ABSTRACT

The present study evaluated the adherence to guideline recommendations regarding the indication for inferior vena cava filter (IVCF) placement, retrieval rates, complications, thrombotic recurrences, and mortality. Patients in whom an IVCF was placed between 2015 and 2020 in a tertiary hospital were retrospectively included. We considered absolute indication of IVCF placement if all the guidelines evaluated agreed on the indication, relative indication if only some guidelines recommended it and without indication if none of the evaluated guidelines recommended it. From the 185 patients included; 47% had an absolute indication, 15% a relative indication, and 38% had no indication. Filter-associated complications and non-removal rates were 12.4% and 41%, respectively. Venous thromboembolism recurrence rate was 17.8%, being filter-associated complications (24.2 vs 9.8%, P = .02) and thrombosis of the inferior cava or iliac veins (12.1 vs 2.6%, P = .03) more frequent in this group. The mortality rate was 40%, with higher mortality risk in patients with co-existing cancer. Previous major bleeding, filter-associated complications, and mortality were associated with a major risk of non-removal. In conclusion, the adherence to guidelines regarding the indication of IVCF placement is still low and IVCF complications are not negligible. This fact is of special concern in the elderly, comorbid, and cancer patients.

PMID:37470426 | DOI:10.1177/00033197231190184

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PubMed articles on: Cancer & VTE/PE

Incidence of and Risk Factors for Thromboembolism After Endoprosthetic Reconstruction in Musculoskeletal Oncology Patients

J Bone Joint Surg Am. 2023 Jul 19;105(Suppl 1):29-33. doi: 10.2106/JBJS.22.01140. Epub 2023 Jul 19.

ABSTRACT

BACKGROUND: The aim of the present study was to assess the incidence of and risk factors for thromboembolic events-including assessment of the intraoperative use of tranexamic acid and postoperative use of chemical thromboprophylaxis-in patients undergoing operative treatment of primary bone or soft-tissue sarcoma or oligometastatic bone disease.

METHODS: This study was performed as a secondary analysis of prospective data collected from the Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) randomized controlled trial, which included 604 patients ≥12 years old who underwent surgical resection and endoprosthetic reconstruction for either primary bone or soft-tissue sarcoma or oligometastatic disease of the femur or tibia. We determined the incidence of thromboembolic events in these patients and evaluated potential risk factors, including patient age, sex, antibiotic treatment group, type of tumor (i.e., primary bone or soft-tissue sarcoma or metastatic bone disease), intraoperative tranexamic acid, tourniquet use, operative time, pathologic characteristics (i.e., American Joint Committee on Cancer grade, vascular invasion, and percent necrosis), postoperative chemical thromboprophylaxis regimen, and surgical site infection. Continuous variables were assessed with use of the Student t test. Categorical variables were assessed with use of the Pearson chi-square test, except when the expected cell counts were <5,

RESULTS: Postoperative thromboembolic events occurred in 11 (1.8%) of 604 patients. Patients who experienced a thromboembolic event had a significantly higher mean (± standard deviation) age (59.6 ± 17.5 years) than those who did not experience a thromboembolic event (40.9 ± 21.8; p = 0.002). Patients randomized to the long-term antibiotic group had a significantly higher incidence of thromboembolic events (9 of 293; 3.1%) than those randomized to the short-term antibiotic group (2 of 311; 0.64%; p = 0.03). Neither intraoperative tranexamic acid nor postoperative chemical thromboprophylaxis were significantly associated with the occurrence of a thromboembolic event.

CONCLUSIONS: Although relatively rare in the PARITY cohort, thromboembolic events were more likely to occur in older patients and those receiving long-term prophylactic antibiotics. Intraoperative tranexamic acid and postoperative chemical thromboprophylaxis were not associated with a greater incidence of thromboembolic events.

LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

PMID:37466577 | DOI:10.2106/JBJS.22.01140

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PubMed articles on: Cancer & VTE/PE

Diagnostic management of acute pulmonary embolism: a prediction model based on a patient data meta-analysis

Eur Heart J. 2023 Jul 15:ehad417. doi: 10.1093/eurheartj/ehad417. Online ahead of print.

ABSTRACT

AIMS: Risk stratification is used for decisions regarding need for imaging in patients with clinically suspected acute pulmonary embolism (PE). The aim was to develop a clinical prediction model that provides an individualized, accurate probability estimate for the presence of acute PE in patients with suspected disease based on readily available clinical items and D-dimer concentrations.

METHODS AND RESULTS: An individual patient data meta-analysis was performed based on sixteen cross-sectional or prospective studies with data from 28 305 adult patients with clinically suspected PE from various clinical settings, including primary care, emergency care, hospitalized and nursing home patients. A multilevel logistic regression model was built and validated including ten a priori defined objective candidate predictors to predict objectively confirmed PE at baseline or venous thromboembolism (VTE) during follow-up of 30 to 90 days. Multiple imputation was used for missing data. Backward elimination was performed with a P-value <0.10.

CONCLUSION: The present model provides an absolute, individualized probability of PE presence in a broad population of patients with suspected PE, with very good discrimination and calibration. Its clinical utility needs to be evaluated in a prospective management or impact study.

REGISTRATION: PROSPERO ID 89366.

PMID:37452732 | DOI:10.1093/eurheartj/ehad417

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PubMed articles on: Cancer & VTE/PE

Pembrolizumab plus lenvatinib as first-line therapy for advanced non-clear-cell renal cell carcinoma (KEYNOTE-B61): a single-arm, multicentre, phase 2 trial

Lancet Oncol. 2023 Jul 11:S1470-2045(23)00276-0. doi: 10.1016/S1470-2045(23)00276-0. Online ahead of print.

ABSTRACT

BACKGROUND: Immunotherapy-based combinations including pembrolizumab plus lenvatinib are the standard of care for patients with first-line clear-cell renal cell carcinoma, but these combinations are not well characterised in non-clear-cell renal cell carcinoma. We aimed to assess the activity and safety of pembrolizumab plus lenvatinib as a first-line treatment for patients with advanced non-clear-cell renal cell carcinoma.

METHODS: KEYNOTE-B61 is a single-arm, phase 2 trial being conducted at 48 sites (hospitals and cancer centres) in 14 countries (Australia, Canada, France, Hungary, Ireland, Italy, Poland, South Korea, Russia, Spain, Türkiye, Ukraine, the UK, and the USA). Adult patients (aged ≥18 years) with previously untreated stage IV non-clear-cell renal cell carcinoma and a Karnofsky performance status of 70% or higher were eligible for enrolment. All enrolled patients received pembrolizumab 400 mg intravenously every 6 weeks for up to 18 cycles (2 years) plus lenvatinib 20 mg orally once daily or until disease progression, unacceptable toxicity, or withdrawal; lenvatinib could be continued beyond 2 years. The primary endpoint was the proportion of patients with a confirmed objective response as per adjusted Response Evaluation Criteria in Solid Tumours (version 1.1) assessed by independent central review. Activity and safety were analysed in all patients who received at least one dose of study treatment (the as-treated population). This trial is registered with ClinicalTrials.gov (NCT04704219) and is no longer recruiting participants but is ongoing.

FINDINGS: Between Feb 23, 2021, and Jan 21, 2022, 215 patients were screened; 158 were enrolled and received treatment. Median age at baseline was 60 years (IQR 52-69), 112 (71%) of 158 patients were male, 46 (29%) were female, 128 (81%) were White, 12 (8%) were Asian, three (2%) were Black or African American, and 15 (9%) were missing data on race. As of data cutoff (Nov 7, 2022), median study follow-up was 14·9 months (IQR 11·1-17·4). 78 of 158 patients had a confirmed objective response (49%; 95% CI 41-57), including nine (6%) patients with a confirmed complete response and 69 (44%) with a confirmed partial response. Grade 3-4 treatment-related adverse events occurred in 81 (51%) of 158 patients, the most common of which were hypertension (37 [23%] of 158), proteinuria (seven [4%]), and stomatitis (six [4%]). Serious treatment-related adverse events occurred in 31 (20%) of 158 patients. Eight (5%) patients died due to adverse events, none of which was considered related to the treatment by the investigators (one each of cardiac failure, peritonitis, pneumonia, sepsis, cerebrovascular accident, suicide, pneumothorax, and pulmonary embolism).

INTERPRETATION: Pembrolizumab plus lenvatinib has durable antitumour activity in patients with previously untreated advanced non-clear-cell renal cell carcinoma, with a safety profile consistent with that of previous studies. Results from KEYNOTE-B61 support the use of pembrolizumab plus lenvatinib as a first-line treatment option for these patients.

FUNDING: Merck Sharp & Dohme (a subsidiary of Merck & Co, NJ, USA), and Eisai.

PMID:37451291 | DOI:10.1016/S1470-2045(23)00276-0

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Clinical presentations of acute pulmonary embolism: A retrospective cohort study

Medicine (Baltimore). 2023 Jul 14;102(28):e34224. doi: 10.1097/MD.0000000000034224.

ABSTRACT

We aimed to investigate whether the unusual clinical presentation of pulmonary embolism (PE) varies by the type of provocation. In this retrospective cohort study, we examined the electronic health records (EHR) records of all patients diagnosed with PE (upon presentation or during hospitalization) presented to our tertiary hospital during 2014 to 2019. Inclusion criteria were the diagnosis of acute PE and age above 18 years. Excluded were all patients to whom complete EHR were not available. The primary outcome was the main presenting symptom, categorized by a multidisciplinary consensus expert committee as either typical or atypical of PE. Comorbidities, vital signs, medications and laboratory results on presentations were recorded. 591 patients were included in the final analysis. Dyspnea was significantly less common and hemoptysis and chest pain more common in the unprovoked PE group (35%, 5%, and 25%, respectively) compared with nonmalignant (42.6%, 0%, and 16.3%) and malignancy-associated (47.7%, 0.9%, and 8.2%) PE (Pv = 0.02, 0.002 and 0.001, respectively). No recorded symptoms were the third most common presentation overall, accounting for a significantly (Pv < 0.001) higher proportion of PE patients with malignancy (19%) whereas atypical presentation was the hallmark of patients with nonmalignant provokation (19.7%) (Pv = 0.005). Accounting for multiple potential confounders, the risk of atypical or asymptomatic presentation was higher with lower heart rates (RR = 0.974 95%C.I. [0.957-0.990]) and higher pulse oximetry saturation (RR = 1.114 95%CI [1.034-1.201]). The clinical presentation of PE varies with different types of provoking factors, with atypical presentation most common in nonmalignant provocation and asymptomatic presentation most prevalent in patients with underlying malignancy. Further studies are needed to determine the effect of said variance on long term clinical outcomes.

PMID:37443506 | PMC:PMC10344497 | DOI:10.1097/MD.0000000000034224

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The impact of body mass index on oncoplastic breast surgery: A multicenter analysis

J Surg Oncol. 2023 Jul 13. doi: 10.1002/jso.27397. Online ahead of print.

ABSTRACT

BACKGROUND: Obesity has nearly tripled in the last 50 years. During the last decades, oncoplastic breast surgery has become an important choice in the surgical treatment of breast cancer. An association exists between higher body mass index (BMI) and wound complications for major operations, but there is scarce literature on oncoplastic surgery. Hence, our aim was to compare the complication rates among patients who underwent oncoplastic surgery, stratified by BMI.

METHODS: Patient data were analyzed from the National Surgical Quality Improvement Program database (NSQIP) for oncoplastic breast procedures (2005-2020). Patients were stratified according to World Health Organization obesity classifications. Multivariate logistic regression was performed to assess risk factors for complications (overall, operative, and wound-related).

RESULTS: From a total of 6887 patients who underwent oncoplastic surgery, 4229 patients were nonobese, 1380 had Class 1 obesity (BMI: 30 to <352 ), 737 Class 2 obesity (BMI: 35 to <402 ), and 541 Class 3 obesity (BMI: ≥ 40 kg/m2 ). Greater operative time was found according to higher BMI (p < 0.001). Multivariate analysis adjusted for baseline characteristics showed that patients with obesity Class 2 (odds ratio [OR] = 1.51, 95% confidence interval [CI]: 1.03-2.23, p = 0.037) and 3 (OR = 1.87, 95% CI 1.24-2.83, p = 0.003) had increased risk of overall and wound complications compared with Nonobese patients. Comparing obese with nonobese patients, there were no differences in rates of deep SSI, organ/space SSI, pneumonia, reintubation, pulmonary embolism, deep vein thrombosis, urinary tract infection, stroke, bleeding, postoperative sepsis, length of stay, and readmission.

CONCLUSIONS: Oncoplastic surgery is a safe procedure for most patients. However, caution should be exercised when performing oncoplastic surgery for patients with Class 2 or 3 obesity (BMI ≥ 35 kg/m2 ), given there was a higher rate of overall and wound-specific complications, compared with patients who were not obese or had Class 1 obesity.

PMID:37448232 | DOI:10.1002/jso.27397

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PubMed articles on: Cancer & VTE/PE

High-intensity interval training and thromboembolic events during chemotherapy for testicular cancer: a retrospective analysis from the Body & Cancer cohort

Acta Oncol. 2023 Jun;62(6):666-672. doi: 10.1080/0284186X.2023.2225145. Epub 2023 Jul 14.

ABSTRACT

Background:Men with testicular cancer receiving platinum-based chemotherapy have an increased risk of thromboembolic events, with incidence rates between 8-24%. A recent trial evaluating the effect of high-intensity interval training (HIIT) prematurely closed as three out of nine participants (33%) in the intervention group developed a thromboembolic event. The purpose of this retrospective cohort study was: 1) (primary) to evaluate the incidence of thromboembolic events in men receiving chemotherapy for testicular cancer who had participated in HIIT during a 6-week exercise program (Body & Cancer) 2) to describe the feasibility of this program.Material and methods: Forty men who had participated in at least one HIIT session from February 2007 to February 2020 were included. Electronic medical records were searched for incident thromboembolic events (arterial and venous) during Body & Cancerand up to one-year post-chemotherapy. Attendance, cardiorespiratory fitness (VO2-peak), and upper and lower extremity muscular strength (1 repetition maximum (RM)) were obtained from the Body & Cancerdatabase.Results: One participant developed a thromboembolic event during Body & Cancer. No participants developed a thromboembolic event in the follow-up period. In all, data represent 160 HIIT sessions with a median attendance of eight sessions [range 1-19]. Statistically significant increases in upper and lower extremity strength were observed (8.6 (4.2 to 13.0) and 26.0 (14.9 to 37.0) kg, respectively). No significant increase in cardiorespiratory fitness was found (0.14 (-0.03 to 0.31) l/min).Conclusion: While conclusions on the safety of HIIT cannot be drawn, data from the present study do not support previous findings cautioning avoidance of HIIT due to a possible added risk of thromboembolic events in men receiving platinum-based chemotherapy for testicular cancer. Considering the potential for positive effects on cardiovascular outcomes associated with HIIT, future studies with robust design should be performed in this population to confirm these observations.

PMID:37450654 | DOI:10.1080/0284186X.2023.2225145

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PubMed articles on: Cancer & VTE/PE

PREDICTORS OF RETRIEVAL AND LONG-TERM MORTALITY IN PATIENTS TREATED WITH INFERIOR VENA CAVA FILTERS

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PubMed articles on: Cancer & VTE/PE

Prevalence and outcomes of type 2 myocardial infarction in patients with cancer: A retrospective analysis from the National Inpatient Sample dataset

Int J Cardiol. 2023 Jul 11:131154. doi: 10.1016/j.ijcard.2023.131154. Online ahead of print.

ABSTRACT

BACKGROUND: This study aimed to investigate the prevalence, clinical characteristics and outcomes of type 2 myocardial infarction (T2AMI) in patients with versus without cancer.

METHODS: All hospitalizations with a primary discharge diagnosis of T2AMI were stratified according to cancer status (secondary diagnosis of any-cancer vs cancer-free) using data from the US National Inpatient Sample (2016-2019). The primary outcome was in-hospital all-cause mortality while secondary outcomes were in-hospital major adverse cardiovascular and cerebrovascular events (MACCE).

RESULTS: Among 61,305 included hospitalizations with primary diagnosis of T2AMI, 3745 (6.1%) were associated with a diagnosis of cancer. Patients with T2AMI and cancer presented more frequently with acute respiratory failure (23.2% vs 18.1%), acute pulmonary embolism (3.7% v 1.3%), major bleeding (6.8% vs 4.1%) and renal failure (51.0% vs 46.8%), compared to patients without. On adjusted analysis, diagnosis of cancer was associated with lower odds of invasive coronary angiography (aOR 0.75, 95% CI 0.60 to 0.93, p = 0.009) but greater odds of mortality (aOR 1.95, 95% C.I. 1.26-2.99 p = 0.002). Among the different types of cancer, adjusted risk of all-cause mortality was higher in patients with colorectal (aOR 4.17 95% CI 1.68-10.32, p = 0.002), lung (aOR 3.63, 95% CI 1.83-7.18, p < 0.001) and haematologic (aOR 2.48, 95% CI 1.22-5.05, p = 0.001) cancer.

CONCLUSIONS: Patients with cancer presenting with T2AMI have lower odds of management with invasive diagnostic coronary angiography and have higher rates of in-hospital all-cause death. Further studies are warranted to improve overall care and outcomes of cancer patients and cardiovascular diseases.

PMID:37442352 | DOI:10.1016/j.ijcard.2023.131154

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PubMed articles on: Cancer & VTE/PE

Heparin reversal with protamine sulfate after Percutaneous Hepatic Perfusion (PHP): is less more?

Cancer Imaging. 2023 Jul 14;23(1):68. doi: 10.1186/s40644-023-00590-7.