Patient Characteristics and Early Clinical Outcomes With Impella 5.5: A Systematic Review and Meta-Analysis.

Data regarding outcomes with Impella 5.5 are limited. The aim of this systematic review and meta-analysis was to summarize patient and treatment characteristics and early clinical outcomes among patients supported by Impella 5.5. A systematic literature search was conducted in PubMed, Scopus, and Cochrane databases from September 2019 to March 2023. Studies reporting outcomes in greater than or equal to 5 patients were included for review. Patient characteristics, treatment characteristics, and early clinical outcomes were extracted. Outcomes included adverse events, survival to hospital discharge, and 30 day survival. Random-effect models were used to estimate pooled effects for survival outcomes. Assessment for bias was performed using funnel plots and Egger's tests. Fifteen studies were included for qualitative review, representing 707 patients. Mean duration of support was 9.9 ± 8.2 days. On meta-analysis of 13 studies reporting survival outcomes, survival to hospital discharge was 68% (95% confidence interval [CI], 58-78%), and 30 day survival was 65% (95% CI, 56-74%) among patients with Impella devices predominantly supported by Impella 5.5 (>60%). There was significant study heterogeneity for these outcomes. Among 294 patients with Impella 5.5 only, survival to discharge was 78% (95% CI, 72-82%) with no significant study heterogeneity. This data present early benchmarks for outcomes with Impella 5.5 as clinical experience with these devices accrues.

Does a Presurgical Antisepsis Protocol Decrease Surgical Site Infections in Young Children?

National standards for surgical site infection (SSI) prevention for children remain elusive. Our institution developed a presurgical antisepsis protocol that included the three components of chlorhexidine gluconate bathing wipes, chlorhexidine gluconate oral rinse, and povidone-iodine nasal swab. This retrospective cohort study examined data from electronic health records to compare SSI rates before and after protocol implementation. We included children aged 2 through 11 years undergoing any surgical procedure with the use of an incision in the OR (N = 1,356). We did not find any difference in the occurrence of SSI before and after the protocol was implemented. Logistic regression showed that an infection present at the time of surgery was the only significant predictor of an SSI. The implementation of a presurgical antisepsis protocol was not associated with SSI rate reduction in this pediatric cohort.

Long-term clinical outcomes and technical factors with the Wallstent for treatment of chronic iliofemoral venous obstruction.

BACKGROUND: Factors affecting long-term clinical outcome and stent patency after iliofemoral venous stenting remain complex and ill-defined. Also, consensus is lacking among clinicians regarding the continuing role for the Wallstent (Boston Scientific, Marlborough, Mass) as dedicated nitinol-based venous stents become available. We undertook this study to review our long-term results using Wallstents and to evaluate the potential role of this stent in the future. METHODS: From 2007 to 2014, there were 77 limbs in 67 consecutive patients that received Wallstents for chronic iliofemoral vein obstruction. Intravascular ultrasound (IVUS) and venography were used to assess lesion type and extent. Baseline clinical severity was assessed with Venous Clinical Severity Score (VCSS) and Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) classification. Clinical improvement was assessed with VCSS at 12, 24, and 36 months. VCSS change ≥4 points was considered significant improvement. Patency was assessed with duplex ultrasound. A retrospective review of patients' records and imaging was conducted to assess baseline and procedural factors associated with long-term clinical outcomes. RESULTS: Lesions were nonthrombotic in 42 limbs (55%) and left-sided in 48 limbs (62%). Ten patients were treated for bilateral venous disease. Patients were predominantly male (55%); median age was 63 years (range, 47-83 years). Median baseline VCSS was 9 (range, 3-23). IVUS and venography estimated equal vessel compromise length in 37 limbs (48%). IVUS estimated a longer lesion in 32 limbs (42%). Stenting correlated with venography and IVUS in 37 limbs (48%) and more closely aligned with IVUS in 35 limbs (45%). Stents extended into the common femoral vein (CFV) in 17 limbs (22%) and into the inferior vena cava in 6 limbs (8%). Sixty-five (97%) patients had available imaging follow-up (median, 50 months). At 72 months, primary patency in the overall cohort was 87%; assisted primary patency and secondary patency were both 95%. In the nonthrombotic subset, assisted primary patency and secondary patency were 100%; primary patency was 97%. In the post-thrombotic subset, primary patency was 75%; assisted primary patency and secondary patency were 88%. Three early failures occurred. Eight patients required reintervention (range, 0.5-80 months); five interventions were to maintain patency. Cox multivariate regression identified that CFV disease predicted later complications. At last VCSS follow-up per patient (median, 26 months), 52 patients (68%) showed ≥4-point VCSS improvement. None had score worsening. CONCLUSIONS: Venous stenting with Wallstents for iliofemoral post-thrombotic or compressive obstruction proved safe and effective through long-term follow-up, with excellent patency rates. The majority of patients exhibited significant clinical improvement. CFV occlusive disease predicts increased complications.

The initial report on 1-year outcomes of the feasibility study of the VENITI VICI VENOUS STENT in symptomatic iliofemoral venous obstruction.

OBJECTIVE: The objective of this study was to assess the safety and efficacy of a dedicated venous stent (the VICI VENOUS STENT; VENITI, Fremont, Calif) for treatment of symptomatic iliofemoral venous outflow obstruction. METHODS: Thirty patients (24 female; median age, 43 years) were enrolled in the feasibility phase of an international, multicenter investigational device exemption trial from June 2014 to February 2015. All patients exhibited unilateral venous disease with ≥50% stenosis in the iliofemoral veins. Patients within 3 months of acute deep venous thrombosis or with prior surgical or endovascular intervention of the target vessel were excluded. Lesions were primarily of post-thrombotic causes (63%), with a left limb-right limb ratio of 5:1. Nine patients (30%) had lesions extending beneath the inguinal ligament. Median baseline stenosis was 91%; 11 patients (37%) had occlusions. RESULTS: Fifty-one stents were implanted successfully in 30 patients. Median residual stenosis was 0%, as estimated by venography and intravascular ultrasound. Median follow-up was 701 days. At 12 months, primary, assisted-primary, and secondary patency was 93%, 96%, and 100%, respectively. The stent occluded in two patients through the 12-month window (occurring at 19 and 385 days). Both occlusions occurred in patients presenting with post-thrombotic obstruction. No patients in this cohort exhibited stent fracture at 12 months. Symptomatic improvement of ≥2 points on the Venous Clinical Severity Score was observed in 23 patients (85%) at 12 months (median score improvement, 5 points). There was a median 12-month pain reduction of 20 mm on the visual analog scale score and 15-point improvement on the Chronic Venous Insufficiency Questionnaire score. Scores improved significantly on all three clinical and quality of life scales at 6 and 12 months. CONCLUSIONS: The VICI VENOUS STENT is safe and feasible for treatment of symptomatic iliofemoral venous obstruction, with excellent 12-month patency rates and significant improvement seen in clinical symptoms and quality of life indices. The pivotal phase (170 patients, 22 centers) of this investigational device exemption trial is currently ongoing.