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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