New devices in current practice and on the horizon CRT · 2016-08-18 · Cardiac Resynchronization...
Transcript of New devices in current practice and on the horizon CRT · 2016-08-18 · Cardiac Resynchronization...
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Richard Kobza
Luzerner Kantonsspital
New devices in current practice and on
the horizon
____________________
CRT
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Institutional research and educational funding:
Abbott, Biotronik, Biosense Webster, Boston,
Medtronic, St. Jude Medical
Disclosures
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• Primary nonpharmacologic therapy for drug
refractory HF & ventricular dyssynchrony
• 20-30% of HF patients have BBB
Cardiac Resynchronization Therapy
Nathaniel M. Hawkins, Mark C. Petrie, et al. Selecting patients forcardiac resynchronization therapy: electrical or mechanicaldyssynchrony? European Heart Journal Jun 2006, 27 (11) 1270-1281
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• 10% unsuccessful LV lead placement
• Surgical epicardial LV lead placement via mini-
thoracotomy or video-assisted thoracoscopic
surgery (VATS)
• 30-40% of patients are nonresponders
Cardiac Resynchronization Therapy
Moss, Arthur J., et al. “Cardiac-resynchronization therapy forthe prevention of heart-failure events.” NEJM 361.14 (2009) 1329-1338.
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What alternatives are available?
• Vector Selection / Quadripolar Leads
• Multisite Pacing
• Transseptal LV Endocardial Pacing
• LV Leadless Endocardial Pacing
• MR in CRT-Patients
Novel Approaches to CRT
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• Ideal lead location may not always be feasible
• Newer leads allow multiple options for LV pacing
• Pacing at optimal vs suboptimal site can
increase acute hemodynamic response by up to
10%
Vector Selection
Asbach, Stefan, et al. Vector selection of a quadripolar leftventricular pacing lead. PLoS One. 2013 Jun 24;8(6)
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Rinaldi C, Burri H, A review of multisite pacing to achieve CRT, Europace Jan 2015;17 (1) 7-17
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Seger M, Hanser F, Dichtl W, et al. Non-invasive imaging... Europace 2014;16:743-749
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Multi Site Pacing
• Stimulation of the LV from more than one
location
• Goal of providing more complete
resynchronization
• Multi-vein Pacing vs Multi-polar Pacing
Behar, J.M., Bostock, J., et al, “Limitations of chronic delivery ofmulti-vein left ventricular stimulation for CRT. J Intervent. Card. Electrophysiol. 2015; 42: 135–14
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Multi Side Pacing
• St. Jude Medical Quadra Assura MP
(CE mark June 2013)
• BIOTRONIK Ilivia 7 HF-T QP (CE mark Jan 2016*)
• Medtronic Amplia Quad CRT-D (CE mark Febr 2016)
* Market Launch exp. September 2016
Rationale:Multi side pacing delivers two pacing pulses on the LV via a quadripolar lead, thus allowing to capture at once a larger area of the myocardium.
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Multiside pacing trials
Thibault 2013: Invasive hemodynamics; MSP improved acute systolic function in 72% patients vs. conventional CRT.
Rinaldi 2013: Post implantechocardiographic evaluation; 64% reduction in dyssynchrony with MSP vs. conventional CRT.
Pappone 2013: Monitoring of pressurevolume loops during implant; MSP significantly improved acute LV hemodynamic parameters as comparedwith conventional CRT.
Rinaldi, Burri, Thibault, Curnis, et al. A review of multisite pacing to achieve cardiac resynchronizationtherapy Europace Jan 2015, 17 (1) 7-17.
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12-month follow-up
in 22 pts.:
Improvement in
• Dyssynchrony
• Hemodynamics
• QRSd
• Longer term data is still needed
Multi Site Pacing
• Pappone et al. Improving cardiac resynchronization therapy response withmultipoint leftventricular pacing: Twelve-month follow-up study. Heart Rhythm. 2015 Jun;12(6):1250-8.
• Tommasoni, Heart Rhythm Meeting 2016
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Mainly dependent on LV lead location and capture:
• Endocardial >>> Epicardial
• Faster impulse propagation
CRT and Hemodynamics
Leclercq F, Hager FX, et al. “Left ventricular lead insertion usinga modified transseptal catheterization technique...” Pacing ClinElectrophysiol 1999;22:1570-5
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• LV endocardial pacing via a transseptal bipolar
active fixation lead
• Access to all regions of the LV
• Lower rate of lead dislodgement
• Faster impulse propagation
Transeptal LV Endocardial Pacing
Babaliaros VC, Green JT, Lerakis S, Lloyd M, Block PC. Emerging Applications for Transseptal Left Heart Catheterization: Old Techniques for New Procedures. JACC. 2008;51(22):2116-2122.
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• Thromboembolic Risk
• Technically difficult
• MV insufficiency
• Infection management
Limitations
Whinnett, Zachary, and Pierre Bordachar. "The risks and benefits oftransseptal endocardial pacing." Current opinion in cardiology 27.1 (2012): 19-23.
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Bordachar P, Derval N, Ploux S, et al. Left VentricularEndocardial Stimulation for Severe Heart Failure. JACC 2010;56(10):747-753
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Bordachar P, Derval N, Ploux S, et al. Left VentricularEndocardial Stimulation for Severe Heart Failure. JACC 2010;56(10):747-753
A: Septum punctured and proximal segment of a guidewire placed in the LAB: Sheath was introduced into the left atrium along the guidewire / lead advanced into LA
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• 138 patients with criteria for CRT
• 40% ischemic cardiomyopathy
• 50% AF
• 78% prior failed CRT attempt
• 22% nonresponder at 6 months
• 75% NYHA FC III-IV
ALSYNC Trial (ALternative site cardiac
reSYNCHronization)
Morgan, John M., et al. "ALternate Site Cardiac ResYNChronization(ALSYNC): a prospective and multicentre study of left ventricularendocardial pacing for cardiac resynchronization therapy." European Heart Journal (2016).
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• Endocardial LV lead placement success
rate89.4%
• Freedom from complications 82.2% at 6
months• Implantation site hematoma (early)
• Aortic puncture at transfemoral implantation
• 6 neurologic events
• Only one death was procedural related (pneumo/hemothorax)
ALSYNC Trial (ALternative site cardiac
reSYNCHronization) Trial Results
Morgan, John M., et al. "ALternate Site Cardiac ResYNChronization(ALSYNC): a prospective and multicentre study of left ventricularendocardial pacing for cardiac resynchronization therapy." European Heart Journal (2016).
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Also at 6 months
• NYHA FC improved in 59% of patients
• LVESV improved in 55% of patients by 15% or
more
• 33% of patients showed improvement of MR by
≥1 class
ALSYNC Trial (ALternative site cardiac
reSYNCHronization) Trial Results
Morgan, John M., et al. "ALternate Site Cardiac ResYNChronization(ALSYNC): a prospective and multicentre study of left ventricularendocardial pacing for cardiac resynchronization therapy." European Heart Journal (2016).
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• Implantable wireless pacing system converts
ultrasound energy to electrical energy
• Electrode, transmitter and battery
• Co-implanted with a pacemaker, ICD, or existing
CRT device
LV Leadless Pacing System
Auricchio, Delnoy, Regoli, et al. First-in-man implantation ofleadless ultrasound-based cardiac stimulation pacingsystem. Europace Aug 2013, 15 (8) 1191-1197.
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LV Leadless Pacing System
Auricchio, Delnoy, Regoli, et al. First-in-man implantation ofleadless ultrasound-based cardiac stimulation pacingsystem. Europace Aug 2013, 15 (8) 1191-1197.
1) Conventional PMgenerates an electricpacing pulse
2) Pulse generator picksup electrical activity byPM
3) Pulse generator sendsultrasonic pulse toreciever-electrodecausing left ventricle topace
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Long-term (6 months) Experience of Clinical
Efficacy and Clinical Events from Two Centers
in 22 patients
– BiV pacing achieved in 100, 91 and 94% of pts at 1, 6 and 12m
– Mean ejection fraction increased
– Mean NYHA reduced
– Mean end systolic / diastolic volumes reduced
Two-center experience in limited number of pts has demonstrated feasibility,
utility and long term outcome of endocardial LV pacing to achieve CRT
WiSE CRT shows promising efficacy in pts unable to benefit from
conventional CRT, non responders / upgrades
LV Leadless Pacing System
Neuzil, Heart Rhythm Congress 2016
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Possibilities with Leadless TechnologyApplications of leadless technology
Dual Chamber
Nanostim
2 Discrete devices: Right Atrium and Right Ventricle
Beat to Beat Communication Chronically retrievable
Leadless
ICD/PM
Leadless ICD system with device-to-device communication to Nanostim
Nanostim device paces, senses, and delivers ATP therapy
Leadless CRT Evaluate leadless options for CRT therapy
delivery Applicable to low and high voltage
Pediatric
Leadless
Miniaturize present leadless pacemaker Fully retrievable Reduce complications from venous adhesions
Temporary
Pacing
Utilize Nanostim for temporary pacing Avoid surgical pocket Retrievability makes this attractive
(RAO)
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Biotronik Boston Medtronic SJM
3.0 T Labelling N/A N/A Full Body N/A
1.5 T Labelling ExclusionIsocenter at orabove eye level, at or below L“
Full body withnew devices
Full body Full body ExclusionIsocenter at orabove eyelevel, at orbelow L“
CRT-D and MRI conditions
Adapted from Auricchio, EHRA Webinar 2016
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Juerg Schwitter et al. Circ Cardiovasc Imaging.
2016;9:e004025
Image Quality of Cardiac Magnetic Resonance Imaging in Patients
With an Implantable Cardioverter Defibrillator System Designed for
the Magnetic Resonance Imaging Environmen
Cardiac MRI canoffer diagnosticinformation in most cases (175 pts)
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• Multiple different approaches for CRT are
evolving which will hopefully improve response
rates.
• Allows individualized therapy for each patient.
• Results are promising, but longer term and
larger studies are still needed.
• The ability to provide CRT-D patients with
access to MRI scans is a significant, necessary
advancement.
Summary
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Thank you!