心肌消融术（PTSMA）是一种成熟的介入治疗方法，适用于药物难治性肥厚型梗阻性心肌病（HOCM），可作为心肌切除术的替代方法。尽管指南建议 PTSMA 应在经验丰富的机构中进行，但在实际临床实践中，它并未集中在这种高容量中心。因此，本研究旨在评估非高容量中心进行 PTSMA 的可行性。我们回顾性分析了 2012 年 8 月至 2020 年 5 月在四个经历 PTSMA 手术少于 20 例的机构接受 PTSMA 的 HOCM 患者。主要临床终点是安全性（全因死亡、电复律治疗室性心动过速或颤动、心脏压塞、永久性起搏器植入和重复干预）和疗效终点（重复干预[PTSMA 或心肌切除术]）的复合终点。共纳入 58 例连续患者。在 30 天随访期间，除 3 例（5.2%）因完全性房室传导阻滞需要永久性起搏器植入外，无重大临床不良事件发生。纽约心脏协会心功能分级 1 或 2 的患者比例从 8.6%显著增加到 100%（p<0.001）。在 Cox 比例风险模型中，静息时左心室流出道压力梯度≥30mmHg（风险比[HR]6.56；95%置信区间[CI]1.44-29.90；p=0.015）和 30 天随访时二尖瓣反流程度≥3 级（HR 10.75；95%置信区间[CI]1.81-63.79；p=0.009）与主要临床不良事件的复合终点相关。本研究表明，在非高容量中心接受 PTSMA 的 58 例患者 30 天临床结局良好，主要复合终点发生率为 5.2%。需要进行更大样本量和更长随访时间的前瞻性研究，以验证 PTSMA 在非高容量中心的安全性和疗效。
