TRI-REPAIR: 30-Day Outcomes of Transcatheter TV Repair in Patients - - PowerPoint PPT Presentation

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;83:897-902
• 2. 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 patients

Study 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.

1

Transfemoral Approach

2

System Insertion

3

Implant Deployment

4

Implant Size Adjustment

Edwards Cardioband Tricuspid Repair Procedure

CAUTION: Investigational device, limited by Federal (or United States) law to investigational use. Exclusively for Clinical Investigation. Not approved for sale in any country.

Pre-Reduction Post-Reduction

Bonn University Hospital

Edwards Cardioband Tricuspid Repair System Transcatheter Tricuspid Valve Repair Fluoroscopic View

CAUTION: Investigational device, limited by Federal (or United States) law to investigational use. Exclusively for Clinical Investigation. Not approved for sale in any country.

Baseline Discharge

Edwards Cardioband Tricuspid Repair System Transthoracic Echocardiogram Result

Bonn University Hospital

CAUTION: Investigational device, limited by Federal (or United States) law to investigational use. Exclusively for Clinical Investigation. Not approved for sale in any country.

Single arm, multi-center, prospective study to evaluate the performance and safety of the Edwards Cardioband System for repair of tricuspid regurgitation

Edwards Cardioband Tricuspid Repair System

FIH Study (TRI-REPAIR)

CAUTION: Investigational device, limited by Federal (or United States) law to investigational use. Exclusively for Clinical Investigation. Not approved for sale in any country.

• 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

• ffered 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
• r 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

Edwards TRI-REPAIR Study

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

Edwards TRI-REPAIR Study

Endpoints

Principal Investigator Location Country Georg Nickenig, MD

Universitätsklinikum Bonn, Bonn

Germany

• R. S. von Bardeleben, MD

Universitätsmedizin der Johannes Gutenberg Universität Mainz, Mainz

Germany Karl-Heinz Kuck, MD

Asklepios, St. Georg, Hamburg

Germany Ulrich Schäfer, MD

Universitäres Herzzentrum Hamburg GmbH (UHZ), Hamburg

Germany Jörg Hausleiter, MD

LMU Klinikum der Universität München, Campus Großhadern, München

Germany 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

Edwards TRI-REPAIR Study

Participating Sites

Variable

Mean (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.

Edwards TRI-REPAIR Study

Demographics

Successful access, deployment and positioning of the Cardioband device 100% (30/30)

Edwards TRI-REPAIR Study

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 Renal Failure

* MVARC Guidelines (Stone et al, 2015) † One patient had two life-threatening bleeding complications (cardiac tamponade, intracranial hemorrhage) and died

Edwards TRI-REPAIR Study

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 Septolateral Diameter (mm) 20 25 30 35 40 45 50 55 Baseline Discharge Septolateral Diameter (mm) *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

0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 Baseline 30 Days

PISA EROA (cm2)

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 Vena Contracta (cm)

Data not fully monitored, subject to change

PISA EROA P<0.001

Stroke Volume (ml)

LV Stroke Volume P=0.06

N=18

1.3±0.4

Edwards TRI-REPAIR Study 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±20 0.9±0.4 1.3±0.4

Edwards TRI-REPAIR Study

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

20 40 60 80 100

Baseline 30 Days

% of population

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

% of population

N=28 Edema P<0.05 261 292

200 225 250 275 300

Baseline 30 Days

Meters Walked

N=23 6MWT ∆ 31 P<0.05

42.6 49.7

10 20 30 40 50 60

Baseline 30 days

KCCQ Score

N=28 KCCQ Score ∆ 7.1 P=0.06

Data not fully monitored, subject to change

Edwards TRI-REPAIR Study

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