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Leadless Pacing Prof. Dr. med. Christof Kolb Klinik für Herz- und Kreislauferkrankungen Abteilung für Elektrophysiologie Deutsches Herzzentrum München
Conflicts of interest
Travel support and lecture honorary
Biotronik Boston Scientific
Bristol Myers Squibb Medtronic
LivaNova/Sorin Group Spectranetics
St. Jude Medical
Advisory Board Biotronik
LivaNova/Sorin Group
Study compensation
Biotronik
Boston Scientific LivaNova/Sorin Group
St. Jude Medical
Leadless Pacing
Why Leadless Pacing?
Lead-associated complications - Pneumothorax - Cardiac perforation - Dislodgement - Venous occlusion - Fracture, insulation failure
Pocket or Generator-related complications - Hematoma - Skin Erosion - Infection - Cosmetic concerns
Pacemaker related adverse events in ~ 1 of 10 patients
Potential Benefits of Leadless Pacing
1
2
3
Percutaneous, less hardware, no cosmetic issues
Reduction of acute and chronic complications
Reduction of complications Short in-hospital stay
Potential Benefits of Leadless Pacing
1
2
3
Percutaneous, less hardware, no cosmetic issues
Reduction of acute and chronic complications
Reduction of complications Short in-hospital stay
Currently only single chamber pacing (VVIR) possible
Micra™ Nanostim™
Size
Longevity
Access site
Fixation
Extraction
41,4 mm 25.9 mm
Femoral Vein (18 Fr.) Femoral Vein (23 Fr.)
Passive Helix (1,3mm) 4 Tines
Dedicated retrieval system Not Recommended
Available systems
CE / FDA approval
MRI compatibility
Oct 2013 / NO
1.5 Tesla 1.5 and 3.0 Tesla
April 2015 / April 2015
10 years (new battery) 10 years
Sources: DHM, Medtronic; Kypta el al. PACE 2016
Implantation of leadless pacemakers
Electrical parameters
Reddy et al. J Am Coll Cardiol 2015; Reynolds et al. N Eng J Med 2016; Piccini et al Heartv Rhythm 2017
Nanostim (n=31 at 1 year) Micra (n= 498 at 3 months and n=47 at 1 year)
Micra compared to transvenous lead
Reddy et al. N Eng J Med 2015; Reynolds et al. N Eng J Med 2016
Nanostim (n=526) Total complications 6.5 % Perforation 1.5 % Dislodgement 1.2 % Groin 1.2 %
Safety
Micra (n=725) Total complications 4.0 % Perforation 1.6 % Groin 0.7 %
Indications Leadless Pacing
Patients with Indication for VVI(R) Pacing • Permanent atrial tachyarrhythmias with 2 or 3° AV Block • Sinus rhythm with 2 or 3° AV or BBB block, low level of physical activity or patients with a lifespan < 10 years • Sinus bradycardia with infrequent pauses or unexplained syncope
Potential further indications ? Venous access problems ? Physically very active patients (avoid pocket) ? After pocket infection ? Patients at increased risk for lead failure or infection ?? Neurocardiogenic syncope of cardioinhibitory type
Leadless Pacing in Children
• Safety and feasibility of leadless pacemakers in patients younger than 18 years is unknown.
• Size of the introducer sheath (18 French/23 French inner diameter) may make its use in children more difficult.
• Devices placed in the smaller right ventricles of children Tricuspid valve problems ? proarrhythmia ?
• Further miniaturization without compromising longevity • Extractability (very limited data in adults; increased risk of
fibrosis in children ?) • Is VVIR pacing acceptable in children / adolescents?
Leadless Pacing in GUCH
• Safety and feasibility of using this leadless pacemaker in adult CHD patients unknown.
• Indications based on adult population indications; single chamber pacing
Unsolved Issues • Morphologically left ventricles (after atrial switch) without trabeculation ? • Retrograde placement in a (single) ventricle ? • Risk of Thrombosis - anticoagulation management ?
The Future?
Tjong et al. Europace 2016
Summary
• Leadless pacing is an exciting new development • Electrical performance comparable with transvenous pacemaker systems. • Acute complications rates similar to transvenous systems but increased
rate of tamponaeds needs to be addressed improvements in implantation techniques beyond the learning curve
• Long-term issues (thrombogenity, proarrhyhtmia, extractability) need to be addressed.
• Currently leadless pacing only in VVIR mode available.
Not a dedicated system for children or GUCH BUT maybe very helpful in individual patients
Thank you for your attention