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© 2010 Boston Scientific. All rights reserved. CRM6-4403-0810 Early CRT Intervention Reduces Death and Heart Failure Events : Updated Insight from MADIT-CRT.

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Presentation on theme: "© 2010 Boston Scientific. All rights reserved. CRM6-4403-0810 Early CRT Intervention Reduces Death and Heart Failure Events : Updated Insight from MADIT-CRT."— Presentation transcript:

1 © 2010 Boston Scientific. All rights reserved. CRM Early CRT Intervention Reduces Death and Heart Failure Events : Updated Insight from MADIT-CRT Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy

2 CRM © 2010 Boston Scientific. All rights reserved. 2Disclaimer Boston Scientific Education and Presentation Resources Boston Scientific Education and Presentation Resources Boston Scientific develops, manufactures and markets a broad array of products and services that enable less-invasive care for some of the most threatening cardiac conditions. Its prescription devices for use by healthcare professionals are regulated by government agencies in each of the countries in which it does business, such as the Food and Drug Administration in the United States (U.S.) or the Ministry of Health in Japan. These regulations often restrict the use of the information that can be disclosed to the public. If the format of the material presented is altered, the appropriate indications, contraindications, precautions, warnings and adverse events should be included. Boston Scientific develops, manufactures and markets a broad array of products and services that enable less-invasive care for some of the most threatening cardiac conditions. Its prescription devices for use by healthcare professionals are regulated by government agencies in each of the countries in which it does business, such as the Food and Drug Administration in the United States (U.S.) or the Ministry of Health in Japan. These regulations often restrict the use of the information that can be disclosed to the public. If the format of the material presented is altered, the appropriate indications, contraindications, precautions, warnings and adverse events should be included. This Presentation has been developed as a service of Boston Scientific. Like any other service, in spite of our best efforts the information in this Presentation may become out of date over time. Nothing on this Presentation should be construed as the giving of advice or the making of a recommendation and it should not be relied on as the basis for any decision or action. The materials on this Web Site are intended for educational purposes only. Boston Scientific accepts no liability for the accuracy or completeness or use of, nor any liability to update, the information contained on this Presentation. These materials are provided "AS IS" WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT. Some jurisdictions do not allow the exclusion of implied warranties, so the above exclusion may not apply to you. This Presentation has been developed as a service of Boston Scientific. Like any other service, in spite of our best efforts the information in this Presentation may become out of date over time. Nothing on this Presentation should be construed as the giving of advice or the making of a recommendation and it should not be relied on as the basis for any decision or action. The materials on this Web Site are intended for educational purposes only. Boston Scientific accepts no liability for the accuracy or completeness or use of, nor any liability to update, the information contained on this Presentation. These materials are provided "AS IS" WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT. Some jurisdictions do not allow the exclusion of implied warranties, so the above exclusion may not apply to you. Copyright and Intellectual Property Copyright and Intellectual Property Boston Scientific hereby authorizes you to copy materials published by it on the Cardiac Rhythm Resources Web Site for non commercial use only, provided any copy of these materials which you make shall retain all copyright and other proprietary notices and any disclaimer contained thereon and on this Web Site. Boston Scientific hereby authorizes you to copy materials published by it on the Cardiac Rhythm Resources Web Site for non commercial use only, provided any copy of these materials which you make shall retain all copyright and other proprietary notices and any disclaimer contained thereon and on this Web Site. Nothing contained herein shall be construed as conferring by implication or otherwise any license or right under any patent or trademark of Boston Scientific or any third party. Except as expressly provided above, nothing contained herein shall be construed as conferring any license or right under any Boston Scientific copyright. Nothing contained herein shall be construed as conferring by implication or otherwise any license or right under any patent or trademark of Boston Scientific or any third party. Except as expressly provided above, nothing contained herein shall be construed as conferring any license or right under any Boston Scientific copyright..

3 CRM © 2010 Boston Scientific. All rights reserved. 3 MADIT-II Building to the Next Question: ICD therapy in patients with chronic ischemic heart disease improved survival but were the same patients with increased risk of heart failure (HF) events. 1 ICD therapy in patients with chronic ischemic heart disease improved survival but were the same patients with increased risk of heart failure (HF) events. 1 MADIT-II: Easier to Qualify for SCD Protection Size: 1218 U.S. patients Endpoint: All-cause mortality (patient follow-up = 20 months) Published: NEJM 2002 Reduction in the risk of death in heart attack survivors with ICDs, when compared to conventional medical therapy (CMT) alone (p = 0.016). 31% *Compared to CMT alone. Goldenberg I, et al. Presented 5/14/2009, HRS session.html. 1. Goldenberg I, et al. Circulation, June

4 CRM © 2010 Boston Scientific. All rights reserved. 4 SCD-HeFT Building to the Next Question: ICD therapy saved NYHA Class II/III patients’ lives from tachyarrhythmias – but a major cause of mortality remained: heart failure (31% of deaths, evenly distributed among treatment arms). 1 ICD therapy saved NYHA Class II/III patients’ lives from tachyarrhythmias – but a major cause of mortality remained: heart failure (31% of deaths, evenly distributed among treatment arms). 1 SCD-HeFT: Preventing SCD in Heart Failure Patients Size: 2521 patients in North America and New Zealand Endpoint: All-cause mortality Published: NEJM Packer DL, Bernstein R, Wood F, et al. Impact of Amiodarone versus implantable cardioverter defibrillator therapy on the mode of death in congestive heart failure patients in the SCD-HeFT trial. Heart Rhythm. 2005;2:S38. Abstract AB20-2. Reduction in the risk of all-cause mortality when using an ICD, in combination with conventional drug therapy (CDT), when compared to CDT alone ( p = 0.007) 23%

5 CRM © 2010 Boston Scientific. All rights reserved. 5 COMPANION Building to the Next Question: CRT-Ds save lives in NYHA Class III/IV HF patients, but pump failure was the most common cause of death (44.4%). 1 CRT-Ds save lives in NYHA Class III/IV HF patients, but pump failure was the most common cause of death (44.4%). 1 70% of HF patients are in NYHA Class I/II. 2 There is a need to slow their progression to symptomatic heart failure. 70% of HF patients are in NYHA Class I/II. 2 There is a need to slow their progression to symptomatic heart failure. COMPANION: Providing New Access to CRT Size: 1520 U.S. patients Endpoint: All-cause mortality or first hospitalization Published: NEJM 2004 Reduction in the risk of all-cause mortality or first hospitalization with CRT-D, in combination with OPT, compared to OPT alone (p = 0.011) 20% 1.Carson P, et al, JACC, 2005 Dec 20; 46(12): O'Connell JB, Bristow MR. Economic impact of heart failure in the United States: time for a different approach. J Heart Lung Transplant Jul- Aug;13(4):S

6 CRM © 2010 Boston Scientific. All rights reserved. 6 Key Learning MADIT II COMPANION SCD-HeFT Ability to save lives from sudden cardiac death… …heart failure remains an issue Bottom Line Bottom Line:

7 © 2010 Boston Scientific. All rights reserved. CRM Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT)

8 CRM © 2010 Boston Scientific. All rights reserved. 8Introduction Heart failure remains a significant health concern; a heart failure event is associated with a five-fold increase in mortality in 5 years. Heart failure remains a significant health concern; a heart failure event is associated with a five-fold increase in mortality in 5 years. Cardiac resynchronization therapy with defibrillation (CRT-D) has been demonstrated to reduce mortality and hospitalizations, improve symptoms, and increase exercise capacity. Cardiac resynchronization therapy with defibrillation (CRT-D) has been demonstrated to reduce mortality and hospitalizations, improve symptoms, and increase exercise capacity. Prior to MADIT-CRT, Boston Scientific CRT-Ds were indicated by FDA for the treatment of patients with the following conditions: Prior to MADIT-CRT, Boston Scientific CRT-Ds were indicated by FDA for the treatment of patients with the following conditions: – Moderate to severe heart failure (NYHA Class III/IV) despite optimal pharmacological therapy – Reduced systolic function (LVEF  35%) – Wide QRS (QRS duration ≥ 120 ms)

9 CRM © 2010 Boston Scientific. All rights reserved. 9 Rationale for Undertaking MADIT-CRT Currently, patients with severe left ventricular systolic dysfunction, a wide QRS complex, and asymptomatic or mildly symptomatic heart failure are indicated for prophylactic ICD therapy without CRT Currently, patients with severe left ventricular systolic dysfunction, a wide QRS complex, and asymptomatic or mildly symptomatic heart failure are indicated for prophylactic ICD therapy without CRT Although ICD therapy is effective for the prevention of sudden cardiac arrest, it does not slow the progression of heart failure Although ICD therapy is effective for the prevention of sudden cardiac arrest, it does not slow the progression of heart failure However, progression of heart failure in these patients is associated with increased mortality and diminished quality of life Retrospective studies of CRT-D in NYHA Class I/II patients reported improvement in echocardiographic variables, suggesting a potential role for CRT-D earlier in the disease process Retrospective studies of CRT-D in NYHA Class I/II patients reported improvement in echocardiographic variables, suggesting a potential role for CRT-D earlier in the disease process Accordingly, MADIT-CRT was undertaken to determine if early intervention with CRT-D in patients with asymptomatic or mild heart failure could reduce death and heart failure events Accordingly, MADIT-CRT was undertaken to determine if early intervention with CRT-D in patients with asymptomatic or mild heart failure could reduce death and heart failure events Higgins et al, JACC (2001) Abraham et al, Circulation (2004)

10 CRM © 2010 Boston Scientific. All rights reserved. 10 MADIT-CRT Primary/Secondary Effectiveness Hypotheses Primary: It was hypothesized that CRT-D would reduce the risk of the combined endpoint of all-cause mortality or heart failure event, whichever came first, when compared with ICD in patients with asymptomatic or mildly symptomatic heart failure with left ventricular dysfunction and wide QRS Primary: It was hypothesized that CRT-D would reduce the risk of the combined endpoint of all-cause mortality or heart failure event, whichever came first, when compared with ICD in patients with asymptomatic or mildly symptomatic heart failure with left ventricular dysfunction and wide QRS A heart failure event was defined as a patient having signs and symptoms of heart failure, with either: A heart failure event was defined as a patient having signs and symptoms of heart failure, with either: – Intravenous decongestive therapy in an outpatient setting, or – Augmented intravenous or oral decongestive therapy during in-hospital stay Secondary: Evaluate the effects of CRT-D, relative to ICD, on the patient-specific rates of recurrent heart failure events over the full study period Secondary: Evaluate the effects of CRT-D, relative to ICD, on the patient-specific rates of recurrent heart failure events over the full study period

11 CRM © 2010 Boston Scientific. All rights reserved. 11 Study Design Designed to detect a 25% reduction in the risk of the primary end point Designed to detect a 25% reduction in the risk of the primary end point – Wang-Tsiatis group-sequential design – 95% power at a two-sided significance level of 5% – Sample size requirement of 1820 patients Randomized controlled trial Randomized controlled trial – Randomization on a 3:2 basis to CRT-D/ICD – Stratified by ischemic status and clinical center Data analyzed on an intention-to-treat basis Data analyzed on an intention-to-treat basis

12 CRM © 2010 Boston Scientific. All rights reserved. 12 Main Inclusion Criteria Ischemic heart disease (NYHA Class I or II) or non-ischemic heart disease (NYHA Class II) for at least three months prior to entry Ischemic heart disease (NYHA Class I or II) or non-ischemic heart disease (NYHA Class II) for at least three months prior to entry Optimal pharmacologic therapy Optimal pharmacologic therapy – Beta blockers, ACE/ARB, and statins (ischemic patients) unless not tolerated or contraindicated Left ventricular ejection fraction ≤ 30% Left ventricular ejection fraction ≤ 30% QRS duration ≥ 130 ms QRS duration ≥ 130 ms Sinus rhythm Sinus rhythm

13 CRM © 2010 Boston Scientific. All rights reserved. 13 Main Exclusion Criteria Currently implanted pacemaker, ICD, or CRT device Currently implanted pacemaker, ICD, or CRT device Current indication for CRT Current indication for CRT Atrial fibrillation within one month of entry Atrial fibrillation within one month of entry NYHA Class III/IV within three months of entry NYHA Class III/IV within three months of entry CABG, PCI, or MI within three months of entry CABG, PCI, or MI within three months of entry

14 CRM © 2010 Boston Scientific. All rights reserved. 14 MADIT-CRT: Methods Led by Dr. Arthur J. Moss Led by Dr. Arthur J. Moss Largest randomized NYHA Class I/II CRT-D trial to date Largest randomized NYHA Class I/II CRT-D trial to date Enrollment Enrollment – 1820 patients, 110 centers, 14 countries Average follow-up Average follow-up – 34.3 months Commercially available devices provided by Boston Scientific were used Commercially available devices provided by Boston Scientific were used Moss AJ, et al. N Engl J Med. 2009;361: Baseline Evaluation To document inclusion/exclusion criteria and establish baseline heart status a Randomization (3:2 CRT-D:ICD) Stratified by center and ischemic status Clinic Follow-up Visits 1 month post-enrollment/randomization, 3 months post- randomization, and quarterly thereafter to a common study closure date b CRT-D + OPT (1089 patients) ICD + OPT (731 patients) a Baseline evaluation includes history and physical exam, electrocardiogram, and echocardiogram. Patients are randomized and then baseline testing is completed including BNP (US only), quality-of-life assessment, 6-minute walk test, and Holter monitor recording (CRT-D patients only). b The 12-month follow-up visit includes echocardiogram, BNP (US only), 6-minute walk test, Holter monitor recording (CRT-D patients only), and device interrogation. Other follow-up visits include history and physical exam, clinical events, and device interrogation. Quality-of- life assessments were conducted at 6-month intervals.

15 CRM © 2010 Boston Scientific. All rights reserved. 15 Study Milestones Primary endpoint was met on June 22, 2009 Primary endpoint was met on June 22, 2009 Results were published online on Sep. 1, 2009, in the NEJM and presented as a late-breaker at ESC Results were published online on Sep. 1, 2009, in the NEJM and presented as a late-breaker at ESC Published in print in the NEJM on Oct. 1, 2009 Published in print in the NEJM on Oct. 1, 2009 PMA submitted to the FDA in December 2009 PMA submitted to the FDA in December 2009 FDA requested updated results through Dec. 31, 2009 FDA requested updated results through Dec. 31, 2009 FDA panel took place on Mar. 18, 2010, and there was unanimous recommendation for approval of the expanded CRT-D indication for the MADIT-CRT left bundle branch block (LBBB) sub-population FDA panel took place on Mar. 18, 2010, and there was unanimous recommendation for approval of the expanded CRT-D indication for the MADIT-CRT left bundle branch block (LBBB) sub-population

16 CRM © 2010 Boston Scientific. All rights reserved. 16 Previously Published and Updated Results MADIT-CRT met its endpoint in June 2009 and results were published in the September 2009 NEJM online addition. Results showed that CRT-D was associated with a 34% reduction in the relative risk of the primary endpoint Primary effectiveness endpoint achieved The FDA requested to see additional 6 months of data analyzed (through December 2009) It was subsequently discovered and validated that in the LBBB subgroup, patients received substantial benefit from CRT-D. Non-LBBB patients did not show evidence of benefit. The LBBB sub-group made up approximately 70% of the total MADIT-CRT population. N Engl J Med Oct 1;361(14): Epub 2009 Sep 1. Cardiac-resynchronization therapy for the prevention of heart-failure events. Moss AJ, Hall WJ, Cannom DS, Klein H, Brown MW, Daubert JP, Estes NA 3rd, Foster E, Greenberg H, Higgins SL, Pfeffer MA, Solomon SD, Wilber D, Zareba W; MADIT-CRT Trial Investigators. 34% 57%

17 CRM © 2010 Boston Scientific. All rights reserved. 17 Consistent Results with LBBB across Subgroups

18 CRM © 2010 Boston Scientific. All rights reserved. 18 LBBB Sub-population Baseline Demographics

19 CRM © 2010 Boston Scientific. All rights reserved. 19 Exploratory Analysis - Hypothesis Generating Only: LBBB Echocardiographic Outcomes CRT therapy was ON during echocardiographic measurements and may have influenced the results.

20 © 2010 Boston Scientific. All rights reserved. CRM Results In asymptomatic or mild heart failure, patients with wide QRS, LV dysfunction, and LBBB on stable optimal heart failure pharmacologic therapy, CRT-D, as compared to ICD, was significantly associated with: – An acceptable safety profile – Primary endpoint showed: 57% reduction (p < 0.001) in the risk of a composite of all- cause mortality or heart failure events. This was driven by: 35% reduction (p = 0.048) in the risk of all-cause mortality, and a 63% reduction (p < 0.001) in the risk of heart failure events – Secondary endpoint showed: 43% reduction (p = 0.001) in the risk of recurrent heart failure events

21 © 2010 Boston Scientific. All rights reserved. CRM New Boston Scientific CRT-D Indication Boston Scientific Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications: – Moderate to severe heart failure (NYHA Class III/IV) with EF ≤ 35% and QRS duration ≥ 120 ms – Left bundle branch block with QRS ≥ 130 ms, EF ≤ 30% and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure

22 CRM © 2010 Boston Scientific. All rights reserved. 22 Identification of patients In order to successfully identify NYHA Class I and II heart failure patients most likely to benefit from CRT-D therapy, begin with an ECG analysis to screen for LBBB and a wide QRS In order to successfully identify NYHA Class I and II heart failure patients most likely to benefit from CRT-D therapy, begin with an ECG analysis to screen for LBBB and a wide QRS How many NYHA Class I and II patients do you see in a week? How many NYHA Class I and II patients do you see in a week? How many of those have LBBB and a wide QRS? How many of those have LBBB and a wide QRS?

23 © 2010 Boston Scientific. All rights reserved. CRM Thank you Questions?

24 CRM © 2010 Boston Scientific. All rights reserved. 24 Indications and Usage Boston Scientific Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications: Moderate to severe heart failure (NYHA Class III-IV) with EF ≤ 35% and QRS duration ≥ 120 ms Left bundle branch block (LBBB) with QRS ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure CONTAK RENEWAL® 3 CRT-Ds Indications and Usage: Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure (NYHA III/IV) who remain symptomatic despite stable, optimal heart failure drug therapy, and have left ventricular dysfunction (EF  35%) and QRS duration  120 ms. Contraindications There are no contraindications for this device. Warnings Read the product labeling thoroughly before implanting the pulse generator to avoid damage to the system. Such damage can result in patient injury or death. Program the pulse generator Tachy Mode to Off during implant, explant or postmortem procedures to avoid inadvertent high voltage shocks. Always have sterile external and internal defibrillator protection available during implant. If not terminated in a timely fashion, an induced tachyarrhythmia can result in the patient's death. Ensure that an external defibrillator and medical personnel skilled in CPR are present during post-implant device testing should the patient require external rescue. Advise patients to seek medical guidance before entering environments that could adversely affect the operation of the active implantable medical device, including areas protected by a warning notice that prevents entry by patients who have a pulse generator. Do not expose a patient to MRI device scanning. Strong magnetic fields may damage the device and cause injury to the patient. Do not subject a patient with an implanted pulse generator to diathermy since diathermy may cause fibrillation, burning of the myocardium, and irreversible damage to the pulse generator because of induced currents. Do not use atrial-tracking modes in patients with chronic refractory atrial tachyarrhythmias. Tracking of atrial arrhythmias could result in VT or VF. Do not use atrial-only modes in patients with heart failure because such modes do not provide CRT. LV lead dislodgment to a position near the atria can result in atrial oversensing and LV pacing inhibition. Physicians should use medical discretion when implanting this device in patients who present with slow VT. Programming therapy for slow monomorphic VT may preclude CRT delivery at faster rates if these rates are in the tachyarrhythmia zones. Do not kink leads. Kinking leads may cause additional stress on the leads, possibly resulting in lead fracture. Do not use defibrillation patch leads with the CRT-D system, or injury to the patient may occur. Do not use this pulse generator with another pulse generator. This combination could cause pulse generator interaction resulting in patient injury or lack of therapy delivery. For specific models, when using a subpectoral implantation, place the pulse generator with the serial number facing away from the ribs. Implanting the pulse generator subpectorally with the serial number facing the ribs may cause repetitive mechanical stress to a specific area of the titanium case, potentially leading to a component failure and device malfunction. Precautions For information on precautions, refer to the following sections of the product labeling: clinical considerations; sterilization, storage and handling; implant and device programming; follow-up testing; explant and disposal; environmental and medical therapy hazards; hospital and medical environments; home and occupational environments. Advise patients to avoid sources of electromagnetic interference (EMI) because EMI may cause the pulse generator to deliver inappropriate therapy or inhibit appropriate therapy. Potential Adverse Events Potential adverse events from implantation of the CRT-D system include, but are not limited to, the following: allergic/physical/physiologic reaction, death, erosion/migration, fibrillation or other arrhythmias, lead or accessory breakage (fracture/insulation/lead tip), hematoma/seroma, inappropriate or inability to provide therapy (shocks/pacing/sensing), infection, procedure related, and component failure. Patients may develop psychological intolerance to a pulse generator system and may experience fear of shocking, fear of device failure, or imagined shocking. In rare cases severe complications or device failures can occur. Refer to the product labeling for specific indications, contraindications, warnings/precautions and adverse events. Rx only. (Rev. M) CRT-D Systems from Boston Scientific CRM

25 CRM © 2010 Boston Scientific. All rights reserved. 25 ICD Systems from Boston Scientific CRM ICD Indications and Usage ICDs are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. ICDs with atrial therapies are also intended to provide atrial antitachycardia pacing and atrial defibrillation treatment in patients who have or are at risk of developing atrial tachyarrhythmias. Contraindications Use of ICD systems are contraindicated in: Patients whose ventricular tachyarrhythmias may have reversible cause, such as 1) digitalis intoxication, 2) electrolyte imbalance, 3) hypoxia, or 4) sepsis, or whose ventricular tachyarrhythmias have a transient cause, such as 1) acute myocardial infarction, 2) electrocution, or 3) drowning. Patients who have a unipolar pacemaker. Warnings Read the product labeling thoroughly before implanting the pulse generator to avoid damage to the ICD system. Such damage can result in patient injury or death. Program the pulse generator ventricular Tachy Mode to Off during implant, explant or post-mortem procedures to avoid inadvertent high voltage shocks. Always have sterile external and internal defibrillator protection available during implant. If not terminated in a timely fashion, an induced tachyarrhythmia can result in the patient’s death. Ensure that an external defibrillator and medical personnel skilled in cardiopulmonary resuscitation (CPR) are present during post-implant device testing should the patient require external rescue. Patients should seek medical guidance before entering environments that could adversely affect the operation of the active implantable medical device, including areas protected by a warning notice that prevents entry by patients who have a pulse generator. Do not expose a patient to MRI device scanning. Strong magnetic fields may damage the device and cause injury to the patient. Do not subject a patient with an implanted pulse generator to diathermy since diathermy may cause fibrillation, burning of the myocardium, and irreversible damage to the pulse generator because of induced currents. Do not use atrial tracking modes (or an AVT device) in patients with chronic refractory atrial tachyarrhythmias. Tracking of atrial arrhythmias could result in VT or VF. (Applies to dual-chamber devices only.) Do not use this pulse generator with another pulse generator. This combination could cause pulse generator interaction resulting in patient injury or lack of therapy delivery. Do not kink leads. Kinking leads may cause additional stress on the leads, possibly resulting in lead fracture. For specific models, when using a subpectoral implantation, place the pulse generator with the serial number facing away from the ribs. Implanting the pulse generator subpectorally with the serial number facing the ribs may cause repetitive mechanical stress to a specific area of the titanium case, potentially leading to a component failure and device malfunction. Precautions For information on precautions, refer to the following sections of the product labeling: clinical considerations; sterilization, storage and handling; implantation and device programming; follow-up testing; explant and disposal; environmental and medical therapy hazards; home and occupational environments. Advise patients to avoid sources of electromagnetic interference (EMI) because EMI may cause the pulse generator to deliver inappropriate therapy or inhibit appropriate therapy. Potential Adverse Events Potential adverse events from implantation of the ICD system include, but are not limited to, the following: allergic/physical/physiologic reaction, death, erosion/migration, fibrillation or other arrhythmias, lead or accessory breakage (fracture/insulation/lead tip), hematoma/seroma, inappropriate or inability to provide therapy (shocks/pacing/sensing), infection, procedure related, psychologic intolerance to an ICD system - patients susceptible to frequent shocks despite antiarrhythmic medical management/imagined shocking, and component failure. In rare cases severe complications or device failures can occur. Refer to the product labeling for specific indications, contraindications, warnings/ precautions and adverse events. Rx only. (Rev. M)

26 CRM © 2010 Boston Scientific. All rights reserved. 26 Back up slide

27 CRM © 2010 Boston Scientific. All rights reserved. 27 COMPANION Size: 1520 U.S. patients Endpoint: All-cause mortality or first hospitalization Published: NEJM 2004 Reduction in the risk of all-cause mortality when using a CRT-D, in combination with OPT, when compared to OPT alone (p value:0.004) 1 36% Clinical Question Does CRT therapy, used in combination with optimal pharmacologic therapy (OPT), significantly improve the quality and duration of life for patients with late- stage symptomatic heart failure versus using OPT alone? 1 COMPANION: Providing New Access to CRT Therapies 1 Bristow MR, et al, NEJM, 2004 ; 350 (21):


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