The Hypertrophic Cardiomyopathy Center of Xijing Hospital pioneered percutaneous intramyocardial septal radiofrequency ablation (PIMSRA) as an innovative treatment for hypertrophic obstructive cardiomyopathy (HOCM) to relieve left ventricular outflow tract obstruction. Clinical studies have confirmed PIMSRA's efficacy, safety and reliability, establishing it as a novel alternative for septal reduction therapy. As a novel interventional approach, comprehensive evaluation of its safety and therapeutic effectiveness is warranted. Therefore, this retrospective study aims to: * Investigate postoperative clinical outcomes and their influencing factors in HOCM patients undergoing PIMSRA; * Analyze morphological and hemodynamic changes including: septal thickness, left ventricular outflow tract gradient, mid-ventricular pressure gradient and left ventricular flow field dynamics; * Examine correlations between clinical/procedural parameters and clinical symptoms, quality of life and cardiac reverse remodeling indicators. This study will provide high-quality evidence to support the clinical application of this novel procedure.
Study Type
OBSERVATIONAL
Enrollment
800
With the real-time guidance of TTE, a radiofrequency electrode needle was percutaneously inserted via the transapical intramyocardial approach into the hypertrophied septum for thermal ablation. Intraoperative TTE and 12-lead electrocardiographic monitoring were employed to assess the ablation extent and prevent vascular and cardiac conduction bundle injury. The success of ablation was confirmed by evaluating contrast medium perfusion defects in the ablated areas and comparing them with the preprocedural hypertrophied septum.
Ultrasound Medicine Department of Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China
Major adverse cardiovascular events
Major adverse cardiovascular events including but not limited to: 1. All-cause death; 2. Arrhythmic events: resuscitated cardiac arrest or ventricular tachycardia/fibrillation, appropriate implantable cardioverter-defibrillator discharge, atrioventricular block, pacemaker implantation and atrial fibrillation; 3. Acute heart failure: acute pulmonary edema, new-onset NYHA class Ⅲ-IV symptoms, and heart failure-related hospitalization; 4. Cardiogenic shock: cardiac disorder that results in a systolic blood pressure \<90 mmHg for ≥30 min (or the need for vasopressors, inotropes or mechanical circulatory support to maintain systolic blood pressure ≥90 mmHg) with evidence of hypoperfusion; 5. Severe systolic anterior motion: the proximal portion of the anterior mitral leaflet moved excessively close to the septum, resulting in extreme LVOT obstruction and acute haemodynamic collapse; 6. Cerebrovascular events: all stroke (ischemic or hemorrhagic) and transient ischemic attacks.
Time frame: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.
Procedure-related adverse events
Any instrument or procedure-related complications, including but not limited to death, emergency surgery, pericardial tamponade requiring pericardiocentesis or surgery, bleeding, procedure-related stroke.
Time frame: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.
Interventricular septal thickness
Maximum septal thickness as measured by echocardiography.
Time frame: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.
Left ventricular outflow tract gradient
Left ventricular outflow tract gradient as measured by echocardiography.
Time frame: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.
New York Heart Association Classification
The New York Heart Association Classification involved 4 classes. I-No limitation of physical activity, II-Slight limitation of physical activity, III-Marked limitation of physical activity, IV-Unable to carry on any physical activity without discomfort. A higher grade means worse heart function.
Time frame: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.
Kansas City Cardiomyopathy Questionnaire score
The Kansas City Cardiomyopathy Questionnaire was a 23-item, self-administered questionnaire that measure the participant's perception of their health status. It quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated from each domain and scaled from 0 to 100, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.
Time frame: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.
Late gadolinium enhancement
Late gadolinium enhancement measured by cardiac magnetic resonance.
Time frame: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.
Mean blood pressure
Mean systolic/diastolic blood pressure measured by ambulatory blood pressure monitoring.
Time frame: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.
Energy loss
Energy loss measured by vector flow mapping.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.