Download (s-icd) system

Initial Clinical Experience with a
Novel, Totally Subcutaneous Implantable
Defibrillator (S-ICD) System
Dominic AMJ Theuns, Lara Dabiri Abkenari, Luc Jordaens
Erasmus MC, Rotterdam, the Netherlands
Financial Disclosure
Relationship
Name of Commercial Company
Consulting Fees/Honoraria
Cameron Health; modest
Speakers’ Bureau
Boston Scientific; modest
Equity Interests/Stock Options
Equity Interests
Royalty Income
Non-Royalty Payments
Officer, Director, or In Any Other
Fiduciary Role
Ownership/Partnership/Principal
Research Grants
Biotronik, Boston Scientific, St Jude Medical; all modest
Fellowship Support
Salary
Ownership/Partnership/Principal
DAMJ Theuns
ESC Stockholm, 01-09-2010
Background
 The implantable cardioverter-defibrillator (ICD) has become
standard therapy in patients
 who have survived life-threatening ventricular arrhythmias
(secondary prevention),
 or who are at risk for ventricular arrhythmias (primary
prevention), irrespective of ischaemic or non-ischaemic
cardiomyopathy.
–
The Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators. A comparison of antiarrhythmic-drug
therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. N Eng J
Med 1997;337:1576-83.
–
Moss et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection
fraction. N Eng J Med 2002;346:877-83.
–
Bardy et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Eng J Med
2005;352:225-37.
–
Theuns et al. Effectiveness of prophylactic implantation of cardioverter-defibrillators without cardiac
resynchronization therapy in patients with ischaemic or nonischaemic cardiomyopathy: A systematic review and
meta-analysis. Europace 2010 (In press).
DAMJ Theuns
ESC Stockholm, 01-09-2010
Background
 The ICD is associated with short- and long-term morbidity,
 Procedure-related complications
Reynolds et al. The frequency and incremental cost of major complications among medicare
beneficiaries receiving implantable cardioverter-defibrillators. J Am Coll Cardiol 2006;47:2493-97.
 Lead-related complications
Kleemann et al. Annual rate of transvenous defibrillation lead defects in implantable cardioverterdefibrillators over a period of >10 years. Circulation 2007;115:2474-80
 Inappropriate shocks
Daubert et al. Inappropriate implantable cardioverter-defibrillator shocks in MADIT II: frequency,
mechanisms, predictors, and survival impact. J Am Coll Cardiol 2008;51:1357-65.
DAMJ Theuns
ESC Stockholm, 01-09-2010
Background
 Development of a novel entirely subcutaneous ICD system,
 Avoiding use of transvenous leads
 Lower incidence of inappropriate device therapy
 Easy implantation procedure
DAMJ Theuns
ESC Stockholm, 01-09-2010
Purpose
 To report our initial clinical experience of the first 26 patients who
received the totally subcutaneous ICD system
DAMJ Theuns
ESC Stockholm, 01-09-2010
Methods
Implantation
© Courtesy of Cameron Health
DAMJ Theuns
ESC Stockholm, 01-09-2010
Methods
Implantation
© Courtesy of Cameron Health
DAMJ Theuns
ESC Stockholm, 01-09-2010
Methods
DAMJ Theuns
ESC Stockholm, 01-09-2010
Methods
DAMJ Theuns
ESC Stockholm, 01-09-2010
Methods
Detection/discrimination
Sensing vectors
2
1.
Primary (xiphoid - CAN)
2.
Secondary (sternal-manubrium – CAN)
3.
Alternate (sternal-manubrium – xiphoid)
1
Captured S-ECG, programmed vector: primary
DAMJ Theuns
ESC Stockholm, 01-09-2010
Results
Clinical characteristics of the study population
Total population
(N = 26)
Demographic data, n (%)
Male gender
21 (81)
Age (years)
57 ± 12
Height (cm)
176 ± 10
Weight (kg)
80 ± 17
BMI (kg/m2)
29 ± 16
Clinical data, n (%)
LVEF
35 ± 15
Ischemic etiology
17 (65%)
Primary prevention
24 (92%)
Pharmacological treatment
DAMJ Theuns
Betablockers
20 (77%)
ACEi/ARBs
23 (91%)
Diuretics
22 (85%)
Statin
15 (58%)
ESC Stockholm, 01-09-2010
Results
ECG and Holter data
Total population
(N = 26)
ECG data, n (%)
PR interval (ms)
170 ± 33
PR > 200 ms
4 (15%)
QRS duration (ms)
106 ± 17
QRS > 120 ms
4 (15%)
LBBB
3 (12%)
Holter data, n (%)
μ Heart rate (bpm)
70 ± 7
Min Heart rate (bpm)
48 ± 5
Longest RR interval (ms)
DAMJ Theuns
1231 ± 181
ESC Stockholm, 01-09-2010
Results
Implantation
 Procedure
 All local anesthesia, except first 2 implants
 Duration < 100 minutes,  50 min.
 Defibrillation threshold testing
 48 induced VF-episodes
 100% sensitivity, 100% conversion success
  time-to-therapy: 13.9 ± 2.5 sec. (range, 11 to 21.6 sec.)
 Induction of AF (3 patients), spontaneous termination
 Post-shock bradycardia pacing (1 patient)
DAMJ Theuns
ESC Stockholm, 01-09-2010
Methods
DFT
65 J
2000 ms
11040 ms
Post shock pacing
DAMJ Theuns
ESC Stockholm, 01-09-2010
Results
Lead migration
 Prevalence, 2 patients
 34 and 461 days after implantation
 Inappropriate shocks in 1 patient
 Both patients (CE-study), no “mandatory” suture sleeve
 Resolved by reintervention & use of suture sleeve
DAMJ Theuns
ESC Stockholm, 01-09-2010
Results
Lead migration
DAMJ Theuns
ESC Stockholm, 01-09-2010
Results
Inappropriate device therapy
 Prevalence, 4 patients
 Rate-dependent RBBB  permanent RBBB
 Oversensing myopotentials
 Wrong vector, low amplitude QRS complex
 Lead migration
 Permanently resolved by,
 Vector selection
 Software update (improved arrhythmia detection)
 Reintervention lead
DAMJ Theuns
ESC Stockholm, 01-09-2010
Results
Inappropriate device therapy
DAMJ Theuns
ESC Stockholm, 01-09-2010
Results
Inappropriate device therapy
DAMJ Theuns
ESC Stockholm, 01-09-2010
Results
Inappropriate device therapy
Alternate
Secondary
Primary
DAMJ Theuns
Alternate
Secondary
Primary
ESC Stockholm, 01-09-2010
Results
Inappropriate device therapy
DAMJ Theuns
ESC Stockholm, 01-09-2010
Results
Spontaneous ventricular arrhythmias
 Prevalence, 4 patients
 Monomorphic ventricular tachycardia (3 patients)
 2 nonsustained, 1 sustained
 Ventricular fibrillation (1 patient)
 Appropriate detection of all ventricular events
DAMJ Theuns
ESC Stockholm, 01-09-2010
Results
Appropriate device therapy
DAMJ Theuns
ESC Stockholm, 01-09-2010
Conclusion
This report on our clinical experience with the S-ICD system,
 Implantation based on anatomical landmarks only, no X-ray
no short-term procedure-related complications
no lead migration after use of suture sleeves
 All VF episodes were accurately detected using SQ-signals
 No inappropriate therapy caused by SVTs
double-counting issues have been resolved
 The S-ICD system is a viable alternative to conventional ICD
systems for selected patients
DAMJ Theuns
ESC Stockholm, 01-09-2010
Bardy GH et al. N Eng J Med 2010; 363:36-44
DAMJ Theuns
ESC Stockholm, 01-09-2010
DAMJ Theuns
ESC Stockholm, 01-09-2010