Karim Saleh

Predictors of response to renal denervation for resistant arterial hypertension: a single center experience.

Background: Renal denervation (RDN) has been shown to reduce blood pressure in patients with resistant arterial hypertension (RAH). We aimed to investigate predictors for response to RDN. Methods: Patients suffering from RAH underwent RDN after exclusion of secondary causes of hypertension. Ambulatory blood pressure measurement (ABPM) for 24 h was performed at baseline, 6 and 12 months after RDN. Response was defined as a at least 5 mmHg 24 h SBP drop at 6 months. A linear regression model was used to analyze an association between baseline variables and response to RDN. Results: In total, 45.6% of patients were responders to RDN. In those, there was a significant reduction in ABPM values at 6 and 12 months (12 months: 24 h SBP: −17.2 ± 9.0 mmHg, P < 0.01; 24 h DBP: −9.0 ± 11.6 mmHg, P < 0.01). Per 10 mmHg increase in baseline 24 h SBP, there was a 5.5 mmHg 24 h SBP reduction at 6 months. Per kg/m2 increase in BMI, 24 h SBP increased by 0.7 mmHg at 6 months. Per increment in antihypertensive drugs used at baseline, there was a 2.7 mmHg 24 h SBP reduction at 6 months. Conclusion: Out of a wide range of baseline variables, elevated systolic ABPM values, BMI and the number of antihypertensive drugs used were associated with response. One has to consider the Hawthorne effect, the regression to the mean phenomenon, the actual effect of sympathetic denervation and the interaction of therapy modification when interpreting data from RDN registries without a control arm.

Effects of Renal Denervation on Ambulatory Blood Pressure Measurements in Patients With Resistant Arterial Hypertension

The sympathetic nervous system is an important factor in hypertension. In patients suffering from resistant hypertension, transfemoral renal sympathetic denervation (RDN) reduces office blood pressure (BP) values.

Removal of Active-Fixation Coronary Sinus Leads Using a Mechanical Rotation Extraction Device

Active fixation coronary sinus (CS) leads are widely used in cardiac resynchronization therapy (CRT). Due to their low dislodgement rates they are an attractive option for implanters. However, extraction of active fixation leads is a complex procedure that bears potential fatal risks for patients.

Clinical safety of an MRI conditional implantable cardioverter defibrillator system: A prospective Monocenter ICD‐Magnetic resonance Imaging feasibility study (MIMI)

The aim of this study was to evaluate the safety and efficacy of the Lumax 740® Implantable Cardioverter Defibrillator (ICD) system in patients undergoing a defined 1.5 Tesla (T) MRI.

Individual-patient visit-by-visit office and ambulatory blood pressure measurements over 24 months in patients undergoing renal denervation for hypertension☆

BACKGROUND Renal denervation (RDN) is a promising treatment option in addition to medical antihypertensive treatment in patients suffering from resistant hypertension. Despite the growing interest in RDN, only few long-term results are published so far. METHODS We systematically investigated the effects of RDN on ABPM in a consecutive series of patients with resistant hypertension out to 24 months. Office BP measurements and ABPM assessment were offered at 3, 6, 12 and 24 months. The patients with an average systolic BP reduction of more than 10 mmHg in office BP 6months after RDN were classified as responders. Additional to this classical responder concept, we categorized response to RDN by an individual-patient visit-by-visit evaluation of office BP and 24-hour-BP, separately. RESULTS We included 32 patients. In 21 patients (65.6%) we found a mean systolic BP reduction >10 mmHg in office BP six months after RDN. These patients were classified as responders. In responders, mean office BP dropped from 175.3 ± 15.9/96 ± 14.2 mmHg to 164.8 ± 24.4/93.2 ± 10.4 mmHg (p=0.040/p=0.323) and mean 24-h BP in ABPM decreased from 146.8 ± 17.0/89.1 ± 11 mmHg to 136.8 ± 15.0/83.2 ± 10.7 mmHg after 24 months (p=0.034/p=0.014). Additionally, we performed a visit-by-visit evaluation of all patients and results were divided in larger-than-median and smaller-than-median response. By this evaluation, we found a high variation of office BP reductions and the 24-hour BP results demonstrated a significant BP reduction in patients with larger-than-median response, which sustained over the 24 months of follow-up. CONCLUSIONS In contrast to the observed variation of office BP measurements, ABPM demonstrated a reproducible and sustained significant BP reduction in patients with larger-than-median response to RDN.

Influence of pseudo-resistance on the effect of renal denervation on 24-hour ambulatory blood pressure levels.

Renal denervation (RDN) is a promising treatment option in addition to medical antihypertensive treatment in patients suffering from resistant hypertension. Despite the growing interest in RDN, the negative result of the Symplicity HTN‐3 trial led to a debate on the efficacy of RDN.

In-Hospital Outcome Comparing Bivalirudin to Heparin in Real-World Primary Percutaneous Coronary Intervention

Randomized controlled trials have shown conflicting results regarding the outcome of bivalirudin in primary percutaneous coronary intervention (PPCI). The aim of this study was to evaluate the in-hospital outcomes of patients receiving heparin or bivalirudin in a real-world setting of PPCI: 7,023 consecutive patients enrolled in the Austrian Acute PCI Registry were included between January 2010 and December 2014. Patients were classified according to the peri-interventional anticoagulation regimen receiving heparin (n = 6430) or bivalirudin (n = 593) with or without GpIIb/IIIa inhibitors (GPIs). In-hospital mortality (odds ratio [OR] 1.13, 95% confidence interval [CI] 0.57 to 2.25, p = 0.72), major adverse cardiovascular events (OR 1.18, 95% CI 0.65 to 2.14, p = 0.59), net adverse clinical events (OR 1.01, 95% CI 0.57 to 1.77, p = 0.99), and TIMI non-coronary artery bypass graft-related major bleeding (OR 0.41, 95% CI 0.09 to 1.86, p = 0.25) were not significantly different between the groups. However, we detected potential effect modifications of anticoagulants on mortality by GPIs (OR 0.12, 95% CI 0.01 to 1.07, p = 0.06) and access site (OR 0.25, 95% CI 0.06 to 1.03, p = 0.06) favoring bivalirudin in femoral access. In conclusion, this large real-world cohort of PPCI, heparin-based anticoagulation showed similar results of short-term mortality compared with bivalirudin. We observed a potential effect modification by additional GPI use and access favoring bivalirudin over heparin in femoral, but not radial, access.