BACKGROUND: Pulsed-field ablation (PFA) represents a new, nonthermal ablation energy for the ablation of atrial fibrillation (AF). Ablation energies producing thermal injury are associated with an inflammatory response, platelet activation, and coagulation activation. OBJECTIVES: This study aimed to compare the systemic response in patients undergoing pulmonary vein isolation (PVI) using pulsed-field and radiofrequency (RF) energy. METHODS: Patients with AF indicated for PVI were enrolled and randomly assigned to undergo PVI using RF (CARTO Smart Touch, Biosense Webster) or pulsed-field (Farapulse, Boston-Scientific) energy. Markers of myocardial damage (troponin I), inflammation (interleukin-6), coagulation (D-dimers, fibrin monomers, von Willebrand antigen and factor activity), and platelet activation (P-selectin, activated GpIIb/IIIa antigen) were measured before the procedure (T1), after trans-septal puncture (T2), after completing the ablation in the left atrium (T3), and 1 day after the procedure (T4). RESULTS: A total of 65 patients were enrolled in the pulsed-field ablation (n = 33) and RF ablation (n = 32) groups. Both groups were similar in baseline characteristics (age 60.5 ± 12.7 years vs 64.0 ± 10.7 years; paroxysmal AF: 60.6% vs 62.5% patients). Procedural and left atrial dwelling times were substantially shorter in the PFA group (55:09 ± 11:57 min vs 151:19 ± 41:25 min; P < 0.001; 36:00 ± 8:05 min vs 115:58 ± 36:49 min; P < 0.001). Peak troponin release was substantially higher in the PFA group (10,102 ng/L [IQR: 8,272-14,207 ng/L] vs 1,006 ng/L [IQR: 603-1,433ng/L]). Both procedures were associated with similar extents (>50%) of platelet and coagulation activation. The proinflammatory response 24 h after the procedure was slightly but nonsignificantly higher in the RF group. CONCLUSIONS: Despite 10 times more myocardial damage, pulsed-field ablation was associated with a similar degree of platelet/coagulation activation, and slightly lower inflammatory response. (The Effect of Pulsed-Field and Radiofrequency Ablation on Platelet, Coagulation and Inflammation; NCT05603637).
BACKGROUND: Hemolysis-related renal failure has been described after pulmonary vein isolation (PVI) with pulsed-field ablation (PFA). OBJECTIVES: This study sought to compare the potential for hemolysis during PVI with PFA vs radiofrequency ablation (RFA). METHODS: In consecutive patients, PVI was performed with PFA or RFA. Blood samples were drawn at baseline, immediately postablation, and 24 hours postablation. Using flow cytometry, the concentration of red blood cell microparticles (RBCμ) (fragments of damaged erythrocytes) in blood was assessed. Lactate dehydrogenase (LDH), haptoglobin, and indirect bilirubin were measured at baseline and 24 hours. RESULTS: Seventy patients (age: 64.7 ± 10.2 years; 47% women; 36 [51.4%] paroxysmal atrial fibrillation) were enrolled: 47 patients were in the PFA group (22 PVI-only and 36.4 ± 5.5 PFA applications; 25 PVI-plus, 67.3 ± 12.4 pulsed field energy applications), and 23 patients underwent RFA. Compared to baseline, the RBCμ concentration increased ∼12-fold postablation and returned to baseline by 24 hours in the PFA group (median: 70.8 [Q1-Q3: 51.8-102.5] vs 846.6 [Q1-Q3: 639.2-1,215.5] vs 59.3 [Q1-Q3: 42.9-86.5] RBCμ/μL, respectively; P < 0.001); this increase was greater with PVI-plus compared to PVI-only (P = 0.007). There was also a significant, albeit substantially smaller, periprocedural increase in RBCμ with RFA (77.7 [Q1-Q3: 39.2-92.0] vs 149.6 [Q1-Q3: 106.6-180.8] vs 89.0 [Q1-Q3: 61.2-123.4] RBCμ/μL, respectively; P < 0.001). At 24 hours with PFA, the concentration of LDH and indirect bilirubin increased, whereas haptoglobin decreased significantly (all P < 0.001). In contrast, with RFA, there were only smaller changes in LDH and haptoglobin concentrations (P = 0.03) and no change in bilirubin. CONCLUSIONS: PFA was associated with significant periprocedural hemolysis. With a number of 70 PFA lesions, the likelihood of significant renal injury is uncommon.
- MeSH
- fibrilace síní * chirurgie MeSH
- hemolýza * MeSH
- katetrizační ablace * škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- prospektivní studie MeSH
- radiofrekvenční ablace škodlivé účinky metody MeSH
- senioři MeSH
- venae pulmonales chirurgie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- srovnávací studie MeSH
BACKGROUND: The PRAGUE-17 (Left Atrial Appendage Closure vs Novel Anticoagulation Agents in Atrial Fibrillation) trial demonstrated that left atrial appendage closure (LAAC) was noninferior to nonwarfarin direct oral anticoagulants (DOACs) for preventing major neurological, cardiovascular, or bleeding events in patients with atrial fibrillation (AF) who were at high risk. OBJECTIVES: This study sought to assess the prespecified long-term (4-year) outcomes in PRAGUE-17. METHODS: PRAGUE-17 was a randomized noninferiority trial comparing percutaneous LAAC (Watchman or Amulet) with DOACs (95% apixaban) in patients with nonvalvular AF and with a history of cardioembolism, clinically-relevant bleeding, or both CHA2DS2-VASc ≥3 and HASBLED ≥2. The primary endpoint was a composite of cardioembolic events (stroke, transient ischemic attack, or systemic embolism), cardiovascular death, clinically relevant bleeding, or procedure-/device-related complications (LAAC group only). The primary analysis was modified intention-to-treat. RESULTS: This study randomized 402 patients with AF (201 per group, age 73.3 ± 7.0 years, 65.7% male, CHA2DS2-VASc 4.7 ±1.5, HASBLED 3.1 ± 0.9). After 3.5 years median follow-up (1,354 patient-years), LAAC was noninferior to DOACs for the primary endpoint by modified intention-to-treat (subdistribution HR [sHR]: 0.81; 95% CI: 0.56-1.18; P = 0.27; P for noninferiority = 0.006). For the components of the composite endpoint, the corresponding sHRs were 0.68 (95% CI: 0.39-1.20; P = 0.19) for cardiovascular death, 1.14 (95% CI: 0.56-2.30; P = 0.72) for all-stroke/transient ischemic attack, 0.75 (95% CI: 0.44-1.27; P = 0.28) for clinically relevant bleeding, and 0.55 (95% CI: 0.31-0.97; P = 0.039) for nonprocedural clinically relevant bleeding. The primary endpoint outcomes were similar in the per-protocol (sHR: 0.80; 95% CI: 0.54-1.18; P = 0.25) and on-treatment (sHR: 0.82; 95% CI: 0.56-1.20; P = 0.30) analyses. CONCLUSIONS: In long-term follow-up of PRAGUE-17, LAAC remains noninferior to DOACs for preventing major cardiovascular, neurological, or bleeding events. Furthermore, nonprocedural bleeding was significantly reduced with LAAC. (PRAGUE-17 [Left Atrial Appendage Closure vs Novel Anticoagulation Agents in Atrial Fibrillation]; NCT02426944).
- MeSH
- cévní mozková příhoda epidemiologie prevence a kontrola MeSH
- fibrilace síní terapie MeSH
- inhibitory faktoru Xa terapeutické užití MeSH
- krvácení epidemiologie MeSH
- lidé MeSH
- následné studie MeSH
- prospektivní studie MeSH
- senioři MeSH
- síňové ouško chirurgie MeSH
- tranzitorní ischemická ataka epidemiologie prevence a kontrola MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- hodnocení ekvivalence MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
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).
- MeSH
- antiarytmika terapeutické užití MeSH
- fibrilace síní * farmakoterapie chirurgie MeSH
- hmotnostní úbytek MeSH
- katetrizační ablace * metody MeSH
- kvalita života MeSH
- lidé MeSH
- multicentrické studie jako téma MeSH
- prospektivní studie MeSH
- randomizované kontrolované studie jako téma MeSH
- recidiva MeSH
- rizikové faktory MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- protokol klinické studie MeSH
- MeSH
- antikoagulancia MeSH
- cévní mozková příhoda * etiologie prevence a kontrola MeSH
- fibrilace síní * komplikace MeSH
- lidé MeSH
- síňové ouško * chirurgie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
OBJECTIVES: This study sought to comprehensively determine the procedural safety and midterm efficacy of hybrid ablations. BACKGROUND: Hybrid ablation of atrial fibrillation (AF) (thoracoscopic ablation followed by catheter ablation) has been used for patients with nonparoxysmal AF; however, accurate data regarding efficacy and safety are still limited. METHODS: Patients with nonparoxysmal AF underwent thoracoscopic, off-pump ablation using the COBRA Fusion radiofrequency system (Estech) followed by a catheter ablation 3 months afterward. The safety of the procedure was assessed using sequential brain magnetic resonance and neuropsychological examinations at baseline (1 day before), postoperatively (2-4 days for brain magnetic resonance imaging or 1 month for neuropsychological examination), and at 9 months after the surgical procedure. Implantable loop recorders were used to detect arrhythmia recurrence. Arrhythmia-free survival (the primary efficacy endpoint) was defined as no episodes of AF or atrial tachycardia while off antiarrhythmic drugs, redo ablations or cardioversions. RESULTS: Fifty-nine patients (age: 62.5 ± 10.5 years) were enrolled, 37 (62.7%) were men, and the mean follow-up was 30.3 ± 10.8 months. Thoracoscopic ablation was successfully performed in 55 (93.2%) patients. On baseline magnetic resonance imaging, chronic ischemic brain lesions were present in 60.0% of patients. New ischemic lesions on postoperative magnetic resonance imaging were present in 44.4%. Major postoperative cognitive dysfunction was present in 27.0% and 17.6% at 1 and 9 months postoperatively, respectively. The probability of arrhythmia-free survival was 54.0% (95% CI: 41.3-66.8) at 1 year and 43.8% (95% CI: 30.7-57.0) at 2 years. CONCLUSIONS: The thoracoscopic ablation is associated with a high risk of silent cerebral ischemia. The midterm efficacy of hybrid ablations is moderate.
- MeSH
- antiarytmika terapeutické užití MeSH
- fibrilace síní * farmakoterapie chirurgie MeSH
- katetrizační ablace * škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- senioři MeSH
- supraventrikulární tachykardie * chirurgie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
Background: Left atrial appendage (LAA) closure (LAAC) is accompanied by a high risk of complications. Due to the complex anatomy of the LAA and the oval-shaped ostium, the proper sizing of the device is often difficult. Purpose: To assess individualized fluoroscopy viewing angles using pre-procedural CT analysis and to compare the results of landing zone measurements obtained from CT, transesophageal echocardiography (TEE), intracardiac echocardiography (ICE), and fluoroscopy. Methods: Patients with indications for LAAC were enrolled. Cardiac CT and TEE were done before the procedure; ICE and fluoroscopy measurements were done peri-procedurally. Multiplanar reconstruction of CT images, using FluoroCT software, was done, and optimal "personalized" viewing angles for fluoroscopy were determined. Moreover, a mean (using multiplanar CT reconstruction, derived from the LAA perimetr) amd maximum (using all four imaging modalitities) landing zone (LZ) of the LAA were masured. Results: Twenty-five patients were analyzed. Despite significant correlation between LZs obtained from different imaging modalities, the values of LZs differed significantly; the mean LZ diameter on CT was 20.60 ± 3.42 mm, the maximum diameters were 21.99 ± 4.03 mm (CT), 18.72 ± 2.44 mm (TEE), 18.20 ± 2.68 mm (ICE), and 17.76 ± 3.24 mm (fluoroscopy). The mean CT diameter matched with the final device selection in 92% patients, while fluoroscopy or TEE maximum diameters in only 72% patients. Optimal viewing angles differed significantly from the fluoroscopy projections usually recommended by the manufacturer in 3 patients. Conclusions: CT provides the best measurement of the LZ and the best prediction of the optimum fluoroscopy projections for the implantation procedure.
- Publikační typ
- časopisecké články MeSH
Závěrečná zpráva o řešení grantu Agentury pro zdravotnický výzkum MZ ČR
Nestr.
Fibrilace síní je nejčastěji se vyskytující arytmií s prevalencí 1-2% a s 5-6% rizikem vzniku kardioembolizační příhody bez antitrombotické léčby. Zdrojem kardioembolizační příhody je trombus, který se při fibrilací síní nejčastěji tvoří v oušku levé síně. K prevence vzniku trombu se proto podává antikoagulační léčba (v minulosti pouze warfarin), která dokáže účinně zabránit u většiny pacientů vzniku trombu v levé síni a tím kardioembolizační příhodě. Antikoagulační léčba je však spojena s rizikem krvácení, které může být u některých pacientů závažné až smrtelné. V poslední době se objevily dvě nové možnosti prevence kardioembolizační příhody u FS. První z nich jsou tzv. nová antikoagulanci (NOAK). Ta taktéž brání vzniku trombu svým antikoagulačním efektem, oproti warfarinu mají však lepší bezpečnostní profil s lehce nižším rizikem krvácení. Druhou alternativou je katetrizační uzávěr ouška levé síně. Cílem projektu je u nejrizikovější skupiny pacientů s fibrilací síní porovnat tyto dvě nové léčebné možnosti v prospektivní, multicentrické randomizované studii.; Atrial fibrillation (AF) is the most common cardiac arrhythmia with a prevalence of 1-2%. Without antithrombotic treatment, the annual risk of a cardioembolic event is 5-6%. The source of a cardioembolic event is a thrombus, which usually forms in the left atrial appendage (LAA). prevention of cardioembolic events involves treatment with anticoagulant drugs, which were limited to, until recently, vitamin K antagonists (e.g. warfarin). Anticoagulant treatment with warfarin can lead to adverse bleeding events, some of which can be life threatening. Recently, two new options for thrombus prevention have been developed. The first is the novel anticoagulants (NOAC), which were associated with slightly better safety profiles due to a lower frequency of intracranial bleeding in large randomized trials . The second option involves interventional occlusion of the LAA. The aim of this project is to compare the LAA occlusion intervention to NOAC pharmacological treatment in a randomized multicenter study of AF patients at high risk of a cardioembolic event.
- MeSH
- antikoagulancia terapeutické užití MeSH
- cévní mozková příhoda prevence a kontrola MeSH
- embolie a trombóza prevence a kontrola MeSH
- fibrilace síní komplikace terapie MeSH
- lidé MeSH
- primární prevence MeSH
- prospektivní studie MeSH
- rizikové faktory kardiovaskulárních chorob MeSH
- síňové ouško MeSH
- srdeční katetrizace MeSH
- srdeční katétry MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
- Konspekt
- Patologie. Klinická medicína
- NLK Obory
- kardiologie
- farmakoterapie
- preventivní medicína
- NLK Publikační typ
- závěrečné zprávy o řešení grantu AZV MZ ČR
Závěrečná zpráva o řešení grantu Agentury pro zdravotnický výzkum MZ ČR
Nestr.
Fibrilace síní je (FS) nejčastěji se vyskytující srdeční arytmií s prevalencí 1-2% v celkové populaci. Je spojena s rizikem kardioembolizační příhody a snížením minutového srdečního výdeje s odpovídajícími symptomy. Hybridní ablace, tj. kombinace kardiochirurgické, miniinvazivní ablace (vytvoření box-léze na zadní stěně levé síně) s následnou katetrizační ablací (kompletizace boxu, event.další ablace), představuje dle velmi recentních studií novou a nadějnou metodu léčby zejména perzistentní a dlouhodobě perzistentní, izolované FS. Studie, která by precizně zhodnotila jak úspěšnost, tak bezpečnost hybridní ablace dosud provedena nebyla. Cílem projektu je přesně stanovit účinnost hybridní ablace pomocí implantabilního EKG záznamníku, jakožto suverénně nejpřesnější metody monitorace rytmu. Dalším cílem je precizně stanovit bezpečnost metody. Kromě klinických parametrů půjde o stanovení četnosti a klinické závažnosti mozkových mikroembolizací pomocí vyšetření transkraniálním Dopplerem během ablace a magnetickou rezonancí mozku a neuropsychologickým vyšetřením před a po zákroku.; Atrial fibrillation (AF) is the most common cardiac arrhythmia with a prevalence of 1-2% in general population. It increases the risk of cardioembolic events and decreases the stroke volume with related symptoms. Recent studies present the hybrid ablation, i.e. combination of surgical, miniinvasive ablation (creation of box-lesion on posterior left atrial wall) with subsequent catheter ablation (box-lesion completion, other ablation), as a new and promising method of treatment of persistent and long-standing persistent, lone AF. However, no clinical study has precisely assessed its both efficacy and safety. The aim of the project is to assess the efficacy of the procedure exactly using an insertable cardiac monitor as the most precise way of rhythm evaluation. Other aim is to evaluate precisely the safety of the procedure. Clinical parameters will be assessed and also the rate and clinical relevance of cerebral microembolism, using a transcranial Doppler during the ablation and cerebral magnetic resonance imaging and neuropsychological assessment before and after the ablation.
- MeSH
- ablace metody MeSH
- chronická nemoc MeSH
- elektrokardiografie MeSH
- fibrilace síní chirurgie MeSH
- hodnocení rizik MeSH
- hrudní chirurgie MeSH
- lidé MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- hodnotící studie MeSH
- Konspekt
- Patologie. Klinická medicína
- NLK Obory
- kardiochirurgie
- NLK Publikační typ
- závěrečné zprávy o řešení grantu AZV MZ ČR
