Cardiology Research, ISSN 1923-2829 print, 1923-2837 online, Open Access
Article copyright, the authors; Journal compilation copyright, Cardiol Res and Elmer Press Inc
Journal website https://www.cardiologyres.org

Original Article

Volume 2, Number 1, February 2011, pages 7-15

Closure of Interatrial Septal Communications: Adverse Events and Lessons Learned

Figures

Figure 1.
Figure 1. (A) and (B) Intra-interventional TEE showing respective positions of device edges and atrial wall (arrows). (C) Large arrowhead showing ruptured left atrial wall, small arrow showing pericardium.
Figure 2.
Figure 2. (A) TTE showing a thrombus on the right atrial side of the device (arrow). (B) TTE 4 months later, showing a thread-like structure attached to the left sided disc.
Figure 3.
Figure 3. (A) Endothelialized left atrial surface of the PFO closure device. (B) Appearance of the ligated left atrial appendage.
Figure 4.
Figure 4. (A) Tracing showing ST-segment elevation in inferior leads after device placement due to air embolism in the right coronary artery. (B) Immediate coronary angiography showing resolution of the air bubbles and patent right (and left (not shown here)) coronary artery.
Figure 5.
Figure 5. (A) Follow up TEE of the patient with central residual shunt (white arrow) following PFO closure with a first Premere® device. (B) Implantation of a second device (black arrow pointing at knob of second device) demonstrating tight closure.
Figure 6.
Figure 6. (A) Intraprocedural TEE showing adequate position of both device arms. (B) Follow up TEE showing leftward malposition of the right atrial disc. (C) Original Amplatzer® device in place, with introducer passed through the residual defect. (D) Second Amplatzer® device in place (white arrow), with tightly closed residual shunt (not shown), with both device ends standing out perpendicularly to the first device (black arrow) and into the respective atrial cavity.
Figure 7.
Figure 7. (A) 35 mm PFO device in place swung around by the large atrial septal aneurysm. (B) Stable 18 mm ASD device filling the defect, grasping both septum primum and secundum (arrows), and not allowing any rocking motion by the atrial septal aneurysm anymore.
Figure 8.
Figure 8. MRI sequence of a severe lesion in the area subtended by the middle cerebral artery. The injury was sustained before PFO closure, most probably due to paradoxical embolism after documented deep venous thrombosis in a 25-year-old woman.

Tables

Table 1. Patient Characteristics
 
PatientsN = 112
ASD: atrial septal defect
IASC: interatrial septal communication
PFO: patent foramen ovale
Device: A = Amplatzer®, C = Atriasept Cardia®, F= Occlutec Figulla®, P = Premere®, S = Swissimplant Solysafe®
Age in years55.2 ± 14.9 (21 - 83)
Gender55 males, 57 females
Months since implantation22.4 ± 13.4 (1 - 60)
Type of IASC112 PFO, 14 ASD
Type of device implantedA = 46, F = 21, C = 23, S = 14, P = 8

 

Table 2. Major Adverse Events (AE) After Interatrial Septal Communication Closure Using Our Standardized Criteria, as Recomputed From 2 Large Studies [1, 2]
 
Major AENot included
Some AE listed on the right hand column are not included in the computing because it is not clear whether they necessitated hospitalizations etc. We have classified other events (residual shunts and “redos”) as unsuccessful or partially successful, in analogy to our 3 cases.
Majunke et al [1]
Total major AE: 15/641 = 2.3%		Early:
2 embolizations, surgery
1 residual shunting, percutaneous closure unsuccessful, surgery
1 sudden death
After 30 days:
2 embolizations and percutaneous retrieval
2 embolizations, surgery
3 surgery for atrial roof erosion
1 major stroke
1 peripheral embolization and percutaneous retrieval
2 surgery for residual shunt		4 Heart failure
3 Minor strokes or TIA
1 pericardiocentesis
1 atrial thrombus formation
10 percutaneous closure for residual shunt or several defects
Wahl et al [2]
Total major AE: 9/525 = 1.7%		Early:
5 embolization and percutaneous retrieval
3 vascular access problems
1 retroperitoneal hematoma		2 pericardiocentesis
4 atrial thrombus formation
16 repeated closure because of residual shunt or new defects