Document Proposes Procedure Volumes to Attain Competency in High-risk PCI

 

(UPDATED) A group of leaders in the field of high-risk coronary interventions and their past or current fellows have provided recommendations around what it would take for operators to attain competency for the most complex procedures.

And they propose that an additional year of training might be needed to get there, citing both limitations in existing general interventional cardiology training programs and advancements in the field of high-risk PCI.

“The thought process was it might be beneficial to develop an actual high-risk fellowship training curriculum,” which can be considered by centers that already have such a program or are thinking of starting one, lead author Rhian Davies, DO (University of Washington, Seattle), told TCTMD.

In their paper, published recently online ahead of print in Catheterization and Cardiovascular Interventions, Davies et al suggest minimum procedural volumes needed to achieve technical competency:

• Successful retrograde or antegrade chronic total occlusion (CTO) PCI: 150
• Intravascular imaging: 100
• Unprotected left main PCI with intravascular imaging: 20
• PCI assisted by hemodynamic support: 15
• Placement of various types of hemodynamic support: 10
• Management of various complications: 10 snaring procedures and 5 cases each involving pericardiocentesis, coil embolization, fat embolization, and bailout
• Large-bore vascular access management: 5

The authors recommend training in the management of cardiogenic shock, including transitions to durable forms of long-term support, for 6 to 8 weeks. They also advocate for the attainment of expertise in managing technical challenges like calcific disease, bifurcations, stent underexpansion, and restenosis; they suggest doing a minimum of 30 cases involving orbital or rotational atherectomy and lithotripsy and five cases involving stent underexpansion or restenosis.

“We really felt like if you’re going to do another year, these are the things that you need to focus on and feel comfortable with coming out,” Davies said.

Interventional cardiologists interviewed by TCTMD largely agreed with the overall thrust of the group’s effort aimed at shoring up training in high-risk PCI, which can vary substantially from program to program.

“There do need to be better standards for how we train interventional cardiologists to do the most complex procedures,” Robert Yeh, MD (Beth Israel Deaconess Medical Center, Boston, MA), told TCTMD, pointing out that patients undergoing coronary interventions are becoming more complex over time and that the gap between operators with an elite set of skills and those with a typical set of skills is widening. “I think that has the potential to adversely impact patient care if patients aren’t . . . put in the right hands,” he commented.

That said, Yeh and others indicated that an additional dedicated training year is not the only way to obtain those skills and that some of the recommendations in the paper might have unintended consequences.

J. Dawn Abbott, MD (Rhode Island Hospital and Brown University, Providence, RI), said, too, that the recommendations should not be overinterpreted. The authors are well-respected, high-volume operators who perform complex PCI and make important contributions to the field, she said, but this document does not carry the same weight as a multisociety training statement. “Something like that would be much more widely accepted and utilized by agencies that regulate fellowships,” Abbott said, calling the paper by Davies et al “a starting point.”

Potential Drawbacks

Davies said that in the initial reaction to the document, commentators got a bit hung up on the specific numbers, when the intent was to introduce standardization to training in the field.

Indeed, on Twitter, much of the chatter revolved around the 150-case minimum volume for CTO PCI, which was seen as a very high bar, particularly when there are not robust randomized data supporting an impact on patient outcomes.

To that point, Davies said there is, in fact, evidence that CTO PCI improves quality of life. The DECISION-CTO trial showed that optimal medical therapy was noninferior to PCI in terms of hard clinical outcomes, with no differences between groups in quality of life. However, EUROCTO showed that quality of life was improved with PCI versus optimal medical therapy.

She also said that 150 CTO PCIs in a year is achievable. “Patients are out there and those numbers are easy to obtain,” she said. “I think there are a lot of institutions already doing over 150, 300, easily, a year.”

But what about the potential unintended consequences of aiming for a number that high, or any number for that matter, and of creating dedicated fellowships for complex PCI?

Yeh pointed out that some interventions—CTO PCI, mechanical circulatory support (MCS), and procedures in frail patients who have been turned down previously, for instance—do not have a strong evidence backing them. “The evidentiary basis for many of the things that we do are not necessarily the strongest. They are weaker than in other areas of cardiovascular medicine,” Yeh said.

Referring specifically to the evidence around CTO PCI, Abdelkader Almanfi, MD (Mercy Health – Lourdes Hospital, Paducah, KY), said, “To recommend certain guidelines for training for something that’s not yet well established in the cardiology community is probably difficult to do. This might be a controversial issue, but we always look for the data first and then we implement the indication and implement the training afterward.”

Yeh said calling for a high number of CTO PCIs during a training year could incentivize unnecessary procedures, noting that the recommended minimum number of complication cases was also high and might push operators to do more interventions to reach those thresholds. Many sites already do 120 or 130 CTO PCIs a year, Yeh said. “So now are those sites that are interested in offering a fellowship going to drum up more volume to be able to support those fellowships? Will there be this psychological pressure to do more procedures? In CTO PCI in particular I think that there’s a lot of discretion that’s necessary for optimal clinical judgement.”

Applying discretion, being judicious, and focusing on the patient “will necessarily lead to fewer procedures at an institution,” he added.

Davies said that experienced operators won’t perform CTO PCI if there’s not a reason to do so. “If the tissue’s not viable, or the patient’s not symptomatic, or if the patient’s not optimized on medication, they have to have a reason for us to go on more than just there’s an occlusion in the artery,” she said. “There’s no reason to risk a patient’s well-being just to do a procedure, so I would say that I think anybody that would be doing this to this level would agree with only doing the procedures when they’re actually indicated.”

Implications for How Operators Get Trained

Yeh also said the implications of setting these benchmarks for training in complex PCI for institutions and individual operators need to be considered. He estimated that perhaps fewer than 10 people have completed these types of fellowships, whereas there are dozens—or more—of highly skilled operators performing complex PCI in the United States right now who accrued their experience over time rather than during a dedicated training year. What impact these recommendations could have on operators who don’t complete a dedicated complex PCI fellowship is important to debate, Yeh said.

He added that he thinks there’s a place for both avenues of attaining the skills needed to perform high-risk PCI procedures, noting that he led a complex PCI program at his center 3 years ago. Even so, its unlikely that the program would have met all of the minimum volume thresholds recommended by Davies et al, he said. The operator who went through that program continued honing his skills in the first few years out of fellowship.

“Training certainly doesn’t end with the end of the fellowship,” Yeh said. “I have slight concerns that the implication of this is that you have to do this to become expert at complex PCI and you can’t otherwise do it. There clearly are alternative pathways which the vast majority of complex operators in this country have taken.”

Others echoed that thought, saying that doing a dedicated extra year of training in high-risk PCI should not be mandatory for operators looking to perform those types of procedures.

Manesh Patel, MD (Duke University School of Medicine, Durham, NC), said, “It’s good to describe what you think the ideal state is. I think the accomplishment of that, whether it’s in a high-risk fellowship or in a separate stepwise approach is really where the crux of the matter is. And I think the unintended consequence of making it a 1-year add-on fellowship is that it then might preclude people from having access to it or have the ability to learn how to do it.”

Davies acknowledged that a dedicated extra year of training isn’t the only way to go. “We’re not saying that you can’t get on-the-job training or get proctored or go to courses, and those sorts of things, because that’s all still readily available outside of this,” she said, adding that doing the additional year “was the best decision for me for sure.”

Abbott said it’s up to individual trainees how much expertise in high-risk PCI they want to obtain at that phase of their careers. “If somebody knows that they—early in their career—want to go out and be a leader in this area and maybe direct a program in chronic total occlusions or start a new program in a hospital that does not have a huge referral center . . . this sort of training would be very advantageous,” she said. “What I would not like to see is that people get fixated on the numbers [and not] the process in which somebody is trained and becomes competent, because many individuals are already gaining a lot of these skills through their first year.”

According to Yeh, existing general interventional cardiology fellowships are not likely to be able to evolve to incorporate the new suggested minimum volume requirements.

Moreover, he added, “even afterwards it’s really, really challenging for the vast majority of institutions to provide this training even separately in a dedicated year. Does that mean that people who graduate from these programs are not equipped to do complex PCI? I think that many operators would push back on that notion. But I think that’s the matter of debate. Where do you draw the line to establish a threshold of competency, which clearly exists on a continuous scale?”

Almanfi said that institutions might consider restructuring fellowships in general cardiology (3 years) and interventional cardiology (1 year) to follow a 2 x 2 model. With that approach, fellows would spend 2 years in general cardiology and then 2 years in interventional cardiology, increasing exposure to more-complex procedures without lengthening the time of training. Almanfi said his fellowship at the Texas Heart Institute followed this format.

“Adding years of training I don’t think is the right solution,” he said. “The best solution in my opinion is to strengthen the current programs and make sure they provide the fellows with appropriate training and make sure they’re ready once they leave interventional training.”

Shoring Up Weaknesses

The purpose of this document, Davies said, was to standardize what should be included in a high-risk PCI fellowship and to show young operators that an additional year of training would be worth it. “And hopefully from here it will allow institutions everywhere to maybe even look back at their own program as it is,” she added, “and see where they can strengthen their weaknesses and grow their interventional program itself and include some of these topics.”

Indeed, Patel said, “I can imagine aside from the CTO [PCI number] a lot of things they’re describing here can be accomplished in many of the existing fellowships in the country.”

He underscored the importance of training fellows in clinical decision-making in addition to the technical skills need to perform procedures. That was touched on in the document, “but one could argue that just as much time that was spent on the procedural techniques could have been spent on thinking about what is the exposure to decision-making, what is the exposure to case reviews, what is the exposure to heart teams, how many of each of those do you have to have, etc.”

For Yeh, the proposals “set an aspirational bar” for what institutions interested in training the next generation of high-risk PCI operators should be thinking about.

“I think in that way it has given many people who do complex PCI and train fellows in these techniques something to think about and [led them] to be self-critical about the types of experience that we are all providing to our trainees,” Yeh said.

“At the same time,” he continued, “I think it also provokes very important discussions about what needs to change in our field in terms of the practice of PCI to prevent any sort of unintended consequences that might emerge from this. And also we need to think carefully about what has generated the inability for our standard training practices to be able to provide better experiences for complex PCI training in the first place.”

Conversations need to be had about how operators are doing too few procedures in general and how there are too many US training sites, Yeh suggested.

“That is why there’s an erosion of high-end clinical technical skill amongst interventional cardiologists,” he said. “So now we’ve created this need based on a system that has too many people in it . . . to train people because they can’t get sufficient training because volume is not concentrated enough. So creation of an additional year of subspecialty fellowship in some ways is a Band-Aid for underlying problems related to poor distribution of the workforce.”

Note: Two co-authors of the paper are faculty members of the Cardiovascular Research Foundation, the publisher of TCTMD.

This story was first published on September 18, 2020, and updated on September 22, 2020.