Implantable Device Therapy: New Technologies

1
Implantable Device Therapy New Technologies
New Paradigms

• Paul Ludmer, M.D., FACC
• EP Director, Summit Medical Center
• President, Cardiovascular Consultants Medical
  Group
• 10/9/09

2
Agenda

• Implantable Device Technology A Brief Review
• Transvenous Leads Current Paradigms and new
  technology
• New Data Pacing Therapy

3
Discussion of Concepts
Advances in Implantable Technology

• Transvenous Leads
• Single and Dual Chamber Devices in HF patients
• CRT Non-Responders
• Patient selection for implantable device therapy

4
Key events in ICD evolution
Innovative, Thinner Longer lasting
Dr. Mirowski Device
Conception

1966
5
New Technologies and Solutions to Old Problems
Transvenous Leads
6
Some Statistics

• 400,000 - 500,000 pacemakers and ICDs are
  implanted yearly throughout the world.
• 7-11 of these devices/leads eventually require
  extraction

Kutalek, Presented in 2009
7
Heart Rhythm. 2007 Jul 4 (7)892-6 17599673
Early failure of a small-diameter high-voltage
implantable cardioverter-defibrillator lead.
Robert G Hauser, Linda M Kallinen, Adrian K
Almquist, Charles C Gornick, William T
Katsiyiannis Minneapolis Heart Institute
Foundation, Minneapolis, Minnesota. BACKGROUND
We have observed a higher than expected rate of
Sprint Fidelis model 6949 lead failures in our
practice. OBJECTIVE The aim of this study was
to assess the performance of small-diameter
Sprint Fidelis high-voltage ICD leads. METHODS
The actuarial survival of Sprint Fidelis model
6949 leads implanted at our center was compared
with that of the Sprint Quattro Secure model
6947. The United States Food and Drug
Administration Manufacturers and User Facility
Device Experience (MAUDE) database was searched
for Sprint Fidelis models. RESULTS The survival
of 583 Sprint Fidelis 6949 leads implanted at our
center between September 2004 and February 2007
was significantly less than 285 Sprint Quattro
Secure model 6947 leads implanted by us between
November 2001 and February 2007 (P .005). Six
patients presented with Sprint Fidelis lead
failure 4-23 months after implant. Five of the
six patients experienced multiple inappropriate
shocks associated with pace-sense conductor and
coil fractures the sixth patient had a fixation
mechanism failure. The MAUDE search rendered
reports for 679 Sprint Fidelis leads. The most
frequent complaints or observations were
inappropriate shocks (33), high impedance (33),
and fracture (35). Of 125 leads analyzed by the
manufacturer, 62 involved fracture of the
pace-sense conductor or coil and the high-voltage
(defibrillation) conductor. CONCLUSIONS The
Sprint Fidelis high-voltage lead appears to be
prone to early failure. Its use should be limited
until the failure mechanism is identified and
corrected. Patients should be evaluated
quarterly, and automatic lead test features
should be enabled. While more data are needed,
routine prophylactic replacement of intact,
normally functioning Sprint Fidelis leads does
not appear justified.
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Industry Innovation Gore-Tex Coated Leads
(RELIANCE G)

• GORE ePTFE-covered coils
• Prevent tissue in-growth
• Defibrillation thresholds unaffected by ePTFE
  covering
• Pores in ePTFE covering do not allow blood and
  tissue cells to pass through, but do allow
  electrically conductive fluid to pass through.

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GORE is a trademark of W. L. Gore Associates
Histology (from a Guidant pre-clinical study,
six months post-implant21) shows function of
ePTFE
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Ongoing Discussions
RV pacing the "Single vs. Dual Debate"
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Which ICD Best? DAVID Study
.4
p0.03
.3
DDDR
.2
Cumulative Probability
VVI
.1
0.0
0
6
12
18
Months to death or first hospitalization for CHF
Number at risk DDDR 250 159 78 21 VVI 256 158 90
25
Wilkoff BL. JAMA 288 31153123, 2002
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INTRINSIC RV Trial
VVI 40 ICD vs. DDDR w/ AV Search Hysteresis
Olshansky B, et al. Circulation 20071159-16
12
Primary End-Point
n1,530
p0.07
Olshansky B, et al. Circulation 20071159-16
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Altitude RV Pacing Survival
Hayes DL, et al. Heart Rhythm 2009 Abstract

• Less than 5 RV pacing improved survival 43
• Remote monitoring provides continuous assessment
  of RV pacing to guide therapy

1.00
n 34,514
0.95
Survival probability
0.90
0.85
0
6
12
18
Months after LATITUDE setup
0 14,970 12,287 8,822 3,176 1-4 5,814
4,753 3,467 1,337 5-34 6,940
5,634 4,003 1,403 35-100 6,790
5,438 3,811 1,371
(0 contains 2 quintiles)
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Atrial Pacing DAVID II Results
Journal of the American College of Cardiology
200953872-880
n600
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Lessons from DAVID I/II, Intrinsic RV, and
Altitude

• Atrial pacing in ICD patients is safe (no
  improved survival with atrial pacing)
• Dual chamber ICDs are safe provided RV pacing is
  avoided
• Lingering question Is there a limit as to how
  far we can extend the AV delay in heart failure
  patients to avoid RV pacing

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Technology and New Data from 2009 Cleveland
Clinic
CRT Non-Responders
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CRT Non-responder Questions

• ? Appropriate Device Programming
• ? AV Optimization
• ? BiV pacing
• ? Afib, PVCs
• ? Optimal Med Therapy
• Other cardiac disease treated
• HTN, DM, Obesity, COPD
• Cardiac Rehab

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Insights from a cardiac resynchronization
optimization clinic as part of a heart failure
disease management programMullens et al JACC
200953765-73

• 75 patients with persistent advanced CHF and/or
  adverse reverse remodeling gt6 months post CRT
• Protocol driven evaluation of non-responders

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(No Transcript)
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Study Algorithm

• Hypothesis for lack of optimal response
• Multidisciplinary recommendations
• Dichotomous Grading Scheme- subjective impression
  of multidisciplinary team with regard to the
  propensity of subsequent clinical improvement
  based on implemented recommendation
• Tried to answer the following questions
• Favorable Intervention (could the team make a
  recommendation for a therapy change)
• Neutral Intervention (team unable to make a
  change that may benefit patient)

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Potential Reasons for Suboptimal Response to CRT
Mullens, J Am Coll Cardiol 20095376573
22
Mullens, J Am Coll Cardiol 20095376573
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Mullens, J Am Coll Cardiol 20095376573
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The Data Shows
Optimize the Device
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Device Based AV Delay Optimization

• Algorithm designed to recommend optimal sensed
  and paced AV delays to maximize LV dP/dt based on
  intrinsic conduction characteristics.
• One-button feature that provides recommended AV
  delay without an echo in under 2.5 min.

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The Data Behind SMART DELAY
(M. Gold et al, J Cardiovasc Electrophysiol, Vol.
18, pp. 490-496, May 2007)
Smart Delay accurately predicts the optimal
AVD among patients Over a wide range of QRS
intervals during CRT in both AS and AP modes.
This technique may obviate the need for
echocardiography for AVD programming
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Clinical EvidenceCRTAVO Study Results
Correlation between SmartDelay recommendations
(during atrial sensing) and the highest
achievable LV dP/dtmax.
Atrial Pacing 96 correlated.
Atrial Sensing 98 correlated.
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New Paradigms
Device Patient Survival
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MADIT II Survival Results
31 Less mortality on top of best medical therapy
with ICDs
1.0
0.9
Probability of Survival
0.8
0.7
0.6
P 0.007
0.0
0
1
2
3
4
Year
Number Needed to Rx
17
30
MADIT II 8 Year Follow-Up
61
45

• 37 Mortality Reduction
• Number needed to Rx 6

Goldenberg et al. Heart Rhythm 2009
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The Data MADIT II 8 Year Follow-Up

• 48 mortality reduction at 8 years in ICD
  patients without worsening HF during the 20 month
  study
• 12 mortality reduction in dual chamber devices
  during the study which increased to 47 at 8
  years with reduction of RV pacing
• The number needed to treat with ICD therapy to
  save a life decreased from 17 at 20 months to 6
  at 8 years

Goldenberg et al. Heart Rhythm 2009
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New Data from HRS 2009
What about caring for patients after they
receive their CRT-D?
ALTITUDE
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ALTITUDE

• Background data from LATITUDE to provide answers
  to meaningful questions about ICD/CRT-D patients
• 85,999 patients
• 47,032 ICD pts and 38,967 CRT-D pts
• Retrospective, non-randomized observational
  cohort study
• Mortality data were obtained through LATITUDE and
  device tracking systems

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ACC/AHA HF Guidelines
Short-term changes in fluid status are best
assessed by measuring changes in body weight 2
1 Hunt, SA ACC/AHA 2005 Guideline Update for the
Diagnosis and Management of Chronic Heart Failure
in the Adult, http//www.acc.org/qualityandscienc
e/clinical/guidelines/failure/update/index.pdf,
pp 9. 2 Ibid. pg. 14.
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Altitude (n85,999) Survival
Saxon LA, Hayes DL, Day JD, et al. Heart Rhythm
2009 Abstract
ICD
Probability of Survival
CRT-D
Year
1
2
3
4
5
0
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Survival by Year Trial Comparison
Saxon LA, Hayes DL, Day JD, et al. Heart Rhythm
2009 Abstract
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Wireless Monitoring
Concepts in Design
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Managing Multiple Co-Morbidities is Challenging
Syncope
Sleep Apnea
Blood Pressure

• Long- term monitoring is positioned to provide
  information in the management of multiple
  diseases that have are related to CVD

SCD Risk Stratification
Atrial Fibrillation
Heart Failure
1.5 to 5mm Patients WW
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Can We Prevent HF Decompensation with CRT by
Treating Early?
New Data
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• 1,800 patients
• 110 centers in 14 countries
• Worlds largest, randomized CRT-D trial
• PI Art Moss, MD (U. Rochester)
• Inclusion
• NYHA class I/II
• EF lt 30
• QRS gt 130ms
• high risk, asymptomatic or mildly symptomatic
  patients
• Testing hypothesis if early intervention with
  bi-v pacing improves survival and HF progression

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• June 23rd, 2009 MADIT CRT Trial met primary
  endpoint
• Boston Sci CRT-Ds associated w/ 29 reduction
  (p0.003) in death or HF interventions when
  compared to traditional ICDs
• The end-game
• 70 of all HF patients in US are class I/II
• 5.5 mil Americans suffer from HF
• This data from MADIT CRT is very applicable to
  the way I will treat my patients going forward
• We will await trial publication and CMS
  indications

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Review
CRT Guidelines
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CRT Guideline Summary

• ACC/AHA/HRS Guidelines for CRT
• Class I (HF III/IV EF lt 35)
• SR, QRS gt 120ms
• Class IIa (HF III/IV EF lt 35)
• Atrial Fibrillation (QRS gt 120ms)
• Normal QRS w/ frequent RV pacing
• Class IIb (HF I/II EF lt 35)
• Patients undergoing implantation of PPM
• or ICD w/ frequent RV pacing

JACC, 5/27/08. Vol 51 21. 2085
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Final Points

• New Technology is available to help us manage
  existing dilemmas with implantable device therapy
  
• Advanced lead/device technology
• New device algorithms and programming options are
  available to help us deal with CRT non-responders
• ICD/CRT-D patient survival is excellent
• The benefit of ICD therapy continues to improve
  with time
• Use of new monitoring tool has the ability to
  enhance patient outcomes

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Questions?

• Paul Ludmer, M.D., FACC
• Cardiovascular Consultants Medical Group