The Long-term Success of Cardiovascular Surgery in Takayasu Arteritis

August 29, 2018 updated by: Maria Elena Soto, MsC and PhD, Instituto Nacional de Cardiologia Ignacio Chavez

The Long-term Success of Cardiovascular Surgery in Takayasu Arteritis. 30 Years of Experience in Mexico, Beyond Forefront Techniques

Takayasu Arteritis (TA) affects medium and large caliber arteries causing stenosis, occlusion or aneurysms. It has great predilection for the aortic arch, subclavian and extracranial arteries. The global prevalence is of 1 to 2% per million inhabitants, which varies by geographical region. The main cause of death in TA is of cardiovascular origin and includes ischemic cardiomyopathy and valvular disease. The aim of this study was to evaluate the surgical experience according to the type of surgery in subjects with TA with and without inflammatory activity.

Methods: This was a retrospective, descriptive, cross-sectional study run between 1977 and 2017. Patients with Takayasu arteritis with more than 3 classification criteria according to the American College of Rheumatology (ACR) were included. The surgeries were classified as: Organ preservation, cardiac, bypass, exclusion and replacement. Inflammatory activity was evaluated.

Study Overview

Status

Completed

Conditions

Arteritis, Takayasu

Detailed Description

A review of the clinical records of patients diagnosed with TA with more than 3 criteria of the American College of Rheumatology (ACR) and undergoing some surgical procedure by the Surgery Service of the National Institute of Cardiology "Ignacio Chávez", in a period of time comprised between 1977 and 2016 was done. Patients of any gender and age who had been operated on by a surgical procedure registered in their medical record were included. Patients intervened in other institutions were excluded. The surgical event was classified into 6 groups: 1) organ-preservation surgery (mainly renal autograft); 2) Bypass (revascularization of affected organs or segments with Woven Dacron graft); 3) Replacement (replacement of affected aortic segment with a Woven Dacron graft); 4) Cardiac Surgery (direct procedures in heart); 5) Exclusion (resection of an affected organ (nephrectomy)), and 6) Other.

Inflammatory activity was evaluated according to the Dabague-Reyes criteria, in which a score greater than or equal to 5 is considered as active inflammation (9).

Statistical analysis: Variables with a loss of the sample data greater than 20% were excluded. The categorical variables were described by percentages and prevalences and the comparison were done by chi square or Fisher's exact test. A statistically significant level was considered when an error α <0.05 was found. Parametric numerical variables are described by measures of central tendency and the comparison is made by Student's T test. The survival analysis was performed using Kaplan-Meier. Ethical aspects were considered according to the Helsinky declaration.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Mexico
- Cdmx
  - Mexico City, Cdmx, Mexico, 14080
    - Nacional Institute of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A review of clinical records of patients with diagnosis of Takayasu arteritis and undergoing some surgical procedure by the surgery service of the National Institute of Cardiology "Ignacio Chávez", in a period between 1977 and 2016 was conducted.

Description

Inclusion Criteria:

Patients of any gender regardless of age that has a diagnosis of TA established by a rheumatologist,
Have a surgical procedure registered in your medical record

Exclusion Criteria:

Not having a digital, physical or microfilmed medical record
Surgical procedures performed at another institution

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Cardiac surgery Direct procedures in heart
Organ preservation Mainly renal autograft
Bypass Revascularization of affected organs or segments with Woven Dacron graft
Exclusion Resection of an affected organ (nephrectomy)
Replacement Replacement of affected aortic segment with a Woven Dacron graft
Other Any surgery that does not include the previous ones

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term survival rate surgery event Time Frame: 45 years	Observed in our study in relation to the mortality associated with the surgical event	45 years
Long-term survival according from other causes Time Frame: 30 years	According to the type of surgery in relation to mortality from other causes	30 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial lesions Time Frame: 30 years	According to Numano's classification	30 years
Inflammatory activity Time Frame: 30 years	Evaluated according to the Dabague-Reyes criteria	30 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cardiologia Ignacio Chavez

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 1977

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

June 26, 2017

Study Registration Dates

First Submitted

August 29, 2018

First Submitted That Met QC Criteria

August 29, 2018

First Posted (Actual)

August 31, 2018

Study Record Updates

Last Update Posted (Actual)

August 31, 2018

Last Update Submitted That Met QC Criteria

August 29, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

20142018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

The Long-term Success of Cardiovascular Surgery in Takayasu Arteritis