Efficacy and safety of the new generation Watchman FLX device compared to the Watchman 2.5: a systematic review and meta-analysis.

The first-generation Watchman 2.5 (W 2.5) presented several limitations, such as challenges in implantation within complex left atrial appendage (LAA) anatomies, higher incidence of peri-device leak, device recapture, and device-related thrombus (DRT). The newer generation Watchman FLX (W-FLX) was introduced with a modified design aiming to overcome these limitations. The purpose of this meta-analysis is to conduct a comparative assessment of the safety and efficacy of the W-FLX and 2.5 devices in clinical practice. The meta-analysis was conducted according to the preferred reporting items for systematic review and meta-analysis protocols (PRISMA). Studies were located through a search strategy utilizing PubMed, Cochrane, Google scholar and MEDLINE from inception to March 2023, with a primary objective to compare the safety and efficacy of the W-FLX and W 2.5 devices. After applying the selection criteria, five studies were included in this analysis. The analysis included five studies comprising 54,727 patients. The W-FLX is associated with an increase in procedural success (OR 7.49 [95% CI 1.98-28.26, P = 0.02; = 0%]), and a significant reduction in mortality (OR 0.52 [95% CI 0.51-0.54, P<0.01; = 0%], major bleeding 0.57 [95% CI 0.51-0.64, P<0.01; = 0%]), device embolism (OR 0.35 [95% CI 0.18-0.70, P = 0.02; = 0%]), and pericardial effusion (OR 0.33 [95% CI 0.26-0.41, P<0.01; = 0%]). The rates of DRT and stroke were similar between the two groups. Compared to the W 2.5, the W-FLX was associated with a higher procedural success rate and significantly reduced adverse outcomes including mortality, major bleeding, device embolization, and pericardial effusion. [Abstract copyright: AJCD Copyright © 2023.

Elective Cancer Surgery in COVID-19-Free Surgical Pathways During the SARS-CoV-2 Pandemic: An International, Multicenter, Comparative Cohort Study.

PURPOSE: As cancer surgery restarts after the first COVID-19 wave, health care providers urgently require data to determine where elective surgery is best performed. This study aimed to determine whether COVID-19-free surgical pathways were associated with lower postoperative pulmonary complication rates compared with hospitals with no defined pathway. PATIENTS AND METHODS: This international, multicenter cohort study included patients who underwent elective surgery for 10 solid cancer types without preoperative suspicion of SARS-CoV-2. Participating hospitals included patients from local emergence of SARS-CoV-2 until April 19, 2020. At the time of surgery, hospitals were defined as having a COVID-19-free surgical pathway (complete segregation of the operating theater, critical care, and inpatient ward areas) or no defined pathway (incomplete or no segregation, areas shared with patients with COVID-19). The primary outcome was 30-day postoperative pulmonary complications (pneumonia, acute respiratory distress syndrome, unexpected ventilation). RESULTS: Of 9,171 patients from 447 hospitals in 55 countries, 2,481 were operated on in COVID-19-free surgical pathways. Patients who underwent surgery within COVID-19-free surgical pathways were younger with fewer comorbidities than those in hospitals with no defined pathway but with similar proportions of major surgery. After adjustment, pulmonary complication rates were lower with COVID-19-free surgical pathways (2.2% v 4.9%; adjusted odds ratio [aOR], 0.62; 95% CI, 0.44 to 0.86). This was consistent in sensitivity analyses for low-risk patients (American Society of Anesthesiologists grade 1/2), propensity score-matched models, and patients with negative SARS-CoV-2 preoperative tests. The postoperative SARS-CoV-2 infection rate was also lower in COVID-19-free surgical pathways (2.1% v 3.6%; aOR, 0.53; 95% CI, 0.36 to 0.76). CONCLUSION: Within available resources, dedicated COVID-19-free surgical pathways should be established to provide safe elective cancer surgery during current and before future SARS-CoV-2 outbreaks

Elective cancer surgery in COVID-19-free surgical pathways during the SARS-CoV-2 pandemic: An international, multicenter, comparative cohort study

PURPOSE As cancer surgery restarts after the first COVID-19 wave, health care providers urgently require data to determine where elective surgery is best performed. This study aimed to determine whether COVID-19–free surgical pathways were associated with lower postoperative pulmonary complication rates compared with hospitals with no defined pathway. PATIENTS AND METHODS This international, multicenter cohort study included patients who underwent elective surgery for 10 solid cancer types without preoperative suspicion of SARS-CoV-2. Participating hospitals included patients from local emergence of SARS-CoV-2 until April 19, 2020. At the time of surgery, hospitals were defined as having a COVID-19–free surgical pathway (complete segregation of the operating theater, critical care, and inpatient ward areas) or no defined pathway (incomplete or no segregation, areas shared with patients with COVID-19). The primary outcome was 30-day postoperative pulmonary complications (pneumonia, acute respiratory distress syndrome, unexpected ventilation). RESULTS Of 9,171 patients from 447 hospitals in 55 countries, 2,481 were operated on in COVID-19–free surgical pathways. Patients who underwent surgery within COVID-19–free surgical pathways were younger with fewer comorbidities than those in hospitals with no defined pathway but with similar proportions of major surgery. After adjustment, pulmonary complication rates were lower with COVID-19–free surgical pathways (2.2% v 4.9%; adjusted odds ratio [aOR], 0.62; 95% CI, 0.44 to 0.86). This was consistent in sensitivity analyses for low-risk patients (American Society of Anesthesiologists grade 1/2), propensity score–matched models, and patients with negative SARS-CoV-2 preoperative tests. The postoperative SARS-CoV-2 infection rate was also lower in COVID-19–free surgical pathways (2.1% v 3.6%; aOR, 0.53; 95% CI, 0.36 to 0.76). CONCLUSION Within available resources, dedicated COVID-19–free surgical pathways should be established to provide safe elective cancer surgery during current and before future SARS-CoV-2 outbreaks

Prognostic model to predict postoperative acute kidney injury in patients undergoing major gastrointestinal surgery based on a national prospective observational cohort study.

Background: Acute illness, existing co-morbidities and surgical stress response can all contribute to postoperative acute kidney injury (AKI) in patients undergoing major gastrointestinal surgery. The aim of this study was prospectively to develop a pragmatic prognostic model to stratify patients according to risk of developing AKI after major gastrointestinal surgery. Methods: This prospective multicentre cohort study included consecutive adults undergoing elective or emergency gastrointestinal resection, liver resection or stoma reversal in 2-week blocks over a continuous 3-month period. The primary outcome was the rate of AKI within 7 days of surgery. Bootstrap stability was used to select clinically plausible risk factors into the model. Internal model validation was carried out by bootstrap validation. Results: A total of 4544 patients were included across 173 centres in the UK and Ireland. The overall rate of AKI was 14·2 per cent (646 of 4544) and the 30-day mortality rate was 1·8 per cent (84 of 4544). Stage 1 AKI was significantly associated with 30-day mortality (unadjusted odds ratio 7·61, 95 per cent c.i. 4·49 to 12·90; P < 0·001), with increasing odds of death with each AKI stage. Six variables were selected for inclusion in the prognostic model: age, sex, ASA grade, preoperative estimated glomerular filtration rate, planned open surgery and preoperative use of either an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker. Internal validation demonstrated good model discrimination (c-statistic 0·65). Discussion: Following major gastrointestinal surgery, AKI occurred in one in seven patients. This preoperative prognostic model identified patients at high risk of postoperative AKI. Validation in an independent data set is required to ensure generalizability

Global, regional, and national burden of disorders affecting the nervous system, 1990–2021: a systematic analysis for the Global Burden of Disease Study 2021

BackgroundDisorders affecting the nervous system are diverse and include neurodevelopmental disorders, late-life neurodegeneration, and newly emergent conditions, such as cognitive impairment following COVID-19. Previous publications from the Global Burden of Disease, Injuries, and Risk Factor Study estimated the burden of 15 neurological conditions in 2015 and 2016, but these analyses did not include neurodevelopmental disorders, as defined by the International Classification of Diseases (ICD)-11, or a subset of cases of congenital, neonatal, and infectious conditions that cause neurological damage. Here, we estimate nervous system health loss caused by 37 unique conditions and their associated risk factors globally, regionally, and nationally from 1990 to 2021.MethodsWe estimated mortality, prevalence, years lived with disability (YLDs), years of life lost (YLLs), and disability-adjusted life-years (DALYs), with corresponding 95% uncertainty intervals (UIs), by age and sex in 204 countries and territories, from 1990 to 2021. We included morbidity and deaths due to neurological conditions, for which health loss is directly due to damage to the CNS or peripheral nervous system. We also isolated neurological health loss from conditions for which nervous system morbidity is a consequence, but not the primary feature, including a subset of congenital conditions (ie, chromosomal anomalies and congenital birth defects), neonatal conditions (ie, jaundice, preterm birth, and sepsis), infectious diseases (ie, COVID-19, cystic echinococcosis, malaria, syphilis, and Zika virus disease), and diabetic neuropathy. By conducting a sequela-level analysis of the health outcomes for these conditions, only cases where nervous system damage occurred were included, and YLDs were recalculated to isolate the non-fatal burden directly attributable to nervous system health loss. A comorbidity correction was used to calculate total prevalence of all conditions that affect the nervous system combined.FindingsGlobally, the 37 conditions affecting the nervous system were collectively ranked as the leading group cause of DALYs in 2021 (443 million, 95% UI 378–521), affecting 3·40 billion (3·20–3·62) individuals (43·1%, 40·5–45·9 of the global population); global DALY counts attributed to these conditions increased by 18·2% (8·7–26·7) between 1990 and 2021. Age-standardised rates of deaths per 100 000 people attributed to these conditions decreased from 1990 to 2021 by 33·6% (27·6–38·8), and age-standardised rates of DALYs attributed to these conditions decreased by 27·0% (21·5–32·4). Age-standardised prevalence was almost stable, with a change of 1·5% (0·7–2·4). The ten conditions with the highest age-standardised DALYs in 2021 were stroke, neonatal encephalopathy, migraine, Alzheimer's disease and other dementias, diabetic neuropathy, meningitis, epilepsy, neurological complications due to preterm birth, autism spectrum disorder, and nervous system cancer.InterpretationAs the leading cause of overall disease burden in the world, with increasing global DALY counts, effective prevention, treatment, and rehabilitation strategies for disorders affecting the nervous system are needed

Efficacy and safety of the new generation Watchman FLX device compared to the Watchman 2.5: a systematic review and meta-analysis

Introduction: The first-generation Watchman 2.5 (W 2.5)TM presented several limitations, such as challenges in implantation within complex left atrial appendage (LAA) anatomies, higher incidence of peri-device leak, device recapture, and device-related thrombus (DRT). The newer generation Watchman FLX (W-FLX)TM was introduced with a modified design aiming to overcome these limitations. The purpose of this meta-analysis is to conduct a comparative assessment of the safety and efficacy of the W-FLX and 2.5 devices in clinical practice. Method: The meta-analysis was conducted according to the preferred reporting items for systematic review and meta-analysis protocols (PRISMA). Studies were located through a search strategy utilizing PubMed, Cochrane, Google scholar and MEDLINE from inception to March 2023, with a primary objective to compare the safety and efficacy of the W-FLX and W 2.5 devices. After applying the selection criteria, five studies were included in this analysis. Results: The analysis included five studies comprising 54,727 patients. The W-FLX is associated with an increase in procedural success (OR 7.49 [95% CI 1.98-28.26, P = 0.02; I2 = 0%]), and a significant reduction in mortality (OR 0.52 [95% CI 0.51-0.54, P\u3c 0.01; I2 = 0%], major bleeding 0.57 [95% CI 0.51-0.64, P\u3c 0.01; I2 = 0%]), device embolism (OR 0.35 [95% CI 0.18-0.70, P = 0.02; I2 = 0%]), and pericardial effusion (OR 0.33 [95% CI 0.26-0.41, P\u3c 0.01; I2 = 0%]). The rates of DRT and stroke were similar between the two groups. Conclusion: Compared to the W 2.5, the W-FLX was associated with a higher procedural success rate and significantly reduced adverse outcomes including mortality, major bleeding, device embolization, and pericardial effusion

Incidence, mechanisms, treatment, and outcomes of donor vessel injury during percutaneous coronary interventions for chronic total occlusion

BACKGROUND: Donor vessel injury is a potentially life-threatening complication of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). AIMS: Our goal was to examine the incidence, mechanisms, treatment, and outcomes of patients with donor vessel injury in a large multicenter CTO PCI registry. METHODS: We analyzed the baseline clinical and angiographic characteristics, and procedural outcomes of 12,349 CTO PCIs performed between 2012 and 2022 at 44 centers. RESULTS: The incidence of donor vessel injury was 0.35% (n = 43). The baseline clinical characteristics of patients with and without donor vessel injury were similar. Cases complicated by donor vessel injury were more complex with higher Japanese CTO score (2.9 ± 1.1 vs. 2.4 ± 1.3; p = 0.004) and lower procedural success rate (69.8% vs. 85.2%; p = 0.004). The retrograde approach was used more commonly in donor vessel injury cases (68.9% vs. 30.9%; p \u3c 0.001). Most (53.5%) donor vessel injuries were guide catheter-induced, whereas 20.9% were due to donor vessel thrombosis. Of the 43 patients with donor vessel injury, 36 (83.7%) were treated with stenting and seven (16.3%) received a left ventricular assist device. The incidence of major adverse cardiovascular events (MACEs) was significantly higher in cases with donor vessel injury (23.3% vs. 2.0%; p \u3c 0.001). Of the 43 patients with donor vessel injury, five patients (11.6%) experienced acute myocardial infarction and four patients (9.3%) died. CONCLUSIONS: Donor vessel injury, occurred in 0.35% of CTO PCIs performed by experienced operators, was mainly due to guide catheter-induced dissection or thrombosis and was associated with lower procedural success and higher MACE

Periprocedural Mortality in Chronic Total Occlusion Percutaneous Coronary Intervention: Insights From the PROGRESS-CTO Registry

BACKGROUND: Death is a rare but devastating complication of chronic total occlusion (CTO) percutaneous coronary intervention. METHODS: We examined the clinical characteristics and procedural outcomes of patients who died periprocedurally in the Prospective Global Registry for the Study of CTO Interventions (PROGRESS-CTO). RESULTS: Of the 12 928 patients who underwent CTO percutaneous coronary intervention between 2012 and 2022, 52 (0.4%) died during the index hospitalization. Patients who died were more likely to have a history of heart failure (43% versus 28%; P=0.023). The J-CTO ([Multicenter CTO Registry of Japan]; 2.8±1.1 versus 2.4±1.3; P=0.019), PROGRESS-CTO mortality (2.6±0.9 versus 1.6±1.1; P\u3c0.001), and PROGRESS-CTO pericardiocentesis (2.9±1.1 versus 1.9±1.3; P\u3c0.001) scores were higher in patients who died. In these patients, the use of left ventricular assist devices was also higher (41% versus 3.5%; P\u3c0.001), and retrograde crossing was more often the first crossing strategy (33% versus 13%; P\u3c0.001). The cause of death was cardiac in 43 patients (83%) and noncardiac in 9 patients (17%). Complications leading to cardiac death were: tamponade in 30 patients (58%), acute myocardial infarction in 9 (17.3%), and cardiac arrest/shock in 4 (7.7%). Noncardiac causes of death were: stroke in 3 (5.8%), renal failure in 2 (3.8%), respiratory distress in 2 (3.8%), and hemorrhagic shock in 2 (3.8%). CONCLUSIONS: Approximately 0.4% of patients who underwent CTO percutaneous coronary intervention died during the index hospitalization. The main cause of death was tamponade in 58%. PROGRESS-CTO complication scores might help in risk stratification and procedural planning in patients undergoing CTO percutaneous coronary intervention