EXPAND STUDY: the largest
contemporary real-world study of
MitraClip NTR/XTR
HIGHEST MITRAL REGURGITATION (MR) REDUCTION ACHIEVED WITH
TRANSCATHETER MITRAL VALVE REPAIR (TMVr)1*
The EXPAND study reported the highest ECL adjudicated MR reduction to date with 89% of patients with MR <=1+ at 1 year.
*TMVr is now also referred to as TEER (transcatheter edge-to-edge repair)
PREDICTABLE PROCEDURE EXPERIENCE WITH MULTIPLE CLIP SIZE2
Significant REDUCTION IN Annualized HEART FAILURE (HF) Hospitalization1*
*Reported to date.
Durable 1-Year Improvement in Quality of Life1*
21.6 Points of Improvement in KCCQ-OS at 1 Year
Significant Improvement in Functional Status Sustained at 1 Year1
80% New York Heart Association (NYHA) I/II Sustained at 1 Year
aPairwise comparison between baseline and 1 year (n=648); baseline and 30 day (n=853); 95% CI shown in brackets.
Note: Health-related quality of life measured by Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score.
*Reported to date.
Excellent Safety Profile
Lowest mortality rate reported to date
Low Rate of Adverse Events at 1 Year
| ADVERSE EVENTS1 | EXPAND (N=1041) |
|---|---|
| All-cause Mortality | 14.9% (147) |
| MI | 1.2% (12) |
| Stroke | 1.2% (12) |
| Leaflet Adverse Events (LAE)3 | 2% (20) |
| Single Leaflet Device Attachment (SLDA) | 1.7% (18) |
| Leaflet injury | 0.4% (4) |
| MV Reintervention | 1.9% (20) |
| MV Stenosis | 0.5% (5) |
The global EXPAND study was a prospective, multicenter, single-arm, international, postmarket, real-world, observational study.
MAT-2410455 v1.0 | Item approved for U.S. use only
- Kar S. Core-Lab Adjudicated Contemporary Clinical Outcomes at 1 Year with MitraClip™ (NTR/XTR) System from Global EXPAND Study. Data presented at TCT 2020.
- Rottbauer WD. Contemporary Clinical Outcomes with MitraClip™ (NTR/XTR) System: Core-lab Echo Results from +1000 Patient the Global EXPAND Study. Data presented at PCR 2020.
- Asch F. Mitral Valve Leaflet Adverse Events with MitraClip™ (NTR/XTR) from the Global EXPAND Study: Expert Panel Review and Recommendations. Data presented at PCR 2020.
†APS defined as successful implantation of the MitraClip device with resulting MR severity of 2+ or less on discharge echocardiogram (30-day echocardiogram is used if discharge is unavailable or uninterpretable). Subjects who die or undergo mitral valve surgery before discharge are considered to be an APS failure.
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Important Safety Information
MITRACLIP™ CLIP DELIVERY SYSTEM
- The MitraClip™ G4 System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.
- The MitraClip™ G4 System, when used with maximally tolerated guideline-directed medical therapy (GDMT), is indicated for the treatment of symptomatic, moderate-to-severe or severe secondary (or functional) mitral regurgitation (MR; MR ≥ Grade III per American Society of Echocardiography criteria) in patients with a left ventricular ejection fraction (LVEF) ≥ 20% and ≤ 50%, and a left ventricular end systolic dimension (LVESD) ≤ 70 mm whose symptoms and MR severity persist despite maximally tolerated GDMT as determined by a multidisciplinary heart team experienced in the evaluation and treatment of heart failure and mitral valve disease.
Contraindications
The MitraClip G4 System is contraindicated in patients with the following conditions: Patients who cannot tolerate, including allergy or hypersensitivity to, procedural anticoagulation or post procedural anti-platelet regime; Patients with known hypersensitivity to clip components (nickel / titanium, cobalt, chromium, polyester), or with contrast sensitivity; Active endocarditis of the mitral valve; Rheumatic mitral valve disease; Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus.
Potential Complications and Adverse Events
The following ANTICIPATED EVENTS have been identified as possible complications of the MitraClip G4 procedure: Allergic reactions or hypersensitivity to latex, contrast agent, anaesthesia, device materials (nickel / titanium, cobalt, chromium, polyester), and drug reactions to anticoagulation, or antiplatelet drugs, Vascular access complications which may require transfusion or vessel repair including: wound dehiscence, catheter site reactions, Bleeding (including ecchymosis, oozing, hematoma, hemorrhage, retroperitoneal hemorrhage), Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation / rupture, vascular occlusion, Emboli (air thrombotic material, implant, device component); Peripheral Nerve Injury; Lymphatic complications; Pericardial complications which may require additional intervention, including: Pericardial effuse on, Cardiac tamponade, Pericarditis; Cardiac complications which may require additional interventions or emergency cardiac surgery, including: Cardiac perforation, Atrial septal defect; Mitral valve complications, which may complicate or prevent later surgical repair, including: Chordal entanglement / rupture, Single Leaflet Device Attachment (SLDA), Thrombosis, Dislodgement of previously implanted devices, Tissue damage, Mitral valve stenosis, Persistent or residual mitral regurgitation, Endocarditis; Cardiac arrhythmias (including conduction disorders, atrial arrhythmias, ventricular arrhythmias); Cardiac ischemic conditions (including myocardial infarction, myocardial ischemia, and unstable / stable angina); Venous thromboembolism (including deep vein thrombosis, pulmonary embolism, post procedure pulmonary embolism); Stroke / Cerebrovascular accident (CVA) and Transient Ischemic Attack (TIA); System organ failure: Cardio-respiratory arrest, Worsening heart failure, Pulmonary congestion, Respiratory dysfunction / failure / atelectasis, Renal insufficiency or failure, Shock (including cardiogenic and anaphylactic); Blood cell disorders (including coagulopathy, hemolysis, and Heparin Induced Thrombocytopenia (HIT)); Hypotension / hypertension; Infection including: Urinary Tract Infection (UTI), Pneumonia, Septicemia; Nausea / vomiting; Chest pain; Dyspnea; Edema; Fever or hyperthermia; Pain; Death; Fluoroscopy, Transesophageal echocardiogram (TEE) and Transthoracic echocardiogram (TTE) -related complications: Skin injury or tissue changes due to exposure to ionizing radiation, Esophageal irritation; Esophageal perforation, Gastrointestinal bleeding.