Endovascular renal sympathetic denervation to improve heart failure with reduced ejection fraction: the IMPROVE-HF-I study.

INTRODUCTION: The aim of the present study was to assess the safety and efficacy of renal sympathetic denervation (RDN) in patients with heart failure with reduced ejection fraction (HFrEF). METHODS: We randomly assigned 50 patients with a left ventricular ejection fraction (LVEF) ≤ 35% and NYHA class ≥ II, in a 1:1 ratio, to either RDN and optimal medical therapy (OMT) or OMT alone. The primary safety endpoint was the occurrence of a combined endpoint of cardiovascular death, rehospitalisation for heart failure, and acute kidney injury at 6 months. The primary efficacy endpoint was the change in iodine-123 meta-iodobenzylguanidine (123I­MIBG) heart-to-mediastinum ratio (HMR) at 6 months. RESULTS: Mean age was 60 ± 9 years, 86% was male and mean LVEF was 33 ± 8%. At 6 months, the primary safety endpoint occurred in 8.3% vs 8.0% in the RDN and OMT groups, respectively (p = 0.97). At 6 months, the mean change in late HMR was -0.02 (95% CI: -0.08 to 0.12) in the RDN group, versus -0.02 (95% CI: -0.09 to 0.12) in the OMT group (p = 0.95) whereas the mean change in washout rate was 2.34 (95% CI: -6.35 to 1.67) in the RDN group versus -2.59 (95% CI: -1.61 to 6.79) in the OMT group (p-value 0.09). CONCLUSION: RDN with the Vessix system in patients with HFrEF was safe, but did not result in significant changes in cardiac sympathetic nerve activity at 6 months as measured using 123I­MIBG.

Imaging the inflammatory activity of sarcoidosis: sensitivity and inter observer agreement of (67)Ga imaging and (18)F-FDG PET.

AIM: The aim of this study was to investigate sensitivity of 67Ga imaging and 18F-FDG PET for sarcoidosis activity and their inter observer variability. METHODS: Thirty-four newly diagnosed, histologically proven sarcoidosis patients were analyzed prospectively. (67)Ga imaging and (18)F-FDG PET were performed, the presence of pulmonary and extra pulmonary lesions was evaluated and inter observer variability of both techniques was assessed. RESULTS: Overall sensitivity to detect active sarcoidosis was 88% for (67)Ga imaging and 97% for (18)F-FDG PET. Although these results were not significantly different, 18F-FDG PET detected more lesions in the mediastinum (P<0.05), hila (P<0.05), lymph nodes (P<0.001) and extra pulmonary regions in general (P<0.001). Inter observer agreement was poor to moderate for (67)Ga imaging (kappa 0.19-0.59) and good to very good for (18)F-FDG PET (kappa 0.65-1.00). CONCLUSION: (18)F-FDG PET is more sensitive than (67)Ga imaging in the assessment of sarcoidosis activity with regard to the mediastinum, hila, lymph nodes and extra pulmonary lesions in general. Furthermore, (18)F-FDG PET demonstrates a very good inter observer agreement in contrast with (67)Ga imaging and (18)F-FDG PET is therefore the nuclear imaging technique of choice in sarcoidosis assessment.

Pulmonary function and postoperative complications after wedge and flap reconstructions of the main bronchus.

Between 1980 and 1989, 8 wedge and 17 flap main bronchoplasties were done in 24 patients (4 carcinoid tumors, 4 benign lesions, 17 carcinomas). Bronchial anastomotic stenoses, pulmonary function, and survival were evaluated. Preoperative ventilation/perfusion scans with preoperative and postoperative spirometry were done in all patients except two who underwent a wedge bronchoplasty. Postoperative bronchoscopy was done in all patients. Follow-up was complete for the patients with carcinoma (N = 17). In the wedge group bronchial anastomotic stenoses occurred in three (38%) of eight patients. All three patients had serious postoperative complications (persistent atelectasis in one, prolonged ventilatory support in two); one patient died and the other two had impaired postoperative pulmonary function. Complete function recovery occurred in only three (38%) of eight patients who underwent wedge bronchoplasty. In the flap group, bronchostenosis occurred in 3 (18%) of 17 patients. The associated complications (mucus retention, minor atelectasis, partial lobar torsion) were mild. Complete pulmonary function recovery occurred in 13 (76%) of 17 patients who had flap bronchoplasty. Actuarial survival, for the patients with carcinoma, was 88%, 47%, and 41% after 1, 3, and 5 years, respectively. The local recurrence rate was 25% (4/16). In our series, flap main bronchoplasties were effective for the resection of bronchial tumors with local involvement of the adjacent main bronchus. Wedge main bronchoplasties, however, were associated with substantial postoperative complications.

Lung function and perfusion after bronchial and pulmonary arterial sleeve resection.

Between January 1985 and December 1991, six patients underwent arterial and bronchial sleeve resections of the left upper lobe. Preoperative and postoperative spirometry, preoperative split pulmonary radionuclide ventilation/perfusion (V/Q) scans and postoperative bronchoscopy were obtained in four patients. Postoperative serial digital vascular images (DVI) of the pulmonary artery were obtained in three patients and one patient had a postoperative V/Q scan. For each patient the preoperative and postoperative forced expiratory volume in is (FEV1) were determined to assess the postoperative ventilatory recovery. At bronchoscopy all patients had a patent bronchial anastomosis. At postoperative DVI, in three patients, vascularization of the residual left lung was delayed and less intense compared with the non-operated right lung. Postoperative V/Q scan, in one patient, showed reduced ventilation and perfusion of the residual lung. Preoperative and postoperative FEV1 of the four patients were 2688/1998 ml, 2154/1752 ml, 2618/2100 ml and 2277/2015 ml. Operative mortality was zero. One patient had a postoperative atelectasis of the left lower lobe. In our series, ventilation and vascularization of the reimplanted and revascularized left lower lobe were reduced. But, in our opinion, the preserved residual lung parenchyma was still a relevant advantage.

Pulmonary function after sleeve lobectomy.

Preoperative and postoperative pulmonary function of 109 sleeve lobectomy patients (90 right upper lobe, 10 left upper lobe, and 9 left lower lobe) were evaluated over a period of 30 years. Ninety-eight men and 11 women, with a mean age of 60 years, were reviewed. The diagnosis was lung cancer in 97 patients and carcinoid tumors in 12 patients. Indications for operation were anatomic suitability in 103 patients, and impaired pulmonary function (forced expiratory volume in 1 second (FEV1) less than 1,200 mL) in 6 patients. The predicted postoperative FEV1 was calculated and compared with the measured postoperative FEV1. Preoperative spirometry and split pulmonary radionuclide ventilation/perfusion scans were used to calculate the predicted postoperative FEV1. Postoperative spirometry had been performed 125 days after operation (range, 25 to 342 days). Our results showed a gradual improvement in postoperative pulmonary function. A complete and stable condition was reached 4 months after operation. Correlation between the predicted (mean, 2,097 mL) and measured FEV1 (mean, 2,067 mL) was good (linear regression and correlation test; r = 0.72). These values did not differ significantly (Wilcoxon signed rank test; p = 0.81). Our findings indicated a complete recovery of the reimplanted lung lobes after sleeve lobectomy.

Exercise 201Tl scintigraphy: evaluation of the additional diagnostic value.

The additional diagnostic yield of exercise 201Tl scintigraphy using both visual and quantitative analysis was determined in 221 patients with known or suspected coronary artery disease (CAD). The coronary arteriogram was adopted as the gold standard. After pretest clinical and exercise electrocardiographic data were taken into consideration, scintigraphy added diagnostic accuracy both in the diagnosis of CAD and of multivessel disease. The diagnostic yield of the scintigraphy in terms of sensitivity and specificity was, however, not significant. In 79% (121/153) of the patients, the diagnosis of the presence, or exclusion, of CAD was highly probable (P > 0.80 or P < 0.20) when considering clinical and exercise data. The diagnosis was, however, not significantly improved by the scintigraphic result. Twenty-seven per cent (20/73) returned a negative scintigraphic results with a high (P > 0.80) prescintigraphic probability for CAD and a positive arteriogram. It was concluded that 201Tl scintigraphy has additional diagnostic value after clinical and exercise parameters were taken into consideration in the diagnosis of coronary artery and multiple vessel disease. It is not recommended to refer patients with either a low or high probability of CAD for screening and diagnosis as in a high proportion of patients the diagnosis of CAD could have been made using clinical or exercise data alone.

Evaluation of the incremental diagnostic value and impact on patient treatment of thallium scintigraphy.

The incremental diagnostic yield of exercise 201Tl scintigraphy with visual and quantitative analysis was determined in 191 patients with known or suspected coronary artery disease (CAD). The coronary arteriogram was used as the gold standard. After pre-test clinical and exercise electrocardiographic data were taken into consideration, scintigraphy was found to have additional diagnostic value both in the diagnosis of CAD and of multivessel disease, with quantitative analysis being superior to visual analysis. The impact of 201Tl scintigraphy on the patient's treatment--conservative treatment versus revascularization--was also evaluated. The impact was relatively low, as the decision for revascularization was based primarily on the angiographic result and the severity of the anginal pain. This result reflects only the decision making process used in our clinic and permits no conclusion to be made concerning the possible value of 201Tl scintigraphy in this type of medical decision making process.

Improvement of diagnosis in the non-invasive assessment of coronary artery disease: enhanced evaluation of quantitative exercise 201thallium imaging by multivariate analysis.

STUDY OBJECTIVE: The aim was to evaluate discriminant analysis, performed in patients without prior myocardial infarction, in enhancing the diagnostic value of quantitative exercise 201thallium scintigraphy. DESIGN: All clinical, electrocardiographic, and scintigraphic variables were first subjected to a univariate analysis. Afterwards a discriminant analysis was done. PATIENTS: 135 patients (104 male) were studied. Age was 24-70 years, mean 55 years. MEASUREMENTS AND MAIN RESULTS: Two discriminant analyses were done. In the first analysis, the ability to detect the presence of coronary artery disease was tested. Significant variables were: (1) history of angina, (2) sex, (3) quantitative analysis of 201thallium scintigraphy, (4) age, (5) ischaemic ST response, (6) angina during the test, and (7) the pressure-rate product. The sensitivity, specificity, and accuracy of classification using the discriminant function were 91%, 87%, and 90%, respectively. The sensitivity was higher than when using only visual interpretation (sensitivity 70%; p less than 0.0002) or quantitative interpretation (sensitivity = 66%; p less than 0.0001) of thallium scans, without significant loss of specificity (p less than 0.5488; p less than 0.6875). In the second analysis, a discriminant function was calculated to detect multivessel disease. Five input variables were selected: (1) number of vessels with stenosis predicted by quantitative analysis, (2) number of vessels with stenosis predicted by visual analysis, (3) ischaemic ST response, (4) sex, (5) angina during the test. Multivariate analysis showed an increase in sensitivity when compared with visual interpretation (78% v 55%; p less than 0.0043) and quantitative analysis (66%; p less than 0.0156). Using the classification, the discriminant function was more accurate than visual analysis (81% v 69%) or quantitative analysis (77%). CONCLUSIONS: The results show that multivariate analysis of non-invasive test results in quantitative thallium exercise testing allows convenient use for clinical purposes with improved results.

Contrast venography: from gold standard to 'golden backup' in clinically suspected deep vein thrombosis.

In a series of 180 patients, clinically suspected of having deep venous thrombosis (DVT), contrast venography was compared with radionuclide phlebography, duplex ultrasonography and strain gauge plethysmography. In most patients lung scintigraphy was also performed to detect pulmonary embolism (PE). Venography was performed on a routine basis. All venograms were read by at least two observers (radiologists or radiologist/resident) and an inter-observer agreement was reached of 96% with a kappa value of 0.935. In six patients venography was technically impossible or inadequate, 58% of the patients actually had DVT and 26% developed pulmonary embolism (PE). Of the patients with proven DVT, 43% developed PE. Of the three other methods duplex scanning scored the best for the detection of proximal thrombosis, with 92%, 90% and 9.2, and strain gauge plethysmography the worst, with values of 72%, 78% and 3.2 for, respectively, sensitivity, specificity and positive likelihood ratio's. On the basis of the presented material and the current literature it is concluded that the choice for a screening test for proximal thrombosis could best be made on the basis of (local) availability, cost-effectiveness and patient comfort. Duplex ultra-sonography is tipped as the most promising method, accepting that distal thrombosis (calf veins) does not play an important role in PE. Contrast venography should be used as a 'golden backup' in any case of doubt.

Is quantitative analysis superior to visual analysis of planar thallium 201 myocardial exercise scintigraphy in the evaluation of coronary artery disease? Analysis of a prospective clinical study.

Quantitative analysis of myocardial exercise scintigraphy has been previously reported to be superior to visual image interpretation for detection of the presence and extent of coronary artery disease. Computer analysis of perfusion defects and washout rate of thallium 201 was performed on scintigrams from a group of 131 consecutive patients (prospective group), using criteria defined from a previous group of 72 patients (initial group), and compared with visual interpretation of scintigrams for detection and evaluation of coronary artery disease. The sensitivity of the quantitative technique with regard to overall detection of coronary artery disease was not significantly different from the visual method (69% and 74%, respectively), whereas the specificity was higher (86% and 68%). Quantitative analysis did not increase the sensitivity of thallium imaging over the visual method in the left anterior descending artery (46% vs 65%) and the right coronary artery (51% vs 72%) but did increase sensitivity in the left circumflex artery (75% vs 47%). Whereas in the initial group quantitative analysis resulted in a better identification of multivessel disease (sensitivity 81% vs 57%), in the prospective group sensitivity decreased (54% vs 67%) without significant loss of specificity. The initial group had a 40% incidence of three-vessel disease and the prospective group, 22% (P less than 0.05). One-vessel disease was higher in the prospective group (32% vs 11%, P less than 0.05). Thus, assessing the quantitative technique in a larger prospective patient population, there was no improvement of detection of the presence and extent of coronary artery disease when compared with visual interpretation.

Quantitative thallium-201 scintigraphy after dipyridamole infusion combined with low level exercise in healthy volunteers.

To establish test specific normal limits for quantitative analysis of uptake and washout of 201Tl after dipyridamole infusion combined with low level exercise, 20 healthy volunteers were studied with low likelihood of coronary artery disease (CAD) assessed by a stepwise probability analysis based on age, sex, symptoms, resting electrocardiogram, and exercise electrocardiography. Likelihood of CAD in these volunteers was calculated as less than or equal to 1%. After dipyridamole infusion combined with low level exercise, one volunteer complained of headache; no other side effects were observed. There were no chest pain complaints. Maximal hemodynamic changes were achieved during the 6th and 7th min of the test. No ST segment depression was recorded. Visual analysis of the 201Tl scintigrams was normal in all volunteers. Mean regional washout at 4 h was 44.37% +/- 2.11%. The regional washout in the 70 degrees LAO view (46.65% +/- 1.10%) was significantly higher than in the anterior and 30 degrees LAO views (43.44% +/- 1.50% and 43.02% +/- 1.45%, respectively). Profiles of uptake and washout of 201Tl were different after dipyridamole infusion combined with low level exercise as compared to maximal exercise. Thus, in quantitative analysis of 201Tl scintigraphy after dipyridamole infusion in conjunction with low level exercise as applied in the present study, it is mandatory to use normal limits of uptake and washout of 201Tl derived from healthy volunteers who underwent the same combined protocol.

Efficacy of intravenous dipyridamole with exercise in thallium-201 myocardial perfusion scintigraphy.

To assess the feasibility and the value of thallium-201 myocardial perfusion imaging with intravenous dipyridamole in combination with low-level exercise, 81 patients with suspected or proven coronary artery disease were studied. All patients underwent coronary arteriography. Significant coronary artery disease (stenoses greater than or equal to 50%) was present in 59 patients (73%); multivessel disease (double- and triple-vessel disease) was observed in 33 patients (42%). The overall sensitivity and specificity of the test were 78% and 86%, respectively. Sensitivity and specificity for detection of multivessel disease were 70% and 92%, respectively. The sensitivity for detecting coronary artery disease in the RCA, LAD, and LCX was 74%, 82% and 48%, respectively, and the specificity was 85%, 88% and 88%, respectively. With the combined procedure no serious side effects were observed. Mild side effects like headache, vertigo and nausea were seen in 12 patients (15%). Twenty volunteers with a less than or equal to 1% likelihood of significant coronary artery disease were examined in the same manner to determine the maximal specificity of the procedure (100%). Thus, the combination of two different stress procedures (exercise testing and dipyridamole infusion) can be performed safely without serious side effects. The presence, location and extent of significant coronary artery disease can be assessed to a similar degree as with conventional exercise thallium-201 scintigraphy, which has major implications for the detection of coronary artery disease in patients who are unable to perform maximal exercise.

Dipyridamole thallium testing: noncardiac side effects, cardiac effects, electrocardiographic changes and hemodynamic changes after dipyridamole infusion with and without exercise.

Thallium-201 scintigraphy in combination with intravenous dipyridamole has been reported to be useful in patients who are unable to perform maximal exercise stress testing. Few reports have dealt with side effects in large numbers of patients. For that reason noncardiac side effects, cardiac effects, electrocardiographic changes, as well as hemodynamic changes were studied in 301 consecutive patients, examined by dipyridamole thallium-201 imaging because of suspected coronary artery disease. The patients were divided into two groups (A and B). Patients in group A (101 patients) received an infusion of 0.14 mg/kg per minute dipyridamole for four minutes. Patients in group B (200 patients) received the same dose of dipyridamole followed by low level exercise (60 rpm/30 Watts) for three minutes to achieve maximal coronary blood flow and to diminish thallium-201 uptake in the gastrointestinal organs. The likelihood of having hemodynamically significant coronary artery disease was the same in both groups. Patients in group B experienced significantly less side effects than patients in group A (11% vs 43%, P less than 0.05). In group B changes in systolic blood pressure (P less than 0.05), heart rate (P less than 0.05), and rate pressure product (P less than 0.05) were more distinct. The occurrence of angina was the same in both groups (47% vs 44%, NS), but ischemic ST segment changes were significantly more frequent in group B than in group A (25% vs 12%, P less than 0.05). Thus, exercise added to dipyridamole infusion compared to dipyridamole infusion alone results in fewer noncardiac side effects, the same prevalence of angina pectoris, and a higher incidence of ST segment changes.

A comparative study of intravenous digital subtraction angiography and ventilation-perfusion scans in suspected pulmonary embolism.

We observed 102 patients suspected of having pulmonary emboli (PE) who underwent ventilation-perfusion (V/Q) lung scintigraphy and IV digital subtraction angiography (DSA). Only five DSA studies were inadequate for interpretation. In 81 of the remaining 97 patients (83.5 percent) the results of both studies correlated regarding the probability of PE. In 50 patients the results of both studies were highly suggestive of PE; in 31 patients DSA and V/Q were normal or classified as low probability of PE. There was disagreement in 3/97; in 13/97 one or both studies were nondiagnostic. The clinical data of these 16 patients are given. Conventional catheter pulmonary angiography was indicated in 11/102 patients to establish a firm diagnosis of PE. The results of V/Q and DSA correlated in 83 percent (49/59) of patients without chronic obstructive pulmonary disease (COPD) and in 84 percent (32/38) of the patients with COPD.

Significance of the site of injection in unexpected right-to-left shunting.

Lung perfusion scintigraphy, with Tc-99m MAA injected into a left antecubital vein, revealed extensive uptake in the myocardium, kidneys, spleen, thyroid, and brain. After a right antecubital injection, a normal pulmonary perfusion pattern was found. This finding is specific for right-to-left shunting due to anomalous systemic venous drainage into the left atrium.

A patient with bilateral superior and inferior caval veins.

We present a case with a very uncommon form of anomalous connection: a normal systemic venous connection to the right atrium existing in combination with left superior and inferior caval veins draining into the left atrium (associated with a large ostium primum atrial septal defect). To our knowledge the present report concerns the third case with this very rare congenital anomaly diagnosed during life.