Cardiac Complication After Vascular Surgery (CCVS)

The Reasons of Repolarization Disturbances Disclosure in Vascular Surgery

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease; Aortic Aneurysm, Abdominal; Ventricular Arrythmia; Cardiac Complication
• Intervention / Treatment: Other: 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 Type: Observational
• Enrollment (Actual): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients diagnosed with abdominal subrenal aortic aneurysms or peripheral arterial disease scheduled for an elective "open" vascular surgery procedure. The study was conducted by the team from Department of Anaesthesiology, Intensive Care and Acute Poisoning of the tertiary teaching hospital at the Pomeranian Medical University in Szczecin, Poland.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
vascular surgery patients; clinically concealed repolarization disturbances during vascular surgery procedure; clinically disclosed cardiac complications during and after vascular surgery procedure	Other: vascular surgery procedure; an elective "open" vascular surgery procedure; ECG Holter recording during the procedure and 24 hours after operation (continuous electrocardiographic tracing (digital Holter ECG monitor)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiac complications	cardiac complications according to European Society of Cardiology	up to 30 days after vascular procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiac complications	cardiac complications according to European Society of Cardiology	during surgical procedure
cardiac complications	cardiac complications according to European Society of Cardiology	one year

Collaborators and Investigators

• Sponsor: Pomeranian Medical University Szczecin
• Investigators: Principal Investigator: Jowita Biernawska, MD, PhD, Department of Anaesthesiology and Intensive Care of the Pomeranian Medical University in Szczecin, Poland.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2010
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: June 8, 2017
• First Submitted That Met QC Criteria: June 13, 2017
• First Posted (Actual): June 15, 2017

Study Record Updates

• Last Update Posted (Actual): June 15, 2017
• Last Update Submitted That Met QC Criteria: June 13, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: vascular surgery; cardiac complications; high risk patient; repolarization disturbances; high risk procedure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Aortic Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: PomeranianMU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No