Live Case Procedures Just as Safe as in Daily Practice

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Interventional cardiology procedures that take place during live case demonstrations can be performed with the same level of safety as those that occur in everyday practice, according to a single-center study published in the February 2012 issue of JACC: Cardiovascular Interventions.

Ariel Roguin, MD, PhD, and colleagues at Rambam Medical Center (Haifa, Israel), documented their experience in treating 101 patients during live transmissions that were part of 15 interventional cardiology conferences between 1998 and 2010. Procedures included coronary (n = 66), carotid (n = 15), congenital heart disease (n = 12), complex electrophysiological mapping and ablation (n = 7), valvular (n = 2), and peripheral (n = 1) interventions.

Evidence of Safety

In 4 of the live cases, the intended procedure was not performed after diagnostic angiography because the expert panel determined treatment should not proceed as planned. Technical success was achieved in all attempted cases but 5, which involved inability to cross a chronic total occlusion, though an additional 8 procedures were considered only partially successful. In the end, 83% of patients had their intended live case procedure fully completed without any major complications.

There were no in-hospital deaths. Major complications (primary endpoint; composite of all-cause death, MI, and stroke) occurred in 2 patients: a rise in serum troponin levels after PCI and a stroke occurring in a patient who underwent pulmonary vein isolation for atrial fibrillation. For the coronary cases, minor complications included 3 instances of ventricular fibrillation that were converted to sinus rhythm using direct current shock and 1 guidewire-induced coronary artery perforation that was clinically uneventful as well as 2 postprocedural access site bleeds.

Researchers paired the 66 coronary procedures with 66 matched controls treated by the same operator but not during live case demonstrations. The risk of major complications was similar between the 2 groups (RR 0.32; 95% CI 0.02-3.62; P = 0.62), as was the likelihood of minor complications (RR 0.31; 95% CI 0.04-1.81; P = 0.27).

Getting to the ‘Heart’

Live cases are the “heart of teaching,” the researchers say.

“Transmission of these demonstrations to a large audience with interactive discussion between the operators and the audience opens the procedural details to criticism, allows better training, advances the practice and science of medicine, accelerates the diffusion of new technologies, and promotes the adoption of innovations,” they note, adding that the courses facilitate “immediate feedback from large groups of experienced physicians and may thus even improve the quality of patient care.”

In a telephone interview with TCTMD, Jeffrey W. Moses, MD, of Columbia University Medical Center/Weill Cornell Medical Center (New York, NY), agreed with the teaching value of live case demonstrations.

Live cases are “clearly fulfilling a need. There has to be some learning for these doctors to want to watch them over and over again,” he said. “What [critics] don’t understand is that many practitioners don’t have the advantages that many doctors have in the academic centers, with a broader expertise around them where they can consult at will with colleagues. Most practitioners are pretty isolated, and sometimes they’re in an environment where frankly people don’t necessarily desire to be too helpful because they’re competitors.”

According to Dr. Moses, who has participated in what he described as “scores” of live cases, seeing how decisions are made under pressure and hearing the panel dialogue are both valuable to audiences. “It’s not about showing off [new technologies],” he said. “It’s not about demonstrating the first time you do something.”

Ensuring the Best for Patients

To maintain the integrity of live cases, it is necessary to not only address informed consent but to also ensure that the procedures have specific objectives and educational value, Dr. Moses stressed. And to avoid distracting the operators during panel discussions, he said, someone must always be assigned to focus solely on the patient.

In an e-mail communication, Dr. Roguin told TCTMD that good clinical judgment is key when performing live cases.

“It is important to walk the thin line of balance between patient safety and the need to show interesting and complex cases for teaching purposes,” he said, suggesting that physicians adopt the 2010 live case recommendations endorsed jointly by several societies including the Society of Cardiovascular Angiography and Interventions and the American College of Cardiology Foundation.

An accompanying editorial by John B. Simpson, MD, PhD, of the medical device company Avinger (Redwood City, CA), asserts that one reason why live cases remain safe is the pressure felt by the operator to rise to the task. “I actually think the fear of failure and embarrassment is that element that most ensures the patient’s safety,” he writes. “I have yet to see or participate in a live transmission where none of the physicians seemed to care about the outcome.”

Dr. Moses noted that the paper’s other editorial, written by Andrew Farb, MD, and Bram D. Zuckerman, MD, both of the US Food and Drug Administration (Silver Spring, MD), confirms his impression of what the agency expects from live cases: a desire for patient safety and a lack of marketing agenda.

Both are being achieved, Dr. Moses said. Over the past 20 years, the annual Transcatheter Cardiovascular Therapeutics scientific symposium has broadcast more than 900 live cases demonstrating interventional cardiology procedures, of which 2 resulted in procedure-related deaths. This track record mirrors the safety demonstrated by Dr. Roguin and colleagues, he noted.

One difference between the 2 types of experience, Dr. Roguin said, is that the current study involved “the same team of operators throughout the years,” whereas large medical meetings transmit from several centers and broadcast to several auditoriums. “These meetings are attended by thousands . . . and have very strong industrial support,” he noted.

In their editorial, Drs. Farb and Zuckerman call for more evidence on live cases. “An international registry of prospectively collected data from live cases presented at major interventional cardiology meetings would greatly enhance our understanding of risks and lead to additional measures to reduce those risks,” they say. “In addition, establishment of the educational value of live cases, though challenging to assess, would support their presumed benefit to medical care.”

Study Details

In general, the live cases were comparable to all coronary procedures in routine practice performed at the center in 2010. Most baseline factors including sex and age were similar, though the live cases were more likely to present with stable angina vs. ACS and to involve the use of intravascular ultrasound and pressure wire. Patients treated in live case transmissions scored relatively high on the Mayo Clinic Risk Score, which predicted a mortality rate of 2% to 5%.

 

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Sources:
1. Eliyahu S, Roguin A, Kerner A, et al. Patient safety and outcomes from live case demonstrations of interventional cardiology procedures. J Am Coll Cardiol Intv. 2012;5:215-224.

2. Farb A, Zuckerman B. Live case demonstration of interventional cardiology procedures: A regulatory perspective [editorial comment]. J Am Coll Cardiol Intv. 2012;5:225-227.

3. Simpson JB. Live case demonstration of interventional cardiology procedures: Is it really safe? [editorial comment]. J Am Coll Cardiol Intv. 2012;5:228.

 

 

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