2019 HRS/EHRA/APHRS/LAHRS focused update to 2015 expert consensus statement on optimal implantable cardioverter‐defibrillator programming and testing

Abstract

The 2015 HRS/EHRA/APHRS/SOLAECE Expert Consensus Statement on Optimal Implantable Cardioverter‐Defibrillator Programming and Testing provided guidance on bradycardia programming, tachycardia detection, tachycardia therapy, and defibrillation testing for implantable cardioverter‐defibrillator (ICD) patient treatment. The 32 recommendations represented the consensus opinion of the writing group, graded by Class of Recommendation and Level of Evidence. In addition, Appendix B provided manufacturer‐specific translations of these recommendations into clinical practice consistent with the recommendations within the parent document. In some instances, programming guided by quality evidence gained from studies performed in devices from some manufacturers was translated such that this programming was approximated in another manufacturer's ICD programming settings. The authors found that the data, although not formally tested, were strong, consistent, and generalizable beyond the specific manufacturer and model of ICD. As expected, because these recommendations represented strategic choices to balance risks, there have been reports in which adverse outcomes were documented with ICDs programmed to Appendix B recommendations. The recommendations have been reviewed and updated to minimize such adverse events. Notably, patients who do not receive unnecessary ICD therapy are not aware of being spared potential harm, whereas patients in whom their ICD failed to treat life‐threatening arrhythmias have their event recorded in detail. The revised recommendations employ the principle that the randomized trials and large registry data should guide programming more than anecdotal evidence. These recommendations should not replace the opinion of the treating physician who has considered the patient's clinical status and desired outcome via a shared clinical decision‐making process.

TABLE OF CONTENTS

Abstract	485
Manufacturer‐Specific Translation of ICD Programming Recommendations: Abbott (Formerly St. Jude Medical)	487
Manufacturer‐Specific Translation of ICD Programming Recommendations: BIOTRONIK	488
Manufacturer‐Specific Translation of ICD Programming Recommendations: Boston Scientific	489
Manufacturer‐Specific Translation of ICD Programming Recommendations: Medtronic	490
Manufacturer‐Specific Translation of ICD Programming Recommendations: MicroPort CRM (Formerly LivaNova and Sorin Group)	491
Appendix 1 Author Disclosure Table	492
Appendix 2 Reviewer Disclosure Table	493

MANUFACTURER‐SPECIFIC TRANSLATION OF ICD PROGRAMMING RECOMMENDATIONS^ǂ

ǂThe manufacturer‐specific programming settings/choices set forth below are based on a compilation of clinical expertise and clinical trial data as reported in the 2015 HRS/EHRA/APHRS/SOLAECE Expert Consensus Statement on Optimal Implantable Cardioverter‐Defibrillator Programming and Testing, of which this Appendix B is a part. These recommended settings/choices represent a diligent and good faith effort on the part of the writing committee to translate the consensus statement recommendations to device settings/choices for the four specified clinical issues/implantable cardioverter‐defibrillator (ICD) therapies where the writing committee considered that there was sufficient consensus and supporting data to make recommendations intended to improve the safety, morbidity, and mortality profile of patients with these clinical issues/ICD therapies. They are the recommendations of the writing committee only. They do not represent the position or recommendations of HRS, EHRA, LAHRS (formerly SOLAECE), or APHRS, nor are they the manufacturer's nominal settings or the precise programming tested during clinical trials of these devices, nor are they necessarily the settings/choices that would be recommended by the manufacturer. These recommended settings/choices are not applicable in all circumstances. As stated in the Introduction to the consensus statement, “The care of individual patients must be provided in context of their specific clinical condition and the data available on that patient.” Each treating physician must carefully consider the circumstances of their individual patient and determine whether these recommended settings/choices are appropriate to their patient's circumstances.

ABBOTT (FORMERLY ST. JUDE MEDICAL)

*Settings that are not nominal are marked with an asterisk.

Brady	Single ChamberVVI 40 bpm
	Dual ChamberDDD, consider Ventricular Intrinsic Preference (VIP) ± rate response
	CRTDDD ± rate response Consider SyncAV* (if intact AV conduction) as appropriate
Detection	In patients with no VT historyVF: 30 intervals*1, 240 or 250 bpm* VT2: 30 intervals*1, 187 bpm*VT: Monitor, at user discretion
	In patients where VT CL is knownVF: 30 intervals*1, 240 or 250 bpmVT2: 30 intervals*1, 187 bpm or 10–20 bpm < VT rate*VT: Therapy at 10–20 bpm < VT rate or Monitor zone
1 Fewer intervals to detect may be reasonable due to the possibility of VT straddling 2 zones that may result in “binning” to both zones, effectively doubling time to detect. Beats that fall out of zone sometimes reset counters so patients with poor sensing should also have fewer detection intervals considered.
Therapy	VF: ATP While Charging, 8 pulses at 85% VT CLAll shocks: Maximum output (unless DFT guided)Note: 1st shock 4–6J lower than full outputVT2: ATP, ≥1 bursts of 8 pulses at 85% VT CLScan step 10 ms, Re‐adaptive ON, Minimum CL 200 msAll shocks ONVT: As for VT2, favoring more ATP2
2 Rarely, hemodynamically stable slow VT can be treated without programming a back‐up shock.
SVT Discriminators 3	Single ChamberFar‐Field Morphology: ON, 90%, 3 of 10All others: “Passive”
	Dual Chamber/CRT‐DFar‐Field Morphology: ON, 90%, 3 of 10Arrhythmia onset: ON (default settings)Interval Stability: ON (default settings)If ALL
	For CRT: Template Auto Update 30 days and Template Pacing Hysteresis ONor Far‐Field Morphology Auto Update OFF
	SVT Upper Limit: 230 bpmSVT Discrimination Timeout: OFFVT Therapy Timeout: OFF
3 SVT Discriminators are not required in Complete Heart Block.
Oversensing Rejection	Low Frequency Attenuation: ON
	SecureSense RV Lead Noise Discrimination: ON

MANUFACTURER‐SPECIFIC TRANSLATION OF ICD PROGRAMMING RECOMMENDATIONS^ǂ

ǂ The manufacturer‐specific programming settings/choices set forth below are based on a compilation of clinical expertise and clinical trial data as reported in the 2015 HRS/EHRA/APHRS/SOLAECE Expert Consensus Statement on Optimal Implantable Cardioverter‐Defibrillator Programming and Testing, of which this Appendix B is a part. These recommended settings/choices represent a diligent and good faith effort on the part of the writing committee to translate the consensus statement recommendations to device settings/choices for the four specified clinical issues/implantable cardioverter‐defibrillator (ICD) therapies where the writing committee considered that there was sufficient consensus and supporting data to make recommendations intended to improve the safety, morbidity, and mortality profile of patients with these clinical issues/ICD therapies. They are the recommendations of the writing committee only. They do not represent the position or recommendations of HRS, EHRA, LAHRS (formerly SOLAECE), or APHRS, nor are they the manufacturer's nominal settings or the precise programming tested during clinical trials of these devices, nor are they necessarily the settings/choices that would be recommended by the manufacturer. These recommended settings/choices are not applicable in all circumstances. As stated in the Introduction to the consensus statement, “The care of individual patients must be provided in context of their specific clinical condition and the data available on that patient.” Each treating physician must carefully consider the circumstances of their individual patient and determine whether these recommended settings/choices are appropriate to their patient's circumstances.

BIOTRONIK

*Settings that are not nominal are marked with an asterisk.

Brady	Single ChamberVVI 40 bpm
	Dual ChamberDDD, consider IRS Plus* / I OPT* ± Closed Loop Stimulation (CLS)* orDDD with Vp Suppression* ± rate response
	CRTDDD; optional DDD‐CLS* or rate response* at user discretion
Detection	In patients with no VT history 1VF: 30/40 intervals* (if programmable, otherwise 24/30), 231 bpm*VT2: 30 intervals*, 188 bpm*VT1: Monitor zone* at user discretion
	In patients where VT CL is knownVF 24/30 intervals*, 231 bpm*VT2: 30 intervals*, 188 bpm* (or 10–20 bpm < VT rate)VT1: Therapy* at 10–20 bpm < VT rate or Monitor zone* at user discretion
1 SVT discriminators are linked to Detection Zones. An alternative configuration would be VF 250 bpm, VT2 231 bpm and VT1 188 bpm with therapy (i.e., no Monitor zone) if >1 ATP attempt desired up to 250 bpm.
Therapy	VF: ATP One‐Shot, 1 burst of 8 pulses at 88%2 CL*, full output shocks (unless DFT guided)VT2: ATP ≥1 bursts* of 8 pulses* at 88%2 CL*, 10 ms scan decrement*, All shocks ONVT1: Monitor zone* or Therapy* as for VT2 (favoring more ATP)3
2 If programmable, otherwise 85%.3 Rarely, hemodynamically stable slow VT can be treated without programming a back‐up shock.
SVT Discriminators 4	Single ChamberMorphMatch5 ON(*)Onset6 OFFStability OFF*Sustained VT Timer OFF
	Dual Chamber/CRT‐DSMART ON (at default settings or adapted to known VT)
4 SVT Discriminators are not required in Complete Heart Block.5 MorphMatch is recommended for patients with narrow QRS complexes and sufficient far‐field amplitude. Otherwise, Onset 20% and Stability 48 ms is a recommended alternative.6 If Onset is programmed ON, the performance of this discriminator is enhanced with a Monitoring Zone enabled.
Others	Lead Integrity check ON (if available)HomeMonitoring ON* (if available)

MANUFACTURER‐SPECIFIC TRANSLATION OF ICD PROGRAMMING RECOMMENDATIONS^ǂ

ǂ The manufacturer‐specific programming settings/choices set forth below are based on a compilation of clinical expertise and clinical trial data as reported in the 2015 HRS/EHRA/APHRS/SOLAECE Expert Consensus Statement on Optimal Implantable Cardioverter‐Defibrillator Programming and Testing, of which this Appendix B is a part. These recommended settings/choices represent a diligent and good faith effort on the part of the writing committee to translate the consensus statement recommendations to device settings/choices for the four specified clinical issues/implantable cardioverter‐defibrillator (ICD) therapies where the writing committee considered that there was sufficient consensus and supporting data to make recommendations intended to improve the safety, morbidity, and mortality profile of patients with these clinical issues/ICD therapies. They are the recommendations of the writing committee only. They do not represent the position or recommendations of HRS, EHRA, LAHRS (formerly SOLAECE), or APHRS, nor are they the manufacturer's nominal settings or the precise programming tested during clinical trials of these devices, nor are they necessarily the settings/choices that would be recommended by the manufacturer. These recommended settings/choices are not applicable in all circumstances. As stated in the Introduction to the consensus statement, “The care of individual patients must be provided in context of their specific clinical condition and the data available on that patient.” Each treating physician must carefully consider the circumstances of their individual patient and determine whether these recommended settings/choices are appropriate to their patient's circumstances.

BOSTON SCIENTIFIC

*Settings that are not nominal are marked with an asterisk.

Brady	Single ChamberVVI, 40 bpm*
	Dual ChamberDDD, consider RYTHMIQ* or AV Search +* ± rate response
	CRTDDD ± rate responseConsider Smart Delay optimization of AV delays
Detection	In patients with no VT history Option 1 – delayed therapyVF: 8 of 10 intervals plus 5‐second duration*, 250 bpm*VT: 8 of 10 intervals plus 12‐second duration*, 185 bpm*VT‐1: Monitor, at user discretionOption 2 – high‐rate therapyVF: 8 of 10 intervals plus 2.5‐second duration*, 200 bpm*VT‐1: Monitor, at user discretion
	In patients where VT cycle length is knownVF: 5‐second duration*, 250 bpm*VT: 12‐second duration*, 185 bpm* or 10–20 bpm < VT rateVT‐1: Monitor Zone or Therapy at ≥12‐second duration*, 10–20 bpm < VT rate
Therapy	VF: QuickConvert ON to 300 bpm* (if available)All shocks: Maximum output (unless DFT guided)VT: ATP‐1: Scan, ≥1 bursts, 8 pulses* at 84%* coupling interval and cycle length (Minimum 200 ms*), 10 ms decrement*ATP‐2: OFF*All shocks: ONVT‐1: As for VT, favoring more ATP1
1Rarely, hemodynamically stable slow VT can be treated without programming a back‐up shock.
SVT Discriminators 2	ICDRhythmID: ON
	CRT‐DOnset/Stability: ON or RhythmID: ON*
	Sustained Rate Duration (SRD): OFF*SVT Discriminators apply only up to 230 bpm
2SVT Discriminators are not required in Complete Heart Block.
Oversensing Rejection	Nonphysiological Signal Detected: ON (Latitude)
Others	Turn on “Beep When Out‐of‐Range” Daily Lead Measurements*RV Pacing Impedance Abrupt Change alert ON (Latitude)Single Chamber: Consider %RV pacing alert ON (Latitude)Dual Chamber: Consider %RV pacing alert in non‐AVB patients ON (Latitude)CRT‐D: Consider CRT % pacing alert ON (Latitude)
SUBCUTANEOUS ICD
Settings:	Shock Zone: ≥230 bpmConditional Zone: ≥200 bpm or 10–20 bpm < VT CL (if known)Consider post‐shock pacing ON

MANUFACTURER‐SPECIFIC TRANSLATION OF ICD PROGRAMMING RECOMMENDATIONS^ǂ

ǂ The manufacturer‐specific programming settings/choices set forth below are based on a compilation of clinical expertise and clinical trial data as reported in the 2015 HRS/EHRA/APHRS/SOLAECE Expert Consensus Statement on Optimal Implantable Cardioverter‐Defibrillator Programming and Testing, of which this Appendix B is a part. These recommended settings/choices represent a diligent and good faith effort on the part of the writing committee to translate the consensus statement recommendations to device settings/choices for the four specified clinical issues/implantable cardioverter‐defibrillator (ICD) therapies where the writing committee considered that there was sufficient consensus and supporting data to make recommendations intended to improve the safety, morbidity, and mortality profile of patients with these clinical issues/ICD therapies. They are the recommendations of the writing committee only. They do not represent the position or recommendations of HRS, EHRA, LAHRS (formerly SOLAECE), or APHRS, nor are they the manufacturer's nominal settings or the precise programming tested during clinical trials of these devices, nor are they necessarily the settings/choices that would be recommended by the manufacturer. These recommended settings/choices are not applicable in all circumstances. As stated in the Introduction to the consensus statement, “The care of individual patients must be provided in context of their specific clinical condition and the data available on that patient.” Each treating physician must carefully consider the circumstances of their individual patient and determine whether these recommended settings/choices are appropriate to their patient's circumstances.

MEDTRONIC

*Settings that are not nominal are marked with an asterisk.

Brady	Single ChamberVVI 40 bpm
	Dual ChamberDDD, consider Managed Ventricular Pacing (MVP; AAI↔DDD) ± rate response
	CRTDDD ± rate response Patient with intact AV conduction and LBBB—Consider Adaptive BiV & LV*
Detection	In patients with no VT historyVF: 30/40 intervals, 188 bpmFVT: OFF1VT: OFFVT Monitor: User discretion
	In patients where VT CL is knownVF: 30/40 intervals, 188 bpmFVT: OFF1VT: 24* intervals2, 10–20 bpm < VT rateVT Monitor: User discretion
1Use of ATP Before/During Charging in the VF zone achieves similar functionality as use of the FVT zone. Multi‐zone programming using FVT may allow tiered ATP therapy.2Consecutive count in VT zone; hence, lower NID as per PainFree SST data.
Therapy	VF: ATP Before* Charging; ChargeSaver ONAll shocks: Full output shocks (unless DFT guided)VT (if ON): Rx1: ATP, ≥1 bursts of 8 pulses at 88% VT CL, 10 ms DecrementRx2‐6: All Shocks ON3
3Rarely, hemodynamically stable slow VT can be treated without programming a back‐up shock.
SVT Discriminators 4	Single ChamberWavelet: ONLimit: 260 ms (230 bpm)Stability: OFFOnset: OFF
	Dual Chamber/CRT‐DPR Logic: ON (Other 1:1 OFF until lead stabilized at ~3 months)Wavelet: ON (if available)SVT Limit: 260 ms (230 bpm)Stability: OFFOnset: OFF
4SVT Discriminators are not required in Complete Heart Block.
Oversensing Rejection	Lead Integrity Alert: ONT‐wave Oversensing: ON (if available)RV Lead Noise: ON* without timeout (if available)

MANUFACTURER‐SPECIFIC TRANSLATION OF ICD PROGRAMMING RECOMMENDATIONS^ǂ

ǂ The manufacturer‐specific programming settings/choices set forth below are based on a compilation of clinical expertise and clinical trial data as reported in the 2015 HRS/EHRA/APHRS/SOLAECE Expert Consensus Statement on Optimal Implantable Cardioverter‐Defibrillator Programming and Testing, of which this Appendix B is a part. These recommended settings/choices represent a diligent and good faith effort on the part of the writing committee to translate the consensus statement recommendations to device settings/choices for the four specified clinical issues/implantable cardioverter‐defibrillator (ICD) therapies where the writing committee considered that there was sufficient consensus and supporting data to make recommendations intended to improve the safety, morbidity, and mortality profile of patients with these clinical issues/ICD therapies. They are the recommendations of the writing committee only. They do not represent the position or recommendations of HRS, EHRA, LAHRS (formerly SOLAECE), or APHRS, nor are they the manufacturer's nominal settings or the precise programming tested during clinical trials of these devices, nor are they necessarily the settings/choices that would be recommended by the manufacturer. These recommended settings/choices are not applicable in all circumstances. As stated in the Introduction to the consensus statement, “The care of individual patients must be provided in context of their specific clinical condition and the data available on that patient.” Each treating physician must carefully consider the circumstances of their individual patient and determine whether these recommended settings/choices are appropriate to their patient's circumstances.

MICROPORT CRM (FORMERLY LIVANOVA AND SORIN GROUP)

*Settings that are not nominal are marked with an asterisk.

Brady	Single ChamberVVI 40 bpm*
	Dual ChamberSafeR (AAI↔DDD) ± rate response, consider DDD* in complete heart block
	CRTDDD ± rate response, consider weekly AV + VV SonR optimization ON1
1Requires SonRtip atrial lead with integrated hemodynamic sensor.
Detection	In patients with no VT historyVF: 20 cycle* + 6/8 majority >255 bpm*FVT: 20 cycle* + 6/8 majority 230 bpmVT: 20 or 30 cycle* + 6/8 majority 185 bpmSlow VT: Monitor zone at user discretion
	In patients where VT CL is knownVF: 20 cycle* + 6/8 majority >255 bpm*FVT: 20 cycle*+ 6/8 majority 230 bpmVT: ≥20 cycle* + 6/8 majority 185 bpm (or 10–20 bpm < VT rate)Slow VT: Monitor zone at user discretion
Therapy	VF: 6 x 42J*FVT: If stable2: 1 x ATP (Burst @ 85% x 8 beats) then 6 x 42J* (unless DFT guided) If unstable: 6 x 42J* (unless DFT guided)VT: ≥1 x ATP (Burst + Scan @ 85% x 8 beats; Scan 8 ms) then all Shocks ON*3
2Satisfaction of stability (nominal value = 30 ms) in the Fast VT zone will not prevent therapy but rather activate programmable burst pacing prior to shock therapy.3Rarely, hemodynamically stable slow VT can be treated without programming a back‐up shock.
SVT Discriminators 4	Single ChamberSingle button programming; Stability+/AccRate, Stability, Degree of Onset, VT long cycle searchNominal settings: Onset 19%, Stability 65 ms (Slow VT, VT); Long cycle extension 10 cycles; Long cycle gap 170 ms
	Dual Chamber/CRT‐DSingle button programming; PARAD+Rate, Stability, AV association analysis, Degree and Chamber of Onset, VT long cycle searchNominal settings: Onset 25%, Stability 65 ms (Slow VT, VT); Long cycle extension 10 cycles; Long cycle gap 170 ms
4SVT Discriminators are not required in Complete Heart Block.
Oversensing Rejection	Daily check Lead impedance ON*Daily check Lead coil continuity ON*Daily check V oversensing alerts ON*T‐wave filtering and noise detection are hardcoded in firmware

APPENDIX 1. Author disclosure table

Writing group member	Employment	Honoraria/Speaking/Consulting	Speakers’ bureau	Research*	Fellowship support*	Ownership/Partnership/Principal/Majority stockholder	Stock or stock options	Intellectual property/Royalties	Other
Martin K. Stiles, MBChB, PhD, FHRS (Chair)	Waikato Hospital, Hamilton, New Zealand	None	None	None	None	None	None	None	None
Laurent Fauchier, MD, PhD	Centre Hospitalier Universitaire Trousseau, Université François Rabelais, Tours, France	1: BMS/Pfizer; 1: Boehringer Ingelheim; 1: Medtronic; 1: Novartis; 2: Bayer HealthCare	None	None	None	None	None	None	None
Carlos A. Morillo, MD, FHRS	Libin Cardiovascular Institute of Alberta, University of Calgary, Calgary, Canada	1: Abbott; 1: Bayer; 1: BMS/Pfizer; 1: Medtronic; 1: Servier	None	None	None	None	None	None	None
Bruce L. Wilkoff, MD, FHRS, CCDS	Cleveland Clinic, Cleveland, Ohio	1: Abbott Vascular; 2: Medtronic; 2: Philips	None	None	None	None	None	None	None

Number value: 0 = $0; 1 = ≤ $10,000; 2 = > $10,000 to ≤ $25,000; 3 = > $25,000 to ≤ $50,000; 4 = > $50,000 to ≤ $100,000; 5 = > $100,000.

^*Research and fellowship support are classed as programmatic support. Sources of programmatic support are disclosed but are not regarded as a relevant relationship with industry for writing group members or reviewers.

APPENDIX 2. Reviewer disclosure table

Peer reviewer	Employment	Honoraria/Speaking/Consulting	Speakers’ bureau	Research*	Fellowship support*	Ownership/Partnership/Principal/Majority stockholder	Stock or stock options	Intellectual property/Royalties	Other
Serge Boveda, MD, PhD	Cardiology Department, Clinique Pasteur, Toulouse, France	1: Boston Scientific; 1: Medtronic; 1: MicroPort	None	None	None	None	None	None	None
Michael R. Gold, MD, PhD, FHRS	Medical University of South Carolina, Charleston, South Carolina	1: Abbott Vascular; 1: EBR Systems; 1: Medtronic; 2: Boston Scientific	None	None	None	None	None	None	1: ABIM
Roberto Keegan, MD	Hospital Privado del Sur and Hospital Español, Bahia Blanca, Argentina	None	None	None	None	None	None	None	None
Valentina Kutyifa, MD, PhD, FHRS, FESC, FACC	University of Rochester Medical Center, Rochester, New York; Adjunct Position at Semmelweis University Heart Center, Budapest, Hungary	1: Biotronik; 1: ZOLL Medical Corporation	None	5: Biotronik; 5: Boston Scientific; 5: ZOLL Medical Corporation	None	None	None	None	None
Chu‐Pak Lau, MD, FHRS, CCDS	The University of Hong Kong, Hong Kong, Hong Kong	None	None	None	None	None	None	None	None
Mark A. McGuire, MBBS, PhD	Heart Rhythm Centre, Newtown, Australia	1: Medtronic	None	None	None	None	None	None	None
Siva K. Mulpuru, MD, FHRS, CCDS	Mayo Clinic Arizona, Phoenix, Arizona	None	0: Medtronic	None	None	None	None	None	None
David J. Slotwiner, MD, FHRS	Weill Cornell Medical College, New York, New York	None	None	None	None	None	None	None	None
William Uribe, MD, MBA, FHRS	CES Cardiología, Medellin, Colombia	1: Abbot Laboratories; 1: Pfizer	None	None	None	None	None	None	None

Number value: 0 = $0; 1 = ≤ $10,000; 2 = > $10,000 to ≤ $25,000; 3 = > $25,000 to ≤ $50,000; 4 = > $50,000 to ≤ $100,000; 5 = > $100,000.

ABIM = American Board of Internal Medicine.

^*Research and fellowship support are classed as programmatic support. Sources of programmatic support are disclosed but are not regarded as a relevant relationship with industry for writing group members or reviewers.