August 12, 2022
- First-ever global consensus guidance published in the Journal of the American College of Cardiology: Cardiovascular Interventions
- Use of IVUS recommended in all phases of lower extremity arterial and venous revascularization procedures to guide clinical decisions
- The results come ahead of the multi-society roundtable sponsored by SCAI on peripheral IVUS in September and the upcoming publications of a large-scale real-world health outcomes study presented at TCT last year
Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced an important milestone in the evolving standard of care for treating patients with peripheral vascular disease (PVD): the establishment of the first-ever global consensus for the appropriate use of intravascular ultrasound (IVUS) in lower extremity arterial and venous interventions.
Published in the August 2022 issue of the Journal of the American College of Cardiology: Cardiovascular Interventions as “Appropriate Use of Intravascular Ultrasound During Arterial and Venous Lower Extremity Interventions,” the new consensus document from 30 global vascular experts recommends routine use of IVUS as a preferred imaging modality in all phases in many peripheral vascular disease (PVD) procedures.
“The voting panelists considered a variety of clinical scenarios and based on their extensive experience, arrived at a strong consensus,” said lead author Eric A. Secemsky, MD, Interventional Cardiologist at Beth Israel Deaconess Medical Center and Assistant Professor of Medicine at Harvard Medical School, Boston USA. “They recommend routine use of IVUS as a preferred imaging modality in all phases for many peripheral interventions, both diagnostic and therapeutic, as it enables such exquisite visualization of the target vessel and lesion. Their recommendations, which withstood the rigor of peer review, can now be considered in the formulation of clinical guidelines for the diagnosis and treatment of peripheral vascular disease.”
PVD affects an estimated 200 million people worldwide, including approximately 40 to 45 million Americans, according to the American Heart Association [1]. The authors noted that minimally invasive approaches for PVD interventions are increasingly common, but traditional imaging techniques like angiography have limitations, including 2-dimensional projections of 3-dimensional vasculature, which can complicate diagnosis and intraprocedural optimization.
“As the global leader in providing vascular solutions to physicians and the patients they serve, we especially value the rigor and independence of this cross-specialty expert consensus,” said Heather Hudnut Page, General Manager and Business Leader for Peripheral Vascular Image Guided Therapy Devices at Philips. “It is exciting to know that this initiative has the potential to standardize the use of IVUS in peripheral interventions and guide clinical decisions to further improve the quality of care procedures for patients.”
Supported in part by research grants from Philips and Boston Scientific, the study was conducted and analyzed independently by Smith Center for Outcomes Research, gathering a wide spectrum of vascular expert opinion to ascertain the role of intravascular imaging in contemporary clinical practice.
Historical milestone
To achieve consensus, the broad, multi-disciplinary, global experts used a rigorous RAND/University of California, Los Angeles appropriateness method. The writing committee generated a systematic and comprehensive list of key clinical scenarios and the role of IVUS in decision-making pathways before voting by a separate committee of world experts in the field who were blind to each other’s responses. The initial results of their work were first shared at a special symposium during the 2021 Vascular Interventional Advances (VIVA) annual meeting. Subsequently, the Smith Center for Outcomes Research team has released a Systematic Literature Review (SLR) [2] summarizing and systematically appraising the number of observational cohort studies in the peripheral vascular space prior to the late-breaking RCT data from Australia further demonstrating benefits of IVUS-guidance in PVD patients. [3] Dr. Secemsky et al. also published a contemporary review in EuroIntervention [4] showing how IVUS imaging can standardize daily practice decisions through a data-driven approach. In the current JACC: Cardiovascular Interventions publication, the experts established clinical agreement to identify optimal use of IVUS and potential gaps to set a standard across medical subspecialties in order to drive positive outcomes for patients.
“Lack of clarity in the appropriate use of IVUS in peripheral vascular procedures has raised important questions in daily interventional practice,” said Sahil Parikh, MD, Director of Endovascular Services at Columbia University Irving Medical Center. “Establishing the appropriate use criteria recommendations is a historical milestone and foundational step towards improving the quality and safety of peripheral vascular procedures.”
Intravascular ultrasound (IVUS)
Philips is the global leader in IVUS solutions, which are part of the company’s comprehensive portfolio of systems, smart devices, software, and services for peripheral vascular disease aimed at helping clinicians decide, guide, treat, and confirm the right therapy for each patient during their procedure. Phased array IVUS is an important imaging tool used during venous and arterial interventions. It provides the fast plug-and-play usability and high-fidelity image resolution needed for pre-procedural planning, intra-procedural guidance, and post-procedural optimization of therapy for patients. Using an array of miniaturized ultrasound transducers mounted on the tip of a catheter, it captures real-time images of vascular disease inside vessels, enabling physicians to standardize and improve procedure care for their patients. Additional workflow optimization is enabled by integrated suite offerings such as Philips’ Azurion 7 with IntraSight platform.
[1] Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Das SR, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Jordan LC, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, O’Flaherty M, Pandey A, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Spartano NL, Stokes A, Tirschwell DL, Tsao CW, Turakhia MP, VanWagner LB, Wilkins JT, Wong SS, Virani SS., American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation. 2019 Mar 05;139(10):e56-e528. [PubMed]
[2] Natesan S, Mosarla RC, Parikh SA, Rosenfield K, Suomi J, Chalyan D, Jaff M, Secemsky EA. Intravascular ultrasound in peripheral venous and arterial interventions: A contemporary systematic review and grading of the quality of evidence. Vasc Med. 2022 Aug;27(4):392-400. doi: 10.1177/1358863X221092817. Epub 2022 May 12. PMID: 35546056.
[3] Allan RB, Puckridge PJ, Spark JI, Delaney CL. The Impact of Intravascular Ultrasound on Femoropopliteal Artery Endovascular Interventions: A Randomized Controlled Trial. JACC Cardiovasc Interv. 2022 Mar 14;15(5):536-546. doi: 10.1016/j.jcin.2022.01.001. PMID: 35272779.
[4] Secemsky EA, Parikh SA, Kohi M, Lichtenberg M, Meissner M, Varcoe R, Holden A, Jaff M, Chalyan D, Clair D, Hawkins B, Rosenfield K. Intravascular ultrasound guidance for lower extremity arterial and venous interventions. EuroIntervention. 2022 Apr 19:EIJ-D-21-00898. doi: 10.4244/EIJ-D-21-00898. Epub ahead of print. PMID: 35438078.
For further information, please contact:
Joost Maltha
Philips Global Press Office
Tel.: +31 6 10 55 8116
E-mail: joost.maltha@philips.com
Fabienne van der Feer
Philips Global Press Office
Tel.: +31 622 698 001
E-mail: fabienne.van.der.feer@philips.
About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and well-being, and enabling better outcomes across the health continuum – from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2021 sales of EUR 17.2 billion and employs approximately 79,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.
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