Real-world evidence demonstrates an appropriate atrial fibrillation population for hybrid convergent approach versus stand-alone cryoballoon ablation: A long-term safety and efficacy study.

INTRODUCTION: A hybrid convergent approach (endocardial and epicardial ablation) demonstrated superior effectiveness in a recent randomized study for long-standing persistent atrial fibrillation (LSPAF). Yet, there is a lack of real-world, long-term evidence as to which patients are best candidates for a hybrid convergent approach compared to standard endocardial cryoballoon pulmonary vein isolation (CB PVI). METHODS AND RESULTS: This single-center, retrospective analysis spanning from 2010 to 2015 compared two distinctly different atrial fibrillation (AF) cohorts; one treated with stand-alone cryoablation and one treated with a hybrid convergent approach. Baseline characteristics described candidates for each approach. The following criteria were utilized to determine CB PVI candidacy: (1) paroxysmal AF (PAF) (stage 3A) with failed class I/III antiarrhythmic drug (AAD) or (2) persistent/LSPAF (stage 3B/3C/3D) with failed class I/III AAD unwilling to undergo hybrid procedure. Selection criteria for the hybrid procedure included: (1) PAF refractory to both class I/III AAD and prior CB PVI (stage 3D) or (2) persistent/LSPAF (stage 3B/3C/3D) with failed class I/III AAD agreeable to hybrid procedure. Prior sternotomy was excluded. Serial electrocardiograms and continuous monitoring evaluated primary efficacy outcome of time-to-first recurrence of atrial arrhythmia after a 90-day blanking period. Secondary outcomes were procedure-related complications and AAD use (at discharge, 12, and 36 months). Kaplan-Meier methods evaluated arrhythmia recurrence. Of 276 patients, 197 (64.2 ± 10.6 years old; 66.5% male; 74.1% 3A-PAF; 18.3% 3B/3D-persistent AF; 1.0% 3C-LSPAF; 6.6% undetermined) underwent CB PVI and 79 (61.4 ± 8.1 years old; 83.5% male; 41.8% 3D-PAF; 45.5% 3B/3D-persistent AF; 12.7% 3C/3D-LSPAF) underwent hybrid procedure. Arrhythmia freedom through 36 months was 55.2% for CB PVI and 50.4% for hybrid (p = .32). Class I AAD utilization at discharge occurred in 38 (19.3%) patients in the CB PVI group and 5 (6.3%) patients in the hybrid group (p = .01). CB PVI class I AAD utilization at 12 months occurred in 14 (9.0) patients versus 0 patients for hybrid convergent (p = .004). Patients with one or more adverse event were as follows: two (1.0%) in the CB PVI group (both transient phrenic nerve palsy) and three (3.7%) in the hybrid group (two with significant bleeding and one with wound infection) (p = .14). CONCLUSION: This study demonstrated that patients with more complex forms of AF (3D-PAF or 3B/3C/3D-persistent/LSPAF) could be well managed with a convergent approach. In a real-world evaluation, outcomes match safety and efficacy thresholds achieved for patients with earlier, less complex AF etiologies treated by CB PVI alone.

Selection of patients for hybrid ablation procedure.

Catheter ablation for treatment of symptomatic non-paroxysmal atrial fibrillation remains challenging. Clinical failure and need for continued medical therapy or repeat ablation is common, especially in more advanced forms of atrial fibrillation. Hybrid ablation has emerged as a more effective and safe therapy than endocardial-only ablation particularly for longstanding persistent atrial fibrillation as demonstrated by the randomized controlled CONVERGE trial. Hybrid ablation requires collaboration of electrophysiologists and cardiac surgeons to develop specific workflows. This review describes the Hybrid Convergent approach in the context of available ablation options and offers guidance for workflow development and patient selection.

The Convergent procedure for AF: A surgeon's perspective.

The Converge IDE Trial demonstrated improved patient outcomes in a challenging persistent and long-standing persistent atrial fibrillation population using a heart team hybrid approach with epicardial and endocardial staged ablations. Surgeons encounter unique circumstances with the surgical epicardial stage of the Convergent procedure which includes unfamiliarity with left atrial posterior anatomy, endoscopic/thoracoscopic visualization, minimally invasive left atrial appendage management, and expanded indications for the procedure. Overcoming these unique challenges is key to the adoption of the Convergent procedure as a critical off-pump approach that should be part of the surgical armamentarium in the treatment of atrial fibrillation.

Adverse events related to AtriCure EPi-Sense Coagulation Device-Analysis of the FDA MAUDE database.

INTRODUCTION: The AtriCure EPi-Sense Device is used for the hybrid convergent procedure, an emerging treatment for persistent atrial fibrillation (AF) and long-standing persistent AF. However, data on the AE related to the EPi-Sense device are scarce. METHODS: Keyword "EPI-SENSE" was searched on the MAUDE database. There were 80 device reports from 2016 to 2020. After excluding reports when the device was not returned for evaluation, 79 device reports were included for final analysis. RESULTS: The adverse events (AE) were broadly classified into 11 categories. The most common complications were pericardial effusion (25.3%), stroke (17.7%), and atrioesophageal fistula (AEF) (8.9%). Death was reported in 15 (19%) cases, 3 of which were due to pulmonary embolism, 6 due to AEF, 3 due to unknown cause, 1 due to sepsis, 2 due to events related to acute renal failure. DISCUSSION: Pericardial effusion is a common AE reported in patients with convergence procedures and is well documented in the CONVERGE trial. The convergent procedure is unique in that the epicardial ablations are performed on the posterior wall with the radiofrequency probe directed towards the heart and away from the esophagus which in theory should reduce esophageal injuries. Despite that, a high number of AEF were noticed. Finally, there were also some reports of saline perfusion malfunction which can lead to injuries due to overheating. CONCLUSION: This analysis of the AE related to the EPi-Sense device highlights several major AE that are previously unreported.

The surgical technique of the convergent procedure.

The convergent procedure is a newly developed hybrid ablation procedure that involves extensive epicardial ablation of the posterior left atrial wall followed by endocardial mapping and addition of pulmonary vein isolation. It is a team-based approach that provides a promising option for patients with persistent and permanent atrial fibrillation. In this manuscript, we present a detailed description of the surgical component of this procedure and include potential pitfalls based on our experience in performing it.

Convergent epicardial-endocardial ablation for treatment of long-standing persistent atrial fibrillation: A review of literature.

BACKGROUND AND AIM OF STUDY: The convergent procedure (CVP) is a hybrid ablation technique via a subxiphoid incision that has recently emerged as a treatment option for non-paroxysmal atrial fibrillation (npAF). By combining endocardial and epicardial ablation into a simultaneous or staged procedure, the pulmonary vein and posterior left atrium can be isolated with transmural lesion sets while minimizing the risk of proarrhythmic gaps that are a known limitation with endocardial linear lesion sets. We reviewed the 12-month outcomes in patients who underwent CVP compared to those who underwent endocardial catheter ablation (CA) and surgical ablation (SA). METHODS: A literature search was conducted using the PubMed database for publications related to CVP. Selected studies included detailed 12-month follow-up of patients, patient characteristics, periprocedural complications, use of antiarrhythmic drugs (AADs), and monitoring method. RESULTS: Five studies with 340 patients who underwent CVP between January 2009 and March 2017 were selected for this review. A total of 8.5% of patients had paroxysmal AF (pAF), 42.2% had persistent AF (peAF), and 49.1% had long-standing persistent AF (lspAF). At 12 months, 81.9% of patients were in sinus rhythm, while 54.1% of patients were in sinus rhythm while not taking AADs. The overall complication rate was 10%. CONCLUSION: CVP had better 1-year efficacy in eliminating AF when compared to CA. However, SA, specifically the Cox Maze IV, had lower rates of AF recurrence in the npAF patient population. Despite its promising 1-year efficacy rates, the periprocedural complication rate for CVP was significantly higher than both CA and SA.

Convergent ablation for persistent atrial fibrillation: Single center experience.

BACKGROUND: Endocardial catheter ablation has been shown to be effective in patients with paroxysmal atrial fibrillation (AF), and significantly less effective in patients with persistent AF (PAF). Lately, there is a trend toward a hybrid approach in the treatment of PAF that may be a more durable treatment for patients with PAF. In this manuscript we report our experience with the convergent ablation procedure in a PAF cohort. METHODS: This is a single center retrospective analysis of 31 patients with PAF who underwent the convergent procedure. All patients underwent surgical epicardial ablation of the posterior left atrial through a subxiphoid approach, followed by radiofrequency endocardial ablations on the same day. Patients were followed at 6 months intervals with static electrocardiograms or implanted devices. RESULTS: Sinus rhythm was achieved intraoperatively in all patients. Recurrence was defined according to Hearlt Rhythm Society definitions. At a median follow up of 17.7 months (IQR 11-24), the recurrence of atrial tachyarrhythmia (AF and atrial flutter) by Kaplan-Meier event free survival analysis occurred in 9 (29%) patients at 1-year follow up and 15 (48%) patients at 2-year follow up with or without the use of antiarrhythmic drugs. Recurrence of AF alone occurred in 4 (13%) patients at 1-year follow up and 9 (29%) patients at 2-year follow up patients. Complication rate in perioperative period was 12.9%. CONCLUSION: Our experience showed the hybrid procedure is a relatively safe and effective option for patients with PAF. Further studies are needed to better determine its long-term outcomes.

Comparison of treatment outcomes between convergent procedure and catheter ablation for paroxysmal atrial fibrillation evaluated with implantable loop recorder monitoring.

INTRODUCTION: While catheter ablation (CA) is an established treatment for symptomatic paroxysmal atrial fibrillation (AF), convergent epicardial and endocardial ablation procedure (CVP) has been primarily used to treat persistent AF. The aim of this single-center, prospective, randomized study was to compare treatment efficacy of CA and CVP in paroxysmal AF patients by monitoring AF, atrial tachycardia (AT), and atrial flutter (AFL) recurrence with Implantable Loop Recorder (ILR). METHODS AND RESULTS: Fifty patients (74% male) with history of paroxysmal AF were randomized between CA and CVP. Outcomes were determined by ILRs; every episode of AF/AT/AFL lasting 6 minutes or more was defined as a recurrence. AF burden (AFB) and required AF reinterventions (cardioversions and repeat ablations) were quantified after a 3-month blanking period. Total procedural (266 ± 44 vs. 242 ± 39 minutes) and ablation duration (52 ± 10 vs. 48 ± 12 minutes) was similar in both groups. Recurrence of AF/AT/AFL was more likely in the CA group compared to the CVP group (OR 3.78 (95% CI (1.17, 12.19), P  =  0.048)). During the follow-up period (mean 30.5 ± 6.9 months), higher AF burden and more reinterventions for recurrent AF were recorded in the CA group. There were more periprocedural complications in the CVP group (12.5%) compared to the CA group (0%). CONCLUSION: Treatment of paroxysmal AF with CVP showed less arrhythmia recurrence compared to CA. In addition, patients after CVP had fewer reinterventions and lower AF burden, but more periprocedural complications.

Hybrid convergent procedure with proactive oesophageal cooling for the treatment of long-standing persistent atrial fibrillation: a case series.

Background: The hybrid convergent procedure is approved to treat symptomatic patients with long-standing persistent atrial fibrillation (AF). Despite direct visualization during surgical ablation as well as the use of luminal oesophageal temperature (LET) monitoring, oesophageal injury is still possible. A dedicated device for proactive oesophageal cooling has recently been cleared by the Food and Drug Administration to reduce the likelihood of ablation-related oesophageal injury resulting from radiofrequency cardiac ablation procedures. This report describes the first uses of proactive oesophageal cooling for oesophageal protection during the epicardial ablation portion of hybrid convergent procedures. Case summary: Five patients with long-standing persistent AF underwent hybrid convergent ablations with the use of proactive oesophageal cooling as means of oesophageal protection. All cases were completed successfully with no adverse effects. Most notably, cases were shorter when compared to cases using LET monitoring, likely due to lack of pauses for overheating of the oesophagus that would otherwise be required to prevent damage to the oesophagus. Discussion: This report describes the first uses of proactive oesophageal cooling for oesophageal protection during the epicardial ablation portion of five hybrid convergent procedures. Use of cooling enabled uninhibited deployment of lesions without the need to pause energy delivery due to elevated temperatures in the oesophagus, providing a feasible alternative to LET monitoring.

Long-Term Outcomes after Convergent Procedure for Atrial Fibrillation.

Background: The aim of this single-center retrospective study was to evaluate the long-term outcomes after the convergent procedure (CP) for treatment of AF. Methods: We analyzed the outcomes of patients that underwent CP from January 2009 until July 2020. A total of 119 patients with paroxysmal AF (23.5%), persistent AF (5.9%), or long-standing persistent AF (70.6%) that attended long-term follow-up were included. The outcomes were assessed 1 year after the CP and at long-term follow-up. At the 1-year follow-up, rhythm and AF burden were assessed for patients with an implantable loop recorder (61.2%). For others, rhythm was assessed by clinical presentation and 12-lead ECG. At long-term follow-up, patients with sinus rhythm (SR) or an unclear history were assessed with a 7-day Holter ECG monitor, and AF burden was determined. Long-term success was defined as freedom from AF/atrial flutter (AFL) with SR on a 12-lead ECG and AF/AFL burden < 1% on the 7-day Holter ECG. Results: At 1-year follow-up, 91.4% of patients had SR and 76.1% of patients had AF/AFL burden < 1%. At long-term follow-up (8.3 ± 2.8 years), 65.5% of patients had SR and 53.8% of patients had AF/AFL burden < 1% on the 7-day Holter ECG. Additional RFAs were performed in 32.8% of patients who had AF or AFL burden < 1%. At long-term follow-up, age, body mass index, and left atrial volume index were associated with an increased risk of AF recurrence. Conclusions: CP resulted in high long-term probability of SR maintenance. During long-term follow-up, additional RFAs were required to maintain SR in a substantial number of patients.

Revolutionizing Atrial Fibrillation Treatment: The Robotic Convergent Plus Procedure.

Atrial fibrillation (AF) is widely accepted to be the most common sustained arrhythmia, with an increasing incidence over time. This is thought to be due to the aging population across the world. AF occurs when abnormal electrical foci result in disorganization of atrial depolarization, though the exact pathophysiology leading to these abnormal foci is not well understood. A range of interventions exist for AF - pharmacological therapies (anti-arrhythmic or negative chronotropic medications), cardioversion, or ablations to interrupt the abnormal conduction pathways. Ablation may be via a catheter-based approach, via a surgical approach using the "Maze" procedure (Cox-Maze IV), or more recently, via a hybrid approach. This first involves a surgical epicardial ablation, with catheter-based endocardial ablation following a few weeks later to ensure durable transmural lesion sets via the "Convergent" procedure. We describe the use of the Da Vinci Xi™ robotic platform to improve the procedure, allowing continuous and improved visualization of the anatomy without the need for potentially harmful retraction of the atrial appendage or the back of the left atrium, as well as increased precision with our mapping tools and more complete ablation. Here, we highlight the advantages over a non-robotic (subxiphoid) Convergent procedure, while outlining the key operative steps in undertaking the "Robotic Convergent Plus" procedure using the Da Vinci Xi™ robotic surgical system.

Mid term freedom from atrial fibrillation following hybrid ablation, a systematic review and meta analysis.

INTRODUCTION: Atrial Fibrillation (AF) is a common tachyarrhythmia affecting 33 million people worldwide. Hybrid AF ablation utilises a surgical (epicardial) ablation followed by an endocardial catheter-based ablation. The aim of this systematic review and meta-analysis is to summarize the literature reporting mid-term freedom from AF following hybrid ablation. METHODS: An electronic search of databases was performed to identify all relevant studies providing mid-term (2 year) outcomes following hybrid ablation for AF. The primary study outcome was to assess the mid-term freedom from AF following hybrid ablation, utilising the metaprop function on Stata® (Version 17.0, StataCorp, Texas, USA). Subgroup analysis was performed to assess the impact of various operative characteristics on mid-term freedom from AF. The secondary outcomes assessed mortality and procedural complication rate. RESULTS: The search strategy identified 16 studies qualifying for inclusion in this meta-analysis, with 1242 patients in total. The majority of papers were retrospective cohort studies (15) and one study was a randomized control trial (RCT). The mean follow up was 31.5 ± 8.4 months. Following hybrid ablation, the overall mid-term freedom from AF was 74.6% and 65.4% for patients off antiarrhythmic drugs (AAD). Actuarial freedom from AF was 78.2%, 74.2% and 73.6% at 1, 2 and 3 years respectively. No significant differences in mid-term freedom from AF based epicardial lesion set (box vs pulmonary vein isolation) or Left atrial appendage/Ganglionated Plexus/Ligament of Marshall ablation or staged vs concomitant procedures. There were 12 deaths overall following the hybrid procedure with a pooled complication rate of 5.53%. CONCLUSION: Hybrid AF ablation offers promising mid-term freedom from AF reported at a mean follow-up of 31.5 months. The overall complication rate remains low. Further analysis of high-quality studies with randomized data and long-term follow up will help verify these results.

Hybrid convergent ablation versus endocardial catheter ablation for atrial fibrillation: a systematic review and meta-analysis of randomised control trials and propensity matched studies.

INTRODUCTION: Atrial fibrillation (AF) is the most common arrhythmia. Hybrid convergent ablation (HCA) is an emerging procedure for treating longstanding AF with promising results. HCA consists of a subxiphoid, surgical ablation followed by completion endocardial ablation. This meta-analysis of randomized control trials (RCT's) and propensity score-matched studies aims to examine the efficacy and safety of HCA compared to endocardial catheter ablation (ECA) alone on patients with AF. METHODS: This review was written in accordance with preferred reporting items for systematic reviews and meta-analyses recommendations and guidance. The primary outcome for the analysis was freedom from AF (FFAF) at final follow up. Secondary outcomes were mortality and significant complications such as tamponade, sternotomy, esophageal injury, atrio-esophageal fistulae post procedurally. RESULTS: Four studies where included, with a total of 233 patients undergoing HCA and 189 patients undergoing ECA only. Pooled analysis demonstrated that HCA cohorts had significantly higher rates of FFAF than ECA cohorts, with an OR of 2.78 (95% CI 1.82-4.24, P < 0.01, I2 = 0). Major post-operative complications were observed in significantly more patients in the HCA group, with an OR of 5.14 (95% CI 1.70-15.54, P < 0.01). There was only one death reported in the HCA cohorts, with no deaths in the ECA cohort. CONCLUSION: HCA is associated with a significantly higher FFAF than ECA, however, it is associated with increased post-procedural complications. There was only one death in the HCA cohort. Large RCT's comparing the HCA and ECA techniques may further validate these results.

The Convergent Atrial Fibrillation Ablation Procedure: Evolution of a Multidisciplinary Approach to Atrial Fibrillation Management.

The treatment of AF has evolved over the past decade with increasing use of catheter ablation in patients refractory to medical therapy. While pulmonary vein isolation using endocardial catheter ablation has been successful in paroxysmal AF, the results have been more controversial in patients with long-standing persistent AF where extrapulmonary venous foci are increasingly recognised in the initiation and maintenance of AF. Hybrid ablation is the integration of minimally invasive epicardial ablation with endocardial catheter ablation, and has been increasingly used in this population with better results. The aim of this article was to analyse and discuss the evidence for the integration of catheter and minimally invasive surgical approaches to treat AF with specific focus on convergent ablation and exclusion of the left atrial appendage using a surgically applied clip.

Short and Intermediate Term Outcomes of the Convergent Procedure: Initial Experience in a Tertiary Referral Center.

PURPOSE: The Convergent procedure is a hybrid, multidisciplinary treatment for symptomatic atrial fibrillation (AF) consisting of minimally invasive surgical epicardial ablation and percutaneous/catheter endocardial ablation. We investigated outcomes following introduction of the Convergent procedure at our institution. METHODS: Retrospective study examining single-center outcomes. Demographic, procedural, and post-procedural variables were collected with follow-up data obtained at 3, 6, and 12 months. RESULTS: In all, 36 patients with paroxysmal (11%) or persistent/long-standing persistent (89%) AF underwent the Convergent procedure. 36% also underwent concomitant left atrial appendage (LAA) exclusion by thoracoscopic placement of an epicardial clip. Mean age 60.6 ± 8.0 years with mean arrhythmia burden of 3.9 ± 2.7 years. All patients had failed prior attempts at medical management, 81% had failed prior cardioversion, and 17% had failed prior catheter ablation. Convergent was performed successfully in all patients with no peri-procedural deaths or major complications. At 3 and 12 months, 77.8% and 77.3% of patients, respectively, were free from symptomatic arrhythmia. 65.8% were off anti-arrhythmic medication at 12 months. CONCLUSIONS: The Convergent procedure is safe and has good short- and intermediate-term clinical success rates. This unique hybrid approach combines strengths of surgical and catheter ablation and should be part of any comprehensive AF treatment program.

The Role of the Electrophysiologist in Convergent Ablation.

Catheter ablation is a well-established treatment for patients with AF in whom sinus rhythm is desired. Both radiofrequency catheter ablation and cryoablation are widely performed, rapidly developing techniques. Convergent ablation is a novel hybrid technique combining an endocardial radiofrequency ablation with a minimally invasive epicardial surgical ablation. Some suggest that hybrid ablation may be more effective than lone endocardial ablation in achieving the elusive goal of maintaining sinus rhythm in patients with non-paroxysmal AF. In this article, the authors examine the safety and efficacy of catheter ablation and convergent ablation for long-standing, persistent AF. We also outline the crucial role that electrophysiologists play, not only as a procedure operator, but also as the coordinator and developer of this multidisciplinary service.

The convergent procedure versus catheter ablation alone in longstanding persistent atrial fibrillation: A single centre, propensity-matched cohort study.

BACKGROUND: Maintenance of sinus rhythm is challenging in patients with longstanding persistent atrial fibrillation (PeAF). Minimally invasive surgical AF ablation may improve outcomes when combined with catheter ablation (the 'convergent' procedure). This study evaluates the safety and efficacy of the convergent procedure versus catheter ablation alone in longstanding PeAF. METHODS: 43 consecutive patients with longstanding PeAF underwent subxiphoid endoscopic ablation of the posterior left atrium followed by catheter ablation from 2013 to 2018. The primary outcome was AF-free survival at 12 months; secondary outcomes included change in EHRA class, echocardiographic data, procedural complications, freedom from anti-arrhythmic drugs (AADs), and long term arrhythmia-free survival. Outcomes were compared with a matched group of 43 patients who underwent catheter ablation alone. Both groups underwent multiple catheter ablations as required. Baseline characteristics were similar between groups. RESULTS: After 12 months, the convergent procedure was associated with increased AF-free survival on AADs (60.5% versus 25.6%, p = .002) and off AADs (37.2% versus 13.9%, p = .025), versus catheter ablation. Allowing for multiple procedures, after 30.5 ±â€¯13.3 months' follow-up the convergent procedure was associated with increased arrhythmia-free survival on AADs (58.1% versus 30.2%, p = .016) and off AADs (32.5% versus 11.6%, p = .036) versus catheter ablation. There were more complications in the convergent procedure group (11.6% versus 2.3%, p = .2). Multivariate analysis identified only the convergent procedure (OR 3.06 (1.23-7.6), p = .017) as predictive of arrhythmia-free survival long term. CONCLUSIONS: In longstanding PeAF, the convergent procedure is associated with improved arrhythmia-free survival versus catheter ablation alone. Complication rates are significant but have been shown to depreciate with experience.

Initial experience with the convergent procedure for longstanding persistent atrial fibrillation: A 5 year dataset.

In patients with longstanding persistent atrial fibrillation (AF), outcomes from catheter ablation remain suboptimal. The convergent procedure combines minimally invasive surgical ablation with subsequent catheter ablation, and may contribute towards maintenance of sinus rhythm in this patient group. We performed the convergent procedure on 43 patients with longstanding persistent AF from 2013-2018. Patients underwent clinical review at 3, 6, and 12 months and thereafter as necessitated by their symptoms. Our dataset describes patients' baseline characteristics and rhythm control protocols, as well as outcomes including arrhythmia recurrence, the need for antiarrhythmic drugs, requirement for repeat rhythm control procedures, and complications. These data provide a real world insight into the risks and benefits of the convergent procedure in patients with longstanding persistent AF.