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.

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.

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.

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.

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

To demonstrate the feasibility and efficacy of the novel InSeal VCD for the closure of large punctureholes following percutaneous structural interventions.Methods and results: Prospective, non-randomised, single-arm, single-centre study with a series ofpatients submitted to endovascular treatment of abdominal and thoracic aortic aneurysm as well as transcatheteraortic valve implantation in whom the InSeal VCD was used to close the access site. These patients werefollowed up for one year with clinical examination, ankle-brachial index and Doppler ultrasound. The primaryendpoint was the occurrence of major vascular complications at the puncture site. From a total of ninepatients screened, seven were selected to receive the InSeal VCD. Technical and therapeutic successes wereachieved in all cases. The sheath profiles used in these procedures ranged from 18 Fr to 25 Fr. No major vascularcomplications were observed during the follow-up period. Average ankle-brachial index pre-interventionand 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 afterusage of higher profile endovascular devices in this study. These results translated into no clinical complicationsup to one-year clinical follow-up.

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.

Recanalization of femoropopliteal chronic total occlusion susing the ENABLER-P balloon catheter system

Purpose: To evaluate the safety and effectiveness of a new system to facilitate intraluminaladvancement of conventional guidewires through chronic total occlusions (CTO) of thesuperficial femoral artery (SFA) and popliteal artery.Methods: The ENABLER-P Balloon Catheter System uses a unique balloon-anchoringmechanism and an automated balloon inflation device for steady, controlled advancementof 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 thesystem, 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 theoverall study population. The average activation time for successful crossing was5.3 minutes (range 0.4–22). Of the 32 cases successfully crossed with the ENABLER-PSystem, all but 1 was successfully recanalized. One (3%) device-related complicationoccurred when the wire was advanced into a side branch when treating a 300-mm-longflush ostial SFA occlusion; the resulting perforation was managed with a covered stentwithout further sequelae.Conclusion: This novel system, which provides enhanced force to a standard guidewire tipfor controlled intraluminal advancement, is a promising device for the treatment ofperipheral CTOs.

Influência dos sintomas pré-procedimentos na evolução hospitalar e tardia das angioplastias carotídeas com implante de stent e sistemas de proteção cerebral / Influence of symptoms pre-procedure in hospital and late evolution of carotid angioplasty with stent implantation and cerebral protection systems

Introdução: A doença carotídea aterosclerótica (DCA) é responsável por 40 por cento dos acidentes vasculares cerebrais (AVC). Apesar de a intervenção carotídea percutânea (ICP) ser uma alternativa à endarterectomia, ainha há poucos dados disponíveis comparando a ICP em pacientes assintomáticos (PAS) versus sintomáticos (PS). O objetivo desta análise foi avaliar essa questão em um grupo consecutivo de pacientes. Métodos: Foram realizadas 262 ICP em 230 pacientes consecutivos, 61 (26,5 por cento) PAS versus 169 (73,5 por cento) PS. A angioplastia carotídea quantitativa (ACQ) foi realizada pré e pós-procedimento e o seguimento clínico, na fase hospitalar e aos 6 e 12 meses. Resultados: As características demográficas foram similares entre os dois grupos, sendo 31 por cento diabéticos. Obtivemos sucesso primário em 100 por cento dos casos, com ausência de complicações maiores em ambos os grupos. Na análise com ACQ, o diâmetro de estenose foi maior no grupo PAS (83,4 maior ou menos 7,6 por cento vs. 74,9 mais ou menos 12,5 por cento; p menor 0,01), mas o grupo PS apresentou lesões mais longas (18,3 mais ou menos 5,7 por cento vs. 21,7 mais ou menos 7,4 por cento; p menor 0,01). Aos 30 dias não houve diferença na incidência de AVC maior...

Background: Carotid atherosclerotic disease (CAD) is responsible for 40% of strokes. Despite percutaneous carotid intervention (PCI) is an alternative to endarterectomy, there is little data available comparing the PCI in asymptomatic vs. symptomatic patients. The purpose of this analysis was to evaluate this issue in a consecutive group of cases. Methods: 262 PCIs were conducted on 230 consecutive patients, 61 (26.5%) in asymptomatic vs. 169 (73.5%) in symptomatic patients. Quantitative carotid angiography (QCA) was performed before and after the procedure and the clinical follow-up obtained in-hospital and at 6 and 12 months. Results: The demographic characteristics were similar between groups; 31% were diabetics. Primary success was obtained in all cases, with no major complications in both groups. QCA analysis revealed a higher diameter stenosis in asymptomatics (83.4% ± 7.6% vs. 74.9% ± 12.5%; p < 0.01), but symptomatic patients had longer lesions (18.3% ± 5.7% vs. 21.7% ± 7.4%; p < 0.01). At 30 days there was no difference in the incidence of major (1.8% vs. 2.0%; p = 0.45) or minor strokes (0 vs. 1.4%; p = 0.19) for both groups. Between 1 and 12 months there have been no additional strokes. A late target vessel revascularization was observed in symptomatic patients but no neurologic deaths in both groups. Conclusion: PCI is safe and effective, with low incidence of complications at 1 and 12 months. The incidence of death, stroke and target vessel revascularization was similar between groups.

Terapia de recanalização endovascular de oclusão da artéria carótida em paciente com acidente vascular cerebral agudo / Percutaneous recanalization of carotid artery occlusion in patient with and acute stroke

Relatamos o caso de uma paciente de 69 anos, que, após a realização de arteriografia carotídea apresentou trombose sintomática da bifurcação carotídea. A paciente foi submetida imediatamente a reperfusão endovascular mecânica, com implante bem-sucedido de stent carotídeo, obtendo reversão completa do déficit neurológivo.

A 69 year-old woman developed symptomatic internal carotid artery thrombosis after carotid angiography. She was immediately submitted to mechanical endovascular reperfusion with successful carotid stent implantation and complete neurological recovery.

Reperfusão endovascular pós-embolia cerebral durante arterografia carotídea / Endovascular reperfusion following crebral embolism during carotid arteriography

Relatamos um caso de um paciente de 72 anos que, durante a realização de uma arteriografia carotídea, apresentou embolia arterial intracerebral sintomática. O paciente foi submetido imediatamente à reperfusão endovscular (mecânica) intracerebral com sucesso (clínico e angiográfico).

Short- and midterm follow-up results of valvuloplasty with balloon catheter for congenital aortic stenosis.

OBJECTIVE: To report short and midtem follow-up results of balloon aortic valvuloplasty to treat congenital aortic stenosis. METHODS: Seventy-five patients (median age: 8 years) underwent the procedure through the retrograde femoral or carotid route. RESULTS: The procedure was completed in 74 patients (98.6%). The peak-to-peak systolic gradient dropped from 79.6 27.7 to 22.3 17.8 mmHg (P<0.001), the left ventricular systolic pressure dropped from 164 39.1 to 110 24.8 mmHg (P<0.001), and the left ventricular end diastolic pressure dropped from 13.3 5.5 to 8.5 8.3 mmHg (P< 0.01). Four patients (5.3%) died due to the procedure. Aortic regurgitation (AoR) appeared or worsened in 27/71 (38%) patients, and no immediate surgical intervention was required. A mean follow-up of 50 38 months was obtained in 37 patients. Restenosis and significant AoR were observed in 16.6% of the patients. The estimates for being restenosis-free and for having significant AoR in 90 months were 60% and 50%, respectively. CONCLUSION: Aortic valvuloplasty was considered the initial palliative method of choice in managing congenital aortic stenosis, with satisfactory short- and midterm results.

Resultados imediatos e de seguimento a médio prazo da valvoplastia com cateter balão para estenose aórtica congênita / Short- and midterm follow-up results of valvuloplasty with balloon catheter for congenital aortic stenosis

OBJECTIVE: To report short and midtem follow-up results of balloon aortic valvuloplasty to treat congenital aortic stenosis. METHODS: Seventy-five patients (median age: 8 years) underwent the procedure through the retrograde femoral or carotid route. RESULTS: The procedure was completed in 74 patients (98.6 percent). The peak-to-peak systolic gradient dropped from 79.6±27.7 to 22.3±17.8 mmHg (P<0.001), the left ventricular systolic pressure dropped from 164±39.1 to 110±24.8 mmHg (P<0.001), and the left ventricular end diastolic pressure dropped from 13.3±5.5 to 8.5±8.3 mmHg (P< 0.01). Four patients (5.3 percent) died due to the procedure. Aortic regurgitation (AoR) appeared or worsened in 27/71 (38 percent) patients, and no immediate surgical intervention was required. A mean follow-up of 50±38 months was obtained in 37 patients. Restenosis and significant AoR were observed in 16.6 percent of the patients. The estimates for being restenosis-free and for having significant AoR in 90 months were 60 percent and 50 percent, respectively. CONCLUSION: Aortic valvuloplasty was considered the initial palliative method of choice in managing congenital aortic stenosis, with satisfactory short- and midterm results