A Randomized Controlled Trial:Treatments on Infundibular Ventricular Septal Defect
A Randomized Controlled Trial:Treatments on Infundibular Ventricular Septal Defect
The purpose of this study is to investigate the security and validity of transesophageal
 echocardiography(TEE)-guided perventricular device closure(TPDC) through minithoracotomy in
 treatment of infundibular ventricular septal defect(IVSD) with asymmetric occluder.
Ventricular septal defect(VSD) , which accounted for about 20% of all congenital heart
 defects (CHDs) , is among the most common congenital heart malformations，among which
 infundibular ventricular septal defects(IVSD) is the least common type(18%）.Multiple names
 for IVSD are in use. They can also be labeled conal VSD, subpulmonary VSD, subarterial VSD,
 doubly committed VSD, intracristal VSD，or supracristal VSD. These multiple denominations are
 not attached to specifically different anatomic subtypes.At present, the main methods to
 treat the specific anatomic condition contain conventional surgical repair(SR) and
 transcatheter interventional closure. The former need extracorporeal circulation，thus the
 side effects of extracorporeal circulation are inevitable，such as on the central nervous
 system, respiratory system, urinary system, etc. Although the latter has the characteristics
 of minimally invasive, patients should be exposed in X-ray withstanding potential risk of
 radiation. On the other hand，there are limits with age for patients who underwent
 transcatheter closure because of small vessel size. Fully developed blood vessels are to
 reach a certain diameter, but children need be up to 3 years old or so. In addition,the
 aortic valve was easily injured by wire and atrioventricular block was reported.Since the
 surrounding structure is complicated and the defect is too high, device closure of an IVSD is
 difficult to succeed in transcatheter approach. Traditional repair via cardiopulmonary
 bypass(CBP) is widely used to treat this kind of diseases. Past decade，with the development
 of technology and society，TEE-guided surgical occlusion through minithoracotomy was used to
 treat CHDs in an increasing number of popularity，avoiding the inherent risks of
 cardiopulmonary bypass and radiation,etc. But it is rarely reported to treat IVSD by
 minimally invasive perventricular device closure without CBP.
Inclusion Criteria:

 (1) patients with single IVSD indicated by TTE，without concomitant cardiac malformation,
 serious arrhythmia or other important non-cardiac diseases；(2) patients whose ventricular
 septal defects from aortic residual < 3 mm, preoperative without aortic regurgitation or
 only mild reflux, defect size ≤10 mm;

 Exclusion Criteria:

 (1) defect size > 10 mm in diameter; （2) Preoperative with above moderate aortic valve
 prolapse (or) closed incompletely; (3) Eisenmenger syndrome caused by pulmonary
 hypertension,(4)decide temporarily to change method before surgery;(5) not signed informed
 consent application