Efficacy of spinal cord stimulation as adjuvant therapy for intractable angina pectoris: A prospective, randomized clinical study

AbstractObjective. In a prospective, randomized study with an 8-week follow-up period, we evaluated the efficacy of spinal cord stimulation on exercise capacity and quality of life in patients with intractable angina.Background. Despite important achievements in therapy for ischemic heart disease, there remain patients with intractable symptoms of angina. In uncontrolled observations, several investigators have reported beneficial effects of spinal cord stimulation as an additional therapy for patients with angina pectoris.Methods. Seventeen patients were randomly assigned to the treatment (implantation within 2 weeks, eight patients) or control (implantation after 8 weeks, nine patients) group. Assessment of exercise capacity was performed by treadmill exercise testing. Quality of life was evaluated by daily and social activity scores and recording sublingual glyceryl trinitrate intake and angina pectoris attacks in a diary. After the 8-week study period, the control group also received the spinal cord stimulation device, and all patients were followed up for 12 months.Results. The treatment but not the control group demonstrated a significant increase in exercise duration (p < 0.02), rate-pressure product (p < 0.03) and time to angina (p < 0.04), with a decrease in ST segment depression (p < 0.05). This was associated with an increase in daily life (p < 0.008) and social activity (p < 0.005) scores and a reduction in glyceryl trinitrate intake (p < 0.004) and episodes of angina pectoris (p < 0.003). During the 1-year follow-up, improvement in an quality of life variables was linear for the entire group compared with baseline. The time to angina, exercise duration and ST segment depression showed a second-order trend.Conclusions. Spinal cord stimulation significantly improves exercise capacity and quality of life. On the basis of an increase in exercise capacity and rate-pressure product, the mechanism by which spinal cord stimulation acts may be related to improved oxygen supply to the heart combined with an analgesic effect

Current and novel renal biomarkers in heart failure

Renal function is the most important predictor of clinical outcome in heart failure (HF). It is therefore essential to have accurate and reliable measurement of renal function and early specific markers of renal impairment in patients with HF. Several renal functional entities exist, including glomerular filtration (GFR), glomerular permeability, tubulointerstitial damage, and endocrine function. Different markers have been studied that can be used to determine changes and the effect of treatment in these entities. In the present review, we summarize current and novel markers that give an assessment of renal function and prognosis in the setting of acute and chronic HF

Biochemical Validation of Patient-Reported Symptom Onset Time in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

AbstractObjectivesThis study evaluated a biochemical validation of patient-reported symptom onset time in patients with ST-segment elevation myocardial infarction (STEMI).BackgroundSymptom onset time is an important metric but has never been formally validated.MethodsThe Mayo Clinic Percutaneous Coronary Intervention (PCI) Registry was interrogated to obtain baseline, procedural, and outcome data on 607 STEMI patients undergoing primary PCI. Biochemical onset time was determined by backward extrapolation of serial increasing cardiac troponin T (cTnT) measurements.ResultsThe median patient-reported onset time was 12 min later than the calculated time of first cTnT increase and was therefore estimated to be 4.2 h later than the biochemical onset time (interquartile range: 1.9 to 11.1 h; p < 0.001), assuming a 4-h interval between coronary occlusion and first cTnT increase. Conventional ischemic time showed no association with infarct size (correlation with peak cTnT: r = 0.023; p = 0.61) or 1-year mortality (hazard ratio: 0.97 per doubling; 95% confidence interval: 0.68 to 1.40; p = 0.88). However, after recalculation of ischemic time with biochemical onset time, significant associations with infarct size (r = 0.14; p = 0.001) and 1-year mortality (hazard ratio: 1.70 per doubling; 95% confidence interval: 1.20 to 2.40; p = 0.003) were found. When underestimation of ischemic time by patient-reported onset time increased, so did the risk of mortality.ConclusionsAlthough our point estimate should be interpreted with caution, our study indicates that the actual onset of STEMI is likely to be earlier than the patient-reported onset time. Recalculation of ischemic time with biochemical onset time greatly enhanced its prognostic value. Underestimation of ischemic time by patient-reported onset time occurred more often in high-risk patients

Pragmatic rules for comparability of biological medicinal products

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Applying multiple criteria decision analysis to comparative benefit-risk assessment: choosing among statins in primary prevention

Decision makers in different health care settings need to weigh the benefits and harms of alternative treatment strategies. Such health care decisions include marketing authorization by regulatory agencies, practice guideline formulation by clinical groups, and treatment selection by prescribers and patients in clinical practice. Multiple criteria decision analysis (MCDA) is a family of formal methods that help make explicit the tradeoffs that decision makers accept between the benefit and risk outcomes of different treatment options. Despite the recent interest in MCDA, certain methodological aspects are poorly understood. This paper presents 7 guidelines for applying MCDA in benefitrisk assessment and illustrates their use in the selection of a statin drug for the primary prevention of cardiovascular disease. We provide guidance on the key methodological issues of how to define the decision problem, how to select a set of nonoverlapping evaluation criteria, how to synthesize and summarize the evidence, how to translate relative measures to absolute ones that permit comparisons between the criteria, how to define suitable scale ranges, how to elicit partial preference information from the decision makers, and how to incorporate uncertainty in the analysis. Our example on statins indicates that fluvastatin is likely to be the most preferred drug by our decision maker and that this result is insensitive to the amount of preference information incorporated in the analysis

Quality of Life and Depressive Symptoms in the Elderly:A Comparison Between Patients With Heart Failure and Age- and Gender-Matched Community Controls

Background: Comparisons of heart failure (FIF) patients with an unselected healthy sample in terms of quality of life (QoL) and depressive symptoms might prove misleading. We compared QoL, and depressive symptoms of a HF population with an age- and gender-matched sample of community dwelling elderly. Methods and Results: Data were collected from 781 HF patients (36% female., age 72 +/- 9; New York Heart Association II-IV) and 781 age- and gender-matched community-dwelling elderly. Participants Completed the Medical Outcome Study 36-item General Health Survey, the Cantril's Ladder of life, and the Center for Epidemiological Studies-Depression scale (CES-D). Analysis of variance techniques e with Welch F test and chi-square tests were used to describe differences in QoL and depressive symptoms between different groups. For both men and women with HF, QoL was reduced and depressive symptoms were elevated when compared with their elderly counterparts (CES-D >= 16: 39% vs. 21 %, P <.001). HF patients had more chronic conditions--specifically diabetes and asthma/chronic obstructive pulmonary disease. Impaired QoL and depressive symptoms were most prevalent among HF patients with comorbidities. Prevalence was also higher in HF patients in the absence of these conditions. Conclusions: HF has it large impact on QoL and depressive symptoms, especially in women with HF. Differences persist, even in the absence of common comorbidities. Results demonstrate the need for studies of representative HF patients with direct comparisons to age- and gender-matched controls. (J. Cardiac Fail 2009;15:17-23

A multi-criteria decision analysis perspective on the health economic evaluation of medical interventions

Abstract A standard practice in health economic evaluation is to monetize health effects by assuming a certain societal willingness-to-pay per unit of health gain. Although the resulting net monetary benefit (NMB) is easy to compute, the use of a single willingness-to-pay threshold assumes expressibility of the health effects on a single nonmonetary scale. To relax this assumption, this article proves that the NMB framework is a special case of the more general stochastic multi-criteria acceptability analysis (SMAA) method. Specifically, as SMAA does not restrict the number of criteria to two and also does not require the marginal rates of substitution to be constant, there are problem instances for which the use of this more general method may result in a better understanding of the tradeoffs underlying the reimbursement decision-making problem. This is illustrated by applying both methods in a case study related to infertility treatment

Off-pump hepatic to azygos connection via thoracotomy for relief of fistulas after a Kawashima procedure:Ten-year results

Objectives: An almost universal incidence of developing pulmonary arteriovenous fistulas after the Kawashima operation has been reported. Exclusion of the hepatic venous flow from the pulmonary circulation causes the development of these malformations. Redirection of hepatic venous flow to the pulmonary circulation mostly leads to the regression of the arteriovenous fistulas.Methods: We analyzed 11 patients with arteriovenous fistulas that developed after the Kawashima operation. The hepatic-to-azygos shunts were performed with an off-pump technique through a lateral thoracotomy in all but one. Operative and postoperative data were retrospectively collected.Results: No intraoperative complications occurred, and no patient died in the hospital. Up to 10-year follow-up showed a significant postoperative improvement of patients' oxygen saturation and New York Heart Association class. Apart from 2 re-thoracotomies for bleeding in 1 patient, no complications occurred and no patient died during follow-up. Two other patients underwent reoperation for an undiagnosed additional hepatic vein. The improvement of patients' oxygen saturation and New York Heart Association class persisted during the follow-up period.Conclusions: The surgical connection can be performed safely with an off-pump technique that avoids the risks related to extracorporeal circulation and circulatory arrest. The results at 10 years follow-up confirmed the efficacy and safety of the surgical technique described.</p

Cardiac Magnetic Resonance Derived Left Ventricular Eccentricity Index and Right Ventricular Mass Measurements Predict Outcome in Children with Pulmonary Arterial Hypertension

Pulmonary arterial hypertension (PAH) is associated with increased right ventricular (RV) afterload, affecting RV remodeling and RV performance, a major determinant of outcome in PAH-patients. In children with PAH, treatment strategy is guided by risk stratification where noninvasive prognosticators are highly needed. The prognostic value of RV characteristics derived by cardiac magnetic resonance (CMR) has been scarcely studied in pediatric PAH. We aimed to identify CMR-derived morphometric and functional RV characteristics prognostic for outcome in children with PAH. From the Dutch National cohort, thirty-eight children with either idiopathic/heritable PAH (IPAH/HPAH) or PAH associated with congenital heart disease (PAH-CHD), who underwent CMR, were included (median (interquartile range) [IQR] age 13.0 years (10.8–15.0), 66% females). Patients had severe PAH, characterized by their World Health Organization Functional Class, increased N-terminal pro-B-type natriuretic peptide and high pulmonary arterial pressure and pulmonary vascular resistance index at time of CMR. RV-ejection fraction (RVEF), indexed RV-mass (RVMi), the ratio between RV and LV mass (RVM/LVM-ratio) and left ventricular eccentricity index (LVEI) all correlated with transplant-free survival from time of CMR. These correlations could not be confirmed in the PAH-CHD group. This study shows that CMR-derived measures reflecting RV function and remodeling (LVEI, RVMi, RVM/LVM-ratio, RVEF) predict transplant-free survival in children with IPAH/HPAH and may be included in risk stratification scores in pediatric PAH.</p

Angioscopic versus angiographic detection of initial detection of intimal dissection and intracoronary thrombus

AbstractObjectives. This study was undertaken to compare coronary angioscopy with angiography for the detection of intimal dissection and intracoronary thrombus.Background. It has been demonstrated previously that coronary angioscopy provides more intravascular detail than cineangiography. Both imaging methods have to be compared directly to assess the additional diagnostic value of angioscopy.Methods. The angiograms and videotapes of 52 patients who had undergone angioscopy were reviewed independently by two observers unaware of other findings. Classic angiographic definitions were used for dissection and thrombus. Angioscopic dissection was defined as visible cracks or fissures on the lumen surface or mobile protruding structures that are contiguous with the vessel wall. Angioscopic thrombus was defined as a red, white or mixed red and white intraluminal mass.Results. Angiography and angioscopy were in agreement in 40.4% of cases in the absence of thrombus and in 11.5% in the presence of thrombus. No fewer than 25 (48.1%) angioscopically observed thrombi remained undetected at angiography. With angioscopy as the standard, although the specificity of angiography for thrombus was 100%, sensitivity was very low at 19%. Angioscopic dissection was present in 40 patients (76.9%) versus angiographic dissection in 15 patients (28.8%). With regard to dissection, there was no correlation between the two imaging methods (rΦ= 0.15, p = 0.29).Conclusions. Coronary angiography underestimates the presence of intracoronary thrombus. Angioscopy and angiography are complementary techniques for detecting and grading intima1dissections