Surgical Mitral Valve Repair The Gold Standard. A. Marc Gillinov, M.D.

Transcription

1 Surgical Mitral Valve Repair The Gold Standard A. Marc Gillinov, M.D.

2 Disclosures Speaker/consultant Edwards Lifesciences Onyx Lifesciences Research support St. Jude Medical Medtronic

3 A Common Case

4 A Common Case 49 year-old man Symptoms Frequent PAC s Mild SOB Systolic murmur

5 Echo

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8 Questions Three questions Repair or replace? Sternotomy or MIS? Surgery or MitraClip?

9 Question #1 Repair vs. Replacement

10 Posterior Leaflet Prolapse Surgeons sweet spot High repair rate Excellent durability Ultra-low risk operation

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14 Degenerative Mitral Disease (n = 4,258) Posterior (n = 3,383) Repair (n = 3,272) Anterior or Bileaflet (n = 875) Replacement (n = 111) Non-Standard (n = 198) Standard (n = 3,074)

15 Operative Mortality 0.07%

16 Follow-up Follow-up 6.5 ± 4.5 years Patient-years 19,918

17 Survival % MV Repair US Matched Years

18 Free of Reoperation % Years

19 100 Return of MR 80 % Years /4+

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22 Repair (%) 100 Mitral Valve Repair Year Gillinov et al; JTCS 2008

23 Answer #1 (Repair/Replace) Repair

24 Question #2 Does a minimally invasive approach compromise the operation?

25 Complete Sternotomy (CST) Partial Sternotomy (PST) Anterolateral Thoracotomy (ANT) Robotic Assistance (ROB)

26 Mitral Repair: The Gold Standard

27 The Gold Standard Is Changing

28 Minimally Invasive Mitral Surgery Patient demand Less trauma Cosmetic appeal More rapid recovery Right surgeon + right patient = right result

29 Right Thoracotomy

30 Remove pillow

31 Robotics

32 Robotics

33 Robotics: Improved Platform

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35 Right Chest Approaches When?

36 Indications and Contraindications YES Valve Repair Replacement (simple) Patient Relatively healthy NO Valve MAC Patient LV dysfunction AI PAD Small femorals Chest wall deformity

37 Safety

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39 STS Database 28,143 isolated mitral valve operations Compare less invasive (femoral cannulation) to standard (central cannulation)

40 Mitral Valve Operations Minimally Invasive Conventional % Year Gammie et al, Ann Thorac Surg: 2010

41 Superior Blood transfusion Equivalent Mortality Results Inferior Reoperation for bleeding Stroke

42 Stroke and Minimally Invasive Surgery Stroke Risk increased 2x Linked to fibrillating/beating heart techniques Causes?Air embolism?particulate--aortic screening not analyzed

43 Stroke and Minimally Invasive Surgery Inferences Avoid fibrillating/beating heart surgery Careful de-airing Preop CT to screen for aortoiliac atherosclerosis

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45 Results Longer Operative time Bypass time Myocardial ischemic time

46 Results Superior Blood loss Postoperative pain control Length of stay Cosmesis Patient satisfaction Equivalent Safety Repair rate Repair durability

47 Question #3 What about percutaneous repair?

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49 EVEREST II Randomized Clinical Trial Study Design 279 Patients enrolled at 37 sites Significant MR (3+-4+) Specific Anatomical Criteria Randomized 2:1 Device Group MitraClip System n=184 Control Group Surgical Repair or Replace n=95 Echocardiography Core Lab and Clinical Follow- Up: Baseline, 30 days, 6 months, 1 year, 18 months, and annually through 5 years

50 Is the Clip Effective?

51 Did the Clip Work? 178 treated with MitraClip 41 without acute procedural success 31 with MR >2+ or mitral operation =106 (60%) Sixty percent have MR < 2+ at 1 year

52 Is the Clip Safe?

53 30 Day Modified MAE (%) 30 Day Adverse Events 50 p SUP < % % Major Bleeding Complication* GI Complication New Onset Atrial Fibrillation Ventilation >48hrs Urgent CV Surgery Stroke Death 0 Device Clip Surgery Control *Major bleeding requiring transfusion 2U, or surgical intervention.

54 Subgroup Analyses for Primary End Point at 12 Months Subgroup Clip Surgery Surgery vs. Clip All patients Sex Male Female Age >70 yr <70 yr MR Functional Degenerative LVEF <60% >60% Feldman et al.; NEJM, /181 (55) 63/114 (55) 37/67 (55) 52/86 (60) 48/95 (51) 26/48 (54) 74/133 (56) 35/68 (51) 64/111 (58) 65/89 (73) 43/59 (73) 22/30 (73) 23/38 (61) 42/51 (82) 12/24 (50) 53/65 (82) 15/28 (54) 50/61 (82) Surgery Better Clip Better

55 Who Would I Refer? Severely reduced LVEF Severe comorbidities Renal dysfunction Hepatic dysfunction COPD Frail Porcelain aorta Multiple previous operations

56 Who Would I Refer? Patients with functional MR

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58 Answer Surgical mitral valve repair