Over 700 patients with drug-refractory paroxysmal atrial fibrillation were randomly assigned to cryoballoon or radiofrequency ablation. Cryoballoon ablation was noninferior to radiofrequency for the ...composite of recurrent atrial arrhythmia, use of antiarrhythmic drugs, or repeat ablation.
According to a 2012 expert consensus statement, catheter ablation of drug-refractory paroxysmal atrial fibrillation is a class I level A indication,
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and pulmonary-vein isolation is the standard approach.
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The two most frequently used ablation technologies for pulmonary-vein isolation differ in the energy source and mode of application. The most common method is the use of radiofrequency current applied in a point-by-point mode, which leads to cellular necrosis by tissue heating; the other method is the use of cryogenic energy applied with a balloon in a single-step mode, which leads to necrosis by freezing (Figure 1). Radiofrequency ablation for atrial . . .
In this multicenter, randomized trial comparing early rhythm control with usual care in patients with early atrial fibrillation and cardiovascular conditions, early rhythm control reduced the rate of ...death from cardiovascular causes and cardiovascular complications and did not affect the number of nights in the hospital.
Pulsed field ablation uses electrical pulses to cause nonthermal irreversible electroporation and induce cardiac cell death. Pulsed field ablation may have effectiveness comparable to traditional ...catheter ablation while preventing thermally mediated complications.
The PULSED AF pivotal study (Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF) was a prospective, global, multicenter, nonrandomized, paired single-arm study in which patients with paroxysmal (n=150) or persistent (n=150) symptomatic atrial fibrillation (AF) refractory to class I or III antiarrhythmic drugs were treated with pulsed field ablation. All patients were monitored for 1 year using weekly and symptomatic transtelephonic monitoring; 3-, 6-, and 12-month ECGs; and 6- and 12-month 24-hour Holter monitoring. The primary effectiveness end point was freedom from a composite of acute procedural failure, arrhythmia recurrence, or antiarrhythmic escalation through 12 months, excluding a 3-month blanking period to allow recovery from the procedure. The primary safety end point was freedom from a composite of serious procedure- and device-related adverse events. Kaplan-Meier methods were used to evaluate the primary end points.
Pulsed field ablation was shown to be effective at 1 year in 66.2% (95% CI, 57.9 to 73.2) of patients with paroxysmal AF and 55.1% (95% CI, 46.7 to 62.7) of patients with persistent AF. The primary safety end point occurred in 1 patient (0.7%; 95% CI, 0.1 to 4.6) in both the paroxysmal and persistent AF cohorts.
PULSED AF demonstrated a low rate of primary safety adverse events (0.7%) and provided effectiveness consistent with established ablation technologies using a novel irreversible electroporation energy to treat patients with AF.
URL: https://www.
gov; Unique identifier: NCT04198701.
The QDOT MICRO™ Catheter is a novel open-irrigated contact force-sensing radiofrequency ablation catheter. It offers very high-power short-duration (vHPSD) ablation with 90 W for 4 s to improve ...safety and efficacy of catheter ablation procedures. Although the QDOT MICRO™ Catheter was mainly designed for pulmonary vein isolation (PVI) its versatility to treat atrial fibrillation (AF) and other types of arrhythmias was recently evaluated by the FAST and FURIOUS study series and other studies and will be presented in this article. Available study and registry data as well as case reports concerning utilization of the QDOT MICRO™ Catheter for the treatment of cardiac arrhythmias including AF, focal and macroreentry atrial tachycardia, typical atrial flutter by cavotricuspid isthmus block, premature ventricular contractions, and accessory pathways were reviewed and summarized. In summary, the QDOT MICRO™ Catheter showed safety and efficacy for PVI and is able to treat also other types of arrhythmias as is was recently evaluated by case reports and the FAST and FURIOUS studies.
Background:The arctic front cryoballoon (AF-CB) provides effective and durable pulmonary vein isolation (PVI) associated with encouraging clinical outcome. The POLARx cryoballoon incorporates unique ...features and design changes that may translate into improved efficacy, safety and further simplified balloon-based procedures. Efficacy and safety of the novel POLARx cryoballoon was compared to the fourth generation AF-CB (AF-CB4).Methods and Results:Twenty-five consecutive patients with paroxysmal or persistent atrial fibrillation were prospectively enrolled, underwent POLARx-based PVI (POLARx group) and were compared to 25 consecutive patients treated with the AF-CB4 (AF-CB4 group). All PVs were successfully isolated utilizing the POLARx and AF-CB4. A significant difference regarding the mean minimal cryoballoon temperatures reached using the AF-CB4 and POLARx (−50±6℃ vs. −57±7℃, P=0.004) was observed. Real-time PVI was visualized in 81% of POLARx patients and 42% of AF-CB4 patients (P<0.001). Utilizing the POLARx, a trend towards shorter median procedure time (POLARx: 45 39, 53 min vs. AF-CB4: 55 50, 60 min; P=0.062) was found. No differences were observed between AF-CB4 and POLARx concerning catheter maneuverability, catheter stability and periprocedural complications.Conclusions:The novel POLARx showed similar safety and efficacy compared to the AF-CB4. A higher rate of real-time PV recordings and significantly lower minimal balloon temperatures were observed using the POLARx.
The European Lead Extraction ConTRolled Registry (ELECTRa), is a prospective registry of consecutive transvenous lead extraction (TLE) procedures conducted by the European Heart Rhythm Association ...(EHRA) in order to identify the safety and efficacy of the current practice of TLE.
European centres performing TLE, invited by the organizing committee on behalf of EHRA, prospectively recruited all consecutive patients undergoing TLE at their institution. The primary endpoint was TLE safety defined by pre-discharge major procedure-related complications including death. Secondary endpoints included clinical and radiological success and overall complication rates. Outcomes were compared between Low Volume (LoV) vs. High Volume (HiV) centers (LoV < 30 and HiV ≥ 30 procedures/year). A total of 3555 consecutive patients (pts) of whom 3510 underwent TLE at 73 centres in 19 European countries were enrolled between November 2012 and May 2014. The primary endpoint of in-hospital procedure-related major complication rate was 1.7% 95% CI 1.3-2.1% (58/3510 pts) including a mortality of 0.5% 95% CI 0.3-0.8% (17/3510 pts). Approximately two-thirds (37/58) of these complications occurred during the procedure and one-third (21/58) in the post-operative period. The most common procedure related complications were those requiring pericardiocentesis or chest tube and/or surgical repair (1.4% 95% CI 1.0-1.8%). Complete clinical and radiological success rates were 96.7% 95% CI 96.1-97.3% and 95.7% 95% CI 95.2-96.2%, respectively. The all cause in-hospital major complications and deaths were significantly lower in HiV centres vs. LoV centres (2.4% 95% CI 1.9-3.0% vs. 4.1% 95% CI 2.7-6.0%, P = 0.0146; and 1.2% 95% CI 0.8-1.6% vs. 2.5% 95% CI 1.5-4.1% P = 0.0088), although those related to the procedure did not reach statistical significance. Radiological and clinical successes were more frequent in HiV vs. LoV centres.
The ELECTRa study is the largest prospective registry on TLE and confirmed the safety and efficacy of the current practice of TLE. Lead extraction was associated with a higher success rate with lower all cause complication and mortality rates in high volume compared with low volume centres.
Abstract
Aims
The Cardioband™ (Edwards Lifesciences) is a transcatheter implant designed to reduce mitral annulus size and mitral regurgitation (MR) severity. We report the 1-year outcomes of ...consecutive patients who underwent the Cardioband procedure between 2013 and 2016.
Methods and results
Sixty patients with moderate or severe secondary MR (72 ± 7 years, 60% ischaemic origin) on guideline-recommended medical therapy were treated and analyzed at 11 European institutions. There were two in-hospital deaths (none device-related), one stroke, two coronary artery complications, and one tamponade. Anchor disengagement, observed in 10 patients (all but one in the first half of the population), resulted in device inefficacy in five patients and led to device modification half way through the study to mitigate this issue. Technical, device, and procedural successes, assessed based on Mitral Valve Academic Research Consortium (MVARC) criteria, were 97% (58/60), 72% (43/60), and 68% (41/60), respectively. At 1-year, overall survival, survival free of readmission for heart failure, and survival free of reintervention (performed in seven patients) were 87%, 66%, and 78%, respectively. In the overall population, MR grade at 12 months was moderate or less 61% and moderate or less in 95% of the 39 patients who underwent a transthoracic echocardiography at 1-year but worsened by at least one grade in 11 patients (22%). Functional status (79% vs. 14% in New York Heart Association Class I/II), quality of life (−19 points on the Minnesota Living with Heart Failure Questionnaire score), and exercise capacity (+58 m by 6MWT) improved significantly (all P < 0.01).
Conclusion
In this multicentre trial, the Cardioband mitral system demonstrated reasonable performance and safety. At 1 year, most patients had moderate or less MR and experienced significant functional improvements. A randomized controlled trial is underway to demonstrate the impact of Cardioband in patients on guideline-directed medical therapy.
Abstract
The clinical efficacy of catheter ablation of paroxysmal atrial fibrillation (AF) remains limited by difficulty in achieving durable pulmonary vein isolation (PVI). Suboptimal catheter tip-to-tissue ...contact force (CF) during lesion delivery is believed to reduce clinical efficacy.
To determine the relationship between catheter CF during irrigated catheter ablation for AF and clinical recurrences during follow-up.
Thirty-two patients with paroxysmal AF underwent PVI by using a radiofrequency ablation catheter with a CF sensor integrated at its tip, and they were followed for 12 months. The relationship between the CF and clinical outcomes was determined.
Acute PVI was achieved in 100% of the veins. Thirty-five percent (351 of 1017) of the applications were placed with an average CF of <10 g (low CF). All patients treated with an average CF of <10 g (5 of 5 patients) experienced recurrences, whereas 80% of the patients treated with an average CF of >20 g (8 of 10 patients) were free from AF recurrence at 12 months. The analysis of the average force-time integral showed that 75% of the patients treated with <500 gs were recurrent whereas only 31% of the patients treated with >1000 gs had recurrences at 12 months.
The CF during catheter ablation for AF correlates with clinical outcome. Arrhythmia control is best achieved when ablation lesions are placed with an average CF of >20 g, and clinical failure is universally noted with an average CF of <10 g.
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