How to learn the techniquesHow to learn the techniques

Francesco Maisano

San Raffaele Scientific Institute

and University Hospital

Milano

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

2

3

I. Complementary skills

II. Availability of resources

III. Crossfertilization

IV. Seamless patient-oriented care

4

I. … percutaneous heart valve treatment requires skill sets independent of the operator’s base discipline

II. … specific training should be required …

III. Those individuals eligible for the procedural training should be confined to experienced interventionalists and surgeons

IV. … most interventionalists are likely to be cardiologists …

V. …surgeons with appropriate training in percutaneous procedures may directely participate…

Surgery Hwy

Cardio

logy

Hwy

TAVI H

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Leadership Team management Patient oriented

approach

Risk managementComorbidities assessmentBiological age determinationQuality of life based decisionsUnbiased treatment choiceHybrid approaches

Less invasive interventionsMinimally invasive surgery Catheter based interventions

ImagingTimingScreening processImage-guided interventions

I. Accredited postgraduate residency or fellowship training program

II. Alternative pathways for practicing physicians

A. IC with extensive structural heart disease experience

B. Surgeons with valve disease and high risk patients experience

AssociationsPost-graduate courses

UniversitiesFellowships

MeetingsPCR, EACTS, AATS,

TCT, etc Industry supported opportunities

General endovascular training

Device-specific trainingImplantationPatient selectionPerioperative

management

I. Decision makingII. Periprocedural care

A. Focus on comorbidity and ageing

B. Management of complicationsIII. Imaging training

A. Patient selectionB. Procedural planningC. Procedural guidance

IV. Learning the basics of catheter skills

A. Cathlab tutorshipB. Simulator training

V. Learning the basics of surgeryA. OR visitsB. Learn the basic surgical skills

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

                             

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

The Simulated Patient - The Simulated Patient - SimanthaSimantha™™

•Clinical scenario and ‘talking head’

•Real patient images

•Responsive hemodynamics

•Exchangeable catheters

•Adverse event scenarios

•Performance Metrics

“real world” experience

1. visiting, 2. proctoring, 3. exchanging ideas4. mutual support,5. Taking decisions 6. sharing

responsibility…

Visiting centers with experience in Structural heart disease, High risk valve surgery,Transcatheter program

Hibrid approach using the skills from Hibrid approach using the skills from Surgery and ICSurgery and IC

Toghether we can

I. TEAM work is the winning strategy

II. Cross-training facilitates collaboration and seamless multidisciplinary care

III. Close collaboration is enabling cross-fertilization and development of hybrid strategies

IV. It is time to reconsider the role of and relationship among surgeons and interventional cardiologists

Aortic valve implant

OPENOPEN MIS MIS PORT ACCESS PORT ACCESS TRANSCATHETER TRANSCATHETER

Invasiveness

Current surgical approach

I. Minimization of invasiveness

A. To mitigate risks

B. Increase acceptanceII. Tailored treatment

A. Anatomical substrate

B. Underlying disease

C. Patient needs

•Perioperative care•Pain management•Best prosthetic material

•Perioperative care•Pain management•Best prosthetic material

CHANGE REQUIRES ENERGY

MIS PORT ACCESS MIS PORT ACCESS Right Thoracotomy With NecklinesRight Thoracotomy With Necklines

Evolving scenario of valve disese

I. Aging / Increased life expectancy

II. Changing style of lifeA. Quality of life over longevityB. ProductivityC. Esthetic appearance

III. Circulation of informationA. Patients awarenessB. Referral pattern

IV. Limited resources / cost containment

I. New indicationsA. Include the new technologies

in the surgical portfolio

II. AdaptationA. Learn new skillsB. Renovate the surgical facilityC. Revise inhospital pathways

III. Competition with cardiologistsA. CE mark – device availabilityB. Collaboration and teamwork

6 Cardiac Surgeons who adapted for the future

Francesco MaisanoMilano

Michael DavidsonBoston

Eric RoselliCleveland

Mat WilliamsNew York

Grayson WheatleyPhoenix

Thomas WaltherLeipzig

The new skillsI. Catheter skillsII. ImagingIII. Research oriented

A. Tracking resultsB. Comparing surgical vs

interventional outcomesC. Participating/designing Clinical

TrialsIV. Additional knowledge

A. Intellectual propertyB. Research and developmentC. EngineeringD. Regulatory

The training from Industry

I. Edwards, Medtronic and St Jude are actively involved in training surgeons on the new skills

A. EDGE

B. BEST

C. ….II. Start-up companies are not structured to offer this

opportunity

A. E-valve, Corevalve

Collaboration is possibleCollaboration is possible

Surgeon: We do not reject anybody !!

Cardiologist: But we do not send them !

Retraining the trained

I. AssociationsA. Post-graduate

coursesB. Training

opportunities during main meetings

II. UniversitiesA. Fellowships

III. MeetingsA. EACTS, AATS, TCT,

PCR, etcIV. Industry

A. General endovascular training

B. Device-specific training

Team up all experts

Voyeuristic attitude

vs

Active position

The future of mitral valve surgery

I. Minimally invasive and transcatheter approach

II. Image guidance and computer aided decision making

III. Devices will beA. ethiology-specific

B. Adjustable

C. Implantable with no or minimal conventional suturing

IV. Early repair

V. Stepwise and combined strategies

The cardiac surgeon of the future

Tailored approach – the best option for the patient

The new “interventional” The new “interventional” cardiac surgeoncardiac surgeon

Francesco MaisanoFrancesco Maisano

San Raffaele University HospitalSan Raffaele University Hospital

Milano - ItalyMilano - Italy

Cross trainingCross trainingre-training the trainedre-training the trained

I. Is cross training necessary?II. Is it feasible?III. How to do it?IV. What are the interventional technical and

cognitive skills needed to run a transcatheter vave procedure?

V. How to renovate the OR facility and train the Team?

VI. How should be the optimal training program?

DISCLOSURESDISCLOSURES

I. Consulting agreement with Edwards Lifesciences LLC for endovascular mitral valve repair

II. Acknowledge relationship with several interventional cardiologists including Maurice Buchbinder, Antonio Colombo, Alec Vahanian, John Webb.

The backgroundThe background

1998 The concept1999 Milano I

1. Open chest2. Closed heart

2001 Milano II1. Transcatheter2. Percutaneou

s2004 Crosstraining2005 First in Man

1. endovascular E2E in the OR

Percutaneous Valve Interventions (PVI) 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….

I. … percutaneous heart valve treatment requires skill sets independent of the operator’s base discipline

II. … specific training should be required …

III. Those individuals eligible for the procedural training should be confined to experienced interventionalists and surgeons

IV. … most interventionalists are likely to be cardiologists …

V. …surgeons with appropriate training in percutaneous procedures may directely participate…

SURGERY CARDIOLOGY

INVASIVENESS

Off pump

Port

access

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ndoscopic

Robotic

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Percutaneous

Valve d

iseas

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Per

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Sep

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A

SD/VSD cl

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Overlapping targets

PVI

The ideal Transcatheter The ideal Transcatheter Valve InterventionalistValve Interventionalist

I. Anatomy

II. Physiology

III. Pathology

IV. Natural history

V. Risk Assessment

VI. Engineering

VII. Research

I. Surgical skills

II. Endovascular skills

III. Knowledge of the materials

IV. Echocardiography

V. Fluoroscopy

VI. Anesthesiology

CrosstrainingCrosstraining a personal experience a personal experience

I. 2003 Design the strategy with Ottavio AlfieriII. 2003 Internal agreement and authorizations

I. Identification of common strategies with Antonio Colombo II. Institution of a study group (TEAM WORK)III. Authorization from Hospital managementIV. Acquisition of the Fluoroscopy equipment / Radioprotection courses

III. 2004 3 months of cath-lab full immersion (3 days/week) I. Basic endovascular skillsII. First operating diagnostic proceduresIII. First assisting in complex procedures

IV. -2005 Continuing training (at least 2 half days/week)I. Interesting cases (mainly non coronary)II. Percutaneous aortic valve implantation

V. 2002–2005 “parallel training”I. Selected readings (manuals and journals)II. Animal labIII. Bench simulatorsIV. Computer simulatorsV. 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 referralsNeed for backup from colleguesSome skills easier to achieve (imaging, decision making, etc)Manipulation skills more intuitive than expectedNew material, instruments, devices to know

Time consuming / need planningVery informative Difficult to get involved activelyMeeting new friends /referrals

No time limitationsNo risk for the patientsDevice specific

Cath labCath lab

I. Vascular access II. CatheterizationIII. AngiographyIV. PTCAV. Non coronary

interventionsVI. Material inventoryVII. Simple diagnostics

done in the OR

Computer simulatorsComputer simulators

I. Highly realistic simulation based endovascular training using realistic 3D patient anatomies, simulating real tools, tactile feedback, different cases, scenarios and complications.

II. Already in use for training for angiography, angioplasty and coronary and carotid stenting

III. Training sessions available at major cardiology meetings

IV. Echo-based simulators needed

Bench SimulatorsBench Simulators

I. Device specificII. Useful to explore the

device function by direct vision

III. Correlation between manipulations and effects

IV. No time limitationsV. Less expensive than

animal lab

Animal LabAnimal Lab

I. Very realistic set-up to learn catheter manipulation and management

II. General endovascular training (e.g. transeptal)

III. Device-specific endovascular skills

IV. Excellent for team training

V. Expensive

Transeptal punctureTranseptal puncture

I. “The” endovascular skill for mitral valve

II. Difficult and riskyIII. Echo guidance

A. SafetyB. Precision

IV. A surgeon invented it – so we can learn it

V. Few (<5%) interventional cardiology centers routinely perform this technique

Imaging and other enabling Imaging and other enabling technologiestechnologies

I. ICE

II. 3D echo

III. Multislice CT

IV. MRI

V. Stereotaxis

VI. Combinations

The Renovation processThe Renovation process

I. The FacilityA. radiologic portable machine

B. The hybrid room

C. The materials

II. The TeamA. Multidisciplinary

TEAMWORK1. Cardiologist

2. Interventional cardiologist

3. Vascular surgeon

4. Echocardiographist

5. Clinical cardiology

6. Anesthesiologist

7. Nurses

Surgery Hwy

Cardiology Hwy

Percutaneous

valve Hw

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Impressions from “cross-training”Impressions from “cross-training”

I. Cross training is feasibleA. Time

B. Dedication

C. Humility – go back to school

D. Positive environment

• Opportunity of learning new stuff

• Broadening the view• Think as the cardiologists• Improve catheter skills for

everyday surgical practice

Standardization of training pathways

The future trainingThe future training

I. Accredited postgraduate residency or fellowship training program

A. Reduce the years spent in general surgery B. 3 years of “general cardiac surgery”C. One additional year for specialization in

1. Pediatric2. General cardiac / Thoracic surgery3. Interventional surgery

II. Alternative pathwayA. Cross trainingB. Bench training and SimulatorsC. Animal labD. EACTS sponsored postgraduate coursesE. Industry sponsored postgraduate courses

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The future interventional The future interventional cardiac surgeoncardiac surgeon

I. Full trained in heart surgery(sub specialized?) and cross trained

II. Minimally invasive as a broad view

III. Patient and disease oriented – expert of the disease and mastering all possible technical solutions: conventional, minimally invasive (endoscopic and robotics) and endovascular treatment

IV. Scientific oriented - Tracking results, Comparing surgical vs interventional outcomes, Participating/designing Clinical Trials

V. Technology and Innovation oriented Intellectual property, Research and development, Engineering, Regulatory

…The Greatest Risk Is Not Taking One…

AcknowledgementsAcknowledgementsI. Ottavio Alfieri (inspiring and letting me doing it)II. My collegues (covering my duties)III. Antonio Colombo (teaching me a lot, and

demonstrating friendship)IV. David Zarbatany (who developed the device and

believed in me from the very beginning)V. Maurice Buchbinder (encouraging me and teaching

with open mind)VI. Edwards Lifesciences LLC (Don Bobo, Stan Rowe,

Marcello Conviti, Luigi Bertana) (understanding the role of surgeons in the catheter evolution)

VII. Pieter Kappetein (envisioning with me the future training requirements )

VIII. My Family (understanding me)

Subclavian access (Corevalve TM)Subclavian access (Corevalve TM)

I. Short delivery distance

II. Painless

III. Local anesthesia

IV. Retrograde approach

Subclavian access (Corevalve TM)Subclavian access (Corevalve TM)

I. Short delivery distance

II. Painless

III. Local anesthesia

IV. Retrograde approach