LONG TERM COMPLICATIONS FOLLOWING PERCUTANEOUS ASD CLOSURE

Transcription

1 LONG TERM COMPLICATIONS FOLLOWING PERCUTANEOUS ASD CLOSURE Zakaria Jalal Cardiopathies congénitales de l enfant et de l adulte Hôpital cardiologique Haut Lévêque Pessac CHU Bordeaux

2 INTRODUCTION Percutaneous closure currently preferred treatment for sasd Effective, high success rate, avoidance of surgical complications Amplatzer Septal Occluder = most widely used device Low short term adverse event rates Rare but potentially serious delayed complications Kotowycz et al. JACC Intrv 2012 Abaci et al. CCI 2013

3 DELAYED COMPLICATIONS Cardiac Erosion Device thrombosis Valvular failure AV Conduction abnormalities Nickel allergy Stroke Endocarditis Atrial arrhythmias

4 CARDIAC EROSION Incidence: 0.04 to 0.28% - underestimated ASO >> CardioSeal/Starflex Atrial dome adjacent aorta Perforation, tamponnade, aortic fistula Surgical (3/4) or medical (1/4) management Amin et al. CCI 2004 DiBardino et al. JTCS 2009 FDA Circulatory System Advisory Panel Meeting 2012

5 Moore J. et al. JACC Interv 2013 Kiab et al. CCI 2012 CARDIAC EROSION - PATHOPHYSIOLOGY Risk factors : Absent or deficient aortic rim Device oversizing Protrusion of the device into atrial and/or aortic wall Flaring of the device around the aortic root Delayed erosion: Oversized device - > recover nominal size Flat profile of the discs Increase in diameter Shearing of the atrial wall/aorta

6 CARDIAC EROSION ECHOGRAPHIC Before closure Poor posterior rim consistency Absence of aortic rim in multiple views Septal mal-alignment Dynamic ASD After closure Tenting of the atrial free wall in the transverse sinus Wedging of the discs between posterior wall and aorta Pericardial effusion Amin et al. CCI 2014

7 CARDIAC EROSION - RECOMMENDATIONS Follow-up of patients: 1 week, 1 month, 6 months and yearly Mandatory device tracking Instructions for use: in the patient and physician labeling a warning regarding patient symptoms that require emergent treatment (e.g., severe chest pain) Standard training of echocardiographers, during device closure and follow-up Patient notifications: additional measures to ensure that patients are well informed of the risks/benefits of transcatheter ASD closure, Education ducate about symptoms Moore J. et al. JACC Interv 2013 Kiab et al. CCI 2012 FDA Circulatory System Advisory Panel Meeting 2012

8 DEVICE THROMBOSIS Metaanalysis of 28,142 pts 203 studies Thrombus incidence : 1.0% (95% CI: %) Review Frankfurt experience ASO << CardioSeal, Starflex, or Helex Up to 2 years after closure Coagulopathies, post procedural AF Strokes: 10-15%, no death Medical management vs surgical explantation Sherman et al. CCI 2004 Krumsdorf et al. JACC 2004 Delaney et al. Congenit Heart Dis Abaci et al. CCI 2013

9 DEVICE THROMBOSIS Healing response of the device Biocompatibility - preclinical animal studies No human studies on endothelialization duration Clinical practice: ASA at least 6 months Incomplete endothelialization 18 m - 7 yrs Confirming complete endothelialization? Chessa et al. Int J Cardiol 2004 Chen et al. Circulation 2011 Thomsen et al. Heart 1998

10 STROKE Metaanalysis of 28,142 pts 203 studies Cerebrovascular events 1.1% (95% CI: %) Danish registry 1167 pts percutaneous closure 47 ± 3 yo Median FU: 5.2 years Stroke > for patients with ASD before/after closure No difference with surgical closure Independant risk factors Device thrombosis AF Kutty et al. Am J Cardiol Abaci et al. CCI 2013 Nyboe et al. Heart 2015

11 ATRIAL ARRHYTHMIAS Metaanalysis 945 pts FU: 30 days 5 years Beneficial effect on pre-existing AF Danish registry 300 pts, FU: 5.2 years No pre-existing atrial arrhytmia Higher risk of new onset of AF - adjusted HR 8.2 (95% CI 6.6 to 10.2) Vecht et al. Heart 2010 Nyboe et al. Heart 2015

12 LATE CONDUCTION ABNORMALITIES 5 cases of delayed cavb Age: 2 16 yo, delay: 6m 4yrs ASO (n=4), Helex (n=1) Early changes -> deterioration of conduction 1 surgical explantation Careful long term cardiac rhythm monitoring Consider device removal in case of early conducting abnormalities resistant to medical management PM implantation Szkutnik et al. Cardiol J 2008 Nehgme et al. Pediatr Cardiol 2009 Dittrich et al. CCI 2015

13 VALVULAR DAMAGE MITRAL REGURGITATION Onset or increase 10% pts Usually trivial to moderate No impact on functional status or prognosis Hypotheses: Alterations of atrial function, stiffness Geometric changes of the left heart Annulus echographic geometric changes N= years ASO device Hiraishi et al. Int Heart Jour 2015 Wilson et al. Heart Lung 2008

14 VALVULAR DAMAGE AORTIC REGURGITATION Schoen et al. 70 pts, ASO (57%) and Cardia (43%) devices 16% patients had pre-existing mild AR Novel or worsened AR in 9% of patients Traction at the non-coronary aortic valve sinus Sadiq et al. 200 pts ASO, Mild AR occurred in 1% correlated with a device-to-defect ratio of >1.3:1 Mayo Clinic Series 118 pts, ASO (88%), Helex (12) Mean FU=1.2 years New or worsening AR = 0.8% (1/118) Schoen et al. Heart 2008 Sadiq et al. Cardiol Young 2012 Loar et al. CCI 2013

15 INFECTIVE ENDOCARDITIS 5 cases in the literature, aged from 4 to 60 years ASO involved in all cases From 11 months up to 4 years after implantation Staphylococcus aureus in all but one case One patient: periodontal scaling without antibiotic prophylaxis 1 month before IE Surgical removal of the device in 3 cases: Incomplete endothelialization No endocarditis related death Slesnick et al. Circulation 2008 Zahr et al. Am J Cardiol 2010 Kim et al. Circulation 2015 Incomplete endothelialization No specific method for confirming complete endothelialization Duration of ASA based on animal studies? Duration of IE prophylaxis?

16 Wertman et al. JACC 2006 Rodés-Cabau et al. AJC 2008 NICKEL ALLERGY Nitinol = Titanium 45% + Nickel 55% Symptoms Migraine Headache Chest discomfort Rash/urticaria Fever Pericardial effusion tamponnade Nickel bloodstream release up to 12 months after closure with ASO

17 NICKEL ALLERGY Local inflammatory reaction Platelet adhesion Microemboli Cerebral infarcts PATHOPHYSIOLOGY Inflammatory mediators LA release Calcitonin gene related peptide levels Symptoms may persist for several months Good response to medical management Clopidogrel Antihistamin Antiinflammatory Corticosteroids Rarely: surgical explantation Symptoms Wei et al. Headache 2012 Ries et al. Am Heart J 2003

18 CONCLUSION Percutaneous ASD closure safe and effective using a great number of devices Long-term complications rate is not null Although rare, some of these can be sudden and potentially lethal Both operators and patients need to be aware of these issues Long-term follow-up is mandatory in order to detect these complications