Non elective cardiac surgery pericardial effusion 1

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Non-elective Cardiac Surgery (Pericardial Effusion) 1 Renal failure 0 Deep wound infection 0 Ventilation > 48 hrs 0 GI complication requiring surgery 0 Septicemia 0 Bleeding requiring transfusion ≥ 2 units 2
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EVEREST Initial FMR Cohort Efficacy Results through Discharge N = 23 * Acute Procedural Success (APS): Defined as placement of one or more Clips resulting in discharge MR severity of 2+ or less, as determined by Core Lab.
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EVEREST Initial FMR Cohort: Freedom From MR > 2+ Kaplan-Meier Acute Procedural Success (APS) Patients
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EVEREST Initial FMR Cohort: Event Free Clinical Success Kaplan-Meier APS Patients Freedom from death, mitral valve surgery, & MR > 2+ (81) (74) (66) (48) (43) (37) (n) (19) (15) (14) (8) (7) (6) (n) 64% 67% 68% 69% 75% 85% 74% 84% 79% 79% 79% 100% 0% 20% 40% 60% 80% 100% 0 6 12 18 24 30 36 42 Time (months) Probability of Event Free Clinical Success All APS Patients Functional APS Patients
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75% (9/12) Improved 17% (2/12) No Change 8% (1/12) Worsened w/o MR > 1+ EVEREST Initial FMR Cohort NYHA Class, APS Patients* (matched data, n = 12) * Excludes patients that went to MV surgery post-Clip prior to 12- months or have not reached 12-month follow-up
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EVEREST Initial FMR Cohort: Surgery Following Clip Procedure N = 23 SURGERY FREE 19/23 Median Follow-up 369 Days Surgery After Clip Implanted (n = 3) 2 Repairs 1 Replacement Surgery After No Clip (n = 1) 1 Replacement No Partial Clip Detachments No Clip Embolizations
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EVEREST Initial FMR Cohort Reverse LV Remodeling APS Patients* (matched data, n = 12) p = 0.006 p = 0.12 p < 0.04 p < 0.03 Diastolic Systolic * Excludes patients that went to MV surgery post-Clip prior to 12-months or have not reached 12-month follow-up
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EVEREST Initial FMR Cohort Conclusions Percutaneous mitral repair with the MitraClip: Effective in reducing MR with a low MAE rate Significant reverse LV remodeling at 1-year Clinical improvement with 58% of patients NYHA Class I at 1-year 79% freedom from death, surgery for valve dysfunction and MR > 2+ at 1-year Surgical options preserved in majority of patients MitraClip facilitates leaflet coaptation reducing MR in functional patients
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Study Limitations Very small number of patients Non randomized Observational study Initial experience – early in learning curve Only 12/19 with acute procedural suceess have 1 year follow up (clinical and echo)
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EVEREST Principal Investigators and Affiliation Ted Feldman, EVEREST I PI, EVEREST II PI Evanston Northwestern Hospital, Evanston, IL Patrick L Whitlow The Cleveland Clinic, Cleveland, OH Hal Wasserman/Bill Gray Columbia University, New York, NY; Danville, CT Michael Rinaldi Sanger Clinic, Charlotte, NC Howard Herrmann
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  • Fall '19
  • mitral valve, Mitral valve prolapse, Mitral regurgitation, mitral valve repair

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