Change in Quality of Life and Cost/Utility Analysis in Open Stage-related Surgical Treatment of Elbow Stiffness

The goals of this study were to examine the improvement in quality of life achieved after open surgical treatment of elbow stiffness and to verify the cost/utility ratio of surgery. Thirtythree patients (22 men and 11 women) underwent surgery. The etiologies of elbow stiffness were posttraumatic conditions (n=26), primary osteoarthritis (n=5), and rheumatoid arthritis (n=2). Surgery included 14 ulnohumeral arthroplasties, 6 ulnohumeral arthroplasties associated with radiocapitellar replacement, 5 ulnohumeral arthroplasties associated with radial head replacement, and 8 total elbow arthroplasties. All patients were evaluated pre- and postoperatively with the Mayo Elbow Performance Score, the Mayo Elbow Performance Index, the modified American Shoulder and Elbow Surgeons score, the Quick Disabilities of the Arm, Shoulder and Hand score, and the Short Form 36 after a mean follow-up of 26 months. Possible variables affecting clinical outcome and quality of life improvement were assessed. The cost/utility ratio was evaluated as diagnosis-related group reimbursement per quality-adjusted life year. Mayo Elbow Performance Scores and modified American Shoulder and Elbow Surgeons scores increased, on average, by 43 and 41 points, respectively (P<.0001). Quick Disabilities of the Arm, Shoulder and Hand scores decreased, on average, by 44 points (P<.0001). The improvement in the SF-36 physical and mental component summary score was 7.6 and 7, respectively (P=.0001 and .0018). The cost/utility ratio ranged between 670 and 817 Euro/quality-adjusted life year. A significant correlation was found between pain score and quality of life improvement. An inverse correlation emerged between pre- and postoperative quality of life score. The current study shows that open surgery significantly improves quality of life and elbow function. Selecting the surgical procedure that most effectively reduces pain appears to be the most relevant variable responsible for quality of life improvement. Surgery shows a satisfactory cost/utility ratio, justifying a health spending increase to reduce the social costs resulting from lingering elbow stiffness

Change in Quality of Life and Cost/Utility Analysis in Open Stage-related Surgical Treatment of Elbow Stiffness

The goals of this study were to examine the improvement in quality of life achieved after open surgical treatment of elbow stiffness and to verify the cost/utility ratio of surgery. Thirtythree patients (22 men and 11 women) underwent surgery. The etiologies of elbow stiffness were posttraumatic conditions (n=26), primary osteoarthritis (n=5), and rheumatoid arthritis (n=2). Surgery included 14 ulnohumeral arthroplasties, 6 ulnohumeral arthroplasties associated with radiocapitellar replacement, 5 ulnohumeral arthroplasties associated with radial head replacement, and 8 total elbow arthroplasties. All patients were evaluated pre- and postoperatively with the Mayo Elbow Performance Score, the Mayo Elbow Performance Index, the modified American Shoulder and Elbow Surgeons score, the Quick Disabilities of the Arm, Shoulder and Hand score, and the Short Form 36 after a mean follow-up of 26 months. Possible variables affecting clinical outcome and quality of life improvement were assessed. The cost/utility ratio was evaluated as diagnosis-related group reimbursement per quality-adjusted life year. Mayo Elbow Performance Scores and modified American Shoulder and Elbow Surgeons scores increased, on average, by 43 and 41 points, respectively (P<.0001). Quick Disabilities of the Arm, Shoulder and Hand scores decreased, on average, by 44 points (P<.0001). The improvement in the SF-36 physical and mental component summary score was 7.6 and 7, respectively (P=.0001 and .0018). The cost/utility ratio ranged between 670 and 817 Euro/quality-adjusted life year. A significant correlation was found between pain score and quality of life improvement. An inverse correlation emerged between pre- and postoperative quality of life score. The current study shows that open surgery significantly improves quality of life and elbow function. Selecting the surgical procedure that most effectively reduces pain appears to be the most relevant variable responsible for quality of life improvement. Surgery shows a satisfactory cost/utility ratio, justifying a health spending increase to reduce the social costs resulting from lingering elbow stiffness

Covered versus Bare-metal Kissing Stents for the Reconstruction of the Aortic Bifurcation in the ILIACS registry

Objective: We compared the early and mid-term outcomes of polytetrafluoroethylene covered stents (CSs) vs bare metal stents (BMSs) used in the kissing conformation for the reconstruction of the aortic bifurcation in aortoiliac obstructive disease. Methods: A multicenter cohort registry (2015-2019) collected data from 1306 patients who had undergone endovascular treatment of aortoiliac arterial obstructive disease. Only patients who had received bilateral iliac kissing stents for TransAtlantic Inter-Society Consensus (TASC) class C and D lesions were included in the present analysis. The 30-day outcomes, mid-term primary patency, and limb salvage rates were compared between the CSs and BMSs in matched patient cohorts after propensity score matching. The follow-up results were analyzed using Kaplan-Meier curves. Cox proportional hazards models were used to identify the predictors of primary patency. Results: A total of 336 patients were treated with kissing stents, 201 with CSs (60%) and 135 with BMSs (40%). In the unmatched cohort, patients receiving CSs were more likely to have critical limb ischemia (41% vs 30%; P = .038), complex iliac lesions, such as TASC D (90% vs 56%; P < .01), and iliac occlusions (59% vs 44%; P < .01). After propensity score matching, 220 patients were selected (110 with CSs and 110 with BMSs), without differences in the clinical presentation (critical limb ischemia, 41% vs 33%; P = .167), or anatomic complexity (TASC D, 66% vs 60%, P = .21; iliac occlusion, 48% vs 49%, P = .89). The 30-day mortality was 0%. The early medical (unmatched, 5% vs 4%, P = 1.00; matched, 5% vs 4%, P = .75) and surgical (unmatched, 5% vs 5%, P = 1.00; matched, 5% vs 3%, P = .72) complication rates were similar between the CSs and BMSs. However, the CSs resulted in a lower risk of intraoperative iliac rupture (0% vs 3.5%; P = .013) and greater ankle-brachial index improvement (0.43 ± 0.22 vs 0.36 ± 0.24; P = .02). At 36 months, the overall primary patency (92% ± 7% vs 92% ± 8%; P = .38), secondary patency (98% ± 3% vs 98% ± 4%; P = .50), and limb salvage (93% ± 9% vs 97% ± 5%; P = .20) rates were similar. In cases of moderate to severe iliac calcification, the CSs showed better results in the matched cohort (100% vs 89% ± 9%; P = .048). On multivariate analysis, CS use (hazard ratio [HR], 1.67; P = .45) did not significantly affect primary patency, but older age (HR, 0.93; P = .03) and kissing stent diameter ≥8 mm (HR, 0.25; P = .03) were significantly associated. Conclusion: In the present multicenter study, the use of kissing stents for the treatment of the aortic bifurcation provided good early and mid-term results. CSs were preferred for more complex lesions, were protective from iliac rupture, and allowed for greater ankle-brachial index improvement. The 3-year patency rates were similar between the CSs and BMSs. However, CSs showed improved results in the case of moderate to severe calcification

Outcomes From the Multicenter Italian Registry on Primary Endovascular Treatment of Aortoiliac Occlusive Disease

Purpose: To report the results of endovascular treatment of iliac and complex aortoiliac occlusive disease (AIOD) in a multicenter Italian registry. Materials and Methods: A retrospective, multicenter, observational cohort study analyzed 713 patients (mean age 68\ub110 years; 539 men) with isolated iliac and complex aortoiliac lesions treated with primary stenting between January 2015 and December 2017. Indications for treatment were claudication in 406 (57%) patients and critical limb ischemia in 307 (43%). According to the TransAtlantic Inter-Society Consensus II (TASC) classification, the lesions were categorized as type A (104, 15%), type B (171, 24%), type C (170, 24%), and type D (268, 37%). Early (&lt;30 days) endpoints included mortality, thrombosis, and major complications. Late major outcomes were primary and secondary patency and freedom from reintervention as estimated by Kaplan-Meier analysis; estimates are given with the 95% confidence intervals (CIs). Associations between baseline variables and primary patency were sought with multivariate analysis; the results are presented as the hazard ratio (HR) and 95% CI. Results: Technical success was achieved in 708 (99%) lesions; in-hospital mortality was 0.6% (n=4). The median follow-up was 11 months (range 0-42). The estimated primary patency rate was 96% (95% CI 94% to 97%) at 1 year and 94% (95% CI 91% to 96%) at 2 years. The estimated secondary patency was 99% (95% CI 97% to 99%) at 1 year and 98% (95% CI 95% to 99%) at 2 years. The estimated freedom from reintervention was 98% (95% CI 96% to 99%) at 1 year and 97% (95% CI 94% to 98.5%) at 2 years. Cox regression analysis demonstrated that the application of a covered stent was associated with an increased need for reintervention (HR 1.4, 95% CI 1.10 to 1.74, p=0.005). Chronic obstructive pulmonary disease was associated with decreased primary patency (HR 3.7, 95% CI 1.25 to 10.8, p=0.018). Conclusion: Endovascular intervention with primary stent placement for aortoiliac occlusive disease achieved satisfactory 2-year patency regardless of the complexity of the lesion. Almost all TASC lesions should be considered for primary endovascular intervention if suitable

Outcomes Analysis of 677 Cases from the Multicenter Italian Registry on Primary Endovascular Treatment of Iliac and Aorto-Iliac Arteries Obstructive Disease (Iliacs Registry)

Introduction - Endovascular revascularization has become the first-line strategy for iliac obstructive lesions (IOL), and also used increasingly as an alternative to conventional surgery for complex aorto-iliac obstructive disease (AIOD). Owing to the good results resembling those of open sur- gery, an endovascular-first strategy have been considered for complex AIOD even in the most recent guidelines if done by an experienced team and if it does not compromise subsequent surgical options. The aim of this study was to analyze the results of the endovascular treatment of IOL and AIOD in a multicenter Italian registry. Methods - Over a 3-year period, ending in December 2017, 677 treatments were performed for IOL and AIOD in eleven Italian hospitals and collected into a dedicated registry database. Intermittent claudication was an indication in 376 (55.5%) patients, whereas critical limb threatening ischemia in 298 (44.0%). Postoperative anti-thrombotic therapy was left at center’s discretion: follow-up evalua- tion was performed at 1, 6 and 12 months after the intervention. Early (&lt;30 days) major end-points were mortality and major complications; late major end-point was freedom from reintervention. Early results were compared with the Chi-square test and the Wilcoxon’s signed rank test; follow-up results were analyzed with Kaplan-Meier survival estimates andcompared with log- rank test. Univariate and multivariate (forward Cox regression) analysis was used to identify potentially sig- nificantpredictors of need for reintervention. Results - We treated 511 (75.4%) males. Overall, mean age was 68 10 (range, 22-96; IQR, 62-76). Accordingly to the TASC II classification we treated 98 (14.5%) type A, 163 (24.1%) type B, 164 (24.2%) type C, and 248 (36.6%) type D lesions: stenoses were 370 (56.2%) and occlusions were 288 (43.8%). We used a totally percutaneous approach in 473 (69.9%): hybrid intervention was carried out in 204 (30.1%) patients, mostly with femoral endarterectomy plus patch plasty. A covered stent was implanted in 207 (30.6%) cases. Overall, a kissing-stent configuration was performed in 243 (36.1%) lesions. Primary technical success was ob- tained in 671 (99.3%) cases: earl mortality occurred in 3 (0.4%) cases, and postoperative complication was observed in 51 (7.5%) patients. Mean ankle-brachial index improved significantly from preoperative to postoperative period (0.5 0.2 vs. 0.9 0.1, P &lt; 0.001). Median hos- pitalization was 5 days (IQR, 2-7). Early thrombosis, major amputation, and mortality was observed in 10 (1.5%), 3 (0.5%), and 4 (0.6%) cases, respectively. During the follow- up 21 (3.1%) died: the estimated survival was 96.3% at 12 months (95%CI: 93.8-97.8) and 90.2% at 36 months (95% CI: 82.7-94.7). Follow-up thrombosis occurred in 17 (2.5%) cases. Estimated primary patency and freedom from rein- tervention was 96% (IC95%: 93.3-97.7) and 97.2% (95%CI: 94.5-98.6) at 12 months, and 95% (95%CI: 89.0-97.6) for both outcomes at 36 months. At Cox regression analysis, no pre/intra/or-postoperative parameters independently predicted loss of primary patency and need for reintervention. Conclusion - In this “real world” registry experience, endovascular revascularization showed to be safe and effective. No independent predictors were found to be associated with the need of reintervention thus indicating that endovascular revascularization for IOL and AOID can be an effective and durable first-line alternative even for the treatment of complex AOI

Endovascular Reconstruction for Total Aorto-Iliac Occlusion

Objectives: To analyze outcomes following endovascular treatment of total occlusion of the infrarenal aorta and aorto-iliac bifurcation in a multicenter Italian registry. Methods: It is a multicenter, retrospective, observational cohort study. From January 2015 to December 2018, 1306 endovascular interventions for aorto-iliac occlusive disease were recorded in the vascular registry. For this analysis, only patients treated for total occlusion of the infrarenal aorta and aorto-iliac bifurcation were included. Early (&lt;30 days) primary outcomes of interest were technical success and mortality. Late major outcomes were primary and secondary patency and freedom from conversion to open aortic surgery. Results: A total of 54 (4.1%) patients met the inclusion criteria. Total percutaneous revascularization was possible in 41 (75.9%) patients and hybrid (endo plus open) intervention in 13 (24.1%) patients. The kissing-stent-graft technique was used in 45 (83.3%) cases, covered endovascular reconstruction of the aortic bifurcation (CERAB) in 5 (9.2%), and a unibody endograft deployed in 4 (7.4%). Technical success was 98.1% (n = 53). There were no episodes of intraoperative or perioperative vessel rupture. Conversion to open surgery was not necessary, and there were no in-hospital deaths. The median patient follow-up time was 16 months (interquartrile range [IQR], 6-27). The estimated primary patency rate was 95.8% +/- 0.03 (95% confidence interval [CI]: 85.5-98.9) at 1 year, 91.4% +/- 0.05 (95% CI: 76.2-97.2) at 2 years, and 85 +/- 0.08 (95% CI: 64.5-94.6) at 3 years. Cox regression analysis demonstrated that sex (hazard ratio [HR]: 0.96; 95% CI: 0.15-6.23, p = 0.963), extent of the occlusion (HR: 0.28; 95% CI: 0.05-1.46, p = 0.130), calcium score (HR: 1.88; 95% CI: 0.31-11.27, p = 0.490), or type of endovascular reconstruction (HR: 0.80; 95% CI: 0.13-5.15, p = 0.804) did not affect primary patency. Secondary patency was 95.5% +/- 0.04 (95% CI: 78.4-99.2) at 3 years. No patients required late conversion to open surgical bypass. Conclusions: Endovascular reconstruction for total occlusion of the infrarenal aorta and aorto-iliac bifurcation was successful using a combination of percutaneous and hybrid revascularization techniques. Estimated patency rates at 3 years of follow-up are promising and are unaffected by the extent of occlusion or type of revascularization

Endovascular Reconstruction for Total Aorto–Iliac Occlusion

Objectives: To analyze outcomes following endovascular treatment of total occlusion of the infrarenal aorta and aorto-iliac bifurcation in a multicenter Italian registry. Methods: It is a multicenter, retrospective, observational cohort study. From January 2015 to December 2018, 1306 endovascular interventions for aorto-iliac occlusive disease were recorded in the vascular registry. For this analysis, only patients treated for total occlusion of the infrarenal aorta and aorto-iliac bifurcation were included. Early (<30 days) primary outcomes of interest were technical success and mortality. Late major outcomes were primary and secondary patency and freedom from conversion to open aortic surgery. Results: A total of 54 (4.1%) patients met the inclusion criteria. Total percutaneous revascularization was possible in 41 (75.9%) patients and hybrid (endo plus open) intervention in 13 (24.1%) patients. The kissing-stent-graft technique was used in 45 (83.3%) cases, covered endovascular reconstruction of the aortic bifurcation (CERAB) in 5 (9.2%), and a unibody endograft deployed in 4 (7.4%). Technical success was 98.1% (n = 53). There were no episodes of intraoperative or perioperative vessel rupture. Conversion to open surgery was not necessary, and there were no in-hospital deaths. The median patient follow-up time was 16 months (interquartrile range [IQR], 6-27). The estimated primary patency rate was 95.8% ± 0.03 (95% confidence interval [CI]: 85.5-98.9) at 1 year, 91.4% ± 0.05 (95% CI: 76.2-97.2) at 2 years, and 85 ± 0.08 (95% CI: 64.5-94.6) at 3 years. Cox regression analysis demonstrated that sex (hazard ratio [HR]: 0.96; 95% CI: 0.15-6.23, p = 0.963), extent of the occlusion (HR: 0.28; 95% CI: 0.05-1.46, p = 0.130), calcium score (HR: 1.88; 95% CI: 0.31-11.27, p = 0.490), or type of endovascular reconstruction (HR: 0.80; 95% CI: 0.13-5.15, p = 0.804) did not affect primary patency. Secondary patency was 95.5% ± 0.04 (95% CI: 78.4-99.2) at 3 years. No patients required late conversion to open surgical bypass. Conclusions: Endovascular reconstruction for total occlusion of the infrarenal aorta and aorto-iliac bifurcation was successful using a combination of percutaneous and hybrid revascularization techniques. Estimated patency rates at 3 years of follow-up are promising and are unaffected by the extent of occlusion or type of revascularization