Breaking News
January 18, 2018 - New precision medicine trial for metastatic pancreatic cancer
January 18, 2018 - Shire Receives FDA Breakthrough Therapy Designation for Maribavir, an Investigational Treatment for Cytomegalovirus (CMV) Infection in Transplant Patients
January 18, 2018 - Pre-Existing Patient-Valve Mismatch Trips Up ViV Implant
January 18, 2018 - Adolescents: health risks and solutions
January 18, 2018 - US woman delivers baby from embryo frozen for 24 years
January 18, 2018 - Study identifies new target for treatment of depression
January 18, 2018 - LJI study reveals key player that promotes skin inflammation in atopic dermatitis
January 18, 2018 - Study devises efficient and economical strategy to screen breast and ovarian cancer gene mutations
January 18, 2018 - Agile Therapeutics, Inc. Receives a Complete Response Letter from the FDA for Twirla (AG200-15) for the Prevention of Pregnancy
January 18, 2018 - Gene Therapy for Inherited Retinal Dystrophy Gets FDA Clearance
January 18, 2018 - Researchers identify a new chemical pathway that helps the brain detect sweet, savory and bitter flavors
January 18, 2018 - IBV develops platform that helps companies to diagnose wellbeing of their workforce
January 18, 2018 - Study to test new precision medicine approach for metastatic pancreatic cancer
January 18, 2018 - World’s first vaccine relieves grass pollen allergy symptoms by at least 25%, study shows
January 18, 2018 - FDA Approves New Indication for Gilotrif (afatinib) in EGFR Mutation-Positive NSCLC
January 18, 2018 - Oncologists Dish on Top Issues for 2018
January 18, 2018 - Researchers identify new potential drug target for Huntington’s disease
January 18, 2018 - Metrohm USA welcomes employees to new headquarters in Florida
January 18, 2018 - Human waste remains main source of fecal pollution in the river Danube
January 18, 2018 - Expert discusses how to stay healthy during flu season
January 18, 2018 - New biomaterials-based system improves T-cell production
January 18, 2018 - Novel gene expression analysis technique can accurately and quickly measure RNA
January 18, 2018 - Grandparents Help Shape Kids’ Views on Aging
January 18, 2018 - Absolutely Zero Stent Thrombosis at 5 Years With Bioabsorbable MiStent
January 18, 2018 - Safe Sleep for Babies | VitalSigns
January 18, 2018 - Pfizer to launch own little white pill
January 18, 2018 - Aged garlic extract may help obese people fight against inflammation, study shows
January 18, 2018 - Patients with monoclonal gammopathy at risk of developing cancer even after 30 years
January 18, 2018 - Researchers reveal potential of multivalent antibodies for HIV prevention, treatment and cure
January 18, 2018 - Dying cancer patients receiving assisted hydration live longer
January 18, 2018 - Potential male birth control pill could be developed from arrow poison
January 18, 2018 - Research reveals cost-effectiveness of whole-population screening for breast, ovarian cancer gene mutations
January 18, 2018 - Genes involved in spinal cord repair of lamprey also present in mammals, study reveals
January 18, 2018 - Researchers unravel key molecular mechanism of autoimmune and inflammatory diseases
January 18, 2018 - The State of the Drug Discovery Nation Unveiled as New Report Provides Vital Insights for the Development of New Medicines
January 18, 2018 - Dutch Study Links Implants to Increased Breast-ALCL Risk
January 18, 2018 - Five addiction experts weigh in on future of opioid crisis. Their forecast: grim
January 18, 2018 - EXD2 enzyme facilitates protein production in mitochondria
January 18, 2018 - Kessler Foundation wins $735,000 grant for training rehabilitation researchers
January 18, 2018 - Researchers find new way to halt growth of breast cancer cells
January 18, 2018 - Cantex Pharmaceuticals, Inc. Announces FDA Orphan Drug Designation Has Been Granted to CX-01 for Treatment of Acute Myeloid Leukemia
January 18, 2018 - Civilians Now Getting Flu-Like Illness Afflicting Troops
January 18, 2018 - Discovery brings stem cell therapy for eye disease closer to the clinic
January 18, 2018 - Guts of surfers more likely to be colonized by antibiotic-resistant bacteria, study reveals
January 18, 2018 - Bacteria linked to periodontitis may play role in onset of cancer
January 18, 2018 - Jazz Pharmaceuticals Submits New Drug Application for Solriamfetol (JZP-110) for Excessive Sleepiness Associated with Narcolepsy and Obstructive Sleep Apnea
January 18, 2018 - Early Menarche, Menopause Tied to Higher CVD Risk
January 18, 2018 - Pioneering new technique could boost understanding of causes of heart disease
January 18, 2018 - New brain imaging techniques show how infants’ brains process ‘touch’
January 18, 2018 - GSK Receives FDA Approval for Expanded Indication for Fluarix Quadrivalent (Influenza Vaccine) for Persons 6 Months and Older
January 18, 2018 - Blood Markers Point to Maladaptive LV Remodeling
January 18, 2018 - Effect of gut bacteria on specific immune cells underlies persistent liver inflammation
January 18, 2018 - Study reveals new diabetes gene in families with rare blood sugar conditions
January 18, 2018 - Fewer Hospitals Closed After Obamacare Expanded Medicaid
January 18, 2018 - At-Home Breath Training Improves Asthma Quality of Life
January 18, 2018 - Obesity can add five weeks of asthma symptoms per year in preschoolers
January 18, 2018 - Neuronal loss is very limited in Alzheimer’s disease, shows new study
January 18, 2018 - A new strategy proposed for drug discovery
January 17, 2018 - Lactation May Lower T2D Risk in Younger Women
January 17, 2018 - New Atopic Dermatitis Yardstick provides practical guidance and management insights
January 17, 2018 - New biodegradable pressure sensor could help monitor serious health conditions
January 17, 2018 - HSS orders Sectra’s 3D pre-operative planning solution for improving patient outcomes
January 17, 2018 - Study identifies six new genes regions associated with diabetes
January 17, 2018 - Women do not receive timely diagnosis for heart disease
January 17, 2018 - AbbVie’s Upadacitinib Shows Positive Results as Monotherapy in Phase 3 Rheumatoid Arthritis Study, Meeting All Primary and Key Secondary Endpoints
January 17, 2018 - Should President Trump’s Physical Include a Cognitive Screen?
January 17, 2018 - Could gene therapy someday eliminate HIV?
January 17, 2018 - Researchers identify new anti-inflammatory drug target
January 17, 2018 - Loxo Oncology Initiates Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Larotrectinib for the Treatment of TRK Fusion Cancers
January 17, 2018 - Trunk Imaging Tied to Higher Nephrectomy Risk
January 17, 2018 - Campaigners incensed at failings in Africa AIDS war
January 17, 2018 - Research opens door to development of new treatment for type 2 diabetes
January 17, 2018 - Uniqsis’ novel reactor system for continuous flow synthesis
January 17, 2018 - Bariatric surgery extends lifespan in obese patients, shows study
January 17, 2018 - Genevac offers miVac DNA for efficient concentration of nucleic acids
January 17, 2018 - Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) as Adjuvant Therapy in Patients with Completely Resected Melanoma with Lymph Node Involvement or Metastatic Disease
January 17, 2018 - Systematic bright light exposure can improve sleep in people treated for cancer
January 17, 2018 - Ewww Moments in the ER: That’s Improbable!
January 17, 2018 - Scientists discover possible cause of colonial-era epidemic in Mexico
January 17, 2018 - Methods from optogenetics, machine learning should help improve treatment options for stroke patients
TMVR Benefits Hold Firm in Post-Market Registry

TMVR Benefits Hold Firm in Post-Market Registry

image_pdfDownload PDFimage_print

Action Points

  • Transcatheter mitral valve repair (TMVR) with the MitraClip, for mitral valve regurgitation, was associated with low in-hospital mortality and high acute procedural success, according to registry data of 2,952 patients treated from 2013 to 2015.
  • Note that degenerative mitral regurgitation affects about 1% to 2% of the general population, and can lead to debilitating heart failure and poor long-term survival in certain patient subsets.

The MitraClip has performed favorably in the U.S. in the years since FDA approval, per post-market surveillance of patients who’ve had the device implanted to treat mitral regurgitation.

From the Society of Thoracic Surgery (STS)/American College of Cardiology Transcatheter Valve Therapy Registry, Paul Sorajja, MD, of Abbott Northwestern Hospital in Minneapolis, and colleagues determined that transcatheter mitral valve repair (TMVR) with the MitraClip was associated with low in-hospital mortality (2.7%) and high acute procedural success (91.8%).

Patients who had linkable Centers for Medicare and Medicaid claims data had encouraging outcomes out of the hospital as well, with mortality observed in 5.2% at 30 days and 25.8% at 1 year. By the end of the year, repeat hospitalization for heart failure had reached 20.2%, and the combination of mortality or heart failure rehospitalization 37.9%, Sorajja’s group reported in the Journal of the American College of Cardiology.

In all, 95.5% were discharged from hospital with mitral regurgitation grade 2 or lower without cardiac surgery and survived to 30 days.

“Our findings demonstrate that commercial transcatheter mitral valve repair is being performed in the United States with acute effectiveness and safety,” the authors concluded. Their study population underwent commercial therapy with the MitraClip after FDA approval in 2013, consisting mainly of those with severe symptoms, degenerative mitral regurgitation, and prohibitive surgical risk.

“These findings, which are consistent with prior reports on the effectiveness and safety of transcatheter mitral valve repair, are important observations as the treatment population expands, new hospital sites for the therapy accrue, and a number of potentially eligible patients remain untreated,” Sorajja’s group suggested.

On multivariable analysis, the predictors of 1-year mortality or heart failure rehospitalization were:

  • Increasing age: HR 1.08 per 5 years (95% CI 1.01-1.15)
  • Dialysis: HR 2.09 (95% CI 1.37-3.28)
  • Left ventricular ejection fraction: HR 0.92 per 5% (95% CI 0.88-0.95)
  • Moderate or severe lung disease: HR 1.28 (95% CI 1.05-1.58)
  • Severe tricuspid regurgitation: HR 1.89 (95% CI 1.48-2.39)
  • Residual mitral regurgitation grade 3 or 4 after the procedure: HR ~2.0 (95% CI ~1.4-2.0)

“Although these findings are interesting, they are no different from the factors associated with a worse outcome after mitral valve surgery. This affirms that patient-related factors are perhaps more important than the method by which mitral regurgitation is approached, either surgically or percutaneously,” commented Steven Bolling, MD, of University of Michigan Health System in Ann Arbor.

In an accompanying editorial, Bolling called MitraClip’s confirmed technical success and safety data the most important findings of the analysis.

“In fact, the safety and low biological impact of this left atrial catheter approach may allow practitioners to treat patients with mitral regurgitation much earlier in their disease course,” he said. “Perhaps therapeutic mitral regurgitation intervention will be possible even long before congestive heart failure, atrial fibrillation, tricuspid regurgitation, pulmonary hypertension, and other complications of mitral regurgitation occur, which may obscure any benefit of obviating the mitral regurgitation.”

The registry used by Sorajja’s group included 2,952 TMVR patients who were treated from 2013 to 2015, of which 63.2% had data linked to CMS administrative claims. Participants had a median age of 82 years and were 55.8% men; they presented with a median STS score of 6.1% for mitral repair and 9.2% for mitral replacement.

Rates of safety events were not excessive: 0.1% for device embolization; 3.9% for major or life-threatening bleeding; 0.4% for stroke, and 0.1% for MI. Conversion to open heart surgery was required by 2.7%.

Notably, mortality and heart failure hospitalization at 1 year grew more likely with increasing severity of residual mitral regurgitation after TMVR. Combined, this endpoint was reported in 35.7%, 39.2%, and 54.4% of those leaving the hospital with grade 1-or-below, grade 2, and grade 3-or-higher jets.

This led the investigators to concluded that their findings “support the rationale for achieving significant mitral regurgitation reduction, including minimizing need for future surgical therapy, with procedural expertise when possible, even though the desired therapeutic goal may be less certain when treating patients with limited or no other therapeutic options.”

Nevertheless, they admitted that the lack of a comparison arm was a limitation of their single-arm registry study. “Such controls, whether medical or surgical, are necessary to determine the magnitude (or lack thereof) of any clinical benefit of TMVR in these patients, particularly in high-risk individuals in which there may be continued adverse events despite initially successful therapy.”

COAPT and MITRA-FR are two trials that are comparing TMVR with guideline-directed medical therapy in two trials, Sorajja’s group said, pointing out that severe tricuspid regurgitation and severe lung disease — both associated with worse survival in the present study — are exclusion criteria for these trials.

Another caveat of the study is the lack of reasoning given for hospitalization or surgery after TMVR.

Bolling said that MitraClip is just one component of the triad approach to mitral valve disease — leaflet grasping, annular ring, and valve replacement — and together these three components “will certainly remain the gold standard when surgical mitral valve disease therapy inevitably gives way to transcatheter mitral valve disease therapies.”

“In the future, we will have all 3 of these gold standard mitral tools in our transcatheter toolbox. MitraClip will probably remain a crucial tool, but perhaps more importantly we will look at the device experience as having been a gateway to the future of catheter-based mitral valve disease therapy,” he predicted.

The study was supported by Abbott Vascular.

Sorajja disclosed relevant relationships with Abbott Vascular, Medtronic, Boston Scientific, and Integer.

Bolling disclosed a relevant relationships with Abbott.

2017-10-30T14:00:00-0400

Tagged with:

About author

Related Articles