Quantitative assessment of angioplasty-induced vascular inflammation with 19F cardiovascular magnetic resonance imaging.

BACKGROUND: Macrophages play a pivotal role in vascular inflammation and predict cardiovascular complications. Fluorine-19 magnetic resonance imaging (19F MRI) with intravenously applied perfluorocarbon allows a background-free direct quantification of macrophage abundance in experimental vascular disease models in mice. Recently, perfluorooctyl bromide-nanoemulsion (PFOB-NE) was applied to effectively image macrophage infiltration in a pig model of myocardial infarction using clinical MRI scanners. In the present proof-of-concept approach, we aimed to non-invasively image monocyte/macrophage infiltration in response to carotid artery angioplasty in pigs using 19F MRI to assess early inflammatory response to mechanical injury. METHODS: In eight minipigs, two different types of vascular injury were conducted: a mild injury employing balloon oversize angioplasty only (BA, n = 4) and a severe injury provoked by BA in combination with endothelial denudation (BA + ECDN, n = 4). PFOB-NE was administered intravenously three days after injury followed by 1H and 19F MRI to assess vascular inflammatory burden at day six. Vascular response to mechanical injury was validated using X-ray angiography, intravascular ultrasound and immunohistology in at least 10 segments per carotid artery. RESULTS: Angioplasty was successfully induced in all eight pigs. Response to injury was characterized by positive remodeling with predominantly adventitial wall thickening and concomitant infiltration of monocytes/macrophages. No severe adverse reactions were observed following PFOB-NE administration. In vivo 19F signals were only detected in the four pigs following BA + ECDN with a robust signal-to-noise ratio (SNR) of 14.7 ± 4.8. Ex vivo analysis revealed a linear correlation of 19F SNR to local monocyte/macrophage cell density. Minimum detection limit of infiltrated monocytes/macrophages was estimated at approximately 410 cells/mm2. CONCLUSIONS: In this proof-of-concept study, 19F MRI enabled quantification of monocyte/macrophage infiltration after vascular injury with sufficient sensitivity. This may provide the opportunity to non-invasively monitor vascular inflammation with MRI in patients after angioplasty or even in atherosclerotic plaques.

Updated trends in percutaneous renal arteriography among radiologists and other specialties.

PURPOSE: Prior studies have demonstrated an overall decline in percutaneous renal artery angioplasty with and without stenting from 1988 to 2009. We evaluated the recent utilization trends in percutaneous renal arteriography (PTRA) among radiologists and non-radiologist providers from 2010 to 2018. METHODS: Data from the 2010-2018 nationwide Medicare Part B fee-for-service database were used to tabulate case volumes for PTRA. Annual utilization rates per 10,000 Medicare beneficiaries were calculated and aggregated based on physician specialty: radiologists, cardiologists, vascular surgeons, general surgeons, or others. RESULTS: From 2010 to 2018, the overall utilization rate of PTRA markedly declined (-72% change; from 15.5 to 4.3 cases per 10,000 Medicare beneficiaries). Proportionally, the cardiologist share of PTRA saw the greatest decline, falling from 74% market share in 2010 (11.4/15.5 cases) to only 36% market share in 2018 (1.6/4.3 cases). The market share of PTRA performed by radiologists grew from 12% market share in 2010 (1.9/15.5 cases) to 28% in 2018 (1.2/4.3 cases); despite this, the absolute number of PTRA performed by radiologists saw a smaller decline over this period (-34%; 1.9 to 1.2 cases). CONCLUSION: The total utilization rates of PTRA in the Medicare population has continued to decline from 2010 to 2018, likely due to clinical trials suggesting limited efficacy of angioplasty and stenting in the treatment of renovascular hypertension and other factors such as declining reimbursement. The overall and per-specialty rates continue to decline, reflecting an overarching trend away from procedural management of renovascular hypertension.

Hospital-Physician Integration Is Associated With Greater Use Of Cardiac Catheterization And Angioplasty.

In the US in recent years, hospital-physician integration has become a dominant form of consolidation in health care. This transition away from independent practice has raised questions about whether hospital-employed physicians may be more likely than independent physicians to refer patients to high-intensity, hospital-based services. We used Medicare claims data from the period 2013-20 to identify patients who received a new diagnosis of stable angina, a common cardiovascular condition that entails clinical discretion in treatment choice. Using linear probability models and an instrumental variables model, we found that patients whose care was managed by a hospital-integrated cardiologist were no more likely to receive stress tests (an office-based procedure) than those whose care was managed by an independent cardiologist. However, these patients were much more likely to receive high-intensity, hospital-based coronary interventions. These results suggest that hospital-physician integration is an important factor in the intensity of treatment received by patients with stable angina. Policy makers may see these findings as additional impetus for more aggressive antitrust enforcement of integrated arrangements between hospitals and physicians and for other regulatory or payment mechanisms that might deter hospitals from using such arrangements to promote high-intensity treatment unnecessarily.

Medical center reimbursement for vascular procedures has increased over time while professional reimbursement has declined.

OBJECTIVE: The United States healthcare system uses different methods for assigning medical center reimbursement (MCR) and professional reimbursement (PR) for clinical services. We hypothesized that PR has not increased proportionately to MCR for the same vascular services. METHODS: MCR and PR were compared for commonly performed inpatient and outpatient vascular procedures between 2012 and 2021. MCR was calculated using the Medicare inpatient prospective payment system and outpatient prospective payment system. MCR is based on the Centers for Medicare and Medicaid Services definition and criteria for comorbidities and the occurrence of complications; thus, changes in MCR were reported as a range based on the degree of comorbidities and complications using the Diagnosis Related Group. PR was calculated using the Medicare physician fee schedule, which assigns a numerical work relative value unit to each surgical service, with final compensation determined by an annually adjusted conversion factor to yield a final dollar amount. The expected reimbursement based on the observed inflation during the study period using the consumer price index was calculated and compared to the actual reimbursement. RESULTS: From 2012 to 2021, MCR for inpatient procedures increased 20% to 26% for carotid endarterectomy, 24% to 27% for femoral endarterectomy, 24% to 27% for femoropopliteal bypass with vein, 14% to 19% for thoracic endovascular aortic repair, and 15% for aortobifemoral bypass. During the same period, PR increased 3.3% for carotid endarterectomy but decreased for femoral endarterectomy (-5.0%), femoropopliteal bypass (-4.6%), thoracic endovascular aortic repair (-4.2%), and aortobifemoral bypass (-5.0%). Comparing the expected reimbursement, adjusted for inflation, to the actual reimbursement, PR experienced a 10% to 17% reduction but MCR outpaced inflation by 3.7% to 10%. For outpatient procedures, MCR increased 117% for tibial angioplasty, 24% for superficial femoral artery (SFA) stenting, 62% for tunneled dialysis catheter (TDC) insertion, and 24% for iliac stenting but decreased 0.43% for arteriovenous fistula (AVF) creation and 7.6% for radiofrequency ablation (RFA). PR increased 0.91% for SFA stenting but decreased for tibial angioplasty (-17%), AVF creation (-6.4%), TDC insertion (-7.1%), iliac stenting (-3.8%), and RFA (-22%). Comparing the expected reimbursement, adjusted for inflation, to the actual reimbursement, PR experienced a 13% to 32% reduction. In contrast, MCR outpaced inflation 7.5% to 88% for tibial angioplasty, SFA stenting, TDC insertion, and iliac stenting but experienced a reduction for AVF (-13%) and RFA (-19%). CONCLUSIONS: MCR for commonly performed vascular procedures has increased and outpaced inflation. In contrast, PR for these same services has decreased across all procedure types. This decrease in PR was exacerbated when adjusted for inflation. This inequity in the reimbursement methods between MCR and PR poses a threat to the viability of the physician workforce. Either changes to the reimbursement methods or a reallocation of reimbursement to physicians are imperative to sustain physician practices.

Nationwide observational study of incidence, management and outcome of spontaneous coronary artery dissection: a report from the Swedish Coronary Angiography and Angioplasty register.

OBJECTIVES: The aim of this study was to conduct a nationwide all comer description of incidence, contemporary management and outcome in Swedish spontaneous coronary artery dissection (SCAD) patients. The incidence of SCAD as well as the management and outcome of these patients is not well described. DESIGN: A nationwide observational study. PARTICIPANTS AND SETTING: All patients with SCAD registered in the Swedish Coronary Angiography and Angioplasty Register from 2015 to 2017 were included. The index angiographies of patients with registered SCAD were re-evaluated at each centre to confirm the diagnosis. Patients with non-SCAD myocardial infarction (MI) (n=32 601) were used for comparison. OUTCOME MEASURES: Outcomes included all-cause mortality, reinfarction or acute coronary reangiography. RESULTS: This study found 147 SCAD patients, rendering an incidence of 0.74 per 100 000 per year and a prevalence of 0.43% of all MIs. The average age was 52.9 years, 75.5% were women and 47.6% presented with ST-segment elevation MI. Median follow-up time for major adverse cardiac event was 17.3 months. Percutaneous coronary intervention was attempted in 40.1% of SCAD patients and 30.6% received stent. The use of antithrombotic agents was similar between the groups and there was no difference regarding outcomes, 10.9% vs 13.4%, p=0.75. Mortality was lower in SCAD patients, 2.7% vs 8.0%, p=0.03, whereas SCAD patients more often underwent acute reangiography, 9.5% vs 4.6%, p<0.01. CONCLUSION: In this nationwide, all comer Swedish study, the overall incidence of SCAD was low, including 25% men which is more and in contrast to previous studies. Compared with non-SCAD MI, SCAD patients were younger, with lower cardiovascular risk burden, yet suffered substantial mortality and morbidity and more frequently underwent acute coronary reangiography.

Cost-Effectiveness of Drug-Coated Balloon Angioplasty Versus Conventional Balloon Angioplasty for Treating Below-the-Knee Arteries in Chronic Limb-Threatening Ischemia: The SINGA-PACLI Trial.

PURPOSE: Drug-coated balloon angioplasty (DCBA) has been studied as a potentially superior option compared to conventional percutaneous transluminal angioplasty (PTA) in treating below-the-knee (BTK) arteries in chronic limb-threatening ischemia (CLTI). The aim of this study is to examine the cost-effectiveness of DCBA versus PTA in BTK arteries based on a randomized controlled trial. MATERIAL AND METHODS: A prospective economic study was embedded in a randomized controlled trial of 138 patients with CLTI. Resource use and health outcomes were assessed at baseline, and at 3, 6 and 12 months post-intervention. Costs were calculated from a societal perspective and health outcomes measured using quality-adjusted life years with probabilistic sensitivity analysis performed to account for subject heterogeneity. RESULTS: Compared with participants randomized to receive PTA, participants randomized to DCBA gained an average baseline-adjusted quality-adjusted life years (QALYs) of .012 while average total costs were USD$1854 higher; this translates to an incremental cost-effectiveness ratio (ICER) of US$154,500 additional cost per QALY gained. However, the estimate of ICER had substantial variance with only 48% of bootstrap ICERs meeting a benchmark threshold of US$57,705 (the average gross domestic product (GDP) per capita of Singapore). CONCLUSION: The use of DCBA in BTK arteries in CLTI patients was not cost-effective compared with PTA. LEVEL OF EVIDENCE: 2, Randomized trial.

Assessment and Management of Transplant Renal Artery Stenosis. A Literature Review.

BACKGROUND: Transplant renal artery stenosis (TRAS) following kidney transplantation is a possible cause of graft failure. This review aimed to summarize the evidence about physiopathology, diagnosis and early and late effectiveness of the endovascular treatment (EVT), including angioplasty and stenting procedures. METHODS: A literature research was performed using Pubmed, Scopus and the Cochrane Library databases (January 2000-September 2020) according to PRISMA guidelines. Studies were included if they describe EVT, percutaneous transluminal angioplasty or stent placement of TRAS, published in English and with a minimum of ten patients. RESULTS: Fifty-six studies were included. TRAS incidence ranges from 1% up to 12% in transplanted kidneys. The TRAS risk factors were: elderly donor and recipient, cytomegalovirus match status, Class II Donor Specific Antibodies (DSA), expanded donor criteria, delayed graft functioning and other anatomical and technical factors. The highest frequency of TRAS presentation is after 3-6 months after kidney transplantation. The most frequent localization of stenosis was para-anastomotic (ranging from 25% to 78%). In 9 studies, all patients were treated by percutaneous transluminal angioplasty (PTA), in 16 studies all patients received percutaneous transluminal stenting (PTS) and in 21 series patients received either PTA or PTS. The twelve months patency rates after EVT ranged from 72% to 94%. The overall complication rate was 9%, with pseudoaneurysms and hematomas as most frequent complications. CONCLUSIONS: TRAS can be successfully and safely treated through an endovascular approach. Stent delivery seems to guarantee a higher patency rate compared to simple angioplasty, however further studies are needed to confirm these results.

Procedural and 12-month in-hospital costs of primary infra-popliteal bypass surgery, infrapopliteal best endovascular treatment, and major lower limb amputation for chronic limb threatening ischemia.

OBJECTIVE: Chronic limb-threatening ischemia (CLTI) is a growing global problem due to the widespread use of tobacco and increasing prevalence of diabetes. Although the financial consequences are considerable, few studies have compared the relative cost-effectiveness of different CLTI management strategies. The Bypass vs Angioplasty in Severe Ischaemia of the Leg (BASIL)-2 trial is randomizing patients with CLTI to primary infrapopliteal (IP) vein bypass surgery (BS) or best endovascular treatment (BET) and includes a comprehensive within-trial cost-utility analysis. The aim of this study is to compare over a 12-month time horizon, the costs of primary IP BS, IP best endovascular treatment (BET), and major limb major amputation (MLLA) to inform the BASIL-2 cost-utility analysis. METHODS: We compared procedural human resource (HR) costs and total in-hospital costs for the index admission, and over the following 12-months, in 60 consecutive patients undergoing primary IP BS (n = 20), IP BET (n = 20), or MLLA (10 transfemoral and 10 transtibial) for CLTI within the BASIL prospective cohort study. RESULTS: Procedural HR costs were greatest for BS (BS £2551; 95% confidence interval [CI], £1934-£2807 vs MLLA £1130; 95% CI, £1046-£1297 vs BET £329; 95% CI, £242-£390; P < .001, Kruskal-Wallis) due to longer procedure duration and greater staff requirement. With regard to the index admission, MLLA was the most expensive due to longer hospital stay (MLLA £13,320; 95% CI, £8986-£18,616 vs BS £8714; 95% CI, £6097-£11,973 vs BET £4813; 95% CI, £3529-£6097; P < .001, Kruskal-Wallis). The total cost of the index admission and in-hospital care over the following 12 months remained least for BET (MLLA £26,327; 95% CI, £17,653-£30,458 vs BS £20,401; 95% CI, £12,071-£23,926 vs BET £12,298; 95% CI, £6961-£15,439; P < .001, Kruskal-Wallis). CONCLUSIONS: Over a 12-month time horizon, MLLA and IP BS are more expensive than IP BET in terms of procedural HR costs and total in-hospital costs. These economic data, together with quality of life data from BASIL-2, will inform the calculation of incremental cost-effectiveness ratios for different CLTI management strategies within the BASIL-2 cost-utility analysis.

The influence of socioeconomic status on outcomes of lower extremity arterial reconstruction.

OBJECTIVE: Although it has been shown that patient socioeconomic status (SES) is associated with the surgical treatments chosen for severe peripheral arterial disease (PAD), the association between SES and outcomes of arterial reconstruction have not been well-studied. The objective of this study was to determine if SES is associated with outcomes following lower extremity arterial reconstruction. METHODS: Patients 40 years and older who had surgical revascularization for severe lower extremity PAD were identified in the Nationwide Readmissions Database, 2010 to 2014. Measures of SES including median household income (MHI) quartiles of patients' residential ZIP codes were extracted. Factors associated with repeat revascularization, subsequent major amputations, hospital mortality, and 30-day all-cause readmission were evaluated using multivariable regression analyses. RESULTS: Of the 131,529 patients identified, the majority (61%) were male, and the average age was 69 years. On unadjusted analyses, subsequent amputations were higher among patients in the lowest MHI quartile compared with patients in the highest MHI quartile (13% vs 10%; overall P < .001). On multivariable analyses, compared with patients in the lowest quartile, those in the highest quartile had lower amputation (adjusted odds ratio [aOR], 0.70; 95% confidence interval (CI), 0.63-0.77; overall P < .001) and readmission (aOR, 0.91; 95% CI, 0.84-0.99; overall P = .028) rates. However, subsequent revascularization (aOR, 1.04; 95% CI, 0.94-1.15) and mortality (aOR, 1.01; 95% CI, 0.79-1.28) rates were not different across the groups. CONCLUSIONS: Lower SES is associated with disproportionally worse outcomes following lower extremity arterial reconstruction for severe PAD. These data suggest that improving outcomes of lower extremity arterial reconstruction may involve addressing socioeconomic disparities.

Exploring the rapid expansion of office-based laboratories and peripheral vascular interventions across the United States.

OBJECTIVE: To characterize the relationship between office-based laboratory (OBL) use and Medicare payments for peripheral vascular interventions (PVI). METHODS: Using the Centers for Medicare and Medicaid Services Provider Utilization and Payment Data Public Use Files from 2014 to 2017, we identified providers who performed percutaneous transluminal angioplasty, stent placement, and atherectomy. Procedures were aggregated at the provider and hospital referral region (HRR) level. RESULTS: Between 2014 and 2017, 2641 providers performed 308,247 procedures. The mean payment for OBL stent placement in 2017 was $4383.39, and mean payment for OBL atherectomy was $13,079.63. The change in the mean payment amount varied significantly, from a decrease of $16.97 in HRR 146 to an increase of $43.77 per beneficiary over the study period in HRR 11. The change in the rate of PVI also varied substantially, and moderately correlated with change in payment across HRRs (R2 = 0.40; P < .001). The majority of HRRs experienced an increase in rate of PVI within OBLs, which strongly correlated with changes in payments (R2 = 0.85; P < .001). Furthermore, 85% of the variance in change in payment was explained by increases in OBL atherectomy (P < .001). CONCLUSIONS: A rapid shift into the office setting for PVIs occurred within some HRRs, which was highly geographically variable and was strongly correlated with payments. Policymakers should revisit the current payment structure for OBL use and, in particular atherectomy, to better align the policy with its intended goals.

Clinical and health status outcomes among patients treated with single as compared to multivessel angioplasty during chronic total occlusion percutaneous coronary interventions: a report from the OPEN CTO registry.

BACKGROUND: Patients with coronary chronic total occlusions (CTO) often have multivessel coronary artery disease. We utilized the OPEN CTO study to evaluate patients who underwent single-vessel versus multivessel percutaneous coronary intervention (PCI) during CTO PCI. METHODS: Patients were considered to have undergone single-vessel CTO PCI if they underwent target-vessel only CTO PCI. Patients who underwent multivessel PCI during their index CTO PCI procedure were considered to have undergone multivessel PCI. The additional lesions treated in the multivessel group could be either a separate CTO lesion in a separate epicardial vessel or PCI attempt of any non-CTO stenosis during the same index procedure. Multivariate regression models were used to evaluate predictors of technical success, in-hospital major adverse cardiac and cerebrovascular events (MACCE), and health status measures. RESULTS: Eighty hundred twenty-one patients underwent single-vessel CTO PCI and 179 (17.9%) underwent multivessel PCI during their CTO PCI procedure. Baseline comorbidities, index CTO lesion complexity, and successful crossing strategies used were similar between the two groups. Total procedural time (142.6 versus 115.9 minutes, P < 0.01) and contrast administered (293.8 versus 255.0 ml, P < 0.01) were increased in the multivessel CTO PCI group. Single-vessel versus multivessel PCI during these cases did not affect the likelihood of achieving technical success [odds ratio (OR) 1.05, 95% confidence interval (CI) 0.63-1.75] nor the risk for MACCE (OR 1.23, 95% CI 0.72-2.11). Quality of life (QOL) metrics were similar between the two groups at baseline and 30-day follow-up. CONCLUSION: There were no significant differences in technical success, in-hospital MACCE rates, or QOL metrics at 30-day follow-up for patients who underwent single-vessel versus multivessel PCI during CTO PCI.

Patient and Institutional Costs of Failure of Angioplasty of the Superficial Femoral Artery.

BACKGROUND: Debate surrounds the optimal management of superficial femoral artery (SFA) disease. Randomized trial data rarely reflect real world findings, specifically the consequences to the patient of angioplasty failure. We observed the effect of a failed SFA angioplasty on the need for repeated clinic visits, hospital readmissions, imaging requirements, and reinterventions. METHODS: We reviewed a consecutive series of 148 patients (94 men, median age 72 years) undergoing solely SFA angioplasty over a 2-year period. Patient preangioplasty demographics and 2-year post-PTA follow-up data were collated, including hospital attendances (inpatient/outpatient), further imaging (including radiation exposure) and revascularization attempts. We defined "failed angioplasty" as presence of clinical symptoms with radiological evidence of significant restenosis after an initial successful primary SFA angioplasty. RESULTS: Fifty-four patients represented with a failed angioplasty (median time of 4 months after index PTA). In this group, failure of index angioplasty resulted in a further 185 restenosis-related clinic visits and a total of 537 bed days of inpatient stay. This group underwent a further 149 imaging events and required a further 34 endovascular revascularization procedures and 12 infrainguinal bypass procedures. These interventions and investigations corresponded to overall effective radiation dose across all patients of 190.69 mSv. Of the cohort of 99 patients who did not have a "failed angioplasty," they required 100 clinic visits, 21 further scans (total radiation dose 6.42 mSv), and 36 bed days of inpatient admission. CONCLUSIONS: Failed angioplasty results in significant additional consequences for patients and health-care systems. Further work should focus on refining decision-making, providing the right procedure to the right patient at the right time.

Impact of Gender Differences on Outcomes of Peripheral Artery Disease Intervention (from a Nationwide Sample).

We aimed to evaluate the role of gender differences in the outcomes of catheter-based peripheral arterial disease interventions on a national level. We queried the National Inpatient Sample Database and identified all patients who presented with acute or symptomatic long term limb ischemia requiring transcatheter nonsurgical peripheral intervention in the years of 2016 to 2017. The primary outcome was major adverse cardiovascular events (MACE), defined as the composite end point of in-hospital mortality, nonfatal stroke, and acute myocardial infarction. Secondary outcomes were the subject components of the primary end point, vascular complications, major bleeding, acute kidney injury, limb amputation, total cost, and length of stay. A total of 58,165 patients were included. The majority were males (57.2%) and of white race (67.1%). On multivariate analysis, female gender was an independent predictor of MACE with an adjusted odd ratio (a-OR) of 1.36 (95% confidence interval [CI]: 1.12 to 1.65, p = 0.002), mortality (a-OR 1.52; 95% CI: 1.12 to 2.04, p = 0.006), nonfatal stroke (a-OR 2.51; 95% CI: 1.56 to 4.03, p < 0.001), major bleeding (a-OR 1.87; 95% CI: 1.53 to 2.28, p < 0.001), and higher cost with an adjusted mean ratio of 1.03 (95% CI: 1.00 to 1.06, p = 0.033). There was no significant difference in the rates of myocardial infarction, vascular complications, limb amputation, acute kidney injury, and length of stay. In conclusion, females presenting with acute or symptomatic long term limb ischemia requiring transcatheter peripheral intervention have a significantly higher composite risk of MACE.

Important considerations for trials for peripheral arterial disease: Lessons learned from the paclitaxel mortality signal: A report on behalf of the registry assessment for peripheral interventional Devices (RAPID) Paclitaxel Pathways Program.

The Registry Assessment of Peripheral Devices (RAPID) convened a multidisciplinary group of stakeholders including clinicians, academicians, regulators and industry representatives to conduct an in-depth review of limitations associated with the data available to assess the paclitaxel mortality signal. Available studies were evaluated to identify strengths and limitations in the study design and data quality, which were translated to lessons learned to help guide the design, execution, and analyses of future studies. We suggest numerous actionable responses, such as the development and use of harmonized data points and outcomes in a consensus lean case report form. We advocate for reduction in missing data and efficient means for accrual of larger sample sizes in Peripheral arterial disease studies or use of supplemental datasets. Efforts to share lessons learned and working collaboratively to address such issues may improve future data in this device area and ultimately benefit patients. Condensed Abstract: Data sources evaluating paclitaxel-coated devices were evaluated to identify strengths and limitations in the study design and data quality, which were translated to lessons learned to help guide the design, execution, and analyses of future studies. We suggest numerous actionable responses, which we believe may improve future data in this device area and ultimately benefit patients.

Cloridrato de Prasugrel para redução de eventos aterotrombóticos em pacientes diabéticos com síndrome coronariana aguda que realizaram angioplastia coronariana primária / Prasugrel hydrochloride to reduce atherothrombotic events in diabetic patients with acute coronary syndrome who underwent primary coronary angioplasty

INTRODUÇÃO: A síndrome coronariana aguda (SCA) é um termo abrangente para: infarto agudo do miocárdio (IAM) com supradesnivelamento do segmento ST, IAM sem supradesnivelamento do segmento ST e angina instável (1,2). A incidência é muito variável entre diferentes países e regiões do mundo (3­8). De acordo com a Organização Mundial da Saúde, doenças isquêmicas do coração foram responsáveis por 12% das mortes observadas em países de média e baixa renda, e aproximadamente 16% das mortes em países da alta renda em 2008 (9). Em particular, pacientes com diabetes mellitus (DM) possuem maior potencial pró-trombótico (3,4) e consequente maior potencial de beneficiarem-se de antiagregantes plaquetários (aspirina, clopidogrel) após uma angioplastia. O prasugrel é um anti-agregante plaquetário da mesma classe do clopidogrel, hoje incorporado ao SUS, e do ticagrelor, cuja incorporação foi rejeitada pela CONITEC. PERGUNTA: O prasugrel é eficaz, seguro e custo-efetivo em relação ao clopidogrel para a redução de eventos cardiovasculares em pacientes com síndrome coronariana aguda (SCA) e diabetes mellitus (DM) que realizaram angioplastia? EVIDÊNCIAS CIENTÍFICAS: Um único ensaio clínico randomizado (TRITON TIMI 38) avaliou prasugrel versus clopidogrel, 23% dos participantes eram diabéticos. Estudo patrocinado pelo demandante. Baixo risco de viés. A análise em pacientes diabéticos é baseada em uma análise de subgrupo. A qualidade da evidência é limitada pois não houve randomização para diabéticos e o estudo não foi controlado para o tipo e gravidade da doença. Ainda, a interação para diabetes não foi significativa (P = 0,09), ou seja, a análise deste subgrupo como um grupo independente não é adequada. A razão de chances, que no estudo pivotal era de 0,76 para redução de infarto foi recalculada para 0,60 no subgrupo de diabéticos. Analisando os resultados do subgrupo de pacientes diabéticos para o desfecho primário composto de morte cardiovascular, infarto e AVC, foram observados eventos em 17,0% no grupo clopidogrel e 12,2% no grupo prasugrel (HR=0,70; IC 0,58 - 0,85). Para morte cardiovascular, 4,2% no grupo clopidogrel e 3,4% no grupo prasugrel (HR=0,85; IC 0,58 - 1,24); IAM não fatal: 13,2% no grupo clopidogrel e 8,2% no grupo prasugrel (HR=0,60; IC 0,48 - 0,76); Trombose de stent: 3,6% no grupo clopidogrel e 2,0% no grupo prasugrel (HR=0,52; IC 0,33 - 0,84). O prasugrel apresentou maior risco de sangramentos não relacionada à cirurgia de revascularização miocárdica: 4,3% no grupo clopidogrel e 5,3% no grupo prasugrel (HR=1,30; IC 0,92 - 1,82). AVALIAÇÃO ECONÔMICA: A avaliação econômica do prasugrel apresentada pelo demandante baseou-se nos resultados do estudo pivotal e em um modelo de custo-efetividade e custo-utilidade utilizado previamente no NICE. Como resultados, prasugrel demonstrou-se ser mais efetivo e com maior custo em relação ao clopidogrel, apresentando uma razão de custo-utilidade incremental (RCEI) de R$ 9.325,00 mil/QALY. O modelo foi refeito pelo parecerista externo, obtendo um novo valor de RCEI de R$ 12.324,53/QALY e com 100% das simulações com valor igual ou inferior a R$ 15.591,13/QALY. RECOMENDAÇÃO PRELIMINAR DA CONITEC: A Conitec, em sua 89ª reunião ordinária, no dia 06 de agosto de 2020, recomendou a não incorporação no SUS de prasugrel para tratamento de pacientes diabéticos com síndrome coronariana aguda pós angioplastia. A recomendação levou em consideração que a população alvo foi mal definida, gerando incertezas no impacto orçamentário e na proposta de redução de preços. A operacionalização da proposta de redução de preços necessita de esclarecimentos. RECOMENDAÇÃO PRELIMINAR DA CONITEC: A Conitec, em sua 89ª reunião ordinária, no dia 06 de agosto de 2020, recomendou a não incorporação no SUS de prasugrel para tratamento de pacientes diabéticos com síndrome coronariana aguda pós angioplastia. A recomendação levou em consideração que a população alvo foi mal definida, gerando incertezas no impacto orçamentário e na proposta de redução de preços. A operacionalização da proposta de redução de preços necessita de esclarecimentos. RECOMENDAÇÃO FINAL DA CONITEC: Os membros da CONITEC presentes na 92ª reunião ordinária, no dia 05 de novembro de 2020, deliberaram por recomendar a não incorporação no SUS do cloridrato de prasugrel para pacientes diabéticos com síndrome coronariana aguda submetidos à angioplastia primária. Os membros presentes entenderam que o medicamento atenderia um subgrupo de pacientes específico e que ainda há incertezas quanto ao seu benefício e segurança. Foi assinado o Registro de Deliberação nº 573.

Management of cardiovascular emergencies during the COVID-19 pandemic.

BACKGROUND: It has been reported that patients attending the emergency department with other pathologies may not have received optimal medical care due to the lockdown measures in the early phase of the COVID-19 pandemic. METHODS: This was a retrospective study of patients presenting with cardiovascular emergencies to four tertiary regional emergency departments in western India during the government implementation of complete lockdown. RESULTS: 25.0% of patients during the lockdown period and 17.4% of patients during the pre-lockdown period presented outside the window period (presentation after 12 hours of symptom onset) compared with only 6% during the pre-COVID period. In the pre-COVID period, 46.9% of patients with ST elevation myocardial infarction underwent emergent catheterisation, while in the pre-lockdown and lockdown periods, these values were 26.1% and 18.8%, respectively. The proportion of patients treated with intravenous thrombolytic therapy increased from 18.4% in the pre-COVID period to 32.3% in the post-lockdown period. Inhospital mortality for acute coronary syndrome (ACS) increased from 2.69% in the pre-COVID period to 7.27% in the post-lockdown period. There was also a significant decline in emergency admissions for non-ACS conditions, such as acute decompensated heart failure and high degree or complete atrioventricular block. CONCLUSION: The COVID-19 pandemic has led to delays in patients seeking care for cardiac problems and also affected the use of optimum therapy in our institutions.

Galectin-3, GDF-15, and sST2 for the assessment of disease severity and therapy response in patients suffering from inoperable chronic thromboembolic pulmonary hypertension.

PURPOSE: This study examined sST2, GDF-15, and galectin-3 as indicators of disease severity and therapy response in chronic thromboembolic pulmonary hypertension (CTEPH). METHODS: This study included 57 inoperable CTEPH patients who underwent balloon pulmonary angioplasty and 25 controls without cardiovascular disease. Biomarker levels were examined in relation to advanced hemodynamic impairment [tertile with worst right atrial pressure (RAP) and cardiac index], hemodynamic therapy response [normalized hemodynamics (meanPAP ≤25 mmHg, PVR ≤3 WU and RAP ≤6 mmHg) or a reduction of meanPAP ≥25%; PVR ≥ 35%, RAP ≥25%]. RESULTS: GDF-15 [820 (556-1315) pg/ml vs. 370 (314-516) pg/ml; p < 0.001] and sST2 [53.7 (45.3-74.1) ng/ml vs. 48.7 (35.5-57.0) ng/ml; p = 0.02] were higher in CTEPH patients than in controls. At baseline, a GDF-15 level ≥1443 pg/ml (AUC 0.88; OR 31.4) and a sST2 level ≥65 ng/ml (AUC 0.80; OR 10.9) were associated with advanced hemodynamic impairment. At follow-up GDF-15 ≤ 958 pg/ml (AUC = 0.74, OR 18) identified patients with optimal hemodynamic therapy response and ≤760 pg/ml (AUC = 0.79, OR 14). CONCLUSION: GDF-15 and sST2 levels are higher in CTEPH and identified patients with advanced hemodynamic impairment. Further, decreased GDF-15 levels at follow-up were associated with hemodynamic therapy response. The diagnostic strength was not superior to NT-proBNP.