Hemodynamic Instability Following Carotid Artery Stenting

Not Applicable

Completed

• Conditions: Carotid Stenting
• Interventions: Procedure: valsalva maneuver

• Registration Number: NCT01056445
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

Hemodynamic instability was controlled in 27 patient during carotid stenting and it was showed that hemodynamic instability can be predicted by Valsalva maneuver before stenting and hemodynamic instability have no prognostic effect on result of carotid stenting.

Detailed Description

One of the important complications of Carotid Artery Stenting (CAS) is post procedural hypotension and bradycardia referred to as Hemodynamic Instability (HI). However its incidence and contribution to short-term prognosis of patients have been of a large debate. In this study we aim to assess the incidence and predictive factors of HI and its role in mortality and morbidity of patients in short-term follow-up.

Materials and Methods: 27 patients were selected based on NASCET criteria and underwent CAS between September 2008 and September 2009. Continuous EKG monitoring \& supine blood pressure (BP) was obtained before and after stent deployment and on the following day to detect HI defined as systolic BP≤90mmHg or heart rate≤60 beats per minute. Patients were asked to perform Valsalva maneuver before and after stent deployment. Valsalva ratio along with other demographic and procedural data was documented and compared between patients with and without incidence of HI.

Results: 17 patients (63%) developed HI after CAS. The degree of stenosis was found to have a significant correlation with occurrence of HI with P value\<0.006. No other risk factor or demographic data showed any correlation with HI. Valsalva Ratio (VR) were significantly lower in HI group compared with non-HI group indicating a significant autonomic dysfunction (P\<0.003). In the follow-up one (4.3%) patient had developed major stroke and others were symptom free.

Conclusion: HI occurs frequently following CAS but seems to be a benign phenomenon and doesn't increase the risk of mortality or morbidity after the procedure in short-term. VR at rest (VR≤1.10) baseline autonomic dysfunction and degree of carotid artery stenosis can be used as measures for prediction of HI after CAS.

Study Timeline

• Status Verified: 2008-03
• Study Start: 2008-05
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Study First Submitted: 2010-01-19
• Study First Submitted QC: 2010-01-25
• Last Update Submitted: 2010-01-25
• Study First Posted: 2010-01-26
• Last Update Posted: 2010-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• every patient with carotid stenting

Exclusion Criteria

• presence of hemodynamic instability and low BP at baseline
• atrial fibrillation
• unstable patients with recent TIA and CVA in last week
• inability of patient to hold respiration for 30 seconds
• refusal of patient

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
carotid stenting without hemodynamic instability	valsalva maneuver	no hemodynamic instability after carotid stenting
carotid stenting and hemodynamic instability	valsalva maneuver	27 patients undergone carotid stenting

Primary Outcome Measures

Name	Time	Method
predictors of hemodynamic instability	0, 1, 6 months

Secondary Outcome Measures

Name	Time	Method
result of carotid stenting	0, 1, 6 months

Trial Locations

Locations (1)

Shiraz University of Medical Sciences, Cardiovascular Research Center; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of