Concomitant Surgical Atrial Fibrillation Ablation in Double Valve Replacement

Guangzhou General Hospital of Guangzhou Military Command

Status: Unknown

Conditions: Atrial Fibrillation; Valvular Heart Disease

Treatments: Procedure: surgical ablation; Procedure: double valve replacement

Study type: Observational

Funder types: Other

Identifiers

NCT03163836

RS2016003

Details and patient eligibility

About

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 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 2 patient groups

double valve replacement group

Description:

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.

Treatment:

Procedure: double valve replacement

surgical ablation group

Description:

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.

Treatment:

Procedure: double valve replacement

Procedure: surgical ablation