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1.
Ann Vasc Surg ; 104: 296-306, 2024 Apr 06.
Article in English | MEDLINE | ID: mdl-38588957

ABSTRACT

BACKGROUND: We investigated the long-term safety and efficacy of anatomical and extra-anatomical bypass for the treatment of unilateral iliac artery disease. METHODS: A systematic search on PubMed, Scopus and Web of science for articles published by June 2023 was performed. We implemented a 2-stage individual participant data meta-analysis and pooled survival probabilities using the multivariate methodology of DerSimonian and Laird. The primary endpoint was primary patency at 5 and 10 years of follow-up. RESULTS: Ten studies encompassing 1,907 patients were included. The 5- and 10-year pooled patency rates for anatomical bypass were 83.27% (95% confidence interval (CI): 69.99-99.07) and 77.30% (95% CI: 60.32-99.04), respectively, with a mean primary patency time representing the duration individuals remained event-free for 10.08 years (95% CI: 8.05-10.97). The 5- and 10-year pooled primary patency estimates for extra-anatomical bypass were 77.02% (95% CI: 66.79-88.80) and 68.54% (95% CI: 53.32-88.09), respectively, with a mean primary patency time of 9.25 years, (95% CI: 7.21-9.68). Upon 2-stage individual participant data meta-analysis, anatomical bypass displayed a decreased risk for loss of primary patency compared to extra-anatomical bypass, hazard ratio 0.51 (95% CI: 0.30-0.85). The 5- and 10-year secondary patency estimates for anatomical bypass were 96.83% (95% CI: 90.28-100) and 96.13% (95% CI: 88.72-100), respectively. The 5- and 10-year secondary patency estimates for extra-anatomical bypass were 91.39% (95% CI: 84.32-99.04) and 85.05% (95% CI: 74.43-97.18), respectively, with non-statistically significant difference between the 2 groups. The 5- and 10-year survival for patients undergoing anatomical bypass were 67.99% (95% CI: 53.84-85.85) and 41.09% (95% CI: 25.36-66.57), respectively. The 5- and 10-year survival for extra-anatomical bypass were 70.67% (95% CI: 56.76-87.98) and 34.85% (95% CI: 19.76-61.44), respectively. The mean survival time was 6.92 years (95% CI: 5.56-7.89) for the anatomical and 6.78 years (95% CI: 5.31-7.63) for the extra-anatomical groups. The pooled overall 30-day mortality was 2.32% (95% CI: 1.12-3.87) with metaregression analysis displaying a negative association between the year of publication and mortality (ß =-0.0065, P < 0.01). Further analysis displayed a 30-day mortality of 1.29% (95% CI: 0.56-2.26) versus 4.02% (95% CI: 1.78-7.03), (P = 0.02) for studies published after and before the year 2000. Non-statistically significant differences were identified between the 2 groups concerning long-term and 30-day mortality outcomes. CONCLUSIONS: While we have demonstrated favorable long-term primary and secondary patency outcomes for both surgical techniques, anatomical bypass exhibited a reduced risk of primary patency loss potentially reflecting its inherent capacity to circumvent the anticipated disease progression in the distal aorta and the contralateral donor artery. The reduction in perioperative mortality observed in our review, coupled with the anachronistic demographic characteristics and inclusion criteria presented in the existing literature, underscores the imperative necessity for contemporary research.

2.
Vasc Specialist Int ; 40: 12, 2024 Apr 25.
Article in English | MEDLINE | ID: mdl-38661144

ABSTRACT

Purpose: This study aims to investigate whether routine screening for silent pulmonary embolism (PE) can be justified in patients with deep vein thrombosis (DVT). Materials and Methods: We retrospectively analyzed the medical records of 201 patients with lower-extremity DVT admitted to the vascular surgery department of a single tertiary university center between 2019 and 2023. All patients underwent clinical evaluation, basic laboratory exams, a whole-leg colored duplex ultrasound, and a computed tomography pulmonary angiography (CTPA), to screen for an occult, underlying PE. Results: The overall incidence of silent PE was 48.8%. The median admission D-dimer level was significantly higher in patients with silent PE than in those without PE (9.60 vs. 5.51 mg/L, P=0.001). A D-dimer value ≥5.14 mg/L was discriminant for predicting silent PE, with a sensitivity of 68.2% and a specificity of 59.3%. Silent PE was significantly more common on the right side, with the embolus located at the main pulmonary, lobar, segmental, and subsegmental arteries in 29.6%, 32.7%, 20.4%, and 17.3%, respectively. A higher incidence of occult PE was observed in patients with iliofemoral DVT (P=0.037), particularly when the thrombus extended to the inferior vena cava (P=0.003). Moreover, iliofemoral DVT was associated with a larger size and a more proximal location of the embolus (P=0.041). Multivariate logistic regression showed that male sex (odds ratio [OR]=2.46, 95% confidence interval [CI]: 1.39-3.53; P=0.026), cancer (OR=2.76, 95% CI: 1.45-4.07; P=0.017), previous venous thromboembolism (VTE) history (OR=2.67, 95% CI: 1.33-4.01; P=0.022), D-dimer value ≥5.14 mg/L (OR=2.24, 95% CI: 1.10-3.38; P=0.033), iliofemoral DVT (OR=2.13, 95% CI: 1.19-3.07; P=0.041), and thrombus extension to the IVC (OR=2.95, 95% CI: 1.43-4.47; P=0.009) served as independent predictors for silent PE. Conclusion: A high incidence of silent PE was observed in patients with lower-extremity DVT. Screening of patients with DVT who have the aforementioned predictive risk factors using CTPA for silent PE may be needed and justified for the efficient management of VTE and its long-term complications.

3.
Acta Chir Belg ; : 1-8, 2024 Mar 08.
Article in English | MEDLINE | ID: mdl-38428446

ABSTRACT

BACKGROUND: We conducted a systematic review to assess the safety and efficacy of Aluminum potassium sulfate and tannic acid (ALTA) sclerotherapy for the treatment of hemorrhoidal disease. METHODS: Our study was conducted in accordance with the PRISMA statement (Preferred Reporting Items for Systematic Reviews and Meta-analyses) 2020. Primary endpoints included overall recurrence and type of recurrence while secondary endpoints included postoperative complications, reintervention, presence of rectal ulcer, rectal stricture, defecation abnormalities and perianal abscess. Α regression analysis, where the percentage of patients with grade II, III and IV hemorrhoidal disease was used as a covariate, was also performed. RESULTS: Twelve studies with 4249 patients met all the inclusion criteria and were eventually included. The crude and pooled estimates of the overall recurrence and complications by the end of follow-up were 10% (95% CI, 6.52%-14.08%) and 5.20% (95% CI, 2.59%-8.52%), respectively. Regression analysis displayed no correlation between recurrence and the grade of hemorrhoid disease II, ß= -0.0012 (95% CI, -0.0074 to 0.0049) (p = .64), grade III ß= -0.0006 (95% CI, -0.0056 to 0.0045) (p = .79) and grade IV ß = 0.0025 (95% CI, -0.0075 to 0.0124). However, a trend suggestive of increased recurrence was observed in patient populations with a higher proportion of grade IV disease. CONCLUSION: ALTA sclerotherapy may be a safe and viable alternative for patients with hemorrhoidal disease. Long-term follow-up and high-quality randomized controlled trials will help define the place of ALTA sclerotherapy in the armamentarium of treatment of hemorrhoids.

4.
Cureus ; 16(2): e54132, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38487140

ABSTRACT

Ulnar artery aneurysms (UAAs), although infrequent, pose limited challenges in terms of timely diagnosis and surgical intervention. Their intricacy lies in discerning and addressing the underlying pathology, often necessitating prolonged hospitalization. Herein, we present a case detailing a giant aneurysm located in the proximal ulnar artery, measuring 5.2 cm in diameter. The patient exhibited negative microbial cultures and non-pathological transthoracic echocardiography (TTE). Successful treatment involved aneurysmal exclusion and saphenous vein graft interposition. While the initial microbiological cultures and TTE yielded negative results, the diagnosis of endocarditis was ultimately confirmed through a subsequent transesophageal echocardiography (TEE) examination. This case report underscores the imperative for heightened clinical suspicion when confronted with upper-limb aneurysms. The diagnostic process necessitates sustained diligence for identifying the underlying pathology, a task that, in certain instances, requires prolonged hospitalization. Both microbiological cultures and TTE have exhibited diminished sensitivity in the diagnosis of infective endocarditis and should consistently be complemented by TEE.

5.
Minerva Surg ; 79(1): 82-91, 2024 Feb.
Article in English | MEDLINE | ID: mdl-37955856

ABSTRACT

We investigated the outcomes of pancreaticoduodenectomy in the presence of an aberrant right hepatic artery (aRHA). We systematically reviewed Medline, Scopus, and Web of Science until April 2023 for studies comparing pancreaticoduodenectomy outcomes with and without aRHA. Endpoints included postoperative mortality, R0 resection margins, pancreatic fistulae, hemorrhage, biliary leak/fistulae, delayed gastric emptying, operative duration, and blood loss. Eight retrospective studies involving 1514 patients were included. The risk ratio (RR) for postoperative mortality and odds ratio (OR) for R0 resection between the aRHA and normal anatomy groups were 1.37 (95%CI:0.74-256) (I2=0%, P=0.99) and 1.03 (95%CI:0.67-1.59) (I2=10%, P=0.35). Besides a longer operative duration in the aRHA group, mean difference (MD) 54.64 (95% CI: 8.51-100.77) (I2=94%, P<0.01), there were no significant differences in secondary endpoints. Meta-regression revealed a significant association between aRHA reconstruction and postoperative mortality (ß=0.0179, P<0.01). This review displayed non-statistically significant differences in terms of surgical and oncological outcomes between patients with aRHA and patients with normal hepatic artery anatomy undergoing pancreaticoduodenectomy. However, the observed trend of increased postoperative mortality in patients with aRHA, combined with extended surgical duration and the link between aRHA reconstruction and postoperative mortality, prevents drawing definitive conclusions. Further research through high-quality studies is warranted.


Subject(s)
Pancreatic Neoplasms , Pancreaticoduodenectomy , Humans , Pancreaticoduodenectomy/adverse effects , Retrospective Studies , Pancreatic Neoplasms/surgery , Pancreatic Neoplasms/pathology , Hepatic Artery/surgery , Hepatic Artery/pathology , Pancreatic Fistula/etiology , Pancreatic Fistula/surgery
6.
J Vasc Surg ; 79(6): 1525-1535.e9, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38104677

ABSTRACT

BACKGROUND: We investigated the early and midterm efficacy and safety of covered endovascular reconstruction of the aortic bifurcation (CERAB) in the treatment of aortoiliac disease (AID). METHODS: A systematic search on PubMed, Scopus, and Web of Science for articles published by August 2023 was performed. The primary end points were primary patency and secondary patency. RESULTS: Eleven retrospective case series, involving 579 patients, were incorporated in the review with 88.9% of the included lesions being categorized as Trans-Atlantic Inter-Society Consensus (TASC) C or D. The pooled primary patency estimates at 12, 24 and 36 months were 94.4% (95% confidence interval [CI], 89.4-99.7), 84.4% (95% CI, 72.3-98.5) and 83.8% (95% CI, 71.4-98.3) respectively. The mean primary patency time, representing the period during which individuals remained event-free, was 51.9 months (95% CI, 43.6-55.4). The pooled 36 months primary patency for studies with a predominantly claudicant patient population (>75% of patients) was 89.4% (95% CI, 78.5-100.0), compared with 71.5% (95% CI, 45.6-100.0) for studies with a mixed population (50% of patients). The pooled 36 months primary patency for studies with a predominantly TASC D patient population (>82% of patients) was 70.4% (95% CI, 46.4-100.0) compared with 91.0% (95% CI, 79.1-100.0) for studies with a more homogenous cohort. The pooled secondary patency estimates at 12, 24, and 36 months were 98.6% (95% CI, 96.2-100.0), 97% (95% CI, 93.1-100.0), and 97% (95% CI, 93.1-100.0), respectively. The pooled technical success, 30-day mortality and 30-day systemic complications estimates were 95.9% (95% CI, 93.7- 97.4), 1.9% (95% CI, 1.0-3.5), and 6.4% (95% CI, 4.4-9.1), respectively. The pooled intraoperative and postoperative 30-day CERAB-related complications estimates were 7.3% (95% CI, 2.0-23.0) and 4.2% (95% CI, 0.7-21.0), respectively. The pooled major amputation and target lesion reinterventions by the end of follow-up were 1.9% (95% CI, 1.0-3.4) and 13.9% (95% CI, 9.9-19.2), respectively. The pooled access site complication estimate was 11.7% (95% CI, 5.9-21.7). CONCLUSIONS: Although this review has showcased the safety and feasibility of the CERAB technique in treating AID, it has also highlighted the necessity for a close and prolonged follow-up period extending beyond 1 year. Moreover, the favorable secondary patency estimates predominantly attained via endovascular reinterventions emphasize a potentially advantageous characteristic of the CERAB technique, particularly valuable when addressing late-stage AID disease or anatomically complex lesions.


Subject(s)
Aortic Diseases , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Iliac Artery , Vascular Patency , Humans , Endovascular Procedures/adverse effects , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis Implantation/mortality , Aortic Diseases/surgery , Aortic Diseases/diagnostic imaging , Aortic Diseases/physiopathology , Aortic Diseases/mortality , Iliac Artery/surgery , Iliac Artery/diagnostic imaging , Iliac Artery/physiopathology , Time Factors , Stents , Risk Factors , Treatment Outcome , Aged , Female , Male , Blood Vessel Prosthesis , Middle Aged , Peripheral Arterial Disease/physiopathology , Peripheral Arterial Disease/surgery , Peripheral Arterial Disease/diagnostic imaging , Prosthesis Design
7.
J Endovasc Ther ; : 15266028231193978, 2023 Aug 17.
Article in English | MEDLINE | ID: mdl-37592807

ABSTRACT

BACKGROUND: Venous leg ulcer (VLU) disease constitutes the most severe form of chronic venous insufficiency. We performed a network meta-analysis and meta-regression to investigate the efficacy and safety of the various available interventions in the treatment of VLU. METHODS: We conducted a systematic research corresponding to the instructions by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement for studies reporting on surgical or endovenous interventions for the treatment of VLU. Following data extraction, we performed a Bayesian network meta-analysis and meta-regression. Primary endpoints included VLU healing and recurrence. The secondary endpoint was postintervention complications. RESULTS: Seventeen studies evaluating the impact of compression monotherapy, radiofrequency ablation (RFA), endovenous laser ablation (EVLA), sclerotherapy, and saphenous vein surgery on VLU treatment, consisting of 2156 patients (2186 VLU) were included. When compared to compression monotherapy, RFA was the only treatment displaying a statistically-significant impact on ulcer healing, odds ratio (OR) 5.80 (95% credibility interval (CI): 1.08-35.07), while EVLA, RR 0.06 (95% CI: 0.00-0.57), sclerotherapy, RR 0.07 (95% CI: 0.00-0.68) and RFA, RR 0.12 (95% CI: 0.01-0.91) were the 3 interventions reducing VLU recurrence. EVLA (SUCRA, 69.65) ranked as the most efficient intervention concerning ulcer recurrence reduction. Regarding postintervention complications, EVLA was the only intervention displaying a statistically-significant increased risk compared to compression monotherapy, RR 14.3 (95% CI: 2.03-172.56). Meta-regression analysis exploring the impact of perforator treatment on VLU failed to predict healing, ß = -0.27 (95% CI: -2.55 to 1.85), recurrence, ß = -0.02 (95% CI: -2.96 to 2.75) and complication outcomes, ß = -0.089 (95% CI: -3.13 to 2.85). During sensitivity analysis, RFA and sclerotherapy failed to sustain their effects on ulcer healing and ulcer recurrence, respectively. In addition, sclerotherapy displayed statistically-significant inferior outcomes compared to both EVLA and RFA regarding ulcer recurrence. CONCLUSION: This is the first network meta-analysis examining the effect of various interventions on VLU disease. While we have demonstrated the efficacy of RFA and ELVA in ulcer recurrence prevention, our results regarding the impact of RFA and sclerotherapy on VLU healing and recurrence, respectively, should be interpreted with caution. In addition, this review raises questions concerning the value of surgery and perforator interventions in the treatment of VLU. Further research through randomized controlled trials is required. CLINICAL IMPACT: Our review has revealed the significant efficacy of endovenous laser ablation (EVLA) and radiofrequency ablation (RFA) in effectively reducing the incidence of ulcer recurrence when compared to compression monotherapy. These outcomes hold the potential to provide relevant insights to both medical practitioners and patients, thereby informing a more prudent and enlightened decision-making approach. Such informed decisions, aimed at mitigating the recurring occurrence of venous leg ulcers, carry profound significance given the considerable socioeconomic implications associated with this medical condition.

8.
Vasc Med ; 28(5): 449-457, 2023 Oct.
Article in English | MEDLINE | ID: mdl-37458188

ABSTRACT

BACKGROUND: We sought to assess the safety and efficacy of endovenous thermal ablation (EVTA) in treating large great saphenous veins (GSV) > 12 mm in diameter. METHODS: We performed a systematic review according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) 2020 for comparative and noncomparative studies depicting EVTA in the treatment of GSV > 12 mm. Primary endpoints included GSV occlusion, technical success, deep vein thrombosis (DVT), and endovenous heat-induced thrombosis (EHIT). We conducted a comparative analysis between GSV > 12 mm and < 12 mm and a meta-regression analysis for two sets of studies, one including the whole dataset, containing treatment arms of comparative studies with GSV < 12 mm and one exclusively for GSV > 12 mm. RESULTS: Seven studies, including 2564 GSV, depicting radiofrequency (RFA) and endovenous laser ablation (EVLA) were included. GSV > 12 mm occlusion, technical success, DVT, and EHIT estimates were 95.9% (95% CI: 93.6-97.8), 99.9% (95% CI: 98.9-100.0), 0.04% (95% CI: 0.0-3.4), and 1.6% (95% CI: 0.3-3.5). Meta-regression revealed a negative association between GSV diameter and occlusion for both the whole dataset (p < 0.01) and the > 12 mm groups (p = 0.04), GSV diameter and technical success for both groups (p < 0.01), (p = 0.016), and GSV diameter and EHIT only for the whole dataset (p = 0.02). The comparative analysis between GSV < 12 mm and GSV > 12 mm displayed an occlusion estimate of OR 1.79 (95% CI: 1.25-2.56) favoring small GSV. CONCLUSION: Whereas we have displayed excellent occlusion and technical success results for the EVTA of GSV > 12 mm, our analysis has illustrated the unfavorable impact of GSV diameter on occlusion, technical success, and EHIT outcomes regardless of the 12 mm threshold. Potential parameter or device adjustments in a diameter-oriented fashion could further enhance outcomes.


Subject(s)
Laser Therapy , Thrombosis , Varicose Veins , Venous Insufficiency , Humans , Saphenous Vein/diagnostic imaging , Saphenous Vein/surgery , Treatment Outcome , Risk Factors , Laser Therapy/adverse effects , Laser Therapy/methods , Varicose Veins/diagnostic imaging , Varicose Veins/surgery , Venous Insufficiency/diagnostic imaging , Venous Insufficiency/surgery
9.
Thyroid ; 33(8): 950-964, 2023 08.
Article in English | MEDLINE | ID: mdl-37166390

ABSTRACT

Background: Image-guided thermal ablation interventions are novel thermal-based modalities used for the treatment of benign thyroid nodules. Methods: We conducted a systematic review and a Bayesian network meta-analysis, examining studies using thermal ablation interventions in the treatment of benign nodular thyroid disease (PROSPERO CRD42022367680). The primary endpoints included volume reduction rate (VRR), and symptomatic score and cosmetic score improvement. Secondary endpoints included vocal disturbances, laryngeal nerve palsy, hypothyroidism, and nodular regrowth (defined by increased nodular volume of >50% for thermal ablation or new nodules arising in remaining thyroid tissue conventional surgery [CS]). Results: We included 16 studies (3 randomized controlled trials [RCTs] and 13 comparative case series), describing radiofrequency ablation (RFA), laser ablation (LA), microwave ablation (MWA), high-intensity focus ultrasound (HIFU), and CS, respectively. The review included data from 4112 patients followed for a mean of 11.9 months. Meta-analyses showed no significant differences among RFA, LA, MWA, HIFU, and CS regarding any of the primary endpoints of VRR, symptomatic score, and cosmetic score. In examining the surface under the cumulative ranking area (SUCRA) ranking, CS (SUCRA, 98.49), LA (SUCRA, 51.58), and MWA (SUCRA, 57.0) were identified as the three interventions that were most likely to result in the largest VRR, symptomatic and cosmetic score reduction. RFA, relative risk (RR) 0.19 [95% credibility interval (CI): 0.06 to 0.48], LA RR 0.23 [CI: 0.06 to 0.79], and MWA RR 0.25 [CI: 0.09 to 0.60] were associated with the greatest reduction in risk for postintervention vocal complications compared with CS, with RFA (SUCRA, 61.62) being ranked as the highest in safety. RFA RR 0.05 [CI: 0.00 to 0.40] and MWA RR 0.16 [CI: 0.02 to 0.73] were associated with a reduced risk of transient laryngeal nerve injury compared with CS. RFA RR 0.00 [CI: 0.00 to 0.00] and MWA RR 0.00 [CI: 0.00 to 0.03] were associated with a reduced risk of hypothyroidism occurrence compared with CS, with RFA (SUCRA, 99.86) yielding the highest safety ranking. RFA was associated with a reduced risk for nodular regrowth RR 0.09 [CI: 0.00 to 0.85], compared with CS. Conclusion: We have comprehensively reviewed the published literature on the efficacy and safety of thermal ablation modalities for benign thyroid nodules. Important research gaps remain regarding a paucity of both long-term data and high-quality RCTs.


Subject(s)
Catheter Ablation , Hypothyroidism , Laser Therapy , Radiofrequency Ablation , Thyroid Nodule , Humans , Thyroid Nodule/surgery , Network Meta-Analysis , Treatment Outcome , Retrospective Studies
10.
Eur J Vasc Endovasc Surg ; 66(4): 560-576, 2023 Oct.
Article in English | MEDLINE | ID: mdl-37209995

ABSTRACT

OBJECTIVE: To assess the safety and efficacy of available interventions in the treatment of lower limb reticular veins and telangiectasias. DATA SOURCES: An electronic search was performed on Scopus, Embase, and Google scholar. REVIEW METHODS: A systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Following data extraction and processing, a Bayesian network meta-analysis and meta-regression was undertaken. The primary endpoint was telangiectasia and reticular vein clearance. RESULTS: Nineteen studies, 16 randomised controlled trials and three prospective case series, including 1 356 patients and 2 051 procedures, were finally incorporated. All interventions, apart from 0.5% sodium tetradecyl sulphate (STS) and 0.25% STS displayed statistically significantly superior telangiectasia and reticular vein clearance compared with normal saline (N/S), Meta-regression analysis employing the type of the venule treated (telangiectasia or reticular vein) as a covariable, revealed a positive correlation between Nd:YAG 1064 nm laser and telangiectasia clearance (ß = 1.38, 95% CI 0.56 - 2.14). Further exploration unveiled the superiority of Nd:YAG 1064 nm in the treatment of telangiectasias compared with all included interventions except 72% chromated glycerin (CG). STS 0.25% increased the risk of hyperpigmentation compared with all interventions except 0.5% STS, and 1% polidocanol. CG 72% decreased the risk of matting compared with polidocanol foam (risk ratio [RR] 0.14, 95% CI 0.02 - 0.80) and STS (RR 0.31, 95% CI 0.07 - 0.92). Non-statistically significant differences were identified between interventions regarding pain outcomes. CONCLUSION: This network meta-analysis has demonstrated a proportional relationship between sclerosant potency and side effect occurrence in the treatment of telangiectasias and reticular veins and the superiority of laser therapy compared with injection sclerotherapy in treating telangiectasias. The transition of telangiectasia and reticular vein treatment from highly potent detergent solutions to equally effective but milder sclerosants could potentially reduce undesirable adverse events.

11.
J Vasc Surg Venous Lymphat Disord ; 11(4): 854-865.e5, 2023 07.
Article in English | MEDLINE | ID: mdl-37030442

ABSTRACT

OBJECTIVE: We assessed the mid-term efficacy and safety of thermal and nonthermal endovenous ablation for the treatment of lower limb superficial venous insufficiency. METHODS: We performed a systematic review in accordance with the PRISMA (preferred reporting items for systematic reviews and meta-analyses) statement and a Bayesian network meta-analysis. The primary end points were great saphenous vein (GSV) closure and venous clinical severity score (VCSS) improvement. A meta-regression using GSV diameter as a covariate was undertaken for the two primary end points. RESULTS: We included 14 studies and 4177 patients, with a mean follow-up of 25.7 months. Radiofrequency ablation (RFA; odds ratio [OR], 3.99; 95% confidence interval [CI], 1.82-10.53), cyanoacrylate ablation (CAC; OR, 3.09; 95% CI, 1.35-8.37), and endovenous laser ablation (EVLA; OR, 2.72; 95% CI, 1.23-7.38) displayed increased odds for GSV closure compared with mechanochemical ablation (MOCA). MOCA inferiority compared with RFA (mean difference [MD], 0.96; 95% CI, 0.71-1.20), EVLA (MD, 0.94; 95% CI, 0.61-1.24), and CAC (MD, 0.89; 95% CI, 0.65-1.15) was also depicted regarding VCSS improvement. EVLA resulted in an increased risk of postoperative paresthesia compared with MOCA (risk ratio [RR], 9.61; 95% CI, 2.32-62.29), CAC (RR, 7.90; 95% CI, 2.44-38.16), and RFA (RR, 6.96; 95% CI, 2.31-28.04). Although the overall analysis identified nonstatistically significant differences for Aberdeen varicose vein questionnaire score improvement, thrombophlebitis, ecchymosis, and pain, further investigation revealed an increase pain profile for EVLA at 1470 nm compared with RFA (MD, 3.22; 95% CI, 0.93-5.47) and CAC (MD, 3.04; 95% CI, 1.05-4.97). A sensitivity analysis displayed a persistent underperformance of MOCA compared with RFA (OR, 4.33; 95% CI, 1.15-55.54) for GSV closure and both RFA (MD, 0.99; 95% CI, 0.22-1.77) and CAC (MD, 0.84; 95% CI, 0.08-1.65) regarding VCCS improvement. Although no regression model reached statistical significance, the GSV closure regression model revealed a trend for considerably decreased efficacy for both CAC and MOCA with larger GSV diameters compared with RFA and EVLA. CONCLUSIONS: Although our analysis has produced skepticism regarding the efficacy of MOCA in the mid-term period for VCSS improvement and GSV closure rates, CAC showed equivalent results compared with both RFA and EVLA. Additionally, CAC displayed a decreased risk of postprocedural paresthesia and pigmentation and induration compared with EVLA. Also, both RFA and CAC had an improved pain profile compared with EVLA 1470 nm. The potential underperformance of nonthermal, nontumescent ablation modalities in ablating large GSVs necessitates further research.


Subject(s)
Paresthesia , Venous Insufficiency , Humans , Network Meta-Analysis , Bayes Theorem , Treatment Outcome , Venous Insufficiency/diagnostic imaging , Venous Insufficiency/surgery , Saphenous Vein/diagnostic imaging , Saphenous Vein/surgery , Pain
12.
Ann Vasc Surg ; 94: 396-406, 2023 Aug.
Article in English | MEDLINE | ID: mdl-37121340

ABSTRACT

BACKGROUND: We investigated the safety and feasibility of single branched endografts in the treatment of zone II thoracic endovascular aortic repair (TEVAR). METHODS: We performed a systematic research on Medline, Scopus and EMBASE for articles published up to February 2023. Primary end points included technical success, 30-day mortality, stroke and spinal cord injury (SCI) as well as unassisted left subclavian artery (LSA) branch patency by the end of follow-up. Secondary end points included early 30-day and persistent endoleaks, new onset dissection and reintervention by the end of follow-up. RESULTS: Fourteen studies, three prospective case series and 11 retrospective case series comprised of 727 patients were finally included. The pooled technical success and 30-day mortality rates were 94.86 % (95% confidence interval (CI): 90.95-97.86) and 0.14% (95% CI: 0.00-0.87). The 30-day stroke and SCI rates were 0.45% (95% CI: 0.00-1.39) and 0.08% (95% CI: 0.00-0.99), respectively, while the unassisted LSA branch patency estimate was 99.12% (95% CI: 97.97-99.86). The early 30-day and persistent endoleak rates were 5.19% (95% CI: 2.45-8.65) and 2.57% (95% CI: 0.36-6.02), whereas new onset dissections and reinterventions estimates were 0.94% (95% CI: 0.17-2.11) and 2.40% (95% CI: 0.41-5.42). CONCLUSIONS: While we have displayed the safety and feasibility of single branched endografts in the treatment of zone II thoracic aortic lesions, physicians should be aware of the persistency displayed by early type I endoleaks eventually requiring reintervention. The variations in device and lesion characteristics accompanied by the short-term follow-up presented in our review do not allow for definite conclusions to be drawn, necessitating further research through high-quality randomized controlled trials.


Subject(s)
Aortic Aneurysm, Thoracic , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Stroke , Humans , Blood Vessel Prosthesis , Subclavian Artery/diagnostic imaging , Subclavian Artery/surgery , Endoleak/diagnostic imaging , Endoleak/etiology , Retrospective Studies , Treatment Outcome , Risk Factors , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/surgery
13.
J Vasc Surg ; 77(4): 1252-1261.e3, 2023 04.
Article in English | MEDLINE | ID: mdl-36328141

ABSTRACT

OBJECTIVE: To assess the short-term and mid-term safety and efficacy of percutaneous endovascular arteriovenous fistula (pAVF) creation. METHODS: A systematic search was implemented corresponding to the PRISMA 2020 and the PRISMA for individual participant data (IPD) systematic reviews 2015. Aggregated data from the included studies were obtained and meta-analyzed regarding both the overall pAVF efficacy and the comparison of pAVF with surgical AVF (sAVF). We performed a two-stage IPD meta-analysis for studies comparing pAVF and sAVF regarding primary and secondary patency. Primary end points included primary patency, secondary patency, and functional cannulation. RESULTS: Eighteen studies with 1863 patients were included. The overall pAVF, primary patency, secondary patency, functional cannulation and abandonment rates were 54.01% (95% confidence interval [CI], 40.69-66.79), 87.27% (95% CI, 81.53-91.42), 79.94% (95% CI, 65.94-89.13), and 15.58% (95% CI, 7.77-28.79), respectively. The overall pAVF, technical success, maturation, reintervention per person-years and mean time to maturation rates were 97.08% (95% CI, 95.66-98.04), 82.13% (95% CI, 71.64-89.32), 0.80 (95% CI, 0.34-1.47), and 58 days (95% CI, 36.64-92.82), respectively. Secondary patency and pAVF abandonment rates where the only end points were WavelinQ and Ellipsys displayed statistically significant differences of 81.36% (95% CI, 76.15-85.65) versus 92.12% (95% CI, 87.94-94.93) and 32.54% (95% CI, 22.23-44.87) versus 11.13% (95% CI, 4.82-23.65). An IPD meta-analysis of hazard ratios for primary and secondary patency between pAVF and sAVF were 1.27 (95% CI, 0.61-2.67) and 1.25 (95% CI, 0.87-1.80), favoring sAVF. Statistically significant difference between pAVF and sAVF were solely depicted for steal syndrome relative risk of 5.91 (95% CI, 1.12-31.12) and wound infections relative risk of 4.19 (95% CI, 1.04-16.88). Plotting of pAVF smoothed hazard estimate displayed an upsurge in the probability of primary patency failure at 1 month after the intervention. CONCLUSIONS: Although we failed to identify statistically significant differences between pAVF and sAVF regarding any of the primary end points, pAVF displayed a decreased risk for steal syndrome and wound infection. Although both the Ellipsys and WavelinQ devices displayed satisfactory secondary patency rates, Ellipsys demonstrated a statistically significant improved rate compared with WavelinQ. Additionally, and despite the borderline statistically insignificant inferior reintervention rate displayed by WavelinQ, one in three WavelinQ pAVFs resulted in abandonment. The introduction of pAVF as a treatment modality calls for standardized definition adjustment and improvement.


Subject(s)
Arteriovenous Fistula , Arteriovenous Shunt, Surgical , Humans , Vascular Patency , Renal Dialysis/methods , Treatment Outcome , Time Factors , Retrospective Studies
14.
J Vasc Surg ; 77(3): 957-963.e3, 2023 03.
Article in English | MEDLINE | ID: mdl-35953002

ABSTRACT

OBJECTIVE: The objective of this study was to evaluate the application of the Global Anatomic Staging System (GLASS) in the endovascular treatment of chronic limb-threatening ischemia (CLTI). METHODS: We performed systematic research between June 2019 and February 2022, including articles investigating the relationship of GLASS classification with the outcomes of endovascular interventions in the treatment of CLTI. Data from the included studies were pooled and meta-analyzed. The primary endpoints were limb-based patency (LBP) at 1-year follow-up and immediate technical failure (ITF). Secondary endpoints included major amputation. We performed subgroup analysis between studies that reported on calcium modifier inclusion during GLASS classification and studies that did not. RESULTS: Eleven studies, including 1816 patients (1975 limbs) met the inclusion criteria. The pooled ITF rates for GLASS stages I, II, and III are 5.52% (95% confidence interval [CI], 3.74%-8.07%), 7.39% (95% CI, 5.32%-10.18%), and 21.07% (95% CI, 13.48%-31.39%) respectively. The pooled LBP for GLASS stages I, II, and III are 68.43% (95% CI, 53.44%-80.37%), 41.52% (95% CI, 18.91%-68.37%), and 38.64% (95% CI, 19.83%-61.57%). The relative risk (RR) for ITF regarding composite GLASS I and II stages vs GLASS III is 3.96 (95% CI, 1.96-7.98). The RR for LBP of GLASS I and II versus GLASS stage III is 1.51 (95% CI, 0.86-2.64). Pooled major amputation rates for the composite GLASS I, II and GLASS III stages are 7.62% (95% CI, 5.44%-10.58%) and 15.43% (95% CI, 11.72%-20.05%) respectively, whereas the RR between GLASS I, II, and GLASS III stages is 1.84 (95% CI, 1.18-2.87). CONCLUSIONS: Our study demonstrated that patients with CLTI undergoing endovascular interventions classified as GLASS stage III had almost a four-fold risk increase for ITF and 1.84 times the risk of major amputation compared with stages I and II. Additionally, GLASS classification correctly predicted ITF for all three stages, whereas it failed to predict stage I and II LBP outcomes. Safe conclusions regarding LBP cannot be drawn due to the low quality and small number of the included studies, necessitating further research. Furthermore, we displayed the importance of calcium moderator inclusion in the accurate classification of GLASS.


Subject(s)
Endovascular Procedures , Peripheral Arterial Disease , Humans , Chronic Limb-Threatening Ischemia , Treatment Outcome , Calcium , Risk Factors , Limb Salvage , Ischemia , Retrospective Studies , Chronic Disease
15.
Thromb Res ; 218: 130-137, 2022 Oct.
Article in English | MEDLINE | ID: mdl-36037548

ABSTRACT

OBJECTIVE: To evaluate the safety and efficacy of perioperative bridging in patients with mechanical heart valves undergoing non-cardiac interventions. MATERIALS AND METHODS: A systematic research using Medline, EMBASE, and Google Scholar was implemented corresponding to the Preferred Reporting Items for Systematic reviews and Meta-analysis (PRISMA) statement. Data from the eligible studies were obtained and meta-analyzed. Primary endpoints included major bleeding and thromboembolism. Secondary endpoints included minor bleeding, overall mortality, and overall bleeding (major and minor bleeding). We conducted a comparative analysis between bridging and non-bridging along with a sensitivity analysis for patients undergoing major and minor operations. RESULTS: Fifteen studies comprised of 2305 patients (2453 bridging episodes) were included. Pooled major bleeding and thromboembolism rates were 3.85 % (95 % CI: 2.12-5.98) (I2 = 69 %, p < 0.01) and 0.39 % (95 % CI: 0.00-1.41) (I2 = 64 %, p < 0.01). Bridging versus non-bridging major bleeding, thromboembolism, and overall bleeding risk ratios (RR) were RR 2.05 (95 % CI: 0.98-4.28) (I2 = 10 %, p = 0.34), RR 1.63 (95 % CI: 0.41-6.50) (I2 = 0 %, p = 0.63) and RR 1.79 (95 % CI: 1.17-2.72) (I2 = 55 %, p = 0.09) respectively. Subgroup analysis displayed major and minor operation thromboembolism and overall bleeding rates of 3.09 % (95 % CI: 0.78-6.43) (I2 = 0 %, p = 0.89) versus 0.14 % (95 % CI: 0.00-1.40) (I2 = 0 %, p = 0.93), test for subgroup differences (p < 0.01) and 17.37 % (95 % CI: 11.73-23.77) (I2 = 0 %, p = 0.61) versus 28.18 % (95 % CI: 22.80-33.88) (I2 = 0 %, p = 0.47), test for subgroup differences (p = 0.01) respectively. CONCLUSION: Our analysis suggests that bridging may potentially put patients at an increased bleeding risk regarding overall bleeding rates, while failing to provide statistically significant benefits concerning thromboembolism and overall mortality compared to non-bridging. Limitations such as the mixed patient population don't allow for definite conclusions to be drawn warrantying further research through randomized controlled trials.


Subject(s)
Heart Valve Prosthesis , Thromboembolism , Anticoagulants , Heart Valves , Hemorrhage/etiology , Humans , Thromboembolism/etiology
16.
Eur J Vasc Endovasc Surg ; 64(4): 299-308, 2022 10.
Article in English | MEDLINE | ID: mdl-35961627

ABSTRACT

OBJECTIVE: To assess the efficacy and safety of carotid artery stenting for the treatment of extracranial carotid artery dissection (CAD). DATA SOURCES: Systematic review using Medline, Scopus, EMBASE, and the Cochrane Library. REVIEW METHODS: A systematic search was performed according to the Preferred Reporting Items for Systematic reviews and Meta-analysis statement. Data from the eligible studies were extracted and meta-analysed. Primary endpoints included post-operative mortality, cerebrovascular events (CEs), and modified Rankin Score for neurological disability (mRS) at 90 days. Subgroup analyses were performed between stenting of spontaneous and traumatic CAD, primary stenting vs. stenting after failed medical therapy (FMT), and stenting of CAD in the presence of tandem occlusions vs. stenting of isolated extracranial CAD. RESULTS: Twenty-four studies with 1 224 patients were included. Pooled post-operative mortality, CE, and mRS 0 - 2 rates were 1.71% (95% confidence interval [CI] 0.83 - 2.80), 6.45% (95% CI 2.80 - 11.10), and 76.13% (95% CI 64.15 - 86.50), respectively. The pooled stroke rate was 2.16% (95% CI 0.0 - 6.64). Spontaneous vs. traumatic CAD mortality rates were 3.20% (95% CI 1.80 - 4.88) and 0.00% (95% CI 0.00 - 1.59) while CE rates were 14.26% (95% CI 6.28 - 24.36) and 1.64% (95% CI 0.0 - 6.08). Primary stenting and stenting after FMT mortality rates were 0.63% (95% CI 0.0 - 5.63) and 0.0% (95% CI 0.0 - 2.24), while CE rates were 5.02% (95% CI 0.38 - 12.63) and 3.33% (95% CI 0.12 - 9.03). Mortality rates for tandem occlusions and isolated extracranial CAD were 5.62% (95% CI 1.76 - 10.83) and 0.23% (95% CI 0.0 - 1.88), respectively, while CE rates were 15.28% (95% CI 6.23 - 26.64) and 1.88% (95% CI 0.23 - 4.51). The methodological index for non-randomised studies score was 8.66 (low). CONCLUSION: Both primary stenting and stenting of spontaneous CAD yielded unfavourable results with respect to stent thrombosis and stroke rates. Conversely, stenting following FMT had acceptable mortality and complication rates corroborating the use of stenting in the setting of CAD as a second line treatment. Due to the low quality of the included studies, definite conclusions cannot be drawn necessitating further research.


Subject(s)
Aortic Dissection , Carotid Stenosis , Stroke , Humans , Stents/adverse effects , Carotid Stenosis/complications , Carotid Stenosis/diagnostic imaging , Carotid Stenosis/surgery , Treatment Outcome , Carotid Arteries/surgery , Stroke/etiology , Aortic Dissection/complications
17.
Ann Vasc Surg ; 85: 424-432, 2022 Sep.
Article in English | MEDLINE | ID: mdl-35398197

ABSTRACT

BACKGROUND: The treatment of infrainguinal peripheral arterial disease often involves complex lesions requiring stent implantation. It is common knowledge that stent length is a negative predictor for restenosis. We investigated the efficacy and safety of spot stenting for the treatment of femoropopliteal lesions. METHODS: We carried out a systematic review for articles published by December 2021 regarding spot stenting in the treatment of peripheral arterial disease. Primary endpoints included primary patency (PP) and freedom from target lesion revascularization (TLR) 12 months postoperatively. We performed a meta-analysis of aggregate data for PP, TLR and technical success and a subgroup analysis between devices dedicated to spot stenting and conventional devices. Following the individual participant data (IPD) extraction, we performed a 2 stage time to event IPD meta-analysis for PP and TLR. Plotting of hazard estimates was performed by applying the Epanechnikov Kernel function. RESULTS: Five studies with 818 patients, 965 lesions and a mean lesion length of 169.2 mm were included. Chronic total occlusions comprised 51.7% of the treated lesions while, 80% of the lesions involved the popliteal artery. The pooled PP 12 months post-operatively is 80.72% (95% confidence interval [CI]: 77.67-83.45) (I2 = 36%), 95% prediction interval (PI) (67.94-89.00). The subgroup analysis between devices dedicated to spot stenting and conventional devices produced similar results of 80.93% (95% CI: 77.17-84.19) (I2 = 0%) and 80.30% (95% CI: 74.72-84.90) (I2 = 62%), respectively. The pooled TLR rate is 13.06% (95% CI: 10.69-15.86) (I2 = 53%). The pooled technical success rate is 98.77% (95% CI: 97.50-99.40) (I2 = 18%). The IPD meta-analysis produced statistically significant results favoring spot stenting over long stenting for both primary endpoints. Primary patency hazard ratio (HR) 2.04. (95% CI: 1.25-3.32) (I2 = 0%, t2 = 0). TLR, HR 1.97 (95% CI: 1.02-3.79) (I2 = 0%, t2 = 0). Plotting of hazard estimates produced diametrically opposite courses for the spot and long stenting curves. The hazards cross over at about 6 months, and at about 10 months when long stenting group faces the highest risk for loss of patency, spot stenting hazard reaches near zero values. The curves for TLR portray similar findings. CONCLUSIONS: Spot stenting is a safe and effective strategy for the treatment of femoropopliteal arterial disease with acceptable short and mid-term primary patency and freedom from TLR rates. Long stenting of the femoral artery doubles the risk of patency loss and TLR compared to spot stenting. The risk of patency loss and TLR in femoral artery spot stenting appears 4 months after the intervention and reaches near zero values at 8 months.


Subject(s)
Angioplasty, Balloon , Peripheral Arterial Disease , Femoral Artery/surgery , Humans , Lower Extremity , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/therapy , Popliteal Artery/diagnostic imaging , Stents , Treatment Outcome , Vascular Patency
18.
J Cardiovasc Surg (Torino) ; 63(2): 137-145, 2022 Apr.
Article in English | MEDLINE | ID: mdl-35005877

ABSTRACT

INTRODUCTION: Stenting of infrainguinal lesions can be rather challenging due to the mechanical stress applied on the arteries during motion. We assessed the short-term and mid-term safety and efficacy of Supera interwoven nitinol stent for the treatment of infrainguinal arterial disease. EVIDENCE ACQUISITION: We conducted a systematic review for articles published from December 2011 up to May 2021 regarding studies assessing the safety and efficacy of Supera interwoven nitinol stents for the treatment of infra-inguinal peripheral arterial disease. Studies that involved synchronous application of the Supera stent and drug delivering devices, or any alternative endoprosthesis were excluded. Pooled Kaplan-Meier survival curves and smoothed hazard estimates were generated. Data were meta-analyzed using a random effects model. Primary endpoints included primary patency and freedom from clinically driven target lesion revascularization (TRL). Secondary endpoints included technical success and major amputation at 1 year post intervention. EVIDENCE SYNTHESIS: Seventeen studies with 2015 patients (65.3% males) and a mean lesion length of 137.2 mm were included. Of the total treated lesions, 44.9% involved femoropopliteal artery and 37.4% the popliteal artery. Chronic total occlusions made up 49% of the treated lesions. There were no stent fractures reported. The pooled technical success rate is 99.84% (95% CI: 99.26-100). Pooled major amputation rate at 1 year is 1.48% (95% CI: 0.47-2.87). Pooled primary patency and freedom from TLR rates at 1 year are 83.5% (95% CI: 80.24-86.54) and 90.32% (95% CI: 88.75-91.79), respectively. Pooling of individual patient data produced primary patency and freedom from TLR rates of 84.48% (95% CI: 82.66-86.11) and 90.81% (95% CI: 88.64-92.58) respectively. According to the smoothed hazard ratio estimate the risk for losing primary patency peaked between 4 and 5 months while the risk for TLR peaked between 7 and 8 months after the intervention. CONCLUSIONS: This review and meta-analysis indicated the safety and efficacy of Supera stents for the treatment of challenging infrainguinal lesions in the short-term and mid-term periods, with acceptable primary patency and freedom from TLR rates. Clinicians should be aware that between 4 and 5 months patients face a higher risk for event occurrence.


Subject(s)
Peripheral Arterial Disease , Alloys , Female , Femoral Artery , Humans , Male , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/therapy , Popliteal Artery/diagnostic imaging , Prosthesis Design , Stents , Treatment Outcome , Vascular Patency
19.
Vasa ; 51(1): 37-45, 2022 01.
Article in English | MEDLINE | ID: mdl-34794339

ABSTRACT

Objectives: Acute lower limb ischemia (ALLI) is a common vascular emergency. However, ALLI presenting as the initial symptom of acute leukemia (AL) is scarce. Here we present a case of ALLI in the setting of acute myeloid leukemia (AML) while systematically reviewing the current literature to withdraw conclusions about the management, prognosis, and treatment for this atypical presentation of AL. Methods: We conducted a systematic electronic research according to Preferred Reporting Items for Systematic Review and Meta-Analysis protocol (PRISMA) for articles published from January 1981 up to January 2021 concerning ALLI in the setting of acute leukemia (AL). Patients' baseline characteristics were recorded and nine outcomes of interest were studied. Results: Twenty-six individuals, 16 males with a mean age of 46.3 years (±20) were included in this review. The diagnosis included 13 AML patients (50%), 11 acute promyelotic leukemia (APL) (42.3%) and two acute lymphoblastic leukemias (ALL) (7.7%). Treatment varied among nine different regimens. Four patients were treated with chemotherapy alone (15.4%), four with thrombectomy alone (15.4%), and 11 with a combination of chemotherapy and thrombectomy (42.3%). Eight major amputations were recorded (30. 8%). Thirty-day mortality was 35.7%. Forty-eight peripheral thrombotic events were recorded with 12 patients suffering recurrent thrombotic events. Conclusion: ALLI as the presenting symptom of AL is a rare condition that carries significant mortality and amputation rates. Timely diagnosis is crucial concerning short-term survival and limb salvage. APL, despite being the rarest form of AL, represented a significant proportion of the patient population in this review. The role of leukostasis in the disease's progression and the efficacy of leukapheresis as a treatment regimen should be further investigated through case-control studies.


Subject(s)
Ischemia , Leukemia, Myeloid, Acute , Acute Disease , Amputation, Surgical , Humans , Ischemia/diagnosis , Ischemia/etiology , Ischemia/therapy , Leukemia, Myeloid, Acute/diagnosis , Leukemia, Myeloid, Acute/therapy , Limb Salvage , Male , Middle Aged , Risk Factors , Time Factors , Treatment Outcome
20.
J Vasc Surg ; 74(2): 646-656.e9, 2021 08.
Article in English | MEDLINE | ID: mdl-34019986

ABSTRACT

OBJECTIVE: We evaluated the safety and efficacy of multilayer flow modulator (MFM) stents (Cardiatis, Isnes, Belgium) for the treatment of complex aortic lesions. METHODS: A systematic electronic research was conducted for studies reported from December 2008 to May 2020. Data extracted from 15 eligible case series (CS) were appropriately pooled and analyzed in a meta-analysis. The patient baseline characteristics were recorded, and 16 outcomes of interest were studied. The primary end points included 30-day all-cause and aneurysm-related mortality, aneurysm-related mortality at 1 year, vessel patency, and any endoleaks, ruptures, reinterventions, and aneurysm exclusion at the end of follow-up. RESULTS: A total of 39 studies (15 CS and 24 case reports), involving 429 patients, met the inclusion criteria. Overall, 436 lesions were treated, and 1521 aortic branches were covered by the multilayer stent. The mean follow-up for the 15 CS with 404 patients was 14.6 months. Compliance with the instructions for use was reported by eight CS, with 75% of the procedures performed within the instructions for use. However, 41% of the patients reported by 12 CS had undergone a previous aortic intervention. The pooled 30-day all-cause and 30-day aneurysm-related mortality rates were 0.56% (95% confidence interval [CI], 0.00%-2.54%) and 0.00% (95% CI, 0.00%-0.80%), respectively. The pooled aneurysm-related mortality at 1 year of follow-up was 5.25% (95% CI, 0.07%-14.91%). The pooled vessel patency at the end of follow-up was 99.12% (95% CI, 97.73%-99.93%). The pooled reintervention and endoleak rates at the end of follow-up were 10.94% (95% CI, 3.64%-20.67%) and 10.70% (95% CI, 4.45%-18.66%), respectively. The crude spinal cord ischemia and renal failure rates were 0.69% and 1.8%, respectively. CONCLUSIONS: The results from the present review and meta-analysis have indicated the safety and efficacy of MFM stents for treating challenging aortic pathologic lesions when used as first-line treatment and within the instructions for use. The almost zero pooled 30-day all-cause and aneurysm-related mortality rates combined with the low crude spinal cord ischemia and renal failure rates indicate the use of MFM stents is a good treatment option for complex aortic lesions in the short- and mid-term periods. The lack of long-term follow-up warrants further research concerning the efficacy of the device in the long term.


Subject(s)
Aortic Diseases/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endovascular Procedures/instrumentation , Stents , Adolescent , Aged , Aged, 80 and over , Aortic Diseases/diagnostic imaging , Aortic Diseases/mortality , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/mortality , Endovascular Procedures/adverse effects , Endovascular Procedures/mortality , Female , Humans , Male , Middle Aged , Postoperative Complications/mortality , Postoperative Complications/therapy , Prosthesis Design , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome
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