New devices in current practice and on the horizon CRT · 2016-08-18 · Cardiac Resynchronization Therapy Nathaniel M. Hawkins, Mark C. Petrie, et al. Selecting patients for cardiac

Richard Kobza

Luzerner Kantonsspital

New devices in current practice and on

the horizon

____________________

CRT

Institutional research and educational funding:

Abbott, Biotronik, Biosense Webster, Boston,

Medtronic, St. Jude Medical

Disclosures

• 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

• 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.

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

• 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)

Rinaldi C, Burri H, A review of multisite pacing to achieve CRT, Europace Jan 2015;17 (1) 7-17

Seger M, Hanser F, Dichtl W, et al. Non-invasive imaging... Europace 2014;16:743-749

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

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.

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.

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

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

• 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.

• 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.

Bordachar P, Derval N, Ploux S, et al. Left VentricularEndocardial Stimulation for Severe Heart Failure. JACC 2010;56(10):747-753

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

• 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).

• 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)


reSYNCHronization) Trial Results


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


reSYNCHronization) Trial Results


• 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.


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

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


Neuzil, Heart Rhythm Congress 2016

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)

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

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)

• 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

Thank you!

Documents

New devices in current practice and on the horizon CRT · 2016-08-18 · Cardiac Resynchronization Therapy Nathaniel M. Hawkins, Mark C. Petrie, et al. Selecting patients for cardiac