NEW ORLEANS -- Some things don't add up about the transcatheter aortic valve replacement (TAVR or TAVI) data, according to allegations presented here at the Society of Thoracic Surgeons (STS) meeting.

When the PARTNER 1A trial first came out in 2011, the trialists concluded that the Sapien valve was non-inferior to surgery out to three years for patients with symptomatic severe aortic stenosis at high surgical risk.

However, some of the PARTNER 1A data were apparently "hidden" to give TAVR a leg up, Anthony Furnary, MD, of the Starr-Wood Cardiac Group of Portland, Oregon, told an STS audience.

"The medical-industrial complex, having invested billions of dollars into the development of TAVI, wanted to ensure regulatory and clinical approval ... In that quest, and to that end, they have withheld important clinical data, which has impaired the ability of the medical community at large to fully evaluate the comparative effectiveness of TAVI to isolated SAVR [surgical aortic valve replacement] and its impact on specific patient populations," Furnary alleged.

"This has irreparably altered clinicians' ability to rationally and safely deploy this excellent technology to the appropriate patient populations without concomitantly, unwillingly and unknowingly doing harm," he continued.

Furnary said he pored over the nearly 1,200 pages of meeting materials from the FDA advisory committee that advised approval of a broader high-risk indication for the Sapien TAVR valve in 2012 (it was first approved in 2011 for inoperable patients).

He found non-publicized numbers showing that TAVR was not non-inferior to SAVR in 1-year survival for men.

"The FDA was highly concerned about this, and it was mentioned no less than three times in the executive summary," Furnary said. He found that the agency had implored Edwards to look further into the issue, resulting in a 2015 meta-analysis confirming this but with a "positive spin" -- that female sex was an independent predictor of late survival after the transcatheter procedure.

Another point of contention for Furnary was "shifty" nomenclature hiding the appropriate "valve implant" comparison. Comparing apples to apples, one would see a 24.5% rate of actual TAVR implant mortality at one year compared with 21.6% for isolated SAVR (without concomitant procedures), according to his calculations, which took into account exclusions and crossovers between trial arms.

"TAVI implants failed to meet non-inferiority to isolated SAVR. In other words, SAVR is superior to TAVI," he said. "None of this was shown in PARTNER 1A."

Yet it was the surgeons who decided at the operating table whether they would do any accompanying procedures on a patient assigned to SAVR, according to fellow surgeon Vinod Thourani, MD, of Piedmont Heart Institute in Atlanta.

"If there's anyone to criticize, it's this room," he said during the session's panel discussion.

Thourani also pointed out that the The New England Journal of Medicine, in which PARTNER 1A was published, does not allow subanalyses. "We have to be careful about poo-pooing the randomized trials a little bit."

Furnary maintained that the trialists had eight years to publish the data and to tell the world that in males, TAVR was not non-inferior in the high-risk population.

"In my opinion, the series of randomized trial data that exists in the TAVR space constitutes some of the highest level of clinical evidence ever generated for a cardiovascular procedure (interventional or surgical)," said interventional cardiologist Ajay Kirtane, MD, SM, of Columbia University Irving Medical Center/NewYork-Presbyterian Hospital in New York City, in an email to MedPage Today.

"Secondary analyses [by Furnary] of what appear to be isolated subgroups and post-randomization treatment cohorts (e.g., after isolated valve implantation, within the as-treated group) are fraught with the potential for erroneous conclusions," continued Kirtane, who was not involved in PARTNER 1A.

Over the course of his STS presentation, Furnary also touched on the higher rates of early stroke and neurological events with TAVR compared to SAVR in PARTNER 1A (even with a transfemoral approach). Aortic regurgitation and reverse modeling also tended to favor the surgical group as well, he said.

"The way things don't add up, it troubles me enormously," said epidemiologist and biostatistician Nick Freemantle, PhD, of University College London. "What we don't have is a randomized trial sponsored by someone other than a manufacturer."

"Where would we be now if the French hadn't sponsored MITRA-FR? We would have a completely different view" of MitraClip for secondary mitral regurgitation, Freemantle noted as an example.

"The truth is out there. You deserve to know the truth, patients deserve to know the truth, and cardiologists need to know the truth," Furnary said. "I do TAVI. I think it's a great thing. I just have a problem with what was presented, how it was presented, and what was not presented."

However, the totality of the data, including intention-to-treat and as-treated analyses and secondary manuscripts, supports the role of TAVR as an alternative to SAVR, Kirtane argued.

"Newer devices, technique iterations, and rigorous neurologic assessments of all randomized patients (which were incorporated into subsequent trial designs in light of the recognized early stroke concerns) have demonstrated the current-day TAVR procedure to be even safer than observed in this early study," he stated.

Nicole Lou is a reporter for MedPage Today, where she covers cardiology news and other developments in medicine. Follow