• Experts Warn Over Lack of Evidence for IVUS in Peripheral Interventions

    New studies highlight need for RCTs, editorialists say

    While the use of intravascular ultrasound (IVUS) imaging has been shown to reduce adverse event risk in percutaneous coronary intervention (PCI), the evidence for its use for peripheral interventions is still uncertain, warn experts.

    A pair of studies –1-year clinical outcome data on IVUS for femoropopliteal lesions in patients with symptomatic peripheral artery disease (PAD) and a 42-expert consensus document on the appropriate use of IVUS during arterial and venous lower extremity interventions, along with an accompanying editorial commentary – provide an update on the evidence for safety and effectiveness of for peripheral interventions.

    Published together online Monday and in the Aug. 8 issue of JACC: Cardiovascular Interventions, the studies provide new evidence and expert perspective around the use of IVUS in a variety of cardiovascular interventions.

    In the editorial, Debabrata Mukherjee, MD, MS, from Texas Tech University Health Sciences Center, El Paso, and Christopher J. White, MD, from the University of Queensland and Ochsner Health System, New Orleans, noted that for peripheral arterial interventions, IVUS has the potential to optimally define vessel dimensions, atherosclerotic plaque morphology, and length and eccentricity of lesions with high precision, while for peripheral venous intervention, IVUS can identify luminal features, such as trabeculations and valvular issues, that are not typically well-visualized on contrast venography.

    “Despite the potential benefits of IVUS over contrast angiography, little prospective high-quality data exist on the effectiveness of IVUS on improving long-term rates of major adverse limb events and target lesion revascularization after peripheral arterial and venous interventions,” the commentators said, adding that there is currently only one randomized trial assessing IVUS in peripheral arterial intervention.

    “As advances in peripheral interventional techniques allow revascularization of increasingly complex arterial and venous lesions, evidence-based approaches to the routine use of invasive imaging technologies, such as IVUS, are warranted,” noted the editorialists.

    However, a consensus document involving 42 experts in peripheral vascular disease and intravascular imaging concluded that IVUS is appropriate for the majority of procedural phases during lower extremity arterial intervention and is “strongly supported” during all iliofemoral venous interventional phases.

    Consensus paper

    Led by Eric A. Secemsky, MD, from Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, the expert consensus opinion was published based on currently available evidence and clinical practice regarding the utility of IVUS during lower extremity arterial and venous interventions.

    Initially, a 12-member writing committee was convened to derive consensus regarding the appropriate clinical scenarios for use of peripheral IVUS. The group iteratively created a 72-question survey representing 12 lower extremity arterial interventional scenarios.

    Separately, a 40-question survey representing eight iliofemoral venous interventional scenarios was constructed, noted Secemsky and colleagues.

    The clinical scenarios were categorized by interventional phases: preintervention, intraprocedure, and postintervention optimization before 30 international vascular experts (15 for each survey) anonymously completed the survey instrument.

    “This consensus document provides the first opportunity to establish the appropriate use of peripheral IVUS during clinically relevant procedural scenarios while the evidence evaluating IVUS use is evolving,” the authors said.

    “For arterial intervention, IVUS use was strongly supported throughout procedural phases. For both the iliac and femoropopliteal artery segments, IVUS was consistently appropriate when used during the intraprocedural and postintervention optimization phases, whereas IVUS use during tibial arterial intervention was deemed appropriate in all procedural phases.”

    “Consistent with contemporary clinical practice, IVUS use was voted appropriate in all iliofemoral venous procedural phases,” they said.

    Secemsky and colleagues noted that while the consensus document identifies situations in which IVUS could be used to optimize peripheral arterial and venous revascularization, future evidence supporting its use are needed – including studies addressing the impact of IVUS on improving long-term rates of major adverse limb events and its cost-effectiveness.

    “Furthermore, greater effort needs to focus on improving operator comfort with peripheral IVUS interpretation and streamlining work flows to minimize time barriers,” they said.

    One-year data

    The second study, led by Takuya Tsujimura, MD, from Kansai Rosai Hospital, Amagasaki, Japan, reported the impact of IVUS imaging on 1-year clinical outcomes after fluoropolymer-based drug-eluting stent (FP-DES) implantation for femoropopliteal lesions in patients with symptomatic PAD.

    Tsujimura and colleagues conducted a post hoc analysis of the CAPSICUM (Contemporary Outcomes Achieved With Paclitaxel Eluting Peripheral Stents to Treat Symptomatic Lower Limb Ischemia and Lesions in the Superficial Femoral Artery or Proximal Popliteal Artery) all-comers study, analyzing data from 1,091 patients. The primary outcome measure was 1-year restenosis. The incidence of aneurysmal degeneration was also assessed.

    A total of 843 (77.2%) patients underwent IVUS-guided FP-DES implantation, they reported, noting that after propensity-score matching, the 1-year restenosis risk was not significantly different between patients who underwent FP-DES implantation with IVUS (11.5%; 95% confidence interval [CI] 9.1%–14.0%) and those who underwent the procedure without IVUS (15.5%; 95% CI 10.9%-20.1%; p = 0.22).

    In contrast, however, the team reported that the frequency of aneurysmal degeneration at 1 year was significantly higher in patients with IVUS than in those without IVUS (19.8%; 95% CI 16.3%-23.4% vs 7.1%; 95% CI: 3.3%-11.0%; P < 0.001).

    Furthermore, Tsujimura and colleagues noted that IVUS use was associated with a lower restenosis risk in patients with chronic total occlusion but not in those without (P for interaction = 0.044).

    “The present study demonstrated that 1-year clinical outcomes, except aneurysmal degeneration, were not significantly different between the IVUS and non-IVUS groups after FP-DES implantation for femoropopliteal lesions,” said the team.

    “Notably, the 1-year incidence of aneurysmal degeneration was higher in the IVUS group than in the non-IVUS group,” they said, adding that randomized controlled trials are now warranted to evaluate the utility of IVUS in EVT with FP-DES for femoropopliteal lesions.

    A paucity of high-quality data?

    The final paper, an expert commentary from Mukherjee and White, noted that while there is some overall observational data to support the use of IVUS in both peripheral arterial and venous interventions, “the paucity of high-quality prospective data precludes making definitive recommendations for its use.”

    Indeed, they noted that the study by Tsujimura and colleagues raises safety concerns after demonstrating a lack of benefit and a “concerning” potential harm.

    The editorialists noted that while the post hoc nature of the study and lack of a core laboratory, both for the angiographic evaluation of the initial procedure and the ultrasound evaluation of restenosis and aneurysmal degeneration, provide significant limitations to the research, the lack of any benefit raises questions.

    “Despite these limitations, the lack of any restenosis benefit with IVUS and higher frequency of aneurysmal degeneration with IVUS, possibly related to use of larger devices, raises concerns about the true effectiveness of IVUS and potential safety issues,” they said.

    They noted that there are several ongoing clinical trials of IVUS underway, adding that “at this time, we recommend waiting for completion … to provide additional insight regarding the effectiveness and safety of IVUS-guided peripheral interventions.”

    “For now, clinicians should consider IVUS or other adjunctive imaging as a useful part of their repertoire for selective peripheral arterial and venous interventional cases, but it is premature to recommend routine IVUS guidance for all peripheral interventional cases,” they concluded.

    Sources:

    Secemsky EA, Mosarla RC, Rosenfield K, et al. Appropriate Use of Intravascular Ultrasound During Arterial and Venous Lower Extremity Interventions. JACC Cardiovasc Interv 2022;15:1558-1568.

    Tsujimura T, Iida O, Takahara M, et al Clinical Impact of Intravascular Ultrasound–Guided Fluoropolymer-Based Drug-Eluting Stent Implantation for Femoropopliteal Lesions. JACC Cardiovasc Interv 2022;15:1569-1578.

    Mukherjee D, White CJ. Role of IVUS Imaging During Arterial and Venous Lower Extremity Interventions: Hype or Meaningful Benefits? JACC Cardiovasc Interv 2022;15:1579-1581.

    Image Credit: Ploypilin – stock.adobe.com

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