Concomitant Surgical Atrial Fibrillation Ablation in Double Valve Replacement

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of Concomitant Surgical Atrial Fibrillation Ablation in Patients Undergoing Double Valve Replacement

Conditions
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Atrial Fibrillation, Valvular Heart Disease

Intervention / Treatment
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* Procedure: double valve replacement
* Procedure: surgical ablation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| double valve replacement group<br>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. | Procedure: double valve replacement<br>* 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.<br>* Other names: coronary artery bypass grafting;|
| surgical ablation group<br>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. | Procedure: double valve replacement<br>* 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.<br>* Other names: coronary artery bypass grafting;Procedure: surgical ablation<br>* Both left and right atrial ablation were performed using a bi-polar radiofrequency ablation clamp.<br>* Other names: coronary artery bypass grafting;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Double Valve Replacement, Atrial Fibrillation Ablation