TRI-REPAIR: 30-Day Outcomes of Transcatheter TV Repair … · TRI-REPAIR: 30-Day Outcomes of Transcatheter TV Repair in Patients With Severe Secondary Tricuspid Regurgitation Georg

TRI-REPAIR: 30-Day Outcomes of Transcatheter TV Repair in Patients With

Severe Secondary Tricuspid Regurgitation

Georg Nickenig, MD

Heart Center

University of Bonn

Germany

Disclosure Statement of Financial Interest

Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or

affiliation with the organization(s) listed below.

Affiliation/Financial Relationship Company• Grant/Research Support • DFG, BMBF, EU, Abbott, AGA, AstraZeneca, Bayer,

Berlin Chemei, Biosensus, Biotronic, BMS, Boehringer Ingelheim, Daiichi Sankyo, Edwards, Medtronic, Mitratech, Novartis, Pfizer, Sanofi Aventis, St. Jude

• Abbott, AGA, AstraZeneca, Bayer, Berlin Chemei, Biosensus, Biotronic, BMS, Boehringer Ingelheim, Daiichi Sankyo, Edwards, Medtronic, Mitratech, Novartis, Pfizer, Sanofi Aventis, St. Jude

• Abbott, AGA, AstraZeneca, Bayer, Berlin Chemei, Biosensus, Biotronic, BMS, Boehringer Ingelheim, Daiichi Sankyo, Edwards, Medtronic, Mitratech, Novartis, Pfizer, Sanofi Aventis, St. Jude

• Consulting Fees/Honoraria

• Other Financial Benefit (participating in clinical study)

1. Singh JP, et.al. Prevalence and Clinical determinants of mitral, tricuspid, and aortic regurgitation, Am J Cardiol. 1999;83:897-9022. McCarthy P.M, Sales V.L , Evolving Indications for Tricuspid Valve Surgery. Curr Treat Options Cardiovasc Med. 2010 Dec; 12(6): 587–597.

Tricuspid regurgitation is frequent but rarely treated

1.6M

TR prevalence

<10,000

Surgical procedures

annually

5,223 patientsStudy shows that moderate to

severe TR increases

mortality*

* Independent of PASP, LVEF, IVC size, RV size/function. Nath. JACC 2004;43:405

Tricuspid regurgitation is associated with

increased mortality

1. Dreyfus Ann Thoracic Surgery 2005

Tricuspid regurgitation is predominately a

consequence of RV and annular dilation: functional TR

Edwards Cardioband Tricuspid Repair System

• Tricuspid annular reduction via transfemoral access

Dedicated technology to treat tricuspid regurgitation

Same concept and similar implant technique used with the Edwards Cardioband

Mitral Repair System

• Short learning curve for Edwards Cardioband Mitral System users

MR TR

CAUTION: Investigational device, limited by Federal (or United States) law to investigational use.

Exclusively for Clinical Investigation. Not approved for sale in any country.

1Transfemoral

Approach2

System

Insertion3

Implant

Deployment4

Implant Size

Adjustment

Edwards Cardioband Tricuspid Repair Procedure



Pre-Reduction Post-Reduction

Bonn University Hospital


Transcatheter Tricuspid Valve Repair Fluoroscopic View



Baseline Discharge


Transthoracic Echocardiogram Result

Bonn University Hospital



Single arm, multi-center, prospective study to evaluate

the performance and safety of the Edwards Cardioband System

for repair of tricuspid regurgitation


FIH Study (TRI-REPAIR)



• Chronic functional tricuspid

regurgitation (FTR) 2+ to 4+ on a

scale of 4+ (moderate to severe)

with annular diameter ≥ 40 mm

with valve systolic pulmonary

pressure (sPAP) ≤ 60mmHg

• New York Heart Association

(NYHA) Class II-IVa

• Symptomatic despite

Guideline Directed Medical

Therapy (GDMT); at minimum

patient on diuretic regimen

• LVEF ≥ 30%

• The local site Heart Team

concur that surgery will not be

offered as a treatment option

Edwards TRI-REPAIR Study

Major Inclusion Criteria

• Aortic, mitral and/or pulmonic valve

stenosis and/or regurgitation ≥

moderate

• Previous tricuspid valve repair or

replacement

• Presence of trans-tricuspid pacemaker

or defibrillator leads which cause

impingement of the tricuspid valve

leaflet as evaluated by

echocardiography

• MI or known unstable angina within the

30 days prior to the index procedure

• Any PCI or transcatheter valvular

intervention within 30 days prior to

the index procedure or planned 3

months post the index procedure

• Cerebrovascular accident (CVA)

within the past 6 months

• Subject is on chronic dialysis and/or

anemia (Hb < 9 g/L)

• Life expectancy of less than 12

months

• Patients with cardiac cachexia


Major Exclusion Criteria

Safety• Overall rate of Major Serious

Adverse Events (MSAEs)* and

serious adverse device effects

(SADE) until hospital discharge and

at post-operative 30 days

Technical• Successful access, deployment and

positioning of the Cardioband device

• Septolateral reduction at intra-

procedure and discharge

Primary Secondary• TR grade, EROA and Regurgitant Volume

(by echocardigraphy)

• Tricuspid annular plane systolic excursion

(TAPSE)

• Technical success

• Functional tests: NYHA, 6MWD and KCCQ

• LVEF

• LVEDVI

• LVESVI

• Blood tests results for: NT-pro BNP, GOT, GGT,

Bilirubin and BUN creatinine clearance

• Diuretic therapy

• Activity by wearable device (selected sites only)

Endpoints will be measured at discharge 1,6,12 and 24 months post procedure and will be compared to baseline

* Death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke


Endpoints

Principal Investigator Location Country

Georg Nickenig, MD Universitätsklinikum Bonn, Bonn Germany

R. S. von Bardeleben, MDUniversitätsmedizin der Johannes Gutenberg

Universität Mainz, Mainz Germany

Karl-Heinz Kuck, MD Asklepios, St. Georg, Hamburg Germany

Ulrich Schäfer, MDUniversitäres Herzzentrum Hamburg GmbH

(UHZ), Hamburg Germany

Jörg Hausleiter, MDLMU Klinikum der Universität München, Campus

Großhadern, MünchenGermany

Stephan Baldus, MD Heart Center University of Köln, Köln Germany

Alec Vahanian, MD Hôpital Bichat-Claude Bernard, Paris France

Azeem M. Latib, MD Ospedale San Raffaele, Milano Italy

Francesco Maisano, MD University Hospital, Zurich Switzerland


Participating Sites

VariableMean (Range) or %

N=30*

Age (years) 75.6 ± 6

Gender Female - 74%

EuroSCORE II (%) 4.2%

Elevated Pulmonary Pressure (>35mmHg by Echo) 46%

Mean Systolic Pulmonary Arterial Pressure (mm Hg) 36 ± 11

LVEF (%) 57 ± 11

Baseline NYHA Class of III or IV (%) 86%

Diabetes 26%

Atrial Fibrillation 93%

Previous Heart Surgery 36%

CABG 23%

Valve Surgery (1x Mitral, 1x Aortic, 1x Aortic & Mitral) 13%

Previous Transcatheter Valve Repair/Replacement 10%

Moderate to Severe Renal Failure 53%

Prior Stroke 13%

Systemic Hypertension 80%

Electrodes in RV 13%

* Study is ongoing. Study demographics are based on available data.


Demographics

Successful access, deployment and

positioning of the Cardioband device100% (30/30)


Procedural outcomes

Adjudicated peri-procedural events n

Death 2

Right ventricular failure 1

Bleeding unrelated to the device† 1

Stroke 1

Bleeding Complications* 3

Life-threatening† 2

Extensive 1

Device Related Cardiac Surgery 0

Renal Failure 0

* MVARC Guidelines (Stone et al, 2015)

† One patient had two life-threatening bleeding complications (cardiac tamponade, intracranial hemorrhage) and died


Adjudicated major safety events at 30 days

44.4±4(34.8-52.2)

37±5(29.8-45.3)

20

25

30

35

40

45

50

Baseline Discharge

Se

pto

late

ralD

iam

ete

r (m

m)

20

25

30

35

40

45

50

55

Baseline Discharge

Se

pto

late

ralD

iam

ete

r (m

m)

*P<0.01

N=26

Edwards TRI-REPAIR Study 17% average reduction in septolateral diameter by core lab

44.4±4

(34.8-52.2)

37±5

(29.8-45.3)

Data not fully monitored, subject to change

0.0

0.2

0.4

0.6

0.8

1.0

1.2

1.4

Baseline 30 Days

0.8±0.5

0.4±0.3

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

Baseline 30 Days

PIS

A E

RO

A (

cm

2)

60±20

45

50

55

60

65

70

Baseline 30 Days

N=17

Vena Contracta

P<0.001

• Large proportion of patients treated with “torrential TR”

• Improvements resulted in most patients achieving lower severity or moderate TR at 30 days.

N=20

Ve

na

Co

ntr

ac

ta (

cm

)


PISA EROA

P<0.001

Str

ok

e V

olu

me

(m

l)

LV Stroke Volume

P=0.06

N=18

1.3±0.4


50% reduction in PISA EROA, 31% reduction in vena contracta,

and 7% improvement in stroke volume by core lab at 30 days

0.8±0.5

0.4±0.3

64.7±12.4

60±200.9±0.4

1.3±0.4


Functional improvement at 30 days

6MWT - 6 Min Walk Test, KCCQ - Kansas City Cardiomyopathy Questionnaire, NYHA Class - New York Heart Association (NYHA) Functional Classification

III

III

II

II

I

0

20

40

60

80

100

Baseline 30 Days

% o

f p

op

ula

tio

n

NYHA Class

P<0.05

N=28

• NYHA functional status and KCCQ QoL scores are left-sided Heart failure clinical endpoints

• Further study needed to understand clinically important endpoints for patients with right-sided heart dysfunction

++ ++

+

+

Absent

Absent

0%

20%

40%

60%

80%

100%

Baseline 30 Days

% o

f p

op

ula

tio

n

N=28

Edema

P<0.05

261

292

200

225

250

275

300

Baseline 30 Days

Me

ters

Wa

lke

d

N=23

6MWT

∆ 31

P<0.05

42.6

49.7

0

10

20

30

40

50

60

Baseline 30 days

KC

CQ

Sc

ore

N=28

KCCQ Score

∆ 7.1

P=0.06



Conclusions

• Use of Edwards Cardioband System for tricuspid

regurgitation is feasible and safe

• Significant annular reduction

• Reduced TR, despite treating a large proportion of patients

with “torrential” TR at baseline

• Improvements in functional status

Documents

TRI-REPAIR: 30-Day Outcomes of Transcatheter TV Repair … · TRI-REPAIR: 30-Day Outcomes of Transcatheter TV Repair in Patients With Severe Secondary Tricuspid Regurgitation Georg