Association of hospital procedural volume with incidence and outcomes of surgical bailout in patients undergoing transcatheter aortic valve replacement.

OBJECTIVES: This study sought to examine the association of hospital procedural volume with the incidence and outcomes of surgical bailout (SB) in patients who undergo transcatheter aortic valve replacement (TAVR). BACKGROUND: SB is required for serious complications during or after TAVR. It remains unclear whether hospital experiences affect the incidence and outcomes of SB. METHODS: We retrospectively identified patients who underwent endovascular TAVR using the Nationwide Readmissions Database 2012-2017. We examined the association of annual hospital procedural volume (annual number of endovascular TAVR cases in each hospital in each year) with the incidence and in-hospital mortality of SB using multivariable logistic regressions and restricted cubic splines. RESULTS: Among 82,764 eligible patients, the incidence of SB was 0.95% (n = 789) and decreased from 2012 to 2017 (from 2.66% to 0.49%; Ptrend < 0.001), while in-hospital mortality of SB remained high over years (from 26.0% to 23.5%; Ptrend  = 0.773). Very-high-volume hospitals (≥200 cases/year), as compared with low-volume hospitals (≤49 cases/year), showed significantly a lower incidence of SB (0.49% vs. 1.81%; adjusted OR = 0.28, 95% CI = 0.21-0.38), but similar in-hospital mortality of SB (26.2% vs. 25.6%; adjusted OR = 0.88, 95% CI = 0.47-1.66). There was a significant nonlinear, inverse association of hospital volume with the incidence of SB, but not with the in-hospital mortality of SB. CONCLUSIONS: Hospitals with higher TAVR volumes have a lower risk of SB, but the in-hospital mortality after SB does not change with hospital TAVR volume. Our findings highlight the importance that physicians should always be aware of the high mortality risk of SB following TAVR regardless of hospital procedural experiences.

Incidence, treatment, and outcomes of acute myocardial infarction following transcatheter or surgical aortic valve replacement.

OBJECTIVES: This study aimed to evaluate the incidence, treatment, and outcomes of acute myocardial infarction (AMI) following transcatheter or surgical aortic valve replacement (TAVR or SAVR). BACKGROUND: Coronary artery disease is common in patients who undergo aortic valve replacement. However, little is known about differences in clinical features of post-TAVR or post-SAVR AMI. METHODS: We retrospectively identified post-TAVR or post-SAVR (including isolated and complex SAVR) patients admitted with AMI using the Nationwide Readmissions Database 2012-2017. Incidence, invasive strategy (coronary angiography or revascularization), and in-hospital outcomes were compared between post-TAVR and post-SAVR AMIs. RESULTS: The incidence of 180-day AMI was higher post-TAVR than post-SAVR (1.59% vs. 0.72%; p < 0.001). Post-TAVR AMI patients (n = 1315), compared with post-SAVR AMI patients (n = 1344), were older, had more comorbidities and more frequent non-ST-elevation AMI (NSTEMI: 86.6% vs. 78.0%; p < 0.001). After propensity-score matching, there was no significant difference in in-hospital mortality between post-TAVR and post-SAVR AMIs (14.7% vs. 16.1%; p = 0.531), but the mortality was high in both groups, particularly in ST-elevation AMI (STEMI: 38.8% vs. 29.2%; p = 0.153). Invasive strategy was used less frequently for post-TAVR AMI than post-SAVR AMI (25.6% vs. 38.3%; p < 0.001). Invasive strategy was associated with lower mortality in both post-TAVR (adjusted odds ratio = 0.40; 95% confidence interval = [0.24-0.66]) and post-SAVR groups (0.60 [0.41-0.88]). CONCLUSIONS: AMI, albeit uncommon, was more frequent post-TAVR than post-SAVR. Patients commonly presented with NSTEMI, but the mortality of STEMI was markedly high. Further studies are needed to understand why a substantial percentage of patients do not receive invasive coronary treatment, particularly after TAVR, despite seemingly better outcomes with invasive strategy.

Cerebral embolic protection and severity of stroke following transcatheter aortic valve replacement.

BACKGROUND: The cerebral embolic protection (CEP) device captures embolic debris during transcatheter aortic valve replacement (TAVR). However, the impact of CEP on stroke severity following TAVR remains unclear. Therefore, we aimed to examine whether CEP was associated with reduced severity of stroke following TAVR. METHODS: This was a retrospective cohort study of 2839 consecutive patients (mean age: 79.2 ± 9.5 years, females: 41.5%) who underwent transfemoral TAVR at our institution between 2013 and 2020. We categorized patients into Sentinel CEP users and nonusers. Neuroimaging data were reviewed and the final diagnosis of a cerebrovascular event was adjudicated by a neurologist blinded to the CEP use or nonuse. We compared the incidence and severity (assessed by the National Institutes of Health Stroke Scale [NIHSS]) of stroke through 72 h post-TAVR or discharge between the two groups using stabilized inverse probability of treatment weighting (IPTW) of propensity scores. RESULTS: Of the eligible patients, 1802 (63.5%) received CEP during TAVR and 1037 (36.5%) did not. After adjustment for patient characteristics by stabilized IPTW, the rate of overall stroke was numerically lower in CEP users than in CEP nonusers, but the difference did not reach statistical significance (0.49% vs. 1.18%, p = 0.064). However, CEP users had significantly lower rates of moderate-or-severe stroke (NIHSS ≥ 6: 0.11% vs. 0.69%, p = 0.013) and severe stroke (NIHSS ≥ 15: 0% vs. 0.29%, p = 0.046). Stroke following CEP use (n = 8), compared with stroke following CEP nonuse (n = 15), tended to carry a lower NIHSS (median [IQR], 4.0 [2.0-7.0] vs. 7.0 [4.5-19.0], p = 0.087). Four (26.7%) out of 15 patients with stroke following CEP nonuse died within 30 days, with no death after stroke following CEP use. CONCLUSIONS: CEP use may be associated with attenuated severity of stroke despite no significant difference in overall stroke incidence compared with CEP nonuse. This finding is considered hypothesis-generating and needs to be confirmed in large prospective studies.

Causes of Death Following Nonmetastatic Colorectal Cancer Diagnosis in the U.S.: A Population-Based Analysis.

INTRODUCTION: Because of the improved colorectal cancer (CRC) survival in the U.S., patients may live long enough after CRC diagnosis to the point where non-cancer-related comorbidities may considerably impact their overall survival. In this study, we perform a long-term analysis of causes of death (CODs) following nonmetastatic CRC with respect to different demographic and tumor-related criteria. MATERIALS AND METHODS: We gained access to the Surveillance, Epidemiology, and End Results data to review patients diagnosed with nonmetastatic CRC during 2000-2015. We calculated standardized mortality ratios (SMRs) for each COD following CRC. SMRs represented the change of risk of a specific COD following CRC diagnoses when compared with the risk in the general U.S. RESULTS: We reviewed 302,345 patients, of whom 112,008 died during the study period. More deaths (68.3%) occurred within 5 years following nonmetastatic CRC diagnosis, with 76,486 deaths. CRC was the most common COD (51.4%) within 5 years of diagnosis followed by heart disease (15.2%) and other cancers (8.4%). As time passed after diagnosis, the number of CRC deaths decreased, and other noncancer causes increased to the point that after 10 years only 10.4% of deaths were attributed to CRC, 15.3% were attributed to other cancers, and 34.2% were secondary to heart disease. CONCLUSION: Following nonmetastatic CRC diagnosis, most deaths remain secondary to CRC. Other causes, including other cancers and cardiovascular disease, represent a significant number of deaths, especially in the 5 years following initial CRC diagnosis. Our findings help guide counseling patients with CRC regarding future health risks. IMPLICATIONS FOR PRACTICE: Most common causes of death following nonmetastatic colorectal cancer (CRC) are heart diseases, other cancers, chronic obstructive pulmonary disease, and cerebrovascular diseases. Physicians should counsel patients regarding survivorship with cancer screening and focus on prevention of noncancer deaths. These findings should be considered by physicians who give care for survivors of nonmetastatic CRC.

The role of EBV in haematolymphoid proliferations: emerging concepts relevant to diagnosis and treatment.

Epstein-Barr virus (EBV) is a ubiquitous gammaherpesvirus with >90% of the adult population worldwide harbouring latent infection. A small subset of those infected develop EBV-associated neoplasms, including a range of lymphoproliferative disorders (LPD). The diagnostic distinction of these entities appears increasingly relevant as our understanding of EBV-host interactions and mechanisms of EBV-driven lymphomagenesis improves. EBV may lower the mutational threshold for malignant transformation, create potential vulnerabilities related to viral alteration of cell metabolism and allow for improved immune targeting. However, these tumours may escape immune surveillance by affecting their immune microenvironment, limiting viral gene expression or potential loss of the viral episome. Methods to manipulate the latency state of the virus to enhance immunogenicity are emerging as well as the potential to detect so-called 'hit and run' cases where EBV has been lost. Finally, measurement of EBV DNA remains an important biomarker for screening and monitoring of LPD. Methods to distinguish EBV DNA derived from virions during lytic activation from latent, methylated EBV DNA present in EBV-associated neoplasms may broaden the utility of this testing, particularly in patients with compromised immune function. We highlight some of these emerging areas relevant to the diagnosis and treatment of EBV-associated LPD with potential applicability to other EBV-associated neoplasms.

National trends of utilization and readmission rates with intravascular ultrasound use for ST-elevation myocardial infarction.

BACKGROUND: Randomized trials have confirmed that intravascular ultrasound (IVUS) guidance for percutaneous coronary interventions (PCI) improves long-term clinical outcomes. However, data on real-world utilization of IVUS in ST-elevation myocardial infarction (STEMI) and the impact on short to mid-term outcomes are scarce. We sought to evaluate the utilization and the readmission rates for IVUS-guided PCI in the setting of STEMI. METHODS: Hospitalizations with a primary diagnosis of STEMI undergoing PCI were included from the Nationwide Readmissions Database (NRD) during 2012-2017. RESULTS: Among 809,601 hospitalizations with STEMI undergoing PCI, 33,644 (4.2%) underwent IVUS-guided PCI. IVUS use increased from 4.2% in 2012 to 5.6% in 2017 (p < .0001). After matching, in-hospital mortality was significantly lower with IVUS use (3.9% vs. 4.6%, p < .0001). The overall readmission rates were similar in both groups. We found that readmission rates due to acute MI at 6 months (5.7% vs. 6%, p = .045) and 11 months (5.1% vs. 6.5%, p = .005) as well as the PCI and mortality rates during readmission at 11 months (2.1% vs. 3%, p = .008, and 0.7% vs. 1.4%, p = .002, respectively) were significantly lower in the IVUS group. CONCLUSIONS: The utilization of IVUS in STEMI appears to be slowly increasing. Although overall readmission rates were similar, IVUS was associated with lower in-hospital mortality, lower rates of readmission due to acute MI at 6 and 11 months, as well as lower PCI and mortality at 11 months. Randomized trials evaluating long-term benefits of IVUS in STEMI are needed.

Short-term outcomes of transcatheter aortic valve replacement for pure native aortic regurgitation in the United States.

OBJECTIVE: We aimed to compare short-term outcomes between transcatheter aortic valve replacement (TAVR) for pure aortic regurgitation (AR) and TAVR for aortic stenosis (AS). BACKGROUND: In patients with severe pure AR for whom surgical valve replacement is infeasible, TAVR is sometimes used off-label. METHODS: Using the Nationwide Readmissions Database 2016-2017, we retrospectively identified patients without prior valve surgery who underwent endovascular TAVR. We compared in-hospital and 30-day outcomes according to the type of aortic valve disease. RESULTS: A total of 81,542 eligible patients were divided into the pure AR (n = 1,222, 1.50%), pure AS (n = 72,690, 89.1%), and AS + AR (n = 7,630, 9.36%) groups. In unadjusted analyses, the pure AR group, compared with the pure AS and AS + AR groups, showed a higher incidence of acute kidney injury (16.8% vs. 9.8% vs. 12.1%, respectively; p < .001) and need of surgical bailout (1.4% vs. 0.4% vs. 0.6%; p < .01). The pure AR group also showed higher in-hospital mortality than the pure AS group (2.4% vs. 1.4%; p = .005). After multivariable adjustment, TAVR for pure AR was significantly associated with a higher risk of acute kidney injury (odds ratio [OR] = 1.64, 95% confidence interval [CI] = 1.33-2.02; p < .001), cardiac tamponade (OR = 1.98, 95% CI = 1.00-3.92; p = .0498), and prolonged hospital stay (OR = 1.59, 95% CI = 1.29-1.95; p < .001) compared with TAVR for pure AS, whereas it was not significantly associated with in-hospital mortality (OR = 1.55, 95% CI = 0.99-2.45; p = .058) and other outcomes. CONCLUSIONS: TAVR may be a reasonable treatment option for selected patients with pure AR with regard to short-term outcomes. However, additional techniques or devices may be necessary to reduce periprocedural risk.

Utilization and outcomes of transcatheter coil embolization for various coronary artery lesions: Single-center 12-year experience.

OBJECTIVE: Determining the outcomes of transcatheter coil embolization (TCE) for several coronary artery lesions. BACKGROUND: TCE has been used as a treatment modality for various lesions in the coronary circulation. However, data on the efficacy and safety of TCE to treat coronary artery fistula (CAF), left internal mammary artery (LIMA) side-branch, coronary artery perforation (CAP), coronary artery aneurysm (CAA), and coronary artery pseudoaneurysm (CAPA) are limited. METHODS: We conducted a retrospective, descriptive analysis of all TCE devices in coronary lesions at our center from 2007 to 2019. Forty-one studied lesions included 25 CAF, 7 LIMA side-branch, 5 CAP, 2 CAA, and 2 CAPA. Short- and 1-year mortality and hospital readmission were reported, in addition to coil-related complications and procedural success. RESULTS: The utilization rate of TCE in coronary artery lesions at our center was found to be 33.8 per 100,000 percutaneous coronary intervention procedures over 12 years. Successful angiographic closure was achieved in 37 out of 41 (87.8%) cases (88, 100, 60, 100, and 100% of CAF, LIMA side-branch, CAP, CAA, and CAPA, respectively). No adverse events were directly related to TCE among the LIMA, CAA, and CAPA cases, and only one patient with CAF required reintervention at 3 months due to coil migration. CONCLUSIONS: Coil embolization in our institution was safe and effective in treating different coronary circulation abnormalities with a 87.8% overall success rate. Further study on the use of vascular plug devices in cases such as CAF or LIMA side-branch would be beneficial to understand the treatment options better.

Impact of atrial fibrillation on outcomes following MitraClip: A contemporary population-based analysis.

OBJECTIVES: Despite the rising use of MC, the impact of preexisting AF, a common comorbidity, on short-term postprocedural outcomes is poorly defined. We sought to assess outcomes between patients with and without atrial fibrillation (AF) who underwent percutaneous mitral valve repair with MitraClip (MC). METHODS: In this retrospective cohort study, the Nationwide Readmissions Database was queried for patients who underwent MC between 2014-2017. Groups were stratified based on the presence of AF. Multivariable logistic regression analyses were performed to identify the association between AF and in-hospital stroke and mortality. RESULTS: Of the 15,570 patients who underwent MC, 7,740 (49.7%) had AF. AF patients were older (82 vs. 79 years, p < .001) and more comorbid. Patients with AF relative to without AF demonstrated increased rates of in-hospital ischemic (1.3% vs .0.7%, p < .001) and hemorrhagic stroke (0.3% vs. 0.1%, p = .007), longer duration of hospitalization (median 3 vs. 2 days, p < .001), and similar in-hospital mortality (2.8% vs. 2.6%, p = .52). After adjusting for comorbidities, age, sex, hospital procedural volume, and CHA2DS2-VASc, the presence of AF was associated with higher in-hospital stroke (OR = 2.096, 95%CI[1.503-2.921], p < .001) but not in-hospital mortality (OR = 1.012, 95%CI[0.828-1.238], p = .904). AF patients were more likely to be readmitted (16.8% vs.14.1%, p < .001) and die (1.5% vs. 0.9%, p = .005) within 30 days of discharge despite similar incidences of stroke (0.7% vs. 0.6%, p = .53). CONCLUSIONS: The increased risk of in-hospital stroke, 30-day mortality, and longer hospitalization suggest the need for increased preprocedural optimization by means of stroke prevention strategies in those with AF undergoing MC.

Association of baseline kidney disease with outcomes of transcatheter mitral valve repair by MitraClip.

OBJECTIVES: This study sought to determine the impact of baseline chronic kidney disease (CKD) on in-hospital outcomes of transcatheter mitral valve repair with MitraClip (MC). BACKGROUND: MC is now an established treatment in high surgical risk patients. However, limited data are available on outcomes of MC in patients with baseline renal dysfunction. METHODS: The authors used data from January 2014 to December 2017 National Readmission Database to identify all patients ≥18 years of age who underwent MC. International classification of diseases (ICD)-9 and ICD-10 codes were used to identify patients with no-CKD, CKD (without chronic dialysis), or end-stage renal disease (ESRD) on dialysis. Multivariable logistic regression models were constructed using generalized estimating equations to examine in-hospital outcomes. RESULTS: Of 13,563 patients undergoing MC, 8,935 (65.8%) had no-CKD, 4,152 (30.6%) had CKD, and 476 (3.5%) had ESRD. ESRD patients compared to CKD and no-CKD had significantly higher mortality (7.2% vs. 2.5% vs. 2.0%; p < .001), higher incidence of bleeding, blood transfusions, and 30 day all cause readmission. CKD patients compared to no-CKD had significantly higher mortality (odds ratio-1.29; CI 1.01-1.65; p = .04), acute kidney injury (odds ratio-3.0; CI 2.69-3.34; p < .001), new in-hospital hemodialysis (odds ratio- 2.70; CI 1.57-4.62; p < .001), blood transfusions, 30 day all cause and congestive heart failure (CHF) readmissions. In-hospital stroke and cardiac tamponade did not differ between the three groups. Patients with baseline kidney disease undergoing MC had higher mortality at high volume centers compared to low volume centers. CHF was the most common cause of readmission postMC in patients with or without preprocedural kidney disease. CONCLUSION: Patients with baseline kidney disease have worse outcomes after MC with higher readmission rates requiring careful patient selection and follow up in this population.

Impact of thoracic aortic aneurysm on outcomes of transcatheter aortic valve replacement: A nationwide cohort analysis.

BACKGROUND: The use of transcatheter aortic valve replacement (TAVR) has expanded to patient populations of varying surgical risk in light of recent clinical trials, yet its role in patients with aortic stenosis and coexisting thoracic aortic aneurysm (TAA) is not well-delineated. We aimed to evaluate whether risk factors and in-hospital outcomes vary between TAVR patients with and without an unruptured TAA. METHODS: The Nationwide Readmissions Database was queried for patients hospitalized between January 2012 and December 2017 who underwent TAVR with and without an unruptured TAA. In-hospital outcomes were compared between cohorts after adjusting for sex, comorbidities, and TAVR approach, and in a subgroup analysis that excluded those with bicuspid aortic valves. RESULTS: Among 171,011 TAVR patients, 1,677 (1%) presented with TAA. Patients with TAA were younger (median age 80 vs. 82 years, p < .001) and more likely to have bicuspid aortic valves (9.3% vs. 0.9%, p < .001). Among patients with aneurysm, 2.6% died, 2.2% developed stroke, 1% developed aortic dissection, and 1.4% experienced cardiac tamponade while hospitalized. After adjusting for age, sex, bicuspid aortic valve, and all comorbidities, TAA was associated with significantly higher risk of post-TAVR aortic dissection (OR = 2.117, 95% CI [1.304-3.435], p = .002) and cardiac tamponade (OR = 1.682, 95% CI [1.1-2.572], p = .02). CONCLUSIONS: While the overall incidence of post-TAVR complications is low, patients with an unruptured TAA should be carefully considered by the Heart Team in weighing the additional risks of aortic dissection and cardiac tamponade after TAVR with those associated with surgery.

Incidence and short-term outcomes of surgical bailout after transcatheter mitral valve repair with the MitraClip system.

OBJECTIVES: This study sought to investigate the incidence and outcomes of surgical bailout (SB) after transcatheter mitral valve repair (TMVr) with MitraClip. BACKGROUND: TMVr poses a risk of serious procedural complications, possibly requiring urgent open surgery for SB. However, little is known about the risk of SB cases after TMVr. METHODS: We retrospectively identified patients who underwent TMVr using the Nationwide Readmissions Database 2014-2017. SB was defined as open thoracotomy for heart and aorta during the same hospitalization. Annual hospital volume was defined as the annual number of TMVr cases in each hospital in each year. RESULTS: Among 15,032 eligible patients, SB was required in 214 (1.42%), of whom 134 (62.6%) underwent mitral valve surgery (113 replacements; 21 repairs). The incidence of SB was decreasing significantly over the 4 years (5.26% in 2014; 0.43% in 2017; ptrend < .001). There was a significant nonlinear, inverse association of annual hospital volume with the incidence of SB. In-hospital death (15.0 vs. 2.1%; p < .001) and other in-hospital adverse events were significantly more frequent in patients with than without SB, whereas the 30-day readmission rate was similar (13.2 vs. 15.1%; p = .572). After adjustment for patient and hospital characteristics, SB was significantly associated with higher in-hospital mortality (odds ratio = 6.67, 95% confidence interval = 4.35, 10.23, p < .001). CONCLUSIONS: This study suggests that although the incidence of SB after TMVr is decreasing, SB is required more frequently in lower-volume hospitals and carries high in-hospital mortality. Further efforts are needed to understand the reasons for SB and improve outcomes in patients needing SB.

The impact of gender and HPV status on anal squamous cell carcinoma survival.

BACKGROUND: Anal cancer is a rare entity and the effect of gender and HPV status on survival is controversial. We aimed to evaluate the difference in overall survival (OS) according to gender and analyzed the effect of HPV status on OS. PATIENTS AND METHODS: The National Cancer Database (NCDB) was queried for patients with anal squamous cell carcinoma between 2004 and 2016. We evaluated the OS based on gender and HPV status using Kaplan-Meier estimates and we used multivariate Cox regression analyses to evaluate factors associated with overall survival. RESULTS: A total of 6133 patients with known HPV status were included for analysis. In the non-metastatic group, male gender was associated with worse OS (HR 1.50, 95% CI 1.32-1.70; P<0.001) whereas HPV status did not affect the OS (HR 1.08, 95% CI 0.96-1.22; P=0.213). In the metastatic group, there was no difference in OS based on gender (HR 1.29, 95% CI 0.91-1.82; P=0.148), whereas HPV-negative status was associated with worse OS (HR 1.52, 95% CI 1.09-2.12; P=0.014). CONCLUSION: Females had better OS only in non-metastatic anal squamous cell carcinoma (ASCC). HPV-negative status was associated with worse OS only in metastatic ASCC.

Second primary malignancies of eye and ocular adnexa after a first primary elsewhere in the body.

PURPOSE: The eye and its adnexal structures can give rise to first or consecutive primary malignancies or to encounter metastasis. Our aim was to define the characteristics of the second primary neoplasms affecting the eye and its adnexa and find the risk modifying factors for them after malignancies elsewhere in the body. METHODS: We have queried the Surveillance, Epidemiology and End-Results "SEER"-9 program of the National Cancer Institute for the malignancies of the eye and its adnexa that occurred between 1973 and 2015. The malignancies were ordered chronologically according to their incidence: first or second primary malignancies. The tumors were classified according to ICD-O-3 classification. Standardized incidence ratios (SIR) and survival probabilities were calculated for subgroups. RESULTS: Among 3,578,950 cancer patients, 1203 experienced a second malignancies of the eye and its adnexa. The first malignancy was diagnosed between 50 and 69 years of age in 58.94% of them. The eyelid showed 280 events, while 50 in lacrimal gland, 181 in the orbit, 21 in the overlapping lesions, 15 in optic nerve, 148 in the conjunctiva, 9 in the cornea, 6 in the Retina, 379 in the choroid, and 93 in the ciliary body. The SIR of a second malignancy after a prior non-Hodgkin lymphoma was 2.42, and in case of previous skin carcinomas it was 3.02, melanoma of skin, and 2.13 and 1.58 in oral cavity/pharynx malignancies. The second ocular and adnexal neoplasms increased steadily over the 5-year periods on contrary to first primary neoplasms. The survival of patients affected with first ocular and adnexal neoplasms was significantly higher than those with second ocular and adnexal neoplasms. On the other side, second primary ocular and adnexal tumors showed a better survival than second primary malignancies elsewhere. CONCLUSIONS: The epidemiological differences between first and second ocular and adnexal primaries suggest different underlying mechanisms. Careful ocular examination should be integrated in the long-term follow-up plan of cancer patients. Special attention should be given to patients with non-Hodgkin's lymphoma and melanoma as first primary.

Causes of death after breast cancer diagnosis: A US population-based analysis.

BACKGROUND: The focus on noncancer causes of death in patients with breast cancer (BC) remains superficial. The objective of the current study was to assess and quantify causes of death after BC diagnosis. METHODS: In total, 754,270 women with BC in the United States who were diagnosed during 2000 through 2015 and retrieved from the Surveillance, Epidemiology, and End Results (SEER) program were studied. Standardized mortality ratios (SMRs) for causes of death were calculated. RESULTS: Of the included patients, 183,002 (24.3%) died during the follow-up period. The greatest proportion of deaths (46.2%) occurred within 1 to 5 years after diagnosis. Most deaths occurred from BC itself or from other cancers, and the number of BC deaths decreased as more years passed after diagnosis. The most common noncancer causes of death within <10 years after diagnosis were heart diseases followed by cerebrovascular diseases. However, >10 years after diagnosis, the most common noncancer causes of death were heart diseases followed by Alzheimer disease. Patients had a statistically significant higher risk of death from chronic liver diseases within 5 to 10 years after diagnosis compared with the general population (SMR, 1.23; 95% CI, 1.09-1.38) and had statistically significant higher risks of death from Alzheimer disease (SMR, 1.21; 95% CI, 1.14-1.29) and from diseases of the heart (SMR, 1.06; 95% CI, 1.02-1.09) >10 years after diagnosis. CONCLUSIONS: Although BC remains the most common cause of death after BC diagnosis, other non-BC causes of death (mainly heart and cerebrovascular diseases) represent a significant number of deaths among patients with BC. These findings provide important insight into how BC survivors should be counselled regarding future health risks.

Structured crowdsourcing enables convolutional segmentation of histology images.

MOTIVATION: While deep-learning algorithms have demonstrated outstanding performance in semantic image segmentation tasks, large annotation datasets are needed to create accurate models. Annotation of histology images is challenging due to the effort and experience required to carefully delineate tissue structures, and difficulties related to sharing and markup of whole-slide images. RESULTS: We recruited 25 participants, ranging in experience from senior pathologists to medical students, to delineate tissue regions in 151 breast cancer slides using the Digital Slide Archive. Inter-participant discordance was systematically evaluated, revealing low discordance for tumor and stroma, and higher discordance for more subjectively defined or rare tissue classes. Feedback provided by senior participants enabled the generation and curation of 20 000+ annotated tissue regions. Fully convolutional networks trained using these annotations were highly accurate (mean AUC=0.945), and the scale of annotation data provided notable improvements in image classification accuracy. AVAILABILITY AND IMPLEMENTATION: Dataset is freely available at: https://goo.gl/cNM4EL. SUPPLEMENTARY INFORMATION: Supplementary data are available at Bioinformatics online.

The utilization of single versus double Perclose devices for transfemoral aortic valve replacement access site closure: Insights from Cleveland Clinic Aortic Valve Center.

INTRODUCTION: Percutaneous femoral access is the preferred access route for transcatheter aortic valve replacement (TAVR). The majority of experienced TAVR centers use two 6F Perclose ProGlide™ devices to close the primary vascular access site, deployed prior to upsizing sheath size with closure completed at the end of the case (the "preclose" approach). A strategy of utilizing a single Perclose device to preclose may have advantages including fewer complications, complexity, and cost, but the safety of this is unknown. This study examines in the safety and efficacy of using a single Perclose versus double Perclose for perclosure of large bore access during TAVR. METHODS: Patients undergoing Transfemoral (TF) TAVR from January 2014 to December 2017 within the Cleveland Clinic Aortic Valve Center were identified. A retrospective review of medical charts was conducted. Vascular complications were defined according to the VARC-2 criteria. RESULTS: A total of 740 patients were included; 487 (65.8%) received a single Perclose device while 253 (34.2%) received double Perclose devices. Baseline characteristics were similar with no differences between the single versus double Perclose groups, respectively. The access sheath size was similar in both groups with (14, 16, and 18 F) being the most common sizes utilized. Of the total 487 patients with single Perclose, 75.6% needed additional closure device (AngioSeal). With double Perclose strategy, additional closure device (AngioSeal) was used in 40.3% patients with 470 (63.5%) patients being successfully perclosed. Vascular complication rates including hematoma, stenosis requiring stenting, pseudoaneurysm, and other major vascular complications were similar between both groups. CONCLUSION: Single 6F ProGlide use for preclosure is a safe strategy for TF TAVR using the S3 valve. Additional closure device was not needed in almost one-quarter of the patients. When necessary, residual bleeding can be controlled with the AngioSeal Device at the end of the procedure. This single device preclose strategy can help to reduce the cost of TAVR procedure without increasing risk.

Does a history of malignancy impact the survival of a subsequent endometrial adenocarcinoma? Should clinical trials eligibility criteria be revisited?

We aimed at finding the impact of prior malignancies on the survival of patients with endometrial adenocarcinoma using SEER database (from 1973 to 2014). We identified 127,988 patients who were diagnosed with endometrial adenocarcinoma (6485 had a prior malignancy), and we compared the overall and cancer-specific survival based on the presence or absence of a prior malignancy and the latency period between the two diagnoses using Kaplan-Meier test and Cox models. Adjusted cox models showed that a history of a prior malignancy neither affected the overall survival nor the cancer-specific survival of stage IV cases in all latency groups except the one diagnosed within 1 year of the first cancer. Therefore, there is no rational explanation for excluding stage IV endometrial adenocarcinoma patients with a prior malignancy from clinical trials except for the group that was diagnosed with endometrial adenocarcinoma within 1 year from the first cancer.Impact statementWhat is already known on this subject? Not enough evidence is found on the impact of prior malignancies on the survival of patients with subsequent endometrial adenocarcinoma.What do the results of this study add? History of a prior malignancy neither affects the overall survival of stage IV endometrial adenocarcinoma nor the cancer-specific survival. Only patients who had their second malignancy diagnosed within one year of the first malignancy should be excluded from clinical trials, while patients diagnosed within one to five years of the first cancer should be encouraged to enrol in clinical trials as they have an enhanced survival than patients without a history of malignancy.What are the implications of these findings for clinical practice and/or further research? We recommend that future researchers should consider including the aforementioned group of patients in their trials to achieve more accurate results and in order not to strip the patients of potential therapeutic benefits of enrolling in clinical trials.

Suicidal death within a year of a cancer diagnosis: A population-based study.

BACKGROUND: The suicide risk after a new cancer diagnosis remains a controversial issue. This study examines the suicide risk within the year after a cancer diagnosis. This is the largest study to assess recent trends in suicide risk after a cancer diagnosis. METHODS: Data were obtained from the Surveillance, Epidemiology, and End Results Program. All patients diagnosed with cancer between 2000 and 2014 were selected. The event was defined as death due to suicide within the first year after a cancer diagnosis, and patients who experienced the event after their diagnosis were observed. The observed/expected (O/E) ratio was assessed as well as the excess risk per 10,000 person-years to determine the suicide risk change after the diagnosis in comparison with the general population. RESULTS: A total of 4,671,989 patients with cancer were included; 1585 committed suicide within 1 year of their diagnosis. The risk of suicide increased significantly with an O/E ratio of 2.52 and with an excess risk of 2.51 per 10,000 person-years. When the risk of suicide was studied according to the cancer site, the highest increases in the O/E ratio came after diagnoses of pancreatic cancer (8.01) and lung cancer (6.05). The risk of suicide also increased significantly after a diagnosis of colorectal cancer with an O/E ratio of 2.08. However, the risk of suicidal death did not increase significantly after breast and prostate cancer diagnoses. CONCLUSIONS: The risk of suicide increases significantly in the first year after a diagnosis of cancer in comparison with the general population, and this increase varies with the type and prognosis of cancer. Close observation and referral to mental health services, when indicated, are important for mitigating such risk.

Impact of prior malignancies on outcome of colorectal cancer; revisiting clinical trial eligibility criteria.

BACKGROUND: Most clinical trials on colorectal cancer (CRC) exclude cases who have history of a prior malignancy. However, no prior research studied this history's actual impact on the survival of CRC. In the paper, we study the effects of having a malignancy preceding CRC diagnosis on its survival outcomes. METHODS: CRC patients diagnosed during 1973-2008 were reviewed using the SEER 18 database. We calculated overall survival and cancer-specific survival of subsequent CRC, and more specifically stage IV CRC, using Kaplan-Meier test and adjusted Cox models. RESULTS: A total 550,325 CRC patients were reviewed, of whom 31,663 had history of a prior malignancy. The most commonly reported sites of a prior malignancy were: prostate, breast, urinary bladder, lung, and endometrium. Patients with history of a prior non-leukemic malignancy or history of a prior leukemia were found to have worse overall survival (HR = 1.165 95%CI = 1.148-1.183, P < 0.001) and (HR = 1.825 95%CI = 1.691-1.970, P < 0.001), respectively. However, CRC patients with history of a prior non-leukemic malignancy showed an improved colorectal cancer-specific survival (HR = .930 95%CI = .909-.952, P < 0.001). Analysis of stage IV CRC patients showed that patients with history of any non-leukemic malignancy did not have a significant change in overall survival. Whereas, patients with a prior leukemia showed a worse overall survival (HR = 1.535, 95%CI = 1.303-1.809, P < 0.001). When analyzed separately, right CRC and left CRC showed similar survival patterns. CONCLUSION: A prior malignancy before CRC -in general- can be associated with worse clinical survival outcomes. These worse outcomes are not observed in stage IV CRC. Considering these results when including/excluding stage IV CRC patients with prior malignancies in clinical trials may play help improve their generalizability.