Note: Ai sensi e per gli effetti dell’Art. 76 D.P.R. 445/2000 consapevole della responsabilità e delle conseguenze civili e penali previste in caso di dichiarazioni mendaci e/o formazione od uso di atti falsi, nonché in caso di esibizione atti contenenti dati non più corrispondenti a verità e consapevole altresì che qualora emerga la non veridicità del contenuto della presente decadranno i benefici per i quali la stessa è rilasciata confermo di essere un OPERATORE SANITARIO.
I contenuti presenti in questo sito contengono informazioni rivolte agli operatori sanitari, in quanto si riferiscono a prodotti rientranti nella categoria dei dispositivi medici che richiedono l’impiego o l’intervento da parte di professionisti del settore medico-sanitario.
Cardiac resynchronization therapy is a proven treatment for selected heart failure patients with a wide QRS. When used in combination with optimal medical therapy, cardiac resynchronization therapy improves symptoms and extends survival.1-5
Clinical Issue – Poor Prognosis for Heart Failure Patients with a Wide QRS
Heart failure – related morbidity and mortality remains a major problem6-9
Heart failure patients with a wide QRS have poor prognoses6-9
Heart failure accounts for over 3.4 million visits to physician offices, hospital outpatient, and emergency departments annually6
Heart failure hospitalizations are especially problematic, with one year readmission rates of 50% and mortality rates of approximately 30% 7,8
In patients with heart failure, sudden death occurs at four times the rate of the general population9
QRS duration and Left Ventricular Ejection Fraction: Predictors of morbidity and mortality
Wide QRS duration is a powerful independent predictor of poor clinical outcomes in patients with HF and reduced left ventricular ejection fraction (LVEF)10
QRS durations ≥ 120 ms are associated with a 33% increased risk of all-cause mortality (38% from worsening HF and 31% from sudden death)11
Clinical studies show that a low EF is a key predictor of sudden cardiac arrest and an effective way to determine a patient's risk for sudden cardiac arrest (SCA).9,12,13
References
1
Cleland JG, Daubert JC, Erdmann E, et al. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med. April 15, 2005;352(15)1539-1549.
2
Cleland JG, Daubert JC, Erdmann E, et al. Longer-term effects of cardiac resynchronization therapy on mortality in heart failure [the CArdiac REsynchronization-Heart Failure (CARE-HF) trial extension phase]. Eur Heart J. August 2006;27(16):1928-1932.
3
Bristow MR, Feldman AM, Saxon LA. Heart failure management using implantable devices for ventricular resynchronization: Comparison of Medical Therapy, Pacing, and Defibrillation in Chronic Heart Failure (COMPANION) trial. COMPANION Steering Committee and COMPANION Clinical Investigators. J Card Fail. September 2000;6(3):276-285.
4
Abraham WT, Fisher WG, Smith AL, et al. Cardiac resynchronization in chronic heart failure. N Engl J Med. June 13, 2002;346(24):1845-1853.
5
Young JB, Abraham WT, Smith AL, et al. Combined cardiac resynchronization and implantable cardioversion defibrillation in advanced chronic heart failure: the MIRACLE ICD Trial. JAMA. May 28, 2003;289(20):2685-2694.
6
Burt CW, Schappert SM. Ambulatory care visits to physician offices, hospital outpatient departments, and emergency departments: United States, 1999-2000. Vital Health Stat 13. September 2004;(157):1-70.
7
Kosiborod M, Lichtman JH, Heidenreich PA, et al. National trends in outcomes among elderly patients with heart failure. Am J Med. July 2006;119(7):616.e1-7.
8
Rathore SS, Masoudi FA, Wang Y, et al. Socioeconomic status, treatment, and outcomes among elderly patients hospitalized with heart failure: findings from the National Heart Failure Project. Am Heart J. August 2006;152(2):371-378.
9
Adabag AS, Therneau TM, Gersh BJ, Weston SA, Roger VL. Sudden death after myocardial infarction. JAMA. 2002;300(17):2022-2029.
10
Hawkins NM, Wang D, McMurray JJ, et al. Prevalence and prognostic impact of bundle branch block in patients with heart failure: evidence from the CHARM programme. Eur J Heart Fail. 2007;9(5):510-517.
11
Wang NC, Maggioni AP, Konstam MA, et al. Clinical implications of QRS duration in patients hospitalized with worsening heart failure and reduced left ventricular ejection fraction. JAMA. 2008;299(22):2656-2666.
12
Lang RM, Bierig M, Devereux RB, et al. Recommendations for chamber quantification: a report from the American Society of Echocardiography’s Guidelines and Standards Committee and the Chamber Quantification Writing Group, developed in conjunction with the European Association of Echocardiography, a branch of the European Society of Cardiology. J Am Soc Echocardiogr. 2005;18(12):1440-1463.
13
Priori SG, Aliot E, Blomstrom-Lundqvist C, et al. Task Force on Sudden Cardiac Death of the European Society of Cardiology [published correction appears in Eur Heart J. 2002;23:257]. Eur Heart J. August 2001;22(16):1374-1450.
Cardiac resynchronization therapy provides atrial-synchronized, biventricular pacing using standard pacing technology combined with a special third lead that is implanted via the coronary sinus and positioned in a cardiac vein to sense and/or pace the left ventricle.1-5
Cardiac resynchronization therapy provides atrial-synchronized, biventricular pacing using standard pacing technology combined with a special third lead that is implanted via the coronary sinus and positioned in a cardiac vein to sense and/or pace the left ventricle.1-5
Following a sensed atrial contraction or atrial-paced event, both ventricles are stimulated to synchronize their contraction.
Cardiac Resynchronization Therapy Reduces Mortality and Morbidity1-5
Implantable Cardiac Resynchronization Therapy Devices Available
Cardiac resynchronization therapy device (CRT-P) or in
combination with an implantable cardiovertor defibrillator
(CRT-D)
Cardiac resynchronization therapy defibrillator
(CRT-D) has painless anti-tachycardia pacing (ATP) and shock therapy
capability to prevent sudden cardiac death
Cardiac Resynchronization Therapy: ACC/AHA Class I Indication6
The Cardiac Resynchronization Therapy current indications have been created based on the results of eight randomized clinical studies including nearly 4,000 patients.6 The level of evidence is so compelling that Cardiac Resynchronization Therapy is recommended as a Class I therapy for the treatment of symptomatic heart failure.6
LVEF ≤ 35%
QRS duration ≥ 120 ms
NYHA Functional Class III or ambulatory IV
Optimal medical therapy
Note: The use of an ICD in combination with cardiac resynchronization therapy should be based on the indications for ICD therapy in the prevention of sudden cardiac death.
Consider Cardiac Resynchronization Therapy
Screen your patients for cardiac resynchronization therapy indications.
References
1
Cleland JG, Daubert JC, Erdmann E, et al. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med. April 14, 2005;352(15):1539-1549.
2
Cleland JG, Daubert JC, Erdmann E, et al. Longer-term effects of cardiac resynchronization therapy on mortality in heart failure [the CArdiac REsynchronization-Heart Failure (CARE-HF) trial extension phase]. Eur Heart J. August 2006;27(16):1928-1932.
3
Bristow MR, Feldman AM, Saxon LA. Heart failure management using implantable devices for ventricular resynchronization: Comparison of Medical Therapy, Pacing, and Defibrillation in Chronic Heart Failure (COMPANION) trial. COMPANION Steering Committee and COMPANION Clinical Investigators. J Card Fail. September 2000;6(3):276-285.
4
Abraham WT, Fisher WG, Smith AL, et al. Cardiac resynchronization in chronic heart failure. N Engl J Med. June 13, 2002;346(24):1845-1853.
5
Abraham WT, Fisher WG, Smith AL, et al. Cardiac resynchronization in chronic heart failure. N Engl J Med. June 13, 2002;346(24):1845-1853.
6
Epstein AE, DiMarco JP, Ellenbogen KA, et al. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices): developed in collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons. Circulation. May 27, 2008;117(21):e350-408.
Cardiac resynchronization therapy defibrillator (CRT-D) with shock therapy capability to prevent sudden cardiac death
Heart failure (HF) patients with CRT devices should receive cardiac resynchronization therapy more than 92% of the time for maximum benefit of the therapy and are at significant risk for thoracic congestion.6
Medtronic implantable devices have unique diagnostics to provide clinicians with information, including Optivol® Fluid Status Monitoring for congestion, to assess their patients’ clinical status and intervene if necessary.
Ensure cardiac resynchronization therapy with Medtronic devices
Medtronic Device Diagnostics
Consider Cardiac Resynchronization Therapy
Screen your patients for cardiac resynchronization
therapy indications:
Moderate to severe heart failure (Class III/IV)
Ventricular dysynchrony (QRS ≥ 120 ms)
LVEF ≤ 35%
Symptomatic despite stable, optimal medical therapy
CRT Therapy Operation (:20,
1.7 MB) CRT Therapy restores the mechanical sequence of
ventricular activation and contraction by pacing both ventricles.
Important Safety Information
Changes in a patient's disease and/or medications may alter the
efficacy of a device's programmed parameters or related features.
References
1
Cleland JG, Daubert JC, Erdmann E, et al. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med. April 14, 2005;352(15):1539-1549.
2
Cleland JG, Daubert JC, Erdmann E, et al. Longer-term effects of cardiac resynchronization therapy on mortality in heart failure [the CArdiac REsynchronization-Heart Failure (CARE-HF) trial extension phase]. Eur Heart J. August 2006;27(16):1928-1932.
3
Bristow MR, Feldman AM, Saxon LA. Heart failure management using implantable devices for ventricular resynchronization: Comparison of Medical Therapy, Pacing, and Defibrillation in Chronic Heart Failure (COMPANION) trial. COMPANION Steering Committee and COMPANION Clinical Investigators. J Card Fail. September 2000;6(3):276-285.
4
Abraham WT, Fisher WG, Smith AL, et al. Cardiac resynchronization in chronic heart failure. N Engl J Med. June 13, 2002;346(24):1845-1853.
5
Young JB, Abraham WT, Smith AL, et al. Combined cardiac resynchronization and implantable cardioversion defibrillation in advanced chronic heart failure: the MIRACLE ICD Trial. JAMA. May 28, 2003;289(20):2685-2694.
6
Koplan BA, Kapla AJ, Weiner S, et al. Heart Faiure Decompensation and All-Cause Mortality in Relation to Percent Biventricular Pacing in Patients with Heart Failure Is a Goal of 100% Biventrecular Pacing Necessary? J Am Coll Cardiol 2009 53:355-60.
There is overwhelming clinical evidence supporting the fact that cardiac resynchronization therapy reverses the course of heart failure progression in moderate to severe heart failure patients. 1-5
Mortality
HF or CV Hospitalizatons
Quality of Life
Exercise Capacity
NYHA Class
CARE-HF
+
+
Reported improvement, but not blinded
COMPANION
+
+
MIRACLE
Not powered for mortality or hospitalization
+
+
+
MIRACLE ICD
+
–
+
Cardiac Resynchronization Therapy Reduces Morbidity and Mortality
CARE-HF Trial1
Cardiac resynchronization therapy:
Reduces risk of all-cause mortality or unplanned CV hospitalizations by 37%
Reduces risk of all-cause mortality by 36%
Reduces risk of unplanned hospitalizations for worsening HF by 52%
CARE-HF Extension Phase2
Cardiac resynchronization therapy:
Reduces risk of all-cause mortality by 40%
Reduces risk of HF mortality by 45%
Reduces risk of sudden death by 46%
References
1
Cleland JG, Daubert JC, Erdmann E, et al. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med. April 14, 2005;352(15):1539-1549.
2
Cleland JG, Daubert JC, Erdmann E, et al. Longer-term effects of cardiac resynchronization therapy on mortality in heart failure [the CArdiac REsynchronization-Heart Failure (CARE-HF) trial extension phase]. Eur Heart J. August 2006;27(16):1928-1932.
3
Bristow MR, Feldman AM, Saxon LA. Heart failure management using implantable devices for ventricular resynchronization: Comparison of Medical Therapy, Pacing, and Defibrillation in Chronic Heart Failure (COMPANION) trial. COMPANION Steering Committee and COMPANION Clinical Investigators. J Card Fail. September 2000;6(3):276-285.
4
Abraham WT, Fisher WG, Smith AL, et al. Cardiac resynchronization in chronic heart failure. N Engl J Med. June 13, 2002;346(24):1845-1853.
5
Young JB, Abraham WT, Smith AL, et al. Combined cardiac resynchronization and implantable cardioversion defibrillation in advanced chronic heart failure: the MIRACLE ICD Trial. JAMA. May 28, 2003;289(20):2685-2694.
Cardiac Resynchronization Therapy and Lead Placement
The implant procedure of a cardiac resynchronization therapy device is much the same as that for a pacemaker or implantable defibrillator, although additional time is required to place the left ventricular lead in a suitable cardiac vein via the coronary sinus.1-5
It is important to note that coronary venous anatomy varies significantly between patients, and in a small percentage of cases, it may not be possible to place the left ventricular lead transvenously. In such situations, some centers are opting for an epicardial approach if the transvenous approach is unsuccessful.
Implanters can face multiple challenges with CRT implant procedures, due to the complexity of a patient’s anatomy:
LV lead positioning can be a challenging, time consuming task.6
Accuracy of lead location by implanting physicians can be problematic.7
In up to 43 percent of cases, procedure times run long (2 hours or more), which may increase fluoroscopy exposure.8
Medtronic CardioGuide™ Implant System: A Real-Time Navigation System for CRT Implants
Now there is a way to guide LV lead placement. By creating 3D images of coronary vessels, the CardioGuide™ Implant System provides real-time navigation to a targeted location for LV lead placement. The imaging software projects the target location from the venogram model onto an overlay and tracks the electrodes’ location using live or recorded fluoroscopy.
The CardioGuide Implant System helps implanters:
Determine their preferred lead location
Identify proper delivery tools
Confirm that a lead is placed in the targeted location, using the system’s lead navigation and tracking capability under live fluoroscopy
An Easy Fit into the CRT Implant Workflow
The CardioGuide System operates as a dedicated PC workstation inside the control room, and within the procedure room on a tablet computer. The application consists of four core phases: system setup, vein analysis, planning, and navigation. It also archives, imports, and exports files and provides database management.
The information provided by the CardioGuide Implant System is intended to serve as an adjunct to information available from venograms and other sources. The information presented by the system is not intended for use as the sole basis of planning and therapeutic decisions. In case of discrepancy between venogram data and system results, the user should use the venograms or other standard clinical practice.
References
1
Cleland JG, Daubert JC, Erdmann E, et al. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med. April 15, 2005;352(15)1539-1549.
2
Cleland JG, Daubert JC, Erdmann E, et al. Longer-term effects of cardiac resynchronization therapy on mortality in heart failure [the CArdiac REsynchronization-Heart Failure (CARE-HF) trial extension phase]. Eur Heart J. August 2006;27(16):1928-1932.
3
Bristow MR, Feldman AM, Saxon LA. Heart failure management using implantable devices for ventricular resynchronization: Comparison of Medical Therapy, Pacing, and Defibrillation in Chronic Heart Failure (COMPANION) trial. COMPANION Steering Committee and COMPANION Clinical Investigators. J Card Fail. September 2000;6(3):276-285.
4
Abraham WT, Fisher WG, Smith AL, et al. Cardiac resynchronization in chronic heart failure. N Engl J Med. June 13, 2002;346(24):1845-1853.
5
Young JB, Abraham WT, Smith AL, et al. Combined cardiac resynchronization and implantable cardioversion defibrillation in advanced chronic heart failure: the MIRACLE ICD Trial. JAMA. May 28, 2003;289(20):2685-2694.
6
Giannola G, Iacopino S, Lombardo E, et al. Efficacy of a tool combining guide-wire and stylet for the left ventricular lead positioning. Europace. February 2011;13(2):244-250.
7
Singh JP, Hummel JD, Coppess MA, et al. LV Lead Location: Do We Know Where We Are? Abstract Presentation, HRS 2012.
8
PPDA Q3FY12/Q4FY12/Q1FY13/Q2FY13 - (Waves 1-4): Economic Considerations for CRT Implants
Recent clinical evidence suggests cardiac resynchronization therapy is underutilized in the United States6:
In the IMPROVE HF Registry, less than 40% of eligible patients received a cardiac resynchronization therapy device at baseline treatment6
54% of patient charts lacked documentation of NYHA class or QRS duration6
Less likelihood of cardiac resynchronization therapy use was independently predicted by older age, narrower QRS duration6
Indicated patients with an ischemic etiology were more likely to have an ICD, while older age, female sex, Black race, or lack of insurance independently predicted that an eligible patient would be less likely to have an ICD7
Improve HF Results
Wide Practice Variation in Guideline Recommended CRT Use (sites with ≥ 5 eligible patients)8
What Can Be Done?
The ACC/AHA recommends various strategies to implement practice guidelines8:
Utilize performance measures
Perform chart audits
Implement reminder systems
Outpatient practice performance improvement initiatives are available to reduce variations in care and increase guideline adherence.
Ask your Medtronic representative about the Sudden Cardiac Arrest Prevention program
References
1
Cleland JG, Daubert JC, Erdmann E, et al. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med. April 14, 2005;352(15):1539-1549.
2
Cleland JG, Daubert JC, Erdmann E, et al. Longer-term effects of cardiac resynchronization therapy on mortality in heart failure [the CArdiac REsynchronization-Heart Failure (CARE-HF) trial extension phase]. Eur Heart J. August 2006;27(16):1928-1932.
3
Bristow MR, Feldman AM, Saxon LA. Heart failure management using implantable devices for ventricular resynchronization: Comparison of Medical Therapy, Pacing, and Defibrillation in Chronic Heart Failure (COMPANION) trial. COMPANION Steering Committee and COMPANION Clinical Investigators. J Card Fail. September 2000;6(3):276-285.
4
Abraham WT, Fisher WG, Smith AL, et al. Cardiac resynchronization in chronic heart failure. N Engl J Med. June 13, 2002;346(24):1845-1853.
5
Young JB, Abraham WT, Smith AL, et al. Combined cardiac resynchronization and implantable cardioversion defibrillation in advanced chronic heart failure: the MIRACLE ICD Trial. JAMA. May 28, 2003;289(20):2685-2694.
6
Fonarow GC, Yancy CW, Albert NM, et al. Heart failure care in the outpatient cardiology practice setting: findings from IMPROVE HF. Circ Heart Fail. 2008;1:98-106. Available at: circheartfailure.ahajournals.org. Accessed July 16, 2008.
7
Mehra MR, Yancy CW, Albert NM. Evidence of clinical practice heterogeneity in the use of implantable cardioverter-defibrillators in heart failure and postmyocardial infarction left ventricular dysfunction: Findings from IMPROVE HF. Heart Rhythm. December 2009;6(12):1727-1734.
8
Curtis AB, Yancy CW, Albert NM, et al. Cardiac resynchronization therapy utilization for heart failure: Findings from IMPROVE HF. Am Heart J. 2009;158:956-64
Resynchronization Animation
CRT Therapy Operation
Implanting a Cardiac Resynchronization Therapy Device
