Programming ICDs - Programming protocols
Device Follow Up Master Class Monday 24 September 2012 14:10 – 14:30
So you implanted an ICD, now what to do with it?
• "Defibrillators are not medications. There is a categorical difference between the two. Medications, you take a pill, and what you get is what you took. • On the other hand, defibrillators are not that way. They're malleable, and they're malleable on the basis of a number of things, including clinical parameters, but in particular they're under the control of the physician, and the programming choices [the physician] makes." Bruce Wilkoff, Cleveland Clinic , Author Prepare Study
• "Defibrillators are not medications. There is a categorical difference between the two. Medications, you take a pill, and what you get is what you took. • On the other hand, defibrillators are not that way. They're malleable, and they're malleable on the basis of a number of things, including clinical parameters, but in particular they're under the control of the physician, and the programming choices [the physician] makes." Bruce Wilkoff, Cleveland Clinic , Author Prepare Study
• • • • •
How many zones? Which cut-off rate Detection intervals/time to intervention? Benefit or disadvantage ATP How should ATP be programmed?
• The technical objective is to deliver only appropriate therapy and to avoid inappropriate therapies especially shocks (high specificity), but without the risk of underdetection of a life-threatening arrhythmia (high sensitivity). • Not to treat too quickly in order to avoid unnecessary therapies particularly in self-terminating arrhythmias which are relatively frequent, but also not too late in order to prevent syncope.
What would an ideal ICD do? 1. Prevent sudden death (100% sensitive for VF) 2. Only treat tachycardias which cause debilitating symptoms and avoid arrhythmic syncope 3. Terminate VTs using ATP where possible, without increasing symptoms or mortality
8
• MADIT (Multicenter Automatic Defibrillator Implantation Trial) II, programming was left to physician discretion, and both singleand double-chamber devices were used. • In clinical practice the programming of an ICD is still individually selected by the physicisian/physiologist
Approaches • Tailored “expert” therapy • Programming by protocol
• First inappropriate implantable cardioverter defibrillator therapy is often due to inaccurate device programming: analysis of the French OPERA registry
• Antoine Leenhardt, Pascal Defaye, Elisabeth Mouton, Marc Delay, Nicolas Delarche Jean-Marc Dupuis, Olivier Bizeau, Philippe Mabo, Saida Cheggour, Dominique Babuty • on behalf of the OPERA Registry investigators • Europace (2012) doi: 10.1093/europace/eus144 • First published online: April 29, 2012
Conclusions • First inappropriate therapy occurred in 11% of 636 ICD recipients followed for ∼2 years. • Nearly 50% of first inappropriate therapy could have been prevented by improving device programming.
“Most ICD patients receive too many shocks” • Bruce Wilkoff MD, Director of Cardiac Pacing and Tachyarrhythmia Devices • Cleveland Clinic • Historically (1995-2004) – 45% patients get therapy from their ICDs, – 23% of patients get inappropriate therapy
• Fear of syncope or delay of the life-saving ICD shock • Most of programming questions have never been studied systematically. • The need for objective data to improve device programming is an important issue
Incidence of syncope during spontaneous VT in ICD patients has been reported at 10%-15% at 2-3 years. Despite successful VT termination, syncope may result in bodily trauma, is socially disabling and is the principal concern underlying driving restrictions in ICD patients Sweeney MO. Antitachycardia pacing for ventricular tachycardia using implantable cardioverter defibrillators:Substrates, methods, and clinical experience Pacing and Clinical Electrophysiology
Evidence • • • • • •
PainFree (ATP for fast VT) Empiric (Empiric vs Tailored) Prepare (prolonged detection) ADVANCE CRT-D (BiV ATP) Treatment of Slow VT (ELA study) PITAGORA vs ramp for fast VT
Evidence • • • • • • • • •
PainFree (ATP for fast VT) Empiric (Empiric vs Tailored) Prepare (prolonged detection) ADVANCE CRT-D (BiV ATP) Treatment of Slow VT (ELA study) PITAGORA vs ramp for fast VT ADVANCE III (prolonged detection) 2012 High rate cut off in primary prevention 2012 More ATP attempts 2012
Figure 2. Distribution of VF, FVT, and VT episodes as a function of arrhythmia cycle length.
Gulizia M M et al. Circ Arrhythm Electrophysiol 2009;2:146153 Copyright © American Heart Association
Strategic Programming of Detection and Therapy Parameters in Implantable Cardioverter-Defibrillators Reduces Shocks in Primary Prevention Patients: Results from the PREPARE (Primary Prevention Parameters Evaluation) Study1 Bruce L. Wilkoff, MD FACC*; Brian D. Williamson, MD FACC*; Richard S. Stern, MD FACC*; Stephen L. Moore, DO FACC*; Fei Lu, MD FACC|*; Sung W. Lee, MD FACC*; Ulrika M. Birgersdotter-Green, MD*; Mark S. Wathen, MD*, Isabelle C. Van Gelder, MD*; Brooke M. Heubner, MS#; Mark L. Brown, PhD#; Keith K. Holloman, BA#; for the PREPARE Study Investigators 1
J Am Coll Cardiol 2008; 52:541-50. * Medtronic Consultant/Advisor & Investigator # Medtronic Employee
VT/VF Detection Detection
Heart Rate
Beats to Detect
VF ON
> 250 bpm
30 of 40
FVT Via VF
182-250 bpm
1 seq ATP, (30 of 40) 30-35J
VT Monitor
167-181 bpm
32
Therapies
30-35 J
None
PR Logic ON: AF/Afl, Sinus Tach (1:1 VT-ST = 66%) or Wavelet ON: SVT Limit = 200 bpm
Morbidity Index (Primary Endpoint)
Incidence rate (events/pt-yr): 0.26 PREPARE vs. 0.69 Control Incidence rate ratio: PREPARE / Control = 0.38 (62% relative reduction), p=0.003 Ratio adjusted for baseline characteristics = 0.44 (56% relative reduction), p=0.002
Conclusion Strategically chosen VT/VF detection and therapy options targeting primary prevention patients can safely reduce the morbidity related to ICD therapy
Conclusion Strategically chosen VT/VF detection and therapy options targeting primary prevention patients can safely reduce the morbidity related to ICD therapy
ADVANCE III • The ADVANCE III trial (Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts III) • - is the first randomized investigation evaluating the reduction of ICD Rx for fast VT due to a prolongation of NID in a general ICD patient cohort. • Results presented at the Heart Rhythm Society’s 33rd Annual Scientific Sessions 2012
ADVANCE III • The ADVANCE III trial (Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts III) • - is the first randomized investigation evaluating the reduction of ICD Rx for fast VT due to a prolongation of NID in a general ICD patient cohort. • Results presented at the Heart Rhythm Society’s 33rd Annual Scientific Sessions 2012
Aim • Does a prolonged detection interval for life threatening VT reduce ICD therapies? • The PREPARE trial demonstrated a reduction of ICD Rx in a cohort of primary prevention patients. Not randomised
Methods • Mean age 65 years (84% were men) • Randomly assigned: – 948 to 30/40 intervals – 954 to 18/24 intervals
• Median follow-up of 12 months. • 39% single-chamber • 31% dual-chamber • 41% CRT-D
Methods • Mean age 65 years (84% were men) • Randomly assigned: – 948 to 30/40 intervals – 954 to 18/24 intervals
• Median follow-up of 12 months. • 39% single-chamber • 31% dual-chamber • 41% CRT-D
Methods • Mean age 65 years (84% were men) • Randomly assigned: – 948 to 30/40 intervals – 954 to 18/24 intervals
1902 patients
• Median follow-up of 12 months. • 39% single-chamber • 31% dual-chamber • 41% CRT-D
Results • 37% reduction in unnecessary therapy. – 346 therapies in the 30/40 arm – 557 in the 18/24 arm
• No statistically significant difference in syncope associated with episodes of ventricular arrhythmia – (2.2 patients per year vs. 1.1 patients per year; P=.21). Mortality was low in both study arms (3.9 patients per year vs. 4.6 patients per year, respectively)
Results • 37% reduction in unnecessary therapy. – 346 therapies in the 30/40 arm – 557 in the 18/24 arm
• No statistically significant difference in syncope associated with episodes of ventricular arrhythmia – (2.2 patients per year vs. 1.1 patients per year; P=.21). Mortality was low in both study arms (3.9 patients per year vs. 4.6 patients per year, respectively)
Conclusion • ADVANCE III is the first randomised trial enrolling primary and secondary prevention patients, both ischemic and non-ischaemic, to assess efficacy and safety of long NID detection in any ICD with anti-tachycardia pacing during charging • The longer NID 30/40 detection window was safe and effective in reducing unnecessary ICD therapies, with no significant difference in syncope events.
• A simplified biventricular defibrillator with fixed long detection intervals reduces implantable cardioverter defibrillator (ICD) interventions and heart failure hospitalizations in patients with non-ischemic cardiomyopathy implanted for primary prevention: the RELEVANT [Role of long dEtection window programming in patients with LEft VentriculAr dysfunction, Non-ischemic eTiology in primary prevention treated with a biventricular ICD] study • Gasparini M, Menozzi C, Proclemer A, Landolina M, Iacopino S, Carboni A, Lombardo E, Regoli F, BIffi M, Burrone V, Denaro A, Borianni G
• Eur Heart J 2009;30:2758-2767. First published on 29 June 2009. doi:10.1093/eurheartj/ehp247.
Results • Appropriate therapies, inappropriate therapies and the total number of shocks were all significantly lower in the Protect group than in the control group • A dramatic reduction in shocks was mainly due to the decrease jn inappropriate shocks, five in the protect group vs. 30 in the control group (P 200 bpm)
VT
On
400ms (150 – 200 bpm)
Therapies Beats to Detect 24 of 30 ATP during charge (x1) followed by the maximum number of maximum energy shocks 16 Burst (2), Ramp (1), 1x shock 10J below the maximum output followed by the maximum number of maximum energy shocks available
Therapies Initial Duration 2.5sec Quick Convert™ ATP ON followed by the maximum number of maximum energy shocks 2.5sec
Scan (2), Ramp (1), 1x shock 10J below the maximum output followed by the maximum number of maximum energy shocks available
Zone Detection Interval/Rate VF
On
VT-2 On
Zone Detection
Interval/Rate
Persistence Therapies Counter
VF
VF ON
250 ms (>240 bpm)
6
VT
VT ON
300 ms 10 (200 -240 bpm)
Slow Slow VT ON 400ms VT (150 – 200 bpm)
10
300 ms (> 200 bpm) 400ms (150 – 200 bpm)
Therapies Detection intervals 24 ATP during charge (x1) followed by the maximum number of maximum energy shocks 16 Burst (2), Ramp (1), followed by the maximum number of maximum energy shocks available
The maximum number of maximum energy shocks Burst (1) followed by the maximum number of maximum energy shocks Burst+scan (2), Ramp (1), 1x shock 10J below the maximum output followed by the maximum number of maximum energy shocks available Zone Interval/Rate
Beats to Detect
VF
Detection counter ATP One Shot followed by the maximum number VF— X = 18 of maximum energy shocks VF— Y = 24
300 ms (> 200 bpm)
Therapies
VT-2 ≥ 400ms Detection counter Burst (2), Ramp (1), 1x shock 10J below the (150 – 200 bpm) VT2 = 16 maximum output followed by the maximum number of maximum energy shocks available VT-1 Off NA NA
• Audit
• Audit • "… if we do this systematically we're going to get systematically better results, and that's what it's all about.” • Bruce Wilkoff, author of the PREPARE Study