Mengyao Zhou1, Shengjun Ta1, Rebecca T Hahn2, David H Hsi3,4, Martin B Leon2, Rui Hu1, Jun Zhang1,5, Lei Zuo1, Jing Li1, Jing Wang1, Bo Wang1, Xiaoli Zhu1, Jiani Liu1, Yupeng Han1, Xiaojuan Li1, Bo Xu6, Lei Zhang1,7, Lihong Hou8, Chao Han1, Jincheng Liu6, Liwen Liu1. 1. Xijing Hypertrophic Cardiomyopathy Center, Department of Ultrasound, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi, China. 2. Columbia University Medical Center/New York Presbyterian Hospital, University of Columbia College of Physicians and Surgeons, New York. 3. Heart & Vascular Institute, Stamford Hospital, Stamford, Connecticut. 4. University of Columbia College of Physicians and Surgeons, New York, New York. 5. Department of Ultrasound, Xi'an New Changan Maternity Hospital, Xi'an, Shaanxi, China. 6. Xijing Hypertrophic Cardiomyopathy Center, Department of Cardiac Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi, China. 7. Department of Cardiology, Xi'an No. 3 Hospital, Northwest University, Xi'an, Shaanxi, China. 8. Xijing Hypertrophic Cardiomyopathy Center, Department of Anesthesiology, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi, China.
Abstract
Importance: Patients with hypertrophic obstructive cardiomyopathy (HOCM) and drug-refractory symptoms and outflow gradients have limited nonsurgical treatment options. The feasibility of percutaneous intramyocardial septal radiofrequency ablation (PIMSRA) has been reported previously; however, procedural and medium-term outcomes are unknown. Objective: To describe the safety and medium-term outcomes of PIMSRA in a large patient cohort with drug-refractory HOCM. Design, Setting, and Participants: This was a single-arm, open-label study of PIMSRA in patients with drug-refractory HOCM. Patients presenting to the Xijing Hospital in Xi'an, China, between October 2016 to June 2020 with hypertrophic cardiomyopathy. Of 1314 patients presenting with HOCM, 244 fulfilled inclusion criteria of severe resting/provoked outflow gradients of 50 mm Hg or higher, and symptoms of New York Heart Association functional class of II or higher refractory to maximum tolerated medications. After discussion among the heart team, 40 patients underwent surgical or alcohol septal reduction therapy and 4 required treatment of significant coronary artery disease. Interventions: PIMSRA performed in patients. Main Outcomes and Measures: The primary outcome was 30-day major adverse clinical events: death, emergency surgery, severe effusion requiring intervention, procedure-related stroke, bleeding, and stroke. Secondary outcomes included 30-day technical success and 90-day improvement in outflow obstruction. Results: The mean (SD) age of 200 patients was 46.9 (14.0) years, and 125 (62.5%) were men. Resting or provoked left ventricular outflow tract gradients were 50 mm Hg or higher. The median (IQR) follow-up for all patients was 19 (6-50) months. Thirty-day major adverse clinical events rate was 10.5% (n = 21): there were 2 in-hospital/30-day deaths (1.0%), 7 patients (3.5%) with pericardial effusion requiring mini-thoracotomy, 12 patients (6%) with pericardial effusion requiring pericardiocentesis, and no bleeding or strokes. Other periprocedural complications included permanent right bundle branch block in 5 patients (2.5%), resuscitated ventricular fibrillation in 2 (1.0%), and septal branch aneurysm in 2 (1.0%). There were no permanent pacemaker implantations. At follow-up, maximum septal thickness was reduced from a mean (SD) of 24.0 (5.1) mm to 17.3 (4.4) mm (P < .001), and left ventricular outflow tract gradient was decreased from a mean (SD) of 79.0 (53.0) mm Hg to 14.0 (24.0) mm Hg (P < .001). Overall, 190 patients (96%) with HOCM were in New York Heart Association functional class I or II at last follow-up. Conclusions and Relevance: This study found that PIMSRA in patients with drug-refractory HOCM may be an effective procedure for relief of left ventricular outflow tract obstruction and symptoms with acceptable complication rates. These results are encouraging and support the design of a randomized clinical trial against well-established septal reduction therapies.
Importance: Patients with hypertrophic obstructive cardiomyopathy (HOCM) and drug-refractory symptoms and outflow gradients have limited nonsurgical treatment options. The feasibility of percutaneous intramyocardial septal radiofrequency ablation (PIMSRA) has been reported previously; however, procedural and medium-term outcomes are unknown. Objective: To describe the safety and medium-term outcomes of PIMSRA in a large patient cohort with drug-refractory HOCM. Design, Setting, and Participants: This was a single-arm, open-label study of PIMSRA in patients with drug-refractory HOCM. Patients presenting to the Xijing Hospital in Xi'an, China, between October 2016 to June 2020 with hypertrophic cardiomyopathy. Of 1314 patients presenting with HOCM, 244 fulfilled inclusion criteria of severe resting/provoked outflow gradients of 50 mm Hg or higher, and symptoms of New York Heart Association functional class of II or higher refractory to maximum tolerated medications. After discussion among the heart team, 40 patients underwent surgical or alcohol septal reduction therapy and 4 required treatment of significant coronary artery disease. Interventions: PIMSRA performed in patients. Main Outcomes and Measures: The primary outcome was 30-day major adverse clinical events: death, emergency surgery, severe effusion requiring intervention, procedure-related stroke, bleeding, and stroke. Secondary outcomes included 30-day technical success and 90-day improvement in outflow obstruction. Results: The mean (SD) age of 200 patients was 46.9 (14.0) years, and 125 (62.5%) were men. Resting or provoked left ventricular outflow tract gradients were 50 mm Hg or higher. The median (IQR) follow-up for all patients was 19 (6-50) months. Thirty-day major adverse clinical events rate was 10.5% (n = 21): there were 2 in-hospital/30-day deaths (1.0%), 7 patients (3.5%) with pericardial effusion requiring mini-thoracotomy, 12 patients (6%) with pericardial effusion requiring pericardiocentesis, and no bleeding or strokes. Other periprocedural complications included permanent right bundle branch block in 5 patients (2.5%), resuscitated ventricular fibrillation in 2 (1.0%), and septal branch aneurysm in 2 (1.0%). There were no permanent pacemaker implantations. At follow-up, maximum septal thickness was reduced from a mean (SD) of 24.0 (5.1) mm to 17.3 (4.4) mm (P < .001), and left ventricular outflow tract gradient was decreased from a mean (SD) of 79.0 (53.0) mm Hg to 14.0 (24.0) mm Hg (P < .001). Overall, 190 patients (96%) with HOCM were in New York Heart Association functional class I or II at last follow-up. Conclusions and Relevance: This study found that PIMSRA in patients with drug-refractory HOCM may be an effective procedure for relief of left ventricular outflow tract obstruction and symptoms with acceptable complication rates. These results are encouraging and support the design of a randomized clinical trial against well-established septal reduction therapies.
Authors: Carey Kimmelstiel; David C Zisa; Johny S Kuttab; Sophie Wells; James E Udelson; Benjamin S Wessler; Hassan Rastegar; Navin K Kapur; Andrew R Weintraub; Barry J Maron; Martin S Maron; Ethan J Rowin Journal: Circ Cardiovasc Interv Date: 2019-07-12 Impact factor: 6.546
Authors: Jippe C Balt; Maurits C E F Wijffels; Lucas V A Boersma; Eric F D Wever; Jurriën M ten Berg Journal: Heart Date: 2014-07-29 Impact factor: 5.994
Authors: Liwen Liu; Jing Li; Lei Zuo; Jinzhou Zhang; Mengyao Zhou; Bo Xu; Rebeccca T Hahn; Martin B Leon; David H Hsi; Junbo Ge; Xiaodong Zhou; Jun Zhang; Shuping Ge; Lize Xiong Journal: J Am Coll Cardiol Date: 2018-10-16 Impact factor: 24.094
Authors: Chihyuan Chuang; Scott Collibee; Luke Ashcraft; Wenyue Wang; Mark Vander Wal; Xiaolin Wang; Darren T Hwee; Yangsong Wu; Jingying Wang; Eva R Chin; Peadar Cremin; Jeanelle Zamora; James Hartman; Julia Schaletzky; Eddie Wehri; Laura A Robertson; Fady I Malik; Bradley P Morgan Journal: J Med Chem Date: 2021-10-04 Impact factor: 7.446
Authors: Josef Veselka; Lothar Faber; Max Liebregts; Robert Cooper; Jaroslav Januska; Jan Krejci; Thomas Bartel; Maciej Dabrowski; Peter Riis Hansen; Vibeke Marie Almaas; Hubert Seggewiss; Dieter Horstkotte; Radka Adlova; Henning Bundgaard; Jurriën Ten Berg; Rodney Hilton Stables; Morten Kvistholm Jensen Journal: J Am Heart Assoc Date: 2017-05-16 Impact factor: 5.501