Conversations in Cardiology: FFR in a Diagnostic-Only Lab and PCI Without On-site Surgery
I know the questions are coming fast so forgive me for putting another in front of you, but Michel Vandormael, MD, of Lower Keys Medical Center (Key West, FL), asks 2 great questions that are worth talking about:
1. Should FFR be allowed to be performed and considered part of a diagnostic coronary angiogram procedure if done by an experienced interventionalist with available bailout equipment (guiding cath, wires, stents, etc) at a site without a PCI program that is remote from the closest PCI center (ground travelling time 3 hours in the case of Key West, flying time a minimum 60 minutes)? Quite often, as you know, you find lesions of ambiguous severity without a culprit after what appears to be a false positive stress test; in these cases, you would like to know before patient transfer, which is costly. Another scenario is when you are at a center doing only STEMI PCI and have ambiguous lesions in noninfarct vessels.
2. You are a STEMI program without on-site surgery, and you are contemplating adding elective PCI procedures. Your nearest PCI elective center is 150 miles away. However, some states like Florida require that you have accumulated a minimum of 300 consecutive diagnostic caths within 1 year with a diagnosis of obstructive CAD or 300 consecutive in-house primary diagnoses of CAD within 1 year. Where are these numbers coming from, and supported by what data? It seems intuitive to me that if you are allowed to do STEMI, you should be authorized to perform elective procedures to improve your volume load and expertise.
To recap, Michel asks:
1. When done by an experienced interventionalist, should FFR be allowed in a diagnostic-only lab without permission to do PCI?
2. Should a program that has received permission to do STEMI without on-site surgery be automatically permitted to do elective PCI? What numbers support moving into elective PCI? Where did these numbers come from?
1. Absolutely yes, an interventional cardiologist can do FFR in a diagnostic-only lab. Six studies also support this position, showing that FFR changes decision making compared with angiography alone (Santana, French Registry, Ahn from Korea, RIPCORD, Mayo Registry, POSTIT). The only caveat is that there should be some PCI equipment for the rare complication. Extending this observation, if you’re going to have a diagnostic-only lab, I also believe that it should have some PCI equipment and a qualified operator to help in the event of a diagnostic catheter-related dissection, particularly of the left main—a rare but known occurrence.
2. STEMI PCI is often of higher risk than elective PCI (though of course dependent on the type of elective lesions taken on). Low- and intermediate-risk patients can do very well in the PCI without onsite surgery system in most labs, and some labs can even do high-risk patients with LV support and transport systems in place for the emergency. The establishment of a safety record makes the hospital administration more comfortable with the program as it moves from low- to high-risk patients. As for the starting numbers to qualify, those appear to come from institutional and operator volume estimates of competency from the guideline writers in 2011 and before. I’m less secure in my knowledge of these precise numbers.
Colleagues, please give us your views.
Bonnie Weiner, MD, of Saint Vincent Hospital (Worcester, MA), replies:
These are both interesting and related questions. We at ACE have been involved with this evolution in the Commonwealth of Pennsylvania as they were dealing with the regulatory transition from STEMI (which any lab can do) to a post-CPORT-E world of oversight/quality assessments. We have also dealt with totally new programs starting up. If appropriate systems are established these transitions can occur safely, but making sure these facilities have the right policies and procedures, transfer agreements, relationships with PCI/surgery programs, and ongoing case reviews is key. One wants to avoid the slippery slope of needing to maintain “numbers” and therefore stretching indications to do so. Without unbiased review, aggregation of data, and understanding what happens to patients who are transferred out, this will easily occur. Data would suggest that the majority of facilities where PCI is being performed without onsite surgery don’t in fact improve access to care, but some clearly do.
There are no right answers here but multiple factors need to be considered. Determination of what is truly in the best interest of the patient—not just convenience—needs to be clarified, quality assessed in a meaningful way, and the appropriate standard operating procedures put in place.
Lloyd Klein, MD, who has a private practice in Melrose Park, IL, replies:
Two great questions. Here are my answers:
1. FFR does have associated complications and requires the same skill subsets as PCI. For this reason, I don’t think an operator should be performing FFR if not credentialed to do PCI. A cath lab that chooses to perform this procedure without the capability to manage the complications that may occur is negligent, in my view. I think this is a terribly bad idea. I have seen and been expert witness to several such cases where a complication of FFR in inexperienced hands has led to a bad outcome.
2. We showed years ago, and it has been confirmed in every good study since, that STEMI without on-site CABG can be done safely, but programs getting into that business must be very well prepared. This means having an experienced PCI operator, trained staff, and a truly working disaster plan. When there is geographic isolation that necessitates such programs, we ought to support them as a society. Moving into elective PCI without a surgeon around is a completely different story. Maybe there is an argument for that in certain places, but I don’t know of such a thing in 2015. Perhaps in Key West or western Texas or northern North Dakota things are so isolated that a surgical program isn’t viable, but then why is an elective PCI program required? Even for ACS, transport should be arranged urgently. I think this is flirting with fire and suggest that elective PCIs should be referred to a center and operator with proven competence.
Robert J. Applegate, MD, of Wake Forest University Baptist Medical Center (Winston-Salem, NC), replies:
Great questions as usual.
It is interesting that FFR is a diagnostic tool but requires a different skill set to perform safely than simple angiography. I agree that FFR (or IVUS/OCT) should only be performed by someone with PCI skills, for all the reasons already stated. I think this should be a vanishing (diminishing) concern as the prevalence of practices utilizing diagnostic-only invasive noninterventional cardiologists diminishes, or at least I assume they are.
Primary PCI for STEMI can be both the most difficult and the easiest of all PCI cases. I don’t really think that the “urgency” of the procedure dictates whether a case should be done without surgical back up. The most important elements are, to my mind, the experience of the operator and staff and the existence of a plan to handle the infrequent PCI disaster.
Michael Kutcher, MD, of Wake Forest University Baptist Medical Center (Winston-Salem, NC), replies:
Excellent points, my good friend Lloyd.
1. I think FFR should not be routinely done at a center without surgery on-site even by an experienced PCI operator unless there are unusual circumstances, such as the need to definitively document ischemia in the face of conflicting reports. A better alternative to “drive-by” FFR would be to take the patient off the table and arrange a noninvasive exercise stress echo, MRI, or nuclear study to document ischemia. Although the incidence of complications with FFR measurement and need for emergency CABG are extremely low, all you need is one in a stable elective patient for a medical legal issue to be raised. Better to be safe than sorry.
2. The NCDR Off-Site paper, CPORT-E, MASS-COM, and Mandeep Singh’s meta-analysis in JAMA all documented the safety and effectiveness of elective PCI in experienced PCI centers that did not have surgery on-site. The caveat is that these centers were well organized and had excellent operators, experienced staff, and good enough safety plans to participate in these data studies. In the randomized trials, they all had 24/7 STEMI coverage. I am concerned that the results of these publications have been extrapolated for economic and prestige reasons to smaller, less well-organized sites with weak commitment and data capture. The ideal PCI volume number is arbitrary and not as much of an issue as the experience levels of the PCI operator and the cath lab staff and the organization of the transport system. Although the 2011 guidelines made elective PCI in off-site centers a IIb indication, they should gone further to mandate that these centers have the resources dedicated for 24/7 coverage of STEMI patients (which is the real reason to justify an off-site program). If a center is dedicated to primary PCI in STEMI patients for mortality/morbidity benefits, they should be permitted to do appropriate risk elective cases to keep the skill set of the staff at a high level. “Boutique” PCI centers that do 9-to-5 STEMI and a preponderance of elective cases are in a grey zone. That being said, I and our interventional group at Wake Forest provide vacation coverage for a PCI operator and cath lab that does not have surgery on-site as part of a strategic “outreach” program. I suspect many on this e-mail chain may be in similar situations.
Dr. Kern replies:
I rarely jump back into the fray but feel compelled to disagree with Lloyd and Michael as my first comments stated. Moreover, as you’ll read below in the comments from Nico H. J. Pijls, MD, PhD, of Catharina Hospital Eindhoven (Eindhoven, the Netherlands), and a rebuttal from Dr. Vandormael, the responses we get most often to these conversations come from only a few people, mostly in academia. I recognize I’m not the best one to be unbiased about FFR, but I hope to counter my bias with studies in support of the position.
From Dr. Pijls:
In my view, FFR can be measured in a strictly diagnostic lab, even without “bailout” equipment, IF AT LEAST performed by a cardiologist who has been trained for PCI and working with wires. We see this in our country every now and then, when an interventionalist moves from an interventional center to a “community” hospital.
I believe that, in trained hands, the risk of undergoing diagnostic FFR is so low that it is counterbalanced by the extra risk to a patient if (after the initial diagnostic angiogram) he had been sent to an interventional center for a second procedure, involving yet another contrast load, bleeding risk, etc. In addition, the type of lesions you are talking about will most likely be moderate, easily accessible, and located in the proximal part of large coronary arteries. As a matter of fact, the cardiologist in the diagnostic lab will not start to do extensive FFR measurements in a patient with multiple complex lesions who needs to be referred for FFR-guided PCI. If the anatomy is such that PCI needs to be done anyway, of course it is better to wait until that second procedure to measure the “questionable” lesion.
So, prerequisites in my view are that “the lesion under review” is the only one—with the implication that in case of negative FFR, you do not need to send the patient for a second invasive procedure—and that the performer is somebody who had a full training elsewhere.
From Dr. Vandormael:
We have been getting opinions but I believe that the forum group is skewed towards the academic world, with a tendency to be conservative and “wise” but sometimes far away from some practical realities of the real world.
We should be more open to what is done and practiced in the world outside the United States while still remaining objective scientists. I feel like it would be appropriate to open the debate with non-academic interventionalists as well as colleagues from Europe, Asia, or India. They have accumulated a lot of experience and data that support a more liberal position on these topics. I am trying to be provocative to help this discussion. I have been in all sides of the game—academic, hospital, and private practice—in my 35-year career as an interventionalist working in different parts of the world, and I have also been young and enthusiastic.
We should consider other options than the easier position of being the wise and conservative physician, protecting self-interest (business), thinking that there are too many “bad” docs out there not knowing what they are doing. Sometimes it could be true, but I personally believe that there are a lot more cautious, experienced, and well-trained interventionalists working hard daily to improve patient outcomes for the benefit of their patients.
Dr. Klein replies:
Ah! The dreaded “academic” curse word! But you know, I am in private practice!
Dr. Kutcher replies:
Great comments and interchange.
I admit that I may be “conservative” about ad hoc FFR in a cath lab without surgical backup—especially if there are other noninvasive alternatives for ischemia evaluation. But I would do it if definitive documentation of ischemia was necessary in the face of other conflicting reports. Like Lloyd, I have been asked to review medical legal cases. So that’s just my opinion, and it is open to this great forum.
But my second comment is misinterpreted. I am not against PCI centers without surgery on-site for STEMI and elective PCI, but I believe the sites have to be well organized with experienced operators and staff.
Even though I am in “academics,” I am still a clinician and really do serve in the “real world” covering the private practice off-site PCI center in our outreach program.
Actually, Lloyd and I are proponents of off-site PCI centers as evidenced by our NCDR paper published in 2009. We got a lot of severe flack for that study and had to fight hard for publication as it was deemed by critics as being “just registry data.” But I like to think our NCDR team (including Greg Dehmer, who is on this e-mail chain) helped influence the indications change from III to IIb for elective PCI in off-site centers in the 2011 guidelines and brought US practice more along the lines of our respected European colleagues. This happened before the confirmatory CPORT and MASS-COM randomized studies were published. Of recent note, attached is the UK Off-Site PCI Registry published in last month’s JACC and the nice editorial by Alice Jacobs—both in line with the comments above.
David Cox, MD, of Lehigh Valley Physician Group (Allentown, PA), replies:
In Pennsylvania, which is a long way from Key West and Idaho, we are in fact seeing hospitals doing elective SOS PCI at centers that do NOT perform 24/7 STEMI. Case example: a hospital doing 50-60 PCIs electively per year with 2-3 STEMIs done only when the PCI doc is at the site doing elective cases. The state requires ACE accreditation (or similar) for these sites and has regulations that state sites should be doing STEMIs 24/7 but grants an exemption to hospitals that do only elective PCI without 24/7 STEMI coverage once they gain accreditation.
This all occurs in a suburban Philadelphia setting 25 miles from multiple major PCI centers, not rural Pennsylvania. FFR is rarely done, and rotational atherectomy and IVUS are unavailable.
This ‘grey zone’ of boutique PCI centers is likely to continue to grow in the United States, especially as the PCI fellows can’t find jobs at major PCI centers and hospitals seek them out to staff a PCI program, with the view that a ‘full service’ cath lab as an important need for their survival.
I’m in private practice as well!
Justin Davies, MD, of National Heart and Lung Institute (London, England), replies:
Very much looking forward to being able to share the pressure wire-related complication rates from both US and global centers when DEFINE-FLAIR reports secondary analyses. This prospective, randomized controlled trial will give us a very good snapshot of the frequency of events and a “measure” of safety in approximately 2,500 patients from all around the world. To me, the limitation for any pressure wire usage is not the ability to perform PCI (which will be very rare with modern wires) but having really good knowledge of the potential pitfalls of marking a top-notch recording (which affect every case).
John Hirshfeld, MD, of the Hospital of the University of Pennsylvania (Philadelphia, PA), replies:
Being another eastern Pennsylvanian, I concur with David’s thoughts.
At 1 level, it would seem to me that if the procedure being done in Key West (or rural northeastern Pennsylvania or the Philadelphia suburbs) is being conducted by a highly skilled, experienced interventionalist who can do FFR safely and interpret the results validly, that would be a good way to spend 10-15 minutes that might spare the patient either another diagnostic procedure or a potentially unnecessary trip to Miami.
That being said, the devil is in the details, which are where attempts to formulate universal policy become challenging.
I expect that large bodies of group data will show that FFR can be performed in such a setting with a safety profile that cannot be distinguished statistically from that of high-volume, highly experienced operators working in high-quality centers. This sort of analysis always glosses over the most important variable, namely who is on the hub end of the catheter. That issue is always obfuscated by the opposite statistical power issue—too little statistical power to enable a valid measurement.
Thus, the real answer to this query is that the individual operator is the true variable. The conundrum is to try to formulate rational policy that will protect the patient, assure quality, and not be so restrictive that people will flout it anyway.
Dr. Kern replies:
Pertinent to this discussion are a paper and editorial in Circulation this week on PCI without surgery. The editorial, by Thomas R. Aversano, MD, of Greater Baltimore Medical Center (Baltimore, MD), is among the most cogent and well-reasoned discussion.
Frederick Welt, MD, of University Hospital (Salt Lake City, UT), replies:
Mort et al, It's a good editorial that is balanced. We all have our own axe to grind here with regard to maintaining volume, and our arguments can always be seen as self-serving. But in a world where the secular trend is towards a reduction in procedures and where the value of PCI for stable disease is increasingly challenged, does it make sense to proliferate low-volume programs? Wouldn’t a happy medium be to have some oversight of program initiation to avoid multiple low volume hospitals competing for a small number of patients? One could presumably use geographical distance and population served to rationally distribute programs. There will always be winners and losers in this game, and I realize that the thorny issue is who decides.
Gregg W. Stone, MD, of Columbia University Medical Center (New York, NY), replies:
Even diagnostic angiography carries a risk of left main and right coronary artery dissection, and of course we don’t require surgical standby for these procedures. At some point it must come down to the absolute risk of the procedure being weighed against cost savings and patient convenience.