The EFFORTLESS SICD Registry. The EFFORTLESS SICD Registry. SICD Implant 11/14/2016

Transcription

1 11/14/2016 VuMedi Webinar: Safety and Efficacy of the Subcutaneous ICD Primary Results of The EFFORTLESS SICD Registry November 21, 2016 Philip Chang, MD, FACC, FHRS Assistant Professor of Medicine and Pediatrics Keck School of Medicine University of Southern California None Disclosures

2 11/14/2016 The EFFORTLESS SICD Registry Evaluation of FactORs ImpacTing CLinical Outcome and Cost EffectiveneSS of the SICD Observational, non-randomized, standard of care evaluation of the SICD system Conducted in 7 countries Czech Rep, Denmark, Germany, Italy, Netherlands, New Zealand, UK Started 2009 following CE Marking of SICD Goal Document clinical-, system-, and patient-related outcome data from SICD patients implanted since device commercial release Target: 1000 patients, 5 years follow-up The EFFORTLESS SICD Registry Included All implanted patients and devices Prospective and retrospectively enrollment 60 months post-implant All scheduled and unscheduled visits in 1 st year Minimum annual visit in years 2-5 SICD Implant Totally subcutaneous ICD system No transvenous lead passage No endocardial lead fixation Indications for implant Conventionally accepted indications for primary and secondary prevention ICDs Contraindications to implant Permanent pacing requirement ATP-terminable VT Previously implanted functional unipolar pacing system At-implant conversion testing At least 1 successful conversion of induced ventricular arrhythmia at 80J Stepdown DFT assessment not required 2

3 11/14/2016 Registry Variables Patient demographics Baseline characteristics, cardiac disease, medications at implant, comorbidities Implant procedure details Induced and spontaneous arrhythmia episodes VT/VF induction at implant Spontaneous arrhythmic events with stored EGMs Spontaneous shocked events SICD system-related complications SICD system-related infections 6 withdrawals 3 inclusion/exclusion violations 1 patient decision 2 investigator decisions 9 deaths (2%) None peri-procedure (30 days post-implant) 1 unknown cause 4 CHF 1 renal 1 stroke (with CHF) 3

4 11/14/2016 Majority of SICDs in previous TV-ICDs were for infection (63%) Pacemakers all tested at max pacing and asynchronous pacing 4

5 11/14/2016 SICD Implant Details Sedation General anesthesia 63% (273/432) Procedure duration ( skin-to-skin ) 69 ± 27 minutes Fluoroscopy No fluoro 87% (310/356) (Where implant details and information were available) SICD Implant Details Conversion testing Documented testing in 90% (410/456) 9 patients noninducible, 8 patients incomplete data 393 patients underwent conversion with complete documentation 392 successfully converted (99.7%) 7 required procedure(s) for SICD repositioning before eventual success (1.7%) 1 patient failed conversion 65J shock successful in 95% 95% CI for DFT conversion efficacy 99.7% (99.2, 100%) Among those tested with 65J shock, mean time to therapy was 15.1 ± 3.8 seconds (7-37 seconds) SICD Programming Device programmed at implant in 431/456 Shock and conditional shock zones Single vs. dual zone 82% dual, 17% single Shock zone detection rate >220 bpm in 84% (362 patients) Sensing vector Primary 50%, secondary 39%, alternate 10% 5

6 11/14/2016 Spontaneous episodes 53% treated (169/317) 29% appropriate (93/317) Appropriate shocks Time to therapy in 77 episodes, 81 shocks 17.5 ± 4.4 seconds Conversion efficacy 96% (90.8, 100% CI) Inappropriate shocks 1-yr rate 7% Single vs. dual zone 12% vs. 6.4% Recurrent inappropriate shocks - 9/32 patients - 2 patients had SICD explanted - 1 patient had SICD turned off SICD Efficacy (pooled) 314 VT/VF episodes detected in 104 patients (11.8%) 115 VT/VF episodes not treated Appropriately detected, spontaneously terminated 76 MVT, 35 PVT/VF, 4 unspecified 199 VT/VF episodes sustained to require 80J shock Incidence of time to first appropriate therapy 1yr 2yr 3yr 6

7 11/14/2016 SICD Efficacy (pooled) 111 discrete VT/VF episodes treated 100 terminated with 1 st shock (90.1%) 109 terminated within 5 shocks (98.2%) 51 PVT/VF events in 32 patients 45 converted with single shock (88.2%) 60 MVT events in 40 patients 55 converted with first shock (91.7%) 12 VT/VF storms in 7 patients 10/12 converted 1 patient with multiple SICD shocks, then external shocks, all with VT conversion followed by re-initiation until eventual external conversion without recurrence Time to therapy 19.2 ± 5.3 seconds SICD Inappropriate Therapies Incidence of time to first inappropriate shock 13.1% at 3 years Dual zone 11.7% Single zone 20.5% Majority of inappropriate shocks occurred in 1 st year post-implant Causes SVT > conditional zone 24% SVT discrimination error 1% T wave oversense 39% Low amplitude signal 21% EMI 8% Complications Invasive procedure required to address 97% complication free rate (first 30 days post-implant) 35 complications in 456 patients (7.7%) Pocket/incision complication 8/35 Hardware/site complication 18/35 Infections 20 documented or suspected (4%) 3 recurrent SICD explant 7

8 11/14/2016 Complication types - Type I device-related - Type II labeling-related - Type III procedure-related (requiring invasive intervention) 108 total complications Types I-III 40% in first 30 days postimplant Complications in 85 patients (9.6%) 14 patients with 2+ complications (1.57%) 71 patients with 1 complication (8%) Pocket/incision complication 30/108 Hardware/site complication 20/ % complications in 1 st 30 days 11.1% complications over 3 years 3-year KM estimate for type I complication 5.4% All-cause mortality - 2-year KM estimate 3.2% (95% CI 1.3%, 5%) - 3-year KM estimate 4.7% (95% CI 0.9%, 8.5%) Elective SICD extraction for pacing 4 patients (0.4%) - New brady pacing indication (1) - New CRT indication (1) - ATP indication (1), V pacing suppression for VT/VF storm (1) 8

9 11/14/2016 Take-away Points Advantages of implant Fluoroless potential Implant procedure time Implant option following transvenous infection Lack of formal stepdown defibrillation threshold testing But very high efficacy with max energy delivery High shock efficacy, but Time to therapy could be shorter? (primary limitation of 80J delivery only) For patient requiring multiple shocks, time in VT/VF can be markedly long Limited programming options if max shocks fail Longer time to therapy = more time for spontaneous conversion Low or comparable mortality rates SICD studies not powered to prospectively assess mortality benefit Complications and inappropriate shocks Reduced with experience and programming Dual zone appears favorable Pocket complications vs. electrode complications 9

10 11/21/2016 Date Clinical Title Subcutaneous-ICD Patient Selection Raul Weiss MD, FAHA, FACC, FHRS and CCDS Director, Electrophysiology Fellowship Program Professor of Medicine The Ohio State University Wexner Medical Center Disclosures Educational and Research support from Boston Scientific, Medtronic, St Jude, Biotronik and Biosense Webster Advisory honoraria from Biosense Webster, Biotronik, Catheter Robotic and Boston Scientific Speaker honoraria from Biotronik, Boston Scientific, St Jude Medical and Biosense Webster The S-ICD System Is Totally Subcutaneous and SICD System Is Placed By Anatomical Landmarks Secondary 80 joules ~60 cc Active can 7.3 year longevity Post-shock pacing MRI compatible Remote monitoring Alternate Primary SQ-RX 1

11 11/21/2016 SICD: Patient Selection Pacing, Monitoring Capabilities, Size and Battery Longevity SICD does not provide, Bradycardia Pacing, CRT or ATP Monitoring SICD has AF monitoring capabilities (current generation) SICD has not heart failure monitoring capabilities Size Size is now 15% smaller (60CCs) than first generation MRI compatibility and Remote Monitoring SICDs are MRI compatible (current generation) SICDs are remote monitoring compatible (current generation) Battery longevity Approx. 7.3 years (compare to about 10 in most single chamber TV-ICDs) Implantation, Short and long Term Risks of TV leads Pocket hematoma Pocket infection or erosion Unexplained pain Lead dislodgement Pericardial effusion or cardiac tamponade Pericarditis Hemothorax Pneumothorax Hemopneumothorax Upper extremity deep venous thrombosis Pulmonary embolism Venous occlusion Superior vena cava syndrome, Tricuspid valve injury Inadvertent implantation of a lead in the left sided cavities Systemic or coronary embolism Death Implantation, Short and long Term Risks of TV leads Pocket hematoma Pocket infection or erosion Unexplained pain Lead dislodgement Pericardial effusion or cardiac tamponade Pericarditis Hemothorax Pneumothorax Hemopneumothorax Upper extremity deep venous thrombosis Pulmonary embolism Venous occlusion Superior vena cava syndrome, Tricuspid valve injury Inadvertent implantation of a lead in the left sided cavities Systemic or coronary embolism Death Complications exclusively related to venous access and endocardial lead delivery 2

12 11/21/2016 OSU Experience with lead From January 2007 to July 2010 Number of Implanted leads 7793 Number of pts requiring emergent surgery: 5 (0.07%) Number of deaths: 2/5 patients (40%) Number of leads extracted 1842 Number requiring emergent surgery: 7 (0.38%) Number of deaths: 3/7 patients (43%) SICD: Patient Selection Long Term Considerations The benefit of a Subcutaneous ICD extends long after implant. The risk of endocarditis/systemic infection is extremely low Theoretically, Lead Failure is expected to be lower Leads Extraction are not associated with vascular or cardiac bleeding ICD Lead Survival Crozier J Interv Card Electrophysiol (2011) 32:

13 11/21/2016 Pre-Qualifying ECG Pre-Qualifying ECG R A LL LA Pre-implant Screening Tool to Identify Patients With Acceptable Sensing Characteristics Prior To The Implant of S-ICD The QRS complex and trailing T-wave are contained within the colored profile 4

14 RA LA LL 14 cm GUIDE (Note: For screening, ECG electrodes should not extend beyond 14 cm arrows) 11/21/2016 Pre-ECG Screening 7% of Patient do Not Qualify SIMULTANEOUS 3-LEAD ECG INCORRECT PROFILE CORRECT PROFILE UNACCEPTABLE ACCEPTABLE LEAD LEAD Peak Zones cm cm LEAD I LEAD II LEAD III 1. RECORD: Supine+Standing 2. SELECT the colored profile. The largest 25 mm/s, 5-20 mm/mv QRS peak must be within a Peak Zone. 3. VERIFY at least one lead is acceptable in all postures. Olde-Nordkamp J Cardiovasc Electrophysiol, Vol. 25, pp , May 2014 modified 7% of Patient do Not Qualify Pre-ECG Screening Males 100% vs. 73%; P < 0.01 HCM 24% vs. 6.6%; P =0.03 Higher weight (92 kg vs. 83 kg; P = 0.01)or higher BMI (29 vs. 27; P = 0.05; Table 2). QTc interval (408 milliseconds vs. 429 milliseconds; P =0.03) QRS duration (107 milliseconds vs. 120 milliseconds; P < 0.01). Particularly, RBBB was more prevalent inpatients who failed the TMS (7.5% vs. 24%; P = 0.05). ECG parameters from lead I and avf of the 12-lead surface ECG did not differ between patients with an appropriate and screening Olde-Nordkamp J Cardiovasc Electrophysiol, Vol. 25, pp , May 2014 modified 8% of Patient do Not Qualify Patients with T-wave inversions in leads I, II, and avf on a standard ECG were 23 times more likely to fail screening ECG Pre-ECG Screening C. Groh et. al. Heart Rhythm 2014;11: N=100 5

15 11/21/2016 Baseline Characteristics Attribute Co-morbidities History Cardiac Surgical History Weiss et. al. Circulation. 2013;128: Statistic/Category N=321 n % Congestive Heart Failure Hypertension Myocardial Infarction Diabetes Atrial Fibrillation Valve Disease COPD 27 8 Stroke 18 6 Percutaneous Revascularization CABG TV-ICD Valve Surgery 18 6 Pacemaker 4 1 Primary & Secondary Prevention Patient Distribution Similar to NCDR Registry S-ICD System IDE Study n = 321 patients NCDR ICD Registry n = 486,025 patients Secondary Prevention 21% Secondary Prevention 22% Primary Prevention 79% Primary Prevention 78% M. Burke, HRS 2013 Specific Patient Populations HCM/LQT 6

16 11/21/2016 Enrollment: EFFORTLESS N = 568 Both Studies N = 13 IDE N = 308 Total Pooled N = 889 Evaluated Cohort N = 865 Not Implanted (n = 7) Missing Baseline Data (n = 17) Long QT N = 27 Mean FU = 21.2 months R Weiss Abstract ESC 2015 Non-Long-QT N = months p=ns Results: Conversion Test Results Long QT Non-Long-QT Patients with Evaluable Conversion Test At least one Successful Conversion <= 65J* 21 (95.5%) 707 (94.4%) At least one Successful Conversion <= 80J^ 22 (100.0%) 738 (98.5%) *p=0.83 ^p=0.56 R Weiss Abstract ESC 2015 Results: Spontaneous VT/VF Efficacy Discrete Episodes Subgroup Long QT Pre-Shock Patients First Shock in Final Shock in Device Episodes Rhythm N (%) Episode Episode MVT 1 1 (3.7%) 1 (100.0%) 1 (100.0%) PVT/VF 4 2 (7.4%) 4 (100.0%) 4 (100.0%) Total 5 3 (11.1%) 5 (100.0%) 5 (100.0%) Non-Long QT MVT (4.7%) 54 (91.5%) 59 (100.0%) 21 PVT/VF (3.6%) 41 (87.2%) 45 (95.7%) Total (6.7%) 95 (89.6%) 104 (98.1%)* * Clinical conversion efficacy was 100%. Of two unconverted discrete episodes One spontaneously terminated after the 5th shock In the other episode, the device prematurely declared the episode ended. A new episode was immediately reinitiated and the VF was successfully terminated with one shock R Weiss Abstract ESC

17 11/21/2016 Effective Conversion of Induced VT/VF in HCM Patients 95.5% successful cardioversion of VT/VF in HCM at <65 J versus 94.3% in non-hcm cases (p= ns) Successful cardioversion at <80 J was achieved at 98.9% of HCM and 98.5% of non-hcm patients (p=ns) 3 Spontaneous VT episodes with 100% success of the first shock in the HCM group Pier D. Lambiase et al Heart Rhythm 2016 In Press SICD: Patient Selection Who SHOUD NOT Received an SICD Patients with bradycardia pacing indication Patients with CRT Indication Patients with pace-terminable VT (Recurrent monomorphic VT. Patients with TV-ICD explantation that had multiple VT termination with ATP. Patients with VT slower than 170 BPM ) Previously implanted unipolar pacemaker Failure of fulfilling Pre-ECG criteria Patient Selection: Conclusions Patients meeting current ICD guidelines indication, In general, if a a single transvenous (TV) lead ICD is considered they are also suitable for a subcutaneous (S) ICD Younger patients, in which the likelihood of survival exceeds the expected lead survival, high infection risk and no vascular access likely will benefit from an SICD Channelopaties patients and HCM Renal failure, immunosuppressed, congenital HD, complex vascular anatomy should be consider for SICD 8

18 11/21/2016 Thank You! 9

19 11/18/2016 S-ICD Implantation Techniques Steven P. Kutalek, MD, FACC, FHRS Drexel University College of Medicine Philadelphia, PA Disclosures Consultant Boston Scientific Spectranetics Research Boston Scientific Medtronic Sorin Speaker Boston Scientific Spectranetics Implant Options 3 Incision Technique Left Lateral Thoracic Pocket Infra-sternal Lead Insertion & Anchoring Supra-sternal Lead Securing 2 Incision Technique Left Lateral Thoracic Pocket Infra-sternal Lead Insertion & Anchoring 1

20 11/18/2016 Two Incision Technique Advantages Reduced procedure time No upper sternal scar Cosmetics Disadvantages May need 3 hands to remove the sheath Less control over coil position Possibility of S curve of the lead Especially in a heavy patient Stay deep on the fascia Dislodgement Tips for a Successful Implantation Know your landmarks 2

21 11/18/2016 S-ICD Placement in a Patient with a Pre-existing LVAD Tips for a Successful Implantation Know your landmarks Maintain meticulous sterility 3

22 11/18/2016 S-ICD Placement in a Patient with a Pre-existing LVAD Tips for a Successful Implantation Know your landmarks Maintain meticulous sterility Get to the fascia Get to the fascia Get to the fascia 4

23 11/18/2016 One Month - PA One Month - Lateral 5

24 11/18/2016 Tips for a Successful Implantation Know your landmarks Maintain meticulous sterility Get to the fascia Tunnel against the fascia 6

25 11/18/2016 7

26 11/18/2016 Tips for a Successful Implantation Know your landmarks Maintain meticulous sterility Get to the fascia Tunnel against the fascia Anchor the lead & device securely Anchor the Device Securely to the Fascia 8

27 11/18/2016 Tips for a Successful Implantation Know your landmarks Maintain meticulous sterility Get to the fascia Tunnel against the fascia Anchor the lead & device securely Close in layers 9

28 11/18/2016 Drexel University Procedural Details Anesthesia: GA - 72%, MAC- 28 % 2 incision technique: 52 % Defibrillation threshold testing: 88% patients Successful - 85% Unsuccessful - 3% Reversed polarity successful in - 2 Device repositioning required in - 1 Drexel University Procedural Details Procedural mortality: None Procedural complications: 3 Bradycardia requiring temporary pacing- 1 Hypercapnic respiratory failure- 1 Hypotension requiring pressor support- 1 Last 10 implants averaged 43 minutes. 10

29 11/21/2016 S-ICD versus Transvenous ICD: What you need to look for during device follow -up Martin C. Burke DO Heart Rhythm Center Disclosures: Boston Scientific: Modest honoraria and research grants Medtronic: Research grants and honoraria AtaCor Medical: Equity St Jude Medical: Research grants and honoraria Overview Differences in device programming between the transvenous ICD and subcutaneous ICD (S-ICD) Basic components of a S-ICD check Managing appropriate and inappropriate therapy How will the S-ICD alter workload/ work flow in the device clinic 1

30 11/21/2016 Differences in device programming between the transvenous ICD and subcutaneous ICD (S-ICD) Transvenous ICDs have up to 2000 programmable features compared to the S-ICD s 4 programmable features Pacing thresholds are not performed with the S-ICD Lead impedance is a measure of shock impedance rather than pacing impedance Battery longevity decreases by a month for every shock delivered Device Programming What is programmab e- S-ICD System Therapies: off or on Dual Therapy Zones Shock Zone: 170 bpm bpm (steps of 10 bpm) Conditional Shock Zone: off or on 170 bpm bpm (minimum 10 bpm less than Shock Zone) Override auto sensing vector selection Post-shock pacing: off or on (50 ppm, max 30 sec, demandbased) Device Programming What is ot programmab e - Automatic shock energy is set at 80J Shocks per episode: Maximum of 5 shocks No brady pacing or ATP programming available Dual zones programmed out of box 2

31 11/21/2016 Basic components of a S-ICD check Presenting Rhythm Episodes Zones Battery Impedance Smart Charge Vectors Tones Presenting Rhythm 3

32 11/21/2016 Episodes Zones Battery 4

33 11/21/2016 Impedance Smart Charge Vectors 5

34 11/21/2016 Tones Typical Print out and Follow Up Typical Episode Print out 6

35 11/21/2016 Managing appropriate and inappropriate therapy Rhythm discrimination INSIGHT algorithm automatically activated when the Conditional Shock Zone is programmed Optional Conditional discrimination zone that involves 3 distinct rhythm analyses to distinguish atrial from ventricular tachycardia. Managing appropriate and inappropriate therapy Managing appropriate/inappropriate therapy 7

36 11/21/2016 Alter Workload/ Work Flow Quicker device check No threshold testing Currently no remote monitoring available Visits every 3 months. Only 4 programmable features: Therapies, Sensing vector selection, post shock pacing, detection zones. 8