<scp>SCAI</scp> guidelines on device selection in <scp>Aorto‐Iliac</scp> arterial interventions

Abstract

Aorto-iliac (Ao-I) disease is quite prevalent and leads to significant limitation in functional status and quality of life. Advances in endovascular therapy (EVT) techniques in the last 25 years, low risk of peri-procedural complications and excellent long-term patency have made it possible to treat most symptomatic patients with Ao-I disease using an endovascular-first rather than a surgical approach in addition to guidelines-directed medical therapy. The approach to intra-procedural assessment of Ao-I lesions has evolved over time to include pressure gradient measurement and intravascular imaging. In 2017, the Society for Cardiovascular Angiography and Interventions (SCAI) published an update to the Appropriate Use Criteria (AUC) for EVT in the Ao-I, femoral-popliteal (FP), infra-popliteal and renal arterial circulations.1 In 2018, a multi-societal AUC document for EVT was released by the American College of Cardiology (ACC)/American Heart Association (AHA)/SCAI/Society of Interventional Radiology (SIR)/Society for Vascular Medicine (SVM).2 However, these documents did not address the selection of specific devices when EVT is indicated. Given the wide spectrum of available endovascular devices and paucity of comparative effectiveness data, SCAI developed the first consensus-based guidelines document for device selection in femoral-popliteal arterial interventions in 2018.3 The purpose of this device-focused consensus document is to provide a comprehensive review of comparative effectiveness data in aorto-iliac arterial interventions, including safety and efficacy of devices, and to provide clinicians with guidance (class of recommendation and level of evidence) for device selection, when these devices are intended as definitive therapy. This document has been developed according to SCAI Publications Committee policies for writing group composition, disclosure and management of relationships with industry (RWI), internal and external review, and organizational approval. The writing group has been organized to ensure diversity of perspectives and demographics, multi-stakeholder representation, and appropriate balance of RWI. The author disclosures are included in Table 1. Before appointment, members of the writing group were asked to disclose all relevant financial relationships with industry from the 12 months prior to their nomination. A majority of the writing group disclosed no relevant financial relationships. Disclosures were periodically reviewed during document development and updated as appropriate. SCAI policy requires that writing group members with a current financial interest be recused from participating in discussions or voting on relevant recommendations. In December 2019, one group member (MRJ) disclosed a new role involving employment by an industry stakeholder; this member was recused from further participation in document development (including voting on recommendations and editing document) on the effective date of the new role, January 1, 2020. The work of the writing committee was supported exclusively by SCAI, a nonprofit medical specialty society, without any commercial support. Writing group members contributed to this effort on a volunteer basis and did not receive payment from SCAI. Abbott, Boston Scientific, Medtronic, American Orthotics and Prosthetics Association, Vactronix, Venarum, Philips An evidence review panel developed a protocol and conducted a systematic review of PubMED, Embase, and CENTRAL datasets using key search terms Data Data S1) according to established PRISMA (preferred reporting items for systematic reviews and meta-analyses) guidelines. Prespecified inclusion criteria for the studies were (1) randomized controlled trials, meta-analyses, registries, nonrandomized comparative studies, case series and cohort studies; (2) studies comparing efficacy and/or safety of endovascular interventions for Ao-I occlusive disease. The search criteria excluded review articles, editorials, interventions for other arterial beds (ie, femoral-popliteal), articles solely studying surgical interventions, or those evaluating interventions for Ao-I aneurysms. Initially, 3,587 articles were identified. After removal of duplicates and screening of titles and abstracts, 397 full text articles were shortlisted. Further screening was conducted based on specific questionnaire and ultimately 131 articles were examined in this document (Figure 1) (Data Data S2). The writing group composed of expert clinicians used a modified Delphi panel methodology to form and rate recommendations based on the data extracted during the systematic review. The panel participated in three rounds of voting, with discussions among the panelists after the first two anonymized rounds. 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 (Table 2). The class (strength) of recommendation (COR) represents the anticipated magnitude of comparative benefit for a group of devices (ie, 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) classification (Table 2).3 The Level of Evidence (LOE) represents the quality and certainty of 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. The draft manuscript was peer reviewed in February 2020 and the document was revised to address pertinent comments. The writing group unanimously approved the final version of the document. The SCAI Publications Committee and Executive Committee endorsed the document as official society guidance in April 2020. SCAI guidelines are primarily intended to help clinicians make decisions about treatment alternatives. SCAI guidelines do not necessarily follow the Food and Drug Administration's (FDA) device labeling or the Instructions for Use (IFUs). Clinicians must consider the clinical and anatomic presentation, setting, and preferences of individual patients to make judgements about the optimal approach. The primary goal of Ao-I arterial revascularization is relief of intermittent claudication leading to improvement in functional status and quality of life (QoL), less commonly to relieve the symptoms or signs of critical limb ischemia (CLI), and occasionally to relieve Ao-I obstruction to facilitate placement of large bore devices (eg, intra-aortic balloon pump, percutaneous left ventricular assist device, transcatheter aortic valve replacement, endovascular aortic repair). Claudication symptoms often manifest as exertional limb discomfort in the proximal limb musculature (ie, buttocks, hips and thighs), suggesting “inflow” arterial obstruction. The desired outcome is to ameliorate the patient's walking ability or to reduce symptoms so that they are no longer lifestyle limiting with improvement of arterial perfusion as demonstrated by improvement in ankle-brachial index (ABI) following treadmill exercise testing.6 The efficacy of revascularization can be gaged using physiologic and anatomic parameters. Physiologic efficacy is examined with exercise testing following revascularization, demonstrating relief of claudication using a standardized protocol and/or by improvement on measures of functional status and QoL (ie, peripheral artery questionnaire). Anatomic efficacy is most often proven by arterial duplex ultrasonography (DUS) of the treated segment (including segments proximal and distal to the treated segment), given its low risk, cost, and accuracy. However, expert consensus panels are uncertain of the use of serial DUS in asymptomatic patients following Ao-I revascularization.7 This 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.5 In patients with claudication, graded treadmill testing or the standardized 6-min walk test may be used.8 In this document, when evaluating comparative effectiveness, clinical and physiologic outcomes are given greater emphasis than surrogate endpoints (eg, DUS-derived restenosis), which in turn are weighted more heavily than procedural success endpoints. When available, cost effectiveness studies were taken into consideration in the recommendations. PTA therapy in Ao-I arteries includes the use of conventional uncoated balloons. Historically, an “uncoated PTA-first” strategy that reserves stent placement for “bail-out” was the common initial treatment approach. This strategy can still be utilized in simple lesions (ie, TASC A or B lesions) given evidence from RCTs. Uncoated PTA still remains an important adjunctive treatment modality for lesion preparation in primary stenting. Outcomes of "uncoated PTA-first” strategy have been compared against supervised exercise and best medical therapy in the randomized, multicenter MIMIC (Adjuvant benefit of angioplasty in patients with MIld to Moderate Intermitent Claudication) trial, showing significant improvements in absolute walking distance among patients treated with PTA.9 A single-center, prospective registry of 984 consecutive patients has demonstrated that PTA was associated with successful outcomes, particularly in those with claudication due to stenosis of the common iliac artery and good runoff.10 An analysis of two consecutive periods examined outcomes of PTA versus PTA plus provisional stenting in 250 patients that underwent 287 procedures (94% had either common or external iliac stenoses).11 Overall, there were no statistically significant differences in the cumulative primary and secondary patency at 4 years. More recently, a strategy of primary stenting for Ao-I disease has been compared to “uncoated PTA-first” plus provisional stenting strategy.12-14 The Dutch iliac stent trial demonstrated that PTA with provisional stenting (for lesions with a residual gradient of >10 mm Hg after PTA) had similar clinical outcomes to primary stenting at 2 years.15 However, this trial excluded patients with more complex anatomy (lesion length > 10 cm or CTOs > 5 cm). By employing a provisional stenting strategy in the iliac artery, stent placement was avoided in 63% of lesions, resulting in a more cost-effective strategy. After 5-years of follow-up there were no significant differences in patency rates, ABI, and quality of life metrics.16 Both strategies appear to provide similar technical success, symptomatic improvement, quality of life and long-term patency for TASC A and B lesions.17 Based upon comparative data for PTA with uncoated balloons versus other devices (see further sections), recommendations for stand-alone uncoated balloon PTA as the intended definitive therapy in Ao-I disease have been derived (Table 3 and 4). Specialty balloons have emerged given a potential advantage for treatment of severely calcified and undilatable lesions. In the coronary arteries the occurrence of balloon slippage, a phenomenon known as “watermelon seeding,” has been described in ~10% of patients during treatment of patients with ISR; this phenomenon has also been observed in clinical practice during Ao-I interventions. Design features include balloons with microtomes (peripheral cutting balloon [Boston Scientific, Inc., Marlborough, MA]) and those with external wire or scaffold to permit plaque scoring (ie, Angiosculpt scoring balloon [Royal Philips, Amsterdam, The Netherlands], Chocolate PTA balloon [TriReme Medical, LLC, Pleasanton, CA]). Despite a lack of RCT data and comparative studies, particularly in Ao-I vessels, specialty balloon usage has dramatically increased over time in lower extremity EVT. In the Blue Cross Blue Shield of Michigan Cardiovascular Consortium PVI Registry of 44,650 prospectively enrolled patients, specialty balloon (namely cutting balloon) utilization increased from 1.8% in 2006 to 15.1% in 2013 (ptrend < .001).18 Available outcomes data are observational and focus on immediate technical success and patency. In the setting of iliac ISR, limited data exist regarding outcomes after cutting balloon angioplasty as a primary treatment modality as well as after conventional PTA failure.19 The use of specialty balloons as adjunctive devices for lesion preparation is not addressed in this document. Consensus recommendations for specialty balloons utilization as the intended definitive therapy in Ao-I disease have been derived below and are based on absence of comparative effectiveness data and cost (Table 5). A primary stenting strategy for symptomatic Ao-I disease has been adopted as the preferred clinical practice based on several trials. In the Dutch iliac stent trial, though there was no difference between a primary stent strategy versus PTA with provisional stenting with respect to 5-year patency rates, complex lesions (CTOs > 5 cm and lesions > 10 cm) were excluded.15 Primary stenting against PTA for iliac lesions ≤8 cm (mean 5.4 cm) was examined in the STents versus AnGioplasty (STAG) trial and showed improved technical success and lower rates of complications with stenting, with similar 2-year patency rates.14 A meta-analysis of >2,000 patients demonstrated a 43% reduction in 4-year failure with stenting compared to PTA alone.20 There are two types of BMS available for Ao-I EVT: balloon expandable (typically composed of stainless steel or cobalt chromium) stents (BES) and self-expanding stents (SES) composed of nitinol or stainless steel. BES can be placed more precisely, may be expanded further post deployment and have greater radial strength.21 These characteristics may make BES better suited for aorto-ostial common iliac lesions (ie, Ao-I bifurcation kissing stents), calcific lesions, or lesions with greater recoil.22 However, BES may create artificial vessel straightening due to enhanced shear force, perhaps promoting more neointimal hyperplasia, especially when used in the EIA.23 are available in longer are more to vessel placement iliac of studies have compared BES and with A large multicenter of patients BES and demonstrated similar primary patency rates at 5 between BES and were in the of stenting In patients underwent bifurcation stenting between and the of and for were and residual stent or did not patency. have been from the stent was not of 2-year primary patency in patients underwent Ao-I kissing stents and in this The trial compared two by patients with claudication or to either the nitinol or stainless steel after procedural success was in patients to the stent of the primary or or vessel was similar The randomized controlled trial to BES and is the trial artery stents for common or external iliac artery occlusive In this trial, patients with or disease and class symptoms were randomized to either BES or was used in of and in of BES and was also more common with than BES had lower compared to BES and lower rates of at 12 In a BES a significant of A significant was observed with respect to less well in heavily calcified lesions than in those with of there was no between lesion or lesion length or lesion differences were observed for walking and no difference in the rates of or were observed between of of the excellent patency rates of for BES and for that endovascular revascularization with BMS be as for most Ao-I lesions. for BES and in Ao-I lesions are primarily based on limited data from studies and expert In a of lesions with Ao-I treated with an uncoated balloon PTA in all patients, adjunctive stenting was in of the The and primary patency rates were and Consensus recommendations for BES and in Ao-I lesions are below (Table and have benefit in the treatment of symptomatic Ao-I occlusive available devices have not been in iliac artery occlusive disease. of are available for iliac with the available in to date mm in have improved patency and reduction in compared to uncoated balloon angioplasty or BMS in in the external iliac and arteries primary patency and from of Given the of a and about with consideration be given regarding the risks and of prior to their use in Ao-I risks of and of be with clinicians of patients have been treated with or devices (Table to there are no randomized or prospective studies that have the role of for the treatment of Ao-I disease. these devices may have a role for Ao-I or However, given the lack of safety and efficacy data the use of in Ao-I and long-term data in of BMS or use be limited at this limited of are available for iliac with the available in to date mm in are to be recommendations be taken into consideration in (Table stents a scaffold with or These stents are used during percutaneous Ao-I artery revascularization either as an endovascular for treatment of disease or for treatment of arterial of and of aneurysms. By plaque from the stents of the arterial by neointimal and reduce compared with stents are commonly used in the treatment of calcified or common iliac vessels, they may provide a safety due to risk of arterial There are two types of stents for Ao-I balloon expandable and to BES and BES provide greater radial and stent greater stents can in of (ie, internal iliac and may longer treatment with In clinical practice types of stents are the and stent The is a stent with an and an of is approved for treatment of it is used during endovascular Ao-I artery This use is supported by the the published multicenter randomized clinical trial The trial included TASC B to lesions in randomized to either stent versus treated with a stent were more to from at months < analysis demonstrated a lower in TASC and lesions with stents versus BMS there was no difference for TASC B lesions between with in the stent The improved patency with the stent was at 5 evidence comparing the stent to a group of BMS better and secondary patency with the TASC classification did not therapy was of long-term patency on The use of stents has also been described for treatment of complex Ao-I using a endovascular of the aortic The balloon expandable was approved in for the treatment of or Ao-I lesions, including Ao-I This stent of stainless steel that are in and with In the symptomatic patients were enrolled in a prospective The primary safety a of device or or in the treated of the was Primary patency, from and from were at and months and at 12 The multicenter patients, iliac lesions) technical success and patency with this stent in iliac artery lesions involving and stenting and/or kissing stent treatment at the Ao-I In TASC and lesions, that over a of patency was The is a self-expanding stent with nitinol its length and an expanded is and approved for the treatment of patients with symptomatic iliac artery lesions. There are no randomized comparing the efficacy and safety of the to other or stents in the iliac A prospective of iliac arteries primary patency rate of at months and at 12 of of the to distal arteries were observed in the The stents in have been used in with or other balloon expandable stents in the and common iliac segments to treat complex Ao-I occlusive disease involving A of Ao-I observed similar patency with the and balloon expandable The stent better in TASC lesions, occlusive lesions with a lesion length > length > cm and in heavily calcified lesions. The balloon expandable stent is the most approved iliac The of a multicenter trial of patients, balloon expandable stent in the treatment of iliac artery occlusive disease the of this stainless steel stent between two primary patency was and from was by These were by improvements in from and QoL Overall, there is limited comparative evidence for the use of stents in the Ao-I artery A meta-analysis of stents in Ao-I and arteries that primary patency was improved with the stents in the not stents are used to treat iliac artery and or arterial aneurysms. However, there are data to the clinical efficacy of especially balloon in treatment of TASC and Ao-I artery lesions. Consensus recommendations for BES and in Ao-I lesions are below (Table 10 and use of devices including and has been in the treatment of Ao-I is the treatment modality with available data. The and prospectively enrolled patients with in segments and lesions at over data, lesion and outcomes for the patients with at one iliac artery lesion treated with lesions) were compared to patients with at one lesion treated with The procedural rates, as the of limiting vessel or were compared in iliac lesions versus lesions. The iliac group had one and one vessel the rates of and limiting were The procedural rate was lower in the iliac group risks of devices in Ao-I include distal and in Ao-I lesions devices can to stent and of stent Further data regarding adjunctive use of devices in Ao-I are (Table In addition to for lesion preparation of the Ao-I arteries have been and intravascular have been approved for angioplasty and treatment of calcified arteries in and 2018, with in the arteries success with respect to patency, longer follow-up demonstrated no benefit compared to conventional studies this lack of and has been for adjunctive treatment in the Ao-I and Medical, by an angioplasty that pressure the vessel vessel and vessel at low studies with intravascular have demonstrated for the management of severely calcified arterial in coronary and peripheral respect to Ao-I artery revascularization, several case have demonstrated potential in the management of Ao-I occlusive particularly when large bore is for an Ao-I are to be Ao-I endovascular has evolved over the several of complications (ie, have been addressed with lesion preparation and stent However, there to the management of this lesion The development of Ao-I for occlusive disease to for these complex to Ao-I occlusive disease to In have emerged as in terms of in other the development of or for Ao-I remains an and for coronary and of intravascular are data on in Ao-I lesions are effectiveness are to provide the approach to the of these The SCAI writing committee conducted a systematic review and analysis of the evidence and developed recommendations for Ao-I EVT. These recommendations are to assist clinicians with relevant scenarios and to device selection in Ao-I based on and quality of evidence for comparative effectiveness, and expert and for their to search and data Data review methodology Data Evidence The is not for the or of any supporting by the than be to the author for the

Topics & Concepts