Feature | June 13, 2013

Two Real-World Studies Demonstrate Positive Outcomes for MitraClip

Findings published demonstrate significant improvements in day-to-day quality of life and similar benefits in both elderly and younger patients

June 13, 2013 — Abbott announced publication of positive outcomes from two European post-approval studies of the catheter-based MitraClip therapy for the treatment of mitral regurgitation (MR). Results from ACCESS-EU, a European prospective study that enrolled 567 patients at 14 sites, have been published in the Journal of the American College of Cardiology. In addition, findings of the investigator-sponsored German TRAnscatheter Mitral Valve Interventions (TRAMI) registry, which enrolled 1,064 patients at 20 German sites, were recently published in EuroIntervention.

Abbott's MitraClip System, which received CE mark in 2008 and is commercially available in Europe and other international markets, is an investigational device in the United States. The device is delivered to the heart through the femoral vein and is designed to reduce MR by clipping together a portion of the leaflets of the mitral valve to allow the heart to more efficiently pump blood.

Data from ACCESS-EU demonstrated that in real-world, post-approval experience in Europe, patients undergoing the MitraClip therapy are predominantly high surgical risk, elderly patients who are mainly affected by functional MR, a type of MR in which a damaged heart impairs the performance of a normal mitral valve. ACCESS-EU showed that in this patient population, the MitraClip procedure demonstrated low rates of hospital mortality and adverse events and provided significant improvements in day-to-day quality of life at one year following treatment.

Findings of the ACCESS-EU study showed:

  • Most patients currently treated in Europe are high surgical risk. The mean age was 74 years, with 45 percent of patients older than 75 years. Most patients had secondary or functional mitral regurgitation (FMR), a type of MR in which a damaged heart impairs the performance of a normal mitral valve; low ejection fraction (most 40 percent or lower); and presented with multiple comorbidities, including coronary artery disease (63 percent), hypertension (76 percent), atrial fibrillation (68 percent) and renal disease (42 percent).
  • An implant success rate of 99.6 percent.
  • No incidence of death or stroke during the MitraClip procedure and in the immediate post-operative period.
  • A majority of patients (91.2 percent) achieved MR reduction to MR grade of 2+ or less (on a scale of 1+ [mild MR] to 4+ [severe MR]) at discharge (p<0.0001).
  • At one year following the procedure, 78.9 percent of patients were free from MR severity of 2+ or more (p<0.0001), and 71.4 percent of patients were in NYHA Functional Class II or Class I compared to 15 percent at baseline (p<0.0001).
  • A large majority of patients (79.2 percent) were discharged to home rather than to a skilled nursing facility.
  • Significant improvements in quality of life. At one year, Six-Minute Walk Test results, which measure distance walked on a flat, hard surface in a six-minute period, improved by a mean of 59.5 meters (p<0.0001). Minnesota Living With Heart Failure results, which measure the effects of symptoms, functional limitations and psychological distress on an individual's quality of life, improved by a mean 13.5 points (p<0.0001).

Results of the TRAMI registry showed similar benefits for the MitraClip therapy in both elderly and younger patients. To evaluate the influence of age, patients were divided into two subgroups: patients 76 years old and above, and patients younger than 76 years of age. The procedure proved to be safe in both groups. Hospital mortality was 2.9 percent in elderly patients and 2.8 percent in younger patients (p=0.96). Major adverse car diovascular or cerebrovascular events (MACCE), defined as a composite endpoint of death, myocardial infarction or stroke, was 3.5 percent vs. 3.4 percent (p=0.93) respectively. The majority of patients – 81.8 percent of elderly patients and 86.2 percent of younger patients (p=0.06) – fully recovered from the MitraClip procedure and were discharged without the need for nursing care. There was substantial relief of heart failure symptoms for the majority of patients, with comparable proportions of patients in NYHA Functional Class II or Class I (69.5 percent and 61.4 percent, respectively; p=n.s.).

For more information: www.abbott.com 

 

Related Content

Fred Hoiberg, Chicago Bulls coach, On-X aortic heart valve, education campaign

Fred Hoiberg, head coach of the NBA Chicago Bulls, is launching a new campaign to help people with heart valve problems on www.heartvalvesurgery.com. Coach Hoiberg, pictured here with his family, wanted a single, life-long solution to his aortic heart valve problem, and received an On-X aortic mechanical valve from On-X Life Technologies Inc. in April 2015.

News | Heart Valve Repair| February 10, 2016
February 10, 2016 — Fred Hoiberg, head coach of the National Basketball Assocation’s (NBA) Chicago Bulls, is launchin
HeartWare, terminated acquisition, Valtech Cardio
News | Structural Heart| February 10, 2016
February 10, 2016 — HeartWare International Inc. and Valtech Cardio Ltd.
Valtech Cardioband, reimbursement, Germany, mitral regurgitation in heart failure
News | Heart Valve Repair| February 09, 2016
Valtech Cardio Ltd. announced that it has received German Neue Untersuchungs und Behandlungsmethoden (NUB) Status 1...
ACC late breakers
News | ACC| February 09, 2016
February 9, 2016 — The late-breaking clinical trial presentations have been announced for the 2016 American College o
Watchman, left atrial appendage closure, LAA occluder
Technology | Left Atrial Appendage (LAA) Occluders| February 09, 2016
February 9, 2016 — Boston Scientific Corp.
transcatheter repair of a mitral valve paravalvular leak

Transcatheter repair of a surgical mitral replacement paravalvular leak with an Amplatzer Vascular Plug II.

Feature | Heart Valve Repair| February 08, 2016 | Dave Fornell
Off-label use of the St.
medtronic corevalve, tavr
News | February 03, 2016 | Dave Fornell
Medtronic announced Feb. 3 that the U.S.
Toshiba, CT-angiography, hybrid OR

Toshiba recently introduced a new line of combined CT and angiography systems, allowing true CT imaging on demand in the interventional lab.

Feature | Angiography| January 27, 2016 | Dave Fornell
All of the major vendors in the United States introduced new systems and technologies in the past few years to reduce...
Sponsored Content | Case Study | Cardiovascular Ultrasound| January 21, 2016
This case study is from the Cardiac Imaging Department, Hospital Clinic, Barcelona, Spain.
Csound, GE ultrasound

4D Clarity, HDlive and cSound acquisition provide excellent TTE and TEE images.

Sponsored Content | Case Study | January 21, 2016
GE Healthcare is taking the next leap in image quality performance, quantification and workflow with the introduction
Overlay Init