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Factors Affect Valve-in-Valve TAVR Outcomes

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Among patients undergoing transcatheter valve-in-valve implantation to repair failed surgical aortic bioprostheses, survival was influenced by valve size and the type of failure, a registry study showed.

A year after undergoing the procedure, 83.2% of the patients were still alive, , of St. Paul's Hospital in Vancouver, and colleagues reported in the July 9 issue of the .

However, patients were more likely to die during that time if they had a small surgical bioprosthesis measuring 21 mm or less (HR 2.04, 95% CI 1.14-3.67) or presented with a degenerated surgical valve resulting from stenosis as opposed to regurgitation (HR 3.07, 95% CI 1.33-7.08).

Action Points

  • Note that this cohort study revealed several risk factors for mortality among patients receiving transcatheter aortic valve replacement after surgical valve failure.
  • Be aware that stenosis as a cause of failure and small surgical valve type were risk factors for mortality after the procedure.

"The valve-in-valve approach may offer an effective, less-invasive treatment for patients with failed surgical bioprostheses and, therefore, the trend toward implantation of bioprostheses in younger patients is expected to grow," the authors wrote.

But, they added, "Thorough assessment of candidates for valve-in-valve implantation is a key step to obtain optimal results. The current analysis highlights the need for meticulous evaluation of bioprosthesis mechanism of failure before attempting a valve-in-valve procedure."

Commenting on the study, Frederick Ling, MD, of the University of Rochester Medical Center, said, “I think that on the basis of this particular registry we’re going to learn a little bit more about what patients to select for if these patients do come up.”

In addition, he told ֱ, “I think that surgeons who actually do surgery now will be thinking about this particular study and trying to potentially optimize their surgical technique in the event that these patients require valve-in-valve.”

Although another operation is considered the standard treatment for patients with degenerated surgical aortic bioprostheses, many patients have a high risk for surgical complications. An alternative is using transcatheter aortic valve replacement (TAVR) to repair the damaged bioprosthesis.

To examine 1-year outcomes with the approach, Dvir and colleagues examined data from the Valve-in-Valve International Data (VIVID) registry. The current analysis included 459 patients (average age 78) who underwent transcatheter valve-in-valve implantation to repair a degenerated surgical bioprosthesis at one of 55 centers in Europe, North America, Australia, New Zealand, and the Middle East. The median time since the last surgical valve replacement was 9 years.

Failure of the surgical bioprosthesis was indicated by stenosis in 39.4% of the patients, regurgitation in 30.3%, and both in 30.3%.

The study was restricted to patients implanted with either an Edwards Sapien or Sapien XT balloon-expandable valve (53.6%) or the self-expandable CoreValve (46.4%) for the transcatheter valve-in-valve procedure.

At 1 month after the procedure, 7.6% of the patients had died and 1.7% had had a major stroke. Of the survivors, 92.6% had good functional status as defined by a New York Heart Association class of I or II.

The stroke rate and the distribution of NYHA functional class did not differ based on the cause of the failure of the surgical bioprosthesis, although mortality was higher in patients presenting with stenosis compared with regurgitation or both (10.5% versus 4.3% and 7.2%, P=0.04).

At 1 month, patients who received an Edwards valve were more likely to have major or life-threatening bleeding and acute kidney injury and those who received CoreValve were more likely to require implantation of a permanent pacemaker and to have residual aortic regurgitation of at least moderate severity.

Differences in survival between groups also were evident at 1 year. Patients with stenosis as the mode of failure were less likely to survive compared with those with regurgitation or both stenosis and regurgitation (76.6% versus 91.2% and 83.9%, P=0.01).

"Higher mortality in the stenosis group could partially be attributed to higher rates of specific life-threatening procedural complications, such as ostial left main obstruction," the authors noted.

In addition, patients with small surgical bioprostheses of 21 mm or less -- which were more common in the stenosis group compared with the regurgitation or combined groups -- were less likely to survive to 1 year compared with those with intermediate valve sizes of more than 21 to less than 25 mm and large valve sizes of 25 mm or greater (74.8% versus 81.8% and 93.3%, P=0.001).

Transcatheter valve type was not associated with survival at 1 year.

In addition to small surgical bioprosthesis size and stenosis as a mode of failure, other factors that predicted the risk of dying in the first year after the procedure included the use of transapical access for the valve-in-valve implantation (HR 2.25, 95% CI 1.26-4.02) and an increase Society of Thoracic Surgeons score (HR per 1% increase 1.01, 95% CI 1.00-1.01).

The authors acknowledged some limitations of the study, including the difficulty in stratifying patients according to the type of surgical bioprosthesis that had degenerated, the lack of echocardiographic data immediately after surgical implantation, and the lack of information on several factors related to clinical outcomes in patients with structural aortic valve disease, including left ventricular mass index, diastolic function, ischemic cardiomyopathy, and frailty.

From the American Heart Association:

Disclosures

Dvir disclosed no relevant relationships with industry. His co-authors disclosed relevant relationships with Edwards Lifesciences, Medtronic, JenaValve, Claret Medical, Merril Lifesciences, Thubrikar, Direct Flow Medical, St. Jude Medical, Boston Scientific, Biotronik, Symetis, Abbott, and Cordis.

Primary Source

Journal of the American Medical Association

Dvir D, et al "Transcatheter aortic valve implantation in failed bioprosthetic surgical valves" JAMA 2014; 312: 162-170.