The effect of renal denervation on arterial stiffness, central blood pressure and heart rate variability in treatment resistant essential hypertension: a substudy of a randomized sham-controlled double-blinded trial (the ReSET trial).

OBJECTIVES: To investigate, whether renal denervation (RDN) improves arterial stiffness, central blood pressure (C-BP) and heart rate variability (HRV) in patients with treatment resistant hypertension. METHODS: ReSET was a randomized, sham-controlled, double-blinded trial (NCT01459900). RDN was performed by a single experienced operator using the Medtronic unipolar Symplicity FlexTM catheter. C-BP, carotid-femoral pulse wave velocity (PWV), and HRV were obtained at baseline and after six months with the SphygmoCor®-device. RESULTS: Fifty-three patients (77% of the ReSET-cohort) were included in this substudy. The groups were similar at baseline (SHAM/RDN): n = 27/n = 26; 78/65% males; age 59 ± 9/54 ± 8 years (mean ± SD); systolic brachial BP 158 ± 18/154 ± 17 mmHg; systolic 24-hour ambulatory BP 153 ± 14/151 ± 13 mmHg. Changes in PWV (0.1 ± 1.9 (SHAM) vs. -0.6 ± 1.3 (RDN) m/s), systolic C-BP (-2 ± 17 (SHAM) vs. -8 ± 16 (RDN) mmHg), diastolic C-BP (-2 ± 9 (SHAM) vs. -5 ± 9 (RDN) mmHg), and augmentation index (0.7 ± 7.0 (SHAM) vs. 1.0 ± 7.4 (RDN) %) were not significantly different after six months. Changes in HRV-parameters were also not significantly different. Baseline HRV or PWV did not predict BP-response after RDN. CONCLUSIONS: In a sham-controlled setting, there were no significant effects of RDN on arterial stiffness, C-BP and HRV. Thus, the idea of BP-independent effects of RDN on large arteries and cardiac autonomic activity is not supported.

Renal Artery Stenting in Consecutive High-Risk Patients With Atherosclerotic Renovascular Disease: A Prospective 2-Center Cohort Study.

Background The aim of this study was to prospectively evaluate the effects of renal artery stenting in consecutive patients with severe atherosclerotic renal artery stenosis and high-risk clinical presentations as defined in a national protocol developed in 2015. Methods and Results Since the protocol was initiated, 102 patients have been referred for revascularization according to the following high-risk criteria: severe renal artery stenosis (≥70%) with true resistant hypertension, rapidly declining kidney function, or recurrent heart failure/sudden pulmonary edema. At baseline, the mean 24-hour ambulatory systolic blood pressure was 166.2 mm Hg (95% CI, 162.0-170.4), the defined daily dose of antihypertensive medication was 6.5 (95% CI, 5.8-7.3), and the estimated glomerular filtration rate was 41.1 mL/min per 1.73m2 (95% CI, 36.6-45.6). In 96 patients with available 3-month follow-up data, mean 24-hour ambulatory systolic blood pressure decreased by 19.6 mm Hg (95% CI, 15.4-23.8; P<0.001), the defined daily dose of antihypertensive medication was reduced by 52% (95% CI, 41%-62%; P<0.001), and estimated glomerular filtration rate increased by 7.8 mL/min per 1.73m2 (95% CI, 4.5-11.1; P<0.001). All changes persisted after 24 month follow-up. Among 17 patients with a history of hospitalization for acute decompensated heart failure, 14 patients had no new episodes after successful revascularization. Conclusions In this prospective cohort study, we observed a reduction in blood pressure and antihypertensive medication, an increase in estimated glomerular filtration rate, and a decrease in new hospital admissions attributable to heart failure/sudden pulmonary edema after renal artery stenting. Registration URL: https://clinicaltrials.gov. Identifier: NCT02770066.

Intrapleural fibrinolysis and DNase versus video-assisted thoracic surgery (VATS) for the treatment of pleural empyema (FIVERVATS): protocol for a randomised, controlled trial - surgery as first-line treatment.

INTRODUCTION: Pleural empyema is a frequent disease with a high morbidity and mortality. Current standard treatment includes antibiotics and thoracic ultrasound (TUS)-guided pigtail drainage. Simultaneously with drainage, an intrapleural fibrinolyticum can be given. A potential better alternative is surgery in terms of video-assisted thoracoscopic surgery (VATS) as first-line treatment. The aim of this study is to determine the difference in outcome in patients diagnosed with complex parapneumonic effusion (stage II) and pleural empyema (stage III) who are treated with either VATS surgery or TUS-guided drainage and intrapleural therapy (fibrinolytic (Alteplase) with DNase (Pulmozyme)) as first-line treatment. METHODS AND ANALYSIS: A national, multicentre randomised, controlled study. Totally, 184 patients with a newly diagnosed community acquired complicated parapneumonic effusion or pleural empyema are randomised to either (1) VATS procedure with drainage or (2) TUS-guided pigtail catheter placement and intrapleural therapy with Actilyse and DNase. The total follow-up period is 12 months. The primary endpoint is length of hospital stay and secondary endpoints include for example, mortality, need for additional interventions, consumption of analgesia and quality of life. ETHICS AND DISSEMINATION: All patients provide informed consent before randomisation. The research project is carried out in accordance with the Helsinki II Declaration, European regulations and Good Clinical Practice Guidelines. The Scientific Ethics Committees for Denmark and the Danish Data Protection Agency have provided permission. Information about the subjects is protected under the Personal Data Processing Act and the Health Act. The trial is registered at www. CLINICALTRIALS: gov, and monitored by the regional Good clinical practice monitoring unit. The results of this study will be published in peer-reviewed journals and presented at various national and international conferences. TRIAL REGISTRATION NUMBER: NCT04095676.

Morphological patterns and distributions in portable chest radiographs of COVID-19-positive cases admitted to a tertiary care hospital: An early experience from Scandinavia.

INTRODUCTION: Chest radiographic (CXR) features, particularly portable CXR findings, of COVID-19 have not yet been systematically described, either as a baseline tool or as a follow-up method, despite the continuing global pandemic. There is a marked paucity of articles detailing the CXR findings vis-à-vis a multitude of articles dedicated to the CT features of COVID-19. The purpose of this article is to describe the morphological and distributional patterns of the lung opacities in CXR and to classify the spectrum of essential features on portable AP chest radiographs of PCR-positive COVID-19 patients admitted in a tertiary care hospital in Scandinavia. To our knowledge, this is the first article to describe the morphological and topographical features of CXRs in COVID-19-positive cases. METHODS: A retrospective analysis of twenty (20) RT-PCR-positive COVID-19 patients admitted to the hospital between 12.03.2020 to 10.04.2020 was done in this study. Morphology and distribution of the opacities were reviewed by two senior consultants and analysed for patterns. RESULTS: Most patients had ground-glass opacities (80-85%) and interspersed interstitial opacities (70-75%), often with a characteristic appearance. The opacities were mostly bilateral (80%) and distributed in the lower zones (and to some extent mid zones) and in the middle and peripheral regions, with a tendency to merge towards the hilar areas. There were high interobserver agreements among various parameters and no significant statistical difference between observer 1 and 2. CONCLUSION: Chest radiographics show characteristic patterns and distributions, which can be used as an adjunct in the diagnosis and follow-up of COVID-19 patients in specific clinical contexts.

Complication Incidences and Treatment Outcomes of Endovascular Aneurysm Repair-A Single-Center Long-Time Follow-Up Study.

BACKGROUND: Few long-time follow-up studies describe all complications, treatment outcome of complications, and mortality in relation to endovascular aneurysm repair (EVAR). The purpose of this study was to evaluate the incidence and treatment outcome including mortality of radiological visible complications related to the EVAR procedure at a single center with up to 10 years' surveillance. MATERIALS AND METHODS: Patients treated with EVAR from March 2006 to March 2016 at a Danish university hospital, 421 in total, were included. Patient and aneurysm characteristics, follow-up, and secondary intervention data were collected from a national database and medical records. Follow-up computed tomography angiography and plain abdominal X-ray reports were reviewed for complications. Scans and X-rays with suspected complications were evaluated by an interventional radiologist. RESULTS: A total of 172 complications in 147 patients, mainly in the beginning of the follow-up period, were found; 35% had a least one complication. The main part of complications (62%) was type II endoleaks, followed by stent graft stenosis (11%), type I endoleaks (9%), and stent graft occlusion (7%). A total of 66 (38%) complications, observed in 55 patients, were treated with reintervention, of which 77% were treated with endovascular procedures and 23% with surgical treatment, that is, 13% of all studied patients had a complication that required a reintervention. The remaining 2 of the 3 complications were treated conservatively. We found no increased all-cause mortality in connection with having a complication including those requiring reintervention. CONCLUSION: We presented a 10-year single-center study of EVAR. Many patients treated with EVAR had a radiological visible complication, mainly in the beginning of the follow-up period. Only a smaller fraction required reintervention and having a reintervention-requiring complication was not connected to increased mortality.

A Long-Time Follow-Up Study of a Single-Center Endovascular Aneurysm Repair (Evar) Endoleak Outcomes.

PURPOSE: The aim of this study was to evaluate the incidence, risk factors, and outcome of endoleaks related to endovascular aneurysm repair (EVAR) procedure at a single center with up to 10 years' surveillance. MATERIALS AND METHODS: All patients treated with EVAR for an abdominal aorta or iliac aneurysm in a 10-year period at a single cardiovascular center in Denmark were included. Data were collected from a national database and patient journals. Follow-up computed tomography angiography and plain abdominal X-ray reports were reviewed. RESULTS: A total of 421 patients were included. There were 125 endoleaks observed in 117 (27.8%) patients after a median 95 days (interquartile range: 90-106 days). There were 16 type I, 107 type II, 1 type III, and 1 type V endoleaks. A total of 33 (7.8%) patients had at least 1 reintervention. Patients with type II endoleaks had significantly fewer active smokers and lower plasma creatinine at baseline. They also more often had one, or both, internal iliac arteries embolized as well as an identified endoleak at the procedural completion angiogram. Non-type II endoleaks were associated with internal iliac artery embolization. There was no association between the occurrence of endoleaks and increased mortality. CONCLUSION: Type II endoleaks are common after EVAR, yet few lead to reintervention. Absence of smoking, low plasma creatinine, embolized iliac arteries, and endoleak on completion angiogram were associated with type II endoleaks, whereas only embolized iliac arteries were associated with non-type II endoleaks. Overall, endoleaks are not associated with increased mortality.

Renal denervation in treatment-resistant essential hypertension. A randomized, SHAM-controlled, double-blinded 24-h blood pressure-based trial.

BACKGROUND: Renal denervation (RDN), treating resistant hypertension, has, in open trial design, been shown to lower blood pressure (BP) dramatically, but this was primarily with respect to office BP. METHOD: We conducted a SHAM-controlled, double-blind, randomized, single-center trial to establish efficacy data based on 24-h ambulatory BP measurements (ABPM). Inclusion criteria were daytime systolic ABPM at least 145 mmHg following 1 month of stable medication and 2 weeks of compliance registration. All RDN procedures were carried out by an experienced operator using the unipolar Medtronic Flex catheter (Medtronic, Santa Rosa, California, USA). RESULTS: We randomized 69 patients with treatment-resistant hypertension to RDN (n = 36) or SHAM (n = 33). Groups were well balanced at baseline. Mean baseline daytime systolic ABPM was 159 ±â€Š12 mmHg (RDN) and 159 ±â€Š14 mmHg (SHAM). Groups had similar reductions in daytime systolic ABPM compared with baseline at 3 months [-6.2 ±â€Š18.8 mmHg (RDN) vs. -6.0 ±â€Š13.5 mmHg (SHAM)] and at 6 months [-6.1 ±â€Š18.9 mmHg (RDN) vs. -4.3 ±â€Š15.1 mmHg (SHAM)]. Mean usage of antihypertensive medication (daily defined doses) at 3 months was equal [6.8 ±â€Š2.7 (RDN) vs. 7.0 ±â€Š2.5 (SHAM)].RDN performed at a single center and by a high-volume operator reduced ABPM to the same level as SHAM treatment and thus confirms the result of the HTN3 trial. CONCLUSION: Further, clinical use of RDN for treatment of resistant hypertension should await positive results from double-blinded, SHAM-controlled trials with multipolar ablation catheters or novel denervation techniques.

Re-intervention after uterine leiomyoma embolisation is related to incomplete infarction and presence of submucous leiomyomas.

OBJECTIVE: To evaluate outcome of invasive gynecological re-interventions after uterine artery embolisation (UAE) in relation to leiomyoma characteristics. DESIGN: A cohort of 114 women with symptomatic myomas underwent UAE. Myoma characteristics were determined by contrast-enhanced magnetic resonance imaging (MRI) before and 6 months after treatment. The median follow-up time after UAE was 55.9 months; (range 20-116). Data on gynecological re-interventions were obtained for all patients and were analysed using the Kaplan-Meier method. Data were obtained on frequency of invasive re-interventions: major myoma procedures (hysterectomy, re-embolisation, laparoscopic or abdominal myomectomy) and outpatient hysteroscopic myoma procedures. Myoma characteristics with impact on outcome of re-interventions were determined by statistical analysis. RESULTS: Total re-intervention rate was 35.1%. Hysterectomy was performed due to myoma related symptoms in 6.1% of patients, but 23.7% of patients underwent additional uterine procedures, mainly outpatient hysteroscopy (15%). Major myoma re-intervention correlated with the extent of the infarct at follow-up MRI (n=107). Patients had undergone major re-intervention (3 years) as follows: infarct group C (<80%, n=16) 44%, infarct group B (80-99%, n=16) 19%, and infarct group A (100%, n=75) 10.1% ((p<0.01) for both A vs B+C and A+B vs C). Major re-interventions were not associated with the presence of submucous myomas; but the hazard ratio (CI 95%) for undergoing hysteroscopic re-intervention was 8.4 (2-29) (p=0.001) in patients with submucous myomas, but 12.7 (5-35) (p<0.0001) in patients with more than one submucous myomas. CONCLUSIONS: Complete infarction after UAE reduces the need for major re-interventions. Assessment of complete infarction may be considered to improve quality in UAE procedures. Patients with more than one submucous myoma at UAE may often have hysteroscopic removal of residual myomas.

[Laparoscopic nephrectomy as treatment of renovascular hypertension]. / Laparoskopisk nefrektomi til behandling af renovaskulær hypertension.

Severe stenosis of a renal artery may result in renovascular hypertension associated with shrinkage and poor function of the affected kidney. In such cases percutaneous renal artery revascularisation can be technical difficult. We describe three cases of uncomplicated laparoscopic nephrectomy of renin-producing small kidneys with postoperative improvement in blood pressure regulation.