BOSTON—Data from the groundbreaking PARTNER trial presented at the ACC.11 this year may create a new era of medicine. While some may be concerned with the almost $25,000 price tag linked to transcatheter aortic valve implantation (TAVI) procedures, Eric M. Horlick, MD, said that TAVI may cost nearly the same as prescribing dabigatran for atrial fibrillation patients, and is more cost-effective than performing catheter ablation procedures, during the Pediatric and Adult Interventional Cardiac Symposium (PICS-AICS) July 27.
“In medicine, when does an era start?” asked Horlick, an interventional cardiologist at the Peter Munk Cardiac Centre, University Health Network in Toronto. “It starts when a randomized controlled trial is completed.
“PARTNER is a foundation for a huge revolution in cardiovascular business,” and is part of an even greater migration toward smaller incisions and safer procedures compared to surgical techniques, Horlick said.
However, he stated that as for creating a revolution in medicine that would transition toward use of the transcatheter approach, physicians must work together and employ a multidisciplinary approach to care.
“How do we plan in adult medicine for this revolution?” asked Horlick. This, he said, is based on technology.
In the PARTNER trial, researchers evaluated the use of the Edwards Lifesciences' Sapien heart valve, which consists of a stainless steel slotted tube stent, bovine pericardial valve and is available in both 23mm and 26mm. Meanwhile, a newer stent generation, the Sapien XT cobalt chromium stent, is currently being evaluated in multiple clinical trials evaluating transcatheter interventions.
Currently, it is still up in the air as to who should perform transcatheter procedures and on whom to perform the procedures. “Cost is the elephant in the room for transcatheter procedures,” Horlick said. “Questions, such as should we spend $25,000 to perform TAVI on a sick 89-year-old patient, still remain.
“Patients in the PARTNER trial patients were very sick people,” Horlick said. Therefore, he said, researchers will now look at where the future of this therapy lies. “Future iterations of this trial are going to be done in moderate to low-risk patients. Who will win: TAVI or surgery?"
PARTNER, which compared outcomes of the transcatheter and surgical aortic valve replacement strategies, reached its primary endpoints swimmingly and showed a 20 percent survival rate for patients who underwent valve implantation. “No therapy in medicine besides dialysis has provided these types of benefits,” Horlick said.
However, many are still concerned with the vascular and technical complications coming out of the findings. While TAVI may improve quality of life and decrease hospitalization for aortic stenosis at one-year, it may also increase the rates of CABG, cerebrovascular diseases and peripheral vascular disease.
In the PARTNER Cohort B trial, Reynolds et al conducted a cost-benefit analysis and found that TAVI patients compared with the non-surgical standard of care have an incremental cost-effectiveness ratio of about $50,200 for each additional year of life gained.
While Horlick said that some may think that TAVI is a much more expensive procedure and may be hesitant to use it, he offered that the procedure is only slightly more expensive than treating atrial fibrillation (AF) patients with dabigatran (Pradaxa, Boehringer Ingelheim) and is less expensive than performing AF ablation, a common procedure used to treat arrhythmias.
However, Horlick offered, “The main story of this trial is stroke, because there was a greater incidence of stroke in the transcatheter valve group.” He offered that in the future, filter devices could be used to prevent carotid embolization that could lead to stroke.
“In high-risk patients for stenosis, TAVI was non-inferior to open surgery,” said Horlick.
What are PARTNER’s implications? "The PARTNER results are setting a completely new standard for the way we evaluate drug therapy. No longer will a patient be compared to drug therapy, they will be compared with TAVI," said Horlick.