Concomitant Surgical Atrial Fibrillation Ablation in Double Valve Replacement

Overview

Current European Society of Cardiology Guidelines recommend concomitant atrial fibrillation (AF) ablation for all symptomatic patients undergoing other cardiac surgeries, but the safety and potential benefits of concomitant atrial fibrillation (AF) ablation at the time of double valve replacement remains unexamined. A retrospective review of patients with AF who underwent double valve replacement with or without concomitant surgical ablation in our institute starting from April 2006.

Full Title of Study: “Impact of Concomitant Surgical Atrial Fibrillation Ablation in Patients Undergoing Double Valve Replacement”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: March 10, 2023

Detailed Description

Persistent AF was defined as AF lasting more than 7 days and long-standing persistent AF as continuous AF for more than 12 months. Concomitant surgical AF ablation was offered to suitable patients as determined by the surgeon, and patients then decided whether to undergo the additional procedure. The operations were performed through median sternotomy and under cardiopulmonary bypass. The bipolar ablation clamp was positioned precisely around the pulmonary veins (PV) for bilateral circular ablation. After Marsh ligament cutting and cross-clamping the ascending aorta, the left atrial appendage was resected and left atrial cavity exposed through an incision behind the interatrial groove. Then, linear ablations were performed between the left and right inferior PVs, between the left and right superior PVs, between the left superior PV and the opening of the left atrial appendage, and between the line connecting bilateral inferior PVs and the mitral valve isthmus. Ablation at the right atrium was then performed. Briefly, the bipolar ablation clamp was positioned around the inferior vena cava (IVC) and right atrial appendage for circular ablation. An L-shaped incision was then made on the anterior wall of the right atrium and linear ablations were performed vertically from the incision to the interatrial groove and tricuspid annulus, to the ablation ring around the right atrial appendage, and from the superior vena cava to the ablation ring around the inferior vena cava. The left atrial appendage was always excluded by resection and the incision was closed with continuous running stitches. Temporary pacemakers were placed in all patients and activated when heart rate was less than 70 beats per minute.

Interventions

  • Procedure: double valve replacement
    • After median sternotomy, cardiopulmonary bypass was established via bicaval and aortic cannulation. After cross-clamping of the aorta and cardioplegia, mitral and aortic replacement were performed. Supplementary procedures such tricuspid annuloplasty, ascending aorta replacement and coronary artery bypass grafting were performed as required. The left atrial appendage was excised to avoid thrombus formation.
  • Procedure: surgical ablation
    • Both left and right atrial ablation were performed using a bi-polar radiofrequency ablation clamp.

Arms, Groups and Cohorts

  • double valve replacement group
    • Patients received aortic+mitral valve replacement at Guangzhou General Hospital of Guangzhou Military Command with persistent or long-standing atrial fibrillation(AF) but did not received concomitant AF ablation. Persistent AF was defined as AF lasting more than 7 days and long-standing persistent AF as continuous AF for more than 12 months. Exclusion criteria for consideration for concomitant AF ablation includes >70 years old, left atrium (LA) diameter >7 cm, or preoperative left ventricle (LV) ejection fraction < 40% and patients falls in these criteria were excluded from this group.
  • surgical ablation group
    • Patients received aortic+mitral valve replacement at Guangzhou General Hospital of Guangzhou Military Command with persistent or long-standing atrial fibrillation(AF) and received concomitant surgical ablation. Persistent AF was defined as AF lasting more than 7 days and long-standing persistent AF as continuous AF for more than 12 months.

Clinical Trial Outcome Measures

Primary Measures

  • mortality
    • Time Frame: from the date of the surgery until the date of death, assess up to 120 months
    • mortality from any cause
  • sinus rhythm rate
    • Time Frame: from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months
    • sinus rhythm rate examined by 24h holter monitoring
  • stroke
    • Time Frame: from the date of surgery until the date of first documented progression or date of death from any cause, assess up to 120 months
    • perioperative stroke
  • third degree heart block requiring permanent pacemaker implantation
    • Time Frame: from the date of surgery until the date of first documented progression or date of death from any cause, assess up to 120 months
    • third degree heart block diagnosed via ECG

Secondary Measures

  • perioperative morbidities
    • Time Frame: from the date of surgery until the date of first documented progression or date of death from any cause, assess up to 30 days
    • Redo for bleeding; Low cardiac output syndrome; Renal failure requiring dialysis; Pneumonia;
  • Warfarin-related bleeding
    • Time Frame: from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months
    • bleeding events occurred during the period when warfarin was used
  • Thromboembolic events
    • Time Frame: from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months
    • thromboembolic events
  • New York Heart Function classification
    • Time Frame: from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months
    • New York Heart Function classification
  • warfarin requirement
    • Time Frame: from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months
    • oral warfarin requirement over 6 moths after the surgery
  • left ventricular ejection fraction
    • Time Frame: from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months
    • left ventricular ejection fraction measured by transthoracic echocardiography
  • left atrium diameter
    • Time Frame: from 6 months after surgery until the date of first documented progression or date of death from any cause, assess up to 120 months
    • left atrium diameter measured by transthoracic echocardiography

Participating in This Clinical Trial

Inclusion Criteria

  • Patients presented to our institute with valvular heart disease requiring double valve replacement and also present with persistent or long-standing persistent atrial fibrillation. – Persistent AF was defined as AF lasting more than 7 days and long-standing persistent AF as continuous AF for more than 12 months. First cardiac surgery, age<70 years. left atrium diameter measured by transthoracic echocardiography<7cm. Left ventricular ejection fraction > 40% Exclusion Criteria:

  • >70 years old, with LA diameter >7 cm, or with LV ejection fraction < 40% , repeated cardiac surgery, concomitant tricuspid valve replacement

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Guangzhou General Hospital of Guangzhou Military Command
  • Provider of Information About this Clinical Study
    • Principal Investigator: Weida Zhang, Director of Cardiovascular Surgery – Guangzhou General Hospital of Guangzhou Military Command
  • Overall Official(s)
    • Weida Zhang, MD, Principal Investigator, Guangzhou General Hospital of Guangzhou Military Command
  • Overall Contact(s)
    • Weida Zhang, MD, 86-020-88654578, weidazhang1958@gmail.com

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