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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:
This study will provide high-quality evidence to support the clinical application of this novel procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypertrophic Obstructive Cardiomyopathy Patients Underwent PIMSRA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Intramyocardial Septal Radiofrequency Ablation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiovascular events | Major adverse cardiovascular events including but not limited to:
| 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are diagnosed with HOCM and with drug-refractory symptoms underwent PIMSRA in Xijing Hospital from 2016 to 2025.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ultrasound Medicine Department of Xijing Hospital, Fourth Military Medical University | Xi'an | Shaanxi | 710032 | China |
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| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
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| 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. | 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. | 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. | 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. | 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. |
| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |