Review of Alternative Access for Transcatheter Aortic Valve Replacement (TAVR)

Aamir Shah, MD, FACS

Associate Director, Aortic Program

Cardiothoracic and Vascular Surgery Cedars-Sinai Medical Center Los Angeles, CA

Background

• Transcatheter Aortic Valve Replacement (TAVR) has become accepted clinical therapy for patients with severe aortic stenosis who are inoperable, high or intermediate surgical risk based on randomized PARTNER A/B/2 trials

• Trans-femoral TAVR is precluded in up to 10-15% of patients with significant aorto-iliac disease

• Alternative approaches have included trans-apical and trans-aortic with increased morbidity

• Current alternative access approaches include subclavian arteries, carotid arteries, and IVC

Multiple Access Sites for TAVR

Carotid

Aortic (TAo)

Trans-septal

IVC to Ao Entry Femoral (TF)

Apical (TA)

Subclavian

Multi-Slice CT

Iliofemoral assessment

TF

Non-calcified Cross-sectional

Diameter > 5.5 mm

No high arch angulation

No significant aortic disease

Alternative access assessment

<inclusion criteria>

CSMC Protocol for Access Planning

CSMC Protocol for Access Planning

Cross sectional Diameter > 5 mm

Diameter > 7 mm if functioning LITA bypass graft

Aortoventricular angle < 70 degrees

No excessive calcification or tortuosity

Left Subclavian assessment

Trans-Subclavian

Trans-aortic assessment Trans-apical assessment

Annulus to access > 70 mm

Calcium free spot in “ TAo zone”

Annulus to apex > 45 mm

No significant LV dysfunction

LV cavity > 40 mm in diastole

TAo TA

Trans-caval assessment

Subclavian with patent LIMA Recommended

Minimum Luminal Diameter

Personal Communication Medtronic CoreValve System

Transapical and Transaortic TAVR TVT Registry 2011-2014

• 4953 pts undergoing TA or TAo TAVR from 2011-2014 in STS ACC TVT Registry

• Mean age 82.8 +/- 6.8 yrs

• STS median predicted mortality Tao 8.8%, TA 7.4%

• TAo increased risk unadjusted 30 day mortality 10.3 vs 8.8%; 1 yr mortality 30.3% vs 25.6%

• No risk adjusted difference in mortality, stroke, or readmission

• Stroke 2.2%, major vascular complications 0.3%

Trans-carotid TAVR

• French TC TAVR Registry, n=93 pts from 2009-2013

• Mean age 79

• STS predicted mortality 7.1%

• Procedural mortality 3.1%

• 30 day mortality 6.3%

• No major vascular complications

• 30 day CVA/TIA rate 6.3%

Mylotte et al, JACC Cardiovasc Interventions 2016;9(5); 472-80

TAVR CSMC

TAVR TF n= 1541 (95.1%)

TAVR Subclav n= 49 (3.0%) TAVR TAo

n= 22 (1.36%)

TAVR TA n= 8 (0.05%)

TAVR 6/14- 7/17; n=1620

CSMC Subclavian Access TAVR

Characteristic Total n=49 (%)

Age 81.3 +/- 8.1

Female 61%

STS Predicted Mortality 10.2 +/- 5.8

BMI (kg/m2) 25.9 +/- 6.0

DM 30.6%

HTN 95.5%

CAD 55.1%

Prior CABG 24.5%

CRI (HD) 34.7% (6.1%)

Cerebrovascular Dx 36.7%

Baseline Characteristics

Characteristic Total n=49, (%)

TTE

EF (%) 56.5 +/- 12.6

Peak gradient (mm Hg) 78.3 +/- 25.7

Mean Gradient (mm Hg) 43.9 +/- 16.8

AVA (cm2) 0.70 +/- 0.25

CT access artery diam (mm)

R Iliofemoral MLD (mm) 4.0 +/- 1.2

L Iliofemoral MLD (mm) 4.1 +/- 1.2

L/R Subclavian artery MLD (mm) 5.8 +/- 1.0

Iliofemoral Access

Left Subclavian Artery Assessment

Procedure Example

① ②

③ ④ Sutured graft Graft puncture

Cerebral Embolic Protection

Results Outcome Total n = 49 (%)

Opeerative Mortality 0 (0%)

Hospital Mortality 2 (4.0%)

TAVR procedural success 100%

Aborted subclavian access 1 (2.0%)

Right subclavian access 6 (12.2%)

Post TAVR mean gradient (mmHg)

5.0 +/- 4.1

LOS post TAVR (days) 4.4 +/- 2.9

Paravalvular Leak (PVL)

None-trace 81.6%

Mild 12.2 %

Mild-moderate 6.1 %

Moderate or greater 0 %

TAVR Valve Type

Outcome Total n= 49 (%)

Valve type

Balloon expandable 34 (69.4%)

Sapien XT 18 (36.7%)

Sapien 3 16 (32.7%)

Self expandable 15 (30.6%)

CoreValve 13 (26.5%)

Portico 2 (4.1%)

Complications

Complication Total n= 49 (%)

Stroke Disabling 1 (2.0%)

Stroke Non-disabling 1 (2.0%)

Myocardial infarction 0 (0%)

Major bleeding complication 0 (0%)

Vascular complication (LSA dissection) 2 (4.1%)

Acute Kidney Injury – stage 3 2 (4.1%)

New PPM 4 (8.2%)

Brachial plexus neuropathy 1 (2.0%)

Transcaval Access for TAVR

Transcaval TAVR

• 100 patients, 2014-2016

• Female 58%

• Ineligible TF access, high risk transthoracic access

• CAD 89%, Prior cardiac surgery 44%

• STS predicted mortality 9.6%

Greenbaum et al, JACC 2017;69(5):511-21

Outcomes at 30 days

• Transcaval access success 99%

• Device success 98/99 pts

• 8 pt required covered stents

• Hospital mortality 4%, Stroke 5%

• 30 day mortality 8%

• Life threatening bleeding 7%, Major vascular complication 13%

• Median LOS 4 days Greenbaum et al, JACC 2017;69(5):511-21

Transcaval case CSMC

Transcaval TAVR

Conclusions

• This series demonstrates feasibility and of safety utilizing subclavian artery for TAVR access

• Facility with all alternative access options allows appropriate treatment of high risk patients who are ineligible for transfemoral TAVR with acceptable operative risk

Thank you

Conclusion