Transcatheter Membranous Ventricular Septal Defect Closure, with Nit-Occlud PFM Device in One Working Group, Long-Term Follow up

Objective: Goal of this work was to evaluate the safety and efficacy of transcatheter closure of ventricular septal defect (VSD) perimembranous (pVSD) with pfm device, Nit Occlud, and long-term results. The VSD is the most common congenital heart disease being mostly membranous. Transcatheter percutaneous closure is a novel technique. Material and methods: Between December 2004 and December 2013, 300 patients with VSD record were admitted to our study, previously admitted to the cath lab at our center for percutaneous treatment of its VSD with different types of devices. All patients were followed until December 2013, between 1 and 109 months. Cases closed with Devices pfm, Nit Occlud is therefore selected. There was thus obtained a sample of 59 cases, 5 cases were dismissed for having no full registration and review of 54 cases was performed. The age range 17 months to 16 years. The VSD type was treated perimembranous 100%. Sub Aortic 12, Sub tricuspid 27, Basal medium 5, and membranous muscle 5, not specified 5. pVSD aneurysm 51, 94.44%. VSD measures were between 1.5 and 16 mm, made by echocardiography or ventriculography. The successful placement of the device was 92.59%. The type of device used was Nit Occlud Coil VSD Le 35 cases, 64.81%, Nit Occlud PDA 19 cases, 35.18%. Complications were mostly minor; among the most relevant major complications was transitory hemolysis in 2 cases, 4%. There were no complete AV blocks between them. Conclusion: Percutaneous closure of perimembranous VSD in experienced hands with Nit Occlud device of pfm can be performed safely and successfully with low morbidity and mortality. Long-term results are favorable, with the percutaneous closure of perimembranous VSD is a less invasive alternative and could be taken as first choice in the treatment of membranous ventricular septal defects. Abbreviations: VSD: Ventricular Septal Defect; PVSD: Perimembranous Ventricular Septal Defect; MVSD: Muscular Ventricular Septal Defect; CAVB: Complete Atrio-Ventricular Blockade; QW: Quick Way; LV: Left Ventricule; RV: Right Ventricule; RS: Residual Shunt Introduction The Ventricular Septal Defect (VSD) is the most common congenital heart defect, and its variant perimembranous (perimembranous VSD) are the highest percentage of them, 70% [1-5]. Percutaneous closure of VSD is only approved in the literature for Muscular VSD (MVSD) [6-9], since in the perimembranous VSD Standard treatment is surgery with extracorporeal circulation [10-29] due to the high rate of complications reported in percutaneous procedures such as complete atrioventricular blockade (CAVB) [30]. Yet the Standard Surgical treatment has risks as CAVB 1.1%, Post Pericardectomy syndrome, residual shunts, besides being a more invasive method for the patient [10,17,29]. Cardiac Catheterization is an alternative to the VSD closure, tested as a method of first choice in closing muscle VSD [6-9] and exists as an alternative treatment in perimembranous VSD since the first reports of percutaneous VSD closure in 1988 [30J Cardiol & Cardiovasc Ther 1(4): JOCCT.MS.ID.555567 (2016) 001 Journal of Cardiology & Cardiovascular Therapy ISSN 2474-7580


Material
It was taken for analysis record of all patients diagnosed with VSD by the working group Hemodynamics Laboratory of Cardiology at Children's Hospital J.M. Los Rios, Caracas, Venezuela, between December 2004 and December 2013 in a sample of 300 cases treated in the cath lab 59 cases treated with Coil Nit Occlud of pfm was selected, discarding 5 cases for not having complete records and 54 cases of membranous VSD closure with pfm Nit Occlud coil were processed.

Method
All features of the technique, patients and pathology described , namely: Access Road: 2 options, the Retrograde, Quick Way (QW ) in which the catheter is passed from Left Ventricule (LV) to Right Ventricule (RV), the device first cone is deployed in the RV and then the second cone is displayed in the LV. Loop method in which the VSD is passed from the left ventricle is advanced with the right guide to a cavity as vena cava or pulmonary artery, the guide is captured and exposed outside the patient by establishing a Femoral Artery -vein loop, the transport catheter of the device progresses from the vein into the left cavities to the Aorta, specifically with Nit -Occluded Spiral Sistem, the device first cone is exposed in the Aorta, deployed at LV and then the second cone is displayed in the RV.     Total 54

Journal of Cardiology & Cardiovascular Therapy
HI 51 Indicated 51 The percentage of patients with indication was 94.44 %.    (Figure 4).

Procedure time
Heparin time was measured, Heparin was placed once VSD diagnosed by TEE or Catheterization, and was counted until the VSD was closed; and fluoroscopy time. Heparin average time was 36 minutes; fluoroscopy average time was 30 minutes.

Access Road
Only one case was closed Retrograde Quick Way from VI, residual restrictive VSD case presented Hemolysis and placed a PDA Nit Occlud to stop hemolysis ( Figures 5 & 6).   If we take into account the premise of not closing those present TCAVB in the procedure, the success rate is 94.33 %, 50 cases of 53 procedures.

Success of the procedure
The causes of failure were: 1 case migration to VD, being rescued; 1 case the device is jam when passing through the aortic valve, when achieve release it migrated to VD; 1 patient with ASD, PDA and VSD already closed with Nit Occlud VSD Le in the same procedure, in the process trying to close the PDA the device is hooked already placed migrating, being rescued later, the ASD was unsuccessfully tried to close with Hellex. The cause of Aborted: 1 case for transient AVB.

The results according to the characteristics of the VSD was assessed by type: Ratio VSD Size and Device size
The Nit -Occlud is recommended to oversize the bigger loop 2-4 mm relative to the opening of the VSD, ie , we take equal size to that dimension of the Loop least 4. Fulfilled with the approach of not overstate the device to seek to avoid the complication of permanent AVB to cause pacemaker, as also in some cases smaller devices were used to leave the device inside the aneurysm [48].
2 nd device placed in the same patient: 2p, of 50 closed, 3.70%; ie, 1p Nit -Occlud VSD Le with Hemolysis solve placing the 2nd Coil Nit -Occlud PDA in the first week, (reported in hemolysis ). We report a late second case 1p perimembranous VSD STR withaneurysm of 10mm, closed with NIT-Occlud VSD Le 10x6, migrated into the aneurysm, with rsidual shunt for 3 years, was placed on the 2nd Nit VSD Le 12x6, stays with minimum residual shunt with minimum Hemodynamics Impact, then the 1st device found migrated and healed in right branch of the pulmonary artery, was attempted to remove it and failed (Figures 5 & 6).

Residual shunt (RS)
Immediate in the catheterization, 20p of the 50p with device 40 %; of them 12p with Nit-Occlud VSD Le, 8p Nit-Occlud PDA,(This device is not designed for VSD closure and is not a fiber-Coil). At follow-up: still wit RS at 24 hour follow-up 11p 22%, all with VSD Le Nit Occlud. All Nit-Occlud PDA Shunt disappeared in 24 hours. Subsequently the RS disappeared one month 7p, 14 %; 5p more disappear on their follow-up to 2 months 2p, 1p to 1 year, 2 years and 5 years respectively. Subtracting 2p 4% of the Nit-Occlud placed persists with minimal RS without Hemodynamics Impact at 9 years of follow up. Starts in the first hours after catheterization, 2p of the 50 closed, 4%. 1p Nit-Occlud PDA of the 19p with Nit-Occlud PDA, 5.26 %, is spontaneously resolves the 2nd day, this tipe of device is no designed to VSD closure, hemolysis subsides spontaneously within 2 days. 1p Nit -Occlud VSD Le of the 35p with that tipe of device, 2.85 % with RS and hemolysis was placed a 2nd Coil Nit Occlud PDA quick Way a week latter and the RS and hemolysis disappeared in 5 days [52] (Figures 5-7).

Transient hemolysis
Immediate Migration: Total 3p of the 54p, 5.55 %. They are rescued named in failed cases.
Migration remaining within the aneurysm: 2p migrated into the aneurysm, 4%, namely: 1p Nit-Occlud VSD Le migrated into the aneurysm (named in placing 2nd device on the same patient in long-term follow up); 1p with Nit-Occlud VSD Le migrating into the aneurysm with RS, removed in surgery at 7 years (named in Surgery).
No Progress transport pod RV to LV throught the VSD: 1p solved with Nit -Occlud PDA ASA Way, because the transport pod is 5F (Figure 2). Migration in the follow up: 1p of the 50 placed 2%; NIT VSD Le migrated to 7 years (reported in 2nd placement device).

Journal of Cardiology & Cardiovascular Therapy Discussion
High level of success in closing perimembranous VSD with Coil Nit Occlud. There were no CAVB including the following 9 years. Most complications were transient, 2p with residual shunting without hemodynamic impact to 9 years and only by large RS 1P and thrombocytopenia removed in surgery at age 7, 2% on follow up to 9 years [60-65].

Conclusion
Transcatheter closure of aneurysm perimembranous VSD with Nit Occlud Coil device has high chance of success with a low level of complications.