Comparing Conventional Physician-Led Education with VR Education for Pacemaker Implantation: A Randomized Study.

INTRODUCTION: Education of patients prior to an invasive procedure is pivotal for good cooperation and knowledge retention. Virtual reality (VR) is a fast-developing technology that helps educate both medical professionals and patients. OBJECTIVE: To prove non-inferiority of VR education compared to conventional education in patients prior to the implantation of a permanent pacemaker (PPM). METHODS: 150 participants scheduled for an elective implantation of a PPM were enrolled in this prospective study and randomized into two groups: the VR group (n = 75) watched a 360° video about the procedure using the VR headset Oculus Meta Quest 2, while the conventional group (n = 75) was educated by a physician. Both groups filled out a questionnaire to assess the quality of education pre- and in-hospital, their knowledge of the procedure, and their subjective satisfaction. RESULTS: There was no significant difference in the quality of education. There was a non-significant trend towards higher educational scores in the VR group. The subgroup with worse scores was older than the groups with higher scores (82 vs. 76 years, p = 0.025). Anxiety was reduced in 92% of participants. CONCLUSION: VR proved to be non-inferior to conventional education. It helped to reduce anxiety and showed no adverse effects.

Sarcopenia and adipose tissue evaluation by artificial intelligence predicts the overall survival after TAVI.

Sarcopenia is a serious systemic disease that reduces overall survival. TAVI is selectively performed in patients with severe aortic stenosis who are not indicated for open cardiac surgery due to severe polymorbidity. Artificial intelligence-assisted body composition assessment from available CT scans appears to be a simple tool to stratify these patients into low and high risk based on future estimates of all-cause mortality. Within our study, the segmentation of preprocedural CT scans at the level of the lumbar third vertebra in patients undergoing TAVI was performed using a neural network (AutoMATiCA). The obtained parameters (area and density of skeletal muscles and intramuscular, visceral, and subcutaneous adipose tissue) were analyzed using Cox univariate and multivariable models for continuous and categorical variables to assess the relation of selected variables with all-cause mortality. 866 patients were included (median(interquartile range)): age 79.7 (74.9-83.3) years; BMI 28.9 (25.9-32.6) kg/m2. Survival analysis was performed on all automatically obtained parameters of muscle and fat density and area. Skeletal muscle index (SMI in cm2/m2), visceral (VAT in HU) and subcutaneous adipose tissue (SAT in HU) density predicted the all-cause mortality in patients after TAVI expressed as hazard ratio (HR) with 95% confidence interval (CI): SMI HR 0.986, 95% CI (0.975-0.996); VAT 1.015 (1.002-1.028) and SAT 1.014 (1.004-1.023), all p < 0.05. Automatic body composition assessment can estimate higher all-cause mortality risk in patients after TAVI, which may be useful in preoperative clinical reasoning and stratification of patients.

Efficacy and Safety of Stereotactic Radiotherapy in Patients With Recurrent Ventricular Tachycardias: The Czech Experience.

BACKGROUND: Stereotactic arrhythmia radiotherapy (STAR) has been proposed recently in patients with refractory ventricular tachycardia (VT). OBJECTIVES: The purpose of this study was to describe the efficacy and safety of STAR in the Czech Republic. METHODS: VT patients were recruited in 2 expert centers after at least 1 previously failed catheter ablation (CA). A precise strategy of target volume determination and CA was used in 17 patients treated from December 2018 until June 2022 (EFFICACY cohort). This group, together with an earlier series of 19 patients with less-defined treatment strategies, composed the SAFETY cohort (n = 36). A dose of 25 Gy was delivered. RESULTS: In the EFFICACY cohort, the burden of implantable cardioverter-defibrillator therapies decreased, and this drop reached significance for direct current shocks (1.9 ± 3.2 vs 0.1 ± 0.2 per month; P = 0.03). Eight patients (47%) underwent repeated CA for recurrences of VT during 13.7 ± 11.6 months. In the SAFETY cohort (32 procedures, follow-up >6 months), 8 patients (25%) presented with a progression of mitral valve regurgitation, and 3 (9%) required intervention (median follow-up of 33.5 months). Two cases of esophagitis (6%) were seen with 1 death caused by the esophago-pericardial fistula (3%). A total of 18 patients (50%) died during the median follow-up of 26.9 months. CONCLUSIONS: Although STAR may not be very effective in preventing VT recurrences after failed CA in an expert center, it can still modify the arrhythmogenic substrate, and when used with additional CA, reduce the number of implantable cardioverter-defibrillator shocks. Potentially serious sides effects require close follow-up.

Virtual Reality for Patient Education about Hypertension: A Randomized Pilot Study.

BACKGROUND: Hypertension challenges arise in part from poor adherence due to inadequate patient education. VR offers immersive learning to improve hypertension knowledge. OBJECTIVE: To compare VR education with traditional verbal education to improve hypertension knowledge. METHODS: In this randomised trial, 182 patients with hypertension were assigned to receive either traditional physician-led education (n = 88) or VR education (n = 94) with equivalent content. The VR group experienced a 3D video using Oculus Quest 2 headsets. Knowledge was assessed post-intervention using a 29-item questionnaire. The primary outcome was the objective score. Subjective satisfaction and responder characteristics were secondary outcomes. RESULTS: Median objective scores were significantly higher for VR (14, IQR 3) versus traditional education (10, IQR 5), p < 0.001, indicating superior hypertension knowledge acquisition with VR. Subjective satisfaction was high in both groups. Participants were categorized into low (first quartile) and medium-high (second to fourth quartiles) responders based on their scores. Low responders had a significantly higher prevalence of older women than medium-high responders (57% vs. 40% female, p = 0.024; 68 vs. 65 years), p = 0.036). CONCLUSIONS: VR outperforms traditional education. Tailoring to groups such as older women can optimise learning.

Exercise-Induced Blood Pressure Dynamics: Insights from the General Population and the Athletic Cohort.

Blood pressure (BP) dynamics during graded exercise testing provide important insights into cardiovascular health, particularly in athletes. These measurements, taken during intense physical exertion, complement and often enhance our understanding beyond traditional resting BP measurements. Historically, the challenge has been to distinguish 'normal' from 'exaggerated' BP responses in the athletic environment. While basic guidelines have served their purpose, they may not fully account for the complex nature of BP responses in today's athletes, as illuminated by contemporary research. This review critically evaluates existing guidelines in the context of athletic performance and cardiovascular health. Through a rigorous analysis of the current literature, we highlight the multifaceted nature of exercise-induced BP fluctuations in athletes, emphasising the myriad determinants that influence these responses, from specific training regimens to inherent physiological nuances. Our aim is to advocate a tailored, athlete-centred approach to BP assessment during exercise. Such a paradigm shift is intended to set the stage for evidence-based guidelines to improve athletic training, performance and overall cardiovascular well-being.

Preparticipation Screening of Athletes: The Prevalence of Positive Family History.

Sudden cardiac death (SCD) is a leading cause of death among athletes, and those with a positive family history (FH) of SCD and/or cardiovascular disease (CVD) may be at increased risk. The primary objective of this study was to assess the prevalence and predictors of positive FH of SCD and CVD in athletes using four widely used preparticipation screening (PPS) systems. The secondary objective was to compare the functionality of the screening systems. In a cohort of 13,876 athletes, 1.28% had a positive FH in at least one PPS system. Multivariate logistic regression analysis identified the maximum heart rate as significantly associated with positive FH (OR = 1.042, 95% CI = 1.027-1.056, p < 0.001). The highest prevalence of positive FH was found using the PPE-4 system (1.20%), followed by FIFA, AHA, and IOC systems (1.11%, 0.89%, and 0.71%, respectively). In conclusion, the prevalence of positive FH for SCD and CVD in Czech athletes was found to be 1.28%. Furthermore, positive FH was associated with a higher maximum heart rate at the peak of the exercise test. The findings of this study revealed significant differences in detection rates between PPS protocols, so further research is needed to determine the optimal method of FH collection.

Early ganglion stellate blockade as part of two-step treatment algorithm suppresses electrical storm and need for intubation.

BACKGROUND: For the treatment of patients with electrical storm (ES), we established a two-step algorithm comprising standard anti-arrhythmic measures and early ultrasound-guided stellate ganglion blockade (SGB). In this single-center study, we evaluated the short-term efficacy of the algorithm and tested the hypothesis that early SGB might prevent the need for intubations. METHODS: Overall, we analyzed data for 70 ES events in 59 patients requiring SGB (mean age 67.7 ± 12.4 years, 80% males, left ventricular ejection fraction 30.0% ± 9.1%), all with implantable cardioverter-defibrillators (ICDs). RESULTS: The mean time from ES onset to SGB was 13.2 ± 12.3 hours. Percentage and mean absolute reduction in shocks at 48 hours after SGB reached 86.8% (-6.3 shocks), and anti-tachycardiac pacing (ATP) declined by 65.9% (-51.1 ATPs; all P < 0.001). Patients with the highest sustained ventricular arrhythmia (VA) burden (shocks ≥10/48 h; ATPs 10-99/48 h and ≥100/48 h) experienced the highest percentage decrease in ICD therapy (shocks -99.1%; ATPs -92.1% and -100.0%, respectively). For clinical response by defined criteria and two outcome periods (1/no sustained VA ≤48 hours post SGB, and 2/no ICD shock or <3 ATPs/day from day 3 to discharge/catheter ablation/day 8), 75.7% and 76.1% experienced complete response, respectively. Catecholamine support, no/low-dose ß-blocker therapy, polymorphic/mixed-type VA, and baseline sinus rhythm versus atrial fibrillation were more frequent in patients with early arrhythmia recurrence. Temporary Horner's syndrome occurred in 67.1%, and no other adverse events were recorded. Intubation and general anesthesia during and after SGB were not needed. CONCLUSION: The presented two-step algorithm for treating ES proved efficacious and safe. The results support implementation of early SGB in routine ES management.

STereotactic Arrhythmia Radioablation (STAR): the Standardized Treatment and Outcome Platform for Stereotactic Therapy Of Re-entrant tachycardia by a Multidisciplinary consortium (STOPSTORM.eu) and review of current patterns of STAR practice in Europe.

The EU Horizon 2020 Framework-funded Standardized Treatment and Outcome Platform for Stereotactic Therapy Of Re-entrant tachycardia by a Multidisciplinary (STOPSTORM) consortium has been established as a large research network for investigating STereotactic Arrhythmia Radioablation (STAR) for ventricular tachycardia (VT). The aim is to provide a pooled treatment database to evaluate patterns of practice and outcomes of STAR and finally to harmonize STAR within Europe. The consortium comprises 31 clinical and research institutions. The project is divided into nine work packages (WPs): (i) observational cohort; (ii) standardization and harmonization of target delineation; (iii) harmonized prospective cohort; (iv) quality assurance (QA); (v) analysis and evaluation; (vi, ix) ethics and regulations; and (vii, viii) project coordination and dissemination. To provide a review of current clinical STAR practice in Europe, a comprehensive questionnaire was performed at project start. The STOPSTORM Institutions' experience in VT catheter ablation (83% ≥ 20 ann.) and stereotactic body radiotherapy (59% > 200 ann.) was adequate, and 84 STAR treatments were performed until project launch, while 8/22 centres already recruited VT patients in national clinical trials. The majority currently base their target definition on mapping during VT (96%) and/or pace mapping (75%), reduced voltage areas (63%), or late ventricular potentials (75%) during sinus rhythm. The majority currently apply a single-fraction dose of 25 Gy while planning techniques and dose prescription methods vary greatly. The current clinical STAR practice in the STOPSTORM consortium highlights potential areas of optimization and harmonization for substrate mapping, target delineation, motion management, dosimetry, and QA, which will be addressed in the various WPs.

Inflammation and fibrosis characterize different stages of myocardial remodeling in patients after stereotactic body radiotherapy of ventricular myocardium for recurrent ventricular tachycardia.

We performed a histological and immunohistochemical analysis of myocardia from 3 patients who underwent radiosurgery and died for various reasons 3 months to 9 months after radiotherapy. In Case 1 (death 3 months after radiotherapy) we observed a sharp transition between relatively intact and irradiated regions. In the myolytic foci, only scattered cardiomyocytes were left and the area was infiltrated by immune cells. Using immunohistochemistry we detected numerous inflammatory cells including CD68+/CD11c+ macrophages, CD4+ and CD8+ T-lymphocytes and some scattered CD20+ B-lymphocytes. Mast cells were diminished in contrast to viable myocardium. In Case 2 and Case 3 (death 6 and 9 months after radiotherapy, respectively) we found mostly fibrosis, infiltration by adipose tissue and foci of calcification. Inflammatory infiltrates were less pronounced. Our observations are in accordance with animal experimental studies and confirm a progress from myolysis to fibrosis. In addition, we demonstrate a role of pro-inflammatory macrophages in the earlier stages of myocardial remodeling after stereotactic radioablation for ventricular tachycardia.

Acetylsalicylic acid in primary prevention of cardiovascular disease.

Acetylsalicylic acid is an effective and widely accepted essential drug in the secondary prevention of ischemic events. Its role in primary prevention has been studied for several decades and still remains controversial. Initial studies showed a reduction in both myocardial infarctions and ischemic strokes, without affecting overall or cardiovascular mortality, but the enrolled subjects were not treated with modern drugs and procedures in primary preventive care as they do today. Recently published studies have also not shown a mortality benefit, but in some sub-populations and groups of patients, the clinical benefit of aspirin continues to outweigh the risks associated with its long-term use. This review article will discuss the development of ASA in primary prevention, the results of the latest studies of the year 2018 and their meta-analyses, current indications for ASA treatment, as well as future perspectives.

Catheter ablation versus antiarrhythmic drugs with risk factor modification for treatment of atrial fibrillation: a protocol of a randomised controlled trial (PRAGUE-25 trial).

INTRODUCTION: Atrial fibrillation (AF), with a prevalence of 2%, is the most common cardiac arrhythmia. Catheter ablation (CA) has been documented to be superior to treatment by antiarrhythmic drugs (AADs) in terms of sinus rhythm maintenance. However, in obese patients, substantial weight loss was also associated with AF reduction. So far, no study has compared the modern non-invasive (AADs combined with risk factor modification (RFM)) approach with modern invasive (CA) treatment. The aim of the trial is to compare the efficacy of modern invasive (CA) and non-invasive (AADs with risk factor management) treatment of AF. METHODS AND ANALYSIS: The trial will be a prospective, multicentre, randomised non-inferiority trial. Patients with symptomatic AF and a body mass index >30 will be enrolled and randomised to the CA or RFM arm (RFM+AAD) in a 1:1 ratio. In the CA arm, pulmonary vein isolation (in combination with additional lesion sets in non-paroxysmal patients) will be performed. For patients in the RFM+AAD arm, the aim will be a 10% weight loss over 6-12 months, increased physical fitness and a reduction in alcohol consumption. The primary endpoint will be an episode of AF or regular atrial tachycardia lasting >30 s. The secondary endpoints include AF burden, clinical endpoints associated with AF reoccurrence, changes in the quality of life assessed using dedicated questionnaires, changes in cardiorespiratory fitness and metabolic endpoints. An AF freedom of 65% in the RFM+AAD and of 60% in the CA is expected; therefore, 202 patients will be enrolled to achieve the non-inferiority with 80% power, 5% one-sided alpha and a non-inferiority margin of 12%. ETHICS AND DISSEMINATION: The PRAGUE-25 trial will determine if modern non-invasive AF treatment strategies are non-inferior to CA. The study was approved by the Ethics Committee of the University Hospital Kralovske Vinohrady. Results of the study will be disseminated on scientific conferences and in peer-reviewed scientific journals. After the end of follow-up, data will be available upon request to principal investigator. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04011800).

Case Report: Repeated Stereotactic Radiotherapy of Recurrent Ventricular Tachycardia: Reasons, Feasibility, and Safety.

Stereotactic body radiotherapy (SBRT) has been reported as an attractive option for cases of failed catheter ablation of ventricular tachycardia (VT) in structural heart disease. However, even this strategy can fail for various reasons. For the first time, this case series describes three re-do cases of SBRT which were indicated for three different reasons. The purpose in the first case was the inaccuracy of the determination of the treatment volume by indirect comparison of the electroanatomical map and CT scan. A newly developed strategy of co-registration of both images allowed precise targeting of the substrate. In this case, the second treatment volume overlapped by 60% with the first one. The second reason for the re-do of SBRT was an unusual character of the substrate-large cardiac fibroma associated with different morphologies of VT from two locations around the tumor. The planned treatment volumes did not overlap. The third reason for repeated SBRT was the large intramural substrate in the setting of advanced heart failure. The first treatment volume targeted arrhythmias originating in the basal inferoseptal region, while the second SBRT was focused on adjacent basal septum without significant overlapping. Our observations suggested that SBRT for VT could be safely repeated in case of later arrhythmia recurrences (i.e., after at least 6 weeks). No acute toxicity was observed and in two cases, no side effects were observed during 32 and 22 months, respectively. To avoid re-do SBRT due to inaccurate targeting, the precise and reproducible strategy of substrate identification and co-registration with CT image should be used.

Radiation-Induced Changes in Ventricular Myocardium After Stereotactic Body Radiotherapy for Recurrent Ventricular Tachycardia.

Stereotactic body radiotherapy (SBRT) has been suggested as a promising therapeutic alternative in cases of failed catheter ablation for recurrent ventricular tachycardias (VTs) in patients with structural heart disease. This case series is the first postmortem immunohistochemical analysis of morphologic changes in the myocardium early and late after SBRT. The present findings are in line with experimental observations on apoptosis followed by fibrosis. This may explain why the effect of SBRT on VT is not predominantly immediate. Together with observation of early recurrences after SBRT for VT, these data suggest that this strategy may have rather delayed antiarrhythmic effects.

Chronic refractory angina pectoris treated by bilateral stereotactic radiosurgical stellate ganglion ablation: first-in-man case report.

BACKGROUND: Refractory angina pectoris (AP) significantly impairs quality of life in patients with chronic coronary syndrome. Several minimally invasive methods (coronary sinus reducer, cell therapy, laser or shockwave revascularization, and spinal cord stimulation) or non-invasive methods (external counterpulzation) have been studied. However, their routine clinical use has not been widely implemented. Surgical or endoscopic sympathectomy is feasible for permanently relieving angina, but is often contraindicated due to the extent of complications associated with it. Neuromodulation by anaesthetic blockade of the left-sided stellate ganglion (SG) has been shown to relieve angina for days or weeks. To provide a long-term anti-anginal effect, novel pharmacological (phenol-based) or radiofrequency ablation techniques have been individually used to permanently destroy sympathetic pathways. CASE SUMMARY: We describe a first-in-man use of stereotactic radiosurgical SG ablation using a linear accelerator (CyberKnife) in a heart failure patient after myocardial infarction with chronic refractory AP. Repeated anaesthetic SG blockade in this patient resulted in a significant, but only short-term, clinical improvement. The left, and subsequently the right, SG was ablated by targeted irradiation. During the 1-year follow-up, the patient remained without angina. We did not observe any clinically relevant early or late complications. Atrial fibrillation that developed 2 months after the second procedure was deemed to be associated with a natural progression of co-existing heart failure. DISCUSSION: We conclude that stereotactic radiosurgical SG ablation has the potential to become a minimally invasive and low-risk procedure to treat refractory angina patients. However, this procedure needs to be evaluated in larger patient populations.

Real-time measurement of ICD lead motion during stereotactic body radiotherapy of ventricular tachycardia.

BACKGROUND: Here we aimed to evaluate the respiratory and cardiac-induced motion of a ICD lead used as surrogate in the heart during stereotactic body radiotherapy (SBRT) of ventricular tachycardia (VT). Data provides insight regarding motion and motion variations during treatment. MATERIALS AND METHODS: We analyzed the log files of surrogate motion during SBRT of ventricular tachycardia performed in 20 patients. Evaluated parameters included the ICD lead motion amplitudes; intrafraction amplitude variability; correlation error between the ICD lead and external markers; and margin expansion in the superior-inferior (SI), latero-lateral (LL), and anterior-posterior (AP) directions to cover 90% or 95% of all amplitudes. RESULTS: In the SI, LL, and AP directions, respectively, the mean motion amplitudes were 5.0 ± 2.6, 3.4. ± 1.9, and 3.1 ± 1.6 mm. The mean intrafraction amplitude variability was 2.6 ± 0.9, 1.9 ± 1.3, and 1.6 ± 0.8 mm in the SI, LL, and AP directions, respectively. The margins required to cover 95% of ICD lead motion amplitudes were 9.5, 6.7, and 5.5 mm in the SI, LL, and AP directions, respectively. The mean correlation error was 2.2 ± 0.9 mm. CONCLUSIONS: Data from online tracking indicated motion irregularities and correlation errors, necessitating an increased CTV-PTV margin of 3 mm. In 35% of cases, the motion variability exceeded 3 mm in one or more directions. We recommend verifying the correlation between CTV and surrogate individually for every patient, especially for targets with posterobasal localization where we observed the highest difference between the lead and CTV motion.

Stereotactic radiosurgery for ablation of ventricular tachycardia.

AIMS: Stereotactic body radiotherapy (SBRT) for ventricular tachycardias (VTs) could be an option after failed catheter ablation. In this study, we analysed the long-term efficacy and toxicity of SBRT applied as a bail-out procedure. METHODS AND RESULTS: Patients with structural heart disease and unsuccessful catheter ablations for VTs underwent SBRT. The planning target volume (PTV) was accurately delineated using exported 3D electroanatomical maps with the delineated critical part of re-entry circuits. This was defined by detailed electroanatomic mapping and by pacing manoeuvres during the procedure. Using the implantable cardioverter-defibrillator lead as a surrogate contrast marker for respiratory movement compensation, 25 Gy was delivered to the PTV using CyberKnife. We evaluated occurrences of sustained VT, electrical storm, antitachycardia pacing, and shock; time to death; and radiation-induced events. From 2014 until March 2017, 10 patients underwent radiosurgical ablation (mean PTV, 22.15 mL; treatment duration, 68 min). After radiosurgery, four patients experienced nausea and one patient presented gradual progression of mitral regurgitation. During the follow-up (median 28 months), VT burden was reduced by 87.5% compared with baseline (P = 0.012) and three patients suffered non-arrhythmic deaths. After the blanking period, VT recurred in eight of 10 patients. The mean time to first antitachycardia pacing and shock were 6.5 and 21 months, respectively. CONCLUSION: Stereotactic body radiotherapy appears to show long-term safety and effectiveness for VT ablation in structural heart disease inaccessible to catheter ablation. We report one possible radiation-related toxicity and promising overall survival, warranting evaluation in a prospective multicentre clinical trial.

Renal denervation in comparison with intensified pharmacotherapy in true resistant hypertension: 2-year outcomes of randomized PRAGUE-15 study.

OBJECTIVES: The randomized, multicentre study compared the efficacy of renal denervation (RDN) versus spironolactone addition in patients with true resistant hypertension. We present the 24-month data. METHODS: A total of 106 patients with true resistant hypertension were enrolled in this study: 52 patients were randomized to RDN and 54 patients to the spironolactone addition, with baseline SBP of 159 ±â€Š17 and 155 ±â€Š17 mmHg and average number of drugs 5.1 and 5.4, respectively. Two-year data are available in 86 patients. Spironolactone addition, as crossover after 1 year, was performed in 23 patients after RDN, and spironolactone addition followed by RDN was performed in five patients. RESULTS: Similar and comparable reduction of 24-h SBP after RDN or spironolactone addition after randomization was observed, 9.1 mmHg (P = 0.001) and 10.9 mmHg (P = 0.001), respectively. Similar decrease of office blood pressure (BP) was observed, 17.7 mmHg (P < 0.001) versus 14.1 mmHg (P < 0.001), whereas the number of antihypertensive drugs did not differ significantly between groups. Crossover analysis showed nonsignificantly better efficacy of spironolactone addition in 24-h SBP and office SBP reduction than RDN (3.7 mmHg, P = 0.27 and 4.6 mmHg, P = 0.28 in favour of spironolactone addition, respectively). Meanwhile, the number of antihypertensive drugs was significantly increased after spironolactone addition (+0.7, P = 0.001). CONCLUSION: In the settings of true resistant hypertension, spironolactone addition (if tolerated) seems to be of better efficacy than RDN in BP reduction over a period of 24 months. However, by contrast to the 12-month results, BP changes were not significantly greater.

Role of Adding Spironolactone and Renal Denervation in True Resistant Hypertension: One-Year Outcomes of Randomized PRAGUE-15 Study.

This randomized, multicenter study compared the relative efficacy of renal denervation (RDN) versus pharmacotherapy alone in patients with true resistant hypertension and assessed the effect of spironolactone addition. We present here the 12-month data. A total of 106 patients with true resistant hypertension were enrolled in this study: 52 patients were randomized to RDN and 54 patients to the spironolactone addition, with baseline systolic blood pressure of 159±17 and 155±17 mm Hg and average number of drugs 5.1 and 5.4, respectively. Twelve-month results are available in 101 patients. The intention-to-treat analysis found a comparable mean 24-hour systolic blood pressure decline of 6.4 mm Hg, P=0.001 in RDN versus 8.2 mm Hg, P=0.002 in the pharmacotherapy group. Per-protocol analysis revealed a significant difference of 24-hour systolic blood pressure decline between complete RDN (6.3 mm Hg, P=0.004) and the subgroup where spironolactone was added, and this continued within the 12 months (15 mm Hg, P= 0.003). Renal artery computed tomography angiograms before and after 1 year post-RDN did not reveal any relevant changes. This study shows that over a period of 12 months, RDN is safe, with no serious side effects and no major changes in the renal arteries. RDN in the settings of true resistant hypertension with confirmed compliance is not superior to intensified pharmacological treatment. Spironolactone addition (if tolerated) seems to be more effective in blood pressure reduction.

Effect of renal denervation on glucose metabolism after a 12 month follow-up.

BACKGROUND: Renal denervation is an invasive endovascular procedure using radiofrequency ablation of the renal arteries. This reduces renal sympathetic activity. However, the effect of renal denervation on glucose metabolism remains unclear. AIM: To evaluate the relation between sympathetic activity and glucose metabolism. METHODS: We enrolled 51 patients with resistant hypertension who underwent renal denervation in our hospital from September 2011 to July 2013. We divided the patients into 4 subgroups: those with diabetes mellitus; those without diabetes mellitus; patients who had undergone bilateral denervation with at least 4 radiofrequency applications to each renal artery. The last subgroup of patients had fewer than 4 applications bilaterally or only unilateral application for anatomical or technical reasons. For all patients the Simplicity flex catheter (Medtronic) was used. Fasting glucose, glycated hemoglobin, albuminuria and C-peptide were measured before the procedure and after 12 months. RESULTS: In all patients (n = 51) fasting glucose levels significantly increased (from 7.4± 2.0 mmol/L to 7.8±2.6 mmol/L; P = 0.032). Glycated hemoglobin increased slightly but not significantly (from 46.1±10.5 mmol/mol to 47.6±13.6 mmol/mol; P = 0.079). There were no significant changes in albuminuria (71.2±191.0 mg/L to 66.1±185.5 mg/L; P = 0.108) or C-peptide levels (1178±429 pmol/L to 1271±565 pmol/L; P = 0.098). CONCLUSIONS: We found no effect of renal denervation on glucose metabolism after 12 months follow-up.