The Natural History, Treatment Pattern, and Outcomes of Patients With Micropapillary Bladder Carcinoma.

OBJECTIVE: Micropapillary bladder carcinoma (MPBC) is a rare variant of urothelial cancer. Most literature on MPBC is from case series reports. This study's objective was to examine the epidemiology, natural history, and prognostic factors of MPBC using a population-based registry, in addition to a literature review. METHODS: The Surveillance, Epidemiology, and End Results (SEER) database identified 98 histologically confirmed MPBC patients from 2001 and 2007. In addition, 213 MPBC cases were identified in published literature. The clinical, demographic characteristics, treatment, and survival outcomes were compared between these 2 cohorts. RESULTS: Among patients identified in SEER, MPBC accounted for approximately 0.01% of primary bladder tumors, with the median age of 72 years (range, 26 to 95 y). Among the MPBC cases, 56.1% had muscle invasive disease, 75.5% had poor or undifferentiated histology, and 30.6% underwent a radical or partial cystectomy. The 1-, 3-, and 5-year overall survival rates for the SEER cohort were estimated at 84.5%, 57.3%, and 42.3%, respectively. Using multivariate analysis, tumor stage and marital status were the most significant predictors for cancer-specific survival. When comparing published single-institution studies to the SEER cohort, significant differences existed in demographic characteristics including age at diagnosis, male-to-female ratio, tumor stage, cystectomy treatment, and survival outcomes, likely reflecting differences in practice patterns. CONCLUSIONS: This is the first population-based study to analyze MPBC's epidemiology, tumor characteristics, and survival rates. Emphases on early detection, cystectomy, and multimodality in treatment are needed.

Prolonged high-pressure is required for optimal stent deployment as assessed by optical coherence tomography.

AIMS: Optimizing stent deployment is important for both acute- and long-term outcomes. High-pressure balloon inflation is the standard for coronary stent implantation. However, there is no standardized inflation protocol. We hypothesized that prolonged high-pressure balloon inflation until stabilization of inflation pressure is superior to a rapid inflation/deflation sequence for both stent expansion and strut apposition. METHODS AND RESULTS: A high-pressure rapid inflation/deflation sequence was deployed followed by angiography to assure no residual stenosis. Optical coherence tomography (OCT) was then performed followed by prolonged inflation until balloon pressure was stabilized for 30 sec using the same balloon at the same pressure as the rapid sequence. A second OCT run was then done. Thirteen thousand nine hundred thirteen stent struts were evaluated by OCT in 12 patients undergoing successful stenting. Stent expansion improved with prolonged (206 ± 115 sec) vs. rapid (28 ± 17 sec) inflation for both minimal stent diameter (3.0 ± 0.5 vs. 2.75 ± 0.44 mm, P < 0.0001) and area (7.83 ± 2.45 vs. 6.63 ± 1.85 mm(2) , P = 0.0003). The number of malapposed struts decreased (45 ± 41 vs. 88 ± 75, P = 0.005) as did the maximal malapposed strut distance (0.31 ± 0.2 vs. 0.43 ± 0.2 mm, P = 0.0001). Factors related to strut malapposition after rapid inflation included localized asymmetry in 67%, stent underexpansion in 75%, and stent undersizing in 67%. CONCLUSIONS: These data demonstrate that prolonged inflation is superior to a rapid inflation/deflation technique for both stent expansion and strut apposition. We recommend for routine stent deployment a prolonged inflation protocol as described above to optimize stent deployment.

Impact of age on clinical presentation, treatment, and cancer-specific survival of patients with small-cell carcinoma of the prostate.

BACKGROUND: The effects of age on clinical presentation, treatment, and outcomes for patients with small-cell carcinoma of the prostate (SCCP) are unclear. METHODS: A retrospective review was performed on 259 patients who were identified with SCCP in the national Surveillance, Epidemiology, and End Results (SEER) registry from January 1973 to December 2004. The patients were categorized into two groups according to age at diagnosis, ie, younger than 75 years (n = 158, 61%) or 75 years and older (n = 101, 39%). Patient and treatment characteristics and cancer-specific survival were compared between the groups. Multivariate analysis was performed to identify independent prognostic factors associated with cancer-specific survival. RESULTS: The median age of the patients was 72 (30-95) years. There was no significant difference in terms of tumor characteristics, concomitant adenocarcinoma grade, SEER stage, and treatment (including prostatectomy and radiation therapy) received between the groups. Median cancer-specific survival was 19 months (95% confidence interval 13-25). By multivariate Cox proportional hazard modeling, older age group (hazard ratio [HR] 1.95; P = 0.001), concomitant high-grade adenocarcinoma (HR 7.13; P = 0.007), and not having prostatectomy (HR 3.77; P = 0.005) were found to be significant independent predictors of poor cancer-specific survival. CONCLUSION: Older patients with SCCP had increased risk of poor cancer-specific survival. Whether this age-related poor outcome can be attributed to more aggressive tumor biology in older patients, or is simply a refection of age-related poor performance status and suboptimal chemotherapy needs further investigation.

The impact of signet-ring cell carcinoma histology on bladder cancer outcome.

BACKGROUND: Signet-ring cell carcinoma (SRCC) of the urinary bladder is a rare entity. No previous studies have directly compared the cancer-specific survival of patients with SRCC to patients with urothelial carcinoma (UC) of the urinary bladder. MATERIALS AND METHODS: Patients with diagnosis of urinary bladder SRCC and UC were identified in the Surveillance, epidemiology, and end results program (SEER) (2001-2004). Demographic of patients and clinical characteristics at diagnosis were compared. Differences in cancer-specific survival were compared using univariate and multivariate analysis. RESULTS: A total of 103 patients with SRCC and 14,648 patients with UC were indentified. Patients with SRCC were younger (P < 0.001), more commonly presented with higher-grade histology (P < 0.001) and advanced stage disease (P < 0.001), in comparison with patients with UC. The 3-year cancer-specific survival rate was 67.0% for patients with UC and 33.2% for SRCC. On multivariate analysis, there was an increased mortality risk in patients with SRCC versus UC (HR 1.49, 95% CI 1.11-2.00, P < 0.01). CONCLUSIONS: Even after adjusting for demographic, surgical, and pathological factors, cancer-specific survival rate was significantly worse in patients with SRCC compared to UC. Further research into the biology of this rare tumor is required to explain these results.

Younger age is an independent predictor for poor survival in patients with signet ring prostate carcinoma.

Objective. The aim of this study was to examine the epidemiology, natural history, treatment pattern, and predictors of long-term survival of signet ring prostate carcinoma (SRPC) patients based on the analysis of the national Surveillance, Epidemiology, and End Results (SEER) database. Methods & Results. Between 1980 and 2004, a total of 93 patients with pathologically confirmed SRPC were identified. The mean age was 70 ± 11 years old. 82.8% of the patients had poorly or undifferentiated histology grade. 13.9% patients presented with metastatic disease. The 1-, 3-, and 5-year cancer-specific survival rates were 94.6%, 89.6%, and 83.8%, respectively. Using multivariate Cox proportional hazard model, younger age (40-50 versus age >70 yrs, P = .01), advanced tumor stage (distant versus local/regional, P = .02), and earlier diagnosis year (before 1995 versus after 1995, P = .01) were predictors of worse cancer specific survival. Conclusions. Despite more aggressive cancer therapy, younger SRPC patients had a worse cancer specific survival. This information could be useful when counseling these patients and emphasizes the need for new strategies and molecular-based therapeutic approaches for younger patients with SRPC.

The natural history and outcomes of the patients with carcinosarcoma involving kidney and renal pelvis.

Background. The objective of this paper was to examine the epidemiology, natural history, and prognostic factors of carcinosarcoma of the kidney and renal pelvis (CSKP) using population-based registry. Patients and Methods. Forty-three patients with CSKP, diagnosed between January 1973 and December 2007, were identified from the national Surveillance, Epidemiology, and End Results (SEER) database and reviewed. Results. 79% of all patients with known SEER stage were classified as having regional or distant stage; almost all the patients with known histology grade had poorly or undifferentiated histology. The median cancer specific survival was 6 months (95% CI 4-9). The 1-year cancer-specific survival rate for entire cohort was 30.2%. There were no differences in terms of age at diagnosis, histological grade, tumor stage on presentation, and frequency of nephrectomy between carcinosarcoma of kidney (CSK) or renal pelvis (CSP). In multivariate analysis, age at diagnosis, tumor stage, and year of diagnosis were found to be significant predictors for cancer-specific survival. Conclusion. CSKP commonly presented as high-grade, advanced stage disease, and was associated with a poor prognosis regardless of location.

Outcomes after carotid artery stenting and endarterectomy in the Medicare population.

BACKGROUND AND PURPOSE: Carotid artery stenting (CAS) is an alternative to carotid endarterectomy (CEA) for stroke prevention. The value of this therapy relative to CEA remains uncertain. METHODS: In 10 958 Medicare patients aged 66 years or older between 2004 and 2006, we analyzed in-hospital, 1-year stroke, myocardial infarction, and death rate outcomes and the effects of potential confounding variables. RESULTS: CAS patients (87% were asymptomatic) had a higher baseline risk profile, including having a higher percentage of coronary and peripheral arterial disease, heart failure, and renal failure. In-hospital stroke rate (1.9% CAS versus 1.4% CEA; P=0.14) and mortality (CAS 0.9% versus 0.6% CEA; P=0.20) were similar. By 1 year, CAS patients had similar stroke rates (5.3% CAS versus 4.1% CEA; P=0.12) but higher all-cause mortality rates (9.9% CAS versus 6.1% CEA; P<0.001). Using Cox multivariable models, there was a similar stroke risk (hazard ratio, 1.28; 95% CI, 0.90-1.79) but CAS patients had a significantly higher mortality (HR, 1.32; 95% CI, 1.02-1.71). Sensitivity analyses suggested that unmeasured confounders could be responsible for the mortality difference. In multivariable analysis, stroke risk was highest in the patients symptomatic at the time of revascularization. CONCLUSIONS: CAS patients had a similar stroke risk but an increased mortality rate at 1 year compared with CEA patients, possibly related to the higher baseline risk profile in the CAS patient group.

Clinical characteristics and outcomes of patients with primary signet-ring cell carcinoma of the urinary bladder.

OBJECTIVE: The aim of this study was to examine the epidemiology, natural history, treatment pattern and predictors of long-term survival of patients with signet-ring cell carcinoma (SRCC) of the urinary bladder based on the analysis of the national Surveillance, Epidemiology, and End Results (SEER) database. METHODS AND RESULTS: In total, 230 patients with pathologically confirmed SRCC of the urinary bladder were identified between 1973 and 2004. The mean age was 65 ± 13 years. Overall, 75.7% of the patients had a poorly differentiated or undifferentiated histology grade, 26.5% presented with metastatic disease, 59 (25.7%) underwent transurethral resection for bladder tumor only and 107 (46.5%) had partial or radical cystectomy. The 1-, 3- and 10-year cancer-specific survival rates were 66.8, 40.6 and 25.8%, respectively. Using multivariable Cox proportional hazard model, age (HR 1.024; p = 0.004), stage (distant vs. local, HR 6.2; p < 0.001) and cystectomy (HR 0.53; p = 0.002) were identified as independent predictors for cancer-specific survival. CONCLUSIONS: Receipt of cystectomy was strongly associated with improved survival in the patients with SRCC of urinary bladder. However, many patients with localized tumors did not receive potentially curative cystectomy. Further studies to address the barriers to the delivery of appropriate care to these patients are warranted.

Clinical features and outcomes of 25 patients with primary adenosquamous cell carcinoma of the prostate.

The aim of the present study was to examine the epidemiology, natural history, treatment and long-term survival of patients with adenosquamous cell carcinoma of the prostate. The Surveillance, Epidemiology, and End Results (SEER) Program database was used to identify ASCC of prostate cases between January 1973 and December 2006. Survival probabilities were estimated using the Kaplan-Meier methods and compared using the log-rank test. A total of 25 patients with adenosquamous cell carcinoma of the prostate were identified during the study period. The median age was 74 years (range 53-98). Twenty percent of study subjects presented with metastatic disease. Among those patients with known grade (n=16), 75% had poorly or undifferentiated histology. A total of 40% of study subjects received radical prostatectomy, while 24% of the patients had primary radiation therapy. The 1-, 3-, and 5-year cancer specific survival rates for the entire cohort were 55.2%, 37.8%, and 30.3%, respectively. For patients who underwent prostatectomy, the 1-, 3-, and 5-year survival rates were 78%, 78%, and 63%, respectively. For the patients who did not receive prostatectomy, the 1-year survival rates were 38.7% and none survived to three years. Adenosquamous cell carcinoma is a rare aggressive subtype of prostate cancer with poor cancer specific survival. The development of new therapeutic approaches for this aggressive tumor is urgently needed.

Clinical features of sarcomatoid carcinoma (carcinosarcoma) of the urinary bladder: analysis of 221 cases.

Background. Urinary bladder sarcomatoid carcinoma (carcinosarcoma) is rare. The objective of this study was to examine the epidemiology, natural history, and prognostic factors of urinary bladder carcinosarcoma using population-based registry. Methods. The Surveillance, Epidemiology, and End Results (SEER) Program database was used to identify cases by tumor site and histology codes. The association between clinical and demographic characteristics and long-term survival was examined. Results. A total of 221 histology confirmed cases were identified between 1973 and 2004, this accounted for approximately 0.11% of all primary bladder tumors during the study period. Median age of the patients was 75 years (range 41-96). Of the patients with a known tumor stage (N = 204), 72.5% had a regional or distant stage; 98.4% of patients with known histology grade (N = 127), had poorly or undifferentiated histology. Multiple primary tumors were indentified in about 40% of study subjects. The majority of patients (95.9%) received cancer directed surgery, 35.8% had radical or partial cystectomy, 15.8% of patients received radiation therapy combination with surgery. The median overall survival was 14 months (95% CI 7-21 months). 1-, 5-, and 10-year cancer specific survival rate were 53.9%, 28.4% and 25.8%. In a multivariate analysis, only tumor stage was found to be a significant prognostic factor for disease-specific survival. Conclusions. Urinary bladder carcinosarcoma commonly presented as high grade, advanced stage and aggressive behavior with a poor prognosis. Emphasis on early detection, including identification of risk factors is needed to improve the outcome for patients with this malignancy.

Refusal of cancer-directed surgery strongly impairs survival of patients with localized hepatocellular carcinoma.

BACKGROUND: This study investigated the frequency of patients with HCC who refused cancer-directed surgery and the characteristics and outcomes of these patients. PATIENTS AND METHODS: A retrospective study was performed using data from the Surveillance, Epidemiology, and End RESULTS (SEER) Program. Characteristics of patients who refused CDS were compared with those who accepted surgery using logistic regression. The effect of refusing CDS on mortality was evaluated by Cox proportional hazards analysis. RESULTS: Among 4373 surgical candidates, 142 patients (3.2%) refused the recommended CDS. The patients who refused CDS were frequently older, African American, widowed or divorced, and had advanced-stage tumors. In a logistic regression analysis, older age, African American, and being divorced or widowed were independently associated with refusal of CDS. After adjusting for other patient and tumor characteristics, the patients who refused CDS had a 2.5-fold (95% confidence interval, 2.339-3.189) higher risk of dying from HCC in comparison with patients who had CDS. CONCLUSIONS: The high rate of refusal may contribute in part to the disparity in utilization of CDS. Of greatest concern is that the patients who declined CDS had an impaired survival. This information might be helpful for patients to make a better-informed decision.

Distal myocardial protection with intracoronary beta blocker when added to a Gp IIb/IIIa platelet receptor blocker during percutaneous coronary intervention improves clinical outcome.

OBJECTIVE: The present study tested the hypothesis that intracoronary (IC) propranolol improves clinical outcomes with percutaneous coronary intervention (PCI) when used with background Gp IIb/IIIa receptor blockade. BACKGROUND: We have previously shown that administration of a relatively large weight-based IC dose of the beta blocker propranolol before PCI decreases the incidence of post-PCI myocardial infarction (MI) and improves short- and long-term outcome. It has previously been shown that administration of a Gp IIb/IIIa receptor blocker decreases post-PCI MI and improves short- and long-term clinical outcome. METHODS: Patients undergoing PCI (n = 400) were randomized in a prospective double-blind fashion to IC propranolol (n = 200) or placebo (n = 200) with eptifibatide administered to all the patients. Myocardial isoform of creatine kinase was measured during the first 24 hr and clinical outcomes at 30 days and 1 year. RESULTS: MI after PCI was seen in 21.5% of placebo and 12.5% of propranolol patients (relative risk reduction 0.42; 95%CI 0.09, 0.63; P = 0.016). At 30 days, the composite end point of death, post-procedural MI, urgent target lesion revascularization, or MI after index hospitalization occurred in 22.5% of placebo vs. 13.5% of propranolol patients (risk reduction 0.43; 95%CI 0.08, 0.65; P = 0.018). Similar results were observed at 1 year with adverse outcomes in 21.5% of propranolol and 32.5% of placebo patients (P = 0.01). CONCLUSION: IC propranolol administration with the background Gp IIb/IIIa receptor blockade significantly reduces the incidence of post-PCI MI and improves the short- and long-term clinical outcome when compared with a Gp IIb/IIIa blocker alone.

Survival advantage in Medicare patients receiving drug-eluting stents compared with bare metal stents: real or artefactual?

BACKGROUND: Concerns have been raised regarding late mortality, particularly from late stent thrombosis, from drug-eluting stents (DES). Randomized clinical trials have shown that DES decrease restenosis but do not decrease mortality compared with bare metal stents (BMS). These studies utilized well-defined clinical and angiographic subsets. In the "real world" drug-eluting stents are used in a much broader crosssection of patients. We evaluated mortality in the first year after implantation of DES, specifically the sirolimus-eluting stent (SES), Cypher vs. BMS in "real world" older patients using the Medicare claims database. METHODS AND RESULTS: Data for the years 2002 (n = 6,890; pre-DES) and 2003 (n = 7,566; first year of DES use) (May through December of each year) were analyzed. BMS and DES groups had similar baseline characteristics except for small but significant differences with BMS patients being somewhat older, having more males and African Americans, and a higher percentage of peripheral artery disease and heart failure while DES patients had a higher percentage of diabetics and patients with prior revascularization procedures. A significant improvement in mortality using both unadjusted and adjusted analyses was observed for DES (6.0% vs. 11.4%, P < 0.0001; hazard ratio 1.98, 95% CI 1.68-2.34). Controlling for comorbidity, extent of disease, and other characteristics by multivariable analysis or by propensity analysis had little impact on these results. On the other hand, there was no change in overall mortality in all stented patients in 2003 compared with all stented patients in 2002. CONCLUSION: An observed mortality benefit for DES compared with BMS in 2003 was observed, demonstrating the safety of DES, and suggesting the possibility of superiority in outcome in older patients with DES vs. BMS. However, the lack of improved survival from 2002 to 2003 in all stented patients suggests that the mortality advantage with DES finding may be due to unidentified selection biases. Our data suggest that DES in the Medicare population is as safe as, and possibly superior, to BMS for survival over the first year after implantation.

Meta-analysis of published reports on the effect of statin treatment before percutaneous coronary intervention on periprocedural myonecrosis.

Myonecrosis, manifested by an increase in cardiac markers, may occur in up to 50% of patients undergoing elective percutaneous coronary intervention (PCI). The degree of periprocedural myonecrosis, measured by the peak creatine kinase-MB fraction, has been associated with incidence of adverse clinical outcomes. Therefore, strategies to decrease myonecrosis may translate into a decrease in mortality. We evaluated the efficacy of statin pretreatment in decreasing the incidence of myonecrosis after PCI on the basis of results of published studies. A systematic search of the PubMed database from its inception to October 2006 and from the references of identified studies was performed. Only studies with concurrent control groups were included. Information on baseline characteristics of included patients and clinical outcomes was independently extracted by 2 investigators. A random effects model was used to pool odds ratios of the incidence of periprocedural myonecrosis in statin-treated patients versus controls. A total of 9 trials was included in the analysis, 2 randomized trials (n = 604) and 7 retrospective cohort studies (n = 4,751), which assessed the impact of statin pretreatment on periprocedural myonecrosis. During this period, 196 of 2,149 patients (9%) in the statin-treated group compared with 455 of 2,602 (17.5%) in the control group (odds ratio 0.45, 95% confidence interval 0.33 to 0.62, p <0.01) developed myonecrosis. In conclusion, based on existing evidence, routine pretreatment with statins may decrease the risk of postprocedure myonecrosis. Large randomized controlled trials addressing the dose, duration, and type of statin on periprocedural myonecrosis are necessary before recommending routine use of statins to prevent myonecrosis in the elective PCI setting.

Implementation and application of a continuous quality improvement (CQI) program for the cardiac catheterization laboratory: one institution's 10-year experience.

There is consensus that a continuous quality improvement (CQI) program is essential in optimizing patient outcomes in the cardiovascular catheterization laboratory. A CQI method was described in guidelines produced by the Society for Cardiovascular Angiography and Interventions (SCAI) in 1993 and 1997. However, little information is available in the medical literature to determine the implementation and application of this approach in a modern catheterization program. This presentation describes the lessons learned from one institution's 10 year CQI experience by using the SCAI blueprint.

Distal myocardial protection during percutaneous coronary intervention with an intracoronary beta-blocker.

BACKGROUND: Experimental studies have demonstrated that intravenous beta-blocker administration before coronary artery occlusion significantly reduces myocardial injury. Clinical studies have shown that intracoronary (IC) propranolol administration before percutaneous coronary intervention (PCI) delays myocardial ischemia. The present study tested the hypothesis that IC propranolol treatment protects ischemic myocardium from myocardial damage and reduces the incidence of myocardial infarction (MI) and short-term adverse outcomes after PCI. METHODS AND RESULTS: Patients undergoing PCI (n=150) were randomly assigned in a double-blind fashion to receive IC propranolol (n=75) or placebo (n=75). Study drug was delivered before first balloon inflation via an intracoronary catheter with the tip distal to the coronary lesion. Biochemical markers were evaluated through the first 24 hours and clinical outcomes to 30 days. Evidence of MI with creatine kinase-MB elevation after PCI was seen in 36% of placebo and 17% of propranolol patients (P=0.01). Troponin T elevation was seen in 33% of placebo and 13% of propranolol patients (P=0.005). At 30 days, the composite end point of death, postprocedural MI, non-Q-wave MI after PCI hospitalization, or urgent target-lesion revascularization occurred in 40% of placebo versus 18% of propranolol patients (hazard ratio 2.14, 95% CI 1.24 to 3.71, P=0.004). CONCLUSIONS: IC administration of propranolol protects the myocardium during PCI, significantly reducing the incidence of MI and improving short-term clinical outcomes.