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Background: The long-term efficacy of drug-coated balloon (DCB) angioplasty for large bifurcation lesions, particularly those involving the left main trunk (LMT), remains unclear., Aims: This study aimed to evaluate the long-term outcomes of directional coronary atherectomy followed by DCB (DCA/DCB) for large bifurcation lesions., Methods: This retrospective multicenter study analyzed 129 cases from the DCA/DCB registry, with 80.4% involving LMT bifurcation lesions. Building on previously reported 12-month outcomes, this study assessed long-term results. The primary endpoint was clinically driven (CD) target lesion revascularization (TLR) at 36 months. Secondary endpoints included CD target vessel revascularization (TVR); CD target vessel failure (TVF); and adverse events, such as all-cause mortality, cardiac death, target vessel acute myocardial infarction (AMI), and the need for coronary artery bypass grafting (CABG), at 24 and 36 months., Results: The mean follow-up was 53.4 ± 23.9 months. The CD-TLR rate was 5.0% at 24 months, and the primary endpoint was 5.9% at 36 months. CD-TVR rates were 14.0% at 24 months and 15.0% at 36 months, while CD-TVF rates were 14.9% at 24 months and 16.7% at 36 months. Adverse events included all-cause mortality rates of 0.8% at 24 months and 1.8% at 36 months, and cardiac death rates of 0.8% at both 24 and 36 months. No target vessel AMI or CABG procedures were reported., Conclusion: The consistently low CD-TLR rate at 36 months supports the efficacy of the DCA/DCB strategy for large bifurcation lesions, including LMT, indicating its sustained effectiveness. These findings highlight the viability of this treatment approach., (© 2024 Wiley Periodicals LLC.)

Objective: To compare the cost-effectiveness of drug-coated balloon angioplasty (DCB) versus plain old balloon angioplasty (POBA) for treatment of arteriovenous fistula (AVF) stenosis., Methods: A Markov model was created to compare DCB versus POBA for AVF stenosis over a 2-year time horizon from a United States payer's perspective. Probabilities related to complications, restenosis, retreatment, and all-cause mortality were obtained from published literature. Costs were calculated using Medicare reimbursement rates and data from published cost analyses, inflation-adjusted to 2021. Health outcomes were measured with quality-adjusted life years (QALY). Probabilistic and deterministic sensitivity analyses were performed with a willingness-to-pay threshold of $100,000/QALY., Results: Base case calculation showed better quality-of-life outcomes but increased cost with POBA compared to DCB, with an incremental cost-effectiveness ratio of $27,413/QALY, making POBA the more cost-effective strategy in the base case model. Sensitivity analyses showed that DCB becomes cost-effective if the 24-month mortality rate after DCB is no more than 3.4% higher than that after POBA. In secondary analyses where mortality rates were equalized, DCB was more cost-effective than POBA until its additional cost reached more than $4213 per intervention., Conclusion: When modeled from a payer's perspective over 2 years, the cost utility of DCB versus POBA varies with mortality outcomes. POBA is cost-effective if 2-year all-cause mortality after DCB is greater than 3.4% higher than after POBA. If 2-year mortality after DCB is less than 3.4% higher than after POBA, DCB is cost-effective until its additional cost per procedure exceeds $4213 more than POBA., Level of Evidence Iv: HISTORICALLY CONTROLLED STUDY.: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 ., (© 2023. Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE).)

Background Patients with severe-stage chronic kidney disease (CKD) were excluded from femoropopliteal disease trials evaluating drug-coated balloons (DCBs) and drug-eluting stents (DESs) versus plain balloon angioplasty (POBA) and bare metal stents (BMSs). We examined the interaction between CKD status and device type for the association with 24-month all-cause mortality and major amputation risk. Methods and Results We studied patients undergoing femoropopliteal interventions (September 2016-December 2018) from Medicare-linked VQI (Vascular Quality Initiative) registry data. We compared outcomes for: (1) early-stage CKD (stages 1-3) receiving DCB/DES, (2) early-stage CKD receiving POBA/BMS, (3) severe-stage (4 and 5) CKD receiving DCB/DES, and (4) severe-stage CKD receiving POBA/BMS. We studied 8799 patients (early-stage CKD: 94%; severe-stage: 6%). DCB/DES use was 57% versus 51% in patients with early-stage versus severe-stage CKD. Twenty-four-month mortality risk for patients with early-stage CKD receiving DCB/DES (reference) was 21% versus 28% (hazard ratio [HR], 1.47 [95% CI, 1.31-1.65]) for those receiving POBA/BMS; patients with severe-stage CKD: those receiving DCB/DES had a 49% (HR, 2.61 [95% CI, 2.06-3.31]) mortality risk versus 52% (HR, 3.64 [95% CI, 2.91-4.55]) for those receiving POBA/BMS (interaction P <0.001). Adjusted analyses attenuated these results. For severe-stage CKD, DCB/DES versus POBA/BMS mortality risk was not significant at 24 months (post hoc comparison P =0.06) but was higher for the POBA/BMS group at 18 months (post hoc P <0.05). Patients with early-stage CKD receiving DCB/DES had the lowest 24-month amputation risk (6%), followed by 11% for early-stage CKD-POBA/BMS, 15% for severe-stage CKD-DCB/DES, and 16% for severe-stage CKD-POBA/BMS (interaction P <0.001). DCB/DES versus POBA/BMS amputation rates in patients with severe-stage CKD did not differ (post hoc P =0.820). Conclusions DCB/DES versus POBA/BMS use in patients with severe-stage CKD was associated with lower mortality and no difference in amputation outcomes.

Objective: Drug-coated balloons (DCB) and drug-eluting stents (DES) have been rapidly adopted for femoropopliteal endovascular interventions due to their favorable patency rates. It is unclear whether choice of using drug coated devices versus bare metal stents (BMS) or plain balloon angioplasty (POBA) as primary treatment in femoropopliteal disease is mostly associated with patient-level factors, safety concerns, or by operator preferences. This study sought to evaluate factors associated with their use in a contemporary dataset., Methods: All femoropopliteal lesions treated with endovascular interventions between 2016 and 2019 from the Vascular Quality Initiative registry were included. For each procedure, a primary treatment was identified based on the following hierarchy: DES > DCB > BMS > POBA. A hierarchical logistic regression model predicting DCB or DES use included patient-level characteristics, key events (period after Centers for Medicare and Medicaid Services reimbursement change, January 2018 [vs before] and period after Katsanos meta-analysis December 2018 [vs before]), and random effects for site and operator. Operator-level variability for DCB and DES use was summarized with an adjusted median odds ratio (MOR)., Results: A total of 57,753 femoropopliteal endovascular procedures were included. Poor functional status (odds ratio [OR], 0.92; 95% confidence interval [CI], 0.90-0.94), prior anticoagulant use (OR, 0.92; 95% CI, 0.87-0.97), higher Rutherford classification (OR, 0.86; 95% CI, 0.84-0.88), chronic kidney disease stage 4 or 5 (OR, 0.92; 95% CI, 0.86-0.98), and the period after the Katsanos meta-analysis publication (OR, 0.3; 95% CI, 0.29-0.32) were associated with a lower odds of DCB or DES use; whereas female sex (OR, 1.12; 95% CI,1.08-1.17), prior lesion treatment (OR, 1.17; 95% CI, 1.11-1.22), diabetes (OR, 1.07; 95% CI, 1.02-1.12), Trans-Atlantic Inter-Society Consensus class B (OR, 1.16; 95% CI, 1.09-1.24) and C (OR, 1.2; 95% CI, 1.12-1.28), and the period after the Centers for Medicare and Medicaid Services reimbursement change (OR, 1.08; 95% CI, 1.03-1.14) were associated with a higher odds of DCB or DES use. Significant variability in use was found across operators (adjusted MOR, 2.70; 95% CI, 2.55-2.85) and centers (adjusted MOR, 2.89; 95% CI, 2.50-3.27)., Conclusions: DCB or DES use in femoropopliteal disease demonstrates wide variability across operators and is linked strongly with external factors, followed by anatomic lesion characteristics and a history of previous interventions. Future work needs to focus on tailoring DCB or DES use to patient and lesion characteristics and to develop appropriate use guidelines integrating these factors., (Copyright © 2022 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Purpose: To study, from a U.S. payer's perspective, the economic consequences of drug-coated balloon (DCB) versus standard percutaneous transluminal angioplasty (PTA) use for the treatment of stenotic lesions in dysfunctional hemodialysis arteriovenous fistulae., Materials and Methods: Cost differences between DCBs and PTA at year 1 and beyond were calculated via 2 methods. The first approach used the mean absolute number of trial-observed access circuit reinterventions through 12 months (0.65 ± 1.05 vs 1.05 ± 1.18 events per patient for DCBs and PTA, respectively) and projected treatment outcomes to 3 years. The second approach was based on the trial-observed access circuit primary patency rates at 12 months (53.8% vs 32.4%) and calculated the cost difference on the basis of previously published Medicare cost for patients who maintained or did not maintain primary patency. Assumptions regarding DCB device prices were tested in sensitivity analyses, and the numbers needed to treat were calculated., Results: Using the absolute number of access circuit reinterventions approach, the DCB strategy resulted in an estimated per-patient savings of $1,632 at 1 year and $4,263 at 3 years before considering the DCB device cost. The access circuit primary patency approach was associated with a per-patient cost savings of $2,152 at 1 year and $3,894 at 2.5 years of follow-up. At the theoretical DCB device reimbursement of $1,800, savings were $1,680 and $2,049 at 2.5 and 3 years, respectively. The one-year NNT of DCB compared to PTA was 2.48., Conclusions: Endovascular therapy for arteriovenous access stenosis with the IN.PACT AV DCB can be expected to be cost-saving if longer follow-up data confirm its clinical effectiveness., (Copyright © 2022 SIR. Published by Elsevier Inc. All rights reserved.)

Peripheral artery disease, along with subsequent critical limb ischemia (CLI), is highly prevalent, increases with age, and carries high morbidity and mortality. Specific devices for treatment of below-the-knee (BTK) lesions are limited. On February 17, 2021, the United States Food and Drug Administration convened a virtual meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee to consider a premarket approval application for the Lutonix 014 Drug-Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Becton, Dickinson and Company, Franklin Lakes, New Jersey) for the treatment of obstructive de novo or non-stented restenotic lesions in BTK vessels (popliteal, tibial, and peroneal arteries) in patients with CLI. We summarize the presentations and the panel deliberations, including voting outcome and recommendations for risk versus benefit., Competing Interests: Declaration of competing interest Ron Waksman– Advisory Board: Abbott Vascular, Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd., Transmural Systems; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance; Transmural Systems. All other authors – None., (Copyright © 2021. Published by Elsevier Inc.)

Background: Meta-analyses of randomised trials of paclitaxel-coated peripheral devices found an association with worse long-term survival., Aims: We aimed to assess long-term mortality in patients treated with drug-coated versus non-drug-coated devices who are insured by Medicare Advantage (MA), an alternative to traditional Medicare that represents >30% of the Medicare eligible population. We analysed data from an MA administrative claims data source that includes both inpatient and outpatient femoropopliteal artery revascularisation procedures., Methods: Patients treated with or without drug-coated devices for femoropopliteal artery revascularisation from 4/2015-12/2017 were studied using Optum's De-identified Clinformatics Datamart Database. Mortality was assessed up to December 2019 using Kaplan-Meier cumulative mortality curves and Cox proportional hazard models. Inverse probability of treatment weighting was used to adjust for differences between groups., Results: Of 16,796 patients revascularised, 4,427 (26.4%) were treated with drug-coated devices: 3,600 (81.3%) balloons and 827 (18.7%) stents. The median follow-up was 2.66 years (IQR 2.02-3.52). Treatment with drug-coated devices was associated with similar long-term mortality to non-drug-coated devices (adjusted HR 1.03, 95% CI: 0.96-1.10; p=0.39). Results were comparable for patients treated with balloons alone (adjusted HR 1.00, 95% CI: 0.92-1.08; p=0.96) or stents (adjusted HR 1.02, 95% CI: 0.88-1.18; p=0.78). These findings did not differ based on treatment setting, disease severity, age, sex or comorbidity burden (interaction p>0.05 for all)., Conclusions: In this large cohort, there was no evidence of increased long-term mortality following treatment with drug-coated devices.

BACKGROUND The long-term safety of paclitaxel-coated devices (PCDs; drug-coated balloon or drug-eluting stent) for peripheral endovascular intervention is uncertain. We used data from the Veterans Health Administration to evaluate the association between PCDs, long-term mortality, and cause of death. METHODS AND RESULTS Using the Veterans Administration Corporate Data Warehouse in conjunction with International Classification of Diseases, Tenth Revision ( ICD-10 ) Procedure Coding System, Current Procedural Terminology, and Healthcare Common Procedure Coding System codes, we identified patients with peripheral artery disease treated within the Veterans Administration for femoropopliteal artery revascularization between October 1, 2015, and June 30, 2019. An adjusted Cox regression, using stabilized inverse probability-weighted estimates, was used to evaluate the association between PCDs and long-term survival. Cause of death data were obtained using the National Death Index. In total, 10 505 patients underwent femoropopliteal peripheral endovascular intervention; 2265 (21.6%) with a PCD and 8240 (78.4%) with a non-PCD (percutaneous angioplasty balloon and/or bare metal stent). Survival rates at 2 years (77.4% versus 79.7%) and 3 years (70.7% versus 71.8%) were similar between PCD and non-PCD groups, respectively. The adjusted hazard for all-cause mortality for patients treated with a PCD versus non-PCD was 1.06 (95% CI, 0.95-1.18, P =0.3013). Among patients who died between October 1, 2015, and December 31, 2017, the cause of death according to treatment group, PCD versus non-PCD, was similar. CONCLUSIONS Among patients undergoing femoropopliteal peripheral endovascular intervention within the Veterans Administration Health Administration, there was no increased risk of long-term, all-cause mortality associated with PCD use. Cause-specific mortality rates were similar between treatment groups.

Background: Recent evidence from randomized controlled trials has raised concerns about the long-term safety of paclitaxel-coated peripheral devices used for femoropopliteal artery revascularization. In response to a call for more real-world data on the safety of these devices, the SAFE-PAD study (Safety Assessment of Femoropopliteal Endovascular treatment with Paclitaxel-coated Devices) was designed with input from the Food and Drug Administration to provide a long-term, comprehensive evaluation of the mortality risk associated with paclitaxel-coated devices among Medicare beneficiaries., Methods and Results: SAFE-PAD is an observational cohort study of fee-for-service Medicare beneficiaries that underwent femoropopliteal artery revascularization with either a drug-coated device or nondrug-coated device from 2015 through 2018. All patients age 66 years or older who underwent revascularization will be identified using a combination of International Classification of Diseases, Tenth Revision procedural codes, Current Procedural Terminology codes, and Healthcare Common Procedure Coding System C-codes. The safety end point of all-cause death will be updated semiannually and continued until the median duration of follow-up surpasses 5 years. Sub-group analyses will be conducted by device type, patient characteristics, and procedural setting. Registration: The SAFE-PAD study has been registered on URL: https://www.clinicaltrials.gov; Unique identifier: NCT04496544., Conclusions: The SAFE-PAD study will evaluate the long-term safety of drug-coated devices compared with nondrug-coated devices for femoropopliteal artery revascularization among a broad, real-world population of patients with peripheral artery disease.

Following the December 2018 publication of a meta-analysis by Katsanos et al reporting higher rates of long-term mortality with the utilization of paclitaxel-related devices (balloons and stents) when compared to control in femoropopliteal arteries, the US Food and Drug Administration (FDA) issued a safety alert in January 2019 and further detailed the implications for future clinical use of these devices in March 2019. The FDA convened a public meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee in June 2019. This report summarizes the proceedings of this meeting and the panel's response to the 12 questions posed by the FDA related to the potentially increased late mortality of drug-coated balloons and drug-eluting stents with paclitaxel in patients with peripheral arterial disease., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Femoropopliteal (FP) artery is one of the most anatomically challenging areas for sustained stent patency. The incidence of FP in-stent restenosis (ISR) is estimated at 50% at 24 months. Prior studies have shown that lesion debulking with laser atherectomy (LA) combined with drug coated balloon (DCB) have superior outcomes compared to LA + balloon angioplasty (BA) ISR, but there have not been studies evaluating 2-year outcomes., Methods: This was a dual-center retrospective cohort study that compared patients with FP-ISR treated with LA + DCB versus LA + BA. Cox regression analysis was used to examine 2-year outcomes of target lesion revascularization (TLR) and the composite outcome of TLR or restenosis. Multivariable analysis was performed for clinical and statistically significant (in the univariate analysis) variables., Results: One hundred and seventeen consecutive patients with Tosaka II (n = 32) and III (n = 85) ISR were analyzed. Sixty-six patients were treated with LA + DCB and 51 with LA + BA. The LA + DCB group had more lesions with moderate to severe calcification (58% vs. 13%; p < .0001). The LA + DCB group was more likely to be treated with the use of embolic protection devices (64% vs. 23%, p < .001) and cutting balloons (61% vs. 6%, p < .001). Bail-out stenting rates were lower in the LA + DCB group (32% vs. 57%, p = .008). LA + DCB was superior (HR: 0.57; 95% CI: 0.34-0.9, p = .027) for the composite outcome of 2-year TLR or restenosis. The 12-month KM estimates for freedom from TLR or restenosis were 66% in the LA + DCB group versus 46% in the LA + BA group. The 24-month KM estimates were 45% in the LA + DCB group versus 24% in the LA + BA group., Conclusions: The combination of DCB + LA was associated with decreased rates of bail-out stenting and improved 2-year TLR or restenosis rates. Randomized clinical trials examining the DCB + LA combination for FP-ISR are needed., (© 2019 Wiley Periodicals, Inc.)

Objective: Drug-coated balloons (DCB) and drug-eluting stents (DES) have significantly altered treatment paradigms for femoropopliteal lesions. We aimed to describe changes in practice patterns as a result of the infusion of these technologies into the treatment of peripheral arterial disease., Methods: We queried the Vascular Quality Initiative registry from 2010 to 2017 for all peripheral vascular interventions involving the superficial femoral artery and/or the popliteal artery. Cases were divided into a PRE and a POST era with a cutoff of September 2016, when specific device identity was first recorded in Vascular Quality Initiative. For each artery, a primary treatment was identified as either plain balloon angioplasty, atherectomy, DCB, bare-metal stent, or DES. The relative distribution of primary treatments between the PRE and POST eras was evaluated, as were lesion characteristics associated with DCB and DES use and regional variability in the adoption of these new technologies., Results: Of 210,666 arteries in the dataset, 91,864 femoropopliteal arteries (across 74,842 procedures in 55,437 patients) were included. Each artery received 1.5 ± 0.6 treatments. Primary treatment use changed from 40% balloon angioplasty, 45% stenting, and 15% atherectomy in the PRE era to 22% plain balloon angioplasty, 26% bare-metal stent, 8% atherectomy, 37% DCB, and 8% DES in the POST era (P < .001). Forty-three percent of arteries received a drug-containing device as a primary or adjunctive therapy and 1.3% received both a DCB and DES in the POST era. DCB use as the primary treatment was highest in lesions with length 10.0 to 19.9 cm (42%), TransAtlantic InterSociety A, B, or C lesions (38%), and lesions with mild to no calcification (38%). DES use was highest in lesions with a length of 20 cm or more (12%), TransAtlantic InterSociety D lesions (13%), and lesions with moderate to severe calcification (9%). The range of use across 18 regions was 125 to 40% for DCB and 1% to 14% for DES. Regional variability was greater for DES (SD 4% vs mean 8%) than for DCB (SD 7% vs mean 29%)., Conclusions: There has been a rapid dissemination of DCB and DES technology in the femoropopliteal vessels, with nearly one-half of arteries receiving a drug-containing therapy in modern practice. DCBs are most used in medium length, minimally calcified lesions and DESs are most used in longer, more heavily calcified lesions. There is significant regional variability in adoption, especially with DES., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Purpose: To present final, 2-year results of a randomized trial comparing paclitaxel-coated vs uncoated balloon angioplasty following vessel preparation with ultra-high-pressure percutaneous transluminal angioplasty (PTA) in hemodialysis arteriovenous fistulae (AVFs)., Materials and Methods: Twenty-three sites enrolled 285 subjects with dysfunctional AVFs located in the arm. Before 1:1 randomization, successful vessel preparation was achieved (full waist effacement, < 30% residual stenosis). Follow-up was clinically driven except for a 6-month office visit., Results: Ninety-six of 141 subjects in the drug-coated balloon (DCB) arm and 111 of 144 in the control arm completed the study. Target lesion primary patency (TLPP) rates for the DCB and control groups were 58% ± 4 vs 46% ± 4 (P = .02) at 9 months, 44% ± 5 vs 36% ± 4 (P = .04) at 12 months, 34% ± 5 vs 28% ± 4 (P = .06) at 18 months, and 27% ± 4 vs 24% ± 4 (P = .09) at 24 months, respectively. Mean time to TLPP event for subjects with an event was longer for DCBs (322 vs 207 d; P < .0001). Fewer interventions were needed to maintain target lesion patency in the DCB group at 9 months (P = .02) but not at 12 (P = .08), 18 (P = .13), or 24 months (P = .19). The noninferiority safety target was met at all intervals (P < .01). Mortality did not differ between groups (P = .27). Post hoc analyses showed equivalent DCB effect in all subgroups., Conclusions: Two-year results demonstrate long-term safety and variable efficacy of DCB angioplasty in AVFs., (Copyright © 2019 SIR. Published by Elsevier Inc. All rights reserved.)

Hydrophilic polymer coatings on intravascular devices lower friction between the device and vasculature, thereby reducing trauma during interventional procedures. Polymer coating embolism-the detachment and downstream embolism of polymer particles-has been reported as an iatrogenic complication of coated interventional devices affecting the vasculature and various organs. The Food and Drug Administration (FDA) acknowledges this complication and continues to work with stakeholders to close gaps in performance testing and standards related to polymer coating integrity. Recent innovations within interventional technologies have led to development of new hydrophilic-coated devices with expanded indications for use. The 2018 FDA draft guidance for intravascular guidewires expands the application of particulate generation testing to most devices and recommends labeling changes to increase industry awareness. This article highlights current procedural trends where the phenomenon of polymer coating embolism may be more prevalent. It describes the mechanisms of polymer separation, reported clinical sequelae, and risk factors for relevant indications. These procedural trends and associated risk factors articulate the need for particulate testing and support the FDA's draft guidance recommendations for performance testing of applied coatings. If standardized, particulate assessments may allow characterization and comparisons of coating integrity among devices from various manufacturers, and are an important foundation for setting particulate limits. As hydrophilic coatings enable endovascular treatment for a range of patient populations, setting particulate limits or finding alternative solutions without compromise to device function may be essential. Particulate testing is relevant to physicians, regulators, and manufacturers for the purposes of product development and quality improvement of interventional devices.

Lubricious polymer coatings are increasingly used on intravascular devices to facilitate easier access and navigation through tortuous blood vessels. Recent reports highlight the separation and downstream embolism of polymer particles affecting the vasculature and various organs. The Food and Drug Administration (FDA) acknowledges polymer coating embolism as an iatrogenic complication of intravascular devices and continues to close gaps in standards related to coating integrity. The Association for the Advancement of Medical Instrumentation established particulate testing as an industry standard for evaluating coating integrity of intravascular devices. The FDA recognizes this standard; however, challenges exist in setting particulate limits that may compromise device function without sufficient clinical data. The microscopic nature of polymer emboli not visible with available imaging modalities has impacted reporting. This has also resulted in a reduced number of manufacturer-driven product development projects related to coating integrity. On the other hand, recent procedural trends have supported the innovation of coated devices with expanded indications, requiring particulate evaluations and release limits. This article proposes a methodology to set particulate limits for intravascular devices given existing clinical, regulatory, and manufacturing challenges. The approach with standardization requirements enables characterization, comparison, and evaluation of lubricious coatings from various manufacturers. It incorporates a step-by-step procedure that adds scrutiny to the application of coatings while ensuring device function is not impacted. Together with particulate assessments, clinicopathologic and animal studies permit an understanding of particulate ranges from commercially available devices and setting of particulate limits for new device evaluations.

Purpose: To report outcomes of a multicenter feasibility study using the FLEX Vessel Prep (VP) System, a novel technology that facilitates plaque incision and lumen gain in stenosed or occluded femoropopliteal arteries prior to balloon angioplasty., Materials and Methods: Two hundred fifty-five patients (mean age 71.8±9.1 years) were treated with the FLEX VP System at 38 centers between December 2015 and November 2017. Average lesion length was 133±88 mm. Average baseline stenosis was 92%±11%; 112 (44.3%) of 253 patients presented with a chronic total occlusion. Conventional or drug-coated balloon (DCB) angioplasty was performed in all patients after vessel preparation. Vessel measurements were derived from angiograms acquired at baseline, after FLEX passage, and after subsequent ancillary procedures. Logistic regression analyses were performed to identify baseline or procedure variables that predicted the need for provisional stenting., Results: Average percent reduction in vessel stenosis following treatment with the FLEX VP System was 27%±17%. No flow-limiting dissection, vessel perforation, or embolization was observed; 15 (5.9%) patients had minor (type A or B) dissections. Provisional stenting was performed in 49 (19.2%) patients. Average stenosis following angioplasty ± stenting was 9.1%±7.4%; 9 (3.6%) patients had significant residual stenosis ≥30%. Logistic regression analyses found that patients with dissections, longer lesions, and those receiving conventional balloon dilation alone were most likely to undergo stenting., Conclusion: In a real-world patient population with long, complex femoropopliteal lesions, use of the FLEX VP System as vessel preparation for angioplasty improved acute outcomes compared to historical controls. The rate of provisional stenting was low, and no serious vessel complications were observed.

Background: Randomized controlled trials have reported favorable 1-year outcomes with drug-coated balloons (DCBs) for the treatment of symptomatic peripheral arterial disease when compared with standard percutaneous transluminal angioplasty (PTA). Evidence remains limited on the durability of the treatment effect with DCBs in the longer term., Methods and Results: IN.PACT SFA is a single-blind, randomized trial (Randomized Trial of IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty [PTA] Balloon Catheter vs Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery [SFA] and/or Proximal Popliteal Artery [PPA]) that enrolled 331 patients with symptomatic (Rutherford 2-4) femoropopliteal lesions up to 18 cm in length. Patients were randomized 2:1 to receive treatment with DCB or PTA. The 36-month assessments included primary patency, freedom from clinically driven target lesion revascularization, major adverse events, and functional outcomes. At 36 months, primary patency remained significantly higher among patients treated with DCB compared with PTA (69.5% versus 45.1%; log rank P <0.001). The rates of clinically driven target lesion revascularization were 15.2% and 31.1% ( P =0.002) for the DCB and PTA groups, respectively. Functional outcomes were similarly improved between treatment groups even though subjects in the DCB group required significantly fewer reinterventions versus those in the PTA group ( P <0.001 for target lesion revascularization, P =0.001 for target vessel revascularization). There were no device- or procedure-related deaths as adjudicated by an independent Clinical Events Committee., Conclusions: Three-year results demonstrate a durable and superior treatment effect among patients treated with DCB versus standard PTA, with significantly higher primary patency and lower clinically driven target lesion revascularization, resulting in similar functional improvements with reduced need for repeat interventions., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01175850 for IN.PACT SFA phase I in the European Union and NCT01566461 for IN.PACT SFA phase II in the United States., (© 2018 The Authors.)

Objective: Despite improvements in endovascular therapy for lower extremity arterial disease, open surgical revascularization is still required when the disease is extensive. Although autogenous vein is the conduit of choice for open femoropopliteal bypass, prosthetic grafts can be an acceptable alternative when adequate vein is not available. The FUSION BIOLINE heparin-coated vascular graft (Maquet Endovascular, Wayne, NJ) was developed to improve the patency rate associated with standard prosthetic grafts. The current study, the FINEST Trial (Comparison of Safety and Primary Patency Between the FUSION BIOLINE Heparin-Coated Vascular Graft and EXXCEL Soft ePTFE), was designed to assess the clinical outcome of heparin-coated and standard vascular grafts in a prospective, randomized, controlled, multicenter trial., Methods: During a 25-month period ending in June 2012, 209 eligible patients scheduled to undergo elective prosthetic femoral to above-knee or below-knee popliteal bypass were randomized to receive a standard expanded polytetrafluoroethylene (ePTFE) graft or the heparin-coated FUSION BIOLINE vascular graft. Among 203 patients in the efficacy analysis, claudication was the presenting symptom in 147 (72.4%), and the site of the distal anastomosis was at the above-knee level in 174 (85.7%). Grafts were assessed by duplex ultrasound imaging and ankle-brachial indices performed postoperatively at discharge and at 30 days, 6 months, and 12 months. The primary efficacy end point was primary patency of the study graft. The primary safety end point was the composite of major adverse events and periprocedural death. Secondary end points included the time to hemostasis of bleeding at the anastomotic suture hole and primary assisted and secondary patency., Results: The primary patency rates at 6 months were 86.4% for the FUSION BIOLINE heparin-coated vascular graft group compared with 70.0% for the standard ePTFE group, a difference of 16.4% (95% confidence interval, 2.7%-29.9%; P = .006), and the respective rates at 12 months were 76.5% and 67.0% (95% confidence interval, -4.8% to 23.0%; P = .05). The mean time to hemostasis of bleeding at the suture hole was 3.5 minutes in the FUSION BIOLINE group and 11.0 minutes in the standard ePTFE group (P < .0001). Major adverse events were significantly lower in the FUSION BIOLINE group, occurring in 17.1%, compared with 30.7% in the standard ePTFE group (P = .033), principally a result of a lower rate of major graft reinterventions through 12 months in the FUSION BIOLINE group (16.2% vs 30.7%)., Conclusions: Data from this randomized multicenter study demonstrated improved midterm patency, less bleeding at the suture hole, and lower major adverse events with the FUSION BIOLINE heparin-coated vascular graft compared with standard ePTFE grafts. Although the ultimate long-term benefit of the graft cannot be ascertained with the data currently available, the utility of the FUSION BIOLINE vascular graft appears promising., (Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Retrospectively assess the frequency of right ventricular outflow tract (RVOT) conduit disruption during transcatheter pulmonary valve replacement (TPVR) and the effectiveness and safety of NuMED Covered Cheatham-Platinum Stents™ (CCPS) for its prevention or treatment., Background: There have been no published reports to date describing the safety and effectiveness of covered stents to prevent or treat RVOT conduit disruption during TPVR., Methods: Data regarding 251 TPVR procedures performed at multiple US investigational sites were retrospectively reviewed to explore the incidence and potential predictors of conduit disruption. In addition, data on the use of 69 CCPS implanted in 50 patients during TPVR was reviewed., Results: The overall incidence of conduit disruption requiring intervention was 6%. The only predictor identified was a very elevated RVOT conduit systolic pressure gradient. A pre-existing conduit tear was present in nine, while 31 developed tears after conduit dilation and three, after TPVR. The CCPS was used prophylactically in seven. Conduit tears were prevented or repaired in 49/50 patients. No CCPS-related acute complications were reported. At 6-month follow-up, no patient had more than mild pulmonary regurgitation and the mean Doppler RVOT gradient (12.7 ± 5.8 mm Hg) comparing favorably with that reported in the Melody TPV® IDE trial (20.0 ± 8.6 mm Hg)., Conclusion: CCPS implantation can successfully treat RVOT conduit disruption without negative impact on the TPV function. This retrospective analysis suggests high RVOT conduit systolic pressure gradient is a risk factor for conduit tears during TPVR., (© 2014 Wiley Periodicals, Inc.)

Introduction: It is a common practice to soak Titan(®) Coloplast penile implants in antibiotic solution prior to implantation. Experience with Inhibizone impregnation suggests that rifampin coating significantly reduces infection rates of penile implant surgery. In this article we describe the results of coating Titan Coloplast penile implants with rifampin/gentamicin solution., Aim: To compare infection rates of Titan(®) Coloplast penile implants coated with vancomycin/gentamycin, rifampin/gentamicin, and Inhibizone-impregnated American Medical Systems (AMS) penile implants., Methods: Chart review was done for all Mentor/Coloplast and AMS implant surgeries performed at our center between the dates January 1, 2002 and February 8, 2010. Infection rates for Titan(®) Coloplast penile implants coated with vancomycin/gentamycin, rifampin/gentamicin, and Inhibizone-impregnated (AMS) penile implants were compared., Main Outcome Measures: Infection rates for penile implants coated with different antibiotics., Results: Infection rates for Titan(®) Coloplast penile implants coated with vancomycin/gentamycin and Inhibizone-impregnated (AMS) penile implants was 4.4% and 1.3%, respectively (P = 0.05). None of the rifampin/gentamicin-coated Titan(®) Coloplast penile implants have developed infection. Rifampin is the common antibiotic both in rifampin/gentamicin-coated Coloplast implants and Inhibizone(®) . The infection rate in this combined rifampin/gentamicin-coated Titan Coloplast implants and Inhibizone-coated AMS implants group was 0.63% (P = 0.03)., Conclusion: Both rifampin/gentamicin-coated Titan(®) Coloplast penile implants and Inhibizone-impregnated (AMS) penile implants appear to have lower infection rates compared with vancomycin/gentamycin-coated Titan(®) Coloplast penile implants The present study does not suggest superiority of rifampin/gentamicin-coated Titan(®) Coloplast penile implants or Inhibizone-impregnated (AMS) penile implants but we strongly suggest that all Titan(®) Coloplast penile implants should be coated with rifampin/gentamicin solution., (© 2010 International Society for Sexual Medicine.)

The differential safety and efficacy profiles of sirolimus-eluting stents when implanted in patients with multivessel coronary artery disease who have increased body mass indexes (BMIs) compared with those with normal BMIs are largely unknown. This study evaluated the impact of BMI on 1-year outcomes in patients with multivessel coronary artery disease treated with sirolimus-eluting stents as part of the Arterial Revascularization Therapies Study Part II (ARTS II). From February to November 2003, 607 patients were included at 45 centers; 176 patients had normal BMIs (<25 kg/m(2)), 289 were overweight (> or =25 and < or =30 kg/m(2)), and 142 were obese (>30 kg/m(2)). At 30 days, the cumulative incidence of the primary combined end point of death, myocardial infarction, cerebrovascular accident, and repeat revascularization (major adverse cardiac and cerebrovascular events) was 3.4% in the group with normal BMIs, 3.1% in overweight patients, and 2.8% in obese patients (p = 0.76). At 1 year, the cumulative incidence of major adverse cardiac and cerebrovascular events was 10.8%, 11.8%, and 7.0% in the normal BMI, overweight, and obese groups, respectively (p = 0.31). In conclusion, BMI had no impact on 1-year clinical outcomes in patients with multivessel coronary artery disease treated with sirolimus-eluting stents in ARTS II.

Objectives: The purpose of this study was to compare the 9-month clinical outcomes of patients treated with paclitaxel-eluting stents (PES) or sirolimus-eluting stents (SES) for coronary artery stenosis., Background: The STENT (Strategic Transcatheter Evaluation of New Therapies) registry is the first multicenter registry in the U.S. to collect long-term outcomes of drug-eluting stents from "real-world" practice., Methods: Data on all percutaneous coronary interventions in 8 U.S. hospital centers were collected in the STENT registry between 2003 and 2005. In this prospective, nonrandomized, observational study, the choice of procedures was at the physicians' discretion. Patients who only received a PES (n = 4,671) or SES (n = 4,555) and completed 9-month follow-up (93.8% of eligible) were included for analysis. Primary end points were death, myocardial infarction (MI), and target vessel revascularization (TVR) at 9 months. Secondary outcomes included major adverse cardiac events (MACE) (any of the 3 primary end points) and stent thrombosis., Results: At 9 months, death, MI, and TVR occurred in 2.2%, 2.0%, and 4.1%, respectively, of the PES group and 2.5%, 2.2%, and 4.3%, respectively, of the SES group (p = NS); MACE occurred in 7.5% of the PES group and 8.0% of the SES group (p = 0.37). After adjustments for group differences in baseline characteristics, TVR (hazard ratio [HR] 0.88, 95% confidence interval [CI] 0.70 to 1.32; p = 0.26) and MACE (HR 0.95, 95% CI 0.81 to 1.12; p = 0.56) were similar for PES and SES. Stent thrombosis at 9 months occurred in 0.7% of both groups., Conclusions: The results of this study show that clinical restenosis and MACE events after PES and SES procedures in "real-world" patients are infrequent and similar at 9 months.

Following standard precautions and hand hygiene guidelines is important to health care workers and the patients they serve. The purpose of this study was to determine the effect of aloe-vera impregnated gloves on attitudes about hand hygiene among many health care workers and perceived sense of skin condition.

In clinical trials of highly selected patients, drug-eluting stents (DESs) decreased restenosis but not the rate of acute myocardial infarction (AMI) or death. Whether DES use has an affect on the rate of AMI or death in unselected patients is uncertain. Bare metal stents (BMSs) were placed in 1,164 consecutive patients in the year before the introduction of DESs. DESs were subsequently placed in 1,285 consecutive comparable patients at Wake Forest Baptist Medical Center. Early and late clinical outcomes were compared. Propensity score analysis was used to adjust outcomes for baseline differences. Patient and procedural characteristics of the 2 groups were similar, with an overall incidence of 72% for acute coronary syndromes (p = NS). At 9 months, target vessel revascularization (2.8% vs 8.6%, p <0.001), AMI (3.7% vs 4.7%, p = 0.257), and death (4.9% vs 7.1%, p = 0.030) were lower in the DES group than in the BMS group. Propensity score-adjusted Cox proportional hazard ratios for DES versus BMS at 9 months were 0.71 (95% confidence interval 0.42 to 1.19) for AMI, 0.56 (95% confidence interval 0.36 to 0.87) for death, and 0.60 (95% confidence interval 0.42 to 0.86) for the combined end point of AMI or death. In conclusion, in this single-center observational study, use of DESs in consecutive unselected patients, most of whom would not have been eligible for inclusion in the randomized trials of DES versus BMS, was associated with lower AMI and death rates than in a comparable group of patients treated with BMSs in mid-term (9-month) follow-up.

Objective: To assess the feasibility and safety of the respiratory infection control (RIC) device, a silver-coated endotracheal tube, and its effect on bacterial burden in the airways., Design: Prospective, randomized, single-blind, multiple-center study., Setting: Three hospitals in Spain and one in the United States., Patients: Patients were eligible adults who required mechanical ventilation for > or =24 hrs and did not have respiratory infections. One hundred forty-nine patients were intubated and analyzed for safety; 121 were intubated > or =24 hrs and analyzed for tube colonization; 67 had negative baseline quantitative endotracheal aspirates and were analyzed for quantitative endotracheal aspirates colonization., Interventions: Intubation with the RIC device or a control endotracheal tube., Measurements and Main Results: The RIC device was associated with delayed colonization on the tube compared with the control device at the threshold of ++, +++, or > or =10(4) colony-forming units/mL (p = .02, log-rank test; p = .10, Wilcoxon's test) and in quantitative endotracheal aspirates at > or =10(6) colony-forming units/mL (p = .08, log-rank test; p = .05, Wilcoxon's test). The RIC device was associated with reduced colonization rate by days on the tube (p = .04, Wilcoxon's test) and in quantitative endotracheal aspirates (p = .05, Wilcoxon's test) at the same thresholds. The RIC device was associated with lower maximal bacterial burden in tracheal aspirates for 7 days (mean log-transformed burden, 4.2 +/- 2.3 vs. 5.5 +/- 1.7 log colony-forming units/mL; p = .02, Wilcoxon's test). Other between-group differences favored the RIC device but were not significant. Five adverse events were considered device related, including three events in the RIC group and two events in the control group., Conclusions: In this prospectively planned, preliminary analysis, the RIC device was feasible and well tolerated. Larger studies are needed to determine whether delayed colonization, reduced colonization rate, and decreased bacterial burden will decrease the incidence of ventilator-associated pneumonia.

A dynamic novel coating, consisting of a hydrophilic polymeric matrix and a bubbling agent, has been developed for precise entry and positioning of needles, and accurate collection of biopsy samples. These coated biopsy needles have been successfully used in in vitro trials. The results are discussed here. Potential application areas include vascular, cardiovascular and orthopaedics.

Drug-eluting stents have rapidly come to dominate the field of coronary intervention, constituting 85% of the US market just one year after introduction. The current utilization of bare metal stents in coronary intervention in the US is quite limited. This article will review technological advances in third-generation bare metal stents, which optimize procedural performance by means of improved flexibility, lower crossing profile, and thinner struts while maintaining fluoroscopic visibility and may portend a continued role for bare metal stents in some settings. This article will review data pertaining to outcomes with new generation bare metal stents and discuss current options for utilization of drug eluting stents versus bare metal stents in the US.

This paper describes affordable equipment for testing bone screw torque, corresponding to ASTM standard F543-00 for testing metallic medical bone screws. Correct testing of thin and long bone screws is essential due to screw failures during insertion and removal of the screws. Furthermore, insertion torque is an important factor in predicting fixation strength, screw pull-out force and effects of surface treatment of screws. The capability of the custom-built tester was determined using polytetrafluoroethylene and wood disc samples and bone screws. Bovine cortical bones allowed testing to the failure limit, i.e. the torque increased in long screws to the fracture limit. For 2.7 and 3.5 mm thick self-tapping cortical bone screws, the failure torques were 30-50 per cent higher than the minimum values required by the standard (1.0 and 2.3 N m respectively). The equipment provided reproducible results and fulfilled the ASTM standard very well. Preliminary testing with amorphous diamond coated bone screws showed good durability of the coating and on average 10-15 per cent lower torque values compared with uncoated screws. The equipment can be used to measure insertion and removal torques as described in the standard. Furthermore, it also allows testing of normal screws and bolts.

This randomized, prospective clinical trial examines the impact of the use of Trillium biopassive surface coating on clinical outcomes after cardiopulmonary bypass (CPB) that may be induced by contact of blood elements with foreign surfaces. The study consisted of 98 consecutive patients randomly assigned to either a CPB circuit that consisted of a Trillium-coated Affinity open reservoir oxygenator or a CPB circuit with an uncoated Affinity open reservoir oxygenator. The operative procedure performed on all 98 patients consisted of either coronary artery bypass graft (CABG), valve, or a combination of the two. Exclusion criteria consisted of patients who presented to the operating room in circulatory arrest. Trillium biopassive surface coating resulted in improved clinical outcomes and fewer adverse events when compared to the control group. Significantly, fewer patients required no blood products (18.3% in the control group vs. 32.7% in the treatment group), even though the control group had a significantly higher pre-bypass hematocrit. Postoperative atrial fibrillation (24.5% vs. 16.3%) and reoperation for bleeding (10.2% vs. 4.1%) showed a much lower incidence in the Trillium group. Significance was not reached because of the small sample size resulting in low power. Trillium circuits result in improved patient outcomes in the treatment group when compared to the control circuit group.

Encapsulated cell technology has the potential to treat a wide range of diseases by the controlled and continuous delivery of biological products to the host. Many biotechnology companies have focused their interest in this technology taking into account the promising pre-clinical and clinical results and the potential clinical market. However, on the long way from clinic to market several issues will have to be addressed, including suitable scientific development, ethical obstacles, government regulations and market forces.

Objective: To compare postoperative inflammation occurring with heparin-surface-modified (HSM) versus non-HSM polymethyl methacrylate intraocular lenses (IOLs) after phacoemulsification., Design: Randomized, double-masked, multicenter, parallel trial., Participants: A total of 367 patients, consisting of routine (n = 220), glaucoma (n = 58), and diabetes (n = 89) patients, from eight US medical centers., Methods: Patients were observed for 1 year after phacoemulsification and lens implantation (week 1, months 1, 3, 6, 12)., Main Outcome Measures: Primary measures of postoperative inflammation defined as the presence of giant cells on the lens surface via specular micrography and cellular deposits via slit-lamp examination., Results: The cross-sectional analyses showed that consistently fewer routine patients with HSM lens implants had giant cells on the IOL than those with non-HSM lens implants across all follow-up visits. The statistical significance (P < 0.05) was observed at all visits except month 12 for routine patients. The diabetes patients also demonstrated the same giant cell difference, and the statistical significance was observed at all visits including month 12. A similar trend was also observed in the glaucoma patients, with statistical significance only at the 3-month visit. For cell deposits, significant differences in favor of the HSM lens (P < 0.05) were observed at 3 months among routine and diabetes patients, and at 3 and 6 months among glaucoma patients. A longitudinal data analysis using the generalized estimating equation approach indicated statistically significant treatment effect of HSM lenses in reducing inflammation in all patients except for cellular deposits in diabetes patients. In all patient groups, sight-threatening complications were not reported either more frequently or with more severity than normally expected for patients who have undergone cataract extraction and IOL implantation., Conclusions: The present study, the only one to have used phacoemulsification in virtually all patients (211/220 [96%] routine, 57/58 [98%] glaucoma, and 84/89 [94%] diabetes) is the largest to evaluate and compare concurrently routine, glaucoma, and diabetes patients. It is also the first US patient population study to document that heparin surface modification reduces postoperative inflammatory responses, as measured by specular micrography and slit-lamp examination, especially in the early postoperative period.

Although it is one of the most frequently utilized devices in the hospitalized patient, the Foley catheter has often been taken for granted. This lack of attention is unfortunate, as the Foley catheter remains one of the primary sources of hospital-acquired infections, which increase morbidity, mortality, and the financial burden on the healthcare system. Although education on the appropriate techniques, proper use, and early removal of Foley catheters is important, such measures unfortunately result in transient benefits. Current technologic advancements have moved the coating technology to a state where bacterial adhesion and migration can be limited and the frequency of catheter-associated urinary tract infections can be reduced. Future technological advances in the Foley catheter will help provide better care and comfort for the catheterized patient.

The occurrence of drug-resistant infections from hospital-based devices has soared in recent years. In response, industry has sought to develop a prophylactic approach with the materials used to construct devices. This article discusses one approach, a process that can be applied to a variety of materials and compares its performance with alternative methodologies.