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2.
Langenbecks Arch Surg ; 403(6): 741-748, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-29911291

RESUMO

PURPOSE: To evaluate the significance of perioperative changes in ankle-brachial index (ABI) with regard to extremity-related outcome in non-diabetic patients with critical limb ischemia (CLI) following revascularization. METHODS: The study represents a subanalysis of the multicentric Registry of First-line Treatment in Patients with CLI (CRITISCH). After exclusion of diabetic patients, conservative cases, and primary major amputation, 563 of 1200 CRITISCH patients (mean age 74 ± 10.7 years) were analyzed. This population was divided into two groups regarding perioperative ABI changes ∆ + 0.15 (Group 1) or ∆ - 0.15 (Group 2). Study endpoints were reintervention and major amputation during a mean follow-up of 14.6 ± 9 months. Logistic regression was performed in order to identify factors for ABI group affiliation. RESULTS: There were 279 patients in Group 1 (49.5%) and 284 in Group 2 (51.5%). ABI sensitivity and specificity regarding vessel patency were calculated to be 54 and 87%. A preoperative ABI ≤ 0.4 [odds ratio (OR) 7.7], patent vessels at discharge (OR 12.2), and secondary interventions (OR 2.4) were identified as factors for Group 1 affiliation. Contrariwise, previous revascularization (OR 0.6), a glomerular filtration rate ≤ 15 ml/min/1.73 m2 (OR 0.3), and TASC A lesions (OR 0.2) were associated with Group 2 affiliation. No statistical difference was found with regard to the need of reintervention. However, time to reintervention was significantly shorter in Group 2 compared to that in Group 1 (10.0 ± 9.5 months vs 12.1 ± 9.1 months; p = 0.005). Amputation rate in Group 2 was 14.4%, significantly higher compared to that in Group 1 (6.0%; p < 0.0001). CONCLUSIONS: Failure of perioperative ABI improvement is associated with a higher probability for amputation and should be valued as prognostic factor in non-diabetic patients with CLI. Patients with no/marginal improvement in ABI after revascularization require close follow-up monitoring and may benefit from early reintervention.


Assuntos
Índice Tornozelo-Braço , Isquemia/diagnóstico , Isquemia/cirurgia , Extremidade Inferior/irrigação sanguínea , Extremidade Inferior/cirurgia , Procedimentos Cirúrgicos Vasculares , Idoso , Idoso de 80 Anos ou mais , Amputação Cirúrgica , Complicações do Diabetes/complicações , Progressão da Doença , Feminino , Humanos , Isquemia/etiologia , Masculino , Pessoa de Meia-Idade , Período Perioperatório , Prognóstico , Sistema de Registros , Reoperação , Medição de Risco , Fatores de Risco , Resultado do Tratamento , Grau de Desobstrução Vascular
3.
Gefasschirurgie ; 21(Suppl 2): 63-70, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27546991

RESUMO

AIM: To survey the scope of vascular surgery services in Germany. METHOD: A total of 308 senior German vascular surgeons received a 19-point questionnaire pertaining to department structure and scope of services. Of these surgeons 223 replied between 16 August 2015 and 23 October 2015 (response rate 72 %), with 62.2 % reporting an additional qualification as an endovascular surgeon according to the guidelines of the German Society for Vascular Surgery and Vascular Medicine (Deutsche Gesellschaft für Gefäßchirurgie und Gefäßmedizin, DGG) and 43.5 % as a DGG® endovascular specialist. RESULTS: The number of respondents fully authorized to train in vascular surgery was 71.3 %, while 28.3 % were authorized for limited training. Authorization as a DGG® endovascular surgeon was reported by 24.2 % and authorization as a DGG® endovascular specialist by 17 % of respondents. All respondents performed endovascular interventions on pelvic vessels and 99.1 % also reported carrying out femoral and popliteal endovascular interventions. Endovascular procedures in crural vessels were carried out by 90.1 % and 93.7 % of vascular surgeons performed endovascular procedures in the region of the abdominal aorta (segment V), arteriovenous (AV) fistulas and shunts (85.2 %), upper extremity vessels (80.3 %), the thoracic aorta (segment III, 68.2 %), renal arteries (62.8 %) and visceral aorta (segment IV, 60.5 %). In all 43.5 % of respondents reported experience with endovascular procedures on the carotid bifurcation. Percutaneous arterial procedures formed the focus of endovascular activity, totalling on average 259 interventions per year and department, followed by diagnostic angiography (without intervention) at 166 procedures per year and hybrid arterial interventions at 141 interventions per year. CONCLUSION: This survey revealed a high level of endovascular expertise among vascular surgeons in Germany. This applies not only to the scope of endovascular activities in diagnosis and treatment but also to the number of estimated annual procedures.

4.
Gefasschirurgie ; 21(Suppl 2): 71-79, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27551877

RESUMO

AIM: On the basis of the CRITISCH registry outcomes in patients with critical limb ischemia (CLI) undergoing lower extremity bypass surgery were analyzed according to the site of distal anastomosis and type of bypass material. PATIENTS AND METHODS: A total of 284 patients with lower extremity bypasses consisting of 75 patients with bypasses above the knee (group 1), 80 with bypasses below the knee (group 2) and 129 crural or pedal bypasses (group 3) were included in the study. Altogether, 159 autologous saphenous vein grafts and 125 synthetic grafts were used. RESULTS: There were no perioperative complications in 191 out of the 284 patients (67.3 %) and 236 of the 284 patients (83.1 %) had open bypasses at hospital discharge. An uneventful postoperative course was observed in 76 % of the patients in group 1, 62.5 % in group 2 and 65.1 % in group 3. Amputation-free survival was 86 % at 1 year in group 1, 65 % in group 2 and 69 % in group 3. For bypasses above the knee synthetic grafts were at least not inferior to vein grafts (amputation-free survival at 1 year: prosthetic bypasses 92 % and saphenous vein grafts 71 %, p = 0.147), whereas in the crural/pedal bypass group vein grafts showed better amputation-free survival at 1 year (76 %) compared with synthetic bypasses (56 %, p = 0.105). Patients with a PREVENT III (PIII) CLI risk score ≤3 exhibited better amputation-free survival at 1 year (78 %) compared to patients with a PIII CLI risk score of 4-7 (69 %, p = 0.053). The same applied to patients with Rutherford class 4 vs. Rutherford class 6 CLI. CONCLUSION: In patients with CLI and above-knee bypasses, vein grafts confer no benefits compared with synthetic grafts for at least 1 year follow-up; however, in the case of more distal anastomoses vein grafts should be preferred.

5.
Langenbecks Arch Surg ; 401(3): 375-80, 2016 May.
Artigo em Inglês | MEDLINE | ID: mdl-26931518

RESUMO

PURPOSE: An estimated 350,000 varicose vein (VV) surgical procedures are performed in Germany each year, with annual treatment costs amounting to about 800 million Euro. To evaluate the outcome quality of this treatment, we examined the intraoperative and postoperative complication rates on record in the VV surgery quality assessment (QA) registry of the German Society for Vascular Surgery (GSVS). METHODS: Data on 89,647 patients (27,463 men, 62,184 women; average age 52.8 years, range 15-96 years) collected in the GSVS varicose surgery QA registry between 2001 and 2009 were analyzed. In these patients, 95,214 surgical procedures were performed on 105,296 limbs. Complication rates were correlated with the type of VV surgical procedure, with whether surgery was performed on an inpatient or outpatient basis, and with the CEAP classification (C stage) and American Society of Anaesthesiologists' (ASA) stage at the time of surgery. Statistical analyses were performed using a chi-square test, a Cochrane-Armitage test, and an odds ratio calculation. RESULTS: Intraoperative and postoperative complication was low (0.18 and 0.43 %, respectively), being the lowest for radiofrequency ablation (0.25 %) but not differing significantly from those for endovenous laser therapy and high ligation and stripping. General complications occurred in 0.67 % of outpatients and in 0.25 % of inpatients, a highly significant statistical difference (p < 0.0001, chi-square test). With regard to C stage, the higher the stage, the higher the local complication rate. A clear correlation was also found between preoperative ASA stage and postoperative complication rates: for ASA stages I and II, the complication rates were 0.2 and 0.5 %, respectively, increasing for ASA stage III to 1.2 % and for ASA IV to 2.2 %. The differences between the ASA classes were highly statistically significant (p < 0.0001, Cochrane-Armitage test) CONCLUSIONS: Outcome quality as reflected in the intraoperative and postoperative complication rates was very good for all patients undergoing inpatient or outpatient VV surgery. Data from the GSVS QA registry shows that VV surgery is performed with very good perioperative results in specialized centers in Germany.


Assuntos
Complicações Intraoperatórias/epidemiologia , Complicações Pós-Operatórias/epidemiologia , Qualidade da Assistência à Saúde , Varizes/cirurgia , Procedimentos Cirúrgicos Vasculares/efeitos adversos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Ablação por Cateter/efeitos adversos , Feminino , Alemanha/epidemiologia , Humanos , Terapia a Laser/efeitos adversos , Masculino , Pessoa de Meia-Idade , Varizes/epidemiologia , Adulto Jovem
6.
Eur J Vasc Endovasc Surg ; 51(3): 350-7, 2016 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-26514638

RESUMO

OBJECTIVE: After multi-branched endovascular aneurysm repair (mbEVAR), renal branch occlusion is the most frequent form of branch failure. Pre-operative renal angulation and post-operative morphology of the renal branch were quantified and their impact on occlusion was analyzed. METHODS: Patients who underwent mbEVAR between January 2010 and December 2013 were reviewed retrospectively. Only renal branches constructed with caudally directed cuffs were included. Patients without post-operative computed (CT) angiography were excluded. The main outcome was the primary patency of the renal branches. The renal angulation and the morphology of renal branch (bridging length, renal coverage length, tortuosity index, and angulation of distal renal artery) were quantified using CT. The impacts of morphology, implanted stents, and patient characteristics were investigated by time to event analyses. RESULTS: Ninety renal arteries in 49 patients were enrolled. Median follow up was 12 months (IQR 6-20 months). Balloon expandable stent grafts were used in 93% (84/90) of renal branches. Self expandable stent grafts were used in 12. Ninety-one percent (82/90) were lined with self expandable bare stents. Ten branches occluded after 8 months (median; IQR 1-14 months). Four of them underwent re-interventions, achieving secondary patency. The median renal angulation was -10° (IQR -40 to 0). The median bridging length was 42 mm (IQR 39-46 mm) and renal coverage 17 mm (IQR 12-22 mm). Median tortuosity index was 1.11 (IQR 1.04-1.19). The angulation of the distal renal artery was 140.7 ± 20.5°. In multivariate analysis, a tortuosity index > 1.11 was identified as the only significant predictor for occlusion (hazard ratio: 4.94; 95% CI: 1.01-24.30, p = .04). CONCLUSIONS: High tortuosity was a significant predictor for the occlusion of renal branches, but renal angulation, bridging length, and the extent of renal coverage were not. By avoiding highly tortuous renal branch paths, good outcomes are expected even in upwardly directed renal arteries. Longer paths are acceptable.


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Procedimentos Endovasculares/efeitos adversos , Tomografia Computadorizada Multidetectores/métodos , Complicações Pós-Operatórias/etiologia , Obstrução da Artéria Renal/diagnóstico por imagem , Artéria Renal/anormalidades , Anormalidade Torcional/complicações , Idoso , Angiografia , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Prótese Vascular , Feminino , Seguimentos , Humanos , Masculino , Complicações Pós-Operatórias/diagnóstico por imagem , Prognóstico , Desenho de Prótese , Artéria Renal/diagnóstico por imagem , Obstrução da Artéria Renal/etiologia , Estudos Retrospectivos , Stents , Fatores de Tempo , Anormalidade Torcional/diagnóstico por imagem , Resultado do Tratamento
7.
Chirurg ; 86(11): 1041-50, 2015 Nov.
Artigo em Alemão | MEDLINE | ID: mdl-26394855

RESUMO

OBJECTIVE: This study determined whether the routine data of a single health insurance company (DAK health) can allow equivalent statements on hospital mortality of endovascular (EVAR) and open (OR) repair of intact (iAAA) and ruptured (rAAA) aortic aneurysms (AAA) in Germany in comparison to clinical registry surveys of the German Vascular Society (GVS). METHODS: The study compared two cohorts that were comparable in group sizes but not identical in terms of the duration of treatment and the selection of the centers. The GVS registry included 5080 patients with iAAA and 485 with rAAA and the DAK data consisted of 5182 patients with iAAA and 576 with rAAA. In GVS (in brackets DAK) 72.6 % (71.0 %) of patients with iAAA received EVAR and 27.4 % (29 %) OR, with rAAA 34.6 % (26.9 %) of patients received EVAR and 65.4 % (73.1 %) OR. Both cohorts were comparable with respect to patient age and gender distribution. RESULTS: Intact AAA: the hospital mortality rate in GVS (DAK in brackets) was 0.95 % (1.4 %) with EVAR and 4.7 % (5.5 %) with OR. For patients less than 80 years old the statements were almost identical when the hospital mortality in the GVS and DAK registers constituted 0.85 % and 0.9 % after EVAR and 3.8 % and 4.0 % after OR, respectively. Patients over 80 years old in particular had a benefit by EVAR as the hospital mortality in GVS (DAK in brackets) was 1.3 % (2.6 %) with EVAR vs. 13.9 % (17.4 %) with OR. A benefit by EVAR was also seen in women. Ruptured AAA: the hospital mortality rate in GVS (DAK in brackets) was 19.6 % (27.1 %) with EVAR and 38.5 % (42.0 %) with OR. Again, particularly patients over 80 years old showed an advantage with EVAR where the hospital mortality was 31.0 % (34.3 %) with EVAR vs. 56.7 % (61.3 %) with OR in this group. CONCLUSION: Hospital mortality is an important quality parameter of endovascular and open repair of iAAA and rAAA. Administrative data of a health insurance company can be used to provide representative and comprehensive statements on inhospital mortality.


Assuntos
Aneurisma Roto/mortalidade , Aneurisma Roto/cirurgia , Aneurisma da Aorta Abdominal/mortalidade , Aneurisma da Aorta Abdominal/cirurgia , Procedimentos Endovasculares/mortalidade , Mortalidade Hospitalar , Complicações Intraoperatórias/mortalidade , Programas Nacionais de Saúde/estatística & dados numéricos , Complicações Pós-Operatórias/mortalidade , Sistema de Registros/estatística & dados numéricos , Sociedades Médicas/estatística & dados numéricos , Idoso , Feminino , Alemanha , Humanos , Masculino , Fatores de Risco
8.
Minerva Chir ; 70(6): 409-16, 2015 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-25916192

RESUMO

AIM: Aim of the study was to determine and compare the incidence of simple renal cysts (SRCs) and abdominal/inguinal wall hernias (AWHs/IHs) in patients with known abdominal aortoiliac aneurysm (AAA) and aortoiliac occlusive disease (AOD) in order to assess if these comorbidities could be promoted as added high risk factors for AAA development. METHODS: Prospectively collected clinical and radiological data of 236 AAA patients, treated at our institution between June 2009 and June 2012, were retrospectively analyzed regarding the number, location and type of SRCs and AWHs. Two hundred thirty-six randomly chosen patients with aortoiliac occlusive disease (AOD) were recruited as control group. RESULTS: SRCs and AWHs were significantly more frequent in the AAA group than in AOD group (68.6% vs. 37.3%, OR=2.110, 95%-CI 1.325-3.359, P=0.002 and 45.3% vs. 24.2%, OR=1.850, 95%-CI 1.153-2.968, P=0.011). In 30.1% of AAA patients both clinical entities were simultaneously detected (OR=2.441, 95%-CI 1.342-4.437, P=0.003), the comorbidity of SRCs and IHs was related to a 3.6-fold increased risk for a coexisting AAA (OR=3.558, 95%-CI 1.622-7.805, P=0.002). CONCLUSION: The findings of this study contribute to the clinical evidence of a significant coexistence of SRCs and AWH/IHs in AAA patients. However, further clinical screening trials and research are necessary to establish the clinical significance of this observation and to assess a possible common pathogenesis of systemic extracellular matrix degeneration in affected individuals.


Assuntos
Aneurisma da Aorta Abdominal/diagnóstico por imagem , Angiografia por Tomografia Computadorizada , Hérnia Ventral/diagnóstico por imagem , Doenças Renais Císticas/diagnóstico por imagem , Idoso , Idoso de 80 Anos ou mais , Aneurisma/diagnóstico por imagem , Aneurisma da Aorta Abdominal/complicações , Índice de Massa Corporal , Estudos de Casos e Controles , Angiografia por Tomografia Computadorizada/métodos , Diagnóstico Diferencial , Feminino , Hérnia Ventral/complicações , Humanos , Artéria Ilíaca/diagnóstico por imagem , Doenças Renais Císticas/complicações , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Cuidados Pré-Operatórios , Estudos Prospectivos , Estudos Retrospectivos , Fatores de Risco , Sensibilidade e Especificidade
9.
Eur J Vasc Endovasc Surg ; 50(1): 60-70, 2015 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-25913050

RESUMO

OBJECTIVE/BACKGROUND: Bridging stent grafts (BSGs) are used to connect the target vessel with the main body during fenestrated or branched aortic endografting (f/bEVAR). No dedicated devices are available for BSG. The aims of this study were to assess the performance of BSGs. METHODS: Between January 2004 and May 2014 the data of patients treated with f/bEVAR were prospectively collected. Only patients treated after January 2010 were included. The main measurement outcome was any BSG related complications. A logistic regression analysis, including target vessel type, type of joint (fenestration or cuff), and type of BSG identified potential risk factors. RESULTS: One hundred and fifty consecutive patients underwent f/bEVAR, and 523 target vessels were involved. These included 104 celiac, 140 superior mesenteric, 275 renal, and four other arteries. The technical success rate was 99% (520/523 target vessels). Balloon expandable BSGs were mainly used (n = 494; 95%), and in 336 (65%) relining stents were combined. The primary reasons for technical failure were the dislocation of the main body (n = 1) and unsuccessful cannulation (n = 2). One was revascularized by means of the periscope technique. Four target vessel injuries were recorded and four renal arteries occluded peri-operatively. After a median follow up of 14 months (interquartile range 5.5-23.0), 13 (2%) BSGs occluded and 19 (4%) required re-interventions. Two SMA occlusions occurred, leading to death in both patients. The patency and freedom from re-intervention rates at 3 years amounted to 85% and 91%, respectively. Use of a branched main body was the only independent risk factor for re-intervention and for the composite event (hazard ratio [HR] 3.5, 95% confidence interval [CI] 1.3-9.9 [p = .02]; and HR 2.8, 95% CI 1.2-7.0 [p < .01], respectively). Of note, the use of relining stents seemed not to prevent BSG related complications. CONCLUSION: The currently used BSGs had low occlusion and re-intervention rates. Modifications of the branched design or dedicated BSG devices may improve outcome, especially after bEVAR.


Assuntos
Aneurisma da Aorta Torácica/cirurgia , Procedimentos Endovasculares , Stents , Enxerto Vascular , Idoso , Procedimentos Endovasculares/efeitos adversos , Humanos , Estudos Prospectivos , Fatores de Risco , Stents/efeitos adversos
10.
Zentralbl Chir ; 140(2): 219-27, 2015 Apr.
Artigo em Alemão | MEDLINE | ID: mdl-25874473

RESUMO

BACKGROUND: This overview comments on clinical trials and meta-analyses from the literature on the treatment of diabetic feet. METHODS: For the literature review, the MEDLINE database (PUBMED) was searched under the key words "diabetic foot". Publications of the last three years (2012 to 2014) were extracted. RESULTS: For patients with diabetic feet, both endovascular (ER) and open (OR) revascularisation techniques are possible. There are not sufficient data to demonstrate whether open bypass surgery or endovascular interventions are more effective in these patients. However, registries show that ER has now in terms of quantity become the preferred method. Angiosome-targeted revascularisation has to be considered in these situations. For the local treatment of a diabetic foot ulcer a variety of dressings are available, the evidence for their recommendation is low. Dressing cost and the wound management properties, e.g. exudate management therefore can influence the choice of dressing. There is no evidence that more expensive dressings as compared to basic dressings offer advantages in terms of healing. In plantar diabetic foot ulcers, non-removable off-loading devices regardless of type are more likely to result in ulcer healing than removable off-loading devices, presumably, because patient compliance with off-loading is facilitated. Meaningful pressure-relieving interventions for treating diabetic foot ulcers also include Achilles tendon lengthening, a plantar fascia release and percutaneous flexor tenotomy. The value of a standardised treatment protocol carried out by a specialist team could be proven in large registries based on decreasing amputation rates. CONCLUSION: This survey reveals a significant disparity between the large number of treatment recommendations and their evidence. For the future, therefore it is imperative to implement nationwide register surveys with respect to treatment and outcome of these patients.


Assuntos
Medicina Baseada em Evidências , Procedimentos de Cirurgia Plástica/métodos , Complicações Pós-Operatórias/etiologia , Procedimentos Cirúrgicos Vasculares/métodos , Comportamento Cooperativo , Pé/irrigação sanguínea , Humanos , Comunicação Interdisciplinar , Microcirurgia/métodos , Cuidados Pós-Operatórios/métodos , Complicações Pós-Operatórias/fisiopatologia , Sistema de Registros , Retalhos Cirúrgicos/cirurgia , Suporte de Carga/fisiologia
11.
J Cardiovasc Surg (Torino) ; 55(4): 483-8, 2014 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-24975735

RESUMO

AIM: The femoral artery remains the access of choice in the majority of peripheral vascular interventions. However, specific conditions indicate catheterization of the brachial artery. Contrary to balloon catheters, the majority of stent delivery systems are too short to facilitate transbrachial implantation of self-expandable stents (SES) in the superficial femoral artery (SFA). We report our experience with a new 150 cm working length SES-delivery system for transbrachial lower extremity interventions. METHODS: All patients treated with the Entrust(TM) delivery system (EDS) for lower extremity peripheral arterial disease (PAD) via a transbrachial access between December 2012 and February 2014 were included into this study. All data were prospectively collected and analyzed. Primary endpoints were the feasibility and safety of the EDS in the transbrachial setting. Secondary endpoints consisted of stent length accuracy after deployment, early clinical outcome and perioperative complications. RESULTS: Thirty-seven EverFlex(TM) stents with Entrust(TM) delivery system were implanted transbrachially in twenty-eight (N.=28) patients. The transbrachial implantation of a SES using the EDS was feasible in all patients. Stent compression or elongation >10%, premature jumping or movements of the implanted stents were not observed in any patient. Although no stent fractures were observed, a single stent occlusion was noticed. Early clinical success was achieved in all but one patient, with one patient requiring a surgical revision of the puncture site due to pseudoaneurysm. CONCLUSION: The early experience with the new SES-delivery system suggests that EDS enables the safe and effective treatment of the lower extremities PAD via a transbrachial approach. However, further evaluation is needed to define whether the use of the new long shaft stent delivery system influences the performance of the EverFlex(TM) stent in the long run.


Assuntos
Artéria Braquial , Cateterismo Periférico/métodos , Procedimentos Endovasculares/instrumentação , Procedimentos Endovasculares/métodos , Extremidade Inferior/irrigação sanguínea , Doença Arterial Periférica/terapia , Stents , Dispositivos de Acesso Vascular , Idoso , Idoso de 80 Anos ou mais , Cateterismo Periférico/efeitos adversos , Procedimentos Endovasculares/efeitos adversos , Desenho de Equipamento , Estudos de Viabilidade , Feminino , Alemanha , Humanos , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico , Estudos Prospectivos , Punções , Fatores de Tempo , Resultado do Tratamento
12.
J Cardiovasc Surg (Torino) ; 55(1): 51-9, 2014 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-24356046

RESUMO

AIM: Endovascular repair has surpassed open surgical treatment as the most common procedure in patients with abdominal aortic aneurysms (AAA), yet its applicability remains limited to those with aortoiliac anatomy suitable for the introduction and deployment of the devices. The current study was performed to assess the safety and efficacy of INCRAFT® (Cordis Corporation, Bridgewater, NJ), an ultra-low-profile device for the treatment of AAA. METHODS: The INNOVATION study is a first in human prospective, multicenter trial involving 6 centers in Europe. From March 2010 to June 2011 60 patients with asymptomatic AAA were treated with the INCRAFT® bifurcated Stent-Graft System. The main inclusion criteria were a proximal aortic neck of 15 mm or more in length and up to 27 mm in diameter; iliac landing zones greater than 10 mm in length and between 9 and 18 mm in diameter; an access vessel large enough to accept the 14F outer diameter of the delivery system; and an aortic bifurcation >18 mm in diameter. The primary endpoint was technical success at one-month; one-year safety endpoints included the absence of device- or procedure-related major adverse events; absence of type I or III endoleaks; and maintenance of device integrity through one year of follow-up. RESULTS: Among 60 patients treated at six centers, the primary endpoint was met in 56 of 58 patients (97%; 95% CI, 88-100%) who came back for one month follow-up, two patients did not come back for their one month follow-up assessments but remained enrolled in the study. Fifty-six had one-year follow-up data showing 100% freedom from aneurysm enlargement with absence of type I and III endoleaks in all patients. There were two patients (3.6%) with a type Ia endoleak which was successfully treated with secondary endovascular intervention in both occasions. Core laboratory evaluation of the postoperative imaging studies documented absence of endograft migration, stent fracture, or limb occlusion. A single patient (1.8%) died within one year due to sepsis unrelated to the AAA. CONCLUSION: The results of the INNOVATION study with the INCRAFT® Stent-Graft are encouraging, with satisfactory clinical outcome and device durability through one-year of follow-up. The INCRAFT® device is a novel ultra-low-profile endograft that holds promise to broaden the patient population eligible for endovascular aneurysm repair.


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular/instrumentação , Prótese Vascular , Procedimentos Endovasculares/instrumentação , Stents , Idoso , Idoso de 80 Anos ou mais , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/mortalidade , Aortografia/métodos , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/mortalidade , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Europa (Continente) , Feminino , Humanos , Masculino , Complicações Pós-Operatórias/etiologia , Estudos Prospectivos , Desenho de Prótese , Fatores de Tempo , Tomografia Computadorizada por Raios X , Resultado do Tratamento
13.
J Cardiovasc Surg (Torino) ; 54(4): 469-75, 2013 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-24013535

RESUMO

AIM: Type II endoleaks with growing aneurysm sac >5 mm in diameter after EVAR require treatment. Different treatment options have been reported. The aim of this study was to evaluate the use of an ethylene-vinyl alcohol copolymer (Onyx) in an endovascular approach. METHODS: Between January 2010 and December 2011, 10 consecutive patients with persistent type II endoleaks leading to aneurysm growth >5 mm were treated in our center by transarterial Onyx embolization by super selective cannulation of the endoleak with microcatheters. Technical success was defined as transarterial Onyx deployment directly into the aneurysm sac. Clinical success was defined as stable or shrinking axial aneurysmal diameter during follow- up using an angiographic computed tomography. RESULTS: Ten patients with 13 persistent type II endoleaks leading to aneurysm sac growth of >5 mm were identified in the time period. Technical success was 92% (12/13 patients). Two patients underwent a staged procedure because several, unconnected type II endoleaks were present. In one patient a cannulation of the inflow vessel responsible for the endoleak was not possible, continued efforts led to a rupture of the hypogastric artery which was treated by covered stent implantation. In one patient an extravasation of onyx out of the aneurysm sac into the inferior vena cava during the embolization process made a transvenous goose snare maneuver necessary to retrieve the dislocated copolymer. No further complications were observed during the mean follow-up of 19.8 months (range, 3-31 months). In all patients with successful embolization the aneurysm sac remained stable or was decreased within the follow-up period. CONCLUSION: Use of Onyx in the endovascular treatment of type II endoleaks after EVAR is feasible, safe when accurately deployed and efficient. Further studies are necessary to evaluate the value of the different treatment modalities (translumbar vs. transarterial).


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular/efeitos adversos , Dimetil Sulfóxido/administração & dosagem , Embolização Terapêutica/métodos , Endoleak/terapia , Procedimentos Endovasculares/efeitos adversos , Polivinil/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aortografia/métodos , Dimetil Sulfóxido/efeitos adversos , Embolização Terapêutica/efeitos adversos , Endoleak/diagnóstico por imagem , Endoleak/etiologia , Feminino , Humanos , Injeções Intra-Arteriais , Masculino , Polivinil/efeitos adversos , Estudos Retrospectivos , Fatores de Tempo , Tomografia Computadorizada por Raios X , Resultado do Tratamento
14.
J Cardiovasc Surg (Torino) ; 54(5): 617-23, 2013 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-24002391

RESUMO

AIM: Aim of the study was to assess the long-term clinical results of primary stent placement in patients with femoro-popliteal lesions and intermittent claudication (IC) or critical limb ischemia (CLI). METHODS: Prospectively collected data of 517 patients (543 limbs) treated for IC (N.=422; 77.5%) and CLI (N.=121; 22.5%), between September 2006 and December 2010 were evaluated. Survival, limb salvage and patency rates were analyzed and multivariate analysis was performed to evaluate possible risk factors for the development of restenosis. RESULTS: Mean patients' age was 70.6 years (SD ±10); 64.8% of the patients (N.=335) were male. Angiography revealed TASC A or B lesions in 64.5% (N.=350), TASC C or D lesions in 35.5% (N.=193) of the patients. Two hundred thirty-two patients had evidence of occluded femoropopliteal artery (42.7%) and the remaining patients had evidence of high grade (>70%) stenosis. In total, 827 bare metal nitinol stents (1.53±0.9 per limb) were used. No early (<30-day) procedure-related death was recorded. After a mean follow-up period of 60 months (SD ±13.5), 69 patients died (13.4%). Eight (1.5%) patients underwent major amputation. The amputation rate was significantly higher in the CLI group compared to the IC group (P=0.03). Primary patency rates were 86.2%, 79.1%, 75.1% and 62.2% after 1, 2, 3 and 5 years, respectively. No difference in terms of patency rates was found between the results of the treatment of TASC A/B versus TASC C/D lesions and the patient groups with IC versus CLI. CONCLUSION: The endovascular-first line treatment with use of nitinol stents for patients with femoropopliteal artery lesions is associated with acceptable long-term patency rates, even in patients with long lesions.


Assuntos
Procedimentos Endovasculares/instrumentação , Artéria Femoral , Claudicação Intermitente/terapia , Isquemia/terapia , Extremidade Inferior/irrigação sanguínea , Doença Arterial Periférica/terapia , Artéria Poplítea , Stents , Idoso , Idoso de 80 Anos ou mais , Ligas , Amputação Cirúrgica , Distribuição de Qui-Quadrado , Constrição Patológica , Estado Terminal , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Feminino , Artéria Femoral/fisiopatologia , Alemanha , Humanos , Claudicação Intermitente/diagnóstico , Claudicação Intermitente/mortalidade , Claudicação Intermitente/fisiopatologia , Isquemia/diagnóstico , Isquemia/mortalidade , Isquemia/fisiopatologia , Estimativa de Kaplan-Meier , Salvamento de Membro , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Razão de Chances , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/fisiopatologia , Artéria Poplítea/fisiopatologia , Modelos de Riscos Proporcionais , Estudos Prospectivos , Desenho de Prótese , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular
15.
J Cardiovasc Surg (Torino) ; 54(1): 83-91, 2013 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-23418641

RESUMO

Carotid artery stenting (CAS) is nowadays considered as alternative therapeutic option to carotid endarterectomy for patients suffering from carotid artery disease. Recent studies and meta-analyses have demonstrated equal performance of carotid stenting to endarterectomy as regard as the overall adverse events (death/stroke rates), especially when periprocedural myocardial infarction and nerve pulses are also included. However, carotid stenting was inferior to endarterectomy when compared in terms of acute and late embolic events. In the present review, we collect all studies available in the published literature regarding the late embolic events. We mainly attempted to gather data regarding the silent embolic events occurring after the acute post-procedural period. We analyzed the results and reported the incidence of the problem. Finally, we aimed to identify possible causes and propose effective solutions to reduce the incidence of late embolic events.


Assuntos
Implante de Prótese Vascular/efeitos adversos , Artérias Carótidas/cirurgia , Estenose das Carótidas/cirurgia , Dispositivos de Proteção Embólica , Embolia Intracraniana , Complicações Pós-Operatórias , Stents , Estenose das Carótidas/complicações , Saúde Global , Humanos , Incidência , Embolia Intracraniana/epidemiologia , Embolia Intracraniana/etiologia , Embolia Intracraniana/cirurgia , Fatores de Tempo
16.
Zentralbl Chir ; 137(5): 466-71, 2012 Oct.
Artigo em Alemão | MEDLINE | ID: mdl-23136106

RESUMO

BACKGROUND: Complications deriving from arterial aneurysm and dissection without signs of atherosclerosis are rare clinical entities. In recent literature case reports show a descriptive similarity of pathological findings summarized as segmental arterial mediolysis (SAM). OBJECTIVE: The purpose of this study was to answer the question whether, among 16 patients suffering from SAM histological findings corresponded and assess causality. MATERIALS AND METHODS: In a prospective prognostic trial sixteen patients were enrolled between 1st January 2008 and 31st October 2011. Inclusion criteria were a lack of atherosclerosis, age under 60 and clinical findings. Most of these sixteen patients were treated as emergency cases of life-threatening blood loss or organ system ischemia. Thirteen of the patients were male, 3 female and their average age was 44 (28-59) years. Localisation of the segmental aneurysm or dissection showed a broad variability from central to renovisceral and peripheral lesions. Imaging diagnostics (e.g., US and CT-A) were complemented by exclusion of positive family history, connective tissue diseases and autoimmune or inflammative disorders. In 8 patients with open vascular reconstructions, it was possible to obtain a biopsy from the target lesion to analyse morphological and immunochemical expression levels (e.g., MMP1-12, vWF, vSMC or CD 68). RESULTS: None of the patients died nor had described familiar associations. Even the examination of twins with sCAD showed no coincidence. Differential diagnostic findings were excluded. All patients agreed to undergo human genetic screening. The 8 biopsy tissues showed homogeneously mediolysis with focal and increasingly confluent lesions. Main findings were that the vessel wall layering was destroyed and that capillarisation was initiated from the adventitial layer. Furthermore, all patients suffered from hypertension associated to the SAM, or developed it during surveillance. CONCLUSION: SAM is a rare, life-threatening diagnosis and has to be taken into consideration in young patients with aneurysm and dissection of unusual locations. Rare vascular diseases should have a forum in future investigations which might highlight molecular genetic triggers and associated diseases, e.g., hypertension and aortic type B dissection.


Assuntos
Aneurisma/diagnóstico , Dissecção Aórtica/diagnóstico , Doença Arterial Periférica/diagnóstico , Túnica Média/patologia , Actinas/análise , Adulto , Dissecção Aórtica/etiologia , Dissecção Aórtica/patologia , Dissecção Aórtica/terapia , Antígenos CD/análise , Antígenos de Diferenciação Mielomonocítica/análise , Biópsia , Feminino , Fator Estimulador de Colônias de Granulócitos e Macrófagos/análise , Humanos , Metaloproteases/análise , Pessoa de Meia-Idade , Doença Arterial Periférica/etiologia , Doença Arterial Periférica/patologia , Doença Arterial Periférica/terapia , Prognóstico , Estudos Prospectivos , Fator de von Willebrand/análise
17.
J Cardiovasc Surg (Torino) ; 53(5): 559-69, 2012 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-22955551

RESUMO

The first randomized controlled trials comparing the two procedures (EVAR versus open repair) for the treatment of abdominal aortic aneurysms showed considerably better short-term outcomes and on the other side higher rates of device-associated reinterventions and remarkable financial burden in the endovascular arm. In the meantime, specialists experience and expertise have been improved significantly. To solve the reported drawbacks and to prevent endografts-associated complications, safer fixation features, lower profile, more flexible design and new revolutionary release and deployment mechanisms of stent-grafts have been also developed and established over the last years. In this review, we present the new EVAR devices and attempt to provide an overview of their premature performance based on the literature and the clinical practice in our institution.


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular/instrumentação , Prótese Vascular , Procedimentos Endovasculares/instrumentação , Stents , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aortografia/métodos , Implante de Prótese Vascular/efeitos adversos , Procedimentos Endovasculares/efeitos adversos , Medicina Baseada em Evidências , Humanos , Desenho de Prótese , Ensaios Clínicos Controlados Aleatórios como Assunto , Sistema de Registros , Medição de Risco , Fatores de Risco , Tomografia Computadorizada por Raios X , Resultado do Tratamento
18.
Vasa ; 41(4): 282-7, 2012 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-22825862

RESUMO

BACKGROUND: This study was initiated to evaluate the cardiovascular benefit of perioperative use of acetylsalicylic acid (ASA) in patients undergoing carotid surgery. PATIENTS AND METHODS: A prospective two-arm comparative study was conducted and focused on cardiac, neurological and bleeding complications for patients with high-grade (> 80 %) asymptomatic or symptomatic (> 60 %), internal carotid artery stenosis based on NASCET criteria who were treated by surgery. Between March 2008 and November 2010, 540 patients underwent carotid endarterectomy in two European vascular centers. In particular, 267 consecutive patients (49.4 %) had taken perioperative ASA in one center; in 273 consecutive patients in the other center ASA administration was stopped 5 days preoperatively. RESULTS: The overall complication rate was lower in the ASA group (5.2 % versus 17.6 %), p < 0.001, 95 %CI [2.1;7.2], OR 3.8. In detail, the myocardial event rate was lower in the ASA arm: 0.7 versus 4.4 %; p = 0.012, OR 6.1 (95 %CI [1.4;27.45]. Concerning stroke, ASA patients benefit from oral antiaggregation as well: 1.5 vs. 5.5 %; p = 0.036), OR 4.5, 95 %CI[1.3;11.7], respectively. The bleeding complications were similar in both subgroups, 8 for the ASA group (3.0 %) and 10 (3.7 %) for the non-ASA group, p = 0.66. Multivariate logistic regression analysis showed significant benefit of the ASA-treatment in patients with hypertension, diabetes mellitus and hypercholesterolemia, p < 0.001. Additionally, female patients of the ASA group also had significantly less overall (p = 0.10, OR5.3), cardiac (p = 0.021, OR 3.6) and neurologic (p = 0.042, OR 6.7) complications. Bleeding risk was not higher in female patients receiving ASA (p = 0.25). CONCLUSIONS: Perioperative use of ASA for patients undergoing carotid endarterectomy is associated with a lower risk of cardiac and neurological events without significant increase of postoperative bleeding necessitating revision.


Assuntos
Aspirina/administração & dosagem , Artéria Carótida Interna/cirurgia , Estenose das Carótidas/terapia , Endarterectomia das Carótidas , Inibidores da Agregação Plaquetária/administração & dosagem , Administração Oral , Idoso , Aspirina/efeitos adversos , Estenose das Carótidas/complicações , Estenose das Carótidas/diagnóstico , Estenose das Carótidas/tratamento farmacológico , Estenose das Carótidas/mortalidade , Estenose das Carótidas/cirurgia , Esquema de Medicação , Endarterectomia das Carótidas/efeitos adversos , Endarterectomia das Carótidas/mortalidade , Feminino , Alemanha , Cardiopatias/etiologia , Cardiopatias/prevenção & controle , Hemorragia/induzido quimicamente , Humanos , Modelos Logísticos , Masculino , Análise Multivariada , Razão de Chances , Período Perioperatório , Inibidores da Agregação Plaquetária/efeitos adversos , Modelos de Riscos Proporcionais , Estudos Prospectivos , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Fatores de Tempo , Resultado do Tratamento
19.
J Cardiovasc Surg (Torino) ; 53(2): 153-9, 2012 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-22456636

RESUMO

AIM: The aim of the present article is to describe a new thoracic stent graft (Zenith TX2 Low-Profile TAA Endovascular Graft). METHODS: Feasibility of endovascular repair of thoracic aortic aneurysms depends on several anatomic factors. A primary limitation is an adequate arterial approach. Since most currently used endografts require large introducer sheaths, patients with severely diseased iliofemoral vessels are often excluded from this less-invasive technique. Attempts to overcome access difficulties increase the risk for arterial access-site complications such as aortoiliac rupture. In addition, highly angulated proximal landing zones provide challenges in obtaining proximal graft conformance and sealing. RESULTS: The introduction of next-generation endografts such as the Zenith TX2LowProfile TAA Endovascular Graft provides a solution for a larger number of patients, including those with small vessels, vascular access problems and tortuous aortic anatomy. CONCLUSION: The ongoing Zenith TX2 Low-Profile Endovascular Graft trial will build further understanding of the performance of the device allowing for treatment of a wider patient population.


Assuntos
Aneurisma da Aorta Torácica/cirurgia , Prótese Vascular , Procedimentos Endovasculares/métodos , Angiografia , Aneurisma da Aorta Torácica/diagnóstico por imagem , Seguimentos , Humanos , Estudos Prospectivos , Desenho de Prótese , Tomografia Computadorizada por Raios X , Resultado do Tratamento
20.
Zentralbl Chir ; 136(5): 426-30, 2011 Oct.
Artigo em Alemão | MEDLINE | ID: mdl-22009540

RESUMO

BACKGROUND: The increasing number of endovascular procedures made aware of a kidney disease induced by contrast media (CM). Contrast-induced nephropathy (= CIN) can develop in 0.6-44 % of the treated patients by angiography and / or endovascular intervention. The incidence in high-risk patients ranges from 50 to 70 %. In most cases CIN is inconspicuous and reversible. But pre-existing chronic kidney disease, diabetes mellitus, age and variable different risk factors (e. g., PAOD) can induce irreversible renal impairment. The purpose of the presented trial is to investigate incidence, predictors, and out-come of CIN in chronic renal failure patients using two different CM; one non-ionic isoosmolar -iodixanol and the other non-ionic low-osmolar iopromide. METHODS: To evaluate the incidence of CIN after endovascular diagnostics and intervention two collectives of 100  patients with chronic renal insufficiency were treated with different contrast media (CM). Inclusion followed prospectively in two collectives. One collective received iopromide (Ultravist™, Bayer Health Care, Lever-kusen, Germany), and the second hundred patients received iodixanol (Visipaque™, Nycomed Amersham, Princeton, New Jersey). Demographics, comorbidities, procedure-related data were completed by serum creatinine levels and GFR (= glomerular filtration rate). Inclusion criteria were a serum creatinine level ≥ 1.5 mg% and a GFR ≤ 60 mL / min. Those parameters were measured twice pre-interventionally, and one time 48-72  hours after the endovascular procedure. RESULTS: Collectives were homogenous and comparable concerning pre-existing risk factors, age and gender. Renal function stayed at a constant level and was independent of contrast medium selection, repectively. Average creatinine levels ranged around 1.77 mg% ±â€Š0.75  standard deviation (SD) pre-interventionally; postinterventional measurement exposed a creatinine level of 1.74 mg% ±â€Š0.74 SD as mean of both collectives. GFR (preinterventional 39.64 mL / min ±â€Š12.48 SD) increased non-significantly to 45.48 mL / min ±â€Š16.82 SD. Pre-existing chronic kidney disease had no effect on renal function parameters; no other risk factors could be evaluated. CONCLUSION: According to cost-effectiveness a low-osmolar monomeric contrast medium (LOCM) is a sufficient selection, under careful renal function control.


Assuntos
Angiografia , Angioplastia com Balão , Meios de Contraste/toxicidade , Iohexol/análogos & derivados , Nefropatias/induzido quimicamente , Nefropatias/prevenção & controle , Falência Renal Crônica/diagnóstico por imagem , Falência Renal Crônica/terapia , Testes de Função Renal , Obstrução da Artéria Renal/diagnóstico por imagem , Obstrução da Artéria Renal/terapia , Ácidos Tri-Iodobenzoicos/toxicidade , Idoso , Idoso de 80 Anos ou mais , Angiografia/economia , Angioplastia com Balão/economia , Meios de Contraste/administração & dosagem , Meios de Contraste/economia , Análise Custo-Benefício , Creatinina/sangue , Feminino , Taxa de Filtração Glomerular/efeitos dos fármacos , Humanos , Iohexol/economia , Iohexol/toxicidade , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores de Risco , Ácidos Tri-Iodobenzoicos/economia
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