Early ablation of newly diagnosed paroxysmal atrial fibrillation (NEWPaAF) versus newly diagnosed persistent atrial fibrillation (NEWPeAF): Comparison of patient populations and ablation outcomes.

INTRODUCTION: Little is known about very early atrial fibrillation (AF) ablation after first AF detection. METHODS: We evaluated patients with AF ablation <4 months from newly diagnosed paroxysmal AF (NEWPaAF) and newly diagnosed persistent AF (NEWPeAF). We compared the two patient populations and compared ablation outcomes to those undergoing later ablation. RESULTS: Ablation was done <4 months from AF diagnosis in 353 patients (135 = paroxysmal, 218 = persistent). Early ablation outcome was best for NEWPaAF versus NEWPeAF for initial (p = 0.030) but not final (p = 0.102) ablation. Despite recent AF diagnosis in both groups, they were clinically quite different. NEWPaAF patients were younger (64.3 ± 13.0 vs. 67.3 ± 10.9, p = 0.0020), failed fewer drugs (0.39 vs. 0.60, p = 0.007), had smaller LA size (4.12 ± 0.58 vs. 4.48 ± 0.59 cm, p < 0.0001), lower BMI (28.8 ± 5.0 vs. 30.3 ± 6.0, p = 0.016), and less CAD (3.7% vs. 11.5%, p = 0.007), cardiomyopathies (2.2% vs. 22.9%, p = 0.0001), hypertension (46.7% vs. 67.4%, p < 0.0001), diabetes (8.1% vs. 17.4%, p = 0.011) and sleep apnea (20.0% vs. 30.3%, p = 0.031). For NEWPaAF, early ablation AF-free outcome was no better than later ablation (p = 0.314). For NEWPeAF, AF-free outcomes were better for early ablation than later ablation (p < 0.0001). Delaying ablation allowed more strokes/TIAs in both AF types (paroxysmal p = 0.014, persistent p < 0.0001). CONCLUSIONS: Patients presenting for early ablation after newly diagnosed persistent AF have more pre-existing comorbidities and worse initial ablation outcomes than patients with NEWPaAF. For NEWPaAF, there was no advantage to early ablation, as long as the AF remained paroxysmal. For NEWPeAF, early ablation gave better outcomes than later ablation and they should undergo early ablation. For both AF types, waiting was associated with more neurologic events, suggesting all patients should consider earlier ablation.

Cardioneuroablation for the management of patients with recurrent vasovagal syncope and symptomatic bradyarrhythmias: the CNA-FWRD Registry.

BACKGROUND: Cardioneuroablation has been emerging as a potential treatment alternative in appropriately selected patients with cardioinhibitory vasovagal syncope (VVS) and functional AV block (AVB). However the majority of available evidence has been derived from retrospective cohort studies performed by experienced operators. METHODS: The Cardioneuroablation for the Management of Patients with Recurrent Vasovagal Syncope and Symptomatic Bradyarrhythmias (CNA-FWRD) Registry is a multicenter prospective registry with cross-over design evaluating acute and long-term outcomes of VVS and AVB patients treated by conservative therapy and CNA. RESULTS: The study is a prospective observational registry with cross-over design for analysis of outcomes between a control group (i.e., behavioral and medical therapy only) and intervention group (Cardioneuroablation). Primary and secondary outcomes will only be assessed after enrollment in the registry. The follow-up period will be 3 years after enrollment. CONCLUSIONS: There remains a lack of prospective multicentered data for long-term outcomes comparing conservative therapy to radiofrequency CNA procedures particularly for key outcomes including recurrence of syncope, AV block, durable impact of disruption of the autonomic nervous system, and long-term complications after CNA. The CNA-FWRD registry has the potential to help fill this information gap.

Very long term outcomes of atrial fibrillation ablation.

BACKGROUND: Little is known about the very long term durability of atrial fibrillation (AF) ablation. OBJECTIVE: The purpose of this study was to evaluate very long term AF ablation outcomes. METHODS: We followed 5200 patients undergoing 7145 ablation procedures. We evaluated outcomes after single and multiple ablation procedures for paroxysmal (PAF; 33.6%), persistent (PeAF; 56.4%), and long-standing (LsAF; 9.9%) AF. We compared 3 ablation eras by initial ablation catheter: early (101 patients) using solid big tip (SBT) catheters (October 2003 to December 2005), intermediate (2143 patients) using open irrigated tip (OIT) catheters (December 2005 to August 2016), and contemporary (2956 patients) using contact force (CF) catheters (March 2014 to December 2021). RESULTS: AF freedom at 5, 10, and 15 years was as follows: initial ablation: PAF 67.8%, 56.3%, 47.6%; PeAF 46.6%, 35.6%, 26.5%; and LsAF 30.4%, 18.0%, 3.4%; final ablation: PAF 80.3%, 72.6%, 62.5%; PeAF 60.1%, 50.2%, 42.5%; and LsAF 43.4%, 32.0%, 20.6%. For PAF and PeAF, CF ablation procedures were better than OIT ablation procedures (P < .0001) and both were better than SBT ablation procedures (P < .001). LsAF had no outcome improvement over the eras. The 8-year success rate after final ablation for CF, OIT, and SBT catheter eras was as follows: PAF 79.1%, 71.8%, 60.0%; PeAF 55.9%, 50.7%, 38.0%; and LsAF 42.7%, 36.2%, 31.8%. Highest AF recurrence was in the first 2 years, with a 2- to 15-year recurrence of 2%/yr. Success predictors after initial and final ablation procedures were younger age, smaller left atrium, shorter AF duration, male sex, less persistent AF, lower CHA2DS2-VASc score, fewer drugs failed, and more recent catheter era. CONCLUSION: After year 2, there is 2%/yr recurrence rate for all AF types. Ablation success is best in the CF catheter era, intermediate in the OIT era, and worst in the SBT era. Over the ablation eras, outcomes improved for PAF and PeAF but not for LsAF. We should follow patients indefinitely after ablation. We need an understanding of how to better ablate more persistent AF.

Ultrasound-guided vascular access for CIED implantation: A step-by-step guide.

INTRODUCTION: Vascular access is required for most cardiac electrophysiology procedures. Over the past 2 decades, ultrasound guidance has increased in utilization as the primary method for assisting operators in gaining access to cardiac implantable electronic device (CIED) implantation. METHODS: Ultrasound guidance using a technique that includes both short-axis and long-axis views combined with a twisting needle motion after maximal tenting provides an extremely safe and reproducible technique for vascular access for all CIED procedures. RESULTS AND CONCLUSIONS: In this manuscript and accompanying videos, a step-by-step guide is explained for optimal ultrasound-guided visualization and needle maneuver technique to maximize safety and efficiency for vascular access in all CIED procedures.

Cost-effectiveness analysis of robotic-arm assisted total knee arthroplasty.

PURPOSE: Total knee arthroplasty (TKA) is widely recognized as an effective treatment for end-stage knee osteoarthritis (OA). Compared with conventional TKA, robotic-arm assisted TKA may improve patients' functionality and resulting quality of life by more accurate and precise component placement. Currently, the literature on cost-effectiveness of robotic-arm assisted TKA in the US is limited. The objective of this study was to assess the cost-effectiveness of robotic-arm assisted TKA relative to TKA in the Medicare-aged population including exploring the impact of hospital volume on cost-effectiveness outcomes. METHODS: We developed a decision-analytic model to evaluate the costs, health outcomes, and incremental cost-effectiveness ratio (ICER) of robotic-arm assisted TKA vs TKA in Medicare population with OA. We evaluated cost-effectiveness at a willingness-to-pay (WTP) threshold of $50,000 per quality-adjusted life-year (QALY). We sourced costs from the literature including episode-of-care (EOC) costs from a Medicare study. We assessed cost-effectiveness of robotic-arm assisted TKA by hospital procedure volume and conducted deterministic (DSA) and probabilistic sensitivity analysis (PSA). RESULTS: For the average patient treated in a hospital with an annual volume of 50 procedures, robotic-arm assisted TKA resulted in a total QALY of 6.18 relative to 6.17 under conventional TKA. Total discounted costs per patient were $32,535 and $31,917 for robotic-arm assisted TKA and conventional TKA, respectively. Robotic-arm assisted TKA was cost-effective in the base case with an ICER of $41,331/QALY. In univariate DSA, cost-effectiveness outcomes were most sensitive to the annual hospital procedure volume. Robotic-arm assisted TKA was cost-effective at a WTP of $50,000/QALY only when hospital volume exceeded 49 procedures per year. In PSA, robotic-arm assisted TKA was cost-effective at a $50,000/QALY WTP threshold in 50.4% of 10,000 simulations. CONCLUSIONS: Despite high robotic purchase costs, robotic-arm assisted TKA is likely to be cost-effective relative to TKA in the Medicare population with knee OA in high-volume hospitals through lowering revision rates and decreasing post-acute care costs. Higher-volume hospitals may deliver higher value in performing in robotic-arm assisted TKA.

Correlation between sinus rhythm deceleration zones and critical sites for localized reentrant atrial flutter: A retrospective multicenter analysis.

Background: Atypical left atrial flutter (AFL) may be macroreentrant or spatially localized. The relationship between the critical isthmus (CI) for localized reentry with sinus rhythm (SR) conduction slowing has not been systematically examined. Objective: To examine the correlation between CI sites for localized AFL (L-AFL) and deceleration zones (DZ) identified by isochronal late activation mapping (ILAM) during baseline rhythm. Methods: Patients with localized AFL who underwent high-density activation mapping of both SR and AFL were retrospectively analyzed. L-AFL was defined as reentry restricted to 2 wall segments of the left atrium. CI was defined by activation mapping and sites of successful termination during ablation. DZ, defined as >3 isochrones within 1 cm radius during baseline rhythm, were correlated to the locations of the CI. Results: Thirty-one consecutive patients that underwent detailed sinus rhythm and AFL high-density activation maps were analyzed at 3 centers. A mean 4060 ± 3275 and 6209 ± 8656 points were collected in ILAM and AFL activation maps, respectively. At least 1 DZ (1.7 ± 0.77) was identified in all patients. ILAM showed 3.27 ± 0.52 isochrones per DZ (168 ± 32 ms), and co-localized to CI sites at a distance of 6.7 ± 3 mm. A total of 34% ± 14% of the AFL cycle length was contained within 0.5 cm of the DZ. Conclusions: In patients with L-AFL, CI co-localized with DZ during baseline rhythm, suggesting that DZ mapping during SR may yield candidate targets for ablation as an adjunct to pulmonary vein isolation to prevent a subtype of AFL.

Procedural and short-term results of electroanatomic-mapping-guided ganglionated plexus ablation by first-time operators: A multicenter study.

INTRODUCTION: Single-center observational studies have shown promising results with fragmented electrogram (FE)-guided ganglionated plexus (GP) ablation in patients with vagally mediated bradyarrhythmia (VMB). We aimed to compare the acute procedural characteristics during FE-guided GP ablation in patients with VMB performed by first-time operators and those of a single high-volume operator. METHODS AND RESULTS: This international multicenter cohort study included data collected over 2 years from 16 cardiac hospitals. The primary operators were classified according to their prior GP ablation experience: a single high-volume operator who had performed > 50 GP ablation procedures (Group 1), and operators performing their first GP ablation cases (Group 2). Acute procedural characteristics and syncope recurrence were compared between groups. Forty-seven consecutive patients with VMB who underwent FE-guided GP ablation were enrolled, n = 31 in Group 1 and n = 16 in Group 2. The mean number of ablation points in each GP was comparable between groups. The ratio of positive vagal response during ablation on the left superior GP was higher in Group 1 (90.3% vs. 62.5%, p = .022). Ablation of the right superior GP increased heart rate acutely without any vagal response in 45 (95.7%) cases. The procedure time was longer in group 2 (83.4 ± 21 vs. 118.0 ± 21 min, respectively, p < .001). Over a mean follow-up duration of 8.0 ± 3 months (range 2-24 months), none of the patients suffered from syncope. CONCLUSION: This multi-center pilot study shows for the first time the feasibility of FE-guided GP ablation across a large group of procedure-naïve operators.

Cost-effectiveness of artificial intelligence monitoring for active tuberculosis treatment: A modeling study.

BACKGROUND: Tuberculosis (TB) incidence in Los Angeles County, California, USA (5.7 per 100,000) is significantly higher than the U.S. national average (2.9 per 100,000). Directly observed therapy (DOT) is the preferred strategy for active TB treatment but requires substantial resources. We partnered with the Los Angeles County Department of Public Health (LACDPH) to evaluate the cost-effectiveness of AiCure, an artificial intelligence (AI) platform that allows for automated treatment monitoring. METHODS: We used a Markov model to compare DOT versus AiCure for active TB treatment in LA County. Each cohort transitioned between health states at rates estimated using data from a pilot study for AiCure (N = 43) and comparable historical controls for DOT (N = 71). We estimated total costs (2017, USD) and quality-adjusted life years (QALYs) over a 16-month horizon to calculate the incremental cost-effectiveness ratio (ICER) and net monetary benefits (NMB) of AiCure. To assess robustness, we conducted deterministic (DSA) and probabilistic sensitivity analyses (PSA). RESULTS: For the average patient, AiCure was dominant over DOT. DOT treatment cost $4,894 and generated 1.03 QALYs over 16-months. AiCure treatment cost $2,668 for 1.05 QALYs. At willingness-to-pay threshold of $150K/QALY, incremental NMB per-patient under AiCure was $4,973. In univariate DSA, NMB were most sensitive to monthly doses and vocational nurse wage; however, AiCure remained dominant. In PSA, AiCure was dominant in 93.5% of 10,000 simulations (cost-effective in 96.4%). CONCLUSIONS: AiCure for treatment of active TB is cost-effective for patients in LA County, California. Increased use of AI platforms in other jurisdictions could facilitate the CDC's vision of TB elimination.

Cost-effectiveness of a hypothetical cell or gene therapy cure for sickle cell disease.

Sickle cell disease (SCD) is a group of inherited genetic conditions associated with lifelong complications and increased healthcare resource utilization. Standard treatment for SCD in the US varies based on stage of the disease and observed clinical severity. In this study, we aim to evaluate the potential cost-effectiveness of a durable cell or gene therapy cure for sickle cell disease from the US healthcare sector perspective. We developed a lifetime Markov model to evaluate the cost-effectiveness of a hypothetical single-administration durable treatment (DT) for SCD provided at birth, relative to standard of care (SOC). We informed model inputs including direct healthcare costs, health state utility weights, transition probabilities, and mortality rates using a retrospective database analysis of commercially insured individuals and the medical literature. Our primary outcome of interest was the incremental cost-effectiveness ratio (ICER) of DT versus SOC evaluated at a base case willingness-to-pay (WTP) threshold of $150,000 per quality-adjusted life year (QALY). We tested the robustness of our base case findings through scenario, deterministic sensitivity (DSA), and probabilistic sensitivity analyses (PSA). In the base case analysis, treatment with DT was cost-effective with an ICER of $140,877/QALY relative to SOC for a hypothetical cohort involving 47% females. Both males (ICER of $135,574/QALY) and females (ICER of $146,511/QALY) were similarly cost-effective to treat. In univariate DSA the base case ICER was most sensitive to the costs of treating males, DT treatment cost, and the discount rate. In PSA, DT was cost-effective in 32.7%, 66.0%, and 92.6% of 10,000 simulations at WTP values of $100,000, $150,000, and $200,000 per QALY, respectively. A scenario analysis showed cost-effectiveness of DT is highly contingent on assumed lifetime durability of the cure. A hypothetical cell or gene therapy cure for SCD is likely to be cost-effective from the US healthcare sector perspective. Large upfront costs of a single administration cure are offset by significant downstream gains in health for patients treated early in life. We find cost-effectiveness outcomes do not vary substantially by gender; however, several model parameters including assumed durability and upfront cost of DT are likely to influence cost-effectiveness findings.

Open-window mapping of accessory pathways utilizing high-density mapping.

PURPOSE: Accessory pathway (AP) mapping is currently based on point-by-point mapping and identifying if a local electrogram's origin is atrial, pathway, or ventricular, which is time-consuming and prone to insufficient mapping. We sought to determine the feasibility of automated and high-density mapping to define AP location using open-window mapping (OWM), which does not rely on defining the electrogram's origin but simply detects the sharpest local signal at each point. METHODS: We enrolled 23 consecutive patients undergoing catheter ablation for atrioventricular reentrant tachycardia. High-density mapping was performed using OWM and ablation was performed. The successful site of ablation was determined by the loss of pathway function. RESULTS: OWM was 100% effective at identifying the successful site of ablation (average mapping time 7.3 ± 4.3 min.) Permanent AP elimination was achieved using a mean radiofrequency energy time of 18.5 ± 24.5 s/patient. Transiently successful ablations were 4.0 ± 1.8 mm from permanently successful sites and had lower contact force (5.1 ± 2.5 g vs. 11.7 ± 9.0 g; P = 0.041). Unsuccessful sites had similar contact force to permanently successful sites (12.2 ± 9.2 g vs. 11.7 ± 9.0 g; P = 0.856) but were 6.4 ± 2.0 mm away from successful sites. CONCLUSION: A novel technique of high-density, automated, and open-window mapping (OWM) effectively localizes APs without the need to differentiate the signal's site of origin. These findings suggest that OWM can be used to rapidly and successfully map and ablate APs. Both distances from the pathway and contact force were shown to be important for pathway ablation.

High-power, short-duration atrial fibrillation ablations using contact force sensing catheters: Outcomes and predictors of success including posterior wall isolation.

BACKGROUND: Little is known about the long-term outcomes and predictors of success of high-power, short-duration (HPSD) contact force (CF) atrial fibrillation (AF) ablations. OBJECTIVE: The purpose of this study was to determine long-term freedom from AF and predictors of freedom from AF for 50-W, 5- to 15-second CF ablation. METHODS: We examined 4-year outcomes and predictors of freedom from AF after AF ablation for 1250 consecutive patients undergoing HPSD CF ablations. RESULTS: Patient demographics were age 66.6 ± 10.5 years, female 30.9%, left atrial (LA) size 4.26 ± 0.66 cm, paroxysmal AF 35.7%, persistent AF 56.6%, and longstanding AF 7.7%. Initial ablation times were procedure 114.2 ± 45.9 minutes, fluoroscopy 15.5 ± 11.5 minutes, and total radiofrequency 20.6 ± 7.7 minutes. TactiCath was used in 47.7%, SmartTouch in 52.3%, and posterior wall isolation (PWI) was performed in 34%. Four-year freedom from AF after multiple ablations were paroxysmal AF 87.0%, persistent AF 71.9%, and longstanding AF 64.9%. Single procedure success was 74.9% for TactiCath, 64.7% for SmartTouch (P <.001), and 73.0% for no PWI vs 58.9% for PWI (P <.0001). PWI did not change outcomes for paroxysmal AF but had worse outcomes for nonparoxysmal AF. Multivariate analysis showed 6 independent predictors of worse outcome after initial ablation: older age (P = .014), female gender (P <.0001), persistent AF (P = .0001), larger LA size (P <.001), PWI (P = .049), and use of SmartTouch vs TactiCath catheter (P = .007). Redo ablations were performed in 13.8%, and the outcome was better when more veins had reconnected after the initial ablation and when AF was paroxysmal. CONCLUSION: Analysis revealed 6 independent predictors of outcome for HPSD CF. At redo ablations, the outcome was better if more veins had reconnected and could be re-isolated.

Cost-effectiveness of chemoradiation followed by esophagectomy versus chemoradiation alone in squamous cell carcinoma of the esophagus.

BACKGROUND: Standard treatment for locally advanced esophageal cancer usually includes a combination of chemotherapy, radiation, and surgery. In squamous cell carcinoma (SCC), recent studies have indicated that esophagectomy after chemoradiation does not significantly improve survival but may reduce recurrence at the cost of treatment-related mortality. This study aims to evaluate the cost-effectiveness of chemoradiation with and without esophagectomy. METHODS: We developed a decision tree and Markov model to compare chemoradiation therapy alone (CRT) versus chemoradiation plus surgery (CRT+S) in a cohort of 57-year-old male patients with esophageal SCC, over 25 years. We used information on survival, cancer recurrence, and side effects from a Cochrane meta-analysis of two randomized trials. Societal utility values and costs of cancer care (2017, USD) were from medical literature. To test robustness, we conducted deterministic (DSA) and probabilistic sensitivity analyses (PSA). RESULTS: In our base scenario, CRT resulted in less cost for more quality-adjusted life years (QALYs) compared to CRT+S ($154 082 for 1.32 QALYs/patient versus $165 035 for 1.30 QALYs/patient, respectively). In DSA, changes resulted in scenarios where CRT+S is cost-effective at thresholds between $100 000-$150 000/QALY. In PSA, CRT+S was dominant 17.9% and cost-effective at willingness-to-pay of $150 000/QALY 38.9% of the time, and CRT was dominant 30.6% and cost-effective 61.1% of the time. This indicates that while CRT would be preferred most of the time, variation in parameters may change cost-effectiveness outcomes. CONCLUSIONS: Our results suggest that more data is needed regarding the clinical benefits of CRT+S for treatment of localized esophageal SCC, although CRT should be cautiously preferred.

Low complication rates using high power (45-50 W) for short duration for atrial fibrillation ablations.

BACKGROUND: Many centers use radiofrequency (RF) energy at 25-35 W for 30-60 seconds. There is a safety concern about using higher power, especially on the posterior wall. OBJECTIVE: The purpose of this study was to examine complication rates for atrial fibrillation (AF) ablations performed with high-power, short-duration RF energy. METHODS: We examined the complication rates of 4 experienced centers performing AF ablations at RF powers from 45-50 W for 2-15 seconds per lesion. In total, 13,974 ablations were performed in 10,284 patients. On the posterior wall, 11,436 ablations used 45-50 W for 2-10 seconds, and 2538 ablations used power reduced to 35 W for 20 seconds. Esophageal temperature monitoring was used in 13,858 (99.2%). RESULTS: Demographics were age 64 ± 11 years, male 68%, left atrial size 4.4 ± 0.7 cm, paroxysmal AF 37%, persistent AF 42%, longstanding AF 20%, antiarrhythmic drugs failed 1.4 ± 0.7, hypertension 54%, diabetes 15%, previous cerebrovascular accident/transient ischemic attack 7%, and CHA2DS2-VASc score 2.1 ± 1.4. Procedural time was 116 ± 41 minutes. Complications were death in 2 (0.014%; 1 due to stroke and 1 due to atrioesophageal fistula), pericardial tamponade in 33 (0.24%; 26 tapped, 7 surgical), strokes <48 hours in 6 (0.043%), strokes 48 hours-30 days in 6 (0.043%), pulmonary vein stenosis requiring intervention in 2 (0.014%), phrenic nerve paralysis in 2 (0.014%; both resolved), steam pops 2 (0.014%) without complications, and catheter char 0 (0.00%). There was 1 atrioesophageal fistula in 11,436 ablations using power 45-50 W on the posterior wall and 3 in 2538 ablated with 35 W on the posterior wall (P = .021), although 2 of the 3 had no esophageal monitoring during a fluoroless procedure. CONCLUSION: AF ablations can be performed at 45-50 W for short durations with very low complication rates. High-power, short-duration ablations have the potential to shorten procedural and total RF times and create more localized and durable lesions.

Catheter ablation for failed surgical maze: comparison of cut and sew vs. non-cut and sew maze.

PURPOSE: To compare findings in patients undergoing atrial fibrillation(AF) and/or atrial flutter(AFl) ablation after failed cut and sew (CS) vs. non-cut and sew (NCS) surgical maze. METHODS: We compared 10 patients with prior CS to 25 with prior NCS maze undergoing catheter ablation after failed maze. RESULTS: Patient demographics: Age 68.3 ± 8.7 CS vs. 68.2 ± 9.2 NCS(P = 0.977), male 70% CS vs. 72% NCS(P = 1.000), LA size 5.11 ± 0.60 cm CS vs. 4.54 ± 0.92 cm NCS(P = 0.096), sternotomy 100% CS vs. 64% of NCS(P = 0.036). Concomitant heart surgery in 100% CS and 68% NCS(P = 0.073). NCS used radiofrequency 84%, cryoablation 8%, microwave 4%, and ultrasound 4%. All maze operations targeted pulmonary vein (PV) isolation. The maze also targeted the mitral isthmus 100% CS vs. 36% NCS(P = 0.001) and the tricuspid isthmus 90% CS vs. 40% NCS (P = 0.018). Maze failure arrhythmia mechanism was AF 0% CS and 56% NCS (P = 0.0006). Nine CS pts failed for AFl and 1 for RA tachycardia. For NCS pts, 11 failed for AFl. CS isolated 94% of PVs and NCS isolated only 26% of PVs (P < 0.0005). At EPS, clinical and induced arrhythmias were ablated and non-isolated PVs were isolated. After final ablation, arrhythmia-free rates were 60% for CS and 52% for NCS (P = 0.723) after 2.99 ± 2.35 years. CONCLUSIONS: After failed surgical maze, CS isolated nearly all PVs and NCS never isolated all PVs and the clinical rhythm was more frequently AF for NCS and AFl for CS. CS remains the surgical gold standard for durable PV isolation.

A cost-effectiveness analysis of reslizumab in the treatment of poorly controlled eosinophilic asthma.

Introduction: Poorly controlled severe eosinophilic asthma is difficult and costly to manage. Reslizumab, an add-on treatment for adults with severe eosinophilic asthma, reduces the number of exacerbations and improves the quality of life (QoL). The objective of this study was to evaluate the cost-effectiveness of reslizumab. Methods: A Markov model was used to compare the cost-effectiveness of add-on reslizumab with the standard-of-care (SOC) from the US societal perspective over a five-year time horizon. Efficacy and safety inputs for the model were based on data from two clinical trials (NCT01287039 and NCT01285323). Other model inputs, including mortality rates, costs, and utility, were estimated from literature, the Centers for Disease Control and Prevention (CDC), the US Department of Veterans Affairs (VA) and the Centers for Medicare and Medicaid Services (CMS). One-way, threshold, and probabilistic sensitivity analyses (PSA) were performed. Adherence, treatment response, and the placebo effect were evaluated in separate scenario analyses. Results: The base case incremental cost-effectiveness ratio (ICER) was $697 403 (2017 USD) per quality-adjusted life-years (QALYs). In the PSA, reslizumab becomes cost-effective in 50% of the iterations at a willingness-to-pay (WTP) threshold of $689 000. The model is most sensitive to the QoL improvement with reslizumab treatment in the one-way and threshold analyses. The response and adherence models had lower ICERs than the base model but still above $500 000. The ICER of the placebo effect model was $29 820. Conclusions: The improvement in QoL and exacerbation rates with reslizumab are associated with high costs, making reslizumab unlikely to be cost-effective at the $200 000 WTP threshold.

Cost-effectiveness of rivaroxaban versus warfarin for treatment of nonvalvular atrial fibrillation in patients with worsening renal function.

BACKGROUND: Nonvalvular atrial fibrillation (NVAF) is highly prevalent and increases the risks of cardiovascular events. In a recent subgroup analysis, treatment response was shown to vary for patients exhibiting worsening renal function (WRF) on-treatment. It is important to understand the cost-effectiveness of novel oral anticoagulant (NOAC) use in this population. METHODS: A cost-effectiveness analysis (CEA) was conducted using a Markov model to determine whether NOAC rivaroxaban treatment is cost-effective relative to warfarin in NVAF patients with on-treatment WRF. Input parameters were sourced from clinical literature including a multicenter clinical trial and subgroup analysis. We studied elderly US male patients at increased risk for stroke (CHADS2 score ≥ 2) undergoing treatment for NVAF and exhibiting WRF. Main outcome measures included total healthcare costs in 2017 US dollars (societal perspective), total quality-adjusted life years (QALYs), incremental cost-effectiveness ratio (ICER), and incremental net monetary benefits (INMB) per-patient. RESULTS: The remaining lifetime use of rivaroxaban is associated with 5.69 QALYs at a cost of $66,075 per patient, while warfarin produced 5.22 QALYs with costs of $78,504 per patient. At a willingness-to-pay (WTP) of $150,000 per QALY, incremental net monetary benefits (INMB) per patient are $83,590. In our population, treatment with warfarin was dominated by rivaroxaban in 99.4% of 10,000 simulations. CONCLUSIONS: Rivaroxaban is likely a dominant treatment over warfarin in elderly US male NVAF patients exhibiting WRF, providing increased QALYs at a decreased overall cost. Application of these findings may require healthcare providers to predict which patients are likely to exhibit WRF.

Atrial fibrillation ablation using very short duration 50 W ablations and contact force sensing catheters.

PURPOSE: The optimal radiofrequency (RF) power and lesion duration using contact force (CF) sensing catheters for atrial fibrillation (AF) ablation are unknown. We evaluate 50 W RF power for very short durations using CF sensing catheters during AF ablation. METHODS: We evaluated 51 patients with paroxysmal (n = 20) or persistent (n = 31) AF undergoing initial RF ablation. RESULTS: A total of 3961 50 W RF lesions were given (average 77.6 ± 19.1/patient) for an average duration of only 11.2 ± 3.7 s. As CF increased from < 10 to > 40 g, the RF application duration decreased from 13.7 ± 4.4 to 8.6 ± 2.5 s (p < 0.0005). Impedance drops occurred in all ablations, and for patients in sinus rhythm, there was loss of pacing capture during RF delivery suggesting lesion creation. Only 3% of the ablation lesions were at < 5 g and 1% at > 40 g of force. As CF increased, the force time integral (FTI) increased from 47 ± 24 to 376 ± 102 gs (p < 0.0005) and the lesion index (LSI) increased from 4.10 ± 0.51 to 7.63 ± 0.50 (p < 0.0005). Both procedure time (101 ± 19.7 min) and total RF energy time (895 ± 258 s) were very short. For paroxysmal AF, the single procedure freedom from AF was 86% at 1 and 2 years. For persistent AF, it was 83% at 1 year and 72% at 2 years. There were no complications. CONCLUSIONS: Short duration 50 W ablations using CF sensing catheters are safe and result in excellent long-term freedom from AF for both paroxysmal and persistent AF with short procedure times and small amounts of total RF energy delivery.

Impact of obesity on atrial fibrillation ablation: Patient characteristics, long-term outcomes, and complications.

BACKGROUND: There is an association between obesity and atrial fibrillation (AF). The impact of obesity on AF ablation procedures is unclear. OBJECTIVE: The purpose of this study was to evaluate the influence of body mass index (BMI) on patient characteristics, long-term ablation outcomes, and procedural complications. METHODS: We evaluated 2715 patients undergoing 3742 AF ablation procedures. BMI was ≥30 kg/m2 in 1058 (39%) and ≥40 kg/m2 in 129 (4.8%). Patients were grouped by BMI ranges (<25, 25-<30, 30-<35, 35-<40, and ≥40 kg/m2). RESULTS: As BMI increased from <25 to ≥40 kg/m2, age decreased from 65.3 ± 11.2 to 61.2 ± 9.2 years (P < .001), left atrial size increased from 3.91 ± 0.68 to 4.72 ± 0.62 cm (P < .005), and CHADS2 scores increased from 1.24 ± 1.10 to 1.62 ± 1.09 (P < .001). As BMI increased, paroxysmal AF decreased from 48.0% to 16.3% (P < .0001) and there was an increase in dilated cardiomyopathy (from 7.6% to 12.4%; P < .0001), hypertension (from 41.0% to 72.9%; P < .0001), diabetes (from 4.3% to 23.3%; P < .0001), and sleep apnea (from 7.0% to 46.9%; P < .0001). For the entire cohort, for BMI ≥35 kg/m2 the 5-year ablation freedom from AF decreased from 67%-72% to 57% (P = .036). For paroxysmal AF, when BMI was ≥40 kg/m2 ablation success decreased from 79%-82% to 60% (P = .064), and for persistent AF, when BMI was ≥35 kg/m2 ablation success decreased from 64%-70% to 52%-57% (P = .021). For long-standing AF, there was no impact of BMI on outcomes (P = .624). In multivariate analysis, BMI ≥35 kg/m2 predicted worse outcomes (P = .036). Higher BMI did not impact major complication rates (P = .336). However, when BMI was ≥40 kg/m2, minor (from 2.1% to 4.4%; P = .035) and total (from 3.5% to 6.7%; P = .023) complications increased. CONCLUSION: In patients undergoing AF ablation, increasing BMI is associated with more patient comorbidities and more persistent and long-standing AF. BMI ≥35 kg/m2 adversely impacts ablation outcomes, and BMI ≥40 kg/m2 increases minor complications.