Rates Of Adverse Clinical Events Research Articles

Empleo del balón de contrapulsación intraaórtico como puente al trasplante cardiaco en España: resultados del estudio ASIS-TC

Introduction and objectivesIn Spain, intra-aortic balloon pump (IABP) has been used frequently as a bridge to urgent heart transplant (HT). We sought to analyze the clinical outcomes of this strategy. MethodsWe conducted a case-by-case, retrospective review of clinical records of 281 adult patients listed for urgent HT under IABP support in 16 Spanish institutions from 2010 to 2015. Pre- and post-transplant survival and adverse clinical events were analyzed. ResultsA total of 194 (69%, 95%CI, 63.3-74.4) patients were transplanted and 20 (7.1%, 95%CI, 4.4-10.8) died during a mean period of IABP support of 10.9±9.7 days. IABP support was withdrawn before an organ became available in 32 (11.4%) patients. Thirty-five (12.5%, 95%CI, 8.8-16.9) patients transitioned from IABP to full-support mechanical devices. Mean urgent waiting list time increased from 5.9±6.3 days in 2010 to 15±11.7 days in 2015 (P=.001). Post-transplant survival rates at 30-days, 1-year, and 5-years were 88.1% (95%CI, 85.7-90.5), 76% (95%CI, 72.9-79.1), and 67.8% (95%CI, 63.7-71.9), respectively. The incidence rate of major adverse clinical outcomes—device dysfunction, stroke, bleeding or infection—during IABP support was 26 (95%CI, 20.6-32.4) episodes per 1000 patient-days. The incidence rate of IABP explantation due to complications was 7.2 (95%CI, 4.5-10.8) cases per 1000 patient-days. ConclusionsIn a setting of short waiting list times, IABP can be used to bridge candidates to urgent HT with acceptable postoperative results, but there were significant rates of adverse clinical events during support.Full English text available from:www.revespcardiol.org/en

EEG correlates of creative thinking process associated with originality in young and elderly adults

There is limited evidence to support decision-making regarding discharge antiplatelet therapy after transcatheter aortic valve implantation (TAVI). The aim of this study was to assess the outcome of patients discharged on single-antiplatelet therapy (SAPT) or dual-antiplatelet therapy (DAPT) after TAVI. Consecutive patients were identified by retrospective review of a dedicated TAVI database of a single high-volume center in Milan, Italy, from January 2009 to May 2015. Our primary end point was the rate of net adverse clinical events defined as a composite of all-cause mortality, major bleeding requiring hospitalization, cerebrovascular accidents, redo-TAVI or surgical aortic valve replacement, and valve thrombosis. A total of 439 patients were included in the final analysis; 108 patients were discharged on SAPT and 331 on DAPT. Reasons for discharge SAPT included high risk of bleeding (n = 33; 31%), postprocedural bleeding (n = 42; 39%), thrombocytopenia (n = 20; 18%), vascular complications (n = 13; 12%). The mean length of DAPT was 5.2 ± 2.7 months. Patients discharged in SAPT had a higher incidence of life-threatening bleeding during the index hospitalization. At follow-up, no differences were observed in the incidence of net adverse clinical event, all-cause or cardiovascular mortality, and cerebrovascular events. A similar rate of valve thrombosis was reported in both groups. In conclusion, prescribing only SAPT after TAVI in selected patients was not associated with an increased risk of events and may be an acceptable alternative to DAPT in elderly patients at high risk of bleeding.

Radial versus femoral access and bivalirudin versus unfractionated heparin in invasively managed patients with acute coronary syndrome (MATRIX): final 1-year results of a multicentre, randomised controlled trial

The Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox (MATRIX) programme was designed to assess the comparative safety and effectiveness of radial versus femoral access and of bivalirudin versus unfractionated heparin with optional glycoprotein IIb/IIIa inhibitors in patients with the whole spectrum of acute coronary syndrome undergoing invasive management. Here we describe the prespecified final 1-year outcomes of the entire programme. MATRIX was a programme of three nested, randomised, multicentre, open-label, superiority trials in patients with acute coronary syndrome in 78 hospitals in Italy, the Netherlands, Spain, and Sweden. Patients with ST-elevation myocardial infarction were simultaneously randomly assigned (1:1) before coronary angiography to radial or femoral access and to bivalirudin, with or without post-percutaneous coronary intervention infusion or unfractionated heparin (one-step inclusion). Patients with non-ST-elevation acute coronary syndrome were randomly assigned (1:1) before coronary angiography to radial or femoral access and, only if deemed eligible to percutaneous coronary intervention after angiography (two-step inclusion), entered the antithrombin type and treatment duration programmes. Randomisation sequences were computer generated, blocked, and stratified by intended new or current use of P2Y12 inhibitor (clopidogrel vs ticagrelor or prasugrel), and acute coronary syndrome type (ST-elevation myocardial infarction, troponin-positive, or troponin-negative non-ST-elevation acute coronary syndrome). Bivalirudin was given as a bolus of 0·75 mg/kg, followed immediately by an infusion of 1·75 mg/kg per h until completion of percutaneous coronary intervention. Heparin was given at 70-100 units per kg in patients not receiving glycoprotein IIb/IIIa inhibitors, and at 50-70 units per kg in patients receiving glycoprotein IIb/IIIa inhibitors. Clinical follow-up was done at 30 days and 1 year. Co-primary outcomes for MATRIX access and MATRIX antithrombin type were major adverse cardiovascular events, defined as the composite of all-cause mortality, myocardial infarction, or stroke up to 30 days; and net adverse clinical events, defined as the composite of non-coronary artery bypass graft-related major bleeding, or major adverse cardiovascular events up to 30 days. The primary outcome for MATRIX treatment duration was the composite of urgent target vessel revascularisation, definite stent thrombosis, or net adverse clinical events up to 30 days. Analyses were done according to the intention-to-treat principle. This trial is registered with ClinicalTrials.gov, number NCT01433627. Between Oct 11, 2011, and Nov 7, 2014, we randomly assigned 8404 patients to receive radial (4197 patients) or femoral (4207 patients) access. Of these 8404 patients, 7213 were included in the MATRIX antithrombin type study and were randomly assigned to bivalirudin (3610 patients) or heparin (3603 patients). Patients assigned to bivalirudin were included in the MATRIX treatment duration study, and were randomly assigned to post-procedure infusion (1799 patients) or no post-procedure infusion (1811 patients). At 1 year, major adverse cardiovascular events did not differ between patients assigned to radial access compared with those assigned to femoral access (14·2% vs 15·7%; rate ratio 0·89, 95% CI 0·80-1·00; p=0·0526), but net adverse clinical events were fewer with radial than with femoral access (15·2% vs 17·2%; 0·87, 0·78-0·97; p=0·0128). Compared with heparin, bivalirudin was not associated with fewer major adverse cardiovascular (15·8% vs 16·8%; 0·94, 0·83-1·05; p=0·28) or net adverse clinical events (17·0% vs 18·4%; 0·91, 0·81-1·02; p=0·10). The composite of urgent target vessel revascularisation, stent thrombosis, or net adverse clinical events did not differ with or without post-procedure bivalirudin infusion (17·4% vs 17·4%; 0·99, 0·84-1·16; p=0·90). In patients with acute coronary syndrome, radial access was associated with lower rates of net adverse clinical events compared with femoral access, but not major adverse cardiovascular events at 1 year. Bivalirudin with or without post-procedure infusion was not associated with lower rates of major adverse cardiovascular events or net adverse clinical events. Radial access should become the default approach in acute coronary syndrome patients undergoing invasive management. Italian Society of Invasive Cardiology, The Medicines Company, Terumo, amd Canada Research Chairs Programme.

Use of Intra-aortic Balloon Pump as a Bridge to Heart Transplant in Spain: Results From the ASIS-TC Study.

In Spain, intra-aortic balloon pump (IABP) has been used frequently as a bridge to urgent heart transplant (HT). We sought to analyze the clinical outcomes of this strategy. We conducted a case-by-case, retrospective review of clinical records of 281 adult patients listed for urgent HT under IABP support in 16 Spanish institutions from 2010 to 2015. Pre- and post-transplant survival and adverse clinical events were analyzed. A total of 194 (69%, 95%CI, 63.3-74.4) patients were transplanted and 20 (7.1%, 95%CI, 4.4-10.8) died during a mean period of IABP support of 10.9±9.7 days. IABP support was withdrawn before an organ became available in 32 (11.4%) patients. Thirty-five (12.5%, 95%CI, 8.8-16.9) patients transitioned from IABP to full-support mechanical devices. Mean urgent waiting list time increased from 5.9±6.3 days in 2010 to 15±11.7 days in 2015 (P=.001). Post-transplant survival rates at 30-days, 1-year, and 5-years were 88.1% (95%CI, 85.7-90.5), 76% (95%CI, 72.9-79.1), and 67.8% (95%CI, 63.7-71.9), respectively. The incidence rate of major adverse clinical outcomes-device dysfunction, stroke, bleeding or infection-during IABP support was 26 (95%CI, 20.6-32.4) episodes per 1000 patient-days. The incidence rate of IABP explantation due to complications was 7.2 (95%CI, 4.5-10.8) cases per 1000 patient-days. In a setting of short waiting list times, IABP can be used to bridge candidates to urgent HT with acceptable postoperative results, but there were significant rates of adverse clinical events during support.

Comparison of Short-term Outcomes of Percutaneous Coronary Intervention between Young Male and Female Patients with Acute Coronary Syndrome

Background:Young women undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) experience greater short-term adverse events than young men. There is a scarcity of data on the short-term adverse outcomes between young Bangladeshi males and females with ACS undergoing PCI.Objectives: This study was conducted to compare the short-term outcomes of PCI between young males and females presenting with ACS.Methods: This prospective observational study was done in the Department of Cardiology, National Institute of Cardiovascular Diseases (NICVD) fromApril 2016 to March 2017. 190 young patients with ACS and undergoing PCI were enrolled. They were equally divided into two groups, group I (young females <55 years) and group II (young males <45 years).Results: The mean age of young females and males was 43.8±6.9 years and 40.1±4.3 years respectively. Young women had significantly higher risk factors of hypertension (62.1% vs 33.7%, p<0.0010) and diabetes (57.9% vs 31.6%, p<0.001) in comparison to young men. Overall, young women experienced significantly greater incidence of short-term adverse events in comparison to young men (14.7% vs. 6.3%, p=0.04) and had significantly higher rates of severe bleeding (6.3% vs 1.1%, p=0.04), vascular access site complications (8.4% vs 2.1%, p=0.04) and recurrent ischaemia at 30 days (7.4% vs. 2.1%, p=0.04). Major adverse cardiac events (MACE) were higher among young females, in comparison to young males (4.1% vs 2.1%, p=0.4). Young females experienced significantly higher rates of short-term net adverse clinical events (NACE) than young males (10.5% vs 3.2%, p=0.04). Female gender (odds ratio [OR] 11.7), diabetes (OR 2.5), hypertension (OR 1.78), decreased ejection fraction (OR 1.41) and smaller stent diameter (OR 1.15) were identified as independent predictors of adverse short-term outcomes among young ACS patients undergoing PCI.Conclusion: Young women experienced significantly more adverse short-term outcomes after PCI. They had significantly greater NACE, largely driven by increased rates of major bleeding. Female gender was an independent predictor of adverse short-term outcomes among young ACS patients undergoing PCI.Bangladesh Heart Journal 2018; 33(1) : 1-9

Comparison of In-hospital Outcomes of Percutaneous Coronary Intervention between Young Male and Female Patients with Acute Coronary Syndrome

Background: Acute coronary syndrome (ACS) among young people is increasingly prevalent. However, there is a scarcity of data on the gender differences of in-hospital adverse outcomes among ACS patients after percutaneous coronary intervention (PCI) among young Bangladeshis. This study was conducted to compare the in-hospital outcomes of PCI between young males and females presenting with ACS.Methods: This prospective observational study was done in the Department of Cardiology, National Institute of Cardiovascular Diseases (NICVD) fromApril 2016 to March 2017. 190 young patients with ACS and undergoing PCI were enrolled. They were equally divided into two groups, group I (young females <55 years) and group II (young males <45 years).Results: The mean age of young females and males was 43.8±6.9 years and 40.1±4.3 years respectively. Young women had significantly higher risk factors of hypertension (62.1% vs 33.7%, p<0.0010) and diabetes (57.9% vs 31.6%, p<0.001) in comparison to young men. Young women had angiographically less severe coronary artery disease (CAD), with significantly higher numbers of ACC/AHA lesion type B2 (40% vs 25.3%, p=0.03) and C (20% vs 9.47%, p=0.03), and greater frequency of multivessel disease. Overall, young women experienced greater incidence of in-hospital adverse events in comparison to young men (13.7% vs. 6.3%, p=0.09) and had significantly higher rates of severe bleeding (6.3% vs 1.1%, p=0.04) and vascular access site complications (8.4% vs 2.1%, p=0.04). Major adverse cardiac events were higher among young females, in comparison to young males (2.1% vs 0%, p=0.47). Young females experienced significantly higher rates of short-term net adverse clinical events (NACE) than young males (10.5% vs 3.2%, p=0.04). Female gender (odds ratio [OR] 11.7), diabetes (OR 2.5), hypertension (OR 1.78), decreased ejection fraction (OR 1.41) and smaller stent diameter (OR 1.15) were identified as independent predictors of adverse in-hospital outcomes among young ACS patients undergoing PCI.Conclusion: Young women with ACS presented with significantly more risk factors and experienced more adverse in-hospital outcomes after PCI, despite angiographically less severe CAD. They had significantly greater NACE, largely driven by increased rates of major bleeding. Female gender was an independent predictor of adverse in-hospital outcomes among young ACS patients undergoing PCI.University Heart Journal Vol. 12, No. 2, July 2016; 61-67

Apolipoprotein A-I: A favorable prognostic marker in infective endocarditis

Decreased apolipoprotein A-I (apoA-I) and high-density lipoprotein cholesterol (HDL-C) are common in inflammation and sepsis. No study with a large sample size has been performed to investigate the prognostic value of apoA-I or HDL-C in infective endocarditis (IE). The present study aimed to explore the prognostic value of apoA-I and HDL-C for adverse outcomes in IE patients. Patients with a definite diagnosis of IE between January 2009 and July 2015 were enrolled and divided into 3 groups according to their apoA-I tertiles at admission. Univariate and multivariate analyses were performed to evaluate the relationship of apoA-I and HDL-C with clinical outcomes. Of the 593 included patients, 40 (6.7%) died in hospital. Patients with lower apoA-I experienced markedly higher rates of in-hospital mortality (10.7%, 7.0%, and 2.5% in tertiles 1-3, respectively; P=.006) and major adverse clinical events (32.5%, 24.1%, and 8.6% in tertiles 1-3, respectively; P<.001). ApoA-I (area under the curve, 0.671; P<.001) and HDL-C (area under the curve, 0.672; P<.001) had predictive values for in-hospital death. Multivariate logistic regression showed that apoA-I <0.90g/L and HDL-C <0.78mmol/L were independent risk predictors for in-hospital death. A multivariate Cox proportional hazard analysis revealed that apoA-I (increments of 1g/L; hazard ratio, 0.36; 95% confidence interval, 0.15-0.87; P=.023) and HDL-C (increments of 1mmol/L; hazard ratio, 0.38; 95% confidence interval, 0.18-0.83; P=.015) were independently associated with long-term mortality. ApoA-I and HDL-C were inversely associated with adverse IE prognosis.

One-Year Clinical Effectiveness Comparison of Prasugrel with Ticagrelor: Results from a Retrospective Observational Study using an Integrated Claims Database.

No direct comparisons of ticagrelor and prasugrel with 1-year clinical follow-up have been reported. Our objective was to compare 1-year clinical outcomes among patients with acute coronary syndrome (ACS) managed with percutaneous coronary intervention (PCI) and treated with either ticagrelor or prasugrel in a real-world setting. This retrospective study included patients from a payer database who were aged ≥18years and had ACS managed with PCI with no history of transient ischemic attack (TIA)/stroke. Data were propensity matched for prasugrel use with a 3:1 prasugrel:ticagrelor ratio. Post-discharge net adverse clinical event (NACE) rate at 1year was evaluated for noninferiority using a pre-defined 20% margin. NACE was a composite of major adverse cardiovascular events (MACE) or rehospitalization for bleeding. In total, 15,788 ACS-PCI patients were included (prasugrel 12,797; ticagrelor 2991). Prasugrel-treated patients were younger; less likely to be female, have prior myocardial infarction (MI), diabetes, or non-ST-segment elevation MI (NSTEMI); and more likely to have unstable angina (UA) than ticagrelor-treated patients. Prior to matching, NACE and MACE (P < 0.01) were lower, with no difference in bleeding with prasugrel compared with ticagrelor. After matching, there was no significant difference in baseline characteristics. Noninferiority was demonstrated for NACE, MACE, and bleeding between prasugrel and ticagrelor. NACE and MACE were significantly lower with prasugrel use, primarily driven by heart failure, with no significant difference in all-cause death, MI, UA, revascularization, TIA/stroke, or bleeding. In this retrospective study, physicians preferentially used prasugrel rather than ticagrelor in younger ACS-PCI patients with lower risk of bleeding or comorbidities. After propensity matching, clinical outcomes associated with prasugrel were noninferior to those with ticagrelor.

Safety of Pedicle Screws in Adolescent Idiopathic Scoliosis Surgery.

To review existing publications on the safety of pedicle screw insertions in adolescent idiopathic scoliosis (AIS). Despite having increased risk for neurological and visceral injuries, the use of pedicle screws have led to increased correction rates in scoliosis surgery. A review was performed on topics pertinent to pedicle screw insertion in AIS, which included pedicle morphometry in AIS, structures at risk during pedicle screw insertion, and accuracy and safety of various pedicle screw insertion techniques. The importance of computer navigation and future research regarding pedicle screw placement in AIS were also briefly reviewed. Many authors have reported abnormal pedicle anatomy in AIS. Injury to the neural structures was highest over the apical region, whereas aortic injury was the highest at T5 and T10. In the proximal thoracic spine, the esophagus could be injured even with screws as short as 25 mm. Overall pedicle perforation rates for perforations >0 and >2 mm (assessed by computed tomography) ranged from 6.4% to 65.0% and 3.7% to 29.9%, respectively. The critical pedicle perforation (>2 mm excluding lateral thoracic) and anterior perforation (>0 mm) rates was reported to range from 1.5% to 14.5% and 0.0% to 16.1%, respectively. Pedicle perforation rates were lower with the use of computer navigation. The incidence of neurological adverse events after scoliosis surgery was 0.06%–1.9%. Aortic injury has only been observed in case reports. According to the available literature, pedicle screw insertion in AIS is considered safe with low rates of clinical adverse events. Moreover, the use of navigation technology has been shown to reduce pedicle perforation rates.

MICAS: An Integrated National Critical Care Retrieval Service

Introduction : The reorganisation of health services and the delivery of the ‘hub and spoke’ Model of Care for Adult Critical Care (HSE 2014) necessitates the requirement to transfer critically ill patients between hospitals to an appropriate location. As specialty services and critical care units are centralised and consolidated, more critically ill patients will need to move between hospitals (NOCA MTA Report 2016). It is generally accepted that trained specialist retrieval teams have lower rates of morbidity, mortality and adverse clinical events (Droogh 2015), yet most critically ill patients in Ireland are transferred by non specialist teams. (Murphy 2016). Funding was made available to develop three regional critical care retrieval hubs to form a national service for the retrieval of critically ill patients in Ireland. A framework did not exist through which these hubs could be connected and enabled. Short Description of Practice Change Implemented : In 2016, the National Transport Medicine Programme, underwent a transformation to a National Transport Medicine Service. The adult retrevial service (MICAS - Mobile Intensive Care Ambulance Service) is identified as the mechanism to enable the three adult critical care retreival hubs. Three local working groups of local and national stakeholders were formed. These included medical and nursing staff from critical care specialties, ambulance personnel, biomedical engineering and the new National Transport Medicine Service. Agreement was reached on ambulance and equipment specifications. A training programme, modelled on a national training programme for inter hosptial transfers, was introduced. Clinical governance strucutres were agred and staff operating in the NTMS follow national Standard Operating Proceedures. Aim and Theory of Change : The philosophy of care in MICAS to provide the highest quality care to critically ill patients whilst transporting them to a facility that meets their medical needs by an appropriately qualified and skilled team of critical care staff. It ensures every patient is transported in a way that maximised, not only their medical care but the safety, dignity and comfort of the patient and their families. It is hypothesised that, an increasing numbers of transports undertaken by MICAS, will result in a reduction in adverse clinical events in transfer and increased staff and patient satisfaction. Additionally, the use of the specialist retrieval team removes the need to deplete the referring hospital of resources. Targeted population and Stakeholders : Targeted population is adult critially ill patients who require transfers between two hospitals under the supervision of a critical care medical team. Stakeholder engagement was important both nationally and locally. Stakeholders included critical care doctors and nurses as both providers and users of the service. Integration with the ambulance service and clinical engineering was a key enabler. Timeline : There are three hubs identified in the model of care: One hub has an existing 5/7 service, which is funded to expand to 7/7. Two new hubs are funded to provide a 5/7 service. A pilot 3/7 serviceis in operation since Q4 2016 on the second site, and is scaling to 5/7 in Q1 2017. The third hub is scheduled to commence operations in Q2 2017. A scaled approach has allowed the integration of care with existing clinical teams prior to expansion on a larger scale. Highlights : The impact of this is yet to be felt systemically. Hoewever, it is estimated that in the region of 1000 critically ill adult patients are transported between hospitals annually, with approximately 100 moved by specialist teams. The outcome of this integration will be that up to 75% of existing transfers are moved by specialist teams. Those that are time critical and out of hours, will still be moved by local (non specialist) teams. Sustainability : Staffing models using a high specialist to trainee ratio are the desired model in the longer term. A secondment model of employment are felt to be sustainable in the short term in order to allow integration and confidence in the new service to grow. Dedicated resources for this service are ringfenced so that as teams are integrated, the level of service can increase.

Development of an education programme – ‘Transporting critically ill adult and child’

Introduction: The reorganisation of health services and the delivery of the ‘hub and spoke’ Model of Care for Adult Critical Care (HSE 2014) and Paediatric Model of care (2010) necessitates the requirement to transfer critically ill patients between hospitals to an appropriate location. Transporting critically ill patients is an integral part of the role of doctors and nurses in Intensive care, Anaesthesia, Emergency Medicine and Paediatrics. Trained specialist retrieval teams have lower rates of morbidity, mortality and adverse clinical events (Droogh et al 2015) and is recommended by most Intensive Care Societies (ICSI,AAGBI, ESICM), yet most critically ill patients in Ireland are transferred by non specialist teams. The isolated nature of transporting the critical patient means that supervision and support is difficult. Short Description of Practice Change Implemented: A one day national training programme was developed for medical, nursing and ambulance staff to address deficits in knowledge and skills regarding the transport environment and in the risks of transporting critically ill patients. Aim and Theory of the change: A standardised approach to patient assessment, preparation and packaging is taught. As this is taught nationally, it is hypothesised that, as there is increasing familiarity with the training programme, this will become the norm across disciplines and hospital sites. A reduction in adverse clinical events in transfer and increased staff and patient satisfaction is expected. Targeted Population and stakeholders: The target population include doctors, nurses and ambulance staff involved in the transport of critically ill adults and children. Stakeholders include the above and also the referring and receiving critical care units nationally, who will benefit from an improved standard of patient care. Timeline: A direct and indirect needs analysis and international standards and practice review was undertaken over a 6 month period, highlighting the deficit in training and the lack awareness of the transport environment. Over 14 months 228 number of participants were taught on 11 days of education. Highlights: An education programme was developed by a consensus of experts. The assessment of the programme was evaluated by satisfaction and feedback from registrants on completion. Feedback from participants has been consistently positive. Sustainability: The programme is limited by the small numbers of faculty specialising in transport medicine. Future expansion will require further development of the training programme to build a national faculty, which can continue roll out of the education. Transferability: The programme has demonstrated already, transferability between hospital sites. CPD accreditation has been granted by the College of Anaesthetists. It is anticipated that the programme can be incorporated into existing post graduate education programmes for doctors, nurses and ambulance staff.

Clinical outcomes of temporary mechanical circulatory support as a direct bridge to heart transplantation: a nationwide Spanish registry.

In Spain, listing for high-urgent heart transplantation is allowed for critically ill candidates not weanable from temporary mechanical circulatory support (T-MCS). We sought to analyse the clinical outcomes of this strategy. We conducted a case-by-case, retrospective review of clinical records of 291 adult patients listed for high-urgent heart transplantation under temporary devices from 2010 to 2015 in 16 Spanish institutions. Survival after listing and adverse clinical events were studied. At the time of listing, 169 (58%) patients were supported on veno-arterial extracorporeal membrane oxygenation (VA-ECMO), 70 (24%) on temporary left ventricular assist devices (T-LVAD) and 52 (18%) on temporary biventricular assist devices (T-BiVAD). Seven patients transitioned from VA-ECMO to temporary ventricular assist devices while on the waiting list. Mean time on T-MCS was 13.1 ± 12.6 days. Mean time from listing to transplantation was 7.6 ± 8.5 days. Overall, 230 (79%) patients were transplanted and 54 (18.6%) died during MCS. In-hospital postoperative mortality after transplantation was 33.3%, 11.9% and 26.2% for patients bridged on VA-ECMO, T-LVAD and T-BiVAD, respectively (P = 0.008). Overall survival from listing to hospital discharge was 54.4%, 78.6% and 55.8%, respectively (P = 0.002). T-LVAD support was independently associated with a lower risk of death over the first year after listing (hazard ratio 0.52, 95% confidence interval 0.30-0.92). Patients treated with VA-ECMO showed the highest incidence rate of adverse clinical events associated with T-MCS. Temporary devices may be used to bridge critically ill candidates directly to heart transplantation in a setting of short waiting list times, as is the case of Spain. In our series, bridging with T-LVAD was associated with more favourable outcomes than bridging with T-BiVAD or VA-ECMO.

Impact of diabetes mellitus on procedural and one year clinical outcomes following treatment of severely calcified coronary lesions with the orbital atherectomy system: A subanalysis of the ORBIT II study.

The goal of the study was to investigate the safety and efficacy of the coronary orbital atherectomy system to treat severe coronary artery calcification (CAC) prior to stent placement in diabetic and non-diabetic patients. The ORBIT II study reported the safety and efficacy of orbital atherectomy treatment in 443 patients with severe CAC. Percutaneous coronary intervention in diabetic patients is associated with an increased risk of major adverse cardiac events (MACE) compared with non-diabetics. The outcomes of diabetic patients who undergo orbital atherectomy are unknown. Patients were sub-grouped as either diabetic (160/443, 36.1%) or non-diabetic (283/443, 63.9%). The MACE rate, defined as cardiac death, myocardial infarction (MI; CK-MB > 3X ULN), and target vessel revascularization, was examined at 30 days and 1 year after treatment. Procedural success was similar in the diabetic and non-diabetic groups (89.3 vs. 88.6%, P = 0.88). There was no significant difference in the 30-day and 1-year MACE rates between the diabetic and non-diabetic groups (30 day: 8.8 vs. 11.3%; P = 0.40; 1 year: 17.1 vs. 16.7%, P = 0.97). The individual components of cardiac death (3.9 vs. 2.9%, P = 0.58), MI (9.4 vs. 11.3%, P = 0.52), and target vessel revascularization (5.9 vs. 5.8%, P = 0.99) were also similar in both groups at 1 year. The rates of adverse clinical events in diabetic patients who underwent orbital atherectomy were low and similar to non-diabetic patients. This study suggests orbital atherectomy is a reasonable treatment strategy for diabetic patients with severe CAC.

Early Detection and Treatment of Atrial Arrhythmias Alleviates the Arrhythmic Burden in Paced Patients: The SETAM Study.

Remote monitoring (RM) can remotely detect atrial tachyarrhythmias (ATAs). The benefit of RM compared to conventional follow-up in the detection and management of ATA was assessed in recipients of dual-chamber pacemakers. The multicenter randomized SETAM study enrolled 595 patients in sinus rhythm with a CHA2 DS2 -VASc score ≥2, without ATA history and untreated with antiarrhythmics and antithrombotics, randomly assigned to RM (RM-ON; n = 291) versus ambulatory follow-up (RM-OFF; n = 304) during 12.8 ± 3.3 months. ATA occurrence, burden, and management were analyzed together with adverse clinical events. Patients were 79 ± 8 years old, 63% men, with a CHA2 DS2 -VASc score of 3.7± 1.2. ATA were detected in 83 patients (28%) in the RM-ON versus 66 (22%) in the RM-OFF group (P = 0.06). The median time between the pacemaker implantation and the first treated ATA was 114 days [44; 241] in the RM-ON versus 224 days [67; 366] in the RM-OFF group (hazard ratio [HR] = 0.56; 95% confidence interval [CI]: 0.37-0.86; P = 0.01). Therapies for ATA were initiated in 92 patients and the time to treatment of ATA was shortened by 44% in the RM-ON group (HR = 0.565; 95% CI: 0.37-0.86; P = 0.01). Over the last 4 months of follow-up, the mean ATA burden was alleviated by 4 hours/day (18%) in the RM-ON group. The rate of adverse clinical events was similar in both groups. Remotely monitored patients were diagnosed and treated earlier for ATA, and subsequently had a lower ATA burden.

Unraveling the Gordian knot: red blood cell storage lesion and transfusion outcomes.

What is following the impressive progress that has been made? During the last couple of years several tremors have shaken the field of Transfusion Medicine. The epicentres of those tremors were located on novel insights into the RBC storage lesion, on emerging connections between storage lesion and post-transfusion performance and effects, and on acknowledging that storage time is only one (rather than the most prominent) of the parameters which contribute to the progression of storage lesion in any given unit of blood. The optimisation of bio-preservation conditions emerged at the same time with all-new scientific knowledge gained by advances in research tools, implementation of technological innovations, and application of elegant in vitro and in vivo models of transfusion. Simultaneously, one after another, all the reported randomised clinical trials concluded, with spectacular consensus, that there is no significant difference in the rate of adverse clinical events (including death) among patients who underwent transfusion with fresh (and presumably good) or standard of care (and presumably bad) blood. The comparative analysis and comprehension of the aforementioned data would set the context for the next generation of research in blood transfusion science, since the need for safer and more efficient transfusions remains.

Angiographic and clinical outcome after crush of everolimus-eluting stent for distal unprotected left main disease.

Few data exist about crushing of EES for distal ULMD. From the Florence ULMD Percutaneous Coronary Interevention Registry consecutive patients with distal ULMD treated with EES were included in the analysis. Patients treated with provisional stenting were compared with patients treated with crush stenting. angiographic in-segment restenosis rate, and 1-year clinical outcome. From 2008 to 2015, 405 patients with distal ULMD were treated with EES: 278 (69%) were treated with provisional stenting while 127 (31%) with crush stenting. Provisional stenting group compared to crush stenting group had higher incidence of acute coronary syndrome on admission (63% vs. 52%; P = 0.033) and of left ventricular ejection fraction ≤ 40% (36% vs. 23%; p= 0.008), while patients treated with crush stenting had more frequently diabetes mellitus (35% vs. 21%; P = 0.003) and 3-vessel coronary artery disease (46% vs. 29%; P < 0.001). Angiographic follow rate was 95%. Restenosis rates were similar: 7.1% in the crush stenting group and 5.8% in the provisional stenting group. There were no differences in 1-year clinical outcome between crush stenting group and provisional stenting group: major adverse cardiac events 11.1% and 11.2%, stent thrombosis 0.8% and 1.4%, respectively. Crush stenting using EES in patients with complex distal ULMD is associated with low rates of restenosis and adverse clinical events and could be considered as a valid double stenting technique in all patients with complex ULMD bifurcation lesions. © 2017 Wiley Periodicals, Inc.

CRT-100.59 Angiographic & Post Angioplasty Profile Of Distal LMCA Bifurcation Intervention With Single Stent Crossover Technique From Distal Unprotected Left Main Coronary Artery To Major Side Branch

Percutaneous coronary intervention (PCI) is a potential alternative to bypass surgery for patients with unprotected left main (LM) coronary artery stenosis. However, PCI for LM bifurcation is technically demanding and has been associated with high rates of adverse clinical events. Randomized

Single-Antiplatelet Therapy in Patients with Contraindication to Dual-Antiplatelet Therapy After Transcatheter Aortic Valve Implantation

There is limited evidence to support decision-making regarding discharge antiplatelet therapy after transcatheter aortic valve implantation (TAVI). The aim of this study was toassess the outcome of patients discharged on single-antiplatelet therapy (SAPT) or dual-antiplatelet therapy (DAPT) after TAVI. Consecutive patients were identified by retrospective review of a dedicated TAVI database of a single high-volume center in Milan, Italy, from January 2009 to May 2015. Our primary end point was the rate of net adverse clinical events defined as a composite of all-cause mortality, major bleeding requiring hospitalization, cerebrovascular accidents, redo-TAVI or surgical aortic valve replacement, and valve thrombosis. A total of 439 patients were included in the final analysis; 108 patients were discharged on SAPT and 331 on DAPT. Reasons for discharge SAPT included high risk of bleeding (n= 33; 31%), postprocedural bleeding (n= 42; 39%), thrombocytopenia (n= 20; 18%), vascular complications (n= 13; 12%). The mean length of DAPT was 5.2 ± 2.7months. Patients discharged in SAPT had a higher incidence of life-threatening bleeding during the index hospitalization. At follow-up, no differences were observed in the incidence of net adverse clinical event, all-cause or cardiovascular mortality, and cerebrovascular events. A similar rate of valve thrombosis was reported in both groups. In conclusion, prescribing only SAPT after TAVI in selected patients was not associated with an increased risk of events and may be an acceptable alternative to DAPT in elderly patients at high risk of bleeding.

Comparison of closed-cell and hybrid-cell stent designs in carotid artery stenting: clinical and procedural outcomes.

IntroductionCarotid artery stenting (CAS) is a promising alternative to surgery in high-risk patients. However, the impact of stent cell design on outcomes in CAS is a matter of continued debate.AimTo compare the periprocedural and clinical outcomes of different stent designs for CAS with distal protection devices.Material and methodsAll CAS procedures with both closed- and hybrid-cell stents performed at our institution between February 2010 and December 2015 were analyzed retrospectively. Adverse events were defined as death, major stroke, minor stroke, transient ischemic attack and myocardial infarction. Periprocedural and 30-day adverse events and internal carotid artery (ICA) vasospasm rates were compared between the closed-cell and hybrid-cell stent groups.ResultsThe study included 234 patients comprising 146 patients with a closed-cell stent (Xact stent, Abbott Vascular) (mean age: 68.5 ±8.6; 67.1% male) and 88 patients with a hybrid-cell stent (Cristallo Ideale, Medtronic) (mean age: 67.2 ±12.8; 68.2% male). There was no significant difference between the groups with respect to periprocedural or 30-day adverse event rates. While there was no difference in terms of tortuosity index between the groups, there was a higher procedural ICA vasospasm rate in the closed-cell stent group (35 patients, 23%) compared with the hybrid-cell stent group (10 patients, 11%) (p = 0.017).ConclusionsThe results of this study showed no significant difference in the clinical adverse event rates after CAS between the closed-cell stent group and the hybrid-cell stent group. However, procedural ICA vasospasm was more common in the closed-cell stent group.

Real-World Multicenter Registry of Patients with Severe Coronary Artery Calcification Undergoing Orbital Atherectomy.

ObjectivesWe evaluated the safety and efficacy of orbital atherectomy in real‐world patients with severe coronary artery calcification (CAC).BackgroundThe presence of severe CAC increases the complexity of percutaneous coronary intervention as it may impede stent delivery and optimal stent expansion. Atherectomy may be an indispensable tool for uncrossable or undilatable lesions by modifying severe CAC. Although the ORBIT I and II trials report that orbital atherectomy was safe and effective for the treatment of severe CAC, patients with kidney disease, recent myocardial infarction, long diffuse disease, severe left ventricular dysfunction, and unprotected left main disease were excluded.MethodsThis retrospective study included 458 consecutive patients with severe CAC who underwent orbital atherectomy followed by stenting from October 2013 to December 2015 at 3 centers.ResultsThe primary endpoint of major adverse cardiac and cerebrovascular events at 30 days was 1.7%. Low rates of 30‐day all‐cause mortality (1.3%), myocardial infarction (1.1%), target vessel revascularization (0%), stroke (0.2%), and stent thrombosis (0.9%) were observed. Angiographic complications were low: perforation was 0.7%, dissection 0.9%, and no‐reflow 0.7%. Emergency coronary artery bypass graft surgery was performed in 0.2% of patients.ConclusionIn the largest real‐world study of patients who underwent orbital atherectomy, including high‐risk patients who were not surgical candidates as well as those with very complex coronary anatomy, acute and short‐term adverse clinical event rates were low. A randomized clinical trial is needed to identify the ideal treatment strategy for patients with severe CAC.