Leadless Pacing. Osama Diab Assistant Prof. of Cardiology Ain Shams University Egypt
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1 Leadless Pacing Osama Diab Assistant Prof. of Cardiology Ain Shams University Egypt
2 The weakest link in Pacemaker system the lead. The more the leads the more the complications Dislodgement Fracture Insulation break Infection Extraction issues Vein thrombosis CS dissection (CRT) Cardiac perforation Pneumothorax Endocarditis Valve injury
3 Risk factors for lead complications in cardiac pacing: A population-based cohort study of 28,860 Danish patients The incidence of any lead complication was 3.6% (3 ms follow up) Risk factor Adjusted Odds Ration 95% CI Chronic HF as indication Implantation in a nonuniversity center Inexperienced operator with <25 implantations Single-lead RA device Dual-chamber pacing CRT-P Passive-fixation RA lead Heart Rhythm, Volume 8, Issue 10, Pages , October 2011
4 Lead Dislodgement During Follow-Up in Nonthoracotomy Requiring Implanted Devices Trial Year Successful Implants, n All Events, n (%) Duration, months Nonthoracotomy ICD systems AVID (1.5) 27 ± 13 CAT (4.0) 0.5 DEFINITE (2.6) 29 ± 14 Total (1.8) Nonthoracotomy CRT systems MIRACLE (5.9) 6 MIRACLE ICD (2.9) 6 CARE-HF (2.8) 0.5 RethinQ (7.6) 6 REVERSE (10.6) 12 MADIT-CRT (CRT arm) , (4.4) 0.5 Total 3, (5.7) J Am Coll Cardiol. 2011;58(10): doi: /j.jacc
5 Complications Related to Coronary Sinus in Recipients of a Nonthoracotomy CRT Device With or Without Defibrillator Trial Year Patients Undergoing Implantation Coronary Vein Dissection, Perforation or Tamponade Coronary Vein Dissection Coronary Vein Perforation Coronary Vein Tamponade MIRACLE (6.2%) 23 (4.0) 12 (2.0) NR MIRACLE ICD (4.5) 15 (3.6) 4 (1.0) NR COMPANION , (1.8) 5 (0.4) 12 (1.0) 5 (0.4) CARE-HF (1.5) 5 (1.2) NR 2 (0.5) RethinQ (0.6) 1 (0.6) NR NR REVERSE (0.5) 3 (0.5) NR NR MADIT-CRT (CRT arm) ,089 5 (0.5) 5 (0.5) NR NR Total 4, (2.0) 57 (1.3) 28 (1.3) 7 (0.4) J Am Coll Cardiol. 2011;58(10): doi: /j.jacc
6 Pneumothorax Related to Implantation of Nonthoracotomy Devices Trial Nonthoracotomy ICD systems Year Patients Undergoing Implantation, n Events, n (%) AVID (1.1) DEFINITE (0.9) MADIT-CRT (ICD arm) (0.8) Total 1, (0.9) Nonthoracotomy CRT systems MIRACLE (0.2) MIRACLE ICD (0.7) CARE-HF (0.5) RethinQ (1.1) REVERSE (0.6) MADIT-CRT (CRT arm) , (1.7) Total 3, (0.9) J Am Coll Cardiol. 2011;58(10): doi: /j.jacc
7 Mortality and complications of lead extraction Circulation: Arrhythmia and Electrophysiology. 2010; 3:
8 Lead extraction versus lead abandonment: Risk versus Risk Risk of Lead Extraction Circulation: Arrhythmia and Electrophysiology. 2010; 3:
9 Complication Rates Associated With PM or ICD generator Replacements and Upgrade Procedures Patients without lead addition: Patients with 1 or more lead addition: Circulation. 2010; 122:
10 Major Complication Rates by Lead Procedure P=0.004 Circulation. 2010; 122:
11 Lead complications in paced population Infection Up to 1.2 within year after implantation Up to 5% of entire population with endocarditis 1% risk of death and 2% risk of major complications at lead extraction Lead interaction with heart and vessels 20% of implanted pts have TR Up to 25% venous thrombosis/stenosis Lead failure Up to 21% within 10 years after implantation
12 Recalls of Medtronic and St Jude leads stimulated increased interest and research in the area of leadless pacemakers Recalls of: Medtronic s Sprint Fidelis leads on October 2007 due to high rate of fractures and breaks. St. Jude s Riata leads on November 2011 due to high rate of failure and erosion.
13 Totally self-contained intracardiac pacemaker Dpickler et al, Journal of Electrocardiology Volume 3, Issues 3 4, 1970, Pages Miniaturization technology Long life battery Totally contained inside the RV Introduced and removed transvenously
14 Energy source Endocardial receiver unit Ultrasound energy EBR technology Magnetic energy Induction technology
15 Intracardiac self contained leadless PM
16 Ultrasound energy: Energy transfer from an US transmitter to a receiver electrode in the heart. Temporary pacing was successful and safe in animal and human studies using external US generator. J Am Coll Cardiol. 2007;50(9):
17 1- Energy transfer efficiency: - A major limitation esp in PM dependant pts 2- US generator: - Apart from WiCS (used for CRT), current generators are external only 3- Transmission beam: - Impact on threshold safety margin. - Thermal effect? 4- Acoustic window: - Body positions and respiratory phases - Obesity, COPD 5- Sensing function: - Not yet addressed Heart rhythm, Vol. 6, No. 6, June 2009
18 WiCS (Wireless Cardiac stimulation) 9 mm
19 WiSE-CRT is a 100 patient feasibility and safety trial being conducted in Europe demonstrating biventricular pacing capture with WiCS (Wireless Cardiac Stimulation System) More than 16 patients successfully treated to date include those with: - Acutely failed CS lead placement - Chronically failed CS leads - Patients upgraded from dual-chamber defibrillators. - Patients who have not yet responded to conventional CRT.
20 Induction technology Magnetic field generated from a transmitter unit to a receiver unit0 in the heart converted into electric stimulation Only in animal models A transmitter unit implanted subcutaneously (primary coil) An endocardial receiver unit implanted in the RV apex (secondary coil) The device can be programmed by telemetry like a conventional PM PACE 2009;32: Europace 2012, online 1 st of Oct (Wieneke et al.)
21 High Density Battery System Totally self contained intracardiac PM Intracardiac VVIR system Cylinder shaped 2.5 cm Steerable catheter~20f 7-10-yr longevity Programmable Placed within RV Basic device and arrhythmia diagnostics Output Amplitude: nom 2.0V; max 5.0V
22 Percutaneous intracardiac leadless pacemaker <1x2.4 cm
23 Intracardiac leadless PM: Wireless connectivity to smart phones
24 Intracardiac leadless PM In a 16-sheep animal study, Medtronic monitored the electrical behavior of animals receiving the device for 24 weeks. At its conclusion, the study showed no adverse events, demonstrating similar pacing results to currently available pacemaker leads.
25 Functionality Implant Support: Impedance measurement, P/R-wave amplitude, pacing threshold Diagnostics Percent paced/sensed Battery longevity Pacing data (threshold/impedance) Extensible to rate response data Electrode Integrity Monitor Rate Hysteresis Noise Reversion Holter Mode
26 Intracardiac leadless PM Avoid lead complications Avoid pocket complications
27 No surgery Fewer acute and chronic complications (no lead) Less exposure to radiation Cosmetic benefit (invisible) More MRI conditional Femoral venous access (avoid subclavian anomalies) No system connections Short hospital stay
28 Large diameter sheath Embolization Repositioning difficulty for high thresholds Pediatric application Memory limitation Longevity limitation (abandon vs explant)
29
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