Pilot interventional randomized clinical trial to study the efficacy of left bundle branch pacing in patients with hypertrophic cardiomyopathy after myectomy for the prevention of progression of heart failure, prevent the occurrence of life-threatening rhythm disturbances and promote reverse remodeling of the LV.
The aim of the study is to evaluate the comparative efficacy and safety of implantation of a cardioverter-defibrillator with left bundle branch block pacing and a dual-chamber cardioverter-defibrillator in patients with HCM and complete left bundle branch block after myectomy at high risk of SCD.
Objectives of the study:
1. To analyze the safety of ICD implantation procedures with LBBB pacing in patients with HCM and LBBB after myectomy at high risk of SCD; 2. To develop a technique for LBBB lead implantation in patients with HCM and LBBB after myectomy; 3. To conduct a comparative analysis of QRS complex duration data based on ECG data before and after surgery, LV activation time, and pacing threshold based on postoperative programming data; 4. To conduct a comparative analysis of the functional class of CHF, NT-proBNP, the presence/absence of interventricular and intraventricular dyssynchrony, the degree of diastolic dysfunction, LVEF, and LV EDV based on echocardiography data before and 12 months after surgery; 5. Conduct a comparative analysis of QRS complex duration data based on ECG data, LV activation time, pacing threshold, the presence of recorded episodes of AF, VT, VF, antitachycardia and shock therapy according to programming data at 3, 6, and 12 months after surgery; 6. Assess quality of life before and 12 months after surgery using the KCCQ-12 questionnaire; 30 patients (15 patients in each group) will be randomly separated into 2 groups. All participants go through ICD programming at 3, 6, and 12 months after myectomy, assessment of left ventricular remodeling based on ECG and echocardiography, NT-proBNP, assessment of quality of life before surgery and 12 months after surgery.
Men and women aged 18 years and older;
Patients with post-myectomy HCM who develop LBBB with a QRS complex greater than 130 ms and a high risk of SCD (HCM Risk-SCD ≥ 6%);
Signed informed consent to participate in the study;
Absence of QRS complex morphology consistent with LBBB in LBBB with a positive QRS complex less than 130 ms;
Presence of baseline complete RBBB;
Heart transplantation or implantation of an LVAD is planned within the next 6 months;
Patients with intermediate or low risk of SCD;
Parallel
ICD with left bundle branch area pacing (LBBAP)
DeviceIncision in the left or right connector area parallel to the key. Vein puncture. Electrodes are passed through the introducer system. Before implantation, a safety electrode is implanted in the LBBB at the apex of the right ventricle. The His bundle is recorded 1-1.5 cm apically (toward the apex of the right ventricle) in the area of the interventricular septum. Pacing from this area of the QRS complex in lead V1 has a "W" morphology. Insert the electrode into the thick interventricular septum. After each ventricular extrasystole, stop inserting and measure the following parameters: 1. Unipolar impedance. The deeper into the septum, the lower the impedance. The target impedance is at least 500 ohms. 2. Change the activation pattern from LBBB to RBBB. 3. Initially, an increase, then a decrease in the unipolar signal. Fix the electrode with invisible U-shaped sutures. Control programming. Layered wound closure.
dual-chamber ICD
DeviceUnder local anesthesia, an incision was made parallel to the clavicle in the left junctional area. A subcutaneous bed for the pacemaker was created. Hemostasis was maintained. The communicating vein was punctured from the wound, and through a system of introducers, it was continuously fixed in the right ventricular septum under fluoroscopic control. The electrode was fixed with a U-shaped suture. The communicating vein was again punctured, and through the system of introducers, an electrode was inserted, which was firmly fixed in the right atrial appendage under fluoroscopic control. The electrode was fixed with a U-shaped suture. The electrodes are connected to the pacemaker. Layered wound suturing is performed. An aseptic dressing is applied.
Serious Adverse Events
Absence of procedural complications requiring emergency surgical intervention (major bleeding, pneumothorax, tamponade, etc.)
Efficiency
Technical Success of the Procedure 1. Reduction in QRS Duration Decrease in paced QRS duration by ≥ 20 ms compared with the baseline intrinsic QRS duration during complete left bundle branch block. Time Frame: At the time of implantation. 2. QRS morphology consistent with conduction system pacing: rSR', rSr', or qR pattern in lead V1. Time Frame: At the time of implantation.
Hospitalization for heart failure, assessment of the functional class of CH, measurement of NT-proBNP, assessment of LV remodeling, antitachycardia and shock therapy, paroxysms of supraventricular tachycardia, quality of life
* Hospitalization for heart failure within 12 months after ICD implantation; * Assessment of the functional class of CHF according to the NYHA classification at 12 months; * Measurement of NT-proBNP at 12 months after ICD implantation; * Assessment of LV remodeling (presence/absence of interventricular and intraventricular dyssynchrony) at 12 months; * Assessment of left ventricular end-diastolic volume at 12 months; * Assessment of left ventricular ejection fraction at 12 months; * Antitachycardia and shock therapy according to ICD programming data at 12 months; * Registered paroxysms of supraventricular tachycardia according to ICD programming data at 12 months; * Assessment of quality of life using the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) at 12 months (0 to 24 = very poor to poor; 25 to 49 = poor to fair; 50 to 74 = fair to good; and 75 to 100 = good to excellent);
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