The effect of tadalafil on psychosocial outcomes in Swedish men with erectile distress: a multicentre, non-randomised, open-label clinical study.

A multicentre, non-randomised, open-label study assessed whether personal distress caused by erectile dysfunction (ED) affected psychosocial outcomes of tadalafil treatment. Eligible Swedish men at least 18 years old reporting > or =3-month history of ED were stratified into two groups (manifest or mild/no distress) based upon a distress question administered at enrollment. Tadalafil 20 mg was taken as needed for 8 weeks. The primary outcome was the difference between the two distress groups in change from baseline in the Psychological and Interpersonal Relationship Scales (PAIRS) spontaneity domain. Secondary outcome measures were PAIRS sexual self-confidence and time concerns domains, Life Satisfaction (LiSat-11) checklist and a Global Assessment of Treatment Response. The study also assessed tolerability. Of 662 men enrolled, 88% had manifest distress and 12% had mild/no distress. Baseline-to-endpoint changes for PAIRS domains were not significantly different between groups. Baseline-to-endpoint changes in LiSat-11 items were not significantly different between groups except for satisfaction with sexual life. Compared with men without ED, below normal baseline satisfaction with partner relationship and family life were normalised at endpoint. Over 90% of men reported improved erection and ability to engage in sexual activity. The most common treatment-emergent adverse events were headache, myalgia, dyspepsia, flushing and back pain. One man discontinued because of myalgia; 630 (95%) completed the study. In conclusion, erectile distress levels vary among patients with ED and distress can affect intra-familiar aspects of life, which may have implications for clinical practise. However, distress does not appear to hinder improvement in both mechanical and psychosocial outcomes of tadalafil treatment.

Cost-effectiveness of spinal cord stimulation versus coronary artery bypass grafting in patients with severe angina pectoris--long-term results from the ESBY study.

The present study is a 2-year follow-up of the 104 patients participating in the ESBY study (Electrical Stimulation versus Coronary Artery Bypass Surgery in Severe Angina Pectoris), a randomised prospective study including patients with increased surgical risk and no prognostic benefit from revascularisation. Hospital care costs, morbidity and causes of death after spinal cord stimulation (SCS) and coronary artery bypass grafting (CABG) were assessed, as well as the complication rate of SCS treatment. SCS proved to be a less expensive symptomatic treatment modality of angina pectoris than CABG (p < 0.01). The SCS group had fewer hospitalisation days related to the primary intervention (p < 0.0001) and fewer hospitalisation days due to cardiac events (p < 0.05). The groups did not differ with regard to causes of death. There were no serious complications related to the SCS treatment.

Long-term effects of spinal cord stimulation and coronary artery bypass grafting on quality of life and survival in the ESBY study.

AIMS: To assess the long-term outcome regarding quality of life and survival in patients who were included in the ESBY study 1992-1995. The ESBY study (Electrical Stimulation versus Coronary Artery Bypass Surgery in Severe Angina Pectoris) included 104 patients-with severe angina, increased surgical risk and no prognostic benefits from revascularization-randomized to coronary artery bypass grafting or spinal cord stimulation. METHODS AND RESULTS: The ESBY patients' quality of life was analysed using two questionnaires, and 5-year mortality was assessed. Quality of life improved significantly 6 months after spinal cord stimulation and coronary artery bypass grafting, respectively, compared to run-in (P<0.001). The results were consistent after 4.8 years. The 5-year mortality was 27.9%. There were no significant differences between the groups. CONCLUSIONS: Spinal cord stimulation as well as coronary artery bypass grafting offered long-lasting improvement in quality of life. Survival up to 5 years was comparable between the groups. Both methods can be considered as effective treatment options for patients with severe angina, increased surgical risks and estimated to have no prognostic benefits from coronary artery bypass grafting.

[Treatment guidelines for refractory angina pectoris now available. Therapeutic methods varying between behavior therapy and heart transplantation]. / Nu finns riktlinjer för behandling av refraktär angina pectoris. Terapimetoderna har varierat från beteendeterapi till hjärttransplantation.

Refractory angina pectoris is defined as severe angina despite optimal medical and surgical/invasive treatment (CABG, PTCA). The epidemiology of this condition is unknown. The estimated yearly incidence is 2,000 patients in Sweden and 30,000-50,000 patients in Europe. The patient group is growing as a result of improved therapy. A number of additional treatment modalities have been developed during the last decades. The article summarises the scientifically and clinical basis of these treatments and gives recommendations concerning their use.

Effects of spinal cord stimulation and coronary artery bypass grafting on myocardial ischemia and heart rate variability: further results from the ESBY study.

In the present study, 24-hour ECG recordings were analyzed from the Electrical Stimulation versus Coronary Artery Bypass Surgery (ESBY) Study where spinal cord stimulation was compared to CABG (coronary artery bypass grafting) in selected patients with severe angina pectoris. During the monitoring period, the spinal cord stimulation was discontinued to evaluate possible long-term effects of this treatment. The number of ischemic episodes and the duration of ischemia decreased in the CABG group at the follow-up when compared to spinal cord stimulation (p<0.05). In spite of this, the number of anginal attacks decreased (p<0.0001) in both groups. The fact that the anginal symptoms decreased in the spinal cord stimulation group in spite of discontinued stimulation and lack of effects on ischemic ST changes could indicate a long-term primary analgesic effect of this treatment in addition to the well-documented acute anti-ischemic effect.

Clinical results of microwave thermotherapy for benign prostatic hyperplasia.

Transurethral microwave thermotherapy is a truly office procedure without the need for anesthesia for the treatment of lower urinary tract symptoms caused by benign prostatic hyperplasia. Several devices have been developed. Continuous refinement of the procedure led to higher energy protocols and high-intensity dose protocols applying the heat-shock strategy. We report on the clinical results of these protocols. Symptom scores improve around 60%, whereas maximum urinary flow rate improve from an average 9 to 10 mL/sec at baseline to 14 to 15 mL/sec during follow-up. No significant differences have been shown between the outcomes with the different devices. Long-term data show satisfactory results after 4 years. Initial clinical results with the heat-shock strategy show results comparable to those of higher-energy protocols with decreased morbidity. Treatment morbidity of higher energy protocols is moderate and consists mainly of the need for catheterization and a higher percentage of retrograde ejaculation. To improve treatment efficacy, patient selection appears to be most important. Prostate size, bladder outlet obstruction, age, and prostate composition are of predictive value for treatment outcome. Further development of the treatment protocols and refinement of the urethral applicators might enhance outcome.

New technologies for the surgical management of symptomatic benign prostatic enlargement: tolerability and morbidity of high energy transurethral microwave thermotherapy.

High-energy transurethral microwave thermotherapy is an attractive alternative outpatient single-session treatment for symptomatic benign prostatic enlargement, with good tolerability, low morbidity and few complications. This paper reviews recent published literature, with a focus on tolerability and morbidity.

Acute ischemic chest pain is not associated with increased calcitonin gene-related peptide (CGRP) levels in peripheral plasma nor in the coronary circulation.

Calcitonin gene-related peptide (CGRP) and substance P co-exist in capsaicin-sensitive primary sensory neurons and are released from the myocardium after activation of sensory nerve fibres as well as by ischemia in animals. This study was undertaken to try to clarify the potential involvement of immunoreactive (ir) CGRP in anginal pain and myocardial ischemia in humans. One clinical group (n = 87) and one experimental group (n = 14) were studied. The clinical group was admitted to a coronary care unit with suspected or definite acute myocardial infarction (AMI). The experimental group consisted of patients with severe angina pectoris (NYHA III-IV). This group was subjected to atrial pacing up to the appearance of angina pectoris. Mean irCGRP levels at admission for the clinical group with and without AMI showed no significant difference. Neither were any significant differences found in irCGRP concentrations between patients with pain as compared to those without pain or in the group who had had chest pain >30 min before hospital admission as compared to those with chest pain <30 min. Extraction ratios for lactate and irCGRP was calculated in the experimental group. No statistically significant covariance was found between irCGRP extraction ratio and lactate extraction ratio (r(xy) = -0.006) at the time of appearance of angina during atrial pacing. Despite the facts that CGRP may be liberated by a variety of physiological stimuli and may act as a potent vasodilator in the human vasculature, no evidence has been found in this study that CGRP release is increased as a consequence of ischemia or ischemic pain.

Clinical outcome of patients treated with spinal cord stimulation for therapeutically refractory angina pectoris. The Working Group on Neurocardiology.

OBJECTIVE: To determine morbidity and mortality characteristics in patients treated with electrical neuromodulation for refractory angina pectoris. DESIGN: A retrospective multicentre study of patients treated with spinal cord stimulation between 1987 and 1997; 21 centres were contacted and 14 responded. SETTING: Specialist centres worldwide. PATIENTS: Questionnaires were returned on 517 patients, of whom 71% were male. One was lost to follow up. Mean (SD) age was 63.9 (10.1) years. Duration of angina pectoris was 8.1 (6.3) years. RESULTS: Before spinal cord stimulation, 66% of the patients had experienced myocardial infarction, 68% had three vessel disease, and in 24% the left ventricular ejection fraction (LVEF) was /= 71 years were independent predictors of mortality. During spinal cord stimulation, New York Heart Association functional class improved from 3.5 to 2.1 (p < 0.01); 25 of the deceased patients (24%) and 32 survivors (8%) experienced myocardial infarction; hospital admissions were significantly (p < 0.001) more common in the deceased group (66% v 37%). CONCLUSIONS: The clinical outcome of patients with intractable angina is not adversely affected by the chronic use of neurostimulation.

[Spinal cord stimulation in angina pectoris--what is the current situation?]. / Ryggmärgsstimulering vid angina--var står vi idag?

Spinal cord stimulation has been used to treat intractable angina pectoris since 1985 with good results. Several studies have shown the treatment to yield both anti-anginal and antiischaemic effects. The mechanisms underlying these effects have been investigated in a number of studies, but remain unclear. In a recent randomised prospective study, where spinal cord stimulation was compared to coronary artery bypass surgery, both treatments yielded adequate relief of symptoms, and there was no subgroup difference in this respect. The article consists in a review of current trends in this field.

Esophageal dysfunction in syndrome X.

Syndrome X is defined as anginal chest pain accompanied by objective signs of ischemia on exercise testing or myocardial scintigraphy, but with angiographically "normal" coronary arteries. The etiology of this enticing syndrome is still not known. Besides myocardial ischemia, esophageal dysfunction and visceral hypersensitivity may play a role in the development of pain. The purpose of this study was to study esophageal function and visceral sensitivity in patients with syndrome X. Twenty consecutive patients with the diagnosis of syndrome X were investigated with esophageal manometry and a 24-hour pH recording. Visceral esophageal sensitivity was explored by balloon distention of the distal esophagus, as well as by instillation of acid. Twelve patients (67% of the 18 evaluated) had some abnormality on 24-hour pH monitoring; 2 had abnormal global acid exposure time (pH <4) and 7 had symptoms coincidental with episodes of pH <4. Seven patients (35%) had esophageal dysmotility including 5 with the "nutcracker" esophagus. Esophageal hypersensitivity to acid (n = 9) or distention (n = 13) was seen in 14 of the 20 patients. Eleven patients received acid suppressive therapy that resulted in amelioration of chest pain in 8 (73%). Thus, results suggest that esophageal hypersensitivity rather than gross functional abnormality is an important factor for the development of chest pain in patients with syndrome X, and that acid in the context of a hypersensitive esophagus is the main culprit. Acid suppression may ameliorate pain in a substantial proportion of patients.

Pressure-flow studies before and after transurethral microwave thermotherapy of benign prostatic hyperplasia using low- and high-energy protocols.

OBJECTIVE: To compare pressure-flow results before and 3 months after transurethral microwave thermotherapy (TUMT) for benign prostatic hyperplasia (BPH), performed with lower and higher energy protocols. PATIENTS AND METHODS: Twenty-four patients were treated using a high-energy protocol performed with a heatshock strategy, i.e. a rapid increase in intraprostatic temperatures to a maximum of 55-67 degrees C. A helical antenna was used which produced maximum heating at the base of the prostate. A further 25 patients were treated using a lower energy protocol with a slow increase in intraprostatic temperatures to a maximum of 45-53 degrees C. A first-generation filament antenna was used with the maximum heat produced at the prostatic apex. All treatments were performed as single-session outpatient procedures of 60-70 min duration. RESULTS: There was a significantly greater improvement in pressure-flow variables, i.e. maximum urinary flow rate, detrusor pressure at maximum flow and minimal urethral opening pressure, in those treated with higher energy TUMT than in those receiving the lower energy protocol. The Madsen and quality-of-life scores, and maximum urinary flow rate on uroflowmetry, were also significantly better in the higher energy group. CONCLUSION: Higher energy TUMT performed using a heat-shock strategy provides a better pressure-flow outcome than lower energy thermotherapy. Compared with previously published results, the outcome after higher energy TUMT is at least similar to other treatment alternatives for BPH.

Esophageal visceral pain sensitivity: effects of TENS and correlation with manometric findings.

Increased esophageal visceral sensitivity has been suggested to be an important factor in the development of esophageal chest pain. Transcutaneous electrical nerve stimulation (TENS) has been found effective in the treatment of visceral heart pain in severe angina pectoris, but its effect on esophageal pain perception is not known. In this study, we used the method of graded intraesophageal balloon distension to study the effects of TENS on esophageal motility and pain sensitivity. In addition, we explored the relationship between manometric findings and esophageal susceptibility to pain. TENS reduced symptoms during balloon distension significantly and decreased peristaltic velocity. Increased visceral perception was positively correlated to the amplitude and duration of the esophageal peristalsis. This study suggests a correlation between increased peristaltic waves and visceral perception in the esophagus. TENS appears to reduce esophageal pain sensitivity and thus may be a useful treatment for noncardiac chest pain of esophageal origin.

Effects of spinal cord stimulation on coronary blood flow velocity.

BACKGROUND: Spinal cord stimulation (SCS) has been used in the treatment of severe angina pectoris since the 1980s. Several studies have shown both an antianginal and an anti-ischaemic effect. There are several theories about the mechanism behind the anti-ischaemic effect of SCS, including the possibility that it is dependent on an increase in coronary flow velocity. OBJECTIVE: To determine if there were effects of SCS on coronary flow velocity during cardiac stress. METHOD: Eight patients with severe anginal pain secondary to coronary artery disease who had been implanted with an SCS device were included in the study. In addition, four patients with syndrome X were examined. If possible, a Doppler guidewire was placed in the vessel corresponding to the ischaemic area revealed on a prior myocardial scintigram. A temporary pacemaker electrode was placed in the right atrium. Atrial pacing started at 80 beats/min and increased by 10 beats/min every 2 min until the patient experienced moderate angina; the pacing frequency was then maintained at the same level. After 2 min of pacing at this frequency, SCS treatment commenced; after a further 5 min, pacing was stopped. Throughout the procedure, coronary flow velocity, assessed as average peak velocity (APV), was monitored continually. RESULTS: APV increased during pacing in all the patients with coronary artery disease (mean increase 53%; P < 0.02). There were no significant changes in APV during maximum pacing frequency when stimulation was introduced. CONCLUSIONS: The results of this study do not support the theory that the anti-ischaemic effect of SCS is dependent on an increase in coronary flow velocity.

Temperature controlled high energy transurethral microwave thermotherapy for benign prostatic hyperplasia using a heat shock strategy.

PURPOSE: We evaluate the clinical outcome of temperature controlled high energy transurethral microwave thermotherapy for benign prostatic hyperplasia using heat shock strategy. MATERIALS AND METHODS: A total of 32 patients were evaluated 3, 6 and 12 months after thermotherapy according to symptom scores, uroflowmetry, residual urine volume, sexual functions and side effects. RESULTS: At 12 months symptom score and maximum flow rate had improved 79% from 13.5 to 2.9, and 71% from 10.0 to 17.1 ml. per second, respectively. Furthermore, bother and quality of life scores and residual and voided urine volumes had improved significantly. However, a higher morbidity than previously shown after lower energy protocols was demonstrated. Treatment influenced sexual functions, especially ejaculation quality, and after treatment 29% of the patients had anejaculation. Significantly less energy was required for prostate volumes 40 ml. or greater to reach the same intraprostatic temperature level as those less than 40 ml. as demonstrated by radiometry. CONCLUSIONS: High energy transurethral microwave thermotherapy using a heat shock strategy is an effective treatment for benign prostatic hyperplasia and produces a better outcome than shown with lower energy protocols. However, the morbidity is not negligible and ejaculation quality is affected. Less relative energy is needed for large than small prostate volumes to reach the same intraprostatic temperature level as demonstrated by radiometry.

Myocardial turnover of endogenous opioids and calcitonin-gene-related peptide in the human heart and the effects of spinal cord stimulation on pacing-induced angina pectoris.

Earlier studies have shown that spinal cord stimulation (SCS) has antianginal and anti-ischemic effects in severe coronary artery disease. In the present study, 14 patients were subjected to right-sided atrial catheterization and atrial pacing. The patients were paced to angina during a control session and during spinal cord stimulation. Myocardial extraction of beta-endorphin (BE) during control pacing (8 +/- 22%) changed to release at the maximum pacing rate during treatment (-21 +/- 47%, a negative value representing release). Furthermore, the results indicate local myocardial turnover of leuenkephalin, BE and calcitonin-gene-related peptide. In addition, it is implied that SCS may induce myocardial release of BE which could explain the beneficial effects in myocardial ischemia.

Electrical stimulation versus coronary artery bypass surgery in severe angina pectoris: the ESBY study.

BACKGROUND: Spinal cord stimulation (SCS) has been shown to have antianginal and anti-ischemic effects in severe angina pectoris. The present study was performed to investigate whether SCS can be used as an alternative to coronary artery bypass grafting (CABG) in selected patient groups, ie, patients with no proven prognostic benefit from CABG and with an increased surgical risk. METHODS AND RESULTS: One hundred four patients were randomized (SCS, 53; CABG, 51). The patients were assessed with respect to symptoms, exercise capacity, ischemic ECG changes during exercise, rate-pressure product, mortality, and cardiovascular morbidity before and 6 months after the operation. Both groups had adequate symptom relief (P<.0001), and there was no difference between SCS and CABG. The CABG group had an increase in exercise capacity (P=.02), less ST-segment depression on maximum (P=.005) and comparable (P=.0009) workloads, and an increase in the rate-pressure product both at maximum (P=.0003) and comparable (P=.03) workloads compared with the SCS group. Eight deaths occurred during the follow-up period, 7 in the CABG group and 1 in the SCS group. On an intention-to-treat basis, the mortality rate was lower in the SCS group (P=.02). Cerebrovascular morbidity was also lower in the SCS group (P=.03). CONCLUSIONS: CABG and SCS appear to be equivalent methods in terms of symptom relief in this group of patients. Effects on ischemia, morbidity, and mortality should be considered in the choice of treatment method. Taking all factors into account, it seems reasonable to conclude that SCS may be a therapeutic alternative for patients with an increased risk of surgical complications.