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1.
Diab Vasc Dis Res ; 17(5): 1479164120930589, 2020.
Article En | MEDLINE | ID: mdl-32589047

BACKGROUND: In many cases, Ilomedin® infusions are applied as part of a perioperative measure in patients with peripheral arterial occlusive disease because it makes a relevant vasodilatatory effect in patients with type 2 diabetes mellitus and with/without peripheral neuropathy. AIMS: A prospective case-control study was performed to investigate the effect of prostanoids on peripheral resistance in patients with type 2 diabetes mellitus and patients without type 2 diabetes mellitus, as well as the role of peripheral neuropathy in patients undergoing arterial reconstruction. METHODS: Sixty patients undergoing arterial reconstruction were enrolled. Sufficient data were collected on 38 patients. Prior to surgery, peripheral nerve conduction velocity was measured. Blood flow volume at the common femoral artery was assessed intraoperatively using a Doppler flowmeter at four time points: at baseline before arterial reconstruction (T0), after reconstruction (T1), after 5 (T2) and 10 min (T3) after intra-arterial application of 3000 ng of Ilomedin. Peripheral resistance units were calculated as a function of mean arterial pressure and flow volume using the following formula: peripheral resistance unit = mean arterial pressure (mm Hg) / flow volume (mL/min). RESULTS: Ilomedin produced an immediate and significant drop of peripheral resistance in patients without type 2 diabetes mellitus as well as in patients with type 2 diabetes mellitus. Patients with peripheral neuropathy showed a less pronounced effect to Ilomedin compared to individuals with normal nerve conduction velocity.


Diabetes Mellitus, Type 2/physiopathology , Iloprost/administration & dosage , Peripheral Arterial Disease/drug therapy , Peripheral Arterial Disease/surgery , Vascular Resistance/drug effects , Vascular Surgical Procedures , Vasodilation/drug effects , Vasodilator Agents/administration & dosage , Adult , Aged , Aged, 80 and over , Case-Control Studies , Diabetes Mellitus, Type 2/diagnosis , Female , Humans , Iloprost/adverse effects , Infusions, Intra-Arterial , Intraoperative Care , Male , Middle Aged , Peripheral Arterial Disease/diagnosis , Peripheral Arterial Disease/physiopathology , Prospective Studies , Treatment Outcome , Vascular Surgical Procedures/adverse effects , Vasodilator Agents/adverse effects , Young Adult
2.
Eur J Vasc Endovasc Surg ; 58(6): 831-838, 2019 Dec.
Article En | MEDLINE | ID: mdl-31615695

OBJECTIVES: At 12 months follow up of the PLIANT study, clinical success and efficacy of the E-liac Stent Graft System (JOTEC GmbH, Hechingen, Germany) were evaluated. Clinical success was defined as aneurysm exclusion (no type I, III, IV endoleak) with primary patency of the internal iliac artery (IIA) and external iliac artery (EIA) on the E-liac implantation side. METHODS: In this prospective multicentre European observational study, clinical and morphological data of 45 patients (93% male, mean age 72 y) were prospectively collected in 11 European centres between July 2014 and June 2016. Forty patients underwent an aorto-iliac (three patients bilaterally) treatment and five an isolated iliac treatment. RESULTS: At 12 months follow up, data were available for 42 patients. Overall clinical success at 12 months was 90%, with a survival rate of 100%. Four patients (10%) did not achieve clinical success, one with an internal iliac artery (IIA) occlusion on the E-liac implantation side, one with an infrarenal type Ia endoleak, and two with type Ib endoleaks in IIA. At 12 months the primary patency rate in the internal iliac artery on the iliac side branch implantation side was 98%. Two patients (5%) received E-liac related re-interventions: one caused by an edge stenosis at the distal end of the graft limb in the external iliac artery (EIA) and one caused by thrombo-embolism in the external iliac artery. Thus, for the EIA, primary and secondary patency rates were 98% and 100%, respectively. CONCLUSIONS: The low device related re-intervention rate of 5%, the high survival rate of 100%, and the high primary patency rates of 98% for the IIA and EIA at 12 month follow up demonstrate the safety and efficacy of the E-liac Stent Graft System. Long term 36 month results are awaited to confirm the efficacy and durability.


Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis/adverse effects , Endoleak/epidemiology , Endovascular Procedures/instrumentation , Graft Occlusion, Vascular/epidemiology , Iliac Aneurysm/surgery , Self Expandable Metallic Stents/adverse effects , Aged , Aged, 80 and over , Blood Vessel Prosthesis Implantation/adverse effects , Computed Tomography Angiography , Endoleak/diagnostic imaging , Endoleak/etiology , Endovascular Procedures/adverse effects , Europe , Female , Follow-Up Studies , Graft Occlusion, Vascular/diagnostic imaging , Graft Occlusion, Vascular/etiology , Humans , Iliac Artery/diagnostic imaging , Iliac Artery/surgery , Male , Middle Aged , Prospective Studies , Reoperation/statistics & numerical data , Treatment Outcome
3.
J Vasc Surg ; 70(4): 1107-1114, 2019 10.
Article En | MEDLINE | ID: mdl-31147136

OBJECTIVE: Internal iliac artery aneurysm (IIAA) is a rare entity. Its treatment can be technically challenging. The aim of this study was to evaluate the treatment possibilities in an era of advanced endovascular techniques and their potential to preserve iliac blood flow while reliably excluding the aneurysm. METHODS: A retrospective analysis of 46 consecutive patients with endovascularly treated IIAA was performed. Data were collected from a single-institution aortoiliac database. The following end points were recorded: technique of aneurysm exclusion, technical success rates, perioperative morbidity and mortality, primary patency, and midterm follow-up. RESULTS: Between September 2009 and May 2016, a total of 46 patients with 55 IIAAs were identified. The majority of patients (n = 39 [84.8%]) had aortoiliac aneurysms and seven had isolated IIAAs (15.2%). The following surgical techniques were used: implantation of iliac branch devices (IBDs; n = 29), occlusion of the internal iliac artery (IIA) by ostium coverage with or without prior coil embolization (n = 23), and other endovascular techniques (n = 3). Primary assisted technical success was achieved in 93.1% of IBD implantations and in 100% of occlusions by ostium coverage and other techniques. Overall 30-day mortality was 4.3% (n = 2) and 0% in electively treated patients. Assisted midterm patency after IBD implantation was 93.1%. Gluteal claudication occurred in seven patients (15.2%) who had undergone intentional or accidental occlusion of the IIA or the superior gluteal artery. Reintervention rates within the midterm follow-up were 13.8% (n = 4) after IBD implantation and 4.3% (n = 1) after coverage of the IIA ostium. No ruptures were observed during follow-up, and no complications occurred during reinterventions. CONCLUSIONS: Implantation of IBD devices for the treatment of hypogastric artery aneurysms shows good technical results with a high primary patency and a low rate of perioperative complications. Although successful aneurysm exclusion while preserving pelvic blood flow is associated with a higher rate of reinterventions during midterm follow-up, it should be taken into consideration, especially in complex endovascular aortoiliac aneurysm repair.


Blood Vessel Prosthesis Implantation , Endovascular Procedures , Iliac Aneurysm/surgery , Aged , Aged, 80 and over , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis Implantation/mortality , Embolization, Therapeutic , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Endovascular Procedures/mortality , Feasibility Studies , Female , Humans , Iliac Aneurysm/diagnostic imaging , Iliac Aneurysm/mortality , Male , Middle Aged , Postoperative Complications/etiology , Prosthesis Design , Retrospective Studies , Risk Factors , Time Factors , Treatment Outcome , Vascular Patency
4.
Vascular ; 26(6): 647-656, 2018 Dec.
Article En | MEDLINE | ID: mdl-30037302

OBJECTIVES: To study the safety and feasibility of the E-liac Stent Graft System® in patients with aorto/iliac aneurysms. METHODS: A prospective multicentric European registry of patients receiving the E-liac Stent Graft System® was conducted. Endpoints of the study included the technical success as well as periprocedural events and 30-day endoleaks, reinterventions, internal and external iliac artery patency and mortality. RESULTS: Between July 2014 and June 2016, a total of 45 patients (93% men, mean age 72 years, range 53-90 years) were enrolled at 11 sites in four European countries. Five patients received an isolated iliac treatment. Thirty-seven patients were treated with a combination of an abdominal stent graft and a unilateral E-liac and three in combination with bilateral E-liac. All E-liac Stent Grafts (48) were implanted in the intended position and the internal iliac arteries were successfully bridged. Two patients did not receive clinical success, due to endoleak type Ia of the aortic stent graft. At 30-day follow-up, clinical success rate was 96%. Three successful endovascular reinterventions were performed within the 30-day follow-up: one due to a type Ia endoleak in the common iliac artery, one due to type Ia endoleak of the aortic stent graft, and one due to bilateral lower limb claudication provoked by stent graft limb stenosis. At 30-day, a 100% survival rate and complete absence of pelvic or buttock ischemia/claudication were reported. Primary patency at 30 days was 100% for the internal iliac artery and 98% for the external iliac artery with an assisted patency of 100% in the latter. CONCLUSIONS: The high clinical success rate, low rates of device-related reinterventions (2%), and excellent patency rate demonstrate the safety and feasibility of the E-liac Stent Graft System. Long-term results are awaited to state efficacy and durability. Clinical Trials.gov. Identifier no. NCT02209194.


Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endovascular Procedures/instrumentation , Iliac Aneurysm/surgery , Stents , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/physiopathology , Blood Vessel Prosthesis Implantation/adverse effects , Computed Tomography Angiography , Endovascular Procedures/adverse effects , Feasibility Studies , Female , Humans , Iliac Aneurysm/diagnostic imaging , Iliac Aneurysm/physiopathology , Male , Middle Aged , Postoperative Complications/etiology , Prospective Studies , Prosthesis Design , Time Factors , Treatment Outcome , Vascular Patency
5.
J Vasc Surg ; 66(5): 1334-1339, 2017 11.
Article En | MEDLINE | ID: mdl-28559175

OBJECTIVE: Endovascular aortic aneurysm repair (EVAR) with a fenestrated device (FEVAR) allows an extension of the proximal sealing zone above the renal arteries to an adequate, healthier segment of the aorta. This feature makes FEVAR an option to treat patients with a diseased aortic neck or type Ia endoleak after EVAR. The aim of this investigation was to present a single-center experience with FEVAR for patients with an abdominal aortic endograft in situ compared with primary FEVAR. METHODS: A prospectively held database on FEVAR patients treated with the fenestrated Anaconda device (Vascutek/Terumo, Inchinnan, Scotland, United Kingdom) at our institution was screened for individuals who had previously undergone EVAR. RESULTS: Between April 1, 2013, and July 31, 2016, 94 fenestrated Anaconda devices were implanted at our institution. Twelve patients with prior EVAR were treated for pathology of the proximal neck: type I endoleak (n = 7), for stent migration with aneurysm progression but no visible endoleak (n = 2), and progressive aortic disease at the level of the visceral segment (n = 3). When redo cases and primary FEVARs were compared, primary technical success rates were 58.3% and 87.8% (P = .02) and primary functional success rates were 91.7% and 95.1%, respectively (P = .62). Perioperative rate of major deployment-related (14.6% and 16.7%) and systemic complications (8.5% and 8.3%) as well as 30-day mortality (6.1% and 0%; P = .5) were comparable between groups. After an average follow-up interval of 10 months (range, 0-43 months), no late occlusions of connecting stents were observed. The late reintervention rates were 11.0% and 16.7%, respectively (P = .57). CONCLUSIONS: The risk of a failure to cannulate one or more visceral arteries through the respective fenestrations was increased in patients who had previously undergone EVAR. This is most likely caused by increased friction between the fenestrated endograft and the failing graft in situ, which may impair the adaption of the unsupported Anaconda device to the aortic wall. As a consequence, fenestrations may not line up perfectly at the respective openings of the visceral or renal arteries, and folding of the fabric may be increased, making cannulation of the fenestrations more difficult.


Aortic Aneurysm/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endoleak/surgery , Endovascular Procedures/instrumentation , Foreign-Body Migration/surgery , Aged , Aortic Aneurysm/diagnostic imaging , Blood Vessel Prosthesis Implantation/adverse effects , Databases, Factual , Endoleak/diagnostic imaging , Endoleak/etiology , Endovascular Procedures/adverse effects , Female , Foreign-Body Migration/diagnostic imaging , Foreign-Body Migration/etiology , Humans , Male , Prosthesis Design , Prosthesis Failure , Reoperation , Retrospective Studies , Risk Factors , Time Factors
6.
Wound Repair Regen ; 24(5): 928-935, 2016 Sep.
Article En | MEDLINE | ID: mdl-27313054

Negative pressure wound therapy (NPWT) is the treatment of choice for chronic wounds; yet, it is associated with considerable workload. Prompted by its nonadhesive and wound-healing properties, this study investigated the effect of an additional polymeric membrane interface dressing (PMD; PolyMem WIC) in NPWT. From October 2011 to April 2013, 60 consecutive patients with chronic leg wounds or surgical site infections after revascularization of lower extremities were randomly allocated to either treatment with conventional NPWT (control arm) or NPWT with an additional PMD (intervention arm). The primary outcome was wound healing achieved within 30 days, the secondary endpoints included: number of days between dressing changes, wound-related pain, cost efficiency, and occurrence of adverse events (ClinTrials.gov Identifier: NCT02399722). Forty-seven patients completed follow-up. No difference in wound healing was observed (p > 0.05) between both study arms. The additional PMD allowed significantly longer wearing times (days) between dressing changes (intervention: 8.8 ± 0.5, control: 4.8 ± 0.2; p < 0.001). Pain was slightly higher in patients randomized to NPWT alone (VAS score: 4.8 ± 2.9) compared to NPWT + PMD (VAS score: 3.0 ± 2.9, p = 0.063). No wound infections were observed. Costs were reduced by 34% per patient in the intervention arm. These results suggest that the combination of NPWT and an additional interface PMD is a safe and economic method for the treatment of chronic wounds, which requires significantly fewer dressing changes for a comparable wound healing.

7.
J Endovasc Ther ; 23(4): 661-5, 2016 Aug.
Article En | MEDLINE | ID: mdl-27193307

PURPOSE: To present the off-label use of an iliac side branch device to connect an accessory right renal artery to a bifurcated endograft in infrarenal aortic aneurysm repair. CASE REPORT: An 83-year-old woman with a 54-mm infrarenal abdominal aortic aneurysm underwent endovascular repair using an iliac side branch device for accessory renal artery salvage. The procedure was technically successful, and no immediate perioperative adverse events were encountered. The creatinine level increased slightly. Six-month follow-up imaging revealed no endoleaks or occlusion. CONCLUSION: Considering the higher perioperative risk associated with open or hybrid procedures for similar cases, this off-label application of a well-recognized endovascular device deserves consideration as an alternative treatment option.


Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endovascular Procedures/instrumentation , Prosthesis Design , Renal Artery/surgery , Stents , Vascular Malformations/complications , Aged, 80 and over , Aortic Aneurysm, Abdominal/complications , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortography/methods , Computed Tomography Angiography , Female , Humans , Multidetector Computed Tomography , Renal Artery/abnormalities , Renal Artery/diagnostic imaging , Treatment Outcome , Vascular Malformations/diagnostic imaging
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