Cardioband system: a novel percutaneous solution for atrioventricular valve insufficiency

Abstract

What is known about The Cardioband in the clinical area? Severe secondary mitral valve insufficiency frequently affects high-risk surgical patients. Cardioband system is a novel percutaneous surgical-like device for direct annuloplasty. It is totally implanted in the beating heart, by transvenous femoral access with minimal impact on hemodynamic and cardiac function during the implantation. It has been demonstrated to be safe and feasible in high-risk patients with functional mitral regurgitation, with high rates of implant success, significant annular reduction and regurgitation improvements. That positively impacts directly on ventricular function, functional status and quality of life. Recently, Cardioband has been used also in tricuspid position, with initial promising results.

Bibliographic review.

Appendices

Appendix 1. Patient’s selection for mitral annuloplasty with Cardioband

ACTIVE TRIAL: NCT03016975

Ages eligible for study: 18 years and older (adult, senior)

Sexes eligible for study: All.

Accepts healthy volunteers: No.

Inclusion criteria:

• Age > 18 years

• Clinically significant functional mitral regurgitation (MR)

• NYHA class II-IV;

• Patient hospitalized due to heart failure during 12 months prior to submission to Central Screening Committee OR elevated Brain Natriuretic Peptid (BNP)

• Patient is able and willing to give informed consent and follow protocol procedures and comply with follow-up visit compliance

Exclusion criteria:

• Degenerative MR including mixed degenerative/functional MR

• Severe mitral annular calcification

• Other severe valve disorders requiring intervention according to current ACC/AHA valve guidelines

• MV anatomy which may preclude proper Edwards Cardioband deployment

• Life expectancy of less than 12 months

• Patient is participating in concomitant research studies of investigational products which have not reached their primary endpoint

• Unwillingness or inability to undergo follow-up investigations/visits

• Other medical, social, or psychological conditions that precludes appropriate consent and follow-up

REPAIR TRAIL NCT02703311

Ages eligible for study: 18 years and older (adult, senior)

Sexes eligible for study: All.

Accepts healthy volunteers: No.

Criteria.

Inclusion criteria:

• Severe (3+ to 4+) secondary mitral regurgitation

• Symptomatic heart failure (NYHA Class III-IVa) despite guideline-directed medical therapy including CRT if indicated

• The Local Site Heart Team concur that surgery will not be offered as a treatment option and that medical therapy is the intended therapy.

• Transfemoral access and transseptal deployment of the Cardioband is determined to be feasible

• Subject is willing and able to provide informed consent and follow protocol

Exclusion criteria:

• EF < 20%

• LVEDD ≥ 70 mm

• Heavily calcified annulus or leaflets

• Significant CAD requiring revascularization

• Active bacterial endocarditis

• Any percutaneous coronary, carotid, endovascular intervention, or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months

• Renal insufficiency requiring dialysis

• Life expectancy of less than 12 months

• Subject is participating in concomitant research studies of investigational products that have not reached their primary endpoint

• Pulmonary hypertension ≥ 70 mmHg at rest

• MV anatomy which may preclude proper device treatment

• Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction and/or severe tricuspid regurgitation

• Severe liver disease

• Patient is pregnant or lactating

• Hypersensitivity to nickel or chromium

• Clinically significant bleeding diathesis or coagulopathy

• History of MV repair

• TIA or CVA within 3 months

Appendix 2. Patient’s selection for tricuspid annuloplasty with Cardioband

TRIREAPIR TRIAL: NCT02981953

Ages eligible for study: 18 years and older (adult, senior)

Sexes eligible for study: All.

Accepts healthy volunteers: No.

Inclusion criteria:

• Chronic functional tricuspid regurgitation (FTR) with annular diameter ≥ 40 mm with valve systolic pulmonary pressure (sPAP) ≤ 60 mmHg

• New York Heart Association (NYHA) class II-IVa

• Symptomatic despite guideline-directed medical therapy (GDMT); at minimum patient on diuretic regimen

• LVEF ≥ 30%

• Patient is willing and able to comply with all specified study evaluations

• The Local Site Heart Team concur that surgery will not be offered as a treatment option

• Transfemoral access of the Cardioband is determined to be feasible

Exclusion criteria:

• Aortic, mitral, and/or pulmonic valve stenosis and/or regurgitation ≥ moderate

• Severe uncontrolled hypertension (systolic BP ≥ 180 mmHg and/or diastolic BP ≥ 110 mmHg)

• Previous TV repair or replacement

• Presence of trans-tricuspid pacemaker or defibrillator leads which are determined as immobile or interfering in the rout of procedure, as evaluated by echocardiography

• Active endocarditis

• MI or known unstable angina within the 30 days prior to the index procedure

• Any percutaneous coronary intervention (PCI) within 30 days prior to the index procedure or planned 3 months post the index procedure

• Hemodynamic instability or on IV inotropes

• Cerebrovascular accident (CVA) within the past 6 months

• Subject is on chronic dialysis

• Anemia (Hb < 9 g/L) not corrected by transfusion

• Bleeding disorders or hypercoaguable state

• Active peptic ulcer or active gastrointestinal (GI) bleeding

• Contraindication to anticoagulants

• Known allergy to stainless steel, nickel, and/or polyester

• Pregnant or lactating, or female of childbearing potential with a positive pregnancy test 24 h before any study-related radiation exposure

• In the judgment of the investigator, co-morbid condition(s) that could limit the subject’s ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study

• Life expectancy of less than 12 months

• Impaired judgment and/or is undergoing emergency treatment

• Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study

• Intra-cardiac masses, thrombi, or vegetations

• Patients with cardiac cachexia