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Abstract Background The optimal dosage for cryoablation of atrial fibrillation (Cryo-AF) is still unknown. To evaluate the efficacy of an individualized freeze duration, we compared the clinical outcome of patients treated with a time-to-pulmonary vein isolation (TT-PVI) or temperature-guided ablation protocol to the outcome of patients treated wit...
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Purpose:
A strategy based on the attainment of the specific parameter of - 40 °C within the first 60 s during cryoenergy applications in the setting of cryoballoon ablation (CB-A) without the use of an inner lumen mapping catheter (ILMC) (Achieve; Medtronic, USA) for the visualization of real-time recordings (RTR) has been previously described. Th...
Aims: To compare the procedural outcomes of cryoballoon ablation (CBA) and radiofrequency ablation (RFA) in atrial fibrillation (AF) patients with the common ostium of inferior pulmonary veins (COIPV) and to explore the effect of COIPV on CBA performance through the assessment of anatomical factors.
Methods: A total of 18 AF patients with COIPV wer...
The aim of the present case series was to characterize the feasibility of a novel size adjustable cryoballoon system (PolarX Fit, Boston Scientific, Marlborough, MA, USA). This cryoballoon catheter can be inflated to two different diameters (28 mm and 31 mm) within the same procedure allowing vein adapted PVI. In summary, the novel size adjustable...
Background
The novel fourth-generation cryoballoon (4th-CB) is characterized by a shorter-tip that potentially facilitates better time-to-isolation (TTI) monitoring. We sought to clarify the advantages and disadvantages of the 4th-CB compared to the second-generation cryoballoon (2nd-CB) in pulmonary vein isolation (PVI).Methods
Forty-one and 49 co...
Background
Cryoballoon ablation is a widely used single-shot technique for pulmonary vein isolation (PVI) in the treatment of paroxysmal atrial fibrillation (AF). Procedural endpoints ensuring maximal PVI durability are important.
Objective
To assess the performance of cryoablation procedural markers to predict long-term PVI.
Methods
In a single...
Citations
... Among the remaining 2344 articles, 2304 articles were excluded according to the title and abstract and the full text of the remaining 40 articles was browsed. Finally, 6 articles were included in the present meta-analysis [5][6][7][8][9][10]. The detailed screening process is shown in Fig. 1. ...
... Furthermore, based on the previous outcomes, Pott et al. boldly updated the TTIP for TTI < 30 s, 30~60 s and > 60 s, and omitted the bonus freezing cycle [8]. Surprisingly, the latest research from Ding et al. not only further reduced the freezing duration added on TTI on the basis of Rottner et al. but also applied cryoenergy according to reaching − 40°C within 60 s when TTI could not be recorded [9]. ...
... Five studies [5,6,[8][9][10], including 2368 PVs, reported the real-time recording of PV potential during ablation, and the recording rate of was 71% (95% CI: 61~81%) with significant heterogeneity (I 2 = 97.9%) (Supplementary materials Fig. 1). ...
Background:
Cryoballoon (CB) has been widely utilized in the treatment of drug-refractory atrial fibrillation (AF), but the balance point between efficacy and safety has been unclear. The protocol based on the time-to-isolation (TTI) was expected to provide patients with individualized ablation strategies.
Methods:
All studies up to June 2020 comparing the CB of TTI-based protocol (TTIP) and conventional protocol (ConP) in PubMed, Embase, and Cochrane Library databases were searched. The pooled OR or SMD with 95% CIs for each outcome were calculated with inverse-variance random effect model. The Egger method was used to evaluate the publication bias and the subgroup analysis was conducted according to the type of atrial fibrillation.
Results:
Six studies enrolling a total of 1770 patients with drug-refractory AF were included. The pool real-time recording of pulmonary veins potential was 71% (95% CI: 61 ~ 81%, I2 = 97.9%) and a similar incidence of freedom from ATs after 1 year (OR: 1.12; 95% CI: 0.86 ~ 1.46, I2 = 0.0%, P = 0.481) was observed between two protocols. No difference was observed in complications (OR: 0.67; 95% CI: 0.43 ~ 1.04, I2 = 0.0%, P = 0.717) and phrenic nerve palsy (OR: 0.70; 95% CI: 0.37 ~ 1.35, I2 = 0.0%, P = 0.807). TTIP could significantly decrease the CB freezes per patient (SMD: - 2.44; 95% CI: - 4.46 to approximately - 0.41; I2 = 99.5%, P = 0.00) and shorten the cryotherapy application time (SMD: - 3.04; 95% CI: - 4.18 to approximately - 1.89; I2 = 97.4%, P = 0.00), procedure time (SMD: - 1.51; 95% CI: - 2.08 to approximately - 0.94; I2 = 95.4%, P = 0.00), and fluorescence time (SMD: - 0.70; 95% CI: - 1.25 to approximately - 0.15; I2 = 95.7%, P = 0.00).
Conclusion:
TTIP is safe and effective and it opens a new chapter in the field of individualized protocol of CB for patients with AF.
... Three studies were excluded based on the wrong comparator (no single freeze group in all cases 13,29,30 ) and, finally, thirteen studies were included in the data synthesis: three RCT's 11, 12, 21 and 10 non-RCT's 9, 10, 12, 22-28 . ...
To conduct a systematic review and meta-analysis to compare the effectiveness and safety of cryoballoon ablation of atrial fibrillation (AF) performed using a single freeze strategy in comparison to an empiric double (‘bonus’) freeze strategy. We systematically searched MEDLINE, EMBASE, and CENTRAL databases from inception to 12 July 2020, for prospective and retrospective studies of patients undergoing cryoballoon for paroxysmal or persistent AF comparing a single vs. bonus freeze strategy. The main outcome was atrial arrhythmia-free survival and eligible studies required at least 12 months of follow-up; the primary safety outcome was a composite of all complications. Study quality was assessed using the Cochrane risk of bias tool and the Newcastle–Ottawa Scale. Thirteen studies (3 randomized controlled trials and 10 observational studies) comprising 3163 patients were eligible for inclusion (64% males, 71.5% paroxysmal AF, mean CHA2DS2-VASc score 1.3 ± 0.9). There was no significant difference in pooled effectiveness between single freeze strategy compared to double freeze strategy [relative risk (RR) 1.03; 95% confidence interval (CI): 0.98–1.07; I2 = 0%]. Single freeze procedures were associated with a significantly lower adverse event rate (RR 0.72; 95% CI: 0.53–0.98; I2 = 0%) and shorter average procedure time (90 ± 27 min vs. 121 ± 36 min, P < 0.001). A trend for lower risk of persistent phrenic nerve palsy was observed (RR 0.61; 95% CI: 0.37–1.01; I2 = 0%). The quality of included studies was moderate/good, with no evidence of significant publication bias. Single freeze strategy for cryoballoon of AF is as effective as an empiric double (‘bonus’) freeze strategy while appearing safer and probably quicker (PROSPERO registration number CRD42020158696).
... Обязательной конечной точкой катетерного лечения ФП является электрическая изоляция всех легочных вен (ЛВ) [1]. Методика проведения КБА УЛВ за последнее время усовершенствовалась [4][5][6][7]. Первоначально для позиционирования криобаллона в ЛВ использовался проводник Guidewire (рис. 1, адаптировано по [9]). Во время процедуры «на проводнике» было возможно лишь косвенно оценить качество воздействия по окклюзии ЛВ и достигнутой минимальной температуре. ...
... Согласно официальной инструкции производителя, рекомендованная продолжительность воздействия при использовании криобаллона второго поколения ArcticFront Advance 28 мм составляет 240 с. Учитывая риск потенциального повреждения окружающих внесердечных структур (диафрагмального нерва, пищевода, бронхов), ряд авторов предложили сократить продолжительность воздействия под контролем времени изоляции ЛВ (time to isolation, TTI) на катетере Achieve до 150-180 с [4,10,11]. ...
Aim To evaluate the effect of cryo-exposure duration and the use of the Achieve circular mapping catheter on efficacy of cryoballoon ablation (CBA).
Material and methods CBA of pulmonary vein ostia (PVO) is a major method for heart rhythm control in patients with atrial fibrillation (AF). Since the inception, the PVO CBA method has evolved; the recommended application time was changed, and the Achieve circular catheter appeared. We performed a retrospective analysis of PVO CBA administered to patients with AF in the I.V. Davydovsky Municipal Clinical Hospital from 2017 through 2019. The study included 100 patients with available clinical and demographic characteristics and remote results of the intervention. Three patient groups were analyzed based on differences in surgical techniques: group 1, Guidewire / 240 (n=31) with the cryoballoon placing on a guidewire and PVO exposure duration of 240 s; group 2, Guidewire / 180 (n=26) with the cryoballoon placing on a guidewire and PVO exposure duration of 180 s; and group 3, Achieve / 180 (n=43) with the cryoballoon placing on the mapping catheter Achieve and PVO exposure duration of 180 с. The follow-up period was 33.2±4.5, 15.2±6.1, and 12.2±4.1 months in the Guidewire / 240, Guidewire / 180, and Achieve / 180 groups, respectively. The intervention was considered effective when there was no relapse at the time of interview. A relapse of AF was determined as one or more paroxysms recorded on electrocardiogram (ECG) or during 24-h ECG monitoring; the “blind period” (first 3 months after the procedure) was excluded from the follow-up. Safety evaluation included clinically significant complications, such as phrenic nerve damage, hemopericardium, gastroparesis, hemoptysis, acute cerebrovascular disease, and formation of atrio-esophageal fistula. Effects of independent factors were determined with binary logistic regression.
Results In the Guidewire / 240 group, efficacy of PVO CBA for the maximum follow-up period was 74.4%, which was significantly different from the value for the Guidewire / 180 group (57.7 %, р=0.015). At the same time, the difference between the Guidewire / 240 and Achieve / 180 groups was statistically non-significant for a comparable follow-up period (р=0.144). Clinically significant complications were absent in all 3 groups. The independent factors that significantly increased the PVO CBA efficacy were the cryo-exposure duration of 240 s compared to 180 s (р= 0.018) and the use of the Achieve catheter (р=0.014).
Conclusion Decreasing the cryo-exposure duration to less than 240 s is impractical (in absence of Achieve mapping catheter) since it impairs the long-term efficacy of PVO CBA and does not influence the risk of complications.
... Procedural sedation plays a key role in many procedures carried out for arrhythmia related issues such as device implant, electrophysiological studies, catheter ablations [18] and DCC [6]. As these procedures can be painful, an adequate level of sedation not only is required but can also reduce the pain-related catecholamine surge therefore preventing the recollection of an unpleasant experience [13]. ...
Background:
A cardiologist-only approach to procedural sedation with midazolam in the setting of elective cardioversion (DCC) for AF has already been proven as safe as sedation with propofol and anaesthesiologist assistance. No data exist regarding the safety of such a strategy during emergency procedures. The aim of this study is to compare the feasibility of sedation with midazolam, administered by a cardiologist, to an anaesthesiologist-assisted protocol with propofol in emergency DCC.
Methods:
Single centre, prospective, open blinded, randomized study including all consecutive patients admitted to the Emergency Department requiring urgent or emergency DCC. Patients were randomized in a 1:1 fashion to either propofol or midazolam treatment arm. Patients in the midazolam group were managed by the cardiologist only, while patients treated with propofol group underwent DCC with anaesthesiologist assistance.
Results:
Sixty-nine patients were enrolled and split into two groups. Eighteen patients (26.1%) experienced peri-procedural adverse events (bradycardia, severe hypotension and severe hypoxia), which were similar between the two groups and all successfully managed by the cardiologist. No deaths, stroke or need for invasive ventilation were registered. Patients treated with propofol experienced a greater decrease in systolic and diastolic blood pressure when compared with those treated with midazolam. As the procedure was shorter when midazolam was used, the median cost of urgent/emergency DCC with midazolam was estimated to be 129.0 € (1st-3rd quartiles 114.6-151.6) and 195.6 € (1st-3rd quartiles 147.3-726.7) with propofol (p < .001).
Conclusions:
Procedural sedation with midazolam given by the cardiologist alone was feasible, well-tolerated and cost-effective in emergency DCC.
... Procedural sedation plays a key role in many procedures carried out for arrhythmia related issues such as device implant, electrophysiological studies, catheter ablations [16] and DCC [6]. As these procedures can be painful, an adequate level of sedation not only is required but can also reduce the pain-related catecholamine surge therefore preventing the recollection of an unpleasant experience [12]. ...
BackgroundA cardiologist-only approach to procedural sedation with midazolam in the setting of elective cardioversion (DCC) for AF has already been proven as safe as sedation with propofol and anaesthesiologist assistance. No data exist regarding the safety of such a strategy during emergency procedures. The aim of this study is to compare the feasibility of sedation with midazolam, administered by a cardiologist, to an anaesthesiologist-assisted protocol with propofol in emergency DCC.Methods
Single centre, prospective, open blinded, randomized study including all consecutive patients admitted to the Emergency Department requiring urgent or emergency DCC. Patients were randomized in a 1:1 fashion to either propofol or midazolam treatment arm. Patients in the midazolam group were managed by the cardiologist only, while patients treated with propofol group underwent DCC with anaesthesiologist assistance.ResultsSixty-nine patients were enrolled and split into two groups. Eighteen patients (26.1%) experienced peri-procedural adverse events (bradycardia, severe hypotension and severe hypoxia), which were similar between the two groups and all successfully managed by the cardiologist. No deaths, stroke or need for invasive ventilation were registered. Patients treated with propofol experienced a greater decrease in systolic and diastolic blood pressure when compared with those treated with midazolam.Conclusions
Procedural sedation with midazolam given by the cardiologist alone was safe, well-tolerated and cost-effective in emergency DCC.
Introduction
The relationship between relative hyperglycemia and ventricular arrhythmia (VA) in critically ill patients admitted to intensive care units (ICU) remains unclear. This study aims to investigate the association between stress hyperglycemia ratio (SHR) and VA in this population. Methods: This retrospective and observational study analyzed data from 4324 critically ill patients admitted to the ICU, obtained from the Medical Information Mart for Intensive Care IV (MIMIC-IV) database. The SHR was calculated as the highest blood glucose level during the first 24 h of ICU admission divided by the admission blood glucose level. Based on the optimal cut-off values under the receiver operating characteristic curve, patients were stratified into high SHR (≥ 1.31) and low SHR (< 1.31) group. To investigate the impact of diabetes mellitus (DM) on the outcome, patients were stratified as low SHR/DM; low SHR/non-DM; high SHR/DM, and high SHR/non-DM. Restricted cubic spline (RCS) and logistic regression analysis were performed to analyze the relationship between SHR and VA.
Results
A total of 4,324 critically ill patients were included in this retrospective and observational study. The incidence of VA was higher in the high SHR group. Multiple-adjusted RCS revealed a “J-shaped” correlation between SHR and VA morbidity. The logistic regression model demonstrated that high SHR was associated with VA. The high SHR/non-DM group had a higher risk of VA than other groups stratified based on SHR and DM. Subgroup analysis showed that high SHR was associated with an increased risk of VA in patients with coronary artery disease.
Conclusion
High SHR is an independent risk factor and has potential as a biomarker of higher VT/VF risk in ICU-admitted patients.
Aim:
We conducted a systematic review and meta-analysis of randomized and observational studies with a control group to evaluate the effectiveness and safety of a time to isolation (TTI)-based strategy of cryoballoon ablation (CBA) in the treatment of atrial fibrillation (AF).
Methods:
Three electronic databases (MEDLINE, Cochrane Central Register of Controlled Trials and Embase) without language restrictions were searched. The intervention assessed was a TTI-based strategy of CBA in the treatment of AF. TTI was defined as the time from the start of freezing to the last recorded pulmonary veins' potential. The comparison of interest was intended conventional protocol of CBA. The primary end point was freedom from atrial arrhythmia.
Results:
Nine studies were deemed eligible (N= 2289 patients). Eight studies reported freedom from atrial arrhythmia and pooled results showed a marginally similar success rate between two protocols (OR: 1.24; 95% CI: 0.98 - 1.56). A prespecified subgroup analysis verified that a high dose TTI strategy (with >120s duration of cryotherapy post TTI) compared to conventional protocol could significantly increase the patients without atrial arrhythmia during follow-up (OR: 1.39; 95% CI: 1.05 - 1.83). TTI strategy could also significantly decrease total procedure time (SMD: - 26.24 minutes; 95% CI: - 36.90 to - 15.57) and phrenic nerve palsy incidence (OR: 0.49; 95% CI 0.29 - 0.84).
Conclusion:
Moderate confidence evidence suggests that an individualized CBA dosing strategy based on TTI and extended (> 2 minutes post TTI) duration of CBA is accompanied by fewer recurrences post AF ablation. This article is protected by copyright. All rights reserved.
