Dataset Information

Septal radioablation therapy for patients with hypertrophic obstructive cardiomyopathy: first-in-human study.

ABSTRACT:

Aims

There is still no non-invasive septal reduction therapy for patients with hypertrophic obstructive cardiomyopathy (HOCM). This study aimed to investigate the feasibility, safety, and efficacy of stereotactic body radiotherapy (SBRT) in patients with drug-refractory symptomatic HOCM.

Methods and results

The radiation target of ventricular septum was determined by multiple anatomical imaging. Stereotactic body radiotherapy was performed with standard techniques. Patients were treated with a single fraction of 25 Gy, followed up at 1, 3, 6, and 12 months by clinical visit. Five patients were enrolled and completed the 12 months follow-up. The mean radioablation time was 21.6 min, and the mean target volume was 10.5 cm³. All five patients survived and showed improvements in symptoms after SBRT. At 12 months post-SBRT, the echocardiography-derived left ventricular outflow tract gradient decreased from 88 mmHg (range, 63-105) to 52 mmHg (range, 36-66) at rest and from 101 mmHg (range, 72-121) to 74 mmHg (range, 65-100) after Valsalva. The end-diastolic thickness of the targeted septum reduced from 23.7 mm (range, 20.3-29) to 22.4 mm (range, 19.7-26.5); 6 min walking distance increased from 190.4 m (range, 50-370) to 412.0 m (range, 320-480). All patients presented with new fibrosis in the irradiated septum area. No radiation-related complications were observed during SBRT and up to 12 months post procedure.

Conclusion

The current study suggests that SBRT might be a feasible radioablation therapeutic option for patients with drug-refractory symptomatic HOCM.

Trial registration

ClinicalTrials.gov Identifier: NCT04686487.

SUBMITTER: Li X

PROVIDER: S-EPMC10371052 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature

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Publications

Septal radioablation therapy for patients with hypertrophic obstructive cardiomyopathy: first-in-human study.

Li Xuping X Zhu Zhaowei Z Liu Jun J Gao Yawen Y Xiao Yichao Y Fang Zhenfei Z Liu Qiming Q Liu Xianling X Hu Chunhong C Ma Fang F Zeng Mu M Liu Zhi Z Hu Lin L Liu Na N Xiang Fan F Hu Xinqun X Huang Lihong L Zhou Shenghua S

European heart journal open 20230523 3

<h4>Aims</h4>There is still no non-invasive septal reduction therapy for patients with hypertrophic obstructive cardiomyopathy (HOCM). This study aimed to investigate the feasibility, safety, and efficacy of stereotactic body radiotherapy (SBRT) in patients with drug-refractory symptomatic HOCM.<h4>Methods and results</h4>The radiation target of ventricular septum was determined by multiple anatomical imaging. Stereotactic body radiotherapy was performed with standard techniques. Patients were t ...[more]

PMID: 37503357

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Project description:BackgroundAlthough surgical treatment of residual obstruction after alcohol septal ablation (ASA) is often challenging in patients with obstructive hypertrophic cardiomyopathy (OHCM) there are very few relevant clinical reports. Thus, outcomes of surgical septal myectomy (SSM) in this subgroup of patients remain to be determined. Therefore, this study aimed to determine the surgical and follow-up outcomes in patients with OHCM exhibiting residual obstruction after ASA.MethodsWe collected case data for 62 patients with OHCM and residual obstruction after ASA who underwent SSM at Fuwai Hospital between January 2002 and June 2019. Propensity score matching with patients having had a myectomy as the only invasive procedure-was conducted in a 1:2 ratio. Echocardiography parameters, surgery results, and follow-up outcomes were compared between the groups.ResultsThe prior ASA group had a higher incidence of complete atrioventricular block (AVB) and subsequently postoperative permanent pacemaker (PPM) implantation than the primary myectomy group (9.7% vs. 1.6%, P=0.01). Two patients died within 30 days after surgery in the prior ASA group, and one patient died in the primary myectomy group, with an operative mortality rate of 3.2% and 0.8%, respectively (P=0.2). The 5-year event-free survival rate was 86.0% in the prior ASA group (median follow-up period: 3.2 years; mean: 3.9±2.6 years; maximum, 10.6 years) and 88.5% in the primary myectomy group (median follow-up period: 2.4 years; mean 2.8±1.7 years; maximum, 9.1 years) (P=0.2). During follow-up, four of 62 (6.5%) patients in the prior ASA group and one of 124 (0.8%) patients in the primary myectomy group progressed to advanced heart failure (P=0.025).ConclusionsPatients with OHCM following ASA are at an increased risk of developing AVB after SSM. Their surgical outcomes, and long-term survival rate were satisfactory and, osimilar to those for patients having had a myectomy as the only invasive procedure. In addition, they had an increased risk of advanced heart failure after SSM in the present study.

Project description:BackgroundIn patients with hypertrophic obstructive cardiomyopathy, atrial fibrillation is associated with heart failure and increased late mortality. However, the role of surgical ablation in these patients is not well defined. The aim of this study was to evaluate the efficacy of the concomitant Cox-Maze IV procedure in patients undergoing septal myectomy for hypertrophic obstructive cardiomyopathy.MethodsBetween 2005 and 2019, 347 patients who underwent septal myectomy at a single institution (Washington University School of Medicine, Barnes-Jewish Hospital, St Louis, MO) were retrospectively reviewed. For patients with hypertrophic obstructive cardiomyopathy and atrial fibrillation who underwent a concomitant Cox-Maze IV procedure, freedom from atrial tachyarrhythmias (ATAs) on or off antiarrhythmic drugs (AADs) was evaluated annually. Predictors of ATA recurrence were identified using Fine-Gray regression, with death as a competing risk.ResultsA total of 42 patients underwent concomitant septal myectomy and Cox-Maze IV procedures. The majority of patients, 69% (29 of 42), had paroxysmal atrial fibrillation with a 2.5-year median duration. Operative mortality was 7% (3 of 42). New York Heart Association functional class was reduced after surgery (P < .01). Rates of freedom from recurrent ATAs at 1- and 5-year intervals were 93% (27 of 29) and 100% (14 of 14), respectively. Rates of freedom from ATAs and AADs were 83% (24 of 29) and 100% (14 of 14) at the same time points, respectively. Increased left atrial diameter predicted first ATA recurrence (P < .01). Cerebrovascular accident risk was lower in patients with atrial fibrillation who underwent concomitant Cox-Maze IV and septal myectomy relative to myectomy only (P = .02).ConclusionsLate freedom from ATAs on or off AADs was excellent after Cox-Maze IV and septal myectomy. Although there was a higher than expected rate of perioperative complications, the study results suggest that concomitant surgical ablation should be considered in selected patients with hypertrophic obstructive cardiomyopathy and atrial fibrillation.

Project description:ImportancePatients 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.ObjectiveTo describe the safety and medium-term outcomes of PIMSRA in a large patient cohort with drug-refractory HOCM.Design, setting, and participantsThis 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.InterventionsPIMSRA performed in patients.Main outcomes and measuresThe 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.ResultsThe 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 relevanceThis 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.

Dataset Information

Septal radioablation therapy for patients with hypertrophic obstructive cardiomyopathy: first-in-human study.

Aims

Methods and results

Conclusion

Trial registration

Publications

Septal radioablation therapy for patients with hypertrophic obstructive cardiomyopathy: first-in-human study.

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