Redesigned transcatheter heart valve shows improvements, study


Redesigned transcatheter heart valve shows improvements, study

Edwards Lifesciences' redesigned non-invasive heart valve replacement system - Sapien XT - showed good performance and was associated with fewer complications compared to the original Sapien, clinical trial researchers explained at the American College of Cardiology's (ACC) 62nd Annual Scientific Session in San Francisco, on Saturday.

The Sapien XT valve has been available in Europe since 2010. In Europe, doctors consider the original Sapien to be obsolete, although it is still being used in the USA because it yet has to be approved by the FDA (Food and Drug Administration). Edwards is compiling data as it seeks FDA approval for the new, redesigned model.

The researchers were announcing the preliminary results from The PARTNER II Trial which showed similar one-year outcomes in major clinical events and mortality between the redesigned Edwards SAPIEN XT transcatheter aortic valve and the original Edwards SAPIEN valve. However, the lower-profile Sapien XT valve was associated with fewer vascular events.

The PARTNER II trial involved inoperable patients with severe, symptomatic aortic stenosis who underwent TAVR (transcatheter aortic valve replacement). With TAVR, the surgeon can replace diseased heart valves by threading the new valve into the correct place through an artery with the use of a catheter - a non-invasive procedure which does not involve chest cracking, open-heart surgery.

In this video, the Sapien XT is implanted by threading a catheter via the upper leg (transfemorally)

TAVR is used for placing both the newly designed Sapien XT and the original Edwards Sapien valve.

Larry L. Wood, Edwards' corporate vice president, transcatheter heart valves, said:

"We are very pleased to see improved outcomes in both the SAPIEN and SAPIEN XT patients, as compared to results from earlier trials. The SAPIEN XT valve was designed to reduce complications of the TAVR procedure, and we believe this has been demonstrated by today's results. Edwards is proud to lead the advancement of cutting-edge innovations for these high-risk patients, supported by rigorous clinical evidence."

The PARTNER II trial spanned from April 2011 to February 2012, it involved 560 individuals at 28 US hospitals, all of them deemed inoperable for open-heart surgery. The participants were randomly selected to receive either of the transcatheter aortic heart valves:

  • 284 received the Sapien XT valve
  • 276 received the Sapien valve
The aim of the study was to demonstrate that the Sapien XT valve is as safe and effective as the older version. Its primary goal focused on a combination of death, stroke and hospital readmissions after 12 months. Dr. Martin Leon, co-lead researcher, said that the results were virtually identical for the two valves.

Below is some of the data Dr. Leon presented:

  • After one year, 22.5% of the Sapien XT patients had died, compared to 23.7% in the Sapien group (the patients' mean age was 84 years).
  • 5.9% of those in the Sapien XT group suffered a stroke within 12 months, compared to 5.7% in the Sapien group
  • There were 40% fewer vascular complications in the Sapien XT group, compared to those in the Sapien group
  • Within 30 days, the death rate (for any cause) in the Sapien XT group was 3.5%, compared to 5.1% in the other group (a difference, but not a statistically significant one)
Dr. Leon described the Sapien XT's 30-day mortality as "about the lowest I have ever seen in TAVR and it happens to be in the sickest of the sick patients, so even though it's not statistically significant, directionally it's encouraging."

Leon explained that with the new device, patients who have smaller vessels with less injury and less trauma can be treated. He added that the positioning of the new valve is more precise.

In 2011, the FDA (Food and Drug Administration) approved the Sapien valve for patients who are unable to undergo traditional open-heart surgery (inoperable patients). In October 2012, the indication was expanded to include high-risk surgical patients. The Sapien XT valve is not yet on the market in the USA; it is an investigational device.

Edwards Lifesciences expects to submit data from Cohort B (inoperable cohort) of the PARTNER II Trial to the FDA during the second quarter of this year, and to complete enrollment of Cohort A (the intermediate risk cohort) in the middle of this year.

About aortic valve replacement

Aortic valve replacement is a procedure performed on patients whose aortic valve is faulty - it is replaced with a healthy valve. A range of diseases can lead to a faulty aortic valve, the valve can either become:
  • Leaky (aortic insufficiency/regurgitation)
  • Partially blocked (aortic stenosis)
Aoritc valves can be replaced with the following approaches:
  • Open-heart surgery
  • Minimally invasive cardiac surgery
  • Transcatheter aortic valve replacement (TAVR)

Opened heart seen from the front. The aortic valve separates the left ventricle from the aorta

About Transcatheter Aortic Valve Replacement (TAVR)

In Transcatheter Aortic Valve Replacement (TAVR), also known as Percutaneous Aortic Valve Replacement (PAVR) or Transcatheter Aortic Valve Implantation (TAVI), a new valve is implanted. It is delivered using a catheter via several access methods:
  • via the upper leg (transfemoral)
  • via the wall of the heart (transapical)
  • coming in beneath the collar bone (subclavian)
  • through a minimally invasive incision into the aorta (direct aortic)
TAVR was developed in Europe and first performed by Professor Alain Cribier at the Hopital Charles Nicolle, Rouen, France. The procedure has been approved in over 50 countries. It has been shown to be effective in improving function in patients with severe aortic stenosis (abnormal narrowing of the aortic valve).

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Section Issues On Medicine: Medical practice