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Boston Scientific — Technical Presentation (March 2014)
22 slides from Boston Scientific's technical presentation, Mar 30, 2014
Slide 1: Long-Term Survival with Cardiac Resynchronization Therapy in Mild Heart Failure Patients
Long-Term Survival with Cardiac Resynchronization Therapy in Mild Heart Failure Patients MADIT-CRT Long Term Follow-Up Adapted from the American College of Cardiology Late Breaking Presentation by Ilan Goldenberg, MD Leviev Heart Center, Sheba Medical Center and Tel Aviv University, Israel March 30,
Slide 2: Background: MADIT-CRT
Background: MADIT-CRT 1820 ICM/NICM pts: EF ≤ 30% QRS ≥ 130 msec NYHA I/II Randomization: CRT-D vs. ICD-only* 3:2 ratio Mean Follow-Up: 2.4 yrs Outcome: HR=0.66 (p=0.001) *Boston Scientific ICD and CRT-D devices Moss A, et al. NEJM. 2009;361:1329-38 2 Slides adapted from those presente
Slide 3: MADIT-CRT Subgroup Analysis
MADIT-CRT Subgroup Analysis Differential clinical response: Gender, QRS duration Moss A, et al. NEJM. 2009;361:1329-38 3 Slides adapted from those presented by Ilan Goldenberg, MD at ACC 2014, Washington, DC USA CRM-235011-AB
Slide 4: MADIT-CRT: QRS Morphology
MADIT-CRT: QRS Morphology LBBB Non-LBBB RBBB IVCD Zareba, W, et al. Circulation. 2011;123:1061-1072 4 Slides adapted from those presented by Ilan Goldenberg, MD at ACC 2014, Washington, DC USA CRM-235011-AB
Slide 5: MADIT-CRT Long-Term Follow-Up Study Purpose
MADIT-CRT Long-Term Follow-Up Study Purpose • Hypothesis: The pronounced reduction in heart failure events associated with CRT during the in- trial period of MADIT-CRT would translate into a long-term survival benefit 5 Slides adapted from those presented by Ilan Goldenberg, MD at ACC 2014, Washingt
Slide 6: Population and Trial Periods
Population and Trial Periods • MADIT-CRT study: In-trial period – 1820 patients: • 88 US centers; 1,271 pts (70%) • 24 Non-US Centers; 549 pts (30%) – In-trial period: December 22, 2004 – June 20, 2009 • MADIT-CRT Long Term Follow-up: Post-trial period – 1691 patients – Last in-trial follow-up visit
Slide 7: MADIT-CRT Long Term Follow-up: Study Design
MADIT-CRT Long Term Follow-up: Study Design 7 Slides adapted from those presented by Ilan Goldenberg, MD at ACC 2014, Washington, DC USA CRM-235011-AB
Slide 8: Outcome Measures
Outcome Measures • Primary end point: – All-cause mortality from enrollment in MADIT- CRT through post-trial follow-up • Secondary endpoints: – Separate occurrence of non-fatal HF events – Combined end point of non-fatal HF event or death 8 Slides adapted from those presented by Ilan Goldenberg, MD
Slide 9: Statistical Analysis
Statistical Analysis • All analyses performed: – On an intention-to-treat basis by original treatment allocation regardless of in-trial and post-trial crossovers – By LBBB status at enrollment with interaction- term analysis 9 Slides adapted from those presented by Ilan Goldenberg, MD at ACC 2014, W
Slide 10: Results
Results 10 Slides adapted from those presented by Ilan Goldenberg, MD at ACC 2014, Washington, DC USA CRM-235011-AB
Slide 11: Follow-Up Data
Follow-Up Data • Follow-up time: – In-trial: 2.4 yrs (IQR = 1.8 – 3.2) – Post-trial: 5.6 years (IQR = 5.1 – 6.4) • Device change: – ICD to CRT-D: 9% – CRT-D to ICD: 5% • Clinical events: – 292 pts died (16%) – 442 pts experienced a non-fatal HF event (24%) 11 Slides adapted from those presented by I
Slide 12: LBBB: All-Cause Mortality
LBBB: All-Cause Mortality NNT = 9 12 Slides adapted from those presented by Ilan Goldenberg, MD at ACC 2014, Washington, DC USA CRM-235011-AB
Slide 13: LBBB: Non-Fatal Heart Failure Events
LBBB: Non-Fatal Heart Failure Events 13 Slides adapted from those presented by Ilan Goldenberg, MD at ACC 2014, Washington, DC USA CRM-235011-AB
Slide 14: Non-LBBB
Non-LBBB All-Cause Mortality Non-Fatal Heart Failure Events 14 Slides adapted from those presented by Ilan Goldenberg, MD at ACC 2014, Washington, DC USA CRM-235011-AB
Slide 15: Multivariate Analysis: Survival Benefit of CRT-D by LBBB Status
Multivariate Analysis Survival Benefit of CRT-D by LBBB Status P- LBBB Non-LBBB Interactio n HR P- HR P- End Point (95% CI) value (95% CI) value 0.59 1.57 All-cause <0.00 (0.43 – (1.03 – 0.04 <0.001 mortality 1 0.80) 2.39) 0.38 1.13 Non-fatal <0.00 (0.30 – (0.80 – 0.48 <0.001 HF are further adjusted
Slide 16: LBBB Subgroup Analysis
LBBB Subgroup Analysis 16 Slides adapted from those presented by Ilan Goldenberg, MD at ACC 2014, Washington, DC USA CRM-235011-AB
Slide 17: Non-LBBB Subgroup Analysis
Non-LBBB Subgroup Analysis 17 Slides adapted from those presented by Ilan Goldenberg, MD at ACC 2014, Washington, DC USA CRM-235011-AB
Slide 18: Summary
Summary • In patients with mild heart failure symptoms, left ventricular dysfunction, and LBBB, early intervention with CRT is associated with a significant long-term survival benefit • No survival benefit found in mild heart failure patients without LBBB 18 Slides adapted from those presented by Il
Slide 19: CRT-D Systems from Boston Scientific
CRT-D Systems from Boston Scientific Indications and Usage These 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 cl
Slide 20: CRT-D Systems from Boston Scientific – PUNCTUA, ENERGEN, and INCEPTA
CRT-D Systems from Boston Scientific – PUNCTUA, ENERGEN, and INCEPTA Indications and Usage The PUNCTUATM, ENERGENTM, and INCEPTATM Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart
Slide 21: ICD Systems from Boston Scientific
ICD Systems from Boston Scientific ICD Indications and Usage ICDs are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life- threatening ventricular arrhythmias. ICDs (i.e. Vitality AVT) with atrial therapies are also intended to provid
Slide 22: ICD Systems from Boston Scientific – PUNCTUA, ENERGEN, and INCEPTA
ICD Systems from Boston Scientific – PUNCTUA, ENERGEN, and INCEPTA ICD Indications and Usage PUNCTUATM, ENERGENTM, and INCEPTATM ICDs are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Contrai
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