Baseline characteristics of patients enrolled in the EMPACT-MI trial.

AIMS: Empagliflozin has been shown to reduce the risk of adverse cardiovascular outcomes in patients with type 2 diabetes and in those with heart failure. The impact of empagliflozin in post-acute myocardial infarction (AMI) patients is unknown. METHODS AND RESULTS: The Study to Test the Effect of Empagliflozin on Hospitalization for Heart Failure and Mortality in Patients with Acute Myocardial Infarction (EMPACT-MI) trial screened 6610 participants with AMI and randomized 6522 to empagliflozin or placebo in addition to standard of care. The median (interquartile) age was 64 (56-71) years and 75.1% of patients were male. Major comorbidities included hypertension (69.1%), type 2 diabetes (31.7%), prior myocardial infarction (13.0%), and atrial fibrillation (10.9%). The majority (74.3%) of patients presented with an ST-elevation myocardial infarction. Overall, 56.9% of patients had acute signs or symptoms of congestion requiring treatment and 78.3% had left ventricular systolic dysfunction with ejection fraction <45%. Clinical characteristics, including baseline demographics, rates of revascularization, and cardiovascular medications at discharge were largely comparable to recent trials of the post-AMI population. CONCLUSION: The EMPACT-MI trial will establish the benefit and risks of empagliflozin treatment in patients with AMI.

Long-term follow-up after surgery for atrial fibrillation with concomitant open heart surgery. / Langtidsoppfølging etter atrieflimmeroperasjon og samtidig åpen hjertekirurgi.

BACKGROUND: Patients with atrial fibrillation and atrial flutter scheduled to undergo open heart surgery can receive ablation treatment of arrhythmogenic foci during the same intervention. Sinus rhythm is restored in the majority in the short term, but the long-term results are more uncertain. This study, which is part of the international CURE-AF trial, evaluates results after Cox-Maze IV surgery for atrial fibrillation in Norway at six-year follow-up. MATERIAL AND METHOD: Nineteen patients were included in this prospective cohort study. Atrial fibrillation had persisted for 40 months in the group with long-standing persistent atrial fibrillation (n = 12) and 6 months in the group with persistent atrial fibrillation (n = 7). Surgery for atrial fibrillation was performed according to the Cox-Maze IV procedure in the CURE-AF protocol. Follow-up in the first 12 months was strictly according to the CURE-AF protocol, thereafter conducted by the primary health service. RESULTS: Sinus rhythm was restored in 11 patients at the time of discharge and in 14 patients six months postoperatively. After 5-6 years of follow-up, all patients with long-standing persistent atrial fibrillation had experienced recurrence. Two achieved sinus rhythm after electroconversion. Six of the seven in the group with persistent atrial fibrillation had sinus rhythm after 5-6 years. INTERPRETATION: The results were good initially, with restoration of sinus rhythm in more than two thirds of the patients after 6-9 months. Five years later, a high recurrence rate was found in patients with long-standing persistent atrial fibrillation. Several recurrences had not been detected by the public health service or treatment had not been attempted.

Cardiovascular outcomes and safety with linagliptin, a dipeptidyl peptidase-4 inhibitor, compared with the sulphonylurea glimepiride in older people with type 2 diabetes: A subgroup analysis of the randomized CAROLINA trial.

AIM: To compare the cardiovascular (CV) safety of linagliptin with glimepiride in older and younger participants in the CAROLINA trial in both prespecified and post hoc analyses. MATERIALS AND METHODS: People aged 40 to 85 years with relatively early type 2 diabetes, inadequate glycaemic control and elevated CV risk were randomly assigned to linagliptin 5 mg or glimepiride 1 to 4 mg. The primary endpoint was time to first occurrence of three-point major adverse CV events (MACE: CV death, non-fatal myocardial infarction, or non-fatal stroke). We evaluated clinical and safety outcomes across age groups. RESULTS: Of 6033 participants, 50.7% were aged <65 years, 35.3% were aged 65 to 74 years, and 14.0% were aged ≥75 years. During the 6.3-year median follow-up, CV/mortality outcomes did not differ between linagliptin and glimepiride overall (hazard ratio [HR] for three-point MACE 0.98, 95.47% confidence interval [CI] 0.84, 1.14) or across age groups (interaction P >0.05). Between treatment groups, reductions in glycated haemoglobin were comparable across age groups but moderate-to-severe hypoglycaemia was markedly reduced with linagliptin (HR 0.18, 95% CI 0.15, 0.21) with no differences among age groups (P = 0.23). Mean weight was -1.54 kg (95% CI -1.80, -1.28) lower for linagliptin versus glimepiride. Adverse events increased with age, but were generally balanced between treatment groups. Significantly fewer falls or fractures occurred with linagliptin. CONCLUSIONS: Linagliptin and glimepiride were comparable for CV/mortality outcomes across age groups. Linagliptin had significantly lower risk of hypoglycaemia and falls or fractures than glimepiride, including in "older-old" individuals for whom these are particularly important treatment considerations.

Subjective recovery from pregnancy-related pelvic girdle pain the first 6 weeks after delivery: a prospective longitudinal cohort study.

PURPOSE: The purpose of this study was to investigate the subjective recovery from pregnancy-related pelvic girdle pain (PGP) during the first 6 weeks after delivery and to detect possible risk factors for a poor recovery. METHODS: The participants were included in this study at the routine ultrasound examination at 18 weeks of pregnancy. The women received a weekly SMS with the question "How many days during the last week has your PGP been bothersome?" The SMS-track from the final 10 weeks of pregnancy and first 6 weeks after delivery were assessed and sorted, based on individual graphs. A total of 130 women who reported PGP during pregnancy and met for clinical examination 6 weeks after delivery were included in the study. RESULTS: In all, 83% of the women experienced substantial recovery from severe or moderate PGP within 6 weeks after delivery. Of these, 44% reported a substantial recovery already within 2 weeks after delivery. More multiparous women, women reporting PGP the year before pregnancy, and women with high pain intensity during pregnancy had a poor recovery. CONCLUSIONS: The prognosis following PGP in pregnancy is good and the majority of women recovered substantially from severe and moderate pregnancy-related PGP within 6 weeks after delivery. For many women, a subjective substantial recovery occurred within 2 weeks after delivery. Predictors for a poor recovery were multiparity, PGP the year before pregnancy and a high pain intensity during pregnancy. These slides can be retrieved under Electronic Supplementary Material.

Adding Chiropractic Treatment to Individual Rehabilitation for Persistent Pelvic Girdle Pain 3 to 6 Months After Delivery: A Pilot Randomized Trial.

OBJECTIVE: The purpose of this study was to investigate the feasibility of conducting a study examining the influence of individualized rehabilitation and chiropractic treatment, compared with individualized rehabilitation alone, in women with persistent dominating 1-sided pelvic girdle pain (PGP) 3 to 6 months after delivery. METHODS: Women were recruited from an outpatient clinic at Stavanger University Hospital, Norway and in a private chiropractic clinic in Stavanger. Those with persistent, dominating 1-sided PGP were included in this pilot study. Those who met inclusion criteria were randomized into 2 groups, one group received individualized rehabilitation and chiropractic treatment and the other group women received individualized rehabilitation alone. Treatment was measured for 20 weeks. RESULTS: Of 330 consenting women who were recruited who reported pelvic pain during pregnancy, 68 reported PGP or low back pain, and 63 consented to fill in a questionnaire. Forty-seven women underwent a clinical examination 3 to 6 months after delivery. During the examination, the women were diagnosed into subgroups for PGP. After exclusion of the women with low back pain only, a total of 13 women were diagnosed with dominating 1-sided PGP and thus included in this study. Six were randomized to the individualized rehabilitation and chiropractic treatment group and 5 to the individualized rehabilitation alone group. After 20 weeks of intervention, both groups reported improvement in disability and pain, but not in general health status. No serious or long-lasting adverse events were registered after treatment or training. CONCLUSION: We found that a study of this nature is feasible. However, the conditions of patient recruitment need to be considered carefully. We learned that a trial to investigate the effect of chiropractic treatment for PGP pain should include all subgroups of PGP to reach an acceptable sample size.

Can a bothersome course of pelvic pain from mid-pregnancy to birth be predicted? A Norwegian prospective longitudinal SMS-Track study.

OBJECTIVE: To explore if pregnant women with pelvic girdle pain (PGP), subgrouped following the results from two clinical tests with high validity and reliability, differ in demographic characteristics and weekly amount of days with bothersome symptoms through the second half of pregnancy. DESIGN: A prospective longitudinal cohort study. PARTICIPANTS: Pregnant women with pelvic and lumbopelvic pain due for their second-trimester routine ultrasound examination. SETTING: Obstetric outpatient clinic at Stavanger University Hospital, Norway. METHODS: Women reporting pelvic and lumbopelvic pain completed a questionnaire on demographic and clinical features. They were clinically examined following a test procedure recommended in the European guidelines for the diagnosis and treatment of PGP. Women without pain symptoms completed a questionnaire on demographic data. All women were followed weekly through an SMS-Track survey until delivery. PRIMARY AND SECONDARY OUTCOME MEASURES: The outcome measures were the results from clinical diagnostic tests for PGP and the number of days per week with bothersome pelvic pain. RESULTS: 503 women participated. 42% (212/503) reported pain in the lumbopelvic region and 39% (196/503) fulfilled the criteria for a probable PGP diagnosis. 27% (137/503) reported both the posterior pelvic pain provocation (P4) and the active straight leg raise (ASLR) tests positive at baseline in week 18, revealing 7.55 (95% CI 5.54 to 10.29) times higher mean number of days with bothersome pelvic pain compared with women with both tests negative. They presented the highest scores for workload, depressed mood, pain level, body mass index, Oswestry Disability Index and the number of previous pregnancies. Exercising regularly before and during pregnancy was more common in women with negative tests. CONCLUSION: If both P4 and ASLR tests were positive mid-pregnancy, a persistent bothersome pelvic pain of more than 5 days per week throughout the remainder of pregnancy could be predicted. Increased individual control over work situation and an active lifestyle, including regular exercise before and during pregnancy, may serve as a PGP prophylactic.

Empagliflozin compared with glimepiride in metformin-treated patients with type 2 diabetes: 208-week data from a masked randomized controlled trial.

AIM: To report results at week 208, including a 104-week masked extension, of the EMPA-REG H2H-SU trial in patients with type 2 diabetes with inadequate glycaemic control on metformin, in which empagliflozin 25 mg given for 104 weeks provided a sustained reduction in glycated haemoglobin (HbA1c) with a small but statistically significant benefit vs glimepiride, sustained reductions in weight and blood pressure, and low risk of hypoglycaemia. RESEARCH DESIGN AND METHODS: Patients with type 2 diabetes and HbA1c 53-86 mmol/mol (7% to 10%) were randomized to empagliflozin 25 mg or glimepiride 1 to 4 mg for 104 weeks as add-on to metformin. Patients who completed the randomized treatment period could participate in a 104-week extension in which they continued the double-blind treatment allocated at randomization. RESULTS: Of 765 and 780 patients treated with empagliflozin and glimepiride, 576 and 549 patients, respectively, entered the extension period of the study. At week 208, the adjusted mean difference in change from baseline in HbA1c with empagliflozin vs glimepiride was -1.96 mmol/mol, 95% CI -3.57, -0.35 (-0.18%, 95% CI -0.33, -0.03); P = 0.0172. Rescue therapy was given to 23% of patients on empagliflozin and 34% on glimepiride (odds ratio 0.56 [95% CI 0.45, 0.71]; P < 0.0001). Confirmed hypoglycaemic adverse events (plasma glucose ≤3.9 mmol/L and/or requiring assistance) occurred in 3% of patients on empagliflozin and 28% on glimepiride (odds ratio 0.08 [95% CI 0.05, 0.13]; P < 0.0001). CONCLUSIONS: In patients with type 2 diabetes, empagliflozin 25 mg as add-on to metformin for 208 weeks reduced HbA1c with a significantly lower risk of hypoglycaemia and a significantly smaller proportion of patients receiving rescue therapy compared with glimepiride.

Long-term effects of exercise programs among helicopter pilots with flying related LBP.

BACKGROUND: Flying related transient Low Back Pain (LBP) among helicopter pilots is considered an occupational distress. OBJECTIVE: To examine if exercise programs can alleviate transient LBP. METHODS: Sixty-five helicopter pilots (92% males), all reporting flying related LBP, responded to an epidemiological survey and a long-term follow-up, 44.8 months later, comprising questions regarding transient LBP and number of sick leaves. Data from 37 pilots participating in two exercise programs, A; general for LBP, B; focused for lumbar trunk (LT), included information from clinical examinations and muscular endurance tests of the LT before and after intervention. Twenty-eight pilots did not participate in any intervention. RESULTS: At long-term follow-up 42% of the pilots still reported flying related transient LBP. Among participants in program B 26% had persistent pain, 70% in program A and 46% among pilots without intervention. Sick-leave reduction was only observed among participants in program B (30% to 4%). Upon re-occurrence of LBP symptoms, half of the pilots in program B again performed exercises to improve their pain. CONCLUSION: This study indicates that exercise programs focused towards lumbar trunk muscular endurance reduces flying related transient LBP and sick-leave among helicopter pilots. These findings may have implications for the pilots' working conditions.

Chiropractic management of dominating one-sided pelvic girdle pain in pregnant women; a randomized controlled trial.

BACKGROUND: The aim of this study was to investigate the outcome of chiropractic management for a subgroup of pregnant women with dominating one-sided pelvic girdle pain (PGP). METHODS: The study population was recruited from a prospective longitudinal cohort study of pregnant women. Women reporting pelvic pain (PP), and who were diagnosed with dominating one-sided PGP after a clinical examination, were invited to participate in the intervention study. Recruitment took place either at 18 weeks, or after an SMS-tracking up to week 29. The women were randomized into a treatment group or a control group. The treatment group received chiropractic treatment individualized to each woman with regards to treatment modality and number of treatments. The control group was asked to return to conventional primary health care. The primary outcome measure was new occurrence of full time and/or graded sick leave due to PP and/or low back pain. Secondary outcome measures were self-reported PP, physical disability and general health status. Proportion of women reporting new occurrence of sick leave were compared using Chi squared tests. Differences in secondary outcome measures were estimated using linear regression analyses. RESULTS: Fifty-Six women were recruited, and 28 of them were randomized into the treatment group, and 28 into the control group. There was no statistically significant difference in sick leave, PP, disability or general health status between the two groups during pregnancy or after delivery. CONCLUSION: The study did not demonstrate superiority of chiropractic management over conventional care for dominating one-sided PGP during pregnancy. However, the analyses revealed wide confidence intervals containing both positive and negative clinically relevant effects. TRIAL REGISTRATION: The study was registered in ClinicalTrials.gov ( NCT01098136 ; 22/03/2010).

Impact of exercise programs among helicopter pilots with transient LBP.

BACKGROUND: Flight related low back pain (LBP) among helicopter pilots is frequent and may influence flight performance. Prolonged confined sitting during flights seems to weaken lumbar trunk (LT) muscles with associated secondary transient pain. Aim of the study was to investigate if structured training could improve muscular function and thus improve LBP related to flying. METHODS: 39 helicopter pilots (35 men and 4 women), who reported flying related LBP on at least 1 of 3 missions last month, were allocated to two training programs over a 3-month period. Program A consisted of 10 exercises recommended for general LBP. Program B consisted of 4 exercises designed specifically to improve LT muscular endurance. The pilots were examined before and after the training using questionnaires for pain, function, quality of health and tests of LT muscular endurance as well as ultrasound measurements of the contractility of the lumbar multifidus muscle (LMM). RESULTS: Approximately half of the participants performed the training per-protocol. Participants in this subset group had comparable baseline characteristics as the total study sample. Pre and post analysis of all pilots included, showed participants had marked improvement in endurance and contractility of the LMM following training. Similarly, participants had improvement in function and quality of health. Participants in program B had significant improvement in pain, function and quality of health. CONCLUSIONS: This study indicates that participants who performed a three months exercise program had improved muscle endurance at the end of the program. The helicopter pilots also experienced improved function and quality of health. TRIAL REGISTRATION: Identifier: NCT01788111 Registration date; February 5th, 2013, verified April 2016.

Outcome After Rewarming From Accidental Hypothermia by Use of Extracorporeal Circulation.

BACKGROUND: Accidental hypothermia with arrested circulation remains a condition associated with high mortality. In our institution, extracorporeal circulation (ECC) rewarming has been the cornerstone in treating such patients since 1987. We here explore characteristics and outcomes of this treatment, to identify significant merits and challenges from 3 decades of experience in ECC rewarming. METHODS: Sixty-nine patients rewarmed by ECC during the period from December 1987 to December 2015 were analyzed. One patient was excluded from the analyses because of combined traumatic cerebral injury. The analysis was focused on patient characteristics, treatment procedures, and outcomes were focused. Survivors were evaluated according to the cerebral performance categories scale. Simple statistics with nonparametric tests and χ2 tests were used. Median value and range are reported. RESULTS: Median age was 30 years (minimum 1.5, maximum 76), and the cause of accidental hypothermia was cold exposure (27.9%), avalanche (5.9%), and immersion/submersion accidents (66.2%). Eighteen patients survived (26.5%). The survival rate did not improve during the years. Survivors had lower serum potassium (p = 0.002), higher pH (p = 0.03), lower core temperature (p = 0.02), and shorter cardiopulmonary resuscitation time (p = 0.001), but ranges were wide. Although suspected primary hypoxia and hypothermia were associated with lower survival, we observed a 10.5% survival of these victims. Sixteen survivors had good outcome (cerebral performance category 1 or 2), whereas 2 patients with suspected primary hypoxia survived with severe cerebral disability (cerebral performance category 3). CONCLUSIONS: Despite extended experience with ECC rewarming, improved handling strategies, and intensive care, no overall improvement in survival was observed. Good outcome was observed even among patients with a dismal prognosis.

Recurrent and Transient Spinal Pain Among Commercial Helicopter Pilots.

OBJECTIVE: The aim of this study was to provide information on the occurrence of spinal pain, i.e., low back and neck pain, among commercial helicopter pilots, along with possible associations between pain and anthropometric and demographic factors and flying exposure. METHODS: Data were collected through a subjective and retrospective survey among all the 313 (294 men, 19 women) full-time pilots employed by two helicopter companies. A questionnaire was used to assess the extent of spinal complaints in a transient and recurrent pain pattern along with information on physical activities, occupational flying experience, and airframes. RESULTS: The survey had 207 responders (194 men, 13 women). The pilots had extensive flying experience. Spinal pain was reported by 67%. Flying-related transient pain was reported among 50%, whereas recurrent spinal pain, not necessarily associated with flying, was reported by 52%. Women experienced more pain, but sample size prevented further conclusions. Male pilots reporting any spinal pain flew significantly more hours last year (median 500 h, IQR 400-650) versus men with no pain (median 445 h, IQR 300-550). Male pilots with transient or recurrent spinal pain did not differ from nonaffected male colleagues in the measured parameters. CONCLUSION: Spinal pain is a frequent problem among male and female commercial helicopter pilots. For men, no significant associations were revealed for transient or recurrent spinal pain with age, flying experience in years, total hours, annual flying time, type of aircraft, or anthropometric factors except for any spinal pain related to hours flown in the last year.

The association between pelvic girdle pain and sick leave during pregnancy; a retrospective study of a Norwegian population.

BACKGROUND: The incidence of pelvic girdle pain (PGP) in pregnancy is wide ranged depending on definition, the utilised diagnostic means, and the design of the studies. PGP during pregnancy has negative effects on activities of daily living and causes long sick leave, which makes it a major public health issue. Our objectives were to explore the frequency of sick leave in pregnancy due to PGP, assess the relationship between different types of pain-related activities of daily living, examine physical workload, type of work in relation to sick leave, and to explore factors that make women less likely to take sick leave for PGP. METHODS: All women giving birth at the maternity ward of Stavanger University Hospital, Norway, were asked to participate and complete a questionnaire on demographic features, PGP, pain-related activities of daily living, sick leave in general and for PGP, frequency of exercising before and during pregnancy. Drawings of pelvic girdle and low back area were used for the localization of pain. PGP intensity was then rated retrospectively on a numerical rating scale. Non-parametric tests, multinomial logistic regression and sequential linear regression analysis were used in the statistical analysis. RESULTS: PGP is a frequent and major cause of sick leave during pregnancy among Norwegian women, which is also reflected in activities of daily living as measured with scores on all Oswestry disability index items. In the multivariate analysis of factors related to sick leave and PGP we found that work satisfaction, problems with lifting and sleeping, and pain intensity were risk factors for sick leave. In addition, women with longer education, higher work satisfaction and fewer problems with sitting, walking and standing, were less likely to take sick leave in pregnancy, despite the same pain intensity as women being on sick leave. CONCLUSIONS: A coping factor in pregnant women with PGP was discovered, most likely dependant on education, associated with work situation and/or work posture, which decreases sick leave. We recommend these issues to be further examined in a prospective longitudinal study since it may have important implications for sick leave frequency during pregnancy.

Intraaortic counterpulsation during cardiopulmonary bypass impairs distal organ perfusion.

BACKGROUND: Recent studies have focused on the use of fixed-rate intraaortic balloon pumping (IABP) during cardiopulmonary bypass (CPB) to achieve pulsatile flow. Because application of an IABP catheter may represent a functional obstruction within the descending aorta, we explored the effect of IABP-pulsed CPB-perfusion with special attention to perfusion above and below the IABP balloon. METHODS: Sixteen animals received an IABP catheter that remained turned off position (NP group, n = 8) or was switched to an automatic mode of 80 beats/min during CPB (PP group, n = 8). Flow-data and pressure-data were obtained above and below the IABP balloon. Tissue perfusion was evaluated by microspheres. RESULTS: IABP-pulsed CPB-perfusion, as assessed at 30 minutes on CPB, increased proximal mean aortic pressure (p < 0.05) and carotid artery blood flow (p < 0.001), but decreased distal mean aortic pressure (p < 0.001). The decrease of distal mean aortic pressure in the PP group was associated with a 75 % decrease (p < 0.001) of renal tissue perfusion. During nonpulsed perfusion the respective variables remained essentially unchanged compared with pre-CPB levels. CONCLUSIONS: Using IABP as a surrogate to achieve pulsatile perfusion during CPB contributes significantly to lowered aortic pressure in the distal portion of aorta and impaired tissue perfusion of the kidneys. The results are focusing on effects that may contribute to organ dysfunction and acute kidney injury. Consequently, assessment of perfusion pressure distal to the balloon should be addressed whenever IABP is used during CPB.

Comparison of empagliflozin and glimepiride as add-on to metformin in patients with type 2 diabetes: a 104-week randomised, active-controlled, double-blind, phase 3 trial.

BACKGROUND: Metformin is the recommended first-line pharmacotherapy for patients with type 2 diabetes. There is no consensus on the optimum second-line pharmacotherapy. We compared the efficacy and safety of the sodium glucose cotransporter 2 inhibitor empagliflozin and the sulfonylurea glimepiride as add-on to metformin in patients with type 2 diabetes. METHODS: In this double-blind phase 3 trial, patients (aged ≥18 years) with type 2 diabetes and HbA1c concentrations of 7-10%, despite metformin treatment and diet and exercise counselling, were randomly assigned in a 1:1 ratio with a computer-generated random sequence, stratified by HbA1c, estimated glomerular filtration rate (eGFR), and region, to empagliflozin (25 mg once daily, orally) or glimepiride (1-4 mg once daily, orally) as add-on to metformin for 104 weeks. Patients and investigators were masked to treatment assignment. The primary endpoint was change from baseline in HbA1c levels at weeks 52 and 104. Differences in the primary endpoint were first tested for non-inferiority (based on a margin of 0·3%). If non-inferiority was shown, differences in the primary endpoint at week 104 were then tested for superiority. Analysis was done on the full-analysis set-ie, patients who were treated with at least one dose of study drug and had a baseline HbA1c value. This study is registered with ClinicalTrials.gov, number NCT01167881. A 104-week extension is ongoing. FINDINGS: Between August, 2010, and June, 2011, 1549 patients were randomly assigned to receive empagliflozin (n=769) or glimepiride (n=780); four patients in the empagliflozin group did not receive the assigned treatment. Empagliflozin was non-inferior to glimepiride at both timepoints. At week 104, adjusted mean difference in change from baseline in HbA1c with empagliflozin versus glimepiride was -0·11% (95% CI -0·19 to -0·02; p=0·0153 for superiority). Adverse events were reported in 661 (86%) patients treated with empagliflozin and 673 (86%) patients treated with glimepiride. Severe adverse events were reported in 72 (9%) patients in the empagliflozin group and 68 (9%) in the glimepiride group. Serious adverse events were reported in 119 (16%) patients in the empagliflozin group and 89 (11%) in the glimepiride group. Confirmed hypoglycaemic adverse events (plasma glucose ≤3·9 mmol/L or requiring assistance) at week 104 were reported in 19 (2%) patients treated with empagliflozin and 189 (24%) patients treated with glimepiride. INTERPRETATION: Empagliflozin might be an effective and a well tolerated second-line treatment option for patients with type 2 diabetes who have not achieved good glycaemic control on metformin. FUNDING: Boehringer Ingelheim and Eli Lilly.

Acute obstruction by Pannus in patients with aortic medtronic-hall valves: 30 years of experience.

BACKGROUND: Acute dysfunction of mechanical aortic valve prostheses is a life-threatening adverse event. Pannus overgrowth, which is fibroelastic hyperplasia originating from the periannular area, is one cause of dysfunction. The aim of this study was to determine the annual incidence of readmittance resulting from acute obstruction caused by pannus during 30 years of observation in patients with Medtronic-Hall aortic valve prostheses and to analyze the risk factors associated with pannus development. METHODS: From 1982 to 2004, 1,187 patients in our department underwent aortic valve replacement with Medtronic-Hall mechanical monoleaflet valve prostheses. As of December 31, 2012, 27 of these patients (2.3%) had presented with acute valve dysfunction caused by pannus obstruction. RESULTS: The annual incidence of pannus was 0.7 per 1,000. The median time from the primary operation to prosthetic dysfunction was 11.1 years (range, 1.2 to 26.8 years). Of the 20 patients who underwent reoperation, 2 died. Seven patients died before reoperation. Women had a higher risk for the development of obstructing pannus, and patients with pannus obstruction were younger. Valve size was not an independent risk factor. CONCLUSIONS: Women and younger patients are at higher risk for pannus development. When acute dysfunction by pannus is suspected in a mechanical aortic valve, an immediate echocardiogram and an emergency aortic valve replacement should be carried out because of the potential of a fatal outcome.

Microvascular fluid exchange during pulsatile cardiopulmonary bypass perfusion with the combined use of a nonpulsatile pump and intra-aortic balloon pump.

OBJECTIVE: To evaluate how pulsed versus nonpulsed cardiopulmonary bypass influences microvascular fluid exchange in an experimental setup combining a nonpulsatile perfusion pump and an intra-aortic balloon pump. METHODS: A total of 16 pigs were randomized to pulsatile cardiopulmonary bypass perfusion with an intra-aortic balloon pump switched to an automatic 80 beats/min mode after the start of cardiopulmonary bypass (pulsatile perfusion [PP] group, n = 8) or to nonpulsatile cardiopulmonary bypass with the pump switched to the off position (nonpulsatile [NP] group, n = 8). Normothermic cardiopulmonary bypass was initiated after 60 minutes of stabilization and continued for 3 hours. The fluid needs, plasma volume, colloid osmotic pressure in plasma, colloid osmotic pressure in interstitial fluid, hematocrit, and total tissue water content were recorded, and the protein masses and fluid extravasation rates were calculated. RESULTS: After cardiopulmonary bypass was started, the mean arterial pressure increased in the PP group and decreased in the NP group. At 180 minutes, the mean arterial pressure of the PP and NP groups was 70.9 ± 2.7 mm Hg and 55.9 ± 2.7 mm Hg, respectively (P = .004). The central venous pressure (right atrium) had decreased in the NP group (P = .002). A decreasing trend was seen in the PP group. No between-group differences were present. The hematocrit and colloid osmotic pressure in plasma and interstitial fluid had decreased similarly in both study groups during cardiopulmonary bypass. The plasma volume of the PP group had decreased initially but then returned gradually to precardiopulmonary bypass levels. In the NP group, the plasma volume remained contracted (P = .02). No significant differences in the fluid extravasation rate were obtained. The fluid extravasation rate of the PP group tended to stay slightly higher than the fluid extravasation rate of the NP group at all measurement intervals. The total tissue water content increased significantly in a number of organs compared with that in the control animals. However, differences in the total tissue water content between pulsed and nonpulsed perfusion were absent. CONCLUSIONS: No significant differences in the fluid extravasation rates were present between pulsed and nonpulsed cardiopulmonary bypass perfusion in the present experimental setup.

Prevalence of low back and pelvic pain during pregnancy in a Norwegian population.

OBJECTIVE: The purpose of this study was to investigate the cumulative prevalence of low back pain (LBP), pelvic pain (PP), and lumbopelvic pain during pregnancy, including features possibly associated with development of pregnancy-related PP, in an unselected population of women. METHODS: A retrospective cohort study was conducted in which all women giving birth at Stavanger University hospital in a 4-month period were asked to participate and to fill in a questionnaire on demographic features, pain, disability, and Oswestry Disability Index. Inclusion criteria were singleton pregnancy of at least 36 weeks and competence in the Norwegian language. RESULTS: Nearly 50% of the women experienced moderate and severe PP during pregnancy. Approximately 50% of them had PP syndrome, whereas the other half experienced lumbopelvic pain. Ten percent of the women experienced moderate and severe LBP alone. These pain syndromes increased sick leave and impaired general level of function during pregnancy. Approximately 50% of women with PP had pain in the area of the symphysis. The analysis of risk factors did not present a unidirectional and clear picture. CONCLUSIONS: Pelvic pain in pregnant women is a health care challenge in which moderate and severe pain develops rather early and has important implications for society. The observed associations between possible causative factors and moderate and severe LBP and PP in this study may, together with results from other studies, bring some valuable insights into their multifactorial influences and provide background information for future studies.

Incidental detection of internal jugular vein thrombosis secondary to undiagnosed benign substernal goiter.

Internal jugular vein thrombosis is a serious event with potentially fatal outcome, where the clinical symptoms may be vague or absent. This paper refers to a rare case where routine carotid Doppler ultrasound prior to coronary artery bypass grafting (CABG) and aortic valve replacement (AVR) in a 76-year-old man, incidentally revealed thrombosis of the right internal jugular vein. Thoracic CT demonstrated an underlying, large, benign substernal multinodular goiter, mainly involving the right lobe, causing compression and displacement of the great vessels. A successful, one-stage operation including ligation of the internal jugular vein to avoid pulmonary embolism and hemithyroidectomy, combined with the scheduled CABG and AVR, was performed. This case illustrates that benign substernal goiter may be associated with asymptomatic internal jugular vein thrombosis. Carotid Doppler ultrasound should involve evaluation of the internal jugular vein concerning thrombosis as its presence may reveal space-occupying lesions in the thorax.