Epidemiological Analysis of 37,424 Carotid Artery Stenosis Intervention Procedures During 11 Years in the Public Health System in Brazil: Stenting has Been More Common Than Endarterectomy.

BACKGROUND: Stroke is a leading cause of death worldwide, with carotid atherosclerosis accounting for 10-20% of cases. In Brazil, the Public Health System provides care for roughly two-thirds of the population. No studies, however, have analysed large-scale results of carotid bifurcation surgery in Brazil. METHODS: This study aimed to describe rates of carotid artery stenting (CAS) and carotid endarterectomy (CEA) performed between 2008 and 2019 in the country through web scraping of publicly available databases. RESULTS: Between 2008 and 2019, 37,424 carotid bifurcation revascularization procedures were performed, of which 22,578 were CAS (60.34%) and 14,846 (39.66%) were CEA. There were 620 in-hospital deaths (1.66%), 336 after CAS (1.48%) and 284 after CEA (1.92%) (P = 0.032). Governmental reimbursement was US$ 77,216,298.85 (79.31% of all reimbursement) for CAS procedures and US$ 20,143,009.63 (20.69%) for CEA procedures. The average cost per procedure for CAS (US$ 3,062.98) was higher than that for CEA (US$ 1,430.33) (P = 0.008). CONCLUSIONS: In Brazil, the frequency of CAS largely surpassed that of CEA. In-hospital mortality rates of CAS were significantly lower than those of CEA, although both had mortality rates within the acceptable rates as dictated by literature. The cost of CAS, however, was significantly higher. This is a pioneering analysis of carotid artery disease management in Brazil that provides, for the first time, preliminary insight into the fact that the low adoption of CEA in the country is in opposition to countries where utilization rates are higher for CEA than for CAS.

Contemporary Trends in Physician Utilization Rates of CEA and CAS for Asymptomatic Carotid Stenosis among Medicare Beneficiaries.

BACKGROUND: Carotid revascularization for asymptomatic carotid artery stenosis (ACAS) has become increasingly controversial in the past few decades as the best medical therapy has improved. The aim of this study was to assess and define contemporary trends in the rate of carotid revascularization procedures for ACAS in the United States and to characterize outlier physicians performing a higher rate of asymptomatic revascularization compared to their peers. METHODS: We used 100% Medicare fee-for-service claims to identify all patients who were newly diagnosed with ACAS between 01/2011-06/2018. Patients with symptomatic carotid artery stenosis, those with prior carotid revascularization, and surgeons who performed ≤10 CEAs during the study period were excluded. We used a hierarchical multivariable logistic regression model to evaluate patient and physician characteristics associated with undergoing a carotid endarterectomy or carotid artery stent procedure within 3 months after the initial diagnosis of ACAS. We also assessed temporal trends in carotid revascularization rates over time using the Cochran-Armitage Trend Test. RESULTS: Overall, 795,512 patients (median age 73.9 years, 50.9% male, 87.6% white) had a first-time diagnosis of ACAS during the study period, of which 23,481 (3.0%) underwent carotid revascularization within 3 months. There was a significant decline in overall carotid artery revascularization rates over time (2011: 3.2% vs. 2018: 2.1%; P < 0.001). The median and mean physician-specific carotid revascularization rates were 2.0% (IQR 0.0%-6.3%) and 4.7% ± 7.1%, respectively. Three-hundred and fifty physicians (5.2%) had carotid revascularization rates ≥19%, which was more than 2 standard deviations above the mean. After adjusting for patient-level characteristics, physician-level variables associated with carotid revascularization for newly diagnosed ACAS included male sex (adjusted OR 1.59, 95% CI 1.35-1.89), more years in practice (≥31 vs. <10 years, aOR 1.64, 95% CI 1.32-2.04), rural practice location (aOR 1.34, 95% CI 1.18-1.52), Southern region practice location (versus Northeast, aOR 1.54, 95% CI 1.39-1.69), and lower volume of ACAS patients (lower versus upper tertile, aOR 2.62, 95% CI 2.39-2.89). Cardiothoracic surgeons had a 1.52-fold higher odds of carotid revascularization compared to vascular surgeons (95% CI 1.36-1.68), whereas cardiologists and radiologists had lower intervention rates (both, P < 0.05). CONCLUSIONS: The current early revascularization rate for newly diagnosed ACAS is <5% among proceduralists in the United States, and has been decreasing steadily since 2014. There are particular physician-level characteristics that are associated with higher rates of carotid revascularization that cannot be fully contextualized without high-level contemporary outcomes data to guide decision making in ACAS.

Contemporary nationwide trends and in-hospital outcomes of adjunctive stenting in patients undergoing catheter-directed thrombolysis for proximal deep venous thrombosis.

OBJECTIVE: Outflow venous stenting as an adjunct to catheter-directed thrombolysis (CDT) is performed to prevent recurrent thrombosis and to reduce the risk of post-thrombotic syndrome. Historical data show that stenting improves outcomes of surgical thrombectomy in patients with iliofemoral deep venous thrombosis (DVT), and recent observational data suggest that stenting improves long-term outcomes of CDT. However, the impact of stenting during CDT on acute safety outcomes is unknown. We sought to investigate the contemporary trends, safety outcomes, and resource utilization of adjunctive stent placement in patients undergoing CDT. METHODS: Patients with proximal lower extremity and caval DVT were identified within the National Inpatient Sample from January 2005 to December 2013. From this data set, we stratified our patients into three groups: patients who received CDT alone, patients who received CDT plus angioplasty, and patients who received CDT plus angioplasty with stenting. We used an inverse probability treatment weighting algorithm to create three weighted cohorts. Cochran-Armitage test was used to evaluate the trends of stent placement among patients treated with CDT. The primary outcome was a composite end point of all-cause mortality, gastrointestinal bleed, or intracranial hemorrhage. RESULTS: A total of 138,049 patients were discharged with a principal diagnosis of proximal and caval DVT; 7097 of these patients received CDT (5.1%). From this group, 2854 (40.2%) were treated with CDT alone, 2311 (32.6%) received adjunctive angioplasty alone, and 1932 (27.2%) received adjunctive angioplasty and stent. Adjunctive stenting had a significantly lower rate of primary composite outcome compared with CDT alone (2.7% vs 3.8%; P = .04). Stent placement was associated with a similar length of stay compared with angioplasty and CDT alone groups (6.8 vs 6.9 vs 7.1 days, respectively; P = .94) and higher in-hospital charges ($115,164.01 ± $76,985.31 vs $98,089.82 ± $72,921.94 vs $80,441.63 ± $74,024.98; P < .001). CONCLUSIONS: This nationwide study suggests that one in four patients undergoing CDT is treated with adjunctive stent placement in the United States. This observational study showed that adjunctive stenting does not adversely affect the acute safety outcomes of CDT; however, it was associated with increased hospital charges.

Ponts trabéculaires iStent® et iStent inject® pour la chirurgie micro-invasive du glaucome (CMIG) / iStent® and iStent inject® Trabecular Bypass for Micro-invasive Glaucoma Surgery (MIGS)

MANDAT: Les ponts trabéculaires iStent® et iStent inject® sont actuellement offerts aux patients atteints de glaucome à angle ouvert, mais leur accès demeure limité. À la demande du Bureau de l'innovation, l'Institut national d'excellence en santé et en services sociaux (INESSS) a évalué la pertinence d'accroître l'accès à une couverture publique pour ces dispositifs. MÉTHODES: Pour réaliser ce mandat et compléter l'information soumise par le fabricant, l'INESSS a procédé à une recherche systématique de la littérature scientifique relative aux ponts trabéculaires iStent® et iStent inject®. Cette recherche a été complétée par une revue de la littérature grise et la collecte de données contextuelles et expérientielles par l'entremise de consultations auprès d'un comité d'experts, de la fondation Vaincre la cécité Canada et de données médico-administratives québécoises. Une analyse de l'efficience, à l'aide d'un modèle économique visant l'évaluation coût-utilité des iStent® et iStent inject® en contexte québécois, a été effectuée. Une analyse d'impact budgétaire potentiel couvrant une période de trois ans a également été réalisée. BESOINS DE SANTÉ: Le glaucome est une neuropathie optique évolutive chronique qui engendre une perte irréversible du champ visuel et qui peut, dans certains cas, mener à la cécité. Il s'agit de la deuxième cause de cécité après la cataracte. Le glaucome primaire à angle ouvert (GPAO) est la forme la plus fréquente. Comme l'incidence du glaucome et de la cataracte augmente avec l'âge, ces affections sont souvent concomitantes chez la population âgée. Même si la maladie est chronique, une détection et un traitement précoces peuvent en ralentir la progression. La stratégie thérapeutique vise principalement la réduction de la pression intraoculaire (PIO), le facteur de risque le plus facilement modifiable. La PIO résulte de l'effet net de la production de l'humeur aqueuse de l'œil et de son élimination, principalement effectuée par l'intermédiaire des mailles trabéculaires ou trabéculum. Le continuum de soins actuel est habituellement mis en œuvre de manière progressive jusqu'à l'atteinte d'une PIO cible. La médication, en première ligne, est généralement suivie par le traitement au laser. La chirurgie de filtration, procédure plus effractive de dernière ligne, peut mener à des complications parfois sévères, peu de patients y auront toutefois recours. L'adhésion au traitement de pharmacothérapie est importante pour l'atteinte de la PIO cible. Cependant, chez certains patients, l'administration de gouttes peut s'avérer difficile (limites relatives à la préhension et à la précision, effets indésirables, etc.), ce qui peut mener à une réduction de l'adhésion au plan de traitement. Des options thérapeutiques supplémentaires permettant de reporter, et peut-être même d'éviter, une intervention chirurgicale plus effractive pour atteindre le niveau de la PIO cible seraient souhaitables. RÉSULTATS: Efficacité, innocuité et qualité de vie: Pour apprécier la valeur thérapeutique des dispositifs iStent® et iStent inject®, quatre essais contrôlés randomisés (ECR) ont été retenus. Pour chaque dispositif, on trouve une étude présentant les interventions et comparateurs suivants, soit l'implantation de deux dispositifs par œil : concurremment avec une phacoémulsification (phaco1 ) vs une phacoémulsification seule; comme traitement indépendant (sans phaco) vs une pharmacothérapie. Lors de l'intervention concurremment avec une chirurgie de la cataracte, chacun des deux groupes a eu besoin de moins de médicaments à la suite de la chirurgie. La réduction du recours à la médication dans le groupe témoin pourrait s'expliquer par la capacité hypotonisante de la phacoémulsification. Lorsque comparés entre eux à 23 mois, les patients chez qui on a implanté le dispositif ont eu besoin de 0,4 médicaments de moins pour maintenir la PIO cible. Lors de l'intervention comme traitement indépendant, à 60 mois de suivi, près de 80 % des patients traités à l'aide de deux dispositifs iStent® n'ont pas eu besoin de médication pour maintenir la PIO cible. En contrepartie, dans le groupe témoin en pharmacothérapie, près de 40 % des patients ont eu besoin de l'addition d'un deuxième médicament. Cependant, les données disponibles n'ont pas permis de mettre en exergue des effets sur l'acuité et le champ visuels de même que sur le recours à des interventions plus effractives. Des données de suivi à plus long terme seront nécessaires. Par ailleurs, aucun ECR répertorié n'a évalué la qualité de vie des patients, alors qu'il s'agit d'un déterminant important dans l'appréciation de la valeur de cette technologie. Concernant l'innocuité, les dispositifs affichent une quantité modérée d'événements indésirables (EI), majoritairement de gravité faible, similaire à ce qui est observé lors des chirurgies de la cataracte. Il est important de rappeler que les devis des ECR présentent certaines lacunes, notamment sur le plan de la répartition aléatoire des sujets (randomisation), de la sélection des patients et de la mesure des paramètres de la médication et de la PIO. Il convient cependant de souligner que masquer une intervention chirurgicale peut s'avérer difficile. L'interprétation des résultats des ECR doit de plus tenir compte du cadre contrôlé qui a cours lors d'un essai clinique où les patients sont volontaires et coopératifs. Cette adhésion des patients au traitement en contexte clinique pourrait différer en contexte réel de soins. RECOMMANDATIONS: L'Institut national d'excellence en santé et en services sociaux (INESSS) est d'avis que la couverture publique des ponts trabéculaires iStent® et iStent inject® pourrait constituer une décision juste et raisonnable si des mesures importantes d'atténuation du fardeau économique étaient mises en œuvre et leur utilisation encadrée par les critères suivants : patient qui ne répond pas à deux médicaments hypotonisants ou plus ou qui présente une condition médicale documentée empêchant l'administration optimale des gouttes; mauvais candidat à une chirurgie de filtration. Autres considérations 1. Compte tenu des incertitudes relatives à la valeur thérapeutique ainsi qu'à l'efficience, l'offre de services devrait être réévaluée ultérieurement à la lumière des nouvelles données disponibles. Un horizon temporel de trois ans est proposé. 2. Tout élargissement des critères proposés ne devrait se concrétiser que dans le contexte d'un développement de la preuve avec le soutien financier du fabricant.

MANDATE: iStent® and iStent inject® trabecular bypasses are provided to patients with open angle glaucoma. However, access to such devices remains limited in the Quebec health system. The Institut national d'excellence en santé et en services sociaux (INESSS), at the request of the Bureau de l'innovation, assessed the pertinence of increasing access to public coverage for those devices. METHODS: To carry out this mandate and supplement the information provided by the manufacturer, INESSS conducted a systematic research of scientific literature on iStent® and iStent inject® trabecular bypasses. This research was complemented by a review of grey literature, contextual and experiential data gathered through consultations with an expert committee and Foundation Fighting Blindness Canada as well as the information retrieved from clinical administrative data from Quebec government databases. A modelbased cost-utility analysis was conducted to evaluate the cost effectiveness of iStent® and iStent inject® in the perspective of the Quebec health system. Also, the potential budgetary impact of an increased access to those devices for a period of three (3) years was also performed. HEALTH NEEDS: Glaucoma is described as an evolving chronic optic neuropathy that leads to irreversible visual field loss and, in certain cases, to blindness. Glaucoma is the second leading cause of blindness after cataract. Primary open-angle glaucoma (POAG) is the most common form of glaucoma. Since the incidence of glaucoma and cataract increases with age, these conditions often appear together in the elderly population. Even if glaucoma is a chronic disease, early detection and treatment can slow down its progression. The treatment strategy aims at reducing intraocular pressure (IOP) - the easiest modifiable risk factor. IOP is the net result of aqueous humor formation in the eye and its elimination through trabecular meshwork or trabeculum. The continuum of care now being used is usually implemented in a gradual manner until the target IOP is attained. In general, medication administered at the primary level of care is followed by laser treatment. Filtration surgery ­ a more invasive last-line procedure ­ can lead to severe complications, but few patients undergo this type of intervention. To achieve the IOP target, it is important to adhere to the pharmacotherapy treatment. But self-administration of eye drops can prove difficult for some patients (for instance, due to limitations in terms of prehension and precision, adverse effects, etc.), thus leading to lower adherence to the treatment plan. Additional therapeutic alternatives that make it possible to postpone and, in some cases, avoid the necessity to undergo more invasive surgery to attain the target IOP would be desirable. RESULTS: effectiveness, safety and quality of life: To appreciate the therapeutic value of iStent® and iStent inject® devices, four randomized controlled studies (RCT) were selected. Separate studies were conducted for both devices, each including the following interventions and comparators, i.e.: Implantation of two devices per eye and phacoemulsification (phaco2 ) vs. phacoemulsification alone; Implantation of two devices per eye w/o phaco vs. pharmacotherapy. In both groups, the patients who underwent intervention and cataract surgery required less medication after their surgery. The use of less medication by the control group could be explained by the hypotonic capacity of phacoemulsification. When compared 23 months after surgery, a reduction of 0,4 medication to maintain the target IOP was observed for the patients who received the device. After a 60-month follow-up period on the patients who underwent implantation alone (without phaco), nearly 80% of those who received two iStent® devices did not require medication to maintain their target IOP. On the other hand, 40% of the patients in the control group in pharmacotherapy required a second medication. With the data available, however, it was not possible to point out the effects on visual acuity and visual field and the use of more invasive interventions. This will require longterm follow-up data. Moreover, none of the RCTs evaluated the patients' quality of life, despite the fact it is an important determinant in estimating the value of this technology. With respect to post-implantation innocuity, the results reveal a moderate number of adverse events ­ of low severity in most cases ­ similar to that observed in patients undergoing cataract surgery. It is important to remember that the RCT specifications analysed have some weaknesses, particularly in terms of random allocation of participants (randomization), patient selection, and measurement of medication and IOP parameters. It is noteworthy to mention, however, that it may be difficult to mask surgical interventions. Interpretation of RCT results must also consider the controlled setting during clinical tests in which patients participate on a volunteer and cooperative basis. The level of adherence to treatment provided in a clinical context may differ in an actual healthcare context. RECOMMENDATIONS: The Institut national d'excellence en santé et en services sociaux (INESSS) is of the opinion that a decision in favour of public coverage of iStent® and iStent inject® trabecular bypasses would be fair and reasonable if significant measures to reduce the cost were implemented and their use governed by the following criteria: Patients who do not respond to at least two (2) hypotonic drugs or with a documented medical condition that prevent optimal administration of eye drops. Poor candidates for filtration surgery. Other considerations: 1. Considering the uncertainties in terms of therapeutic value and costeffectiveness, access to this service should be re-evaluated in light of new available data. The suggested time-horizon for a re-evaluation is three (3) years. 2. Any extension of the proposed criteria should only come to fruition in an evidence development context with the financial support of the manufacturer.

Epidemiological Analysis of Carotid Artery Stenosis Intervention during 10 years in the Public Health System in the Largest City in Brazil: Stenting Has Been More Common than Endarterectomy.

BACKGROUND: Stroke is the second leading cause of death worldwide with approximately 5.7 million cases/year, and carotid atherosclerosis accounts for 10 to 20% of cases. METHODS: In Brazil, the Unified Health System (Sistema Único de Saúde [SUS]) is a tax-funded public health care system that provides care for roughly half the population. São Paulo is the eighth largest city in the world with an estimated population of over 12 million people, of whom more than 5 million rely solely on SUS. This study aimed to describe rates of carotid artery stenting (CAS) and carotid endarterectomy (CEA) performed between 2008 and 2017 in the city of São Paulo through web scraping of publicly available databases. RESULTS: Three thousand seven hundred and four carotid revascularization procedures were performed between 2008 and 2017, of which 2,432 were CAS (65.7%). Rates of CAS ranged from 59.9% in 2016 to 86% in 2011. There were 57 in-hospital deaths (1.54%), 34 after CAS (1.4%; 34/2,432) and 23 after CEA (1.81%; 23/1,272) (P = 0.562). SUS reimbursements were US $7,862,017.09 (81.44% of all reimbursements) for 2,432 CAS procedures and US $1,792,324.06 (18.56%) for 1,272 CEA procedures. Average SUS reimbursement for CAS (US $3,232.73) was more than double than that for CEA (US $1,409.05). CONCLUSIONS: In a city whose population exceeds that of some European countries, costs of CAS and CEA to the public health care system totaled more than US$ 9 million over 10 years. Epidemiologically, CAS was performed more commonly than CEA with no difference in in-hospital mortality between CAS and CEA, but reimbursements were 2.29 times higher for CAS. The low adoption of CEA in São Paulo is in contrast to countries where utilization rates are higher for CEA than for CAS.

Temporal Trends Analysis of the Characteristics, Management, and Outcomes of Women With Acute Coronary Syndrome (ACS): ACS Israeli Survey Registry 2000-2016.

Background Cardiovascular disease remains a leading cause of death among women. Despite improvements in the management of patients with acute coronary syndrome (ACS), women with an ACS remain at higher risk. Methods and Results We performed a time-dependent analysis of the management and outcomes of women admitted with ACS who enrolled in the prospective biennial ACS Israeli Surveys between 2000 and 2016. Surveys were divided into 3 time periods (2000-2004, 2006-2010, and 2013-2016). Outcomes included 30-day major adverse cardiac events (death, myocardial infarction, stroke, unstable angina, stent thrombosis, urgent revascularization) and 1-year mortality. Overall, 3518 women were admitted with an ACS. Their mean age (70±12 years) was similar among the time periods. Over the time course of the study, more women were admitted with non-ST-elevation ACS (51.9%, 59.6%, and 66.1%, respectively; P<0.001), and statins and percutaneous coronary intervention were increasingly utilized (66%, 91%, 93%, and 42%, 60%, and 68%, respectively; P<0.001 for each). Among women with ST-segment-elevation myocardial infarction, more primary percutaneous coronary interventions were performed (48.5%, 84.7%, and 95.3%, respectively; P<0.001). The rate of 30-day major adverse cardiac events has significantly decreased over the years (24.6%, 18.6%, and 13.5%, respectively; P<0.001). However, 1-year mortality rates declined only from 2000 to 2004 (16.9%, 12.8%, and 12.3%; P=0.007 for the overall difference), and this change was not significant after propensity matching or multivariate analysis. Conclusions Over more than a decade, 30-day major adverse cardiac events have decreased among women with ACS. Advances in pharmacological treatments and an early invasive approach may have accounted for this improvement. However, the lack of further reduction in 1-year mortality rates among women suggests that more measures should be provided in this high-risk population.

Temporal trends in the utilization and outcomes of percutaneous coronary interventions in patients with liver cirrhosis.

OBJECTIVES: We sought to assess the national trends in the utilization and outcomes of percutaneous coronary interventions (PCI) in patients with cirrhosis. BACKGROUND: Contemporary data on PCI in patients with liver cirrhosis are limited. METHODS: The National-Inpatient-Sample was used to identify patients who underwent PCI between 2003 and 2016. We examined the annual PCI rate, and compared the in-hospital morbidity, mortality, resource utilization, and cost following PCI in patients with and without cirrhosis. RESULTS: A total of 8,860,178 PCI hospitalizations were identified, of those, 20,339 (0.2%) were performed in patients with cirrhosis. Annual PCI rates decreased overtime in patients without liver cirrhosis but increased in those with cirrhosis (Ptrend < .001). Patients with cirrhosis had a characteristic clinical, demographic, and socioeconomic profile compared with those without cirrhosis. The use of bare-metal stents decreased from 69.1 to 11.4% in the noncirrhosis group, and from 81.9 to 21.3% in the cirrhosis group. Compared with propensity-matched patients without cirrhosis, PCI in cirrhotic patients was associated with higher in-hospital mortality across all indications (STEMI 19.1 vs. 11.5%, p = .002; NSTEMI 8.7 vs. 5.6%, p = .002; and UA/SIHD 7.7 vs. 4.3%, p < .001). Cirrhotic patients also had significantly higher rates of acute kidney injury, but similar rates of vascular complications and stroke. Additionally, cirrhotic patients had longer hospitalizations, were less likely to be discharged home, and accrued higher cost across all PCI indications. CONCLUSIONS: Patients with cirrhosis who are deemed "suitable PCI candidates" in current practice remain at high-risk for worse short-term morbidity and mortality, and higher cost of care.

Provider Trends in Atherectomy Volume between Office-Based Laboratories and Traditional Facilities.

BACKGROUND: As patient care is being increasingly transitioned out of the hospital and into the outpatient setting, there is a growing interest in developing office-based angiography suites, that is, office-based laboratories. Office-based care has been associated with increased efficiency and greater patient satisfaction, with substantially higher reimbursement directly to the physicians providing care. Prior studies have demonstrated a shift of revascularization procedures to office-based laboratories with a concomitant increase in atherectomy use, a procedure with disproportionately high reimbursement in comparison to other peripheral revascularization techniques. We sought to determine provider trends in endovascular procedure volume, settings, and shifts in practice over time, specific to atherectomy. METHODS: Using Centers for Medicare & Medicaid Services Provider Utilization and Payment Data Public Use Files from 2013 to 2015, we identified providers who performed diagnostic angiography (DA), percutaneous transluminal angioplasty (PTA), stent placement (stent), and atherectomy, and procedures were aggregated at the provider level. Trends in procedures performed in office-based laboratory and facility-based settings were analyzed. Atherectomy was specifically analyzed using the total number and proportion of office-based laboratory procedures, and providers were stratified into quintiles by case volume. RESULTS: Between 2013 and 2015, 5,298 providers were identified. Over this time period, the number of providers performing atherectomy increased 25.7%, with the highest quintile of atherectomy providers performing an average of 263 cases (range 109-1,455). The proportion of physicians who performed atherectomy only in the office increased from 39.8% to 50.7% from 2013 to 2015, whereas only 20.8% of physicians who performed DA, PTA, or stent in 2015 did so only in an office-based laboratory. Of the physicians with the highest atherectomy volume, 77.8% operated only in the office in 2015, and these physicians increased their atherectomy volume to 114.1% during the study period. Of those physicians who transitioned to a solely office-based laboratory practice over the study period, atherectomy volume increased 63.4%, which was disproportionate compared with the growth of their DA, PTA, and stent volume. CONCLUSIONS: Over this short study period, a rapid shift into the office setting for peripheral intervention occurred, with a concomitant increase in atherectomy volume that was disproportionate to the increase in other peripheral interventions. This increase in office-based laboratory atherectomy occurred in the setting of increased reimbursement for the procedure and despite a lack of data supporting superiority over PTA/stent.

Survival benefit from recent changes in management of men and women with ST-segment elevation myocardial infarction treated with percutaneous coronary interventions.

BACKGROUND: Nowadays, the majority of patients with myocardial infarction with ST-segment elevation (STEMI) are treated with primary percutaneous coronary interventions (PCI). In recent years, there have been ongoing improvements in PCI techniques, devices and concomitant pharmacotherapy. However, reports on further mortality reduction among PCI-treated STEMI patients remain inconclusive. The aim of this study was to compare changes in management and mortality in PCI-treated STEMI patients between 2005 and 2011 in a real-life setting. METHODS: Data on 79,522 PCI-treated patients with STEMI from Polish Registry of Acute Coronary Syndromes (PL-ACS) admitted to Polish hospitals between 2005 and 2011 were analyzed. First, temporal trends of in-hospital management in men and women were presented. In the next step, patients from 2005 and 2011 were nearest neighbor matched on their propensity scores to compare in-hospital, 30-day and 1-year mortality rates and in-hospital management strategies and complications. RESULTS: Some significant changes were noted in hospital management including shortening of median times from admission to PCI, increased use of drug-eluting stents, potent antiplatelet agents but also less frequent use of statin, beta-blockers and angiotensin converting enzyme inhibitors and angiotensin II receptor blockers. There was a strong tendency toward preforming additional PCI of non-infarct related arteries, especially in women. After propensity score adjustment there were significant changes in inhospital but not in 30-day or 1-year mortality rates between 2005 and 2011. The results were similar in men and women. CONCLUSIONS: There were apparent changes in management and significant in-hospital mortality reductions in PCI-treated STEMI patients between 2005 and 2011. However, it did not result in 30-day or 1-year survival benefit at a population level. There may be room for improvement in the use of guideline-recommended pharmacotherapy.

Comparison of the Cost of Drug-Eluting Stents versus Bare Metal Stents in the Treatment of Critical Limb Ischemia in the United States.

BACKGROUND: Despite significant technical advancement in the last decade, the durability of endovascular management of critical limb ischemia (CLI) remains highly debatable. Drug-eluting stents (DESs) are being popularized for the management of CLI after its precedent success in coronary intervention. Initial reports on the durability of DES are promising. However, little is known on the additional cost of this relatively newer technology. The aim of this study is to compare the cost of the traditional bare metal stents (BMSs) to the newly introduced DES in a large cohort of CLI patients. METHODS: Using the Premier database (2009-2015), we identified all patients with CLI undergoing DES and BMS. A multivariable generalized linear model was implemented to examine in-hospital cost adjusting for patients' characteristics, comorbidities, and regional characteristics. RESULTS: A total of 20,702 patients with CLI underwent peripheral artery revascularization using BMS (18,924 [91.41%]) or DES (1,778 [8.6%]). Majority of patients were males (53%) and whites (71%). Patients undergoing BMS were slightly younger (median age [interquartile range]: 70 [62-79] versus 71 [63-80]) and were more likely to be smokers (46% vs. 39%) and have a history of cerebrovascular disease (10% vs. 8%) and chronic pulmonary disease (24.5% vs. 20.9%) as compared with those undergoing DES (all P < 0.05). On the other hand, DES patients had a high prevalence of diabetes (4% vs. 3%) and renal disease (25% vs. 22%) (both P < 0.05). There was also a significant increase in the proportion of patients undergoing DES and a corresponding decrease in BMS (P < 0.001) over the study period. Median total in-hospitalization cost (BMS: $13,342 [8,574 to 21,166], DES: $13,243 [8,560-20,232], P = 0.76) was similar for both approaches. After adjusting for potential confounders, DES was associated with $407 higher cost than BMS (adjusted mean difference [95% confidence interval]: 407 [17 to 798], P = 0.04). In addition, the cost was $672 higher in teaching hospitals, $1,153 higher in Rural areas, and increased in all regions compared with the Midwest (adjusted mean difference [95% confidence interval]-South: $293 [31 to 555], Northeast: $2,006 [1,517 to 2,495], West: $3,312 [2,930 to 3,695], all P < 0.05). CONCLUSIONS: In this large cohort of CLI patients, after controlling for potential confounders, we demonstrated that the cost of endovascular revascularization is significantly higher in patients undergoing DES than those undergoing BMS. Regional disparities in cost were also observed. Further studies looking at the long-term durability and costs of DES versus BMS are needed.

Temporal Trends in Coronary Angiography and Percutaneous Coronary Intervention: Insights From the VA Clinical Assessment, Reporting, and Tracking Program.

OBJECTIVES: The aim of this study was to evaluate temporal trends in characteristics and outcomes among patients referred for invasive coronary procedures within a national health care system for veterans. BACKGROUND: Coronary angiography and percutaneous coronary intervention remain instrumental diagnostic and therapeutic interventions for coronary artery disease. METHODS: All coronary angiographic studies and interventions performed in U.S. Department of Veterans Affairs cardiac catheterization laboratories for fiscal years 2009 through 2015 were identified. The demographic characteristics and management of these patients were stratified by time. Clinical outcomes including readmission (30-day) and mortality were assessed across years. RESULTS: From 2009 to 2015, 194,476 coronary angiographic examinations and 85,024 interventions were performed at Veterans Affairs facilities. The median numbers of angiographic studies (p = 0.81) and interventions (p = 0.22) remained constant over time. Patients undergoing these procedures were progressively older, with more comorbidities, as the proportion classified as having high Framingham risk significantly increased among those undergoing angiography (from 20% to 25%; p < 0.001) and intervention (from 24% to 32%; p < 0.001). Similarly, the median National Cardiovascular Data Registry CathPCI risk score increased for diagnostic (from 14 to 15; p = 0.005) and interventional (from 14 to 18; p = 0.002) procedures. Post-procedural medical management was unchanged over time, although there was increasing adoption of transradial access for diagnostic (from 6% to 36%; p < 0.001) and interventional (from 5% to 32%; p < 0.001) procedures. Complications and clinical outcomes also remained constant, with a trend toward a reduction in the adjusted hazard ratio for percutaneous coronary intervention mortality (hazard ratio: 0.983; 95% confidence interval: 0.967 to 1.000). CONCLUSIONS: Veterans undergoing invasive coronary procedures have had increasing medical complexity over time, without attendant increases in mortality among those receiving interventions. As the Department of Veterans Affairs moves toward a mix of integrated and community-based care, it will be important to account for these demographic shifts so that quality can be maintained.

Evolution of Coronary Stent Technology and Implications for Duration of Dual Antiplatelet Therapy.

Dual antiplatelet therapy (DAPT) has represented for decades the cornerstone of treatment for the prevention of ischemic complications, including stent thrombosis, in patients undergoing percutaneous coronary intervention (PCI). Despite the evolution in stent technologies, which has allowed the reduction in the minimum required duration of DAPT, the optimal duration of DAPT to ensure the best safety and efficacy still remains largely debated. Indeed, the results from investigations regarding the optimal DAPT duration based on stent type is limited. Overall, DAPT duration should be defined as a minimal period needed to prevent the vulnerable phase of having stent thrombosis, which may indeed be more stent specific, from that required for secondary prevention of ischemic complications, which may depend on the general risk profile of the patient. The present manuscript is an overview on the optimal duration of DAPT after stent implantation, providing an overview on the evolution of stent technology over the past decades and how this has impacted considerations on DAPT duration as well providing future perspectives in the field.

Trends of ureteral stent usage in surgery for diverticulitis.

BACKGROUND: Many believe that the use of ureteral stents in colorectal surgery for diverticulitis aids prevention and easier identification of ureteral injuries; others argue that the added time, cost, and risks of stent placement negate potential benefits. Even among providers who use stents, selective use is common. Among unclear consensus, it remains unknown if the use of stents is growing. MATERIALS: Patients in the National Inpatient Sample who underwent a partial colectomy or anterior rectal excision for diverticulitis between 2000 and 2013 were included (n = 811,071). Trends in ureteral stent use, multivariate logistic regression of factors influencing stent placement, and linear regression of length of stay (LOS) and costs associated with stent use were examined. RESULTS: Usage of ureteral stents increased from 6.66% in 2000 to 16.30% in 2013 (P < 0.0001). Rates of stent usage were higher with laparoscopic surgery (19.31% versus 12.31% open, P < 0.0001). Regression demonstrated patients in the Northeast (Midwest odds ratio (OR) 0.49 [0.37-0.66] P < 0.0001, South OR 0.60 [0.45-0.80] P = 0.0004, West OR 0.30 [0.22-0.41], P < 0.0001), and those whose admission was elective (OR 2.37 [2.08-2.69], P < 0.0001) were more likely to receive stents. Stent use was associated with an increased LOS (0.55 days, P < 0.0001) and cost ($1,983, P < 0.0001). CONCLUSIONS: The use of ureteral stents in surgery for diverticulitis has steadily increased since 2000, despite the lack of consensus of their overall benefit. Stent usage is associated with laparoscopic surgery and varies widely among regions of the country. Further studies are required to truly understand the risk-benefit ratio of ureteral stenting and to determine if its increased use is warranted.

Emerging Technologies in Flow Diverters and Stents for Cerebrovascular Diseases.

PURPOSE OF REVIEW: Stents and flow diverters have revolutionized the treatment of cerebrovascular disease. Guglielmi coils, flexible microcatheters, and first-generation intracranial stents, such as Neuroform (Stryker Neurovascular) and Enterprise stents (Codman/DePuy-Synthes), have paved the way for the development of the Pipeline Embolization Device (PED) (ev3/Covidien/Medtronic) and other endovascular approaches. RECENT FINDINGS: This review discusses the historical development of flow diverter technologies from the PED to similar devices, such as the Surpass stent (Stryker Neurovascular), the Flow-Redirection Endoluminal Device (FRED; MicroVention, Inc.), the SILK stent (Balt Extrusion), and the p64 Flow Modulation Device (Phenox). In addition, the potential use of drug-eluting stents and various bioresorbable scaffolds (e.g., poly-L-lactic acid, magnesium), new developments in stent material (e.g., thin-film nitinol), design (e.g., biocompatible polymers, embedded microcircuitry, flow models), and potential applications for flow diverters will be considered. Endovascular treatment of cerebrovascular disease is rapidly advancing via continued development of new technology.

Carotid Endarterectomy and Carotid Artery Stenting in the US Medicare Population, 1999-2014.

Importance: Carotid endarterectomy and carotid artery stenting are the leading approaches to revascularization for carotid stenosis, yet contemporary data on trends in rates and outcomes are limited. Objective: To describe US national trends in performance and outcomes of carotid endarterectomy and stenting among Medicare beneficiaries from 1999 to 2014. Design, Setting, and Participants: Serial cross-sectional analysis of Medicare fee-for-service beneficiaries aged 65 years or older from 1999 to 2014 using the Medicare Inpatient and Denominator files. Spatial mixed models adjusted for age, sex, and race were fit to calculate county-specific risk-standardized revascularization rates. Mixed models were fit to assess trends in outcomes after adjustment for demographics, comorbidities, and symptomatic status. Exposures: Carotid endarterectomy and carotid artery stenting. Main Outcomes and Measures: Revascularization rates per 100 000 beneficiary-years of fee-for-service enrollment, in-hospital mortality, 30-day stroke or death, 30-day stroke, myocardial infarction, or death, 30-day all-cause mortality, and 1-year stroke. Results: During the study, 937 111 unique patients underwent carotid endarterectomy (mean age, 75.8 years; 43% women) and 231 077 underwent carotid artery stenting (mean age, 75.4 years; 49% women). There were 81 306 patients who underwent endarterectomy in 1999 and 36 325 in 2014; national rates per 100 000 beneficiary-years decreased from 298 in 1999-2000 to 128 in 2013-2014 (P < .001). The number of patients who underwent stenting ranged from 10 416 in 1999 to 22 865 in 2006 (an increase per 100 000 beneficiary-years from 40 in 1999-2000 to 75 in 2005-2006; P < .001); by 2014, there were 10 208 patients who underwent stenting and the rate decreased to 38 per 100 000 beneficiary-years (P < .001). Outcomes improved over time despite increases in vascular risk factors (eg, hypertension prevalence increased from 67% to 81% among patients who underwent endarterectomy and from 61% to 70% among patients who underwent stenting) and the proportion of symptomatic patients (all P < .001). There were adjusted annual decreases in 30-day ischemic stroke or death of 2.90% (95% CI, 2.63% to 3.18%) among patients who underwent endarterectomy and 1.13% (95% CI, 0.71% to 1.54%) among patients who underwent stenting; an absolute decrease from 1999 to 2014 was observed for endarterectomy (1.4%; 95% CI, 1.2% to 1.5%) but not stenting (-0.1%; 95% CI, -0.5% to 0.4%). Rates for 1-year ischemic stroke decreased after endarterectomy (absolute decrease, 3.5% [95% CI, 3.2% to 3.7%]; adjusted annual decrease, 2.17% [95% CI, 2.00% to 2.34%]) and stenting (absolute decrease, 1.6% [95% CI, 1.2% to 2.1%]; adjusted annual decrease, 1.86% [95% CI, 1.45%-2.26%]). Additional improvements were noted for in-hospital mortality, 30-day stroke, myocardial infarction, or death, and 30-day all-cause mortality as well as within demographic subgroups. Conclusions and Relevance: Among fee-for-service Medicare beneficiaries, the performance of carotid endarterectomy declined from 1999 to 2014, whereas the performance of carotid artery stenting increased until 2006 and then declined from 2007 to 2014. Outcomes improved despite increases in vascular risk factors.

Comparison of cost of care for tethered versus non-tethered ureteric stents in the management of uncomplicated upper urinary tract stones.

BACKGROUND: Many surgeons use a stent after ureteroscopic lithotripsy (URSL). For short-term stenting purposes, a surgeon has the choice of either a tethered or a non-tethered stent. Stents may be associated with complications that entail an additional cost to their use. There is a paucity of data on the direct healthcare cost of using stent type after either primary or secondary URSL. METHODS: We retrospectively reviewed medical records for patients who underwent URSL for uncomplicated urolithiasis between January 2013 and December 2013 at two tertiary referral hospitals. Costs data was sourced from the costing department with complete data available for 134 patients. The overall medical care cost was estimated by computing the cost of surgery, stent-related emergency department presentations, re-admissions and stent removal. RESULTS: A total of 113 patients had tethered stents and 21 had non-tethered stents, with similar age and gender composition between the two groups and complications rates. The mean cost of URSL and stent placement was A$3071.7 ± A$906.8 versus A$3423.8 ± A$808.4 (P = 0.049), mean cost of managing complications was A$309.4 ± A$1744.8 versus A$31.3 ± A$98.9 (P = 0.096), mean cost of out-patient clinic stent removal was A$222.5 ± A$60 versus A$1013.6 ± A$75.4 (P < 0.001) for endoscopic stent removal, overall mean cost of care was A$3603.6 ± A$1896.7 versus A$4468.1 ± A$820.8 (P = 0.042) for tethered and non-tethered stents, respectively. CONCLUSION: It is cheaper to use a tethered ureteric stent compared with non-tethered stents for short-term stenting after uncomplicated URSL, with a mean cost saving of A$864.5.

Editor's Choice - Carotid Stenosis Treatment: Variation in International Practice Patterns.

OBJECTIVES: The aim was to determine current practice for the treatment of carotid stenosis among 12 countries participating in the International Consortium of Vascular Registries (ICVR). METHODS: Data from the United States Vascular Quality Initiative (VQI) and the Vascunet registry collaboration (including 10 registries in Europe and Australasia) were used. Variation in treatment modality of asymptomatic versus symptomatic patients was analysed between countries and among centres within each country. RESULTS: Among 58,607 procedures, octogenarians represented 18% of all patients, ranging from 8% (Hungary) to 22% (New Zealand and Australia). Women represented 36%, ranging from 29% (Switzerland) to 40% (USA). The proportion of carotid artery stenting (CAS) among asymptomatic patients ranged from 0% (Finland) to 26% (Sweden) and among symptomatic patients from 0% (Denmark) to 19% (USA). Variation among centres within countries for CAS was highest in the United States and Australia (from 0% to 80%). The overall proportion of asymptomatic patients was 48%, but varied from 0% (Denmark) to 73% (Italy). There was also substantial centre level variation within each country in the proportion of asymptomatic patients, most pronounced in Australia (0-72%), Hungary (5-55%), and the United States (0-100%). Countries with fee for service reimbursement had higher rates of treatment in asymptomatic patients than countries with population based reimbursement (OR 5.8, 95% CI 4.4-7.7). CONCLUSIONS: Despite evidence about treatment options for carotid artery disease, the proportion of asymptomatic patients, treatment modality, and the proportion of women and octogenarians vary considerably among and within countries. There was a significant association of treating more asymptomatic patients in countries with fee for service reimbursement. The findings reflect the inconsistency of the existing guidelines and a need for cooperation among guideline committees all over the world.

Trends in Bare-Metal Stent Use in the United States in Patients Aged ≥65 Years (from the CathPCI Registry).

In 2006, the United States (US) Food and Drug Administration published advisory highlighting concerns for late drug-eluting stent thrombosis; its impact on US bare-metal stent (BMS) utilization is unknown. We examined rates of BMS use among Medicare patients at 946 US hospitals in the CathPCI Registry who underwent percutaneous coronary intervention (PCI) during 3 periods: (1) 2004 to 2006 preadvisory (n = 166,458); (2) 2007 to 2008 postadvisory (n = 216,318); and (3) 2012 to 2014 contemporary (n = 827,948). We examined predicted risks of target vessel revascularization and bleeding among BMS recipients by period. We compared 1-year repeat revascularization and death/myocardial infarction risks among BMS recipients immediately preadvisory and postadvisory. BMS were used in 15.8% of preadvisory, 40.9% of postadvisory, and 20.0% of contemporary PCI procedures. Although 19.5% of preadvisory BMS patients had a predicted target vessel revascularization risk ≥15%/year, this decreased to 16.7% postadvisory (p <0.001), and increased back to 18.7% among contemporary BMS recipients (p <0.001). In contrast, 12.3% of preadvisory BMS recipients had a predicted bleeding risk ≥5%/year, compared with 14.6% postadvisory (p <0.001), and 18.2% in contemporary BMS recipients (p <0.001). Postadvisory BMS recipients had a lower risk of repeat revascularization (12.8% vs 14.6%, adjusted hazard ratio 0.87, 95% CI 0.84 to 0.90) but no difference in the composite risk of death/myocardial infarction (15.9% vs 15.9%, adjusted hazard ratio 0.97, 95% CI 0.93 to 1.00). In conclusion, a surge in BMS use after the advisory was not associated with an increased risk of repeat revascularization or adverse outcomes in BMS-treated patients. One in 5 contemporary PCI procedures still involve BMS implantation.