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A Very Late Life-Threatening Complication After Percutaneous Closure of an Atrial Septal Defect
Accepted Manuscript A very late life-threatening complication after percutaneous closure of an atrial septal defect Giancarlo Scognamiglio, MD, PhD, Rosaria Barracano, MD, Diego Colonna, MD, Agostino Mattera Iacono, MD, Giuseppe Santoro, MD, Andrea Spadafora, MD, Gianantonio Nappi, MD, Maria Giovanna Russo, MD, Berardo Sarubbi, MD, PhD PII:
S0828-282X(16)30934-5
DOI:
10.1016/j.cjca.2016.09.003
Reference:
CJCA 2254
To appear in:
Canadian Journal of Cardiology
Received Date: 16 August 2016 Revised Date:
5 September 2016
Accepted Date: 8 September 2016
Please cite this article as: Scognamiglio G, Barracano R, Colonna D, Mattera Iacono A, Santoro G, Spadafora A, Nappi G, Russo MG, Sarubbi B, A very late life-threatening complication after percutaneous closure of an atrial septal defect, Canadian Journal of Cardiology (2016), doi: 10.1016/ j.cjca.2016.09.003. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT A very late life-threatening complication after percutaneous closure of an atrial septal defect.
Giancarlo Scognamiglio MD, PhD 1*, Rosaria Barracano MD 1, Diego Colonna MD 1, Agostino
Maria Giovanna Russo MD 1, Berardo Sarubbi MD, PhD 1
1
Paediatric Cardiology and G.U.C.H. Unit, A.O.R.N. “Ospedali dei Colli”, 2nd University of
SC
Naples, Naples, Italy
Department of Cardiothoracic Sciences, Second University of Naples, Naples, Italy.
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Mattera Iacono MD 1, Giuseppe Santoro MD 1, Andrea Spadafora MD 2, Gianantonio Nappi MD 2,
Short title: very late complication of ASD device closure
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Word count: 942
* Address for correspondence: Dr. Giancarlo Scognamiglio
Hospital
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GUCH Unit - Division of Cardiology, Second University of Naples, AO Dei Colli- Monaldi
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Leonardo Bianchi Street 1, 80131 Naples, Italy Tel+390817062682, Fax+39 0818819648 E-mail: [email protected] Keywords: congenital heart disease; atrial septal defect; cardiac catheterization; septal occluder device; complications; aortic dissection
ACCEPTED MANUSCRIPT Brief summary
Percutaneous device closure of secundum atrial septal defects (ASD) has showed excellent longterm results and a low complication rate. However, adverse events, albeit rare, can be potentially
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life-threatening if not promptly recognized and treated. We report a case of asymptomatic aortic
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erosion occurred 13 years after the procedure who underwent successful surgical repair.
ACCEPTED MANUSCRIPT Abstract Percutaneous closure is widely recognized as the first therapeutic option in the majority of cases of secundum atrial septal defects (ASD), due to its high effectiveness and safety. Nonetheless, with the progressive increase of implanted devices and follow-up duration, several
RI PT
adverse events, some of them potentially life-threatening, have been reported.
We report the case of an asymptomatic aortic erosion occurred thirteen years after the procedure. The main feature of our case is the very late occurrence of a life-threatening asymptomatic
SC
complication of ASD percutaneous closure, which should prompt a life-long surveillance in this
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EP
TE D
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population.
ACCEPTED MANUSCRIPT Case report Transcatheter device closure of ostium secundum atrial septal defects (ASD) is nowadays considered a cost-effective alternative to conventional surgical closure, due to its excellent longterm results. However, although it is deemed generally safe, potentially fatal adverse events have
RI PT
been reported.
We describe the case of a twenty-year-old male patient with an ostium secundum ASD who underwent a successful percutaneous implantation of a 18-mm Amplatzer™ Atrial Septal Occluder
SC
(St. Jude Medical Inc., St. Paul, Minnesota) at the age of five years. The ASD size was evaluated with “dynamic” stretched balloon approach (Equalizer™ Balloon – Boston Scientific, Marlborough,
M AN U
MA). The device was not oversized with respect to the ASD stretched diameter. Follow-up was uneventful, with serial transthoracic echocardiograms performed on a regular twoyear basis showing correct device position in absence of residual shunt and/or any elements suggestive of procedure-related complications..
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However, thirteen years later, at the scheduled assessment, the patient was fully asymptomatic, but the transthoracic echocardiogram showed an aneurismal dilatation of the ascending aorta with an intimal flap in its lumen (Figure 1). The septal device did not appear dislocated and neither residual
EP
atrial shunt, nor pericardial effusion were present. A thorough review of previous echo studies did not reveal any known factor suggestive of potential ASD device erosion.
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Computed tomography scan confirmed the diagnosis by clearly showing the intimal flap arising from the aortic root, just few centimeters distally to the annulus, and extending up to the mid ascending aorta. Furthermore, the edge of the occluder device appeared to protrude into the aortic lumen (Figure 2, Panels A-B). Accordingly, our patient underwent a successful surgical repair with Amplatzer device removal, ASD patch closure and replacement of the ascending aorta with a Dacron graft. Intraoperative findings confirmed an erosion of the right atrial roof extending to the adjacent aortic wall, at the
ACCEPTED MANUSCRIPT level of the non-coronary sinus, due to a partial protrusion of the atrial disc of the occluder device (Figure 2, Panel C). At 1-year assessment the patient is in good health. Erosion of the aortic or atrial wall is an infrequent but life-threatening complication of percutaneous septal defect closure, with an estimated rate of about 0.1-0.3%.1,2 Although it is also reported in
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paediatric age, the relative risk appears to be greater in adults, since, to our knowledge, there are no reports of deaths related to ASD device erosion in paediatric age. Furthermore, patients diagnosed with late erosion after implant are significantly older than those presenting earlier. 3 The reasons are
SC
not fully clear, but different tissue properties may have a potential role. As in our patient an ASD occluder was implanted in childhood and no signs of erosion were present at serial echoes, we can
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assume that further factors other than age at implant can contribute to the timing of onset of the erosion. The most common documented site of perforation is a combination of the atrium and aorta adjacent to the device, suggesting a mechanism of erosion. Unfortunately, from the current literature and available registry data, there is neither conclusive data nor consensus about
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predisposing factors of cardiac perforation or erosion by the device.4 Several risk factors have been implicated as possible causes, as they increase the chance of contact between the device and the atrial wall: absent or deficient superior–anterior rim and inadequate device sizing (either over-sizing
EP
and under-sizing).5 In our patient the device appeared correctly sized, although a prevalent anterosuperior extension of the ASD with deficient retro-aortic rim was reported.
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The main feature of our case is the very late occurrence of such a potentially catastrophic complication, as, to the best of our knowledge, this represents the latest documented case of aortic erosion after the procedure. This aspect, along with the absence of any symptoms throughout the follow-up, justifies a careful long-term surveillance of these patients and highlights the need of accumulating body of data to shed more light on the causes and possible solutions for this serious complication. Disclosures The authors have no conflicts of interest to disclose.
ACCEPTED MANUSCRIPT
References 1. DiBardino DJ, McElhinney DB, Kaza AK, Mayer JE Jr. Analysis of the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience database for adverse events
RI PT
involving Amplatzer septal occluder devices and comparison with the Society of Thoracic Surgery congenital cardiac surgery database. J Thorac Cardiovasc Surg 2009;137:1334–41. 2. Amin Z, Hijazi ZM, Bass JL, Cheatham JP, Hellenbrand WE, Kleinman CS. Erosion of
SC
Amplatzer septal occluder device after closure of secundum atrial septal defects: review of
Interv 2004;63:496 –502.
M AN U
registry of complications and recommendations to minimize future risk. Catheter Cardiovasc
3. McElhinney DB, Quartermain MD, Kenny D, Alboliras E, Amin Z. Relative Risk Factors for Cardiac Erosion Following Transcatheter Closure of Atrial Septal Defects: A Case-Control Study. Circulation. 2016;133:1738-46
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4. Wang J, Patel M, Xiao M, Xu Z, Jiang S, Sun X et al. Incidence and predictors of asymptomatic pericardial effusion after transcatheter closure of atrial septal defect. EuroIntervention. 2016;12:e250-6
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5. Crawford GB, Brindis RG, Krucoff MW, Mansalis BP, Carroll JD. Percutaneous atrial septal occluder devices and cardiac erosion: a review of the literature. Catheter Cardiovasc Interv.
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2012;80:157-67.
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FIGURE LEGENDS
Figure 1: Transthoracic echocardiogram showing a dissected aneurysm of the ascending aorta.
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Arrow indicates the intimal flap
Figure 2: Three-dimensional CT-scan reconstruction of the thoracic aorta showing the extension of
SC
the dissected tract (Panel A). CT scan evidence of the interatrial device tip protruding into the lumen of the aortic root (Panel B, arrow). CT = Computed tomography. Intraoperative image of
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erosion of the right atrial wall (Panel C, arrow). Asterisk: atrial septal occluder device.
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S0828-282X(16)30934-5
DOI:
10.1016/j.cjca.2016.09.003
Reference:
CJCA 2254
To appear in:
Canadian Journal of Cardiology
Received Date: 16 August 2016 Revised Date:
5 September 2016
Accepted Date: 8 September 2016
Please cite this article as: Scognamiglio G, Barracano R, Colonna D, Mattera Iacono A, Santoro G, Spadafora A, Nappi G, Russo MG, Sarubbi B, A very late life-threatening complication after percutaneous closure of an atrial septal defect, Canadian Journal of Cardiology (2016), doi: 10.1016/ j.cjca.2016.09.003. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT A very late life-threatening complication after percutaneous closure of an atrial septal defect.
Giancarlo Scognamiglio MD, PhD 1*, Rosaria Barracano MD 1, Diego Colonna MD 1, Agostino
Maria Giovanna Russo MD 1, Berardo Sarubbi MD, PhD 1
1
Paediatric Cardiology and G.U.C.H. Unit, A.O.R.N. “Ospedali dei Colli”, 2nd University of
SC
Naples, Naples, Italy
Department of Cardiothoracic Sciences, Second University of Naples, Naples, Italy.
M AN U
2
RI PT
Mattera Iacono MD 1, Giuseppe Santoro MD 1, Andrea Spadafora MD 2, Gianantonio Nappi MD 2,
Short title: very late complication of ASD device closure
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Word count: 942
* Address for correspondence: Dr. Giancarlo Scognamiglio
Hospital
EP
GUCH Unit - Division of Cardiology, Second University of Naples, AO Dei Colli- Monaldi
AC C
Leonardo Bianchi Street 1, 80131 Naples, Italy Tel+390817062682, Fax+39 0818819648 E-mail: [email protected] Keywords: congenital heart disease; atrial septal defect; cardiac catheterization; septal occluder device; complications; aortic dissection
ACCEPTED MANUSCRIPT Brief summary
Percutaneous device closure of secundum atrial septal defects (ASD) has showed excellent longterm results and a low complication rate. However, adverse events, albeit rare, can be potentially
RI PT
life-threatening if not promptly recognized and treated. We report a case of asymptomatic aortic
AC C
EP
TE D
M AN U
SC
erosion occurred 13 years after the procedure who underwent successful surgical repair.
ACCEPTED MANUSCRIPT Abstract Percutaneous closure is widely recognized as the first therapeutic option in the majority of cases of secundum atrial septal defects (ASD), due to its high effectiveness and safety. Nonetheless, with the progressive increase of implanted devices and follow-up duration, several
RI PT
adverse events, some of them potentially life-threatening, have been reported.
We report the case of an asymptomatic aortic erosion occurred thirteen years after the procedure. The main feature of our case is the very late occurrence of a life-threatening asymptomatic
SC
complication of ASD percutaneous closure, which should prompt a life-long surveillance in this
AC C
EP
TE D
M AN U
population.
ACCEPTED MANUSCRIPT Case report Transcatheter device closure of ostium secundum atrial septal defects (ASD) is nowadays considered a cost-effective alternative to conventional surgical closure, due to its excellent longterm results. However, although it is deemed generally safe, potentially fatal adverse events have
RI PT
been reported.
We describe the case of a twenty-year-old male patient with an ostium secundum ASD who underwent a successful percutaneous implantation of a 18-mm Amplatzer™ Atrial Septal Occluder
SC
(St. Jude Medical Inc., St. Paul, Minnesota) at the age of five years. The ASD size was evaluated with “dynamic” stretched balloon approach (Equalizer™ Balloon – Boston Scientific, Marlborough,
M AN U
MA). The device was not oversized with respect to the ASD stretched diameter. Follow-up was uneventful, with serial transthoracic echocardiograms performed on a regular twoyear basis showing correct device position in absence of residual shunt and/or any elements suggestive of procedure-related complications..
TE D
However, thirteen years later, at the scheduled assessment, the patient was fully asymptomatic, but the transthoracic echocardiogram showed an aneurismal dilatation of the ascending aorta with an intimal flap in its lumen (Figure 1). The septal device did not appear dislocated and neither residual
EP
atrial shunt, nor pericardial effusion were present. A thorough review of previous echo studies did not reveal any known factor suggestive of potential ASD device erosion.
AC C
Computed tomography scan confirmed the diagnosis by clearly showing the intimal flap arising from the aortic root, just few centimeters distally to the annulus, and extending up to the mid ascending aorta. Furthermore, the edge of the occluder device appeared to protrude into the aortic lumen (Figure 2, Panels A-B). Accordingly, our patient underwent a successful surgical repair with Amplatzer device removal, ASD patch closure and replacement of the ascending aorta with a Dacron graft. Intraoperative findings confirmed an erosion of the right atrial roof extending to the adjacent aortic wall, at the
ACCEPTED MANUSCRIPT level of the non-coronary sinus, due to a partial protrusion of the atrial disc of the occluder device (Figure 2, Panel C). At 1-year assessment the patient is in good health. Erosion of the aortic or atrial wall is an infrequent but life-threatening complication of percutaneous septal defect closure, with an estimated rate of about 0.1-0.3%.1,2 Although it is also reported in
RI PT
paediatric age, the relative risk appears to be greater in adults, since, to our knowledge, there are no reports of deaths related to ASD device erosion in paediatric age. Furthermore, patients diagnosed with late erosion after implant are significantly older than those presenting earlier. 3 The reasons are
SC
not fully clear, but different tissue properties may have a potential role. As in our patient an ASD occluder was implanted in childhood and no signs of erosion were present at serial echoes, we can
M AN U
assume that further factors other than age at implant can contribute to the timing of onset of the erosion. The most common documented site of perforation is a combination of the atrium and aorta adjacent to the device, suggesting a mechanism of erosion. Unfortunately, from the current literature and available registry data, there is neither conclusive data nor consensus about
TE D
predisposing factors of cardiac perforation or erosion by the device.4 Several risk factors have been implicated as possible causes, as they increase the chance of contact between the device and the atrial wall: absent or deficient superior–anterior rim and inadequate device sizing (either over-sizing
EP
and under-sizing).5 In our patient the device appeared correctly sized, although a prevalent anterosuperior extension of the ASD with deficient retro-aortic rim was reported.
AC C
The main feature of our case is the very late occurrence of such a potentially catastrophic complication, as, to the best of our knowledge, this represents the latest documented case of aortic erosion after the procedure. This aspect, along with the absence of any symptoms throughout the follow-up, justifies a careful long-term surveillance of these patients and highlights the need of accumulating body of data to shed more light on the causes and possible solutions for this serious complication. Disclosures The authors have no conflicts of interest to disclose.
ACCEPTED MANUSCRIPT
References 1. DiBardino DJ, McElhinney DB, Kaza AK, Mayer JE Jr. Analysis of the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience database for adverse events
RI PT
involving Amplatzer septal occluder devices and comparison with the Society of Thoracic Surgery congenital cardiac surgery database. J Thorac Cardiovasc Surg 2009;137:1334–41. 2. Amin Z, Hijazi ZM, Bass JL, Cheatham JP, Hellenbrand WE, Kleinman CS. Erosion of
SC
Amplatzer septal occluder device after closure of secundum atrial septal defects: review of
Interv 2004;63:496 –502.
M AN U
registry of complications and recommendations to minimize future risk. Catheter Cardiovasc
3. McElhinney DB, Quartermain MD, Kenny D, Alboliras E, Amin Z. Relative Risk Factors for Cardiac Erosion Following Transcatheter Closure of Atrial Septal Defects: A Case-Control Study. Circulation. 2016;133:1738-46
TE D
4. Wang J, Patel M, Xiao M, Xu Z, Jiang S, Sun X et al. Incidence and predictors of asymptomatic pericardial effusion after transcatheter closure of atrial septal defect. EuroIntervention. 2016;12:e250-6
EP
5. Crawford GB, Brindis RG, Krucoff MW, Mansalis BP, Carroll JD. Percutaneous atrial septal occluder devices and cardiac erosion: a review of the literature. Catheter Cardiovasc Interv.
AC C
2012;80:157-67.
ACCEPTED MANUSCRIPT
FIGURE LEGENDS
Figure 1: Transthoracic echocardiogram showing a dissected aneurysm of the ascending aorta.
RI PT
Arrow indicates the intimal flap
Figure 2: Three-dimensional CT-scan reconstruction of the thoracic aorta showing the extension of
SC
the dissected tract (Panel A). CT scan evidence of the interatrial device tip protruding into the lumen of the aortic root (Panel B, arrow). CT = Computed tomography. Intraoperative image of
AC C
EP
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erosion of the right atrial wall (Panel C, arrow). Asterisk: atrial septal occluder device.
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