Results of Palliative Stenting in Malignant Superior Vena Cava Syndrome Analyzing Self-Expanding Stainless Steel and Nitinol Venous Bare Metal Stents.

PURPOSE: The purpose was to analyze the technical, clinical, and survival outcomes of our patients with malignant superior cava vein syndrome (SVCS) treated with endovascular approach and analyze the efficacy of different stent types used. MATERIAL AND METHODS: It is an observational, retrospective, single-center study. From 2006 to 2023, 42 patients (32 male, 10 female, mean age 62 years, age range, 41-87 years) underwent percutaneous stent placement for malignant SVCS. One stainless steel stent (Wallstent) and 2 venous nitinol stent type (Sinus-XL, Venovo) were used. Follow-up mean was 276 days. RESULTS: A total of 53 stents were deployed. Clinical success was 97.6% in less 24 hours. Technical success was achieved in 97.6%. No complications were found except 1 patient died during the procedure due to stent migration and atrial dissociation (2.3%). Overall intraprocedural stent migration rate was 11.9% (18.8% stainless steel stent, 9.6% nitinol stent, p>0.05). Overall survival rates were 87.8%, 41.99%, and 34.12%, and overall primary patency rates were 100%, 93.3%, 91.6% at 1, 6, and 12 months, respectively. CONCLUSIONS: Endovascular treatment is a safe and effective therapeutic option for SVCS with high technical and clinical success rates and low complication and recurrence rates. CLINICAL IMPACT: The malignant superior cava vein syndrome is a rare clinical entity treated classically with radiation and chemotherapy with a slower response, or surgical bypass, which is an aggressive surgical technique. Endovascular treatment offers a low-invasive technique with quick clinical resolution and good permeability results. However, further studies are lacking to deal with procedure technical characteristics, stent type used, technical complications, and medium- and long-term patency studies. This study aims to evaluate all these items, analysing self-expanding stainless steel and nitinol venous bare metal stents, and add value to endovascular treatment, confirming the good results of this technique.

Efficacy and Safety of Covered Stents Versus Bare-Metal Stents for Aortoiliac Occlusive Disease: A Systematic Review and Meta-Analysis.

PURPOSE: This study aimed to assess the efficacy and safety outcome of covered stents (CSs), as compared with bare-metal stents (BMSs), for the treatment of patients with aortoiliac occlusive disease (AIOD). MATERIALS AND METHODS: A systematic literature search was conducted in PubMed, Embase, and Cochrane Library up to August 2023 to identify all studies comparing efficacy and safety outcomes of CSs versus BMSs for treating AIOD. Our outcome was primary patency, secondary patency, technical success, ankle-brachial index (ABI) variation, target lesion revascularization (TLR), limb salvage, complications, and long-term survival. Dichotomous outcomes were pooled as relative risks (RR) or hazard ratio with the 95% confidence interval (CI). Continuous outcomes were pooled as weighted mean differences and 95% CI. Model selection was based on the heterogeneity of the included studies. RESULTS: There were 10 studies (2 randomized controlled trials, 8 retrospective cohort studies), comprising 1676 sample size. Compared with BMSs, CSs use was associated with better primary patency of patients with a Trans-Atlantic Inter-Society Consensus II (TASC) D lesion (RR, 1.15, 95% CI, 1.04 to 1.27, p=0.007), TLR (RR, 0.39, 95% CI, 0.27 to 0.56, p<0.001), technical success (RR, 1.01, 95% CI, 1.00 to 1.02, p=0.010), and long-term survival (RR, 1.06, 95% CI, 1.01 to 1.11, p=0.020). There is no difference between CSs and BMSs regarding primary patency of all patients, secondary patency, variation in ABI, limb salvage, and complications. CONCLUSIONS: Compared with BMSs, CSs used in AIOD was associated with more favorable primary patency in patients with TASC D lesions, TLR, technical success rates, and patient long-term survival. These results provide evidence of the advantages of using CSs for AIOD treatment. Future studies focusing on long-term variations in ABI, primary patency of different degrees of calcification, vascular segments, and TASC classification are warranted. CLINICAL IMPACT: Although several studies evaluated the clinical efficacy of CS in the context of AIOD treatment, the significance and consistency of these findings were not determined to date. We found that CS was used in AIOD associated with better technical success rate, long-term patient survival, lower target lesion revascularization, and higher primary patency of patients with a Trans-Atlantic Inter-Society Consensus II D lesion when compared with BMSs. Our study provides evidence supporting the superiority of CSs over BMSs in the treatment of AIOD, and furnishing clinicians with guidance for treatment decisions.

The BioMimics 3D Helical Centreline Nitinol Stent in Chronic Limb Threatening Ischaemia and Complex Lesions: Three Year Outcomes of the MIMICS-3D Registry.

OBJECTIVE: There is a need for improved outcomes in the endovascular treatment of patients suffering from chronic limb threatening ischaemia (CLTI), highly calcified lesions, and chronic total occlusions (CTOs). The helical centreline self expanding BioMimics 3D stent might be particularly useful in these high risk subsets, combining flexibility and fracture resistance with radial strength. Herein, the performance of the BioMimics 3D stent was assessed in these high risk subsets. METHODS: MIMICS-3D is a prospective, multicentre, European real world registry. This was a post hoc analysis, comparing patients with CLTI vs. intermittent claudication (IC), lesions with bilateral calcification vs. those without (peripheral arterial calcium scoring system [PACSS] 3,4 vs. PACSS 0 - 2), and CTO vs. no CTO. Propensity score matching was performed to reduce the impact of baseline variables. The 36 month endpoints were clinically driven target lesion revascularisation (CD-TLR), death, major target limb amputation, and stent patency. RESULTS: A total of 507 patients were enrolled. At 36 months, patients with CLTI had lower freedom from major amputation than patients with IC (92.6% vs. 100%, p < .001). In terms of primary patency, patients with CTO had lower patency rates than those without (63.9% vs. 77.8%, p = .003), but the difference reduced after propensity score matching (70.5% vs. 76.8%, p = .43). Primary patency was not impaired for patients with PACSS 3,4 or patients with CLTI. Freedom from CD-TLR was not significantly different among the groups and was 73.8% for CLTI vs. 78.9% for IC (p = .15), 77.6% for PACSS 3,4 vs. 78.7% for PACSS 0 - 2 (p = .55), and 75.6% for CTO vs. 81.0% for no CTO (p = .11). CONCLUSIONS: The outcome of the MIMICS-3D registry suggests that the BioMimics 3D stent is effective in the endovascular treatment of complex femoropopliteal lesions and in CLTI. Future randomised controlled trials should confirm its non-inferiority or superiority compared with existing alternatives.

Different drugs in drug-eluting stents for peripheral artery disease: a systematic evaluation and Bayesian meta-analysis.

Drug-eluting stents (DESs) have become the first-line treatment for symptomatic peripheral arterial disease (PAD). Currently, there are many types of DESs on the market. The same type of DESs has different concentrations, and various drugs in them show uneven efficacy. The selection of DESs remains controversial. This study was aimed at comparing the long-term real-world outcomes of different DESs in the treatment of peripheral arterial occlusive disease (PAOD). The databases including Cochrane Library, Embase, and PubMed were searched with a time frame until March 25, 2023. The primary patency (PP) and target lesion revascularization (TLR) at 6 months were used as the primary endpoints. A total of 32 studies (5467 patients) were eligible. At the six-month follow-up, DES-Evero 1 ug/mm2 ranked first in terms of PP, with a significant difference from BMSs (RR [95% CI] = 1.6). DES-Siro 0.9 ug/mm2, DES-Siro 1.4 ug/mm2, DES-Siro 1.95 ug/mm2, DES-PTX 0.167 ug/mm2, DES-PTX 1 ug/mm2 and covered stents (CSs) showed significantly better PPs than BMSs. In terms of TLR, DES-Siro 0.9 ug/mm2 (0.31) ranked first, and DES-Evero 1 ug/mm2 ranked last. Among the treatment modalities for PAD, different DESs showed overall encouraging results in improving PP and TLR compared with BMSs. DES-Evero 1 ug/mm2 showed the best PP, but it had the highest reintervention rate at 6 months. Sirolimus-eluting stents were not always more effective with higher concentrations of sirolimus. Among various DESs, sirolimus-eluting stents and everolimus-eluting stents were superior to paclitaxel-eluting stents.

Cost-utility analysis of early versus delayed endovascular intervention in critical limb-threatening ischemia patients with rest pain.

OBJECTIVE: The prevalence of chronic limb-threatening ischemia (CLTI) and poor health outcomes are high in Germany. Serious consequences of CLTI such as amputation and mortality can be effectively prevented by the early use of evidence-based therapeutic measures such as endovascular intervention. We have developed a cost-utility analysis to compare endovascular intervention with bare metal stents (BMSs) and endovascular intervention after conservative treatment from the German payer perspective. METHODS: A Markov model, with a 5-year time horizon and seven states, was developed: (1) intervention, (2) stable 1, (3) major amputation, (4) reintervention, (5) stable 2, (6) care, and (7) all-cause death. Transition probabilities were obtained by pooling the outcomes from multiple clinical studies. The costs were estimated using data from the German diagnosis-related group system, the German rehabilitation fund, and related literature. Health-state utilities were obtained from the reported data. The primary outcomes were the quality-adjusted life-years (QALYs) and costs. RESULTS: Early BMS intervention after 5 years resulted in a cost of €23,913 and an increase of 2.5 QALYs per patient, and endovascular intervention with BMS after conservative treatment after 5 years resulted in a cost of €18,323 and an increase of 2 QALYs per patient. The incremental cost-effectiveness ratio was €12,438. The number of major amputations was reduced by 6%. The results of the structural, deterministic, and probabilistic sensitivity analyses were robust. CONCLUSIONS: Early endovascular intervention with BMS resulted in more QALYs and a reduced risk of major amputation for early-stage CLTI patients. Our results showed that early endovascular intervention is very cost-effective according to World Health Organization recommended cost-effectiveness thresholds. However, the clinical decision regarding the use of early endovascular intervention should be determined by individual patient-level eligibility and the physician's judgment.

Unexpected Bare Metal Stent Migration Associated With Aortic Remodeling After PETTICOAT Technique for Aortic Dissection.

PURPOSE: To report a unique case of bare metal stent migration in the overlapping zone and subsequent distal stent graft-induced new entry (SINE) after the Provisional Extension to Induce a Complete Attachment (PETTICOAT) technique for aortic dissection. CASE REPORT: A 67-year-old man underwent thoracic endovascular aortic repair (TEVAR) using the PETTICOAT technique for acute complicated type B aortic dissection. The postoperative course was uneventful, and follow-up computed tomography (CT) showed not only favorable aortic remodeling but also progressive bare metal stent migration in the overlapping zone between the stent graft and the bare metal stent. A 6-month postoperative CT revealed a distal SINE, and the patient underwent re-TEVAR to cover the new entry. Postoperative CT demonstrated successful repair of the distal SINE. The patient is currently in good health 2 years after the reintervention. CONCLUSION: Surgeons should consider the potential risk of device migration due to favorable aortic remodeling after TEVAR for aortic dissection, especially with the use of additional bare metal stents.

Covered Stents vs Bare Metal Stents for Aortoiliac Arterial Diseases: A Systematic Review and Meta-Analysis.

PURPOSE: Covered stents and bare metal stents (BMS) have been regarded as viable treatment options for aortoiliac arterial diseases. We performed this systematic review and meta-analysis to compare the efficacy of covered stents with BMS for aortoiliac arterial diseases. MATERIALS AND METHODS: The Cochrane Library, Embase, and Medline databases were searched by 2 authors (C.Z. and Z.W.) to retrieve all studies comparing the outcomes of covered stents vs BMS for aortoiliac arterial diseases. The Cochrane tool and the Newcastle-Ottawa scale were used to assess the risk of bias in randomized controlled trials and observational studies, respectively. The outcomes at the same stage reported in at least 2 studies were pooled together. The fixed effects model combined the data when I2<50%, otherwise the random effects model was applied. The results for dichotomous variables were presented as odds ratio (OR) or risk difference and 95% confidence interval (CI); continuous variables were reported as mean difference and 95% CI. RESULTS: Herein, 10 studies with a total of 1695 limbs were included. The covered stents significantly increased the freedom from target lesion revascularization (OR 2.85, 95% CI: 1.28-6.33, p=0.010) compared to the BMS during a 24-month follow-up. However, no statistically significant difference was found in the technical success, primary patency, secondary patency, major adverse events (MAEs), ankle-brachial index (ABI) improvement, limb salvage, and survival between the two groups. CONCLUSION: Compared to BMS, covered stents appear to have similar technical success, primary patency, secondary patency, MAEs, ABI improvement, limb salvage, and survival but may have advantages in reducing target lesion revascularization. More well-designed, prospective studies are warranted to determine such findings. CLINICAL IMPACT: Covered stents may increase freedom from target lesion revascularization (TLR) compared to bare metal stents (BMS) in the treatment of aortoiliac arterial diseases. However, technical success, primary patency, secondary patency, major adverse events (MAEs), ABI improvement, limb salvage, and survival were similar. The aforementioned results are still not sufficient to draw a solid conclusion about the selection of stents for aortoiliac arterial diseases. More well-designed, prospective studies are warranted to determine such findings.

Bare Stent Fracture After TEVAR With the Modified Restrictive Bare Stent (RBS) Technique in Type B Aortic Dissections.

PURPOSE: The aim was to assess the mid-term aortic remodeling and bare-metal stent (BMS) integrity of the restricted bare stent (RBS) technique reconstruction in aortic dissections. MATERIALS AND METHODS: This retrospective cohort study included prospectively collected patients treated with the modified RBS technique between 2017 and 2020. The preoperative, postoperative, and last follow-up computed tomographic (CT) scans were analyzed in the centerline at the mid-descending, celiac trunk (CeT), and the mid-abdominal levels for false lumen (FL) patency, aortic diameter, and true lumen (TL) diameter changes. Bare-metal stent integrity was assessed in the 3-dimensional multiplanar reformats. RESULTS: The median follow-up of the cohort (n=17) was 26 (11, 45) months. The procedure was mainly performed with the Relay NBS endograft (15/17; 88%) + E-XL BMS (17/17; 100%). Postoperative mortality, paraplegia, stroke, renovisceral vessel loss, and type I and III endoleaks were not observed. BMS fractured in 6 patients (6/17; 36%), damaged the dissection flap in 4/17 (24%), and led to the reperfusion of the FL and re-interventions with TEVAR (4/17; 24%). Two patients without FL reperfusion showed stable CT follow-ups 13 and 17 months after the fracture diagnosis. The TL expansion was seen at all landmarks and peaked in the thoracic aorta (+10; 6, 15; p<0.001). The FL thrombosis after modified RBS was only relevant in the thoracic aorta (p<0.001) and at CeT (p=0.003). The aortic diameter was stable in the thoracic aorta and increased at distal landmarks (CeT [+5; 1, 10; p=0.001]; mid-abdominal [+3; 1, 5; p=0.004]). CONCLUSION: The modified RBS technique could not stop aortic growth below the diaphragm and prevent new membrane rupture due to the fractures of the BMS and consecutive flap damage with the reperfusion of the FL. CLINICAL IMPACT: The treatment of complicated type B aortic dissections with TEVAR has become a standard. Particularly, patients with true lumen collapse and malperfusion may benefit from a more aggressive treatment strategy including proximal TEVAR and distal bare-metal stent implantation to re-open the true lumen and to prevent distal stent-induced new entry. However, this study reports the challenges of this approach with a high rate of bare-metal stent fractures during the follow-up. The fractures that occurred at the site of vertical nitinol bridges led to the dissection membrane ruptures and the reperfusion of the false lumen with consecutive dilatation. A close follow-up is mandatory to detect this complication and to treat the patients with TEVAR extension.

Network Analysis of Endovascular Treatment Strategies for Femoropopliteal Arterial Occlusive Disease.

PURPOSE: Endovascular treatment of femoropopliteal arterial diseases remains controversial. We conducted a Bayesian network meta-analysis of randomized controlled trials aiming to investigate the efficacy differences between paclitaxel- or sirolimus-eluting stents, covered stents, drug-coated balloons, bare metal stents, and percutaneous transluminal angioplasty. METHOD: MEDLINE, Embase, Ovid, and other relevant online material were searched up to October 21, 2020. Primary endpoints were primary patency and target lesion revascularization at 6, 12, and more than 24 months. RESULTS: Thirty-eight eligible trials included 6026 patients. In terms of primary patency, drug eluting stents were ranked as the most effective treatment based on the surface under the cumulative ranking curve values at 6 (80.6), 12 (78.4), and more than 24 months (96.5) of follow-ups. In terms of target lesion revascularization, drug eluting stents were ranked as the most effective treatment based on the surface under the cumulative ranking curve values at 6 (90.3), 12 (71.3), and more than 24 months (82.1) of follow-ups. Covered stents and bare metal stents had higher ranks in target lesion revascularization than those in primary patency. Sirolimus stents had a higher rank than paclitaxel stents. CONCLUSION: Drug eluting stents showed encouraging results in primary patency rates and freedom from target lesion revascularization at all phases of follow-up for femoropopliteal arterial diseases. Sirolimus stents appear to be more effective in femoropopliteal segment than paclitaxel stent.

Perioperative Antiplatelet Bridging With Cangrelor: A Cohort Study and Narrative Review.

BACKGROUND: In patients who received a cardiac stent, practice guidelines recommend dual antiplatelet therapy (DAPT). However, an urgent procedure may be required necessitating interruption of DAPT. Intravenous cangrelor was previously shown to be an alternative due its short-half life and quick onset/offset. OBJECTIVE: To determine the safety and effectiveness of cangrelor bridging for patients undergoing invasive procedures in a veteran population. METHODS: Retrospective cohort of patients from Michael E. DeBakey VA Medical Center and the VA North Texas Health Care Systems who underwent perioperative cangrelor bridging. The primary outcome was the incidence of bleeding using the Bleeding Academic Research Consortium (BARC) criteria. The secondary outcome was a composite of nonfatal stroke, myocardial infarction (MI), mortality, and unplanned revascularization within 30 days. A narrative review was also performed to summarize cangrelor bridging for noncardiac invasive procedure. RESULTS: There were 41 patients that met the eligibility criteria. Patients were predominantly Caucasian (57.5%) men with a median age of 70 years. The median duration on cangrelor bridging was 2.6 days with 11 and 30 patients undergoing cardiac and noncardiac invasive procedures, respectively. Nine patients (22%) had a bleeding event of which 8 were minor. One was severe due to significant iliopsoas hematoma following drain placement. All bleeding events occurred postoperatively except for 2 perioperative events that occurred during orthopedic procedures. Ischemic events up to 30 days occurred in 3 patients (7.3%) which consisted of 1 (2.4%) nonfatal MI requiring revascularization and 2 (4.9%) deaths, 1 of which was sudden cardiac. CONCLUSION AND RELEVANCE: This study suggests that cangrelor bridging may be a reasonable alternative to holding oral P2Y12 inhibitors in patients requiring interruption of antiplatelet therapy for an urgent surgery/invasive procedure.

A sex-based analysis of 5-year outcomes following stenting for the treatment of aorto-iliac occlusive disease.

OBJECTIVES: The aim of this study was to evaluate the impact of sex on mid-term outcomes following stenting for aorto-iliac occlusive disease (AIOD). METHODS: The Covered versus Balloon Expandable Stent Trial (COBEST) compared the safety and efficacy of the covered stent (CS) with those of the bare metal stent (BMS) in the treatment of hemodynamically significant AIOD. It was identified that CS provided a significant benefit. The primary endpoint of our analysis was the rate of primary patency 5 years following stenting for AIOD (inclusive of both CS and BMS) in both sexes. RESULTS: Of the 168 lesions treated, 103 (61%) were present in men and 65 (39%) were present in women. Of the concomitant comorbidities, diabetes mellitus was significantly more common in women (17.5% vs 41.5%, p = .006). Although chronic limb threatening ischemia (CLTI) at the time of intervention was more common in women, the difference was not significant (16.5% vs 24.6%, p = .395). Sex was not associated with the primary patency rate (male; 0.70, 95% confidence interval [CI]: 0.23-2.19, p = .543). When considering both male sex and the utilization of BMS, no significant impact was found on the primary patency rate (hazard ratio [HR]: 3.43, 95% CI: 0.69-17.10, p = .133). All-cause mortality at 60 months was 22.6% in men compared to 19.4% in women (p = .695). CONCLUSIONS: No significant difference was identified in the primary patency rate between the sexes. Further investigation is warranted to ascertain whether sex-specific interventional guidelines are required in this regard.

Replacement of pulmonary venous stent during Fontan operation.

Post-operative pulmonary venous stenosis is a poor prognostic factor in single-ventricle haemodynamics. Implantation of a drug-eluting stent is a therapeutic option. However, due to their small size, they inevitably become inadequate as the patient grows. We present the first case, to the best of our knowledge, of the replacement of a small-diameter stent with a large-diameter stent during Fontan surgery.

The Rate of Postoperative Complications in Complicated Acute, and Subacute Type B Aortic Dissections after TEVAR vs. PETTICOAT Procedures: Systematic Review and Meta-Analysis.

Background and Objectives: Provisional extension to induce complete attachment (PETTICOAT) is suggested as being associated with a lower incidence of aorta-related events and fewer reinterventions compared to thoracic endovascular aortic repair (TEVAR) in patients with complicated acute, and subacute type B aortic dissections. Materials and Methods: This article is a systematic review and meta-analysis following the PRISMA guidelines. The Medline, PubMed, Embase, and Cochrane databases were searched, starting on 21 February 2022 and ending on 22 June 2022, to identify studies that investigated the rate of postoperative complications in patients treated with the PETTICOAT compared to the TEVAR. A random effects meta-analysis was performed. Of 2350 studies, 5 studies involving 360 patients were included: 143 patients after the PETTICOAT procedure and 217 after the TEVAR. Results: The meta-analysis of all studies showed that the rate of secondary endovascular reinterventions was smaller in patients treated with the PETTICOAT (n = 3 studies; OR, 0.30; 95% CI, 0.10 to 0.94; p = 0.04). The results of other postoperative complications (30-day mortality, mortality during follow-up, paraplegia, stroke, and occurrence of endoleak) were lower in the PETTICOAT group but were not statistically significant. The rate of postoperative renal failure was lower in patients treated with the TEVAR (n = 4; OR, 1.08; 95% CI, 0.46 to 2.51; p = 0.86). Conclusion: This meta-analysis suggests that the PETTICOAT procedure is related to the lower rate of secondary endovascular reinterventions for complicated acute, and subacute type B aortic dissections.

Mid-term Efficacy and Safety of Drug-coated Balloon versus Nitinol Bare Metal Stent for Primary Lesions in Femoropopliteal Artery Disease.

OBJECTIVES: To compare drug-coated balloon (DCB) and bare metal stent (BMS) for primary lesions in femoropopliteal artery disease in Chinese population and to make subgroup analysis between the groups. METHODS: Patients with primary lesions who underwent BMS or DCB treatment of a single tertiary vascular center were included and followed up for 24 months. Clinical and anatomic status were reported using the criteria recommended by the Society for Vascular Surgery. The primary endpoint included primary patency, clinically target limb revascularization, composite safety endpoint and all-cause death over 24 months assessed by Kaplan-Meier. Secondary endpoints included technical success rate and stent-related complications. RESULTS: A total of 284 patients with 324 limbs were pooled into analysis and most of the baseline characteristics did not show significant difference. A total of 74 in BMS group and 71 in DCB group were claudicants while 83 in BMS group and 56 in DCB group suffered from chronic limb threatening ischemia (CLTI). The mean cumulative lesion length was 18.7 ± 9.8cm in BMS group while 17.2 ± 10.3cm in DCB group. Kaplan-Meier estimates of primary patency were 75.3% and 80.9% for BMS and DCB groups at 12 months while decreased to 63.9% and 70.2% at 24 months (log-rank P = 0.167), respectively. Freedom from clinically driven target limb revascularization was 86.8% and 92.7% for BMS and DCB groups at 12 months while dropped to 82.5% and 85.9% at 24 months (log-rank P = 0.342). Estimates of primary patency between BMS and DCB group did not show significant difference on lesions with poor runoff (58.8% vs. 67.3%, log-rank P = 0.127), severe calcification (64.5% vs. 69.4%, log-rank P = 0.525) and popliteal artery involvement (59.3% vs. 60.3%, log-rank P = 0.695) at 24 months. The overall survival (92.6% for BMS, 90.3% for DCB, log-rank P = 0.391) and freedom from composite safety endpoint (79.3% for BMS, 79.2% for DCB, log-rank P = 0.941) showed no significant difference at 24 months. CONCLUSIONS: Over the 24 month follow-up, BMS and DCB showed equivalent efficacy and safety outcomes for primary femoropopliteal artery disease, which indicated the reduction of permanent metallic implant insertion might be possible.

Venous stent versus conventional stent for the treatment of central vein obstruction in hemodialysis patients: a retrospective study.

BACKGROUND: Endovascular treatment is a first-line treatment for upper thoracic central vein obstruction (CVO). Few studies using bare venous stents (BVS) in CVO have been conducted. PURPOSE: To evaluate the treatment performance of upper thoracic central vein stenosis between BVS and conventional bare stent (CBS) in hemodialysis patients. METHODS: Hemodialysis patients with upper thoracic central vein obstruction who underwent endovascular treatment at the interventional unit of our institution from 1 January 2008 to 31 December 2018 were enrolled in the present study. CBS was used to treat central vein obstruction in 43 patients and BVS in 34 patients. We compared the primary patency rates and complications between the two stent types. P values < 0.05 were considered statistically significant. RESULTS: The patient demographic data between the CBS and BVS groups were similar. The characteristics of the lesions, procedures, and complications were not significantly different between the two groups (P > 0.05). There were no statistically significant differences of primary patency rates at three and six months between the BVS and CBS groups (94.1% vs. 86.0% and 73.5% vs. 58.1%, respectively; P > 0.05). The primary patency rate at 12 months in the BVS group was significantly higher than that in the CBS group (61.8% vs. 32.6%; P = 0.008). CONCLUSION: Endovascular treatment of central vein obstruction with BVS provided a higher primary patency rate at 12 months than CBS.

Late onset infection of covered and bare metal arterial stents.

OBJECTIVE: The objective was to present the case of a late covered iliac stent late infection and report a comprehensive literature review on diagnosis and outcomes in this setting. METHODS: A comprehensive review of the literature was performed through MedLine by two independent reviewers from 1990 to 2020 on reported cases of arterial stent late onset infection over arterial stents. The data about on the risk factors, clinical presentation, treatment and outcomes were collected. RESULTS: Twenty-two studies were selected as pertinent for the analysis, totalling 24 patients including the indexed case. Infection occurred at a median of 22 months postoperatively (range 2-120 months) over a bare metal stent in 66.7% (n 16) of cases versus 33.3% (n 8) over a covered stent. Clinical presentation included local symptoms (local pain, oedema, petechiae or skin rash) in 21 (87.5%) cases and non-specific systemic symptoms (fever, sepsis, chills and leucocytosis) in 8 cases (33.3%). In 4 cases (16.7%), patients presented with haemorrhagic shock upon arterial rupture. The bacteria most frequently encountered were S. aureus (54.2% of cases). Several factors were supposed to be responsible for the infection including among which procedure-related (non-aseptic technique, lack of prophylactic antibiotics and repetitive punctures at the access site) or related to pre-existing patient's clinical conditions (immunosuppression, diabetes and concurrent infection) have been considered responsible for the infection. Treatment consisted in antibiotics alone (2 patients, 8.3%) or in association with surgical explant, both with or and without revascularization (n 21, 87.5%). In one case, an endovascular coiling was performed. Complications occurred in 29.2% (n 7) of cases and included the need for amputation, bowel resection, endocarditis, pulmonary failure or pneumonia. Overall, three patients (12.5%) died from a septic shock or multi-organ failure. CONCLUSIONS: Intravascular stent infection is a rare but fearsome condition associated with high morbidity and mortality.

Algorithm of Femoropopliteal Endovascular Treatment.

Background and Objectives: Indications for the endovascular treatment of femoropopliteal lesions have steadily increased over the past decade. Accordingly, the number of devices has also increased, but the choice of the best endovascular treatment remains to be defined. Many devices are now available for physicians. However, in order to obtain a high success rate, it is necessary to respect an algorithm whose choice of device is only one step in the treatment. Materials and Methods: The first step is, therefore, to define the approach according to the lesion to be treated. Anterograde approaches (femoral, radial, or humeral) are distinguished from retrograde approaches depending on the patient's anatomy and surgical history. Secondarily, the lesion will be crossed intraluminally or subintimally using a catheter or an angioplasty balloon. The third step corresponds to the preparation of the artery, which is essential before the implantation of the device. It has a crucial role in reducing the rate of restenosis. Several tools are available and are chosen according to the lesion requiring treatment (stenosis, occlusion). Among them, we find the angioplasty balloon, the atherectomy probes, or intravascular lithotripsy. Finally, the last step corresponds to the choice of the device to be implanted. This is also based on the nature of the lesion, which is considered short, up to 15 cm and complex beyond that. The choice of device will be between bare stents, covered stents, drug-coated balloons, and drug-eluting stents. Currently, drug-eluting stents appear to be the treatment of choice for short lesions, and active devices seem to be the preferred treatment for more complex lesions, although there is a lack of data. Results: In case of failure to cross the lesion, the retrograde approach is a safe and effective alternative. Balloon angioplasty currently remains the reference method for the preparation of the artery, the aim of which is to ensure the intraoperative technical success of the treatment (residual stenosis < 30%), to limit the risk of dissection and, finally, to limit the occurrence of restenosis. Concerning the treatment, the drug-eluting devices seem to present the best results, whether for simple or complex lesions. Conclusions: Endovascular treatment for femoropopliteal lesions needs to be considered upstream of the intervention in order to anticipate the treatment and the choice of devices for each stage.

Network meta-analysis of drug-coated balloon angioplasty versus primary nitinol stenting for femoropopliteal atherosclerotic disease.

OBJECTIVE: Primary nitinol stenting (PNS) and drug-coated balloon (DCB) angioplasty are two of the most common endovascular interventions for femoropopliteal atherosclerotic disease. Although many prospective randomized controlled trials have compared PNS or DCB with plain balloon angioplasty (POBA), no studies have directly compared PNS against DCB therapy. The purpose of this network meta-analysis is to determine whether there is a significant difference in outcomes between PNS and DCB. METHODS: The primary outcome measure was binary restenosis, the secondary outcome measures were target lesion revascularization (TLR) and change in the ankle-brachial index (ABI). Outcomes were evaluated at 6, 12, and 24 months. A literature review identified all randomized controlled trials published before March 2020 that compared DCB with POBA or PNS with POBA in the treatment of native atherosclerotic lesions of the femoropopliteal artery. Studies were excluded if they contained in-stent stenosis or tibial artery disease that could not be delineated out in a subgroup analysis. Network meta-analysis was performed using the network and mvmeta commands in STATA 14. RESULTS: Twenty-seven publications covering 19 trials were identified; 8 trials compared PNS with POBA and 11 trials compared DCB with POBA. The odds of freedom from binary restenosis for patients treated with DCB compared with PNS at 6 months was 1.19 (95% confidence interval [CI], 0.63-2.22), at 12 months was 1.67 (95% CI, 1.04-2.68), and at 24 months was 1.36 (95% CI, 0.78-2.37). The odds of freedom from TLR for patients treated with DCB compared with PNS at 6 months was 0.66 (95% CI, 0.12-3.80), at 12 months was 1.89 (95% CI, 1.04-3.45), and at 24 months was 1.68 (95% CI, 0.82-3.44). The mean increase in ABI for patients treated with PNS compared with DCB at 6 months was 0.06 higher (95% CI, -0.03 to 0.15), at 12 months was 0.05 higher (95% CI, 0.00-0.09), and at 24 months was 0.07 higher (95% CI, -0.01 to 0.14). CONCLUSIONS: Both DCB and PNS demonstrated a lower rate of binary restenosis compared with POBA at the 6-, 12-, and 24-month timepoints. When comparing DCB with PNS through network meta-analysis, DCB had a statistically lower rate of a binary restenosis and TLR at the 12-month timepoint. This network meta-analysis demonstrates that both DCB and PNS are superior to POBA, and that PNS is a satisfactory substitute for DCB when paclitaxel is not desirable.

Increased mortality with paclitaxel-eluting stents is driven by lesion length.

BACKGROUND: Endovascular stenting has become the first-line treatment of symptomatic peripheral artery disease of the femoropopliteal axis (FPA). Several randomized clinical trials have reported that paclitaxel-eluting stents (PESs) significantly reduce the rates of restenosis. However, a meta-analysis investigating paclitaxel-coated devices in the FPA showed a significant increase in all-cause mortality after the use of PES. The aim of this study was to compare the long-term, real-world outcomes of bare-metal stents (BMSs) and PESs for treating FPA occlusive disease. METHODS: A retrospective review of the medical records of 296 patients who underwent FPA stenting between January 2011 and December 2017 was performed. Patients were grouped into BMS and PES groups. The primary end point was all-cause mortality. Secondary end points included limb salvage, primary patency, primary assisted patency, and secondary patency. A comparison between the two groups within TransAtlantic Inter-Society Consensus (TASC) II subgroups was also performed. RESULTS: Of the study cohort, 101 patients (34%) received PES, whereas 195 patients (66%) underwent BMS placement. Median follow-up time was 23 months (interquartile range, 7-40 months). The 2-year all-cause mortality estimates were 12% for the PES group compared with 11.4% for the BMS group (P = .26). There were no differences in the 2-year limb salvage (90.7% vs 92%; P = .4), primary patency (78.8% vs 81.1%; P = .62), primary assisted patency (100% vs 96.5%; P = .4), and secondary patency (100% vs 98.6%; P = .26) between the PES and the BMS groups, respectively (all P > .05). These findings persisted when patients were stratified by TASC II lesions. Among patients with TASC C and D lesions, the use of PES was associated with significantly higher 2-year all-cause mortality (23.9% vs 5.1%; P = .05). After adjustment for age and other potential confounders, PES use was associated with significant increase in all-cause mortality (adjusted hazard ratio, 2.3; 95% confidence interval, 1.31-27 P = .02) in TASC C and D patients. CONCLUSIONS: Consistent with the meta-analysis of several randomized clinical trials, the use of PES in a real-world setting was associated with a twofold increase in the risk of death. However, these findings were seen only among patients with TASC C and D lesions, who required multiple longer stents and potentially larger paclitaxel dose. There was no advantage in terms of patency in PES vs BMS in this population with extensive disease. Further studies of larger populations are required.

Italian Multicenter Registry of Bare Metal Stent Use in Modern Percutaneous Coronary Intervention Era (AMARCORD): A multicenter observational study.

OBJECTIVES: We aimed to evaluate the use of bare metal stent (BMS) implantation in current percutaneous coronary intervention (PCI) era, focusing on indications for use and clinical outcomes. BACKGROUND: Limited data on BMS usage in current clinical practice are available. METHODS: All patients who underwent PCI with at least one BMS implantation in 18 Italian centers from January 1, 2013 to December 31, 2017, were included in our registry. Rates of BMS use and reasons for BMS implantations were reported for the overall study period and for each year. Primary outcomes were mortality, bleeding (Bleeding Academic Research Consortium-BARC and Thrombolysis in Myocardial Infarction-TIMI non-CABG definitions), and major adverse cardiac events (MACE) defined as the composite of all-cause and cardiac death, any myocardial infarction, target vessel revascularization, or any stent thrombosis. RESULTS: Among 58,879 patients undergoing PCI in the study period, 2,117 (3.6%) patients (mean age 73 years, 69.7% males, 73.3% acute coronary syndrome) were treated with BMS implantation (2,353 treated lesions). The rate of BMS implantation progressively decreased from 10.1% (2013) to 0.3% (2017). Main reasons for BMS implantation were: ST-elevation myocardial infarction (STEMI) (23.1%), advanced age (24.4%), and physician's perception of high-bleeding risk (34.0%). At a mean follow-up of 2.2 ± 1.5 years, all-cause and cardiac mortality were 25.6 and 12.7%, respectively; MACE rate was 35.3%, any bleeding rate was 13.0% (BARC 3-5 bleeding 6.3%, TIMI non-CABG major bleeding 6.1%). CONCLUSION: In a large, contemporary, real-world, multicenter registry, BMS use progressively reduced over the last 5 years. Main reasons for BMS implantation were STEMI, advanced age, and physician's perception of high-bleeding risk. High rates of mortality and MACE were observed in this real-world high-risk population.