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When Hercules needs Zeus! Hypertrophic Cardiomyopathy and ICDs: An update on practice and the future Chris Monkhouse Cardiac Scientist, Clinical lead for devicesObjectives 1. What is an ICD 2. Why would HCM need this 3. How do we select patients 4. What are the outcomes with HCM 5. What is the choice with the type of deviceWhy do we use ICDs? a) To make people jump b) To spend lots of money c) To prevent sudden arrhythmic death d) To stop them going through airport scanners e) To stop them driving lorriesWhy do we use ICDs? a) To make people jump b) To spend lots of money c) To prevent sudden arrhythmic death d) To stop them going through airport scanners e) To stop them driving lorriesRestoring sinus rhythmICDs used to be massive!In the 1990s what was the indication for ICD implant? A. Previous myocardial infarction B. Ejection fraction less than 25% C. 2 x consultants agreement D. 2 x previous resuscitated arrests E. Inherited cardiomyopathyIn the 1990s what was the indication for ICD implant? A. Previous myocardial infarction B. Ejection fraction less than 25% C. 2 x consultants agreement D. 2 x previous resuscitated arrests E. Inherited cardiomyopathySecondary prevention of SCDPrimary evidence- most cited MADIT II trial- 2002 Investigator led sponsored by industry (Guidant- Boston Scientific)at Lower cut-off for EF- 25% than previous studies 20 months follow upModern Implantable DefibrillatorsHypertrophic CardiomyopathyHCM ICD guidelinesGuideline advice… The VF zone of the device should be programmed at >220/min to minimize shocks from rapidly conducted AF. The newly developed subcutaneous ICD lead system (S-ICD™, Boston Scientific) has FDA approval and may be considered in HCM patients who have no indication for pacingRCT for SICDPretorian Trial- review Authors • Based in Amsterdam – Lead Dr R Knops • Large volume SICD service, early adopter and proctor for best practice • Multicentre- 39 centres in Europe and America • Trial supported by Boston Scientific- (maker of SICD) • Authors completed disclosure forms- multiple contradicting personal consulting fees • Detailed protocol and design review published in NEJM • Industry not involved in trial except for fundingPretorian Trial- review Research question? • Non-inferiority trial • A study that tests whether a new treatment is not worse than an active treatment it is being compared to. Non-inferiority trials are sometimes done when a placebo (an inactive treatment) cannot be used. • Device related complications and inappropriate shocks • Some of these are not the same Pretorian Trial- review Patient selection • TV Vs SICD Primary / secondary prevention Class 1/ 2a indication for ICD • Excluding: need for pacing/ ATP • Patients failing “appropriate SICD” sensing vector testPretorian Trial- review Predictor Variables • ICD programming • Patient selection • No difference in variables seen • Low numbers of some variables • EF • QRS duration • Remote monitoring • Callum K, Graune C, Bowman E, Molden E, Leslie SJ. Remote fewer inappropriateshocks and reduced time to medical with assessment in a remote and ruralarea. World J Cardiol. 2021 33791078; PMCID: PMC7988594.330/wjc.v13.i3.46. PMID:Pretorian Trial- review Supplementary material • ICD programming Pretorian Trial- review Outcomes? • Inappropriate shocks • Unnecessary shocks- not defined pre-trial • “According to the end-point definition, which was based on earlier ICD trials, these shocks were classified as appropriate clinically desirable — could be considered to be unnecessary. • Device related complications • Included all comps. However many compilations are not the samePretorian Trial- review Conclusion • Honest limitations • Limited follow up duration to 48 months • Device was non-inferior • “The results of our trial showed that among patients with an indication for ICD therapy but not for pacing therapy, the subcutaneous ICD was noninferior to the transvenous ICD with respect to the cumulative incidence of the primary end point of device-related complications or inappropriate shocks.”Pretorian Trial- review Validity • Valid • Expected results • Good sampling • Good detail • Technicalities- device has changed a lot since inception • Does not discuss cost • Device was non-inferior • Should be used as an option, not trying to be superior • Likely to be non inferior in most cohortsPretorian Trial- review Summary • Adds tostvidence • 1 RCT for SCID VS TV ICD • Device was non-inferior on grouped complications • Higher in Inappropriate shocks • Lower in device related complications (lead) • Look to be considered as an option in some cohortsNew features What about? • Extended SICD detection • New Bandpass filter • Automatic vector screening • Remote monitoring for SICD patientsImplications for HCM ATLAS trial- no published in Peer review Abstract only • 503 patients- RCT • Lead related complications- SICD superior • 93 HCM patientsImplications for HCM ATLAS trial- no published in Peer review Abstract only • Lead related complications- SICD superior • 93 HCM patientsImplications for HCM Can this trial be extrapolated? • Only 22 HCM patients included in this trial • Are younger • More likely to have TV lead complications • Remote monitoring for SICD now available • HCM more likely for inappropriate shocksWhat type of device would you have? A. SICD B. TV ICDAny comments? Pretorian Trial https://www.nejm.org/doi/full/10.1056/NEJMoa1915932Thank you Chris Monkhouse @chris_monkhouse