Implantable Cardioverter Defibrillator Technology in Perspective: From Remote Monitoring to Leadless Devices

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1 UNIVERSITA DEGLI STUDI DI MILANO I.R.C.C.S POLICLINICO SAN DONATO CENTRO PER LO STUDIO E LA TERAPIA DELLLE MALATTIE CARDIOVASCOLARI E. MALAN Implantable Cardioverter Defibrillator Technology in Perspective: From Remote Monitoring to Leadless Devices Riccardo Cappato, MD

2 Disclosures Equity and Intellectual Property Rights: Cameron Health Consultant to: Boston Scientific; Medtronic; St. Jude; Biosense Webster; ELA Sorin Speaker s Bureau: Boston Scientific; Medtronic; St. Jude; Biosense Webster; BARD; Sanofi Aventis Investigator: Medtronic; Biosense Webster; Sanofi Aventis; Cameron Health, BARD Grants: Boston Scientific; Medtronic; St. Jude; Biosense Webster; BARD; ELA Sorin

3 ICD in Perspective: From Remote Monitoring to Leadless Devices Introduction The number of pts receiving ICD technology continues to escalate (in 2006, > 234,000 carriers in US and > 87,000 carriers in Europe) Current technology has proven highly effective and safe; still limitations and complications prevent optimal efficiency

4 ICD in Perspective: From Remote Monitoring to Leadless Devices Introduction Recent technologies have been developed to compliment current limitations; among them are: remote monitoring subcutaneous defibrillator

5 Remote Monitoring

6 ICD in Perspective: From Remote Monitoring to Leadless Devices Remote monitoring Aim To provide remote detection and transmission of data relevant to device function and malfunction Relevance of technical and clinical meaning

7 Sticherling et al, 2009

8 ICD in Perspective: From Remote Monitoring to Leadless Devices Remote monitoring Commonly detected and transmitted data in remote device monitoring Technical Battery status Pacing lead impedance Shock impedance Sensing amplitude Automated threshold measurements Percent of stimulated beats Periodic intracardiac electrogram (IGM)

9 ICD in Perspective: From Remote Monitoring to Leadless Devices Remote monitoring Commonly detected and transmitted data in remote device monitoring Medical Arrhythmias Detected VT or VF episodes Detection of AF Treated VT or VF episodes Heart failure Continuous intra-thoracic impedance measurement Heart rate variability Heart rate istograms

10 Sticherling et al, 2009

11 Sticherling et al, 2009

12 Sticherling et al, 2009

13 ICD in Perspective: From Remote Monitoring to Leadless Devices Remote monitoring Areas of uncertainty Legal issues Reimbursement Cost-efficiency

14 ICD in Perspective: From Remote Monitoring to Leadless Devices Remote monitoring Legal issues How fast must a physician react to the electronically transmitted alerts? Property, privacy and safety of the patient data Specific definition of responsabilities by legal body will be sufficient to protect physician from suit?

15 Cost-efficiency AL-KHATIB et al, 2010

16 Cost-efficiency AL-KHATIB et al, 2010

17 Cost-efficiency AL-KHATIB et al, 2010

18 Leadless ICD

19 Advances in Subcutaneous ICDs Introduction Long-term, lead failure persists as an ICD limitation despite decades of innovation in leads design Lead failure either generates inappropriate shocks or impedes appropriate therapy Failed leads often require removal, a procedure associated with a potential risk of morbidity and mortality

20 Advances in Subcutaneous ICDs Aim of technology The entirely Subcutaneous (S) -ICD is designed to provide the life-saving benefit of conventional ICDs whilst avoiding the shortcomings of transvenous leads By simplifying implant techniques, S-ICD are also meant for expanding the use of ICDs in clinical practice

21 Advances in Subcutaneous ICDs The S-ICD system The S-ICD consists of a tripolar parasternal electrode (polycarbonate-urethane 55D, 3 mm diameter) connected to an electrically active pulse generator located in the left lateral thorax

22 Subcutaneous Defibrillation

23 Subcutaneous Defibrillation

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25 Advances in Subcutaneous ICDs The S-ICD detection system Detection signals from the two sense electrodes or between either sense electrode and the ICD can

26 Subcutaneous Defibrillation

27 Advances in Subcutaneous ICDs The S-ICD detection system The ICD automatically selects the signals from the two best vectors for arrhythmia selection and for avoiding double counting and T-wave oversensing

28 Advances in Subcutaneous ICDs The S-ICD detection system Once signals are validated as free of noise and double detection, feature analysis followed by rate detection sorts rhythm type and need for therapy A conditional discrimination zone incorporating a feature extraction technique can be programmed between bpm to avoid treating supraventricular tachycardia

29 Advances in Subcutaneous ICDs The S-ICD detection system Arrhythmia reconfirmation follows capacitor charging to avoid shocking non-sustained ventricular arrhythmias All shocks are 80J with reverse polarity possible 50 bpm demand pacing is available post-shock for 30 seconds using a 200 ma biphasic transthoracic pulse delivered between canister and shock coil Pacing is activated only after >3 second of post-shock asystole

30 Advances in Subcutaneous ICDs Acute defibrillation testing Following incision closure, VF was induced by 50Hz stimulation between the shock coil and the canister to confirm appropriate detection and termination of VF Two consecutive successful defibrillations at 65J were required in each patient providing a 15J safety margin for this 80J device

31 Advances in Subcutaneous ICDs Participating centers Policlinico San Donato, Milan, I Auckland City Hospital, Auckland, NZ Liverpool Heart and Chest Hospital, Liverpool, UK Glasgow Royal Infirmary, Glasgow, UK Kings College Hospital, London, UK Burdenko Military Hospital, Moscow, Rus Papworth Hospital, University of Cambridge, Cambridge, UK Erasmus Medical Center, Rotterdam, NL St. Antonius Hospital, Nieuwegein, NL University Medical Groeningen, Groeningen, NL AMC, Amsterdam, NL Russell s Hall Hospital, Dudley, UK

32 Advances in Subcutaneous ICDs 55 pts (44 males, 11 females) Age, 56±13 years (22-84) LVEF, 0.34±0.13 ( ) Underlying heart disease Ischemic in 37 Non-ischemic in 10 Congenital in 2 Other in 6 Results Bardy et al, 2010

33 Advances in Subcutaneous ICDs Results Defibrillation testing not possible in 2 patients intra-operative hemodynamic instability in 1 inability to induce VF in 1 This resulted in 53 evaluable patients Bardy et al, 2010

34 Advances in Subcutaneous ICDs Results Of 137 episodes of induced VF, 100% were detected by the S-ICD Conversion efficacy on 2 successive inductions was 52/53 (98%) at 65J 50 patients converted using standard polarity 2 using reverse polarity Mean time to therapy was 14.0±2.5 sec Bardy et al, 2010

35 Advances in Subcutaneous ICDs Results Mean skin-to-skin implant time, including at least 2 induction/termination tests separated by at least 5 min between inductions, 67±33 min for a procedure never done by most of the implanters min for those that did 3 implants Bardy et al, 2010

36 Advances in Subcutaneous ICDs Complications Lead reposition for success in 1 pt Minor lead migration without clinical impact was noted in 2 pts Parasternal lead dislodgement due to inadequate anchoring of the tip electrode (requiring repositioning within a week of surgery) in 2 pts Oversensing due to an inadequately inserted electrode into the header block in 1 pt (resolved by means of reprogramming of the detection vector) Bardy et al, 2010

37 Advances in Subcutaneous ICDs Complications Pocket infection in 1 pt (having ignored advice to not lift weights immediately post-operatively) Failure to meet the conversion success criterion of 65J at implant 1 pt (who subsequently received a transvenous ICD) there were no pocket erosions! Bardy et al, 2010

38 Advances in Subcutaneous ICDs Spontaneous events during follow-up Four spontaneous fast VT events were detected in 3 pts All patients were non-syncopal and none experienced an adverse event All events were successfully treated by 80J shocks Bardy et al, 2010

39 Spontaneous Events

40 ICD in Perspective: From Remote Monitoring to Leadless Devices Conclusions Remote monitoring offers unprecedented opportunities for technical and clinical assessment of ICD function Provided the positive perception of both patients and physicians, its applicability to daily clinical practice depends on solid demonstration of cost-efficiency

41 ICD in Perspective: From Remote Monitoring to Leadless Devices Conclusions S-ICD represents a novel approach for the prevention of VT/VF induced sudden death S-ICDs avoid procedural difficulties and complications associated with transvenous leads S-ICD are not indicated in patients requiring anti-bradycardia pacing or with documented regular VT

42 S-ICD : Who would be eligible? Numbers Index cases Most cases GUCH Thrombotic disease Pediatric cases Advisories Secondary prevention (no CRT) Primary prevention (SCD-HeFT, MADIT- 2)

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46 Advances in Subcutaneous ICDs The S-ICD detection system Once signals are validated as free of noise and double detection, feature analysis followed by rate detection sorts rhythm type and need for therapy A conditional discrimination zone incorporating a feature extraction technique can be programmed between bpm to avoid treating supraventricular tachycardia

47 Leadless pacing

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50 pa

51 ll

52 Programming Simplicity only four programmable choices