© 2010 boston scientific. all rights reserved. crm6-4403-0810 early crt intervention reduces death...

© 2010 Boston Scientific. All rights reserved. CRM6-4403-0810

Early CRT Intervention Reduces Death and Heart Early CRT Intervention Reduces Death and Heart Failure Events : Failure Events :

Updated Insight from MADIT-CRTUpdated Insight from MADIT-CRT

Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization TherapyMulticenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy

22CRM6-4403-0810© 2010 Boston Scientific. All rights reserved.

DisclaimerDisclaimer• Boston Scientific Education and Presentation ResourcesBoston 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 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 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 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 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.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 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 Like any other service, in spite of our best efforts the information in this Presentation may become out of date over time.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 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 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 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, 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 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.NON-INFRINGEMENT. Some jurisdictions do not allow the exclusion of implied warranties, so the above exclusion may not apply to you.

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MADIT-II

Building to the Next QuestionBuilding to the Next Question: : • ICD therapy in patients with chronic ischemic ICD therapy in patients with chronic ischemic

heart disease improved survival but were the same heart disease improved survival but were the same patients with increased risk of heart failure (HF) events.patients with increased risk of heart failure (HF) events.11

MADIT-II: Easier to Qualify for SCD ProtectionMADIT-II: Easier to Qualify for SCD ProtectionMADIT-II: Easier to Qualify for SCD ProtectionMADIT-II: Easier to Qualify for SCD Protection

Size: 1218 U.S. patientsSize: 1218 U.S. patients

Endpoint: All-cause mortality Endpoint: All-cause mortality (patient follow-up = 20 months)(patient follow-up = 20 months)

Published: NEJM 2002Published: NEJM 2002

Reduction in the risk of deathin 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 2009. http://www.heartrhythmondemand.org/webcasts/heartrhythm2009/sessions/090502SP11.7552/ session.html. 1. Goldenberg I, et al. Circulation, June 2006. http://circ.ahajournals.org/cgi/content/full/CIRCULATIONAHA.105.577262/DC1.


SCD-HeFT

Building to the Next Question: Building to the Next Question: • ICD therapy savedICD therapy saved NYHA Class II/III patients’ lives from tachyarrhythmias – but a NYHA Class II/III patients’ lives from tachyarrhythmias – but a

major cause of mortality remained: heart failure major cause of mortality remained: heart failure (31% of deaths, evenly distributed among treatment arms).(31% of deaths, evenly distributed among treatment arms).11

SCD-HeFT: Preventing SCD in Heart Failure PatientsSCD-HeFT: Preventing SCD in Heart Failure PatientsSCD-HeFT: Preventing SCD in Heart Failure PatientsSCD-HeFT: Preventing SCD in Heart Failure Patients

Size: 2521 patients in North America Size: 2521 patients in North America and New Zealandand New Zealand

Endpoint: All-cause mortalityEndpoint: All-cause mortality


1 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 Reduction in the risk of all-cause mortality when using an ICD, in combination with when using an ICD, in combination with conventional drug therapy (CDT), when conventional drug therapy (CDT), when compared to CDT alone (compared to CDT alone (p = 0.007)p = 0.007)

23%23%


COMPANION

Building to the Next Question:Building to the Next Question: • CRT-Ds save lives in NYHA Class III/IV HF patients, but CRT-Ds save lives in NYHA Class III/IV HF patients, but

pump failure was the most common cause of death (44.4%).pump failure was the most common cause of death (44.4%).11 • 70% of HF patients are in NYHA Class I/II.70% of HF patients are in NYHA Class I/II.2 2 There is a need to slow There is a need to slow

their progression to symptomatic heart failure.their progression to symptomatic heart failure.

COMPANION: Providing New Access to CRTCOMPANION: Providing New Access to CRTCOMPANION: Providing New Access to CRTCOMPANION: Providing New Access to CRT

Size: 1520 U.S. patientsSize: 1520 U.S. patients

Endpoint: All-cause mortality or first Endpoint: All-cause mortality or first hospitalizationhospitalization


Reduction in the risk of all-cause Reduction in the risk of all-cause mortality or first hospitalization with mortality or first hospitalization with CRT-D, in combination with OPT, CRT-D, in combination with OPT, compared to OPT alone compared to OPT alone (p = 0.011)(p = 0.011)

20%20%

1. Carson P, et al, JACC, 2005 Dec 20; 46(12): 2329-34.2. O'Connell JB, Bristow MR. Economic impact of heart failure in the United States: time for a different approach. J Heart Lung Transplant. 1994 Jul-

Aug;13(4):S107-12.


Key LearningKey Learning

MADIT II

COMPANION

SCD-HeFT

Ability to save lives from sudden cardiac death…

…heart failure remains an issue

Bottom LineBottom Line:


Multicenter Automatic Defibrillator Multicenter Automatic Defibrillator Implantation Trial with Cardiac Implantation Trial with Cardiac

Resynchronization Therapy (MADIT-CRT)Resynchronization Therapy (MADIT-CRT)


IntroductionIntroduction

• Heart failure remains a significant health concern; a heart failure event Heart failure remains a significant health concern; a heart failure event is associated with a five-fold increase in mortality in 5 years.is associated with a five-fold increase in mortality in 5 years.

• Cardiac resynchronization therapy with defibrillation (CRT-D) has been Cardiac resynchronization therapy with defibrillation (CRT-D) has been demonstrated to reduce mortality and hospitalizations, improve demonstrated to reduce mortality and hospitalizations, improve symptoms, and increase exercise capacity. symptoms, and increase exercise capacity.

• Prior to MADIT-CRT, Boston Scientific CRT-Ds were indicated by FDA Prior to MADIT-CRT, Boston Scientific CRT-Ds were indicated by FDA for the treatment of patients with the following conditions:for the treatment of patients with the following conditions:

– Moderate to severe heart failure (NYHA Class III/IV) despite optimal Moderate to severe heart failure (NYHA Class III/IV) despite optimal pharmacological therapypharmacological therapy

– Reduced systolic function (LVEF Reduced systolic function (LVEF 35%) 35%)– Wide QRS (QRS duration ≥ 120 ms)Wide QRS (QRS duration ≥ 120 ms)


Rationale for Undertaking MADIT-CRTRationale for Undertaking MADIT-CRT

• Currently, patients with severe left ventricular systolic dysfunction, a Currently, patients with severe left ventricular systolic dysfunction, a wide QRS complex, and asymptomatic or mildly symptomatic heart wide QRS complex, and asymptomatic or mildly symptomatic heart failure are indicated for prophylactic ICD therapy without CRTfailure are indicated for prophylactic ICD therapy without CRT

• Although ICD therapy is effective for the prevention of sudden cardiac Although ICD therapy is effective for the prevention of sudden cardiac arrest, it does not slow the progression of heart failurearrest, it does not slow the progression of heart failure

However, progression of heart failure in these patients is associated However, progression of heart failure in these patients is associated with increased mortality and diminished quality of lifewith increased mortality and diminished quality of life

• Retrospective studies of CRT-D in NYHA Class I/II patients reported Retrospective studies of CRT-D in NYHA Class I/II patients reported improvement in echocardiographic variables, suggesting a potential improvement in echocardiographic variables, suggesting a potential role for CRT-D earlier in the disease processrole for CRT-D earlier in the disease process

• Accordingly, MADIT-CRT was undertaken to determine if early Accordingly, MADIT-CRT was undertaken to determine if early intervention with CRT-D in patients with asymptomatic or mild heart intervention with CRT-D in patients with asymptomatic or mild heart failure could reduce death and heart failure eventsfailure could reduce death and heart failure events

Higgins et al, JACC (2001)Abraham et al, Circulation (2004)


MADIT-CRT Primary/Secondary Effectiveness HypothesesMADIT-CRT Primary/Secondary Effectiveness Hypotheses

• Primary:Primary:It was hypothesized that CRT-D would reduce the risk of the combined endpoint 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 of all-cause mortality or heart failure event, whichever came first, when compared with ICD in patients with asymptomatic or mildly symptomatic heart compared with ICD in patients with asymptomatic or mildly symptomatic heart failure with left ventricular dysfunction and wide QRSfailure with left ventricular dysfunction and wide QRS

• A heart failure event was defined as a patient having signs and symptoms of A heart failure event was defined as a patient having signs and symptoms of heart failure, with either:heart failure, with either:

– Intravenous decongestive therapy in an outpatient setting, orIntravenous decongestive therapy in an outpatient setting, or– Augmented intravenous or oral decongestive therapy during in-hospital Augmented intravenous or oral decongestive therapy during in-hospital

staystay

• Secondary:Secondary:Evaluate the effects of CRT-D, relative to ICD, on the patient-specific rates of Evaluate the effects of CRT-D, relative to ICD, on the patient-specific rates of recurrent heart failure events over the full study periodrecurrent heart failure events over the full study period

•


Study DesignStudy Design

• Designed to detect a 25% reduction in the risk of the primary Designed to detect a 25% reduction in the risk of the primary end pointend point– Wang-Tsiatis group-sequential design Wang-Tsiatis group-sequential design – 95% power at a two-sided significance level of 5%95% power at a two-sided significance level of 5%– Sample size requirement of 1820 patientsSample size requirement of 1820 patients

• Randomized controlled trialRandomized controlled trial– Randomization on a 3:2 basis to CRT-D/ICDRandomization on a 3:2 basis to CRT-D/ICD– Stratified by ischemic status and clinical center Stratified by ischemic status and clinical center

• Data analyzed on an intention-to-treat basisData analyzed on an intention-to-treat basis


Main Inclusion Criteria Main Inclusion Criteria

• Ischemic heart disease (NYHA Class I or II) or non-ischemic Ischemic heart disease (NYHA Class I or II) or non-ischemic heart disease (NYHA Class II) for at least three months prior to heart disease (NYHA Class II) for at least three months prior to entryentry

• Optimal pharmacologic therapyOptimal pharmacologic therapy

– Beta blockers, ACE/ARB, and statins (ischemic patients) Beta blockers, ACE/ARB, and statins (ischemic patients) unless not tolerated or contraindicatedunless not tolerated or contraindicated

• Left ventricular ejection fraction ≤ 30%Left ventricular ejection fraction ≤ 30%

• QRS duration ≥ 130 msQRS duration ≥ 130 ms

• Sinus rhythmSinus rhythm


Main Exclusion CriteriaMain Exclusion Criteria

• Currently implanted pacemaker, ICD, or CRT deviceCurrently implanted pacemaker, ICD, or CRT device

• Current indication for CRTCurrent indication for CRT

• Atrial fibrillation within one month of entryAtrial fibrillation within one month of entry

• NYHA Class III/IV within three months of entryNYHA Class III/IV within three months of entry

• CABG, PCI, or MI within three months of entryCABG, PCI, or MI within three months of entry


MADIT-CRT: MethodsMADIT-CRT: Methods• Led by Dr. Arthur J. MossLed by Dr. Arthur J. Moss

• Largest randomized NYHA Largest randomized NYHA Class I/II CRT-D trial to dateClass I/II CRT-D trial to date

• EnrollmentEnrollment

– 1820 patients, 110 centers, 1820 patients, 110 centers, 14 countries14 countries

• Average follow-upAverage follow-up

– 34.3 months34.3 months

• Commercially available devices Commercially available devices provided by Boston Scientific provided by Boston Scientific were usedwere used

Moss AJ, et al. N Engl J Med. 2009;361:1329-1338.

Baseline EvaluationTo document inclusion/exclusion criteria and establish baseline heart statusa

Randomization (3:2 CRT-D:ICD)Stratified by center and ischemic status

Clinic Follow-up Visits1 month post-enrollment/randomization, 3 months post-randomization, and quarterly thereafter to a common studyclosure dateb

CRT-D + OPTCRT-D + OPT(1089 patients)(1089 patients)

ICD + OPTICD + OPT(731 patients)(731 patients)

aBaseline 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).

bThe 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.


Study MilestonesStudy Milestones

• Primary endpoint was met on June 22, 2009Primary endpoint was met on June 22, 2009

• Results were published online on Sep. 1, 2009, in the Results were published online on Sep. 1, 2009, in the NEJMNEJM and and presented as a late-breaker at ESC presented as a late-breaker at ESC

• Published in print in the Published in print in the NEJMNEJM on Oct. 1, 2009 on Oct. 1, 2009

• PMA submitted to the FDA in December 2009PMA submitted to the FDA in December 2009

• FDA requested updated results through Dec. 31, 2009FDA requested updated results through Dec. 31, 2009

• FDA panel took place on Mar. 18, 2010, and there was FDA panel took place on Mar. 18, 2010, and there was unanimous recommendation for approval of the expanded unanimous recommendation for approval of the expanded CRT-D indication for the MADIT-CRT left bundle branch block CRT-D indication for the MADIT-CRT left bundle branch block (LBBB) sub-population(LBBB) sub-population


Previously Published and Updated ResultsPreviously 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. 2009 Oct 1;361(14):1329-38. 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%


Consistent Results with LBBB across SubgroupsConsistent Results with LBBB across Subgroups


LBBB Sub-population Baseline DemographicsLBBB Sub-population Baseline Demographics


Exploratory Analysis - Hypothesis Generating Only: Exploratory Analysis - Hypothesis Generating Only: LBBB Echocardiographic OutcomesLBBB Echocardiographic Outcomes

CRT therapy was ON during echocardiographic measurements and may have influenced the results.

2020© 2010 Boston Scientific. All rights reserved. CRM6-4403-0810 2020

ResultsResults

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

2121© 2010 Boston Scientific. All rights reserved. CRM6-4403-0810 2121

New Boston Scientific CRT-D IndicationNew 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


Identification of patientsIdentification of patients

• In order to successfully identify NYHA Class I and II heart failure In order to successfully identify NYHA Class I and II heart failure patients most likely to benefit from CRT-D therapy, begin with an patients most likely to benefit from CRT-D therapy, begin with an ECG analysis to screen for LBBB and a wide QRSECG 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?


Thank youThank you

Questions?Questions?


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


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)


Back up slideBack up slide


COMPANIONSize: 1520 U.S. patientsSize: 1520 U.S. patients

Endpoint: All-cause mortality orEndpoint: All-cause mortality orfirst hospitalizationfirst hospitalization


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 QuestionDoes 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): 2140-2150.

© 2010 boston scientific. all rights reserved. crm6-4403-0810 early crt intervention reduces death...

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