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Background: Reimbursements for professional services performed by clinicians are under constant scrutiny. The value of a vascular surgeon's services as measured by work relative value units (wRVUs) and professional reimbursement has decreased for some of the most common procedures performed. Hospital reimbursements, however, often remain stable or increases. We sought to evaluate fistulagrams as a case study and hypothesized that while wRVUs and professional reimbursements decrease, hospital reimbursements for these services increased over the same time period., Methods: Medicare 5% claims data were reviewed to identify all fistulagrams with or without angioplasty or stenting performed between 2015 and 2018 using current procedural terminology codes. Reimbursements were classified into 3 categories: medical center (reimbursements made to a hospital for a fistulagram performed as an outpatient procedure), professional (reimbursement for fistulagrams based on compensation for procedures: work RVUs, practice expense RVU, malpractice expense RVU), and office-based laboratory (OBL, reimbursement for fistulagrams performed in an OBL setting). Medicare's Physician Fee Schedule was used to calculate wRVU and professional reimbursement. Medicare's Hospital Outpatient Prospective Payment System-Ambulatory Payment Classification was used to calculate hospital outpatient reimbursement., Results: From 2015 to 2018, we identified 1,326,993 fistulagrams. During this study period, vascular surgeons experienced a 25% increase in market share for diagnostic fistulagrams. Compared with 2015, total professional reimbursements from 2017 to 2018 for all fistulagram procedures decreased by 41% (-$10.3 million) while OBL reimbursement decreased 29% (-$42.5 million) and wRVU decreased 36%. During the same period, medical center reimbursement increased by 6.6% (+$14.1 million)., Conclusions: Vascular surgeons' contribution to a hospital may not be accurately reflected through traditional RVU metrics alone. Vascular surgeons performed an increasing volume of fistulagram procedures while experiencing marked reductions in wRVU and reimbursement. Medical centers, on the other hand, experienced an overall increase in reimbursement during the same time period. This study highlights that professional reimbursements, taken in isolation and without consideration of medical center reimbursement, undervalues the services and contributions provided by vascular surgeons., (Copyright © 2020. Published by Elsevier Inc.)

Background: Paclitaxel-containing devices (PTXDs) significantly reduce reintervention in patients with symptomatic femoropopliteal peripheral artery disease. A recent aggregate-data meta-analysis reported increased late mortality in patients with peripheral artery disease treated with PTXDs. We performed an individual patient data meta-analysis to evaluate mortality., Methods: Manufacturers of US Food and Drug Administration-approved and commercially available devices in the United States provided deidentified individual patient data for independent analysis. Cox proportional hazards 1-stage meta-analysis models using intention-to-treat methods were used for the primary analysis. A secondary analysis of recovered missing vital status data was performed. The impact of control crossover to PTXDs, cause-specific mortality, and drug dose mortality were assessed., Results: A total of 2185 subjects and 386 deaths from 8 PTXD trials with 4-year median follow-up were identified. The primary analysis indicated a 38% (95% CI, 6% to 80%) increased relative mortality risk, corresponding to 4.6% absolute increase, at 5 years associated with PTXD use. Control and treatment arm loss to follow-up and withdrawal were 24% and 23%, respectively. With inclusion of recovered vital status data, the excess relative mortality risk was 27% (95% CI, 3%-58%). This observation was consistent across various scenarios, including as-treated analyses, with no evidence of increased risk over time with PTXDs. Mortality risk tended to be increased for all major causes of death. There were no subgroup differences. No drug dose-mortality association was identified., Conclusions: This individual patient data meta-analysis, based on the most complete available data set of mortality events from PTXD randomized controlled trials, identified an absolute 4.6% increased mortality risk associated with PTXD use.

Background: In the current era of treatment of pulmonary hypertension (PH) in Japan, combination therapy has been frequently used thanks to the medical insurance system. Additionally, pulmonary balloon angioplasty (BPA) is widely performed for chronic thromboembolic PH (CTEPH)., Methods: To elucidate the long-term prognosis and the prognostic factors among all five subtypes of PH in this new era, we examined the current status of management of PH from November 2012 to April 2016 in the multicenter registry by the Japanese Pulmonary Circulation Society., Results: Among 1253 consecutive patients registered from 20 PH centers in Japan, we analyzed 997 patients with mean pulmonary arterial pressure ≥ 25 mmHg by right heart catheterization. Transplant-free survival at 5 years in pulmonary arterial hypertension (PAH), PH due to left-heart disease, PH due to lung diseases, CTEPH, and miscellaneous PH were 74.0, 69.3, 63.7, 92.0, and 55.3%, respectively. Of note, 32% of PAH patients were treated with double combination therapy and 42% of those with triple combination therapy, and 66% of CTEPH patients with BPA. Although PAH patients with triple combination therapy had worse hemodynamic parameters than those with other medications, triple combination therapy showed the best prognosis. BPA in CTEPH improved survival even when adjusted for the key background factors., Conclusions: In the current era of PH treatment in Japan, the five-year transplant-free survival rate in this study was 74% for PAH and 92% for CTEPH, in which active combination medical therapy for PAH and higher performance rate of BPA for CTEPH may be involved., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Background: Current guidelines give balloon pulmonary angioplasty (BPA) a Class IIb recommendation for use in inoperable chronic thromboembolic pulmonary hypertension (CTEPH), as its safety and efficacy remain poorly defined. We conducted a systematic review and meta-analysis to evaluate BPA effectiveness., Methods: Medline, Cochrane Library and Scopus were searched for original studies from database inception dates until 24th May 2018. Prospective studies reporting outcomes before and after BPA in inoperable CTEPH patients were included. Studies with <20 patients were excluded. Data were pooled using a random effects model represented as weighted mean differences with 95% confidence intervals (CIs)., Results: Seventeen noncomparative studies comprising 670 CTEPH patients (mean age 62 years; 68% women) were included. Meta-analysis showed significantly decreased mean pulmonary artery pressure (-14.2 mm Hg [95% CI -18.9, -9.5]), pulmonary vascular resistance (-303.5 dyn·s/cm 5 [95% CI -377.6, -229.4]) and mean right atrial pressure (-2.7 mm Hg [95% CI -4.1, -1.3]) after BPA. Six-minute walk distance (67.3 m [95% CI 53.8, 80.8]) and cardiac output (0.2 l/min [95% CI 0.0, 0.3]) were significantly increased following BPA. From 12 studies reporting mortality with median follow-up of 9 months after BPA (range, 1-51 months), pooled incidence of short (≤1 month) and long-term mortality (>1 month) was 1.9% and 5.7%, respectively., Conclusion: This systematic review and meta-analysis suggests mildly improved hemodynamics and overall low mortality rates following BPA in inoperable CTEPH patients. This non-comparative evidence can be used to facilitate decision making until the results of larger, controlled studies become available., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Background: Balloon pulmonary angioplasty (BPA) has shown beneficial effects for chronic thromboembolic pulmonary hypertension (CTEPH). However, previous studies have shown less cardiac output improvement and symptoms remaining after BPA, implying poor right ventricular (RV) function recovery. Therefore, we investigated the residual RV dysfunction after BPA to reveal risk factors, clinical effects, and possible underlying histopathological mechanisms., Methods and Results: We investigated 61 consecutive CTEPH patients who underwent cardiovascular magnetic resonance before and 3 and 12 months after BPA series. Residual dysfunction (RD) of RV was defined as RV end-diastolic volume index >100 ml/m 2 or RV ejection fraction (EF) <45% at 12-month follow-up. Patients were divided into RD (44%) and normalized dysfunction (ND) (56%) groups. Compared with the ND group, the RD group had significantly worse World Health Organization (WHO) functional class at follow-up. No significant hemodynamic differences were observed between the groups. On multivariable logistic regression analysis, male sex (odds ratio [OR] 12.5, p = 0.004) and prolonged QRS duration (OR 1.08, p = 0.029) were independently associated with residual RV dysfunction. Additionally, RV histopathology in 11 CTEPH autopsy cases showed that QRS duration was correlated with RV fibrosis area., Conclusions: Relatively high percentage (44%) of residual RV dysfunction with worse WHO functional class was observed in CTEPH patients even after BPA. Prolonged QRS duration may predict poor recovery in RV function after BPA., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Background: Pulmonary endarterectomy (PEA) is the treatment of choice for chronic thromboembolic pulmonary hypertension (CTEPH). However, persistent pulmonary hypertension continues in 5-35% of patients after PEA. Recently, balloon pulmonary angioplasty (BPA) showed promise as a strategy for patients with non-operable CTEPH. Therefore, we investigated the usefulness of BPA for residual pulmonary hypertension after PEA., Methods: Fifteen patients with residual pulmonary hypertension after PEA received 71 BPA sessions (4.7 ± 1.4 sessions/patient). The mean time between the PEA and the first BPA session was 28.1 ± 25.8 months. All patients underwent a comprehensive diagnostic work-up, including right heart catheterization, functional and laboratory tests, before, and 6-4 weeks after the BPA sessions., Results: After BPA, the mean pulmonary arterial pressure decreased from 44.7 ± 6.4 to 30.8 ± 7.5 mm Hg (31% decline; p < 0.001). Pulmonary vascular resistance decreased from 551.9 ± 185.2 to 343.8 ± 123.8 dyn∗s/cm -5 (38% decline; p < 0.001). The 6-min walking distance increased from 383 ± 104 to 476 ± 107 m (mean change +93 m; p < 0.001). In two sessions (2.8%), serious periprocedural complications occurred. During a mean follow-up of 18 ± 14.3 months, one patient died two months after the last BPA session. Fourteen patients survived., Conclusions: BPA could be a promising therapeutic strategy for persistent pulmonary hypertension after PEA in patients with CTEPH., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Conventional therapies for transcatheter treatment of patients with infrainguinal obstructive disease remain compromised by high restenosis rates. Drug-coated balloons (DCB) offer a novel therapeutic alternative targeting the source of neo-intimal hyperplasia, without the need for a permanent endovascular scaffold and their inherent limitations. A systematic research of the medical databases (Pubmed) has been conducted for this up-to-date review. Key words, such as "drug-coated balloons" (DCB), "drug-eluting balloon," "in-stent-restenosis" (ISR), "de-novo stenosis," "plain old angioplasty," "atherectomy," "debulking," "superficial femoral artery," "popliteal artery," "above/below the knee," and "peripheral artery disease" have been used for literature search. Furthermore, data from reviews, original contributions, randomized controlled studies, observational studies, registries and single center experiences have been considered. Overall, an increasing level of evidence supports the use of DCB for the treatment of long, complex, heavily calcified femoropopliteal non-occlusive and occlusive lesions, including failure after BM stent implantation due to ISR. However, more studies will be necessary to investigate the long-term effects of DCB-treatment in these real-world lesions.

Four decades after its introduction into clinical practice, coronary balloon angioplasty is still used during most coronary interventions. Conventional balloon angioplasty is frequently used to predilate complex or severe lesions and remains of major value to optimise the results of stent implantation. Plain balloon angioplasty is still used alone in some anatomic scenarios where stent implantation is not desirable (very small vessels or diffuse lesions, large resistant thrombus burden, side branches of bifurcations). However, this technique is hampered by a relatively high restenosis risk. Recently, drug-coated balloons (DCB) have been shown to provide an attractive new tool for the "leave nothing behind" strategy. Many studies have demonstrated that DCB are indeed safe and effective. Evidence of the value of DCB in patients with ISR is overwhelming. DCB are attractive for selected de novo coronary lesions (small vessels, diffuse disease, side branches). DCB have also gained major evidence supporting their clinical efficacy in the peripheral arterial territory. Further studies are required to elucidate the relative value of DCB compared with alternative strategies (namely new-generation drug-eluting stents) in different clinical and anatomic scenarios.

Purpose of Review: This review paper provides a summary on the use of drug-coated balloons in peripheral artery disease. It covers the main drug-coated balloon (DCB) trials. It is divided into categories of lesions: superficial femoral artery and popliteal lesions, infra-popliteal lesions and in-stent restenosis. It also includes an overview of the future of DCBs, highlighting the main ongoing trials., Recent Findings: The latest research on DCB focuses on newer types of DCBs, mainly paclitaxel-coated but with lower doses. Another area of latest DCB research is its use in superficial femoral artery and popliteal artery in-stent restenosis, with superior outcomes. Drug-coated balloons produce better outcomes than percutaneous transluminal angioplasty alone in de novo and in-stent restenosis lesions of superficial femoral artery and popliteal arteries. More data are needed to demonstrate efficacy and safety of DCBs in infrapopliteal disease. Newer DCBs and adjunctive therapy may provide improved outcomes for peripheral artery disease interventions.

Background: Numerous studies have reported favorable outcomes using drug-coated balloons (DCBs) for treatment of symptomatic peripheral artery disease of the superficial femoral and popliteal arteries. However, the treatment effect compared with an uncoated balloon has differed greatly among the randomized trials, with better outcomes observed with higher-dose DCBs. This European trial was designed to assess the safety and effectiveness of a next-generation low-dose (2-µg/mm 2 surface dose of paclitaxel) DCB., Methods: This was a prospective, randomized, multicenter, single-blinded trial. Patients were randomized (3:1) to treatment with a low-dose DCB or an uncoated percutaneous transluminal angioplasty (PTA) balloon. The primary safety end point was a composite of freedom from device- and procedure-related death through 30 days after the procedure and freedom from target limb major amputation and clinically driven target lesion revascularization through 12 months after the procedure. The primary effectiveness end point was primary patency at 12 months., Results: Patients were randomized to treatment with a DCB (222 patients, 254 lesions) or uncoated PTA balloon (72 patients, 79 lesions) after successful predilatation. Mean lesion length was 7.2 and 7.1 cm, and 19.2% and 19.0% of lesions represented total occlusions, respectively. The primary safety end point was met, and superiority was demonstrated; freedom from a primary safety event was 94.1% (193 of 205) with DCB and 83.3% (50 of 60) with PTA, for a difference of 10.8% (95% confidence interval, 0.9%-23.0%). The primary effectiveness end point was met, and superiority of DCB over PTA was achieved (83.9% [188 of 224] versus 60.6% [40 of 66]; P <0.001). Outcomes with DCB were also superior to PTA per the Kaplan-Meier estimate for primary patency (89.0% versus 65.0% at 365 days; log-rank P <0.001) and for rates of clinically driven target lesion revascularization (5.9% versus 16.7%; P =0.014)., Conclusions: Superiority with a low-dose DCB for femoropopliteal interventions was demonstrated over PTA for both the safety and effectiveness end points., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01858363., (© 2017 The Authors.)

Background: Atherosclerosis in the superficial femoral artery is common in patients suffering from peripheral artery disease. Paclitaxel-eluting balloon (PEB) angioplasty, stenting, and directional atherectomy (DA) have provided new options for the treatment of superficial femoral artery disease; however, the comparative efficacy of these interventional strategies remains uncertain., Methods: One hundred and fifty-five patients with symptomatic peripheral artery disease due to de novo superficial femoral artery stenotic or occlusive lesions were randomized to treatment with plain balloon angioplasty (BA) followed by PEB angioplasty and stenting (n=48), BA and stenting (n=52), or DA with distal protection and bailout stenting (n=55). The primary end point of the study was percentage diameter stenosis after 6 months measured by angiography. Other end points included target lesion revascularization, thrombosis, ipsilateral amputation, binary restenosis, and all-cause mortality at 6 and 24 months., Results: Baseline and lesion characteristics were comparable in all groups with a mean lesion length of 65.9±46.8 mm and 56% total occlusions. At 6 months angiography, the percent diameter stenosis was significantly lower in patients treated by PEB angioplasty and stenting (34±31%) as compared with BA angioplasty and stenting (56±29%, P =0.009) or DA (55±29%, P =0.007). Similarly, binary restenosis was significantly lower after treatment with PEB and stenting as compared with BA and stenting or DA. Clinical follow-up at 24 months revealed a lower risk for target lesion revascularization after PEB angioplasty and stenting as compared with BA and stenting or DA. We found no difference in terms of target lesion thrombosis and mortality among groups, and no patient underwent amputation., Conclusions: Treatment of de novo superficial femoral artery lesions with PEB angioplasty and stenting is superior to BA angioplasty and stenting or DA in terms of angiographic diameter stenosis at 6 months and target lesion revascularization at 24 months., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00986752., (© 2017 American Heart Association, Inc.)

In looking toward the future of chronic thromboembolic pulmonary hypertension, the following four clinical questions deserve careful consideration: (1) What is inoperable disease, and how is it defined? (2) Is there a role for targeted medical therapy in technically operable, proximal disease? (3) Where does balloon pulmonary angioplasty fit into the treatment algorithm? (4) How should we approach patients with symptomatic chronic pulmonary thromboembolism without pulmonary hypertension? The search for these answers will continue to propel this field forward. Consequently, the crossroads we find ourselves at signal opportunity and hope for future advances.

Background: The vertebral artery (VA) ostium (VAO) is a common stenosis site. Most patients with VAO stenosis refractory to medical treatment are treated endovascularly using stenting. To optimally cover the ostial plaque, which frequently extends into the adjacent subclavian artery, part of the stent must overhang in the subclavian artery. This configuration makes subsequent VA access very challenging in cases of in-stent or distal vertebrobasilar pathology; it also obstructs the distal subclavian artery., Objective: To determine whether angioplasty at the ostium with a dual balloon (Flash Ostial) specially designed to allow the subclavian end of the stent to flare might circumvent these problems and, most importantly, provide optimal plaque coverage around the vertebral ostium., Methods: Between June 2012 and July 2014, 11 patients with symptomatic VAO stenosis refractory to best medical therapy were treated with stenting and dual balloon Flash angioplasty. Demographics, results, and outcomes were reviewed., Results: A total of 12 VAO stenting-dual balloon angioplasty procedures were performed (mean stenosis, 83.6%; range, 78-90%). Nine patients had mild-to-moderate (40-60%) contralateral VAO stenosis. The initial average modified Rankin Scale (mRS) score was 1.25. In all cases, immediate postangioplasty angiography showed excellent stent apposition against the VA and around the ostium in the subclavian artery. No permanent perioperative complications or deaths occurred. At a mean follow-up of 10.8 months (range 2-24), all patients had symptom resolution and no evidence of symptomatic restenosis on neuroimaging/Doppler studies; the average mRS score was 0.66. Three patients continued to have previously diagnosed mid-cervical VA stenosis; one of them had postprocedure dissection and an asymptomatic in-stent stenosis at 8 months., Conclusions: Safety and feasibility were demonstrated using the Ostial Flash system for VAO stenting and angioplasty. No permanent perioperative complications were seen., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Background: Adults with congenital heart disease are a relatively new population that progressively increases in size and complexity. In Italy, there are no accurate data concerning the distribution of congenital defects and the long-term outcome relating to both congenital heart disease per se and comorbidities, due to the aging process., Methods: The Piedmont Adult Congenital Heart Disease Registry has been designed to investigate these aspects and to support a high quality healthcare development for grown-up congenital heart patients. Within 2 years, 459 consecutive patients routinely followed in 10 divisions of cardiology in Piedmont were included in the project. Electronic dedicated software has supported data collection., Results: Mean age of patients is 35 ± 16 years. Septal defects are the most common type of congenital heart disease (35.3%). At baseline evaluation, 71.7% of patients reported a previous surgical and/or percutaneous treatment and 6.3% an electrophysiological procedure. Freedom from intervention is 44%, 81% and 56% at the age of 18, 30 and 45 years, respectively. Patients who had a treatment during infancy show a better intervention-free survival (p=0.038) compared with patients treated during adulthood. Despite the majority of the population had an almost preserved functional status, 27.5% had ≥1 long-term sequelae (arrhythmias 27.5%; pulmonary hypertension 5.2%; neurological problems 4.1%; cyanosis 4.8%; liver dysfunction 2.4%; enteropathy 2.4%; lung disease 2.2%). During 2 years of follow-up, the estimated mortality rate is 0.88%., Conclusions: Adults with congenital heart disease are a heterogeneous population of relatively young patients with relevant clinical and social problems. The late sequelae related to both the underlying heart disease and the advancing age require continuous monitoring and lifelong specialized care.

Background: Stenting for aortic coarctation (CoA) has been accepted as an alternative to surgery for adolescents and adults, but only a few case have been reported in Japan. The purpose of this study was to provide a detailed review of Japanese national data on stenting of CoA., Methods: In a subanalysis of the data of the Japanese Society of Pediatric Interventional Cardiology (JPIC), we identified 35 patients with CoA who underwent stenting. We analyzed procedural characteristics including factors that may have contributed to hemodynamic effectiveness, and we compared these parameters between the patients under and over 15 years of age., Results: The mean ratio of balloon diameter/minimum lumen diameter (MLD) before stenting was 1.7 (range, 1.2-4.0), and the mean difference between the balloon diameter and the reference vessel diameter was -0.7 mm (range, -5.0 to +3.0 mm). %MLD/balloon diameter, which was defined as [(balloon diameter - MLD after dilation)/balloon diameter] × 100 predicted achievement of <10 mmHg pressure gradient after stenting. The sensitivity and the specificity of its cut-off of 7% were 93% and 47% (AUC, 0.7), respectively. There was no statistical difference between the two age groups under and over 15 years of age, in terms of selection criteria of stent size, balloon type used for deployment and immediate angiographic and hemodynamic result., Conclusions: Stenting for CoA was clinically effective with few complications in Japan, even in patients not fully grown., (© 2015 Japan Pediatric Society.)

Background: Evidence from large, randomized, controlled peripheral artery disease trials reporting long-term outcomes using drug-coated balloons (DCBs) is limited. Previously, the DCB showed favorable 1-year outcomes compared with conventional percutaneous transluminal angioplasty (PTA), yet durability of the treatment effect with DCBs remains unknown., Objectives: This study sought to investigate the longer-term outcomes of a paclitaxel-eluting DCB compared to PTA for femoropopliteal lesions., Methods: We enrolled 331 patients with symptomatic (Rutherford 2 to 4) femoropopliteal lesions up to 18 cm in length. Patients were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The 24-month assessments included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), major adverse events, and quality of life and functional outcomes as assessed by the EuroQOL-5D quality-of-life questionnaire, walking impairment questionnaire, and 6-min walk test., Results: At 24 months, patients treated with DCB showed significantly higher primary patency when compared with PTA (78.9% vs. 50.1%; p < 0.001). The rates of CD-TLR were 9.1% and 28.3% (p < 0.001) for the DCB and PTA groups, respectively. The overall mortality rate in the DCB group was 8.1% versus 0.9% in the PTA group (p = 0.008). There were no device- or procedure-related deaths and no major amputations in either group through 24-month follow-up. The rate of vessel thrombosis was low (1.5% DCB vs. 3.8% PTA; p = 0.243), with no new events reported between 1 and 2 years. Both groups showed similar functional improvement at 2 years, although DCB patients achieved this level of function with 58% fewer reinterventions., Conclusions: The 24-month outcomes from the trial demonstrate a durable and superior treatment effect of DCB versus PTA with significantly higher primary patency, lower CD-TLR, and similar functional status improvement with fewer repeat interventions. (Randomized Trial of IN.PACT Admiral Drug Eluting Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease [INPACT SFA I]; NCT01175850; and IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [SFA] and Proximal Popliteal Artery [PPA] [INPACT SFA II]; NCT01566461)., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Due to demographic changes, peripheral arterial occlusive disease (PAD) has become one of the most prevalent diseases in western industrial nations. In recent years the trend towards initial endovascular treatment approaches has further continued. Because of the high primary success and low complication rates, intervention-based revascularization strategies are the method of choice in the majority of cases. The treatment strategy should always be assessed in a multidisciplinary setting and if possible, within a designated vascular center. One of the main limitations of interventions is the occurrence of restenosis, in particular in infrapopliteal arterial lesions. A major progress arose from drug-eluting balloons, which dramatically reduced restenosis rates particular for femoropopliteal lesions. A potential alternative strategy could be the use of a combination therapy, such as plaque removal followed by insertion of drug-eluting balloons; however, economic issues have to be kept in mind for such approaches.

Introducing anti-restenotic drug-based treatment modalities in femoropopliteal interventions is the potential revolutionizing reperfusion treatment of peripheral artery disease. Durability of recanalization procedures using drug-coated balloons (DCB) and drug-eluting stents (DES) yields in excellent mid-term and long-term technical and clinical outcomes and may be cost saving on the long term as compared to traditional treatment modalities such as plain old balloon angioplasty (POBA) and bare metal nitinol stent implantation. Drug-eluting bioresorbable scaffolds are another drug-based promising treatment option but are still investigational. In particular, DCB provide a novel method to locally deliver paclitaxel into the arterial wall without the need of a chronically implanted delivery system or even if those devices will be indicated, they can be delivered focally. Following the first positive pilot studies, two large pivotal trials have confirmed superiority of DCB over plain old balloon angioplasty (POBA) in the treatment of TASC II A and B femoropopliteal lesions. Even for more complex femoropopliteal lesions such as long lesions and instent restenosis, single center studies and small randomized studies have shown promising mid-term technical and clinical results. For DES, follow-up data for the only commercially available device are now presented up to 5 years with excellent clinical outcome regarding freedom from target lesion revascularization and improvement of walking capacity. This review article summarizes the current knowledge and perspectives of drug-based endovascular treatment modalities in femoropopliteal interventions and discusses still unresolved needs.

Infrapopliteal arterial disease is a challenging problem to treat. A shift toward an endovascular treatment approach over surgical bypass has occurred over recent years. Although current standard percutaneous transluminal balloon and bare metal stents are employed, their durability and outcomes are questionable. A number of endovascular advancements in the treatment of infrapopliteal (IP) arterial disease have recently been made. We review the recent literature for new atherectomy, stent, and balloon technologies.

Background: Drug-coated balloons (DCBs) have shown promise in improving the outcomes for patients with peripheral artery disease. We compared a paclitaxel-coated balloon with percutaneous transluminal angioplasty (PTA) for the treatment of symptomatic superficial femoral and popliteal artery disease., Methods and Results: The IN.PACT SFA Trial is a prospective, multicenter, single-blinded, randomized trial in which 331 patients with intermittent claudication or ischemic rest pain attributable to superficial femoral and popliteal peripheral artery disease were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The primary efficacy end point was primary patency, defined as freedom from restenosis or clinically driven target lesion revascularization at 12 months. Baseline characteristics were similar between the 2 groups. Mean lesion length and the percentage of total occlusions for the DCB and PTA arms were 8.94 ± 4.89 and 8.81 ± 5.12 cm (P=0.82) and 25.8% and 19.5% (P=0.22), respectively. DCB resulted in higher primary patency versus PTA (82.2% versus 52.4%; P<0.001). The rate of clinically driven target lesion revascularization was 2.4% in the DCB arm in comparison with 20.6% in the PTA arm (P<0.001). There was a low rate of vessel thrombosis in both arms (1.4% after DCB and 3.7% after PTA [P=0.10]). There were no device- or procedure-related deaths and no major amputations., Conclusions: In this prospective, multicenter, randomized trial, DCB was superior to PTA and had a favorable safety profile for the treatment of patients with symptomatic femoropopliteal peripheral artery disease., Clinical Trial Registration Url: http://www.clinicaltrials.gov. Unique Identifiers: NCT01175850 and NCT01566461., (© 2014 The Authors.)

Carotid artery occlusion is one of the most frequent and treatable causes of ischemic strokes. Although carotid endarterectomy (CEA) is recognized as the gold standard for treating symptomatic, severe carotid stenosis, investigations have sought to demonstrate the efficacy of carotid angioplasty and stenting (CAS) as a potential alternative to surgical management. Patient selection is crucial in the judicious application of CAS and CEA. Recent investigations have emphasized the potential of endovascular procedures to complement rather than replace surgical techniques for treating a wide spectrum of carotid disease.

Carotid artery stenosis is the major cause of the stroke associated with ischemic origin and carries increased mortality and morbidity. Since carotid artery endarterectomy (CEA) was first performed in 1950, in conjunction with the advanced technology and increased experience under the guidance of randomized controlled trials, balloon angioplasty and carotid artery stenting, which have similar mortality and morbidity, have become comparable with CEA. Determining the optimal treatment option for each patient is the most important issue in carotid artery stenosis. Today, there have been improvements in technology and recent advances in the cardiovascular sciences. Moreover, there is increased experience, increased attention to patient selection, and a team approach to find the most suitable treatment for the patient. In this review, we briefly discuss the current treatment approaches for carotid artery stenosis under the guidance of the modern studies.

Background: Few data are available on very long-term follow-up after treatment for isolated pulmonary valve stenosis (PVS), either surgically or by percutaneous balloon angioplasty (PBA)., Methods and Results: All patients with isolated PVS were selected from our database of congenital heart defects. Their records were reviewed systematically. We identified 79 surgically treated patients with a median follow-up of 22.5 years (range 0-45 years) and 139 PBA patients with median follow-up of 6.0 years (range 0-21 years). Echocardiographic and catheterization parameters indicate excellent results of both techniques in relieving the transpulmonary gradient. However, after initial surgery 20.3% of patients needed a cardiac re-intervention: 81% for severe pulmonary valve regurgitation, but none for residual pulmonary stenosis. After initial PBA a cardiac re-intervention was needed in 9.4% of patients. In 85% the indication was residual pulmonary stenosis, in none of them pulmonary regurgitation, although almost all patients developed a mild pulmonary regurgitation. Freedom of re-intervention after surgery was 98.4%, 93.5%, 87.7%, 70.9% and 55.7% at 5, 10, 20, 30 and 40 years postoperatively. Freedom of re-intervention in the PBA group was 95.1%, 87.5% and 84.4% at 5, 10 and 20 years post-procedure., Conclusions: Both surgery and PBA are safe and successful in relieving the acute transpulmonary gradient. Long-term results of surgery are worse than previously thought due to severe PR. After PBA re-interventions for residual stenosis are frequently needed and the incidence of mild PR is high. Very long-term results of PBA are still unknown., (Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.)

Purpose: Debate exists as to the benefit of angioplasty vs bypass graft in the treatment of lower extremity peripheral vascular disease. The associated costs are poorly defined in the literature. We sought to determine national estimates for the costs, utilization, and outcomes of angioplasty and bypass graft for the treatment of both claudication and limb threat., Methods: We searched the Nationwide Inpatient Sample (NIS) database (1999-2007), identifying patients who had an identifiable International Classification of Disease (ICD)-9 diagnosis code of atherosclerotic disease (claudication [440.21] or limb threat [440.22-440.24]). Of these, only patients who underwent intervention of angioplasty ± stent (percutaneous transluminal angioplasty [PTA; 39.50-39.90]), peripheral bypass graft (BPG; 39.29) or aortofemoral bypass (ABF; 39.25) were included. We compared demographics, costs, and comorbidities, as well as multivariable-adjusted outcomes of in-hospital mortality and major amputation. Additionally, we used the New Jersey State Inpatient and Ambulatory databases in order to better understand the influence of outpatient procedures on current volume and trends., Results: There were 563,143 patients identified (PTA: 38%, BPG: 50%, ABF: 6%; 5.1%: multiple procedure codes). Patients who had PTA and BPG were similar in age (70.4 vs 69.5 years) but older than patients who had ABF (61.8 years, P < .01). Patients who underwent PTA were more often women (PTA: 46%, BPG: 42%, ABF: 45.2%; P < .01). Average costs for PTA increased over 60% for claudication between 2001 and 2007 ($8670 to $14,084) and limb threat ($13,903 to $23,196). For BPG, average costs increased 36% for both claudication ($9322 to $12,681) and limb threat ($16,795 to $22,910). In 2007, the average cost per procedure of PTA was higher than BPG for both claudication ($13,903 vs $12,681; P = .02) and limb threat ($23,196 vs $22,910; P = .04). The number of patients per year undergoing PTA increased threefold (15,903 to 46,138) for claudication and limb threat (6752 to 19,468). For BPG, procedures per year decreased approximately 40% for both claudication (13,625 to 9108) and limb threat (25,575 to 13,762). In-hospital mortality was similar for PTA and BPG groups for claudication (0.1% vs 0.2%; P = .04) and limb threat (2.1% vs 2.6%; P < .01). In-hospital amputation rates were significantly higher for patients who had PTA (7%) than BPG (3.9%, odds ratio [OR], 1.67 [1.49-1.85]; P < .01) or patients who underwent ABF (3.0%; OR, 2.32 [1.79, 3.03]; P < .01)., Conclusion: PTA has altered the treatment paradigm for lower limb ischemia with an increase in costs and procedures. It is unclear if this represents an increase in patients or number of treatments per patient. Although mortality is slightly lower with PTA for all indications, amputation rates for limb-threat patients appear higher, as does the average cost. Longitudinal studies are necessary to determine the appropriateness of PTA in both claudication and limb-threat patients. The mortality benefit with PTA may be ultimately lost, and average costs elevated, if multiple interventions are performed on the same patients., (Copyright © 2011 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

The drug-eluting balloon (DEB) is an exciting new technology that holds much promise. As an evolving technology undergoing intensive research, the device is being constantly refined and its numerous potential applications studied. Though initially created to fulfil specific needs in the coronary vasculature, there is great potential for its use in other vascular territories and structures including the management of valvular, congenital heart and neuro-interventional pathologies. In addition, the application of this device in conjunction with other existing technologies may enhance the clinical results.

Within the past decade, we have witnessed the exponential growth of novel percutaneous transcatheter therapies for the treatment of valvular and congenital heart disorders among others. Consequently, a new field has emerged in the world of adult cardiovascular medicine known as "structural heart disease interventions." We herein provide a contemporary review highlighting many of the important historical landmarks that have set the stage for the development of this new and exciting subspecialty, and introduce a comprehensive overview of the structured training and challenges that will be required to master this field. To our knowledge, our Structural Heart Disease fellowship constitutes one of the very first dedicated training programs in the United States. We believe our experience may be of value to other similar emerging programs across the country and the world.

Introduction: Advances in endovascular interventions have expanded the options available for the invasive treatment of lower extremity peripheral arterial disease (PAD). Whether endovascular interventions substitute for conventional bypass surgery or are simply additive has not been investigated, and their effect on amputation rates is unknown., Methods: We sought to analyze trends in lower extremity endovascular interventions (angioplasty and atherectomy), lower extremity bypass surgery, and major amputation (above and below-knee) in Medicare beneficiaries between 1996 and 2006. We used 100% samples of Medicare Part B claims to calculate annual procedure rates of lower extremity bypass surgery, endovascular interventions (angioplasty and atherectomy), and major amputation between 1996 and 2006. Using physician specialty identifiers, we also examined trends in the specialty performing the primary procedure., Results: Between 1996 and 2006, the rate of major lower extremity amputation declined significantly (263 to 188 per 100,000; risk ratio [RR] 0.71, 95% confidence interval [CI] 0.6-0.8). Endovascular interventions increased more than threefold (from 138 to 455 per 100,000; RR = 3.30; 95% CI: 2.9-3.7) while bypass surgery decreased by 42% (219 to 126 per 100,000; RR = 0.58; 95% CI: 0.5-0.7). The increase in endovascular interventions consisted both of a growth in peripheral angioplasty (from 135 to 337 procedures per 100,000; RR = 2.49; 95% CI: 2.2-2.8) and the advent of percutaneous atherectomy (from 3 to 118 per 100,000; RR = 43.12; 95% CI: 34.8-52.0). While radiologists performed the majority of endovascular interventions in 1996, more than 80% were performed by cardiologists and vascular surgeons by 2006. Overall, the total number of all lower extremity vascular procedures almost doubled over the decade (from 357 to 581 per 100,000; RR = 1.63; 95% CI: 1.5-1.8)., Conclusion: Endovascular interventions are now performed much more commonly than bypass surgery in the treatment of lower extremity PAD. These changes far exceed simple substitution, as more than three additional endovascular interventions were performed for every one procedure declined in lower extremity bypass surgery. During this same time period, major lower extremity amputation rates have fallen by more than 25%. However, further study is needed before any causal link can be established between lower extremity vascular procedures and improved rates of limb salvage in patients with PAD.

The incidence of restenosis after percutaneous peripheral interventions (PPI) varies considerably depending upon the vascular bed but appears to be highest in the femoropopliteal and tibioperoneal arteries. The restenosis process in the periphery does not appear to stop at the 6-month mark, as seen with bare metal stents in the coronary arteries, but continues for a longer time, possibly years, after the intervention. This review evaluates the incidence of restenosis following lower extremity arterial interventions and potential drugs or devices that could alter this process, including nonpharmacological (stents, cryoplasty, Cutting Balloon angioplasty, atherectomy, brachytherapy, and photodynamic therapy) and pharmacological (systemic and direct drug delivery) approaches. A global strategy to achieve optimal outcome with PPI is offered: (1) obtain excellent acute angiographic results with less dissection and recoil, (2) protect the distal tibial vascular bed, and (3) reduce smooth muscle cell proliferation with pharmacological intervention.

Endovascular stent implantation was introduced to femoropopliteal procedures almost 2 decades ago. Initial results with balloon-expandable stainless steel stents and self-expanding Elgiloy stents, however, were disappointing. In particular, recurrence rates after long-segment femoropopliteal stenting were catastrophically high, in the range of 60% to 80% at 1 year. Also, attempts to resolve the problem of in-stent restenosis (ISR) using first-generation covered stent-grafts led to unsatisfactory results, high procedural complication rates due to large introducers, and a high incidence of graft thrombosis, which did not make these devices convincing alternatives to bare metal stents. After years of stagnation, however, recent developments in femoropopliteal stent technology have been promising. Self-expanding nitinol stents have been evaluated in several prospective studies. Initial problems with stent fractures seem to be resolved using second-generation devices; for the first time, stenting has been shown to be beneficial compared to balloon angioplasty in longer femoropopliteal lesions. Nevertheless, although superior to balloon angioplasty, nitinol stenting is still associated with a considerable restenosis rate, and treatment of ISR remains problematic. Future concepts to further improve long-term patency after femoropopliteal stenting therefore are under investigation, including drug-eluting stents, biodegradable stents, and coated stent-grafts. From a current perspective, femoropopliteal stenting remains the Achilles' heel of the interventionist.

Background: The objectives of our study were to examine long-term (1986-2003) trends in the use of percutaneous coronary interventions (PCI) and thrombolytic therapy in the management of patients hospitalized at all Central Massachusetts medical centers with acute myocardial infarction (AMI). Our secondary study goal was to examine factors associated with use of these coronary reperfusion strategies. Limited contemporary data are available about changing trends in the use of coronary reperfusion strategies, particularly from a population-based perspective., Methods: The sample consisted of 9422 greater Worcester (MA) residents hospitalized with AMI at all metropolitan Worcester medical centers in 10 annual periods between 1986 and 2003., Results: Divergent trends in the use of PCI and thrombolytic therapy during hospitalization for AMI were noted. Use of thrombolytic therapy increased after its introduction to clinical practice in the mid-1980s through the early 1990s with a progressive decline in use thereafter. In 2003, 3.5% of patients hospitalized with AMI were treated with clot lysing therapy. Marked increases in the use of PCI during hospitalization for AMI were noted over time. In 2003, 42.1% of patients with AMI received a PCI. Several demographic and clinical factors were associated with the use of these different treatment strategies., Conclusions: The results of our study in a large New England (United States) community suggest evolving changes in the hospital management of patients with AMI. Current management practices emphasize the utilization of PCI to restore coronary reperfusion to the infarct related artery.

Carotid stenting has been in evolution for the past 15 years. Initially limited by a lack of dedicated equipment, pivotal trials using both dedicated stent technology and embolic protection filters in patients at high risk for surgical endarterectomy have been largely completed, and results have compared favorably to both direct and historical surgical controls. While this has led to Food and Drug Administration approval of at least six carotid stent systems in the US, European randomized trials in standard surgical risk patients have had mixed results and confused the perception of the place of this technology in the care of patients with carotid stenosis. Current US trials are in progress, one nearing completion, and they will further contribute an understanding as to the place of stent therapy in the standard surgical risk patient, regardless of symptomatic status.

While popularization of carotid bifurcation intervention occurred only 10 years ago, the rapidity with which technology changed in performing the procedure was astounding. Restrictions upon the performance of the procedure has likely held off continued rapid advancement, nevertheless, there are devices currently in trial and more that have at least been conceived of which will decrease the risks associated with carotid bifurcation intervention. In the following article, device advances that the practicing carotid interventionalist can expect to see within the next few years are reviewed and a look to the future is presented as well.

Objective: The use of infrainguinal percutaneous transluminal angioplasty (PTA) has increased, but patterns of use have not been well studied. Academic institutions (AIs) and nonacademic institutions (NAIs) may have developed different practice patterns and may have different associated outcomes., Methods: A retrospective statewide population-based administrative database was evaluated for patients undergoing PTA (1997-2004)., Results: A total of 1718 patients underwent PTA for claudication (51.9%), rest pain (12.1%), and ulceration or gangrene (23.1%). The use of infrainguinal stents (62.4% vs 60.8%), elective procedures (76.3% vs 79.8%), in-hospital death (1.6% vs 2.2%), 30-day mortality (2.1% vs 3.3%), readmission rates (17.1% vs 15.9%), and reintervention rates after readmission (38.5% vs 42.9%) were similar between groups. Increased use of PTA was noted in AIs versus NAIs (239.5% vs 53.9%). AIs were significantly less likely to perform PTA for rest pain (7.5% vs 14.4%, P < .05)., Conclusion: AIs had a more recent increase in the use of PTA, but less often used PTA for patients with rest pain compared with NAIs. Both center types had higher than expected 30-day readmission and reintervention rates. Further understanding of the implementation and associated outcomes of PTA is required.

Lower extremity peripheral arterial occlusive disease poses a unique challenge to traditional angioplasty-based endovascular therapies. The diffuse nature of lower extremity atherosclerotic disease, the presence of chronic total occlusions, poor distal runoff, and the presence of critical limb ischemia all have contributed to the disappointing results of balloon angioplasty for complex infrainguinal arterial disease. These challenges have spawned the development of a host of new technologies in an attempt to improve the safety and effectiveness of percutaneous revascularization for lower extremity peripheral arterial occlusive disease. This review summarizes the recent advances in available technologies, including novel angioplasty balloons; nitinol stents, stent grafts, and drug-eluting stents; excisional, laser, and rotational atherectomy devices; devices for crossing total occlusions; true-lumen reentry devices; thrombectomy catheters; and embolic protection devices.

Background and Purpose: Acute basilar artery occlusion is an infrequent but potentially fatal cause of stroke, both in adults and children. We present our experience with a 6-year-old child and we investigate the rationality for late treatment of acute basilar occlusion in children., Methods: We report the case of a 6-year-old boy with acute basilar artery occlusion presented with a full blown locked-in syndrome, admitted to the endovascular suite 44 h after the stroke onset, and we review all the reported cases of basilar artery occlusions presented with locked-in syndrome in children., Results: Six hours following admission the basilar artery was partially recanalized by intra-arterial thrombolysis combined with mechanical clot angioplasty. After 12 h, the patient was awake, oriented, his speech function was fully restored and he had only a mild right hemiparesis that recovered completely after a month., Conclusions: To our knowledge, this is the first report of complete clinical recovery after delayed (50 h) endovascular recanalization of basilar artery in a child. Intra-arterial thrombolysis combined with cerebral angioplasty, can successfully restore the patency of the basilar artery and the neurologic deficit of children with acute basilar artery occlusion, even after a considerable delay.