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

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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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AS

BV

AS

BV

AS

BV

AS

BV

AS

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BV

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oil (

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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

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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