How To Test For A High Threshold And Fail An Implant

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Clifton Miles
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1 Ventricular defibrillation testing during ICD implant: a French multicenter study Pascal Defaye, Arnaud Lazarus, Gilles Landes, Pierre Mondoly, Jean-Marc Mansourati, Daniel Gras, Jean-Marc Dupuis, Nicolas Delarche, Olivier Bizeau, Elisabeth Mouton, Nicolas Sadoul on behalf of the Leader study investigators University Hospital, Grenoble, Clinic Bizet, Paris, University Hospital, Nantes, University Hospital, Toulouse, University Hospital, Brest, Clinic Nantaises, Nantes University Hospital, Angers, General Hospital, Pau, General Hospital, Orléans, Boston Scientific, Montigny le Bretonneux, France, University Hospital, Nancy, France ESC 2011, Paris, August 29th

2 DECLARATION OF CONFLICT OF INTEREST Boston Guidant : research grants, consulting Sorin group : research grants, consulting Medtronic : research grants, consulting

Introduction (1) During ICD implant procedures, it is common practice to perform a defibrillation testing (DT) in order : To assess the reliability of the device for

3 Introduction (1) During ICD implant procedures, it is common practice to perform a defibrillation testing (DT) in order : To assess the reliability of the device for both VF detection and VF termination And to determine the defibrillation threshold (DFT) 10 J safety margin ( standard of care ) Mean DFT = 9 ± 5J (Shorofsky PACE 2004)

Introduction (2) DT is considered as the critical determinant of a successful implant procedure Although the risk associated with DT is low, serious complications may occur such as : transient

4 Introduction (2) DT is considered as the critical determinant of a successful implant procedure Although the risk associated with DT is low, serious complications may occur such as : transient ischemic attack, cardiopulmonary arrest, cardiogenic shock, embolic events (in case of AF or in the presence of thrombi in the left ventricle) and even death (<1%) these complications may be a consequence of VF induction per se and/or the difficulty in defibrillating the heart

5 Introduction (3) Physicians have recently focused on DT because of: The increase number of ICD implantation and the changes in the technology of ICD which results in lower DFTs The spread out of resynchronisation therapy with ICD backup in patients who may not tolerate DT complications

6 DT: to test or not to test? Pros Assessment of device efficacy Troubleshooting a high threshold Shock polarity reversal, New lead position, (Dual coil), SQ patch High energy devices, DT ensures that the system provides appropriate VF sensing Cons Probability of high threshold and failed implant is small DFT is probabilistic and shocks below threshold may be effective Shocks may cause haemodynamic compromise Lack of data that demonstrate increased mortality among patients with high DFT

7 Aims of the study The aims of this study were : To observe real world defibrillation testing procedures To compare the characteristics of patients with or without DT To compare the severe adverse events during the implant procedure the follow up of these two populations

8 Patient selection, study design Patients with class I or class II implant indications Implanted ICD : Vitality, Renewal TM (Guidant) Follow-up at: 3-6 months and at 12 months Mainly a French prospective, observational, multicenter study (42 centres + 1 in Czech Republic) Started on January 2005, closed on July 2010 Number of enrolled patients: n = 904

9 Patients characteristics N= 904 Age 62.1 ± 12.8 yrs Male 85.4 % Prophylactic indication 62.0 % LVEF 36.5 ± 15.6% NYHA III+IV 45.7 % QRS ± 38.0 ms SVT history 29.3 % Ischemic cardiomyopathy 62.2 % Dilated cardiomyopathy 25.7 % Mean FU months

10 DT and patient characteristics Total Tested patients Not Tested patients P value (904) (group 1) (810) (group 2) (94) Men ns Age, (mean ± SD), y 62.1 ± ± ± 11.6 <0.01 LVEF, (mean ± SD) (%) 31.5 ± ± ± 8.2 <0.001 NYHA class III+IV (%) <0.001 QRS (mean ± SD), ms ± ± ± 37.5 <0.001 Cardiomyopathy Ischemic (%) Dilated (%) Other disorders (%) None (%) ns <0.05 <0.01 ns Permanent AF, n (%) 90 (10%) 74 (9.2%). 16 (17.4) <0.05 CRT-D (%) <0.001 Primary prevention (%) <0.001 Beta-blockers <0.05 Amiodarone ns ACE inhibitors/arb ns Antiplatelets ns Anticoagulants ns

DT and indications n = 94 Prophylactic n = 810 Secondary 20.4 21.2 40.

11 DT and indications n = 94 Prophylactic n = 810 Secondary , Not tested patients P < Tested patients

12 Reasons for not performing DT n = 92 Poor haemodynamic status n (%) 59 (62.8) Others 29 (19) Primary indication 11 (11.7) AF (with/without anticoagulants) 9 (9.6) No anesthesiologist 3 (3.2) Pacing-dependant patient 3 (3.2) Other cardiac reasons 2 (2.1) Complication during the implant 1 (1.1) 6 unknown reasons

13 DT and ICD models * Vitalty Renewal 4 Renewal 4 HE Not tested ** Tested NS * p < 0.01 ** p < 0.05 Pts without DT were predominantly implanted with CRT-D (15.7 vs 5.5% p< 0.01) High energy ICD are similarly implanted in the 2 groups

14 Arrhythmia therapy ( months ) First Appropriate Tx (%) First Inappropriate Tx (%) Not tested (n=94) Aetiology 11 VT (79) + 3 VF Aetiology 2 AF+4 AA + 1 noise Tested (n=810) 14 (15) 164 (20.2) ns 142 VT (87) + 22 VF 7 (7.4) 56 (6.9) ns 14 AF+23 AA+17 ST + 2 noise p

15 Serious Adverse Events ( months ) Not tested Tested p n= 386 SAE (n=94) n (n/pt)* (n=810) n (n/pt) Total 53 (0.57) 337 (0.41) = 0.01 Device related 11 (0.12) 132 (0.16) ns Not Device related 43 (0.46) 205 (0.26) < 0.01 * n/pt = number SAE/patient

16 Serious Adverse Events Peri procedural period * = n SAE/pt; p<0.05 Tested (810) 11 ( 0.014*) Not tested (94) 4 (0.043*) Tamponade 1 Pneumothorax 1 Pocket hematoma 1 Hemiplegia 1 Renal insufficiency 1 LV lead issue 2 High energy upgrade 2 Dual coil RV lead upgrade 1 Heart failure 2 Inappropriate Tx (AF) 1 FA cardioversion 1 Non cardiac 1

17 Serious Adverse Events Follow-up period / Device related (without deaths) n (%) Tested (810) Not tested (94) Atrial lead repl. or reposit. 3 (0.4) RV lead repl. or reposit. 16 (2.0) 2 (2.1) LV lead repl. or reposit. 22 (2.7) 5 (5.3) Pocket infection/hematoma 18 (2.2 ) 2 (2.1) Connection problem 4 (0.5) Appropriate Tx 12 (1.5) Inappropriate Tx 12 (1.5) 1 (1.1) System explant 7 (0.9) HE upgrade 2 (2.5) Slow VT not detected 6 (0.7) Other 15 (1.9) TOTAL * p= ns 117 (0.14/pt)* 10 (0.11/pt)

18 Serious Adverse Events Follow-up period / Device related n (%) Tested (810) Not tested (94) Atrial lead repl. or reposit. 3 (0.4) RV lead repl. or reposit. 16 (2.0) 2 (2.1) LV lead repl. or reposit. 22 (2.7) 5 (5.3) Pocket infection/hematoma 18 (2.2 ) 2 (2.1) Connection problem 4 (0.5) Appropriate Tx 12 (1.5) Inappropriate Tx 12 (1.5) 1 (1.1) System explant 7 (0.9) HE upgrade 2 (2.5) Slow VT not detected 6 (0.7) Other 15 (1.9) Deaths 9 (0.1) 1 (0.1) TOTAL * p= ns 126 (0.15/pt)* 11 (0.12/pt)

19 Serious Adverse Events Follow-up period / not device related (without deaths) n (%) Tested pts (810) Not tested pts (94) Heart failure 50 (6.2) 3 (3.2 ) Ischemic disease 16 (2.0 ) 2 (2.1) Atrial disorder 9 (1.1 ) 1 (1.1) Ventricular disorder 6 (0.7) 0 (0) Arrhythmic storm 4 (0.5) 1 (1.1) Other cardiac events 30 (3.7) 7 (7.4) Non cardiac events 45 ( 5.6) 12 (12.8) Unknown 0 (0) 1 (1.1) TOTAL * p= (0.20/pt)* 27 (0.29/pt)

20 Serious Adverse Events Follow-up period / not device related n (%) Tested pts (810) Not tested pts (94) Heart failure 50 (6.2) 3 (3.2 ) Ischemic disease 16 (2.0 ) 2 (2.1) Atrial disorder 9 (1.1 ) 1 (1.1) Ventricular disorder 6 (0.7) 0 (0) Arrhythmic storm 4 (0.5) 1 (1.1) Other cardiac events 30 (3.7) 7 (7.4) Non cardiac events 45 ( 5.6) 12 (12.8) Unknown 0 (0) 1 (1.1) Death 38 (4.7) 14 (14.9) TOTAL * p= (0.25/pt)* 41 (0.44/pt)

21 Causes of deaths n (%) Total (904) Tested pts (810) Not tested pts (94) Heart failure 24 (2.7) 15 (1.9) 9 (9.6) <0.001 p Myocardial infarction 2 (0.2) 2 (0.2) 0 (0) ns Cardiac arrest 1 (0.1) 1 (0.1) 0 (0) ns Arrhythmic 3 (3.3) 3* (0.4) 0 (0) ns Electromechanical dissociation 3 (3.3) 2 (0.2) 1 (1.1) ns Non cardiac 22 (2.4) 18 (2.2) 4 (4.3) ns Unknown 7 (7.8) 6* (0.7) 1* (1.1) ns Total <0.001 * = potentially device related

22 Adverse Events All causes mortality 100% 95% 90% 85% 80% 75% 70% 65% 60% 55% 50% 45% 40% 35% 30% 25% 20% 15% 10% 5% 0% p=< No inductions (ITT) Inductions (ITT)

23 The population without DT included mainly patients with a primary indication and with a more serious heart failure condition leading to a higher overall mortality. Randomized studies are needed to assess long-term outcomes. Conclusions In this "real life" study, up to 10% of pts were not tested. Poor haemodynamic status is the main clinical reason to avoid defibrillation testing As compared to induced patients Non-tested patients are sicker (older patients, higher HF incidence) and are more often implanted for primary indications The incidence of SAE is higher in non-tested patients during this short F.U as well as the overall mortality

on behalf of the AUGMENT-HF Investigators

on behalf of the AUGMENT-HF Investigators One Year Follow-Up Results from AUGMENT-HF: A Multicenter Randomized Controlled Clinical Trial of the Efficacy of Left Ventricular Augmentation with Algisyl-LVR in the Treatment of Heart Failure* Douglas