Real Life Outcomes of Infrapopliteal Endovascular and Surgical Bypass Intervention for Chronic Limb Threatening Ischaemia in GLASS Stages II and III.

OBJECTIVE: Great efforts have been made to choose between bypass surgery and angioplasty as the first choice for revascularisation in chronic limb threatening ischaemia (CLTI). Endovascular therapy predominates despite limited evidence for its advantages. The purpose of this observational cohort study was to investigate outcomes after open and endovascular infrapopliteal revascularisation in extensive infrainguinal arterial disease. METHODS: The medical records of 1 427 patients who underwent infrainguinal revascularisation exclusively for CLTI in the period January 2014 to February 2019 were reviewed. After detailed analysis, only infrapopliteal revascularisations classified as GLASS stage II or III were considered, resulting in 326 procedures. In total, 127 patients underwent endovascular therapy and 199 patients underwent bypass graft surgery (BGS). The primary endpoints included amputation free survival (AFS) and overall survival (OS). Secondary endpoints included the analyses of multiple factors related to long term AFS. RESULTS: Regarding the primary endpoint, AFS was 75.2% and 65.2% at one and three years, respectively. OS at one and three years was 91.2% and 83.1%, respectively. In the univariable analysis, the hazard of the combined endpoint of major amputation or death was higher after bypass surgery than after endovascular therapy (hazard ratio [HR] 1.80, 95% confidence interval [CI] 1.13 - 2.89; p = .013). After either revascularisation method, TASC II femoropopliteal D was associated with a higher risk of amputation or death (HR 1.69, 95% CI 1.10 - 2.58; p = .015). Multivariable Cox regression analysis revealed no association between the variables analysed for AFS. CONCLUSION: Patients with CLTI submitted to infrapopliteal revascularisation and classified as GLASS II and III had satisfactory AFS and OS rates after an individualised team conference decision. Furthermore, the revascularisation modality (endovascular or open) did not influence the AFS results.

Mid- to long-term clinical and echocardiographic outcomes after transcatheter aortic valve replacement with a new-generation, self-expandable system.

OBJECTIVES: The aim of the study was to evaluate mid- to late clinical and echocardiographic outcomes after transcatheter aortic valve replacement (TAVR) with Acurate neo™ (Boston Scientific, Boston, MA). BACKGROUND: TAVR is an established treatment for aortic stenosis (AS). Few data exist on mid- to long-term outcomes and durability after new-generation valves. METHODS: All consecutive patients (n = 104) who underwent Acurate neo™ implantation from 2012 to 2018 were included. Follow-up was systematically performed at 1, 6, 12, and 24 months and yearly thereafter. Outcomes were reported according to VARC-2, and structural valve deterioration (SVD) or bioprosthetic valve failure defined accordingly to new definitions. RESULTS: Mean age was 82 ± 5.4 years, 56.7% were female and the Society of Thoracic Surgeons score for mortality was 5.9 ± 4%. Patients were followed for a median of 3 years (1,092 days; IQR 1.5-4 years), and the maximum follow-up was 7 years. All-cause mortality values at 1 and 5 years were 8.5% and 40.5%, respectively. No relevant changes in mean gradient and orifice area occurred (7.9 ± 3.8 mmHg and 1.9 ± 0.3 cm2 at 1 year; 6.6 ± 2.1 mmHg and 1.8 ± 0.3 cm2 at 5 years), and there was a significant rate of paravalvular leaks resolution at 1, 2, and 3 years (p = .004; p < .001; p < .001, respectively). None of the patients had leaflet thrombosis or endocarditis. One patient developed SVD at 84 months. CONCLUSIONS: Acurate neo™ was associated with sustained echocardiographic results. Reassuring mid- to long-term outcomes was observed in this cohort of elderly patients with severe AS.

Recanalization of femoropopliteal chronic total occlusions using the ENABLER-P Balloon Catheter System.

PURPOSE: To evaluate the safety and effectiveness of a new system to facilitate intraluminal advancement of conventional guidewires through chronic total occlusions (CTO) of the superficial femoral artery (SFA) and popliteal artery. METHODS: The ENABLER-P Balloon Catheter System uses a unique balloon-anchoring mechanism and an automated balloon inflation device for steady, controlled advancement of a standard non-hydrophilic guidewire. The system was evaluated in 37 patients (22 men; mean age 67 years (range 41-87) with femoropopliteal CTOs averaging 86 mm in length (range 10-340). The device was used in a variety of occlusions, including heavily calcified, long, and fibrotic lesions. After successful guidewire recanalization facilitated by the system, occluded arterial segments were treated conventionally with balloon angioplasty, atherectomy, and stents as appropriate. RESULTS: The primary endpoint of successful crossing was achieved in 86% (32/37) of the overall study population. The average activation time for successful crossing was 5.3 minutes (range 0.4-22). Of the 32 cases successfully crossed with the ENABLER-P System, all but 1 was successfully recanalized. One (3%) device-related complication occurred when the wire was advanced into a side branch when treating a 300-mm-long flush ostial SFA occlusion; the resulting perforation was managed with a covered stent without further sequelae. CONCLUSION: This novel system, which provides enhanced force to a standard guidewire tip for controlled intraluminal advancement, is a promising device for the treatment of peripheral CTOs.

Comparison of computed tomography venography and intravascular ultrasound in screening and classification of iliac vein obstruction in patients with chronic venous disease.

OBJECTIVE: To investigate power of computed tomography venography (CTV) to identify and characterize iliac vein obstruction (IVO) compared with intravascular ultrasound (IVUS) examination in highly symptomatic patients with chronic venous disease (CVD). METHODS: CVD CEAP C3-6 limbs with visual analog scale for pain score of greater than 3 and/or Venous Clinical Severity Scale of greater than 8 were prospectively investigated with CTV and IVUS examination. The segment of maximum IVO was verified and categorically classified: group I, 0% to 49%; group II, 50% to 79%; and group III, 80% or greater. The CTV's screening power to detect the point and degree of maximum IVO was compared with IVUS. RESULTS: The CTV point of maximum IVO was 80% in the left limb, 10% in the right limb, 10% bilaterally; 2% in the inferior vena cava; 91% in the common iliac vein (CIV) confluence (41.6% below the CIV confluence, 34.5 at the CIV confluence, and 23.9% above the CIV confluence); 7% at the external iliac vein (kappa index 0.841; P < .001, when compared with IVUS). The distal venous segment considered free of obstruction was above inguinal ligament: 68% (CIV, 47%; external iliac vein, 21%) 32% below the inguinal ligament (common femoral vein, 26%; deep femoral vein, 6%) (kappa index 0.671; P = .023, when compared with IVUS). The power of CTV to detect an IVO of 50% or greater (groups II and III) when compared with IVUS achieved a sensitivity and specificity ratio of 94.0% and 79.2%, respectively. The positive predictive value was 94%, the negative predictive value was 79.1%, accuracy was 86.7% (kappa, 0.733), and interobserver agreement was 92.1% (95% confidence interval, 87.1-97.7; kappa, 0.899). CONCLUSIONS: CTV is a powerful screening method in determining the precise point of compression and classifying IVO in limbs with symptomatic CVD when compared with IVUS. The prevalence of an obstruction above the iliac vein confluence is significant and should be considered in iliac vein stenting treatment strategy. The tomographic classification system proposed here may help to define the optimum technique of treatment, prognosis, and comparison of outcome results.

Randomized double-blinded study comparing medical treatment versus iliac vein stenting in chronic venous disease.

OBJECTIVE: Iliac vein stenting has emerged as the procedure of choice in the treatment of iliac vein obstruction (IVO). However, clinical outcomes have never been studied by a randomized clinical trial. Our purpose was to compare medical and endovascular treatment results in symptomatic chronic venous disease (CVD) patients with significant IVO documented by intravascular ultrasound (IVUS). METHODS: Patients with Clinical, Etiology, Anatomy, and Pathophysiology clinical class C3 to C6 and a visual analog scale for pain (VAS pain) score >3 were considered eligible. We randomly assigned limbs with ≥50% IVO on IVUS to undergo medical treatment alone or medical treatment plus iliac vein stenting. The patient and clinical physician were blinded. Primary outcomes included change from baseline in VAS pain score, Venous Clinical Severity Score, and 36-Item Short Form Health Survey quality of life questionnaire. Secondary outcomes included stent integrity, migration, and patency rates at 6 months. RESULTS: Of 207 CVD patients, 58 (28%) were eligible and eight (14%) were excluded; 51 of 85 class C3 to C6 limbs (60%) had ≥50% IVO by IVUS. Iliac vein stenting, in randomized patients, was 100% technically successful. At 6 months' follow-up, the mean VAS pain score declined from a median of 8 to 2.5 in patients receiving stents and from 8 to 7 in patients receiving only medical treatment (P < .001). The Venous Clinical Severity Score dropped from a median of 18.5 to 11 after stenting and from 15 to 14 with medical treatment (P < .001). The 36-Item Short Form Health Survey (0-100) improved from a total median score of 53.9 to 85.0 with stenting and 48.3 to 59.8 after medical treatment (P < .001). There was no stent fracture or migration, and the primary, assisted primary, and secondary patency rates were 92%, 96%, and 100%, respectively (median, 11.8; range, 6-18 months). CONCLUSIONS: Endovascular treatment of IVO with stenting is safe and promotes effective relief of symptoms and improvement in quality of life compared with medical treatment alone in symptomatic CVD patients. Our results echo those achieved in numerous previously published nonrandomized clinical series.

First-in-man assessment of the InSeal VCD, a novel closure device for large puncture accesses.

AIMS: To demonstrate the feasibility and efficacy of the novel InSeal VCD for the closure of large puncture holes following percutaneous structural interventions. METHODS AND RESULTS: Prospective, non-randomised, single-arm, single-centre study with a series of patients submitted to endovascular treatment of abdominal and thoracic aortic aneurysm as well as transcatheter aortic valve implantation in whom the InSeal VCD was used to close the access site. These patients were followed up for one year with clinical examination, ankle-brachial index and Doppler ultrasound. The primary endpoint was the occurrence of major vascular complications at the puncture site. From a total of nine patients screened, seven were selected to receive the InSeal VCD. Technical and therapeutic successes were achieved in all cases. The sheath profiles used in these procedures ranged from 18 Fr to 25 Fr. No major vascular complications were observed during the follow-up period. Average ankle-brachial index pre-intervention and at one-month follow-up were 0.85 and 0.82, respectively. CONCLUSIONS: The InSeal VCD was shown to be effective in achieving acute and chronic haemostasis after usage of higher profile endovascular devices in this study. These results translated into no clinical complications up to one-year clinical follow-up.

Percutaneous implantation of endoprostheses in the carotid arteries.

OBJECTIVE: To assess the in-hospital evolution of patients undergoing percutaneous stent placement in the carotid arteries. METHODS: From August 1996 to April 2001, we studied 86 patients with carotid arterial obliterative lesions > 70% who were treated with percutaneous stent placement in the carotid arteries. We assessed the rate of success of the implantation and of the procedure, the types of stents used, mortality rate, and neurological complications. RESULTS: Successful implantation was obtained in 98.9% of the cases, and the procedure was successful in 91.8%. The Wallstent was the most frequently used stent (73 patients - 77%). Cerebral strokes occurred as follows: 3 (3.2%) transient ischemic attacks, 1 (1.1%) minor stroke, and 3 (3.1%) major strokes. One (1.1%) patient died during hospitalization. CONCLUSION: The high rate of success of stent implantation (98.9%) in addition to the low rate of cerebral stroke/death (4.2%) showed the efficiency and safety of percutaneous stent placement in carotid arteries.

Analysis of the sensitivity and specificity of noninvasive imaging tests for the diagnosis of renal artery stenosis.

BACKGROUND: Aging and atherosclerosis are related to renovascular hypertension in elderly individuals. Regardless of comorbidities, renal artery stenosis is itself an important cause of cardiovascular morbidity and mortality. OBJECTIVE: To define the sensitivity, specificity, positive predictive value, and negative predictive value of noninvasive imaging tests used in the diagnosis of renal artery stenosis. METHODS: In a group of 61 patients recruited, 122 arteries were analized, thus permitting the definition of sensitivity, specificity, and the relative contribution of each imaging study performed (Doppler, scintigraphy and computed tomographic angiography in comparison to renal arteriography). RESULTS: The mean age was 65.43 years (standard deviation: 8.7). Of the variables related to the study population that were compared to arteriography, two correlated with renal artery stenosis, renal dysfunction and triglycerides. The median glomerular filtration rate was 52.8 mL/min/m². Doppler showed sensitivity of 82.90%, specificity of 70%, a positive predictive value of 85% and negative predictive value of 66.70%. For tomography, sensitivity was 66.70%, specificity 80%, positive predictive value 87.50% and negative predictive value 55.20%. With these findings, we could identify the imaging tests that best detected stenosis. CONCLUSION: Tomography and Doppler showed good quality and efficacy in the diagnosis of renal artery stenosis, with Doppler having the advantage of not requiring the use of contrast medium for the assessment of a disease that is common in diabetics and is associated with renal dysfunction and severe left ventricular dysfunction.

Randomized comparison of distal and proximal cerebral protection during carotid artery stenting.

OBJECTIVES: This study sought to randomly compare cerebral protection with ANGIOGUARD (Cordis Corporation, Bridgewater, New Jersey) with Mo.Ma (Invatec/Medtronic Vascular Inc, Santa Rosa, California) during carotid artery stenting (CAS), using diffusion-weighted magnetic resonance imaging (DW-MRI) to detect new ischemic cerebral lesions. The number, size, and location of lesions were analyzed. BACKGROUND: The choice of the type of cerebral protection during CAS is controversial. METHODS: From July 2008 to July 2011, 60 patients undergoing CAS were randomized to ANGIOGUARD or Mo.Ma, distributed by chance, 30 patients for each group. All patients underwent DW-MRI before and after CAS. An independent neuroradiologist blinded to the cerebral protection used analyzed the images. Univariate and multivariate logistic models were fitted to analyze new ischemic lesions. Alternatively, a propensity score approach was used to reduce the bias due to differences between the groups. For the number of lesions, we used Poisson regression models. RESULTS: New ischemic lesions seen on DW-MRI were present in 63.3% of the ANGIOGUARD group versus 66.7% of the Mo.Ma cohort (p = 0.787). The number of ischemic cerebral lesions per patient, when present, was significantly lower in the Mo.Ma group (a median of 6 lesions per patient vs. a median of 10 in the ANGIOGUARD, p < 0.001). Most lesions were small (<0.5 mm) and localized in the ipsilateral territory. One patient in the ANGIOGUARD group had a minor stroke during CAS (1.66%). CONCLUSIONS: New ischemic lesions seen on DW-MRI were present in both groups in >60%, but the number of lesions per patient was greater in the ANGIOGUARD group. No death or disabling stroke occurred during at least 1 year of follow-up in both cohorts.

Avaliação da sensibilidade e especificidade dos exames não invasivos no diagnóstico da estenose de artéria renal / Analysis of the sensitivity and specificity of noninvasive imaging tests for the diagnosis of renal artery stenosis

FUNDAMENTO: O envelhecimento e a aterosclerose estão relacionados à hipertensão renovascular em indivíduos idosos. Independentemente das comorbidades, a estenose de artéria renal é, por si só, importante causa de morbidade e mortalidade cardiovascular. OBJETIVO: Definir a sensibilidade, a especificidade, o valor preditivo positivo e o valor preditivo negativo dos exames não invasivos utilizados no diagnóstico de estenose da artéria renal. MÉTODOS: Um grupo de 61 pacientes recrutados permitiram a análise de 122 artérias e a definição de sensibilidade, especificidade e da contribuição relativa de cada exame realizado (Doppler, cintilografia e angiotomografia, comparados a arteriografia renal). RESULTADOS: A média das idades foi de 65,43 (desvio padrão: 8,7) anos. Das variáveis relacionadas à população do estudo e comparadas à arteriografia, duas estiveram correlacionadas à estenose da artéria renal, à disfunção renal e aos triglicerídeos. A mediana do ritmo de filtração glomerular foi de 52,8 mL/min/m². O Doppler identificou sensibilidade de 82,90%, especificidade de 70%, valor preditivo positivo de 85% e valor preditivo negativo de 66,70%. Para a tomografia, encontraram-se sensibilidade de 66,70%, especificidade de 80%, valor preditivo positivo de 87,50% e valor preditivo negativo de 55,20%. Esses achados permitiram identificar os exames que melhor detectavam a estenose. CONCLUSÃO: A tomografia e o Doppler mostraram qualidade e grande possibilidade no diagnóstico de estenose da artéria renal, com vantagem para o segundo, pois não há necessidade do uso de meio de contraste na avaliação de uma doença que, frequentemente, ocorre em diabéticos e associa-se à disfunção renal e à disfunção ventricular esquerda grave.

BACKGROUND: Aging and atherosclerosis are related to renovascular hypertension in elderly individuals. Regardless of comorbidities, renal artery stenosis is itself an important cause of cardiovascular morbidity and mortality. OBJECTIVE: To define the sensitivity, specificity, positive predictive value, and negative predictive value of noninvasive imaging tests used in the diagnosis of renal artery stenosis. METHODS: In a group of 61 patients recruited, 122 arteries were analized, thus permitting the definition of sensitivity, specificity, and the relative contribution of each imaging study performed (Doppler, scintigraphy and computed tomographic angiography in comparison to renal arteriography). RESULTS: The mean age was 65.43 years (standard deviation: 8.7). Of the variables related to the study population that were compared to arteriography, two correlated with renal artery stenosis, renal dysfunction and triglycerides. The median glomerular filtration rate was 52.8 mL/min/m². Doppler showed sensitivity of 82.90%, specificity of 70%, a positive predictive value of 85% and negative predictive value of 66.70%. For tomography, sensitivity was 66.70%, specificity 80%, positive predictive value 87.50% and negative predictive value 55.20%. With these findings, we could identify the imaging tests that best detected stenosis. CONCLUSION: Tomography and Doppler showed good quality and efficacy in the diagnosis of renal artery stenosis, with Doppler having the advantage of not requiring the use of contrast medium for the assessment of a disease that is common in diabetics and is associated with renal dysfunction and severe left ventricular dysfunction.

Pseudoaneurisma embolomicótico da artéria femoral comum na endocardite infecciosa / Embolomycotic pseudoaneurysm of the commom femoral artery in infective endocarditis

Paciente do sexo masculino, seis anos de idade, com quadro clínico e ecocardiográfico compátivel com endocardite infecciosa de valva mitral, apresentou como complicaçäo, pseudoaneurisma embolomicótico da artéria femoral comum direita. Submetido a tratamento cirúrgico com a reconstruçäo arterial, evoluiu satisfatoriamente

Incidência de atelectasias no pós-operatório de revascularizaçäo do miocardio / Incidence of atelectasia in the postoperative period of myocardial revascularization

Os autores analisaram as complicaçöes pulmonares que ocorreram em 437 casos de pós-operatório de revascularizaçäo do miocárdio, sendo que as atelectasias segmentares à esquerda foram os sinais mais freqüentes. Foi revista a bibliografia e foram discutidos alguns factores etiológicos