Leadless pacemakers and subcutaneous ICD s: will we use them for most of our patients? K.-H. Kuck Asklepios Klinik St. Georg Hamburg, Germany

Transcription

1 Leadless pacemakers and subcutaneous ICD s: will we use them for most of our patients? K.-H. Kuck Asklepios Klinik St. Georg Hamburg, Germany

2 Disclosure Statement Research Grants Consultant / Advisory Board Ownership Interests Speaker s Bureau Honoraria Biosense Webster, Stereotaxis, Medtronic, St. Jude, Cardiofocus, Abbott St. Jude, Edwards, Stereotaxis, Mitralign, Cardiofocus, BMDSys, ACT, Maya, Apama, Topera, Recor, Endosense, SynapticMed, Shareholder Endosense Biosense Webster, Medtronic, St. Jude, Abbott, Cardiofocus, Biotronik Fellowship Support None Other Off-label drugs/devices None None

3 Leadless PM and SubQ ICD The weakest link of a pacemaker or ICD is the lead. The more leads, the more complications.

4 Leadless PM and SubQ ICD Lead Problems: Lead dislodgement Lead malfunction Lead fracture Lead infection Cardiac perforation with or without cardiac tamponade Coronary sinus dissection Hemo-/Pneumothorax Vein thrombosis Cardiac valve injury Lead thrombi

5 Leadless PM and SubQ ICD Circulation. 2000;102:

6 CASH Total mortality Kuck KH et al, Circulation. 2000;102:

7 CASH SCD mortality Kuck KH et al, Circulation. 2000;102:

8 Implantation-Related Complications of Implantable Cardioverter- Defibrillatorsand Cardiac Resynchronization Therapy Devices JB van Rees et al, J Am Coll Cardiol 2011;58:

9 Implantation-Related Complications of Implantable Cardioverter- Defibrillatorsand Cardiac Resynchronization Therapy Devices JB van Rees et al, J Am Coll Cardiol 2011;58:

10 Implantation-Related Complications of Implantable Cardioverter- Defibrillatorsand Cardiac Resynchronization Therapy Devices JB van Rees et al, J Am Coll Cardiol 2011;58:

11 The REPLACE Registry pts without (cohort A) and those with (cohort B) a planned transvenous lead addition JE Poole et al, Circulation. 2010;122:

12 The REPLACE Registry pts without (cohort A) and those with (cohort B) a planned transvenous lead addition JE Poole et al, Circulation. 2010;122:

13 The REPLACE Registry pts without (cohort A) and those with (cohort B) a planned transvenous lead addition JE Poole et al, Circulation. 2010;122:

14 JE Poole et al, Circulation. 2010;122: The REPLACE Registry pts without (cohort A) and those with (cohort B) a planned transvenous lead addition Conclusions Pacemaker and implantable cardioverter-defibrillator generator replacements are associated with a notable complication risk, particularly those with lead additions. These data support careful decision making before device replacement, when managing device advisories, and when considering upgrades to more complex systems.

15 Disclosure Statement FDA NEWS RELEASE For Immediate Release: Aug. 16, 2012 Media Inquiries: Sarah Clark-Lynn, , Consumer Inquiries: 888-INFO-FDA FDA recommends X-ray or other imaging on implanted heart defibrillators with St. Jude Medical Riata leads to help guide treatment Agency orders the company to collect data on the wire insulation function

16 1. Unmet Needs in Cardiac Pacing Prevention of SCD Pocket hematoma (5%, heparin ++) Lead dislodgement (0.5% per lead) Chronic lead reliability issues: Crush, fracture, abrasion, etc. (in: pocket, subclavian V., the heart) System connections (battery change +++) Device pocket complications: Erosion through the skin: 0.4% after 1 st implant, 4.5% after replacement Pain at incision/pocket

17 1. Unmet Needs in Cardiac Pacing Infection Up to 1.2% within a year after procedure Up to 5% of the entire population with endocarditis 1% risk of death and 2% risk of major complications at lead extraction Lead interactions with vasculature and heart structures: Tricuspid valve impairment (20% of implanted pts with TV regurgitation) Venous stenosis/thrombosis (up to 25%) SVC syndrome (<1%) Cosmesis Availability of specialists for implant/follow-up Emerging Markets

18 1. Unmet Needs in Cardiac Pacing Pacing lead failure Up to 21% within 10 years after pacemaker implantation Defibrillator lead failure Lead replacement is mandatory in 38% within 8 years after ICD implantation

19 Trends in CRM Technologies Subcutaneous ICD Leadless pacing

20 Bardy GH et al. NEJM 2010; DOI:

21 Subcutaneous ICD Bardy GH et al, N Engl J Med 2010;363:36-44

22 Subcutaneous ICD Bardy GH et al, N Engl J Med 2010;363:36-44

23 Subcutaneous ICD Bardy GH et al. NEJM 2010; DOI:

24 Subcutaneous ICD BardyGH et al, N Engl J Med 2010;363:36-44

25 Subcutaneous ICD BardyGH et al, N Engl J Med 2010;363:36-44

26 Subcutaneous ICD BardyGH et al, N Engl J Med 2010;363:36-44

27 Subcutaneous ICD In 52 of the 53 patients who were tested (98%), two consecutive episodes of induced arrhythmia were successfully converted at 65 J After 10±1 months and 46 patient-years of follow- up, 54 of 55 patients (98%) were alive 12 patients had complications - pocket infection in 2, minor lead migration in 2, parasternal lead dislodgement in 4, oversensing or inadequate sensing in 4 A total of 12 episodes of spontaneous ventricular tachycardia were detected and successfully treated in 3 patients BardyGH et al, N Engl J Med 2010;363:36-44

28 Subcutaneous ICD European Heart Journal (2012) 33,

29 Subcutaneous ICD 3 sensing vectors Jarman J et al, European Heart Journal (2012) 33,

30 Subcutaneous ICD 3 sensing vectors European Heart Journal (2012) 33,

31 Subcutaneous ICD inappropriate shock due to T-wave oversensing Jarman JWE et al, European Heart Journal (2012) 33,

32 Subcutaneous ICD delayed appropriate shock Jarman JWE et al, European Heart Journal (2012) 33,

33 Subcutaneous ICD During median follow-up of 9 months (range 3 15 months), three children required re-operation. Eighteen clinical shocks were delivered in six patients. Ten shocks in four patients were inappropriate due to T- wave over-sensing. Within the eight shocks for ventricular arrhythmia, three were delivered for VF, among which two had delays in detection with time to therapy of 24 and 27 s. Jarman JWE et al, European Heart Journal (2012) 33,

34 Subcutaneous ICD issues Improve DFT VT/VF Sensing Not designed to treat VA at a rate <170 b/min No pacing, no ATP, no CRT Randomized study comparing the transvenous ICD vs subq ICD warrented

35 Subcutaneous ICD indications (1) patients willing to avoid the risks related to transvenous ICD leads, in particular, lead extraction; (2) young patients with arrhythmogenic syndromes/channelopathies with good ventricular function and infrequent events (especially if the clinical arrhythmia is ventricular fibrillation or polymorphic ventricular tachycardia); (3) patients with recurrent, relapsing transvenous lead failures or infections;

36 Subcutaneous ICD indications (4) failure to achieve vascular access for transvenous lead placement; (5) as a bridge to heart transplantation when preservation of vascular access is desirable; (6) need or desire to avoid radiation exposure; (7) children >30 kg (this could prove to be the ICD of choice, especially if a smaller pediatric version will become available).

37 Leadless Pacemaker Potential Benefits Miniaturized, Leadless VVIR Pacer + Steerable Sheath/Catheter Reduced Invasiveness No surgery Fewer complications (no lead or subq device) Less radiation exposure for implanter (femoral) More cosmetic for patient ( invisible ) Improved Efficiency Simpler procedure; no surgery Femoral venous access No system connections MRI conditional More Cost-Effective Therapy Reduced length of hospital stay Fewer acute and chronic complications

38 Potential Clinical Risks Fixation/dislodgement Large-bore catheters (20-26Fr) Access challenges Hemostasis Vascular complications Low, stable chronic thresholds Thromboembolic risk Extraction? Battery exchange

39

40 System proposed by Spickler in 1970

41 PACE 2009; 32: Trends in CRM Technologies Leadless Pacing of the Heart Using Induction Technology: A Feasibility Study HEINRICH WIENEKE, M.D.,* THOMAS KONORZA, M.D.,* RAIMUND ERBEL, M.D.,* and ERHARD KISKER, PH.D. From the *West-German Heart Center, University Clinics Essen, Essen, Germany; and Institute of Applied Physics, Heinrich-Heine University Duesseldorf, Duesseldorf, Germany

42 PACE 2009; 32: Trends in CRM Technologies The stimulation system consists basically of two components: (1) a transmitter unit (primary coil) implanted under the skin or the major pectoral muscle just above the heart and (2) a small receiver unit (secondary coil) implanted in the right or left chamber of the heart The energy for the voltage pulse to stimulate the heart is transmitted by the magnetic field. Thereby, the subcutaneous coil generates an alternating magnetic field and the receiver coil in the heart converts some fraction of the energy of this magnetic field directly into voltage pulses for stimulation

43 Trends in CRM Technologies Wieneke H et al, PACE 2009; 32:

44 Heart Rhythm 2006;3: Trends in CRM Technologies Feasibility and safety of a novel technology for pacing without leads Debra S. Echt, MD, Mark W. Cowan, BS, Richard E. Riley, MS, Axel F. Brisken, PhD From EBR Systems, Inc., Sunnyvale, California.

45 Leadless Pacing: Acoustic Energy Intracardiac receiver converts ultrasound from transmitter and converts it to electral energy 24 pts. tested during EP study 80 pacing RA, RV, LV sites tested, consistent capture at 77 sites Ultrasound window Lee KL. J Am Coll Cardiol 2007; 50:

46 Leadless Pacing: Acoustic Energy WiSE Device: Receiver: 9 mm plus small lead, 0.05 cc Transmitter: implanted over the apex, connected to battery implanted in the abdomen 0.05cc Electrode

47 WiSE-CRT Study Wireless Stimulation Endocardially for CRT, 100 pts. Purpose: To evaluate the safety and performance of the WiCS-LV System in patients with indications for CRT. Primary Outcome Measures: Safety: Procedure and device-related adverse events Bi-ventricular pacing capture Inclusion Criteria: Patients with standard indication for CRT based upon the most recent guidelines AND meeting criteria for one of these three categories: PM and ICD upgrades, LV lead failures, Non responders Status: Study on-hold due to perforations, 11 implants

48 Leadless Pacemaker: Intracardiac Intracardiac VVIR pacemaker ~20F, ~24 mm length, 7-10 yr longevity Steerable Catheter +

49 Chronic Animal Study of Leadless Pacer Design

50 What is the Leadless Pacer? Cylinder Shape 7 year longevity VVI(R) Programmable Placed within RV Typical diagnostics

51 Potential Benefits Reduced Device pocket complications Pocket hematoma Erosion through the skin Pain at incision / pocket Frozen shoulders and post-implant arm restrictions Reduced Infection No pocket so no pocket infection No lead to track infection into bloodstream No lead fractures No unsightly bulge under skin No inappropriate system connections

52 Study Purpose Measure chronic electrical behavior of a pacemaker device small enough to be implanted within the right ventricle Begin to learn the important issues regarding electrode performance with the leadless pacer concept Bonner MD. Abstract presented at the Heart Rhythm congress 2011 in San Francisco

53 Study Methods Chronic Sheep model Jugular implant All implants in right ventricular apex 16 animals, 1 device per animal Plastic capsules with attached wires Tip electrode with steroid Large ring anode Electrodes attached to Advisapacemaker with wires Weekly manual awake monitors 6 month duration Bonner MD. Abstract presented at the Heart Rhythm congress 2011 in San Francisco

54 Results Devices in apex No dislodgements No adverse events Infections Tamponade Damage to valves or other structures No thrombo embolism No pericardial blood Bonner MD. Abstract presented at the Heart Rhythm congress 2011 in San Francisco

55 Pacing Threshold over Time Bonner MD. Abstract presented at the Heart Rhythm congress 2011 in San Francisco

56 R-wave Amplitude Bonner MD. Abstract presented at the Heart Rhythm congress 2011 in San Francisco