Advances in Vascular and Cardiac Hybrid Procedures. Eric E. Roselli, MD

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1 Advances in Vascular and Cardiac Hybrid Procedures Eric E. Roselli, MD

2 Disclosures Medtronic Cook Investigator, consultant Terumo Apica Edwards

3 % of Population Baby-Boomers now > 60 U.S. Population over Age to Year

4 Boomers Expectations Conformity Informed consumers Revolution Internet webmd, hospital-based Print journalism newspapers, periodicals Television commercials, Oprah, Oz Health Literacy Access Highest Quality Accountability

5 Minimally Invasive Revolution Small Incisions Intraluminal Robotics Approaches Percutaneous Endovascular Transcatheter

6 MISurgical Techniques Parasternal thoracotomy Partial upper sternotomy Mini-thoracotomy Robotic totally endoscopic Transapical / Transfemoral Safety must be maintained

7 High Hazard Industry Highly complex Technically demanding Mishaps occur Human factors can be ameliorated by system processes Roselli, et al. Reoperations...Rescue. JThoracCVSurg 2008;135:

8 Cardiovascular Care Last Resort Adapting to Δ Advocates for Safety

9 Treatment Options for Complex CardioVascular Disease Make the patient amenable to the currently available devices Hybrid Approach Apply current devices off-label Make new devices applicable to different disease patterns

10 Aortic Surgery 2,000 1,500 Open Asc Arch Repair Open Des Thor Repair Endo Des Thor Repair Open Abd Repair Endo Abd Repair 1,282 % 1,

11 TEVAR n > 1500 at CCF

12 Disease Knows No Boundaries

13 Extensive Aneurysmal Disease Descending + Distal Arch Proximal Arch + Proximal Descending Proximal Arch + Thoracoabdominal + / - Dissection

14 Mesenteric Debranching

15 TAA - EVAR Roselli EE, Greenberg RK, et al. JTCVS 2007

16 Standard TAAA Device Design # 1? Plus in-situ fenestration?

17 Fenestrated Devices Entering Mainstream

18 Space / structure Fixed imaging Data visualization Equipment Hybrid OR

19 Chronic Dissection - Hybrid Solution Pre Post Debranching From: Ascending, Infrarenal or Iliacs Vivacqua A, Roselli E, et al. Ann Thorac Surg, Aorta-Visceral Bx

20 Hybrid Type 2 TAAA: Endo ET n=22 Stentgraft Open Graft VivacquaA, RoselliE, et al. EurJCTSurg, 2014, in press.

21 Complex Arch Disease Requires a Tailored Approach

22 Endovascular Elephant Trunk Completion 1st stage 2nd stage Roselli EE, et al. JTCVS, 2013.

23 Arch Debranching Hybrid 2 stage 1 stage Roselli EE, et al. Antegrade Repair, ATS, 2010.

24 Hybrid Arch Debranching Issues Emboli, Retrograde dissection Size disparity Partial/full sternotomy Proximal aortic disease Associated CV disease Endoleaks

25 Results of Hybrid Arch Repairs Stentgraft in Zone 0 or 1 Study Mortality Stroke SCI IaEL Weigang, % 0% 0% 0% Melissano,07 7.7% 7.7% 0% 19% Czerny,07 7.4% 0% 0% 15% Up to 11% retrograde dissection Bergeron,06 8% 8% 4% 12% AndersenND, HughesGC, et al. JvascSurg 13 Saleh,06 0% 0% 0% 0% Schumacher,06 20% 4% 0% 12% TOTAL 15/144(10%) 5/144(3.5%) 1/144(.7%) 15(10%) Schoder EurJVascEndovSurg, 09.

26 Frozen Elephant Trunk

27 86y/o asc an, chronic dissx

28 Hypothermic Circ Arrest, Selective Brain Perfusion

29 Completion CT

30 Simplified FET for Acute Dissection n = 40 Hybrid OR Novel technique Safe and effective Promotes false lumen thrombosis Expedites tx of ischemia Roselli EE, et al. JTCVS, 2013.

31 Repairing Retrograde Dissection Circ Arrest, Reverse Frozen Elephant Trunk Idrees J, Roselli EE, et al. JTCVS, 2014

32 Hybrid Repair Post-Coarct Aneurysm Idrees J, Roselli EE, et al. JTCVS, 2013.

33 Dedicated Devices Coming Thoraflex Device is Investigational

34

35 View Thru Rt Mini Thoracotomy Robotically-assisted Cardiac Surgery l November 3, 2014 l 35

36 Antegrade Device Delivery

37 Branch Arch Devices Valiant Mona LSA Gore branch Presented at 2013 AATS, Minneapolis, MN

38 Mona LSA System

39 Total Arch Branched Devices

40 High Risk Ascending TEVAR N = 22 Acute Type A Dissection 9 IMH with PAU 2 Pseudoaneurysm 9 Complicated Chronic Dissx 2 Roselli EE, et al. JTCVS, 2014

41 Transapical Repair Acute Type A Dissection Roselli EE, et al; JACC Int, 2013

42 Transaxillary Repair Ascending Pseudoaneurysm

43 Acute Type A with Aneurysm Tx are Complementary NOT Competitive Endoleak Rupture

44

45 Alternate Access: Transapical 1/3 rd screened poor femoral access

46 Delivery and Positioning

47 Transapical TAVI Currently requires mini-thoracotomy

48 Less Invasive Apical Access Automated suturing devices Implantable access and closure devices Potential for percutaneous/port access Re-accessible

49 Ongoing Aortic Valve Trials Intuity Edwards Perceval Sorin Portico St Jude GLX Edwards Solo Sorin Direct Flow XT Edwards S3 Edwards

50 Complex Mitral Procedures Artificial Chordae for MR?Direct approach for MVReplacement Balloon occlusion device for MR

51 ? Composite Valve and Ascending?

52 TAVR, TEVAR, Carotid SG

53 Coronary Hybrids + PCI

54 Hybrid Procedures Aortic aneurysm and dissection Optimizing sealing and fixation, coverage Coronary ITA plus DES Valve Transcather valves Coronary plus Valve Atrial fibrillation Intra plus extracardiac ablation, LAA Thoracic Endobronchial plus VATS Structural Heart options are growing quickly

55 Intraop Team: Personnel Intense OR Surgeon(s) + fellow(s) Anesthesiologist + resident / CRNA OR Nurses, scrub techs RNFA/PA Perfusionist 50% more staff Cath Lab Interventional Cardiologist + fellow(s) Cath Lab Nurses OR and control room Radiology technologist Perfusion Anesthesia Rad Tech Int Cards RN Surgeons Imaging

56

57 Staffing is Expensive Early Duplication of Teams / Roles Potential for Improved Efficiency Cross-Training to achieve efficient staffing models Anesthesia and Cards Imaging + Cath lab and OR nurse + Radiology techs and nurses/pa + Int Cards and Surgeon hybrid ~ Residents, fellows ~ Perfusionist

58 Preparedness Rescues Pump Under Wraps Hybrid OR Best Suited for TAVR Simple Rescue Table Cannulas in reach

59 Expediency and Efficiency Requires A Team Approach The Bull Pen Pump in Action Perfusion Tech RN PA

60 Emergency Use of CPB in TAVR: Importance of Heart Team n = 303; CPB n = 12 (9TA, 3TF) Reasons: severe AI 5 embolization 3 coronary occ 2 bleeding 2 Add procedures: PCI 2 valve in valve 4 SAVR 3 Mortality: 2 / 12 (16%) Roselli EE, et al. JTCVS 14

61 A familiar, experienced, Multi-skilled TEAM with the Proper EQUIPMENT for Imaging, performance and rescue in a Versatile LOCATION will Succeed and Can Continuously Improve!

62 Per Capita National Health-Care Spending 10,000 8,000 6,000 4,000 2, s 1980s 1990s 2000s Source: Medicare Board of Trustees The Wall Street Journal

63 We must ALL get better, TOGETHER! Quality Requires measurement of outcomes Enforced with pay for performance Improvement depends upon INNOVATION Devices/procedures, Knowledge of dz Health care delivery Education Data collection/analysis

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