Breaking News
October 18, 2018 - FDA Approves Talzenna (talazoparib) for gBRCAm HER2-Negative Locally Advanced or Metastatic Breast Cancer
October 18, 2018 - Many U.S. adults confused about primary care, study shows
October 18, 2018 - With philanthropic gifts, Stanford poised to make major advances in neurosciences | News Center
October 18, 2018 - Researchers discover why heart contractions are weaker in individuals with HCM
October 18, 2018 - Participation in organized sport during childhood may have long-term skeletal benefits
October 18, 2018 - Probiotic/antibiotic combination could eradicate drug-resistant bacteria
October 17, 2018 - More Socioeconomic Challenges for Hispanic Women With HIV
October 17, 2018 - 49,XXXXY syndrome – Genetics Home Reference
October 17, 2018 - Scientists uncover possible new causes of Tourette syndrome
October 17, 2018 - Girl undergoes unusual heart surgery after compassionate-use exemption | News Center
October 17, 2018 - Health Issues That Are Sometimes Mistaken for Gluten Sensitivity
October 17, 2018 - Elective induction of labor at 39 weeks may be beneficial option for women and their babies
October 17, 2018 - New smart watch algorithms can accurately monitor wearers’ sleep patterns
October 17, 2018 - Researchers demonstrate epigenetic memory transmission via sperm
October 17, 2018 - FDA, DHS announce memorandum of agreement to address cybersecurity in medical devices
October 17, 2018 - Health Tip: Know the Risks of Chicken Pox
October 17, 2018 - Immunotherapy effective against hereditary melanoma
October 17, 2018 - Researchers reveal new mechanism for how animal cells stay intact | News Center
October 17, 2018 - Alzheimer's Goes Under the Cryo-Electron Microscope
October 17, 2018 - Medicare for all? CMS chief warns program has enough problems already
October 17, 2018 - Metrohm Raman introduces Mira P handheld Raman system
October 17, 2018 - Expanding the knowledge about hippocampus to better understand cognitive deficits in MS
October 17, 2018 - Study of Nigerian breast cancer patients reveals prevalence of aggressive molecular features
October 17, 2018 - Many healthy children may have metabolic risk factors, finds study
October 17, 2018 - A new antibiotic could be a better, faster treatment for tuberculosis
October 17, 2018 - “I will not become a Robot Doctor”: A medical student vows to practice compassion
October 17, 2018 - Study findings may explain sporadic outbreaks of C. difficile infections in hospitals
October 17, 2018 - Purdue researchers develop new chemical process to find better drug ‘fits’ for patients
October 17, 2018 - Yale researchers develop way to attack RNA with small-molecule drugs
October 17, 2018 - New pragmatic study launched to understand the effectiveness of new type 2 diabetes drug
October 17, 2018 - Alnylam Announces Plan to Initiate Rolling Submission of a New Drug Application and Pursue Full Approval for Givosiran
October 17, 2018 - Nine cases of polio-like illness suspected in children in illinois
October 17, 2018 - Eisai enters into agreement with Eurofarma for development and sales of lorcaserin in 17 countries
October 17, 2018 - Patients once thought incurable can benefit from high-dose radiation therapy
October 17, 2018 - Researchers awarded grant to advance testing of experimental heroin vaccine
October 17, 2018 - Researchers examine SSRI use during pregnancy and major gestational malformations
October 17, 2018 - FDA grants Rare Pediatric Disease Designation for Immusoft’s Iduronicrin genleukocel-T
October 17, 2018 - Reliable Respiratory announces acquisition of Attleboro Area Medical Equipment
October 17, 2018 - Study reveals link between childhood abuse and higher arthritis risk in adulthood
October 17, 2018 - Research shows people over 65 are not performing enough physical activity
October 17, 2018 - FDA Approves Liletta (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Five Years
October 17, 2018 - Weight gain after smoking cessation linked to increased short-term diabetes risk
October 17, 2018 - Researchers find opportunity to control salt-sensitive hypertension without exercising
October 17, 2018 - Women not warned about cancer associated with breast implants
October 17, 2018 - Metrohm offers robust handheld Raman analyzer for Defense and Security
October 17, 2018 - Modeling Non-Numerical Data in Systems Biology
October 17, 2018 - Research aims to address health disparities in African-American men
October 17, 2018 - Human and cattle decoys trap outdoor-biting mosquitoes in malaria endemic regions
October 17, 2018 - High Circulating Prolactin Level Inversely Linked to T2DM Risk
October 17, 2018 - Study finds gene variant predisposes people to both Type 2 diabetes and low body weight
October 17, 2018 - Metrohm software products make it easy to comply with ALOCA and ALCOA+ guidelines
October 17, 2018 - Network of doctors identify the cause of 31 new conditions
October 17, 2018 - Notable improvement in brain cancer survival among younger patients but not much for elderly
October 17, 2018 - Scientists shed light on roles of transcription factors, TP63 and SOX2, in squamous cell carcinoma
October 17, 2018 - Costs of Medicare Diabetes Prevention Program may be higher than expected reimbursement
October 17, 2018 - Misuse of prescription opioids or benzodiazepines associated with suicidal thoughts
October 17, 2018 - New research seeks to address sex disparities in women’s health
October 17, 2018 - C-Section Rates Have Nearly Doubled Since 2000: Study
October 17, 2018 - Talking to Your Kids About STDs
October 17, 2018 - New classification of periodontal and peri-implant diseases and conditions
October 17, 2018 - Herbert D. Kleber, Pioneer in Addiction Treatment, Dies at 84
October 17, 2018 - Health effects of smoke-filled atmosphere
October 17, 2018 - Down syndrome may hold important clues to onset of Alzheimer’s disease
October 17, 2018 - A special report on US’ aging societies
October 17, 2018 - Birth mode may have acute effects on neurodevelopment, study suggests
October 17, 2018 - Global health innovation system fails to deliver affordable treatments to patients, says report
October 17, 2018 - Simple, inexpensive test quickly detects antibiotic-resistant ‘superbugs’
October 17, 2018 - New drugs could reduce risk of heart disease when added to statins
October 17, 2018 - Visible and valued: Stanford Medicine’s first-ever LGBTQ+ Forum
October 17, 2018 - HVP vaccination not linked with rise in teen risky sex
October 17, 2018 - Potential ‘early warning markers’ for sepsis discovered
October 17, 2018 - Who knew? Life begins (again) at 65
October 17, 2018 - Application of blood pressure guidelines ups treatment
October 17, 2018 - Stanford researchers find that small molecule may help treat enzyme deficiency
October 17, 2018 - Speed Cameras Save Money and Lives in New York City
October 17, 2018 - Men who conform to ‘the man box’ more likely to consider suicide and violence
October 17, 2018 - Researchers aim to create more authentic organoids for drug testing, transplantation
October 16, 2018 - New blood test for pediatric brain tumor patients offers safer approach than surgical biopsies
October 16, 2018 - Age-related estrogen increase may be the culprit behind inguinal hernias in men
October 16, 2018 - Skills-Based Intervention Did Not Cut Systolic BP After Stroke, TIA
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