This article is more than 5 years old. Information may no longer be current.
Transseptal access confers lower mortality in mitral valve-in-valve repair
SAN FRANCISCO — Among patients who underwent transcatheter valve-in-valve repair of a failed surgical mitral valve, those who had transseptal access had lower mortality than those who had transapical access at 1 year, according to data presented at TCT 2019.
Both groups had lower mortality than was predicted for repeat surgical mitral valve repair.
In the cohort of 1,576 patients who had a transcatheter valve-in-valve procedure with a balloon-expandable valve (Sapien 3, Edwards Lifesciences), 1-year mortality occurred in 15.8% of those who had transseptal access and 21.7% of those who had transapical access (HR = 0.67; 95% CI, 0.47-0.97), Mayra Guerrero, MD, interventional cardiologist at Mayo Clinic, said during a press conference.
Technical success did not differ between the groups (transseptal, 97.13%; transapical, 94.58%), she said.
At 30 days, 5% of the transseptal group had died compared with 8.1% of the transapical group (P = .07), but CV death was significantly higher in the transapical group (2.1% vs. 5.1%; P = .01) and death rates were lower than expected from the STS Predicted Risk of Mortality (11% in transseptal group; 11.7% in transapical group; observed: expected ratio in transseptal group, 0.45; observed: expected ratio in transapical group, 0.65), Guerrero said.
Rates of stroke, mitral valve reintervention, new dialysis, new pacemaker, device thrombosis, left ventricular ejection fraction did not differ between the groups at 30 days and 1 year, nor did mean gradient, according to the researchers.
NYHA class and Kansas City Cardiomyopathy Questionnaire overall summary score improved in both groups between baseline and 30 days and between baseline and 1 year, but the groups did not differ from each other in those metrics, Guerrero said.
Transapical access compared with transseptal access was an independent predictor of 1-year mortality (HR = 0.58; 95% CI, 0.37-0.9), as were baseline KCCQ overall summary score, baseline estimated glomerular filtration rate, cardiogenic shock, moderate or severe tricuspid insufficiency, perforation and conversion to open-heart surgery.
“Transcatheter mitral valve-in-valve is preferable to redo mitral valve surgery and should be the standard of care for patients with failed surgical prosthesis who have favorable anatomy,” Guerrero said at the press conference.
She noted mortality rates for repeat mitral valve surgery have historically been in the 11% to 12% range, while those for mitral valve-in-valve procedures have traditionally been lower.
The cases from the present study were taken from procedures documented in the TVT registry between June 2015 and August 2019. The mean age of patients was 73 years and 59% were women.
“Transcatheter mitral valve repair using the Sapien 3 is associated with high technical success, low complication rates and a 30-day mortality rate lower than that predicted by the STS score,” Guerrero said here. – by Erik Swain
Reference:
Guerrero M, et al. Late-Breaking Science 2. Presented at: TCT Scientific Symposium; Sept. 25-29, 2019; San Francisco.
Disclosures: The statistical analysis was performed by Edwards Lifesciences but the authors had complete control of the analysis and content. Guerrero reports she received research grant support from Edwards Lifesciences.
Perspective
Back to Top
There are several interesting findings from the study of the SAPIEN 3 valve being used in a mitral valve-in-valve procedure that are parallel to the earliest TAVR studies. In the present study, the cases using a transseptal approach showed a substantially better outcome than the transapical approach, just as the transfemoral approach emerged as the best access for TAVR. In contrast to the early TAVR studies, however, this one doesn’t have a surgical comparator group. Nonetheless, it quantifies a roughly 40% reduction in mortality by using a transseptal approach. That should be the go-forward route. In addition, the 30-day mortality was roughly half what one would expect from a comparable surgical group. That is indirect evidence suggesting this approach is a way to substantially reduce mortality.
The transseptal approach works very well for a mitral valve procedure. The transapical approach is the most direct path, but going through the chest has a substantial physical cost versus a transvenous, transseptal approach. Entering the venous system and crossing the septum is overall a kinder and gentler route for the patient to tolerate, especially in terms of recovery.
The next step in mitral valve-in-valve research will be to take a less ill patient cohort and compare a transcatheter-treated group with a surgical group.