The document discusses the need for cross-training of surgeons and interventional cardiologists in percutaneous heart valve treatment. It states that the procedure requires skills independent of one's base discipline, and that specific training is required. Those undergoing the procedural training should be experienced interventionalists or surgeons. The document then outlines various pathways for acquiring the necessary skills through simulation, proctoring, visiting other centers, and industry-supported opportunities.

1. How to learn the techniques Francesco Maisano San Raffaele Scientific Institute and University Hospital Milano

2. Speaker ’ s name: Francesco Maisano  I have the following potential conflicts of interest to report:  Consulting for Edwards Lifesciences LLC, Micardia Corp, Medtronic Inc, Nycomed  Honoraria from St Jude Medical  Royalties from Edwards Lifesciences LLC

4. Complementary skills Availability of resources Crossfertilization Seamless patient-oriented care

5. … percutaneous heart valve treatment requires skill sets independent of the operator’s base discipline … specific training should be required … Those individuals eligible for the procedural training should be confined to experienced interventionalists and surgeons … most interventionalists are likely to be cardiologists … … surgeons with appropriate training in percutaneous procedures may directely participate…

6. Surgery Hwy Cardiology Hwy TAVI Hwy

7. Leadership Team management Patient oriented approach Risk management Comorbidities assessment Biological age determination Quality of life based decisions Unbiased treatment choice Hybrid approaches Less invasive interventions Minimally invasive surgery Catheter based interventions Imaging Timing Screening process Image-guided interventions

8. Accredited postgraduate residency or fellowship training program Alternative pathways for practicing physicians IC with extensive structural heart disease experience Surgeons with valve disease and high risk patients experience

10. Associations Post-graduate courses Universities Fellowships Meetings PCR, EACTS, AATS, TCT, etc Industry supported opportunities General endovascular training Device-specific training Implantation Patient selection Perioperative management

11. Decision making Periprocedural care Focus on comorbidity and ageing Management of complications Imaging training Patient selection Procedural planning Procedural guidance Learning the basics of catheter skills Cathlab tutorship Simulator training Learning the basics of surgery OR visits Learn the basic surgical skills

12. No major aircraft company today launches a new aircraft without simultaneously contracting for a suite of simulation devices.

13. Simulation: learning the basics – Hands-on simulators and bench models

14. The Simulated Patient - Simantha ™ Clinical scenario and ‘talking head’ Real patient images Responsive hemodynamics Exchangeable catheters Adverse event scenarios Performance Metrics

16. “ real world” experience visiting, proctoring, exchanging ideas mutual support, Taking decisions sharing responsibility… Visiting centers with experience in Structural heart disease, High risk valve surgery,Transcatheter program

21. Hibrid approach using the skills from Surgery and IC

22. Toghether we can TEAM work is the winning strategy Cross-training facilitates collaboration and seamless multidisciplinary care Close collaboration is enabling cross-fertilization and development of hybrid strategies It is time to reconsider the role of and relationship among surgeons and interventional cardiologists

23. Aortic valve implant OPEN MIS PORT ACCESS TRANSCATHETER Invasiveness

24. Current surgical approach Minimization of invasiveness To mitigate risks Increase acceptance Tailored treatment Anatomical substrate Underlying disease Patient needs Perioperative care Pain management Best prosthetic material

25. CHANGE REQUIRES ENERGY

26. MIS PORT ACCESS Right Thoracotomy With Necklines

27. Evolving scenario of valve disese Aging / Increased life expectancy Changing style of life Quality of life over longevity Productivity E sthetic appearance Circulation of information Patients awareness Referral pattern Limited resources / cost containment

28. New indications Include the new technologies in the surgical portfolio Adaptation Learn new skills Renovate the surgical facility Revise inhospital pathways Competition with cardiologists CE mark – device availability Collaboration and teamwork

29. 6 Cardiac Surgeons who adapted for the future Francesco Maisano Milano Michael Davidson Boston Eric Roselli Cleveland Mat Williams New York Grayson Wheatley Phoenix Thomas Walther Leipzig

30. The new skills Catheter skills Imaging Research oriented Tracking results Comparing surgical vs interventional outcomes Participating/designing Clinical Trials Additional knowledge Intellectual property Research and development Engineering Regulatory

31. The training from Industry Edwards, Medtronic and St Jude are actively involved in training surgeons on the new skills EDGE BEST … . Start-up companies are not structured to offer this opportunity E-valve, Corevalve

32. Collaboration is possible Cardiologist: But we do not send them ! Surgeon: We do not reject anybody !!

33. Retraining the trained Associations Post-graduate courses Training opportunities during main meetings Universities Fellowships Meetings EACTS, AATS, TCT, PCR, etc Industry General endovascular training Device-specific training

34. Team up all experts

35. Voyeuristic attitude vs Active position

36. The future of mitral valve surgery Minimally invasive and transcatheter approach Image guidance and computer aided decision making Devices will be ethiology-specific Adjustable Implantable with no or minimal conventional suturing Early repair Stepwise and combined strategies

37. The cardiac surgeon of the future Tailored approach – the best option for the patient

38. The new “interventional” cardiac surgeon Francesco Maisano San Raffaele University Hospital Milano - Italy

39. Cross training re-training the trained Is cross training necessary? Is it feasible? How to do it? What are the interventional technical and cognitive skills needed to run a transcatheter vave procedure? How to renovate the OR facility and train the Team? How should be the optimal training program?

40. DISCLOSURES Consulting agreement with Edwards Lifesciences LLC for endovascular mitral valve repair Acknowledge relationship with several interventional cardiologists including Maurice Buchbinder, Antonio Colombo, Alec Vahanian, John Webb.

41. The background 1998 The concept 1999 Milano I Open chest Closed heart 2001 Milano II Transcatheter Percutaneous 2004 Crosstraining 2005 First in Man endovascular E2E in the OR

42. Percutaneous Valve Interventions (PVI) DIFFERENT POINTS OF VIEW Will never work / will never impact my practice Another chapter of cardiac surgery at risk of extinction / Another reason to fight with the Cardiologists An opportunity to offer a better treatment to our patients / to widen indications / to get more surgical candidates The official position….

43. … percutaneous heart valve treatment requires skill sets independent of the operator’s base discipline … specific training should be required … Those individuals eligible for the procedural training should be confined to experienced interventionalists and surgeons … most interventionalists are likely to be cardiologists … … surgeons with appropriate training in percutaneous procedures may directely participate…

44. Overlapping targets SURGERY CARDIOLOGY INVASIVENESS Off pump Port access Endoscopic Robotics Percutaneous Valve disease Peripheral stenting CPS Septal ablation ASD/VSD closure PVI

45. The ideal Transcatheter Valve Interventionalist Anatomy Physiology Pathology Natural history Risk Assessment Engineering Research Surgical skills Endovascular skills Knowledge of the materials Echocardiography Fluoroscopy Anesthesiology

46. Crosstraining a personal experience 2003 Design the strategy with Ottavio Alfieri 2003 Internal agreement and authorizations Identification of common strategies with Antonio Colombo Institution of a study group (TEAM WORK) Authorization from Hospital management Acquisition of the Fluoroscopy equipment / Radioprotection courses 2004 3 months of cath-lab full immersion (3 days/week) Basic endovascular skills First operating diagnostic procedures First assisting in complex procedures -2005 Continuing training (at least 2 half days/week) Interesting cases (mainly non coronary) Percutaneous aortic valve implantation 2002–2005 “parallel training” Selected readings (manuals and journals) Animal lab Bench simulators Computer simulators Interventional meetings (TCT, PCR, JIM) Conflicting interests (cardiac surgeons, interventionalists, vascular surgeons, electrophysiology) Hospital management not ready – lack of clinical application Time consuming and difficult to reproduce Clinical activity at risk / troubles with referrals Need for backup from collegues Some skills easier to achieve (imaging, decision making, etc) Manipulation skills more intuitive than expected New material, instruments, devices to know Time consuming / need planning Very informative Difficult to get involved actively Meeting new friends /referrals No time limitations No risk for the patients Device specific

47. Cath lab Vascular access Catheterization Angiography PTCA Non coronary interventions Material inventory Simple diagnostics done in the OR

48. Computer simulators Highly realistic simulation based endovascular training using realistic 3D patient anatomies, simulating real tools, tactile feedback, different cases, scenarios and complications. Already in use for training for angiography, angioplasty and coronary and carotid stenting Training sessions available at major cardiology meetings Echo-based simulators needed

49. Bench Simulators Device specific Useful to explore the device function by direct vision Correlation between manipulations and effects No time limitations Less expensive than animal lab

50. Animal Lab Very realistic set-up to learn catheter manipulation and management General endovascular training (e.g. transeptal) Device-specific endovascular skills Excellent for team training Expensive

51. Transeptal puncture “ The” endovascular skill for mitral valve Difficult and risky Echo guidance Safety Precision A surgeon invented it – so we can learn it Few (<5%) interventional cardiology centers routinely perform this technique

52. Imaging and other enabling technologies ICE 3D echo Multislice CT MRI Stereotaxis Combinations

53. The Renovation process The Facility radiologic portable machine The hybrid room The materials The Team Multidisciplinary TEAMWORK Cardiologist Interventional cardiologist Vascular surgeon Echocardiographist Clinical cardiology Anesthesiologist Nurses

54. Impressions from “cross-training” Cross training is feasible Time Dedication Humility – go back to school Positive environment Opportunity of learning new stuff Broadening the view Think as the cardiologists Improve catheter skills for everyday surgical practice Surgery Hwy Cardiology Hwy Percutaneous valve Hwy Standardization of training pathways

55. The future training Accredited postgraduate residency or fellowship training program Reduce the years spent in general surgery 3 years of “general cardiac surgery” One additional year for specialization in Pediatric General cardiac / Thoracic surgery Interventional surgery Alternative pathway Cross training Bench training and Simulators Animal lab EACTS sponsored postgraduate courses Industry sponsored postgraduate courses Courtesy of P.Kappetein

56. The future interventional cardiac surgeon Full trained in heart surgery(sub specialized?) and cross trained Minimally invasive as a broad view Patient and disease oriented – expert of the disease and mastering all possible technical solutions: conventional, minimally invasive (endoscopic and robotics) and endovascular treatment Scientific oriented - Tracking results, Comparing surgical vs interventional outcomes, Participating/designing Clinical Trials Technology and Innovation oriented Intellectual property, Research and development, Engineering, Regulatory

57. … The Greatest Risk Is Not Taking One…

58. Acknowledgements Ottavio Alfieri (inspiring and letting me doing it) My collegues (covering my duties) Antonio Colombo (teaching me a lot, and demonstrating friendship) David Zarbatany (who developed the device and believed in me from the very beginning) Maurice Buchbinder (encouraging me and teaching with open mind) Edwards Lifesciences LLC (Don Bobo, Stan Rowe, Marcello Conviti, Luigi Bertana) (understanding the role of surgeons in the catheter evolution) Pieter Kappetein (envisioning with me the future training requirements ) My Family (understanding me)

63. Subclavian access (Corevalve TM) Short delivery distance Painless Local anesthesia Retrograde approach

67. Subclavian access (Corevalve TM) Short delivery distance Painless Local anesthesia Retrograde approach