Thoughtful Insights at TCT: Tackling Resistant Hypertension, Long SFA Lesions, and Complex Carotid Disease
Washington, DC—Conversations about the future of renal denervation for systemic hypertension and carotid artery stenting (CAS), as well as the place for expensive technologies in treating long superficial femoral artery (SFA) occlusions took center stage at the “Endovascular Disease and Hypertension” session held on the last day of TCT 2014.
All 3 topics were highlighted by case presentations followed by “thoughtful insights” responses and a panel discussion.
Renal Denervation for Systemic Hypertension
Justin Davies, MBBS, PhD, of Hammersmith Hospital (London, England), presented a case involving a 42-year-old woman suffering from hypertension who underwent renal denervation. The case was noteworthy because she recorded 4 to 10 BP measurements at home each day for the 3 months following the procedure. That record demonstrated a reduction of 31 mm Hg in the average systolic pressure and substantial variability of up to 30 mm Hg in a single day.
In his “thoughtful insights” presentation, Krishna Rocha-Singh, MD, of the Prairie Heart Institute at St. John’s Hospital (Springfield, IL), said that variability is a recurrent theme in renal denervation, including variability in BP, anatomy, and procedural technique.
“We understand that variable anatomy may be best addressed by other technologies, not just monopolar [radiofrequency] energies, but those technologies that may provide a more uniform and reliable denervation pattern,” he said.
Stephen G. Worthley, MBBS, PhD, of Royal Adelaide Hospital (Adelaide, Australia), said that BP variability “has hampered us in terms of looking at responses,” and agreed that newer technologies can mitigate at least some of the variability of the procedure.
“More consistent performance of the procedure will be afforded by having the multielectrode systems,” he said, adding that sham-controlled studies like SYMPLICITY HTN-3, in which renal denervation did not demonstrate efficacy, need to be performed to prove their worth.
In addition, there seemed to be agreement that using ambulatory BP as the primary endpoint in future trials would eliminate some of the observed variability in readings.
Medication adherence is another issue introducing variability that needs to be addressed in studies moving forward, Dr. Rocha-Singh added. Dr. Davies agreed, saying that “in the vast majority of cases I doubt there is real resistance, and it’s largely resistance to taking the therapies [that] is the problem.”
Despite those challenges to studying renal denervation, however, there was a general consensus on the panel that in 10 years the procedure would be a viable option for treating at least a “reasonable minority” of patients with hypertension.
Management of Long SFA Occlusions
The next case involved a 66-year-old man with bilateral SFA disease. The right SFA was treated with orbital atherectomy, angioplasty, and stenting, whereas the left SFA—which had a CTO and a disease length of about 30 cm—was treated with an array of technologies that included a crossing device, a Chocolate balloon (TriReme Medical/Cordis) to address calcium, a Supera interwoven nitinol stent (Abbott Vascular), a self-expanding conventional nitinol stent, and OCT.
In his “thoughtful insights” response, William A. Gray, MD, of Columbia University Medical Center (New York, NY), said the case “really was a tour de force of the kind of toolset that we have available to us in the SFA.” He added that the continued patency observed through 12 months was “remarkable” considering the length of the disease, which is associated with restenosis rates of 30% to 40%.
But some panelists questioned the use of such expensive technologies, none of which are supported by level I evidence.
John R. Laird, Jr., MD, of the University of California, Davis Medical Center (Sacramento, CA), said the patient appeared to benefit from the procedure but might also have had a positive outcome from the use of a hydrophilic guide wire and a standard balloon. He noted that for long SFA occlusions, only 1 technology—a covered stent—has been shown to improve outcomes in a randomized trial.
Mark W. Burket, MD, of the University of Toledo Medical Center (Toledo, OH), echoed the cost message: “You could’ve started with a guide wire and a catheter and saved quite a bit of money.”
He added, “One of the tricky things about cost analysis is if you spend all your money up front, then your long-term costs are automatically high, whereas if you do a balloon up front, you incur the costs later on. There’s no guarantee that you will incur those costs, whereas when you frontload it, it’s guaranteed that it’s going to be an expensive procedure.”
Using a Zilver PTX stent (Cook Medical) would not necessarily bring the expense of the procedure down either, Dr. Burket said, noting that multiple stents would have to be used for a lesion of this length, increasing the upfront cost.
Complex Carotid Disease in the Elderly
A final case involving an elderly man with complex carotid disease sparked discussion about how treatment decisions are modified in patients as they reach age 80 and beyond.
The case presenter, Duane Pinto, MD, MPH, of Beth Israel Deaconess Medical Center (Boston, MA), noted that these patients have a higher prevalence of type III aortic arches, more severe aortic arch atherosclerosis, excessive vessel tortuosity, lesion calcification, and decreased cerebral and cardiac reserve.
In addition, he said, treatment goals change as patients grow older, with more importance placed on living independently with intact cognitive function than on extending life.
There are 3 main questions to ask when faced with an elderly person with carotid disease, Michael R. Jaff, DO, of Massachusetts General Hospital (Boston, MA), said in his “thoughtful insights” presentation:
- How likely is it that the patient will survive another 5 years?
- Is the patient symptomatic?
- Who is doing the procedure?
Dr. Pinto underscored the significance of the final question when he pointed to data showing that patients of all ages have a lower risk of adverse outcomes from CAS when treated by operators who have performed more than 225 procedures.
The problem, Dr. Gray noted, is that overall CAS volumes are falling, making it difficult for individual operators to maintain a sufficient procedure load. Most of the available stenting registries established to give patients access to the procedure are no longer operational, he said, meaning that access is currently limited to high-risk symptomatic patients that make up about 10% of those potentially requiring revascularization.
The limited volumes are making it difficult to find sites with sufficient caseloads to participate in the CREST 2 trial comparing stenting and endarterectomy, Dr. Gray said.
But Dr. Jaff questioned whether CREST 2 will provide any definitive answers in the endarterectomy-vs-stenting debate anyway, and he said the only good thing that will come out of the study is the companion registry of patients who are either not eligible for the trial or opt not to be randomized. “Then at least if we can get the skilled operators to do carotid stenting in appropriate patients we can really prove that that’s a viable and important option,” he said.
Mark C. Bates, MD, of West Virginia University (Charleston, WV), predicted that the debate will continue to be waged for years. Currently, however, “surgery, at least in the hands of a vascular surgeon who is competent and has a documented low stroke risk, is a better solution for patients,” he said.
Disclosures:
- Dr. Davies reports receiving grant/research support and consulting fees/honoraria from Medtronic and Volcano and having intellectual property/royalty rights with Volcano.
- Dr. Gray reports receiving consulting fees/honoraria/speaker’s bureau payments from Abbott Vascular, Cordis, Medtronic, St. Jude Medical, and WL Gore.
- Dr. Bates reports receiving consulting fees/honoraria/speaker’s bureau payments from Vascular Dynamics; having equity in CeloNova BioSciences and Nexeon MedSystems; and having royalty/intellectual property rights with Biosensors, CeloNova BioSciences, and Nexeon MedSystems.
- Dr. Burket reports receiving grant/research contracts from Atrium, Bard Medical, Biotronik, and Cook Medical and consulting fees/honoraria/speaker’s bureau payments from Biotronik, Cardinal, Cook Medical, and Covidien.
- Dr. Worthley reports receiving consulting fees/honoraria/speaker’s bureau payments from Medtronic and St. Jude Medical.
- Drs. Laird and Rocha-Singh report relationships with multiple device companies.
- Dr. Jaff reports relationships with multiple pharmaceutical and device companies.
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Todd Neale is the Associate News Editor for TCTMD and a Senior Medical Journalist. He got his start in journalism at …
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