The Structural "State of the Heart" in 2018: TAVR updates, Mitral/Tricuspid updates, and Electrosurgery - James Stewart, MD

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The Structural "State of the Heart" in 2018: TAVR updates, Mitral/Tricuspid updates, and Electrosurgery - James Stewart, MD
The Structural “State of the Heart” in 2018:
TAVR updates, Mitral/Tricuspid updates, and
               Electrosurgery
                   James Stewart, MD
                  Emory St. Joseph’s Hospital
 Assistant Professor, Emory Structural Heart and Valve Center
                  Emory School of Medicine
The Structural "State of the Heart" in 2018: TAVR updates, Mitral/Tricuspid updates, and Electrosurgery - James Stewart, MD
Disclosures
• Edwards Lifesciences: Proctor
The Structural "State of the Heart" in 2018: TAVR updates, Mitral/Tricuspid updates, and Electrosurgery - James Stewart, MD
What’s New in TAVR
           Expanding Indications

6.2%
           High risk        Partner III- Low Risk AS Trial
          (STS > 8%)
        Intermediate risk   Early TAVR – asymptomatic
13.9%      (STS 4-8%)
                                        AS
           Low risk
79.9%
          (STS
The Structural "State of the Heart" in 2018: TAVR updates, Mitral/Tricuspid updates, and Electrosurgery - James Stewart, MD
What’s New in TAVR- Adjunctive Devices
Stroke Protection with Claret Medical Cerebral
                                Proximal Filter
                               (Innominate Artery)
                                    9–15 mm

                                                     Distal Filter
                                                     (LCC Artery)
                                                      6.5–10 mm
The Structural "State of the Heart" in 2018: TAVR updates, Mitral/Tricuspid updates, and Electrosurgery - James Stewart, MD
Valve in Valve: “Cracking” for Valve Enlargement
                                             EMORY
The Structural "State of the Heart" in 2018: TAVR updates, Mitral/Tricuspid updates, and Electrosurgery - James Stewart, MD
Surgical valve fracturing with ViV TAVR         EMORY

                     • Mean gradient 25mmHg
                       immediately post-SAVR. 8
                       years later MG 62mmHg,
                       NYHA IV Sxs, repeat
                       hospitalizations

                     • Patient discharged the
                       following day

                     • Mean gradient
The Structural "State of the Heart" in 2018: TAVR updates, Mitral/Tricuspid updates, and Electrosurgery - James Stewart, MD
TMV Replacement
                  US Early Feasibility Trials

                                             Tendyne
CardiAQ-Edwards

                           Intrepid
                           (Twelve)

                                           Neovasc Tiara
  Caisson
The Structural "State of the Heart" in 2018: TAVR updates, Mitral/Tricuspid updates, and Electrosurgery - James Stewart, MD
Transcatheter Mitral Valves
      in Early Clinical Studies
                            Both
                       Transseptal and
                         Transapical               Transapical Only               Transseptal
                                                                                     Only

                          CardiAQ-
                          Edwards        Tendyne      Twelve            Tiara      Caisson

Delivery System Size        33 Fr         32 Fr        35 Fr            32 Fr        31 Fr

Valve Size                 40 mm         27 mm        27 mm           35, 40 mm     27 mm
The Structural "State of the Heart" in 2018: TAVR updates, Mitral/Tricuspid updates, and Electrosurgery - James Stewart, MD
Abbott Tendyne Implant Video
The Structural "State of the Heart" in 2018: TAVR updates, Mitral/Tricuspid updates, and Electrosurgery - James Stewart, MD
Transcatheter Mitral Valve Replacement

• 30 day mortality 3%
     (Muller et al, JACC 2017)
Right Sided Interventions: Tricuspid Valve Disease

                              • Dedicated devices – Early
                                Feasibility with the FORMA
                                device (Edwards Lifesciences)

                              • Ongoing Tricuspid Valve in
                                Valve and Valve in Ring
                                procedures

                              • Dedicated techniques for
                                Tricuspid repair- NIH & Emory
Transcatheter Electrosurgery
• What is it?
                                       0.014”

• Application of an external source
                                       guidewire

  of electrical current outside the    0.014” to

  body to “electrify” the guidewire    0.035” wire
                                       convertor

  inside the body for the purposes
  of perforating live or prosthetic
  tissue.
                                      0.035”
                                      microcatheter

                                                             Electrosurgery
                                                             pencil

                                                      Back end of
                                                      0.014” guidewire
Transcatheter Electrosurgery
• Why?
                                      0.014”

• To expand percutaneous
                                      guidewire

  transcatheter valve therapy to      0.014” to

  patients:                           0.035” wire
                                      convertor

   • High risk or inoperable using
     conventional open surgical
     techniques                      0.035”
                                     microcatheter

   • Poor vascular access
                                                            Electrosurgery
                                                            pencil

                                                     Back end of
                                                     0.014” guidewire
EMORY with NIH/NHLBI Partnership
                                      NIH

• Vasilis Babaliaros MD     • Robert J. Lederman MD
• Bradley G. Leshnower MD   • Jaffer M. Khan MD
• Robert A. Guyton MD       • Toby Rogers MD
• Chandan Devireddy MD      • Adam Greenbaum MD (Henry Ford)
• Kreton Mavromatis MD
• James Stewart MD
Current Applications of
           Transcatheter Electrosurgery
1) TAVR patients with inadequate transfemoral access
->Transcaval TAVR

2) TMVR patients to prevent LVOT obstruction
->LAMPOON

3) TAVR VIV patients to prevent coronary obstruction
->BASILICA

4) TMVR patients with previous Alfieri stitch
->ELASTIC
Transcaval TAVR
                             Greenbaum, Babaliaros.. Lederman, JACC, 2017

A transfemoral catheter solution
   to alternative TAVR access
Alternative Access for TAVR
             Historical-Intrathoracic
    direct
    aortic

                                        transapical

    Iliac-aortic
    conduits
Alternative Access for TAVR
               Newer-Extrathoracic
    Carotid                          subclavian/
                                     Percutaneous axillary

  Transcaval
Transcaval access

                                                                                                   Electrified wire cross-
                                          CT-based plan    Angiogram          Lateral “bullseye”   ing into aortic snare

 A: Cross from IVC through calcium-free   Introducer sheath from    Amplatzer muscular VSD
 window into prepositioned aortic snare   femoral vein into aorta   occluder 8mm                   Final
 B: Exchange for rigid guidewire                                                      Halabi .. Lederman, JACC, 2013
 C: Deliver sheath and TAVR                                                Greenbaum, O’Neill .. Lederman, JACC, 2014
 D: Close with nitinol occluder                                         Greenbaum, Babaliaros.. Lederman, JACC, 2017
NHLBI
                                                                                  Transcaval

Transcaval IDE Main Findings
                                                                                       TAVR
                                                                                 Prospective
                                                                                        Trial

                         17 sites, n=100
Transcaval Success
• “Successful transcaval
  crossing, TAVR, and closing”

         1
                                                *92% 30-day survival
                 Success 99
                 Failure 1
                                           No death attributable to transcaval
        99                                         access or closure

• 1 failure to cross
• No adverse event from the
  failure to cross
                                                Greenbaum, Babaliaros.. Lederman, JACC, 2017
Transcaval bleeding and
                                                                                          NHLBI
                                                                                      Transcaval
                                                                                           TAVR
                                                                                     Prospective

contemporary adjudicated TAVR trials                                                        Trial

                        Partner-II*       Transcaval           Partner-II*
                      Trans-femoral                          Trans-apical or
                                                              Trans-aortic
                         n=775               n=100               n=236
   STS predicted
                          5.8%                9.6%                  5.8%
   mortality
   Life-threatening                           12%
   or disabling           6.7%           (7% transcaval-           22.6%
   bleeding                                 related)

                                 * MB Leon et al, N Engl J Med, 2016; 374(17):1609

                                                Greenbaum, Babaliaros.. Lederman, JACC, 2017
LAMPOON                                  Greenbaum, Babaliaros.. Lederman, JACC, 2017

Intentional Laceration of the Anterior Mitral
    Leaflet to Prevent LVOT ObstructioN
   A transfemoral catheter solution
         to LVOT obstruction
The Long Anterior Leaflet
                        An overlooked problem in TMVR

Surgeons resect the leaflet and preserve the chords

The AML physically obstructs the prosthetic   The AML obstructs the closing jet,           Flow through a narrowed LVOT pulls the AML
leaflet, preventing coaptation                preventing prosthetic leaflet closure        further to the LVOT via the Bernoulli effect

                                                                                      JM Khan, JACC Cardiovasc Interv. 2016; Sep 12, 9(17):1835
                                                                                      Greenbaum et al. Cath Card Intv 2017
TMVR: LVOT Obstruction from AML

                               Prevalence
                               • Real prevalence unknown
                               • >50% screen failures for
                                 LVOT obstruction risk1
                               • 9-22% of patients in reported
                                 series for valve-in-ring and
                                 valve-in-MAC have fatal
                                 LVOT obstruction2

• Viewed from LVOT   LAMPOON    1Guerrero,  Personal Communication 2017
                                2JM   Khan, JACC Cardiovasc Interv. 2016; Sep 12, 9(17):1835
jaffar.khan@nih.gov
                                                                                                             lederman@nih.gov

          Initial Human Experience (pre-IDE)
Feature                                 Findings (n=18)
Setting                                 Valve-in-Ring: n=7; Valve-in-Band: n=2; Valve-in-MAC: n=9
LAMPOON laceration success              18/18
Hemodynamic instability immediately     1/18 (severe AS planned for concomitant TAVR)
after LAMPOON
Neo-LVOT predicted (mean ± SD)          37 ± 4 mm2 (excluding 5 for ‘long leaflet’)
LVOT gradient, pre / post (mean ± SD)   7.2 ± 7.5 mmHg / 15.5 ± 17.4 mmHg (excluding 5 for ‘long leaflet’)
Emergency surgery                       0/18
Bail-out ASA                            1/18 (from mal-deployment, fatal)
Stroke                                  0/18
Survival (hospital)                     14/18 (3 deaths from severe PVL in MAC; 1 death from mal-deployment
                                        and LVOT obstruction)
Survival (30d)                          13/18 (1 death d23 from severe right heart failure)
Survival (1 year)                       6/8
BASILICA
Bioprosthetic Aortic Scallop Intentional Laceration to
   prevent Iatrogenic Coronary Artery obstruction

 A transfemoral catheter solution to coronary obstruction
Introduction

      Coronary obstruction:
      A devastating complication of TAVR

                                           Ribeiro H et al. VIVID registry. EHJ 2017 (in press)
Introduction
               Coronary obstruction in ViV TAVR
The BASILICA concept

A single leaflet tear
could prevent coronary obstruction
The BASILICA concept
                                               BASILICA
          Leaflet wire traversal and snaring
                                               Technique   Leaflet slicing
EMORY          1 st
                                in MAN DOUBLE
                              BASILICA
                                                            Leaflet slicing

               GC+GW for
               LCC-BASILICA

GC+GW for
RCC-BASILICA

  Bilateral protection               LCC-BASILICA   RCC-BASILICA
Preserved coronary flow
BASILICA
• BASILICA has been applied in 7 patients to date
• Bioprostheses (stented and stentless)
• Bioprosthetic AS and AI
• Native aortic stenosis
• Dual right and left coronary cusps
• Balloon-expandable and self-expandable THV devices
• A prospective IDE trial will begin shortly
ELASTIC
  Transcatheter mitral valve replacement after
transcatheter Electrosurgical Laceration of Alfieri
                     STItCh
Alfieri stitch failure

    Mitral ring
                                             LA
                                         M

Alfieri
stitch                                            L

                                    LV

                  Double orifices
ELASTIC: Laceration of Alfieri stitch
ELASTIC: Freedom from double orifices

 Valve deployment inside of single orifice of the previous mitral ring
Transcatheter Mitral Valve in Ring after ELASTIC

        Well-seated valve without significant PVL/MR
Jim Stewart MD        404-314-9392
Vasilis Babaliaros MD 678-557-4514
VALVE COORDINATOR: 404-416-6940
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