Advances in Revascularization for Peripheral Artery Disease: Revascularization in PAD

Beckman, Joshua A.; Schneider, Peter A.; Conte, Michael S.

doi:10.1161/circresaha.121.318261

Cited by 119 publications

(91 citation statements)

References 230 publications

(257 reference statements)

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“…Given the superiority of DCBs over BA in improving TLR and maintaining primary patency, several ethical principles, including patient beneficence and justice, are called into question [ 15 ]. Future studies should consider following the trends for the need for revascularization and claudication rates in patients managed by interventional cardiologists before and after PTC withdrawal to evaluate for discrepancies [ 16 , 17 ].…”

Section: Discussionmentioning

confidence: 99%

Changes to Drug-Coated Balloon Reimbursement Affect Peripheral Arterial Disease Patient Care: A Single-Center Experience

Samia¹,

Adams²

2022

Cureus

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Introduction: Balloon angioplasty (BA) and stenting have long been the mainstays of endovascular therapy in peripheral arterial disease (PAD). However, the rise of drug-coated balloons (DCBs) has revolutionized care in recent years, with multiple clinical trials showing superiority over BA in maintaining primary patency and freedom from target lesion revascularization (TLR). With the recent drop of the add-on payment for DCBs, a barrier for their use and consequently reduced therapy adoption in PAD might arise. We assessed if this affected physicians' behavior and hospital administration towards stocking and using DCBs. Methods: This single-center, retrospective study evaluated DCB utilization in 2017 versus 2018. Data were collected in two groups: 1) July 1, 2017, to December 31, 2017 - with pass-through code (PTC) - prior medical billing reimbursement - and 2) January 1, 2018, to June 30, 2018 - without PTC - markedly reduced reimbursement. Patients treated for superficial femoral artery (SFA) or popliteal artery (POP) disease were included. The study aimed to determine changes in DCB utilization between the years with and without PTC, and we investigated the treatments that have replaced DCBs. Additionally, we aimed to collect data on readmissions and procedure costs compared to national data. Results: From July through December 2017, 350 DCBs were used in 209 patients (1.675 DCBs per patient), while from January through June 2018, 256 DCBs were used in 180 patients (1.422 DCBs per patient) - a 15.07% reduction in DCBs per patient. The detailed numbers of DCB-treated patients were presented as fractions of total interventions in the groups with and without PTC. Conclusion: The findings of this study show a statistically significant reduction in DCB usage following PTC withdrawal. There are several ethical implications to these findings, primarily highlighting patient beneficence and justice. Moving forward, it will be important to determine if this shift in treatment is owed to other treatment strategies such as BA, BA and atherectomy, BA and bare-metal stents (BMS), or BA and drug-eluting-stents (DES). The next steps should also include determining procedure costs and comparing readmission rates.

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Section: Discussionmentioning

confidence: 99%

Changes to Drug-Coated Balloon Reimbursement Affect Peripheral Arterial Disease Patient Care: A Single-Center Experience

Samia¹,

Adams²

2022

Cureus

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“…Surgical-based revascularizations that aim to provide a blood flow in the ischemic tissue through direct interventions in the affected vasculature, such as implantation of the catheter, vascular stent, or balloon, are currently the first choice and the standard strategy for restoring blood perfusion in PAD patients 14 , 15 . While these strategies could reach 60% to 80% efficacy in correctly selected patients 16 , there are several limitations to their application: (1) the optimal timing and indications remain controversial; (2) some patients may suffer from severe postoperative complications; and (3) some patients are not suitable for revascularization 16 - 19 . Indeed, 20 to 40% of patients with CLI could not receive surgical-based revascularization treatments due to already severely damaged vessels, and many of these “no-option” patients required amputation to prevent the generation of other complications 19 , 20 .…”

Section: Introductionmentioning

confidence: 99%

Therapeutic angiogenesis-based strategy for peripheral artery disease

Han¹,

Luo²,

Marcelina³

et al. 2022

Theranostics

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Peripheral artery disease (PAD) poses a great challenge to society, with a growing prevalence in the upcoming years. Patients in the severe stages of PAD are prone to amputation and death, leading to poor quality of life and a great socioeconomic burden. Furthermore, PAD is one of the major complications of diabetic patients, who have higher risk to develop critical limb ischemia, the most severe manifestation of PAD, and thus have a poor prognosis. Hence, there is an urgent need to develop an effective therapeutic strategy to treat this disease. Therapeutic angiogenesis has raised concerns for more than two decades as a potential strategy for treating PAD, especially in patients without option for surgery-based therapies. Since the discovery of gene-based therapy for therapeutic angiogenesis, several approaches have been developed, including cell-, protein-, and small molecule drug-based therapeutic strategies, some of which have progressed into the clinical trial phase. Despite its promising potential, efforts are still needed to improve the efficacy of this strategy, reduce its cost, and promote its worldwide application. In this review, we highlight the current progress of therapeutic angiogenesis and the issues that need to be overcome prior to its clinical application.

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“…Typically, a guidewire is passed through an accessible artery to reach the narrowed area and a balloon is deployed to reopen the lumen. While the immediate effect on blood flow is readily achieved, the intervention damages the blood vessel wall which triggers a cascade of acute inflammatory and regenerative responses that result in intimal hyperplasia and vascular remodeling ( 1 ). The vascular remodeling commonly leads to re-stenosis and ultimately occlusion of the intervened vessels ( 2 ).…”

Section: Introductionmentioning

confidence: 99%

“…In order to maintain patency in the long term, many times additional devices like stents or balloons coated with anti-proliferative drugs are used on the intervened vessels. Clearly, a better understanding of the processes that underly the vascular response to injury and remodeling is key to develop effective treatments to improve long-term patency of revascularization procedures ( 1 ).…”

Section: Introductionmentioning

confidence: 99%

3D Printed Bioreactor Enabling the Pulsatile Culture of Native and Angioplastied Large Arteries

Matos¹,

Maselli²,

McVey³

et al. 2022

Front. Cardiovasc. Med.

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Routine interventions such as balloon angioplasty, result in vascular activation and remodeling, often requiring re-intervention. 2D in vitro models and small animal experiments have enabled the discovery of important mechanisms involved in this process, however the clinical translation is often underwhelming. There is a critical need for an ex vivo model representative of the human vascular physiology and encompassing the complexity of the vascular wall and the physical forces regulating its function. Vascular bioreactors for ex vivo culture of large vessels are viable alternatives, but their custom-made design and insufficient characterization often hinders the reproducibility of the experiments. The objective of the study was to design and validate a novel 3D printed cost-efficient and versatile perfusion system, capable of sustaining the viability and functionality of large porcine arteries for 7 days and enabling early post-injury evaluations. MultiJet Fusion 3D printing was used to engineer the EasyFlow insert, converting a conventional 50 ml centrifuge tube into a mini bioreactor. Porcine carotid arteries either left untreated or injured with an angioplasty balloon, were cultured under pulsatile flow for up to 7 days. Pressure, heart rate, medium viscosity and shear conditions were adjusted to resemble arterial in vivo hemodynamics. Tissue viability, cell activation and matrix remodeling were analyzed by immunohistochemistry, and vascular function was monitored by duplex ultrasound. Culture conditions in the EasyFlow bioreactor preserved endothelial coverage and smooth muscle organization and extracellular matrix structure in the vessel wall, as compared to static culture. Injured arteries presented hallmarks of early remodeling, such as intimal denudation, smooth muscle cell disarray and media/adventitia activation in flow culture. Duplex ultrasound confirmed continuous pulsatile blood flow conditions, dose-dependent vasodilator response to nitroglycerin in untreated vessels and impaired dilator response in angioplastied vessels. The scope of this work is to validate a low-cost, robust and reproducible system to explore the culture of native and injured large arteries under pulsatile flow. While the study of vascular pathology is beyond the scope of the present paper, our system enables future investigations and provides a platform to test novel therapies and devices ex vivo, in a patient relevant system.

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Advances in Revascularization for Peripheral Artery Disease: Revascularization in PAD

Cited by 119 publications

References 230 publications

Changes to Drug-Coated Balloon Reimbursement Affect Peripheral Arterial Disease Patient Care: A Single-Center Experience

Changes to Drug-Coated Balloon Reimbursement Affect Peripheral Arterial Disease Patient Care: A Single-Center Experience

Therapeutic angiogenesis-based strategy for peripheral artery disease

3D Printed Bioreactor Enabling the Pulsatile Culture of Native and Angioplastied Large Arteries

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