The Effect of Breast Augmentation on the Quality of Echocardiography Test

Sponsor

Hadassah Medical Organization (Other)

Overall Status

Completed

CT.gov ID

NCT01945463

Collaborator

(none)

Enrollment

Actual Duration (Months)

Study Details

Study Description

Brief Summary

Breast augmentation surgery is currently the most common elective plastic surgery performed in the US. With regards to the surgical technique, there are 4 incisional sites available for breast augmentation, each with its advantages and disadvantages: Axillary, Periareolar, inframammary, and umbilical. The implant is inserted in either a subglandular (beneath breast tissue), submuscular (underneath the Pectoralis Major), or "dual-plane" (combination of both) manner.

Echocardiography is the most commonly used diagnostic test in cardiology for the evaluation of cardiac structure and function. Its use has increased dramatically in the last decades. We have encountered three women with congenital heart disease who have undergone breast augmentation, and their echocardiographic images were significantly limited after the implantation. There is only one case report in the medical literature suggesting that breast implants interfere with echocardiographic views .

The underlying physical property of the silicone breast implants that causes interference with the ultrasound beam during echocardiographic examination is not known and has not been studied. Similar to air in the lung but to a lesser degree, silicone breast implants appear to prevent penetration of ultrasound beams. The poor penetration appears to be persistent and unrevealing despite increase in gain or change in the ultrasound wave's frequency.

Many women elect breast augmentation for cosmetic reasons. Women with congenital heart disease who have undergone cardiac surgery may have breast asymmetry or distortion and desire augmentation accordingly.

Knowledge of the extent of impairment of breast implants to the echocardiographic examination is important for few reasons:

Women with heart disease who need echocardiographic follow up and wish to undergo breast augmentation should be consulted as to the limitation of the echocardiographic examination following the procedure.
Women without heart disease considering breast augmentation should be informed of potential echocardiographic interference, if echocardiography be needed in the future,
Different surgical techniques may cause different masking effect.
Different implants size and shape may cause different masking effect.

Condition or Disease	Intervention/Treatment	Phase
Breast Augmentation

Study Design

Study Type:

Observational

Actual Enrollment :

4 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Actual Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Aug 1, 2016

Actual Study Completion Date :

Aug 1, 2016

Outcome Measures

Primary Outcome Measures

Proportion of women in which the breast implant will affect the quality of the Echo test. [one month]
The women will be gone through two Echo tests, the first before the operation and the second six weeks after the operation. The physician will compare the two tests.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

1. Women with heart disease who need echocardiographic follow up and wish to undergo breast augmentation

Exclusion Criteria:

Unwillingness to participate.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hadassah Medical Organization

ClinicalTrials.gov Identifier:

NCT01945463

Other Study ID Numbers:

0378-13

First Posted:

Sep 18, 2013

Last Update Posted:

Nov 28, 2017

Last Verified:

Aug 1, 2017

Study Results

No Results Posted as of Nov 28, 2017