Minimally invasive replacement heart valves are again high on the list at the annual Transcatheter Cardiovascular Therapeutics conference this year, with the latest data dumps from market leaders and arch-rivals Edwards Lifesciences (NYSE:EW) and Medtronic (NYSE:MDT) showing clear benefits for transcatheter aortic valve implants and a shocker from St. Jude Medical (NYSE:STJ).
Five-year data from the Partner trial of Edwards’ Sapien device showed that only 14% of patients in the study were alive after 5 years, but the survival benefit for the cohort implanted with the Sapien valve enjoyed a significant survival benefit and better quality of life compared with the control arm.
Another study, using Medtronic’s CoreValve device in extreme-risk patients, also showed a survival benefit for the TAVI device at 24 months. A separate analysis of that CoreValve study showed the valve’s cost-effectiveness compared with open heart surgery in high-risk patients after 1 year.
An Italian study comparing both the Sapien and CoreValve devices with open heart surgery in low-risk patients, however, suggested similar mortality rates for TAVI and open heart procedures.
And in a shocking development, St. Jude said it’s hitting the pause button on all implantations of its Portico valve pending further analysis of 4D CT scans showing a potential problem with the valve.
Five-year Partner data shows survival benefit for TAVI
The Partner trial’s 5-year data on Sapien revealed that almost all of the inoperable patients in the study, who were an average of 83 years old when Partner launched, died within 5 years of TAVI treatment or standard care. But the all-cause mortality rate for the Sapien arm at 5 years was 71.8%, compared with 93.6% for the usual care control arm (the mortality rate in the U.S. for the same age and gender cohort is 40%, according to MedPage Today).
And the survival rate in the last 2 years of the study showed that 61% of the TAVI patients still alive at 3 years survived to the 5-year mark, compared with 33% of the control group.
"If you look at median survival, if you have standard therapy you live less than a year, and if you do TAVR, you live 2½ years. This is a big difference," Kapadia said, according to heartwire. "And these 2½ years are a functionally good 2½ years."
The results make Partner the benchmark for future studies, according to Dr. Jeff Popma of the Beth Israel Deaconess Medical Center in Boston.
"This is the worst of the outcomes we expect to see, and everything from now on will be better than that," Popma said. "We’re still doing the right thing by treating these patients: They get quality of life and they get improvement; these are overwhelming data."
Medtronic’s CoreValve at 2 years
Medtronic’s CoreValve device showed showed an all-cause mortality rate of 38.0% in an extreme-risk group, topping a 57.9% performance goal, according to MedPage Today. Medtronic said the rate of major stroke for the TAVI group was 5.1%.
Among high-risk patients, CoreValve TAVI at 1 year proved to be cost-effective compared with open heart valve replacement surgery, according to data presented by Dr. Matthew Reynolds of Lahey Hospital & Medical Center in Burlington, Mass.
"It’s encouraging to see that for patients at high risk for surgery, [TAVI] with the CoreValve system provides a greater chance for a longer and higher quality of life, likely due to faster recovery from the procedure, at a reasonable cost," Reynolds said in prepared remarks. "In an age where healthcare costs are under increased scrutiny, it is especially important and reassuring to know that this new self-expanding valve also is cost effective for the U.S. healthcare system. And we can expect costs associated with length-of-stay, complications and ICU days to decrease as this therapy transitions into commercial use and implanters gain greater experience."
Sapien, CoreValve equivalent to open heart in Observant trial
Both the Sapien and CoreValve devices were roughly equivalent to open heart surgery among lower-risk patients, according to a study presented by Dr. Marco Barbanti of the Ferrarotto Hospital in Catania, Italy. The all-comers study compared 650 patients implanted with either Sapien or CoreValve with 650 patients treated with surgical aortic valve replacement. Among the TAVI cohort, the mortality rate at 12 months was 13.1%, compared with 13.3% for the SAVR arm.
"Right now, I’m not suggesting that TAVI should be used in patients at intermediate risk, but this is a [snapshot] of what is happening in Europe. The trend is this," Barbanti told heartwire. "My personal feeling is that in the future, even intermediate-risk patients will be treated with TAVI, and I’m sure it won’t be superior to SAVR for certain outcomes, but for mortality, I think they will probably be the same."