Medtronic international the future of cardiac resynchronisation therapy
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The Future of Cardiac Resynchronization Therapy
Michael Hill, PhDMedtronic, plc
Heart Failure 2015Sevilla, Spain
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Innovation in Medical TechnologyIndustry engineers/scientists partnership with
clinicians is the foundation of medical device innovation for unmet medical needs
PARTNERSHIP
INDUSTRY CLINICIANS
unmet medical need
medical technology
Innovation in Medical TechnologyIndustry engineers/scientists partnership with
clinicians is the foundation of medical device innovation for unmet medical needs
PARTNERSHIP
INDUSTRY CLINICIANS
unmet medical need
medical technology
InSync Model 8040 and Custom 10492 (Model 2187)
Val d’Or, St Cloud, France
September 16, 1997
First Implant
European Society of Cardiology Guidelines
• Seven of the 11 trials studying the effects of Cardiac Resynchronization Therapy are Medtronic supported.
5Brignole M, et al. 2013 ESC guidelines. Eur Heart J. 2013.BLOCK-HF Anne Curtis 2014
• Eight of the 12 trials studying Cardiac Resynchronization Therapy were Medtronic supported.
Response rates are less than desired
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Complication rates are relatively high compared to those for ICDs and Pacemakers
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CRT implantations times are long and unpredictable
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Meta-analysis: Cardiac Resynchronization Therapy for Patients With Less Symptomatic Heart Failure. Nawaf et al. AmCol Phy2011
Despite the success of CRT, significant needs are unmet by current CRT technology
Innovate Solutions at Every Stage of Care
Proven solutions with highest standard in clinical evidence
CRT Value = Patient Outcomes + Efficiency
MAXIMIZE CRT RESPONSE EFFORTLESS CRT
AdaptivCRT™: Synchronized LV PacingNormal conduction to RV Synchronized LV pacing
• LV stimulus timed to fuse with intrinsic RV conduction• Continuous, dynamic optimization of AV/VV intervals for LV
or BiV Pacing
AdaptivCRT:
• Produced mostly synchronized LV pacing
• Resulted in better clinical response at 6 months
% R
espo
nder
s (im
prov
ed C
CS
)
p = 0.04
AdaptivCRT with Normal AV intervals (n=150)Control with Normal AV (n=91)
Improved clinical outcomes for patients with Normal AV Conduction
% LV Only Pacing:
73±25% 0%
Martin DO, et al. Heart Rhythm. Published online July 12, 2012.
• Reduced 30-Day HF Readmissions by 47%• 61% lower risk of AF-related Adverse Events
10 | MDT Confidential
Effective CRT in the Guidelines
Clinical response to CRT depends on the proportion of effective bi-ventricular pacing during daily activity
% Pacing Is Not the Complete Story
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Device EGMs can be used to assess Effective CRT Pacing
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0
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AS
BV
AS
BV
AS
BV
AS
BV
AS
BV
AS
BV
LVTi
p to
RVC
oil (
mV)
100% pacing, but only 50% “Effective LV Capture”
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EffectivCRT during AF
Attempts to provide consistent CRT evoked response during AF by adjusting pace timing based on observed morphology.
Beat Effective Pacing?
Pacing Rate
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30 0.1 0.2-50
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50LVTip-RVCoil EGM
Time (sec)
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60 80 100 120 140
% E
ffic
acy
Heart Rate (BPM)
AFCAFRCAFR+ HighCAFR+ Low
% E
ffect
ive
CR
T P
acin
g
Impact on Effective Pacing: Animal Study Data
Improvement in % effective CRT delivered+20%
Without Effective CRTEffective CRT HighEffective CRT Low
Attain Performa is an Advanced Quad Lead
1 Biffi M, et al, Utilizing Short Spacing between Quadripolar LV lead Electrodes to Avoid PNS. Cardiostim 2014, Poster presentation, Session 56P 2 Biffi M, et al. Effect of Bipolar Electrode Spacing on Phrenic Nerve Stimulation and Left Ventricular Pacing Thresholds, Circ Arrhythm Electrophysiol. 2012;5:815-8203 Biffi M1, Zanon F, Bertaglia E, et al., Short-spaced dipole for managing phrenic nerve stimulation in patients with CRT: the "phrenic nerve mapping and stimulation EP" catheter study Heart Rhythm. 2013 Jan;10(1):39-45
• Short Bipolar Electrode Spacing option to avoid PNS1-3
• Steroid on all electrodes for better thresholds
• Compatible with all Medtronic left heart lead delivery tools
• Family of Lead Shapes for Varying Patient Anatomies
Stability for Every Patient. Every Anatomy. Safely.
• Flexibility…Utilize large diameter vessels• Precision…Fixate in exact desired location• Stability…Confidence in acute and chronic lead position• Safety…Designed for repositioning and extraction
16 | MDT Confidential and Proprietary; Do Not Copy or Distribute
NG Quad Active Fix
Attain Stability Design/Mfg Update
Next Generation QUAD lead w/ ACTIVE FIXDEVELOPMENT PROPOSAL
Designed for greater stability and safe extraction
Morgan J. et. al. Late-Breaking Clinical Trials II, HRS 2014, May 8, 2014, San Francisco
Safety and Efficacy of Left Ventricular Endocardial Lead Pacing for Cardiac Resynchronization Therapy:
Primary Results of the ALternate Site Cardiac ResYNChronization (ALSYNC) Study
RF Guide wireDilator
6248 Inner Catheter (Purple)Deflectable (6227ATS)
SafeSheath Hemostatic Valves
Touhy Borst Valve (optional)
Baylis
CONFIDENTIAL 18Title | Description60
60 | MDT Confidential
60 | Draft. MDT Confidential
Dual-Chamber Pacing
Two leadless pacers in/on RA and RV for dual-chamber pacing: AAIR + VDD
One leadless pacer in/on LV
Atrial Synchronous RV- Pacing (VDD)
•15-20 yr longevity•Novel atrial sensing/detection from ventricle
•15-20 yr longevity
•Telem M (wireless)
•Increased diagnostics and monitoring (sensors)
•Downsized device
•>15 year longevity
VVI/R
One leadless pacer in/on the RV for single-chamber pacing
•Basic single-chamber pacer
•Limited feature set
•7 -10 yr longevity
•Telem B
Atrial Synchronous LV- Pacing for CRT
Eventually, all pacing therapies could be leadless…
One leadless pacer in/on the RV provides atrial-synchronous
pacing
…and numerous percutaneous implant approaches possible: in-chamber, coronary vein, epicardial
Becky Dolan 2009
The Future of Cardiac Resynchronization Therapy
CRT will be a quick, safe, simple and predictable procedure with a low complication risk
• 85-90% response rate• <0.1% dislodgement; no PNS• >90% procedures less than 60 mins• “Leadless” and “wireless”
Thank You
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