Long-Term Effectiveness and Safety of Femoropopliteal Drug-Coated Balloon Angioplasty : 5-Year Results of the Randomized Controlled EffPac Trial.

PURPOSE: This study aimed to assess 5-year effectiveness and safety of femoropopliteal angioplasty with the Luminor® 35 drug-coated balloon (DCB). MATERIALS AND METHODS: The EffPac trial was a prospective, multicenter, randomized controlled trial that enrolled 171 patients of Rutherford category 2 to 4 with medium length femoropopliteal lesions. Patients were allocated 1:1 to either Luminor® 35 DCB angioplasty or plain old balloon angioplasty (POBA). Assessment at 5 years included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), clinical improvement, and target limb amputation. Long-term vital status was ascertained in 97.1% of the participants. RESULTS: Kaplan-Meier curves at 5 years demonstrate a primary patency of 61.4% after DCB angioplasty and 53.5% after POBA (log-rank p = 0.040) with a decreasing difference throughout the observation period. Freedom from TLR was 82.1% and 73.7%, respectively (log-rank p = 0.050). Incidence of primary clinical improvement was similar between groups (61% DCB vs. 64% POBA, p = 0.94). Major target limb amputation was necessary in one POBA-group participant. Freedom from all-cause death at 5 years was 88.5% after DCB and 86.0% after POBA (log-rank p = 0.34). CONCLUSIONS: Primary patency after femoropopliteal DCB angioplasty remained superior to POBA throughout 5 years, however, with decreasing difference. Clinical improvement, freedom from TLR, and all-cause mortality were similar between groups over the long term. (Effectiveness of Paclitaxel-Coated Luminor® Balloon Catheter Versus Uncoated Balloon Catheter in the Superficial Femoral Artery [EffPac]; NCT02540018).

Acute Aortic Syndrome Revisited: JACC State-of-the-Art Review.

The purpose of this paper is to describe all available evidence on the distinctive features of a group of 4 life-threatening acute aortic pathologies gathered under the name of acute aortic syndrome (AAS). The epidemiology, diagnostic strategy, and management of these patients has been updated. The authors propose a new and simple diagnostic algorithm to support clinical decision making in cases of suspected AAS, thereby minimizing diagnostic delays, misdiagnoses, and unnecessary advanced imaging. AAS-related entities are reviewed, and a guideline to avoid imaging misinterpretation is provided. Centralization of patients with AAS in high-volume centers with high-volume surgeons is key to improving clinical outcomes. Thus, the role of multidisciplinary teams, an "aorta code" (streamlined emergent care pathway), and aortic centers in the management of these patients is boosted. A tailored patient treatment approach for each of these acute aortic entities is needed, and as such has been summarized. Finally, a set of prevention measures against AAS is discussed.

Drug-coated Balloon Angioplasty of Femoropopliteal Lesions Maintained Superior Efficacy over Conventional Balloon: 2-year Results of the Randomized EffPac Trial.

Background Paclitaxel drug-coated balloon (DCB) catheter angioplasty is the preferred treatment for revascularization of femoropopliteal lesions in peripheral artery disease, but mortality is a safety concern. Purpose To assess 2-year efficacy and safety of DCB angioplasty compared with conventional balloon angioplasty (also known as plain old balloon angioplasty or POBA). Materials and Methods This prospective, multicenter, randomized controlled trial enrolled consecutive participants with symptomatic superficial femoral and/or popliteal artery disease at 11 German centers between September 2015 and December 2016. Participants underwent DCB angioplasty or conventional balloon angioplasty. Primary outcome of 6-month late lumen loss showed superiority of DCB angioplasty over conventional balloon angioplasty. Evaluation at 2 years included secondary outcomes of primary patency and target lesion revascularization (TLR) estimated with Kaplan-Meier analysis, clinical and hemodynamic improvement, quality of life, target limb amputation, and all-cause mortality. Results A total of 171 participants (mean age, 69 years ± 8; 111 men) were evaluated. At 2 years, primary patency was achieved in 90.2% (95% confidence interval [CI]: 80.4%, 95.2%) of DCB angioplasty and 62.7% (95% CI: 50.0%, 73.0%) of conventional balloon angioplasty participants (P < .001). Freedom from TLR occurred in 97.2% (95% CI: 89.1%, 99.3%) of DCB angioplasty and 78% (95% CI: 66.5%, 86.0%) of conventional balloon angioplasty participants (P = .001). The groups did not differ in sustained improvement from baseline to 2 years in Rutherford-Becker category (row mean scores difference, 1.7; P = .19) and showed no difference in mean improvement in the Walking Impairment Questionnaire score (-0.8%; 95% CI: -11.8%, 10.2%; P = .88), EuroQol Group's five-dimension index of quality of life (-0.06; 95% CI: -0.17, 0.03; P = .20), or ankle-brachial index (0.03; 95% CI: -0.08, 0.14; P = .57). No major amputation was necessary. One DCB angioplasty and two conventional balloon angioplasty participants died (risk ratio, 0.48; 95% CI: 0.04, 5.10). Conclusion At 2 years after paclitaxel drug-coated balloon (DCB) angioplasty, primary patency and freedom from target lesion revascularization remained superior compared with conventional balloon angioplasty. DCB angioplasty resulted in sustained clinical and hemodynamic improvement with no increased risk of mortality. © RSNA, 2020 Online supplemental material in available for this article.

Diagnostic yield of 18F-FDG PET/CT in suspected diagnosis of vascular graft infection: A prospective cohort study.

BACKGROUND: Prosthetic vascular graft infection (PVGI) is a severe complication associated with high morbidity and mortality. Clinical diagnosis is complex, requiring image testing such as CT angiography or leukocyte scintigraphy, which has considerable limitations. The aim of this study was to know the diagnostic yield of PET/CT with 18F-Fluorodeoxyglucose (18F-FDG) in patients with suspected PVGI. METHODS: We performed a prospective cohort study including 49 patients with suspected PVGI, median age of 62 ± 14 years. Three uptake patterns were defined following published recommendations: (i) focal, (ii) patched (PVGI criteria), and (iii) diffuse (no PVGI criterion). RESULTS: Sensitivity, specificity, and positive and negative predictive values for 18F-FDG-PET/CT were 88%, 79%, 67%, and 93%, respectively. 18F-FDG-PET/CT identified 14/16 cases of PVGI showing a focal (n = 10) or patched pattern (n = 4), being true negative in 26/33 cases with either a diffuse pattern (n = 16) or without uptake (n = 10). Five of the seven false-positive cases (71%) showed a patched pattern and all coincided with the application of adhesives for PVG placement. CONCLUSIONS: 18F-FDG-PET/CT is a useful technique for the diagnosis of PVGI. A patched pattern on PET/CT in patients in whom adhesives were applied for prosthetic vascular graft placement does not indicate infection.

Prospective Multicenter Study of the Low-Profile Relay Stent-Graft in Patients with Thoracic Aortic Disease: The Regeneration Study.

BACKGROUND: To evaluate the early safety and clinical performance of the new low-profile RelayPro Thoracic Stent-Graft System in patients with thoracic aortic disease. METHODS: This was an international, prospective, single-arm study in patients diagnosed with thoracic aorta disease (aneurysm, pseudoaneurysm, dissection, penetrating atherosclerotic ulcer, or intramural hematoma) and treated with a RelayPro stent-graft (in bare stent and/or nonbare stent configurations). The primary endpoints were freedom from aneurysm or dissection-related mortality and stent-graft performance. RESULTS: A total of 31 patients were treated with the RelayPro thoracic stent-graft between 2014 and 2015 at 8 sites in Italy and Spain. Mean age was 72.1 (±10.2) years and 77% were male, 74% with hypertension, and 42% with a history of smoking. Twenty-four (77%) had aneurysms (fusiform in 46%, saccular in 42%, pseudoaneurysm in 12%); 5 (16%) had penetrating atherosclerotic ulcer; and 2 (6%) had chronic Type B dissection. Mean vascular access diameter was 9.1 mm (6-13 mm); 7 patients (23%) had vascular access of 7 mm or less. Technical success was 100% (primary, 90%; assisted primary, 10%). Freedom from aneurysm/dissection-related mortality through 30 days was 100%. Freedom from device-related major adverse events through 30 days was 94%. At 1 year, there was 1 (3%) type Ib and 1 (3%) type II endoleak, 1 (3%) nonaneurysm-related late death, and 1 (3%) secondary intervention (to correct type Ib endoleak). CONCLUSIONS: The RelayPro has a 3-4 French profile reduction to allow endovascular repair of thoracic aortic disease in patients with smaller anatomies. This study shows good initial stent-graft performance and a favorable early safety profile.

Worldwide results from the RESTORE II on elective endografting of thoracic aneurysms and dissections.

OBJECTIVE: To assess safety, performance, and efficacy of the RELAY thoracic stent graft (Bolton Medical, Barcelona, Spain) in the treatment of patients who require elective thoracic endovascular aortic repair including aneurysms and dissections. METHODS: The RELAY Endovascular Registry for Thoracic Disease II (RESTORE II) is a multicenter, prospective, international cohort study involving 21 centers in 12 countries worldwide. All consecutively included patients underwent elective thoracic endovascular aortic repair with a RELAY or RELAY NBS stent graft (including off the shelf and custom-made devices) to repair thoracic aortic aneurysms or dissections. Demographic, clinical, and aortic parameters were Web-based registers. Safety and efficacy data were collected for a follow-up period of 24 months. RESTORE was a precedent registry involving European sites that used RELAY first-generation devices. RESULTS: A total of 173 patients were enrolled in the registry from October 2010 to September 2014 (aneurysm [n = 99]/dissection [n = 74]). Overall technical success of the intervention reached 97.1% irrespective of the etiology and geographic origin of patients. Baseline clinical heterogeneity was observed between devices concerning the etiology of the disease and certain comorbidities and/or risk factor distribution (diabetes, hypertension, myocardial infarction, angina pectoris). An average of 1.36 stent graft components were used per patient, with mean intended treatment length of 197.0 ± 87.7/188.7 ± 103.1 mm and mean access site diameter of 10.3 ± 8.2/9.7 ± 1.7 mm in aneurysms/dissections, respectively. The rate of all-cause 30-day mortality was lower than in the RESTORE registry (4.0% vs 7.2%). Perioperative neurologic complications were infrequent: paraplegia/paraparesis (2.9%) and stroke (0.6%) (vs 2.0% and 1.6% in the RESTORE registry). Freedom from all-cause mortality at 2 years was 93.6%. At the final completion angiography, device-associated complications were detected in 4.6% of the patients (vs 5.3% in the RESTORE) and endoleak rate was 6.4% (type I 5.8% and type II 1.7%). CONCLUSIONS: The worldwide results of the RESTORE II registry show the safety and effectiveness of RELAY and RELAY NBS stent grafts for elective endovascular thoracic aortic repair. Compared with the RESTORE registry, the device presents a lower rate of perioperative complications.

Effect of a postoperative exercise program on arteriovenous fistula maturation: A randomized controlled trial.

Exercises after arteriovenous fistula (AVF) creation may help to improve maturation; however, their usefulness has only been examined in indirect, non-comparative studies or small trials. Between June 2013 and November 2014, we included all ambulatory patients with stages 5-5D chronic kidney disease who were candidates for the creation of a native AVF in our center. After surgery, all patients were randomized to an exercise group or a control group with single-blind control. At 1 month postoperatively, clinical maturation (expert nurse inspection) and ultrasonographic maturation (flow >500 mL/min, venous diameter >5 mm and depth <6 mm) were assessed in all patients. A total of 72 patients were randomized, 3 were lost to follow-up, and 69 were finally analyzed. The mean age was 66.8 years (standard deviation 13.8), 70.0% were men, and 65.2% were in pre-dialysis. After surgery (42.0% had distal AVF), the patients were randomized (31 controls, 38 exercise group). At 1 month after surgery, global clinical and ultrasonographic maturation was assessed in 88.4% and 78.3% of AVF, respectively (kappa = 0.539). Non-significant differences in clinical or ultrasonographic maturation were seen between exercise and control group (94.7% vs. 80.6%, P = 0.069; 81.6% vs. 74.2%, P = 0.459). A stepwise logistic regression was performed to control previously analyzed asymmetrically distributed confounding factors (AVF localization), revealing that the exercise group showed greater clinical, but not ultrasonographic, maturation (odds ratio [OR] 5.861, 95% confidence interval: 1.006-34.146 and OR 2.403, 0.66-8.754). A postoperative controlled exercise program after AVF creation seems to increase 1-month clinical AVF maturation in distal accesses. Furthermore, exercise programs should be taken into account, especially in distal accesses.

Evaluation of abdominal aortic aneurysm after endovascular repair: prospective validation of contrast-enhanced US with a second-generation US contrast agent.

PURPOSE: To prospectively assess the accuracy of contrast agent-enhanced (CE) ultrasonography (US) with a second-generation US contrast agent in the detection and classification of endoleaks after endovascular repair of abdominal aortic aneurysms (EVAR), with computed tomographic (CT) angiography as the reference standard. MATERIALS AND METHODS: Institutional review board and written informed consent were obtained. Thirty-five patients who underwent EVAR were enrolled in a prospective study that consisted of CT angiography and CE US studies performed at 1- and 6-month follow-up and performed yearly thereafter. CE US was performed after bolus injection of 2.4 mL of sulfur hexafluoride by using equipment with specific software for contrast studies. Angiography was performed in patients who had type II endoleaks with an increase in aneurysm sac size and in patients with type I or III endoleaks. CE US sensitivity, specificity, positive and negative predictive values, and accuracy were determined for endoleak detection, and Cohen κ statistic was used to assess agreement of CE US and CT angiographic findings for endoleak classification. RESULTS: A total of 126 CT angiographic and CE US studies were performed. CT angiography depicted 34 endoleaks in 16 patients (type IA, n=1; type IB, n=1; type II inferior mesenteric artery, n=2; type II lumbar artery, n=28; type II complex, inferior mesenteric, and lumbar arteries, n=2). CE US depicted 33 endoleaks. Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of CE US in endoleak detection were 97%, 100%, 100%, 98%, and 99%, respectively. CE US enabled correct classification of 26 of 33 endoleaks. No clinically important endoleak was missed at CE US. CONCLUSION: CE US yields good sensitivity, specificity, and accuracy in endoleak detection, and it might represent a noninvasive tool that can be used in the follow-up of patients who undergo EVAR.

Practical utility of on-line clearance and blood temperature monitors as noninvasive techniques to measure hemodialysis blood access flow.

BACKGROUND/AIMS: Access blood flow (Qa) measurements are recommended by the current guidelines as one of the most important components in vascular access maintenance programs. This study evaluates the efficiency of Qa measurement with on-line conductivity (OLC-Qa) and blood temperature monitoring (BTM-Qa) in comparison with the gold standard saline dilution method (SDM-Qa). SUBJECTS AND METHODS: 50 long-term hemodialysis patients (42 arteriovenous fistulas/8 arteriovenous grafts) were studied. Bland-Altman and Lin's coefficient (ρ(c)) were used to study accuracy and precision. RESULTS: Mean values were 1,021.7 ± 502.4 ml/min SDM-Qa, 832.8 ± 574.3 ml/min OLC-Qa (p = 0.007) and 1,094.9 ± 491.9 ml/min with BTM-Qa (p = NS). Biases and ρ(c) obtained were -188.8 ml/min (ρ(c) 0.58) OLC-Qa and 73.2 ml/min (ρ(c) 0.89) BTM-Qa. The limits of agreement (bias ± 1.96 SD) obtained were from -1,119 to 741.3 ml/min (OLC-Qa) and -350.6 to 497.2 ml/min (BTM-Qa). CONCLUSIONS: BTM-Qa and OLC-Qa are valid noninvasive and practical methods to estimate Qa, although BTM-Qa was more accurate and had better concordance than OLC-Qa compared with SDM-Qa.