Cardiac Complication After Vascular Surgery

Completed

• Conditions: Aortic Aneurysm, Abdominal; Peripheral Arterial Disease; Ventricular Arrythmia; Cardiac Complication
• Interventions: Other: vascular surgery procedure

• Registration Number: NCT03188341
• Lead Sponsor: Pomeranian Medical University Szczecin

Brief Summary

The vascular surgery is a highest risk procedure when considering postoperative complications associated with the cardiovascular system. The leading clinical presentation is acute hemodynamic decompensation. However, one of the possible pathomechanisms might be repolarization disturbances. Many of perioperative risk factors of cardiac complications are modifiable. The identification may help in the global perioperative risk reduction.

Aim: The aim of the study was an identification of the factors which may release clinically overt repolarization disturbances.

Methods: The study group consisted of 100 patients, diagnosed with abdominal subrenal aortic aneurysms or peripheral arterial disease scheduled for an elective "open" vascular surgery procedure. The authors investigated whether age, gender, comorbidities or some perioperative factors (including hemodynamic, metabolic or genetic) were related to the occurrence of clinically concealed repolarization disturbances or clinically disclosed cardiac complications in postoperative time up to 30 day and one year after vascular surgery procedure.

Detailed Description

Vascular surgery is thought as the highest risk procedure in the context of cardiac complications. The range may include acute coronary syndrome, acute circulatory failure, severe arrhythmias, syncope and sudden cardiac death. The patient population is considered as a high risk, too. Popular calculators used for risk stratifications are based on preoperative patient's history and some general laboratory results. However, general status of the patient changes dynamically during vascular procedures leading to acquired increased risk. For this reason, sole preoperative risk prediction based on standard calculators is unsuitable and suboptimal. Advanced monitoring systems may record some temporary disturbances (e.g. ventricular repolarization disturbances), which may be asymptomatic. The clinical significance in postoperative risk prediction of such observations remains undefined. On the other hand, many of perioperative cardiac complications are caused by modifiable factors. The identification may help in the global perioperative risk reduction.

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2016-12
• Status Verified: 2017-06
• Study Completion: 2017-06
• Study First Submitted: 2017-06-08
• Study First Submitted QC: 2017-06-13
• Last Update Submitted: 2017-06-13
• Study First Posted: 2017-06-15
• Last Update Posted: 2017-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• adult patients diagnosed with abdominal subrenal aortic aneurysms or peripheral arterial disease scheduled for an elective "open" vascular surgery procedure

Exclusion Criteria

• heart stimulation,
• atrioventricular and intraventricular conduction defects,
• atrial fibrillation recorded before of the study,
• antiarrhythmic drug treatment (except beta-blockers),
• unoptimal patient general status (uncontrolled diabetes, active infection)
• reoperation
• emergency operations

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
vascular surgery patients	vascular surgery procedure	* clinically concealed repolarization disturbances during vascular surgery procedure * clinically disclosed cardiac complications during and after vascular surgery procedure

Primary Outcome Measures

Name	Time	Method
cardiac complications	up to 30 days after vascular procedure	cardiac complications according to European Society of Cardiology

Secondary Outcome Measures

Name	Time	Method
cardiac complications	one year	cardiac complications according to European Society of Cardiology