Thermic sealing in femoral catheterization: First experience with the Secure Device

Background: Devices currently used to achieve hemostasis of the femoral artery following percutaneous cardiac catheterization are associated with vascular complications and remnants of artificial materials are retained at the puncture site. The Secure arterial closure Device induces hemostasis by utilizing thermal energy, which causes collagen shrinking and swelling. In comparison to established devices, it has the advantage of leaving no foreign material in the body following closing. This study was designed to evaluate the efficacy and safety of the Secure Device to close the puncture site following percutaneous cardiac catheterization. Methods: The Secure Device was evaluated in a prospective non-randomized single-center trial with patients undergoing 6 F invasive cardiac procedures. A total of 67 patients were enrolled and the device was utilized in 63 patients. Fifty diagnostic and 13 interventional cases were evaluated. Femoral artery puncture closure was performed immediately after completion of the procedure. Time to hemostasis (TTH), time to ambulation (TTA) and data regarding short-term and 30-day clinical follow-up were recorded. Results: Mean TTH was 4:30 ± 2:15 min in the overall observational group. A subpopulation of patients receiving anticoagulants had a TTH of 4:53 ± 1:43 min. There were two access site complications (hematoma > 5 cm). No major adverse events were identified during hospitalization or at the 30 day follow-up. Conclusions: The new Secure Device demonstrates that it is feasible in diagnostic and interventional cardiac catheterization. With respect to safety, the Secure Device was non-inferior to other closure devices as tested in the ISAR closure trial

Transesophageal echocardiography-guided versus fluoroscopy-guided patent foramen ovale closure : A single center registry

Percutaneous closure of patent foramen ovale (PFO) is conventionally performed under continuous transesophageal echocardiographic (TEE) guidance. We aimed to evaluate whether a simplified procedural approach, including pure fluoroscopy-guidance and final TEE control, as well as an aimed 'next-day-discharge' is comparable with the conventional TEE-guided procedure in terms of periprocedural and intermediate-term outcomes.All patients who underwent a PFO closure at our center between 2010 and 2022 were retrospectively included. Prior to June 2019 cases were performed with continuous TEE guidance (TEE-guided group). Since June 2019, only pure fluoroscopy-guided PFO closures have been performed with TEE insertion and control just prior to device release (fluoroscopy-guided group). We analyzed procedural aspects, as well as long term clinical and echocardiographic outcomes.In total 291 patients were included in the analysis: 197 in the TEE-guided group and 94 in the fluoroscopy-guided group. Fluoroscopy-guided procedures were markedly shorter (48 ± 20 min vs. 25 ± 9 min; p < .01). There was no difference in procedural complications, including death, major bleeding, device dislodgement, stroke or clinically relevant peripheral embolization between the two groups (.5% vs. 0%; p = .99). Hospital stay was also shorter with the simplified approach (2.5 ± 1.6 vs. 3.5 ± 1.2 days; p < .01), allowing 85% same-day discharges during the last 12 months of observation period. At 6 ± 3 months echocardiographic follow-up a residual leakage was described in 8% of the TEE-guided cases and 2% of the fluoroscopy-guided cases (p = .08).While a complete TEE-free PFO closure might have potential procedural risks, our approach of pure fluoroscopy-guided with a brisk final TEE check seems to be advantageous in terms of procedural aspects with no sign of any acute or intermediate-term hazard and it could offer an equitable compromise between the two worlds: a complete TEE procedure and a procedure without any TEE

Az első perkután aortabillentyű-beültetés Magyarországon = The first percutaneous aortic valve implantation in Hungary

Panaszos aortabillentyű-szűkületben szenvedő betegek számára a billentyűcsere felbecsülhetetlen prognosztikai előnyt jelent. A thoracotomia, az aortotomia és a szívmotor alkalmazásából adódó morbiditás és mortalitás alternatív megoldások kereséséhez vezetett. A transzkatéteres endovascularis aortabillentyű-beültetéssel szerzett kezdeti tapasztalatok igazolták az eljárás megvalósíthatóságát és hatékonyságát, az akkori eszközökkel azonban a beavatkozás meglehetősen nehézkes volt. Időközben az eszközök és a beültetés technikája látványos fejlődésnek indultak, az operatőrök is egyre gyakorlottabbakká váltak. Megjelentek a ballonnal kinyitható és az önmaguktól kinyíló endoprotézisek, a perkután transfemoralis és a transapicalis megközelítés is megtalálni látszik a helyét előnyös és kedvezőtlen tulajdonságaiknak köszönhetően. A beavatkozás sikeraránya és klinikai kimenete folyamatosan javul. A közelmúltban zárult tanulmányok azt mutatják, hogy a magas kockázatú, idős betegeknél, a perkután módszer morbiditása és mortalitása a hagyományos sebészi technikáénál lényegesen kedvezőbb. Több mint egy év alapos előkészületeit követően, a Gottsegen György Országos Kardiológiai Intézetben 2008. november 11-én, Kelet-Közép-Európában először sikeres perkután aortabillentyű-beültetést végeztünk két idős, kritikus aortabillentyű-szűkületes betegnél. A betegek hétnapos kezelés után, nagyon jó általános állapotban hagyták el az intézetet. | Aortic valve replacement can produce dramatic benefit in the setting of symptomatic aortic stenosis. The potential for morbidity and mortality associated with thoracotomy, cardiopulmonary bypass, and aortotomy has fostered a search for alternatives. Early experience with transcatheter endovascular aortic valve implantation demonstrated feasibility and efficacy, but the procedure was difficult to reproduce. However, equipment, techniques, and experience have evolved rapidly. Balloon-expandable and self-expanding prostheses and percutaneous femoral artery and open left ventricular apical access have found favor, each with potential advantages and disadvantages. Procedural success rates and clinical outcomes continue to improve. Current studies suggest that morbidity and mortality rates of percutaneous aortic valve implantations are much better in comparison to conventional surgery in selected high-risk patients. On November 11, 2008, in the Gottsegen György Hungarian Institute of Cardiology we performed the first two successful percutaneous aortic valve implantations in Central and Eastern Europe, following a more than one-year preparation period. After seven days the patients were discharged in very good conditions

Indications and Outcome in Patients Undergoing Left Atrial Appendage Closure—The Austrian LAAC Registry

Background: Complete real-world data on the indications and outcomes of left atrial appendage closure (LAAC) outside of clinical trials are rare. In this study, we stratified patients undergoing LAAC by indication groups. Methods: This analysis of the national multicentre Austrian LAAC Registry comprised all patients that underwent LAAC up until 2018 at the currently active centres in Austria. The baseline characteristics, procedural details and outcomes between the following indication groups were compared: bleeding as an indication for LAAC (&ldquo;bleeding&rdquo; group) vs. thromboembolism despite oral anticoagulation (OAC; &ldquo;thromboembolism&rdquo; group) vs. an intolerance to OAC for reasons other than the above (&ldquo;other&rdquo; group). Results: The analysis included 186 patients, with 59.7% in the &ldquo;bleeding&rdquo; group, 8.1% in the &ldquo;thromboembolism&rdquo; group and 32.2% in the &ldquo;other&rdquo; group. The CHADS2 score was the highest in the &ldquo;thromboembolism&rdquo; group and the HAS-BLED score was the highest in the &ldquo;bleeding&rdquo; group. The procedural outcomes were similar between groups (implantation success, 97.3%), with major complications occurring in 7.0% of patients. One-year survival free from stroke, bleeding or LAAC-associated hospitalisation was 83.9%, 90.0% and 81.4% in the &ldquo;bleeding&rdquo;, &ldquo;thromboembolism&rdquo; and &ldquo;other&rdquo; groups, respectively (p = 0.891). Conclusions: In routine clinical practice, LAAC was used in a heterogeneous patient population with atrial fibrillation (AF) and contraindication, inefficacy or intolerance to OAC. The long-term outcome was favourable in all groups

Impact of On-Site Cardiac Surgery on Clinical Outcomes After Transfemoral Transcatheter Aortic Valve Replacement

OBJECTIVES This study sought to investigate the outcome of high-risk and inoperable patients with severe symptomatic aortic stenosis undergoing transfemoral transcatheter aortic valve replacement (TAVR) in hospitals with (iOSCS) versus without institutional on-site cardiac surgery (no-iOSCS). BACKGROUND Current guidelines recommend the use of TAVR only in institutions with a department for cardiac surgery on site. METHODS In this analysis of the prospective multicenter Austrian TAVI registry, 1,822 consecutive high-risk patients with severe symptomatic aortic stenosis undergoing transfemoral TAVR were evaluated. A total of 290 (15.9%) underwent TAVR at no-iOSCS centers (no-iOSCS group), whereas the remaining 1,532 patients (84.1%) were treated in iOSCS centers (iOSCS group). RESULTS Patients of the no-iOSCS group had a higher perioperative risk defined by the logistic EuroSCORE (20.9% vs. 14.2%; p CONCLUSIONS Patients undergoing transfemoral TAVR in hospitals without iOSCS had a significantly higher baseline risk profile. After propensity score matching short-and long-term mortality was similar between centers with and without iOSCS. (c) 2018 by the American College of Cardiology Foundation