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Introduction and AimRadial artery approach angiography is the current gold standard for coronary status diagnostics and eventual percutaneous revascularization (PCI). Currently, application of adequate, patent hemostasis based physical torniquets are used for puncture site control, to avoid bleeding, radial artery occlusion and damage (RAO and RAD). The Radial Artery Puncture Hemostasis Evaluation (RAPHE) is a prospective, randomized, multicenter clinical trial designed to investigate new, simplified techniques of radial artery hemostasis utilizing physical compression free methods.Methods and ResultsThe RAPHE study has been designed to evaluate the efficacy and safety of two non-compression based radial artery hemostasis methods: a 100% chitosan bioactive hemostatic dressing and a purpose-built radial potassium-ferrate based topical hemostasis disc. These devices will be investigated in a standalone configuration. Control group is a standard pneumatic airbladder-based compression device. A total of 600 patients will be enrolled in a three-way randomization (1:1:1) with two study and one control groups. Safety and efficacy endpoints are RAO, puncture site hematoma formation and RAD respectively, consisting of dissection, (pseudo)aneurism and/or fistula formation, measured post-procedure and at sixty days.ConclusionThe results from this trial will provide valuable information on new, simplified methods of radial artery hemostasis options and possibly simplify post-puncture management of patients.Clinical Trial Registration[www.ClinicalTrials.gov], identifier [NCT04857385].

Background Puncture site vascular complications are relatively common during invasive electrophysiology. One of the most promising measures to minimize these adverse events is the use of vascular ultrasound during puncture. Objective We aimed to carry out a meta-analysis comparing conventional, anatomically guided femoral venous puncture to ultrasound-guided puncture during electrophysiology procedures, which, in contrast to, the previous meta-analyses, used a uniform endpoint and involved novel trials resulting in higher patients numbers. Methods We conducted a systematic search in relevant electronic databases for articles reporting the rate of vascular complications during EP procedures both with and without ultrasound guidance. We defined major vascular complications (MVCs, as defined in the 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus) as the primary endpoint. Secondary endpoints were arteriovenous fistula, pseudoanerurysm and major bleeding separately, and minor vascular complications and accidental arterial punctures. Statistical analysis was performed using a random effect model with the Mantel-Haenszel method. Results A total of 23605 patients were included in the 14 articles matching our selection criteria, and there were data on the primary outcome in 15160 of them (in 11 articles), with 236 (1.6%), who reached the primary endpoint of an MVC. Routine application of ultrasound guidance significantly reduced the incidence of major vascular complications (42/5645 vs. 194/9515, OR 0.36 [0.23–0.55], p<0.001). Furthermore, we found significantly lower incidence in several of our secondary endpoints: for total vascular complications the OR was 0.27 [0.13–0.53] (p<0.001), for major bleedings the OR was 0.42 [0.24–0.74] and for inadvertent artery puncture the OR was 0.24 [0.15–0.38] (p<0.001). Data was insufficiently reported in respect of arteriovenous fistulae and of pseudoanerurysms specifically. Conclusion With more than double of the number of patients compared to the previous meta-analyses, and with a more consistent MVC definition, we showed that ultrasound guidance for femoral venous puncture has significant benefits, most importantly reduces the incidence of major vascular complications and total vascular complications. Our results underscore the need for a randomized controlled trial in the question, with potentially important implications for daily clinical practice and patient safety. Funding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Project no. NVKP_16-1–2016-0017 (“National Heart Program”) has been implemented with the support provided by the Ministry of Innovation and Technology of Hungary from the National Research, Development and Innovation Fund of Hungary, financed under the NVKP_16 funding scheme. -Project no. MEC_R-141548 has been implemented with the support provided by the Ministry of Innovation and Technology of Hungary from the National Research, Development and Innovation Fund, financed under the MEC_R_21 funding scheme.

Although radial access is the current gold standard for the implementation of percutaneous coronary interventions (PCI), post-procedural radial compression devices are seldom compared with each other in terms of safety or efficacy. Our group aimed to compare a cost effective and potentially green method to dedicated radial compression devices, with respect to access site complications combined in a device oriented complex endpoint (DOCE), freedom from which served as our primary endpoint. Patients undergoing PCI were randomized to receive either the cost effective or a dedicated device, either of which were removed using patent hemostasis. Twenty-four hours after the procedure, radial artery ultrasonography was performed to evaluate the access site. The primary endpoint was assessed using a non-inferiority framework with a non-inferiority margin of five percentage points, which was considered as the least clinically meaningful difference. The cost-effective technique and the dedicated devices were associated with a comparably low rate of complications (freedom from DOCE: 83.3% vs. 70.8%, absolute risk difference: 12.5%, one-sided 95% confidence interval (CI): 1.11%). Composition of the DOCE (i.e., no complication, hematoma, pseudoaneurysm, and radial artery occlusion) and compression time were also assessed in superiority tests as secondary endpoints. Both the cost-effective technique and the dedicated devices were associated with comparably low rates of complications: p = 0.1289. All radial compression devices performed similarly when considering the time to complete removal of the respective device (120.0 (inter-quartile range: 100.0–142.5) for the vial vs. 120.0 (inter-quartile range: 110.0–180) for the dedicated device arm, with a median difference of [95% CI]: 7.0 [−23.11 to 2.00] min, p = 0.2816). In conclusion, our cost-effective method was found to be non-inferior to the dedicated devices with respect to safety, therefore it is a safe alternative to dedicated radial compression devices, as well as seeming to be similarly effective.

Mechanical circulatory support (MCS) was introduced in the 1960s, of which there is short-, mid- and long-term forms. This brief review discusses our experiences with the primary modality used in Hungary, the veno-arterial extracorpo­real membrane oxygenator (VA-ECMO). We introduced the device with the most relevant information and summarized our clinic’s registry with patient characteristics and results in whom we applied this modality next to data of international studies. We collected data retro- and prospectively from 2012 to 2020 from patients treated with the VA-ECMO at our clinic. The primary endpoint we used was all cause mortality in this patient population of critical condition. Every indication, potential peripheral-central conversion and primary operation technique was involved in the analysis. We found that age above 65 and initial pH under 7.2 significantly affects mortality data. Acute coronary syndrome (ACS) as primary indication showed to be nearly significant, and acute rejection after hTX was a beneficial clinical scenario regarding survival. In international literature diabetes mellitus, elevated levels of lactate, kidney- and hepatic insufficiency were identified as contributing mortality predictors as well. Our results mostly coincide with the international mortality and risk factor data. Time is a very important factor for the survival of these patients. Therefore, it is very important to refer the patient’s refractory to non-MCS therapy to centers with VA-ECMO capability in time.