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
Emory St. Joseph’s Hospital
Assistant Professor, Emory Structural Heart and Valve Center
Emory School of Medicine
Disclosures • Edwards Lifesciences: Proctor
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
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
Valve in Valve: “Cracking” for Valve Enlargement
EMORY
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
TMV Replacement
US Early Feasibility Trials
Tendyne
CardiAQ-Edwards
Intrepid
(Twelve)
Neovasc Tiara
Caisson
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
Abbott Tendyne Implant Video
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 & EmoryTranscatheter 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” guidewireTranscatheter 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” guidewireEMORY 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 MDCurrent 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
->ELASTICTranscaval TAVR
Greenbaum, Babaliaros.. Lederman, JACC, 2017
A transfemoral catheter solution
to alternative TAVR accessAlternative Access for TAVR
Historical-Intrathoracic
direct
aortic
transapical
Iliac-aortic
conduitsAlternative Access for TAVR
Newer-Extrathoracic
Carotid subclavian/
Percutaneous axillary
TranscavalTranscaval 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, 2017NHLBI
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, 2017Transcaval 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, 2017LAMPOON Greenbaum, Babaliaros.. Lederman, JACC, 2017
Intentional Laceration of the Anterior Mitral
Leaflet to Prevent LVOT ObstructioN
A transfemoral catheter solution
to LVOT obstructionThe 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 2017TMVR: 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):1835jaffar.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) 6/8BASILICA 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 TAVRThe BASILICA concept A single leaflet tear could prevent coronary obstruction
The BASILICA concept
BASILICA
Leaflet wire traversal and snaring
Technique Leaflet slicingEMORY 1 st
in MAN DOUBLE
BASILICA
Leaflet slicing
GC+GW for
LCC-BASILICA
GC+GW for
RCC-BASILICA
Bilateral protection LCC-BASILICA RCC-BASILICAPreserved 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
STItChAlfieri stitch failure
Mitral ring
LA
M
Alfieri
stitch L
LV
Double orificesELASTIC: 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/MRJim Stewart MD 404-314-9392 Vasilis Babaliaros MD 678-557-4514 VALVE COORDINATOR: 404-416-6940
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