Ultrasonography Evaluation of Diaphragm Kinetics in Patients Undergoing Atrial Fibrillation Ablation With Cryoballoon

Study Overview
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Brief Summary
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The purpose of this study to assess the diaphragm kinetics with Tissue Doppler Imaging in patients undergoing atrial fibrillation ablation with cryoballoon

Detailed Description
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This study is designed to evaluate the diaphragm kinetics with ultrasonography parameters in patients who underwent pulmonary vein isolation (PVI) for atrial fibrillation (AF) by Cryoballoon. Due to the proximity of the pulmonary veins to the phrenic nerve, phrenic nerve paralysis can be seen rarely during the procedure. In contemporary practice, phrenic nerve damage is detected by visual monitoring of diaphragm movement as a result of pacing with high output by placing the intracardiac stimulation catheter at the level of the superior vena cava. However, subclinical nerve damage may be critical regarding respiratory functions, especially in patients with comorbidities. It has been shown in the literature that the evaluation of diaphragm kinetics with Tissue Doppler Imaging (TDI) can be used in effective ventilation monitoring and weaning. However, this technique has not been used in patients who have previously undergone cryoballoon therapy. It is aimed to investigate the positive or negative effects on diaphragm kinetics, as a very cost-effective and rapidly accessible technique, with the help of this technique.

Official Title
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Prospective Evaluation of Diaphragm Kinetics With Tissue Doppler Imaging in Patients Undergoing Atrial Fibrillation Ablation With Cryoballoon

Conditions
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Atrial Fibrillation, Phrenic Nerve Paralysis

Intervention / Treatment
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* Diagnostic Test: Tissue Doppler Imaging
* Diagnostic Test: M Mode Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for AF ablation with a cryoballoon ≥18 years old Patients with interpretable diaphragm ultrasound before the operation Patients giving informed consent Exclusion Criteria: Patients who did not give consent Patients with phrenic nerve palsy Morbid obesity

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Cryoballoon pulmonary vein isolation for atrial fibrillation ablation<br>Diaphragmatic kinetics of participants before and after pulmonary vein isolation will be evaluated with the Tissue Doppler and M Mode Imaging. | Diagnostic Test: Tissue Doppler Imaging<br>* With tissue Doppler ultrasonography (TDI), the maximum contraction rate of the diaphragm, maximum relaxation rate, and integral against time will be examined.<br>* Other names: GE Vivid T8 Ultrasonography System;Diagnostic Test: M Mode Imaging<br>* Diaphragm displacement during inspiration and expiration will be measured with M mode imaging<br>* Other names: GE Vivid T8 Ultrasonography System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of subclinical phrenic nerve injury with changes in diaphragm kinetics, before and after the procedure | Unlike the traditional method, diaphragm Tissue Doppler imaging (TDI) will be used to diagnose phrenic nerve injury in patients during cryoballoon ablation. This method aims to detect the damages that may have occurred even though no visible damage has occurred. The peak contraction velocity (PCV) that has been found to be effective on weaning success will be used in TDI. The literature shows that the PCV measured by TDI in healthy humans is 1.32 ⨦ 0.39 cm/sec. Based on this, the patient's baseline and post-procedure PCVs will be compared. | Preoperative baseline and postoperative first hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of subclinical diaphragm damage on morbidity | Side effects that may occur as a consequence of these will be observed in patients with subclinical diaphragm injury. | Preoperative baseline and postoperative 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary vein isolation, Atrial fibrillation ablation, Arrhythmia, Phrenic nerve, Tissue doppler imaging, Diaphragm kinetics