News der kardialen Device - Therapie! Christian Binggeli! Rhythmologie Klinik St. Anna, Luzern! HerzGefässZentrum Zürich, KlinikImPark, Zürich!
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1 News der kardialen Device - Therapie! Christian Binggeli! Rhythmologie Klinik St. Anna, Luzern! HerzGefässZentrum Zürich, KlinikImPark, Zürich!
2 Complications after Implantation / Replacement / Upgrade or lead revision (transvenous Systems)! Kirkfeldt et al, Eur Heart J. 2014!
3 Complications after Implantation / Replacement / Upgrade or lead revision (transvenous Systems)! Complexity! Skills! Kirkfeldt et al, Eur Heart J. 2014!
4 Complications after Implantation / Replacement / Upgrade or lead revision (transvenous Systems)! at 6 months! Major complications (%) modified from Kirkfeldt et al, Eur Heart J. 2014!
5 SICD! Subcutaneous System! Heart / Vasculature untouched! Therapies:! Biphasic shock, 80 J! Postshock pacing only! Charge time < 10 s!
6 SICD! Volume:!! Weight:!! Thickness:!! Battery Longevity:!59.5 cc!!130 grams!!12.7 mm!!7.3 y!
7 SICD! Commercially distributed in some European countries since 2009! FDA approval 2012! Indications:! Same as ICD! - no symptomatic bradycardia! - no frequent VTs that can be terminated with ATP! Contraindications!!- Unipolar pacemaker! 3-5% of patients not elegible (T-wave oversensing)!
8 SICD!
9 SICD! Effortless Registry: Major Complications requiring Intervention! Major complications (%)! modified from Lambiase et al, EHJ 2014!
10 SICD! Effortless Registry! 456 Patients, 317 Episodes in 85 Patients! Conversion Efficacy in Testing!99.7 %! Overall shock conversion rate!96 %! Appropriate Therapies!!7.2 % (Patients)! Inappropriate Therapies!!7.0 % (Patients)! Lambiase et al, EHJ 2014
11 SICD! Effortless Registry: Appropriate and Inappropriate Shocks! T-Wave! Oversensing! VT/VF Discrete Episodes! Low Amplitude Signals! SVT! VT/VF storm! extracardiac Oversensing! modified from Lambiase et al, EHJ 2014!
12 SICD! Does what it is supposed to do! Moderate Complication rate (beginning of learning curve?)! no Rx! Shock Box!
13 Leadless Pacemaker!
14 Leadless Pacemaker! System proposed by Spickler in 1970!
15 Leadless Pacemaker! 5-7 mm diameter, mm length! Bipolar Sensing! Battery years! retrievable! VVIR!
16 Leadless Pacemaker! Dr. S. Richter, Leipzig!
17 Leadless Pacemaker! Developments, Questions! Mechanical issues, perforations! stiff device!
18 Leadless Pacemaker! Developments, Questions! Mechanical issues, perforations, embolization!!(nanostim > Micra?)! Only VVIR -> combine multiple communicating devices into a multi site pacing system?! Retrievability: might be different after a few months compared to elective battery replacement! R-function (heat driven in Nanostim model)?!
19 ICD! well established since > 3 decades in high risk patients! secondary prophylaxis! primary prophylaxis! but! -> patients with reversible causes for arrhythmias?! -> patients awaiting ICD Implantation! -> patients after MI!!Dinamit, Hohnloser et al, NEJM 2004!!Valiant, Solomon et al, NEJM, 2005! -> patients with system infection!
20 Wearable Cardiac Defibrillator! Life Vest!
21 Wearable Cardiac Defibrillator! Life Vest! - Elastic belt and shoulder strap! 4 dry sensing electrodes!! 3 defibrillation electrodes! - battery (24 h use, 2 h charge)! g! - loop recorder, no pacing! - vibration signal, 2 sound alarms! - button to withhold the shock! Adler et al, Circulation Monophasic shock (230 J), biphasic shock (150 J)!
22 Wearable Cardiac Defibrillator! WEARIT/BIROAD: 289 Patienten, 8 events in 6 patients, 901 pts months!!feldmann, Klein et al. Pacing Clin Electrophysiology, 2004! FDA approved 2002! Does what it is supposed to do, low shock incidence!!chung et al, JACC 2010!!WEARIT-II, ESC 2014! No proarrhythmia published so far! No randomized study! VEST registry: ongoing, Life Vest randomized vs. standard care after MI!!Primary Endpoint: sudden death 3 months after MI!
23 Wearable Cardiac Defibrillator! Limitations and Gaps of Knowledge - post MI patients did receive appropriate shocks for VT/VF in DINAMIT, which did not result in improved survival! - similar results in IRIS (Steinbeck et al, NEJM 2009)! do appropriate therapies in this period translate into improved survival?! same outcomes with shocks from transvenous lead vs. subcutaneous vs. skin leads?! Patient selection: Small subgroup of post MI patients at risk! ICDs prescribed by arrhythmia specialists, wearable defibrillators by physicians less experienced in the management of arrhythmias! -> more complications (programming, inappropriate shocks)?!
24 Sympathetic Nerve Activity and Survival In Heart Failure Muscle Sympathetic Nerve Activity! Plasma Norepinephrine! controls!! Heart Failure! Überlebensrate 10 s! months! Cohn et al, NEJM, 1984!
25 Vagus Stimulation in Heart Failure! Zannad et al, Eur Heart J, 2014
26 Vagus Stimulation in Heart Failure! ANTHEM HF: randomized left vs right Vagal Nerve Stimulation! Pemchand et al, J Card Fail, 2014!!- 60 patients!!- significant improvement in LVEF!!- no control group! NECTAR HF: first sham controlled trial! Zannad et al, Eur Heart J, 2014!!- 96 patients, 63 treated!!- study negative! INNOVATE HF: ongoing trial!!- different device with additional sensor in the right ventricle!!- first results expected in 2016!
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