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Structural Heart

 - Evolut_R_23mm

The FDA approved Medtronic’s CoreValve Evolut R device on June 23, giving physicians in the U.S. who perform transcatheter aortic valve replacement (TAVR) procedures the ability to recapture and reposition a valve during implantation.

 - thumbs up

The FDA approved the third-generation transcatheter aortic valve replacement (TAVR) device by Edwards Lifesciences, giving the company permission to market the Sapien 3 system as a treatment for high-risk patients with severe aortic stenosis.

 - Mitral Valve Repair

An analysis of more than 25 years of data at the Cleveland Clinic found that surgical procedures were more successful than “watchful waiting” for patients with severe degenerative mitral regurgitation.

 - structural heart, Medtronic CoreValve

Transcatheter aortic valve replacement (TAVR) continued to hold its own against surgery in low-risk patients with severe aortic stenosis, based on two-year results presented May 19 at EuroPCR in Paris.

 - Melody Transcatheter Pulmonary Valve

After a median follow-up period of 4.5 years, most patients who underwent transcatheter pulmonary valve replacement with the Melody valve had positive hemodynamic and clinical results, according to a prospective study.

 

More Stories

More than 45% of patients in UK survive 5 years after TAVR

Five years after patients underwent transcatheter aortic valve replacement (TAVR), 45.5 percent were still alive, according to an analysis of a United Kingdom registry.

Concomitant tricuspid annuloplasty and MV repair is safe and effective

For patients undergoing mitral valve (MV) repair, concomitant tricuspid annuloplasty was safe and effective and minimized the risk of tricuspid regurgitation, according to a retrospective analysis.

Early discharge after TAVR appears safe, feasible with Sapien XT

Early discharge of patients who underwent transcatheter aortic valve replacement (TAVR) using a Sapien XT valve was safe and feasible, according to a single-center study. The hospital has managed to cut the mean length of stay in transfemoral cases by almost half.

FDA recalls TigerPaw II after reports of tearing

The FDA issued a Class I recall on more than 4,100 TigerPaw II implantable left atrial appendage occlusion devices based on reports of possible tissue tearing and bleeding.

Levi Watkins, pioneering cardiac surgeon, dies

Levi Watkins Jr., MD, a pioneering cardiac surgeon known for both clinical and civil rights achievements, died April 11 of complications from a stroke. He was 70 years old.

Red blood cell storage duration does not affect outcomes after cardiac surgery

A randomized trial of patients undergoing complex cardiac surgery found that the duration of red blood cells stored for transfusions was not associated with a significant change in the Multiple Organ Dysfunction Score seven days after the operation.

FDA lets Direct Flow take on CoreValve

The FDA has allowed Direct Flow Medical to expand its pivotal trial to include high-risk patients, more centers and comparison with a commercially available transcatheter aortic valve replacement (TAVR) valve.

FDA allows less anticoagulation with On-X valve

The FDA expanded the labeling for a mechanical aortic valve by approving a lower International Normalized Ratio (INR) that is closer to an unmedicated range.

TAVR's growing presence

We are a quarter of the way into 2015 and TAVR already is jockeying to be the top story of the year.

FDA clears CoreValve for valve-in-valve treatment

Medtronic snagged another victory for its CoreValve device with expanded FDA approval of its use in valve-in-valve procedures in inoperable and high-risk patients.

Hospital volumes influence ECMO outcomes in adults

Annual hospital extracorporeal membrane oxygenation (ECMO) case volume may influence mortality, particularly in adults, according to an analysis of international registry data. 

Elevated postop BUN level may predict stroke likelihood

A simple blood test done immediately after cardiac surgery may provide an effective indication of a patient’s postoperative stroke risk. An acutely elevated blood urea nitrogen (BUN) level after an operation was “by far” the most powerful predictor of postcardiac surgical stroke in a case-control study.

Guidelines outline criteria for transcatheter pulmonic valve replacement

Experts in transcatheter valve replacement offered guidelines for treating pediatric and adult pulmonic valve patients, including the development of multidisciplinary heart care teams to let patients understand the gamut of options from a variety of experienced specialists.

ACC.15: TAVR safe and effective in low-risk patients, with caveats

When comparing transcatheter and surgical aortic valve replacements, findings presented at the American College of Cardiology scientific sessions noted that there were no differences in death, stroke, or MI at one year. However, there were some differences in outcomes, leaving neither on top.

ACC.15: PARTNER I outcomes equal for TAVR, surgery at 5 years

High-risk patients with severe aortic stenosis had similar outcomes at five years in both arms of the PARTNER I trial, a finding that the presenter at the American College of Cardiology scientific session called a win for the intervention.

ACC.15: CoreValve’s advantage over surgery widens at 2 years

So it wasn’t a fluke. Two-year results from the CoreValve pivotal trial for high-risk patients with severe aortic stenosis reaffirmed that the transcatheter aortic valve replacement device is superior to standard surgery. The results were presented March 15 at the American College of Cardiology scientific session.

Benefit of restrictive transfusions with coronary surgery put in doubt

Secondary analysis of data from the TITRe2 trial found restrictive transfusion thresholds following cardiac surgery not superior to liberal thresholds when evaluating morbidity and cost at three months.

TAVR death rate rises to 23.7 percent at 1 year in registry analysis

Updating a prior report on 30-day transcatheter aortic valve replacement (TAVR) outcomes of Medicare patients, researchers found several characteristics significantly associated with one-year mortality, according to an article published March 10 in JAMA.

An ACC highlight & why it matters

Here is what I am looking forward to at the American College of Cardiology’s confab next weekend—besides warm weather and sunshine.

Early discharge safe with minimal anesthesia, transfemoral TAVR

French researchers suggest that with the right transcatheter aortic valve, the right approach, local anesthesia and minimal complications, patients can be discharged early with no added risk.