BackgroundVerapamil is traditionally applied prophylactically in transradial procedures to prevent radial artery spasm. However, verapamil may have side effects and is contraindicated in some clinical settings.Methods and ResultsDuring an investigator‐initiated, randomized, double‐blind trial, we evaluated the need for preventive verapamil administration. After vascular access was established, patients received either 5 mg verapamil (n=297) or placebo (n=294). We compared the rate of access site conversions as primary end point using a superiority margin of 5%. Occurrence of code breaks (composite of conversions and unplanned use of verapamil), overall verapamil use, procedural and fluoroscopic times, contrast volume, and subjective pain were investigated as secondary end points. The rate of access site conversions was not different in the 2 arms (placebo 1.7% versus verapamil 0.7%, P=0.28, difference 1.0%, 95% CI for the difference −1.1% to 3.3%). Proportion of code breaks was similar in the 2 groups (3.4% versus 1.3%, P=0.11), whereas overall verapamil use was markedly lower in the placebo arm (2.0% versus 100%, P<0.0001). Procedural time (median [IQR] 16.0 minutes [9.0 to 30.0 minutes] versus 17.0 minutes [10.0 to 31.0 minutes], P=0.37), fluoroscopic time (4.4 minutes [2.1 to 9.6 minutes] versus 4.8 minutes [2.4 to 10.7 minutes], P=0.28), contrast volume (72.5 mL [48.0 to 146.0 mL] versus 75.5 mL [47.0 to 156.5 mL], P=0.74), and pain score (P for trend=0.12) were comparable in the 2 groups.ConclusionsThe preventive use of verapamil may be unnecessary for transradial procedures. The omission of prophylactic verapamil may not only reduce the rate of potential complications related to the drug but also allow the safe extension of the transradial method to those with contraindications to verapamil.Clinical Trial RegistrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT01402427.
Background: Recently published studies suggested that digoxin may increase mortality in heart failure with reduced ejection fraction (HFrEF). However, in the vast majority of former trials serum digoxin concentration (SDC) was not measured and therapy was not SDC-guided. Aim: To assess the impact of SDC-guided digoxin therapy on mortality in HFrEF patients. Methods: Data of 580 HFrEF patients were retrospectively analyzed. In patients on digoxin, SDC was measured every 3 months and digoxin dosage was SDC-guided (target SDC: 0.5-0.9 ng/mL). All-cause mortality of digoxin users and nonusers was compared after propensity score matching (PSM). Results: After 7.1 ± 4.7 years follow-up period (FUP) all-cause mortality of digoxin users (n = 180) was significantly higher than nonusers (n = 297
Background
The use of the renin-angiotensin-aldosteron-system inhibitor (RAASi) regime is crucial to reduce the mortality and morbidity of heart failure with reduced ejection fraction (HFrEF). However, it is well known that among real life circumstances it is challenging to reach the guideline-recommended target doses (TDs) of RAASi-s, due to the occurrence of side effects (e.g. hyperkalemia). Based on the ESC expert consensus document, it is recommended to reduce the RAASi dosages or discontinue the therapy when significant hyperkalemia (HK) occurs (serum potassium >5.0 mmol/l or >6.0 mmol/l, respectively). Within the last years, trials of patiromer and zirconium cyclosilicate demonstrated dose-dependent effect of these drugs enhancing potassium level lowering. The ongoing DIAMOND study examining the effect of patiromer among patients with previous HK (se potassium >5mmol/l) in the effect of RAASi-s in HFrEF hopefully will answer the question whether the use of a potassium binder and in its effect the use of TD-s of RAASi translates to significant mortality benefit in HFrEF.
Aim
To assess the prevalence of RAASi uptitration limiting HK and to assess the potential suitability of potassium binders among HFrEF patients followed-up regularly at a heart failure outpatient clinic (HFOC).
Methods
Data of 557 consecutive HFrEF patients (NYHA: 3.1±0.8; LVEF: 27.4±6.6%; age: 61.2±13.0 years; male: 76.3%; ischemic: 47.2%; atrial fibrillation: 27.3%; diabetes: 35.7%; hypertension: 72.7%, systolic blood pressure: 124.3±24.3mmHg, eGFR: 65.6±23.6 ml/min/1.73m2) was analyzed. At baseline ACEi/ARBs in 33.6%, BBs in 40.9%, MRAs in 37.9% of the total cohort (TC) were used.
Results
After therapy optimization (TO) ACEis/ARBs were applied in 97.5% and TD (equivalent to at least 10 mg of enalapril b.i.d.) was reached in 59.4% of the TC. BBs in 90.7%, TDs of BBs in 48.3%, MRAs in 64.3%, TDs of MRAs in 24.6% of the TC were applied. In 100 patients (17.9%) the TDs of ACEi/ARBs and MRAs were reached simultaneously. Among those 457 patients not reaching the TD of ACEi/ARBs and/or the TD of MRAs the occurrence of HK (se potassium >5 mmol/l) was quite frequent (45.3%, 207 patients), the prevalence of HK with the need of permanent dose reduction of RAASi regime (se potassium>5.5 mmol/l) was 10.5% (48 patients) and the prevalence of HK resulting permanent discontinuation of RAASi (se potassium >6.0 mmol/l) was 2.8% (13 patient) during the TO.
Conclusions
The current ESC guidelines recommend the use of TDs or maximal tolerated doses of RAASi-s in HFrEF. In a real-world patient cohort when every effort was made to reach the TDs, the TD of ACEi/ARBs and the TD of MRAs was reachable only in 17.9% of patients due the side effects observed during the TO. The occurrence of HK preventing to reach the TD, resulting down-titration or temporary/permanent discontinuation of RAASi-s and representing potential suitability for potassium binders is significant among optimally treated HFrEF patients.
Funding Acknowledgement
Type of funding source: None
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