Estimulación cardiaca sin cables 08/10/2015 13:30-15:00h Casa del Corazón, Madrid http://marcapasossincables.secardiologia.es #marcapasossincables La estimulación sin cables: resultados a medio plazo Dr. Lluís Mont Girbau, Hospital Clínic (Barcelona) @Montgirbau

1. Estimulación cardiaca sin cables
Resultados y complicaciones de la
estimulación cardíaca sin cables
Lluís Mont

2. Estimulación cardiaca sin cables
 Minimiza los riesgos y las complicaciones
tradicionales de los marcapasos:
 infeccion
Neumotorax
Desplazamiento
 decúbitos
 fracturas de electrodos
Ventajas potenciales de los sistemas sin
electrodos
5

3. Estimulación cardiaca sin cables
El sistema debería proporcionar
–Mayor confort para el paciente
–Compatibilidad con Resonancia
–Duración de baterías suficiente
–Posibilidad de retirada del sistema
6

4. Estimulación cardiaca sin cables
Marcapassos sin cables
• Nanostim , St Jude
• Micra, Medtronic.
7

5. Estimulación cardiaca sin cables
Nanostim™ Leadless pacemaker
• Energy efficient
– High-capacity CFx battery
– Lower resistance due to lack of
lead
– Low-power conductive
communication
• Compatible with Merlin™ Patient
Care System
• Electrode design is identical to a St.
Jude Medical electrode with same
steroid elution
The Nanostim™ VVIR pacemaker is introduced through the femoral vein into the right
ventricle.
8

6. Estimulación cardiaca sin cables
9
Permanent Leadless Cardiac Pacing Results of the LEADLESS Trial
Vivek Y. Reddy, MD; Reinoud E. Knops, MD; Johannes Sperzel, MD; Marc A. Miller, MD; Jan Petru, MD; Jaroslav
Simon, MD; Lucie Sediva, MD; Joris R. de Groot, MD, PhD;Fleur V.Y. Tjong, MD; Peter Jacobson, BS; Alan Ostrosff,
MS; Srinivas R. Dukkipati, MD;Jacob S. Koruth, MD; Arthur A.M. Wilde, MD, PhD; Josef Kautzner, MD, PhD;
Petr Neuzil, MD, PhD
Circulation. 2014;129:1466-1471

7. Estimulación cardiaca sin cables
The Nanostim™ Leadless Pacemaker Retrieval System
• Similar to delivery system
– Flexible with deflectable tip
– Integrated protective sleeve
– 18 F
• Either single loop or triple loop
snare
• Handle with three functions:
1. Steering the deflectable tip for accurate passage
2. Grabbing and docking the LP
3. Rotating the LP
11

8. Estimulación cardiaca sin cables Reddy et al. N Engl J Med 2015

9. Estimulación cardiaca sin cables Reddy et al. N Engl J Med 2015
• Successfully implanted in 96%
• Efficacy end point: threshold < 2V R > 5 90%
• Device dislodgment with percutaneous
retrieval 1.7%
• Cardiac perforation 1.3%

10. Estimulación cardiaca sin cables
Active Fixation “Tines”
Electrically Inactive
Cathode (2.5mm2 CapSure Sense
steroid eluting
Anode (22mm2 min) Proximal Retrieval Feature
Size
• Volume: 0.75cc
• Mass: 2g
• Length: 25.9mm
• Width: 20Fr
Capabilities
• Pacing Mode: VVIR
• Bipolar sensing (18mm spacing)
• Programmable (RF
communication with
programmer)
• Capture Management
• Rate Response
• Essential Diagnostics: battery
status, pacing threshold, pacing
impedance, % paced
• Device can be manually
deactivated and automatically
deactives at EOS
Battery
• 9.6 / 7.1 year longevity
― 1.5V / 2.0V threshold if 100%
paced @ 60 bpm
18 mm Electrode Spacing
Electrical Isolation (Parylene)
15
Micra, Medtronic

11. Estimulación cardiaca sin cables
Animal implants
16

12. Estimulación cardiaca sin cables
Conventional Micra TPS
Total volume 10.6cc* 0.8 cc
Mass 21.5 grams 2.0 grams
Rate Response
Subcutaneous
Accelerometer
Intracardiac
Accelerometer
Communication Model 2090 Programmer
Model 2090
Programmer
Fixation Helical coil or tines Flexible tines
MR conditional 1.5 T 1.5 T + 3 T
Battery Service
Life
10.3 years† 9.6 years†
*Medtronic model ADSR01 with 30 cm by 6 Fr lead
†Projected based on ADSR01 and Micra use conditions of 100% pacing at 60 bpm, 1.5 V at 0.24 ms, and 500
Ω
17

13. Estimulación cardiaca sin cables
Performance of a Miniaturized
Transcatheter Pacing System:
First Clinical Experience and Results
Philippe Ritter, Gabor Z. Duray, Clemens Steinwender, Kyoko
Soejima, Razali Omar, Lluıs Mont, Lucas VA Boersma, Reinoud E.
Knops, Larry Chinitz, Shu Zhang, Calambur Narasimhan, John
Hummel, Michael Lloyd, Timothy Alexander Simmers, Andrew
Voigt, Verla Laager, Kurt Stromberg, Matthew D. Bonner, Todd J.
Sheldon, and Dwight Reynolds, Micra Transcatheter Pacing Study
Group
Eur Heart J 2015
18

14. Estimulación cardiaca sin cables
Study Prespecified Analyses
Study enrollments completed
Early Performance
N = 140
(60 pts to 3 months)
Primary Objectives
N = 700+
(300 pts to 6 months)
Long-term
Performance
N = 700+
(700+ pts to 12 months)
23

15. Estimulación cardiaca sin cables
Patient Flow Diagram
Implant attempted (n = 140)
Successful Micra TPS implant (n = 140)
Failed Micra TPS implant (n = 0)
Follow-up (average 1.9 ± 1.8 months)
Death* (n = 1)
Lost to follow-up (n = 0)
Discontinued intervention (n = 0)
Analyzed for early performance objectives
(n = 140)
*One patient death occurred 139 days post-implant, was not cardiovascular related, and was determined to be
unrelated to the procedure or system.
25

16. Estimulación cardiaca sin cables
Baseline Characteristics
Patients
(n=140)
Male gender 85, 61%
Age (years) 78 (21 – 94)
Height (cm) 170 (144 – 190)
Weight (kg) 76 (41 – 148)
Body Mass Index 26 (20 – 45)
One or more comorbidity 136, 97%
Primary Indication
Bradycardia with permanent or persistent
AT/AF
Sinus node dysfunction
Atrioventricular block
Other reasons
91, 65.0%
22, 15.7%
19, 13.6%
8, 5.7%
Median and ranges reported
26

17. Estimulación cardiaca sin cables
Results: Micra TPS Implant
2727

18. Estimulación cardiaca sin cables
Micra TPS Deployments During
Implant
• Median of 1 deployment per procedure
• 59% successful in first deployment
• 81% successful within two deployments
• 96% successful within four deployments
28

19. Estimulación cardiaca sin cables
Results: Safety
(n=140)
• Serious Adverse Event rate 5.7%
• 2 patients with prolonged hospitalization (1.4%)
• No dislodgements (0%)
• No infections (0%)
• No reoperations (0%)
• No related deaths (0%)
29

20. Estimulación cardiaca sin cables
Serious Adverse Events
N (pts, %)
DYSRHYTHMIAS
Transient AV block 2 (2, 1.4%)
RBBB 1 (1, 0.7%)
VT 1 (1, 0.7%)
VF 1 (1, 0.7%)
CARDIAC
Pericardial effusion, no tamponade 1 (1, 0.7%)
Acute MI 1 (1, 0.7%)
Pericarditis 1 (1, 0.7%)
OTHER
Arterial pseudoaneurysm 1 (1, 0.7%)
TOTAL 9 (8, 5.7%)
*Occurred in patient with 18 deployments who had 3 vessel disease
†Resolved after thrombin injection
30

21. Estimulación cardiaca sin cables
Min 3 3 2 2
Max 20 20 21 21
R-Wave Sensing Amplitude
Mean ± standard deviation
32

22. Estimulación cardiaca sin cables
Min 0.25 0.25 0.25 0.25
Max 3.50 3.00 2.13 1.25
Pacing Capture Threshold
Mean ± standard deviation
P-Value <0.001
(vs 2.0V)
33

23. Estimulación cardiaca sin cables
Pacing Impedance
Mean ± standard deviation
Min 450 440 420 450
Max 1540 1130 1080 1000
34

24. Estimulación cardiaca sin cables
Expected Micra TPS Longevity
Based on use conditions of 60 patients
followed to 3 months
•Median pacing = 49% (IQR 10%, 75%)
•Median pacing capture threshold at 0.24
ms = 0.38 V (IQR 0.38 V, 0.57 V)
•Median pacing impedance = 640 Ω (IQR
540 Ω, 725 Ω)
Battery longevity estimated at an average
of 12.6 years (range 8.6 – 14.4 years)*
36

25. Estimulación cardiaca sin cables
Expected Micra TPS Longevity
37

26. Estimulación cardiaca sin cables
Conclusions
Early performance of first 140 patients provides initial evidence
that Micra TPS can safely and effectively be applied.
– 100% implant success in wide range of patients
– No procedural-related deaths
– Serious adverse event rate with Micra TPS appears
to be in line with traditional systems
– Electrical performance remains stable at 3 months,
with expected average longevity of ≥10 years
Long-term safety and benefit will be further evaluated in the
ongoing trial.
38