September 2023 | Issue 70
Featured in this issue:
www.cardiovascularnews.com
10 Heart teams
Survey highlights lack of uniformity
Societies weigh in on renal denervation as US FDA considers device approvals “Advancements like renal denervation are imperative to enhancing shared decision-making that can lead to better treatment and outcomes for patients,” the Society for Cardiovascular Angiography & Interventions (SCAI) said in August amid a regulatory review of two renal denervation systems for reducing blood pressure in adults with uncontrolled hypertension.
S
CAI is the latest society, and the first in the USA, to endorse renal denervation as a device-based option for individuals with high blood pressure who may not respond to or tolerate existing treatments including drug therapy or lifestyle modification. In August, the interventional cardiology organisation issued a position statement in which it emphasised the conditions under which interventionalists may opt to select renal denervation for their patients. “Device therapies targeting the renal sympathetic nervous system hold promise as adjuncts to abate or interventions to abolish hypertension, depending upon the underlying severity of blood pressure elevation,” said Herbert Aronow (Michigan State University College of Human Medicine, East Lansing, USA), chair of the writing group that composed the position paper. “This statement emphasises that, with appropriate patient selection, evaluation, and strict implementation of operator training standards and facility requirements, renal denervation treatment can be provided in an optimal fashion to this patient population.” In Europe, where the use of renal denervation is more advanced, proponents of the technique now have the added weight of guidance from the European Society of Hypertension (ESH), which for the first time includes the statement that the technique can be proposed as an adjunctive therapy in select patients with resistant hypertension. The guidelines were first presented during the ESH’s 32nd annual European meeting on hypertension and cardiovascular protection (24–26 June, Milan, Italy). They cite recent randomised trials, including the RADIANCEHTN and RADIANCE II trials, investigating the Paradise (ReCor Medical) ultrasound renal denervation system, and SPYRAL HTN-OFF MED, investigating the Symplicity Spyral (Medtronic) radiofrequency device, as having shown that the treatment can be associated with a significant, albeit not marked, reduction in office and ambulatory blood pressure in patients with uncontrolled hypertension. An earlier version of the ESH guidelines—which were published jointly with the European Society of Cardiology (ESC) in 2018—had advocated against the routine use of device-based therapies for hypertension, until further evidence of their safety and efficacy came to light. But, with the addition of evidence from the latest generation of sham-controlled trials has come a revitalised optimism in the potential impact of renal
16 Profile
David HildickSmith
21 Low contrast PCI
DCR4Contrast trial results
denervation as a blood pressure lowering therapy. The new guidelines state that the therapy can be considered as an option if patients have an estimated glomerular filtration rate (eGFR) of at least 40ml/min/1.732, in spite of the use of antihypertensive drug combination therapy, or if drug treatment elicits serious side effects and poor quality of life. And, for patients with true hypertension, the document notes that renal denervation can be considered as an additional therapy in patients with true resistant hypertension and an eGFR of at least 40ml/min/1.732. “In the last guidelines, done in 2018 by the European Society of Hypertension and the European Society of Cardiology, it was said that there was no evidence that renal denervation lowered blood pressure, because of the negative data from the first fully controlled trial,” Giuseppe Mancia (University MilanoBicocca, Milan, Italy), who co-chaired the writing committee for guidelines, told Cardiovascular News, discussing the development of the renal denervation field. “Since then, we have had five or six studies with a shamdenervated group in which there was a reduction in both office and ambulatory blood pressure after renal denervation. In addition, there are data from registries, now up to three years from around 3,000 patients who have undergone renal denervation, showing that the reduction in blood pressure is
ESH guidelines are presented at the organisation's annual meeting. Bottom row (l-r): Paradise (Recor Medical) and Spyral (Medtronic) catheters Continued on page 6
27 Medtech Insights: Ian Meredith
ESC 2023
Hot Line trials add weight to case for intravascular imaging during PCI DATA FROM THREE randomised trials and a meta-analysis presented at the European Society of Cardiology (ESC) congress (25–28 August, Amsterdam, The Netherlands) offer new insights into the use of intravascular imaging— either optical coherence tomography (OCT) or intravascular ultrasound (IVUS)—to optimise outcomes during percutaneous coronary intervention (PCI). Attendees to the ESC 2023 main arena session heard evidence from the ILUMIEN IV trial, looking at OCT-guided PCI in high-risk patients; the OCTOBER trial, which assessed OCT-guidance in bifurcation lesions; and OCTIVUS, a comparison of OCT and IVUS in a broad population of patients. The session finished with the presentation of a “real-time” updated network meta-analysis, integrating data from both the ILUMIEN IV and OCTOBER trials. Presenters and panellists broadly agreed that the new data, taken in totality, make a strong case for the incorporation of intravascular imaging into clinical practice. First presenting ILUMIEN IV results, investigator Ziad Ali (St Francis Hospital, Roslyn, USA) reported that the use of OCT contributed to a larger minimum stent area than when using angiographic guidance, but the trial found that there was no reduction in the co-primary endpoint of target vessel failure at two years. The impact of the pandemic on enrolment may have played a role in the neutral result, Ali said. The trial, results of which were published simultaneously to presentation in the New England Journal of Medicine (NEJM), was conducted at 80 sites in 18 countries, randomising a total of 2,487 patients to either OCT-guided PCI (1,233) or Continued on page 6