Adherent skin barrier drape use is associated with a reduced risk of cardiac implantable device infection: Results from a prospective study of 14,225 procedures.

Background: Cardiac implantable electronic device (CIED) infection is a costly and highly morbid complication. Perioperative interventions, including the use of antibiotic pouches and intensified perioperative antibiotic regimens, have demonstrated marginal efficacy at reducing CIED infection. Additional research is needed to identify additional interventions to reduce infection risk. Objective: We sought to evaluate whether adherent skin barrier drape use is associated with a reduction in CIED infection. Methods: A prospective registry of all CIED implantation procedures was established at our institution in January 2007. The registry was established in collaboration with our hospital infection prevention team with a specific focus on prospectively identifying all potential CIED infections. All potential CIED infections were independently adjudicated by 2 physicians blinded to the use of an adherent skin barrier drape. Results: Over a 13-year period, 14,225 procedures were completed (mean age 72 ± 14 years; female 4,918 (35%); new implants 10,005 (70%); pulse generator changes 2585 (18%); upgrades 1635 (11%). Of those, 2469 procedures (17.4%) were performed using an adherent skin barrier drape. There were 103 adjudicated device infections (0.73%). The infection rate in patients in the barrier use groups was 8 of 2469 (0.32%) as compared with 95 of 11,756 (0.8%) in the nonuse group (P = .0084). In multivariable analysis, the use of an adherent skin barrier drape was independently associated with a reduction in infection (odds ratio 0.32; 95% confidence interval 0.154-0.665; P = .002). Conclusion: The use of an adherent skin barrier drape at the time of cardiac device surgery is associated with a lower risk of subsequent infection.

Screening tools for the detection of clinically silent cardiac sarcoidosis.

BACKGROUND: clinically silent cardiac sarcoidosis (CS) may be associated with adverse outcomes, hence the rationale for screening patients with extracardiac sarcoidosis. The optimal screening strategy has not been clearly defined. METHODS: patients with extra-cardiac sarcoidosis were prospectively included and underwent screening consisting of symptom history, electrocardiography (ECG), transthoracic echocardiogram, Holter, and signal-averaged ECG (SAECG). Cardiac magnetic resonance (CMR) was performed in all patients. Clinically silent CS was defined as CMR demonstrating late gadolinium enhancement (LGE) in a pattern compatible with CS according to a majority of independent and blinded CMR experts. Significant cardiac involvement was defined as the presence of LGE ≥6% and/or a positive fluorodeoxyglucose-positron emission tomography. RESULTS: among the 129 patients included, clinically silent CS was diagnosed in 29/129 (22.5%), and 19/129 patients (14.7%) were classified as CS with significant cardiac involvement. There was a strong association between hypertension and CS (p < 0.05). Individual screening tools provided low diagnostic yield; however, combination of tests performed better, for example, a normal Holter and a normal SAECG had negative predictive values of 91.7%. We found consistently better diagnostic accuracy for the detection of CS with significant cardiac involvement. CONCLUSION: clinically silent CS and CS with significant cardiac involvement were found in 22.5% and 14.7% of patients with extra-cardiac sarcoidosis. The association with hypertension raises the possibility that some cases of hypertensive cardiomyopathy may be mistaken for CS. Screening with readily available tools, for example Holter and SAECG, may help identifying patients without CS where additional CMR is not needed.

High-power short-duration versus low-power long-duration ablation for pulmonary vein isolation: A substudy of the AWARE randomized controlled trial.

INTRODUCTION: Pulmonary vein isolations (PVI) are being performed using a high-power, short-duration (HPSD) strategy. The purpose of this study was to compare the clinical efficacy and safety outcomes of an HPSD versus low-power, long-duration (LPLD) approach to PVI in patients with paroxysmal atrial fibrillation (AF). METHODS: Patients were grouped according to a HPSD (≥40 W) or LPLD (≤35 W) strategy. The primary endpoint was the 1-year recurrence of any atrial arrhythmia lasting ≥30 s, detected using three 14-day ambulatory continuous ECG monitoring. Procedural and safety endpoints were also evaluated. The primary analysis were regression models incorporating propensity scores yielding adjusted relative risk (RRa ) and mean difference (MDa ) estimates. RESULTS: Of the 398 patients included in the AWARE Trial, 173 (43%) underwent HPSD and 225 (57%) LPLD ablation. The distribution of power was 50 W in 75%, 45 W in 20%, and 40 W in 5% in the HPSD group, and 35 W with 25 W on the posterior wall in the LPLD group. The primary outcome was not statistically significant at 30.1% versus 22.2% in HPSD and LPLD groups with RRa 0.77 (95% confidence interval [CI]) 0.55-1.10; p = .165). The secondary outcome of repeat catheter ablation was not statistically significant at 6.9% and 9.8% (RRa 1.59 [95% CI 0.77-3.30]; p = .208) respectively, nor was the incidence of any ECG documented AF during the blanking period: 1.7% versus 8.0% (RRa 3.95 [95% CI 1.00-15.61; p = .049) in the HPSD versus LPLD group respectively. The total procedure time was significantly shorter in the HPSD group (MDa 97.5 min [95% CI 84.8-110.4)]; p < .0001) with no difference in adjudicated serious adverse events. CONCLUSIONS: An HPSD strategy was associated with significantly shorter procedural times with similar efficacy in terms of clinical arrhythmia recurrence. Importantly, there was no signal for increased harm with a HPSD strategy.

Do barrier dressings reduce cardiac implantable device infection: Protocol for a randomized controlled trial (BARRIER-PROTECT).

Background: Cardiac implantable electronic device (CIED) procedures can be associated with serious complications, including infection with significant mortality and morbidity, necessitating removal of the device and prolonged hospitalization. One potential pathophysiological mechanism is pocket contamination at the time of device implantation. Therefore, steps taken to prevent contamination at this stage can potentially reduce CIED infections.The barrier dressing, an adhesive material applied to the skin, has the potential to reduce the colonization of the surgical site with host flora that can predispose to infection. There are a limited number of randomized prospective studies on barrier dressing use during various surgeries, but it has never been systematically studied in CIED implantation. Objectives: Do Barrier Dressings Reduce Cardiac Implantable Device Infection? (BARRIER-PROTECT trial; NCT04591366) is a single-centre, prospective, double-armed, single-blinded, randomized controlled trial designed to evaluate the use of an intra-operative adhesive barrier dressing to reduce the risk of end-of-procedure pocket swab positivity. We hypothesize that adhesive draping during implant procedures will reduce the risk of contamination from the skin flora. Also, we aim to investigate if the end-of-procedure pocket swab culture positivity can be used as a potential surrogate marker of CIED infection. Methods and Design: Patients undergoing a second or later procedure on the same device pocket (pulse generator change, lead/pocket revision or upgrade) will be enrolled. Eligible and consenting patients will be equally randomized to the use of barrier dressing or not using an automated web-based system. Patients, but not the operator, will be blinded to the arm. The person performing the pocket swabs will also be blinded. The primary endpoint is the end-of-procedure pocket swab culture positivity. The main secondary endpoint is the CIED infection rate. Discussion: This is the first randomized controlled trial to assess the effectiveness of using a barrier adhesive draping on reducing the end-of-procedure pocket swab culture positivity. In this study, we are exploring a low-cost intervention that may significantly reduce CIED infection. Also, having a valid surrogate marker for CIED infection at the time of implant will facilitate design of future clinical trials.

Incidence of Atrial Fibrillation as the Initial Manifestation of Cardiac Sarcoidosis: Insights From a Catheter Ablation Registry.

Background: Cardiac sarcoidosis (CS) is a rare form of arrhythmogenic cardiomyopathy; a delayed diagnosis can lead to significant consequences. Patients with clinically manifest CS often have minimal extracardiac involvement and thus frequently present initially to cardiology. Indeed, certain specific arrhythmic scenarios should trigger investigations for undiagnosed CS. Atrial fibrillation (AF) has been described as one of the presenting features of CS; however, the incidence of this presentation is not known. Methods: At our institution, cardiac computerized tomography is routinely performed prior to catheter ablation for AF. Noncardiac incidental findings are described by radiologists and are followed-up by interval investigations. We systematically reviewed noncardiac reports from 1574 consecutive patients in our prospective AF ablation registry. Specifically, we used text-scraping techniques to search on the following keywords: "adenopathy" and "sarcoidosis." Detailed chart review of identified cases was then performed to evaluate results of interval investigations and assess long-term outcomes. Results: Twenty of 1574 patients (1.3%) had noncardiac reports containing "adenopathy" and/or "sarcoidosis." After interval imaging and a follow-up period averaging 60 ± 35 months, only 2 patients of 1574 (0.13%) were diagnosed with CS. Four of 20 (20%) had a previous history of extracardiac sarcoidosis, and another 1 of 20 (5%) was subsequently diagnosed with extracardiac sarcoidosis. However, none of these 5 patients had evidence of cardiac involvement. Conclusions: CS is a rare finding among patients undergoing a first-time AF ablation. Our findings suggest that AF is an uncommon initial presentation of CS. Thus, investigations for CS in patients with AF are not warranted routinely, unless additional suggestive clinical features are present.

Contexte: La sarcoïdose cardiaque (SC) est une forme rare de cardiomyopathie arythmogène; un retard dans le diagnostic peut entraîner d'importantes conséquences. Les patients qui présentent une SC cliniquement manifeste ont souvent une atteinte extracardiaque minime, et consultent donc souvent d'abord en cardiologie. En effet, certains scénarios arythmiques précis devraient déclencher la recherche de signes d'une SC non diagnostiquée. La fibrillation auriculaire (FA) a été décrite comme un signe indicateur de SC; on ne connaît toutefois pas l'incidence de ce signe. Méthodologie: Dans notre établissement, la tomodensitométrie cardiaque est souvent réalisée avant une ablation par cathéter de la FA. Les découvertes non cardiaques fortuites sont décrites par les radiologues, puis font l'objet d'un suivi par des examens d'imagerie réalisés à intervalles déterminés. Nous avons systématiquement évalué les éléments non cardiaques signalés chez 1 574 patients consécutifs dans notre registre prospectif sur l'ablation de la FA. Nous avons utilisé des techniques de dépouillement du texte pour trouver les mots-clés suivants : « adenopathy ¼ (adénopathie) et « sarcoidosis ¼ (sarcoïdose). Un examen du dossier médical complet des cas retenus a été réalisé pour évaluer les résultats des examens de suivi et évaluer les résultats à long terme. Résultats: Parmi les 1 574 patients, 20 (1,3 %) présentaient des notes non cardiaques contenant les termes « adenopahy ¼ (adénopathie) ou « sarcoidosis ¼ (sarcoïdose). Après l'examen d'imagerie et une période de suivi d'une durée moyenne de 60 ±35 mois, seuls deux patients (0,13 %) ont reçu un diagnostic de SC. Quatre des 20 patients visés (20 %) présentaient des antécédents de sarcoïdose extracardiaque, et un patient sur 20 (5 %) a reçu un diagnostic de sarcoïdose extracardiaque à la suite de l'intervention. Toutefois, aucun de ces cinq patients ne montrait de signes d'atteinte cardiaque. Conclusions: La SC est une occurrence rare chez les patients qui subissent une première ablation de la FA. Nos constats indiquent que la FA est une présentation initiale peu commune de la SC. Aussi, la recherche de la SC chez les patients atteints de FA n'est pas justifiée dans une procédure de routine, à moins que d'autres caractéristiques cliniques pointant vers cette affection ne soient présentes.

An International Survey of Current Clinical Practice in the Treatment of Cardiac Sarcoidosis.

Cardiac sarcoidosis (CS) is a potentially serious form of infiltrative cardiomyopathy. Despite scarce evidence, immunosuppressive treatment is generally recommended, but local routines may vary significantly. We sought to survey the clinical practices in the treatment of CS, with the aim that the results may suggest future research priorities. We conducted a web-based survey focused on treatment-naive patients with CS. We subclassified CS according to the presence/absence of overt cardiac presentation (clinically manifest/silent) and to the presence/absence of active inflammation (metabolically active/inactive by fluorodeoxyglucose positron emission tomography). The survey was developed jointly by the authors and administered to expert clinicians (n = 79) involved in CS treatment. An agreement threshold was set at 70%. A total of 62 of 79 respondents (78.5%) from 12 countries completed the survey. The agreement threshold was reached for: (1) always treating clinically manifest, metabolically active CS, 57 of 62 (91.9%), (2) never treating clinically silent, metabolically inactive CS, 44 of 62 (71.0%), (3) not requiring histopathologic confirmation of sarcoidosis before treatment initiation, (49 of 62, 79.0%), (4) using fluorodeoxyglucose positron emission tomography for assessing treatment indication (44 of 62, 71.0%) and treatment response (44 of 62, 71.0%), and (5) using prednisone as a first-line agent (100%), although respondents were divided on monotherapy (69.4%) or combination with methotrexate 25.8%. The approach to particular scenarios, tapering, and duration of treatment showed the greatest variation in response. In conclusion, in this survey of clinical practice, important aspects of CS treatment reached the agreement threshold, whereas others showed a great degree of clinical equipoise.

Standard vs Augmented Ablation of Paroxysmal Atrial Fibrillation for Reduction of Atrial Fibrillation Recurrence: The AWARE Randomized Clinical Trial.

Importance: Recurrent atrial fibrillation (AF) commonly occurs after catheter ablation and is associated with patient morbidity and health care costs. Objective: To evaluate the superiority of an augmented double wide-area circumferential ablation (WACA) compared with a standard single WACA in preventing recurrent atrial arrhythmias (AA) (atrial tachycardia, atrial flutter, or atrial fibrillation [AF]) in patients with paroxysmal AF. Design, Setting, and Participants: This was a pragmatic, multicenter, prospective, randomized, open, blinded end point superiority clinical trial conducted at 10 university-affiliated centers in Canada. The trial enrolled patients 18 years and older with symptomatic paroxysmal AF from March 2015 to May 2017. Analysis took place between January and April 2022. Analyses were intention to treat. Interventions: Patients were randomized (1:1) to receive radiofrequency catheter ablation for pulmonary vein isolation with either a standard single WACA or an augmented double WACA. Main Outcomes and Measures: The primary outcome was AA recurrence between 91 and 365 days postablation. Patients underwent 42 days of ambulatory electrocardiography monitoring after ablation. Secondary outcomes included need for repeated catheter ablation and procedural and safety variables. Results: Of 398 patients, 195 were randomized to the single WACA (control) arm (mean [SD] age, 60.6 [9.3] years; 65 [33.3%] female) and 203 to the double WACA (experimental) arm (mean [SD] age, 61.5 [9.3] years; 66 [32.5%] female). Overall, 52 patients (26.7%) in the single WACA arm and 50 patients (24.6%) in the double WACA arm had recurrent AA at 1 year (relative risk, 0.92; 95% CI, 0.66-1.29; P = .64). Twenty patients (10.3%) in the single WACA arm and 15 patients (7.4%) in the double WACA arm underwent repeated catheter ablation (relative risk, 0.72; 95% CI, 0.38-1.36). Adjudicated serious adverse events occurred in 13 patients (6.7%) in the single WACA arm and 14 patients (6.9%) in the double WACA arm. Conclusions and Relevance: In this randomized clinical trial of patients with paroxysmal AF, additional ablation by performing a double ablation lesion set did not result in improved freedom from recurrent AA compared with a standard single ablation set. Trial Registration: ClinicalTrials.gov Identifier: NCT02150902.

A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery (LENIENT).

BACKGROUND: Arm restriction after cardiac implantable electronic device (CIED) placement is common practice despite minimal supporting evidence. Patients receive a range of restriction recommendations of variable durations with the goal of reducing complications such as wound dehiscence, infection, lead dislodgement, or hematoma formation. These movement limitations can lead to emotional stress and anxiety, complications such as frozen shoulder, and upper extremity venous thrombosis due to immobilization. There are no published clinical trials assessing the benefits and risks of arm restrictions post-CIED implant. OBJECTIVES: The randomized trial of lenient vs strict arm and activity instruction post-CIED surgery (LENIENT trial; NCT04915261) is a single center nonblinded randomized prospective study designed to evaluate lenient compared to restrictive post-CIED care instructions. We hypothesize that there will be no significant difference in complications between the arms. METHODS/DESIGN: All patients receiving a de novo CIED or those with upgrades and revisions requiring a new lead implant will be enrolled. Subjects are enrolled in a nonblinded randomized prospective trial with 6 randomly assigned 8-month periods, during which either a lenient or restrictive postoperative activity instructions will be given to all patients. Postoperative instructions are given at the time of discharge and further reinforced by recurrent interactive voice recognition (IVR) phone calls, text messages and emails. The requirement for individual consent has been waived. The primary end point is a composite of (1) lead dislodgement, (2) frozen shoulder, (3) upper extremity venous thrombosis, (4) clinically significant hematoma, and (5) infection occurring within 52 weeks of index surgery. The study is a noninferiority trial with a sample size of 1,250 per group. DISCUSSION: This is the first large randomized clinical trial designed to establish an evidence-based postoperative standard of care for patients undergoing CIED implantation. This will improve the quality of care provided to patients and help guide implanting physicians providing postoperative care instructions. TRIAL REGISTRATION: ClinicalTrials.gov NCT04915261.

Arrhythmic Events and Mortality in Patients With Cardiogenic Shock on Inotropic Support: Results of the DOREMI Randomized Trial.

BACKGROUND: Inotropic support is widely used in the management of cardiogenic shock (CS). Existing data on the incidence and significance of arrhythmic events in patients with CS on inotropic support is at high risk of bias. METHODS: The Dobutamine Compared to Milrinone (DOREMI) trial randomized patients to receive dobutamine or milrinone in a double-blind fashion. Patients with and without arrhythmic events (defined as arrhythmias requiring intervention or sustained ventricular arrhythmias) were compared to identify factors associated with their occurrence, and to examine their association with in-hospital mortality and secondary outcomes. RESULTS: Ninety-two patients (47.9%) had arrhythmic events, occurring equally with dobutamine and milrinone (P = 0.563). The need for vasopressor support at initiation of the inotrope and a history of atrial fibrillation were positively associated with arrhythmic events, whereas predominant right ventricular dysfunction, previous myocardial infarction, and increasing left ventricular ejection fraction were negatively associated with them. Supraventricular arrhythmic events were not associated with mortality (relative risk [RR], 0.97; 95% confidence interval [CI], 0.68-1.40; P = 0.879) but were positively associated with resuscitated cardiac arrests and hospital length of stay. Ventricular arrhythmic events were positively associated with mortality (RR, 1.66; 95% CI, 1.13-2.43; P = 0.026) and resuscitated cardiac arrests. Arrhythmic events were most often treated with amiodarone (97%) and electrical cardioversion (27%), which were not associated with mortality. CONCLUSIONS: Clinically relevant arrhythmic events occur in approximately one-half of patients with CS treated with dobutamine or milrinone and are associated with adverse clinical outcomes. Five factors may help to identify patients most at risk of arrhythmic events.

Negative Association of Smoking History With Clinically Manifest Cardiac Sarcoidosis: A Case-Control Study.

Background: The etiology of sarcoidosis is still unknown and is likely related to a genetic susceptibility to unidentified environmental trigger(s). Our group and others have extensively described a specific phenotype of primarily Caucasian patients who have clinically manifest cardiac sarcoidosis (CS). In this study, we sought to explore whether smoking is associated with this specific phenotype of sarcoidosis. Methods: We performed a case-control study. Cases with clinically manifest CS were prospectively enrolled in the Cardiac Sarcoidosis Multi-Center Prospective Cohort Study (CHASM-CS registry; NCT01477359) and answered a standardized smoking history questionnaire. Cases were matched 10:1 with controls from the Ontario Health Study. Pretreatment positron emission tomography scans with 18F-fluorodeoxyglucose were compared for smokers vs nonsmokers. Results: Eighty-seven cases met the inclusion criteria. A total of 82 of 87 (94.3%) answered the questionnaire and were matched with 820 controls. A clear negative association of sarcoidosis and smoking was found, with 23 of 82 CS cases (28.0%) being current or ex-smokers, vs 392 of 820 controls (47.8%; P = 0.0006). CS patients with a smoking history had significantly less lifetime consumption (8.31 ± 9.20 pack-years) than the controls (15.34 ± 10.84 pack-years; P < 0.003). On 18F-fluorodeoxyglucose-positron emission tomography scan, the mean standardized uptake value of the left ventricle was 4.2 ± 8.98 in lifetime nonsmokers vs 2.89 ± 2.07 in patients with a smoking history (P < 0.0001). Conclusions: We describe a strong negative association between smoking history and clinically manifest CS. Nonsmokers had more severe myocardial inflammation (greater mean standardized uptake value of the left ventricle) than did patients with a smoking history. Further research is needed to understand these associations and whether they have therapeutic potential.

Introduction: L'étiologie de la sarcoïdose est encore inconnue et est possiblement liée à une susceptibilité génétique à un ou des déclencheurs environnementaux inconnus. Notre groupe et d'autres groupes ont exposé sous tous ses aspects un phénotype particulier chez des patients principalement blancs qui ont une sarcoïdose cardiaque (SC) manifeste sur le plan clinique. Dans la présente étude, nous avons cherché à explorer si le tabagisme est associé à ce phénotype particulier de la sarcoïdose. Méthodes: Nous avons réalisé une étude cas témoins. Les cas qui avaient une SC manifeste sur le plan clinique ont été inscrits de façon prospective à l'étude CHASM-CS (Cardiac Sarcoidosis Multi-Center Prospective Cohort Study, registre CHASM-CS; NCT01477359) et ont répondu à un questionnaire standardisé sur les antécédents de tabagisme. Les cas ont été appariés 10:1 aux témoins de l'Étude sur la santé Ontario. Nous avons comparé avant le traitement la tomographie par émission de positons au 18F-fluorodéoxyglucose des fumeurs vs des non-fumeurs. Résultats: Quatre-vingt-sept cas répondaient aux critères d'inclusion. Un total de 82 sur 87 (94,3 %) cas ont rempli le questionnaire et ont été appariés à 820 témoins. Nous avons observé une association négative claire entre la sarcoïdose et le tabagisme, soit 23 sur 82 cas de SC (28,0 %) qui fumaient actuellement ou étaient des ex-fumeurs vs 392 sur 820 témoins (47,8 % ; P = 0,0006). Les patients atteints de SC qui avaient des antécédents de tabagisme avaient une consommation significativement moindre durant leur vie (8,31 ± 9,20 paquets-années) que les témoins (15,34 ± 10,84 paquets-années ; P < 0,003). À la tomographie par émission de positons au 18F-fluorodéoxyglucose, la valeur moyenne de fixation normalisée du ventricule gauche était de 4,2 ± 8,98 chez les non-fumeurs de toujours vs 2,89 ± 2,07 chez les patients qui avaient des antécédents de tabagisme (P < 0,0001). Conclusions: Nous démontrons une forte association négative entre les antécédents de tabagisme et la SC manifeste sur le plan clinique. Les non-fumeurs avaient plus d'inflammation myocardique grave (une plus grande valeur moyenne de fixation normalisée du ventricule gauche) que les patients qui avaient des antécédents de tabagisme. D'autres recherches sont nécessaires pour comprendre ces associations et savoir s'ils ont un potentiel thérapeutique.

Characterization of arrhythmia substrate to ablate persistent atrial fibrillation (COAST-AF): Randomized controlled trial design and rationale.

BACKGROUND: Atrial low voltage area (LVA) catheter ablation has emerged as a promising strategy for ablation of persistent atrial fibrillation (AF). It is unclear if catheter ablation of atrial LVA increases treatment success rates in patients with persistent AF. OBJECTIVE: The primary aim of this trial is to assess the potential benefit of adjunctive catheter ablation of atrial LVA in addition to pulmonary vein isolation (PVI) in patients with persistent AF, when compared to PVI alone. The secondary aims are to evaluate safety outcomes, the quality of life and the healthcare resource utilization. METHODS/DESIGN: A multicenter, prospective, parallel-group, 2-arm, single-blinded randomized controlled trial is under way (NCT03347227). Patients who are candidates for catheter ablation for persistent AF will be randomly assigned (1:1) to either PVI alone or PVI + atrial LVA ablation. The primary outcome is 18-month documented event rate of atrial arrhythmia (AF, atrial tachycardia or atrial flutter) post catheter ablation. Secondary outcomes include procedure-related complications, freedom from atrial arrhythmia at 12 months, AF burden, need for emergency department visits/hospitalization, need for repeat ablation for atrial arrhythmia, quality of life at 12 and 18 months, ablation time, and procedure duration. DISCUSSION: Characterization of Arrhythmia Mechanism to Ablate Atrial Fibrillation (COAST-AF) is a multicenter randomized trial evaluating ablation strategies for catheter ablation. We hypothesize that catheter ablation of atrial LVA in addition to PVI will result in higher procedural success rates when compared to PVI alone in patients with persistent AF.

Should they stay, or should they go: Do we need to remove the old cardiac implantable electronic device if a new system is required on the contralateral side?

Background: Ipsilateral approach in patients requiring cardiac implantable electronic device (CIED) revision or upgrade may not be feasible, primarily due to vascular occlusion. If a new CIED is implanted on the contralateral side, a common practice is to explant the old CIED to avoid device interaction. Objective: The purpose of this study was to assess a conservative approach of abandoning the old CIED after implanting a new contralateral device. Methods: We used an artificial intelligence algorithm to analyze postimplant chest radiographs to identify those with multiple CIEDs. Outcomes of interest included device interaction, abandoned CIED elective replacement indicator (ERI) behavior, subsequent programming changes, and explant of abandoned CIED. Theoretical risk of infection with removal of abandoned CIED was estimated using a validated scoring system. Results: Among 12,045 patients, we identified 40 patients with multiple CIEDs. Occluded veins were the most common indication for contralateral implantation (n = 27 [67.5%]). Fifteen abandoned CIEDs reached ERI, with 4 reverting to VVI 65. One patient underwent explant due to device interaction, and 2 required device reprogramming. Of 32 patients with an implantable cardioverter-defibrillator, 8 (25%) had treated ventricular arrhythmia. There were no failed or inappropriate therapies due to interaction. Eighteen patients (45%) had hypothetical >1% annual risk of hospitalization for device infection if the abandoned CIED had been explanted. Conclusion: In patients requiring new CIED implant on the contralateral side, abandoning the old device is feasible. This approach may reduce the risk of infection and concerns regarding abandoned leads and magnetic resonance imaging scans. Knowledge of ERI behavior is essential to avoid device interactions.

Rhythm-Monitoring Strategy and Arrhythmia Recurrence in Atrial Fibrillation Ablation Trials: A Systematic Review.

Background: : The rhythm-monitoring strategy after catheter ablation (CA) for atrial fibrillation (AF) impacts the detection of atrial arrhythmia recurrence and is not well characterized. We performed a systematic review and meta-regression analysis to determine whether the duration and mode of rhythm monitoring after CA affects detection of atrial arrhythmia recurrence. Methods: Databases were systematically searched for randomized controlled trials of adult patients undergoing first CA for AF from 2007 to 2021. Duration and strategy of rhythm monitoring were extracted. Meta-regression was used to identify any association between duration of monitoring and detection of atrial arrhythmia recurrence. The primary measure of outcome was single-procedure recurrence of atrial arrhythmia. Results: The search strategy yielded 57 trial arms from 56 randomized controlled trials comprising 5322 patients: 36 arms of patients with paroxysmal AF (PAF), and 21 arms of patients with persistent AF (PeAF) or both PAF/PeAF. Intermittent monitoring was associated with detection of significantly less atrial arrhythmia recurrence than continuous monitoring in PAF arms (31.2% vs 46.9%, P = 0.001), but not in PeAF/PAF-PeAF combined arms (43.3% vs 63.6%, P = 0.12). No significant relationship was seen between the duration of intermittent rhythm monitoring and atrial arrhythmia recurrence detection in either the PAF (P = 0.93) or PeAF/PAF-PeAF combined arms (P = 0.20). Conclusions: Continuous rhythm monitoring detected higher atrial arrhythmia recurrence rates, compared to intermittent rhythm monitoring, in patients with PAF. The duration of intermittent monitoring did not show a statistically significant relationship to the yield of arrhythmia detection, in near identical cohorts of trial subjects undergoing similar interventions, with clinical and research implications.

Contexte: La stratégie qui consiste à surveiller le rythme cardiaque après une ablation par cathéter dans le traitement de la fibrillation auriculaire (FA) a un effet sur la détection de récidive de l'arythmie auriculaire, mais elle n'est pas bien définie. Nous avons mené une revue systématique et une méta-régression pour déterminer si le mode employé pour surveiller le rythme après une ablation par cathéter et la durée de cette surveillance ont un effet sur la détection de récidive de l'arythmie auriculaire. Méthodologie: Des bases de données ont été systématiquement épluchées à la recherche d'essais contrôlés randomisés menés auprès d'adultes subissant leur première ablation par cathéter pour une FA entre 2007 et 2021. La durée et la stratégie utilisées dans la surveillance du rythme ont été recensées. La méta-régression a été utilisée pour déceler tout lien entre la durée de la surveillance et la détection d'une récidive de l'arythmie auriculaire. Le paramètre d'évaluation principal était la récidive de l'arythmie auriculaire avec une seule intervention. Résultats: La stratégie de recherche a fait ressortir 57 groupes de 56 essais contrôlés randomisés comprenant 5 322 patients : 36 groupes de patients présentant une FA paroxystique et 21 groupes de patients présentant une FA persistante ou ces deux types de FA (paroxystique et persistante). La surveillance intermittente a été associée à une moins grande détection de cas d'arythmie auriculaire récidivante, comparativement à la surveillance constante (31,2 % vs 46,9 %, p = 0,001), ce qui n'a pas été le cas dans les groupes où les types de FA (persistante ou paroxystique et persistante) étaient combinés (43,3 % vs 63,6 %, p = 0,12). Aucun lien notable n'a été observé entre la durée de la surveillance intermittente du rythme et la détection de l'arythmie auriculaire récidivante dans le groupe FA paroxystique (p = 0,93) ou dans le groupe des types de FA combinés (p = 0,20). Conclusions: Le taux de détection de l'arythmie auriculaire récidivante était plus élevé avec la surveillance constante qu'avec la surveillance intermittente chez les patients atteints de FA paroxystique. La durée de la surveillance intermittente n'a pas eu de lien statistiquement significatif avec le rendement de détection de l'arythmie, dans des cohortes presque identiques de participants aux essais subissant des interventions similaires, comportant des implications cliniques ou expérimentales.

Outcomes of a comprehensive strategy during repeat atrial fibrillation ablation.

BACKGROUND/PURPOSE: Atrial fibrillation (AF) recurs post-ablation in 30-40% of patients. The approach to a repeat ablation, beyond isolation of reconnected pulmonary veins (PVs), is not well established. We sought to prospectively assess outcomes and predictors of recurrence among consecutive patients who underwent repeat AF ablation with a standardized approach. METHODS: This was a single-center prospective study of consecutive patients who underwent repeat AF ablation. Our protocol consisted of six steps: PV re-isolation, ablation of left atrial low-voltage areas (LVAs), ablation of isoproterenol-induced non-PV triggers, electrophysiology study (EPS) and ablation of induced AVNRT/AVRT, ablation of induced clinical atrial flutters, and lastly empiric ablation as per operator discretion if no other ablation was performed. RESULTS: Among 725 AF ablations performed during the study period, 74 were repeat ablations. Of those undergoing repeat ablation, 53 (72%) had PV reconnection, 30 (41%) had LVAs, seven (10%) had non-PV triggers, five (7%) had AVNRT, and 15 (20%) had typical atrial flutter. Following repeat ablation, arrhythmia-free survival was 65% at 1 year. The absence of PV reconnection was the only factor independently associated with recurrence after repeat ablation (recurrence rate 71%, adjusted OR 7.91, 95% CI 2.31-27.16, p = 0.001). CONCLUSIONS: A comprehensive approach to repeat AF ablation including PV re-isolation, LVA ablation, non-PV trigger ablation, EPS, and flutter ablation was associated with a 65% 1-year arrhythmia-free survival. The absence of PV reconnection was the only independent predictor of arrhythmia recurrence. Further research is needed to identify therapies beyond PV isolation for patients undergoing repeat ablation.

Augmented wide area circumferential catheter ablation for reduction of atrial fibrillation recurrence (AWARE) trial: Design and rationale.

BACKGROUND: Recurrence of atrial fibrillation (AF) after a pulmonary vein isolation procedure is often due to electrical reconnection of the pulmonary veins. Repeat ablation procedures may improve freedom from AF but are associated with increased risks and health care costs. A novel ablation strategy in which patients receive "augmented" ablation lesions has the potential to reduce the risk of AF recurrence. OBJECTIVE: The Augmented Wide Area Circumferential Catheter Ablation for Reduction of Atrial Fibrillation Recurrence (AWARE) Trial was designed to evaluate whether an augmented wide-area circumferential antral (WACA) ablation strategy will result in fewer atrial arrhythmia recurrences in patients with symptomatic paroxysmal AF, compared with a conventional WACA strategy. METHODS/DESIGN: The AWARE trial was a multicenter, prospective, randomized, open, blinded endpoint trial that has completed recruitment (ClinicalTrials.gov NCT02150902). Patients were randomly assigned (1:1) to either the control arm (single WACAlesion set) or the interventional arm (augmented- double WACA lesion set performed after the initial WACA). The primary outcome was atrial tachyarrhythmia (AA; atrial tachycardia [AT], atrial flutter [AFl] or AF) recurrence between days 91 and 365 post catheter ablation. Patient follow-up included 14-day continuous ambulatory ECG monitoring at 3, 6, and 12 months after catheter ablation. Three questionnaires were administered during the trial- the EuroQuol-5D (EQ-5D) quality of life scale, the Canadian Cardiovascular Society Severity of Atrial Fibrillation scale, and a patient satisfaction scale. DISCUSSION: The AWARE trial was designed to evaluate whether a novel approach to catheter ablation reduced the risk of AA recurrence in patients with symptomatic paroxysmal AF.