489
Views
12
CrossRef citations to date
0
Altmetric
Device Profile

Amplatzer patent foramen ovale occluder: safety and efficacy

, , ORCID Icon &
Pages 173-182 | Received 01 Nov 2018, Accepted 07 Feb 2019, Published online: 18 Feb 2019

References

  • Hart RG, Diener H-C, Coutts SB, et al. Embolic strokes of undetermined source: the case for a new clinical construct. Lancet Neurol. 2014;13(4):429–438.
  • Messé SR, Gronseth G, Kent DM, et al. Practice advisory: recurrent stroke with patent foramen ovale (update of practice parameter). Neurology. 2016;87(8):815.
  • Kernan WN, Ovbiagele B, Black HR, et al. Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014;45(7):2160–2236.
  • Whitlock RP, Sun JC, Fremes SE, et al. Antithrombotic and thrombolytic therapy for valvular disease. Chest. 2012;141(2):e576S–e600S.
  • Arauz A, Murillo L, Márquez JM, et al. Long-term risk of recurrent stroke in young cryptogenic stroke patients with and without patent foramen ovale. Int J Stroke. 2012;7(8):631–634.
  • Saver JL, Carroll JD, Thaler DE, et al. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med. 2017;377(11):1022–1032.
  • Mas J-L, Derumeaux G, Guillon B, et al. Patent foramen ovale closure or anticoagulation vs antiplatelets after stroke. N Engl J Med. 2017;377(11):1011–1021.
  • Søndergaard L, Kasner SE, Rhodes JF, et al. Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. N Engl J Med. 2017;377(11):1033–1042.
  • Lee PH, Song J-K, Kim JS, et al. Cryptogenic stroke and high-risk patent foramen ovale. J Am Coll Cardiol. 2018;71(20):2335–2342.
  • King T, Mills NL. Nonoperative closure of atrial septal defects. Surgery. 1974;75(3):383–388.
  • Bridges ND, Hellenbrand W, Latson L, et al. Transcatheter closure of patent foramen ovale after presumed paradoxical embolism. Circulation. 1992;86(6):1902–1908.
  • Meier B. Patent foramen ovale and closure technique with the Amplatzer occluder. 2014. Available from: www.hindawi.com/journals/scientifica/2014/129196.
  • Collado FMS, Poulin M, Murphy JJ, et al. Patent foramen ovale closure for stroke prevention and other disorders. J Am Heart Assoc. 2018;7(12):e007146.
  • Meier B. Patent foramen ovale – Amplatzer PFO occluders. In: Interventions in Structural, Valvular, and Congenital Heart Disease. Sievert H, Qureshi SA, Wilson N, Hijazi ZM (eds). CRC Press, second edition, 2015. pp 501-522.
  • Wahl A, Tai T, Praz F, et al. Late results after percutaneous closure of patent foramen ovale for secondary prevention of paradoxical embolism using the Amplatzer PFO occluder without intraprocedural echocardiography. JACC Cardiovasc Interv. 2009;2(2):116–123.
  • Meier B. Pacman sign during device closure of the patent foramen ovale. Catheter Cardiovasc Interv. 2003;60(2):221–223.
  • Wahl A, Windecker S, Meier B. Percutaneous closure of patent foramen ovale with the Amplatzer PFO occluder. In: Herrmann HC, editor. Interventional cardiology. Totowa, NJ: Humana Press; 2005. p. 143–160.
  • Susuri N, Obeid S, Ulmi M, et al. Second transcatheter closure for residual shunt following percutaneous closure of patent foramen ovale. EuroIntervention. 2017;13(7):858–866.
  • Agarwal S, Bajaj NS, Kumbhani DJ, et al. Meta-analysis of transcatheter closure versus medical therapy for patent foramen ovale in prevention of recurrent neurological events after presumed paradoxical embolism. Jacc Cardiovasc Interv. 2012;5(7):777–789.
  • Onorato E, Melzi G, Casilli F, et al. Patent Foramen Ovale with paradoxical embolism: mid-term results of transcatheter closure in 256 patients. J Interv Cardiol. 2003;16(1):43–50.
  • Trabattoni D, Gaspardone A, Sgueglia GA, et al. Amplatzer versus Figulla occluder for transcatheter patent foramen ovale closure. EuroIntervention. 2017;12(17):2092–2099.
  • Schwerzmann M, Windecker S, Wahl A, et al. Percutaneous closure of patent foramen ovale: impact of device design on safety and efficacy. Heart. 2004;90(2):186–190.
  • Tsivgoulis G, Katsanos AH, Mavridis D, et al. Percutaneous patent foramen ovale closure for secondary stroke prevention: network meta-analysis. Neurology. 2018;91(1):e8–18.
  • Hornung M, Bertog SC, Franke J, et al. Long-term results of a randomized trial comparing three different devices for percutaneous closure of a patent foramen ovale. Eur Heart J. 2013;34(43):3362–3369.
  • Melikian N, MacCarthy PA. The spectrum of PFO closure devices. Cardiol Today. 2017;11:55–57.
  • Rigatelli G, Zuin M. Transcatheters for closure of patent foramen ovales. Expert Rev Med Devices. 2018;15(4):277–281.
  • Majunke N, Baranowski A, Zimmermann W, et al. A suture not always the ideal solution: problems encountered in developing a suture-based PFO closure technique. Catheter Cardiovasc Interv. 2009;73(3):376–382.
  • Sievert H, Ruygrok P, Salkeld M, et al. Transcatheter closure of patent foramen ovale with radiofrequency: acute and intermediate term results in 144 patients. Catheter Cardiovasc Interv. 2009;73(3):368–373.
  • Reiffenstein I, Majunke N, Wunderlich N, et al. Percutaneous closure of patent foramen ovale with a novel FlatStentTM. Expert Rev Med Devices. 2008;5(4):419–425.
  • Mullen MJ, Hildick-Smith D, De Giovanni JV, et al. BioSTAR evaluation study (BEST): a prospective, multicenter, phase I clinical trial to evaluate the feasibility, efficacy, and safety of the BioSTAR bioabsorbable septal repair implant for the closure of atrial-level shunts. Circulation. 2006;114(18):1962–1967.
  • Van Den Branden BJ, Post MC, Plokker HW, et al. Patent foramen ovale closure using a bioabsorbable closure device. JACC Cardiovasc Interv. 2010;3(9):968–973.
  • Happel CM, Laser KT, Sigler M, et al. Single center experience: implantation failures, early, and late complications after implantation of a partially biodegradable ASD/PFO-device (BioStar®). Catheter Cardiovasc Interv. 2015;85(6):990–997.
  • Mehan VK, Wahl A, Walpoth N, et al. Instant percutaneous closure of patent foramen ovale in patients with acute myocardial infarction and normal coronary arteries. Catheter Cardiovasc Interv. 2006;67(2):279–282.
  • Dao CN, Tobis JM. PFO and paradoxical embolism producing events other than stroke. Catheter Cardiovasc Interv. 2011;77(6):903–909.
  • Nozari A, Dilekoz E, Sukhotinsky I, et al. Microemboli may link spreading depression, migraine aura, and patent foramen ovale. Ann Neurol. 2010;67(2):221–229.
  • Kanwar SM, Noheria A, DeSimone CV, et al. Coincidental impact of transcatheter patent foramen ovale closure on migraine with and without aura – a comprehensive meta-analysis. Clin Trials Regul Sci Cardiol. 2016;15:7–13.
  • Dowson A, Mullen MJ, Peatfield R, et al. Migraine Intervention With STARFlex Technology (MIST) Trial: a prospective, multicenter, double-blind, sham-controlled trial to evaluate the effectiveness of patent foramen ovale closure with STARFlex septal repair implant to resolve refractory migraine headache. Circulation. 2008;117(11):1397–1404.
  • Mattle HP, Evers S, Hildick-Smith D, et al. Percutaneous closure of patent foramen ovale in migraine with aura, a randomized controlled trial. Eur Heart J. 2016;37(26):2029–2036.
  • Tobis JM, Charles A, Silberstein SD, et al. Percutaneous closure of patent foramen ovale in patients with migraine. J Am Coll Cardiol. 2017;70(22):2766–2774.
  • Meier B. Patent foramen ovele, good reasons to close it. Dtsch Med Wochenschr. 1946–2018;143(5):354–356.
  • Kheiri B, Abdalla A, Osman M, et al. Percutaneous closure of patent foramen ovale in migraine. JACC Cardiovasc Interv. 2018;11(8):816–818.
  • Knauth M, Ries S, Pohimann S, et al. Cohort study of multiple brain lesions in sport divers: role of a patent foramen ovale. BMJ. 1997;314(7082):701.
  • Schwerzmann M, Seiler C, Lipp E, et al. Relation between directly detected patent foramen ovale and ischemic brain lesions in sport divers. Ann Intern Med. 2001;134(1):21–24.
  • Allemann Y, Hutter D, Lipp E, et al. Patent foramen ovale and high-altitude pulmonary Edema. JAMA. 2006;296(24):2954.
  • Lovering AT, Elliott JE, Davis JT. Physiological impact of patent foramen ovale on pulmonary gas exchange, ventilatory acclimatization, and thermoregulation. J Appl Physiol. 2016;121(2):512–517.
  • Shanoudy H, Soliman A, Raggi P, et al. Prevalence of patent foramen ovale and its contribution to hypoxemia in patients with obstructive sleep Apnea. Chest. 1998;113(1):91–96.
  • Soliman A, Shanoudy H, Liu J, et al. Increased prevalence of patent foramen ovale in patients with severe chronic obstructive pulmonary disease. J Am Soc Echocardiogr. 1999;12:99–105.
  • Meier B. Some air for closure of the patent foramen ovale. JACC Cardiovasc Interv. 2012;5(4):420–421.
  • Cheng TO. Platypnea-orthodeoxia syndrome: etiology, differential diagnosis, and management. Catheter Cardiovasc Interv. 1999;47(1):64–66.
  • Zaker‐Shahrak R, Fuhrer J, Meier B. Transseptal puncture for catheter ablation of atrial fibrillation after device closure of patent foramen ovale. Catheter Cardiovasc Interv. 2008;71(4):551–552.
  • Honari G, Ellis SG, Wilkoff BL, et al. Hypersensitivity reactions associated with endovascular devices. Contact Dermatitis. 2008;59(1):7–22.
  • Fukahara K, Minami K, Reiss N, et al. Systemic allergic reaction to the percutaneous patent foramen ovale occluder. J Thorac Cardiovasc Surg. 2003;125(1):213–214.
  • Ries MW, Kampmann C, Rupprecht H-J, et al. Nickel release after implantation of the Amplatzer occluder. Am Heart J. 2003;145(4):737–741.
  • Verma SK, Tobis JM. Explantation of patent foramen ovale closure devices. JACC Cardiovasc Interv. 2011;4(5):579–585.
  • Mojadidi MK, Elgendy AY, Elgendy IY, et al. Transcatheter patent foramen ovale closure after cryptogenic stroke. JACC Cardiovasc Interv. 2017;10(21):2228–2230.
  • 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(2):302–309.
  • Amin Z, Hijazi ZM, Bass JL, et al. PFO closure complications from the AGA registry. Catheter Cardiovasc Interv. 2008;72(1):74–79.
  • Meier B. Optimal stroke prevention in patients with patent foramen ovale. Lancet Neurol. 2018;17(12):1027–1028.
  • Madhkour R, Meier B. Patent foramen ovale closure, a contemporary review. Struct Heart. 2018;2(2):114–120.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.