Υποδόριος Απινιδωτής (S- ICD) Εμμ Μ. Κανουπάκης MD, PhD, FESC Πανεπιστημιακό Νοσοκομείο Ηρακλείου
Το πρόβλημα
Τα όπλα
Το αποτέλεσμα % Mortality Reduction 31% 37% 20% 54% 60% 31% 23% AVID CASH CIDS MADIT MUSTT MADIT II SCD-HeFT Μείωση θνητότητας
Η διαφλέβια εμφύτευση έχει επιπλοκές κάποιες φορές σοβαρές : pneumothorax cardiac perforation pericardial effusion - tamponade upper extremities DVT pulmonary embolism infection endocarditis
Lead malfunction Inappropriate/ineffective therapy Kleemann T et al. Circulation 2007;115:2474-2480
Lead malfunction Kleemann T et al. Circulation 2007;115:2474-2480
Recalled leads
Lead extraction Increased mortality and morbidity
Ένα σύστημα που θα άφηνε την καρδιά και τα αγγεία:
The S-ICD system 78x65x15mm - 69ml - 145gr
Προκλήσεις Αξιοπιστία στην απινίδωση διάταξη ηλεκτροδίων απαιτούμενη ενέργεια Υψηλή ευαισθησία στην ανίχνευση και διάκριση των αρρυθμιών
2001-2004 78 pts Bardy et al. N Engl J Med 2010;363:36-44
2004-2005 DFT comparison 49 consecutive patients: The S-ICD was as effective as a TV-ICD for terminating induced VF, although with a significantly higher mean energy (36.6±19.8 J vs. 11.1±8.5 J, p<0.001) Bardy et al. N Engl J Med 2010;363:36-44
Εμφύτευση S-ICD Anatomical landmarks, one shot fluoroscopy
Far-field signals Surface Intra-cardiac S-ICD ECG
Far-field signals Surface Intra-cardiac S-ICD ECG
Far-field sensing vectors ιδανική σχέση R/T για αποφυγή: double counting, T-wave oversensing
Rhythm discrimination INSIGHT algorithm Rate, SR template, Waveform analysis, QRS width
Διάκριση αρρυθμιών Gold et al. J Cardiovasc Electrophysiol 2012;23:359-366
Διάκριση αρρυθμιών ευαισθησία & ειδικότητα The sensitivity for the detection of VTs was uniformly excellent (100%) However, the S-ICD showed higher specificity (98%) for discrimination of supraventricular arrhythmias than single- or dual- chamber TV-ICDs (76.7%) Gold et al. J Cardiovasc Electrophysiol 2012;23:359-366
Θεραπευτικές ζώνες Conditional zone: rhythm discrimination for SVT Shock zone: rate detection only
The addition of Conditional Zone was strongly associated with a reduction in inappropriate shocks and did not result in prolongation of detection times or increased syncope Gold M et al. Heart Rhythm2014;11:1352 1358
Απινίδωση Capacitor charge time: <10 sec Arrhythmia reconfirmation Shock: 80J non-programmable Reverse shock polarity if unsuccessful Postshock asystole >3.5sec: pacing at 50 bpm for 30 sec
Κλινικές μελέτες αποτελεσματικότητας & ασφάλειας
2008-2009 Permanent S-ICD pilot study 6 pts in New Zealand, 55 pts in Europe: Primary end point: efficacy in terminating 2 subsequent episodes of induced VF Results: detection sensitivity 100% & conversion efficacy 98% 12 of 12 (100%) spontaneous VTA were detected and treated No adverse events Bardy et al. N Engl J Med 2010;363:36-44
Major S-ICD trials No. of pts Olde Nordkamp et al. 118 (2012) Jarman et al. (2013) 111 Weiss et al. (2013) (IDE) 314 Lambiase et al. (2014) 472 Age 50±15 33 (10 87) 52±16 (EFFORTLES 49±18 S) FU 49±18 mo 12.7±7.1 mo 330 days 498 days
Major S-ICD trials outcomes Olde Nordkamp et al. (2012) Jarman et al. (2013) Weiss et al. (2013) (IDE) Lambiase et al. (2014) (EFFORTLES S) Induced VF successful termination Spontaneous (%) VF/VT successful termination: N/A 100 100 100 8/45 (100) 13/24 (100) 21/119 (95.2) 85/317 (96.1)
Major S-ICD trials complications Infection n (%) Inappropriate shock rate (%) Olde Nordkamp et al. (2012) Jarman et al. (2013) Weiss et al. (2013) (IDE) Lambiase et al. (2014) (EFFORTLES S) 7 (5.9) 11 (9.9) 18 (5.6) 18 (4) 13 15 13.1 7
The S-ICD (IDE) Clinical Study The S-ICD System is safe, well tolerated and effective at detecting and treating both induced and spontaneous VT/VF Weiss et al. Circulation. 2013;128:944-953
FDA approval
Μειονεκτήματα & σημεία κριτικής
Δεν παρέχει Μόνιμη βηματοδότηση Αντι-ταχυκαρδιακή βηματοδότηση Δυνατότητα καρδιακού επανασυγχρονισμού Remote-monitoring μέχρι σήμερα
Απρόσφορες εκφορτίσεις
Λοιμώξεις initial experience, bulk of PG, 3-incisions, battery longevity BUT non-invasive management
Καθυστέρηση για θεραπεία MDT "ATP During Charge" 15.3 BSC QuickConvert 16.3 MDT "ATP Charge Saver" MDT "Lead Integrity Alert (30/40 w/ Charge Saver)" 21.0 24.6 0 6.3 12.5 18.8 25.0 Mean time to therapy: spontaneous VT ~20 sec
Ποιοι ασθενείς είναι κατάλληλοι
1 st step: check for ECG eligibility The screening process
The Screening process is used to analyze: QRS amplitude QRS to T-wave amplitude ratios QRS width and morphology consistency in SR using multiple patient postures
Collecting the Surface ECG Record 10 sec ECG in at least two postures: supine standing
Evaluating the Surface ECG
Evaluating the Surface ECG
Evaluating the Surface ECG A patient is considered suitable for implant if: at least one surface ECG lead (sense vector) is acceptable for all tested
Failure rate & predictors S-ICD screening failure rate: 7.4-14.8% predictors of failure: increased body weight hypertrophic cardiomyopathy prolonged QRS duration R:T ratio <3 on the surface ECG lead with the largest T wave presence of TWIs Groh C et al. Heart Rhythm 2014;11:1361 1366
Προτιμώμενη επιλογή σε ασθενείς με: Δύσκολη αγγειακή προσπέλαση συγγενείς καρδιοπάθειες Νέοι με συγγενείς διαυλοπάθειες έντονη δραστηριότητα Υψηλό κίνδυνο λοίμωξης ιστορικό λοίμωξης ICD ή lead malfunction ανοσοκαταστολή, αιμοκάθαρση, προσθετικές βαλβίδες SCA survivors with preserved EF Παιδιατρικοί ασθενείς
EFFORTLESS Registry: a broad range of indications 20% 3% 13% 10% 3% 13% 38% Ischemic Channelopathy Congenital Non ischemic C HCM ARVD Idiopathic VF Lambiase P et al. Europ Heart J 2014; 35:1657 1665
S-ICD suitability TV-ICD pts not reaching one of the following end points at 5 years followup: an atrial and/or right ventricular pacing indication successful ATP without a subsequent shock an upgrade to a CRT-D device de Bie M et al. Heart. 2013;99:1018 23
S-ICD suitability TV-ICD pts not reaching one of the following end points at 5 years followup: an atrial and/or right ventricular pacing indication successful ATP without a subsequent shock 55.5% an upgrade to a CRT-D device de Bie M et al. Heart. 2013;99:1018 23
Το μέλλον 20% thinner (15.7 to 12.6 mm) 7 yrs battery longevity (Li/MnO2) antenna for remote care
Non-inferiority? Superiority?
Πλεονεκτήματα Αποφυγή αγγειακών επιπλοκών και λοιμώξεων Δεν απαιτείται ακτινοσκόπηση Ευκολότερη αφαίρεση σε περίπτωση επιπλοκών Μικρότερη ζημιά στο μυοκάρδιο μετά το shock Αισθητικοί λόγοι
The S-ICD (IDE) Clinical Study The primary safety end point was: 180-day S-ICD system complication-free rate The primary effectiveness end point was: induced VF conversion rate Weiss et al. Circulation. 2013;128:944-953