Cost to Medicare of acute kidney injury in percutaneous coronary intervention.

BACKGROUND: Acute kidney injury (AKI), including contrast-induced AKI (CI-AKI), is an important complication of percutaneous coronary intervention (PCI), resulting in short- and long-term adverse clinical outcomes. While prior research has reported an increased cost burden to hospitals from CI-AKI, the incremental cost to payers remains unknown. Understanding this incremental cost may inform decisions and even policy in the future. The objective of this study was to estimate the short- and long-term cost to Medicare of AKI overall, and specifically CI-AKI, in PCI. METHODS: Patients undergoing inpatient PCI between January 2017 and June 2020 were selected from Medicare 100% fee-for-service data. Baseline clinical characteristics, PCI lesion/procedural characteristics, and AKI/CI-AKI during the PCI admission, were identified from diagnosis and procedure codes. Poisson regression, generalized linear modelling, and longitudinal mixed effects modelling, in full and propensity-matched cohorts, were used to compare PCI admission length of stay (LOS) and cost (Medicare paid amount inflated to 2022 US$), as well as total costs during 1-year following PCI, between AKI and non-AKI patients. RESULTS: The study cohort included 509,039 patients, of whom 104,033 (20.4%) were diagnosed with AKI and 9,691 (1.9%) with CI-AKI. In the full cohort, AKI was associated with +4.12 (95% confidence interval = 4.10, 4.15) days index PCI admission LOS, +$11,313 ($11,093, $11,534) index admission costs, and +$14,800 ($14,359, $15,241) total 1-year costs. CI-AKI was associated with +3.03 (2.97, 3.08) days LOS, +$6,566 ($6,148, $6,984) index admission costs, and +$13,381 ($12,118, $14,644) cumulative 1-year costs (all results are adjusted for baseline characteristics). Results from the propensity-matched analyses were similar. CONCLUSIONS: AKI, and specifically CI-AKI, during PCI is associated with significantly longer PCI admission LOS, PCI admission costs, and long-terms costs.

Postoperative Anticoagulation in Vascular Reconstructions Associated with Malignancies.

BACKGROUND: The invasion of truncal arteries and veins by malignant neoplasms is rare and the surgical treatment remains a challenge. Several techniques can be used to re-establish blood flow in a resected vessel and choice of the ideal vascular substitute frequently arises a debate. Comparative studies between prosthetic and autologous grafts disclose conflicting patency results. The aim of this study is to compare patency outcomes of vascular reconstructions performed using autologous or prosthetic replacement grafts in surgical oncology, in light of a standardized antithrombotic protocol used in our institution since 1997. METHODS: This retrospective study compared patency of prosthetic versus autologous interposition grafts following the resection of malignancies in 117 patients between September 1997 and February 2020. The 181 reconstruction procedures performed were analyzed according to the body segment involved, and divided into: head and neck, thorax, abdomen, and extremities. RESULTS: Overall survival estimates after 24 and 60 months were 53.2% (standard error 4.8%) and 38.1% (standard error 4.9%), respectively. No significant difference was observed between overall arterial patency, using autologous or synthetic grafts (P = 0.41). Overall venous patency showed a tendency to be lower in synthetic grafts, although no significant difference was observed (P = 0.062). For both arterial and venous reconstructions in the extremities (upper and lower limbs), significantly higher patency was observed using autologous grafts. CONCLUSIONS: Autologous long-term graft patency may be superior to prosthetic in vascular reconstructions associated with malignancies of the extremities. This outcome was obtained using a standardized post-operative anticoagulation protocol.

Seroprevalence of SARS-CoV-2 antibodies in the poorest region of Brazil: results from a population-based study.

Population-based seroprevalence studies on coronavirus disease 2019 (COVID-19) in low- and middle-income countries are lacking. We investigated the seroprevalence of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) antibodies in Sergipe state, Northeast Brazil, using rapid IgM-IgG antibody test and fluorescence immunoassay. The seroprevalence was 9.3% (95% CI 8.5-10.1), 10.2% (95% CI 9.2-11.3) for women and 7.9% (IC 95% 6.8-9.1) for men (P = 0.004). We found a decline in the prevalence of SARS-CoV-2 antibodies according to age, but the differences were not statistically significant: 0-19 years (9.9%; 95% CI 7.8-12.5), 20-59 years (9.3%; 95% CI 8.4-10.3) and ≥60 years (9.0%; 95% CI 7.5-10.8) (P = 0.517). The metropolitan area had a higher seroprevalence (11.7%, 95% CI 10.3-13.2) than outside municipalities (8.0%, 95% CI 7.2-8.9) (P < 0.001). These findings highlight the importance of serosurveillance to estimate the real impact of the COVID-19 outbreak and thereby provide data to better understand the spread of the virus, as well as providing information to guide stay-at-home measures and other policies. In addition, these results may be useful as basic data to follow the progress of COVID-19 outbreak as social restriction initiatives start to be relaxed in Brazil.

Inferior Vena Cava Filter in Cancer Patients: On Whom Should We Be Placing Them?

BACKGROUND: Standard treatment for venous thromboembolism is anticoagulation; vena cava filter placement is an alternative in special situations. We aimed to evaluate the outcomes in patients with cancer undergoing filter placement in a cancer center during a 10-year period and assess which preoperatory variables were associated with poorer survival. METHODS: Retrospective unicenter analysis during a 10-year period was carried out in patients with cancer who had undergone placement of vena cava filter. Early deaths were those that occurred less than 30 days after the filter placement or that occurred during the same hospital stay of the placement. RESULTS: About 250 patients were analyzed. About 51.6% were females; 77.2% had proximal lower limb deep vein thrombosis; 34.8% had contraindications to anticoagulation; 32.8% presented bleeding after the onset of anticoagulation; and 18.4% had the filter implanted because they were going to undergo surgery and could not be anticoagulated immediately after. About 51.2% of the filters were removable. However, only 2 had the filter removed. About 59.2% had metastatic disease at the time of filter placement. About 31.2% fulfilled criteria for early death. Of those, 34 patients were put in palliative care after filter insertion (median, 13.5 days). Body mass index >18 kg/m2, the absence of metastatic disease, and filter placement during the same anesthesia of another surgery (especially if elective and curative) were associated with a higher chance of survival. CONCLUSIONS: Multidisciplinary evaluation (and possibly consideration for palliation) should take place before the decision to insert a vena cava filter in severe oncologic cases depending on overall status. Patients with a greater chance of survival at a 3 or 5 years interval seem to be those whose filters were placed in the perioperative context of other surgeries (specially elective and curative), who were not undernourished, and whose disease was not metastatic at that time. For patients who survived, an active investigation protocol for filter removal should be implemented.

The Role of the Heart Team in Patients with Diffuse Coronary Artery Disease Undergoing Coronary Artery Bypass Grafting.

BACKGROUND: In patients eligible for coronary artery bypass grafting, no data assess the importance of the Heart Team in programming the best surgical strategy for patients with diffuse coronary artery disease (CAD). This study aims to determine the contribution of the Heart Team in predicting the feasibility of coronary artery bypass graft and angiographic surgical success in these patients based on visual angiographic analysis. METHODS: Patients with diffuse and severe CAD undergoing incomplete coronary artery bypass graft surgery were prospectively included. One-year postoperative coronary angiograms were obtained to evaluate graft occlusion. Two clinical cardiologists, two cardiovascular surgeons, and one interventional cardiologist retrospectively analyzed preoperative angiograms. A subjective scale was applied at a single moment to quantify the chance of successful coronary artery bypass grafting for each coronary territory with anatomical indication for revascularization. Based on individual scores, the Heart Team's and the specialists' scores were calculated and compared. RESULTS: The examiners evaluated 154 coronary territories, of which 85 (55.2%) were protected. The Heart Team's accuracy for predicting the angiographic success of the surgery was 74.9%, almost equal to that of the surgeons alone (73.2%). Only the interventional cardiologist predicted left anterior descending territory grafting success. The Heart Team had good specificity and reasonable sensitivity, and the surgeons had high sensitivity and low specificity in predicting angiographic success. CONCLUSION: The multispecialty Heart Team achieved good accuracy in predicting the angiographic coronary artery bypass graft success in patients with diffuse CAD, with a high specificity and reasonable sensitivity.

Orthognathic surgery in class II patients: a longitudinal study on quality of life, TMD, and psychological aspects.

OBJECTIVES: To evaluate, longitudinally, the impacts of orthognathic surgery in patients with skeletal class II malocclusion on oral health-related quality of life (OHRQoL), temporomandibular disorders (TMD) and psychological symptoms. MATERIALS AND METHODS: Forty-three patients with skeletal class II malocclusion who were submitted to orthognathic surgery were evaluated during their preoperative and postoperative periods. They answered the short version of the Oral Health Impact Profile (OHIP-14) and were also diagnosed according to Axes I and II of the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). The evolution of OHRQoL and TMD before and after surgery was verified, and the relationships among these variables were found through statistical analysis using Wilcoxon, McNemar, chi-square, and Mann-Whitney tests, with a 5% significance level. RESULTS: The median of the overall OHIP-14 score and five domains decreased after orthognathic surgery (p < 0.05), the functional limitation domain increased (p = 0.014), and the physical disability domain did not show an association (p = 0.133). There were improvements in articular pain (p = 0.016), chronic pain (p = 0.019), and nonspecific physical symptoms excluding pain (p = 0.013). In addition, an association was found between poorer OHRQoL (overall scale and domains) and the Axis II variables of the RDC/TMD (p < 0.05). CONCLUSION: Orthognathic surgery improved perceived OHRQoL, articular pain, and chronic pain. The conditions of Axis II of the RDC/TMD interfered with OHRQoL postoperatively. CLINICAL RELEVANCE: Although orthognathic surgery improves QoL and some TMD conditions in skeletal class II patients, poorer postoperative outcomes are observed when psychological conditions are present.

Mapping the technological landscape of SARS, MERS, and SARS-CoV-2 vaccines.

PURPOSE: The last two decades have seen the emergence of several viral outbreaks. Some of them are the severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), and severe acute respiratory syndrome 2 (SARS-CoV2) - the cause of the coronavirus disease 2019 (COVID-19). Ever, vaccines for emergency use have been authorized for the control and prevention of COVID-19. Currently, there is an urgent need to develop a vaccine for prophylaxis of COVID-19 and for other future epidemics. METHODS: This review describes patented vaccines for SARS and MERS-CoV and vaccines developed and approved for emergency use against the new coronavirus (COVID-19). The European Patent Office and the World Intellectual Property Organization were the patent databases used using specific terms. In addition, another search was carried out in the Clinical Trials in search of ongoing clinical studies focused on the COVID-19 vaccine. RESULTS: The patent search showed that most vaccines are based on viral vector platforms, nucleic acids, or protein subunits. The review also includes an overview of completed and ongoing clinical trials for SARS-CoV-2 in several countries. CONCLUSION: The information provided here lists vaccines for other types of coronavirus that have been used in the development of vaccines for COVID-19.

Percutaneous endovascular delivery of calcium chloride to the intact porcine carotid artery: A novel animal model of arterial calcification.

OBJECTIVE: The present study evaluated the effect of endovascular administration of calcium chloride to the carotid artery of swines, to create a model of arterial calcification. METHODS: Fifteen Large White pigs were used for the study. Via endovascular treatment, carotid arteries were exposed during 9 min to either calcium chloride (experimental artery) or saline (control artery) with the use of the TAPAS catheter. Intravascular ultrasound (IVUS) imaging was obtained at baseline, postprocedure and at 30 days. Optical coherence tomography (OCT) imaging was obtained in vitro after carotids were harvested. Longitudinally cut parallel arterial segments were placed in a system of delicate clamps and underwent uniaxial strain test. All arteries underwent histopathological examination. RESULTS: Calcium chloride treated segments showed extensive circumferential parietal calcification evident on both IVUS and OCT. Reduction in minimal lumen area on IVUS was evident in experimental arteries both at 24 hr and 30 days postprocedure. Histopathologic assessment (Von Kossa stain) confirmed medial calcification with mild intimal thickening. Biomechanical testing showed treated segments to have smaller breaking strength and less elastic deformation than controls. CONCLUSION: We developed a nonexpensive, reproducible model of early carotid medial calcification in pigs. Our model has the potential to help the development of research to unravel mechanisms underlying arterial calcification, the use of current or new devices to treat calcified lesions as well as to serve as an option for training interventionalists on the use of such devices.

Depression, temporomandibular disorders, and genetic polymorphisms in IL6 impact on oral health-related quality of life in patients requiring orthognathic surgery.

PURPOSE: To assess oral health-related quality of life (OHRQoL) in patients requiring orthognathic surgery, and evaluate if depression, temporomandibular disorders (TMD), and genetic polymorphisms in interleukin-6 (IL6) influence their OHRQoL. METHODS: A total of 132 individuals included in three different groups. Two groups were composed by patients with dentofacial deformity (DFD) Class II (n = 44) or Class III (n = 44) malocclusions, requiring orthognathic surgery. The control group (n = 44) included individuals without DFD. Patients from all groups were evaluated in preoperative appointments to assessOHRQoL, TMD, and genetic polymorphisms in IL6. OHRQoL was assessed using the 14-item Oral Health Impact Profile (OHIP-14). TMD and depression were assessed using Research Diagnostic Criteria for Temporomandibular Disorders protocol. The genetic polymorphisms rs1800795 and rs1800796 in IL6 were assessed through genomic DNA using real-time polymerase chain reaction. RESULTS: OHIP-14 scores were increased in patients with depression, myofascial pain, and inflammatory temporomandibular joint alterations in the right side, regardless of sex and DFD group. Individual homozygous CC in rs1800795 had increased values in domains "social disability" and "handicap" of the OHIP-14 compared with those who were homozygous GG. Individual heterozygous CG in the rs1800796 demonstrated increased values in domain "psychological discomfort" compared with those homozygous for CC and GG. CONCLUSION: In individuals requiring orthognathic surgery, depression, TMD, and genetic polymorphisms in IL6 contribute to negative impact on OHRQoL. These physical and emotional conditions, together with biological pathways, should receive more attention in treatment plans, in order to improve the patients' quality of life.

Association between oestrogen receptors and female temporomandibular disorders.

Objective: To evaluate if temporomandibular disorders (TMDs) are associated with genetic polymorphisms in ESR1 and ESR2, which are genes encoding oestrogen receptor alpha (ERα) and beta (ERß). Also, we included an animal model to check if ERα and ERß are expressed in the temporomandibular joint (TMJ) during adolescence.Materials and methods: A total of 139 teenagers and 93 adults were diagnosed according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMDs). The DNA was collected and the markers ESR1 and ERS2 were genotyped. Additionally, immunohistochemistry was performed in TMJ tissues from female Wistar rats during puberty. All data were submitted to statistical analysis with confidence interval of 95%.Results: Teenagers presented more disc displacement and arthralgia than adults (p < .05). The genetic polymorphism rs1256049 in ESR2 was associated with disc displacement (p = .040; OR = 10.50/95%CI 1.17-98.74) and arthralgia (p = .036; OR = 7.20/95%CI 1.10-46.88) in adults. The ERα and ERß are expressed in rat TMJ tissues.Conclusions: We provide evidence that ESR2 is associated with TMD and could be a genetic marker for this condition in adult women. Furthermore, oestrogens receptors are presented in TMJ of adolescent female rats.

An alternative approach to treatment of inferior vena cava filter perforation.

We report a case of inferior vena cava filter perforation immediately after filter implantation, recognized intraoperatively in a patient undergoing laparotomy for resection of locally advanced ovarian cancer. We describe an alternative approach with strut resection, less invasive than filter removal, enabling the device to be maintained and bleeding to be controlled.

Relatamos um caso de perfuração de veia cava inferior imediatamente após o implante de um filtro. A complicação foi reconhecida no intraoperatório de uma laparotomia para ressecção de um câncer de ovário localmente avançado. Descrevemos uma abordagem alternativa, menos invasiva do que a remoção do filtro, consistindo na ressecção das hastes do dispositivo. Essa abordagem permitiu a manutenção do filtro e o controle efetivo do sangramento.

Twenty years of experience in vascular reconstructions associated with resection of malignant neoplasms in a single cancer center.

OBJECTIVE: Vascular invasion is no longer considered to be an absolute contraindication to tumor removal, and complex reconstructions are part of the daily activity of vascular surgeons in specialized cancer centers. Our aim was to report a single-center experience of complex vascular reconstructions involving en bloc resection of tumors and patients' long-term survival and graft patency outcomes. To the best of our knowledge, this is the largest report of vascular reconstructions published to date, with the longest follow-up. METHODS: Between September 1997 and January 2016, there were 91 patients who underwent 92 arterial and 47 venous reconstruction procedures in this retrospective cohort study. Long-term survival and patency outcomes were analyzed for all study patients and individually assessed in different body segments (head and neck, thorax, upper limbs, abdomen, and lower limbs). RESULTS: The estimated mean and median follow-up times were 112.66 and 100 months, respectively. The 24- and 60-month survival estimates for the patients overall were 55.3% and 31.1%, respectively. Survival estimates were significantly lower in the head and neck cases compared with the other body segments. The primary arterial patency rates at 24 and 60 months were 96.7% and 84.9%, respectively, and they were similar in all body segments. The venous patency rates were 71.4% and 64.2% at 24 and 60 months, respectively. Seven cases (7.6%) of arterial vascular complications were observed. CONCLUSIONS: Vascular reconstruction performed in conjunction with oncologic resection is a feasible treatment option for tumors with vessel involvement. When surgery is performed in specialized centers, low perioperative morbidity and long-term patency rates are expected irrespective of the vascular territory undergoing intervention.

Application of the MADS classification system in a "mega mammoth" stent trial: Feasibility and preliminary clinical implications.

OBJECTIVES AND BACKGROUND: We attempted to test the feasibility of application of the MADS classification system in the largest stent trial to date and evaluate the preliminary clinical implications of this approach. METHODS: In the randomized GLOBAL LEADERS trial, testing two different antiplatelet strategies in patients undergoing PCI with bivalirudin and biolimus-eluting stents, the e-CRF was dedicated to bifurcation treatment according to the MADS classification. Based on this e-CRF, the techniques used for bifurcations treatment in GLOBAL LEADERS were described and compared with two large, all-comer registries of bifurcations treatment (I-BIGIS and COBIS), used as historical controls. RESULTS: Among 15,991 patients enrolled in the trial, 22,921 lesions treated at the index and staged procedure were available for analysis and 2,757 of these lesions were bifurcations and 7 were trifurcation lesions. The e-CRF-based MADS classification was achieved in 2,757 of these lesions (100%). 80.3% of bifurcations were treated using a single stent, 18.9% using 2 stents and 0.7% using 3 stents. Overall, the "main across side first" approach (A) was used in 77.4% with the "side branch first" approach (S) being the second most frequently used technique (10.2%). A single stent was used in the majority of the "A" approach (87.9%). A reduction in the use of 2-stent techniques (from 33.9 to 18.9%) was observed between GLOBAL LEADERS and I-BIGIS. The "A" approach was the most frequently used technique in GLOBAL LEADERS, while in COBIS the "S" strategy was most frequently employed. CONCLUSIONS: Application of the MADS classification through an e-CRF was feasible in the largest stent trial today and provided useful information about the trends observed overtime in the treatment of bifurcation lesions.

Safety and Effectiveness of Suture-mediated Arterial Closure Device in Hepatocellular Carcinoma Patients Who Underwent Drug-Eluting Beads Transarterial Chemoembolization.

BACKGROUND: The number of transarterial percutaneous procedures has risen over the years, consequently reducing puncture site related complications has become a necessity. To this end, the use of arterial closure devices has been growing progressively and their benefits have become a focus of research. The purpose of this study is to assess the safety and effectiveness of a suture-mediated closure device, Perclose ProGlide® (Abbott Vascular, Redwood City, CA), in patients with liver disease and hepatocellular carcinoma who underwent transarterial liver chemoembolization with drug-eluting beads. MATERIALS AND METHODS: A cohort of 253 hepatocellular carcinoma patients who underwent 449 procedures of transarterial liver chemoembolization with drug-eluting beads using the Perclose Proglide device was prospectively studied. The main endpoints evaluated were the technical success of the device, defined as complete hemostasis achieved within 3 min after the closure, and the incidence of puncture-site complications. The secondary endpoints evaluated were the correlation between epidemiological factors, coagulation profile and degree of liver disease, and the occurrence of complications. RESULTS: Technical success was achieved in 96% of the cases. Among patients who underwent repeated procedures using the same vascular access, this rate was 95.3%. Puncture-site complications were observed in 7 procedures (1.56%); 4 (0.89%) were due to hemorrhage, 2 (0.44%) hematomas and 2 (0.44%) pseudoaneurysms; 2 (0.44%) due to limb ischemia; and 1 (0.22%) due to arterial dissection. Among them, 3 cases required intervention. The statistical analysis of demographic characteristics, Child-Pugh classification, and coagulation status did not show a significant correlation with the occurrence of complications. Of the 449 procedures, only 4 (0.89%) needed hospitalization due to puncture-site complications. CONCLUSIONS: The use of Perclose Proglide is safe and effective in patients with liver disease and hepatocellular carcinoma who underwent transarterial liver chemoembolization with drug-eluting beads.

Hemodynamic analysis of a novel bioresorbable scaffold in porcine coronary artery model.

BACKGROUND: The shear stress distribution assessment can provide useful insights for the hemodynamic performance of the implanted stent/scaffold. Our aim was to investigate the effect of a novel bioresorbable scaffold, Mirage on local hemodynamics in animal models. METHOD: The main epicardial coronary arteries of 7 healthy mini-pigs were implanted with 11 Mirage Microfiber sirolimus-eluting Bioresorbable Scaffolds (MMSES). Optical coherence tomography (OCT) was performed post scaffold implantation and the obtained images were fused with angiographic data to reconstruct the coronary artery anatomy. Blood flow simulation was performed and Endothelial Shear Stress(ESS) distribution was estimated for each of the 11 scaffolds. ESS data were extracted in each circumferential 5-degree subunit of each cross-section in the scaffolded segment. The generalized linear mixed-effect analysis was implemented for the comparison of ESS in two scaffold groups; 150-µm strut thickness MMSES and 125-µm strut thickness MMSES. RESULTS: ESS was significantly higher in MMSES (150 µm) [0.85(0.49-1.40) Pa], compared to MMSES (125 µm) [0.68(0.35-1.18) Pa]. Both MMSES (150 µm) and MMSES (125 µm) revealed low recirculation zone percentages per luminal surface area [3.17% ± 1.97% in MMSES (150 µm), 2.71% ± 1.32% in MMSES (125 µm)]. CONCLUSION: Thinner strut Mirage scaffolds induced lower shear stress due to the small size vessels treated as compared to the thick strut version of the Mirage which was implanted in relatively bigger size vessels. Vessel size should be taken into account in planning BRS implantation. Small vessels may not get benefit from BRS implantation even with a streamlined strut profile. This pilot study warrants comparative assessment with commercially available bioresorbable scaffolds.

Determinants of success and hemodynamic impact of balloon postdilatation of self-expanding transcatheter aortic valves.

OBJECTIVES: To explore the rate, the determinants of success, and the hemodynamic impact of balloon postdilatation (BPD) of self-expanding transcatheter heart valves (SE-THVs) BACKGROUND: BPD is commonly used to optimize valve expansion and reduce paravalvular leakage (PVL) after transcatheter aortic valve implantation (TAVI) without clearly knowing its hemodynamic benefits. METHODS: Patients (n = 307) who received a SE-THV were stratified according to whether a BPD was performed or not. Patients who received BPD were stratified according to the severity of PVL remaining after BPD into two groups: Successful BPD (≤mild PVL + BPD) and Failed BPD (moderate-severe PVL + BPD). RESULTS: BPD was performed in 121 patients (39.4%) and was successful in 106 patients (87.6% of attempts). A ratio of the postdilatation balloon diameter to the annulus diameter ≤0.95 was an independent predictor of BPD failure (OR: 10.72 [2.02-56.76], P = .005). Peak transvalvular pressure gradient (PG) was lower in the Successful BPD group (14[12-22] mm Hg) than in the Failed BPD group (18[16-23] mm Hg, P = .029), and did not rise in either group during follow-up (median [IQR], 364[161-739] days). CONCLUSION: BPD was performed in 39% of patients who received a SE-THV, and was successful in the majority of attempts. BPD failure was more likely in patients with a small postdilatation balloon-to-annulus diameter ratio. Effective BPD improved THV hemodynamic performance, and this was maintained in the intermediate-term post-TAVI.

Comparison between Saline Solution Containing Heparin versus Saline Solution in the Lock of Totally Implantable Catheters.

BACKGROUND: There are only 3 studies comparing the efficacy of 2 different types of lock used in totally implantable catheters regarding occlusion or reflux dysfunction. The present study contains the largest published casuistry (862 patients) and is the only one that analyzes 3 parameters: occlusion, reflux dysfunction, and flow dysfunction. METHODS: This was a retrospective study of patients operated at a large oncology center and followed up in the outpatient clinic between 2007 and 2015. The patients were divided into 2 groups according to the type of lock: the Hep group (heparine), whose lock was composed of saline solution 0.9% with heparin (100 IU/mL) and the SS group (saline solution), whose lock was composed of saline solution 0.9%. RESULTS: The Hep group was composed of 270 patients (31%) and the SS group of 592 patients (69%). Regarding occlusion, there were 8 cases in the Hep group (2.96%) and 8 in the SS group (1.35%; P = 0.11); in relation to reflux dysfunction, there were 8 cases in the Hep group (2.96%) and 8 in the SS group (1.35%; P = 0.11); in relation to flow dysfunction, there was 1 case in the Hep group (0.37%) and 4 cases in the SS group (0.68%; P = 1). CONCLUSIONS: There was no statistically significant difference between the groups regarding occlusion, reflux dysfunction, and flow dysfunction.

Impact of the SYNTAX scores I and II in patients with diabetes and multivessel coronary disease: a pooled analysis of patient level data from the SYNTAX, PRECOMBAT, and BEST trials.

AIMS: To assess the impact of the SYNTAX scores I and II in outcomes after percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) for patients with diabetes and multivessel disease (MVD). METHODS AND RESULTS: We performed a patient-level pooled analysis of three large randomized trials of patients with MVD. The impact of coronary anatomic complexity as measured by the SYNTAX score in the differences in outcomes following PCI and CABG was assessed at a median follow-up of 5 years. We also assessed the performance of the SYNTAX II score model in patients with and without diabetes. From the 3280 patients enrolled in the three trials, a total of 1068 (32.6%) had diabetes. The rate of the composite of death, myocardial infarction (MI), or stroke was similar in the PCI and CABG arms in patients with low-intermediate (≤32) SYNTAX scores (15.1% vs. 14.9%, respectively; P = 0.93) while it was significantly higher in the PCI arm in patients with high (≥33) SYNTAX scores (24.5% vs. 13.2%, respectively; P = 0.018). The SYNTAX score II showed good calibration and moderate discrimination ability in patients with diabetes (c-index = 0.68) as well as in those without (c-index = 0.67). CONCLUSIONS: Differences in 5 years outcomes following PCI and CABG for patients with MVD and diabetes were influenced by anatomic complexity as measured by the SYNTAX score. The SYNTAX score II mortality prediction model showed similar performance regardless of the diabetes status.

Late thrombotic events after bioresorbable scaffold implantation: a systematic review and meta-analysis of randomized clinical trials.

AIMS: To compare the long-term safety and efficacy of bioresorbable vascular scaffold (BVS) with everolimus-eluting stent (EES) after percutaneous coronary interventions. METHODS AND RESULTS: A systematic review and meta-analysis of randomized clinical trials comparing clinical outcomes of patients treated with BVS and EES with at least 24 months follow-up was performed. Adjusted random-effect model by the Knapp-Hartung method was used to compute odds ratios (OR) and 95% confidence intervals (CI). The primary safety outcome of interest was the risk of definite/probable device thrombosis (DT). The primary efficacy outcome of interest was the risk of target lesion failure (TLF). Five randomized clinical trials (n = 1730) were included. Patients treated with Absorb BVS had a higher risk of definite/probable DT compared with patients treated with EES (OR 2.93, 95%CI 1.37-6.26, P = 0.01). Very late DT (VLDT) occurred in 13 patients [12/996 (1.4%, 95%CI: 0.08-2.5) Absorb BVS vs. 1/701 (0.5%, 95%CI: 0.2-1.6) EES; OR 3.04; 95%CI 1.2-7.68, P = 0.03], 92% of the VLDT in the BVS group occurred in the absence of dual antiplatelet therapy (DAPT). Patients treated with Absorb BVS had a trend towards higher risk of TLF (OR 1.48, 95%CI 0.90-2.42, P = 0.09), driven by a higher risk of target vessel myocardial infarction and ischaemia-driven target lesion revascularization. No difference was found in the risk of cardiac death. CONCLUSION: Compared with EES, the use of Absorb BVS was associated with a higher rate of DT and a trend towards higher risk of TLF. VLDT occurred in 1.4% of the patients, the majority of these events occurred in the absence of DAPT.

Clinical outcomes of state-of-the-art percutaneous coronary revascularization in patients with de novo three vessel disease: 1-year results of the SYNTAX II study.

Aims: To investigate if recent technical and procedural developments in percutaneous coronary intervention (PCI) significantly influence outcomes in appropriately selected patients with three-vessel (3VD) coronary artery disease. Methods and results: The SYNTAX II study is a multicenter, all-comers, open-label, single arm study that investigated the impact of a contemporary PCI strategy on clinical outcomes in patients with 3VD in 22 centres from four European countries. The SYNTAX-II strategy includes: heart team decision-making utilizing the SYNTAX Score II (a clinical tool combining anatomical and clinical factors), coronary physiology guided revascularisation, implantation of thin strut bioresorbable-polymer drug-eluting stents, intravascular ultrasound (IVUS) guided stent implantation, contemporary chronic total occlusion revascularisation techniques and guideline-directed medical therapy. The rate of major adverse cardiac and cerebrovascular events (MACCE [composite of all-cause death, cerebrovascular event, any myocardial infarction and any revascularisation]) at one year was compared to a predefined PCI cohort from the original SYNTAX-I trial selected on the basis of equipoise 4-year mortality between CABG and PCI. As an exploratory endpoint, comparisons were made with the historical CABG cohort of the original SYNTAX-I trial. Overall 708 patients were screened and discussed within the heart team; 454 patients were deemed appropriate to undergo PCI. At one year, the SYNTAX-II strategy was superior to the equipoise-derived SYNTAX-I PCI cohort (MACCE SYNTAX-II 10.6% vs. SYNTAX-I 17.4%; HR 0.58, 95% CI 0.39-0.85, P = 0.006). This difference was driven by a significant reduction in the incidence of MI (HR 0.27, 95% CI 0.11-0.70, P = 0.007) and revascularisation (HR 0.57, 95% CI 0.37-0.9, P = 0.015). Rates of all-cause death (HR 0.69, 95% CI 0.27-1.73, P = 0.43) and stroke (HR 0.69, 95% CI 0.10-4.89, P = 0.71) were similar. The rate of definite stent thrombosis was significantly lower in SYNTAX-II (HR 0.26, 95% CI 0.07-0.97, P = 0.045). Conclusion: At one year, clinical outcomes with the SYNTAX-II strategy were associated with improved clinical results compared to the PCI performed in comparable patients from the original SYNTAX-I trial. Longer term follow-up is awaited and a randomized clinical trial with contemporary CABG is warranted. ClinicalTrials.gov Identifier: NCT02015832.