OBJECTIVE: This systematic review included clinical trials of Food and Drug Administration-approved vaginal estrogens. The primary

 

Abstract

OBJECTIVE: This systematic review included clinical trials of Food and Drug Administration-approved vaginal estrogens. The primary objective of this systematic review was to examine the comparative safety of the Food and Drug Administration-approved vaginal estrogen preparations among postmenopausal women.

METHODS: We performed a PubMed search of the primary literature from January 1, 1966 to July 16, 2019 for English-language clinical trials. Manual review of retrieved citations identified additional citations.

RESULTS: Of 882 retrieved citations, 75 clinical trials met inclusion criteria. Maximum trial duration was 52 weeks. None of the trials predesignated breast or endometrial cancer, cardiovascular events, or venous thromboembolism as primary outcomes. Studies were not designed to rule out an increase in endometrial carcinoma risk with long-term use of vaginal estrogen. There were few head-to-head comparisons. Fifty trials examined serum sex steroid and gonadotrophin levels; assay methodologies varied. Serum estradiol levels were 11 pg/mL at baseline or during placebo use and increased to a mean of 30 pg/mL after treatment. Estradiol levels were usually highest during the first 12 weeks of treatment, and were higher for estrogen creams than for inserts or rings. The 22 trials of endometrial thickness and the 15 trials of endometrial biopsy did not clearly demonstrate endometrial proliferation after vaginal estrogen treatment, but data were limited, and studies did not always perform systematic endometrial biopsy.

CONCLUSIONS: Newer low-dose estradiol rings, tablets, and inserts appear to induce the least increases in serum hormones, possibly indicating greater safety. Limited evidence in trials lasting up to 52 weeks suggest endometrial safety of vaginal estrogen use. Long-term trials are needed. : Video Summary:http://links.lww.com/MENO/A513.

PMID: 31913230 [PubMed - as supplied by publisher]

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Cost-Effectiveness of Extended Thromboprophylaxis in Patients Undergoing Colorectal Surgery from a Canadian Health Care System Perspective.

//www.ncbi.nlm.nih.gov/corehtml/query/egifs/https:--tools.ovid.com-images-wklogo.jpg Related Articles

Cost-Effectiveness of Extended Thromboprophylaxis in Patients Undergoing Colorectal Surgery from a Canadian Health Care System Perspective.

Dis Colon Rectum. 2019 11;62(11):1381-1389

Authors: Trepanier M, Alhassan N, Sabapathy CA, Liberman AS, Charlebois P, Stein BL, S Feldman L, Lee L

Background Little is known about how practicing Internal Medicine (IM) clinicians perceive diagnostic error, and whether p

 

Abstract

Background Little is known about how practicing Internal Medicine (IM) clinicians perceive diagnostic error, and whether perceptions are in agreement with the published literature. Methods A 16-question survey was administered across two IM practices: one a referral practice providing care for patients traveling for a second opinion and the other a traditional community-based primary care practice. Our aim was to identify individual- and system-level factors contributing to diagnostic error (primary outcome) and conditions at greatest risk of diagnostic error (secondary outcome). Results Sixty-five of 125 clinicians surveyed (51%) responded. The most commonly perceived individual factors contributing to diagnostic error included atypical patient presentations (83%), failure to consider other diagnoses (63%) and inadequate follow-up of test results (53%). The most commonly cited system-level factors included cognitive burden created by the volume of data in the electronic health record (EHR) (68%), lack of time to think (64%) and systems that do not support collaboration (40%). Conditions felt to be at greatest risk of diagnostic error included cancer (46%), pulmonary embolism (43%) and infection (37%). Conclusions Inadequate clinician time and sub-optimal patient and test follow-up are perceived by IM clinicians to be persistent contributors to diagnostic error. Clinician perceptions of conditions at greatest risk of diagnostic error may differ from the published literature.

PMID: 31913847 [PubMed - as supplied by publisher]

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Venous thromboembolism risk with contemporary lenalidomide-based regimens despite thromboprophylaxis in multiple myeloma: A systematic review and meta-analysis.

Venous thromboembolism risk with contemporary lenalidomide-based regimens despite thromboprophylaxis in multiple myeloma: A systematic review and meta-analysis.

Cancer. 2020 Jan 08;:

Authors: Chakraborty R, Bin Riaz I, Malik SU, Marneni N, Mejia Garcia A, Anwer F, Khorana AA, Rajkumar SV, Kumar S, Murad MH, Wang Z, Khan SU, Majhail NS

Cancer therapeutics-related cardiac dysfunction(CTRCD)is receiving more attention.Risk factors assessment before cancer therapy,cardia

Abstract

Cancer therapeutics-related cardiac dysfunction(CTRCD)is receiving more attention.Risk factors assessment before cancer therapy,cardiac function monitoring during and after cancer therapy,and early detection and treatment of myocardial injury are key to preventing clinical heart failure.The incidence and severity of cardiotoxicity can be reduced by measures such as reducing drug dose,adjusting administration route,and using low toxic drugs.Cardioprotective agents including anti-heart failure drugs and dexrazoxane are important for the prevention and treatment of CTRCD.Patients with advanced heart failure may also benefit from mechanical treatments including cardiac resynchronization therapy and mechanically-assisted ventricular devices.This article reviews the recent advances in the prevention and treatment of CTRCD.

PMID: 31907138 [PubMed - in process]

9 January 2020

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Cancer & Heart (Cardio-Oncology, Cardiotoxicity, TEV)

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A survey of outpatient Internal Medicine clinician perceptions of diagnostic error.

A survey of outpatient Internal Medicine clinician perceptions of diagnostic error.

Diagnosis (Berl). 2020 Jan 09;:

Authors: Matulis JC, Kok SN, Dankbar EC, Majka AJ

A growing number of effective cancer therapies is associated with cardiovascular (CV) toxicities including myocardial injury or dysfunction,

 

Abstract

A growing number of effective cancer therapies is associated with cardiovascular (CV) toxicities including myocardial injury or dysfunction, leading to reduced ventricular function, and increased risk of heart failure. As the timing of administration of cancer treatment is known, the potential for risk stratification pre-treatment, and appropriate surveillance and monitoring during treatment, and intervention with cardio-protective treatment strategies in patients exhibiting early evidence of CV toxicity is an appealing clinical strategy. The field of cardio-oncology has developed, and the application of monitoring strategies using CV biomarkers and CV imaging has been to focus of many studies and is now implemented in dedicated cardio-oncology services supporting oncology centres. In this article, we review the background and rationale for monitoring, the different options and their strengths, weaknesses and where they are helpful in specific cardiotoxic cancer therapies, and the impact in cardio-oncology care.

PMID: 31908616 [PubMed]

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[Prevention and Treatment of Cancer Therapeutics-related Cardiac Dysfunction].

[Prevention and Treatment of Cancer Therapeutics-related Cardiac Dysfunction].

Zhongguo Yi Xue Ke Xue Yuan Xue Bao. 2019 Dec 30;41(6):842-850

Authors: Chen WG, Zhao L

BACKGROUND: Extensive multi-visceral resection, including components of the urinary tract, is often required to achieve clea

 

Abstract

BACKGROUND: Extensive multi-visceral resection, including components of the urinary tract, is often required to achieve clear resection margins, which is now well established as a key predictor of long-term survival for locally advanced pelvic tumours. The aims of this study were to analyse major morbidity and factors predicting complications and long-term outcomes following a urological procedure within extended radical resections.

METHODS: Data were collected from prospective databases at two high-volume institutions specialising in extended radical resections for locally advanced and recurrent pelvic malignancies between 1990 and 2015. The primary endpoints were general major complications (Clavien-Dindo ≥ 3) and factors influencing complications and overall survival after urological resection.

RESULTS: A total of 646 consecutive patients requiring an extended radical resection for locally advanced or recurrent pelvic malignancies were identified. The median age was 63 years (range 19-89 years) and the majority were female (371; 57.4%). A urological resection was performed as part of the resection in 226 patients (35.0%). The overall 30-day major complication rate was significantly higher in the urological intervention group (23%; n = 52) compared to the non-urological group (12.9%; n = 54 patients; p = 0.001). Intestinal anastomotic leak (p = 0.001) and intra-abdominal collections (p = 0.001) were more common in the urological cohort. Ileal conduit formation was an independent predictor of major morbidity (OR 1.95; 95% CI 1.24-3.07; p = 0.004). Independent prognostic markers for poor 5-year survival following urological procedures were recurrent tumour, cardiovascular disease, previous thromboembolic event and postoperative pulmonary embolism.

CONCLUSIONS: Extended radical resections which include a urological resection are associated with significantly more major morbidity than those without urological resection. Ileal conduit formation is independently associated with the development of major morbidity. Five-year overall survival is no different for patients who had or did not have urological resection as part of extended radical surgery for locally advanced or recurrent pelvic malignancy.

PMID: 31907722 [PubMed - as supplied by publisher]

14:34

Cancer & Heart (Cardio-Oncology, Cardiotoxicity, TEV)

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Cardiology care delivered to cancer patients.

Cardiology care delivered to cancer patients.

Eur Heart J. 2020 Jan 07;41(2):205-206

Authors: Asteggiano R, Aboyans V, Lee G, Salinger S, Richter D

PMID: 31909424 [PubMed - in process]

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Monitoring the heart during cancer therapy.

Monitoring the heart during cancer therapy.

Eur Heart J Suppl. 2019 Dec;21(Suppl M):M44-M49

Authors: Habibian M, Lyon AR

The ACS established an online risk calculator to help surgeons make patient-specific estimates of postoperative morbidity and mortality

Abstract

The ACS established an online risk calculator to help surgeons make patient-specific estimates of postoperative morbidity and mortality. Our objective was to assess the accuracy of the ACS-NSQIP calculator for estimating risk after curative intent resection for primary GI neuroendocrine tumors (GI-NETs). Adult patients with GI-NET who underwent complete resection from 2000 to 2017 were identified using a multi-institutional database, including data from eight academic medical centers. The ability of the NSQIP calculator to accurately predict a particular outcome was assessed using receiver operating characteristic curves and the area under the curve (AUC). Seven hundred three patients were identified who met inclusion criteria. The most commonly performed procedures were resection of the small intestine with anastomosis (N = 193, 26%) and partial colectomy with anastomosis (N = 136, 18%). The majority of patients were younger than 65 years (N = 482, 37%) and ASA Class III (N = 337, 48%). The most common comorbidities were diabetes (N = 128, 18%) and hypertension (N = 395, 56%). Complications among these patients based on ACS NSQIP definitions included any complication (N = 132, 19%), serious complication (N = 118, 17%), pneumonia (N = 7, 1.0%), cardiac complication (N = 1, 0.01%), SSI (N = 80, 11.4%), UTI (N = 17, 2.4%), venous thromboembolism (N = 18, 2.5%), renal failure (N = 16, 2.3%), return to the operating room (N = 27, 3.8%), discharge to nursing/rehabilitation (N = 22, 3.1%), and 30-day mortality (N = 9, 1.3%). The calculator provided reasonable estimates of risk for pneumonia (AUC = 0.721), cardiac complication (AUC = 0.773), UTI (AUC = 0.716), and discharge to nursing/rehabilitation (AUC = 0.779) and performed poorly (AUC < 0.7) for all other complications Fig. 1). The ACS-NSQIP risk calculator estimates a similar proportion of risk to actual events in patients with GI-NET but has low specificity for identifying the correct patients for many types of complications. The risk calculator may require modification for some patient populations.

PMID: 31908214 [PubMed - in process]

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Complications and 5-year survival after radical resections which include urological organs for locally advanced and recurrent pelvic malignancies: analysis of 646 consecutive cases.

Complications and 5-year survival after radical resections which include urological organs for locally advanced and recurrent pelvic malignancies: analysis of 646 consecutive cases.

Tech Coloproctol. 2020 Jan 06;:

Authors: Peacock O, Waters PS, Kong JC, Warrier SK, Wakeman C, Eglinton T, Murphy DG, Heriot AG, Frizelle FA, McCormick JJ

To facitinib and baricitinib are two of the currently available Janus kinase (JAK) inhibitors for the treatment of patients

 

Abstract

To facitinib and baricitinib are two of the currently available Janus kinase (JAK) inhibitors for the treatment of patients with RA. Randomized controlled trials have shown that these JAK inhibitors are as efficacious as biological DMARDs. Safety profiles of these JAK inhibitors in randomized controlled trials and their long-term extension studies have been demonstrated; however, real world evidence remains to be established to bridge the gap between randomized controlled trials and rheumatology clinics. Fundamentally, no difference in the screening, prevention, and monitoring of infections between JAK inhibitors and biological DMARDs exists. However, increased risk of herpes zoster is probably common to all JAK inhibitors. No indication of increased risk for malignancy in patients with RA treated with JAK inhibitors has been reported. To evaluate risks of relatively rare serious adverse events such as thromboembolic events, gastrointestinal perforation, and interstitial lung disease in clinical settings, accumulation of cases with these events are needed. Continuous pharmacovigilance activity is absolutely warranted to establish the safety of JAK inhibitors in patients with RA and other rheumatic diseases.

PMID: 30806708 [PubMed - indexed for MEDLINE]

8 January 2020

13:02

Cancer & Heart (Cardio-Oncology, Cardiotoxicity, TEV)

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Evaluating the ACS-NSQIP Risk Calculator in Primary GI Neuroendocrine Tumor: Results from the United States Neuroendocrine Tumor Study Group.

Evaluating the ACS-NSQIP Risk Calculator in Primary GI Neuroendocrine Tumor: Results from the United States Neuroendocrine Tumor Study Group.

Am Surg. 2019 Dec 01;85(12):1334-1340

Authors: Armstrong EA, Beal EW, Lopez-Aguiar AG, Poultsides G, Cannon JG, Rocha F, Crown A, Barrett J, Ronnkleiv-Kelly S, Fields RC, Krasnick BA, Idrees K, Smith PM, Nathan H, Beems MV, Maithel SK, Schmidt CR, Pawlik TM, Dillhoff M

Complex aortic atheroma is a high-risk factor for recurrent embolic stroke. An accurate identification of stroke etiology

 

Abstract

Complex aortic atheroma is a high-risk factor for recurrent embolic stroke. An accurate identification of stroke etiology is clinically important; however, it can be challenging. A 91-year-old man with atrial fibrillation was diagnosed with cardioembolic stroke and treated with mechanical thrombectomy. The removed thrombus microscopically contained foamy cells, suggesting an atheroembolism. An autopsy revealed an atherosclerotic lesion with ulceration, located in the aortic arch. At the lesion, the plaque had microscopically ruptured into the lumen. We therefore concluded that the aortic atherosclerotic lesion was the embolic source. Removed thrombi should be pathologically examined even if a cardioembolic stroke is clinically suspected.

PMID: 31178514 [PubMed - indexed for MEDLINE]

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Growing evidence of the safety of JAK inhibitors in patients with rheumatoid arthritis.

//www.ncbi.nlm.nih.gov/corehtml/query/egifs/https:--academic.oup.com-images-oup_pubmed.png //www.ncbi.nlm.nih.gov/corehtml/query/egifs/https:--www.ncbi.nlm.nih.gov-corehtml-pmc-pmcgifs-pubmed-pmc.png Related Articles

Growing evidence of the safety of JAK inhibitors in patients with rheumatoid arthritis.

Rheumatology (Oxford). 2019 02 01;58(Suppl 1):i34-i42

Authors: Harigai M

PURPOSE: Anthracycline chemotherapy (AC) is associated with acute reductions in cardiopulmonary fitness (V˙O2peak).

 

Abstract

PURPOSE: Anthracycline chemotherapy (AC) is associated with acute reductions in cardiopulmonary fitness (V˙O2peak). We sought to determine whether changes in V˙O2peak and cardiac function persisted at 12 months post-AC completion, and whether changes in cardiac function explain the heightened long-term heart failure risk.

METHODS: Women with breast cancer scheduled for AC (n = 28) who participated in a nonrandomized trial of exercise training (ET; n = 14) or usual care (UC; n = 14) during AC completed a follow-up evaluation 12 months post-AC completion (16 months from baseline). At baseline, 4 months, and 16 months, participants underwent a resting echocardiogram (left ventricular ejection fraction; global longitudinal strain), a blood sample (troponin; B-type natriuretic peptide), a cardiopulmonary exercise test, and cardiac MRI measures of stroke volume (SV), heart rate, and cardiac output (Qc) at rest and during intense exercise.

RESULTS: Seventeen women (UC, n = 8; ET, n = 9) completed evaluation at baseline, 4 months, and 16 months. At 4 months, AC was associated with 18% and 6% reductions in V˙O2peak in the UC and ET groups, respectively, which persisted at 16 months (UC, -16%; ET, -7%) and was not attenuated by ET (interaction, P = 0.10). Exercise Qc was lower at 16 months compared with baseline and 4 months (P < 0.001), which was due to a blunted augmentation of SV during exercise (P = 0.032; a 14% reduction in peak SV), with no changes in heart rate response. There was a small reduction in resting left ventricular ejection fraction (baseline to 4 months) and global longitudinal strain (between 4 and 16 months) and an increase in troponin (baseline to 4 months), but only exercise Qc was associated with V˙O2peak (R = 0.47, P < 0.01).

CONCLUSION: Marked reductions in V˙O2peak persisted 12 months after anthracycline-based chemotherapy, which was associated with impaired exercise cardiac function.

CLINICAL TRIAL REGISTRATION: ACTRN12616001602415.

PMID: 30829962 [PubMed - indexed for MEDLINE]

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Aortogenic Embolic Stroke Diagnosed by a Pathological Examination of Endovascularly Removed Thrombus: An Autopsy Report.

//www.ncbi.nlm.nih.gov/corehtml/query/egifs/http:--linkout.jstage.jst.go.jp-logo.gif //www.ncbi.nlm.nih.gov/corehtml/query/egifs/https:--www.ncbi.nlm.nih.gov-corehtml-pmc-pmcgifs-pubmed-pmc.png Related Articles

Aortogenic Embolic Stroke Diagnosed by a Pathological Examination of Endovascularly Removed Thrombus: An Autopsy Report.

Intern Med. 2019 Oct 01;58(19):2851-2855

Authors: Usui G, Hashimoto H, Sugiura Y, Nishi Y, Kusakabe M, Horiuchi H, Okubo S, Morikawa T

Rationale: Exosomes are emerging as a promising drug delivery carrier. However, rapid uptake of exosomes by the

 Abstract

Rationale: Exosomes are emerging as a promising drug delivery carrier. However, rapid uptake of exosomes by the mononuclear phagocyte system (MPS) remains an obstacle for drug delivery into other targeted organs, including the heart. We hypothesized that prior blocking of uptake of exosomes by the MPS would improve their delivery to the targeted organs. Methods: Exosomes were isolated from the cell culture medium. Fluorescence-labeled exosomes were tracked in vitro and in vivo by fluorescence imaging. The expression of clathrin heavy chain (Cltc), cavolin1, Pak1 and Rhoa, known genes for endocytosis, were profiled in various cell lines and organs by qPCR. The knockdown efficiency of siRNA against Cltc was analyzed by Western blotting. Exosomecontrol and exosomeblocking were constructed by encapsulating isolated exosomes with siControl or siClathrin via electroporation, while exosometherapeutic was constructed by encapsulating isolated exosomes with miR-21a. Doxorubicin-induced cardiotoxicity model was used to verify the therapeutic efficiency of the exosome-based miR-21a delivery by echocardiography. Results: Exosomes were preferentially accumulated in the liver and spleen, mainly due to the presence of abundant macrophages. Besides the well-known phagocytic effect, efficient endocytosis also contributes to the uptake of exosomes by macrophages. Cltc was found to be highly expressed in the macrophages compared with other endocytosis-associated genes. Accordingly, knockdown of Cltc significantly decreased the uptake of exosomes by macrophages in vitro and in vivo. Moreover, prior injection of exosomeblocking strikingly improved the delivery efficiency of exosomes to organs other than spleen and liver. Consistently, compared with the direct injection of exosometherapeutic, prior injection of exosomeblocking produced a much better therapeutic effect on cardiac function in the doxorubicin-induced cardiotoxicity mouse model. Conclusions: Prior blocking of endocytosis of exosomes by macrophages with exosomeblocking successfully and efficiently improves the distribution of following exosometherapeutic in targeted organs, like the heart. The established two-step exosome delivery strategy (blocking the uptake of exosomes first followed by delivery of therapeutic exosomes) would be a promising method for gene therapy.

PMID: 31903116 [PubMed - in process]

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Persistent Impairment in Cardiopulmonary Fitness after Breast Cancer Chemotherapy.

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Persistent Impairment in Cardiopulmonary Fitness after Breast Cancer Chemotherapy.

Med Sci Sports Exerc. 2019 08;51(8):1573-1581

Authors: Foulkes SJ, Howden EJ, Bigaran A, Janssens K, Antill Y, Loi S, Claus P, Haykowsky MJ, Daly RM, Fraser SF, LA Gerche A