A Modular Communicative Leadless Pacing-Defibrillator System.

BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (ICD) is associated with fewer lead-related complications than a transvenous ICD; however, the subcutaneous ICD cannot provide bradycardia and antitachycardia pacing. Whether a modular pacing-defibrillator system comprising a leadless pacemaker in wireless communication with a subcutaneous ICD to provide antitachycardia and bradycardia pacing is safe remains unknown. METHODS: We conducted a multinational, single-group study that enrolled patients at risk for sudden death from ventricular arrhythmias and followed them for 6 months after implantation of a modular pacemaker-defibrillator system. The safety end point was freedom from leadless pacemaker-related major complications, evaluated against a performance goal of 86%. The two primary performance end points were successful communication between the pacemaker and the ICD (performance goal, 88%) and a pacing threshold of up to 2.0 V at a 0.4-msec pulse width (performance goal, 80%). RESULTS: We enrolled 293 patients, 162 of whom were in the 6-month end-point cohort and 151 of whom completed the 6-month follow-up period. The mean age of the patients was 60 years, 16.7% were women, and the mean (±SD) left ventricular ejection fraction was 33.1±12.6%. The percentage of patients who were free from leadless pacemaker-related major complications was 97.5%, which exceeded the prespecified performance goal. Wireless-device communication was successful in 98.8% of communication tests, which exceeded the prespecified goal. Of 151 patients, 147 (97.4%) had pacing thresholds of 2.0 V or less, which exceeded the prespecified goal. The percentage of episodes of arrhythmia that were successfully terminated by antitachycardia pacing was 61.3%, and there were no episodes for which antitachycardia pacing was not delivered owing to communication failure. Of 162 patients, 8 died (4.9%); none of the deaths were deemed to be related to arrhythmias or the implantation procedure. CONCLUSIONS: The leadless pacemaker in wireless communication with a subcutaneous ICD exceeded performance goals for freedom from major complications related to the leadless pacemaker, for communication between the leadless pacemaker and subcutaneous ICD, and for the percentage of patients with a pacing threshold up to 2.0 V at a 0.4-msec pulse width at 6 months. (Funded by Boston Scientific; MODULAR ATP ClinicalTrials.gov NCT04798768.).

Comparison of outcomes and required tools between transvenous extraction of pacemaker and implantable cardioverter defibrillator leads: Insight from single high-volume center experience.

INTRODUCTION: Reports of comparison with procedural outcomes for implantable cardioverter defibrillator (ICD) and pacemaker (PM) transvenous lead extraction (TLE) are old and limited. We sought to compare the safety, efficacy, and procedural properties of ICD and PM TLE and assess the impact of lead age. METHODS: The study cohort included all consecutive patients with ICD and PM TLE in the Cleveland Clinic Prospective TLE Registry between 2013 and 2022. Extraction success, complications, and failure employed the definitions described in the HRS 2017 TLE guidelines. RESULTS: A total of 885 ICD leads, a median implant duration of 8 (5-11) years in 810 patients, and 1352 PM leads of 7 (3-13) years in 807 patients were included. Procedural success rates in ICD patients were superior to those of PM in >20 years leads but similar in ≤20 years leads. In the PM group, the complete success rate of TLE decreased significantly according to the increase of lead age, but not in the ICD group. ICD TLE required more extraction tools compared with PM TLE but cases with older leads required non-laser sheath extraction tools in both groups. The most common injury site in major complication cases differed between ICD and PM TLE, although major complication rates showed no difference in both groups (2.7% vs. 1.6%, p = .12). CONCLUSION: The procedural success rate by TLE is greater for ICD patients than PM patients with leads >20 years old but requires more extraction tools. Common vascular complication sites and the impact of lead age on procedural outcomes and required tools differed between ICD and PM TLE.

Acute post-procedural inducibility is a poor predictor of clinical outcomes in high-risk patients (PAINESD > 17) undergoing scar-related ventricular tachycardia ablation.

AIMS: Ventricular tachycardia (VT) non-inducibility in response to programmed ventricular stimulation (PVS) is a widely used procedural endpoint for VT ablation despite inconclusive evidence with respect to clinical outcomes in high-risk patients. The aim is to determine the utility of acute post-ablation VT inducibility as a predictor of VT recurrence, mortality, or mortality equivalent in high-risk patients. METHODS AND RESULTS: We conducted a retrospective analysis of high-risk patients (defined as PAINESD > 17) who underwent scar-related VT ablation at our institution between July 2010 and July 2022. Patients' response to PVS (post-procedure) was categorized into three groups: Group A, no clinical VT or VT with cycle length > 240 ms inducible; Group B, only non-clinical VT with cycle length > 240 ms induced; and Group C, all other outcomes (including cases where no PVS was performed). The combined primary endpoint included death, durable left ventricular assist device placement, and cardiac transplant (Cox analysis). Ventricular tachycardia recurrence was considered a secondary endpoint (competing risk analysis). Of the 1677 VT ablation cases, 123 cases met the inclusion criteria for analysis. During a 19-month median follow-up time (interquartile range 4-43 months), 82 (66.7%) patients experienced the composite primary endpoint. There was no difference between Groups A and C with respect to the primary [hazard ratio (HR) = 1.21 (0.94-1.57), P = 0.145] or secondary [HR = 1.18 (0.91-1.54), P = 0.210] outcomes. These findings persisted after multivariate adjustments. The size of Group B (n = 13) did not permit meaningful statistical analysis. CONCLUSION: The results of post-ablation PVS do not significantly correlate with long-term outcomes in high-risk (PAINESD > 17) VT ablation patients.

Cryoballoon pulmonary vein isolation versus radiofrequency ablation of the pulmonary veins and left atrial posterior wall: Patient-reported outcomes.

BACKGROUND: Data are lacking on patient-reported outcomes (PRO) following cryoballoon ablation (CBA) versus radiofrequency ablation (RFA). We sought to evaluate QoL and clinical outcomes of cryoballoon pulmonary vein isolation only (CRYO-PVI-ONLY) versus RFA with PVI and posterior wall isolation (RF-PVI+PWI) in a large prospective PRO registry. METHODS: Patients who underwent AF ablation (2013-2016) at our institution were enrolled in an automated, prospectively maintained PRO registry. CRYO-PVI-ONLY patients were matched (1:1) with RF-PVI+PWI patients based on age, gender, and type of AF (paroxysmal vs. persistent). QoL and clinical outcomes were assessed using PRO surveys at baseline and at 1-year. The atrial fibrillation symptom severity scale (AFSSS) was the measure for QoL. Additionally, we assessed patient-reported clinical improvement, arrhythmia recurrence, and AF burden (as indicated by AF frequency and duration scores). RESULTS: A total of 296 patients were included (148 in each group, 72% paroxysmal). By PRO, a significant improvement in QoL was observed in the overall study population and was comparable between CRYO-PVI-ONLY and RF-PVI+PWI (baseline median AFSSS of 11.5 and 11; reduced to 2 and 4 at 1 year, respectively; p = 0.44). Similarly, the proportion of patients who reported improvement in their overall QoL and AF related symptoms was high and similar between the study groups [92% (CRYO-PVI-ONLY) vs. 92.8% (RF-PVI+PWI); p = 0.88]. Arrhythmia recurrence was significantly more common in the CRYO-PVI-ONLY group (39.7%) compared to RF-PVI+PWI (27.7 %); p = 0.03. Comparable results were observed in paroxysmal and persistent AF. CONCLUSION: CRYO-PVI-ONLY and RF-PVI+PWI resulted in comparable improvements in patient reported outcomes including QoL and AF burden; with RF-PVI+PWI being more effective at reducing recurrences.

Impact of redo ablation for atrial fibrillation on patient-reported outcomes and quality of life.

INTRODUCTION: Catheter ablation for atrial fibrillation (AF) is frequently used for the purpose of rhythm control and improved quality of life (QoL). Although success rates are high, a significant proportion of patients require redo ablation. Data are scarce on patient-centered outcomes and QoL in patients undergoing redo AF ablation. We aimed to assess QoL and clinical outcomes using a large prospectively maintained patient-reported outcomes (PRO) registry. METHODS: All patients undergoing redo AF ablation (2013-2016) at our center were enrolled in a prospective registry for outcomes and assessed for QoL using automated PRO surveys (baseline, 3 and 6 months after ablation, every 6 months thereafter). Data were collected over 3 years of follow-up. The atrial fibrillation symptom severity scale (AFSSS) was used as the main measure for QoL. Additional variables included patient-reported improvement, AF burden, and AF-related healthcare utilization including emergency room (ER) visits and hospitalizations. RESULTS: A total of 848 patients were included (28% females, mean age 63.8, 51% persistent AF). By automated PRO, significant improvement in QoL was noted (baseline median AFSSS of 12 [5-18] and ranged between 2 and 4 on subsequent assessments; p < .0001), with ≥70%of patients reported remarkable improvement in their AF-related symptoms. The proportion of patients in AF at the time of baseline survey was 36%, and this decreased to <8% across all time points during follow-up (p < .0001). AF burden was significantly reduced (including frequency and duration of episodes; p < .0001), with an associated decrease in healthcare utilization after 6 months from the time of ablation (including ER visits and hospitalizations; p < .0001). The proportion of patients on anticoagulants or antiarrhythmics decreased on follow-up across all time points (p < .0001 for all variables). CONCLUSION: Most patients derive significant QoL benefit from redo AF ablation; with reduction of both AF burden and healthcare utilization.

Impact of obesity on catheter ablation of atrial fibrillation: Patient characteristics, procedural complications, outcomes, and quality of life.

INTRODUCTION: Obesity is a well-known risk factor for atrial fibrillation (AF). We aim to evaluate the effect of baseline obesity on procedural complications, AF recurrence, and symptoms following catheter ablation (CA). METHODS: All consecutive patients undergoing AF ablation (2013-2021) at our center were enrolled in a prospective registry. The study included all consecutive patients with available data on body mass index (BMI). Primary endpoint was AF recurrence based on electrocardiographic documentation. Patients were categorized into five groups according to their baseline BMI. Patients survey at baseline and at follow-up were used to calculate AF symptom severity score (AFSS) as well as AF burden (mean of AF duration score and AF frequency score; scale 0: no AF to 10: continuous and 9 frequencies/durations in between). Patients were scheduled for follow-up visits with 12-lead electrocardiogram at 3, 6, and 12 months after ablation, and every 6 months thereafter. RESULTS: A total of 5841 patients were included (17% normal weight, 34% overweight, 27% Class I, 13% Class II, and 9% Class III obesity). Major procedural complications were low (1.5%) among all BMI subgroups. At 3 years AF recurrence was the highest in Class III obesity patients (48%) followed by Class II (43%), whereas Class I, normal, and overweight had similar results with lower recurrence (35%). In multivariable analyses, Class III obesity (BMI ≥ 40) was independently associated with increased risk for AF recurrence (hazard ratio, 1.30; confidence interval, 1.06-1.60; p = .01), whereas other groups had similar risk in comparison to normal weight. Baseline AFSS was lowest in normal weight, and highest in Obesity-III, median (interquartile range) 10 (5-16) versus 15 (10-21). In all groups, CA resulted in a significant improvement in their AFSS with a similar magnitude among the groups. At follow-up, AF burden was minimal and did not differ significantly between the groups. CONCLUSION: AF ablation is safe with a low complication rate across all BMI groups. Morbid obesity (BMI ≥ 40) was significantly associated with reduced AF ablation success. However, ablation resulted in improvement in QoL including reduction of the AFSS, and AF burden regardless of BMI.

Extraction outcomes of implantable cardioverter-defibrillator leads vary by manufacturer and model family.

AIMS: Transvenous lead extraction (TLE) of implantable cardioverter-defibrillator (ICD) leads is considered challenging. The structure of each ICD leads is variable between manufacturer and model families. The net impact of lead family on the safety and effectiveness of TLE is poorly characterized. We assessed the safety and efficacy of ICD TLE and the impact of manufacturer ICD model family on the outcomes. METHODS AND RESULTS: The study cohort included all consecutive patients with ICD who underwent TLE between 2013 and 2022 and are enrolled in the Cleveland Clinic Prospective TLE Registry. A total of 885 ICD leads (median implant duration 8 years) in 810 patients were included. Complete ICD TLE success was achieved in 97.2% of the leads (n = 860) and in 98.0% of the patients (n = 794). Major complications occurred in 22 patients (2.7%). Complete procedural success rate varied by manufacturer and lead family; Medtronic 98.9%, Abbott 95.9%, Boston Scientific 95.0%, Biotronik 91.2%, P = 0.03, and Linox family leads had the lowest, 89.7% P = 0.02. Multivariable predictors of incomplete ICD lead removal included ICD lead age > 10 years and Linox family lead. Multivariable predictors of major complications included ICD lead age > 15 years and longer lead extraction time, and predictors of all-cause mortality within 30 days included lead extraction for infection, end-stage renal disease, and higher New York Heart Association functional class. CONCLUSION: Complete and safe ICD lead removal rate by TLE is extremely high but varied by manufacturer and lead family. Linox family lead and >10 years lead age were independent predictors of incomplete lead removal.

Optimal left ventricular ejection fraction in risk stratification of patients with cardiac sarcoidosis.

AIMS: Identifying patients with cardiac sarcoidosis (CS) who are at an increased risk of sudden cardiac death (SCD) poses a clinical challenge. We sought to identify the optimal cutoff for left ventricular ejection fraction (LVEF) in predicting ventricular arrhythmia (VA) and all-cause mortality and to identify clinical and imaging risk factors in patients with known CS. METHODS AND RESULTS: This retrospective cohort included 273 patients with well-established CS. The primary endpoint was a composite of VA and all-cause mortality. A modified receiver operating curve analysis was utilized to identify the optimal cutoff for LVEF in predicting the primary composite endpoint. Cox proportional hazard regression analysis was used to identify independent risk factors of the outcomes. At median follow-up of 7.9 years, the rate of the primary endpoint was 38% (83 VAs and 32 all-cause deaths). The 5-year overall survival rate was 97%. The optimal cutoff LVEF for the primary composite endpoint was 42% in the entire cohort and in subjects without a history of VA. Younger age, history of VA, lower LVEF, and any presence of scar by cardiac magnetic resonance (CMR) imaging and/or positron emission tomography (PET) were found to be independent risk factors for the primary endpoint and for VA, whereas lower LVEF, baseline NT-proBNP, and any presence of scar were independent risk factor of all-cause mortality. CONCLUSION: Among patients with CS, a mild reduction in LVEF of 42% was identified as the optimal cutoff for predicting VA and all-cause mortality. Prior VA and scar by CMR or PET are strong risk factors for future VA and all-cause mortality.

The utility of a novel mapping algorithm utilizing vectors and global pattern of propagation for scar-related atrial tachycardias.

BACKGROUND: Activation maps of scar-related atrial tachycardias (AT) can be challenging to interpret due to difficulty in inaccurate annotation of electrograms, and an arbitrarily predefined mapping window. A novel mapping software integrating vector data and applying an algorithmic solution taking into consideration global activation pattern has been recently described (Coherent™, Biosense Webster "Investigational"). OBJECTIVE: We aimed to assess the investigational algorithm to determine the mechanism of AT compared with the standard algorithm. METHODS: This study included patients who underwent ablation of scar-related AT using the Carto 3 and the standard activation algorithm. The mapping data were analyzed retrospectively using the investigational algorithm, and the mechanisms were evaluated by two independent electrophysiologists. RESULTS: A total of 77 scar-related AT activation maps were analyzed (89.6% left atrium, median tachycardia cycle length of 273 ms). Of those, 67 cases with a confirmed mechanism of arrhythmia were used to compare the activation software. The actual mechanism of the arrhythmia was more likely to be identified with the investigational algorithm (67.2% vs. 44.8%, p = .009). In five patients with dual-loop circuits, 3/5 (60%) were correctly identified by the investigational algorithm compared to 0/5 (0%) with the standard software. The reduced atrial voltage was prone to lead to less capable identification of mechanism (p for trend: .05). The investigational algorithm showed higher inter-reviewer agreement (Cohen's kappa .62 vs. .47). CONCLUSIONS: In patients with scar-related ATs, activation mapping algorithms integrating vector data and "best-fit" propagation solution may help in identifying the mechanism and the successful site of termination.

Antibiotic eluting envelopes: evidence, technology, and defining high-risk populations.

Cardiovascular implantable electronic devices (CIED) are effective and important components of modern cardiovascular care. Despite the dramatic improvements in the functionality and reliability of these devices, over time patients are at risk for developing several morbidities, the most feared of which are local and systemic infections. Despite significant financial investment and aggressive therapy with hospitalization, intravenous antibiotics, and transvenous lead extraction, the outcomes include a 1-year mortality rate as high as 25%. This risk of infection has increased over time, likely due to the increased complexity of the surgical interventions required to insert and replace these devices. The only way to reduce this morbidity and mortality is to prevent these infections, and other than preoperative antibiotics, there were little data supporting effective therapy until the WRAP-IT trial provided randomized data showing that pocket infections can be reduced by 60% at 12 months and major CIED infections reduced by 40% at 1 year with the use of the absorbable antibiotic eluting envelope in patient CIED procedures at high risk of infection. Not all CIED procedures are at high risk of infection and justify the use of the envelope, but cost-effectiveness data support the use of the antibiotic envelope particularly in patients with defibrillator replacements, revisions, and upgrades, such as to a resynchronization device and in patients with prior CIED infection, history of immunocompromise, two or more prior procedures, or a history of renal dysfunction.

Performance of diagnostic criteria in patients clinically judged to have cardiac sarcoidosis: Is it time to regroup?

BACKGROUND: The diagnosis of cardiac sarcoidosis (CS) is challenging. Because of the current limitations of endomyocardial biopsy as a reference standard, physicians rely on advanced cardiac imaging, multidisciplinary evaluation, and diagnostic criteria to diagnose CS. AIMS: To compare the 3 main available diagnostic criteria in patients clinically judged to have CS. METHODS: We prospectively included patients clinically judged to have CS by a multidisciplinary sarcoidosis team from November 2016 to October 2017. We included only incident cases (diagnosis of CS within 1 year of inclusion). We applied retrospectively the following diagnostic criteria: the World Association of Sarcoidosis and Other Granulomatous Diseases (WASOG), the Heart Rhythm Society (HRS), and the Japanese Circulation Society (JCS) 2016 criteria. RESULTS: We identified 69 patients. Diagnostic criteria classified patients as follows: WASOG as highly probable (1.4%), probable (52.2%), possible (0%), some criteria (40.6%), and no criteria (5.8%); HRS as histological diagnosis (1.4%), probable (52.2%), some criteria (40.6%), and no criteria (5.8%); JCS as histological diagnosis (1.4%), clinical diagnosis (58%), some criteria (39.1%), and no criteria (1.4%). Concordance was high between WASOG and HRS (κ = 1) but low between JCS and the others (κ = 0.326). CONCLUSIONS: A high proportion of patients clinically judged to have CS are unable to be classified according to the 3 main diagnostic criteria. There is low concordance between JCS criteria and the other 2 criteria (WASOG and HRS).

Repeat ablation or medical management alone for recurrent arrhythmias after ablation of persistent atrial fibrillation.

INTRODUCTION: Management of persistent atrial fibrillation (PersAF) remains challenging, and many patients are left on medical therapy after a failed first ablation. In patients with recurrent symptomatic arrhythmias after PersAF ablation, we aimed to compare outcomes of repeat ablation and medical therapy versus medical therapy alone. METHODS AND RESULTS: All 682 consecutive patients with recurrent symptomatic arrhythmia after a first ablation for PersAF at our institution (2005-2012) were included. Repeat ablation with continuation of medical therapy was performed in 364 patients (Group 1) and 318 were only medically managed (Group 2). The outcome of interest was freedom from arrhythmia recurrence beyond a 3-month blanking period. Separate analyses were performed to assess this endpoint totally off antiarrhythmics (primary endpoint) or alternatively with/without use of antiarrhythmics (secondary endpoint). Over a median follow-up of 26 months, 41.5% of Group 1 patients met the primary endpoint and remained free from arrhythmia recurrence off antiarrhythmics (vs. 14.5% in Group 2, P < 0.0001). At last follow-up, antiarrhythmics continued to be required for rhythm control in 40.1% and 46.2% of patients in Groups 1 and 2, respectively (P < 0.0001). The secondary endpoint was met in 60.2% versus 32.1% of patients in Groups 1 and 2, respectively (P < 0.0001). In multivariable Cox analyses, repeat ablation was associated with significant reduction in arrhythmia recurrences compared to medical therapy alone (HR 0.48, 95% CI 0.35-0.65, P < 0.0001). CONCLUSION: In patients with recurrent symptomatic arrhythmia after ablation of PersAF, repeat ablation was associated with significant reduction in arrhythmia recurrences compared to routine medical therapy alone.

Persistent Atrial Fibrillation Ablation With or Without Contact Force Sensing.

INTRODUCTION: Arrhythmia recurrences remain common after ablation of persistent atrial fibrillation (PersAF). Contact force (CF)-sensing catheters have been introduced for objective assessment of contact during radiofrequency application and have been suggested to improve outcomes in ablation of paroxysmal AF, but little is known about their role in PersAF ablation. We aimed to compare the procedural profiles and outcomes of (PersAF) ablation with or without using CF-sensing catheters. METHODS: All consecutive patients undergoing first time ablation for PersAF between April 2014 and January 2015 at the Cleveland Clinic were included. Substrate modification was performed in addition to isolation of the pulmonary veins. Success rates were determined off antiarrhythmics over 1 year of follow-up. RESULTS: The study included 174 patients (77 CF and 97 non-CF). Ablation with CF-sensing catheters resulted in shorter procedures (median 204 vs. 216 minutes, P = 0.04) and shorter fluoroscopy time (36 vs. 48 minutes, P = 0.0005), without statistical difference in radiation dose (225 vs. 270 milligrays, P = 0.1). Arrhythmia recurrences were less likely to be observed in the CF-sensing group (27.6% vs. 46.4%, P = 0.01, log-rank P = 0.004). In multivariable Cox analyses, the use of CF-sensing catheters was associated with a lower risk of arrhythmia recurrence (hazard ratio 0.49, 95% confidence interval 0.27-0.85, P = 0.01). CONCLUSIONS: Compared to non-CF sensing, the use of CF-sensing catheters for PersAF ablation is associated with shorter procedures, shorter fluoroscopy time, and reduction in arrhythmia recurrences.

Six-month electrical performance of the first dual-chamber leadless pacemaker.

BACKGROUND: The first dual-chamber leadless pacemaker (DC-LP) system consists of 2 separate atrial and ventricular devices that communicate to maintain synchronous atrioventricular pacing and sensing. The initial safety and efficacy were previously reported. OBJECTIVE: The purpose of this study was to evaluate the chronic electrical performance of the DC-LP system. METHODS: Patients meeting standard dual-chamber pacing indications were enrolled and implanted with the DC-LP system (Aveir DR, Abbott), including right atrial and ventricular helix-fixation LPs (atrial leadless pacemaker [ALP], ventricular leadless pacemaker [VLP]). Pacing capture threshold, sensed amplitude, and pacing impedance were collected using the device programmer at prespecified timepoints from 0-6 months postimplant. RESULTS: De novo devices were successfully implanted in 381 patients with complete 6-month data (62% male; age 69 ± 14 years; weight 82 ± 20 kg; 65% sinus nodal dysfunction, 30% atrioventricular block). ALPs were implanted predominantly in the right atrial appendage anterior base and VLPs primarily at the mid-to-apical right ventricular septum. From implant to 1 month, pacing capture thresholds (0.4-ms pulse width) improved in both ALPs (2.4 ± 1.5 V to 0.8 ± 0.8 V; P <.001) and VLPs (0.8 ± 0.6 V to 0.6 ± 0.4 V; P <.001). Sensed amplitudes improved in both ALPs (1.8 ± 1.3 mV to 3.4 ± 1.9 mV; P <.001) and VLPs (8.8 ± 4.0 mV to 11.7 ± 4.2 mV; P <.001). Impedances were stable in ALPs (334 ± 68 Ω to 329 ± 52 Ω; P = .17) and reduced in VLPs (789 ± 351 Ω to 646 ± 190 Ω; P <.001). Electrical measurements remained relatively stable from 1-6 months postimplant. No differences in electrical metrics were observed among ALP or VLP implant locations. CONCLUSION: This first in-human evaluation of the new dual-chamber leadless pacemaker system demonstrated reliable electrical performance throughout the initial 6-month evaluation period.

Efficacy of Drug-Coated Balloon Angioplasty in Pulmonary Vein Stenosis or Total Occlusion.

BACKGROUND: Current therapies for pulmonary vein stenosis (PVS) or pulmonary vein total occlusion (PVTO) involving angioplasty and stenting are hindered by high rates of restenosis. OBJECTIVES: This study compares a novel approach of drug-coated balloon (DCB) angioplasty and stenting with the current standard of care in PVS or PVTO due to pulmonary vein isolation (PVI). METHODS: A retrospective single-center study analyzed patients with PVS or PVTO due to PVI who underwent either angioplasty and stenting (NoDCB group; December 2012-December 2016) or DCB angioplasty and stenting (DCB group; January 2018-January 2021). Multivariable Andersen-Gill regression analysis assessed the risk of restenosis and target lesion revascularization (TLR). RESULTS: The NoDCB group comprised 58 patients and 89 veins, with a longer median follow-up of 35 months, whereas the DCB group included 26 patients and 33 veins, with a median follow-up of 11 months. The DCB group exhibited more PVTO (NoDCB: 12.3%; DCB: 42.4%; P = 0.0001), with a smaller reference vessel size (NoDCB: 10.2 mm; DCB: 8.4 mm; P = 0.0004). Follow-up computed tomography was performed in 82% of NoDCB and 85% of DCB, revealing lower unadjusted rates of restenosis (NoDCB: 26%; DCB: 14.3%) and TLR (NoDCB: 34.2%; DCB: 10.7%) in the DCB group. DCB use was associated with a significantly lower risk of restenosis and TLR (HR: 0.003: CI: 0.00009-0.118; P = 0.002). CONCLUSIONS: The novel approach of DCB angioplasty followed by stenting is effective and safe and significantly reduces the risk of restenosis and reintervention compared with the standard of care in PVS or PVTO due to PVI.

Spontaneous dissociated firing from the pulmonary veins during ablation of paroxysmal atrial fibrillation: implications and impact on arrhythmia-free survival.

BACKGROUND: Following pulmonary vein isolation (PVI) for the treatment of paroxysmal atrial fibrillation (AF), spontaneous dissociated firing (DiFi) from the isolated veins may be observed. Little is known about the significance and prognostic implications of this phenomenon. We sought to determine the relationship between DiFi and ablation outcomes. METHODS: The study population consisted of 156 paroxysmal AF patients who underwent first time PVI and were found to have spontaneous DiFi from the pulmonary veins (PVs). Their outcomes were compared to a population of 156 propensity-matched controls from our prospectively maintained AF ablation data registry. RESULTS: DiFi was most frequently observed from the right superior PV and occurred in 89 patients (57.1%). After 24 months of follow-up, patients with DiFi had better success rates compared to those with silent veins after isolation (88.5% vs 75%, P = 0.002). The overall distribution of types of recurrent arrhythmia was similar between DiFi patients and their matched controls (P = NS). During repeat ablations, DiFi patients were less likely to have PV conduction recovery (60% vs 93.3%, P = 0.02). Importantly, none of the veins with DiFi during index procedures was found to have conduction recovery. CONCLUSION: In patients with paroxysmal AF undergoing ablation, DiFi from the PVs after their isolation was associated with improved ablation outcomes. It is possible that DiFi is an indicator of successful durable isolation of the PVs. The findings suggest that confirmation of exit block may be warranted to improve AF ablation outcomes.

Endovascular management of a pulmonary artery pseudoaneurysm secondary to mucormycosis: A case report.

The development of pulmonary artery pseudoaneurysm (PAP) secondary to pulmonary mucormycosis (PM) is exceedingly rare. Without immediate intervention, PAPs can result in life-threatening hemorrhage as these weakening vessels are prone to rupture. To avoid such an occurrence, procedures that restrict blood flow to the vulnerable region are typically performed. The present case study details the effective employment of endovascular coil embolization in treating a patient with PAP due to pulmonary mucormycosis.

Clinical predictors of incomplete coronary sinus lead removal during transvenous lead extraction in patients with cardiac resynchronization therapy.

BACKGROUND: Reports of coronary sinus (CS) lead removal include small studies with short implant durations. Procedural outcomes for mature CS leads removed with long duration implantation are unavailable. OBJECTIVE: The purpose of this study was to examine the safety, efficacy, and clinical predictors of incomplete CS lead removal by transvenous lead extraction (TLE) in a large long implant duration cardiac resynchronization therapy patient cohort. METHODS: Consecutive patients with cardiac resynchronization therapy devices in the Cleveland Clinic Prospective TLE Registry who had TLE between 2013 and 2022 were included in the analysis. RESULTS: CS leads (N = 231; implant duration 6.1 ± 4.0 years) removed from 226 patients were included, using powered sheaths for 137 leads (59.3%). Complete CS lead extraction success was achieved in 95.2% of leads (n = 220) and in 95.6% of patients (n = 216). Major complications occurred in 5 patients (2.2%). Patients who had the CS lead extracted first had significantly higher incomplete removal rates than when the other leads were first removed. Multivariable analysis showed that older CS lead age (odds ratio 1.35; 95% confidence interval 1.01-1.82; P = .03) and removal of the first CS lead (odds ratio 7.48; 95% confidence interval 1.02-54.95; P = .045) were independent predictors of incomplete CS lead removal. CONCLUSION: The complete and safe lead removal rate of long implant duration CS leads by TLE was 95%. However, CS lead age and the order in which leads were extracted were the independent predictors of incomplete CS lead removal. Therefore, before the CS lead is extracted, physicians should first extract the leads from the other chambers and use powered sheaths.