Agenda

A unique educational event centered on obligatory attendee participation

Continuing Intervention for Aortic Lesions*

Proposed Goals:

  1. To describe the frequency of and contributing factors for additional and secondary interventions
  2. To better understand the clinical and engineering challenges with additional and secondary interventions
  3. To identify clinical and engineering information needs

* Previous Stent Summit agendas focused on areas of the arterial system (e.g., abdominal, thoraco-abdominal, ascending and arch) and various lesion types (e.g., dissection, aneurysm, stenosis).
The 2017 agenda focuses on the cross-cutting issue of additional and secondary interventions after prior open and endovascular repair.

8:00 AM Registration Opens
Continental Breakfast
8:30-8:40 AM Introduction
Matthew Eagleton, MD (Cleveland Clinic)
Dorothy Abel (US Food and Drug Administration)
8:40-9:00 AM View Presentation View Presentation Update on progress from Greenberg Stent Summit 2016
Kelly Emerton, PhD and Eric Roselli, MD (Cleveland Clinic)
David Minion, MD (University of Kentucky)
9:00-10:00 AM State of the Union (or separation as the case may be)
9:00-9:15 AM Clinical Perspective: Endovascular and surgical reinterventions – how patients present
Matthew Eagleton, MD (Cleveland Clinic)
9:15-9:30 AM Patient Perspectives: Endovascular and surgical reinterventions – effects of different types of interventions and follow-up requirements on quality of life
[Cleveland Clinic patient(s)]
9:30-10:00 AM Discussion
10:00-10:15 AM Break
10:15-3:15 PM Fractures: When are they important; why do they happen; how should patients with fractures be managed; what are the potential risks and benefits of secondary interventions?
10:15-10:25 AM View Presentation FDA Perspective: When do fractures matter with respect to PMA submission?
Dorothy Abel (US Food and Drug Administration)
10:25-10:35 AM Research Perspective: Finding fractures: lessons from CT and conventional x-ray imaging
Ken Ouriel, MD (Syntactx)
10:35-10:45 AM View Presentation Clinical Perspective: When do fractures matter to the clinician?
Patrick Kelly, MD (Sanford Vascular Associates)
10:45-10:55 AM Engineering Perspective: When do fractures matter most to an engineer?
Blayne Roeder, PhD (Cook Medical)
10:55-11:15 AM Discussion
11:15-12:15 PM Case Study: Fractures observed during follow-up
Clinical Discussants: Sean Lyden, MD (Cleveland Clinic)
Ravikumar Veeraswamy, MD (Medical University of South Carolina)
Blinded to the patient management and status
11:15-11:25 AM Clinician (unblinded): Presentation of the case
Hence Verhagen, MD (Erasmus University Medical Center)
11:25-11:35 AM View Presentation Clinician (blinded): Comment on the potential concerns (or lack thereof), and proposed management
William Jordan, MD (Emory University)
11:35-11:40 AM View Presentation Engineer: What I would worry about if it was my device - Potential concerns with different management options
Scott Rush (Bolton Medical)
11:40-11:50 AM Discussion

Unblinded to the patient management and status
11:50-11:55 AM Clinician: What really happened - Presentation of the rationale for patient management and the status of the case
Hence Verhagen, MD (Erasmus University Medical Center)
11:55-12:05 PM Discussion
12:05-12:10 PM View Presentation Engineer: Perspective of an engineer familiar with the technology regarding why the case went the way it did (e.g. the contributing factors that led to the fracture(s)
Craig Myers (Medtronic)
12:10-12:15 PM Discussion
12:15-1:45 PM Lunch
1:45-2:00 PM Introduction to small group exercises and assignment of groups
Matthew Eagleton, MD (Cleveland Clinic)
2:00-2:45 PM View Presentation View Presentation Small group case studies: Fractures observed during follow-up

Unblinded to the patient management and status
Clinician: Presentation of the case
  • Anthony Lee, MD (Boca Raton Regional Hospital)
  • Daniel Clair, MD (University of South Carolina)
  • Michael Dake, MD (Stanford University)
  • Manish Mehta, MD (Vascular Health Partners)

Blinded to the patient management and status
  • Clinicians and engineers propose a management strategy and support the decision, explaining why other strategies were not selected
2:45-3:15 PM Report from each group leader: Presentation of the case, group discussion and reveal of the status of the case with discussion
3:15-3:30 PM Break
3:30-4:15 PM Deep dive into engineering with manufacturers' true stories – not just one case, but the whole story (both recent and historic examples may be shared)
(All questions can be asked. Not all will be answered.)
3:30-3:45 PM Mike Nilson (W.L. Gore & Associates, Inc.)
3:45-4:15 PM Craig Myers (Medtronic)
4:15-5:30 PM Unique Ascending and Arch Challenges
Clinical Discussants: Jean Panneton, MD (Eastern Virginia Medical School)
Wilson Szeto, MD (University of Pennsylvania)
Luis Sanchez, MD (Washington University)
4:15-4:30 PM View Presentation State of the Union
Eric Roselli, MD (Cleveland Clinic)
4:30-5:30 PM View Presentation Case studies with paired clinicians and manufacturers (two 30 min cases with discussion)

Present the case, what happened, and why the case went the way it did (e.g. the contributing factors that led to the problem, comment on why the management has worked or didn't work so far, continuing concerns)

  • Carlos Timaran, MD (UT Southwestern Medical Center)
  • Jarin Kratzberg (Cook Medical)

  • Jean Bismuth, MD (Houston Methodist Hospital)
  • Onica Ramey (W.L. Gore and Associates. Inc.)
5:30 PM Adjourn
6:30 PM Dinner at Shoreby Club
8:00 AM Registration Opens
Continental Breakfast
8:30-12:00 PM Type IIIb Endoleaks (aortic devices and branch-related): When are they important; why do they happen; how should patients with Type IIIb endoleaks be managed (some can be fixed, others may be more difficult); what are the potential risks and benefits of secondary interventions?

Clinical Discussants: Andres Schanzer, MD (UMass Memorial Medical Center)
Mark Fillinger, MD (Dartmouth-Hitchcock Medical Center)
Robert Rhee, MD (Maimonides Medical Center)
8:30-8:40 AM Clinical Perspective: It's the patients' fault
Nabil Chakfé, MD, PhD (University Hospital of Strasbourg)
8:40-8:50 AM Engineering Perspective: It's the engineers' fault (and the clinicians for not telling us what we need to know)
Peter Ziegler (W.L. Gore & Associates, Inc.)
8:50-9:15 AM Discussion
9:15-10:15 AM Case Study: Type IIIb endoleaks observed during follow-up

Blinded to the patient management and status
9:15-9:20 AM View Presentation Clinician (unblinded): Presentation of the case
Zachary Arthurs, MD (San Antonio Military Medical Center)
9:20-9:30 AM View Presentation Clinician (blinded): Comment on the potential concerns (or lack thereof), and proposed management approach
Mark Farber, MD (University of North Carolina, Chapel Hill)
9:30-9:35 AM Engineer: What I would worry about if it was my device - Potential concerns with different management options
Jonathan Furlong (W.L. Gore & Associates, Inc.)
9:35-9:45 AM Discussion

Unblinded to the patient management and status
9:45-9:50 AM View Presentation Clinician: What really happened - Presentation of the rationale for patient management and the status of the case
Zachary Arthurs, MD (San Antonio Military Medical Center)
9:50-10:00 AM Discussion
10:00-10:05 AM Engineer: Perspective of an engineer familiar with the technology regarding why the case went the way it did (e.g. the contributing factors that led to the endoleak(s), comment on why the management has worked or didn't work so far, continuing concerns)
Carlos Ortega (Endologix)
10:05-10:15 AM Discussion
10:15-10:30 AM Break
10:30-11:15 AM View Presentation Small group case studies: Type IIIb observed during follow-up

Unblinded to the patient management and status
Clinician: Presentation of the case and group leader
  • Adam Beck, MD (University of Alabama)
  • Ross Milner, MD (University of Chicago)
  • Nabil Chakfé, MD, PhD (University Hospital of Strasbourg)
  • Matthew Sweet, MD (University of Washington)

Blinded to the patient management and status
  • Clinicians and engineers propose a management strategy and support the decision, explaining why other strategies were not selected
11:15-11:45 AM Report from each group leader: Presentation of the case, group discussion and reveal of the status of the case with discussion
11:45-12:00 PM Manufacturers' true stories – not just one case, but the whole story
(All questions can be asked. Not all will be answered.)
Carlos Ortega (Endologix)
12:00-1:30 PM Lunch
1:30-4:30 PM Migration and Component Separation (aortic devices and branch-related): When are they important; why do they happen; how should patients with migrations be managed; what are the potential risks and benefits of secondary interventions?

Clinical Discussants: Ezequiel Parodi, MD (Cleveland Clinic)
David Deaton, MD (Cleveland Clinic)
Adam Beck, MD (University of Alabama)
1:30-1:37 PM View Presentation Clinical Perspective: It's the patients' fault
Benjamin Starnes, MD (University of Washington)
1:37-1:44 PM Engineering Perspective: It's the engineers' fault (and the clinicians for not telling us what we need to know)
Mark Svendsen (Cook Medical)
1:44-2:00 PM Discussion
2:00-2:20 PM Case Study: Migration or component separation observed during follow-up
2:00-2:05 PM View Presentation Unblinded to the patient management and status
Clinician: Presentation of the case, the rationale for patient management and the status of the case
Matt Thompson, MD (Endologix)
2:05-2:10 PM Engineer: Perspective of an engineer familiar with the technology regarding why the case went the way it did (e.g. the contributing factors that led to the migration, comment on why the management has worked or didn't work so far, continuing concerns)
Peter Costandi (Endologix)
2:10-2:20 PM Discussion
2:20-3:00 PM View Presentation Small group case studies: Migration or component separation observed during follow-up

Unblinded to the patient management and status
  • Clinician: Presentation of the case and group leader
  • Joshua Adams, MD (Carillion Health)
  • Cherrie Abraham, MD (Oregon Health and Science University)
  • David Minion, MD (University of Kentucky)
  • Matthew Sweet, MD (University of Washington)

Blinded to the patient management and status
  • Clinicians and engineers propose a management strategy and support the decision, explaining why other strategies were not selected
3:00-3:30 PM Report from each group leader: Presentation of the case, group discussion and reveal of the status of the case with discussion
3:30-3:45 PM Break
3:45-5:30 PM Toxicity, Biocompatibility, Sterility and Corrosion-Related Problems
3:45-3:55 PM View Presentation Early Inflammatory Responses with Vascular Devices
James Anderson, MD, PhD (Case Western Reserve University)
3:55-4:05 PM Clinical Perspective: Acute implantation syndrome vs sterility-related, toxicity-related, biocompatibility-related or corrosion-related (e.g. nickel allergy, fracture) events
TBD
4:05-4:15 PM View Presentation Nitinol Expert Perspective: Corrosion/nickel release case study
Alan Pelton
4:15-4:30 PM Discussion – Are there any other clinical cases or things to monitor?
4:30-4:40 PM View Presentation FDA Perspective: Past vs. current expectations for evaluations and documentation
Valerie Merkle, PhD (US Food and Drug Administration)
4:40-5:10 PM View Presentation Industry Perspectives: Why have things changed?
(Three 10 min talks)
James Moore (W.L. Gore & Associates, Inc.)
Arif Iftekhar (Endologix)
Robert Whirley
5:10-5:30 PM Discussion – Is there a clear understanding of what FDA expects and why?
5:30 PM Adjourn
6:30 PM Punch Bowl Social Club


⇑ Return to Top 
9:00 AM Wrap Up
  • What are the important items covered?
  • What topics can we begin to address as group/individual?
  • Who will follow up with progress on these items next year?
  • What should we discuss next year?