SCAI consensus guidelines for device selection in femoral‐popliteal arterial interventions

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Abstract

The Society for Cardiovascular Angiography and Interventions (SCAI) has a history of prioritizing quality initiatives in the field of endovascular therapy (EVT) for peripheral artery disease (PAD). In 2017, SCAI updated the 2014 Appropriate Use Criteria (AUC) for EVT in the aorto-iliac, femoral-popliteal (FP), infra-popliteal and renal arterial circulations, promoting data-driven procedural decision making and understanding of relative risks and benefits of EVT in specific clinical and anatomic scenarios 1. In 2016, the updated AHA/ACC PAD Guidelines document provided contemporary recommendations for diagnosis and management of lower extremity PAD 2. However, these documents did not address the selection of specific devices when EVT is indicated. Device choices for EVT in the FP arterial bed remain challenging due to a wide spectrum of available endovascular device options and a paucity of comparative effectiveness data. The purpose of this first device-focused consensus document is to provide a review of comparative effectiveness data, including safety and efficacy of FP devices, and to provide clinicians with guidance and recommendations for device selection, when these devices are intended as the definitive or adjunctive therapy. This document provides recommendations applicable to devices used for EVT in FP disease. The goal is to guide clinical judgment with an emphasis on evidence-based and cost-effective utilization. This document is intended as a guide to improve decision making regarding EVT device selection for patients undergoing EVT. A balanced writing group was nominated and selected based on their EVT expertise, with consideration of relationships with industry and professional specialty or area of focus. The Writing Group Chairman and ≥50% of the members had no relevant relationships with industry (Table 1). The recommendations listed, whenever possible, were based on randomized controlled trials (RCTs) and meta-analyses, but also included registries, nonrandomized comparative studies, case series, cohort studies, and expert opinion. The writing committee chose the studies to highlight in this document; the final summary of the reviewed and most relevant clinical data is included in the Supporting Information Tables S1-S7. Abbott Vascular—advisory board Boston Scientific—advisory board Cardiovascular Systems—advisory board Cook—advisory board Gore—consultant Spectranetics—consultant, advisory board Non-Compensated Advisor: Abbott Vascular; Boston Scientific; Cordis, a Cardinal Health Company; Medtronic Compensated Advisor: Philips/Volcano; Micell; Vactronix; Venarum; American Orthotics and Prosthetics Association Equity Investment: PQ Bypass; Primacea; Gemini; eFemoral; Embolitech; Vascular Therapies; Sano V Abbott Vascular—advisory board Boston Scientific—advisory board Medtronic—advisory board Philips/Spectranetics—advisory board Abiomed—Speaker ACIST Medical—Grants/Research Support AstraZeneca—Speaker General Electric—Consultant Medtronic—Grants/Research Support Osprey Medical - Consultant Abbott Vascular—advisory board, consultant Atrium—grants/research support (national PI) Bard—grants/research support (national PI) Capture Vascular—advisory board, consultant Cardinal Health—advisory board, consultant Contego—advisory board, consultant Cook—advisory board Cruzar—advisory board, consultant, Ownership/Stock Owner/Shareholder Endospan—advisory board, consultant, Ownership/Stock Owner/Shareholder Eximo—advisory board, consultant, Ownership/Stock Owner/Shareholder Medtronic—advisory board, consultant Abbott - advisory board, consultant Boston Scientific - advisory board, consultant Phillips - advisory board, consultant ACIST Medical—Grants/Research Support Boston Scientific—Ownership/Stock Owner/Shareholder The Class (strength) of Recommendation (COR) represents the anticipated magnitude and certainty of comparative benefit for a group of devices (i.e., symptom improvement, patency, functional status, and/or quality of life) against the risks and cost of the device use based on the SCAI (modified ACC/AHA guideline recommendation) 3 classification (Table 2). The Level of Evidence (LOE) provides evidence supporting the effect of the devices on the basis of the type, quality, quantity, and consistency of data. The COR and LOE are determined independently; any COR may be paired with any LOE. Class I (Strong) Benefit ⋙ Risk (&Cost) Class IIa (Moderate) Benefit ≫ Risk (&Cost) Class IIb (Weak) Benefit ≥ Risk (&Cost) Class III: No Benefit (Moderate) Benefit = Risk (&Cost) Class III: Harm (Strong) Risk > Benefit (&Cost) The committee used a modified Delphi panel methodology, which employed an expert panel of clinicians who rated a series of anatomical scenarios with respect to COR/LOE. The panel participated in three rounds of voting, with communication among the panelists after the first anonymized round. Each panelist had equal weight in determining the final rating. Agreement among panelists was achieved when >80% of the recommendations ratings for the scenarios were concordant (Tables 2 and 3). IIB C-LD IIB C-EO IIA B-R IIA C-EO IIA C-EO III H C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB B-R III NB C-EO IIA A I B-R I A IIB B-R III NB C-EO III NB C-EO III NB C-EO III NB C-EO IIB B-R IIB C-EO IIA A I B-R I A IIB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO IIB A III NB C-LD IIA A I B-R I A IIB B-R III NB C-LD III NB C-LD III NB C-LD III NB C-LD III NB B-R III NB C-LD IIA A I B-R I A IIB B-R III NB C-LD III NB C-LD III NB C-LD III NB C-LD III NB B-NR III NB C-EO IIA B-NR I B-NR I B-R IIA B-R III NB C-EO III NB C-EO III NB C-EO III NB C-EO IIB B-NR IIB C-LD IIA C-LD I C-LD I C-LD IIB C-EO III NB C-LD III NB C-LD III NB C-LD III NB C-LD III NB B-NR III NB C-LD IIA C-LD I C-LD I C-LD IIB C-EO III NB C-LD III NB C-LD III NB C-LD III NB C-LD III NB B-NR III NB C-LD IIA C-EO I C-EO I C-LD IIA C-EO III NB C-EO III NB C-EO III NB C-EO IIB B-R III NB C-EO IIA B-R I B-R I B-R IIB C-LD III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB B-R III NB C-EO IIA B-R I B-R I B-R IIB B-R III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB B-NR III NB C-EO IIA C-LD I B-NR I B-NR IIA B-R III NB C-EO III NB C-EO III NB C-EO III NB C-EO IIB B-R III NB C-LD III NB C-EO IIB C-LD I B-R IIB C-LD IIA B-R III NB C-EO III H C-EO III NB C-EO III NB B-R III NB C-LD III NB C-EO IIA C-LD I B-R IIB B-R IIA B-R III NB C-EO III H C-EO III NB C-EO III NB B-NR III NB C-EO III NB C-EO IIA C-LD I B-R IIA B-R IIA B-R III NB C-EO III H C-EO III NB C-EO The use of the adjunctive devices for lesion preparation, such as atherectomy or specialty balloons, is separately addressed in this document including recommendations for both dilatable and undilatable lesions (Table 4). Atherectomy may be chosen as the adjunctive device for lesion preparation, whereas DCB may be selected as the intended definitive treatment. IIB C-EO III NB C-EO IIB C-EO IIB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO IIB C-EO III NB C-EO IIB C-EO IIB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO 6. Diffuse SFA lesion III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO IIA C-EO IIB C-LD III NB C-EO IIA C-EO IIB C-EO IIA C-EO IIB C-LD III NB C-EO IIA C-EO IIB C-EO IIA C-EO IIB C-LD III NB C-EO IIA C-EO IIB C-EO IIB C-EO III NB C-EO III NB C-EO IIB C-EO III NB C-EO IIB C-EO III NB C-EO III NB C-EO IIB C-EO III NB C-EO IIB C-EO III NB C-EO III NB C-EO IIB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO III NB C-EO IIA B-R III NB C-EO III H C-EO III NB C-EO III NB C-EO IIA B-R III NB C-EO III H C-EO III NB C-EO III NB C-EO IIA B-R III NB C-EO III H C-EO III NB C-EO The cost of the devices (Table 5) was considered secondary to examining efficacy and safety data when determining COR/LOE, particularly for devices with limited comparative clinical data that could justify their additional cost. 8.75 (CPT® Code 37224) $5085 (APC 5192) 10.24 (CPT® Code 37226) $10,510 (APC 5193) 11.75 (CPT® Code 37225) $10,510 (APC 5193) There has been a lack of consistent definitions and nomenclature across clinical trials of devices, drugs or biologics for the treatment of PAD. In an effort to overcome this barrier, the Peripheral Academic Research Consortium (PARC) developed consensus definitions for clinically meaningful outcomes and endpoints 4. The current consensus document recommends adopting the PARC definitions for acute procedural and technical success of EVT, short- and long-term surrogate endpoints of procedural success (using imaging and physiologic measures), and functional/clinical outcome definitions 4. In patients with claudication, functional assessments using standardized validated treadmill protocols or 6-min hall walk testing should be used. In CLI patients, limb outcomes with respect to major and minor lower extremity amputation, wound healing, ischemic rest pain, and major adverse limb events (MALE) should be examined. In this document, when evaluating comparative effectiveness, clinical and functional outcomes (e.g., clinically driven TLR) were given greater emphasis than surrogate endpoints (e.g., DUS-derived restenosis), which in turn were weighted more heavily than procedural success endpoints. When available, cost effectiveness studies were also taken into consideration in the recommendations. Lower extremity PAD has classically been defined by the anatomic segments affected as aorto-iliac, femoral-popliteal (FP) segment, and below knee infra-popliteal (IP) or infrageniculate arteries. The FP segments represent the common femoral artery (CFA), profunda femoris artery (PFA), superficial femoral artery (SFA) and popliteal artery, the longest nonbranched vessel. In this document, we discuss devices specific to the above-knee FP segment, while separately addressing CFA disease. The CFA bifurcation lesions refer to lesions that involve the common femoral bifurcation and ostial SFA/PFA; however, the recommendations also apply to isolated CFA disease. The above-knee popliteal artery segment includes the P1 (from intercondylar fossa to proximal edge of patella) and P2 (from proximal part of patella to center of knee joint space) popliteal segments. In addition to anatomical location, the lesions are classified according to length, stenosis versus occlusion, degree of calcification, and whether they represent de novo or in-stent restenosis (ISR). The TASC classification has previously placed FP lesions into 4 categories according to lesion length and whether disease is stenotic or occlusive 5. However, in this document and relevant to existing data for devices in RCTs, we have defined lesion length as focal (20 cm), which is consistent with the AUC document 1. Given that definitions for degree of calcification varied between trials, we have provided recommendations for a general category of moderate-severely calcified lesions (≥180° degree of calcification involving both sides of vessel at same location). The lesion is considered undilatable if it could not be fully expanded during a balloon predilation. In stent restenosis (ISR) is defined as a stenosis or occlusion within a previously placed stent, regardless of whether the original stent was bare metal, drug eluting, or a covered stent. When EVT is considered, there are technical considerations such as choice of access site, the use of embolic protection and the use of re-entry devices. In this document, the choice of access site is left to the discretion of the operator. In some chronic total occlusions (CTOs), antegrade crossing results in subintimal wire passage and the need for re-entry into the true lumen. A number of re-entry devices and techniques have been described 6. Occasionally during FP treatment, an embolic protection device (EPD) may be appropriate, and several are commercially available. The utilization of re-entry or EPDs is beyond the scope of this document. Surgical endarterectomy has historically been the treatment of choice for CFA disease 7, 8. However, recent reports of EVT (DCB, atherectomy, stenting) 9, 10 and a randomized trial of stenting versus surgery 11 have demonstrated high technical success, improved safety and comparable patency for EVT compared to open surgery for CFA lesions. Data derived from a large pooled analysis (n = 1,014) from the Vascular Quality Initiative, demonstrate low procedural morbidity with CFA EVT (77% cases were PTA) 12. The TECCO (The Endovascular Versus Open Repair of the Common Femoral Artery) trial randomized 117 patients with de novo disease to CFA endarterectomy or stent placement 11. Of note, in the stenting group, 1/3 were treated with balloon-expandable stents, particularly in lesions that involved the common femoral bifurcation. There were more early complications in the surgical group (26% vs. 12.5%, P = 0.05) and longer of with surgery vs. P however, at 2 there were no in from patency or the clinical between the 2 on the randomized trial and expert recommendations for EVT in CFA disease are in therapy includes the use of that stent placement for has historically been the common treatment However, this is no longer the of given the evidence from in of DCB and therapy with an adjunctive treatment for lesion in stenting or DCB drug and in with atherectomy devices. on comparative data for with versus devices recommendations for as the intended definitive therapy in FP disease have been derived (Table 3). of treatment in FP disease demonstrated that with was to bare stents, covered stents, and with respect to technical success, restenosis and lesions cm), data the patency at at 2 and at 3 data from of bare to demonstrate a benefit of in lesions of However, as lesion length (i.e., lesions cm), data of bare with of FP lesion calcification the of patients undergoing EVT for FP disease balloon was in of to lesions In lesions with more calcification, the balloon success was data highlight the of balloon in calcified lesions. patency balloon in at remain with after a subintimal from at to at with balloon particularly for segments of or stents, have also been with restenosis and balloon has demonstrated outcomes when compared to DCB and atherectomy in lesions on comparative clinical data, DCB or as the definitive device therapy for most lesions in the FP segment, with or adjunctive be (Table (i.e., the balloon The the peripheral balloon the balloon and the Peripheral to address the of balloon - the to calcified and undilatable lesions. In specialty balloon studies are and the is Information There are no between specialty or (e.g., of the devices have demonstrated their but have a cost (Table 4). In clinical specialty are used as the intended definitive therapy but as the lesion devices. on limited data consensus recommendations for specialty utilization as the intended definitive therapy (Table as as the adjunctive therapy (Table in FP disease have been were developed to address the (e.g., acute and long-term (e.g., of a between lesion length and restenosis has been demonstrated in FP stenosis or occlusion to demonstrate in in patency or in with versus demonstrated an benefit of including the (The Versus with in Femoral and the versus In The SFA and/or Artery) studies, of which patients with length FP disease Information studies were pooled in a 2014 of 11 RCTs, patients with or CLI and TASC A or lesions these trials demonstrated patency by and and patency by with versus However, at patency by and were between versus A number of recent studies have for treatment of FP including in longer calcification, of but not lesions these studies have not included any comparative devices, that limited the relative effectiveness or comparative safety of the devices be Information of to and DCB are to their relative (Table The is a stent, which was developed for treatment of the FP segment to provide both a stent and drug to The randomized trial patients with and SFA or proximal popliteal disease to or the group had patency than the group patients who a secondary for use was also with patency compared to of this demonstrated from vs. There was also a improved from among patients treated with a versus studies with endpoints have the outcomes of in the a and the Information The was a of patients with PAD treated with The patency was and the from was The TASC lesion of this included lesions with a lesion length of patency was and from with a stent of In the of patency was at and from was (Table three have been in and RCTs, and have been for the treatment of FP and The with from 2 to and in with and and Information A analysis of DCB trials that there may not be a effect and that the treatment of DCB devices may on their including drug and to clinical trials between the are to their relative to data have DCB to be cost in the FP segment the current options for FP DCB recommendations based on the LOE from several (Table The for the of and 2 the DCB with a of of 2 with a and and The trial patients randomized to DCB versus but were not at = and procedural were and the 2 trial the use of the DCB in FP in patients A of patency by was at with DCB versus vs. P = A large number of patients treated with the DCB were from safety events vs. P = including low of and embolic secondary efficacy endpoints compared between and DCB were in treated with A pooled analysis of patients of the and from the SFA versus for the of Femoral and Artery) trial that patency at was improved in the DCB versus and at vs. vs. P vs. P DCB use was to in of clinically driven at which also at vs. vs. P vs. P The DCB to for use in de novo and FP lesions was the DCB from the trial series The DCB a of 2 and is with a The and in the and of the and patients of the patency vs. P and clinically driven vs. P = were in the DCB versus at among patients of the restenosis vs. P = and clinically driven were lower vs. P = in the DCB group at The use of DCB in FP lesions and has been in several The Versus for of Femoral Artery) trial randomized patients with SFA to DCB versus lesion length DCB was with a of in to vs. P = In the a of the DCB in patients, the clinical cohort included with lesions (n = de novo lesions (n = and (n = patency at was and clinically driven at was and data the of the DCB in lesions. of DCB in the in Peripheral for a DCB (n = versus (n = for FP in patients with CLI both restenosis and clinically driven were for DCB However, at 3 were in DCB and the trial was a evaluating DCB (n = versus (n = in patients with SFA and CLI from was in the DCB cohort at vs. P long-term results are not available. The use of covered is for treatment of FP disease. stent covered with expanded and a stent to the are not for ostial lesions involving a major or in the of on current efficacy data and risks of device consensus recommendations for covered in FP disease have been derived Information Tables In the randomized with versus bare stent in the treatment of lesions in superficial femoral artery occlusive patency at versus vs. P = in FP lesions In covered had a patency at vs. P = had greater patency compared to however, a on In the at 3 patency were not between patients treated with the and who vs. In the with in the of Femoral patency at was which was not affected by device vs. vs. or lesion length vs. were in a with patency not affected by lesion length in lesions versus in P = The trial randomized patients with FP to or with placement the patency was with stenting) versus with stent In a were treated for length TASC with of of restenosis of in acute limb more covered compared to covered stent of and edge restenosis have been as the to stent The regarding stent and acute limb as the for covered have in limited utilization of these devices as definitive therapy for most de novo FP lesions (Table the by or of has been used in the FP segment, the lack of comparative outcomes data to justify the additional cost of these devices. atherectomy devices have been developed the including and devices Information There are no atherectomy to or should be that these devices are (Table and are used as a definitive but as the adjunctive therapy for lesion this document provides recommendations for atherectomy devices intended as the definitive therapy (Table and recommendations for devices to be used for lesion (Table data regarding adjunctive use of atherectomy devices, particularly in ostial and popliteal are The of in the treatment of de novo FP disease was in the of of the for the of This a patency of in with no between and The use of was with a low use of However, was with a of and of arterial However, comparative evidence to support the use of this device as a definitive treatment in FP it is to justify the use of based on cost. the trial of of the for the of the use of DCB or DCB in patients with lesions between and The trial no between the with respect to for DCB vs. for DCB and patency as by for DCB vs. for DCB and atherectomy devices lack comparative evidence to support their use as a definitive studies of and a number of recent trials of in FP disease Information have been The comparative trial the trial to Benefit of in by to Atherectomy in randomized patients to or In this from or restenosis was not at with vs. with There is no comparative evidence to support the use of the atherectomy devices as a definitive treatment The of the Atherectomy included patients at in the FP and in the with stenosis were lesions were rated to have to high in adverse events in of driven at in and at in restenosis as by in of lesions. by of therapy was first used in an SFA in The randomized Peripheral compared the to and to demonstrate any patency for the device in SFA occlusions The for of trial randomized patients with FP to versus of the in lesions of were but was by to be to support the use of this in lesions. trial (n = compared DCB to DCB in CLI patients with occlusion of the FP segment secondary to The patency at were in the DCB group versus DCB A number of adjunctive than specialty such as and have been in FP which data or to demonstrate available and/or with respect to procedural success or restenosis such as for calcified undilatable FP disease are The SCAI writing committee a review and analysis of the evidence and developed recommendations for FP EVT. recommendations are a first to provide clinicians with relevant anatomical scenarios to guide device selection based on and quality of evidence for comparative effectiveness, and expert opinion. in the Supporting Information may be in the supporting for this Tables The is not for the or of any supporting by the than should be to the for the

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