2015 HRS/EHRA/APHRS/SOLAECE Expert Consensus Statement on Optimal ICD Programming and Testing

Authors, Journal, Affiliations, Type, DOI

• Chair/Co-Chairs: Bruce L. Wilkoff (Cleveland Clinic), Laurent Fauchier (Tours, France), Martin K. Stiles (Waikato NZ), Carlos A. Morillo (McMaster); 35 writing committee members from HRS, EHRA, APHRS, SOLAECE
• Journal: Heart Rhythm, Vol 13, No 2, February 2016 (e50–e86)
• Published: 2016 (published online November 2015)
• Type: International expert consensus statement; 32 recommendations; each balloted by all 35 writing members; >83% (mean 96%) consensus required per recommendation
• Endorsed by: ACC, AHA, Canadian Heart Rhythm Society, Cardiac Arrhythmia Society of Southern Africa
• DOI: 10.1016/j.hrthm.2015.11.018
• Funding/COI: Multiple industry COIs declared in Appendix A (device-manufacturer relationships among writing members)

Overview

The first international multi-society evidence-based consensus on ICD programming, covering four domains: (1) bradycardia mode and rate programming, (2) tachycardia detection, (3) tachycardia therapy, and (4) intraprocedural defibrillation threshold testing. The central paradigm shift from rapid/aggressive detection toward prolonged detection (30/40 intervals; ≥200 bpm VF cutoff) is supported by ~7,000 patients across PREPARE, RELEVANT, MADIT-RIT, ADVANCE III, and PROVIDE — reducing inappropriate therapies 50–76% and potentially improving survival without increasing syncope. ATP is validated as first-line therapy even at fast VT rates (188–250 bpm). Routine defibrillation testing (DT) is shown non-mandatory for standard left-sided transvenous implants via SIMPLE (n=2,500 RCT; noninferior without DT) and NORDIC-ICD.

Keywords

ICD programming; tachycardia detection; antitachycardia pacing; defibrillation threshold testing; ATP; inappropriate shock; SVT-VT discrimination; prolonged detection; VF zone; right ventricular pacing; bradycardia mode

Key Takeaways

Background

• ICD benefit and risk are directly impacted by programming — "flexibility is both a great strength and a weakness"
• Prior to this document, no official international guidance existed for ICD programming
• Early ICD culture favoured rapid detection and short time-to-therapy; stored EGMs and primary prevention data revealed that inappropriate and avoidable shocks are common and independently associated with adverse outcomes
• 32 recommendations balloted by 35 writing members; mean 96% approval; all exceed 83% minimum threshold
• Recommendations are specific to adult patients and may not apply to paediatric populations

Bradycardia Mode and Rate Programming

Single vs Dual-Chamber Mode

• In ICD patients without a bradycardia indication, RV stimulation should be minimised — DAVID trial showed DDDR-70 associated with worse HF and mortality vs VVI-40 backup pacing, primarily from unnecessary RV pacing
• Dual-chamber pacing is associated with lower AF incidence and stroke vs VVI (meta-analyses of pacemaker trials) but no mortality difference; benefit is primarily symptom improvement (avoidance of pacemaker syndrome) and exercise capacity
• Choice should be individualised: stronger case for dual-chamber in patients with sinus node disease; weaker evidence in AV block for hard endpoints
• AV interval programming: minimise RV pacing percentage using MVP or extended AV delay algorithms; avoid AV intervals >250–300 ms (risk of AV desynchronisation arrhythmia)
• Long baseline PR intervals (>230 ms) increase AF risk regardless of pacing mode and may negate MVP benefit

Rate Modulation

• VVIR superior to VVI for QoL and exercise capacity in AF + AVB patients
• DDDR vs DDD: inconsistent benefit; ADEPT trial failed to show superiority of DDDR
• AF + AVJ ablation: VVIR preferred; minimum rate 80–90 bpm for first 1–2 months post-ablation to prevent bradycardia-dependent QT prolongation and SCD risk

CRT-D: Biventricular Pacing Percentage

• Biventricular pacing should be maintained as close to 100% as possible
• MADIT-CRT: <90% biventricular pacing → no CRT benefit vs ICD alone; ≥97% → significant reduction in HF events and death
• Every 1% increase in biventricular pacing: 6% reduction in HF/death, 10% reduction in death alone
• Adaptive CRT (aCRT) algorithm withholds RV pacing when intrinsic RV conduction is normal; demonstrated safe and effective in prospective double-blind RCT

Tachycardia Detection Programming

Prolonged Detection Duration (Key Paradigm Shift)

• Recommended: 30/40 intervals (or equivalent time-based delay) as default detection strategy — supersedes conventional 12/16 or 18/24 interval settings

• Meta-analysis: 50% reduction in inappropriate shocks; 30% reduction in all-cause mortality; no increase in syncope
• Extended detection applies to both primary and secondary prevention (ADVANCE III secondary prevention substudy confirmed safety with 36% reduction in appropriate shocks and no excess syncope)

Rate Criteria (VF Zone Cutoff)

• VF zone ≥200 bpm for primary prevention patients — MADIT-RIT Arm B (200 bpm cutoff): 80% relative reduction in inappropriate therapy vs conventional 170 bpm; all-cause mortality 3.2% vs 6.6% at 1.4 years
• Overlap of SVT and VT rates highest between 181–213 bpm — supports raising VF cutoff beyond 180 bpm
• Secondary prevention: programme VT zone 10–20 bpm below documented clinical VT rate; no randomised rate-cutoff comparison exists
• Amiodarone effect: lower rate cutoff when patient is on amiodarone (drug slows VT into SVT zone)

Multi-Zone Detection

• Multi-zone programming preferred over single-zone for modern ICD programming — allows tiered ATP therapy and SVT-VT discrimination by zone
• ALTITUDE REDUCES registry: dual-zone programming → fewer shocks than single-zone for rates <200 bpm

SVT-VT Discrimination

• Components: ventricular interval regularity (stability), atrioventricular rate comparison, morphology discriminator, onset (sinus tachycardia rejection)
• Morphology discriminator: only non-interval-based discriminator; compares EGM morphology to stored conducted baseline template; primary component of single-chamber algorithms
• SVT-VT discrimination algorithms should be enabled; historically reduced inappropriate shocks by 17% (CareLink database n=106,513); Monte Carlo simulation predicted 75–79% SVT shock reduction with modern algorithms
• SVT limit: programme up to 200–222 bpm; not to exceed 230 bpm in adults without specific indication
• Dual-chamber discriminators not superior to single-chamber for most patients; meta-analyses show no advantage for mortality or inappropriate therapy; atrial lead-related complications a risk of dual-chamber systems
• Duration-based safety-net override features (force shock if SVT persists beyond a time limit): programme OFF or ≥5–10 minutes to avoid inappropriate shocks

S-ICD Detection

• S-ICD screening ECG mandatory pre-implant (R:T ratio assessment across 3 sensing vectors, supine and standing)
• Dual-zone programming (conditional shock zone + shock zone) preferred over single-zone — conditional zone uses stepwise morphology discrimination
• Detection duration: 18/24 intervals (nonprogrammable); confirmation algorithm at end of charging
• Shock at fixed 80 J (nonprogrammable)

Tachycardia Therapy Programming

ATP — First-Line Therapy

• ATP before shock is endorsed as first-line for VT, including fast VT (CL 240–320 ms / 188–250 bpm)
• PainFREE Rx II: first-line ATP for VT 188–250 bpm → 71% relative shock reduction
• PREPARE: ATP-first programming (182–250 bpm) → absolute shock reduction 17% → 9% at 1 year without arrhythmic syncope
• Efficacy: first ATP burst 64% effective for fast VT (188–250 bpm); second burst increases to 83%
• Up to 2 ATP burst attempts recommended — value beyond 2 bursts is limited
• Burst vs ramp: PITAGORA ICD (n=206; 36 months): burst more effective than ramp for fast VT (CL 240–320 ms)
• ADVANCE-D: 8-pulse ATP as effective and safe as 15-pulse ATP
• ATP during ICD capacitor charging: validated as safe and effective (reduces total shock burden)
• Inappropriate ATP: increases mortality in MADIT-RIT and MADIT-CRT — SVT-VT discrimination and high rate cutoffs critical to prevent inappropriate ATP

ICD Shocks — Morbidity and Mortality

• Appropriate shocks — 5-fold increased mortality in SCD-HeFT; 32% increased mortality in 4-trial pooled analysis (n=2,135)
• Inappropriate shocks — 2-fold increased mortality in SCD-HeFT; 52% fewer inappropriate shocks with remote monitoring (ECOST study)
• Shocked patients had worse survival than ATP-only patients in MADIT-CRT analysis
• Emotional morbidities: anxiety, depression, PTSD in ICD recipients; phantom shocks reported in ~5%
• Mortality after first shock: ~10% within days, ~25% at 1 year, ~40% at 2 years (leading cause: progressive HF)
• Goal: minimise both appropriate and inappropriate shocks through strategic programming

Therapy Classification

• Appropriate: response to sustained VA (VT/VF) or haemodynamically poorly tolerated arrhythmia
• Inappropriate: response to SVT (sinus tachycardia, AF, flutter, SVT), signal misinterpretation, lead failure, noise
• Avoidable: appropriate or inappropriate therapies preventable by programming (self-terminating VA, ATP-susceptible VT, SVT with discriminators)
• Phantom: patient perception of therapy not confirmed on interrogation

Intraprocedural Testing of Defibrillation Efficacy (DT)

Key Evidence

• SIMPLE trial (Healey/Birnie 2015; n=2,500 randomised; 1,253 DT vs 1,247 no-DT; mean 3.1-year follow-up): primary outcome (arrhythmic death or failed appropriate shock) noninferior without DT (7% vs 8%/year; HR 0.86; 95% CI 0.65–1.14; P noninferiority <0.001). Second safety composite (events most likely caused by DT): 3.2% vs 4.5% (P=0.08). Conclusion: routine DT does not improve shock efficacy or reduce arrhythmic death.
• NORDIC-ICD (n=1,077; 540 DT vs 537 no-DT; median 22.8 months): first shock efficacy noninferior without DT (3.0% difference in favour of no-DT; P noninferiority <0.001); 112 procedure-related SAEs in 94 DT patients (17.6%) vs 74 no-DT patients (13.9%; P=0.095)
• SAFE-ICD (prospective observational; n=2,120; 41 Italian centres): no difference in composite of severe implant complications, SCD, or resuscitation at 2 years between DT and no-DT
• RAFT substudy (n=145 randomised): perioperative complications low regardless of DT; nonsignificant increase in death/HF hospitalisation with DT

Current Recommendation

• Routine DT can be safely omitted for left-sided transvenous ICD implants with well-positioned lead (R-wave ≥5–7 mV, adequate pacing threshold, verified connection)
• Applies to: primary and secondary prevention; ischaemic and non-ischaemic cardiomyopathy
• DT still reasonable in: HCM, congenital channelopathies, right-sided implant, generator replacement with uncertain lead function, high-threshold suspicion
• DT still required: S-ICD — no current data to support omission with subcutaneous lead configuration
• Absolute contraindications to DT: intracardiac thrombus; AF without ≥3 weeks therapeutic anticoagulation (thromboembolic risk); haemodynamic instability

DT-Related Complications

• Perioperative mortality: 0.2–0.4% within 30 days; in-hospital death 0.03% (NCDR)
• Transient CNS hypoperfusion during VF induction (EEG-confirmed); no lasting cognitive dysfunction at 24–48h
• Myocardial injury markers (hs-troponin T elevated post-DT); true MI during DT is rare (NCDR: 0.02%)
• Stroke/TIA: 0.026–0.05% (primarily in AF with inadequate anticoagulation)
• Refractory VF requiring ≥3 external rescue shocks: ~0.5%
• High defibrillation threshold (DT failure at max output): ~1–5% depending on patient population and definition; may require lead revision or addition of SVC coil

Single vs Dual-Coil Leads

• MODALITY registry (n=469 with DT): no significant difference in shock success rate between single- and dual-coil leads; cathodal shock polarity independently predicted shock failure (OR 2.37; 95% CI 1.12–5.03)
• Anodal shock programming preferred for both single- and dual-coil systems

Limitations of the Document

• Consensus document (not guideline) — no formal Class I/IIa/IIb structure applied to some recommendations
• 2015 evidence base — subsequent trials (e.g., MADIT S-ICD, PainFree SST, EV-ICD) published after this document
• Manufacturer-specific programming guidance (Appendix B) only available online; cross-manufacturer translation of interval-based recommendations involves approximation
• S-ICD section based on limited 2015 data; the S-ICD ecosystem has expanded considerably since
• Detection duration data from primary prevention-dominant populations; secondary prevention evidence limited to ADVANCE III substudy (25% of enrolled patients)
• Defibrillation testing trials (SIMPLE/NORDIC-ICD) used single manufacturer; not all lead configurations or channelopathy substrates represented
• Industry COI among writing committee members (multiple device manufacturers)
• No paediatric applicability

Key Concepts Mentioned

• concepts/Antitachycardia-Pacing — mechanism, evidence, programming parameters
• concepts/SVT-VT-Discrimination — algorithm architecture, discriminator components
• concepts/Ventricular-Oversensing — T-wave oversensing; lead failure algorithms

Key Entities Mentioned

• entities/ICD — primary subject; programming recommendations
• entities/S-ICD — detection programming; DT requirement
• entities/CRT — biventricular pacing percentage optimisation in CRT-D

Wiki Pages Updated

• Created wiki/sources/icd-programming-hrs-2015.md
• Updated wiki/entities/ICD.md — ICD programming section added; source_count 5→6
• Updated wiki/sourceindex.md
• Updated wiki/wikiindex.md
• Updated log.md