Predictors of prolonged hospitalization of COVID-19 patients.

PURPOSE: Despite the importance of hospital bed network during the pandemic, there are scarce data available regarding factors predictive of prolonged length of hospitalization of COVID-19 patients. METHODS: We retrospectively analyzed a total of 5959 consecutive hospitalized COVID-19 patients in period 3/2020-6/2021 from a single tertiary-level institution. Prolonged hospitalization was defined as hospital stay > 21 days to account for mandatory isolation period in immunocompromised patients. RESULTS: Median length of hospital stay was 10 days. A total of 799 (13.4%) patients required prolonged hospitalization. Factors that remained independently associated with prolonged hospitalization in multivariate analysis were severe or critical COVID-19 and worse functional status at the time of hospital admission, referral from other institutions, acute neurological, acute surgical and social indications for admission vs admission indication of COVID-19 pneumonia, obesity, chronic liver disease, hematological malignancy, transplanted organ, occurrence of venous thromboembolism, occurrence of bacterial sepsis and occurrence of Clostridioides difficile infection during hospitalization. Patients requiring prolonged hospitalization experienced higher post-hospital discharge mortality (HR = 2.87, P < 0.001). CONCLUSIONS: Not only severity of COVID-19 clinical presentation but also worse functional status, referral from other hospitals, certain indications for admission, certain chronic comorbidities, and complications that arise during hospital stay independently reflect on the need of prolonged hospitalization. Development of specific measures aimed at improvement of functional status and prevention of complications might reduce the length of hospitalization.

Three year results of endovascular therapy with a new generation nitinol stent for femoro-popliteal artery lesions - a single-center outcome analysis of a subcohort of MISAGO 2 study.

BACKGROUND: Advances in stent technology have widened the field of indications for stent treatment of femoro-popliteal artery lesions, however the use of stents in bending arterial segments is restricted because some first- and second-generation nitinol stent designs did not respond well to the mechanical forces of femoro-popliteal segments in motion which pose a substantial risk of stent fracture inducing in-stent-stenosis. New generation nitinol stents are supposed to overcome these limitations but long-term results are rare. PATIENTS AND METHODS: In forty-five patients (mean age 68 y, range 50 - 85) with peripheral arterial disease (TASC II A-C, Rutherford category 2 - 5) forty-six lesions of the superficial femoral artery (37) or popliteal artery (9) were treated [25 high-grade stenoses, mean length 53 mm (range 30 - 145 mm); 21 chronic total occlusions, mean length 74 mm (range 30 - 180 mm)]. 74 % of lesions were located in the mobile bending arterial segments in the distal femoral or the popliteal segment. Clinical reevaluation performed at discharge, at 6, 12, 24, and 36 months included at least the measurement of ankle-brachial index (ABI) and duplex sonography. RESULTS: Procedural success rate was 100 %. At 6, 12, 24, and 36 months, cumulative primary patency rate was 93.5 %, 84.8 %, 80.5 %, and 74.3 % (SE<10); freedom from target lesion revascularization rate was 95.7 %, 89.2 %, 84.9 %, and 79.3 % (SE<10); Rutherford category and ABI improved in all patients and clinical success was maintained in more than 85 % of patients. CONCLUSIONS: Sustained technical and clinical success and good clinical long-term results were achieved with Misago™ nitinol stent implantation in femoro-popliteal lesions with moderate risk for in-stent-stenosis, and in the distal femoral and popliteal mobile segment.

MISAGO 2: one-year outcomes after implantation of the Misago self-expanding nitinol stent in the superficial femoral and popliteal arteries of 744 patients.

PURPOSE: To evaluate the safety and efficacy of the Misago self-expanding rapid-exchange nitinol stent system for the treatment of femoropopliteal occlusive disease in a prospective multicenter observational trial (ClinicalTrials.gov; identifier NCT01118117). METHODS: Between April and October 2008, the registry enrolled 744 patients (496 men; 69 ± 10 years) who had symptomatic ≥ 70% stenosis or occlusion of the superficial femoral or popliteal arteries treated with the Misago stent. Mean length of the 750 lesions was 63.9 mm; 282 (37.6%) vessels were completely occluded. Primary study endpoints were the need for target lesion revascularization (TLR) and event-free survival rates for the assessment of efficacy and safety, respectively. At 6 and 12 months post intervention, clinical symptoms of recurrent ischemia and/or claudication, Rutherford category, and ankle-brachial index (ABI) at rest were assessed. RESULTS: In the study period, 945 stents were successfully deployed in the 750 lesions. The overall TLR rate was 10.1% among 671 (90.3%) patients evaluated at 1 year [3.1% among 709 (95.3%) patients at 6 months]. Event-free survival at 12 months was 84.9%. Mean ABIs improved by ≥ 0.1 in three quarters of the patients (76.0%) over 12 months. The Rutherford grade improved or remained stable in the majority of patients (95.5%) after 1 year. Stent fractures (13 grade 1, 2 grade 2) in 3.1% of stents examined radiographically (n=484) at 1 year were not related to any clinical events. Primary patency was recorded in 574 (87.6%) patients evaluated at 1 year post procedure. CONCLUSION: The Misago rapid-exchange nitinol stent showed promising efficacy and safety results, with a low stent fracture rate, in patients with femoropopliteal disease, making it a safe and reliable treatment option.

Management of diffuse hepatocellular carcinoma (≧ 10 Lesions) with doxorubicin-loaded DC beads is a safe and effective treatment option.

BACKGROUND: Multinodular hepatocellular carcinoma (HCC; ≥ 10 lesions) has been considered a controversial indication for transarterial chemoembolization (TACE) based on the extent of disease and the belief that no clinical benefit can be achieved. The aim of this study was to assess the safety and efficacy of chemoembolization with doxorubicin-eluting beads (DEBDOX) in the treatment of multinodular HCC. PATIENTS AND METHODS: A 503-patient prospective multinational DC Bead registry database from 6/2007 to 2/2010 identified 176 patients treated for HCC with DEBDOX. RESULTS: There were 42 patients with multinodular HCC compared to 134 with non-multinodular HCC. After a median follow-up of 12 months, the multinodular group response rate according to modified RECIST criteria was 56% and median overall survival was 7.6 months, compared to 57% and 15 months in the non-multinodular group (p = 0.08). CONCLUSIONS: Multinodular HCC represents a more advanced stage of disease; however, DEBDOX treatment is safe and effective when compared to historical controls and current best systemic therapy. Continued hepatic arterial therapy and evaluation is needed in this clinical subset to further confirm these results.

Hepatic arterial therapy as a bridge to ablation or transplant in the treatment of hepatocellular carcinoma.

Hepatocellular carcinoma (HCC) is a challenging malignancy as a result of the advanced course at presentation. Recent interventional advances have improved treatment of lesions unamenable to resection using drug-eluting microbeads delivered into the hepatic circulation. We hypothesize that the use of hepatic arterial therapy (HAT) will safely identify appropriate patients who can proceed to ablation and/or transplantation. We evaluated our open-label, multicenter, multinational, single-arm study including 240 patients with intermediate-staged HCC who received drug-eluting beads and were not initial candidates for transplantation or resection. We reviewed the resulting clinical data to determine factors leading to possible ablation or transplant. Of 240 patients undergoing HAT, 14 (5.8%) received ablation or transplant. We compared those receiving ablation or transplant with those receiving only HAT. Groups were similar regarding sex, age, median number of tumors (one; range, 1 to 25), Child's score, tobacco and alcohol abuse, and treatment type. Patients who were downstaged were more likely to have: hepatitis-related tumors (76 to 66%, P = 0.02), distinct lesions on imaging (92 to 76%, P = 0.004), and less than 25 per cent parenchymal involvement (84 to 59%, P = 0.0001). These patients typically had one tumor frequently in the left lobe (58.8 vs 30.9%, P = 0.0001), accessible through segmental arteries (47 vs 17%, P = 0.001), with increased segmental branch occlusion (57 vs 39%, P = 0.02). HAT should be considered a potential bridging therapy to eventual ablation or transplant in the multimodal treatment of HCC.

Hepatic arterial infusion of doxorubicin-loaded microsphere for treatment of hepatocellular cancer: a multi-institutional registry.

BACKGROUND: Hepatic intra-arterial therapy for unresectable hepatocellular cancer (HCC) has been shown to improve overall survival, but can have significant toxicity. A recent prospective randomized controlled trial demonstrated superior response rates and significantly less morbidity and doxorubicin-related adverse events with drug-eluting beads with doxorubicin (DEBDOX) compared with conventional chemoembolization. The aim of this study was to confirm the efficacy of DEBDOX for the treatment of unresectable HCC. STUDY DESIGN: This open-label, multicenter, multinational single-arm study included 118 intermediate-staged HCC patients who were not candidates for transplantation or resection. Patients received DEBDOX at each treatment. Complications and response rates to treatment were analyzed. RESULTS: There were 118 patients who received a total of 186 DEBDOX treatments with a median total treatment dose of 75 mg (range 38 to 150 mg), and median overall total hepatic exposure of 150 mg (range 150 to 600 mg). Five lesions were targeted, with a median size of 5.3 cm (range 1.0 to 16.9 cm). Severe adverse events related to liver dysfunction were seen after 4% of treatments. Overall survival was a median of 14.2 months (range 5 to 30 months), with progression-free survival of 13 months and hepatic-specific progression-free survival of 16 months. Okuda class less than 1 at time of treatment, reduction of alpha-fetoprotein of 1,000 ng/mL at the first post-treatment evaluation, delivery of more than 200 mg doxorubicin, and less than 25% liver involvement were all predictors of favorable overall survival assessed by multivariable analyses. CONCLUSIONS: Hepatic intra-arterial injection of DEBDOX is safe and effective in the treatment of HCC, as demonstrated by a minimal complication rate and robust and durable tumor response.

Precision hepatic arterial irinotecan therapy in the treatment of unresectable intrahepatic cholangiocellular carcinoma: optimal tolerance and prolonged overall survival.

BACKGROUND: Unresectable intrahepatic cholangiocellular carcinoma (ICC) carries a poor prognosis, and there are few chemotherapeutic treatments to prolong survival. The purpose of this study was to assess the efficacy of drug-eluting bead (DEB) therapy by transarterial infusion for unresectable ICC. METHODS: A prospective multicenter study of ICC patients who received hepatic arterial DEB therapy. RESULTS: Twenty-four patients with unresectable ICC were treated with DEB. Ten patients (41.6%) had recurrent ICC after prior radiofrequency ablation (n = 3) or hepatectomy (n = 7). Twenty patients (80%) had received prior chemotherapy, mostly of gemcitabine (n = 8) or Eloxatin (n = 6). The percent of overall liver involvement was < 25% (n = 8), 26% to 50% (n = 11), and > 50% (n = 4). Ten patients (40%) had sites of extrahepatic disease located at lymph nodes (n = 5), bone (n = 2), peritoneum (n = 1), lung (n = 1), and mouth (n = 1). A total of 42 DEB treatments were administered. Eight were administered in combination with systemic chemotherapy of FOLFOX (n = 4) or Gemzar (n = 4). Twelve patients (48%) received a second treatment, and 4 patients (16%) received a third treatment. The median length of stay was 23 h (23-72 h). Eleven adverse reactions (26.2%) were reported. Of these, 7 (63.6%) were minor (less than grade 3). One patient died from hepatorenal syndrome. The disease of one patient was downstaged to resection. After a median follow-up of 13.6 months, the median overall survival of a multitherapeutic regimen with DEB therapy was significantly greater than chemotherapy alone (17.5 vs. 7.4 months; P = 0.02). CONCLUSIONS: Bead therapy is safe and effective in patients with unresectable ICC. There is a marked survival benefit when DEB therapy is used as adjunctive therapy.