Purpose: To compare the total initial treatment costs for open surgery, endovascular revascularization, and primary major amputation within a single-payer healthcare system. Methods: A multicenter, retrospective analysis was undertaken to evaluate 1138 patients with symptomatic peripheral artery disease (PAD) who underwent 1017 endovascular procedures, 86 open surgeries, and 35 major amputations between 2013 and 2016. A cost-mix analysis was performed on individual patient data generated for selected diagnosis-related groups. Mean costs are presented with the 95% confidence interval (CI). Results: There was no intergroup difference in demographics or private health insurance status. However, the amputation group had a higher proportion of emergency procedures (68.6% vs 13.3% vs 27.9%, p<0.001) and critical limb ischemia (88.6% vs 35.9% vs 37.2%, p<0.001) compared with the endovascular therapy and open surgery groups, respectively. The endovascular revascularization group spent less time in hospital and used fewer intensive care unit (ICU) resources compared with the open surgery and major amputation groups (hospital length of stay: 3.4 vs 10.0 vs 20.2 days, p<0.01; ICU: 2.4 vs 22.6 vs 54.6 hours, p<0.01), respectively. While mean prosthetic and device costs were higher in the endovascular group [AUD$2770 vs AUD$1658 (open) and AUD$1219 (amputation), p<0.01], substantial disparities were observed in costs associated with longer operating theater times, length of stay, and ICU utilization, which resulted in significantly higher costs in the open and amputation groups. After adjusting for confounders, the AUD$18,396 (95% CI AUD$16,436 to AUD$20,356) mean cost per admission for the endovascular revascularization group was significantly less (p<0.001) than the open surgery (AUD$31,908, 95% CI AUD$28,285 to AUD$35,530) and major amputation groups (AUD$43,033, 95% CI AUD$37,706 to AUD$48,361). Conclusion: Endovascular revascularization procedures for PAD cost the health payer less compared with open surgery and primary amputation. While devices used to deliver contemporary endovascular therapy are more expensive, the reduction in bed days, ICU utilization, and related hospital resources results in a significantly lower mean total cost per admission for the initial treatment.
To assess the prevalence of carotid stent fractures and quantify any associated restenosis or clinical events in a single-center experience.Seventy-eight consecutive patients were recorded in a prospective database between 2003 and 2007. Nearly two thirds (51, 65%) were available for follow-up, which included magnified multiplanar radiography and selective duplex ultrasonographic studies to evaluate fracture and restenosis in 53 self-expanding stents (49 open-cell and 4 closed-cell designs). The images were assessed independently by 2 vascular radiologists blinded to the patients' clinical data.There was 1 (1.9%) stent fracture with no associated adverse events or restenosis. Six (11%) stents had an irregular "fish-scale" appearance that was easily confused for fracture and seen only in the open-cell stents.Stent fractures do occur in the carotid artery; however, they are rare and, in our experience, have no clinical sequelae. Radiological assessment should be incorporated into clinical and ultrasound surveillance protocols.
Purpose: To report the initial clinical experience with percutaneous deep vein arterialization (PDVA) to treat critical limb ischemia (CLI) via the creation of an arteriovenous fistula. Methods: Seven patients (median age 85 years; 5 women) with CLI and no traditional endovascular or surgical revascularization options (no-option CLI) were recruited in a pilot study to determine the safety of PDVA. All patients were diabetic; 4 had Rutherford category 6 ischemia. Six were classified at high risk of amputation based on the Society for Vascular Surgery WIfI (wound, ischemia, and foot infection) classification. The primary safety endpoints were major adverse limb events and major adverse coronary events through 30 days and serious adverse events through 6 months. Secondary objectives included clinical efficacy based on outcome measures including thermal measurement, transcutaneous partial pressure of oxygen (TcPO 2 ), clinical improvement at 6 months, and wound healing. Results: The primary safety endpoints were achieved in 100% of patients, with no deaths, above-the-ankle amputations, or major reinterventions at 30 days. The technical success rate was 100%. Two myocardial infarctions occurred within 30 days, each with minor clinical consequences. All patients demonstrated symptomatic improvement with formation of granulation tissue, resolution of rest pain, or both. Complete wound healing was achieved in 4 of 7 patients and 5 of 7 patients at 6 and 12 months, respectively, with a median healing time of 4.6 months (95% confidence interval 84–192). Median postprocedure peak TcPO 2 was 61 mm Hg compared to a preprocedure level of 8 mm Hg (p=0.046). At the time of wound healing, 4 of 5 of patients achieved TcPO 2 levels of >40 mm Hg. There were 2 major amputations, 1 above the knee after PDVA thrombosis and 1 below the knee for infection. Three patients died of causes unrelated to the procedure or study device at 6, 7, and 8 months, respectively. Limb salvage was 71% at 12 months. Conclusion: PDVA is an innovative approach for treating no-option CLI and represents an alternative option for the “desert foot,” potentially avoiding major amputation. Our results demonstrate its safety and feasibility, with promising early clinical results in this small cohort.
BackgroundThe overall goal of this report is to provide a high-level, practical approach to managing venous outflow obstruction (VOO).MethodsA group of vascular surgeons from Australia and New Zealand with specific interest, training, and experience in the management of VOO were surveyed to assess current local practices. The results were analyzed and areas of disagreement identified. After this, the group performed a literature review of consensus guidelines published by leading international organizations focused on the management of chronic venous disease, namely, the Society for Vascular Surgery, American Venous Forum, European Society for Vascular Surgery, American Vein and Lymphatic Society, Cardiovascular and Interventional Radiology Society of Europe, and American Heart Association. These guidelines were compared against the consensus statements obtained through the surveys to determine how they relate to Australian and New Zealand practice. In addition, selected key studies, reviews, and meta-analyses on venous stenting were discussed and added to the document. A selection of statements with >75% agreement was voted on, and barriers to the guideline's applicability were identified. The final recommendations were further reviewed and endorsed by another group of venous experts.ResultsThe document addresses two key areas: patient selection and technical aspects of venous stenting. Regarding patient selection, patients with clinically relevant VOO, a Clinical-Etiologic-Anatomic-Physiologic score of ≥3 or a Venous Clinical Severity Score for pain of ≥2, or both, including venous claudication, with evidence of >50% stenosis should be considered for venous stenting (Level of Recommendation Ib). Patients with chronic pelvic pain, deep dyspareunia, postcoital pain affecting their quality of life, when other causes have been ruled out, should also be considered for venous stenting (Level of Recommendation Ic). Asymptomatic patients should not be offered venous stenting (Level of Recommendation IIIc). Patients undergoing thrombus removal for acute iliofemoral deep vein thrombosis, in whom a culprit stenotic lesion of >50% has been uncovered, should be considered for venous stenting (Level of Recommendation Ib).ConclusionsPatients with VOO have been underdiagnosed and undertreated for decades; however, in recent years, interest from physicians and industry has grown substantially. International guidelines aimed at developing standards of care to avoid undertreating and overtreating patients are applicable to Australia and New Zealand practice and will serve as an educational platform for future developments.
Purpose: To report the use of adjunctive venography for the treatment of superficial venous reflux. Methods: Two hundred consecutive patients (mean age 60.9 years, range 33–86; 128 women) with chronic venous disease underwent saphenous or perforator vein ablation in 268 limbs (305 venous trunks) guided by adjunctive venography and fluoroscopy in addition to ultrasound between October 2010 and May 2016. Intraprocedural venograms were independently evaluated by 2 vascular specialists to identify the presence of venous anomalies and the need for fluoroscopy-guided maneuvers to successfully complete venous ablation. Intraprocedural venography results were compared with preoperative venous duplex scan reports to ascertain if the duplex study could be of value in identifying preoperatively any anatomical variants that may pose a technical challenge to the operator. Results: In this cohort, 542 venograms (2.0/limb) were performed with a mean duration of 4.9±9.1 minutes (range 1–48). Two thirds of patients (132, 66%) had anomalies or abnormalities within the target vein; more than a third (88, 44%) required an endovascular maneuver to successfully complete the ablation and 17% (34) of cases were impossible to complete without adjunctive fluoroscopic guidance. Per-patient comparison of intraprocedural venography with preoperative venous duplex reports identified 21 (11%) patients with abnormalities detected on ultrasound (23 anomalies) compared with 123 (64%) on venography (193 anomalies). This gave ultrasound a 17.1% sensitivity, 100% specificity and positive predictive value, and 40.7% negative predictive value. Conclusion: Venography is a valuable addition to ultrasound to facilitate complete ablation of insufficient saphenous veins in selected patients with complex anatomy.
Purpose: To assess the incidence and predictors of severe, persistent postprocedural hypotension (PPH) after carotid artery stenting (CAS). Materials and Methods: A total of 146 patients (mean age 72.8 years; 104 men) who underwent 160 CAS procedures using a standardized protocol at 3 vascular centers were retrospectively analyzed. The primary endpoint was postprocedural hypotension, defined as a reduction in systolic blood pressure (SBP) >40 mm Hg from baseline or an SBP of <90 mm Hg sustained for >1 hour after CAS. Potential prognostic factors for postprocedural hypotension were identified and subjected to logistic regression analyses; outcomes are presented as the odds ratios (ORs) with 95% confidence intervals (CIs). Results: PPH developed in 36 (24.7%) patients after 37 (23.1%) CAS procedures. These patients had significantly longer intensive care unit and hospital stays than those who did not develop hypotension (p<0.001). PPH was associated with severe lesion calcification (OR 6.28, 95% CI 1.81 to 21.98, p=0.004) and contrast volume (OR 1.02, 95% CI 1.01 to 1.02, p<0.001). A 4-fold increase in the risk of PPH (OR 4.22, 95% CI 1.38 to 13.33, p=0.012) was found between the embolic protection device most associated with PPH (Angioguard) and the device least associated with PPH (Emboshield NAV6). A similar trend was also observed for the Precise vs Xact stents (OR 6, 95% CI 2.08 to 17.6, p=0.001). Bootstrapped multivariable modeling identified the Precise stent and contrast volume as significant predictors of persistent postprocedural hypotension. Further investigation of the contrast volume revealed associations with sex, severe calcification, arch type, previous coronary artery bypass surgery, and primary stenting, suggesting that the contrast volume reflects the complexity of the procedure. Conclusion: The complexity of the procedure and type of stent may play a role in the development of postprocedural hypotension after CAS.
Objective: Compare long-term mortality, secondary intervention and secondary rupture following elective endovascular aneurysm repair (EVAR) and open surgical repair (OSR). Background: EVAR has surpassed OSR as the most common procedure used to repair abdominal aortic aneurysm (AAA), but evidence regarding long-term outcomes is inconclusive. Methods: We included patients in linked clinical registry and administrative data undergoing EVAR or OSR for intact AAA between January 2010 and June 2019. We used an inverse probability of treatment-weighted survival analysis to compare all-cause mortality, cause-specific mortality, secondary interventions and secondary rupture, and evaluate the impact of secondary interventions and secondary rupture on all-cause mortality. Results: The study included 3460 EVAR and 427 OSR patients. Compared to OSR, the EVAR all-cause mortality rate was lower in the first 30 days [adjusted hazard ratio (HR) = 0.22, 95% confidence interval (CI) 0.140.33], but higher between 1 and 4 years (HR = 1.29, 95% CI 1.12–1.48) and after 4years (HR = 1.41, 95% CI 1.23–1.63). Secondary intervention rates were higher over the first 30 days (HR = 2.26, 95% CI 1.11–4.59), but lower between 1 and 4years (HR = 0.59, 95% CI 0.48–0.74). Secondary aortic intervention rates were higher across the entire follow-up period (HR = 2.52, 95% CI 2.06–3.07). Secondary rupture rates did not differ significantly (HR = 1.06, 95% CI 0.73–1.55). All-cause mortality beyond 1 year remained significantly higher for EVAR after adjusting for any secondary interventions, or secendary rupture Conclusions: EVAR has an early survival benefit compared to OSR. However, elevated long-term mortality and higher rates of secondary aortic interventions and subsequent aneurysm repair suggest that EVAR may be a less durable method of aortic aneurysm exclusion.
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