Risultati per: Springer: Nuove riviste open access di Medicina Generale

Circulation, Volume 150, Issue Suppl_1, Page A4146716-A4146716, November 12, 2024. Background:Femoral access is predominantly used for mechanical thrombectomy in stroke patients with large vessel occlusions. Following interventional cardiology guidelines, routine radial access has been proposed as an alternative, though its safety and efficacy remain controversial. We aimed to evaluate the efficacy and safety of radial versus femoral access for mechanical thrombectomy in patients with stroke.Hypothesis:In mechanical thrombectomy for stroke patients with large vessel occlusions, could the transradial access (TRA) result in comparable efficacy but fewer access site complications compared to transfemoral access (TFA)?Methods:A systematic search was performed in PubMed, Scopus, Cochrane, Embase, and Web of Science databases from inception to May 2024, to identify studies measuring the efficacy and safety of radial versus femoral access for mechanical thrombectomy in patients with stroke. The meta-analysis was performed using the Review Manager and Open Meta Analyst.Results:Ten studies (2,277 participants) were included in the review. There were no significant differences between radial and femoral access in terms of successful recanalization (0R: 1.01; 95% CI, 0.59,1.73; p=0.98), complete recanalization (OR: 1.08; 95% CI, 0.60,1.94; p=0.81), favorable functional outcomes (0R: 0.86; 95% CI, 0.53,1.41; p=0.56), first-pass reperfusion (OR: 0.89; 95% CI, 0.67,1.19; p=0.44), number of passes (MD: 0.10; 95% CI, -0.13,0.33; p=0.4), access-to-reperfusion time (MD: -3.92; 95% CI, -9.49,1.65; p=0.17), or symptomatic intracranial hemorrhage (OR: 0.95; 95% CI, 0.55,1.65; p=0.86). However, access site complications were significantly less frequent in the TRA group as compared with the TFA group (OR: 0.21; 95% CI, 0.08,0.60; p=0.004). Meta-regression showed no significant associations for publication year, mean age, gender, or baseline NIHSS scores with clinical outcomes.Conclusion:This meta-analysis indicates that TRA and TFA provide comparable outcomes in mechanical thrombectomy for acute ischemic stroke, with TRA resulting in fewer access site complications. Further large-scale randomized trials are recommended to confirm these findings and potentially support a shift towards TRA in neurovascular procedures.

Circulation, Volume 150, Issue Suppl_1, Page A4143943-A4143943, November 12, 2024. Background:Intrapericardial delivery of antiarrhythmic drugs and regenerative therapies is a growing field for infants and children who suffer from certain cardiac diseases. Typically, this is performed under fluoroscopic and/or ultrasonic guidance. Pericardial access via thoracoscopy provides direct visualization of the heart, enabling the operator to avoid injuries to critical cardiac structures, and to visualize intrapericardial injections for targeted drug therapies.Objective:To demonstrate the feasibility of minimally-invasive intrapericardial injections under direct visualization using a novel thoracic access port in immature swine.Methods:Minimally-invasive procedures were performed in 12 Sinclair piglets (8 at 1-month old, 4.1 ± 1.5 kg; 4 at 5-months old, 26.3 ± 1.0 kg). A single 1.2 cm incision just to the left of the subxiphoid process allowed for temporary insertion of the thoracic access port. An EndoCAMeleon thoracoscope with active insufflation was used to visualize the thoracic cavity and the heart (pericardium). An 18-gauge needle was used to gain access to the intrapericardial space. Saline or dyed saline was injected through the needle and/or sheath with direct visualization and confirmed on the thoracoscope. Following the procedure, the access tool was removed and the incision was sutured closed. All studies were performed under IACUC approval.Results:Minimally-invasive intrapericardial injections were successfully performed in 8 infant- and 4 child-sized swine with real-time visualization (Figure). The average time between the incision and pericardial needle access was 16.8 ± 5.0 minutes. No adverse events were observed from either the intrapericardial fluid injection or the use of the thoracic access tool.Conclusion:We demonstrated the feasibility and safety of minimally-invasive intrapericardial injections under direct visualization in swine using a novel thoracic access port. Direct targeted pericardial injection of medications or gene therapies can be performed using this technique. This approach holds promise for providing an alternative to cardiac restoration in infant and pediatric patients who are not amenable to traditional therapies.

Circulation, Volume 150, Issue Suppl_1, Page A4118076-A4118076, November 12, 2024. Introduction:The occurrence of innominate artery stenosis is less prevalent compared to subclavian artery disease. Small studies suggest up to 8% of individuals initially diagnosed with suspected subclavian steal syndrome may present with innominate artery lesions. Deployment of an embolic protection filter within the internal carotid artery during percutaneous intervention of the innominate artery presents a solution to mitigate embolism.Case:A 70-year-old female with a history of peripheral vascular disease presented with claudication in both arms, manifested as pain in both arms. Her left subclavian was stented months prior to presentation. An aortogram revealed severe stenosis of the innominate artery (Figure 1). Since multiple attempts to cross the lesion antegrade from the femoral access site were unsuccessful, we proceeded with the successful deployment of an embolic protection filter in the right internal carotid artery via our right radial artery access site (Figure 2). Using the right radial artery, we passed a long run-through guidewire into the distal abdominal aorta. Due to severe aortic tortuosity, we were unable to snare the wire from the aorta. Therefore, we upsized the radial sheath to 7 French over both wires (runthrough and bare). Using a support catheter, we exchanged the runthrough wire for a Glidewire Advantage. We advanced an 8 x 29mm balloon expandable stent to the area of innominate stenosis and deployed it (Figure 3). We postdilated the stent with a 14mm balloon. Angiography demonstrated adequate expansion. On follow up, the patient was without claudication and had triphasic flow in the innominate and left subclavian arteries.Discussion:Treating innominate artery stenosis via radial access employing a sole entry point for both embolic protection and treatment administration offers a substitute where additional access is infeasible. Modern embolic protection techniques are superior due to their flexibility and ease of use. In this case, placing the embolic protection device in the carotid artery was mandatory through the sole radial access to prevent trapping the filter behind the innominate artery stent. We were able to perform both the embolic device placement and the stenting with the same radial access.Conclusion:Endovascular intervention of innominate artery stenosis via radial access, utilizing a single radial access for both embolic protection and treatment delivery, presents an alternative when femoral access is not feasible.

Circulation, Volume 150, Issue Suppl_1, Page A4139852-A4139852, November 12, 2024. Despite current modestly effective triglyceride (TG) lowering therapies, the availability of more effective agents for persistently lowering elevated TGs and risk of acute pancreatitis remains a continuing need. More recently identified triglyceride-rich lipoproteins (TRLs), specifically remnant cholesterol (RC)-rich particles, are important drivers of ASCVD risk independent of LDL-C, driving development of more effective TG-directed therapies. Apolipoprotein C3 (APOC3) raises TGs by inhibiting lipoprotein lipase (LPL) dependent and -independent pathways. Plozasiran, a RNAi agent targeting APOC3 mRNA in hepatocytes, demonstrated large reductions in circulating APOC3, TGs, TRL-RC with a good safety profile in placebo-controlled trials.Here we report extension data to characterize long term safety and efficacy of plozasiran in subjects with elevated TGs.Plozasiran was studied in subjects with mixed hyperlipidemia (entry TGs 150-499 mg/dl) and severe hypertriglyceridemia (entry TGs >500-4000 mg/dl) in separate Phase 2 trials (MUIR and SHASTA-2). Subjects completing double-blind, placebo-controlled treatment could enter this open-label extension. Endpoints included changes in fasting TG levels, other lipid and lipoprotein parameters and safety assessments for up to 24 months. Data cut-off was 5/16/24 for this analysis, (up to 15 months of follow up) in the ongoing study.251 and 165 subjects from MUIR and SHASTA-2 entered the extension in which all received plozasiran 25 mg SQ dosed quarterly. 10, 25 or 50 mg of plozasiran under blinded conditions produced mean reductions in TGs of -52 to -64% (MUIR) and -69 to -74% (SHASTA-2), 12 weeks (trough) after the second dose. Corresponding trough reductions in the extension ranged from -44 to -73% (MUIR) and -62 to -86% (SHASTA-2) through 15 months follow-up. Common reported AEs were consistent with the index studies and patient populations and mean HbA1c did not increase, providing further evidence that long-term safety remains favorable with repeated dosing and longer observation periods.Extended open-label treatment with plozasiran in subjects with moderate to severely elevated TGs continue to show reductions of TG levels and safety consistent with the blinded index studies, demonstrating incidence rate and severity of TEAEs remain favorable with repeated dosing and longer observation. Results of additional lipid and lipoprotein parameters are also consistent with the blinded index data and will also be reported.

Circulation, Volume 150, Issue Suppl_1, Page A4122122-A4122122, November 12, 2024. Background:Chronic total occlusion (CTO) contributes to increased mortality because it is often revascularized by percutaneous coronary intervention (PCI). Traditionally, transfemoral (TF) access has been preferred in CTO-PCI owing to its high procedural complexity and ease of introduction of a large guide catheter. Transradial (TR) access is gaining popularity in PCI, but its efficacy in CTO-PCI has not been well investigated.Methods:We searched major databases to retrieve studies comparing TR and TF access in patients with CTO who underwent PCI. The DerSimonian and Laird random-effects model was used to pool the odds ratios (OR) and mean differences (MD) with 95% confidence intervals. Statistical significance was considered at p

Circulation, Volume 150, Issue Suppl_1, Page A4141954-A4141954, November 12, 2024. Introduction:Redo-transcatheter aortic valve replacement (TAVR) is a promising treatment for transcatheter aortic valve degeneration, becoming increasingly relevant with an aging population. In redo-TAVR, the leaflets of the initial (index) transcatheter aortic valve (TAV) are displaced vertically when the second TAV is implanted, creating a cylindrical cage that can impair coronary cannulation and flow. The risk of coronary obstruction after redo-TAVR can reach as high as 20% and is affected by several factors, including the first TAV design, implantation depth, commissural alignment, and choice of the second TAV. Preventing coronary obstruction and maintaining coronary access is essential, especially in young and low-risk patients.Hypothesis:Laser ablation of TAV index leaflets can effectively create openings to prevent coronary obstruction and ensure coronary access in at-risk patients undergoing redo-TAVR.Aim:This study aimed to develop a new leaflet modification strategy using laser ablation to prevent coronary obstruction and facilitate coronary access after redo-TAVR.Methods:To evaluate the feasibility of the leaflet modification technique using laser ablation, initially, a medical-grade ultraviolet laser was used for ablation through pericardial leaflet tissue. Following this intervention, computational fluid dynamics simulations were utilized to assess the efficacy of the resulting perforations in promoting coronary flow after sinus sequestration in redo-TAVR. These simulations played a crucial role in ensuring that these changes would facilitate the restoration of coronary circulation.Results:Laser ablation of pericardium leaflets was successful, demonstrating the feasibility of creating openings in the TAV leaflets (Fig. 1a). Flow simulation results showed that ablation of index valve leaflets can effectively mitigate the flow obstruction caused by sinus sequestration in redo-TAVR, with the extent of restoration dependent on the number and location of the ablated openings (Fig. 1b).Conclusions:Laser ablation could be a viable method for leaflet modification in redo-TAVR, serving as a new tool in interventional procedures.

Circulation, Volume 150, Issue Suppl_1, Page A4140605-A4140605, November 12, 2024. Background:Radial artery (RA) access has become common in cardiac catheterization due to fewer vascular complications and MACE compared to transfemoral approach (TFA). However, anatomic variations are more profound in the upper-extremity.Research Question:What are common anatomic variations encountered during transradial approach (TRA) coronary angiography and what association do they have with adverse outcomes and procedural challenges?Methods:We performed a single-center retrospective analysis of 926 patients who underwent coronary angiography through TRA via the right upper-extremity where RA angiogram was performed from 01/2010 to 01/2023. Multivariate logistic regression was utilized to estimate the odds ratio (OR) of the association between anatomic variations and adverse outcomes and procedural challenges.Results:A total of 926 patients with a mean age of 59.9 years were studied with 30.4% being female. Common comorbidities were HTN (82.2%), HLD (51.8%), and DM (45%). About 32% of patients had an anatomic variation. Prevalences were 14.4% radial tortuosity, 12% high RA bifurcation, 11.9% M-sign, and 1% RA loops. These patients were older (P

Circulation, Volume 150, Issue Suppl_1, Page A4134878-A4134878, November 12, 2024. Background:Vascular Closure utilizing Suture Based Devices (SBD) is an established approach for large-bore arterial access in percutaneous procedure patients. Standard of care uses two devices when accessing the artery with 8 Fr sheaths and above. The bailout use of Plug-based devices (PBD) is well established, but little is known about the intentional combination of SBD with PBD and how this technique compares to the standard approach. We aimed to compare these different approaches in this meta-analysis.Methods:PubMed, Scopus, and Cochrane databases were searched for observational studies comparing the hybrid approach to the standard one utilizing exclusively SBDs for arterial closure in large bore vascular access and reported the outcomes of (1) Access-related complications (ARC); (2) Major bleeding; (3) All bleeding events; (4) Need for surgical intervention; (5) Need for endovascular intervention ; (6) Device failure; (7) Pseudoaneurysm. Heterogeneity was examined with I2 statistics. A random-effects model was used for all outcomes.Results:We included five observational studies with 1,586 patients, of whom 1,489 (93.8%) underwent TAVI and 97 (6.1%) EVAR. Sheath size had an average of 20.56 Fr in the EVAR patients. ARC (RR 0.48; 95% CI 0.28-0.81; p

Circulation, Volume 150, Issue Suppl_1, Page A4138516-A4138516, November 12, 2024. Introduction:Serious mental illness (SMI) is associated with higher risk of immediate procedural complications after transcatheter aortic valve replacement (TAVR), including myocardial infarction, major bleeding, and acute renal failure. There is limited data on the impact of SMI on in-hospital mortality and 30-day readmissions. We aimed to evaluate access to and outcomes after TAVR for patients with SMI compared to those without SMI.Methods:We performed a retrospective cohort study of adults aged ≥18 years who received TAVR with a primary diagnosis of aortic stenosis using the Healthcare Cost and Utilization Project State Inpatient Database and State Ambulatory Surgery and Services Database in FL, MD, VT, UT, and WI (2016-2019). SMI was defined using ICD-10 codes for schizophrenia spectrum, mood, or anxiety disorders. Primary outcomes include in-hospital mortality, 30-day readmission, length of stay, and routine discharge. The secondary outcome was access type (elective vs. urgent/emergent). Multivariable logistic and negative binomial regression models with adjustment for patient demographics, co-morbidities, and hospital characteristics were used to examine outcomes.Results:Of 21,905 patients who underwent TAVR for aortic stenosis, 2,954 (13.5%) patients had SMI. Overall, 16,762 (76.5%) of patients had elective procedures. Patients with SMI were more likely to be female (59% vs. 41%, p

Circulation, Volume 150, Issue Suppl_1, Page A4144305-A4144305, November 12, 2024. Background and Purpose:Transfemoral access (TFA) has been the standard for neuro-interventional procedures, but it carries risks such as pseudoaneurysm formation and arterial occlusion. Transradial access (TRA) is a newer alternative that may reduce these complications. This study aims to compare the clinical outcomes of TRA versus TFA in mechanical thrombectomy (MT) for acute ischemic stroke (AIS).Methods:A systematic review and meta-analysis was conducted following PRISMA guidelines. Databases searched included PubMed/MEDLINE, Cochrane Library, and Google Scholar up to April 7, 2024. A random-effects model was used for analysis, and study quality was assessed using the Newcastle-Ottawa Scale and Cochrane Risk of Bias (RoB 2) tool.Results:The search identified 1389 records, and 13 studies (12 observational, 1 RCT) with 4803 patients (TRA: 855, TFA: 3948) were included. TRA showed no significant difference in successful recanalization (TICI 2b-3) compared to TFA [RR: 0.98; 95% CI: 0.94 – 1.03]. Complete recanalization (TICI 3) was also similar [RR: 1.08; 95% CI: 0.96 – 1.21]. Fluoroscopy time, reported by four studies, showed no significant difference [RR: -1.76; 95% CI: -7.54 – 4.02]. Hospital stay duration from three studies was comparable [MD: -0.52; 95% CI: -1.25 – 0.21]. The access-to-perfusion time reported by ten studies showed no significant difference [MD: -1.70; 95% CI: -8.11 – 4.72]. The mean number of passes from eight studies showed no significant difference [MD: 0.10; 95% CI: -0.06 – 0.27].Procedural complications were lower in the TRA group but not statistically significant [6.09% vs. 8.77%, RR: 0.71; 95% CI: 0.46 – 1.09]. TRA had significantly fewer access site complications [RR: 0.23; 95% CI: 0.08 – 0.62]. Symptomatic intracranial hemorrhage from seven studies showed no significant difference [RR: 1.0; 95% CI: 0.72 – 1.38]. NIHSS score at discharge showed no significant difference [MD: 1.31; 95% CI: -2.14 – 4.76]. In-hospital mortality from two studies showed no significant difference [RR: 0.56; 95% CI: 0.26 – 1.20]. Ninety-day mortality from three studies showed no significant difference [RR: 1.15; 95% CI: 0.98 – 1.36].Conclusion:TRA is as effective as TFA for MT in AIS and significantly reduces the risk of access site complications. Further large-scale RCTs are warranted to confirm these findings and refine the clinical guidelines for optimal access strategy in neuro-interventional procedures.

Circulation, Volume 150, Issue Suppl_1, Page A4137880-A4137880, November 12, 2024. Aims:Despite efforts to promote physical activity, the prevalence of physical inactivity continues to rise. Exercise access influences population activity levels, but county-level variation in physical activity and its link to cardiovascular disease (CVD) mortality is unclear. We explored the associations between access to exercise opportunities, levels of physical inactivity, and CVD mortality across U.S. countiesMethods:The County Health Rankings and Roadmaps data and CDC WONDER mortality data were integrated. We compared age-adjusted CVD mortality across county-level quartiles of access to exercise opportunities and physical inactivity. Stratification was performed based on age, sex, race, and urbanization. The rate ratio (RR) for CVD mortality was calculated using generalized linear models.Results:CVD mortality decreased from high to low values of the county-level of physical activity across all demographic subgroups (P

Circulation, Volume 150, Issue Suppl_1, Page A4142323-A4142323, November 12, 2024. Introduction/Background:There is an urgent need to improve lipid control as one in four adults in the United States has elevated low-density lipoprotein cholesterol (LDL-C). Many non-statin lipid-lowering therapies such as ezetimibe, pro-protein convertase subtilisin-kexin type 9 inhibitors (PCSK9i), bempedoic acid, and icosapent ethyl are recommended for LDL-C and cardiovascular risk reduction, but usage remains suboptimal. Proposed barriers include payer restrictions and patient costs, but the extent of these issues for Medicare beneficiaries in the contemporary period is poorly defined.Research Questions/Hypotheses:To what extent do Medicare Prescription Drug Plans provide coverage or use payer management strategies to restrict access to lipid-lowering medications? What are the patient out-of-pocket expenses for these therapies?Methods/Approach:Plan coverage, payer restrictions, and annual out-of-pocket costs were extracted from Medicare Prescription Drug Plan files from July-September 2023. Medications studied included generic atorvastatin, rosuvastatin, and ezetimibe as well as brand-name PCSK9i, bempedoic acid, and icosapent ethyl.Results/Data:Among 4,754 plans, coverage of lipid-lowering therapies varied widely. Generic atorvastatin, rosuvastatin, and ezetimibe were universally covered, while branded therapies such as alirocumab and bempedoic acid were covered by only one-half and one-third of plans, respectively. Nearly all plans providing coverage placed non-generic medications in high cost-sharing tiers and required prior authorization for alirocumab (96% of plans), evolocumab (94% of plans), and bempedoic acid (93% of plans). Median annual out-of-pocket costs ranged from $71 to $147 for generic statins and ezetimibe, while patient expenses for all branded lipid-lowering therapies exceeded $1,000.Conclusions:Lack of coverage, widespread prior authorization requirements, and high out-of-pocket costs jeopardize access to non-generic lipid-lowering medications, and likely contribute to their low utilization in the mitigation of cardiovascular disease risk. Some cost toxicity for patients may be alleviated by the Inflation Reduction Act and additional Medicare negotiations on drug pricing, however addressing the barriers of limited coverage and payer restrictions will be paramount to improve use of these therapies.

Circulation, Volume 150, Issue Suppl_1, Page A4139550-A4139550, November 12, 2024. Background:Increased healthcare coverage and access leads to better cardiovascular outcomes. Policymakers are currently assessing strategies to expand coverage and access through government programs, but Americans’ views on health care remain poorly characterized.Methods:We used the 2022 General Social Survey (GSS) to assess perceptions of US healthcare coverage, access, and equity. We examined responses to 3 questions for all respondents, and stratified by age, income, and political affiliation: (1) whether the rich have easier access to health care, (2) whether it is unfair that those with higher incomes can afford better health care, and (3) whether respondents would be willing to pay higher taxes to improve the level of health care for all. GSS survey weights were used to generate nationally representative estimates.Results:Our analyses included 3544 survey respondents (weighted mean [SD] age, 47.1 [17.9] years). The majority of US adults agreed that the rich have easier access to health care (79.5%, [95% CI 75.7%, 83.3%]). Overall, more than half of Americans believe that differential access based on income is unfair (56.5% [52.0%, 60.9%]), with significant variation based on political party affiliation (Democrats 70.8% [62.4%, 79.2%]) vs Republicans 34.0% [25.9%, 42.1%], p < 0.001). In terms of expanding coverage, 10.7% [8.1%, 13.3%] of Americans were willing to pay higher taxes to improve the level of health care for all, with stronger support among Democrats than Republicans (20.3% [14.4%, 26.2%] vs 2.6% [0.6%, 4.5%], p < 0.001). We found no statistically significant variation in responses based on respondent age and income.Conclusions:In this national study, we find that Americans’ views on healthcare coverage, access, and equity are divided along partisan lines. Despite broad agreement that access is inequitable, only 1 in 10 Americans are willing to pay higher taxes to increase health care coverage nationwide. These results may inform policy priorities around expanding care coverage – including preventative screening, guideline-directed therapies, and in-hospital care for cardiometabolic conditions – with the goal of improving cardiovascular health in the US.

New England Journal of Medicine, Ahead of Print.

Introduction
Post-COVID-19 condition, or syndrome, also known as long COVID, is an infection-associated chronic condition that can develop after a SARS-CoV-2 infection and last at least 3 months to years. Despite representing a high burden for the Unified Health System (SUS), which has affected millions of Brazilians, it has received limited attention in Brazil. Prevalence studies to date have failed to include a broad representation of the population, and there has been insufficient exploration of the impact on people’s lives and the burden of and barriers to accessing health services. This article presents the research protocol for the quantitative component of a mixed methods project to produce evidence to inform SUS’s provision of care for long COVID. The protocol was designed to study long COVID in SUS patients hospitalised for COVID-19 in a large city in Southeast Brazil to capture symptoms and factors associated with the syndrome, effects on quality of life and employment, health needs, use of health services and barriers to accessing necessary healthcare.

Methods and analysis
An ambidirectional cohort study to capture data retrospectively and prospectively from adults previously discharged from SUS hospitals for COVID-19. The study involves up to two telephone surveys with the patients or proxies selected from a sampling plan for population estimates. Survey questions include baseline and follow-up data on demographic, socioeconomic, comorbidities, work status, health-related quality of life, vaccination status, long COVID symptoms, healthcare needs, use and barriers to access. Descriptive and appropriate multivariable analyses will be employed.

Ethics and dissemination
The project was approved by the Research Ethics Committees of participant institutions and by the Brazilian National Research Ethics Commission. All participants provided verbal consent. We plan to publish articles in scientific journals and multimedia resources for SUS professionals and the general population.