Developing High Medical Technology,a Challenge for Developing Countries: The Percutaneous Closure of Atrial Septal Defects Using Nit-Occlud ASD-R: Early and Mid-term Results
Restricted accessResearch articleFirst published online July, 2019
Developing High Medical Technology,a Challenge for Developing Countries: The Percutaneous Closure of Atrial Septal Defects Using Nit-Occlud ASD-R: Early and Mid-term Results
To assess the efficacy and safety of the Nit-Occlud ASD-R (PFM S.R.L, La Paz, Bolivia) in the percutaneous closure of secundum atrial septal defects (ASD).
Patients and Methods:
Fifty-three consecutive patients with median age of 11 years (range 3-67) and mean weight 27.1 kg (range 13-75 kg), treated in two cardiology centers between May 2007 and March 2011.
Results:
Mean fluoroscopy time was 14 minutes (5-53), mean procedure time was 70 minutes (45-150), mean defect size, as measured by the stop-flow technique, was 17.8 mm (5.6-31), and mean stent size of the implanted device was 18 mm (6-28), which is 0.98 times the defect size. Successful closure of the ASD without major complications was achieved in 49 of 53 patients. In 71.4% of patients in whom device implantation was accomplished, there was no evidence of a persistent shunt at the completion of the procedure. This closure rate increased to 91.7% after 24 hours, with 95.8% closure after three months and 100% closure after six months. Device embolization occurred in one patient within 24 hours of implantation and required surgical device removal and ASD closure. There were no other major complications and no deaths during the period of follow-up (average 72 months; range 59-105 months).
Conclusion:
The Nit-Occlud ASD-R device is safe and effective with very good closure rates.
HoffmanJEChristiansonR. Congenital heart disease in a cohort of 19502 births with long term follow up. Am J Cardiol. 1978;42(4):641–647.
2.
EmmanoulidesGCAllenHDRiemenschneiderTA. Heart Disease in Infants, Children and Adolescents, Including the Fetus and Young Adults. Baltimore, MD: Williams & Wilkins; 1995:60–69.
3.
MiaoCYZuberbuhlerJSZuberbuhlerJR. Prevalence of congenital cardiac anomalies at high altitude. J Am Coll Cardiol. 1988;12(1):224–228.
4.
HeathAFreudenthalFTaboadaCMendesJ. Pulmonary hypertension and congenital heart defects at high altitude. In: YuanJXJGarciaJGNHalesCARichSArcherSLWestJB, eds. Textbook of Pulmonary Vascular Disease. Berlin, Germany: Springer Science Business Media; 2011:1223–1230.
5.
HelgasonHJonsdottirG. Spontaneous closure of atrial septal defects. Pediatr Cardiol. 1999;20(3):195–199.
6.
MurphyJGGershBJMcGoonMD. Longterm outcome after surgical repair of isolated atrial septal defect. Follow up at 27 to 32 years. N Engl J Med. 1990;323(24):1645–1650.
7.
LammersAHagerAEickenALangeRHauserMHessJ. Need for closure of secundum atrial septal defect in infancy. J Torac Cardiovasc Surg. 2005;129(6):1353–1357.
8.
MeijboomFHessDJSzatmariA. Long–term follow up (920 years) after surgical closure of atrial septal defect at a young age. Am J Cardiol. 1993;72(18):1431–1434.
9.
KirklinJWBarrattBoyesBG. Atrial septal defect and partial anomalous pulmonary venous connection. In: KirklinJWBarratt BoyesBG, eds. Cardiac surgery. 2nd ed. New York, NY: Churchill Livingstone; 1993:609–644.
10.
GalalMOWobstAHaleesZ. Perioperative complications following surgical closure of atrial septal defect type II in 232 patients a baseline study. Eur Heart J. 1994;15(10):1381–1384.
11.
BragaSLSousaAGPedraCAEstevesCAPedraSRFontesVF. Clinical efficacy and safety of the percutaneous treatment of secundum atrial septal defect with the Amplatzer occluder. Arq Bras Cardiol. 2004;83(Spec No):7–13.
12.
OhoSIshizawaAAkagiTDodoHKatoH. Transcatheter closure of atrial septal defects with the Amplatzer septal occluder a Japanese clinical trial. Circ J. 2002;66(9):791–794.
13.
PatelALopezKBanerjeeAJosephACaoQLHijaziZM. Transcatheter closure of atrial septal defects in adults > or =40 years of age: immediate and followup results. J Interv Cardiol. 2007; 20(1):82–88.
14.
DalviBVPintoRJGuptaA. Device Closure of Large Atrial Septal Defects Requiring Devices ≥20 mm in Small Children Weighing <20 kg. Catheter Cardiovasc Inter. 2008;71(5):679–686.
15.
LopezKDalviBVBalzerD. Transcatheter closure of large secundum atrial septal defects using the 40 mm Amplatzer septal occluder: results of an international registry. Catheter Cardiovasc Interv. 2005;66(4):580–584.
16.
RossiRICardosoCOMachadoPRFrancoisLGHorowitzESSarmentoLR. Transcatheter closure of atrial septal defect with Amplatzer device in children aged less than 10 years old: immediate and late followup. Catheter Cardiovasc Interv. 2008;71(2):231–236.
17.
MasuraJGavoraPPodnarT. Longterm outcome of transcatheter secundumtype atrial septal defect closure using Amplatzer septal occluders. J Am Coll Cardiol. 2005;45(4):50–55.
18.
HengrussameeKKatekangpluPPorapakkhamP. Immediate, short and intermediate results of transcatheter closure of secundumtype atrial septal defect using Amplatzer septal occluder devices. J Med Assoc Thai. 2008;91(7):995–1001.
19.
BergerFEwertPAbdulKhaliqHNürnbergJHLangePE. Percutaneous closure of large atrial septal defects with the Amplatzer Septal Occluder: technical overkill or recommendable alternative treatment?J Interv Cardiol. 2001;14(1):63–67.
20.
StaniloaeCSElKhallyZIbrahimRDoreADe GuisePMercierLA. Percutaneous closure of secundum atrial septal defect in adults a single center experience with the Amplatzer septal occluder. J Invasive Cardiol. 2003;15(7):393–397.
21.
SpiesCTimmermannsISchräderR. Transcatheter closure of secundum atrial septal defects in adults with the Amplatzer septal occluder: intermediate and longterm results. Clin Res Cardiol. 2007;96(6):340–346.
22.
OmeishAHijaziZM. Transcatheter closure of atrial septal defects in children & adults using the Amplatzer Septal Occluder. J Interv Cardiol. 2001;14(1):37–44.
23.
KazmiTSadiqMAsifurRehmanHyder NLatifF. Intermediate and longterm outcome of patients after device closure of ASD with special reference to complications. J Ayub Med Coll Abbottabad. 2009;21(3):117–121.
24.
CelikerAOzkutluSKaragözTAyabakanCBilgiçA. Transcatheter closure of interatrial communications with Amplatzer device: results, unfulfilled attempts and special considerations in children and adolescents. Anadolu Kardiyol Derg. 2005;5(3):159–164.
25.
KongXCaoKYangR. Transcatheter closure of secundum atrial septal defect using an Amplatzer septal occluder. Chin Med J. 2002;115(1):126–128.
26.
LeeCHKwokOHFanKChauEYipAChowWH. Transcatheter closure of atrial septal defect using Amplatzer septal occluder in Chinese adults. Catheter Cardiovasc Interv. 2001;53(3):373–377.
27.
BialkowskiJKarwotBSzkutnikMBanaszakPKusaJSkalskiJ. Closure of atrial septal defects in children. Texas Heart Inst J. 2004;31(3):220–223.
28.
DuZDHijaziZMKleinmanCSSilvermanNHLarntzK, Amplatzer Investigators. Comparison between transcatheter and surgical closure of secundum atrial septal defect in children and adults: results of a multicenter nonrandomized trial. J Am Coll Cardiol. 2002;39(11):1836–1844.
29.
ViscontiKJBichellDPJonasRANewburgerJWBellingerDC. Development outcome after surgical versus interventional closure of secundum atrial septal defect in children. Circulation. 1999;100(suppl 19):145–150.
30.
PeironeAContrerasAFerreroAda CostaRNPedraSFPedraCA. Immediate and short-term outcomes after percutaneous atrial septal defect closure using the new Nit-Occlud ASD-R device. Catheter Cardiovasc Interv. 2014;84(3):464–470. doi:10.1002/ccd.25434. Epub 2014 Feb 27.
31.
BulutMOYucelIKKucukMBalliSBasarEZCelebiA. Initial experience with the Nit-Occlud ASD-R: short-term results. Pediatr Cardiol. 2016;37(7):1258–1265. doi:10.1007/s00246-016-1426-3. Epub 2016 Jun 9.
32.
LangNSchmitzCLehneA. Preclinical evaluation of a new selfexpanding device for closure of muscular ventricular septal defects in a pig model. Catheter Cardiovasc Interv. 2010;75(3):408–415.
33.
BueckerASpuentrupEGrabitzR. Real-time-MR guidance for placement of a self-made fully MR-compatible atrial septal occluder: in vitro test. Rofo. 2002;174(3):283–285.
34.
BueckerASpuentrupEGrabitzR. Magnetic resonance-guided placement of atrial septal closure device in animal model of patent foramen ovale. Circulation. 2002;106(4):511–515.
SpiesCKhandelwalATimmermannsISchräderR. Incidence of atrial fibrillation following transcatheter closure of atrial septal defects in adults. Am J Cardiol. 2008;102(7):902–926.
