TRANSCATHETER OCCLUSION OF ANEURYSMAL SUBAORTIC VENTRICULAR SEPTAL DEFECTS BY MEANS OF NIT-OCCLUD (PFM) DETACHABLE COILSPRIMARY EXPERIENCE IN A TERTIARY CENTER.
Keywords: Aneurysmal sub aortic perimembranous,Device embolisation, Heart block,Intravascular hemolysis, Nit-Occlud (PFM) detachable Coils, Percutaneous occlusion, Ventricular septal defect.
Ventricular septaldefect (VSD) is the commonest amongst CHDs (20 to 25%) excluding bicuspid aortic valve. Peri membranous defects are the most prevalent among the VSDs (80%)1-5. Surgical closure of VSDs had been the mainstay of management since Gibbon, Lillehei, and Kirklin advent bypass technique in the 1950s to successfully close ASDs6 till Rashkind reported percutaneous closure VSD's in an animal model in the early 1970s7. Lock et al first attempted this in human's in 19888. Variable success since then have been reported with the use of devices which were originally designed for closure of other intracardiac defects (Rashkind umbrella device, Lock clamshell, Cardioseal, coils, Sideris buttoned device, Amplatzer etc)9. Complications include conduction disturbances10, device embolization, aortic regurgitation, tricuspid regurgitation, hemolysis, residual shunts9and rarely infective endocarditis11-13.
Although success and complication rate of both methods is comparable percutaneous closure of VSDs is relatively less invasive, has quick recovery and shorter hospital stay14-16. Even incidence of the most serious complication i-e complete AV block has not been higher in percutaneous closure as compared to surgery16. The Nitinol coil system (Nit-OccludLe) developed by PFM specially for transcatheter occlusion of perimembranous defects with aneurysmal septum and cone-shaped muscular VSD defects is available since 2010. The device consists of a nitinol coil fitted with polyester fibres. Its offers minimal complication rate due to its unique flexible design. Nitinol wire have demonstrated to be elastic, adaptable and better malleable to cardiac structures especially when deployment entails the risk of causing a heart block or aortic leaflet damage.
We report our very first experience in deploying Nit-Occlud (PFM, Cologne, Germany) devices for the purpose of occluding subaortic aneurysmal ventricular septal defects at a tertiary cardiac center in Pakistan.
MATERIAL AND METHODS
The PFM device has a 0.25mm primary windings and secondary coil loops. The primary windings are made over a straight core wire, creating an extremely adaptable straight tension spring with an internal diameter of 0.25mm and an outer diameter of 0.96 mm. A 0.04mm flat wire is introduced into the lumen of the primary windings. The spring is wound around a feature with an hour glass contour and is shock - heat treated. This procedure forms two disks with a 2mm small central part. The distal disk is larger and much firmer than the proximal disk. The proximal disk is reversed so that the device has a cone in cone shape. Procedure was performed under general anaesthesia for children younger than 12 years. For older children and adults' local anaesthesia was used. Both arterial and venous femoral access was obtained. A basic angiogram in 25 degree cranial and 25 degree left anterior oblique (LAO) position with a Pigtail catheter was done to clearly delineate the VSD.
Judkins right heart or a cut pigtail catheter from the left ventricular side was advanced across the VSD over 0.035inch Terumo exchange wire in the right ventricle and then pulmonary artery or right SVC. Terumo wire was then snared out via RFV to form an AV loop and allowing us a stable rail road for advancement of 7to 8 F long sheath (Mullen Cook) across the VSD and aortic valve in the ascending aorta. Evaluation for size, shape, location, physiology, pressure restrictiveness, shunt volume of the ventricular septal defects (with special attention to nearby structures, chordae and size of the aortic rim) chamber size, cardiac function and associated defects was performed by 2D echocardiography using Philips IE 33 with a 5MHz transducer using standard imaging views.
Presence of any degree of aortic insufficiency with or without prolapse, involvement of aortic cusps with element of aortic right cusp prolapse and any subsequent grade of aortic valve insufficiency (AI) was also documented. Where the echocardiographic window was not optimal (in some adults cases) TEE study was performed. Our size selection for a certain size of the defect was based on the following approximate assumption; we simply doubled the maximal size of the defect at the LV end at end diastole to correspond to the device size for the LA disk, for e.g. NitOcclud device with a diameter of 16 mm was suitable for a subaortic perimembranous VSD with a maximum diameter of 8mm from the LV end. Nit-Occlud has rounded edges and has a disk-like geometry.
The central portion is flexible with better adaptation to the VSD anatomy as shown in Figure after successful closure of the defect. Our collection of patients was primarily aimed at pursuing the subaorticperimembranous VSDs with or without any grade of AI.
In total 12 cases were performed. Our patients mean age was 8 years with SD 5.7. Mean procedural time was 52.69 mins with SD of 12. Total fluoroscopy time 15 +- 8.5 min. Mean of 54 ml of contrast was used with a SD of 19.6ml. Ten cases were done in general anaesthesia and 2 cases were done in local anaesthesia. 5 were males and 7 patients were females. One patient weighing 3kg, had his PDA occluded by PFM device too. We had no absent pulses following the procedure. Size 5 F and 6F were used for venous access. And size 4F, 5F and 6F were used for the arterial access. In 2 patients we were able to cross the VSD from the RV side and did not need to create a AV loop for the procedure. In 1 patient we had to retrieve the VSD device as we could not achieve a satisfactory deployment and occlusion of the defect. The device was snared and replaced with a PDA occlude. Four patients had intravascular hemolysis secondary to residual shunts across the device.
In two patients, the hemolysis was brief and resolved the next day with hydration and mere observation. In two patients the device had to be pulled out following a persistent fall in hemoglobin and intravascular hemolysis. One of these had his device removed surgically following a 5-day wait, and the other patient had his device removed by transcatheter approach following a wait of 7 days. A VSD muscular device was then used instead. Immediately post procedure, we did not encounter any patient with heart block or arrhythmia, aortic or tricuspid valve regurgitation and infective endocarditis.
We expressed continuous variables as ranges and mean +- standard deviation. Qualitative variables were expressed as percentages. All statistical analyses were performed using SPSS version 20.0; IBM SPSS Software for Predictive Analytics; SPSS, Chicago, IL, United States of America), a p-value <0.05 was considered statistically significant.
Percutaneous VSD device closure is effective and safe. Successful closure can be achieved in 91.9 to 99% cases8, 17-24 using various devices9,17,19,25-27. Consistent with this, we achieved a successful device implantation in 91.6%. 7 out of 12 (58.3%) patients had complete immediate closure and 4 (33%) had mild to moderate residual leak. We have documented a closure rate of 81.8% at 4 months follow up. 36.3% of our pt's experienced adverse events in early post procedure period whereas none during the follow-up as compared to total 20.5% and serious events in 1.9% of patients in a recently published data of VSD closure with the Nit-Occlude Le VSD-Coil in 110 patients22. Intravascular hemolysis is a relatively common complication following coil occlusion of VSD's in the immediate post procedure period because of residual shunt across the device, causing mechanical fragmentation of red blood cells28,29.
Hemolysis which occurs in 0.7-15% of cases10,28 is usually transient, resolves with conservative management but some may need blood transfusion19,20,22 or might need surgical retrieval of the device in case of massive or persistent hemolysis17. In our study four patients experienced hemolysis and two needed blood transfusion because of progressive fall in Hb who ultimately needed retrieval of the device followed by surgical patch closure in one and percutaneous device closure with muscular VSD device in the other one. In the remaining two it was resolved spontaneously in couple of days with improved hydration, although residual shunt persisted on TTE. Cardiac arrhythmias are not uncommon after device closure of pMVSD due to the defect proximity to the conduction system.
Complete heart block has been reported in 0.23-6.4% in several studies17-20,24,30 which usually occurs immediately after the procedure due to device oversizing, squeezing effect of the device, direct compression or can present late due to fibrous tissue formation secondary to inflammation19,31. Adverse hemodynamic outcome may result from commonly occurring right or left BBB. A relatively rare complete LBBB which can potentially cause chamber enlargement or heart failure in some, may resolve with or without steroid therapy19,24,32,34. In the current study none of pt's had either complete heart block or BBB in the immediate post procedure follow up period. Post procedure aortic and tricuspid valve regurgitation are other known complications which usually results from device impingement on valvular leaflets, damage to the aortic valve leaflets or interference with chordae tendinae during device deployment leading to AR or TR respectively34,17,35.
In one study TR was seen in 5.4% of cases35 and surgical intervention was required in severe or progressive AR17,20 or TR24. This highlights the importance of monitoring with trans thoracic echo in the pre, intra, and post procedure period. Inner experience one pt had mild to moderate AR following coil occlusion caused by impingement of device on aortic leaflets along with residual shunt resulting in IV hemolysis needing device retrieval. One of our pt's had transient AR in the immediate post procedural period but resolved later. None of our pt's had TR. Other serious complications like Infective endocarditis and device embolisation are so far reported once by Amal M11 and Haas NA22 respectively but luckily none of our patients had device embolisation or infective endocarditis.
Our preliminary experience with Nit-Occlud devices has been inspiring with fairly safe and effective results. However we need to acquire more experience in handling and implantation of this device for both restrictive PM VSDs and also be well acquainted of appropriate patient selection, short-comings and attendant complications to reduce complications risk. The device holds tremendous potential if used for aneurysmal peri membranous VSDs in our setup as the largest chunk of congenital defects are small restrictive PMVSDs for whom serious surgical procedures are not warranted.
LIMITATION OF STUDY
This is a retrospective study done on a very small sample size of a single centre with a short follow-up period.
CONFLICT OF INTEREST
This study has no conflict of interest to be declared by any author.
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|Publication:||Pakistan Armed Forces Medical Journal|
|Date:||Feb 28, 2019|
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