Author + information
- Laura Mauri1,
- Saibal Kar2,
- D. Scott Lim3,
- Ramon Quesada4,
- Tanvir Bajwa5,
- Paul Grayburn6,
- Vivek Rajagopal7,
- Chad Rammohan8,
- James Hermiller9 and
- Ted Feldman10
EVEREST II REALISM is a prospective, multi-center, continued access study to collect data on “real world” use of MitraClip in high risk (HR) and non-high risk (NHR) patients. Baseline demographics, clinical and acute procedural data are presented.
HR was defined as STS score ≥12% or pre-specified risk factors. As of December 2013, 628 HR and 271 NHR patients were enrolled.
Mean ages of HR and NHR patients were 77 and 74 years respectively. Mean STS score in HR was 11±7%. Baseline characteristics in HR and NHR vary with respect to extent of co-morbidities and NYHA Class status. A majority of patients were in NHYA Class III/IV and had atrial fibrillation. A higher percentage of HR patients had CAD and prior CABG surgery. A majority of HR had functional mitral regurgitation (MR). In HR, 96% of patients received 1 or 2 MitraClip devices with a mean hospital stay of 3.2 days. MR ≤2+ was observed in 90% of patients at discharge. In NHR, 95% of patients received 1 or 2 MitraClip devices with a mean hospital stay of 2.8 days. MR ≤2+ was observed in 89% of patients at discharge. Mortality at 30 days was 4.2% in HR and 1.5% in NHR. There were no intra-procedural deaths in either group.
Baseline data indicate that patients treated with MitraClip in REALISM are elderly and have significant co-morbidities. The procedural data demonstrate the feasibility, acute safety and acute effectiveness of MitraClip in a complex “real world” US population.
|High Risk Arm|
|Non-High Risk Arm|
|Age (mean ± SD)||77 ± 11 years||74 ± 11 years|
|Coronary Artery Disease||78%||49%|
|Moderate to Severe Renal Disease||30%||9%|
|Prior CABG Surgery||54%||17%|
|NYHA Functional Class III/IV||85%||55%|
|Functional Mitral Regurgitation||70%||32%|
|LV Ejection Fraction (mean ± SD)||47 ± 14%||56 ± 11%|
|LVIDs (mean ± SD)||4.4 ± 1.1 cm||3.7 ± 0.9 cm|