The document discusses the future of cardiac resynchronization therapy (CRT). It notes that while CRT has been successful, current technology still has unmet needs like suboptimal response rates, relatively high complication rates, and long unpredictable procedure times. The document outlines Medtronic's work to address these issues through innovations like AdaptivCRT technology, which aims to produce more synchronized left ventricular pacing for improved outcomes. It also discusses the development of leadless pacing technologies and percutaneous approaches that could simplify CRT and reduce risks in the future. The overall message is that CRT technology will continue to advance towards making the procedure quicker, safer, simpler and more predictable with higher response rates and lower complication risks.

1. The Future of Cardiac
Resynchronization Therapy
Michael Hill, PhD
Medtronic, plc
Heart Failure 2015
Sevilla, Spain
1

2. 2

3. Innovation in Medical Technology
Industry engineers/scientists partnership with
clinicians is the foundation of medical device
innovation for unmet medical needs
PARTNERSHIP
INDUSTRY CLINICIANS
unmet medical need
medical technology

4. Innovation in Medical Technology
Industry 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

5. 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.

6. Response rates are less than
desired
1
Complication rates are relatively
high compared to those for ICDs
and Pacemakers
2
CRT implantations times are long
and unpredictable
3
1
32
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

7. 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

8. AdaptivCRT™: Synchronized LV Pacing
Normal 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

9. AdaptivCRT:
• Produced mostly
synchronized LV pacing
• Resulted in better clinical
response at 6 months
%Responders(improvedCCS)
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. 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

11. 11
Device EGMs can be used to assess Effective CRT Pacing
-5
0
5
AS
BV
AS
BV
AS
BV
AS
BV
AS
BV
AS
BV
LVTiptoRVCoil(mV)
100% pacing, but only 50% “Effective LV Capture”

12. 12
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
1
4
2
3
0 0.1 0.2
-50
0
50
LVTip-RVCoil EGM
Time (sec)

13. 13 | MDT Confidential
0
10
20
30
40
50
60
70
80
90
60 80 100 120 140
%Efficacy
Heart Rate (BPM)
AF
CAFR
CAFR+ High
CAFR+ Low
%EffectiveCRTPacing
Impact on Effective Pacing: Animal Study Data
Improvement in
% effective CRT
delivered
+20%
Without Effective CRT
Effective CRT High
Effective CRT Low

14. 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-
820
3 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

15. 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. 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 FIX
DEVELOPMENT PROPOSAL
Designed for greater stability and safe extraction

17. 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

18. CONFIDENTIAL 18
Title | 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

19. 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”

20. Thank You