1. Early Feasibility Studies Investigator Perspective
Mayra Guerrero, MD, FACC, FSCAI
Director of Cardiac Structural Interventions
NorthShore University HealthSystem
CRT 2017
Washington, DC
Feb 19, 2017

2. Disclosure Statement of Financial Interest
Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.
Affiliation/Financial Relationship
Company
Research Grant Support, Proctor
Consultant
Speaker’s Bureau
Edwards Lifesciences
Tendyne Holdings/Abbott
Abiomed
Off label use of products and investigational devices will be discussed in this presentation

3. We need early feasibility studies
How early?

4. No animal model or MAC Can’t replicate comorbidities
Can’t replicate anatomic features to evaluate:
Anchoring
LVOT obstruction, etc
We needed to move to EFS with limited data
from VinV, VinR and V in MAC registries

5. Registy Limitations Self reported outcomes Missing data
Lack of imaging core labs
Lack of event adjudication
Potential for bias errors at many levels

6. Mitral Implantation of TRAnscatheter vaLves
The MITRAL Trial
Mitral Implantation of TRAnscatheter vaLves
Inclusion Criteria
Native MV (MAC)
Valve-in-Ring
Valve-in-Valve
Calcific MS (MVA ≤1.5 cm2)
Severe MR + Mod MS
NYHA II or greater
Not surgical candidate
Failing surgical ring
Severe MR or MS
NYHA II or greater
Not surgical candidate
Failing Bioprosthesis
Severe MR or MS
NYHA II or greater
Not surgical candidate
“Goal Transeptal Access in Most Patients”

7. Clinical Outcomes relative to experience
104 patients from 47 centers in 11 countries (Sept 2012-April 2016)
Outcome
First 1/3
(n=32)
n (%)
Second 1/3 (n=32)
Third 1/3
(n=40)
Technical success * MVARC criteria
20 (62.5%)
27 (84.4%)
32 (80%)
30 Day Mortality
12 (37.5%)
7 (21.9%)
6 (15%)
Complications
Valve Embolization
3 (9.3%)
1 (3.1%)
LVOTO
4 (12.5%)
2 (6.2%)
5 (12.5%)
Need for a second valve
2 (5%)
Cardiac Perforation
2 (6.25%)
Conversion to open surgery
EuroPCR 2016

8. Role of Anterior Leaflet Resection prior to TMVR

9. Role of Anterior Leaflet Resection prior to TMVR

10. Role of Anterior Leaflet Resection prior to TMVR
6-month follow
NYHA I
Mean MVG 4 mmHg
Mean LVOT gradient 5 mmHg

11. Surgical Implantation of TRAnscatheter vaLve in Native MAC
SITRAL Trial
Surgical Implantation of TRAnscatheter vaLve in Native MAC
Baylor Research Institute
PI Robert Smith, MD
30 patients
Start April 2016
Transatrial TMVR with SAPIEN 3

12. Percutaneous Anterior Leaflet Laceration prior to TMVR
LAMPOON
Laceration of the Anterior Mitral leaflet to Prevent LVOT ObstructioN
Khan et al, JACC Intv 2016;9:

13. Laceration of the Anterior Mitral leaflet to Prevent LVOT ObstructioN
LAMPOON Trial
Laceration of the Anterior Mitral leaflet to Prevent LVOT ObstructioN
PI Robert Lederman, MD NHLBI
Locations:
Emory University
Henry Ford Hospital
Evanston Hospital

14. Clinical Outcomes relative to experience
This learning curve should be faster with EFS than with Registries
Outcome
First 1/3
(n=32)
n (%)
Second 1/3 (n=32)
Third 1/3
(n=40)
Technical success * MVARC criteria
20 (62.5%)
27 (84.4%)
32 (80%)
30 Day Mortality
12 (37.5%)
7 (21.9%)
6 (15%)
Complications
Valve Embolization
3 (9.3%)
1 (3.1%)
LVOTO
4 (12.5%)
2 (6.2%)
5 (12.5%)
Need for a second valve
2 (5%)
Cardiac Perforation
2 (6.25%)
Conversion to open surgery

15. Severe MV Disease and Severe MAC
Prior Algorhitm…
Severe MV Disease and Severe MAC
Symptomatic Patient Despite Medical Treatment
Surgical Candidate?
Yes No
MV Replacement
Palliative Care

16. Severe MV Disease and Severe MAC
Evolving Algorithm thanks to EFS…
Severe MV Disease and Severe MAC
Symptomatic Patient Despite Medical Treatment
Surgical Candidate?
Yes No
MAC related
Technical Challenges?
Favorable Anatomy for Transeptal TMVR
with Balloon Expandable THV?
No due to
High Risk
of LVOTO
No due to inadequate
calcium for anchoring No
Yes
Yes
Tendyne
compassionate use
or trial when available
MVR
SITRAL Trial ?
Alcohol Septal Ablation
LVOTO risk lower? or
MITRAL
Trial
Unfavorable
Anatomy
for ASA
Yes No
LAMPOON
Trial

17. Conclusions We need early feasibility studies
Sometimes earlier than usual when no animal model exists
When done responsibly, will provide meaningful data
Working with FDA on EFS is a great learning opportunity
Many patients benefit from EFS

18. Thank You