CATANIA, ITALY — It can be feasible and safe to do an ad hoc PCI based on a screening angiography performed before planned, same-session transcatheter aortic-valve replacement (TAVR), researchers conclude based on their prospective cohort study[1].
There were, however, case-selection precautions built into their protocol. For example, any very distal lesions or those in small coronaries and all chronic total occlusions (CTO) identified at the screening angiography were ineligible for ad hoc PCI, note the authors, led by Dr Marco Barbanti (Ferrarotto Hospital, University of Catania, Italy).
Also, the planned TAVR was postponed for a month unless the PCI was "successful and uncomplicated," use of contrast agent had not been excessive, and the patient was stable.
Typically, coronary angiography as part of the pre-TAVR workup is performed in a separate procedure, followed by valve implant a week or few weeks later, the group writes in their report published August 2, 2017 in Circulation: Cardiovascular Intervention.
As TAVR is extended to broader populations in greater numbers, "there is growing interest in a more efficient system for patient assessment."
Their strategy of same-session angiography and TAVR, with PCI as an added option, was safe, did not adversely affect outcomes, and "has the potential to improve the cost-effectiveness of a TAVR program and to shorten the assessment time, reducing the waiting lists of accepted TAVR candidates," they write.
The single-center study was observational, they caution, and so its conclusions can be only tentative. And, "whether this strategy could also be adopted in other centers with different logistics is unknown."
"Certainly More Convenient"
"About all you can conclude is that the protocol they used seems to be relatively safe," Dr James C Blankenship (Geisinger Medical Center, Danville, PA), who was not involved in the study, told theheart.org | Medscape Cardiology.
Angiography, discretionary PCI, and TAVR all at the same session "is certainly more convenient," Blankenship said, but "safety always trumps convenience." The greater contrast load compared with staged procedures would increase risk for some patients, for example.
"On the other hand, there could be some advantage to doing it [TAVR] relatively sooner, because some of these people are critically ill," he said.
"If you do a diagnostic cath as part of the workup, and then you do a PCI and then you wait a month or two to get the TAVR done, there's a nontrivial chance they could end up dying from the delay," he said. "It might actually in some ways be safer than doing the PCI first and then putting off the TAVR for some period of time."
An editorial accompanying the report[2] was also cautiously optimistic about the strategy and the study, saying it "represents another step forward toward combined (vs staged) coronary and TAVR procedures, particularly in an era where the increasing experience of heart teams along with the newer-generation transcatheter valves has made TAVR procedures safer and simpler," writes Dr Josep Rodés-Cabau (Quebec Heart and Lung Institute, Laval University, Quebec City).
But, he noted, there was patient-selection bias as well as, by design, a highly selective approach to choosing target lesions for ad hoc PCI. "The patients included in this study had a low to moderate surgical risk, much lower than that in most prior TAVR studies," and the cohort's prevalence of significant CAD also seems on the low side, he writes.
TAVR Was Rarely Postponed
Among their 604 patients undergoing TAVR, about 23% were found to have severe CAD by standard definitions, and as a result about 9% of the total cohort underwent PCI before implantation of a prosthetic valve. TAVR was postponed for a month in two patients (0.3%) whose PCI required excessive contrast agent, the group reported. Severe CAD that was not treated with PCI was seen in 13.8% of the total cohort.
Effect of Ad Hoc PCI on Selected Procedural Variables
End points | No angiographic CAD, n=468 | Ad hoc PCI, n=51 | CAD at angiography, no PCI, n=83 | P |
---|---|---|---|---|
Contrast agent (mL) | 105 | 150 | 100 | <0.001* |
Procedural time (min) | 43 | 55 | 42 | 0.011* |
Major vascular complications (%) | 5.3 | 7.8 | 4.8 | 0.727 |
Minor vascular complications (%) | 7.7 | 9.8 | 12.0 | 0.396 |
The three subgroups—those without significant CAD by angiography, those receiving ad hoc PCI before TAVR, and those seen with significant CAD but not receiving PCI—had comparable 2-year rates of a composite of death, disabling stroke, and MI: 14.8%, 10.4%, and 15.4%, respectively (P=0.765).
Nor were there significant differences in in-hospital death, cerebrovascular events, major bleeding, or acute kidney injury.
"Possible Drawbacks"
Rodés-Cabau pointed to some "possible drawbacks of combining coronary and TAVR procedures." Such a strategy "may mean obtaining the main or secondary femoral accesses for the TAVR procedure immediately after a coronary intervention under full anticoagulation and dual antiplatelet therapy." On the other hand, he notes, in this cohort there didn't seem to be increased risk of vascular complications or bleeding.
In fact, a PCI procedure in practice can appear fairly straightforward at the beginning, but "you can get into hot water really fast. And yet these guys really seem not to have gotten into hot water," Blankenship said. "That's very impressive, and I'm not sure that your average operator can match their success. So I'm not sure it can be reproduced at lower-volume centers."
Still, the same-session strategy "may well catch on as time goes by and people get more used to it."
One possible obstacle that may differ in the US compared with other parts of the world, he said, is how same-session angiography and TAVR with an option of PCI might affect hospital staffing and scheduling issues.
The authors in Italy state that "TAVR procedures were performed in a standard catheterization laboratory. . . . When no CAD was found, the catheterization laboratory was then equipped for TAVR."
At most US centers, according to Blankenship, "you do two, maybe three of these a day, and it's a big production. You get the anesthesiologist in, and you have a dedicated hybrid lab or operating room." Following the study's scenario, "you would have to be prepared that you may not end up doing the TAVR, then you've wasted, as it were, a TAVR slot."
Also, "It's a common model that you have a day a week when you do the TAVRs, and you have everything and everybody arranged ahead of time," including the anesthesiologist and a backup-surgery team.
Medicare requires surgical backup for TAVR, Blankenship noted, and "at our center, there's a whole surgical team on standby for the one case in 50" when they are needed.
It won't be very efficient, he said, if PCI may or may not be performed after the angiography and TAVR might be postponed. If it is, "then you've screwed up your schedule."
Barbanti reports being a consultant for Edwards Lifesciences; disclosures for the coauthors are listed in the paper. Blankenship said he is his center's principle investigator on several multicenter trials funded by Abbott/St Jude Medical, Boston Scientific, and Bionics. Rodés-Cabau reports receiving research grants from Edwards Lifesciences and Medtronic.
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Medscape Medical News © 2017
Cite this: Same-Session Angiography, Ad Hoc PCI Feasible for Select TAVRs - Medscape - Aug 15, 2017.
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