Clinical trial NCT06538987: Anesthetic Management in Patients Undergoing Epicardial Ablation
Official title: Anesthetic Management in Patients Undergoing Epicardial Ablation for the Treatment of Ventricular Tachycardia; Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Tachycardia
Keywords: anesthesia
ventricular tachycardia
Electrophysiology
electro-anatomic mapping
catheter ablation
risk assessment
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Since it is a retrospective study, patients who underwent epicardial ablation within the specified date range will be included. Although the estimated number of cases cannot be predicted, it is a rare and specialized procedure. No group has been determined, the characteristics of the patients and their anesthesia management will be examined in an observational study.

Brief summary: The study is a retrospective study and is descriptive in nature. In this study, the investigators aimed to emphasize the importance of anesthesia management by cardiac risk assessment of patients undergoing epicardial ablation under general anesthesia and analysis of complications that developed during the procedure.

Detailed description: The study is retrospective observational and data were collected by examining the files of all epicardial ablation patients received in the angiography unit starting from 30.10.2020 until 30.10.2022 after ethics committee approval is obtained. Baseline characteristic features of the patients Sex, Age, (years, BMI (kg/m2) Hypertension, Coronary artery disease, COPD (Chronic obstructive pulmonary disease), CKD (Chronic kidney disease) Electrical storm, and ventricular tachycardia etiology, Ischemic cardiomyopathy, Dilated cardiomyopathy, the presence of ARVC (Arrhythmogenic Right Ventricular Cardiomyopathy), Hypertrophic cardiomyopathy will be recorded. NHYA classification will be examined in two groups as NHYA I or II and NHYA III or IV, also estimated glomerular filtration rate, left ventricular ejection fraction, PAAINESD (acute hemodynamic decompensation risk assessment score), iVT score (Risk of VT recurrence) Score information will be recorded. Ventricular tachycardia focus locations, dopamine, dobutamine, norepinephrine infusion requirement during the procedure, arrest development during the procedure, fluoroscopy time and ablation times will be recorded. In the follow-up of the patients after the procedure Causes of death, decompensated heart failure, transient ischemic attack, development of acute renal failure, and recurrence of ventricular tachycardia will be recorded. PAAINESD score (acute hemodynamic decompensation risk assessment score) will be recorded. The PAAINESD Score, developed to estimate the risk of periprocedural hemodynamic decompensation, has values ranging from 0 to 35 points (or 0 to 31 \[PAINESD\] when the modifiable intraprocedural variable "general anesthesia" is excluded). duration of the procedure, the need for inotropes during the procedure, whether the patient needed mechanical ventilation after the procedure, and the success rates after the procedure will be recorded.

PAINESD Pulmonary disease (chronic obstructive pulmonary disease) 5 Age \>60 years 3 Anaesthesia (general) 4 Ischaemic cardiomyopathy 6 NYHA class III or IV 6 Ejection fraction \<25 % 3 Storm (VT). 5 Diabetes 3 Data will be analyzed in three separate categories, the characteristics of the patients before the procedure, during the procedure and after the procedure. Descriptive tables and percentages of parameters will be created by statistical analysis.

Eligibility criteria: Inclusion Criteria: • age \> 18 years old who underwent elective VT ablation between 2020 - 2022,

* primary anesthetic type listed as general anesthesia

Exclusion Criteria: • age \< 18 years,

* missing follow-up data,
* patients who have previously undergone epicardial ablation

Primary outcomes:
measure: sex
timeFrame: 2 years
measure: age
timeFrame: 2 years
measure: weight
timeFrame: 2 years
measure: height
timeFrame: 2 years
measure: Hypertension
timeFrame: 2 years
measure: Diabetes mellitus
timeFrame: 2 years
measure: Coronary artery disease
timeFrame: 2 years
measure: Chronic obstructive pulmonary disease
timeFrame: 2 years
measure: Chronic kidney disease
timeFrame: 2 years
measure: Systolic pulmonary artery pressure
timeFrame: 2 years
measure: Left ventricular ejection
timeFrame: 2 years
measure: PAAINESD (Acute hemodynamic decompensation risk assessment, ranging from 0 to 35 points, 35 point is the worst) score
timeFrame: 2 years
measure: ASA ( American Society of Anesthesiologists (ASA) physical status classification ranging from I to IV
timeFrame: 2 years
measure: Hemoglobin
timeFrame: 2 years
measure: glomerular filtration rate (eGFR)
timeFrame: 2 years
measure: Total procedural time
timeFrame: 2 years
measure: Fluoroscopy time
timeFrame: 2 years
measure: Ablation time
timeFrame: 2 years
Secondary outcomes:
measure: Transient ischemic attack after procedure
timeFrame: 2 years
measure: Exitus during the follow-up
timeFrame: 2 years
measure: cause of death
timeFrame: 2 years
Other outcomes:
Locations:
city: Eski̇şehi̇r
country: Turkey
facility: University of Eskisehir Osmangazi
state: Odunpazarı
Study officials:
affiliation: University of Eskişehir Osmangazi
name: ferda yaman, Assoc prof
role: PRINCIPAL_INVESTIGATOR
References: