Unselected Group Of Patients Research Articles

Hospital Anxiety and Depression Scale: Factor Structure, Internal Consistency and Convergent Validity in Patients with Dizziness

Psychiatric comorbidities, particularly anxiety-related pathologies, are often observed in dizzy patients. The Hospital Anxiety and Depression Scale (HADS) is a widely used self-report instrument used to screen for anxiety and depression in medical outpatient settings. The purpose of this study was to assess the factor structure, internal consistency and convergent validity of the HADS in an unselected group of patients with dizziness. The HADS and the Dizziness Handicap Inventory (DHI) were administered to 205 dizzy patients. An exploratory factor analysis was conducted and indicated a 3-factor structure, inconsistent with the 2-subscale structure (i.e. anxiety and depression) of the HADS. The total scale was found to be internally consistent, and convergent validity, as assessed using the DHI, was acceptable. Overall findings suggest that the HADS should not be used as a tool for psychiatric differential diagnosis, but rather as a helpful screener for general psychiatric distress in the two domains of psychiatric illness most germane in dizzy patients.

Chronic Pain Review Following Lichtenstein Hernia Repair : A Personal Series

Introduction: Chronic groin pain is both a topical subject and important outcome measurement following inguinal hernia repair. It has been suggested its incidence is related to the management of the nerves of the inguinal canal as well as the type of mesh used and methods of fixation for both open and laparoscopic surgery. The level of pre-operative and post operative pain, its duration as well as complications may all be factors in predicting whether chronic pain could develop. The method of measurement of chronic pain is itself a contentious issue. It is now apparent that the qualitative measurement of activity and functional status as well as quantitative is important. As a result several uniform methods of assessing chronic post-operative pain have been designed, validated and implemented. One of these is used here. Methods: A study reviewing a consecutive series of Lichtenstein repairs performed by a single experienced hernia surgeon was carried out. 248 inguinal hernia patients operated on in 2005 were reviewed. Patients were contacted via telephone at a median of 50 months. Franneby’s recently validated inguinal pain questionnaire was used to assess the incidence of chronic pain. Results: 185 (75%) patients were able to be contacted for follow-up, making a total of 213 inguinal hernia repairs (including bilateral and recurrent hernias). At the time of review 3% of patients reported having pain. No patients reported that pain or discomfort was limiting their work, exercise or activities of daily living. No patients had disabling pain. Conclusion: Chronic pain did not appear to be a major problem within this cohort of patients. The Lichtenstein technique can produce favourable results in terms of chronic pain for unilateral, bilateral and recurrent inguinal hernias in an unselected group of patients with the usual mix of risk factors and complications.

Improved survival after non-traumatic subarachnoid haemorrhage with structured care pathways and modern intensive care

ObjectivePatients with subarachnoid haemorrhage (SAH) often require multidisciplinary management and their treatment is difficult to standardize. The aim was to describe baseline characteristics, care pathways and discharge status in an unselected group of patients with first ever non-traumatic SAH, and to examine whether their care pathways and outcomes vary. MethodsPatients admitted with first ever non-traumatic SAH to a neurosurgical unit (NSU) in Sweden during a period of 18 months in 2009–2010 were included. The data was retrospectively collected from patient charts. ResultsA total of 131 patients were admitted with first ever non-traumatic SAH. Forty-nine (37%) patients initially sought medical care nearby the NSU and 82 (63%) in other parts of the catchment area. The average age was 55.5 years and 79 (60%) were female. In 98 (75%) cases, a ruptured aneurysm was found to be the cause of SAH. There was a significant correlation between poor clinical grade at admission and poor patient outcome (p<0.0005). No significant correlation between early aneurysm treatment and improved clinical outcome were seen. No significant differences in outcome were seen between patients who initially sought medical care nearby the NSU and those in other parts of the catchment area. There was no difference seen in the number of patients who had follow-up at the NSU depending on where they initially sought help. ConclusionThis study shows an improvement in survival after SAH compared to earlier studies in Sweden. The results are indicative of effective management of all patients with SAH in the catchment area that are treated at the NSU. A nationwide registry to assess the overall management of patients treated for SAH would be useful to further investigate patients with SAH.

Abstract B38: Melanoma patient-derived xenografts accurately models the disease and develop fast enough to guide treatment decisions

Abstract The development of novel therapies against melanoma would benefit from individualized tumor models to ensure the rapid and accurate identification of biomarkers of therapy response. Previous studies have suggested that patient-derived xenografts (PDXes) could be used in biomarker of response discovery. However, the clinical utility of PDXes in guiding real-time treatment decisions have only been reported in anecdotal forms. In the present study we aimed to develop a platform of melanoma patient-derived xenografts (PDXes), to assess whether treatment responses in mice would be applicable as a pre-selection tool for clinical trials. To that end, tumor biopsies from patients with stage III and IV metastatic malignant melanoma were transplanted into immunocompromised mice. Most melanoma biopsies generated serially transplantable PDX models, and their histology, and mutation status resembled their corresponding patient biopsy. RNAseq demonstrated that the expression profiles of the tumors are maintained throughout several passages in mice. The potential treatment for one patient was revealed by an in vitro drug screen and treating PDXes with the MEK inhibitor trametinib. In another patient, the BRAF mutation predicted the response of both the patient and its corresponding PDXes to MAP kinase pathway-targeted therapy. Importantly, in this unselected group of patients, the time from biopsy for generation of PDXes until death was significantly longer than the time required to reach the treatment phase of the PDXes. Thus, we demonstrate that it would be clinically meaningful to use this type of platform for a large proportion of melanoma patients as a pre-selection tool in clinical trials. Citation Format: Berglind O. Einarsdottir, Roger Olofsson Bagge, Joydeep Bhadury, Henrik Jespersen, Lisa M. Nilsson, Jan Mattsson, Katarina Truvé, Peter Naredi, Ola Nilsson, Marcela Davila Lopez, Ulrika Stierner, Lars Ny, Jonas A. Nilsson. Melanoma patient-derived xenografts accurately models the disease and develop fast enough to guide treatment decisions. [abstract]. In: Proceedings of the AACR Special Conference on Advances in Melanoma: From Biology to Therapy; Sep 20-23, 2014; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Res 2015;75(14 Suppl):Abstract nr B38.

Single nucleotide polymorphisms: the role of breast cancer development and clinical perspective

Background. Breast cancer (BC) is the most prevalent cancer in women worldwide. Genetic susceptibility to BC is heterogeneous including mutations with medium to high penetrance and single nucleotide polymorphisms (SNPs) with low penetrance. Precise assessment of genetic risk would allow to personalize the programs of prevention and treatment of BC and to reduce mortality. Objective. We aimed to determine the frequencies of single nucleotide polymorphisms rs2981582 (FGFR2), rs3817198 (LSP1), rs889312 (5q11), rs13281615 (8q24), rs13387042 (2q35), rs3803662 (16q12) in unselected group of BC patients and healthy women in Russian population, to reveal possible associations of these polymorphisms with BC development. Subjects and methods. An unselected group of 963 patients with BC and control group of 591 healthy female blood donors were examined. Whole peripheral blood samples were used to extract genomic DNA. Real-time polymerase chain reaction with melting curves analysis was performed for SNP genotyping. Results: Minor allele frequencies were as follows: 41.6±1.1% and 36.2±1.1% for rs2981582 (FGFR2), 35.3±1.1% and 34.3±1.1% for rs3817198 (LSP1), 39.3±1.1% and 43.7±1.1% for rs13387042 (2q35), 27.7±1.0% and 27.8±1.0% for rs889312 (5q11), 46.2±1.1% and 44.7±1.1% for rs13281615 (8q24), 35.7±1.1% and 29.9±1.1% for rs3803662 (16q12) in group of BC patients and group of healthy women respectively. The obtained ORs for BC were 1.26 (95% CI, 1.11–1.41; p=0.003) for rs2981582, OR=0.84 (95% CI, 0.69–0.98; p=0.02) for rs13387042 and OR=1.30 (95% CI, 1.14–1.45; p=0.002) for rs3803662. Conclusion: We confirmed the associations of previously identified SNPs rs2981582 (FGFR2), rs13387042 (2q35) and rs3803662 (16q12) with BC in Russian population.

Sunitinib therapy for metastatic renal cell carcinoma: A urologist’s perspective

Objective: Sunitinib is seldom initiated and managed by urologists, and patients with metastatic renal cell carcinoma are often referred to geographically distant centres. We present the outcomes of patients on sunitinib therapy in a single-centre urological department. To the best of our knowledge, we provide one of the only urology-led services for these patients in the United Kingdom. Method: Between August 2009 and January 2013, an unselected group of patients with metastatic renal cell carcinoma receiving sunitinib therapy were analysed. Twenty-eight patients (20 males, eight females) with an average age of 64.8 years were included in our study. Results: Patients were seen on average 10.8 days following MDT and were given fortnightly appointments to monitor progress. There were 176 cycles of sunitinib delivered. A total of 39.3% patients required at least one dose reduction. The commonest adverse events were diarrhoea (71%), mucositis (46%) and hand-foot syndrome (36%). Partial response and stable disease were observed in 27.1% and 45.8% of patients, respectively. Progression-free survival (PFS) and overall survival (OS) were 8.6 months and 15.2 months, respectively. Compared to the literature, there were lower rates of haematological adverse events in our study; however, PFS and OS, response rates and dose reductions were comparable. Conclusions: This study highlights that such patients can be safely and effectively managed in a local hospital setting with a dedicated urological team, allowing for better continuity of care.

Catheter tip malposition after percutaneous placement of tunneled hemodialysis catheters.

The percutaneous catheterization of central veins is increasingly used in nephrological practice as a temporary or permanent vascular access. The aim of our study was to present and to analyze episodes of catheter tip malposition during percutaneous tunneled hemodialysis catheter insertion in the large, unselected group of patients. All patients who underwent the procedure of catheter insertion in our department during year 2012 were analyzed retrospectively. One hundred four tunneled hemodialysis catheters were inserted in 101 patients. In 58 patients, the catheter was inserted at the initiation of hemodialysis therapy as the first access and in 46 the catheter was placed because of the failure of the existing one. In 68 patients, the catheter was inserted into the right internal jugular vein and in 20 patients into the left internal jugular vein (LIJV). Subclavian veins were used in five cases and femoral veins in 11 cases. Malposition of the catheter tips occurred in six patients. In all cases, the LIJV was cannulated. In two cases, the catheter tip malposition was in the right innominate vein and in four cases in the azygos vein. Our data demonstrate that with the blind insertion of tunneled hemodialysis catheters, the risk of catheter tip malposition is significantly higher with the left side insertion. As catheter insertion through the LIJV holds very high (30%) risk of the tip malposition, it should always be performed under the fluoroscopic control.

Aerosolised liposomal amphotericin B to prevent aspergillosis in acute myeloid leukaemia: Efficacy and cost effectiveness in real-life

Chemotherapy-induced neutropenia can be complicated by invasive pulmonary aspergillosis (IPA). In 2008, liposomal amphotericin B (L-AmB) inhalation was shown to prevent IPA in a placebo-controlled trial. Patients with acute myeloid leukaemia (AML) are the subset of haematology patients at high risk for IPA. In 2008, L-AmB inhalation prophylaxis became the standard of care for all AML patients in Erasmus MC. In this study, the efficacy and cost effectiveness of L-AmB inhalation were evaluated in a prospective cohort of AML patients. In total, 127 consecutive AML patients received chemotherapy and prophylactically inhaled L-AmB during their first and second chemotherapy cycles; 108 patients treated for AML at the same sites from 2005–2008 served as controls. A standardised diagnostic protocol was used and probable/proven IPA served as the primary endpoint. Diagnostic and therapeutic costs were also comprehensively analysed and compared. A significant decrease in probable/proven IPA in the L-AmB inhalation group was observed (L-AmB 9.5% vs. controls 23.4%; P=0.0064). Systemic antifungal therapy given at any time during the entire AML therapy decreased from 52.8% to 29.9%. Per-patient equipment and drug costs for L-AmB inhalation (1292 €/patient) were more than compensated for by a decrease in costs for diagnostics and therapeutic voriconazole use (−1816 €/patient). No serious adverse events related to L-AmB inhalation were observed. In an unselected AML patient group, L-AmB inhalation resulted in a significant and substantial decrease in IPA and was cost saving. Now that azole resistance is more frequent, non-azole-based prophylaxis may become an attractive strategy.

Statin adherence and LDL cholesterol levels. Should we assess adherence prior to statin upgrade?

BackgroundAdherence to statin therapy has been shown to be suboptimal. In statin-treated patients with residual elevated low density lipoprotein cholesterol (LDL-C) levels the physician must decide whether to switch to a more potent statin or try and achieve better adherence. We examined the association between adherence and LDL-C within low, moderate and high intensity statin groups in a “real world” setting. MethodsWe assessed annual adherence by the mean MPR (Medication Possession Ratio = number of purchased/prescribed daily doses) in unselected patient group. Statins were stratified (ACC/AHA Guideline) into low, moderate and high intensity groups. The impact of adherence on LDL levels was assessed by LOESS (locally weighted scatter plot smoothing). ResultsOut of 1183 patients 173 (14.6%) were treated with low, 923 (78.0%) with moderate and 87 (7.4%) with high intensity statins. Statin intensity was inversely associated with adherence (MPR 77±21, 73±22 and 69±21% for low, moderate and high intensity respectively, p=0.018). Non-adjusted LDL levels decreased with higher adherence: a 10% adherence increase resulted in LDL decrease of 3.5, 5.8 and 7.1mg/dL in low, moderate and high intensity groups. Analysis of the adherence effect on LDL levels adjusted for age, DM and ischemic heart disease showed that MPR above 80% was associated with an additional decrease in LDL levels only in the high intensity group. ConclusionsIncreased adherence to statins beyond an MPR of 80% improves LDL levels only among patients given high intensity therapy. Switching from lower to higher intensity therapy may be more effective than further efforts to increase adherence.

Conventional versus fast track anaesthesia in an unselected group of patients undergoing revisional bariatric surgery

IntroductionFast track care has proven to be safe and effective in primary bariatric procedures. The number of more complex revisional procedures is expected to rise over the next years. The aim was to evaluate the potential benefits and safety of a fast-track protocol in an unselected group of patients undergoing Roux-en-Y Gastric Bypass (rRYGBP) as revision. MethodFor this retrospective study, all patients undergoing rRYGBP between January 2005 and December 2013 were included and categorized between conventional care (CC) and fast track care (FT). Patient characteristics, operative details and intra- and early postoperative complications < 30 days were analysed. ResultsA total of 407 patients were included for analysis. 303 patients (74.4%) received peri- and postoperative treatment according to the fast track protocol. Mean age of the study population was 44.0 ± 8.9 years; mean pre-primary procedure BMI was 45.7 ± 7.0 kg/m2. A total of 54 (13.3%) postoperative complications were registered (CC 19.2% vs FT 11.2%; p = 0.038). Both operative time (CC 135.3 ± 42.6 minutes vs FT 79.3 ± 29.3 minutes; p < 0.001) as well as hospital stay (CC 5.1 ± 6.3 days vs FT 3.1 ± 5.3 days; p < 0.001) were significantly shorter in the FT group. A multivariate analysis on postoperative complications showed that fast track was not predictive for the occurrence of complications (OR = 0.853; 95% CI [0.403–1.804]; p = 0.677). ConclusionFast track care appears to be safe and efficient for patients undergoing revisional Roux-en-Y gastric bypass, but postoperative outcome may be highly dependent on surgical experience.

NSAIDs, statins, low-dose aspirin and PPIs, and the risk of oesophageal adenocarcinoma among patients with Barrett's oesophagus: a population-based case–control study

ObjectivesNon-steroidal anti-inflammatory drugs (NSAIDs), proton pump inhibitors (PPIs), low-dose aspirin and statins may decrease the risk of oesophageal adenocarcinoma (OAC) among patients with Barrett's oesophagus (BO). However, previous studies did...

Survival and relapse free period of 2926 unselected older breast cancer patients: A FOCUS cohort study

BackgroundPrevious studies have shown that breast cancer survival decreases with increasing age among older patients who participate in trials. However, trial participants differ from patients in the general population. Therefore, the aim of this study was to evaluate the association between age and breast cancer outcome in an unselected group of older breast cancer patients. MethodsWe included all older (65 years and older) consecutive breast cancer patients, diagnosed between 1997 and 2004 from a geographically defined area in the Netherlands. Primary outcome was relative survival and the secondary endpoint was breast cancer recurrence. These outcomes were compared between two age-categories (65–74 years and ≥75 years). ResultsFive-year relative survival was 91.9% in patients aged 65–74 years, and 84.3% in patients aged ≥75 years. This corresponded with a higher excess risk of death in patients aged ≥75 years as compared to patients aged 65–74 years (multivariable relative excess risk of death: 1.73 (95% CI 1.20–2.49)). The risks of locoregional recurrence, distant recurrence and contralateral breast cancer were similar in both age-categories. ConclusionsBreast cancer survival deteriorates with increasing age among unselected older breast cancer patients. Of note, this was not accompanied by an increased risk of recurrence. This study shows that not only in relatively healthy patients who participate in a trial, but in all older breast cancer patients, outcome deteriorates with increasing age. These findings urge the need for age-specific breast cancer studies, in order to obtain evidence-based medicine in this large and heterogeneous group of patients.

Prospective, Observational Study to Assess the Safety of Rituximab(R) in Combination with Chemotherapy in Patients with Previously-Untreated or Relapsed or Refractory B Cell-Lineage Chronic Lymphocytic Leukaemia (B-CLL): Final Results

Aim and Background: MABERYC non-interventional study was designed to characterize the type, severity and frequency of all adverse events (AEs)/serious-AEs (SAEs) occurring on-treatment and in the year following rituximab infusion. Secondary objectives included response rate (CR/PR) and to evaluate the clinical utility and the validity of a specific comorbidity scale (CoLLECT scale) for B-CLL patients, planned to recognize patients who may benefit from some special pharmacological approach.Methods: Between November 2010 and February 2012, data were collected prospectively from B-CLL patients, in 47 Spanish hospitals, starting a new treatment with an R-based chemotherapeutic scheme in accordance with normal clinical practice at the time of enrollment. Safety analyses were conducted by closely monitoring patients throughout the study. AEs and SAEs were tabulated by NCI-Common Toxicity Criteria (NCI-CTC), v4.0. In order to validate the CoLLECT scale, specifically designed for this study, assessment of comorbidity was planned at baseline and 12 months following treatment finalization, using three subscales (low [0-3], moderate [4-7] and high [>7]) with ten different indexes. Changes were categorized in improvement (reduction ≥2), no changes (variation <2) and worsening (increase ≥2).Results: A total of 218 patients have been enrolled, 108 and 110 pts in the first-line and pre-treated arm, respectively. The median age (range) of the whole series was 69 (r: 39–87) years. ECOG status varied across the two groups, with a ≤1 ECOG status score of 99%, and 84% of first-line and pre-treated patients, respectively. The baseline characteristics on both arms are shown in Table 1. [Display omitted] 1448 AEs were reported on treatment, 50% of them considered as drug-related. The most frequently related-AE in first-line and pre-treated arm included: neutropenia (34/30%); fever (18/12%); nausea (15/11%); thrombocytopenia (10/17%), febrile neutropenia (FN) (10/9%), and anemia (7/16%). Overall, the treatment was well tolerated and the toxicity profile differed according to the treatment arm (Table 2). Treatment discontinuations due to related-AEs in the first-line and pre-treated arm was of 9 and 11% on-treatment, fatal AEs occurred in 3% and 4%, respectively. [Display omitted] In the overall population by IWG response criteria, the best response on treatment was CR in 28% and PR in 30% of patients (nPR in 4% of patients). Although, based on fairly different number of patients by scheme that preclude a completely valid statistical comparison, the complete and partial response rate (CR/PR) in the first-line arm was as follows: BR (50/31%), FCR (43/25%), R+others (29/43%) and ClbR cohort (23/46%), while in the pre-treated arm the response rate was higher in the BR (20/16%), followed by FCR (19/24%), R+others (5/52%) and ClbR cohort (15/40%).Mean CoLLECT score was higher in older patient, higher ECOG, previously treated and those receiving less aggressive treatments. Changes in CoLLECT showed CR could be associated to improvement in comorbidity. CR was reached by 53% of patients with COLLECT improvement, 47% without changes, and 32% worsening.Conclusion: In this unselected group of B-CLL patients taken from normal clinical practice, the AEs frequency was related to immunochemotherapy scheme as well as the stage of treatment. Rituximab seems an effective and relatively safe option when added to any chemotherapy regimen. With the help of the CoLLECT scale, which is related with patient´s profile, treatment regimen prescribed, CR and AEs, patient’s co-morbidity can be assessed and assist on decision-making about the intensity of the inmmunochemotherapy regimen to be prescribed. DisclosuresNo relevant conflicts of interest to declare.

Temsirolimus for patients with metastatic renal cell carcinoma: outcomes in patients receiving temsirolimus within a compassionate use program in a tertiary referral center.

AimTemsirolimus has shown efficacy as first-line treatment of patients with metastatic renal cell carcinoma and poor prognostic features. The efficacy of temsirolimus in other clinical settings, such as second-line therapy, is unclear. The aim of this study was to investigate the outcomes of an unselected group of patients with renal cancer treated with temsirolimus in a compassionate use program.Patients and methodsThis retrospective analysis included all patients receiving temsirolimus at a tertiary referral center between November 2007 and October 2008. Information was obtained through review of patient notes, electronic records, and pharmacy records. Baseline characteristics, prognostic features, and previous treatments were recorded for all patients. Outcome measures were response rate, progression-free survival (PFS), overall survival (OS), and toxicities.ResultsThirty-eight patients were included in the analysis, with median age of 62 years, among whom 37% were untreated and 63% had received one or more previous treatments. Thirty-four percent of the patients had three or more poor prognostic factors. Four patients (11%) achieved a partial response (PR); in all four of these patients, the PR was confirmed by two subsequent computed tomography (CT) scans, and in one patient, the PR lasted for more than 18 months. A total of 34% achieved stable disease, and 50% had disease progression. Median OS was 7.6 months (95% confidence interval [CI] 4.8–10.5), and median PFS was 3.2 months (95% CI 1.0–5.5). Patients with two or fewer poor prognostic factors had a survival of 10.12 months compared with 5.03 months of those with three or more. Median survival was 14.9 months for untreated patients and 6.4 months for previously treated patients.ConclusionOur results indicate some efficacy of temsirolimus in untreated patients with renal tumors and poor-intermediate prognosis, although the limitations of small sample size and retrospective nature must be taken into account. The role of temsirolimus in previously treated patients remains controversial given the recently published results of the INTORSECT trial and the discrepancies between the few published series.

Low frequency of HNPCC-associated microsatellite instability and aberrant MMR protein expression in early-onset bladder cancer.

Recently, it was shown that patients with Lynch syndrome due to an MSH2 mutation are at increased risk for the development of bladder cancer. To further this discussion, we screened the largest investigated cohort of patients with early-onset bladder cancer for microsatellite instability (MSI) and mismatch repair (MMR) deficiency to determine a possible role of Lynch syndrome in young patients with bladder cancer. A total of 109 cases of bladder tumors from young patients (aged <45 years) were examined for MSI (Bethesda consensus panel). Expression of MMR proteins (hMLH1, hMSH2, and hMSH6) was evaluated by immunohistochemistry using a tissue microarray. Results were compared with a series of unselected consecutive bladder tumors (n = 95). Regarding the frequency of MSI high (1% vs 0%) or abnormal expression of MMR proteins (2% vs 6.5%), no significant difference between the early-onset and unselected patient group was found. In young patients with bladder tumors, MSI and defects in MMR protein expression were not more frequent than in a series of consecutive bladder tumors. Most bladder tumors in young patients are not to be attributed to Lynch syndrome.

PROCEDURAL SUCCESS AND CLINICAL OUTCOME OF TRYTON,A DEDICATED BIFURCATION STENT USE IN COMPLEX BIFURCATION LESIONS IN UNSELECTED PATIENTS: A SINGLE CENTRE REGISTRY DATA

Coronary Bifurcation Lesions (CBL) account for approximately of 15% of all lesions treated with Percutaneous Intervention (PCI). While main branch (MB) stent with provisional side branch (SB) stenting is the preferred approach in the treatment of coronary bifurcations, not uncommonly a 2-stent strategy with SB stenting is required to maintain patency of the MB and SB. There remains no consensus on the optimal 2 stent strategy because of paucity in data.Consequently, dedicated bifurcation stents have been designed to treat both the MB and SB without compromising the carina of CBL`s. The Tryton Side-Branch Stent (Tryton Medical, Inc., MA, and USA) is one of the dedicated bifurcations which have shown promising long term outcome in FIM trial and other selective registries. We prospectively evaluated the safety and efficacy of the Tryton Side-Branch Stent in an unselected group of patients who were treated with PCI for CBL within our centre. Data from the in hospital Cardiac Catheter Laboratory Registry between 2009 -2013 identified 38 successive patients who were treated with Tryton Side-Branch Stent. Procedural information was obtained from British Cardiac Intervention Society database. Follow up data was collected by reviewing follow up clinic letters via in hospital database over a mean period of 18 months. Mortality data was verified with Welsh Demographic Service data base. The Tryton stent was successfully deployed in 97% cases with 74% of patients being males, mean age of 71yrs. 92% of cases were done via radial access using 6F sheaths. The indications for PCI were: Stable angina 17(45%), NSTEMI 18(47%) STEMI 3(8%). Of all the CBL, 68% were true bifurcation lesion as per Medina classification. The median angle between the MB and SB was at 60 degrees. Most lesions (75%) were crossed with BMW wires with IVUS used in 7(18%) cases. Final kissing balloon inflation was carried out in 30(79%) of cases. Mean MB and SB stent diameter was 3.5mm and 2.75 respectively. Procedural success was 97% with 1 in-hospital mortality. Both TVR and TLR were at 0% with no cases of stent thrombosis. Most CBL can be safely and efficiently treated with the Tryton dedicated Side Branch stent and is not associated with any significant short or long term major adverse cardiac events. This study demonstrates that dedicated stents can be used in a wide spectrum of clinical presentations and can be safely delivered in default transradial PCI centres.

Further evidence in support of the association between venous thrombosis and atherosclerosis: A case–control study

IntroductionWhether there is an association between venous thromboembolism (VTE) and atherosclerosis is still controversial. AimsIn a case–control study conducted on subjects older than 50, we assessed the prevalence of symptomatic or subclinical atherosclerosis in a group of unselected patients with unprovoked VTE, and compared it with that of patients with secondary VTE and of matched control individuals free from VTE disorders. MethodsCases and controls were enquired about the presence of previous symptomatic manifestations of atherosclerosis. Those with a negative history underwent the ultrasound assessment of carotid arteries following a standardized procedure. An intima-media thickness higher than 0.9mm or the detection of at least one carotid plaque was regarded as a subclinical manifestation of atherosclerosis. After adjusting for age, gender and risk factors for atherosclerosis, we calculated the odds ratio (OR) for symptomatic or subclinical atherosclerosis in patients with unprovoked VTE as compared to those with secondary VTE and controls. ResultsWe recruited 100 patients with unprovoked VTE, 100 with secondary VTE and 100 control individuals. In patients with unprovoked VTE, the adjusted OR for symptomatic or subclinical atherosclerosis was 5.1 (95% CI, 2.0 to 13.1) in comparison to patients with secondary VTE, and 14.5 (95% CI, 5.8 to 36.3) in comparison to controls. The prevalence of atherosclerosis was higher in patients with secondary VTE than in controls (OR, 3.1; 95% CI, 1.6 to 6.1). ConclusionThe results of this study confirm the presence of a strong association between venous thrombosis and atherosclerosis.

Anxiety predicts mortality in ICD patients: results from the cross-sectional national CopenHeartICD survey with register follow-up.

Although highly effective in preventing arrhythmic death, patients receiving an implantable cardioverter defibrillator (ICD) may still experience psychological difficulties such as anxiety, depression, and reduced quality of life. The objectives of this study were to describe patient-reported outcomes among ICD patients: (1) compared to a matched healthy population, (2) compared by ICD indication, (3) factors predicting patient-reported outcomes, and (4) if patient-reported outcomes predicted mortality. The study was a mailed survey to an unselected group of patients 18+ years old receiving ICD between January 1, 2011 and June 30, 2011 (n = 499). The following instruments were used: SF-36, Hospital Anxiety and Depression Scale, HeartQoL, EQ-5D, and the Multidimensional Fatigue Inventory. The response rate was 72%. Mean age was 65.5 years and 82% patients were males. Fifty-three percent of patients had primary prevention indication ICD. Compared to an age- and gender-matched population without disease, the ICD population had worse mental health (55.0 vs 51.7 points) and physical health (52.6 vs 41.9 points). Patients with primary prevention indication had lower levels of perceived health, quality of life, and fatigue; for example, physical health 39.8 versus 44.3 points, compared to secondary prevention indication. Anxiety, poor perceived health, fatigue, and low quality of life were all predictors of mortality, anxiety being the strongest with an adjusted odds ratio of 4.17 (1.49; 11.66). Patients with primary prevention ICD had lower levels of perceived health, quality of life, and more fatigue. Anxiety, poor perceived health, fatigue, and low quality of life were all predictors of mortality.

Imatinib mesylate lacks efficacy in relapsed/refractory peripheral T cell lymphoma

Platelet derived growth factor-α (PDGFR-α) is expressed in peripheral T cell lymphoma, not otherwise specified (PTCL, NOS). Imatinib mesylate demonstrated in vitro cytotoxicity against primary PTCL, NOS cells. We initiated a trial of imatinib in 12 patients with relapsed or refractory T-cell non-Hodgkin lymphoma (T-NHL). PDGFR-α expression by immunohistochemistry and fluorescence in situ hybridization (FISH) to assess for FIP1L1–PDGFR-α fusion and/or PDGFR-α amplification were not required for study entry. We documented no objective responses. The median progression-free survival was 21.0 days (90% confidence interval [CI] 15.0, 28.0) and median overall survival was 154 days (90% CI 35, 242). Four patients had tissue available for analysis of PDGFR-α by immunohistochemistry and three of these patients’ tumors expressed PDGFR-α. Imatinib was not effective for the treatment of peripheral T cell lymphoma in an unselected group of patients in which PDGFR-α expression was not required for study entry.

Multiple sclerosis clinical course and cardiovascular disease risk - Swedish cohort study.

Cardiovascular disease (CVD) risk amongst multiple sclerosis (MS) patients appears raised, but few studies have examined CVD risk amongst an unselected MS patient group. MS course may be relevant for CVD risk. Our aim was to assess CVD risk and variation by course in MS patients. The Multiple Sclerosis Register identified 7667 patients who received an MS diagnosis between 1964 and 2005. They were matched by age, period, region and sex with 76045 members of the general population without MS using Swedish registers. Poisson regression compared the two cohorts to estimate the relative risk for CVD, overall, as well as grouped and individual CVD diagnoses. MS patients had an increased adjusted relative risk (with 95% confidence intervals; number of MS cohort events) for CVD of 1.31 (1.22-1.41; n=847), with some variation by course: relapsing-remitting 1.38 (1.17-1.62; n=168); secondary progressive 1.30 (1.18-1.53; n=405) and primary progressive 1.15 (0.93-1.41; n=108). The association for the relapsing-remitting course was not significant after excluding the first year of follow-up. Overall incidence rates per 1000 person-years for CVD are 11.8 (11.06-12.66) for the MS cohort and 8.8 (8.60-9.05) for the non-MS cohort. The most pronounced association was for deep vein thrombosis: relapsing-remitting 2.16 (1.21-3.87; n=14), secondary progressive 3.41 (2.45-4.75; n=52) and primary progressive 3.57 (1.95-6.56; n=15). MS was associated with ischaemic stroke but largely during the first year of follow-up. MS was associated with a decreased relative risk for angina pectoris and atrial fibrillation. There is a significantly increased relative risk for CVD in MS, particularly for venous thromboembolic disorders in progressive MS, suggesting immobility as a possible factor. An increased frequency of ischaemic stroke in MS is most probably due to surveillance bias resulting from diagnostic investigations for MS. There is no increased relative risk for ischaemic heart disease in MS and atrial fibrillation appears to be less common than amongst the general population.