MADIT-CRT Webinar
Important MADIT-CRT Data Information
- This webinar is to be viewed in its entirety. Chapters are provided for ease of navigation.
- The following results presented by Dr. Moss reflect the full MADIT-CRT population for events occurring on or before June 22, 2009. The data used to support Boston Scientific's LBBB indication reflect an additional 6 months of data for events occurring on or before Dec 31, 2009.
- Subgroup analyses and substudies are exploratory and the results are considered suggestive and not definitive. Future studies would be needed to confirm these conclusions.
- Boston Scientific's CRT-D indication from the MADIT-CRT study is limited to the LBBB sub-population of that study.
- Boston Scientific does not intend to promote the use of its products for any other use than those approved by the FDA.
This Webinar was recorded on October 19, 2010
Chapter 1: Evolution of Device Therapy
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Chapter 2: Updated MADIT-CRT Findings
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Chapter 3: Boston Scientific's FDA Indication
In trying to understand the differences between men and women enrolled in the trial, a large disparity in the prevalence of left bundle branch block was discovered. Women were far more likely than men to have left bundle branch block. Looking at the LBBB population alone, there was a 57% reduction in the primary endpoint, while non-LBBB patients saw no improvement in outcomes. These findings prompted Boston Scientific’s new CRT-D indication for high risk1, NYHA Class I and II patients with LBBB.
1 High-risk is defined as QRS width ≥ 130 ms, LVEF ≤ 30%, and LBBB
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Chapter 4: MADIT-CRT - Clinical Application
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Chapter 5: MADIT-CRT Q-A
- Will there be a CMS national coverage decision?
- Is this indication exclusive to Boston Scientific?
- When it comes to device replacement, what do I do with patients that already have a CRT-D but do not have LBBB?
- What is your recommended diagnostic protocol for potential MADIT-CRT patients?
- Can you elaborate on the findings of LV lead location and response?
- Was there any benefit in women without LBBB?
- Why were patients with a QRS duration between 120 and 130 not included?
- Was RV pacing avoided in the ICD group?
- Can you elaborate on the cost-benefit of a CRT-D device?
- What happened to the RBBB patients and what was their outcome?