Skip to main content Accessibility help
×
Home

Amplatzer occluder versus CardioSEAL/STARFlex occluder: a meta-analysis of the efficacy and safety of transcatheter occlusion for patent foramen ovale and atrial septal defect

  • Yifei Li (a1) (a2), Kaiyu Zhou (a1) (a3), Yimin Hua (a1) (a3), Chuan Wang (a2), Liang Xie (a2), Jie Fang (a4), Xin Rong (a2) and Jiantong Shen (a5)...

Abstract

Objective

Percutaneous transcatheter occlusion has benefited thousands of patients suffering from patent foramen ovale and atrial septal defect. However, no general agreement has been reached on the superiority among occluders. Thus, a meta-analysis between the two most commonly adopted types of occluders was conducted.

Methods

The literature review has identified relevant studies up to May, 2011 in the databases of PubMed, EMBASE, the Cochrane Central Register of Controlled Trials, and World Health Organization clinical trials registry centre. Meta-analysis was performed in a fixed/random effects model using Revman 5.1.1. Information on complications and outcomes was extracted.

Results

Analysis from included studies reports an outcome in favour of the Amplatzer. The Amplatzer has proven its superiority in efficacy with a significantly lower risk of early (95% confidence interval = 0.09–0.34) and long-term (95% confidence interval = 0.14–0.97) residual shunt rate for atrial septal defect occlusion, although no significant difference in performance has been reported for patent foramen ovale. In addition, the Amplatzer has also remarkably reduced the risk of embolisation by the device (95% confidence interval = 0.07–0.45) for atrial septal defect and new-set atrial fibrillation (95% confidence interval = 0.18–0.48) for patent foramen ovale. On evaluation of recurrent thrombotic events, it was found that the Amplatzer greatly lowered the rate of thrombus formation on the device (95% confidence interval = 0.02–0.21) for patent foramen ovale; however, no statistical difference was found on atrial septal defect evaluation. However, the result indicated no statistically significant difference between the two kinds of occluders in stroke and transient ischaemic attack of patent foramen ovale.

Conclusion

The meta-analysis has proven the Amplatzer to be the superior occluder, serving better prognosis with more fluent procedure and less complications.

Copyright

Corresponding author

Correspondence to: Dr K. Zhou, MD, Department of Pediatric Cardiovascular Disease, West China Second University Hospital, Sichuan University; Ministry of Education Key Laboratory of Women and Children's Diseases and Birth Defects, Chengdu, Sichuan 610041, China. Tel: +86 28 85501352; Fax: +86 28 85501059; E-mail: kaiyuzhou313@163.com

References

Hide All
1. Hoffman, JI, Kaplan, S. The incidence of congenital heart disease. J Am Coll Cardiol 2002; 39: 18901900.
2. Lechat, P, Mas, JL, Lascault, G, et al. Prevalence of patent foramen ovale in patients with stroke. N Engl J Med 1988; 318: 11481152.
3. Di Tullio, MR, Sacco, RL, Sciacca, RR, Jin, Z, Homma, S. Patent foramen ovale and the risk of ischemic stroke in a multiethnic population. J Am Coll Cardiol 2007; 49: 797802.
4. Wahl, A, Krumsdorf, U, Meier, B, et al. Transcatheter treatment of atrial septal aneurysm associated with patent foramen ovale for prevention of recurrent paradoxical embolism in high-risk patients. J Am Coll Cardiol 2005; 45: 377380.
5. Cottens, D, Van De Bruaene, A, Troost, E, Willems, R, Moons, P, Budts, W. Influence of percutaneous transcatheter closure of an atrial septal defect on the atrioventricular conduction. Acta Cardiol 2011; 66: 309314.
6. Moake, L, Ndinjiakat, SK. Transcatheter device closure for atrial septal defect: safety, efficacy, complications, and costs. Crit Care Nurs Clin North Am 2011; 23: 339348.
7. Tang, C, Zeng, Z, Li, J, Cao, WZ, Huang, P. Amplatzer transcatheter and surgical closure for ostium secundum atrial septal defect: a systematic review. Chin J Evid Based Med 2007; 7: 267275.
8. Berger, F, Ewert, P, Bjornstad, PG, et al. Transcatheter closure as standard treatment for most interatrial defects: experience in 200 patients treated with the Amplatzer Septal Occluder. Cardiol Young 1999; 9: 468473.
9. Carminati, M, Chessa, M, Butera, G, et al. Transcatheter closure of atrial septal defect with the STARFlex device: early results and follow-up. J Interv Cardiol 2001; 14: 319324.
10. Das, GS, Voss, G, Jarvis, G, Wyche, K, Gunther, R, Wilson, RF. Experimental atrial septal defect closure with a new, transcatheter, self-centering device. Circulation 1993; 88: 17541764.
11. Rome, JJ, Keane, JF, Perry, SB, Spevak, PJ, Lock, JE. Double-umbrella closure of atrial defects. Initial clinical applications. Circulation 1990; 82: 751758.
12. Sideris, EB, Sideris, SE, Thanopoulos, BD, Ehly, RL, Fowlkes, JP. Transvenous atrial septal defect occlusion by the buttoned device. Am J Cardiol 1990; 66: 15241526.
13. Sievert, H, Babic, UU, Hausdorf, G, et al. Transcatheter closure of atrial septal defect and patent foramen ovale with ASDOS device (a multi-institutional European trial). Am J Cardiol 1998; 82: 14051413.
14. Zahn, EM, Wilson, N, Cutright, W, Latson, LA. Development and testing of the Helex septal occluder, a new expanded polytetrafluoroethylene atrial septal defect occlusion system. Circulation 2001; 104: 711716.
15. Deeks, JJ, Dinnes, J, D'Amico, R, et al. Evaluating non-randomised intervention studies. Health Technol Assess 2003; 7: iiix; 1-173.
16. Hammerstingl, C, Bauriedel, B, Stusser, C, et al. Risk and fate of residual interatrial shunting after transcatheter closure of patent foramen ovale: a long term follow up study. Eur J Med Res 2011; 16: 1319.
17. Luermans, JG, Post, MC, ten Berg, JM, Plokker, HW, Suttorp, MJ. Long-term outcome of percutaneous closure of secundum-type atrial septal defect in adults. EuroIntervention 2010; 6: 604610.
18. von Bardeleben, RS, Richter, C, Otto, J, et al. Long term follow up after percutaneous closure of PFO in 357 patients with paradoxical embolism: difference in occlusion systems and influence of atrial septum aneurysm. Int J Cardiol 2009; 134: 3341.
19. Staubach, S, Steinberg, DH, Zimmermann, W, et al. New onset atrial fibrillation after patent foramen ovale closure. Catheter Cardiovasc Interv 2009; 74: 889895.
20. Becker, M, Frings, D, Schröder, J, et al. Impact of occluder device type on success of percutaneous closure of atrial septal defect – a medium-term follow-up study. J Interv Cardiol 2009; 22: 503510.
21. Taaffe, M, Fischer, E, Baranowski, A, et al. Comparison of three patent foramen ovale closure devices in a randomized trial (Amplatzer versus CardioSEAL-STARflex versus Helex occluder). Am J Cardiol 2008; 101: 13531358.
22. Luermans, JG, Post, MC, Plokker, HW, Ten Berg, JM, Suttorp, MJ. Complications and mid-term outcome after percutaneous patent foramen ovale closure in patients with cryptogenic stroke. Neth Heart J 2008; 16: 332336.
23. Hildick-Smith, D, Behan, M, Haworth, P, Rana, B, Thomas, M. Patent foramen ovale closure without echocardiographic control: use of “standby” intracardiac ultrasound. JACC Cardiovasc Interv 2008; 1: 387391.
24. Slavin, L, Tobis, JM, Rangarajan, K, Dao, C, Krivokapich, J, Liebeskind, DS. Five-year experience with percutaneous closure of patent foramen ovale. Am J Cardiol 2007; 99: 13161320.
25. Mareedu, RK, Shah, MS, Mesa, JE, McCauley, CS. Percutaneous closure of patent foramen ovale: a case series and literature review. Clin Med Res 2007; 5: 218226.
26. Harms, V, Reisman, M, Fuller, CJ, et al. Outcomes after transcatheter closure of patent foramen ovale in patients with paradoxical embolism. Am J Cardiol 2007; 99: 13121315.
27. Egred, M, Andron, M, Albouaini, K, Alahmar, A, Grainger, R, Morrison, WL. Percutaneous closure of patent foramen ovale and atrial septal defect: procedure outcome and medium-term follow-up. J Interv Cardiol 2007; 20: 395401.
28. Aslam, F, Iliadis, AE, Blankenship, JC. Percutaneous closure of patent foramen ovale: success and outcomes of a low-volume procedure at a rural medical center. J Invasive Cardiol 2007; 19: 2024.
29. Post, MC, Suttorp, MJ, Jaarsma, W, Plokker, HW. Comparison of outcome and complications using different types of devices for percutaneous closure of a secundum atrial septal defect in adults: a single-center experience. Catheter Cardiovasc Interv 2006; 67: 438443.
30. Alaeddini, J, Feghali, G, Jenkins, S, Ramee, S, White, C, Abi-Samra, F. Frequency of atrial tachyarrhythmias following transcatheter closure of patent foramen ovale. J Invasive Cardiol 2006; 18: 365368.
31. Post, MC, Van Deyk, K, Budts, W. Percutaneous closure of a patent foramen ovale: single-centre experience using different types of devices and mid-term outcome. Acta Cardiol 2005; 60: 515519.
32. Ilkhanoff, L, Naidu, SS, Rohatgi, S, Ross, MJ, Silvestry, FE, Herrmann, HC. Transcatheter device closure of interatrial septal defect in patients with hypoxia. J Interv Cardiol 2005; 18: 227232.
33. Azarbal, B, Tobis, J, Suh, W, Chan, V, Dao, C, Gaster, R. Association of interatrial shunts and migraine headaches: impact of transcatheter closure. J Am Coll Cardiol 2005; 45: 489492.
34. Varma, C, Benson, LN, Warr, MR, et al. Clinical outcomes of patent foramen ovale closure for paradoxical emboli without echocardiographic guidance. Catheter Cardiovasc Interv 2004; 62: 519525.
35. Krumsdorf, U, Ostermayer, S, Billinger, K, et al. Incidence and clinical course of thrombus formation on atrial septal defect and patient foramen ovale closure devices in 1,000 consecutive patients. J Am Coll Cardiol 2004; 43: 302309.
36. Butera, G, Carminati, M, Chessa, M, et al. CardioSEAL/STARflex versus Amplatzer devices for percutaneous closure of small to moderate (up to 18 mm) atrial septal defect. Am Heart J 2004; 148: 507510.
37. Braun, M, Gliech, V, Boscheri, A, et al. Transcatheter closure of patent foramen ovale (PFO) in patients with paradoxical embolism. Periprocedural safety and mid-term follow-up results of three different device occluder systems. Eur Heart J 2004; 25: 424430.
38. Anzai, H, Child, J, Natterson, B, et al. Incidence of thrombus formation on the CardioSEAL and the Amplatzer interatrial closure devices. Am J Cardiol 2004; 93: 426431.
39. Butera, G, De Rosa, G, Chessa, M, et al. Transcatheter closure of atrial septal defect in young children: results and follow-up. J Am Coll Cardiol 2003; 42: 241245.
40. Bialkowski, J, Kusa, J, Szkutnik, M, et al. Percutaneous catheter closure of atrial septal defect. Short-term and mid-term results. Rev Esp Cardiol 2003; 56: 383388.
41. Chessa, M, Carminati, M, Butera, G, et al. Early and late complications associated with transcatheter occlusion of secundum atrial septal defect. J Am Coll Cardiol 2002; 39: 10611065.
42. Veldtman, GR, Razack, V, Siu, S, et al. Right ventricular form and function after percutaneous atrial septal defect device closure. J Am Coll Cardiol 2001; 37: 21082113.
43. Sievert, H, Horvath, K, Zadan, E, et al. Patent foramen ovale closure in patients with transient ischemia attack/stroke. J Interv Cardiol 2001; 14: 261266.
44. Krumsdorf, U, Keppeler, P, Horvath, K, Zadan, E, Schrader, R, Sievert, H. Catheter closure of atrial septal defect and patent foramen ovale in patients with an atrial septal aneurysm using different devices. J Interv Cardiol 2001; 14: 4955.
45. Butera, G, Bini, MR, Chessa, M, Bedogni, F, Onofri, M, Carminati, M. Transcatheter closure of patent foramen ovale in patients with cryptogenic stroke. Ital Heart J 2001; 2: 115118.
46. Acar, P, Saliba, Z, Bonhoeffer, P, Sidi, D, Kachaner, J. Assessment of the geometric profile of the Amplatzer and Cardioseal septal occluders by three dimensional echocardiography. Heart 2001; 85: 451453.
47. Webster, MW, Chancellor, AM, Smith, HJ, et al. Patent foramen ovale in young stroke patients. Lancet 1988; 2: 1112.
48. Mas, JL, Arquizan, C, Lamy, C, et al. Recurrent cerebrovascular events associated with patent foramen ovale, atrial septal aneurysm, or both. N Engl J Med 2001; 345: 17401746.
49. Paciaroni, M, Agnelli, G, Bertolini, A, et al. Risk of recurrent cerebrovascular events in patients with cryptogenic stroke or transient ischemic attack and patent foramen ovale: the FORI (Foramen Ovale Registro Italiano) study. Cerebrovasc Dis 2011; 31: 109116.
50. Quek, SC, Hota, S, Tai, BC, Mujumdar, S, Tok, MY. Comparison of clinical outcomes and cost between surgical and transcatheter device closure of atrial septal defect in Singapore children. Ann Acad Med Singapore 2010; 39: 629633.
51. Porstmann, W, Wierny, L, Warnke, H. Closure of ductus arteriosus persistens without thoractomy. Z Gesamte Inn Med 1968; 23: 142143.
52. Rahman, MA, Djer, MM, Lefi, A. Transcatheter closure of secundum atrial septal defect with Amplatzer septal occluder: experience at Dr Soetomo Hospital Surabaya Indonesia. Cardiol Young 2010; 20 (Suppl 1): S392.
53. Morgan, G, Lee, KJ, Chaturvedi, R, Benson, L. A biodegradable device (BioSTAR(trademark)) for atrial septal defect closure in children. Catheter Cardiovasc Interv 2010; 76: 241245.
54. Poommipanit, P, Levi, D, Shenoda, M, Tobis, J. Percutaneous retrieval of the locked HELEX septal occluder. Catheter Cardiovasc Interv 2011; 77: 892900.
55. Thaman, R, Faganello, G, Gimeno, JR, et al. Efficacy of percutaneous closure of patent foramen ovale: comparison among three commonly used occluders. Heart 2011; 97: 394399.
56. Tomar, M, Khatri, S, Radhakrishnan, S, Shrivastava, S. Intermediate and long-term followup of percutaneous device closure of fossa ovalis atrial septal defect by the Amplatzer septal occluder in a cohort of 529 patients. Ann Pediatr Cardiol 2011; 4: 2227.
57. Otto, A, Aytemir, K, Ates, AH, et al. Transcatheter closure of secundum atrial septal defect using amplatzer and figulla septal occluder in adult patients: intermediate and long term follow-up results. Int J Cardiol 2011; 147 (Suppl 2): S70.
58. Sadiq, M, Kazmi, T, Rehman, AU, Latif, F, Hyder, N, Qureshi, SA. Outcome of device closure of ASD in intermediate and long term. Cardiol Young 2010; 20 (Suppl 2): S96.
59. Han, YM, Gu, X, Titus, JL, et al. New self-expanding patent foramen ovale occlusion device. Catheter Cardiovasc Interv 1999; 47: 370380.
60. Dogan, U, Ozdemir, K, Narin, C, Akilli, H, Gulec, H, Gok, H. Embolization of atrial septal occluder device into the pulmonary artery. Int J Cardiol 2010; 140 (Suppl 1): S82.
61. Shirodkar, S, Patil, S, Pinto, R, Dalvi, B. Successful retrieval of migrated Amplatzer septal occluder. Ann Pediatr Cardiol 2010; 3: 8386.
62. Amanullah, MM, Siddiqui, MT, Khan, MZ, Atiq, MA. Surgical rescue of embolized amplatzer devices. J Card Surg 2011; 26: 254258.
63. Pieculewicz, M, Przewlocki, T, Wilkolek, P, et al. Arrhythmias after transcatheter closure of persistent foramen ovale are related to the type of the implanted device. Eur Heart J 2010; 31 (Suppl 1): S181.
64. Montgomery, J, Semder, C, Mendes, L, Fredi, J, Piana, R. Incidence of arrhythmia after percutaneous closure of PFO or ASD. Catheter Cardiovasc Interv 2011; 77 (Suppl 1): S30.
65. Taniguchi, M, Akagi, T, Ohtsuki, S, et al. Transcatheter closure of atrial septal defect in elderly patients with permanent atrial fibrillation. Catheter Cardiovasc Interv 2009; 73: 682686.
66. Khositseth, A, Cabalka, AK, Sweeney, JP, et al. Transcatheter amplatzer device closure of atrial septal defect and patent foramen ovale in patients with presumed paradoxical embolism. Mayo Clin Proc 2004; 79: 3541.
67. Canpolat, U, Yorgun, H, Ates, AH, et al. Periprocedural thrombus formation during transcatheter closure of atrial septal defect with amplatzer (registered trademark) septal occluder. Int J Cardiol 2010; 140 (Suppl 1): S84S85.
68. Barcin, C, Kursaklioglu, H, Baysan, O, Gungor, M, Kose, S. Percutaneous closure of atrial septal defect in adults: a single center experience. Int J Cardiol 2010; 140 (Suppl 1): S3S4.
69. Reiss, N, Schuett, U, Maleszka, A, Kleikamp, G, Schenk, S, Gummert, J. Surgical removal of occluder devices: complications and pitfalls. Heart Surg Forum 2009; 12: E143E146.

Keywords

Metrics

Full text views

Total number of HTML views: 0
Total number of PDF views: 0 *
Loading metrics...

Abstract views

Total abstract views: 0 *
Loading metrics...

* Views captured on Cambridge Core between <date>. This data will be updated every 24 hours.

Usage data cannot currently be displayed