Promising Early Valve-in-Valve Results Seen in Small Nordic Registry

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For patients undergoing transcatheter valve-in-valve procedures to replace failed bioprostheses, low rates of 30-day mortality, major complications, and paravalvular leak are encouraging, as is the high 1-year survival rate, according to registry data presented at the American Academy of Thoracic Surgery Annual Meeting on May 6, 2013, in Minneapolis, MN.

Leo Ihlberg, MD, PhD, of Helsinki University Hospital (Helsinki, Finland), reported results from the Nordic Valve-in Valve Registry, which included 45 aortic procedures performed at 11 centers in Finland, Sweden, Norway and Denmark from 2008 to 2012. All involved transcatheter aortic valve replacement (TAVR) inside surgically implanted bioprosthetic valves that had degenerated. The average time since surgery was 8.7 ± 3.5 years.

The Sapien or Sapien XT (Edwards Lifesciences, Irvine, CA) was used in 33 cases, while CoreValve (Medtronic, Minneapolis, MN) was used in 12. Access routes were transapical (n = 25), transfemoral (n = 17), transaortic (n = 2), and subclavian (n = 1).

Few Complications, But High Gradients Persist in Some

No deaths occurred during the procedure, and the technical success rate was 96%. At 30 days, all-cause mortality was 4% (1 cardiac-related death, 1 aspiration pneumonia). The average hospital length of stay was 8.0 ± 3.9 days.

Major complications within 30 days were rare and included periprocedural MI (4%), major stroke (2%), and major vascular complication (2%). In addition, the majority of patients in both the Sapien/Sapien XT and CoreValve groups were in NYHA Class II (48% and 52%, respectively) at 30 days. With 1 exception, all patients had either no (79%) or mild (19%) paravalvular leaks. The single case of moderate paravalvular leak occurred in a CoreValve patient.

Mean and peak gradients as well as valve area and LVEF were similar between the Sapien/Sapien XT and CoreValve groups (table 1).

Table 1. Valve Function at 30 Days

At 30 days, 17% of all patients had aortic gradients greater than 20 mm Hg. That number remained unchanged at 12 months. In Kaplan-Meier analysis, 1-year survival for the entire cohort was 88%.

According to the study authors, follow-up was not long enough to assess the effect of high gradient or the durability of the procedure over time.

Too Small for Definitive Conclusions

In a telephone interview with TCTMD, Philippe Généreux, MD, of Columbia University Medical Center (New York, NY), said the findings extend those of other valve-in-valve reports but stressed that the registry is small and retrospective with no central core lab. It stands in contrast to the Global Valve-in-Valve Registry, for example, which collects data from over 50 centers in Europe, North America, Australia, New Zealand, and the Middle East.

“Interest in valve-in-valve procedures is definitely increasing, so registry data are useful and always nice to see,” Dr. Généreux said. “It is doable, it’s feasible, it’s safe and it may be a very good solution for very sick patients who are not candidates for a second surgery.”

That being said, the high gradients seen in 17% of patients at 1 year remains a concern, he added.

“Given the fact that these patients are at high risk and old, the gradients appear to be acceptable, but we will have to see if it becomes a problem with longer follow-up,” Dr. Généreux noted. Whether the gradients could increase the risk for degeneration of the replacement valve or for thromboembolic events remains to be defined, he said.

“I think what we can say right now is the early data, including this registry, are encouraging,” Dr. Généreux said.

He also noted that while the Global registry showed half the risk for high gradients with CoreValve compared with Sapien, the Nordic registry does not reflect that pattern.

Study Details

The mean age of patients was 80.6 years and 58% were men. Mean EuroScore, EuroScore II, and Society of Thoracic Surgery score were 35.4, 16.3 and 14.6, respectively. Cause of bioprosthetic valve failure was stenosis/combined in 58% (mean and peak aortic valve gradients of 77 mm Hg and 45 mm Hg, respectively) and regurgitation in 42%

Source:

Ihlberg L. Early clinical outcome of transcatheter valve-in valve implantation in the Nordic countries. Presented at: American Academy of Thoracic Surgery Annual Meeting; May 6, 2013; Minneapolis, MN.

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