1. Implantation of Balloon-Expandable THVs in Native Mitral Valves with Severe MAC
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. Surgical MVR for MAC Comorbidities increase risk
Technically challenging
Rupture of posterior wall of LV
Many pts untreated due to risk
Casarotto et al, G Ital Cardiol 1977;7(4):
Goodney et al, Ann Thorac Surg 2003;76:
Vohra et al, J Heart Valve Dis 2011;20(6):624-6.

4. TMVR in MAC Global Registry
115 patients from 48 centers in 11 countries (Sept 2012-Feb 2017)
Underwent TMVR with compassionate use of aortic THV
Balloon expandable 95%, Lotus+DFM 5% (TA 44%, TS 38%, atrial 18%)
First 64 patients…Technical success 72%, 30-Day Mortality 29.7%
Guerrero et al, J Am Coll Cardiol Intv July 2016;9:

5. Patient Characteristics
n (%), or mean (range)
Age
73 ± 13 (39-96)
Female
66%
NYHA II
8.5%
III
41.5% IV
50%
Diabetes
38%
COPD
44.8%
Atrial Fibrillation
45%
Renal Failure
35%
Prior CABG
34%
Prior AVR
47.5%
STS score
14.43± 10 (1-41)

6. Procedural Outcomes n (%) 78/109 (76%) 16/109 (14.6%) 12/109 (11%)
Technical success by MVARC criteria
78/109 (76%)
Need for second valve (migration=7, MR=9)
16/109 (14.6%)
LVOT obstruction with hemodynamic compromise
12/109 (11%)
Valve embolization
5/109 (4.5%)
Conversion to open surgery (embolization=2,
LV perforation=1, LVOTO=1)
4/109 (3.6%)
LV perforation (surgery=1, conservative=1)
2/109 (1.8%)
Pulmonary Vein Perforation
1 (0.9%)

7. 30 Day/Procedural Mortality
28/109 (25.6%)
n (%)
Cardiovascular
11/109 (10.1 %)
LVOT Obstruction
3 (2.9%)
LV Perforation
2 (1.9%)
Complete AV block 1%
MI due to air emboli / Pulmonary vein perforation
Stroke
PEA arrest
1 % MR
Non-Cardiac
17/109 (15.5 %)
Multi-organ failure
9 (8.6%)
Pneumonia
Thoracentesis related bleeding complication
Infection

8. 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

9. Role of Alcohol Septal Ablation
Baseline
After Alcohol Ablation
Courtesy of Dr. William O’Neill
After TMVR
Guerrero et al, CCI 2016 July 5. doi: /ccd

10. Alcohol Septal Ablation as bail out for LVOTO
6 patients were treated with ETOH ablation as bail out
Reduction of LVOT gradient in all 6 cases
One recurred the following day (suspected edema)
One died of AVB and one died of MOF 3 weeks later
4 out of 6 were discharged from the hospital *
Guerrero et al, In Press CCI 2017

11. Role of Alcohol Septal Ablation prior to TMVR
Pre-ablation
Post-ablation
Courtesy of Dr. Dee Dee Wang
8 patients successfully treated with TMVR after alcohol ablation
(TMVR in MAC Registry and MITRAL Trial)

12. Role of Anterior Leaflet Resection prior to TMVR

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

14. 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:

15. 1-Year Follow-up TMVR in MAC Registry
Work in Progress… Data lock scheduled May 2017
As of … excluding non-balloon expandable valves in registry (Lotus, DFM)
109 patients
25.6% 30-day mortality
81 Survived 30 days
8 had procedure after June 2016
73 eligible for
1-year follow-up by May 2017
11 deaths after 30 days
62 Patients
13 (1-year follow-up not due until May 2017)
49 Patients
24 (1-year follow-up due data being collected)
25 survivors
with 1-year follow-up data submitted

16. 1 valve reintervention (V-in-V for MR 9 months from index procedure)
Deaths After 30 Days
11/109 (10.1%)
n (%)
Cardiovascular
5/109 (4.6 %)
Sudden death 1
Valve thrombosis at 2 months (subtherapeutic INR)
Endocarditis
Stroke
Heart failure
Non-Cardiac
6/109 (5.5 %)
C2 fracture after fall
Failure to thrive
GI bleed
Sepsis
Suspected infection 2
1 valve reintervention (V-in-V for MR 9 months from index procedure)

17. NYHA Class

18. 1-Year Echocardiogram EF 51.2 (30-83) mmHg Mean MVG MVA LVOT gradient
2.02 ( ) cm2
LVOT gradient
6.5 (0-37) mmHg
Trace or mild MR
70%
No MR
30%

19. The MITRAL Trial Inclusion Criteria www.clinicaltrials.gov
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

20. 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

21. 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

22. 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

23. Severe MV Disease and Severe MAC
Evolving Algorithm…
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

24. Severe MV Disease and Severe MAC
Evolving Algorithm…
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

25. Conclusions
TMVR in MAC is feasible & outcomes are improving with experience
TMVR may evolve into a viable option for non-surgical patients
Patients who survive TMVR with balloon-expandable aortic THVs experience sustained improvement of symptoms at 1 year
THV performance is maintained at 1 year
Anticoagulation post-TMVR should be considered (ideal duration ?)
Prospective clinical trials are needed (MITRAL, SITRAL, LAMPOON)

26. Thank You