Original article
Percutaneous closure of patent foramen ovale with Atriasept II device in nickel allergic patients Valeria Cammalleri, Gian Paolo Ussia, Massimo Marchei, Saverio Muscoli, Domenico Sergi, Massimiliano Macrini and Francesco Romeo There are concerns about percutaneous closure of patent foramen ovale (PFO) using nitinol-alloys devices in patients with nickel hypersensitivity. We describe our experience with Atriasept II (Cardia Eagan, Minnesota, USA) used in four patients with known nickel allergy. No intraprocedural or in-hospital adverse events occurred. The follow-up was negative for allergic manifestations, without complications, as assessed by echocardiography. Because of the risk of adverse outcomes in nickel-allergic patients, devices with higher biocompatibility, low-profile, and low nickel content should be preferred in cases of known hypersensitivity.
Introduction Various devices are now available for the percutaneous closure of a patent foramen ovale (PFO), allowing the clinician to select the most appropriate one for a given patient and the interatrial septum morphology. Most of the devices currently used consist of a metallic alloy containing various quantities of nickel. However, hypersensitivity to nickel is a known problem, and may occur in up to 15% of the general population.1 In current clinical practice, patients with nickel allergy are treated with standard metallic devices, and complications related to allergic reactions have been infrequently reported. Atriasept II (Cardia Eagan, Minnesota, USA) is a new occluder with a minimal amount of exposed nitinol, so that the possibility of nickel release is reduced, and this could be an advantage in patients with known nickel hypersensitivity. In view of the reported high risk of adverse outcomes in nickel allergic patients receiving interatrial occluders, we assessed the outcomes in our allergic patients following treatment with Atriasept II for PFO closure.
Device description The Atriasept II (Cardia Eagan, Minnesota, USA) is a double umbrella device with left and right-sided nitinol struts and two polyfluoroethylene discs. The complete system consists of three components: the device, the delivery forceps, and the introducer. The device is fully retrievable, and is comprised of four materials: nitinol struts with titanium caps on each end, titanium centerposts, polyvinyl alcohol, and polypropylene sutures. The frame of the device is constructed from two titanium 1558-2027 ß 2014 Italian Federation of Cardiology
Atriasept II, containing less metallic material, appears to be a safe option in allergic patients undergoing PFO closure. J Cardiovasc Med 2014, 15:350–352 Keywords: complications, nickel, patent foramen ovale Department of Cardiovascular Disease, Tor Vergata University of Rome, Rome, Italy Correspondence to Gian Paolo Ussia, Department of Cardiovascular Disease, Tor Vergata University of Rome, Rome, Viale Oxford, 81 00133 Rome, Italy Tel: +39 0620904009; fax: +39 0620904008; e-mail: [email protected]
centerposts and three sets of stranded nitinol wires. Three sizes are currently available; 20, 25 and 30 mm.
Case series From April 2012 to May 2013, 65 patients underwent successfully catheter-based PFO closure. Among these, there were four young female patients (6%) with a strong nickel allergy, diagnosed from the clinical history and patch-tests (Table 1). All four patients had a previous cardiovascular accident, and signs of subcortical ischemia on cerebral MRI. All individuals underwent contrast enhanced trans-cranial Doppler, followed by contrast trans-esophageal echocardiogram in order to confirm the diagnosis, distinguish pulmonary from intracardiac shunts, and evaluate the anatomy of the interatrial septum. In all patients, PFO closure was performed in the catheterization laboratory with local anesthesia, under intracardiac echocardiography with an 8-F AcuNav Ultrasound Catheter (Siemens Medical, Munich, Germany) inserted from the right femoral vein. All the procedures were performed according to the standard technique, except for the PFO balloon-sizing. A 25-mm Table 1
Clinical data of the four patients with diagnosed nickel
allergy
Age (years) Sex Neurological symptoms PFO diagnosis PFO morphology
Case 1
Case 2
Case 3
Case 4
38 Female TIA cTCD, cTEE ASA
21 Female TIA cTCD, cTEE Tunnel-like
41 Female TIA cTCD, cTEE ASA
48 Female TIA cTCD, cTEE //
ASA, atrial septum aneurysm; cTCD, contrast transcranial Doppler; cTEE, contrast transesophageal echocardiography; PFO, patent foramen ovale; TIA, transient ischemic attack. DOI:10.2459/01.JCM.0000435613.63310.d8
Copyright © Italian Federation of Cardiology. Unauthorized reproduction of this article is prohibited.
Patent foramen ovale closure Cammalleri et al. 351
Atriasept II device was implanted in each patient (Fig. 1). Intraprocedurally, no evidence of residual interatrial shunt was detected by right atrial angiogram with contrast injection (Fig. 2); intracardiac echocardiography sets also showed the stable position of the device, with very lowprofile and no interference with the aorta or other cardiac structures. Mean procedural and fluoroscopy times were 15 2 and 4 1 min, respectively. No complications occurred during the procedure and in-hospital stay. All four patients were discharged home the day after the procedure with double antithrombotic therapy for 6 months. In all cases, trans-thoracic echocardiogram performed before discharge, and at 30 days and 6 months showed the absence of device dislodgement, thrombus formation, residual shunt, or erosions. In addition, no cardiovascular accidents, arrhythmia, or any allergic reactions were observed.
Discussion Percutaneous PFO closure is a relatively safe procedure with a major complication rate of between 0.2 and 1.5% and minor complications from 7.9 to 11.5%.2 Newer devices and smaller catheters have led to safer procedures. Nevertheless, concerns exist about the risk of allergic reactions in patients receiving metallic devices. The metal struts of these occluders are usually alloys containing nitinol (45% titanium and 55% nickel) and may cause an allergic response with possible intracardiac mast cell activation. Approximately, 15% of the general population are sensitized to nickel,1 but currently allergic patients are treated with nickel-containing devices. Hypersensitivity to nickel has been variously associated with systemic adverse side-effects (pericarditis, contact dermatitis, chest pain, migraine headache, and palpitations) in patients undergoing percutaneous closure of interatrial shunts, with the risk of surgical explantation reported in case reports.3,4 However, a correlation between nickel-serum levels and allergy has never been
demonstrated, and the allergic response to an indwelling device is not well-understood and might not only depend on the solubility of nickel ions. It has been reported that nickel is released into the blood, typically peaking 1–3 months after implantation, until a calciumphosphate and stable oxide film layer have formed or until endothelialization is completed,3 and it may be that the release of small amounts of nickel over a long period acts as a trigger for allergic reactions,3 particularly in hypersensitivity people. Reddy et al.5 reported a small institutional experience with a Helex device (W.L. Gore & Associates, Inc., Flagstaff, Arizona, USA) implanted in six patients positive to nickel allergy on skin testing. The Helex device has a minimal amount of exposed nitinol, with the majority of the circumferential nitinol support frame enclosed in an expanded polytetrafluoroethylene occlusion membrane. None of the Helex patients developed an allergic reaction, significant chest pain, or arrhythmia. When compared with nickel-allergic patients treated with Amplatzer (AGA Medical Corporation, Minnesota, USA) or Premere (St Jude Medical, Minnesota, USA) reported by Rigatelli et al.,6 Helex patients had a significantly lower prevalence of chest pain (P ¼ 0.005) and device allergic syndrome (P ¼ 0.001). Atriasept II contains less metal material, particularly nitinol, compared with other devices.7 Following its introduction, the device has been modified without changing the general concept, with the advantages of a low-profile, self-centering, and retrieve/reposition ability. The recent model has a minimal amount of exposed nitinol, present only in the device struts. Therefore, the possibility of nickel release is reduced, and this could be an advantage in patients with known nickel hypersensitivity. On the basis of this evidence, all patients scheduled for PFO closure should be screened routinely for metal
Fig. 1
(a)
(b)
RA
LA
Intracardiac echocardiography during opening of the Atriasept II left atrial disc, pulled back against the interatrial septum (a) and fluoroscopy, in 258 left anterior oblique projection immediately after Atriasept II occluder was released (b). RA, right atrium; LA, left atrium.
Copyright © Italian Federation of Cardiology. Unauthorized reproduction of this article is prohibited.
352 Journal of Cardiovascular Medicine 2014, Vol 15 No 4
Fig. 2
four patients with a documented nickel allergy who did not develop a hypersensitivity response to the Atriasept II device. Our experience, even though very limited, indicates that this device is easy to use, and results in an effective immediate closure of the defect with low rate of adverse events. Hence, given the reported high risk of adverse outcomes in nickel-allergic patients receiving interatrial occluders, a device with higher biocompatibility, low-profile, and with low nickel content should be preferred. Future research and randomized trials are clearly needed to investigate the frequency of nickel allergic syndromes and compare different contemporary devices used for interatrial shunt closure.
References 1
2
Right atrial angiography with contrast injection, showing no evidence of residual interatrial shunt.
3
4
allergy. In cases of skin test positivity, devices with a lower nickel content should be preferred. Additionally, clinicians should be prompt to recognize early hypersensitivity reaction in patients with unusual postprocedural courses. We describe the absence of allergic symptoms in
5 6 7
Warshaw EM, Belsito DV, DeLeo VA, et al. North American contact dermatitis group patch-test results, 2003–2004. Dermatitis 2008; 19:129– 136. Khairy P, O’Donnell CP, Landzberg MJ. Transcatheter closure versus medical therapy of patent foramen ovale and presumed paradoxical thromboemboli: a systematic review. Ann Intern Med 2003; 139:753–760. Ussia GP, Cammalleri V, Mule` M, et al. Percutaneous closure of patent foramen ovale with a bioabsorbable occluder device: single-centre experience. Catheter Cardiovasc Interv 2009; 74:607–614. Verma SK, Tobis JM. Explantation of patent foramen ovale closure devices: a multicenter survey. JACC Cardiovasc Interv 2011; 4:579–585. Reddy BT, Patel JB, Powell DL, et al. Interatrial shunt closure devices in patients with nickel allergy. Catheter Cardiovasc Interv 2009; 74:647–651. Rigatelli G, Cardaioli P, Giordan M. Nickel allergy in interatrial shunt devicebased closure patients. Congenit Heart Dis 2007; 2:416–420. Stolt VS, Chessa M, Aubry P, et al. Closure of ostium secundum atrial septum defect with the Atriasept occluder: early European experience. Catheter Cardiovasc Interv 2010; 75:1091–1095.
Copyright © Italian Federation of Cardiology. Unauthorized reproduction of this article is prohibited.
Percutaneous closure of patent foramen ovale with Atriasept II device in nickel allergic patients Valeria Cammalleri, Gian Paolo Ussia, Massimo Marchei, Saverio Muscoli, Domenico Sergi, Massimiliano Macrini and Francesco Romeo There are concerns about percutaneous closure of patent foramen ovale (PFO) using nitinol-alloys devices in patients with nickel hypersensitivity. We describe our experience with Atriasept II (Cardia Eagan, Minnesota, USA) used in four patients with known nickel allergy. No intraprocedural or in-hospital adverse events occurred. The follow-up was negative for allergic manifestations, without complications, as assessed by echocardiography. Because of the risk of adverse outcomes in nickel-allergic patients, devices with higher biocompatibility, low-profile, and low nickel content should be preferred in cases of known hypersensitivity.
Introduction Various devices are now available for the percutaneous closure of a patent foramen ovale (PFO), allowing the clinician to select the most appropriate one for a given patient and the interatrial septum morphology. Most of the devices currently used consist of a metallic alloy containing various quantities of nickel. However, hypersensitivity to nickel is a known problem, and may occur in up to 15% of the general population.1 In current clinical practice, patients with nickel allergy are treated with standard metallic devices, and complications related to allergic reactions have been infrequently reported. Atriasept II (Cardia Eagan, Minnesota, USA) is a new occluder with a minimal amount of exposed nitinol, so that the possibility of nickel release is reduced, and this could be an advantage in patients with known nickel hypersensitivity. In view of the reported high risk of adverse outcomes in nickel allergic patients receiving interatrial occluders, we assessed the outcomes in our allergic patients following treatment with Atriasept II for PFO closure.
Device description The Atriasept II (Cardia Eagan, Minnesota, USA) is a double umbrella device with left and right-sided nitinol struts and two polyfluoroethylene discs. The complete system consists of three components: the device, the delivery forceps, and the introducer. The device is fully retrievable, and is comprised of four materials: nitinol struts with titanium caps on each end, titanium centerposts, polyvinyl alcohol, and polypropylene sutures. The frame of the device is constructed from two titanium 1558-2027 ß 2014 Italian Federation of Cardiology
Atriasept II, containing less metallic material, appears to be a safe option in allergic patients undergoing PFO closure. J Cardiovasc Med 2014, 15:350–352 Keywords: complications, nickel, patent foramen ovale Department of Cardiovascular Disease, Tor Vergata University of Rome, Rome, Italy Correspondence to Gian Paolo Ussia, Department of Cardiovascular Disease, Tor Vergata University of Rome, Rome, Viale Oxford, 81 00133 Rome, Italy Tel: +39 0620904009; fax: +39 0620904008; e-mail: [email protected]
centerposts and three sets of stranded nitinol wires. Three sizes are currently available; 20, 25 and 30 mm.
Case series From April 2012 to May 2013, 65 patients underwent successfully catheter-based PFO closure. Among these, there were four young female patients (6%) with a strong nickel allergy, diagnosed from the clinical history and patch-tests (Table 1). All four patients had a previous cardiovascular accident, and signs of subcortical ischemia on cerebral MRI. All individuals underwent contrast enhanced trans-cranial Doppler, followed by contrast trans-esophageal echocardiogram in order to confirm the diagnosis, distinguish pulmonary from intracardiac shunts, and evaluate the anatomy of the interatrial septum. In all patients, PFO closure was performed in the catheterization laboratory with local anesthesia, under intracardiac echocardiography with an 8-F AcuNav Ultrasound Catheter (Siemens Medical, Munich, Germany) inserted from the right femoral vein. All the procedures were performed according to the standard technique, except for the PFO balloon-sizing. A 25-mm Table 1
Clinical data of the four patients with diagnosed nickel
allergy
Age (years) Sex Neurological symptoms PFO diagnosis PFO morphology
Case 1
Case 2
Case 3
Case 4
38 Female TIA cTCD, cTEE ASA
21 Female TIA cTCD, cTEE Tunnel-like
41 Female TIA cTCD, cTEE ASA
48 Female TIA cTCD, cTEE //
ASA, atrial septum aneurysm; cTCD, contrast transcranial Doppler; cTEE, contrast transesophageal echocardiography; PFO, patent foramen ovale; TIA, transient ischemic attack. DOI:10.2459/01.JCM.0000435613.63310.d8
Copyright © Italian Federation of Cardiology. Unauthorized reproduction of this article is prohibited.
Patent foramen ovale closure Cammalleri et al. 351
Atriasept II device was implanted in each patient (Fig. 1). Intraprocedurally, no evidence of residual interatrial shunt was detected by right atrial angiogram with contrast injection (Fig. 2); intracardiac echocardiography sets also showed the stable position of the device, with very lowprofile and no interference with the aorta or other cardiac structures. Mean procedural and fluoroscopy times were 15 2 and 4 1 min, respectively. No complications occurred during the procedure and in-hospital stay. All four patients were discharged home the day after the procedure with double antithrombotic therapy for 6 months. In all cases, trans-thoracic echocardiogram performed before discharge, and at 30 days and 6 months showed the absence of device dislodgement, thrombus formation, residual shunt, or erosions. In addition, no cardiovascular accidents, arrhythmia, or any allergic reactions were observed.
Discussion Percutaneous PFO closure is a relatively safe procedure with a major complication rate of between 0.2 and 1.5% and minor complications from 7.9 to 11.5%.2 Newer devices and smaller catheters have led to safer procedures. Nevertheless, concerns exist about the risk of allergic reactions in patients receiving metallic devices. The metal struts of these occluders are usually alloys containing nitinol (45% titanium and 55% nickel) and may cause an allergic response with possible intracardiac mast cell activation. Approximately, 15% of the general population are sensitized to nickel,1 but currently allergic patients are treated with nickel-containing devices. Hypersensitivity to nickel has been variously associated with systemic adverse side-effects (pericarditis, contact dermatitis, chest pain, migraine headache, and palpitations) in patients undergoing percutaneous closure of interatrial shunts, with the risk of surgical explantation reported in case reports.3,4 However, a correlation between nickel-serum levels and allergy has never been
demonstrated, and the allergic response to an indwelling device is not well-understood and might not only depend on the solubility of nickel ions. It has been reported that nickel is released into the blood, typically peaking 1–3 months after implantation, until a calciumphosphate and stable oxide film layer have formed or until endothelialization is completed,3 and it may be that the release of small amounts of nickel over a long period acts as a trigger for allergic reactions,3 particularly in hypersensitivity people. Reddy et al.5 reported a small institutional experience with a Helex device (W.L. Gore & Associates, Inc., Flagstaff, Arizona, USA) implanted in six patients positive to nickel allergy on skin testing. The Helex device has a minimal amount of exposed nitinol, with the majority of the circumferential nitinol support frame enclosed in an expanded polytetrafluoroethylene occlusion membrane. None of the Helex patients developed an allergic reaction, significant chest pain, or arrhythmia. When compared with nickel-allergic patients treated with Amplatzer (AGA Medical Corporation, Minnesota, USA) or Premere (St Jude Medical, Minnesota, USA) reported by Rigatelli et al.,6 Helex patients had a significantly lower prevalence of chest pain (P ¼ 0.005) and device allergic syndrome (P ¼ 0.001). Atriasept II contains less metal material, particularly nitinol, compared with other devices.7 Following its introduction, the device has been modified without changing the general concept, with the advantages of a low-profile, self-centering, and retrieve/reposition ability. The recent model has a minimal amount of exposed nitinol, present only in the device struts. Therefore, the possibility of nickel release is reduced, and this could be an advantage in patients with known nickel hypersensitivity. On the basis of this evidence, all patients scheduled for PFO closure should be screened routinely for metal
Fig. 1
(a)
(b)
RA
LA
Intracardiac echocardiography during opening of the Atriasept II left atrial disc, pulled back against the interatrial septum (a) and fluoroscopy, in 258 left anterior oblique projection immediately after Atriasept II occluder was released (b). RA, right atrium; LA, left atrium.
Copyright © Italian Federation of Cardiology. Unauthorized reproduction of this article is prohibited.
352 Journal of Cardiovascular Medicine 2014, Vol 15 No 4
Fig. 2
four patients with a documented nickel allergy who did not develop a hypersensitivity response to the Atriasept II device. Our experience, even though very limited, indicates that this device is easy to use, and results in an effective immediate closure of the defect with low rate of adverse events. Hence, given the reported high risk of adverse outcomes in nickel-allergic patients receiving interatrial occluders, a device with higher biocompatibility, low-profile, and with low nickel content should be preferred. Future research and randomized trials are clearly needed to investigate the frequency of nickel allergic syndromes and compare different contemporary devices used for interatrial shunt closure.
References 1
2
Right atrial angiography with contrast injection, showing no evidence of residual interatrial shunt.
3
4
allergy. In cases of skin test positivity, devices with a lower nickel content should be preferred. Additionally, clinicians should be prompt to recognize early hypersensitivity reaction in patients with unusual postprocedural courses. We describe the absence of allergic symptoms in
5 6 7
Warshaw EM, Belsito DV, DeLeo VA, et al. North American contact dermatitis group patch-test results, 2003–2004. Dermatitis 2008; 19:129– 136. Khairy P, O’Donnell CP, Landzberg MJ. Transcatheter closure versus medical therapy of patent foramen ovale and presumed paradoxical thromboemboli: a systematic review. Ann Intern Med 2003; 139:753–760. Ussia GP, Cammalleri V, Mule` M, et al. Percutaneous closure of patent foramen ovale with a bioabsorbable occluder device: single-centre experience. Catheter Cardiovasc Interv 2009; 74:607–614. Verma SK, Tobis JM. Explantation of patent foramen ovale closure devices: a multicenter survey. JACC Cardiovasc Interv 2011; 4:579–585. Reddy BT, Patel JB, Powell DL, et al. Interatrial shunt closure devices in patients with nickel allergy. Catheter Cardiovasc Interv 2009; 74:647–651. Rigatelli G, Cardaioli P, Giordan M. Nickel allergy in interatrial shunt devicebased closure patients. Congenit Heart Dis 2007; 2:416–420. Stolt VS, Chessa M, Aubry P, et al. Closure of ostium secundum atrial septum defect with the Atriasept occluder: early European experience. Catheter Cardiovasc Interv 2010; 75:1091–1095.
Copyright © Italian Federation of Cardiology. Unauthorized reproduction of this article is prohibited.
