Case Reports
Cobrahead Deformity in the Right Atrial Disc of a New-Generation Occlutech Figulla Flex II Atrial Septal Defect Occluder Device
Teoman Kilic, MD Ertan Ural, MD Tayfun Sahin, MD
Cobrahead deformity is a known (but uncommon) phenomenon associated with the left atrial disc of the Amplatzer or Occlutech Figulla septal occluder device during percutaneous transcatheter atrial septal defect closure. It has also been postulated that the right atrial disc of the Amplatzer septal occluder device might upon occasion exhibit the cobrahead malformation. To date, only one case report concerning the cobrahead deformity in the right atrial disc of an Amplatzer septal occluder has been published, if we discount a report published as a letter to the manufacturer. Here we present the first report (known to us) of a cobrahead deformity in the right atrial disc of an Occlutech Figulla Flex II atrial septal defect occluder device during transcatheter closure of a complex atrial septal defect. (Tex Heart Inst J 2015;42(5):454-7)
C
obrahead deformity is a rare phenomenon associated, in particular, with the left atrial (LA) disc of septal occluder devices during transcatheter atrial septal defect (ASD) closure.1 Although cobrahead deformity of the LA disc of the Amplatzer® septal occluder (ASO) (St. Jude Medical, Inc.; St. Paul, Minn) and the Occlutech® Figulla® Flex II septal occluder (FSO) (Occlutech International AB; Helsingborg, Sweden) devices is well known, the appearance of the same deformity in the right atrial (RA) disc is very rare.2-4 To our knowledge, the cobrahead deformity in the RA disc of the new-generation flex devices has never before been described. We present the first report of a cobrahead deformity in the RA disc of an FSO device during transcatheter closure of a complex ASD.
Key words: Cardiac catheterization/methods; cobrahead deformity; equipment failure; heart septal defects, atrial/therapy; prosthesis failure; septal occluder device/ new generation From: Invasive Cardiology Research and Application Unit, Department of Cardiology, Kocaeli University Medical Faculty, 41380 Kocaeli, Turkey Address for reprints: Teoman Kilic, MD, Invasive Cardiology Research and Application Unit, Department of Cardiology, Kocaeli University Medical Faculty, Umuttepe Yerleskesi, 41380 Kocaeli, Turkey E-mail: [email protected] © 2015 by the Texas Heart ® Institute, Houston
454
Case Report In March 2013, a 30-year-old man with increasing dyspnea on exertion, and upon palpitation at rest, was referred for closure of his secundum ASD, which was associated with enlargement of the right-sided chambers and bidirectional shunting. Transesophageal echocardiography (TEE) revealed the defect to be 20 mm in diameter. The aortic rim was absent, and the atrioventricular valve rim and the superior rim were short and floppy. During right-sided heart catheterization, the mean pulmonary artery pressure was 26 mmHg, the pulmonary vascular resistance was 2 Wood units, and the Qp/Qs ratio was 2.75. Therefore, transcatheter closure of the ASD was planned. Written informed consent was obtained from the patient, and the procedure was carried out while the patient was under deep sedation without endotracheal intubation. During the balloon-sizing procedure, the stretched diameter of the ASD was 27 to 28 mm on different views. The stop-flow diameter of the ASD was also 28 mm. The discrepancy between these measurements and the size of the ASD as measured by means of TEE was thought to be the result of an excessively mobile and short, floppy atrioventricular valve and superior rims. The defect was considered to be a rather complex ASD. Because the aortic rim was deficient, we decided to close the defect with a 33-mm, new-generation Occlutech Figulla Flex II ASD device. The device was loaded into a 12F Mullins sheath. There was no difficulty with the device during the loading phase. Neither was there any resistance during advancement, nor any kinking of the delivery catheter. The device was deployed via the standard technique. Nevertheless, the LA disc could not be aligned parallel to the atrial septum. We therefore attempted the left upper pulmonary vein (LUPV) technique. During that attempt, we observed on fluoroscopy a
http://dx.doi.org/10.14503/THIJ-14-4179
Volume 42, Number 5, 2015
collapse at the midpoint and a bulging at the lateral edges of the LA disc, together with a possible cobrahead deformity of the RA disc (Fig. 1). The bulging at the lateral edges of the LA disc on fluoroscopy was confirmed by TEE (Fig. 2). The device was immediately withdrawn from the body. Macroscopic examination confirmed the cobrahead deformity in the RA disc, as well as the collapse at the midpoint of the LA disc and bulging at its 2 edges (Fig. 3). Although there was no problem in the delivery sheath (such as a kink), we exchanged the 12F
Mullins sheath for a 14F Mullins sheath. We restored the device to its original shape manually and reloaded it into the 14F Mullins sheath. To avoid advancing the delivery catheter too far into the body of the LA, we again attempted the standard technique. However, the device again could not be aligned parallel to the septum and prolapsed into the RA. Consequently, we repeated the LUPV technique and successfully aligned the LA disc parallel to the septum. However, TEE at the bicaval plane revealed localized bulging of the RA disc and partial occlusion of the superior vena cava orifice with the RA disc of the device (Fig. 4). We immediately removed the new-generation device and used the LUPV technique to deploy—successfully and with no adverse sequelae—an old-generation 33-mm Occlutech Figulla ASD Occluder N device (Fig. 5).
Fig. 2 Transesophageal echocardiogram shows bulging at the lateral edges of the left atrial disc of the Figulla Flex II device. Supplemental motion image is available for Figure 2.
Fig. 3 Photograph during macroscopic examination shows the cobrahead deformity of the right atrial disc of the Figulla Flex II device. Fig. 1 Fluoroscopic images after the execution of the left upper pulmonary vein technique show A) the collapse in the midpoint and the bulging at the lateral edges (arrows) of the left atrial disc of the Occlutech Figulla Flex II device, and B) the initial phase (arrow) of cobrahead deformity in the right atrial disc. Supplemental motion image is available for Figure 1.
Texas Heart Institute Journal
Discussion Cobrahead deformity is a phenomenon rarely associated with ASO or FSO device deployment during transRA “Cobra” in New-Generation ASD Closure Device
455
Fig. 4 Transesophageal echocardiogram shows localized bulging of the right atrial disc of the Figulla Flex II device and partial occlusion of the superior vena cava orifice. Supplemental motion image is available for Figure 4.
Fig. 5 Fluoroscopic image shows the successful implantation (via the left upper pulmonary vein technique) of an old-generation 33-mm Occlutech Figulla ASD Occluder N device. Supplemental motion image is available for Figure 5.
catheter ASD closure.1,4 Cooke and colleagues 1 first described it in the LA discs of the ASO devices. Several causes have been postulated for LA cobrahead deformity, including opening the device against the body of the LA (for example, the LA wall, the LA appendage, or the pulmonary vein orifice); difficulty in loading the device; twisting the device while advancing it through a smaller sheath, or kinking the delivery catheter; and a manufacturing defect.1 Similar mechanisms can cause LA cobra deformity in the FSO device, the structure of which is similar to that of the ASO (and the deployment techniques the same).4 The first report about the 456
RA “Cobra” in New-Generation ASD Closure Device
cobrahead deformity in the LA disc of the FSO was published by Aaron and colleagues,4 who postulated that the chief underlying cause of the problem was the twisting or compression of the device during its advancement through the sheath. As already stated, only one case of cobrahead malformation of the RA disc of the ASO device has to date been published,2 although another case 3 was reported in the form of a letter to the company. Cobrahead RA disc deformity of the new-generation flex devices has never before been described. Unlike the well-described theories for the development of LA cobrahead deformity, the mechanisms that underlie RA cobrahead malformation are unclear. One proposed mechanism is spontaneous rotation of the disc in ASO devices that exceed 18 mm in diameter: the greater length of wire between the disc margin and the center of the device compromises its memory of shape.2 Trehan and associates 3 claimed that simple clockwise rotation of the delivery cable could correct the RA cobrahead deformity. To the best of our knowledge, their maneuver has not yet been validated in other cases. Although there are no published supporting data, some operators prefer to use the new-generation flexible ASD closure devices in patients with complex ASDs (deficient aortic rims), on the conjecture that the risk of aortic erosion declines in devices that contain less metal in the LA disc. However, in our judgment, a variety of maneuvers used for the closure of large complex ASDs—like the LUPV, the right upper pulmonary vein, and the LA roof techniques—can cause deformities in a flexible device. One of the causes for the development of these deformities might be the smaller amount of metal in the device, which could both reduce its memory of shape and decrease its resistance to compression by the LA wall, LA appendage, or pulmonary vein orifice. In our patient, the bulging at the lateral edges of the LA disc and the cobrahead deformity itself occurred during our execution of the LUPV technique. There was no difficulty during the loading phase of the device, and no resistance or kinking of the delivery system throughout its advancement. Other proposed mechanisms for RA cobrahead deformity, such as spontaneous rotation of the disc or twisting, were also absent from the case reported here. Because localized bulging at the lateral edges of the LA disc reappeared after the exchange of the 12F Mullins sheath for a 14F, we believe that the reason, in this present case, for the bulging in the LA disc and the development of RA cobrahead deformity is our application of the LUPV technique and the consequent high pressure of LUPV tissue upon a soft and flexible device. When a situation such as this arises, the device should immediately be withdrawn, and delivery should be reattempted with a larger sheath. In our patient, the whole device was removed after the deformity was observed. Volume 42, Number 5, 2015
We then corrected the deformity manually (with the device out of the body) and delivered the same device through a larger sheath. When a bulge was observed in the RA disc toward the vena cava, we decided to withdraw the occluder device a second time and to carry out ASD closure with another device, to avoid the risk of superior vena cava syndrome.
References 1. Cooke JC, Gelman JS, Harper RW. Cobrahead malformation of the Amplatzer septal occluder device: an avoidable compilation [sic] of percutaneous ASD closure. Catheter Cardiovasc Interv 2001;52(1):83-5. 2. Waight DJ, Hijazi ZM. Amplatzer devices: benign Cobrahead formation. Catheter Cardiovasc Interv 2001;52(1):86-7. 3. Trehan V, Mukhopadhyay S, Yusuf J, Gupta MD, Suryavanshi S, Mehta V. Cobra head deformity of Amplatzer septal occluder. Indian Heart J 2005;57(1):78-9. 4. Aaron S, Mainzer G, Lorber A. Taming the “cobra”: an approach to “cobra-like” formation seen in the Occlutech atrial septal defect and patent foramen ovale occluders. Catheter Cardiovasc Interv 2012;79(4):678-80.
Texas Heart Institute Journal
RA “Cobra” in New-Generation ASD Closure Device
457
Cobrahead Deformity in the Right Atrial Disc of a New-Generation Occlutech Figulla Flex II Atrial Septal Defect Occluder Device
Teoman Kilic, MD Ertan Ural, MD Tayfun Sahin, MD
Cobrahead deformity is a known (but uncommon) phenomenon associated with the left atrial disc of the Amplatzer or Occlutech Figulla septal occluder device during percutaneous transcatheter atrial septal defect closure. It has also been postulated that the right atrial disc of the Amplatzer septal occluder device might upon occasion exhibit the cobrahead malformation. To date, only one case report concerning the cobrahead deformity in the right atrial disc of an Amplatzer septal occluder has been published, if we discount a report published as a letter to the manufacturer. Here we present the first report (known to us) of a cobrahead deformity in the right atrial disc of an Occlutech Figulla Flex II atrial septal defect occluder device during transcatheter closure of a complex atrial septal defect. (Tex Heart Inst J 2015;42(5):454-7)
C
obrahead deformity is a rare phenomenon associated, in particular, with the left atrial (LA) disc of septal occluder devices during transcatheter atrial septal defect (ASD) closure.1 Although cobrahead deformity of the LA disc of the Amplatzer® septal occluder (ASO) (St. Jude Medical, Inc.; St. Paul, Minn) and the Occlutech® Figulla® Flex II septal occluder (FSO) (Occlutech International AB; Helsingborg, Sweden) devices is well known, the appearance of the same deformity in the right atrial (RA) disc is very rare.2-4 To our knowledge, the cobrahead deformity in the RA disc of the new-generation flex devices has never before been described. We present the first report of a cobrahead deformity in the RA disc of an FSO device during transcatheter closure of a complex ASD.
Key words: Cardiac catheterization/methods; cobrahead deformity; equipment failure; heart septal defects, atrial/therapy; prosthesis failure; septal occluder device/ new generation From: Invasive Cardiology Research and Application Unit, Department of Cardiology, Kocaeli University Medical Faculty, 41380 Kocaeli, Turkey Address for reprints: Teoman Kilic, MD, Invasive Cardiology Research and Application Unit, Department of Cardiology, Kocaeli University Medical Faculty, Umuttepe Yerleskesi, 41380 Kocaeli, Turkey E-mail: [email protected] © 2015 by the Texas Heart ® Institute, Houston
454
Case Report In March 2013, a 30-year-old man with increasing dyspnea on exertion, and upon palpitation at rest, was referred for closure of his secundum ASD, which was associated with enlargement of the right-sided chambers and bidirectional shunting. Transesophageal echocardiography (TEE) revealed the defect to be 20 mm in diameter. The aortic rim was absent, and the atrioventricular valve rim and the superior rim were short and floppy. During right-sided heart catheterization, the mean pulmonary artery pressure was 26 mmHg, the pulmonary vascular resistance was 2 Wood units, and the Qp/Qs ratio was 2.75. Therefore, transcatheter closure of the ASD was planned. Written informed consent was obtained from the patient, and the procedure was carried out while the patient was under deep sedation without endotracheal intubation. During the balloon-sizing procedure, the stretched diameter of the ASD was 27 to 28 mm on different views. The stop-flow diameter of the ASD was also 28 mm. The discrepancy between these measurements and the size of the ASD as measured by means of TEE was thought to be the result of an excessively mobile and short, floppy atrioventricular valve and superior rims. The defect was considered to be a rather complex ASD. Because the aortic rim was deficient, we decided to close the defect with a 33-mm, new-generation Occlutech Figulla Flex II ASD device. The device was loaded into a 12F Mullins sheath. There was no difficulty with the device during the loading phase. Neither was there any resistance during advancement, nor any kinking of the delivery catheter. The device was deployed via the standard technique. Nevertheless, the LA disc could not be aligned parallel to the atrial septum. We therefore attempted the left upper pulmonary vein (LUPV) technique. During that attempt, we observed on fluoroscopy a
http://dx.doi.org/10.14503/THIJ-14-4179
Volume 42, Number 5, 2015
collapse at the midpoint and a bulging at the lateral edges of the LA disc, together with a possible cobrahead deformity of the RA disc (Fig. 1). The bulging at the lateral edges of the LA disc on fluoroscopy was confirmed by TEE (Fig. 2). The device was immediately withdrawn from the body. Macroscopic examination confirmed the cobrahead deformity in the RA disc, as well as the collapse at the midpoint of the LA disc and bulging at its 2 edges (Fig. 3). Although there was no problem in the delivery sheath (such as a kink), we exchanged the 12F
Mullins sheath for a 14F Mullins sheath. We restored the device to its original shape manually and reloaded it into the 14F Mullins sheath. To avoid advancing the delivery catheter too far into the body of the LA, we again attempted the standard technique. However, the device again could not be aligned parallel to the septum and prolapsed into the RA. Consequently, we repeated the LUPV technique and successfully aligned the LA disc parallel to the septum. However, TEE at the bicaval plane revealed localized bulging of the RA disc and partial occlusion of the superior vena cava orifice with the RA disc of the device (Fig. 4). We immediately removed the new-generation device and used the LUPV technique to deploy—successfully and with no adverse sequelae—an old-generation 33-mm Occlutech Figulla ASD Occluder N device (Fig. 5).
Fig. 2 Transesophageal echocardiogram shows bulging at the lateral edges of the left atrial disc of the Figulla Flex II device. Supplemental motion image is available for Figure 2.
Fig. 3 Photograph during macroscopic examination shows the cobrahead deformity of the right atrial disc of the Figulla Flex II device. Fig. 1 Fluoroscopic images after the execution of the left upper pulmonary vein technique show A) the collapse in the midpoint and the bulging at the lateral edges (arrows) of the left atrial disc of the Occlutech Figulla Flex II device, and B) the initial phase (arrow) of cobrahead deformity in the right atrial disc. Supplemental motion image is available for Figure 1.
Texas Heart Institute Journal
Discussion Cobrahead deformity is a phenomenon rarely associated with ASO or FSO device deployment during transRA “Cobra” in New-Generation ASD Closure Device
455
Fig. 4 Transesophageal echocardiogram shows localized bulging of the right atrial disc of the Figulla Flex II device and partial occlusion of the superior vena cava orifice. Supplemental motion image is available for Figure 4.
Fig. 5 Fluoroscopic image shows the successful implantation (via the left upper pulmonary vein technique) of an old-generation 33-mm Occlutech Figulla ASD Occluder N device. Supplemental motion image is available for Figure 5.
catheter ASD closure.1,4 Cooke and colleagues 1 first described it in the LA discs of the ASO devices. Several causes have been postulated for LA cobrahead deformity, including opening the device against the body of the LA (for example, the LA wall, the LA appendage, or the pulmonary vein orifice); difficulty in loading the device; twisting the device while advancing it through a smaller sheath, or kinking the delivery catheter; and a manufacturing defect.1 Similar mechanisms can cause LA cobra deformity in the FSO device, the structure of which is similar to that of the ASO (and the deployment techniques the same).4 The first report about the 456
RA “Cobra” in New-Generation ASD Closure Device
cobrahead deformity in the LA disc of the FSO was published by Aaron and colleagues,4 who postulated that the chief underlying cause of the problem was the twisting or compression of the device during its advancement through the sheath. As already stated, only one case of cobrahead malformation of the RA disc of the ASO device has to date been published,2 although another case 3 was reported in the form of a letter to the company. Cobrahead RA disc deformity of the new-generation flex devices has never before been described. Unlike the well-described theories for the development of LA cobrahead deformity, the mechanisms that underlie RA cobrahead malformation are unclear. One proposed mechanism is spontaneous rotation of the disc in ASO devices that exceed 18 mm in diameter: the greater length of wire between the disc margin and the center of the device compromises its memory of shape.2 Trehan and associates 3 claimed that simple clockwise rotation of the delivery cable could correct the RA cobrahead deformity. To the best of our knowledge, their maneuver has not yet been validated in other cases. Although there are no published supporting data, some operators prefer to use the new-generation flexible ASD closure devices in patients with complex ASDs (deficient aortic rims), on the conjecture that the risk of aortic erosion declines in devices that contain less metal in the LA disc. However, in our judgment, a variety of maneuvers used for the closure of large complex ASDs—like the LUPV, the right upper pulmonary vein, and the LA roof techniques—can cause deformities in a flexible device. One of the causes for the development of these deformities might be the smaller amount of metal in the device, which could both reduce its memory of shape and decrease its resistance to compression by the LA wall, LA appendage, or pulmonary vein orifice. In our patient, the bulging at the lateral edges of the LA disc and the cobrahead deformity itself occurred during our execution of the LUPV technique. There was no difficulty during the loading phase of the device, and no resistance or kinking of the delivery system throughout its advancement. Other proposed mechanisms for RA cobrahead deformity, such as spontaneous rotation of the disc or twisting, were also absent from the case reported here. Because localized bulging at the lateral edges of the LA disc reappeared after the exchange of the 12F Mullins sheath for a 14F, we believe that the reason, in this present case, for the bulging in the LA disc and the development of RA cobrahead deformity is our application of the LUPV technique and the consequent high pressure of LUPV tissue upon a soft and flexible device. When a situation such as this arises, the device should immediately be withdrawn, and delivery should be reattempted with a larger sheath. In our patient, the whole device was removed after the deformity was observed. Volume 42, Number 5, 2015
We then corrected the deformity manually (with the device out of the body) and delivered the same device through a larger sheath. When a bulge was observed in the RA disc toward the vena cava, we decided to withdraw the occluder device a second time and to carry out ASD closure with another device, to avoid the risk of superior vena cava syndrome.
References 1. Cooke JC, Gelman JS, Harper RW. Cobrahead malformation of the Amplatzer septal occluder device: an avoidable compilation [sic] of percutaneous ASD closure. Catheter Cardiovasc Interv 2001;52(1):83-5. 2. Waight DJ, Hijazi ZM. Amplatzer devices: benign Cobrahead formation. Catheter Cardiovasc Interv 2001;52(1):86-7. 3. Trehan V, Mukhopadhyay S, Yusuf J, Gupta MD, Suryavanshi S, Mehta V. Cobra head deformity of Amplatzer septal occluder. Indian Heart J 2005;57(1):78-9. 4. Aaron S, Mainzer G, Lorber A. Taming the “cobra”: an approach to “cobra-like” formation seen in the Occlutech atrial septal defect and patent foramen ovale occluders. Catheter Cardiovasc Interv 2012;79(4):678-80.
Texas Heart Institute Journal
RA “Cobra” in New-Generation ASD Closure Device
457
