The Cardiac Surgeon of the Future

Transcription

1 The Cardiac Surgeon of the Future Gorav Ailawadi, MD Chief, Section of Adult Cardiac Surgery Professor, Surgery & Biomedical Engineering Director, Minimally Invasive Cardiac Surgery July 19, 2017

2 Disclosures Abbott Vascular: Consultant Edwards Lifesciences: Consultant Medtronic: Consultant Mitralign: Consultant St. Jude: Consultant Atricure: Consultant All are modest

3 Objectives To understand opportunities lost in cardiac surgery To understand the potential benefits of new technologies in Cardiac Surgery To understand the future of cardiac diseases

4 Outline Cardiac Surgery: Brief History Current and Novel Approaches to Valve Disease Future of Our Specialty

5 Andreas Gruentzig German Physician Developed and Performed 1st PCI in 1977 Reported 4 successful cases at AHA Concept shunned by cardiac surgeons

6 Present Day CABG Volumes

7 Present Day Cardiologists

8 Pacemaker Engineer Earl Bakken developed 1 st pacemaker 1 st implanted pacer by Surgeon Ake Senning What happened?

9 Rising Pacemaker Volume

10 Where are the Opportunities for Cardiac Surgeons today?

11 Current Revolution in Valve Diseases

12 Aortic Valve

13 Millions Aging US Population Independent clinical factors associated with degenerative aortic valve disease include the following: Increasing age Male gender Hypertension Smoking Elevated lipoprotein A Elevated LDL cholesterol Population Age 65 and Over and Age 85 and Over, Selected Years and Projected and Over 85 and Over 10 LDL = low-density lipoprotein Note: Data for are projectors of the population Reference population: 2008 these data refer to the resident population. Projected Population. Accessed January 30, US Census Bureau, Decennial Census, Population Estimates and Projections.

14 Prevalence of AS AS is estimated to be prevalent in up to 7% of the population over the age of Million People in United States Over the Age of 65 7% More likely to affect men than women; 80% of adults with symptomatic AS are male Percentage Diagnosed with AS Ramaraj R, et al. BMJ. 2008;336(7643):

15 Percent Mortality in Standard Rx Perspectives Year Survival: Metastatic Cancer % 28% 23% 23% 30% 28% 12% 12% 5% 5% 3% * 3% * Breast Lung Colorectal Prostate Ovarian Severe Inoperable A Breast Lung Colorectal Prostate Ovarian Severe Inoperable AS Courtesy of Murat Tuzcu, MD

16 Aortic Valve Replacement Options Open Heart (Full Sternotomy/ Incision) Minimally Invasive Approaches Sutureless Aortic Valve Replacement TAVR (Transcatheter Replacement)

17 Minimally Invasive AVR Upper hemi-sternotomy R 2 nd Intercostal

18 Minimally Invasive AVR Useful for Young and Old Speeds in Recovery, Return to work

19 Minimally Invasive AVR Provides Equivalent Outcomes to Conventional AVR without Increased Cost: An Analysis of a Multi-Institutional Regional STS Database Ravi K. Ghanta MD 1, Damien J. Lapar MD, MSc 1, John A. Kern MD 1, Irving L. Kron MD 1, Allen M. Speir MD 2, Edwin Fonner Jr., DrPH 3, Mohammed Quader MD 4, and Gorav Ailawadi MD 1 1 University of Virginia, Charlottesville, VA USA 2 Inova Heart and Vascular Institute, Falls Church, VA USA 3 Virginia Cardiac Surgery Quality Initiative, Richmond, VA USA 4 Virginia Commonwealth University, Richmond, VA, USA

20 Mini vs Conventional AVR Volume AVR and Mini-AVR Volume (754 patients; ) Partial Sternotomy (159; 87%) Right Thoracotomy (23; 13%) Mini AVR % Conventional AVR %

21 Operative Characteristics Propensity Matched Cohort Conventional AVR (n=181) Mini AVR (n=181) *Bypass Time (mins) *Cross-Clamp Time (mins) *Intraop Blood Products 68 (37.6%) 32 (17.7%) <0.001 p Mini AVR Increased Bypass & Cross-Clamp Time. Decreased Intraop Blood Products

22 Outcomes Propensity Matched Cohort Conventional AVR (n=181) Mini AVR (n=181) Death 5 (2.8%) 5 (2.8%) 1.00 Stroke 2 (1.1%) 4 (2.2%) 0.69 Renal Failure 4 (2.2%) 3 (1.7%) 1.00 Atrial Fibrillation 42 (23.2%) 45 (24.9%) 0.81 Deep Sternal Wound Infection 1 (0.6%) 1 (0.6%) 1.00 Reop for Bleed 8 (4.4%) 7 (3.9%) 1.00 *Blood Product Transfusion 75 (41.4%) 54 (29.9%) 0.03 Prolonged Ventilation 20 (11.0%) 23 (12.7%) 0.46 Vent Time (hours) 6.9 (4.4, 13.6) 6.1 (4.0, 15.6) 0.43 ICU Length of Stay (hours) 42.9 (24.6, 74.4) 45.5 (23.3, 93.4) 0.80 Hospital Length of Stay (days) 6.0 (5.0, 9.0) 6.0 (4.0, 9.0) 0.12 Equivalent Mortality and Morbidity. Equivalent Vent Time and Length of Stay. Decreased Blood Products with Mini-AVR. p

23 Next Generation of AVR: Sutureless Transcatheter Aortic Valve Replacement has changed our thinking about need for sutures during AVR Several New Technologies in Study to evaluate use of Sutureless AVR

24 Potential Benefits: Why Sutureless? Shorter Cross Clamp Time May be beneficial for early postop recovery May allow more Minimally invasive Incisions for AVR May be beneficial for Multiple valve procedures May have lower gradients

25 Perceval

26 Perceval Implantation

27 FDA Perceval Trial

28 Transcatheter Aortic Valve Replacement Has Revolutionized AVR AVR without incision, without CPB

29 TAVR Deployment

30 TAVR Summary Limitations: Pacemaker Need, Paravalvular leak, Neurologic events TAVR approved for High risk/ Inoperable Patients (STS risk > 8%) 85yo F s/p CABG, lives in a Wheelchair on Oxygen TAVR approved for Intermediate Risk (STS 3-8%) 80yo Active F with Creatinine 1.8

31 All-Cause Mortality at 30 Days Edwards SAPIEN Valves (As Treated Patients) PARTNER I and II Trials Overall and TF Patients SAPIEN SXT SAPIEN 3

32 Aortic Stenosis Patient Algorithm Low Risk (STS<4) AVR PARTNER 3 Trial Med Risk (STS 3-8) AVR (Stented/Sutureless) TAVR Mid-risk Hi Risk (STS>8) Inoperable (STS>15) AVR (Stented/Sutureless) Apical conduit TAVR TAVR Medical Tx

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34 Alternative Approach Case 84yo 2 previous CABG Calcified iliacs Calcified LV aneurysm Conventional not feasible Transcaval?

35 Caval to Aorta

36 Closure Device

37 Mitral Valve

38 Prevalence (%) of moderate to severe valve disease Mitral >> Aortic Valve Disease Increases with Age All valve disease Mitral valve disease Aortic valve disease < >75 Age (years) > 9.3% for 75 year olds (p<.0001)

39 Mitral Valve Options Open Heart (Full Sternotomy) Minimally Invasive (Right Chest Port Access) Robotic Mitral Surgery Transcatheter/ MitraClip Novel Repair/ Replacement Devices

40 Mitral Repair

41 Minimally Invasive: Incision Comparison Hemi-sternotomy Mini-thoracotomy Robotic

42 Technique for MIS Mitral Surgery

43 MitraClip vs. MIS Surgery 91 yo M with class 2 CHF Severe MR, P2 Flail, A2 Torn Cord Referred for MitraClip

44 Preop Echo

45 Mini Mitral Repair Video

46 Postop Echo

47 2 Months Postop

48 Age Patients Who Underwent Mini-Valve Surgery (N>300) Age Range

49 What if Surgery Not an Option? Transcatheter Options available Tradeoff of less invasive for less efficacy Many novel devices on horizon

50 MitraClip Therapy Approved for Prohibitive Risk DMR Indication: The MitraClip Clip Delivery System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.

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52 Case Example 88yo F with ischemic MR s/p MI with 2 coronary stents placed 3/09 MR 3+, EF 45% Symptomatic Class III CHF Able to ambulate but mostly Sedentary hospitalized last year for CHF STS risk of Mortality: 7% STS risk of Morbidity or Mortality: 28.2%

53 MitraClip Placement

54 3D TEE Imaging

55 Post-Procedure

56 Surgeon Involvement as a Percent of Total US Procedures Remains Flat to Declining Despite growing interest, cardiac surgeons are involved in ONLY ~15% of all MitraClip cases performed in the US 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Other Surgeon Abbott Vascular Confidential, for advisory board purposes only. Do not distribute, reproduce, or excerpt Abbott. All rights reserved. 56

57 Percent Patients Percent Patients Improvement in MR Similar Surgeon vs. Cardiologist Surgeon Treated Cohort (N = 47) Non-Surgeon Treated Cohort (N = 372) Baseline 4+ Discharge Baseline 4+ Discharge

58 Transcatheter Mitral Repair -What s on the horizon?

59 Neochord

60 The Harpoon Device FACILITATES Image-guided Placement and Anchoring of eptfe Cords ENABLES Real-time Titration of eptfe Cords on the Beating Heart and Maximization of Coaptation Courtesy of J Gammie

61 Harpoon Technology: Low-profile (8 F) Delivery System Preformed eptfe Knot Knot Formed on Atrial Surface of Mitral Leaflet Secure Anchoring of eptfe Suture to Leaflet Courtesy of J Gammie

62 Valtech Cardioband Procedure - Step by Step 1 Transseptal Puncture 2 System Insertion 3 Implant Deployment 4 Implant Size Adjustment 62

63 90% patients with MR 2 At 12 Months % MR 2+ at Discharge 86% MR 2+ at 1 Month 85% MR 2+ at 6 Months 90% MR 2+ at 12 Months Baseline Discharge 1 month 6 months 12 months N=35 N=33 N=29 N=20 N=10 24/33 Patients with MR Mild at discharge 63

64 MILLIPEDE PERCUTANEOUS ANNULOPLASTY Percutaneous, or Minimally Invasive annuloplasty ring Designed to effectively resolve functional valve regurgitation Reproduce the surgical gold standard clinical outcomes in cath lab CONFIDENTIAL - PROPERTY OF MILLIPEDE LLC

65 Mitral Replacement

66 Ischemic MR, Preop Echo 56yo previous Inferior MI, Severe symptomatic IMR EF 40%, severely tethetered P3

67 MVR Video

68 Abbott Vascular Confidential, for advisory board purposes only. Do not distribute, reproduce, or excerpt Abbott. All rights reserved. 68

69 Transcatheter Mitral Valve Repair/ Replacement >$2.5 Billion spent in last 6 months for 6 companies with a combined total of ~50 cases! Abbott Vascular Confidential, for advisory board purposes only. Do not distribute, reproduce, or excerpt Abbott. All rights reserved. 69

70 Transcatheter Mitral Valves in Early Clinical Studies Transseptal and Transapical Transapical Only Transsepta l Only CardiAQ- Edwards Tendyne Twelve Tiara Caisson Delivery System Size 33 Fr 32 Fr 35 Fr 32 Fr 31 Fr Valve Size 40 mm 27 mm 27 mm 35, 40 mm 27 mm

71 Tendyne Implant Video

72 Tricuspid Valve The Forgotten Valve Less Commonly Affected Associated with Significant Comorbidity Simplest Valve to fix surgically Op Mortality ~10% in nation

73 Procedure Animation Site Initiation Presentation Confidential 04 November 2015

74 Hybrid OR

75 Emerging Interface (2010) Surgery Transcatheter Valve Therapy Abbott Vascular Confidential, for advisory board purposes only. Do not distribute, reproduce, or excerpt Abbott. All rights reserved. 75

76 Overlapping Interface (2020) Surgery Transcatheter Valve Therapy Abbott Vascular Confidential, for advisory board purposes only. Do not distribute, reproduce, or excerpt Abbott. All rights reserved. 76

77 Future Cardiac Surgeon Must be comfortable in Hybrid OR Must Accept Change (Patients accept inferior result for less invasive approach) Must Work well in Team with Cardiologists

78 Conclusions 1. Cardiac Surgeons were Considered The Cheetahs of the Animal Kingdom 2. Cardiac Surgeons Know How to perform Complex Interventions in Less Invasive Ways 3. With aging population and numerous new technologies, this is an Amazing Time for our Specialty

79 Thank you! UVA Advanced Heart Valve Center MDs: Ailawadi, Dent, Kern, Kron, Lim, Ragosta, Yarboro Study coordinators: Bailes, Cosner, Garrison, McKeel, Simon NP/PA: Hardy, Armstron Administrator: Laramy