Trial Outcomes & Findings for A New Operation for the Treatment for Long-standing Atrial Fibrillation (NCT NCT03347695)
NCT ID: NCT03347695
Last Updated: 2021-10-29
Results Overview
Freedom from AF in patients with longstanding persistent AF undergoing MVS at 6 months and 12 months. AF will be measured by 7 days continuous Holter monitoring at 6 months and 12 months post-surgery; and freedom of AF will be defined by absence of AF lasting \> 30 seconds at 12 months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
140 participants
Primary outcome timeframe
3, 6, and 12 months after the operation
Results posted on
2021-10-29
Participant Flow
Participant milestones
| Measure |
A New Operation (Selected Pilot Study)
Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.
Left atrial geometric volume reduction, pulmonary veins island isolation and left appendage ligation (Selected): Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.
|
A New Operation
Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.
Left atrial geometric volume reduction, pulmonary veins island isolation and left appendage ligation: Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
120
|
|
Overall Study
COMPLETED
|
20
|
115
|
|
Overall Study
NOT COMPLETED
|
0
|
5
|
Reasons for withdrawal
| Measure |
A New Operation (Selected Pilot Study)
Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.
Left atrial geometric volume reduction, pulmonary veins island isolation and left appendage ligation (Selected): Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.
|
A New Operation
Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.
Left atrial geometric volume reduction, pulmonary veins island isolation and left appendage ligation: Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.
|
|---|---|---|
|
Overall Study
Death
|
0
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
A New Operation for the Treatment for Long-standing Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
A New Operation (Selected Pilot Study)
n=20 Participants
Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.
Left atrial geometric volume reduction, pulmonary veins island isolation and left appendage ligation (Selected): Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.
|
A New Operation
n=120 Participants
Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.
Left atrial geometric volume reduction, pulmonary veins island isolation and left appendage ligation: Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
49.3 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
52.3 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
51.9 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
20 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
20 participants
n=5 Participants
|
120 participants
n=7 Participants
|
140 participants
n=5 Participants
|
|
Hypertension
|
1 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Prior stroke
|
0 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Diabetes
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Smoking History
|
2 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
NYHA Class III or Class IV
|
20 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Long-standing persistent AF
|
20 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Atrial fibrillation duration
|
19.4 months
STANDARD_DEVIATION 6.5 • n=5 Participants
|
23.6 months
STANDARD_DEVIATION 9.7 • n=7 Participants
|
23.0 months
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
EuroScore
|
1.8 units on a scale
STANDARD_DEVIATION 1.6 • n=5 Participants
|
1.8 units on a scale
STANDARD_DEVIATION 1.4 • n=7 Participants
|
1.8 units on a scale
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Preoperative amiodarone intake
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Preoperative Digoxin intake
|
11 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Preoperative beta-blocker intake
|
5 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Preoperative NT-proBNP level
|
1555.3 pg/ml
STANDARD_DEVIATION 1233.2 • n=5 Participants
|
1482.3 pg/ml
STANDARD_DEVIATION 1321.8 • n=7 Participants
|
1493.0 pg/ml
STANDARD_DEVIATION 1305.0 • n=5 Participants
|
|
Preoperative creatine level
|
77.5 μmol/l
STANDARD_DEVIATION 16.3 • n=5 Participants
|
79.4 μmol/l
STANDARD_DEVIATION 44.9 • n=7 Participants
|
79.1 μmol/l
STANDARD_DEVIATION 42.0 • n=5 Participants
|
|
left ventricular diastolic diameter
|
48.7 milimeters
STANDARD_DEVIATION 7.0 • n=5 Participants
|
49.7 milimeters
STANDARD_DEVIATION 7.5 • n=7 Participants
|
49.6 milimeters
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
left ventricular systolic diameter
|
34.0 milimeters
STANDARD_DEVIATION 5.7 • n=5 Participants
|
33.6 milimeters
STANDARD_DEVIATION 5.7 • n=7 Participants
|
33.7 milimeters
STANDARD_DEVIATION 5.7 • n=5 Participants
|
|
left ventricular ejection fraction
|
57.1 %
STANDARD_DEVIATION 8.1 • n=5 Participants
|
60.5 %
STANDARD_DEVIATION 8.7 • n=7 Participants
|
60.0 %
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
left atrial anteroposterior diameter
|
55.0 milimeters
STANDARD_DEVIATION 3.3 • n=5 Participants
|
54.8 milimeters
STANDARD_DEVIATION 9.3 • n=7 Participants
|
54.9 milimeters
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
left atrial transversal diameter
|
59.4 milimeters
STANDARD_DEVIATION 6.3 • n=5 Participants
|
59.6 milimeters
STANDARD_DEVIATION 13.1 • n=7 Participants
|
59.6 milimeters
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
left atrial superoinferior diameter
|
68.9 milimeters
STANDARD_DEVIATION 6.3 • n=5 Participants
|
72.0 milimeters
STANDARD_DEVIATION 15.4 • n=7 Participants
|
71.5 milimeters
STANDARD_DEVIATION 14.5 • n=5 Participants
|
|
Mitral Lesion
|
20 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Aortic Lesion
|
0 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Tricuspid Lesion
|
0 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Coronary Heart Disease
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
mitral valve procedure
mitral valve replacement
|
20 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
mitral valve procedure
mitral valve repair
|
0 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
aortic valve replacement
|
0 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Tricuspid valve repair
|
0 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Concomitant CABG
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Total surgery time
|
221.6 minutes
STANDARD_DEVIATION 33.9 • n=5 Participants
|
230.7 minutes
STANDARD_DEVIATION 48.4 • n=7 Participants
|
229.4 minutes
STANDARD_DEVIATION 46.6 • n=5 Participants
|
|
aortic cross-clamp duration
|
44.4 minutes
STANDARD_DEVIATION 17.8 • n=5 Participants
|
52.5 minutes
STANDARD_DEVIATION 23.5 • n=7 Participants
|
51.4 minutes
STANDARD_DEVIATION 22.9 • n=5 Participants
|
|
Total cardiopulmonary bypass time
|
95.5 minutes
STANDARD_DEVIATION 19.0 • n=5 Participants
|
106.8 minutes
STANDARD_DEVIATION 33.4 • n=7 Participants
|
105.2 minutes
STANDARD_DEVIATION 31.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3, 6, and 12 months after the operationPopulation: Twenty patients were enrolled in pilot study and 120 patients were enrolled in latter prospective study.
Freedom from AF in patients with longstanding persistent AF undergoing MVS at 6 months and 12 months. AF will be measured by 7 days continuous Holter monitoring at 6 months and 12 months post-surgery; and freedom of AF will be defined by absence of AF lasting \> 30 seconds at 12 months
Outcome measures
| Measure |
A New Operation (Selected Pilot Study)
n=20 Participants
Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure(selected patients)
|
A New Operation
n=120 Participants
Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure
|
|---|---|---|
|
Numbers of Participants Free From AF
at discharge
|
20 Participants
|
96 Participants
|
|
Numbers of Participants Free From AF
3 months after the operation
|
20 Participants
|
97 Participants
|
|
Numbers of Participants Free From AF
6 months after the operation
|
20 Participants
|
97 Participants
|
|
Numbers of Participants Free From AF
12 months after the operation
|
20 Participants
|
98 Participants
|
PRIMARY outcome
Timeframe: 1 hour after operationCardiopulmonary bypass (CPB) technology is used in most cardiovascular surgeries. These surgeries utilize CPB, which has been associated with some adverse effects. This is most likely due to exposure of blood to abnormal surfaces and conditions leading to systemic inflammatory responses. Prolonged CPB duration is associated with worse clinical outcomes.
Outcome measures
| Measure |
A New Operation (Selected Pilot Study)
n=20 Participants
Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure(selected patients)
|
A New Operation
n=120 Participants
Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure
|
|---|---|---|
|
Intraoperative Cardiopulmonary Bypass Duration
|
44.4 minutes
Standard Deviation 17.8
|
52.5 minutes
Standard Deviation 23.5
|
PRIMARY outcome
Timeframe: Within 30 days after surgeryThe adverse events within 30 days after surgery, including: death, stroke, serious cardiac events (heart failure, myocardial infarction), cardiac re-hospitalizations, transient ischemic attack, pulmonary embolism, peripheral embolism, coronary artery injury, anatomical excessive bleeding, deep sternal wound infection/mediastinitis, damage to specialized conduction system requiring permanent pacemaker, and superior vena cava stenosis.
Outcome measures
| Measure |
A New Operation (Selected Pilot Study)
n=20 Participants
Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure(selected patients)
|
A New Operation
n=120 Participants
Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure
|
|---|---|---|
|
The Adverse Events Within 30 Days After Surgery
death
|
0 Participants
|
2 Participants
|
|
The Adverse Events Within 30 Days After Surgery
stroke
|
0 Participants
|
1 Participants
|
|
The Adverse Events Within 30 Days After Surgery
serious cardiac events (heart failure, myocardial infarction)
|
0 Participants
|
1 Participants
|
|
The Adverse Events Within 30 Days After Surgery
deep sternal wound infection/mediastinitis
|
0 Participants
|
1 Participants
|
|
The Adverse Events Within 30 Days After Surgery
transient ischemic attack, pulmonary embolism, peripheral embolism
|
0 Participants
|
0 Participants
|
|
The Adverse Events Within 30 Days After Surgery
coronary artery injury
|
0 Participants
|
0 Participants
|
|
The Adverse Events Within 30 Days After Surgery
anatomical excessive bleeding
|
0 Participants
|
0 Participants
|
|
The Adverse Events Within 30 Days After Surgery
damage to specialized conduction system requiring permanent pacemaker
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 months and 12 months post-surgeryPopulation: Twenty patients were enrolled in pilot study and 120 patients were enrolled in latter prospective study. Two of 120 patients died in 30d after surgery，leaving 118 patients to be included in this cohort.
echocardiographic change in left atrial anteroposterior diameter
Outcome measures
| Measure |
A New Operation (Selected Pilot Study)
n=20 Participants
Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure(selected patients)
|
A New Operation
n=118 Participants
Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure
|
|---|---|---|
|
Change in Left Atrial Anteroposterior Diameter
6 months post-surgery
|
37.0 milimeters
Standard Deviation 3.0
|
39.6 milimeters
Standard Deviation 6.7
|
|
Change in Left Atrial Anteroposterior Diameter
12 months post-surgery
|
36.8 milimeters
Standard Deviation 3.1
|
39.2 milimeters
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: 6 months and 12 months post-surgeryPopulation: Twenty patients were enrolled in pilot study and 120 patients were enrolled in latter prospective study. Two of 120 patients died in 30d after surgery，leaving 118 patients to be included in this cohort.
echocardiographic change in left atrial transversal diameter
Outcome measures
| Measure |
A New Operation (Selected Pilot Study)
n=20 Participants
Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure(selected patients)
|
A New Operation
n=118 Participants
Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure
|
|---|---|---|
|
Change in Left Atrial Transversal Diameter
12 months post-surgery
|
40.3 milimeters
Standard Deviation 4.7
|
42.5 milimeters
Standard Deviation 7.7
|
|
Change in Left Atrial Transversal Diameter
6 months post-surgery
|
40.5 milimeters
Standard Deviation 4.6
|
42.1 milimeters
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: 6 months and 12 months post-surgeryPopulation: Twenty patients were enrolled in pilot study and 120 patients were enrolled in latter prospective study. Two of 120 patients died in 30d after surgery，leaving 118 patients to be included in this cohort.
echocardiographic change in left atrial superoinferior diameter
Outcome measures
| Measure |
A New Operation (Selected Pilot Study)
n=20 Participants
Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure(selected patients)
|
A New Operation
n=118 Participants
Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure
|
|---|---|---|
|
Change in Left Atrial Superoinferior Diameter
6 months post-surgery
|
50.3 milimeters
Standard Deviation 3.6
|
54.7 milimeters
Standard Deviation 8.2
|
|
Change in Left Atrial Superoinferior Diameter
12 months post-surgery
|
50.3 milimeters
Standard Deviation 3.8
|
55.7 milimeters
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: 6 months and 12 months post-surgeryPopulation: Twenty patients were enrolled in pilot study and 120 patients were enrolled in latter prospective study. Two of 120 patients died in 30d after surgery，leaving 118 patients to be included in this cohort.
The peak late trans-mitral flow velocity (A wave) reappearance means recover of efficient left atrial contraction which indicates lower rate of thrombosis. Usually these is no A wave for AF patients. The peak late trans-mitral flow velocity 6 months and 12 months post-surgery, which will be measured by transthoracic echocardiography.
Outcome measures
| Measure |
A New Operation (Selected Pilot Study)
n=20 Participants
Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure(selected patients)
|
A New Operation
n=118 Participants
Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure
|
|---|---|---|
|
The Number of Participants Who Will be Detected the Peak Late Trans-mitral Flow Velocity (A Wave) Reappearance
peak late trans-mitral flow velocity (A) reappearance rate 6 months post-surgery
|
18 Participants
|
80 Participants
|
|
The Number of Participants Who Will be Detected the Peak Late Trans-mitral Flow Velocity (A Wave) Reappearance
peak late trans-mitral flow velocity (A) reappearance rate 12 months post-surgery
|
18 Participants
|
84 Participants
|
SECONDARY outcome
Timeframe: Within 12 monthsPopulation: Twenty patients were enrolled in pilot study and 120 patients were enrolled in latter prospective study. Two of 120 patients died in 30d after surgery，leaving 118 patients to be included in this cohort.
MACEs within 12 months after surgery: defined as a non-weighted composite score of: death, stroke, worsening heart failure (+1 NYHA Class), CHF hospitalization, and mitral valve \[MV\] re-intervention.
Outcome measures
| Measure |
A New Operation (Selected Pilot Study)
n=20 Participants
Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure(selected patients)
|
A New Operation
n=118 Participants
Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure
|
|---|---|---|
|
MACEs Within 12 Months After Surgery
death
|
0 Participants
|
2 Participants
|
|
MACEs Within 12 Months After Surgery
stroke
|
0 Participants
|
3 Participants
|
|
MACEs Within 12 Months After Surgery
worsening heart failure (+1 NYHA Class)
|
0 Participants
|
1 Participants
|
|
MACEs Within 12 Months After Surgery
mitral valve [MV] re-intervention
|
0 Participants
|
1 Participants
|
|
MACEs Within 12 Months After Surgery
Pacemaker implantation
|
0 Participants
|
1 Participants
|
Adverse Events
A New Operation (Selected Pilot Study)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
A New Operation
Serious events: 24 serious events
Other events: 2 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
A New Operation (Selected Pilot Study)
n=20 participants at risk
Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.
Left atrial geometric volume reduction, pulmonary veins island isolation and left appendage ligation (Selected): Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.
|
A New Operation
n=120 participants at risk
Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.
Left atrial geometric volume reduction, pulmonary veins island isolation and left appendage ligation: Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.
|
|---|---|---|
|
General disorders
30-day (in-hospital) mortality
|
0.00%
0/20 • Within 12 Months After Surgery
in-hospital mortality rate, stroke or transient ischemic attack(TIA), heart failure, permanent pacemaker implantation, renal failure, pneumonia, sepsis, respiratory failure, and multiple organ dysfunction syndrome, which are defined by protocol within 12 months after surgery.
|
1.7%
2/120 • Number of events 2 • Within 12 Months After Surgery
in-hospital mortality rate, stroke or transient ischemic attack(TIA), heart failure, permanent pacemaker implantation, renal failure, pneumonia, sepsis, respiratory failure, and multiple organ dysfunction syndrome, which are defined by protocol within 12 months after surgery.
|
|
Nervous system disorders
stroke or transient ischemic attack(TIA)
|
0.00%
0/20 • Within 12 Months After Surgery
in-hospital mortality rate, stroke or transient ischemic attack(TIA), heart failure, permanent pacemaker implantation, renal failure, pneumonia, sepsis, respiratory failure, and multiple organ dysfunction syndrome, which are defined by protocol within 12 months after surgery.
|
3.3%
4/120 • Number of events 4 • Within 12 Months After Surgery
in-hospital mortality rate, stroke or transient ischemic attack(TIA), heart failure, permanent pacemaker implantation, renal failure, pneumonia, sepsis, respiratory failure, and multiple organ dysfunction syndrome, which are defined by protocol within 12 months after surgery.
|
|
Cardiac disorders
heart failure
|
0.00%
0/20 • Within 12 Months After Surgery
in-hospital mortality rate, stroke or transient ischemic attack(TIA), heart failure, permanent pacemaker implantation, renal failure, pneumonia, sepsis, respiratory failure, and multiple organ dysfunction syndrome, which are defined by protocol within 12 months after surgery.
|
0.83%
1/120 • Number of events 1 • Within 12 Months After Surgery
in-hospital mortality rate, stroke or transient ischemic attack(TIA), heart failure, permanent pacemaker implantation, renal failure, pneumonia, sepsis, respiratory failure, and multiple organ dysfunction syndrome, which are defined by protocol within 12 months after surgery.
|
|
Cardiac disorders
permanent pacemaker implantation
|
0.00%
0/20 • Within 12 Months After Surgery
in-hospital mortality rate, stroke or transient ischemic attack(TIA), heart failure, permanent pacemaker implantation, renal failure, pneumonia, sepsis, respiratory failure, and multiple organ dysfunction syndrome, which are defined by protocol within 12 months after surgery.
|
0.83%
1/120 • Number of events 1 • Within 12 Months After Surgery
in-hospital mortality rate, stroke or transient ischemic attack(TIA), heart failure, permanent pacemaker implantation, renal failure, pneumonia, sepsis, respiratory failure, and multiple organ dysfunction syndrome, which are defined by protocol within 12 months after surgery.
|
|
Renal and urinary disorders
renal failure
|
0.00%
0/20 • Within 12 Months After Surgery
in-hospital mortality rate, stroke or transient ischemic attack(TIA), heart failure, permanent pacemaker implantation, renal failure, pneumonia, sepsis, respiratory failure, and multiple organ dysfunction syndrome, which are defined by protocol within 12 months after surgery.
|
3.3%
4/120 • Number of events 4 • Within 12 Months After Surgery
in-hospital mortality rate, stroke or transient ischemic attack(TIA), heart failure, permanent pacemaker implantation, renal failure, pneumonia, sepsis, respiratory failure, and multiple organ dysfunction syndrome, which are defined by protocol within 12 months after surgery.
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
5.0%
1/20 • Number of events 1 • Within 12 Months After Surgery
in-hospital mortality rate, stroke or transient ischemic attack(TIA), heart failure, permanent pacemaker implantation, renal failure, pneumonia, sepsis, respiratory failure, and multiple organ dysfunction syndrome, which are defined by protocol within 12 months after surgery.
|
5.0%
6/120 • Number of events 6 • Within 12 Months After Surgery
in-hospital mortality rate, stroke or transient ischemic attack(TIA), heart failure, permanent pacemaker implantation, renal failure, pneumonia, sepsis, respiratory failure, and multiple organ dysfunction syndrome, which are defined by protocol within 12 months after surgery.
|
|
Infections and infestations
sepsis
|
0.00%
0/20 • Within 12 Months After Surgery
in-hospital mortality rate, stroke or transient ischemic attack(TIA), heart failure, permanent pacemaker implantation, renal failure, pneumonia, sepsis, respiratory failure, and multiple organ dysfunction syndrome, which are defined by protocol within 12 months after surgery.
|
0.83%
1/120 • Number of events 1 • Within 12 Months After Surgery
in-hospital mortality rate, stroke or transient ischemic attack(TIA), heart failure, permanent pacemaker implantation, renal failure, pneumonia, sepsis, respiratory failure, and multiple organ dysfunction syndrome, which are defined by protocol within 12 months after surgery.
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
0.00%
0/20 • Within 12 Months After Surgery
in-hospital mortality rate, stroke or transient ischemic attack(TIA), heart failure, permanent pacemaker implantation, renal failure, pneumonia, sepsis, respiratory failure, and multiple organ dysfunction syndrome, which are defined by protocol within 12 months after surgery.
|
1.7%
2/120 • Number of events 2 • Within 12 Months After Surgery
in-hospital mortality rate, stroke or transient ischemic attack(TIA), heart failure, permanent pacemaker implantation, renal failure, pneumonia, sepsis, respiratory failure, and multiple organ dysfunction syndrome, which are defined by protocol within 12 months after surgery.
|
|
General disorders
multiple organ dysfunction syndrome
|
0.00%
0/20 • Within 12 Months After Surgery
in-hospital mortality rate, stroke or transient ischemic attack(TIA), heart failure, permanent pacemaker implantation, renal failure, pneumonia, sepsis, respiratory failure, and multiple organ dysfunction syndrome, which are defined by protocol within 12 months after surgery.
|
1.7%
2/120 • Number of events 2 • Within 12 Months After Surgery
in-hospital mortality rate, stroke or transient ischemic attack(TIA), heart failure, permanent pacemaker implantation, renal failure, pneumonia, sepsis, respiratory failure, and multiple organ dysfunction syndrome, which are defined by protocol within 12 months after surgery.
|
|
Surgical and medical procedures
Reoperation
|
0.00%
0/20 • Within 12 Months After Surgery
in-hospital mortality rate, stroke or transient ischemic attack(TIA), heart failure, permanent pacemaker implantation, renal failure, pneumonia, sepsis, respiratory failure, and multiple organ dysfunction syndrome, which are defined by protocol within 12 months after surgery.
|
0.83%
1/120 • Number of events 1 • Within 12 Months After Surgery
in-hospital mortality rate, stroke or transient ischemic attack(TIA), heart failure, permanent pacemaker implantation, renal failure, pneumonia, sepsis, respiratory failure, and multiple organ dysfunction syndrome, which are defined by protocol within 12 months after surgery.
|
|
Infections and infestations
deep sternal infection
|
0.00%
0/20 • Within 12 Months After Surgery
in-hospital mortality rate, stroke or transient ischemic attack(TIA), heart failure, permanent pacemaker implantation, renal failure, pneumonia, sepsis, respiratory failure, and multiple organ dysfunction syndrome, which are defined by protocol within 12 months after surgery.
|
0.83%
1/120 • Number of events 1 • Within 12 Months After Surgery
in-hospital mortality rate, stroke or transient ischemic attack(TIA), heart failure, permanent pacemaker implantation, renal failure, pneumonia, sepsis, respiratory failure, and multiple organ dysfunction syndrome, which are defined by protocol within 12 months after surgery.
|
|
Cardiac disorders
infective endocarditis
|
0.00%
0/20 • Within 12 Months After Surgery
in-hospital mortality rate, stroke or transient ischemic attack(TIA), heart failure, permanent pacemaker implantation, renal failure, pneumonia, sepsis, respiratory failure, and multiple organ dysfunction syndrome, which are defined by protocol within 12 months after surgery.
|
0.83%
1/120 • Number of events 1 • Within 12 Months After Surgery
in-hospital mortality rate, stroke or transient ischemic attack(TIA), heart failure, permanent pacemaker implantation, renal failure, pneumonia, sepsis, respiratory failure, and multiple organ dysfunction syndrome, which are defined by protocol within 12 months after surgery.
|
Other adverse events
| Measure |
A New Operation (Selected Pilot Study)
n=20 participants at risk
Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.
Left atrial geometric volume reduction, pulmonary veins island isolation and left appendage ligation (Selected): Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.
|
A New Operation
n=120 participants at risk
Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.
Left atrial geometric volume reduction, pulmonary veins island isolation and left appendage ligation: Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum.
|
|---|---|---|
|
Infections and infestations
superficial wound infection
|
0.00%
0/20 • Within 12 Months After Surgery
in-hospital mortality rate, stroke or transient ischemic attack(TIA), heart failure, permanent pacemaker implantation, renal failure, pneumonia, sepsis, respiratory failure, and multiple organ dysfunction syndrome, which are defined by protocol within 12 months after surgery.
|
1.7%
2/120 • Number of events 2 • Within 12 Months After Surgery
in-hospital mortality rate, stroke or transient ischemic attack(TIA), heart failure, permanent pacemaker implantation, renal failure, pneumonia, sepsis, respiratory failure, and multiple organ dysfunction syndrome, which are defined by protocol within 12 months after surgery.
|
Additional Information
Dr. Liangwan Chen
Fujian Medical University Union Hospital
Phone: 861335825333
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place