15 research outputs found

    Outcomes and costs analysis of Externalized PyeloUreteral versus internal Double-J ureteral stents after paediatric laparoscopic Anderson-Hynes pyeloplasty

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    BACKGROUND: The gold standard treatment for Uretero-Pelvic Junction Obstruction (UPJO) is laparoscopic dismembered pyeloplasty according to the Anderson-Hynes technique. The internal Double-J ureteral (DJ) and the Externalized PyeloUreteral (EPU) stents are usually the drainage of choice. Only a few articles have compared the clinical impact of the different drainage techniques on the perioperative morbidity and none presented a cost analysis of the incurred hospital stay. OBJECTIVE: To present the clinical outcome and financial analysis of a cohort of children who underwent a laparoscopic pyeloplasty comparing the use of the DJ versus EPU stent. STUDY DESIGN: Retrospective study of consecutives children who underwent laparoscopic Anderson-Hynes pyeloplasty in a single tertiary paediatric referral centre from January 2017 to March 2020. Patients were grouped according to the type of stent used: DJ stent vs EPU stent. RESULTS: Fifty-three laparoscopic pyeloplasties were performed on 51 patients: 27 (50.9%) had an EPU stent and 26 (49.1%) a DJ stent. There was no statistically significant difference between the two patient groups with regards to surgical time, hospital stay, stent-related complications or the need for re-do surgery. All the EPU stents were removed with an outpatient admission 8.1 days ± 3.1 after surgery while the DJ stents were removed with a cystoscopy 61.6 days ± 30.2 after surgery (p value < 0.001). On a financial analysis (Figure), the hospital costs for stent removal were significantly lower for the EPU stent group (£ 686.7 ± 263.4 vs £ 1425 ± 299.5, p value < 0.01). DISCUSSION: Both drainage methods have some disadvantages. Possible complications associated with DJ stents include migration and artificial vesicoureteral reflux which may lead to higher incidence of Urinary Tract Infections. Possible disadvantages of the EPU stent insertion are related to the damage of the renal parenchyma and to the risk of developing skin site infections and urinary leaks. However, in our series the EPU stent has not been associated with a higher incidence of bleeding, leakage or discomfort. In addition to clinical considerations, there is a financial implication to be considered. With this regard, the EPU stent was associated with a significant reduction in the incurred hospital costs. CONCLUSIONS: The use of DJ and EPU stents is equivalent in regards of overall complications and success rates. DJ and EPU stents provided comparable success and complication rates, however the latter avoids the need of an additional general anaesthesia and reduces the overall incurred hospital costs

    A comprehensive evaluation of sexual and reproductive outcomes following robot-assisted retroperitoneal lymph node dissection for nonseminomatous germ cell tumor

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    Sexual disorders following retroperitoneal pelvic lymph node dissection (RPLND) for testis tumor can affect the quality of life of patients. The aim of the current study was to investigate several different andrological outcomes, which may be influenced by robot-assisted (RA) RPLND. From January 2012 to March 2020, 32 patients underwent RA-RPLND for stage I nonseminomatous testis cancer or postchemotherapy (PC) residual mass. Modified unilateral RPLND nerve-sparing template was always used. Major variables of interest were erectile dysfunction (ED), premature ejaculation (PE), dry ejaculation (DE), or orgasm alteration. Finally, fertility as well as the fecundation process (sexual intercourse or medically assisted procreation [MAP]) was investigated. Ten patients (31.3%) presented an andrological disorder of any type after RA-RPLND. Hypospermia was present in 4 (12.5%) patients, DE (International Index of Erectile Function-5 [IIEF-5] &lt; 25) in 3 (9.4%) patients, and ED in 3 (9.4%) patients. No PE or orgasmic alterations were described. Similar median age at surgery, body mass index (BMI), number of nodes removed, scholar status, and preoperative risk factor rates were identified between groups. Of all these 10 patients, 6 (60.0%) were treated at the beginning of our robotic experience (2012-2016). Of all 32 patients, 5 (15.6%) attempted to have a child after RA-RPLND. All of these 5 patients have successfully fathered children, but 2 (40.0%) required a MAP. In conclusion, a nonnegligible number of andrological complications occurred after RA-RPLND, mainly represented by ejaculation disorders, but ED occurrence and overall sexual satisfaction deficit should be definitely considered. No negative impact on fertility was described after RA-RPLND

    Safety and Efficacy of Vacuum Assisted Thrombo-Aspiration in Patients with Acute Lower Limb Ischaemia: The INDIAN Trial

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    Objective: The aim was to evaluate the short term safety and effectiveness of the Penumbra/Indigo aspiration thrombectomy Systems (Penumbra Inc.) in patients with acute lower limb ischaemia. (ALLI). Recently, endovascular vacuum assisted thrombectomy devices, similar to those used in the management of acute ischaemic stroke, have become available for peripheral arteries, but data are still scarce. Methods: To assess vessel patency, a modified Thrombolysis in Myocardial Infarction (TIMI) classification, called TIPI (Thrombo-aspiration In Peripheral Ischaemia), is proposed. The TIPI flow is assessed at presentation, immediately after treatment with the study device, and after all adjuvant procedures. The primary outcome is the technical success of the thrombo-aspiration with the investigative system, defined as near complete or complete revascularisation TIPI 2 \u2013 3. Safety and clinical success rate were collected at one month. Results: One hundred and fifty patients were enrolled. The mean age was 72.4 years and 73.3% were male. Rutherford grade on enrolment was I in 16%, IIa in 40.7%, and IIb in 43.3% with a mean ankle brachial index of 0.19. Primary technical success (TIPI 2 \u2013 3 flow) was achieved in 88.7% of patients. Adjunctive procedures included angioplasty/stenting of chronic atherosclerotic lesions (n = 39), thrombolysis (n = 31), covered stenting (n = 15), and supplementary Fogarty embolectomy (n = 6). After all interventions, assisted primary technical success was 95.3% (TIPI 2 \u2013 3 in 143/150). No systemic bleeding complications or device related serious adverse events were reported. At one month follow up, one death, and one below the knee amputation were recorded. Primary patency was 92% (138/150), and the re-intervention rate was 7.33%, resulting in an assisted primary and secondary patency of 94% and 99.33%, respectively. Conclusion: Results from the INDIAN registry reveal that mechanical thrombectomy using the Indigo system is safe and effective for revascularisation of ALLI as a primary therapy

    Comparison of aortoiliac repair with iliac branch endoprosthesis versus hypogastric occlusion in aortoiliac aneurysms

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    BACKGROUND: The CARIBE Study aims to assess the outcome of endovascular repair (EVAR) with iliac branch endoprosthesis (IBE) in patients with aorto-iliac aneurysms extending to iliac bifurcation, comparing these results with those of EVAR with hypogastric occlusion present in the recent published literature.METHODS: Patients with aorto-iliac aneurysms anatomically suitable for EVAR with IBE, are included in the study.RESULTS: Primary safety outcome measure are total and aneurysm related death free survival. Efficacy endpoints include: iliac branch patency, aneurysmal sac exclusion and freedom from reinterventions or conversion to open repair. Patient reported outcomes are evaluated with Walking Impairment Questionnaire (WIQ), International Index of Erectile Function-5 (IIEF-5) and quality of life Euro-Qual EQ-5D Questionnaire.CONCLUSIONS: Comparison with recent hystorical literature obtained in patients with EVAR with HA occlusion will offer data useful for correct information of patients affected by aorto-iliac aneurysms

    Comparison of aortoiliac repair with iliac branch endoprosthesis versus hypogastric occlusion in aortoiliac aneurysms

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    BACKGROUND: The CARIBE Study aims to assess the outcome of endovascular repair (EVAR) with iliac branch endoprosthesis (IBE) in patients with aorto-iliac aneurysms extending to iliac bifurcation, comparing these results with those of EVAR with hypogastric occlusion pres¬ ent in the recent published literature. METHODS: Patients with aorto-iliac aneurysms anatomically suitable for EVAR with IBE, are included in the study. RESULTS: Primary safety outcome measure are total and aneurysm related death free survival. Efficacy endpoints include: iliac branch patency, aneurysmal sac exclusion and freedom from reinterventions or conversion to open repair. Patient reported outcomes are evaluated with Walking Impairment Questionnaire (WIQ), International Index of Erectile Function-5 (IIEF-5) and quality of life Euro-Qual EQ-5D Questionnaire. CONCLuSIONS: Comparison with recent hystorical literature obtained in patients with EVAR with HA occlusion will offer data useful for correct information of patients affected by aorto-iliac aneurysms

    Preliminary results of endovascular aneurysm sealing from the multicenter Italian Research on Nellix Endoprosthesis (IRENE) study

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    Objective: Because of advances in technology and experience of the operator, endovascular aneurysm repair (EVAR) has supplanted open repair to treat abdominal aortic aneurysm (AAA). The low 30-day mortality and morbidity of EVAR make the endovascular approach particularly suitable for patients at high surgical risk. However, endoleak or endograft migration requiring secondary intervention or open surgical conversion is a limitation of EVAR. The Nellix system (Endologix, Inc, Irvine, Calif) has been designed to seal the entire AAA to overcome these limitations with EVAR. We report the results of a retrospective, multicenter study with endovascular aneurysm sealing (EVAS) aimed to assess technical success, procedure-related mortality, complications, and reinterventions. Methods: This study included patients selected for elective treatment with the Nellix device per the endovascular repair protocol at 16 Italian vascular centers. All patients were enrolled in a postoperative surveillance imaging program including duplex ultrasound investigations, computed tomography, and magnetic resonance controls following local standards of care. Results: From 2013 to 2015, there were 335 patients (age, 75.5 \ub1 7.4 years; 316 men) who underwent elective EVAS. In 295 cases (88.0%), EVAS was performed under standard instructions for use of the Nellix system. Preoperative aneurysm diameter was 55.5 \ub1 9.4 mm (range, 46-65 mm). The inferior mesenteric artery and lumbar arteries emerging from the AAA were patent in 61.8% and 81.3% of cases, respectively. Chimney grafts were electively carried out in eight cases (2.4%). One (0.3%) intraprocedural type IB endoleak was observed and promptly corrected. Device deployment was successful in all patients, with no perioperative mortality. Early ( 6430 days) complications included 1 (0.3%) type IA endoleak, 2 (0.6%) type II endoleaks (0.6%), 2 (0.6%) stent occlusions (0.6%), 3 (0.9%) distal embolizations, and 2 (0.2%) femoral artery dissections. Six (2.9%) patients underwent reinterventions. At 1-year follow-up, complications included 3 (1.1%) type II endoleaks, 4 (1.4%) type IA endoleaks, 1 (0.3%) type IB endoleak, 2 (0.7%) distal stent migrations, 5 (1.8%) distal embolizations, and 1 (0.3%) stent occlusion. Twelve patients (3.7%) underwent reinterventions, including four (1.4%) surgical conversions due to aortoduodenal fistula (1), endograft infection (1), and type IA endoleak that was unsuccessfully treated percutaneously (2). Two AAA-related deaths occurred. Freedom from aneurysm-related reintervention was 98.3% at 1-month and 94.7% at 12-month follow-up. Conclusions: The preliminary results of this real-world multicenter study showed that EVAS with Nellix for the management of AAAs appears feasible. This device platform is associated with acceptable procedure-related mortality and low overall complication and reintervention rates. Definitive conclusions on the value of this novel device await long-term follow-up data

    Unibody Endograft Using AFX 2 for Less Invasive and Faster Endovascular Aortic Repair: Protocol for a Multicenter Nonrandomized Study

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    Since the introduction of endovascular aortic repair (EVAR) for treatment of abdominal aortic aneurysms (AAAs), progressive improvements in results have been achieved. However, conventional bifurcated stent grafts have been proven to have a nonnegligible risk of failure and secondary intervention, principally due to the lack of adequate proximal sealing. The unique AFX 2 Endovascular AAA System (Endologix, Irvine, CA) unibody device, which provides different sealing and fixation features compared with conventional devices, seems to overcome these limitations

    Preliminary six-month outcomes of LIMBSAVE (treatment of critical Limb IscheMia with infragenicular Bypass adopting in situ SAphenous VEin technique) registry

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    Objectives: Guidelines recommend open bypass surgery for long occlusions of infrainguinal arteries. In situ saphenous vein bypass is a standardized technique. The aim of this study was to report preliminary six-month outcomes of a national, multicenter, observational, prospective registry based on the examination of treatment of critical Limb IscheMia with infragenicular Bypass adopting the in situ SAphenous VEin technique (LIMBSAVE). Methods: From January 2018 until October 2019, 428 patients from 41 centers were enrolled in the LIMBSAVE registry. Data were prospectively collected in a dedicated database, including demographics, preoperative risk factors, clinical and diagnostic preoperative assessments, intraoperative measures (including safety and effectiveness of the valvulotome during the surgical procedures), and 30-day follow-up data. Furthermore, estimated six-month outcomes according to Kaplan\u2013Meier curves in terms of primary patency, primary assisted patency, secondary patency, and limb salvage were evaluated. Results: Patients were predominantly male (n = 332, 77.6%) with a mean age of 73.3 years (range 39\u201395). Technical success, defined as bypass pulse after use of the valvulotome, was obtained in all cases. The proximal anastomosis could be reached by the valvulotome in all cases. The mean number of valvulotome uses was 2.5 (range 1\u20135). No vein perforation was reported. In nine cases (2.1%), a vein lesion with intramural hemorrhage occurred. The mean length of hospital stay was 11.1 days (range 1\u201360). At 30-day follow-up, the overall bypass patency rate was 97.4%, and the rate of open or endo reinterventions for failing bypass was 5.4%. At six-month follow-up, the estimated primary patency, primary assisted patency, secondary patency, and limb salvage were 78.1%, 86.2%, 92.1%, and 94.7%, respectively. Conclusions: Preliminary intraprocedural outcomes of the LIMBSAVE registry show that the in situ technique with the valvulotome is safe and effective in disrupting valves and obtaining pulsatility in the saphenous vein. The complication rate related to the use of the valvulotome is low. The six-month preliminary outcomes in terms of overall patency and limb salvage are promising. Further examinations and continuous follow-up are needed to evaluate long-term outcomes
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