To Intervene or Not to Intervene When the TAVR Patient Has CAD: New Insights
CHICAGO, IL—Physicians and surgeons working in the TAVR space have, for years, debated the what to do—if anything—about severe coronary artery disease identified in the work-up of patients undergoing transcatheter aortic valve replacement. After viewing new data presented today at TVT 2016, a panel of experts appeared to agree that in contrast to the see-it, fix-it approach of the past, most concomitant coronary disease can be left untouched.
“When we first started doing TAVI, I think we all thought that it was absolutely critical to fix every [coronary] lesion, because several research protocols mandated that we do so,” session moderator Raj Makkar, MD (Cedars-Sinai Medical Center, Los Angeles, CA), observed. “As we’ve progressed in our practice, I think we’ve all become comfortable doing TAVI in the presence of CAD, and I think we’ve all come to realize that not every 70% lesion in a 90-year-old needs to be fixed. And most of us are happy settling with [treating only] very, very proximal critical lesions [that might interfere with] the TAVI.”
The dilemma, however, is a common one. The reported prevalence of CAD among patients undergoing TAVR ranges from 50 to 75%, and reports are mixed about its prognostic implications. As recently as last month, Swiss data reported at EuroPCR 2016 suggested that rates of major adverse cardiovascular and cerebrovascular events and death within this subset was nearly twice that of patients getting new valves who have no underlying CAD.
One Center’s Experience
Cardiovascular surgeon Mark Russo, MD (RWJBarnabas Health, West Orange, NJ) offered a surgeon’s perspective on the topic. “It’s my belief that in the setting of severe [aortic stenosis], coronary disease is mostly B.S.” he said bluntly. He pointed out that severe aortic stenosis increases ischemic burden and in most cases is the likely cause of symptomatic cardiac ischemia. When the aortic stenosis/gradient is fixed, wall stress, oxygen demand, and ischemic burden are all decreased, positioning aortic valve replacement as the best treatment for cardiac ischemic in these patients, he said.
“If CAD was not problematic pre-TAVR, it will be even less of a threat post-TAVR,” he said.
The only “burning questions,” he continued, are whether the CAD burden impacts the safety of the TAVR procedure or patient outcomes post-TAVR.
To address this, Russo and colleagues conducted a retrospective review of 364 patients who underwent TAVR at their center between May 2012 and September 2015. Pre-TAVR CAD burden was calculated using the SYNTAX score, the extent of myocardium at risk, and the number of diseased coronary arteries (defined as stenosis > 70%).
In terms of intraprocedural safety, investigators looked at the need for emergent cardiopulmonary bypass, used in 2 patients (0.5%)—here, they saw no relationship between need for bypass and any of the factors related to CAD burden. Since July 2014, he added, no patient has been placed on cardiopulmonary bypass.
In terms of TAVR outcomes, Russo et al looked at death or need for post-TAVR revascularizations out to 30 months according to baseline SYNTAX score, extent of myocardium at risk, and number of diseased vessels. In all three analyses, there were no significant differences between groups with lower versus higher coronary disease burden. These findings, he noted, are largely in keeping with the conclusions of a comprehensive review on the topic of severe AS and coronary artery disease by Goel et al, published in 2013.
“Our single-center analysis of high-risk and inoperable TAVR patients suggests that the need for revascularization following TAVR is low, and short- and intermediate-term survival is not associated with ischemic burden,” he concluded.
Also speaking during today’s session, Torsten Vahl, MD (Columbia University Medical Center, New York, NY), pointed out that most of what is being done now is at the operator’s discretion. But he agreed with Russo that “most cardiologists feel that severe aortic stenosis is the most prominent coronary lesion they will encounter.” Therefore, once that’s fixed, medical therapy is sufficient for the any coronary artery lesions, “particularly if angina is not present,” he said.
Exceptions to this are patients with severe proximal lesions that could affect the success of the TAVR procedure and patients with reduced LV function. “If you create slow flow,” Vahl said, “they can quickly get into an ischemic spiral that’s hard to recover from.”
Whether more aggressively treating coronary lesions does, indeed, affect outcomes remains unclear, he conceded. To address this question, Vahl and colleagues conducted a retrospective, single-center review of all patients treated with TAVR between January 2012 and December 2014 at their institution. Decision about how to manage coronary revascularization was also a heart team decision, taking into account coronary anatomy, myocardium at risk, and comorbidities.
Over this period, 739 patients underwent TAVR only, 74 patients underwent TAVR plus PCI, and 76 underwent staged procedures—PCI followed by TAVR at a later date.
As Vahl showed here at TVT, 30-day and 1-year mortality as well as in-hospital stroke rates were no different among the three groups. Similarly, rates of new major vascular complications and need for transfusions did not differ, although investigators saw a trend towards higher life-threatening bleeding among patients undergoing the combined procedure.
Regardless of when the PCI was performed, Vahl explained that they only moved ahead with the procedure if the affected vessels were proximal to the aortic valve, or if they were in vessels supplying large myocardial territories. Patients with significant renal impairment or complex coronary lesions were not included.
In a panel discussion following Vahl and Russo’s presentations, moderator Thomas Walther, MD (Kerckhoff Klinik Bad Nauheim, Germany), noted that the question of intervening or not in the setting of CAD and aortic stenosis is the subject of an ongoing trial, ACTIVATION, being led by Martyn Thomas, MD (St. Thomas’ Hospital, London, England).
But panel members polled by Walther as to what their centers are doing appeared to be mostly content with a conservative strategy.
“It really depends on the patient profile and the coronary anatomy,” said Gorav Ailawadi, MD (University of Virginia Health System, Charlottesville, VA). “If they have proximal large vessels that have tight stenosis, we tend to treat them in a staged fashion”—revascularization first, following with TAVR “about 2 weeks later.”
The patient’s long-term risk plays a role in the decision-making, he added. “If they are an older patient, they are probably not going to be as affected long term by their coronary artery disease. And in those patients, particularly with more distal disease, you can certainly get away with a TAVR alone and only based on angina would we continue to treat their CAD.”
Russo says this strategy is roughly the same as what’s done at his hospital, and he notes that less than 5% of patients end up coming back for an unplanned PCI. Of note, however, this percentage is in the patients for whom TAVR is currently approved: high-risk, largely inoperable patients. “As we move to lower-risk patients, I think the CAD is going to be a bigger issue,” he predicted.
Marco Barbanti, MD (Ferrarotto Hospital, Catania, Italy), likewise said it really depends on whether the lesions are proximal to the aortic valve and what degree of myocardium is at risk. “In terms of timing I think it also depends on when the coronary angiogram is performed,” he commented. “In the last few years, we were performing the angiogram during TAVI so if we found any significant lesion proximal, we performed PCI during the procedure, just before valve deployment.”
The situation is a bit different in the setting of ACS and MI, Makkar observed. Neither the ACS guidelines nor the aortic stenosis guidelines, in neither Europe nor the United States, give any guidance on how to handle a patient with both, he noted. In the setting of ACS, “if you’ve got a critical lesion, it’s better to just go ahead and fix it and leave the aortic stenosis alone and see if the patient is truly symptomatic, unless of course there are other features. If the aortic valve area is .4 and the gradients are really high and the anatomy is very suitable for TAVR, then I think the risks of the procedures are very low [when] doing them in the same setting.”
Walther, for his part, stressed that patient safety needs to come first. The amount of contrast used in combined procedures is typically higher, he pointed out. It’s also important to consider the progression of coronary artery disease, particularly as TAVR moves into younger patients.
“We’ve only been speaking about elderly patients, because all the data is in octogenarians, but as we think about doing these procedures in younger patients, it will be of big importance to implant a valve where you can safely access the coronaries later on, in case you need to,” Walther said.
Finally, there are also reimbursement issues to consider. In Germany, Walther said, operators who elect to perform both PCI and TAVR in the same setting will typically not be reimbursed for the PCI. “If the patient is stable, why not do the PCI? Then come back after 4 weeks and do the TAVI,” he said.
- Vahl reports having no conflicts.
- Russo reports receiving consulting fees/honoraria from Edwards Lifesciences.
- Makkar reports having no conflicts.
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Russo MJ. Replacing the valve is usually sufficient to manage severe AS and coronary disease. Presented at: TVT 2016. June 17, 2016. Chicago, IL.
Vahl T. Strategies and timing of PCI in patients with CAD undergoing TAVR: results from a large single-center experience. Presented at: TVT 2016. June 17, 2016. Chicago, IL.