Real-world experience with a Paclitaxel-Coated Balloon for the treatment of atherosclerotic infrainguinal arteries: 12-month interim results of the BIOLUX P-III registry first year of enrolment / Experiência real com balão revestido com paclitaxel para o tratamento de artérias infrainguinais ateroscleróticas: resultados após 12 meses do primeiro ano de seleção de pacientes para o registro BIOLUX P-III

Abstract Background Endovascular management of atherosclerotic infrainguinal arteries recently shifted towards drug eluting devices, designed to locally prevent the restenosis process. Numerous clinical studies report an advantage of drug coated balloons over uncoated balloon angioplasty in treating lower extremity peripheral artery disease. However, as coating and balloon platforms are different, each device requires dedicated clinical evaluations. Objective The aim of the study is to further investigate the safety and effectiveness of a Paclitaxel-Coated Balloon for the treatment of atherosclerotic infrainguinal arteries in a real-world setting. Methods 203 patients out of a final sample of 882 were enrolled in this prospective multicenter, observational, all-comers registry during the first 12 months. The primary endpoints were major adverse events (defined as procedure or device related death within 30 days post index procedure, clinically-driven target lesion revascularization or major target limb amputation) at 6 months and freedom from clinically-driven target lesion revascularization at 12 months. Both endpoints were adjudicated by a Clinical Events Committee. Results Mean patient age was 70.2±10.4 years (60.1% male). 47.3% of the patients were diabetic and 67.5% had a history of smoking. Severe claudication was reported in 37.4% and 40% had critical limb ischemia. 257 lesions, including 13.2% in the infrapopliteal territory, were treated with Passeo-18 Lux (mean lesion length 75.1 mm±69.4, 20% occlusions, 76.3% calcified). At 6 months, the rate of major adverse events was 5.5% (95%CI 3.1-9.7). Freedom from clinically-driven target lesion revascularization at 12 months was 93.2% (95%CI 89.1-95.8). All causes mortality was 6.5% (95%CI 3.8-11.0) and overall amputation rate was 4.2% (95%CI 2.1-8.3) at 12 months. Conclusion In a real-world environment, the BIOLUX P-III registry preliminary results confirm the safety and efficacy of the Paclitaxel-Coated Passeo-18 Lux balloon as a stand-alone treatment option for atherosclerotic infrainguinal arteries.

Resumo Contexto O manejo endovascular de artérias infrainguinais ateroscleróticas recentemente tem mudado para dispositivos farmacológicos, desenhados para impedir localmente o processo de reestenose. Numerosos estudos clínicos descrevem uma vantagem da angioplastia com uso de balões farmacológicos sobre os balões convencionais no tratamento de doença arterial periférica dos membros inferiores. No entanto, considerando que as plataformas do revestimento farmacológico e dos balões são diferentes, cada dispositivo requer avaliações clínicas específicas. Objetivo Fazer investigação adicional sobre a segurança e eficácia de um balão revestido com paclitaxel para o tratamento de artérias infrainguinais ateroscleróticas em um cenário de mundo real. Métodos 203 pacientes de uma amostra final de 882 pacientes foram incluídos neste registro prospectivo observacional multicêntrico de inclusão sequencial, durante os primeiros 12 meses. Os desfechos primários foram eventos adversos maiores (definidos como morte relacionada ao procedimento ou ao dispositivo em até 30 dias após o procedimento-índice, necessidade de revascularização da lesão-alvo ou amputação significativa do membro-alvo) em 6 meses e ausência de de revascularização da lesão-alvo em 12 meses. Ambos os desfechos foram adjudicados por um comitê de eventos clínicos. Resultados A idade média foi 70,2±10,4 anos (60,1% sexo masculino). 47,3% dos pacientes eram diabéticos, e 67,5% tinham história de tabagismo. Claudicação severa foi relatada em 37,4%, e 40% apresentava isquemia crítica de membro. 257 lesões, incluindo 13,2% em território infrapoplíteo, foram tratadas com o balão Passeo-18 Lux (comprimento médio das lesões 75,1 mm±69,4, 20% oclusões, 76,3% calcificadas). Aos 6 meses, a taxa de eventos adversos maiores foi de 5,5% (95%CI 3,1-9,7). A ausência de revascularização da lesão-alvo aos 12 meses foi de 93,2% (95%CI 89,1-95,8). Mortalidade por todas as causas foi de 6,5% (95%CI 3,8-11,0) e a taxa geral de amputação foi de 4,2% (95%CI 2,1-8,3) aos 12 meses. Conclusão Em um cenário de mundo real, os resultados preliminares do registro BIOLUX P-III confirmam a segurança e eficácia do balão revestido com paclitaxel Passeo-18 Lux como opção de tratamento único para artérias infrainguinais ateroscleróticas.

High-pressure balloon assessment of pelviureteric junction prior to laparoscopic "vascular hitch"

ABSTRACT Aim To assess if calibration of the ureteropelvic junction (UPJ) using a high-pressure balloon inflated at the UPJ level in patients with suspected crossing vessels (CV) could differentiate between intrinsic and extrinsic stenosis prior to laparoscopic vascular hitch (VH). Materials and Methods We reviewed patients with UPJO diagnosed at childhood or adolescence without previous evidence of antenatal or infant hydronephrosis (10 patients). By cystoscopy, a high-pressure balloon is sited at the UPJ and the balloon inflated to 8-12 atm under radiological screening. We considered intrinsic PUJO to be present where a ‘waist’ was observed at the PUJ on inflation of the balloon and a laparoscopic dismembered pyeloplasty is performed When no ‘waist’ is observed we considered this to represent extrinsic stenosis and a laparoscopic VH was performed. Patients with absence of intrinsic PUJ stenosis documented with this method are included for the study. Results Six patients presented pure extrinsic stenosis. The mean age at presentation was 10.8 years. Mean duration of surgery was 99 min and mean hospital stay was 24 hours in all cases. We found no intraoperative or postoperative complications. All children remain symptoms free at a mean follow up of 14 months. Ultrasound and renogram improved in all cases. Conclusion When no ‘waist’ is observed we considered this to represent extrinsic stenosis and a laparoscopic VH was performed. In these patients, laparoscopic transposition of lower pole crossing vessels (‘vascular hitch’) may be a safe and reliable surgical technique.

Single therapeutic catheterization for treatment of native coarctation of aorta and large patent ductus arteriosus using a covered stent.

A 20-year-old girl was diagnosed to have severe coarctation of the aorta, large patent ductus arteriosus and severe pulmonary artery hypertension. She underwent single therapeutic catheterization for the treatment of native coarctation of aorta and closure of ductus arteriosus using 39 mm long Cheatham-Platinum covered stent. The procedure was done successfully under local anesthesia without any complication. This appears to be a safe strategy while dealing with an adolescent or an adult with this combination of lesions.

Percutaneous transluminal angioplasty using a cutting balloon for stenosis of the arch vessels in aortoarteritis.

Percutaneous transluminal angioplasty with or without stenting of steno-occlusions in the supra-aortic arch vessels in aortoarteritis is associated with suboptimal results and higher restenosis rates, particularly in those with diffuse disease. We report two cases of stand-alone cutting balloon angioplasty for patients who presented with critical stenosis of the common carotid artery, and occlusion of the subclavian artery, respectively.

Comparison of in-hospital and follow-up results of directional atherectomy and stenting for ostial lesions of the left anterior descending coronary artery.

Lesions at the ostium of the left anterior descending coronary artery constitute a distinct group because of suboptimal results and higher restenosis rate after balloon angioplasty. Several non-balloon devices have been used to improve the outcome of dilatation of such lesions. We retrospectively compared the in-hospital and follow-up results of directional coronary artherectomy and stents for the treatment of ostial lesions of the left anterior descending artery. Out of 37 patients, 12 underwent directional coronary atherectomy and 25, stent implantation. The two strategies were deployed at different periods over the past five years. The baseline clinical and angiographic characteristics were comparable in the two groups. Directional coronary atherectomy was done using 7Fr atherocath with adjunctive balloon angioplasty in all. All the stents were deployed using moderate to high pressure balloon inflation after adequate predilatation. While the pre-procedure luminal diameter stenosis was similar in the two groups (87.3 +/- 8.8% vs 89.3 +/- 7.2%; p = NS), the residual stenosis was significantly lower in the stent group (5 +/- 2.8%) compared to directional coronary atherectomy (18.7 +/- 9.8; p = 0.02). There was no significant difference in the primary success rate between the two devices (91.6% directional coronary atherectomy vs 100% stent; p = NS). One patient in the directional coronary atherectomy group developed acute closure followed by emergency coronary artery bypass graft surgery and death. No major complication was observed in the stent group. Over a mean follow-up of 9.9 +/- 11.6 months following directional coronary atherectomy and 8.6 +/- 4.4 months after stenting, significantly higher number of patients (60%) developed recurrence of angina or any event following directional coronary atherectomy compared to stent (15.8%; p < 0.02). There was no myocardial infarction, coronary artery bypass graft surgery or death in either group on follow-up. The need for target lesion revascularisation was significantly higher in the directional coronary atherectomy group (50%) compared to stenting (10.5%; p < 0.02). Comparing directional coronary atherectomy with stent, the event-free survival was 80 percent vs 94.7 percent at three months and 50 percent vs 84.7 percent, both at six and nine months, respectively. In conclusion, stenting of the left anterior descending artery ostial lesion results in a significantly lesser post-procedure residual stenosis, improved in-hospital outcome, a lesser need for target lesion revascularisation and much improved event-free survival on follow-up as compared to directional coronary atherectomy. Therefore, stenting appears to be a more favourable treatment option compared to directional coronary atherectomy for the treatment of ostial lesions in the left anterior descending artery.

Tratamiento percutáneo de fístula arteriovenosa traumática con el sistema EndoPro 1 de Cragg / Percutaneous treatment of traumatic arteriovenous fistula with Cragg EndoPro system 1

Este reporte describe el cierre de una fístula arteriovenosa (FAV) subclavio-subclavia traumática, con el implante percutáneo transluminal de una endoprótesis, en un hombre de 25 años de edad, que rehusó tratamiento convencional. Bajo sedación, analgesia intravenosa y anestesia local se practicó arteriodisección de la arteria humeral izquierda. Posteriormente se puncionó y se colocó un introductor 10 Fr el cual se avanzó en forma retrógrada hasta cubrir la FAV previo control angiográfico. Posteriormente, se liberó un stent cubierto autoexpandible de Cragg bajo control fluroscópico. El stent fue adosado a la pared del vaso con un balón de Grüntzig. La arteriografía de control mostró el cierre total de la fístula. No hubo complicaciones. El paciente fue dado de alta a las 48 horas. El estudio de Triplex Scan al año de seguimiento mostró ausencia de la fístula y permeabilidad de la endoprótesis, así como de los vasos distales. Esta experiencia demuestra la viabilidad de la técnica, así como la permeabilidad de la endoprótesis a un año, sin embargo se requiere de experiencia adicional y de seguimiento para valorar adecuadamente este procedimiento invasivo a escala mínima en el manejo de las fístulas arteriovenosas

Immediate and follow-up clinical outcome after multivessel coronary stenting.

Seventy-two out of 656 patients treated by coronary stenting between January 1995 to May 1997 underwent elective multivessel stenting as a strategy for nonsurgical revascularization in patients with two-vessel (n = 37) and three-vessel (n = 35) disease. Their age ranged from 35 to 77 years (mean: 53.6 +/- 9.2) and the majority (77.8%) were males. The patients were included if the target vessel was more than 2.7 mm in diameter and subserved a moderate to large area of viable myocardium, provided the target lesion was considered approachable by stent. In all, 160 stents were deployed in 146 vessels with a mean of 2.2 stents per patient. The procedure was performed on all the target lesions in one stage in 51(70.8%) and two stages in 21(29.2%) patients. Two-vessel stenting was done in all except 2 patients who received stents in all the three major arteries. Successful deployment of the stent was achieved at the target site in all patients without any major in-hospital complications including subacute stent thrombosis, myocardial infarction (MI), emergency bypass graft surgery (CABG) or death. Clinical follow-up was available in 66(91.6%) patients at a mean of 7.8 +/- 5.5 months. The actuarial survival rates were 98.6, 96.7 and 94.6 percent, respectively at one, 3 and 6 to 12 months after the procedure with an event-free survival (absence of death, MI, recurrence of angina or any revascularization) of 98.5 percent at one, 93 percent at 3, 83.2 percent at 6 and 68.4 percent at 12 months. Only 15(22.7%) patients developed any event and target lesion revascularization was required in 8(12%) patients. In conclusion, multivessel stenting in patients with two- and three-vessel coronary disease is feasible, safe and effective in preventing major in-hospital complications as well as reducing the recurrence of clinical events and need for revascularization on follow-up.

Angioplastía transluminal percutánea con catéter balón en coartación aórtica nativa: experiencia a largo plazo / Long term study of percutaneous angioplasty in native aortic coarctation

De agosto de 1988 a octubre de 1993, 19 pacientes portadores de coartación aórtica nativa (CoAo) fueron sometidos a angioplastía transluminal percutánea con balón (ATPB). Doce fueron hombres (63.1 por ciento) y 7 mujeres (36.9 por ciento), con edad promedio de 22 ñ 7.7 años (extr. 16-52). Todos eran portadores de hipertensión arterial al momento del procedimiento, con una presión sistólica de 190 ñ 32.3 mmHg (extr. 160-240). El gradiente de presión sistólica (GPS) fue de 77 ñ 24 mmHg (extr. 45-130), un diámetro del anillo de coartación de 4.2 ñ 0.9 mm, el diámetro promedio de los catéteres balón utilizados fue de 18.3 ñ 1.7 mm (extr. 15-20). En todos los pacientes, el procedimiento se efectuó bajo anestesia local y con la técnica habitual de Seldinger. Después de efectuar el procedimiento, el GPS así como la presión arterial descendieron a 5.0 ñ 4.1 mmHg y 130 ñ 20.6 mmHg respectivamente y la ampliación del anillo presentó un aumento de 4.2 ñ 0.9 a 14.1 ñ 1.6 mm. En ninguno de los procedimientos se presentaron complicaciones: en el seguimiento 11 pacientes se han vuelto a cateterizar en un lapso de 24.7 ñ 12.6 meses (extr. 10-48) con un GPS de 5 ñ 2 mmHg y se observó un aumento en el diámetro del anillo a 15.4 ñ 1.2 mm. En estos sujetos vueltos a estudiar no se evidenciaron aneurismas en el sitio de la dilatación; el resto de los sujetos intervenidos llevan un control por consulta externa: 17 de ellos se mantienen normotensos sin tratamiento médico y dos únicamente han requerido de terapia antihipertensiva con mejor control a dosis bajas. Nuestra experiencia sugiere que la ATPB en CoAo tipo diafragma a cualquier edad es segura y muy efectiva con mejoría sostenida a mediano y largo plazo

High pressure stent-assisted balloon coronary angioplasty: a case report.

We reported the first high pressure stent assisted balloon angioplasty successfully implanted in this country. The use of intracoronary stent and its future direction were also reviewed. Regimen for post stent can be adjusted for each individual patient.

Angioplastía transluminal percutánea de los troncos supraórticos / Percutaneus transluminal angioplasty of the supraortic branches

La angioplastía transluminal percutánea (ATP) de los troncos supraórticos son en la actualidad un método seguro, eficaz y económico para el tratamiento de las lesiones estenóticas de los vasos con destino cervicoencefálico, además de que los indices de morbimortalidad son similares o menores a los publicados para endarterectomía. Este trabajo presenta una revisión bibliografíca de la técnica, indicaciones, resultados y complicaciones de la ATP. La puede llegar a ser método de elección par el tratamiento de las estenósis no ulceradas de los troncos supraórticos.

Assistência de enfermagem a pacientes submetidos à aterectomia coronária direcionada / Nurse assistance to patientes undertaken to directional coronary atherectomy

Os avanços tecnológicos proporcionaram o surgimento de novos instrumentos para o tratamento de lesöes ateroscleróticas no laboratório de cateterismo cardíaco. Dentre eles, está o aterótomo de Simpson, que se desenvolve para remover tecido da parese arterial e, com isto, superar limitaçöes da angioplastia coronária. O alto índice de sucesso primário, com estenoses residuais mínimas e as baixas taxas têm consagrado o método nos dias atuais. A enfermeira, através da sistematizaçäo de sua assistência, com orientaçöes pré-aterectomia e cuidados bem planejados durante e após o procedimento, tem conseguido atender às expectativas, näo só dos pacientes e dos familiares, mas também para uma boa evoluçäo e agilizaçäo da trajetória do paciente para a alta hospitalar

Angioplastia coronária utilizando material de última geraçäo: resultados imediatos / Effects of sympathetic blockade on postinfarction cardiac hy pertrophy and myocardial contractility

Objetivo Apresentar os resultados imediatos de pacientes submetidos a angioplastia coronária com cateteres de baixo perfil. Métodos No período de 16/6/89 a 28/9/90, foram tratados deforma consecutiva, 74 pacientes, com idade média de 55 anos, a maioria com doença de um vaso (92%) e boa função ventricular (88%), totalizando 80 lesões, 26 tipo A, 54 tipo B, de acordo com a classificação da Força Tarefa sobre angioplastia coronária do American College of Cardiology American Heart Association (FT-ACC/AHA). Os resultados foram analisados por quatro observadores: um cardiologista clínico (Ocli), um cirurgião cardiovascular (Ocir) e dois hemodinamicistas (H1, H2). Resultados Observou-se queda significativa do grau de obstrução pós-angioplastia, na opinião dos quatro observadores: 0cli = 83 ± 10,7/9,0 ± 14; 0cir = 86 ± 13/9,3 ± 11; H1 = 88,6 ± 7,0/8,5 ± 12; H2 = 88,5 ± 8,0/8,3 ± 12 (P < 0.001). O sucesso foi alcançado em 94,5% dos casos e a incidência de complicações foi de 2,7%. Conclusão O elevado perceptual de sucesso primário e a baixa incidência de complicações observados nessa série, podem ser creditados à seleção dos casos e à qualidade do material utilizado.

Purpose To present immediate results of percutaneous transluminal coronary angioplasty (PTCA) with the use of last generation catheter devices. Methods 74 pacients underwent PTCA meanage 55 years the majority of them with disease of one vessel (92%) and good left ventricular function (88%). There was a total of 80 lesions treated, 26 type A and 54 type B according to the Task Force for Coronary Angioplasty of the American College of Cardiology American Heart Association Classification. Results were analysed by separate observers: one clinical cardiologist (C), one cardiovascular surgeon (S) and two hemodynamicists (H1, H2). Results A significant fail in the degree of coronary obstruction was demonstrated post PTCA in the opinion of the observers: C = 83 ± 10.7/9.0 ± 14; S = 86 ± 13.0/9.3 ± 11; H1 = 88.6 ± 7.0/8.5 ±12; H2 = 88.5 ± 8.0/8.3 ± 12 (P < 0.001). Angiographic sucess was attained in 94.6% of the cases and the complication rate was low 2,7%. Conclusion The high primary success and the low complication rates seen in this series can be attributed to the careful selection of cases and advanced performance of the catheterization devices that were used

Tratamiento endoluminal de los aneurismas de aorta / Intraluminal treatment in abdominal aortic aneurysms

Debido al aumento de la población añosa, los cirujanos vasculares se encuentran con mayor frecuencia con pacientes portadores de aneurismas de aorta abdominal que tienen múltiples y severas enfermedades asociadas. El presente estudio se refiere a la experiencia animal y a los primeros casos clínicos de un nuevo tratamiento de los aneurismas que es la inserción retrógrada de una prótesis vascular fijada a "stends" metálicos que se implantan a través de un balón que al inflarse expande al "stends" y lo fija a la pared aórtica. En el trabajo experimental se crearon aneurismas de aorta en perros reemplazando la aorta infrarrenal con una prótesis de dacron en forma de aneurisma; después de cuatro semanas se excluye el aneurisma desde la luz implantando desde la arteria femoral, en forma retrógrada la combinación de "stend" y prótesis. Desde setiembre de 1990 se implantaron 6 pacientes. Un paciente debió ser operado después de implantar la prótesis demasiado alejada de las arterias renales. Todos los pacientes evolucionaron favorablemente