Direct Transcatheter Valve in MAC: A new solution for an old problem

Hyde M. Russell, MD

Chief, Cardiac Surgery

NorthShore University HealthSystem

The fishing was good; it was the catching that was bad.-A.K. Best

"Do not tell fish stories where the people know you. Particularly, don't tell them where they know the fish."Mark Twain

Disclosures

• Financial Disclosures: none

• Off Label: yes

• Credits: many

Mitral Annular Calcification

• First Described 1908• Occurs in 10% pts in large autopsy series• Higher prevalence and more severe disease

in women.• Associated Complications:

• Mitral stenosis / regurgitation• Embolic phenomenon• Atrial Fibrillation• Conduction Defects• Endocarditis

• Associated Conditions:• Hypertension• Aortic Stenosis

Carpentier AF, Pellerin M, Fuzellier JF, et al. JTCVS 1996; 111;718-30

Surgical Treatment: Resect or Respect

• Resection of calcium bar with annular reconstruction

• Atrial sliding plasty

• Anterior leaflet foldover

• LA to LV conduit

• Cusa ultrasonic debridement

Surgical Challenges

• Safely dealing with calcium• AV groove disruption

• Circumflex artery injury

• Obtaining large enough orifice

• Seating the prosthesis

• Para-Valve Leak

• LVOT obstruction

Transcatheter Valve in MAC - History

• 2012: Prof Thierry Carrel – Berne, Switzerland• Sapien XT Valve in MAC

• 2013: El Khoury – Brussels, Belgium• Bailout use of Sapien XT during complex mitral operation

• Bovine pericardium reinforcement after valve deployment to treat paravalve leak

Workup

• Echo

• TEE

• Cath

• CT Scan

Imaging – CT Scan

• Minimum 64 slice CT scanner with retrospective gating.

• Images obtained at 5-10% increments of cardiac cycle• Mitral area & diameter made in diastolic phase

• LVOT measurements usually made at 30-45% systolic phase, when LVOT is smallest.

• 3Mensio analysis

• Simulation of valve overlay to assess Neo-LVOT

• Neo-LVOT of 250mm2 should have low risk of LVOT obstruction

CT Imaging

LVOT Obstruction with TMVR

Surgery

• Exposure:• Sternotomy, Bi-Caval Cannulation, Standard Mitral Exposure

• Right Thoracotomy• Axillary arterial cannulation, Femoral Venous, Trans-venous Pacer, 4th ICS

• Maze Procedure when necessary / desired

• Tricuspid ring if TR ≥ 2+

Valve Preparation

Valve Prep Video

Implantation

• Anterior Leaflet resection; resection of subvalvular chords.

• Annular Sutures

• Marks

• Commisure suture to make circular

• Guiding Sutures

• Inflation volume – extra 5-10cc above nominal.

Implant Video

Post-Implantation Assessment

• Intra-op TEE• Regurgitation

• Gradient

• Leaflet mobility

• LVOT

• Post-op Echo

• Post-op CT

Intra-op Echo - Post-Implant

Intra-op Echo - Post-Implant

PRE

POST

Results• Multi-Center - multiple techniques

• 26 Patients• 100% Technical success• 81% Survival to Discharge• 73% 30-day Survival

• Single Center - uniform technique, pt selection• 10 Patients• 100% Technical and Procedural success

• No pt with more than mild PVL, No LVOT obstruction.

• 100% Survival to Discharge• Average LOS 7.9 days• 100% 30-day survival

Date of

SurgeryAge Sex STS LVEF

Prior CV

Surgery

Baseline

LVOT

(mm2)

Predicted

Neo-LVOT

(mm2)

Valve SizeConcurrent

AVR

Concurrent

TV RepairCPB Time

Cross

Clamp

Time

ICU Days Vent Hours

Patient 1 3/3/2017 65 M 12.0% 65% Yes 357 120 29 mm No No 103 70 3 9

Patient 2 6/8/2017 78 F 6.3% 66% Yes 400 213 29 mm No Yes 112 88 2 9

Patient 3 7/3/2017 74 M 8.0% 65% Yes 512 292 29 mm No No 185 90 3 7

Patient 4 10/5/2017 87 F 8.5% 60% No 352 109 29 mm No No 89 55 3 6

Patient 5 10/11/2017 80 M 13.0% 37% Yes 517 299 29 mm No No 151 N/a* 2 10

Patient 6 12/14/2017 77 M 5.8% 65% Yes 472 335 29 mm No No 187 N/a* 3 10

Patient 7 1/25/2018 75 F 8.0% 65% No 249 53 26 mm No Yes 151 104 2 5

Patient 8 4/12/18 69 F 3% 69% No 293 37 26mm No Yes 180 160 2 13

Patient 9 67 F 5% 62% Yes 29mm No No * *

Patient 10 83 F 8% 60% Yes 29mm No No 6 24

Evanston Hospital

MITRAL Trial

Inclusion Criteria

Severe MS (MVA ≤1.5 cm2)

Severe MR + Moderate MS

Native MV (MAC)

n=30

Valve-in-Ring

n=30

Valve-in-Valve

n=30

Severe MS (MVA ≤1.5 cm2)

At least Moderate-Severe MR

90 patients extremely high surgical risk (STS PROM >15% or M&M >50%)

SAPIEN XT SAPIEN 3

Results of MViR

Presented at TCT

Nov 1st, 2017

NYHA II or greater

Severe MS (MVA ≤1.5 cm2)

At least Moderate-Severe MR

Results of MViMAC

Presented at TCT

Nov 1st, 2017

Results of MViV

Presented at AHA

Nov 13th, 2017

Evanston Hospital

MAC Procedural Outcomes

OutcomesIn-Hospital

n=31

30 Days

n=30

All-Cause Mortality

5 (16.1%)Transeptal=1

Transapical=1

Transatrial=3

5 (16.6%)

Cardiovascular death 1 (3.2%) 1 (3.3%)

Non-Cardiac death4 (12.9%)

MOF=44 (13.3%)

1 patient withdrew consent while being discharged after successful transatrial TMVR

50% Transseptal or TA(TS=15, TA=1)

Difficult anatomy for TS=1

50% Transatrial (n=15)Risk of LVOTO=3

Risk of embolization=6

Both=6

Evanston Hospital

SITRAL TrialSurgical Implantation of TRAnscatheter vaLve in Native MAC

Baylor Research Institute

PI Robert Smith, MD

30 patients

Start April 2016

Transatrial TMVR with SAPIEN 3

www.clinicaltrials.gov

Conclusions

• Reproducible, effective technique

• Allows for larger prosthesis with safer implant (lower risk of AV groove disruption, circumflex injury).

• Promising early results

• Sizing is critically important to avoid PVL, LVOT obstruction• This is a planned operation, not a bailout procedure

• This is still an open procedure! Patient selection remains crucial…

• Questions? - hrussell@northshore.org