Chấp nhận dùng máy phá rung tự động ảnh hưởng từ cá ca dùng ICD có hiệu quả

ICD Therapy Presents Patient Identification, Clinical and Economic Challenges • Patients with Ventricular Tachycardia VT/Ventricular Fibrillation VF are at risk of sudden cardiac death

Aditya Vaidya

BS Electrical Engineering

M Eng Management IBHRE Certified

ICD Therapy Presents Patient Identification,

Clinical and Economic Challenges

• Patients with Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) are at risk of sudden cardiac death (SCD)

• ICD is the most successful therapy to prevent SCD 1

• Many patients without symptoms die from SCD if not rescued timely

• Some patients often face accessibility to care and economic challenges 2,3

1 http://www.hrsonline.org/PatientInfo/Treatments/ICD/icd_faqs.cfm

2 Lyne J Inappropriate ICD shocks – challenges and advances Arrhythmiawatch Published online September 28, 2011

3 Boriani G, Biffi M, Martignani C, et al Expenditure and value for money: the challenge of implantable cardioverter defibrillators QJM May 2009;102(5):349-356

Challenges in Patient

Selection:

Access to Appropriate

Diagnostic Tools

Automatic detection added

Longevity and ECG memory increased (to

3 yrs., 49.5 minutes), with episode logs, ICD sensing technology, MRI labeling, and remote monitoring added

AF detection and long-term trended diagnostics (the Cardiac Compass and AF

Summary Reports) added Reveal is developed to help diagnose

unexplained syncope

ScreenLink Medtronic ScreenLink is an evidence-based app designed to facilitate screening of patients qualifying for ICD and/or CRT therapies

Sprint Quattro ® Family of Defibrillation Leads

Sprint Quattro Secure ® S

Model 6935 Active Fixation, Single Coil

Sprint Quattro

Model 6944 Passive Fixation, Dual Coil

Sprint Quattro Secure

Model 6947 Active Fixation, Dual Coil

The Standard for Exceptional Performance

Backed by the Most Comprehensive Performance Monitoring System in the Industry1

1 Sweeney MO, et al J Cardiovasc Electrophysiol 2001;12:402-410

Sprint Quattro Family of Leads

1 Medtronic Product Performance Report,

2011 First Edition, Issue 64

2 St Jude Medical Product Performance

Report, April 2011

3 Boston Scientific Product Performance

Report 2011, Q3 Summary Edition

4 Borleffs CJ, van Erven L, van Bommel

RJ, et al Circ Arrhythm Electrophysiol

2009;2:411-416

The Standard for Performance 1

survival rate at 9 years when measured by this active

1 Medtronic PPR 2012 2nd edition – 6947 Sprint Quattro Secure lead

1 yr 99.5 2364

%

#

2 yr 99.2 1675

3 yr 98.9 963

4 yr 98.6 733

5 yr 98.1 579

6 yr 97.7 425

7 yr 97.2 280

8 yr 96.7 152

9 yr 96.0 53

90

100

80

10 9

8 7

6 5

4 3

2 1

0

6947 Sprint Quattro Secure

DEVICE SURVIVAL PROBABILITY

Medtronic DF4 Connector and Lead System

Designed for Simplicity, Engineered

for Reliability Tested for Safety 1

Lead Pin

• additional visual confirmation

1 Tekmen, Mohac “Worldwide Sales Memo 2012.” Medtronic DF4 system is designed to perform beyond the 1.5x safety factor for electrical isolation defined in ISO 27186 Medtronic data on file January 26, 2012

2 Himes, Adam “Worldwide Sales Memo 2012.” The new DF4 lead has over 58% reduction in lead connector volume Medtronic data on file

January 26, 2012

3 Medtronic Product Performance Report, 2011 First Edition, Issue 64

Device

• Smoother contouring

Evolution of Device Shape

Evera® XT DR 34cc

Benefits of PhysioCurve ® Shape

Potential benefits of this fully tapered design include 2-7 :

• Enhanced patient comfort

• Improved cosmetic appearance at the

implant site

• Minimal pocket preparation for replacement

procedures

• Designed with lead wrap in mind: landing area to

minimise additional stress on the lead 8

Reduces overall skin pressure by

30% versus non-contoured devices

while maintaining a 35 J output 1

1 Flo, Daniel IS4/DF4 Device Shape Analysis January 2013 Medtronic data on file

2 Gold MR, et al J Am Coll Cardiol 1996;28:1278-1282

3 Kolker AR, et al Ann Plast Surg 2007;59:26-29

4 Kadish A, et al Circulation 2005;111:3327-3335

5 Sowell LV, et al J Womens Health (Larchmt) 2006;15:830-835

6 Ceelen KK, et al J Biomech 2008;41:3399-3404

7 Shapiro M, et al Indian Pacing Electrophysiol J 2004;4:213-216

8 Medtronic data on file October 30, 2009

Up to 25% Greater Longevity*

1 Medtronic Evera XT and Protecta XT Manuals

*As compared to Protecta XT DR

Evera ® XT’s Longevity increase is

due to 1 :

• Increased battery capacity

and reduced current drain

Why Avoiding Shocks is Important

To Reduce Pain and

Anxiety and Increase Device Acceptance 1

To Reduce Healthcare Burden and Improve Patient Quality of Life 1

Avoiding Shocks May Improve Survival/Heart Failure 2

1 Wathen MS,, et al, for the PainFREE Rx II Investigators Circulation 2004;110:2591-2596

2 Sweeney MO, et al Differences in effects of electrical therapy type on health care utilization in the MVP ICD Trial HRS, 2010

With SmartShock Technology, 98% of Patients Are Free of Inappropriate Shocks at 1 Year 1

1 Volosin KJ, et al J Cardiovasc Electrophysiol 2011;22:280-289

SmartShock ™ Technology Includes Six Exclusive Algorithms that Discriminate True Lethal Arrhythmias from Other Arrhythmic

and Nonarrhythmic Events 1,2

1 Heintze J, Schloss E, Auricchio A, Zeng C, Sterns L No compromise in VT/VF detection with novel tachyarrhythmia discrimination features in implantable cardioverter defibrillators

2 Wilkoff BL Current topics in ICD Primary Prevention December 28, 2006

3 Volosin KJ, et al J Cardiovasc Electrophysiol 2010;22:280-289

4 Poole JE, et al N Engl J Med 2008;359:1009-1017

See Protecta XT CRT-D, DR, and VR Clinician Manuals for technical details

Protecta ™ XT Predicted Performance 3,4

At nominal settings (SmartShock Technology, ATP During Charging™, NID 18/24)

PR Logic does not apply to the VR devices

Anti-Tachycardia Pacing Improves Quality of Life

• A study concluded that shocked Ventricular Arrythmia (VA) episodes are associated with mortality risk Shocked patients have substantially higher

VA episode burden and poorer survival compared with ATP-only-treated patients 1

• A quality of life meta-analysis study found that activation of

anti-tachycardia pacing should be performed in every ICD patient in order to minimize painful shocks and consequent deterioration of quality of life 2

1 Sweeney MO, et al Heart Rhythm 2010;7:353-360

2 Francis J, et al Indian Pacing Electrophysiol J 2006;1:173-181

SmartShock ® 2.0 Evidence

• In Primary Prevention Patients

– PREPARE showed a 63% reduction in shocks for patients

programmed with strategically chosen programming, including a NID of 30/40, as compared to historical trials 1

• In Secondary Prevention Patients

– ADVANCE III showed a 37% reduction of shock and ATP

therapies for patients programmed to 30/40 as compared to

18/24 with no difference in syncopal events 3

1 Wilkoff BL, et al J Am Coll Cardiol 2008;52:541-550

2 Sweeney MO, et al Circulation 2005;111:2898-2905

3 Gasparini M, et al Late Breaking Trial Session 1-4, HRS 2012

Reducing shocks for both primary and secondary patients is important 1,2

OMNI 3,000 patients

PainFREE SST

Medtronic Exclusive Technology:

Industry-Leading AT/AF Solutions

Challenges in Patient Therapy:

Longevity

Studies Confirm that Medtronic Defibrillation Devices Last Longer 1-5

1 Knops P, et al PACE 2009;32:1276-1285

2 Schaer BA, et al Heart Rhythm 2009;6:1737-1743

3 Biffi M, et al Europace 2008;10:1288-1295

4 Kallinen L, et al 2009 http://spo.escardio.org/eslides/view.aspx?eevtid=33&id=1913

US Experience 4 Kaplan-Meier curve for event-free survival of ICDs replaced because of battery depletion for the manufacturers 5

5 Joep Thijssen, MD, et al Leiden University Medical Center, Leiden, The Netherlands Available online 15 November 2011;pg 5

Challenges in Patient Care:

Device Diagnostic Data

OptiVol ® Fluid Status Monitoring

Volume overload is a major

complication for patients with

moderate-to-severe HF and is a frequent cause of

the “revolving door” of hospital

admissions and discharges 1

OptiVol Fluid Status Monitoring provides

unique insight into thoracic fluid buildup

for more informed patient care 2

Combined diagnostics including OptiVol

Fluid Status Monitoring identified

patients at 5.5 times increased risk for

HF hospitalization 3

1 Sackner-Bernstein J What is heart failure and what are the treatment options? Complex questions In: Hayes DL, Wang PJ, Sackner-Bernstein J, Asirvatham SJ, eds

Resynchronization and Defibrillation for Heart Failure: A Practical Approach Oxford, England: Blackwell Publishing; 2004:1-2

2 Medtronic Consulta®, Concerto®, and InSync Sentry® CRT-Ds and Secura® and Virtuoso® DR/VR ICDs System Reference Guides

3 Whellan DJ, Ousdigian KT, AL-Khatib SM, et al, for the PARTNERS Study Investigators Combined heart failure device diagnostics identify patients at higher risk of subsequent heart failure hospitalizations: results from PARTNERS HF (Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure) study J Am Coll Cardiol 2010; 55(17):1803-1810

Cardiac Compass ® Trends

and Heart Failure Management Report

Patient information can be entered in the patient

information screen prior to implant, and that data is

automatically populated to TherapyGuide

Explains parameter suggestions based

on results of clinical studies and common best practices

Provides parameter suggestions based on

a patient’s condition and status

Ask The ICD

Select the right therapy for the patient

Implant reliable leads with good

defibrillation threshold

Reduce inappropriate shocks

Patient Alerts and Device Diagnostic Data

Thank You

The Medtronic Mission

Alleviate pain, Restore health, and Extend life