Update:Transcatheter Aortic Valve Implantation

Ganesh ManoharanMBBCh, BAO, MD, FRCP(I), FRCP(Edin), FESC

Consultant Cardiologist, RVH, Belfast

Training Programme Director, Cardiology, NIMDTA

Hon Senior Lecturer, QUB

First clinical insertion of prosthetic valve

Dr Charles A Hufnagel1916 – 1989

Professor of SurgeryGeorgetown University

1952

Do Patients with Valvular Heart Disease Receive Treatment According to Established Guidelines?

The Euro Heart Survey on Valvular Heart Disease

• 92 hospitals from 25 countries• 5001 patients from April – July 2001

Surgery denied in 33% of symptomatic elderly

patients

Age and LV function were key reasons

Aortic Valve Replacement

• General anesthesia

• Sternotomy

• On pump

• Excellent results!

• Increasing mortality with age

• Increased mortality in redo procedures

• Increased mortality with comorbidities

• Increased morbidity in elderly patients:

• Longer ICU stay, hospital stay and recovery

Reference Pt number Pt Characteristics In-HospitalMortality

Filsoufi (2008) 231 ≥80yrs (48% CABG) 5.2

Ferrari (2010) 124 ≥80yrs (Isolated AVR) 5.4

de Vincentis (2008) 345 ≥80yrs (70% CABG) 7.5

Langanay (2006) 442 ≥80yrs (19% CABG) 7.5

Leontyev (2009) 282 ≥80yrs (Isolated AVR) 7.8

Melby (2007) 245 ≥80yrs (57% CABG) 9.0

Kolh (2007) 220 ≥80yrs (26% CABG) 9.0

Gulbins (2008) 236 ≥80yrs (91% CABG) 9.3

Bose (2007) 68 ≥80yrs (46% CABG) 13

Outcome of sAVR or sAVR+CABG in Elderly

9 Studies; Total 2193 patients Range: 5.2 – 13Weighted Av: 8.9%

Mean age 64.8±10.4

Age 70-80 as univariantpredictor

Risk with elderly: Bleeding, infection, wound healing, extended ICU and hospital stay, prolonged recovery,

mental state....

Philipp Bonhoeffer – 1st Pulmonary transcatheter valve implantation

Melody valve

12th of September 2000

Proof of Concept Design

16+ years since first TAVI

Prof Alan Cribier and the 1st TAVR patient

16 April 2002

Medtronic CoreValveSize 23, 26, 29, 31

Annulus: 18 -29mm

Edward SapienSize 23, 26, 29

Annulus: 18-27mm

18F TF for all

TF (16F eS) and TA

TF (18F eS) and TA

TF (20F eS)and TA

eS = e-Sheath

1st Gen Work-Horse TAVI Devices

G Manoharan, Royal Victoria, Belfast

1st TAVI in Ireland: 6th February 2008

Funding secured for 2 years from Ulster Garden Villages, Cardiac Research Funds, RVH and The Heart Trust Fund

Features of New CE Mark Devices

Repositionable

External Skirt

Device Fixation

Conformable Frame

Lower Profile

Delivery System

Improved Outcome

Current Generation TAVI Devices

Images not to scale

Edwards

Sapien

Medtronic

Evolut R

Abbott

PorticoBoston Scientific

Balloon

Expandable

Self

Expanding

Self

Expanding

Mechanically

Expandable

X

SymetisLotus

Self

Expanding

Medtronic

Evolut PRO

Self

Expanding

TAVI Delivery Systems

TAVI Access Options

• Transfemoral

• Subclavian

• Axillary

• Direct Aortic

• Transapical

• Carotid

• Transcaval

Post Procedure Angio

Self-Expanding: Resheatable and Repositionable

TAVI Procedure: Balloon Expandable

Evidence for Suitable Patients

Randomised Clinical Data available:

1. Inoperable patients

2. High risk patients

3. Intermediate risk patients

Inoperable and High Risk

TAVI Superior to Medical Therapy

TAVI = SAVR

TAVI Superior to SAVR

3 yr Follow-UP: TAVI Superior to SAVR

Valve DurabilityThus far, TAVI durability maintained

Intermediate Risk Patients

TAVI (all access) Similar to SAVR in Intermediate Risk Patients

Trans-Femoral TAVI Superior to SAVR in Intermediate Risk Patients

Intermediate Surgical Risk Predicted risk of operative mortality ≥3% and <15%

Heart Team EvaluationAssess inclusion/exclusion

Risk classification

RandomizationStratified by need for revascularization

TAVR SAVR

TAVR + PCI SAVR + CABGTAVR only SAVR only

Baseline neurological assessments

Screening CommitteeConfirmed eligibility

37

SURTAVI Trial Design

Reardon et al; NEJM 2017

n (%) or mean ± SD TAVR (N=864) SAVR (N=796)

Age, years 79.9 ± 6.2 79.7 ± 6.1

Male sex 498 (57.6) 438 (55.0)

Body surface area, m2 1.9 ± 0.2 1.9 ± 0.2

STS PROM, % 4.4 ± 1.5 4.5 ± 1.6

Logistic EuroSCORE, % 11.9 ± 7.6 11.6 ± 8.0

Diabetes mellitus 295 (34.1) 277 (34.8)

Serum creatinine >2 mg/dl 14 (1.6) 17 (2.1)

Prior stroke 57 (6.6) 57 (7.2)

Prior TIA 58 (6.7) 46 (5.8)

Peripheral vascular disease 266 (30.8) 238 (29.9)

Permanent pacemaker 84 (9.7) 72 (9.0)

Baseline Characteristics*

*mITT population; no significant difference in any baseline characteristics 38

0%

5%

10%

15%

20%

25%

30%

0 6 12 18 24

All-

Cau

se M

ort

alit

y o

r D

isab

ling

Stro

ke

Months Post-ProcedureNo. at Risk

796 674 555 407 241

864 755 612 456 272TAVR

SAVR

All-Cause Mortality or Disabling Stroke

24 Months

TAVR SAVR

12.6% 14.0%

39

TAVR = SAVR

0%

2%

4%

6%

8%

10%

0 6 12 18 24

Dis

ablin

g St

roke

Months Post-ProcedureNo. at Risk

796 674 555 407 241

864 755 612 456 272TAVR

SAVR

Disabling Stroke

24 Months

TAVR SAVR95% CI for Difference

2.6% 4.5% -4.0, 0.1

40

TAVR > SAVR

Hemodynamics*

Ao

rtic

Val

ve A

rea,

cm

2

AV

Mean

Grad

ient, m

m H

g

TAVR had significantly better valve performance over SAVR at all follow-up visits

*Core lab adjudicated 41

Total Aortic Regurgitation*

61% 93% 61% 90% 60% 90%

36%

7%

34%

9%

35%

9%3%

1%5%

1%5%

1%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

TAVR(N=832)

SAVR(N=707)

TAVR(N=599)

SAVR(N=506)

TAVR(N=299)

SAVR(N=244)

Discharge 12 Months 24 Months

Severe

Moderate

Mild

None/trace

* Implanted population, core lab adjudicated 42

Improved PVL outcome in TAVI compared to High Risk IDE study possibly due to use of CT sizing and adherence to best practice

• TAVR had significantly less 30 day stroke, AKI, atrial fibrillation and transfusion use and a superior quality of life at 30 days.

• TAVR resulted in significantly improved AV hemodynamics with lower mean gradients and larger aortic valve areas than SAVR through 24 months.

• SAVR had less residual aortic regurgitation, major vascular complications and fewer new pacemakers.

• Need for a new pacemaker after TAVR was not associated with increased mortality.

Summary

43

Current Gen TAVI: 30D Moderate/Severe PVL

1213

16.9

24.2

911.5

3.5 4

1 1.7

0

5

10

15

20

25

30

Partner High Risk:Sapien

Advance: CoreValve Partner 2: Sapien Partner 2: XT CoreValve: High Risk CoreValve: ExtremeRisk

Sapien 3 Portico Lotus Direct Flow

Mod/severe (%)

Evolut R Pro = 0 Mod/Severe

SAVR vs TAVI

The US FDA have approved 2 new studies using the new generation TAVI devices (Evolut R and Sapien 3) in low

risk surgical patientsRESULTS: ACC 2019!

TAVI in Clinical Practice Today: Summary 1

• Standard of care for high risk and inoperable patients with symptomatic severe AV disease

• Overall numbers are increasing in each unit

• ‘Moderate risk’ patients are increasingly being offered TAVI

• Further increase expected, being driven by data and patient choice

TAVI in Clinical Practice Today: Summary 2

• Technological advances are impacting positively on TAVI outcome

• Improving outcomes are also due to better patient selection (HEART Team) and operator expertise

• TAVI under local anaesthesia increasing

• Low risk patient - will depend on x2 studies currently ongoing (FDA studies)

Thank You

Ganesh ManoharanMBBCh, BAO, MD, FRCP(I), FRCP(Edin), FESC

Consultant Cardiologist, RVH, Belfast

Training Programme Director, Cardiology, NIMDTA

Hon Senior Lecturer, QUB