November 29, 2023

Medical Experts Dispute a Hospital’s Claims on Heart Device Data

This month, University Medical Center of Southern Nevada said in a statement, “results to date show significantly improved outcomes for our cardiac patients” who got heart implants made by a little-known company, Biotronik. The statement was attributed to Kathleen Silver, the chief executive of the hospital.

Ms. Silver issued that statement after an article in The New York Times reported that cardiologists there switched in 2008 to using Biotronik devices after that company started paying them thousands of dollars in consulting fees.

A hospital spokeswoman later said in response to a reporter’s question that Ms. Silver’s comments were based on data drawn from a national registry of heart patients who received an implanted defibrillator. University Medical Center also provided The Times with limited data from that registry that it said backed its contention.

But several experts knowledgeable about that defibrillator database said in separate interviews that it did not track how device recipients fared after they left a hospital. As a result, it cannot and does not provide data to hospitals or manufacturers about the long-term performance of any company’s device. It also does not produce data that can be used to compare the performance of competing implants made by different companies.

“To saying that we are doing better is a bridge too far for the data they have,” said Dr. Jeptha Curtis, an assistant professor of medicine at Yale, who has worked on research studies involving registry data.

Told of the experts’ assessments, Danita Cohen, the spokeswoman for the Las Vegas hospital, responded in writing by stating, “By way of clarification, U.M.C. did not intend to say that our better outcomes can be attributed to a particular device.”

She added that the hospital’s remarks about “improving patient outcomes” were intended to mean that its use of the defibrillator database was helping it monitor its performance.

The hospital’s disputed claims may intensify scrutiny of the ties between the Las Vegas physicians, Biotronik and a company called Western Medical that acts as the company’s sales representative in Nevada and several other states. Those ties are currently under review by state officials in Nevada. The Justice Department started a separate investigation last year into Biotronik’s sales and marketing practices.

The Times article focused on relationships between a device industry sales official named Caesar Fonte and cardiologists at a Las Vegas practice, Nevada Heart and Vascular. Before 2008, when Mr. Fonte worked at Boston Scientific, a defibrillator producer, the same cardiologists were paid consultants to that company and almost exclusively used its devices, hospital data shows.

Then in 2008, Mr. Fonte quit Boston Scientific and started Western Medical, the Biotronik distributor. The implant specialists at Nevada Heart and Vascular then became paid consultants to Biotronik and switched to using its devices in nearly all patients.

Both Biotronik, the physicians and Mr. Fonte have rejected any suggestion that the consulting fees were inducements to get them to use the company’s devices.

The defibrillator database is part of the National Cardiovascular Data Registry, a project run by the American College of Cardiology Foundation, in conjunction with a professional medical group, the Heart Rhythm Society. It is often referred to as the ICD registry, which is short for implantable cardioverter-defibrillator, the device’s formal name.

In 2004, Medicare mandated the creation of a national ICD registry as a condition for approving payments for defibrillators for a new class of patients, for whom evidence of a benefit was equivocal. Implant makers, who have realized vastly added sales from the Medicare ruling, supported the registry for one year then cut back financing. Its is now underwritten by hospitals, but limited financing has restricted the data it can collect.

Essentially, during a procedure to implant a defibrillator, information is collected about areas like a patient’s heart function and other medical conditions. If an existing defibrillator is being replaced by a new one, a hospital can also indicate one of several reasons why such a replacement is being performed.

The information from the national ICD registry provided by University Medical Center to The Times reflected data from two of those device replacement fields. It showed that for a four-year period between 2007 and 2010, no device had been replaced at University Medical Center because it had been recalled or because it had malfunctioned.

Earlier, when providing the data, Ms. Cohen, the hospital spokeswoman, said that its results were “highly significant” when compared with the national average for such replacement reasons. The hospital added that Biotronik has not issued any recent device recalls.

Experts like Dr. Curtis said, however, that the hospital’s data was effectively meaningless because there was no way of knowing from it whether a device being replaced at U.M.C. had been initially implanted there, or whether devices implanted at U.M.C. were later replaced elsewhere.

“If they are thinking that no news is good news from the registry, then they are misunderstanding what function the registry is performing,” said another registry expert at Yale, Dr. Harlan Krumholz.

The national ICD registry does report back to hospitals about in-hospital complication rates related to device implantation procedures so they can compare it with the national average. Asked for its complication rate, U.M.C. declined to release it.

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