Decisions and delays within stroke patients' route to the hospital: a qualitative study.

STUDY OBJECTIVE: We examine acute stroke patients' decisions and delays en route to the hospital after onset of symptoms. METHODS: This was a qualitative study carried out in the West Midlands, United Kingdom. Semistructured interviews were conducted with 30 patients (6 accompanied by partners). Patients were asked about their previous experience of having had a stroke and their initial engagement with health services. "One sheet of paper" and thematic analyses were used. RESULTS: Three potential types of delay were identified from onset of symptoms to accessing stroke care in the hospital: primary delays caused by lack of recognition of symptoms or not dealing with symptoms immediately, secondary delays caused by initial contact with nonemergency services, and tertiary delays in which health service providers did not interpret the patients' presenting symptoms as suggestive of stroke. The main factors determining the speed of action by patients were the presence and influence of a bystander and the perceived seriousness of symptoms. CONCLUSION: Despite campaigns to increase public awareness of stroke symptoms, the behavior of both patients and health service providers apparently led to delays in the recognition of and response to stroke symptoms, potentially reducing access to optimum and timely acute specialist assessment and treatment for acute stroke.

The association between prehospital care and in-hospital treatment decisions in acute stroke: a cohort study.

BACKGROUND: Hospital prealerting in acute stroke improves the timeliness of subsequent treatment, but little is known about the impact of prehospital assessments on in-hospital care. OBJECTIVE: Examine the association between prehospital assessments and notification by emergency medical service staff on the subsequent acute stroke care pathway. METHODS: This was a cohort study of linked patient medical records. Consenting patients with a diagnosis of stroke were recruited from two urban hospitals. Data from patient medical records were extracted and entered into a Cox regression analysis to investigate the association between time to CT request and recording of onset time, stroke recognition (using the Face Arm Speech Test (FAST)) and sending of a prealert message. RESULTS: 151 patients (aged 71±15 years) travelled to hospital via ambulance and were eligible for this analysis. Time of symptom onset was recorded in 61 (40%) cases, the FAST test was positive in 114 (75%) and a prealert message was sent in 65 (44%). Following adjustment for confounding, patients who had time of onset recorded (HR 0.73, 95% CI 0.52 to 1.03), were FAST-positive (HR 0.54, 95% CI 0.37 to 0.80) or were prealerted (HR 0.26, 95% CI 0.18 to 0.38), were more likely to receive a timely CT request in hospital. CONCLUSIONS: This study highlights the importance of hospital prealerting, accurate stroke recognition, and recording of onset time. Those not recognised with stroke in a prehospital setting appear to be excluded from the possibility of rapid treatment in hospital, even before they have been seen by a specialist.

Cost-effectiveness of optimizing acute stroke care services for thrombolysis.

BACKGROUND AND PURPOSE: Thrombolysis in acute stroke is effective up to 4.5 hours after symptom onset but relies on early recognition, prompt arrival in hospital, and timely brain scanning. This study aimed to establish the cost-effectiveness of increasing thrombolysis rates through a series of hypothetical change strategies designed to optimize the acute care pathway for stroke. METHODS: A decision-tree model was constructed, which relates the acute management of patients with suspected stroke from symptom onset to outcome. Current practice was modeled and compared with 7 change strategies designed to facilitate wider eligibility for thrombolysis. The model basecase consisted of data from consenting patients following the acute stroke pathway recruited in participating hospitals with data on effectiveness of treatment and costs from published sources. RESULTS: All change strategies were cost saving while increasing quality-adjusted life years gained. Using realistic estimates of effectiveness, the change strategy with the largest potential benefit was that of better recording of onset time, which resulted in 3.3 additional quality-adjusted life years and a cost saving of US $46,000 per 100,000 population. All strategies increased the number of thrombolysed patients and the number requiring urgent brain imaging (by 9% to 21% dependent on the scenario). Assuming a willingness-to-pay of US $30,000 per quality-adjusted life year gained, the potential budget available to deliver the interventions in each strategy ranged from US $50,000 to US $144,000. CONCLUSIONS: These results suggest that any strategy that increases thrombolysis rates will result in cost savings and improved patient quality of life. Healthcare commissioners could consider this model when planning improvements in stroke care.

Atrioesophageal fistula during cryoballoon ablation for atrial fibrillation.

To date, there is 1 case report publication of AE fistula during the employment of the first-generation cryoballoon (Gen-1). Recently the Arctic Front Advance system (second-generation cryoballoon) was introduced into the US and EU markets. For the purpose of peer education, we report a case of AE fistula that occurred during the utilization of the second-generation cryoballoon (Gen-2). Additionally, we review current best practices that may reduce the risk of AE fistula during any AF ablation procedure.

Limitations of the DF-4 defibrillator connector necessitating device removal.

The DF-4 implantable defibrillator connector was recently released for clinical practice. This connector facilitates lead to device connection, reduces bulk in the device pocket, and eliminates the risk of incorrect device connection. Unfortunately, new technology often introduces new challenges. We report the case of a 63-year-old male with chronic systolic heart failure referred for cardiac resynchronization therapy-defibrillator implant. Limitations implicit to the current iteration of this technology include a lack of additional connectivity. In the present case, these limitations ultimately warranted device removal and reimplant with a traditional trifurcating IS-1/DF-1 connector.

Paramedic decision making: prehospital thrombolysis and beyond.

BACKGROUND: Mortality from acute myocardial infarction is influenced by the speed at which reperfusion therapy is delivered. In the U.K., prehospital thrombolysis (PHT), administered by paramedics, has been developed to improve call to needle (CTN) times. Recently, it has been shown in randomised trials that mortality can be further reduced by primary percutaneous coronary intervention (PPCI). This project was developed to assess current ST-elevation myocardial infarction practice in a district general hospital and to prepare paramedics for PPCI. METHODS: Data were collected prospectively over a 12-month period for all patients who received thrombolysis for a presumed myocardial infarct. The primary outcome measures for each case were who delivered the thrombolysis, either the paramedic crew or the hospital, and if the patient did not receive PHT the reason why not. Secondary outcome measures included the CTN time. RESULTS: 153 patients received thrombolysis over the time period (99 men, 54 women, mean age 66 ± 15 years). Of this group, 55 patients received PHT (35.9%) with a median CTN time of 36 min (inter-quartile range (IQR) 30-42 min). The commonest reason for exclusion from receiving PHT was that the patient's history did not fit the eligibility criteria (25% of cases). CONCLUSIONS: Paramedics are able to deliver PHT promptly and safely. With the focus now on PPCI, it is anticipated that not only will paramedics be able to select patients for delivery to a heart attack centre for PPCI, they will be selecting many more patients for this treatment than have up to now received PHT.

State of the art in developmental toxicity screening methods and a way forward: a meeting report addressing embryonic stem cells, whole embryo culture, and zebrafish.

A meeting was convened so that users of three models for in vitro developmental toxicity (embryonic stem cells, whole embryo culture, and zebrafish) could share their experiences with each model, and explore the areas for improvement. We present a summary of this meeting and the recommendations of the group.

The ramp power test: a power assessment during a functional task for older individuals.

BACKGROUND: Power is critical to mobility and activities of daily living and is a key determinant of independence and falls prevention. Therefore, the quantification of power in older persons is critical. The power tests currently available are often expensive, potentially dangerous, and not reflective of everyday activities. We present a modification of an existing field test that uses ambulation up a standard access ramp to quantify functional power in older individuals. METHODS: Three hundred sixty-three women and 157 men, aged 73.1 +/- 7.0 years, ambulated up a standard access ramp (1:12 rise/run ratio) as quickly as possible. Each person performed one practice and two timed trials. RESULTS: Comparisons with accepted power measures and reported patterns of change with aging supported the validity of the ramp power test. The test was found to be reliable across multiple trials and days. Pair-wise comparisons showed that for women the test was sensitive to differences in power output by half-decade, whereas for men it could distinguish between 9 of the 15 comparisons among age groups. Percentile scores are reported by half-decade for power in both genders. In > 1200 trials performed during this study, only one injury (a slightly strained hamstring) occurred. CONCLUSIONS: The ramp power test is valid and reliable and can safely distinguish power by half-decade in women and among the majority of age groups in men. Its safety, low cost, and ease of administration make it a feasible diagnostic tool to assess functional power levels in ambulatory older persons.

When has service provision for transient ischaemic attack improved enough? A discrete event simulation economic modelling study.

OBJECTIVES: The aim of this study was to examine the impact of transient ischaemic attack (TIA) service modification in two hospitals on costs and clinical outcomes. DESIGN: Discrete event simulation model using data from routine electronic health records from 2011. PARTICIPANTS: Patients with suspected TIA were followed from symptom onset to presentation, referral to specialist clinics, treatment and subsequent stroke. INTERVENTIONS: Included existing versus previous (less same day clinics) and hypothetical service reconfiguration (7-day service with less availability of clinics per day). OUTCOME MEASURES: The primary outcome of the model was the prevalence of major stroke after TIA. Secondary outcomes included service costs (including those of treating subsequent stroke) and time to treatment and attainment of national targets for service provision (proportion of high-risk patients (according to ABCD2 score) seen within 24 hours). RESULTS: The estimated costs of previous service provision for 490 patients (aged 74±12 years, 48.9% female and 23.6% high risk) per year at each site were £340 000 and £368 000, respectively. This resulted in 31% of high-risk patients seen within 24 hours of referral (47/150) with a median time from referral to clinic attendance/treatment of 1.15 days (IQR 0.93-2.88). The costs associated with the existing and hypothetical services decreased by £5000 at one site and increased £21 000 at the other site. Target attainment was improved to 79% (118/150). However, the median time to clinic attendance was only reduced to 0.85 days (IQR 0.17-0.99) and thus no appreciable impact on the modelled incidence of major stroke was observed (10.7 per year, 99% CI 10.5 to 10.9 (previous service) vs 10.6 per year, 99% CI 10.4 to 10.8 (existing service)). CONCLUSIONS: Reconfiguration of services for TIA is effective at increasing target attainment, but in services which are already working efficiently (treating patients within 1-2 days), it has little estimated impact on clinical outcomes and increased investment may not be worthwhile.

Defibrillation energy requirements using a left anterior chest cutaneous to subcutaneous shocking vector: implications for a total subcutaneous implantable defibrillator.

BACKGROUND: Subcutaneous implantable defibrillators (ICDs) are being developed to facilitate ICD implantation. OBJECTIVE: The purpose of this study was to estimate the human defibrillation energy requirement (DER) using a left chest cutaneous (Q) to subcutaneous (SQ) shocking vector. METHODS: Twenty patients undergoing implantation of an indicated ICD were enrolled (15 males, age = 63 +/- 12 years; ejection fraction = 0.27 +/- 0.14). Defibrillation testing was performed using an investigational system consisting of an external defibrillator and a constructed connector to deliver a shock between a pectoral SQ can and a cardiac apical Q electrode. Two attempts at defibrillation using this configuration were allowed. Stage 1 testing started at 70 J with a step-down/step-up to 50 or 100 J, respectively. Stage 2 testing began at 50 J with a step-down/step-up to 30 or 70 J. RESULTS: During stage 1, a 70-J shock was successful in 7/9 (78%) patients. A second attempt was successful in 7/7 patients using a 50-J shock. In the two remaining patients, a second attempt using a 100-J shock was successful. During stage 2, a 50-J shock was successful in 10/11 (91%) patients. The protocol could not be completed in 2/11 patients. Of the remaining nine patients, a second defibrillation was successful in seven (78%) using a 30-J shock. CONCLUSIONS: The defibrillation energy requirement (DER) of this study vector was 50 J or less in most patients. This low DER supports further investigation of a totally SQ-ICD. However, the DER of 100 J in two patients indicates that further investigation is needed regarding DER variability and safety margins.

Tacrolimus in cardiac transplantation: efficacy and safety of a novel dosing protocol.

BACKGROUND: Although used for more than 20 years, optimal dosing strategies of most immunosuppressants have never been determined. Tacrolimus, one of the newer agents used in solid-organ transplantation, is gaining increasing popularity because of its ability to reverse refractory rejection in cyclosporine-treated patients and its favorable side-effect profile. As with many other immunosuppressive agents, absorption and metabolism vary between individuals, which complicates dosing. METHODS: We hypothesized that a 1-mg dose of tacrolimus may be used to gauge each patient's metabolism. A novel dosing scheme was evaluated to establish the safety and efficacy of this approach. Outcomes were incidence of renal insufficiency and treatment efficacy as assessed by the rejection grade on the first endomyocardial biopsy. RESULTS: The risk of renal insufficiency was low, with only a 3% rise in creatinine at 7 days posttransplant. The risk of renal insufficiency was highest during the first 3 days of tacrolimus therapy, and the change in tacrolimus level during this time was identified as the single best predictor of renal insufficiency. From days 4 to 7, the rise in tacrolimus level had much less influence on renal function. Ninety-two percent of patients had a low- or intermediate-grade first cardiac biopsy. CONCLUSIONS: It was shown that this conservative initial dosing approach, which guarantees renal safety, is not associated with an increased risk of allograft rejection. We conclude that administration of tacrolimus via a tailored protocol soon after transplantation ensures a safe and effective means of immunosuppression.

Intraperitoneal pocket for left ventricular assist device placement.

BACKGROUND: Implantation of the HeartMate Implanted Pneumatic or Vented Electric Ventricular Assist Device requires that the pump be implanted either in the peritoneal cavity or in the abdominal wall. Both sites have been problematic. METHODS: We describe a new technique in which an intraperitoneal pocket is created, using Gore-Tex Dual Mesh Plus Biomaterial with Holes, to contain the ventricular assist device. This shields the ventricular assist device from the peritoneal contents and avoids abdominal wall dissection. Thirty consecutive patients who underwent implantation using this technique were compared with 16 patients who underwent implantation before this technique was in use. RESULTS: Thirty consecutive patients underwent implantation, and 2 of those patients underwent re-implantation because of device failure (16/30 HeartMate Implanted Pneumatic, 14/30 HeartMate Vented Electric, and 2/14 HeartMate Vented Electric replaced with the HeartMate Implanted Pneumatic). Twenty-five patients have undergone explantation. Pocket infections in patients who have had implanted devices for >1 month decreased from 4 of 13 before the pockets were used to 1 of 25 with the intraperitoneal pockets (Fisher's exact test p = 0.038). Two hernia repairs were required after explantation when the biomaterial pocket was used. A decrease in return to surgery for bleeding was noted after the pocket was used (7/16 without the pocket and 3/32 with the pocket; Fisher's exact test, p = 0.010). CONCLUSIONS: Bleeding complications and pocket infections decreased in this early experience. Further study is necessary to confirm the apparent decrease in complication rate by using this new technique in this small cohort of patients.

Atrial pacing or ventricular backup-only pacing in implantable cardioverter-defibrillator patients.

BACKGROUND: The need for pacing support in typical ICD patients is unknown. OBJECTIVE: This study sought to determine whether atrial pacing with ventricular backup pacing is equivalent to ventricular backup pacing only in implantable cardioverter-defibrillator (ICD) patients. METHODS: We randomized 1,030 patients from 84 sites with indications for ICDs, with sinus rhythm, and without symptomatic bradycardia to atrial pacing with ventricular backup at 60 beats/min (518) or ventricular backup pacing at 40 beats/min (512). The primary end points were time to death, heart failure hospitalization (HFH), and heart failure-related urgent care (HFUC). RESULTS: Follow-up was 2.4 ± 0.8 years when the trial was stopped for futility. There were 355 end point events (103 deaths, 252 HFH/HFUC) in 194 patients favoring ventricular backup pacing (event-free rate 77.7% vs. 80.3% for atrial pacing at 30 months; hazard ratio 1.14, upper confidence bound 1.59, prespecified noninferiority threshold 1.21), therefore equivalence between pacing arms was not demonstrated. Overall HFH/HFUC rates were slightly higher during atrial pacing (event-free rate 85.4% vs. 86.4% for ventricular backup pacing). Exploratory analyses revealed that the difference in HFH/HFUC rates was largely seen in patients with a PR interval ≥230 ms. There were no differences between groups for atrial fibrillation, ventricular tachycardia/ventricular fibrillation, quality of life, or echocardiographic measurements. Fewer patients in the atrial pacing group were reported to develop an indication for bradycardia pacing (3.7% vs. 7.3%, P = .0053). CONCLUSION: Equivalence between atrial pacing and ventricular backup pacing only could not be demonstrated. CLINICAL TRIALS IDENTIFIER: NCT00281099.

Normal or near normal myocardial perfusion stress imaging in patients with severe coronary artery disease.

BACKGROUND: Normal or near normal myocardial perfusion stress imaging (MPI) suggests the absence of life-threatening coronary artery disease (CAD). Nevertheless, there are instances where severe left main or three-vessel CAD may be present despite no significant perfusion abnormalities on MPI. METHODS: Review of Tl-201 or Tc-99m sestamibi MPI over a period of 5 years to ascertain the features that may prevent misdiagnosis. Out of 9171 tests, 3992 (44%) were interpreted as normal or near normal. For clinical reasons, 98 (2%) of these patients underwent coronary angiography within 6 months. RESULTS: A total of 3992 patients were interpreted as normal or near normal. Seventy (22 men/48 women; 58 +/- 13 years) did not have obstructive CAD. Nine (six men/three women; 64 +/- 8 years) had either left main (n = 3), three-vessel CAD with or without left main (n = 3) or severe proximal left anterior descending (n = 3) disease. Although both normal patients and patients with CAD had similar proportions of imaging artifacts, those with severe CAD had significantly more markers of CAD (increased lung Tl-201 uptake, transient ischemic cavity dilatation, stress-induced ST-segment depression, chest pain, and/or hypotension with exercise; P < 0.01; no CAD vs. severe CAD; two-tail Fisher's Exact Test). Similarly, patients with moderate CAD by coronary angiography (n = 19), and a random sample of 250 patients (82 men/168 women; 62 +/- 14 years) with normal or near normal MPI who did not undergo coronary angiography, had similar proportions of imaging artifacts but significantly fewer markers of CAD. CONCLUSION: When dealing with individual patients, the referring physician and the interpreter of MPI studies should consider severe CAD when there are markers of CAD despite normal or near normal perfusion images.

MRI in patients with cardiac devices.

Given the advances of MRI and cardiovascular technology, it is becoming increasingly likely that a patient with a cardiovascular device will be a candidate for an MRI procedure. However, many cardiac devices are currently considered to be contraindicated in the MR environment. This may prove to be a significant public health problem as many patients in need of MRI are denied the procedure because of the presence of a cardiovascular device. However, research studies have shown that with proper precautions and technique patients with cardiac devices can undergo successful MRI safely on the current platforms.

The gallon-jug shelf-transfer test: an instrument to evaluate deteriorating function in older adults.

This study examined the validity, reliability, and discriminatory capacity of the gallon-jug shelf-transfer (GJST) test. Six hundred fifty-three independent-living older adults (463 women age 72.9 +/- 7.0 years, 190 men age 74.3 +/- 6.7 years) participated. Participants moved five 1-gallon jugs (approximately 3.9 kg) from a knee-high to a shoulder-high shelf as quickly as possible. The GJST showed an exponential performance decline with age, and there were significant correlations between the GJST and common functional tests (p<.001). High within-day and between-days reliability was detected. The test also detected differences resulting from training status (p<.01) and training protocols (p<.05). The GJST is a valid, reliable, inexpensive, safe, and easily administered clinical test for identifying physically vulnerable elders who could benefit from interventions such as exercise to improve their physical capacities and maintain independence.

Correlation analyses and regression modeling between isokinetic testing and on-court performance in competitive adolescent tennis players.

Tennis requires skill, physical attributes, and strategy. Ball velocity and placement are two of the most important components in winning the faster-paced modern game. Although isokinetic testing has been used to evaluate physical characteristics and injury potential in tennis players, few studies have compared isokinetics and on-court performance. Such a comparison would help establish links between speed-specific properties of functioning muscles and stroke production and could affect overall training strategy. This study compared isokinetic peak torque (PT), average power (AP), and total work (TW) during specific testing patterns correlated with ball velocity or stroke accuracy during the service, forehand, and backhand and developed predictive equations for each stroke using these variables. Thirty-five players, aged 13-18 years with at least 4 years playing experience, were evaluated using internal and external shoulder rotation, leg extension, and diagonal throwing motions. Ball velocity was measured using a radar gun. Accuracy was evaluated on the basis of shot position and depth. Significant correlations were found between ball velocity and a number of isokinetic variables, while no significant correlations were observed with shot accuracy. Significant isokinetic variables for each stroke were entered into regression models. One isokinetic speed sufficiently predicted ball velocity for each stroke, since no increase in predictive capacity was observed with the addition of other isokinetic parameters. We conclude that isokinetics at testing speeds between 1.57 and 4.71 rad.s(-1) can effectively predict ball velocity, but not accuracy, and that our results may be helpful in planning strategies for training and rehabilitation.