Use of Cryoenergy to Faciltate Myectomy in Hypertrophic Obstructive Cardiomyopathy: Comparison With the Classical Approach

Completed

• Conditions: Septal Hypertrophy; Obstructive Hypertrophic Cardiomyopathy
• Interventions: Procedure: Cryo myectomy; Procedure: Myectomy

• Registration Number: NCT05726799
• Lead Sponsor: Michele De Bonis

Brief Summary

In some patients, septal hypertrophy extends more distally, from the subaortic portion of the septum to the midventricular portion. In these patients, classic transaortic surgical myectomy may not be effective in removing the midventricular obstruction, resulting in a suboptimal surgical outcome. These patients may present recurrence of symptoms and not have an improvement in the prognosis related to the treatment of hypertrophic cardiomyopathy, in some cases determining the need for reoperation. Since 2015, our Institute has used a surgical technique that allows us to improve transaortic exposure of the interventricular septum, using a probe with application of cryoenergy the hypertrophic portion of the septum is hooked and in this way the myectomy can be extended more distally, performing a more complete removal of the myocardium.

The aim of this study is to compare the results obtained with classical myectomy compared to myectomy performed with the aid of cryoenergy.

The primary endpoint is the comparison in terms of mortality between patients undergoing classical myectomy versus those undergoing cryoenergy-assisted myectomy.

Secondary endpoints are: extent of myectomy, persistence of residual left ventricular outflow tract obstruction, persistence of mitral regurgitation related to systolic anterior motion of the mitral leaflets, occurrence of ventricular defect, and need for PM implantation.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-05
• Primary Completion: 2019-10-15
• Study Completion: 2019-10-15
• Study First Submitted: 2023-01-26
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-03
• Last Update Submitted: 2023-02-03
• Study First Posted: 2023-02-14
• Last Update Posted: 2023-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• adult patients (≥ 18 years)
• meeting the clinical and echocardiographic criteria that made them candidates for isolated myectomy or in combination with other surgical procedures:
• LV outflow tract instantaneous peak gradient >50mmHg at rest or during stimulation
• interventricular septum >16mm,
• NYHA functional class III-IV, despite maximal medical therapy
• operated in San Raffaele Hospital with classic or cryo myectomy between 2015 and 2018.

Exclusion Criteria

• extent of myectomy not reported in the operative report;
• left ventricular outflow tract gradient not reported in pre- or postoperative echocardiography.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cryoenergy	Cryo myectomy	-
Classic Myectomy	Myectomy	-

Primary Outcome Measures

Name	Time	Method
Mortality	Up to 4 years

Trial Locations

Locations (1)

IRCCS Ospedale San Raffaele; 🇮🇹 Milan, Italy