Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Federal State Budget Institution Clinical Hospital, Moscow, Russia | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Background: Thoracoscopic ablation is an effective treatment of patients with atrial fibrillation. Nowadays, 2 types of ablative devices are available in clinical practice allowing one to perform the thoracoscopic procedure - Medtronic and AtriCure. However, the contemporary clinical literature does not have enough data that would compare these two approaches.
Aims: to perform a comparative analysis of the short-term results of two minimally invasive strategies in thoracoscopic ablation for atrial fibrillation.
Methods:
The retrospective study was performed in which included 232 patients underwent thoracoscopic ablation for atrial fibrillation in two clinical centers for the period from 2016 to August 2021. The patients were divided into 2 groups. The first group was represented by those patients to whom a Medtronic device was applied (n=140), the second group was treated with an AtriCure device (n=92). The patients were comparable in their age, gender, initial severity of the condition. The follow-up consisted of laboratory tests, chest Х-ray, electrocardiography, 24-hour Holter monitor, echocardiography. The structure and prevalence of intraoperative and postoperative complications, specifics of the postoperative period were compared between the two groups.
Patients of the thoracoscopic group were divided into 3 subgroups: I - low (no HF), II - medium (possible) and III - high risk of HF (HF confirmed) (Table 1). A statistically significant difference was found for the indicator: age (in the "high probability" group in relation to the "low probability" group by an average of 5.5 years; p=0.002) (Table 1). The clinical characteristics of patients in the studied subgroups are presented in Table 2, no significant difference was found for any of the compared indicators.
The nature of the cardiac arrhythmia and the severity of clinical symptoms are presented in Table 3. Significant differences were obtained for the following indicators: CHADS2VASc (in group III, "high probability" in relation to group I, "low probability" by an average of 1 point; p=0.008); HFA-PEFF (in group III, "high probability" by relative to group I "low probability" by an average of 5 points; p<0.001). Also, significant dynamics was obtained by the frequency of diagnosis of paroxysmal and long-lasting persistent forms of AF (p=0.025). Significant differences were obtained in the number of patients with 3 FC of heart failure (in group III, compared with group I, 5.3% vs 0.0%, respectively)
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AtriCure | Experimental | Group of patients to whom was applied AtriCure device during thoracoscopic ablation. |
|
| Medtronic | Active Comparator | Group of patients to whom was applied Medtronic device during thoracoscopic ablation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thoracoscopic surgical ablation | Procedure | Thoracoscopic surgical ablation is a minimally invasive procedure used to treat atrial fibrillation by creation Box Lesion Set using Radio Frequency Energy. Pulmonary veins isolation was performed using ablation clamps, whereas isolation of the posterior left atrium (box) was performed using a clamping Medtronic or a linear nonclamping AtriCure device. |
| Measure | Description | Time Frame |
|---|---|---|
| The number of intraoperative complications | The number of intraoperative complications (Mortality, Stroke, Transient ischaemic attack, Sternotomy for bleeding, Mini-sternotomy for bleeding, Mini-thoracotomy for bleeding, Bleeding with discontinuation of procedure) | Day 1 |
| Postoperative complications | Postoperative complications: Major complications (Death, Reinterventions, Re-intubation without haemodynamic instability, Re-intubation due to haemodynamic instability, Venous lung infarction, Lung emboli, Permanent phrenic nerve paralysis, Stroke, Transient ischaemic attack, Atrium-oesophagus fistula, Myocardial infarction, Renal failure necessitating dialysis, Sepsis) and Minor complications (Pericardial fluid necessitating pericardiocentesis, Permanent pacemaker implantation, Thoracostomy drain, Infections, Delirium, Gastrointestinal bleeding) | 1 mounth |
| Heart rhythm | Heart rhythm (sinus rhythm, atrial fibrillation, pacemaker rhythm) | at the time of discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of atrial fibrillation | Development of recurrence of atrial fibrillation after thoracoscopic ablation | period after 3 month - 5 year. |
| Cardiac Remodeling | Assessment cardiac remodeling after thoracoscopic ablation (indexed left atrial volume, ejection fraction, systolic pulmonary artery pressure) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alexander V Troitskiy, MD, SD | Federal Research and Clinical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal State Budget Institution Clinical hospital | Moscow | 107143 | Russia | |||
| Federal Research Clinical Center of Federal Medical & Biological Agency |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Zotov AS, Troitsky AV, Silaev AA, Sakharov ER, Sukhotin VN, Shelest OO, Khabazov RI, Timashkov DA. Short-Term Results of Two Strategies in Thoracoscopic Ablation for Lone Atrial Fibrillation. Journal of Clinical Practice. 2022;13(3):5-16.doi: https://doi.org/10.17816/clinpract110719 |
Not provided
Not provided
There is no current plan to share individual participant data (IPD).
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| after discharge - 5 year |
| Functional class of heart failure | Assessment of the functional class of heart failure after thoracoscopic ablation | 1-5 year. |
| Stroke and Transitory ischemic attack | Development of Stroke and Transitory ischemic attack after thoracoscopic ablation | after discharge - 5 year |
| Unplanned cardiovascular hospitalization | Unplanned non-cardiovascular hospitalization after thoracoscopic ablation | after discharge - 5 year |
| Moscow |
| 115682 |
| Russia |