Comparison of ten policy options to equitably reduce children's exposure to unhealthy food marketing.

OBJECTIVE: Reducing children's exposure to unhealthy food marketing is crucial to combat childhood obesity. We aimed to estimate the reduction of children's exposure to food marketing under different policy scenarios and assess exposure differences by socio-economic status. DESIGN: Data on children's exposure to unhealthy food marketing were compiled from a previous cross-sectional study in which children (n 168) wore wearable cameras and Global Positioning System (GPS) units for 4 consecutive days. For each exposure, we identified the setting, the marketing medium and food/beverage product category. We analysed the percentage reduction in food marketing exposure for ten policy scenarios and by socio-economic deprivation: (1) no product packaging, (2) no merchandise marketing, (3) no sugary drink marketing, (4) no confectionary marketing in schools, (5) no sugary drink marketing in schools, (6) no marketing in public spaces, (7) no marketing within 400 m of schools, (8) no marketing within 400 m of recreation venues, (9) no marketing within 400 m of bus stops and (10) no marketing within 400 m of major roads. SETTING: Wellington region of New Zealand. PARTICIPANTS: 168 children aged 11-14 years. RESULTS: Exposure to food marketing varied by setting, marketing medium and product category. Among the ten policy scenarios, the largest reductions were for plain packaging (60·3 %), no sugary drink marketing (28·8 %) and no marketing in public spaces (22·2 %). There were no differences by socio-economic deprivation. CONCLUSIONS: The results suggest that plain packaging would result in the greatest decrease in children's exposure to food marketing. However, given that children are regularly exposed to unhealthy food marketing in multiple settings through a range of marketing mediums, comprehensive bans are needed to protect children's health.

Mechanisms, predictors, and evolution of severe peri-device leaks with two different left atrial appendage occluders.

AIMS: Incomplete left atrial appendage occlusion (LAAO) due to peri-device leak (PDL) is a limitation of the therapy. The Amulet IDE trial is the largest randomized head-to-head trial comparing the Amulet and Watchman 2.5 LAAO devices with fundamentally different designs. The predictors and mechanistic factors impacting differences in PDLs within the Amulet IDE trial are assessed in the current analysis. METHODS AND RESULTS: An independent core lab analysed all images for the presence or absence of severe PDL (>5 mm). The incidence, mechanistic factors, predictors using propensity score-matched controls, and evolution of severe PDLs through 18 months were assessed. Of the 1878 patients randomized in the trial, the Amulet occluder had significantly fewer severe PDLs than the Watchman device at 45 days (1.1 vs. 3.2%, P < 0.001) and 12 months (0.1 vs. 1.1%, P < 0.001). Off-axis deployment or missed lobes were leading mechanistic PDL factors in each device group. Larger left atrial appendage (LAA) dimensions including orifice diameter, landing zone diameter, and depth predicted severe PDL with the Watchman device, with no significant anatomical limitations noted with the Amulet occluder. Procedural and device implant predictors were found with the Amulet occluder attributed to the learning curve with the device. A majority of Watchman device severe PDLs did not resolve over time through 18 months. CONCLUSION: The dual-occlusive Amplatzer Amulet LAA occluder provided improved LAA closure compared with the Watchman 2.5 device. Predictors and temporal observations of severe PDLs were identified in the Amulet IDE trial. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov Unique identifier NCT02879448.

Generating political priority for skin cancer primary prevention: A case study from Aotearoa New Zealand.

ISSUES ADDRESSED: Skin cancer is highly prevalent but preventable, yet little research has been done on the challenges in generating political priority for skin cancer prevention. This qualitative study aimed to identify the political challenges to, facilitators of, and strategies to strengthen skin cancer prevention. The focus was on the case of Aotearoa New Zealand (NZ): a country with high skin cancer rates, but limited investment in primary prevention. METHODS: Data sources included 18 national key informant interviews and documentary analysis. Data were analysed inductively for emerging themes and framed using a conceptual framework of political priority. RESULTS: Challenges to advocates for skin cancer primary prevention include limited resources and competing priorities. Political-level challenges include a lack of quick results compared with other initiatives vying for political attention, lack of negative externalities and, in NZ, misalignment with health system priorities. Challenges in the evidence base include the perceived conflict of sun protection with Vitamin D and physical activity, the lack of data on the financial burden of skin cancer and relatively low temperatures in NZ. Facilitators include strong policy community cohesion and issue framing, and weak opposition. Promising strategies to strengthen skin cancer prevention in NZ could include network building, using framing that resonates with policy makers and addressing key knowledge gaps in NZ, such as the financial burden of skin cancer. CONCLUSION: Advocacy for skin cancer prevention faces challenges due to advocates' limited resources, political challenges such as lack of quick results and gaps in evidence. Nonetheless, the initiative encounters little opposition and can be framed in ways that resonate with policy makers. SO WHAT?: Skin cancer is highly preventable, but advocates for prevention initiatives have struggled to gain political traction. This study identifies several strategies that could help raise the political profile for skin cancer prevention.

Comparative data on left atrial appendage occlusion efficacy and clinical outcomes by age group in the Amplatzer™ Amulet™ Occluder Observational Study.

AIMS: Left atrial appendage occlusion (LAAO) may be considered for patients with non-valvular atrial fibrillation (NVAF) and a relative/formal contraindication to anticoagulation. This study aimed to summarize the impact of aging on LAAO outcomes at short and long-term follow-up. METHODS AND RESULTS: We compared subjects aged <70, ≥70 and <80, and ≥80 years old in the prospective, multicentre Amplatzer™ Amulet™ Occluder Observational Study (Abbott, Plymouth, MN, USA). Serious adverse events (SAEs) were reported from implant through a 2-year post-LAAO visit and adjudicated by an independent clinical events committee. Overall, 1088 subjects were prospectively enrolled. There were 265 subjects (24.4%) <70 years old, 491 subjects (45.1%) ≥70 and <80 years old, and 332 subjects (30.5%) ≥80 years old, with the majority (≥80%) being contraindicated to anticoagulation. As expected, CHA2DS2-VASc and HAS-BLED Scores increased with age. Implant success was high (≥98.5%) across all groups, and the proportion of subjects with a procedure- or device-related SAE was similar between groups. At follow-up, the observed ischaemic stroke rate was not significantly different between groups, and corresponding risk reductions were 62, 56, and 85% when compared with predicted rates for subjects <70, ≥70 and <80, and ≥80 years old, respectively. Major bleeding and mortality rates increased with age, while the incidence of device-related thrombus tended to increase with age. CONCLUSIONS: Despite the increased risk for ischaemic stroke with increasing age in AF patients, LAAO reduced the risk for ischaemic stroke compared with the predicted rate across all age groups without differences in procedural SAEs.

Where do the children play? An objective analysis of children's use of green space.

Green space is important for health, yet, objective research on children's use of green space is sparse. This study aimed to objectively assess children's use of green space in both public and private settings during their summer leisure time, using wearable cameras. Images from cameras worn by 74 children were analysed for green space use over 4 days. Children spent an average of ∼1/10 h of leisure time in green space in the summer months, were physically active 68%, and with others 85%, of the time. Green spaces are important places for children's health because they are places they frequent and places where they are physically active and socialize. Wearable cameras provide an effective method for objective assessment of green space use.

Electrical wavefront fusion in heart failure patients with left bundle branch block and cardiac resynchronization therapy: Implications for optimization.

BACKGROUND: Novel metrics of electrical dyssynchrony based on multi-electrode mapping and ECG-based markers of fusion are better predictors of cardiac resynchronization therapy (CRT) response than QRS duration. OBJECTIVE: To describe a new methodology for measuring electrical synchrony based on wavefront fusion and electrocardiographic cancellation in patients with CRT and its potential for CRT optimization. METHODS: Patients with left bundle branch block (LBBB) type conduction and CRT (n = 84) were studied at multiple device settings using an ECG belt (53 anterior and posterior electrodes). The area between combinations of anterior and posterior curves (AUC) was calculated and cardiac resynchronization index (CRI) defined as percent change in AUC compared to LBBB. RESULTS: In 14 patients with complete heart block or atrial fibrillation, CRI at optimal ventriculo-ventricular delay (VVD) (40 ± 19 ms) was significantly higher than with simultaneous biventricular pacing (BiVp) (90 ± 8.6% vs. 54.2 ± 24.2%, p < 0.001). In all 70 patients paced LV-only, LV-paced wavefront was ahead of native wavefront at short atrio-ventricular delay (AVD) and CRI increased with increase in AVD, peaked, and then decreased. Optimal CRI during LV-only pacing was significantly better than optimal CRI with simultaneous BiVp (89.6 ± 8% vs. 64.4 ± 22%, p < 0.001), and occurred at AVD 68 ± 22 ms less than the atrial-RV sensed interval. With sequential BiVp, best CRI was 83.9 ± 13% (with LV preactivation of 40 ± 20 ms). Best CRI at any setting was markedly better than CRI at standard setting (91.6 ± 7.7% vs. 52.7 ± 23.3, p < 0.001). CONCLUSION: We describe a novel non-invasive investigational tool that quantifies wavefront fusion and electrical dyssynchrony, and may allow for individualized CRT optimization.

An objective methodology capturing online commodity marketing and other harms.

Increasingly life is lived online, yet little is known about the actual nature and extent of online content that people view due to the difficulty of recording real time exposure. This includes people's exposure to harmful commodity marketing. This study aimed to develop a methodology to assess the nature and extent of exposure to, and engagement with, unhealthy commodity marketing and other public health harms online, particularly children's exposure. A convenience sample of 16 young adult participants (aged 21-29) recorded their device usage for 2 days using Zoom software. Data were coded and analysed to assess the nature and extent of marketing for alcohol, gambling, junk food and smoking products. Four focus groups were conducted with participants to explore their data collection and coding experiences, and results assessed using thematic analysis. The study found that, with some modifications, this method was feasible for gathering real-time objective data from the online world that can be analysed for a range of public health harms, including marketing of unhealthy commodities. Larger studies are recommended to build global evidence for public health action in the online world.

Studying third-parties and environments: New Zealand sun-safety research.

Wearable cameras have been used to study health behaviours, but their utility in assessing third-party behaviours and the built environment is uncertain. This paper reports on the feasibility of using wearable cameras for this purpose in a study of sun-protective behaviours and shade availability during school lunch-breaks. The Kids'Cam study provided 168 children (aged 11-13 years), recruited from 16 randomly selected schools in the Wellington region of New Zealand, with wearable cameras. The devices automatically captured images every 7 s from the child's perspective. Images captured during school lunch-breaks by a random sample of 15 children who took part during terms 4 and 1 (October 2014-April 2015) were selected and assessed for usability. The feasibility of studying third-party sun-protective behaviours and school shade availability was assessed for a subset of 320 images. Of the 3492 eligible lunch-break images, 96.4% were useable; the remainders were excluded due to obstruction, blurriness or unsuitable camera position. Overall, 1278 children and 108 shade structures were observed in the sample images. The use of shade, hats, sleeves, collars and sunglasses could be determined for 97.0%, 77.2%, 74.4%, 47.6% and 54.9% of children, respectively. All shade structures could be classified according to type, and canopy composition could be assessed for 95.4% of structures. Wearable cameras are a feasible tool for assessing sun-safety, particularly shade availability, hat wearing and shade use. This methodology could be used to objectively study other third-party health-related behaviours, and other features of the built environment.

Are children smoke-free at home? Using wearable cameras to study children's exposure to smoking and smoking paraphernalia in private spaces.

BACKGROUND: There is limited evidence available on the nature of children's exposure to smoking and smoking paraphernalia in private spaces (homes and cars). We aimed to evaluate the extent and nature of children's exposure to smoking in these settings using image data captured by wearable cameras. METHODS: One-hundred and sixty-eight children wore wearable cameras for 4 days that automatically took pictures every 7 s. Images captured in private spaces (n = 140,818) by children living in households with a smoker (n = 34) were screened for instances of smoking and smoking paraphernalia. RESULTS: A total of 37 incidents of smoking-four indoor, 21 outdoor, and two in-vehicles-and 62 incidents of smoking paraphernalia were observed. Most smoking incidents in homes (21 of 33) took place outdoors. CONCLUSIONS: The findings support health promotion efforts to make smokers more aware that smoking paraphernalia may normalize smoking for children. The methodology (wearable cameras) appears to have high utility for studying health behaviours in private spaces.

Body surface activation mapping of electrical dyssynchrony in cardiac resynchronization therapy patients: Potential for optimization.

BACKGROUND: Electrical synchronization is likely improved by cardiac resynchronization therapy (CRT), but is difficult to quantify with 12-lead ECG. We aimed to quantify changes in electrical synchrony and potential for optimization with CRT using a body-surface activation mapping (BSAM) system. METHODS: Standard deviation of activation times (SDAT) was calculated in 94 patients using BSAM at baseline CRT (CRTbl), native, and different CRT configurations. RESULTS: SDAT decreased 20% from native to CRTbl (p<0.01) and an additional 26% (p<0.01) at optimal CRT (CRTopt), the minimal SDAT setting. Patients with LBBB and patients with QRS duration ≥150ms had higher native SDAT and greater decrease with CRTbl (p<0.01); however, the improvement from CRTbl to CRTopt was similar in all four groups (range: 24-28%). CRTopt was achieved with biventricular pacing in 52% and LV-only pacing in 44%. We propose that improved wavefront fusion demonstrated by BSAMs contributed substantially to the improved electrical synchrony. CONCLUSION: Optimization potential is similar regardless of pre-CRT QRS morphology or duration. BSAM could possibly improve CRT response by individualizing device programming to minimize electrical dyssynchrony.

On the underutilization of cardiac resynchronization therapy.

Cardiac resynchronization therapy (CRT) is an exciting therapy that can treat patients with systolic heart failure and left ventricular dysfunction who have a wide QRS complex. Indications for its use have been refined and expanded based on recent clinical data and guidelines, yet the rate of new CRT implants in the United States has not changed much over the past 8 years. Many patients receiving implantable cardioverter-defibrillators can benefit from, but are not receiving, appropriately-indicated CRT devices. We summarize data on CRT use, discuss reasons for probable underutilization, and provide recommendations for augmenting proper and effective use of this highly beneficial therapy.

The Cost-Effectiveness of Primary Prevention Interventions for Skin Cancer: An Updated Systematic Review.

OBJECTIVE: Preventing the onset of skin malignancies is feasible by reducing exposure to ultraviolet radiation. We reviewed published economic evaluations of primary prevention initiatives in the past decade, to support investment decisions for skin cancer prevention. METHODS: We assessed cost-effectiveness, cost-utility and benefit-cost analyses published from 1 September 2013. Seven databases were searched on 18 July 2023 and updated on 15 November 2023. Studies must have reported outcomes in terms of monetary costs, life years, quality-adjusted life years or variant thereof. A narrative synthesis was undertaken and reporting quality was assessed by three reviewers using the Consolidated Health Economic Evaluation Reporting Standards checklist. RESULTS: In total, 12 studies were included with five studies located in Australia; three in North America and the remaining four in Europe. Interventions included restricting the use of indoor tanning devices (7 studies), television advertising, multi-component sun safety campaigns, shade structures plus protective clothing provision for outdoor workers and provision of melanoma genomic risk information to individuals. Most studies constructed Markov cohort models and adopted a societal cost perspective. Overall, the reporting quality of the studies was high. Studies found highly favourable returns on investment ranging from US$0.35 for every $1 spent on prevention, up to €3.60 for every €1 spent. Other studies showed substantial skin cancers avoided, gains in life years, quality-adjusted survival, and societal cost savings. CONCLUSIONS: From both population health and economic perspectives, allocating limited health care resources to primary prevention of skin cancer is highly favourable.

Generating political priority for alcohol policy reform: A framework to guide advocacy and research.

INTRODUCTION: While effective policies exist to reduce alcohol-related harm, political will to enact them is low in many jurisdictions. We aimed to identify key barriers and strategies for strengthening political priority for alcohol policy reform. METHODS: A framework synthesis was conducted, incorporating relevant theory, key informant interviews (n = 37) and a scoping review. Thematic analysis informed the development of a framework for understanding and influencing political priority for alcohol policy. RESULTS: Twelve barriers and 14 strategies were identified at multiple levels (global, national and local). Major barriers included neoliberal or free trade ideology, the globalised alcohol industry, limited advocate capacity and the normalisation of alcohol harms. Strategies fell into two categories: sector-specific and system change initiatives. Sector-specific strategies primarily focus on influencing policymakers and mobilising civil society. Examples include developing a clear, unified solution, coalition building and effective framing. System change initiatives target structural change to reduce the power imbalance between industry and civil society, such as restricting industry involvement in policymaking and securing sustainable funding for advocacy. A key example is establishing an international treaty, similar to the Framework Convention on Tobacco Control, to support domestic policymaking. DISCUSSION AND CONCLUSIONS: Our findings provide a framework for understanding and advancing political priority for alcohol policy. The framework highlights that progress can be achieved at various levels and through diverse groups of actors. The importance of upstream drivers of policymaking was a key finding, presenting challenges for time-poor advocates, but offering potential facilitation through effective global leadership.

Feasibility of Amulet occluder implantation after failed left atrial appendage occlusion attempt: Insights from the EMERGE LAA postapproval study.

BACKGROUND: Although expertise in left atrial appendage occlusion (LAAO) has grown, certain intricate anatomies may pose challenges, rendering them unsuitable for LAAO with the selected device. OBJECTIVE: This analysis aimed to characterize outcomes of patients with prior failed percutaneous LAAO procedures who underwent a subsequent attempt with an Amulet occluder in the EMERGE LAA postapproval study. METHODS: Patients enrolled in the National Cardiovascular Data Registry LAAO Registry who had an Amulet occluder implantation attempt between Food and Drug Administration approval (August 14, 2021) and June 30, 2023, were evaluated. A safety end point through 7 days or hospital discharge (whichever was later) and major adverse events through 45 days were reported. RESULTS: A total of 8591 patients underwent attempted Amulet occluder implantation, of whom 244 patients had prior failed LAAO. Implantation success was 88.9% and 96.2% in patients with prior failed LAAO and index LAAO, respectively (P < .001). The safety composite end point was low, occurring in 1.6% and 0.8% of patients with prior failed LAAO and index LAAO, respectively (P = .148). Any major adverse event through 45 days occurred in 7.4% and 6.3% of prior failed LAAO and index LAAO patient cohorts, respectively (P = .497); most adverse events were similar between the groups (P > .05). At 45 days, peridevice leak ≤3 mm was achieved in >90% of patients in either group. CONCLUSION: A high degree of implantation success with a low rate of adverse events can be achieved with the Amulet occluder. The findings imply that the dual occlusive mechanism Amulet occluder facilitates successful closure, even in challenging anatomic scenarios.

The Epidemiology of Domain-Specific Physical Activity in New Zealand Adults: A Nationally Representative Cross-Sectional Survey.

BACKGROUND: Surveillance of domain-specific physical activity (PA) helps to target interventions to promote PA. We examined the sociodemographic correlates of domain-specific PA in New Zealand adults. METHODS: A nationally representative sample of 13,887 adults completed the International PA Questionnaire-long form in 2019/20. Three measures of total and domain-specific (leisure, travel, home, and work) PA were calculated: (1) weekly participation, (2) mean weekly metabolic energy equivalent minutes (MET-min), and (3) median weekly MET-min among those who undertook PA. Results were weighted to the New Zealand adult population. RESULTS: The average contribution of domain-specific activity to total PA was 37.5% for work activities (participation = 43.6%; median participating MET-min = 2790), 31.9% for home activities (participation = 82.2%; median participating MET-min = 1185), 19.4% for leisure activities (participation = 64.7%; median participating MET-min = 933), and 11.2% for travel activities (participation = 64.0%; median MET-min among participants = 495). Women accumulated more home PA and less work PA than men. Total PA was higher in middle-aged adults, with diverse patterns by age within domains. Maori accumulated less leisure PA than New Zealand Europeans but higher total PA. Asian groups reported lower PA across all domains. Higher area deprivation was negatively associated with leisure PA. Sociodemographic patterns varied by measure. For example, gender was not associated with total PA participation, but men accumulated higher MET-min when taking part in PA than women. CONCLUSIONS: Inequalities in PA varied by domain and sociodemographic group. These results should be used to inform interventions to improve PA.

Watching the watchers: assessing the nature and extent of children's screen time using wearable cameras.

AIM: Children's screen use has increased rapidly in recent years, yet little is known about this use in real-time due to reliance on self-report or proxy data sources. Screens provide benefits such as educational content and social connection, but also pose health risks including obesity, depression, poor sleep and poor cognitive performance. In this cross-sectional observational study, we aimed to determine the nature and extent of children's after-school screen time using wearable cameras. METHOD: Children aged 11-13 years took part in the New Zealand Kids'Cam project in 2014/2015. Each child wore a camera that passively captured images of their surroundings every 7 seconds. Images from 108 children were manually coded. RESULTS: Children spent over a third of their time on screens, including over half their time after 8pm. Television accounted for the highest proportion of screen time (42.4%), followed by computers (32.0%), mobile devices (13.0%) and tablets (12.6%). Approximately 10% of children's screen time involved multiple screen use. CONCLUSION: Guidelines are needed to promote healthy screen time behaviour among children. Further research is also needed to monitor the impact of screens on children's wellbeing, including any socio-demographic differences, and to identify innovations to protect children from harm in the online space.

3-Year Outcomes From the Amplatzer Amulet Left Atrial Appendage Occluder Randomized Controlled Trial (Amulet IDE).

BACKGROUND: The Amulet (Abbott) left atrial appendage occluder investigational device exemption trial is the largest randomized trial evaluating the safety and effectiveness of the Amulet left atrial appendage occluder compared with the Watchman 2.5 device (Boston Scientific) through 5 years. OBJECTIVES: This analysis evaluated the device effect on 3-year outcomes in the Amulet investigational device exemption trial. METHODS: The medication regimen and key clinical outcomes were reported through 3 years including: 1) the composite of ischemic stroke or systemic embolism (SE); 2) the composite of all strokes, SE, or cardiovascular (CV) death; 3) major bleeding; and 4) all-cause death and CV death. RESULTS: A total of 1,878 patients at 108 sites were randomized. A significantly higher percentage of patients were free of oral anticoagulation usage at 3 years with Amulet (96.2%) vs Watchman (92.5%) (P < 0.01). Clinical outcomes were comparable for the composite of ischemic stroke or SE (5.0% vs 4.6%; P = 0.69); the composite of all strokes, SE, or CV death (11.1% vs 12.7%; P = 0.31); major bleeding (16.1% vs 14.7%; P = 0.46); all-cause death (14.6% vs 17.9%; P = 0.08); and CV death (6.6% vs 8.5%; P = 0.14) for Amulet and Watchman, respectively. Through 3 years, device factors (device-related thrombus or peridevice leak ≥3 mm) preceded ischemic stroke events and CV deaths more frequently in Watchman compared with Amulet patients. CONCLUSIONS: The Amulet occluder demonstrated continued safety and effectiveness with over 96% free of oral anticoagulation usage through 3 years in a high-risk population compared to the Watchman device. (AMPLATZER Amulet LAA Occluder Trial [Amulet IDE]; NCT02879448).

Incidence, Predictors, and Clinical Outcomes of Device-Related Thrombus in the Amulet IDE Trial.

BACKGROUND: Device-related thrombus (DRT) following left atrial appendage occlusion (LAAO) can lead to adverse clinical outcomes. DRT rates and outcomes from randomized trials are limited. OBJECTIVES: This analysis investigated the incidence, predictors, and clinical outcomes of DRT following LAAO in the Amulet IDE (AMPLATZER Amulet LAA Occluder Trial) trial. METHODS: Successful implants occurred in 903 patients with an Amulet occluder (dual occlusive mechanism device) and 885 patients with a Watchman device (single occlusive mechanism device). These patients were then followed through 18 months and DRT was assessed by transesophageal echocardiography. RESULTS: The overall incidence of DRT was 3.9% (n = 70) with 3.4% (n = 30) in dual occlusive mechanism device patients and 4.8% (n = 40) in single occlusive mechanism device patients. Most DRTs (n = 19 of 31) were identified early (≤45 days) on the dual occlusive mechanism device, whereas most of the DRTs (n = 31 of 42) were identified late (>45 days) on the single occlusive mechanism device. Strong predictors of DRT included atrial fibrillation at time of procedure (HR: 2.44; 95% CI: 1.42-4.22; P < 0.01), female sex (HR: 1.65; 95% CI: 1.01-2.71; P = 0.04), and older age (HR: 1.04; 95% CI: 1.01-1.08; P = 0.02). There were no stroke events following DRT in the dual occlusive mechanism device group and 3 stroke events following DRT in the single occlusive mechanism device group. Patients with DRT were at a greater risk for cardiovascular mortality compared with non-DRT patients (8.7% vs 3.9%; HR: 2.33; 95% CI: 1.01-5.39; P = 0.04). CONCLUSIONS: Incidence of DRT following LAAO was low. Early DRTs are seen with the dual occlusive mechanism device and late DRTs are seen with the single occlusive mechanism device. Increased cardiovascular mortality risk in patients with DRT should be further investigated. (AMPLATZER Amulet LAA Occluder Trial; NCT02879448).

Comparison of cardiac resynchronization therapy outcomes in patients with New York Heart Association functional class I/II versus III/IV heart failure.

BACKGROUND: Several randomized trials have shown that cardiac resynchronization therapy (CRT) benefits New York Heart Association (NYHA) functional class I/II heart failure (HF) patients, but it is unknown if similar outcomes occur in the real-world. METHODS AND RESULTS: All patients receiving CRT between 2003 and 2008 with ejection fraction (EF) ≤35% and QRS duration ≥120 ms were included. Outcomes assessed were subjective clinical response, echocardiographic response, and survival free of cardiovascular (CV) hospitalization. Baseline demographics in functional class I/II (n = 155) and functional class III/IV (n = 512) were similar, except for differences in age and several comorbidities. Clinical response was similar in both groups. The functional class I/II group had a greater decrease in left ventricular (LV) end-diastolic dimension (P = .031), and trended toward greater improvements in LV end-systolic dimension (P = .056) and EF (P = .059). The functional class I/II group had a better 5-year survival rate (79 vs 54%; P < .0001) and survival free of CV hospitalization (45% vs 26%; P < .0001). CONCLUSIONS: In this real-world clinical scenario, NYHA functional class I/II CRT patients improved clinical status, and LV function and size as good as or better than those in NYHA functional class III/IV patients. These observations provide further support for the use of CRT in patients with mild symptoms of HF.

Cardiac resynchronization therapy in the real world: comparison with the COMPANION study.

BACKGROUND: Several clinical trials have confirmed that cardiac resynchronization therapy (CRT) improves outcomes in well defined patient populations. It is uncertain, however, whether outcomes are similar in real-world clinical settings. This study compared outcomes after CRT with defibrillator (CRT-D) in a large real-world private-practice cardiology setting with those in the COMPANION multicenter trial. METHODS AND RESULTS: A total of 429 consecutive patients who received CRT-D for standard indications (group 1) were retrospectively compared with the 595 patients (group 3) in the COMPANION CRT-D cohort regarding survival and survival free of cardiovascular (CV) hospitalization. A subgroup of the group 1 patients who met the COMPANION entrance criteria (group 2) was also compared with the COMPANION cohort (group 3) both with and without propensity-matching statistical analysis. Survival and survival free of CV hospitalization was better in group 1 than in group 3. Survival in group 2 with and without propensity matching was similar to group 3. However, survival free of CV hospitalization was better in the real-world patients (group 2) even after adjustment for differences in baseline characteristics. CONCLUSIONS: Survival and CV hospitalization outcomes in a real-world clinical setting are as good as, or better than, those demonstrated in the COMPANION research trial.