From Bench To Bedside: Can the Improvements in LVAD Design Mitigate Adverse Events and Increase Survival Rate?

2014 ◽  
Vol 33 (4) ◽  
pp. S155
Author(s):  
V. Tarzia ◽  
G. Di Giammarco ◽  
M. Maccherini ◽  
T. Bottio ◽  
V. Tursi ◽  
...  
2021 ◽  
Vol 10 (7) ◽  
pp. 1389
Author(s):  
Wojciech Wieczorek ◽  
Jarosław Meyer-Szary ◽  
Milosz J. Jaguszewski ◽  
Krzysztof J. Filipiak ◽  
Maciej Cyran ◽  
...  

Cardiac arrest (CA) is associated with high mortality and poor life quality. Targeted temperature management (TTM) or therapeutic hypothermia is a therapy increasing the survival of adult patients after CA. The study aim was to assess the feasibility of therapeutic hypothermia after pediatric CA. We performed a systematic review and meta-analysis of randomized controlled trials and observational studies evaluating the use of TTM after pediatric CA. The primary outcome was survival to hospital discharge or 30-day survival. Secondary outcomes included a one-year survival rate, survival with a Vineland adaptive behavior scale (VABS-II) score ≥ 70, and occurrence of adverse events. Ten articles (n = 2002 patients) were included, comparing TTM patients (n = 638) with controls (n = 1364). In a fixed-effects meta-analysis, survival to hospital discharge in the TTM group was 49.7%, which was higher than in the non-TTM group (43.5%; odds ratio, OR = 1.22; 95% confidence interval, CI: 1.00, 1.50; p = 0.06). There were no differences in the one-year survival rate or the occurrence of adverse events between the TTM and non-TTM groups. Altogether, the use of TTM was associated with a higher survival to hospital discharge; however, it did not significantly increase the annual survival. Additional high-quality prospective studies are necessary to confer additional TTM benefits.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Clara Vigneron ◽  
Julien Charpentier ◽  
Sandrine Valade ◽  
Jérôme Alexandre ◽  
Samy Chelabi ◽  
...  

Abstract Background Major therapeutic advances including immunotherapy and targeted therapies have been changing the face of oncology and resulted in improved prognosis as well as in new toxic complications. The aim of this study is to appraise the trends in intensive care unit (ICU) admissions and outcomes of critically ill patients with solid malignancies. We performed a retrospective single-centre study over a 12-year period (2007–2018) including adult patients with solid malignancies requiring unplanned ICU admission. Admission patterns were classified as: (i) specific if directly related to the underlying cancer; (ii) non-specific; (iii) drug-related or procedural adverse events. Results 1525 patients were analysed. Lung and gastro-intestinal tract accounted for the two main tumour sites. The proportion of patients with metastatic diseases increased from 48.6% in 2007–2008 to 60.2% in 2017–2018 (p = 0.004). Critical conditions were increasingly related to drug- or procedure-related adverse events, from 8.8% of ICU admissions in 2007–2008 to 16% in 2017–2018 (p = 0.01). The crude severity of critical illness at ICU admission did not change over time. The ICU survival rate was 77.4%, without any significant changes over the study period. Among the 1279 patients with complete follow-up, the 1-year survival rate was 33.2%. Independent determinants of ICU mortality were metastatic disease, cancer in progression under treatment, admission for specific complications and the extent of organ failures (invasive and non-invasive ventilation, inotropes/vasopressors, renal replacement therapy and SOFA score). One-year mortality in ICU-survivors was independently associated with lung cancer, metastatic disease, cancer in progression under treatment, admission for specific complications and decision to forgo life-sustaining therapies. Conclusion Advances in the management and the prognosis of solid malignancies substantially modified the ICU admission patterns of cancer patients. Despite underlying advanced and often metastatic malignancies, encouraging short-term and long-term outcomes should help changing the dismal perception of critically ill cancer patients.


2016 ◽  
Vol 9 (3) ◽  
pp. 147-157 ◽  
Author(s):  
Koji Teramoto ◽  
Yoshitomo Ozaki ◽  
Jun Hanaoka ◽  
Satoru Sawai ◽  
Noriaki Tezuka ◽  
...  

Background: The dendritic cell (DC)-based vaccine targeting the highly immunogenic tumor antigen, MUC1, has been promising for a cancer immunotherapy; however, predictive biomarkers for beneficial clinical responses of the vaccine remain to be determined. Methods: DCs loaded with MUC1-derived peptide were subcutaneously administered to patients with MUC1-positive non-small cell lung cancer (NSCLC) that was refractory to standard anticancer therapies, every 2 weeks. The effectiveness and tolerability of the vaccine were evaluated, and predictive biomarkers of clinical responses were explored. Results: Between August 2005 and May 2015, 40 patients received the vaccines. The median survival time (MST) after the initial vaccination was 7.4 months, and the 1-year survival rate was 25.0%. The MST for patients who received more than six vaccinations was 9.5 months, and the 1-year survival rate was 39.3%. In this cohort, patients who experienced immune-related adverse events, including skin reactions at the vaccination site and fever, had significantly longer survival times compared with patients without those immune-related adverse events (12.6 versus 6.7 months, p = 0.042). Longer survival times were also observed in patients whose peripheral white blood cells contained >20.0% lymphocytes (12.6 versus 4.5 months; p = 0.014). MUC1-specific cytotoxic immune responses were achieved in all of seven patients analyzed who received six vaccinations. Conclusion: The MUC1-targeted DC-based vaccine induced an antitumor immune response that promoted prolonged survival of patients with refractory NSCLC. The occurrence of immune-related adverse events and having a higher percentage of peripheral lymphocytes were predictive biomarkers of a beneficial clinical response during cancer immunotherapy for NSCLC.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Xiaoyu Liu ◽  
Liying Zheng ◽  
Jing Han ◽  
Lu Song ◽  
Hemei Geng ◽  
...  

AbstractPrevious studies on the adverse events of acute pulmonary embolism (APE) were mostly limited to single marker, and short follow-up duration, from hospitalization to up to 30 days. We aimed to predict the long-term prognosis of patients with APE by joint assessment of D-dimer, N-Terminal Pro-Brain Natriuretic Peptide (NT-ProBNP), and troponin I (cTnI). Newly diagnosed patients of APE from January 2011 to December 2015 were recruited from three hospitals. Medical information of the patients was collected retrospectively by reviewing medical records. Adverse events (APE recurrence and all-cause mortality) of all enrolled patients were followed up via telephone. D-dimer > 0.50 mg/L, NT-ProBNP > 500 pg/mL, and cTnI > 0.40 ng/mL were defined as the abnormal. Kaplan–Meier curve was used to compare the cumulative survival rate between patients with different numbers of abnormal markers. Cox proportional hazard regression model was used to further test the association between numbers of abnormal markers and long-term prognosis of patients with APE after adjusting for potential confounding. During follow-up, APE recurrence and all-cause mortality happened in 78 (30.1%) patients. The proportion of APE recurrence and death in one abnormal marker, two abnormal markers, and three abnormal markers groups were 7.69%, 28.21%, and 64.10% respectively. Patients with three abnormal markers had the lowest survival rate than those with one or two abnormal markers (Log-rank test, P < 0.001). After adjustment, patients with two or three abnormal markers had a significantly higher risk of the total adverse event compared to those with one abnormal marker. The hazard ratios (95% confidence interval) were 6.27 (3.24, 12.12) and 10.7 (4.1, 28.0), respectively. Separate analyses for APE recurrence and all-cause death found similar results. A joint test of abnormal D-dimer, NT-ProBNP, and cTnI in APE patients could better predict the long-term risk of APE recurrence and all-cause mortality.


Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 2713-2713
Author(s):  
Norina Tanaka ◽  
Yoichi Imai ◽  
Aya Watanabe ◽  
Kenjiro Mitsuhashi ◽  
Kentaro Yoshinaga ◽  
...  

Abstract Background: Although many salvage regimens have been used in patients with relapse or refractory lymphoma, these have limitations in elderly or patients with complications due to toxicity and restricted tolerability. In particular, the treatment strategy for patients with severe comorbidity remains to be determined. The combination of ifosfamide, carboplatin, and etoposide (ICE) has been used for relapse and refractory non-Hodgkin lymphoma since the 1990s. Ifosfamide, an alkylating agent, is a key drug in the ICE regimen, which is non-cross resistant with cyclophosphamide. In practice, there are various regimens of ICE treatment. The outpatient-based fractionated regimen of ICE (fractionated ICE) described in 2003 by Herzberg et al involves a different method of ifosfamide-administration from that originally described. Although ifosfamide 5000 mg/m2 is continuously infused for 24 h according to the original ICE regimen, it is infused in three equally divided doses over 2 h on days 1-3 of each cycle in the fractionated ICE regimen. Unlike the original ICE regimen, the modified regimen can be performed in outpatient clinics. The efficacy and tolerability of fractionated ICE as both a salvage and stem cell mobilization regimen have been confirmed in relapse/refractory patients. Many studies have reported the efficacy of the addition of rituximab to chemotherapy for diffuse large B-cell lymphoma patients (DLBCL). However, no study has reported the efficacy of rituximab addition to the fractionated ICE regimen. In this study, we analyzed the efficacy and toxicity of fractionated ICE with rituximab (fractionated R-ICE) as a salvage regimen in relapse/refractory DLBCL patients (Table 1). Further, we compared the response and survival rate after fractionated R-ICE between patients with severe comorbidity and other patients. Method: We retrospectively analyzed the records of 66 patients with relapse or refractory DLBCL diagnosed between 2000 and 2014. Comorbidities were evaluated using Charlson Comorbidity Index (CCI), and National Cancer Institute Common Toxicity Criteria were used to define toxicities. Result: Among the 66 patients, 55 received salvage therapies, 30 received fractionated R-ICE, and 25 received it as a second-line salvage therapy. Efficacy and toxicity is demonstrated in Table 2. The overall response rate (ORR) to fractionated R-ICE was 46.7% (n=14) (complete response [CR], 26.7% [n=8], partial response, 20% [n=6]); 1 year survival rate after relapse was 56.7%, and the duration of 50% survival after relapse was 2.4 years. During the cycles, myelosuppression was the most serious toxicity, followed by grade 4 hematological adverse events were 18 (60%) patients, respectively. A previous study showed poor prognosis in patients with high CCIs before the first R-CHOP treatment. In our study, the ratio of patients with chemotherapy dose reduction less than 30% was comparable between low (0 or 1) and high (≥2) CCIs estimated before the fractionated R-ICE therapy. There was no significant difference of survival duration after relapse between low and high CCI (Figure 1). The items used for estimating CCI such as diabetes (n=5), heart disease (n=4), tumor (n=4), and collagen disease (n=3) did not affect survival. Conclusion: Although patients in our study were old (median: 71 y, range 50-85 y), the CR rate was similar to that of previous studies involving ICE therapy (CR rate 12.5-37%) or R-ICE therapy (CR rate 25-53%). Our results suggest that comorbidities do not have significant impact on the outcome of patients with relapse or refractory DLBCL treated with fractionated R-ICE. Although myelosuppression was severe in patients with high CCI scores, there was no increased incidence of infection or other adverse events. Fractionated R-ICE is supposed to be useful as a salvage therapy, which can be performed in outpatient clinics for relapse/refractory DLBCL patients including those who were older or having high CCI scores. Disclosures No relevant conflicts of interest to declare.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. TPS11572-TPS11572 ◽  
Author(s):  
Sant P. Chawla ◽  
Victoria S. Chua ◽  
Katherine Kim ◽  
Paul Stendahl Dy ◽  
Micaela Kristina Paz ◽  
...  

TPS11572 Background: Talimogene laherparepvec (TVEC), an oncolytic HSV expressing huGMCSF, may be synergistic with trabectedin (T) and nivolumab (N) in treating advanced sarcoma. Objectives: (1) To evaluate the best overall response by RECIST v1.1, progression-free survival rate (PFS), and overall survival rate, (2) To determine the incidence of conversion of an unresectable tumor to a resectable one, and (3) To evaluate the incidence of adverse events related to the drug combination. Methods: This is an open label phase 2 study. A total of 40 patients will receive T (1.2 mg/m2 CIV over 24 hours q3 weeks), N (240 mg IV over 30 min q 2 weeks) and TVEC (intratumorally q 2 weeks according to tumor size). Eligible patients are those with histopathologically confirmed diagnosis of locally advanced, unresectable or metastatic sarcoma including desmoid tumor and chordoma, previously untreated or treated, with measurable disease by RECIST v1.1, and at least, one accessible tumor for intratumoral injection of TVEC. Currently, 31 of the 40 patients have been enrolled. Statistical Considerations: Continuous variables will be summarized by the sample size (n), mean, standard deviation, first and third quartiles, minimum and maximum. Categorical variables will be summarized by the n and percent in each category. Point estimates for efficacy endpoint incidences will be accompanied by a 2-sided 95% exact binomial CI. Time to event endpoints will be summarized descriptively using the KM method. Safety (incidence and severity of adverse events and significant laboratory abnormalities) will be performed on all patients (ITT population). Patient incidence of all treatment emergent AEs will be tabulated by system organ class and preferred term. Clinical trial information: 03886311 .


2018 ◽  
Vol 17 (4) ◽  
pp. 4-11 ◽  
Author(s):  
A. О. Shevchenko ◽  
E. A. Nikitina ◽  
N. N. Koloskova ◽  
О. P. Shevchenko ◽  
S. V. Gotje

Aim. To evaluate the prevalence of arterial hypertension (AH) in heart transplant recipients, and its influence on the risk of adverse events, as the efficacy and safety of antihypertension medications (AHM).Material and methods. To the study, were consequently included all heart transplant recipients operated in the Shumakov Centre during the years 2013 to 2016 and survived 90 days after orthotopic heart transplantation.Results. Totally, 353 recipients included, with AH or AHM intake in anamnesis in 62 (17,6%). Within 90 days post-surgery, AH that demanded  for medication therapy was found in 151 (42,8%) patients. In posttransplant AH patients there were the following specific parameters in preoperational period: higher body mass index — 25,7±4,1 vs 24,9±4,4 (р=0,026), blood creatinine concentration — 100,6±62,6 vs 68,8±4,8 (р<0,001), donor heart posterior wall thickness — 11,9±0,8 vs 11,3±0,7 (р=0,034), creatinine concentration in 3 month after operation  — 131,7±101,6 vs 94,1±46,5 (p<0,001). There was relation revealed, of AH development risk with anamnesis of AH and renal failure, as a necessity for renal replacement therapy within 30 days post surgery and episodes of acute antibody-mediated reaction on transplant. In the recipients taking angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers (ACEi/ARB) before operation, the survival rate free from adverse events was better than in those taking calcium channel blockers (CCB) (plog-rank=0,042).Conclusion. The results of the study point on high prevalence of AH in heart recipients. Presence of AH in anamnesis, renal failure, episodes of humoral, but not cellular, reaction to the transplant, and donor heart hypertrophy do significantly increase the probability of AH development after transplantation. Comparison revealed significant benefit of ACEi/ ARB versus CCB as antihypertension medications in either monotherapy or in combination with diuretics.


2021 ◽  
Vol 38 (1) ◽  
Author(s):  
Quan Wang ◽  
Xu Zhang ◽  
Wentao Sun ◽  
Hua Li

Objectives: To investigate the effect and clinical value of the application of vacuum assisted closure (VAC) combined with multiple flaps in the treatment of severe hand trauma. Methods: A total of 100 patients with severe hand trauma admitted to Harrison International Peace Hospital from September 2015 to September 2020 were selected and randomly divided into two groups according to the randomized block method: the single flap repair group and the combined repair group, with 50 patients in each group. Patients in the single flap repair group underwent flap repair according to their condition, while those in the combined repair group were treated with VAC prior to flap repair. The range of motion and hand sensation scores were compared between the two groups, and their levels of interleukin-8 (IL-8), tumor necrosis factor (TNF) and lipopolysaccharide (LPS) were tested by enzyme-linked immunosorbent assay (ELIS). Moreover, the flap survival rate and the incidence of adverse events were recorded and compared between the two groups. Results: Compared with the single flap repair group, the combined repair group had higher range of motion and hand sensation score (p<0.05), lower levels of IL-8, TNF and LPS (p<0.05), higher flap survival rate (p<0.05), and lower incidence of adverse events (p<0.05). Conclusion: VAC combined with multiple flaps boasts significant trauma repair effect and preferable clinical application value in the treatment of patients with severe hand trauma, which is principally reflected in significantly improving the hand function of patients and remarkably alleviating the inflammatory response of patients. doi: https://doi.org/10.12669/pjms.38.1.4631 How to cite this:Wang Q, Zhang X, Sun W, Li H. Clinical study on vacuum assisted closure combined with multiple flaps in the treatment of severe hand trauma. Pak J Med Sci. 2022;38(1):---------. doi: https://doi.org/10.12669/pjms.38.1.4631 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


2021 ◽  
Vol 8 ◽  
Author(s):  
Tingting Shu ◽  
Panpan Feng ◽  
Xiaozhu Liu ◽  
Li Wen ◽  
Huaqiao Chen ◽  
...  

Background: Pulmonary arterial hypertension (PAH) patients with pregnancy have high maternal mortality. This study aimed to provide clinical evidence with multidisciplinary team (MDT) management and to evaluate the clinical outcomes in PAH patients during the perinatal period.Methods: We conducted a retrospective evaluation of PAH patients pregnant at the First Affiliated Hospital of Chongqing Medical University between May 2015 and May 2021.Results: Twenty-two patients (24 pregnancies) were included in this study and received MDT management, and 21 pregnancies chose to continue pregnancy with cesarean section. Nine (37.5%) were first-time pregnancies at 27.78 ± 6.16 years old, and 15 (62.5%) were multiple pregnancies at 30.73 ± 3.71 years old. The average gestational week at hospitalization and delivery were 29.38 ± 8.63 weeks and 32.37 ± 7.20 weeks, individually. Twenty-one (87.5%) pregnancies received single or combined pulmonary vasodilators. The maternal survival rate of PAH patients reached 91.7%. Fifteen (62.5%) pregnancies were complicated with severe adverse events. Patients with complicated adverse events showed lower percutaneous oxygen saturation (SpO2), lower albumin, lower fibrinogen, higher pulmonary artery systolic pressure (PASP), higher blood pressure, longer activated partial thromboplastin time, and longer coagulation time. Fourteen (66.7%) pregnancies with cesarean sections were prematurely delivered and 85.7% newborns who survived after the operation remained alive.Conclusion: The survival rate of parturients with PAH was improved in relation to MDT and pulmonary vasodilator therapy during the perinatal period compared with previous studies. SpO2, albumin, PASP, blood pressure, and coagulation function should be monitored carefully in PAH patients during pregnancy.


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