TCT 2016 | Washington DC | November 1, 2016

Mid-Term Hemodynamic Trends and

Between Echo Changes in Transcatheter

Aortic Valves in the PARTNER 1 Trial

Pamela S. Douglas, MD

on behalf of The PARTNER Trial Investigators

and The PARTNER Publications Office

Five Year Results

Background and Aims

• TAVR is a safe and effective treatment for severe AS

• The long term durability of transcatheter heart valves (THV)

and potential implications for patient outcomes are

incompletely understood

• The PARTNER 1 trial provides a rich, existing data resource

to address the following aims:

– Determine the longitudinal hemodynamic profile of the SAPIEN THV

– Assess the incidence of severely abnormal hemodynamics

– Relate these findings to clinical events of death and reintervention

Methods: All TAVRs from PARTNER IA, IB, Continued Access

Population characteristics

• Mean age 84.5 yrs

• 48% female

• 95% NYHA class 3-4

• 92% obstructive CAD

• Severe AS: AVA 0.65 cm2

• THV size: 52% 23; 48% 26

• Access: 43% TA ; 57% TF

Survival w/o reintervention

• 39% at 5 years by non-

adjusted parametric estimate

Successful TAVR

N = 2,482

TAVR with serial post

implant echo data

N = 2,404; 10,560 echoes

Median f/u 2.9 years

Mean f/u 2.6 ± 1.6 years

Total follow-up: 6,493 pt-yrs

No serial post

implant echo

N = 78

7d: 157 2y: 401

30d: 337 3y: 269

6m: 258 4y: 308

1y: 391 5y: 282

Last

echo

data

Longitudinal Hemodynamic Trends: Summary

• Population modeling of hemodynamic trends nonlinear, mixed-

effects model showed two phases, with consistency across

variables (mean gradient, DVI, [EOA])

– Early favorable changes immediately post implant: suggesting early

remodeling of SAPIEN THV and/or changes in physiology/LV function

– Later mid-term stability out to 5y: suggesting freedom from structural valve

deterioration as would be expected for mid term follow up in bioprostheses

– Similar patterns were seen in surgical AVR patients in PARTNER IA

• Death/Reintervention was associated with lower mean AV

gradient, EF and SVI up to 3 y, with no relationship to DVI [EOA]

– The association of these distinct hemodynamic patterns with death likely

reflects a primary causative role for low flow/low output states due to

underlying or concomitant disease rather than valve deterioration

Valve Safety: Summary

Reintervention, Hemodynamic ‘Outliers’

• Re-intervention was rare, became less frequent over time

and was usually not due to structural deterioration of THV

– Protocol-driven echo data were temporally distant and uninformative,

highlighting the critical importance of real time clinical data

• Severely abnormal hemodynamics on echoes were not

closely associated with excess death or reintervention

– VARC-2 cut points for mild AS were commonly met by both TAVR

and SAVR, and may not adequately discriminate adverse changes

Conclusions

• This evaluation of 2404 TAVR patients in the PARTNER I trial,

encompassing 6493 patient years of follow up, is the largest, core-

lab based study of transcatheter heart valves to date

• Population hemodynamic trends show excellent durability of the

SAPIEN THV without structural deterioration to 5 years

• Similarly, severely abnormal hemodynamics which might be

suggestive of valve thrombosis or stenosis in individual patients

were rare in this protocol-driven data base

• Together, these data demonstrate excellent mid-term durability of

THV, suggesting that the low 5 year survival observed in this cohort

is not related to adverse hemodynamics or THV deterioration

Thank you to the dedicated study teams at all the PARTNER Sites!

Special thanks to the

participants in this writing group

Martin B. Leon, MD

Michael J. Mack, MD

Lars G. Svensson, MD, PhD

John G. Webb, MD

Rebecca T. Hahn, MD

Philippe Pibarot, DVM, PhD

Neil J. Weissman, MD

D. Craig Miller, MD

Samir Kapadia, MD

Howard C. Herrmann, MD

Susheel Kodali, MD

Raj Makkar, MD

Vinod H. Thourani, MD

Stamatios Lerakis, MD

Ashley Lowry, MS

Jeevanantham Rajeswaran, PhD

Matthew T. Finn, MD

Maria Alu, MM

Craig R. Smith, MD

Eugene Blackstone, MD