PARTNER II: Valve-in-Valve Repair Safe Alternative to Reoperation in Failed Aortic Prosthetic Valves

Deborah Brauser

October 19, 2015

SAN FRANCISCO, CA – Valve-in-valve repair of failed surgical bioprosthetic heart valves may offer a safe option for patients considered to be at high risk for repeated surgical procedures, suggests new research.

One-year results from the PARTNER II trial of 197 nonrandomized patients who received the Sapien XT (Edwards Lifesciences) valve-in-valve device had a 13.4% all-cause mortality rate (the primary end point) and an 8.9% rate of cardiac mortality.

The device, which had been available for standard transcatheter aortic-valve repair (TAVR) in both the US and Europe, received expanded FDA approval last week to include valve-in-valve repair. It will now join the CoreValve System (Medtronic), which was approved for the same indication earlier this year.

Further results from the study, which were presented here at TCT 2015, showed a 3.7% 1-year stroke rate in these high-risk participants and an 11.8% rehospitalization rate.

Dr Danny Dvir

"The other options for failed bioprosthesis are either to continue with medical management or perform 'redo surgery,' " Dr Danny Dvir (St Paul's Hospital, Vancouver, BC) told heartwire from Medscape. "To repeat the previous surgery is associated with a lot of comorbidity, and the mortality is not minimal. I think we have . . . proof for a good alternative."

Dr Roxana Mehran (Mount Sinai School of Medicine, New York, NY), codirector of TCT, told heartwire that she was excited about the results and the FDA approval, and she thinks it will become the "default therapy" for the patient population.

At a press briefing, discussant Dr Samir R Kapadia (Cleveland Clinic, OH) agreed. "There are enough data now that if you're a high-risk patient, this would be preferred therapy, along with the CoreValve," he said. Although he cautioned that the study did not provide any randomized data, the procedure "should definitely be standard of care at this stage."

High-Risk Group

The current analysis combined 97 participants in the original PARTNER II valve-in-valve registry (55.7% men; mean age, 80.1 years), conducted between June 2012 and April 2013, and 100 participants from the PARTNER II valve-in-valve extended registry (65% men; mean age, 77 years), conducted between May and December 2013.

All patients had "symptomatic severe stenosis or regurgitation of a surgical aortic-tissue valve," reported Dvir to attendees. They also had an estimated reoperation surgical mortality or major morbidity of 50% or higher and were able to tolerate a 23-mm or 26-mm Sapien XT device. Exclusion criteria included surgical valve size less than 21 mm.

"This was a very high-risk group," said Dvir. The overall STS score was 9.7, 95.4% of patients were NYHA class 3 or 4, 70.6% had coronary artery disease, 49.7% had atrial fibrillation, and 33% were considered frail.

At 30 days, the all-cause mortality was 4.1% in the 197 valve-in-valve patients, which went up to just 13.4% at 1 year. When examining the original vs extended registry groups, the latter had 0% all-cause mortality at 30 days, "which astonished us," said Dvir, and a rate of 7.2% at 1 year.

Other outcomes in the total study population at 30 days and 1 year included 3.6% and 8.9%, respectively, for cardiac mortality; 2.5% and 3.7% for all strokes; and 7.3% and 11.8% for rehospitalization.

Clinical Implications

In addition, NYHA class improved significantly from 57.9% in class 3 and 37.6% in class 4 at baseline to just 10.5% and 1.1%, respectively, at 30 days (P<0.0001). The percentages remained similar at 1 year (9.5% and 2.5%, respectively).

Six-minute-walk test distance also improved significantly at 30 days (P<0.0001), but was not significant at 1 year. However, the overall Kansas City Cardiomyopathy Questionnaire summary score, which measures quality of life, improved significantly at both 30 days (P<0.0001) and 1 year (by 35 points from baseline, P=0.001).

Echocardiograms showed that left ventricular (LV) ejection fraction increased significantly from baseline to 1 year (P=0.02), and LV mass index decreased significantly at both 30 days (P<0.0001) and 1 year (P=0.0002). At 30 days, there were also significant decreases in total moderate and severe aortic regurgitation (P<0.0001), and in moderate and severe mitral (P=0.0002) and tricuspid (P=0.002) regurgitation.

Finally, the most common procedural complications were major bleeding (n=29) and acute kidney injury (n=16).

"The clinical implication we believe is that valve-in-valve TAVR . . . is a beneficial therapeutic alternative to reoperation in patients with failed aortic bioprosthesis," said Dvir to attendees, adding that the investigators were very pleased with the low outcome rates.

"We saw excellent freedom from death, stroke, and major adverse events. And a significant clinical benefit in terms of symptoms, functional status, and quality of life," he said.

Valve Size Concerns

Dr Jeffrey Popma

After the presentation, discussant Dr Jeffrey Popma (Beth Israel Deaconess Medical Center, Boston, MA), co–principal investigator of the US CoreValve trials, asked about the lowest stent diameter that was used.

"The reason this is important is because the surgical valve is already smaller than the native aortic valve. So if you're putting another valve inside, you could start losing diameter. And you don't want to make it too small," moderator Dr Ajay Kirtane (New York-Presbyterian Hospital/Columbia University Medical Centre, NY) explained to attendees.

"For the Edwards valve, because the valve is at the same level, there's the potential for further constraint, whereas the CoreValve sits above and so may be less of an issue," added Kirtane, who is also a codirector for TCT.

Dvir noted that 21 mm was the lowest valve size accepted. "But I think we should move away from those questions and look at the survival rates of these patients," he said. "When we gained experience with how to screen for these patients, no patients out of 100 patients died at 30 days."

However, some discussants pointed out that this was based on selecting larger valves. "If you select appropriately and don't treat those really small valves, then the data can look really good," noted Kirtane.

Dvir agreed. "In my practice, there are data suggesting that you need to rethink whether these patients are good candidates for this procedure," he said. "However, in further analyses, we did see some influence of small valves on clinical outcomes."

"The bottom line is that, as clinicians, we're going to make the best decisions for our patients," said Popma, adding that there may be advantages for each device in certain circumstances. "I think we're willing to give real estate to both sides."

Dvir reported being a consultant for Edwards Lifesciences and Medtronic.

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