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Cardiac Catheterisation - Atrial Septal defect device closure

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Background

Literature on post-implantation complications

From two large US multi-centre trials, the overall complication rate ranges from 4.8 to 7.2%.1,2

Device embolization rates reported between 0.5% and 1.1%.1,3-5 This usually occurs during and immediately after procedure, but can occur in months following device implantation (No reported cases of device embolization beyond first year following implantation).

Arrhythmia rates reported between 3.4% and 5.2%.1,6 Common amongst those with pre-procedural atrial arrhythmias (may be presenting symptom in adult patients) and high incidence in this group of patients even without device closure.

Other, rarer, complications reported by St Jude Medical include device thrombosis (rare with administration of Aspirin in first 6 months), infection (routine endocarditis prophylaxis for first 6 months), Nickel allergy (rare, as skin contact allergen, and if systemic, subsides after few months), new mitral regurgitation (associated with device abutting the mitral valve - preventable with careful selection of patients), TIA or stroke and residual/recurrent defect (reduced with careful patient selection).7,15

Late complications (beyond 1 year post-device implantation) not including device erosion have not been reported, with single and multi-centre publications up to 15 years of follow-up.1-4,8

Device erosion is rare, with reported incidence of 0.043-0.3%. McElhinney et al.9 published in 2016 the combined data from the Erosion Board, reporting a total of 125 erosion events between 2002 and 2014. Of these 56% occurred in adults, but nearly 20% were in children <10 years old. Median duration from implant to erosion was 14 days, with 16 reported beyond 1 year and 6 beyond 5 years. The majority presented with acute onset of pleuritic chest pain with tamponade, but 14% presented on routine follow-up with aorta to left atrial fistula without pericardial effusion. The study identified associations with device erosion from multivariate analysis including:

  • Deficiency of any rim (NB 25-50% of patients have deficient aortic rim)
  • Device size >5mm larger than static ASD diameter
  • Low body weight:device size ratio in kg:mm (erosion group ratio mean 2.52 +/- 1.39)

A report is noted of device erosion occurring 8 years and 7 months post device implantation.10 There is one reported case of device erosion following closure with an Occlutech Figulla device11 but erosion post implantation of an Occlutech device seems to be extremely rare.15

An association has been reported between migraine and patent foramen ovale and migraines can occur, either as a new issue or at greater frequency, post ASD device closure.18 The Canoa study, in adults undergoing ASD closure, suggested that addition of clopidogrel to aspirin post procedure may decrease migraine incidence at 3 month follow up.19

Our experience with device-related complications

From the first 581 procedures, there have been a total of 24 complications (4.1%). This includes 10 device embolizations, 9 arrhythmias, 2 vascular access related complications, one device erosion, one malposed device and one probable wire perforation of the left atrial appendage. There was one mortality which was related to device embolization. The latest device embolization (and complication) was noted at 8 month follow-up and the single erosion occurred day 8 post-procedure. All arrhythmias diagnosed and managed prior to discharge. This period covers up to 17 years follow-up.12

Literature on follow-up recommendations

St Jude Medical recommend clinical and echocardiography follow-up at discharge, 1 week, 1 month, 6 months and 12 months, then annually thereafter.13

ASE/AHA (from 2008 Guidelines for the Management of Adults with Congenital Heart Disease) recommend clinical and echocardiography follow-up at discharge, 1 month, 6 months, 12 months, then annually thereafter (level of evidence: C).14

No reported literature at time of review on centres discharging patients post-device implantation.

Large device size definition has varied but authors have used 20mm and above in adults and ≥20mm/m2 in children 16,17

Starship/Auckland City Hospital follow-up guideline

Follow-up Period
Assessment Notes
Pre-discharge (Day 1 post catheter)  Clinical review
ECG
Echocardiogram
Inform of endocarditis prophylaxis for first 6 months
General advice (as below)
1 month Clinical review
ECG
Echocardiogram
 
12 months Clinical review
ECG
Echocardiogram
Reinforcement of general advice
Consider discharge following this review if
- RV normalised
- No atrial arrhythmia concerns
- No higher risk features*
Every three to five years ongoing (review at age 15 for children and at 5 years post implant for adults) Clinical review
ECG
Echocardiogram
If higher risk features*, persistent RV dilation, atrial arrhythmia

* Higher risk features (to be determined by interventionist performing procedure and noted in discharge correspondence) include:

  • Deficiency of any rim
  • Device size >5mm larger than the static ASD diameter
  • Larger device for weight at implant e.g. >20mm in adult patient or body weight:device size ratio <3.0 or ASD size >20mm/m2
  • Residual ASD/shunt
  • More than one device
  • Other concerns, as determined by the treating cardiologist

General advice

  • All patients to receive details of the device implanted (preferably a device card)
  • Endocarditis prophylaxis for 6 months
  • Aspirin to be stopped at 6 months post-device closure, unless other indication
  • If unexplained chest pain, breathlessness or palpitations following ASD device closure at any stage (including those discharged from follow-up) all patients must be clearly advised they should seek urgent medical attention for assessment of possible late device erosion.

References

  1. Du ZD, Hijazi ZM, Kleinman CS, et al. Comparison between transcatheter and surgical closure of secundum atrial septal defect in children and adults: results of a multicentre nonrandomized trial. J Am Coll Cardiol 2002; 39: 1836-1844.
  2. Everett AD, Jennings J, Sibinga E, et al. Community use of the amplatzer atrial septal defect occluder: results of the multicentre MAGIC atrial septal defect study. Pediatr Cardiol 2009; 30: 240-247.
  3. DiBardino DJ, McElhinney DB, Kaza AK, et al. Analysis of the US Food and Drug Administration Manufacturer and User Facility Device Experience database for adverse events involving Amplatzer septal occluder devices and comparison with the Society of Thoracic Surgery congenital cardiac surgery database. J Thorac Cardiovasc Surg 2009; 137: 1334-1341.
  4. 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: 1061-1065.
  5. Levi DS, Moore JW. Embolization and retrieval of the Amplatzer septal occluder. Catheter Cardiovasc Interv 2004; 61: 543-547.
  6. Johnson JN, Marquardt ML, Ackerman MJ, et al. Electrocardiographic changes and arrhythmias following percutaneous atrial septal defect and patent foramen ovale device closure. Catheter Cardiovasc Interv 2011; 78: 254-261.
  7. Moore J, Hegde S, El-Said H, et al. Transcatheter device closure of atrial septal defects: a safety review. JACC Cardiovasc Interv 2013; 6: 433-442.
  8. Godart F, Houeijeh A, Recher M, et al. Complications after transcatheter ASD closure with the amplatzer septal occlude. Arch Cardiovasc Dis Supp Jan 2015; 7(1): 97.
  9.  McElhinney DB, Quartermain MD, Kenny D, et al. Relative risk factors for cardiac erosion following transcatheter closure of Atrial septal defects: a case-control study. Circulation 2016; 133: 1738-1746.
  10.  Roberts W, Parmar J, Rajathurai T. Very late erosion of amplatzer septal occluder device presenting as pericardial pain and effusion 8 years after placement. Cath Cardiovasc Interv 2013; 8: E592-4.
  11.  Wagdi P. Closure of interatrial septal communications: adverse events and lessons learned. Cardiol Res 2011; 2 (1): 7-15.
  12.  Mitchelson B, O'Donnell C, Ruygrok P, et al. Transcatheter closure of secundum atrial septal defects: Has fear of device erosion altered outcomes? Cardiol in the Young 2017: 1-9. doi:10.1017/S1047951116002663.
  13.  St Jude Medical. ASO physician letter 16 January 2013, https://sjm.com/~/media/pro/resources/product-performance/amplatzer-septal-occluder/aso_physician_letter_16_jan_2013.ashx
  14.  Warnes C, Williams R, Bashore T, et al. ACC/AHA 2008 guidelines for the management of adults with congenital heart disease: executive summary. Circ 2008; 118: 2395-451.
  15.  Haas NA, Soetemann DB, Ates I et al. Closure of Secundum Atrial Septal Defects by Using the Occlutech Occluder Devices in More Than 1300 patients: The IRFACODE Project: A Retrospective Case series. Cath and Cardiovascular Interventions 2016 88:571-581
  16.  Turner DR, Owada CY, Sang CJ et al. Closure of Secundum Atrial Septal Defects With the Amplatzer Septal Occluder. A Prospective, Multicenter, Post Approval Study Circ and Cardiovascular Interv. 2017; 10:1-7
  17.  Long-Term Outcomes After Percutaneous Closure of Ostium Secundum Atrial Septal Defect in the Young. A nationwide cohort study. Jalal Z, Hascoet S, Gronier C et al JACC Cardiovascular Interventions 11(8) 795-804
  18.  Migraine Intervention with Starflex Technology (MIST) Trial. Dowson A, Mullen M, Peatfield R et al. Circulation 2008;117:1397-1404.
  19.  Effect of Clopidogrel and Aspirin vs Aspirin Alone on Migraine Headaches After Transcatheter Atrial Septal Defect Closure The CANOA Randomized Clinical Trial. Josep Rodés-Cabau, Eric Horlick, Reda Ibrahim et al. JAMA. 2015;314(20):2147-2154.

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Document Control

  • Date last published: 04 July 2018
  • Document type: Clinical Guideline
  • Services responsible: Paediatric Cardiology
  • Author(s): Clare O'Donnell
  • Owner: Clare O'Donnell
  • Editor: Marion Hamer
  • Review frequency: 2 years