Ureteral Stents: Impact on Quality of Life.

Ureteral stents have an indispensable place in urology, and indications for their use are increasing. However, stents can affect their users' quality of life negatively because of complications and adverse effects. This descriptive research aimed to determine the effect of ureteral stenting on quality of life. The study sample consisted of 75 patients. Data were collected using a questionnaire form, the SF-36 Quality of Life Scale, and the International Prostate Symptom Score. Patients were interviewed twice (before stenting and 1 month after stenting). The data were analyzed with descriptive statistics methods. This research determined that patients with ureteral stents had increased lower urinary tract symptoms and significantly reduced quality of life.

Recurrent Hospitalization Among Patients With Atrial Fibrillation Undergoing Intracoronary Stenting Treated With 2 Treatment Strategies of Rivaroxaban or a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy.

BACKGROUND: Patients with atrial fibrillation who undergo intracoronary stenting traditionally are treated with a vitamin K antagonist (VKA) plus dual antiplatelet therapy (DAPT), yet this treatment leads to high risks of bleeding. We hypothesized that a regimen of rivaroxaban plus a P2Y12 inhibitor monotherapy or rivaroxaban plus DAPT could reduce bleeding and thereby have a favorable impact on all-cause mortality and the need for rehospitalization. METHODS: Stented subjects with nonvalvular atrial fibrillation (n=2124) were randomized 1:1:1 to administration of reduced-dose rivaroxaban 15 mg daily plus a P2Y12 inhibitor for 12 months (group 1); rivaroxaban 2.5 mg twice daily with stratification to a prespecified duration of DAPT of 1, 6, or 12 months (group 2); or the reference arm of dose-adjusted VKA daily with a similar DAPT stratification (group 3). The present post hoc analysis assessed the end point of all-cause mortality or recurrent hospitalization for an adverse event, which was further classified as the result of bleeding, a cardiovascular cause, or another cause blinded to treatment assignment. RESULTS: The risk of all-cause mortality or recurrent hospitalization was 34.9% in group 1 (hazard ratio=0.79; 95% confidence interval, 0.66-0.94; P=0.008 versus group 3; number needed to treat=15), 31.9% in group 2 (hazard ratio=0.75; 95% confidence interval, 0.62-0.90; P=0.002 versus group 3; number needed to treat=10), and 41.9% in group 3 (VKA+DAPT). Both all-cause death plus hospitalization potentially resulting from bleeding (group 1=8.6% [P=0.032 versus group 3], group 2=8.0% [P=0.012 versus group 3], and group 3=12.4%) and all-cause death plus rehospitalization potentially resulting from a cardiovascular cause (group 1=21.4% [P=0.001 versus group 3], group 2=21.7% [P=0.011 versus group 3], and group 3=29.3%) were reduced in the rivaroxaban arms compared with the VKA arm, but other forms of rehospitalization were not. CONCLUSIONS: Among patients with atrial fibrillation undergoing intracoronary stenting, administration of either rivaroxaban 15 mg daily plus P2Y12 inhibitor monotherapy or 2.5 mg rivaroxaban twice daily plus DAPT was associated with a reduced risk of all-cause mortality or recurrent hospitalization for adverse events compared with standard-of-care VKA plus DAPT. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01830543.

A multiregional registry experience using an electronic medical record to optimize data capture for longitudinal outcomes in endovascular abdominal aortic aneurysm repair.

OBJECTIVE: Registries have been proven useful to assess clinical outcomes, but data entry and personnel expenses are challenging. We developed a registry to track patients undergoing endovascular aortic aneurysm repair (EVAR) in an integrated health care system, leveraging an electronic medical record (EMR) to evaluate clinical practices, device performance, surgical complications, and medium-term outcomes. This study describes the registry design, data collection, outcomes validation, and ongoing surveillance, highlighting the unique integration with the EMR. METHODS: EVARs in six geographic regions of Kaiser Permanente were entered in the registry. Cases were imported using a screening algorithm of inpatient codes applied to the EMR. Standard note templates containing data fields were used for surgeons to enter preoperative, postoperative, and operative data as part of normal workflows in the operating room and clinics. Clinical content experts reviewed cases and entered any missing data of operative details. Patient comorbidities, aneurysm characteristics, implant details, and surgical outcomes were captured. Patients entered in the registry are followed up for life, and all relevant events are captured. RESULTS: Between January 2010 and June 2013, 2112 procedures were entered in the registry. Surgeon compliance with data entry ranges from 60% to 90% by region but has steadily increased over time. Mean aneurysm size was 5.9 cm (standard deviation, 1.3). Most patients were male (84%), were hypertensive (69%), or had a smoking history (79%). The overall reintervention rate was 10.8%: conversion to open repair (0.9%), EVAR revision (2.6%), other surgical intervention (7.3%). Of the reinterventions, 27% were for endoleaks (I, 34.3%; II, 56.9%; III, 8.8%; IV and V, 0.0%), 10.5% were due to graft malfunction, 3.4% were due to infection, and 2.3% were due to rupture. CONCLUSIONS: Leveraging an EMR provides a robust platform for monitoring short-term and midterm outcomes after abdominal aortic aneurysm repair. Use of standardized templates in the EMR allows data entry as part of normal workflow, improving compliance, accuracy, and data capture using limited but expert personnel. Assessment of patient demographics, device performance, practice variation, and postoperative outcomes benefits clinical decision-making by providing complete and adjudicated event reporting. The findings from this large, community-based EVAR registry augment other studies limited to perioperative and short-term outcomes or small patient cohorts.

Patient access and 1-year outcomes of percutaneous coronary intervention facilities with and without on-site cardiothoracic surgery: insights from the Veterans Affairs (VA) Clinical Assessment, Reporting, and Tracking (CART) program.

BACKGROUND: The safety of percutaneous coronary intervention (PCI) at medical facilities without on-site cardiothoracic (CT) surgery has been established in clinical trials. However, the comparative effectiveness of this strategy in real-world practice, including impact on patient access and outcomes, is uncertain. The Veterans Affairs (VA) health care system has used this strategy, with strict quality oversight, since 2005, and can provide insight into this question. METHODS AND RESULTS: Among 24,387 patients receiving PCI at VA facilities between October 2007 and September 2010, 6616 (27.1%) patients underwent PCI at facilities (n=18) without on-site CT surgery. Patient drive time (as a proxy for access), procedural complications, 1-year mortality, myocardial infarction, and rates of subsequent revascularization procedures were compared by facility. Results were stratified by procedural indication (ST-segment-elevation myocardial infarction versus non-ST-segment-elevation myocardial infarction/unstable angina versus elective) and PCI volume. With the inclusion of PCI facilities without on-site CT surgery, median drive time for patients treated at those facilities decreased by 90.8 minutes (P<0.001). Procedural need for emergent coronary artery bypass graft and mortality rates were low and similar between facilities. Adjusted 1-year mortality and myocardial infarction rates were similar between facilities (hazard ratio in PCI facilities without relative to those with on-site CT surgery, 1.02; 95% confidence interval, 0.87-1.2), and not modified by either PCI indication or PCI volume. Subsequent revascularization rates were higher at sites without on-site CT surgery facilities (hazard ratio, 1.21; 95% confidence interval, 1.03-1.42). CONCLUSIONS: This study suggests that providing PCI facilities without on-site CT surgery in an integrated health care system with quality oversight improves patient access without compromising procedural or 1-year outcomes.

North American SOLITAIRE Stent-Retriever Acute Stroke Registry: choice of anesthesia and outcomes.

BACKGROUND AND PURPOSE: Previous work that predated the availability of the safer stent-retriever devices has suggested that general anesthesia (GA) may have a negative impact on outcomes in patients with acute ischemic stroke undergoing endovascular therapy. METHODS: We reviewed demographic, clinical, procedural (GA versus local anesthesia [LA], etc), and site-adjudicated angiographic and clinical outcomes data from consecutive patients treated with the Solitaire FR device in the investigator-initiated North American SOLITAIRE Stent-Retriever Acute Stroke (NASA) Registry. The primary outcomes were 90-day modified Rankin Scale, mortality, and symptomatic intracranial hemorrhage. RESULTS: A total of 281 patients from 18 centers were enrolled. GA was used in 69.8% (196/281) of patients. Baseline demographic and procedural factors were comparable between the LA and GA groups, except the former demonstrated longer time-to-groin puncture (395.4±254 versus 337.4±208 min; P=0.04), lower National Institutes of Health Stroke Scale (NIHSS; 16.2±5.8 versus 18.8±6.9; P=0.002), lower balloon-guide catheter usage (22.4% versus 49.2%; P=0.0001), and longer fluoroscopy times (39.5±33 versus 28±22.8 min; P=0.008). Recanalization (thrombolysis in cerebral infarction ≥2b; 72.94% versus 73.6%; P=0.9) and rate of symptomatic intracranial hemorrhage (7.1% versus 11.2%; P=0.4) were similar but modified Rankin Scale ≤2 was achieved in more LA patients, 52.6% versus 35.6% (odds ratio, 1.4 [1.1-1.8]; P=0.01). In multivariate analysis, hypertension, NIHSS, unsuccessful revascularization, and GA use (odds ratio, 3.3 [1.6-7.1]; P=0.001) were associated with death. When only anterior circulation and elective GA patients were included, there was a persistent difference in good outcomes in favor of LA patients (50.7% versus 35.5%; odds ratio, 1.3 [1.01-1.6]; P=0.04). CONCLUSIONS: The NASA Registry has demonstrated that clinical outcomes and survival are significantly better in patients treated with LA, without increased symptomatic intracranial hemorrhage risk. Future trials should prospectively evaluate the effect of GA on outcomes.

[Final results from four clinical studies in the field of cardiovascular diseases integrated in the "Mattoni del SSN - Mattone Outcome" Project]. / Le sperimentazioni dell'area cardiovascolare del Progetto Mattoni del SSN - Mattone Outcome: risultati finali. Sperimentazione dell'integrazione di fonti informative cliniche e amministrative del Programma PROGRESSI.

Observational outcome studies represent a valid approach to evaluating comparative treatment effectiveness in real populations. The main objective of outcome research is to underline what works and what does not work in the field of health assistance. In 2004 the Italian Ministry of Health launched the Project "Mattone Misura dell'Outcome" aimed at assessing the introduction of procedures and methods for the systematic evaluation of outcomes in the national health system. A new experience, the PROGRESSI program (PROGRamma ESiti per SIVeAS e LEA), started in 2008 with the aim to further develop the methodologies for outcome evaluation. In this Supplement the final results from four clinical studies named "Sperimentazioni dell'area cardiovascolare del Progetto Mattoni" are presented. These studies started between 2005 and 2007 and their main objectives were to evaluate: --the contribution of information from current informative systems and clinical studies in risk-adjustment methodologies; --the advisability of introducing some clinical items in current informative systems to improve outcome estimates; --the goodness of follow-up procedures from current informative systems; and --the role of disease registries in the validation of comparative evaluation measures. The four studies were designed as voluntary prospective multicentre studies. Results concerning the characteristics of the enrolled populations as well as the risk-adjustment models built using information from current informative systems and/or clinical information are presented. As expected, each study produced specific remarks both in terms of clinical findings and contribution of different informative systems to the risk-adjustment models. In general, models built with information from both current informative systems and clinical information show the best performance. Findings from these analyses will provide the public health system with suitable indications to improve statistical methodologies for outcome estimates.

[Analysis of Brazilian Public Health System values for complete percutaneous myocardial revascularization in multi-arterial patients]. / Análise dos valores SUS para a revascularização miocárdica percutânea completa em multiarteriais.

BACKGROUND: The Brazilian Public Health System (SUS, acronym in Portuguese) establishes that coronary angioplasty with the double implant stent must not exceed 20% of the angioplasties, resulting in the need of assigning most of the procedures in patients with multiarterial disease. OBJECTIVE: The objective of the present study was to assess the paid values by the SUS in order to obtain the complete percutaneous myocardial revascularization in the SUS patients with the multiarterial disease, related to the number of necessary procedures and of implanted stents. METHODS: A total of 141 patients with multiarterial coronary disease, submitted to a successful complete revascularization, were included by the stent implant with coronariography in a 6-month period of post-implant. The complete revascularization was defined as the percutaneous treatment of all stenosis > 70% in vessels with diameter > 2 mm. For the costs analysis, the values from the Sistema de Informações Hospitalares (SIH) of the SUS table were considered as R$ 2,263.77, for the procedure; and R$ 2,034.23, per implanted stent. RESULTS: In the period from 7/2006 to 12/2007, 416 stents were implanted in 141 patients. The mean age was of 59.7 +/- 9.9 years old, prevailing the male sex (68.1%). The number of vessels was 356 and the lesions number corresponded to 416. In order to obtain the complete revascularization by the coronary stent implant, it was necessary to stagger in up to four procedures. The mean time between the 1st and 2nd, 2nd and 3rd and 3rd and 4th angioplasties was of 45.8 +/- 37.7; 55.4 +/- 55.3 and 33.5 +/- 19.1 days, respectively. CONCLUSION: The complete percutaneous revascularization in patients from the SUS with the multiarterial coronary disease, carried out in most of them staggered, causes considerable elevation of public expenses due to the increase of procedures' number.

Análise dos valores SUS para a revascularização miocárdica percutânea completa em multiarteriais / Analysis of Brazilian Public Health System values for complete percutaneous myocardial revascularization in multi-arterial patients

FUNDAMENTO: O Sistema Único de Saúde (SUS) estabelece que a angioplastia coronariana com o implante de duplo stent não deve exceder 20 por cento das angioplastias, resultando na necessidade de escalonar a maioria dos procedimentos nos pacientes com doença multiarterial. OBJETIVO: O objetivo do presente estudo foi avaliar os valores remunerados pelo SUS para a obtenção da revascularização miocárdica percutânea completa em pacientes do SUS com doença multiarterial relacionados ao número de procedimentos necessários e de stents implantados. MÉTODOS: Foram incluídos 141 pacientes com doença coronariana multiarterial, submetidos à revascularização completa com sucesso pelo implante de stent, com coronariografia aos 6 meses pós-implante. A revascularização completa foi definida como o tratamento percutâneo de todas as lesões com percentual de estenose > 70 por cento, em vasos com diâmetro > 2 mm. Para análise dos custos, foram considerados os valores da Tabela SIH/SUS de R$ 2.263,77 para o procedimento e R$ 2.034,23 por stent implantado. RESULTADOS: No período de 07/2006 a 12/2007 foram implantados 416 stents em 141 pacientes. A idade média foi de 59,7 ± 9,9 anos, com predomínio do sexo masculino (68,1 por cento). O número de vasos foi 356 e o número de lesões 416. Para a obtenção da revascularização completa pelo implante de stent coronáriano foi necessário o escalonamento em até 4 procedimentos. O tempo médio entre a 1ª e 2ª, 2ª e 3ª e 3ª e 4ª angioplastias foi de 45,8 ± 37,7, 55,4 ± 55,3 e 33,5 ± 19,1 dias, respectivamente. CONCLUSÃO: A revascularização percutânea completa em pacientes do SUS com doença coronariana multiarterial, realizada em sua grande maioria de forma escalonada, ocasiona considerável elevação de gastos públicos devido ao aumento do número de procedimentos.

BACKGROUND: The Brazilian Public Health System (SUS, acronym in Portuguese) establishes that coronary angioplasty with the double implant stent must not exceed 20 percent of the angioplasties, resulting in the need of assigning most of the procedures in patients with multiarterial disease. OBJECTIVE: The objective of the present study was to assess the paid values by the SUS in order to obtain the complete percutaneous myocardial revascularization in the SUS patients with the multiarterial disease, related to the number of necessary procedures and of implanted stents. METHODS: A total of 141 patients with multiarterial coronary disease, submitted to a successful complete revascularization, were included by the stent implant with coronariography in a 6-month period of post-implant. The complete revascularization was defined as the percutaneous treatment of all stenosis > 70 percent in vessels with diameter > 2 mm. For the costs analysis, the values from the Sistema de Informações Hospitalares (SIH) of the SUS table were considered as R$ 2,263.77, for the procedure; and R$ 2,034.23, per implanted stent. RESULTS: In the period from 7/2006 to 12/2007, 416 stents were implanted in 141 patients. The mean age was of 59.7 ± 9.9 years old, prevailing the male sex (68.1 percent). The number of vessels was 356 and the lesions number corresponded to 416. In order to obtain the complete revascularization by the coronary stent implant, it was necessary to stagger in up to four procedures. The mean time between the 1st and 2nd, 2nd and 3rd and 3rd and 4th angioplasties was of 45.8 ± 37.7; 55.4 ± 55.3 and 33.5 ± 19.1 days, respectively. CONCLUSION: The complete percutaneous revascularization in patients from the SUS with the multiarterial coronary disease, carried out in most of them staggered, causes considerable elevation of public expenses due to the increase of procedures' number.

Adding cilostazol to dual antiplatelet therapy achieves greater platelet inhibition than high maintenance dose clopidogrel in patients with acute myocardial infarction: Results of the adjunctive cilostazol versus high maintenance dose clopidogrel in patients with AMI (ACCEL-AMI) study.

BACKGROUND: Optimal platelet inhibition is an important therapeutic adjunct in patients acute myocardial infarction (AMI) undergoing coronary stenting. Whether adjunctive cilostazol to dual antiplatelet therapy (triple antiplatelet therapy) can inhibit enhanced platelet reactivity in patients with AMI yet has not been determined. The aim of this study was to assess the degree of platelet inhibition by triple antiplatelet therapy in patients with AMI. METHODS AND RESULTS: Immediately after emergency room arrival, patients with AMI received clopidogrel (600-mg loading dose, followed by 75 mg daily) and aspirin (300-mg loading dose and 200 mg daily throughout the study period). After patients underwent coronary stenting (n=90), they were randomly assigned to 1 of 3 groups before discharge: standard group, clopidogrel of 75 mg daily (n=30); high maintenance dose (MD) group, clopidogrel of 150 mg daily (n=30); and triple group, adjunctive cilostazol of 100 mg twice daily to clopidogrel of 75 mg daily (n=30). Platelet reactivity was assessed at predischarge and 30-day follow-up by conventional aggregometry and the VerifyNow P2Y12 assay. Predischarge platelet reactivities were similar in the 3 groups. At 30-day follow-up, inhibition of maximal aggregation with 20 microM ADP stimuli was 6.0% in the standard group, 19.1% in the high-MD group, and 42.4% in the triple group (P<0.001), whereas inhibition of late aggregation with 20microM ADP stimuli was 10.8%, 38.1%, and 66.4%, respectively (P<0.001). Similar results were demonstrated when 5 microM ADP was used. Furthermore, percent changes of P2Y12 reaction unit were significantly different among regimens (10.6% in the standard group, 30.7% in the high-MD group, and 43.0% in the triple group; P<0.001). With respect to high-postclopidogrel platelet reactivity (prespecified as 20 microM ADP-induced maximal aggregation >50% of light transmission), fewer patients in the triple group (13.3%) met the criteria as compared with those in the standard (76.7%) and high-MD groups (56.7%) at 30-day follow-up (P<0.001). In the triple group, there were more potent and consistent platelet inhibitions by all parameters as compared with the high-MD group except for percent changes of P2Y12 reaction unit (P=0.071). CONCLUSIONS: Among patients with AMI undergoing coronary stenting, triple antiplatelet therapy results in a greater antiplatelet effect at 30 days as compared with a high-MD clopidogrel or standard dual antiplatelet therapy.

Why physicians favor use of percutaneous coronary intervention to medical therapy: a focus group study.

BACKGROUND: Percutaneous coronary intervention (PCI) is performed in many patients with stable coronary artery disease, despite evidence of little clinical benefit over optimal medical therapy. OBJECTIVE: To examine physicians' beliefs, practices, and decision-making regarding elective PCI. DESIGN: Six focus groups, three with primary care physicians and three with cardiologists. Participants discussed PCI using hypothetical case scenarios. Transcripts were analyzed using grounded theory, and commonly expressed themes regarding the decision-making pathway to PCI were identified. PARTICIPANTS: Twenty-eight primary care physicians and 20 interventional and non-interventional cardiologists in Butte County, Orange County, and San Francisco Bay Area, California, in 2006. RESULTS: A number of factors led primary care physicians to evaluate non-symptomatic or minimally symptomatic patients for coronary artery disease and refer them to a cardiologist. The use of screening tests often led to additional testing and referral, as well as fear of missing a coronary stenosis, perceived patient expectations, and medicolegal concerns. The end result was a cascade such that any positive test would generally lead to the catheterization lab, where an "oculostenotic reflex" made PCI a virtual certainty. CONCLUSIONS: The widespread use of PCI in patients with stable coronary artery disease--despite evidence of little benefit in outcomes over medical therapy--may in part be due to psychological and emotional factors leading to a cascade effect wherein testing leads inevitably to PCI. Determining how to help physicians better incorporate evidence-based medicine into decision-making has important implications for patient outcomes and the optimal use of new technologies.

High-dose bolus tirofiban and sirolimus eluting stent versus abiciximab and bare metal stent in acute myocardial infarction (STRATEGY) study--protocol design and demography of the first 100 patients.

BACKGROUND: Primary bare metal stenting and abciximab infusion are currently considered the best available reperfusion strategy for acute ST-segment elevation myocardial infarction (STEMI). Sirolimus eluting stents (SES), compared to bare metal stent (BMS), greatly reduce the incidence of binary restenosis and target vessel revascularisation (TVR), but their use on a routine basis results in a significant increase in medical costs. With current European list prices, the use of tirofiban instead of abciximab would save enough money to absorb the difference between SES and BMS. AIM: To assess whether in patients with STEMI the combination of SES with high dose bolus (HDB) tirofiban results in a similar incidence of major cardiovascular events (MACE) but in a lower binary restenosis rate after six months compared to BMS and abciximab. METHODS AND RESULTS: 160 patients are required to satisfy the primary composite end-point, including MACE and binary restenosis. The study is ongoing: the current paper focuses on the methodology and demography of the first 100 patients so far enrolled. Patients randomised to HDB tirofiban (n = 50, mean age: 62 +/- 12, 40 males) and abciximab (n = 50, mean age: 63 +/- 12, 38 males) do not differ for medical history, presentation profile, medications at discharge, angiographic profile and creatine-kinase MB-fraction at peak. CONCLUSIONS: The results of the trial will be available by the end of 2004: they will be crucial for the cardiologists to know whether the gold standard for AMI treatment should be reconsidered after the introduction of SES into the clinical practice.

Challenges associated with the integration of endovascular repair of abdominal aortic aneurysms in a community hospital.

PURPOSE: There has been considerable debate regarding the proper place for endovascular repair (ER) of abdominal aortic aneurysms (AAAs) versus traditional open repair (OR). Our study compared preoperative patient demographics and outcomes for elective, asymptomatic AAA repairs performed at our center over a 33-month period. METHODS: For this study, we selected 342 consecutive elective infrarenal AAA repairs performed between July 1, 2000, and March 31, 2003, at Riverside Methodist Hospital. The patients underwent either ER or OR, depending on patient and surgeon collaborative determinations. Ruptured and symptomatic AAAs were excluded from our study. Preoperative demographics, anesthesia, complications, and discharge status for the 2 groups were analyzed, and statistical analysis was done to determine statistically significant differences. RESULTS: The preoperative status of the ER and OR patient groups were essentially similar. There were only 3 significant differences between the 2 groups: alcohol use was higher for the OR group than for the ER group (12.0% versus 5.2%; P = .04), and the incidence of type II diabetes mellitus and peripheral vascular disease were lower for the OR group compared with the ER group (6.7% versus 13.4% [P = .04] and 18.3% versus 30.6% [P = .008], respectively). The OR group used more general anesthesia than the ER group (99% versus 86%; P < .001) and had more complications, including dysrhythmia (8.65% versus 1.59%; P = .005), ileus (13.94% versus 0.79%; P < .0001), infection (8.17% versus 0.0%; P = .0007), respiratory complications (12.50% versus 1.59%; P = .0003), and renal complications (5.29% versus 0.79%; P = .032). The ER group had a higher rate of wound hematoma (4.76% versus 0.48%; P = .007). ER patients also had significantly less blood loss (379 mL versus 1930 mL; P < .001), a better independent discharge status (P < .0001), a shorter length of stay (1.8 days versus 8.2 days; P < .001), and a lower mortality rate (0.75% versus 3.85%; P = .0954). CONCLUSIONS: From our study we cautiously continue to encourage the consideration of the ER of AAAs in our patient population while being mindful of its limitations.

[Diagnosis and treatment of pancreatic carcinoma in the region of Amsterdam Comprehensive Cancer Care Center in 1997]. / Diagnostiek en behandeling van het pancreascarcinoom in de regio van het Integraal Kankercentrum Amsterdam in 1997.

OBJECTIVE: To describe the diagnostic work-up and treatment of patients with a pancreatic carcinoma in the Amsterdam area, the Netherlands, particularly in general hospitals. DESIGN: Retrospective, descriptive. METHOD: During 1997, 286 patients with a pancreatic carcinoma were diagnosed in 20 hospitals in the Amsterdam area. Diagnostic work-up and treatment data were collected from the medical records and analysed. RESULTS: Ninety percent of the patients presented in one of the 17 general hospitals (n = 252; 132 men and 154 women; mean age: 70 years). Thirty-five percent of them underwent diagnostic investigations which did not focus directly on pancreatic pathology. Ultrasound was performed in 97% of patients (4% in combination with Doppler) and CT in 60% (4% spiral CT). Endoscopic retrograde cholangiopancreatography (ERCP) was performed in 39% of these patients and endoprostheses were only inserted in half the cases. Thirty-five percent of the patients who underwent both CT and ERCP underwent ERCP first. Ninety-nine patients (39%) were referred to a reference hospital for further investigation or treatment. The period between the first investigation and the histological diagnosis was 4 weeks. CONCLUSION: In the diagnostic work-up of patients with a pancreatic carcinoma, invasive diagnostic procedures were often performed before the non-invasive tests. Spiral CT was used minimally and ERCP was frequently performed without subsequent biliary drainage. The mean duration of diagnostic work-up was relatively long.

Decreasing mortality with primary percutaneous coronary intervention in patients with acute myocardial infarction: the Mayo Clinic experience from 1991 through 1997.

OBJECTIVE: To characterize and determine the overall impact of changes in primary percutaneous coronary intervention (PCI) on the clinical outcome of patients presenting within 24 hours of acute myocardial infarction (AMI). PATIENTS AND METHODS: We retrospectively analyzed a prospective PCI registry for 1073 consecutive patients undergoing primary PCI for AMI at the Mayo Clinic in Rochester, Minn, from 1991 through 1997. The primary outcome measure was mortality from any cause within 30 days and 1 year. RESULTS: The number of patients treated for AMI by primary PCI per year increased from 119 in 1991 to 193 in 1997. Intracoronary stent use increased from 1.7% in 1991 to 64.8% in 1997 (P < .001). This coincided with an increase in ticlopidine use from 3.6% in 1994 to 62.1% in 1997 (P < .001) and in abciximab use from 2.7% in 1995 to 63.2% in 1997 (P < .001). An increase in beta-blocker (58.3% to 75.3%; P < .001), angiotensin-converting enzyme inhibitor (0.9% to 40.0%; P < .001), and 3-hydroxy-3-methylglutaryl coenzyme A reductase use (1.9% to 40.5%; P < .001) as well as a decrease in calcium channel antagonist (34.3% to 8.4%; P < .001) use occurred on discharge. From 1991 through 1997, there was a significant decrease in the 30-day mortality rate (10.1% to 5.2%; P = .05). The 1-year mortality rate also decreased (13.4% in 1991 to 10.4% in 1997) (P = .09). After adjustment for other confounding variables, treatment in more recent years was associated with a significant decrease in death at 30 days (odds ratio, 0.89; 95% confidence interval, 0.79-1.00; P = .05) and during long-term follow-up (odds ratio, 0.93; 95% confidence interval, 0.87-1.00; P = .04). CONCLUSIONS: Percutaneous coronary intervention methods of reperfusion for AMI, along with adjuvant pharmacotherapy, have changed over recent years and have been associated with improved short- and long-term survival.

Interventional cardiology and intracoronary stents--a changing practice: approved vs. nonapproved indications.

Our objective was to document change in stent usage in a single practice over time and to study "off-label" compared to Food and Drug Administration (FDA)-approved indications. Although only two intracoronary stents have been approved by the FDA, the relatively limited approved indications do not account for the dramatic increase in stent implantation. This increase has important implications for patient health care delivery. This study of stent usage in a single center over a 36-mo period included all patients treated with coronary stents at the Mayo Clinic from January 1993-December 1995, and evaluated the relative difference in frequency between "off-label" and FDA-approved indications for implantation. During the 36-mo period of study, 3,614 interventional procedures were done and one or more stents were placed in 25.4% of patients. The proportion of patients receiving stents increased throughout this time: during the first 6-mo period, stents were placed in 6.2% of procedures; during the last 6-mo period, stents were placed in 46.3% of procedures, an eightfold increase. During the final 6 mo, an unapproved device or an unapproved indication for an approved device constituted 59.4% of all stent procedures. In addition, use of the non-FDA-approved adjunctive treatment regimen without warfarin increased from 2.9% in the first 6-mo period of observation to 82.7% in the last 6 mo. The use of stents increased strikingly over a 36-mo period, from 6% to 46% of all procedures. The majority of implantations were performed either for an "off-label" unapproved indication or with an unapproved device.