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1. Systematic Multi-Domain Alzheimer's Risk Reduction Trial (SMARRT): Study Protocol.

Author

Yaffe, Kristine, Barnes, Deborah E, Rosenberg, Dori, Dublin, Sascha, Kaup, Allison R, Ludman, Evette J, Vittinghoff, Eric, Peltz, Carrie B, Renz, Anne D, Adams, Kristin J, and Larson, Eric B

Subjects
Humans, Alzheimer Disease, Single-Blind Method, Risk Reduction Behavior, Aged, Aged, 80 and over, Health Promotion, Female, Male, Randomized Controlled Trials as Topic, Alzheimer’s disease, dementia, health promotion, integrated delivery of health care, risk reduction behavior, Alzheimer's disease, Neurology & Neurosurgery, Clinical Sciences, Neurosciences, Cognitive Sciences
Abstract

This article describes the protocol for the Systematic Multi-domain Alzheimer's Risk Reduction Trial (SMARRT), a single-blind randomized pilot trial to test a personalized, pragmatic, multi-domain Alzheimer's disease (AD) risk reduction intervention in a US integrated healthcare delivery system. Study participants will be 200 higher-risk older adults (age 70-89 years with subjective cognitive complaints, low normal performance on cognitive screen, and ≥ two modifiable risk factors targeted by our intervention) who will be recruited from selected primary care clinics of Kaiser Permanente Washington, oversampling people with non-white race or Hispanic ethnicity. Study participants will be randomly assigned to a two-year Alzheimer's risk reduction intervention (SMARRT) or a Health Education (HE) control. Randomization will be stratified by clinic, race/ethnicity (non-Hispanic white versus non-white or Hispanic), and age (70-79, 80-89). Participants randomized to the SMARRT group will work with a behavioral coach and nurse to develop a personalized plan related to their risk factors (poorly controlled hypertension, diabetes with evidence of hyper or hypoglycemia, depressive symptoms, poor sleep quality, contraindicated medications, physical inactivity, low cognitive stimulation, social isolation, poor diet, smoking). Participants in the HE control group will be mailed general health education information about these risk factors for AD. The primary outcome is two-year cognitive change on a cognitive test composite score. Secondary outcomes include: 1) improvement in targeted risk factors, 2) individual cognitive domain composite scores, 3) physical performance, 4) functional ability, 5) quality of life, and 6) incidence of mild cognitive impairment, AD, and dementia. Primary and secondary outcomes will be assessed in both groups at baseline and 6, 12, 18, and 24 months.

Published
2019

2. Transcatheter Aortic Valve Implantation With or Without Preimplantation Balloon Aortic Valvuloplasty: A Systematic Review and Meta-Analysis.

Author

Bagur, Rodrigo, Kwok, Chun, Nombela-Franco, Luis, Ludman, Peter, de Belder, Mark, Sponga, Sandro, Gunning, Mark, Nolan, James, Diamantouros, Pantelis, Teefy, Patrick, Chu, Michael, Mamas, Mamas, and Kiaii, Bob

Subjects
aortic stenosis, aortic valve replacement, balloon aortic valvuloplasty, transcutaneous aortic valve implantation, transfemoral aortic valve implantation, Aged, 80 and over, Aortic Valve, Aortic Valve Stenosis, Balloon Valvuloplasty, Epidemiologic Methods, Female, Hospital Mortality, Humans, Male, Transcatheter Aortic Valve Replacement, Treatment Outcome
Abstract

BACKGROUND: Preimplantation balloon aortic valvuloplasty (BAV) is considered a routine procedure during transcatheter aortic valve implantation (TAVI) to facilitate prosthesis implantation and expansion; however, it has been speculated that fewer embolic events and/or less hemodynamic instability may occur if TAVI is performed without preimplantation BAV. The aim of this study was to systematically review the clinical outcomes associated with TAVI undertaken without preimplantation BAV. METHODS AND RESULTS: We conducted a search of Medline and Embase to identify studies that evaluated patients who underwent TAVI with or without preimplantation BAV for predilation. Pooled analysis and random-effects meta-analyses were used to estimate the rate and risk of adverse outcomes. Sixteen studies involving 1395 patients (674 with and 721 without preimplantation BAV) fulfilled the inclusion criteria. Crude device success was achieved in 94% (1311 of 1395), and 30-day all-cause mortality occurred in 6% (72 of 1282) of patients. Meta-analyses evaluating outcomes of strategies with and without preimplantation BAV showed no statistically significant differences in terms of mortality (relative risk [RR] 0.61, 95% CI 0.32-1.14, P=0.12), safety composite end point (RR 0.85, 95% CI 0.62-1.18, P=0.34), moderate to severe paravalvular leaks (RR 0.68, 95% CI 0.23-1.99, P=0.48), need for postdilation (RR 0.86, 95% CI 0.66-1.13, P=0.58), stroke and/or transient ischemic attack (RR 0.72, 95% CI 0.30-1.71, P=0.45), and permanent pacemaker implantation (RR 0.80, 95% CI 0.49-1.30, P=0.37). CONCLUSIONS: Our analysis suggests that TAVI procedures with or without preimplantation BAV were associated with similar outcomes for a number of clinically relevant end points. Further studies including a large number of patients are needed to ascertain the impact of TAVI without preimplantation BAV as a standard practice.

Published
2016

3. Pediatric-Based Intervention to Motivate Mothers to Seek Follow-up for Depression Screens: The Motivating Our Mothers (MOM) Trial

Author

Fernandez y Garcia, Erik, Joseph, Jill, Wilson, Machelle D, Hinton, Ladson, Simon, Gregory, Ludman, Evette, Scott, Fiona, and Kravitz, Richard L

Subjects
Paediatrics, Biomedical and Clinical Sciences, Behavioral and Social Science, Clinical Research, Pediatric, Depression, Brain Disorders, Mental Illness, Clinical Trials and Supportive Activities, Mental Health, Good Health and Well Being, Adult, Child, Child, Preschool, Depression, Postpartum, Depressive Disorder, Female, Humans, Infant, Infant, Newborn, Mothers, Motivation, Motivational Interviewing, Patient Acceptance of Health Care, Patient Education as Topic, Pediatrics, Pilot Projects, Referral and Consultation, Young Adult, depression care seeking, maternal depression, motivational intervention, primary care, screening, Paediatrics and Reproductive Medicine
Abstract

ObjectiveTo determine the initial effectiveness of a novel, pediatric office-based intervention in motivating mothers to seek further assessment of positive depression screens.MethodsIn this pilot randomized controlled trial, English-speaking mothers (n = 104) with positive 2-question depression screens and presenting with children 0 to 12 years old for well-child care to a general pediatric training clinic received interventions from a trained research assistant. The Motivating Our Mothers (MOM) intervention included office-based written and verbal targeted depression education and motivational messages encouraging further depression assessment and a semistructured telephone booster delivered 2 days later. The control intervention included nontargeted written and verbal messages and 2 days later, an attention control telephone survey. Both groups received a list of depression care resources. The primary outcome was the proportion of mothers in each group who reported trying to contact any of 6 types of resources to discuss the positive screen at 2 weeks after intervention (ClinicalTrials.gov NCT01453790).ResultsDespite 6 contact attempts, 10 MOM and 9 control mothers were lost to follow-up. More mothers in the MOM intervention tried to contact a resource compared to control (73.8% vs 53.5%, difference 20.3%, 95% confidence interval for difference -0.1 to 38.5, P = .052).ConclusionsMothers receiving the MOM intervention made more attempts to contact a resource for follow-up of positive depression screens. If found effective in larger studies, MOM may prove a promising approach for motivating depression screen-positive mothers identified in general pediatric settings within and beyond the postpartum period to seek further depression assessment and support.

Published
2015

4. Factors Associated with Successful Discontinuation of Hormone Therapy

Author

Newton, Katherine M, Reed, Susan D, Nekhyludov, Larissa, Grothaus, Louis C, Ludman, Evette J, Ehrlich, Kelly, and LaCroix, Andrea Z

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Mental Health, Sleep Research, Depression, Clinical Research, Estrogen, Behavioral and Social Science, Good Health and Well Being, Aged, Case-Control Studies, Estrogen Replacement Therapy, Estrogens, Female, Health Surveys, Hot Flashes, Humans, Interviews as Topic, Massachusetts, Medication Adherence, Menopause, Middle Aged, Multivariate Analysis, Odds Ratio, Progestins, Socioeconomic Factors, Surveys and Questionnaires, Treatment Outcome, Medical and Health Sciences, Public Health, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundCareful management of symptoms, particularly sleep and mood disturbances, may assist women in discontinuing hormone therapy (HT). We sought to describe characteristics associated with successful HT cessation in women who attempted to discontinue estrogen pills/patches with or without progestin.MethodsWe invited 2,328 women, aged 45-70, enrolled January 1, 2005, to May 31, 2006, at Group Health in Washington State and Harvard Vanguard Medical Associates in Massachusetts, to participate in a telephone survey about HT practices. For the sample, we selected 2,090 women with estrogen dispensings (pharmacy data) during the study period, 200 women without HT dispensing after January 2005, and 240 women with no estrogen dispensings; 1,358 (58.3%) completed the survey. These analyses are based on survey responses.ResultsAmong 802 women who attempted HT discontinuation, the mean age was 50 years, 93% were postmenopausal, 90% were white, 30% had had a hysterectomy, and 75% experienced hot flashes after discontinuation. Those who did not succeed had greater trouble sleeping (74% vs. 57%) and mood disturbances (51% vs. 34%) than those who succeeded. In multivariable analyses, factors associated with successful discontinuation included doctor advice (odds ratio [OR] 2.62, 95% confidence interval [CI] 1.68-4.08), lack of symptom improvement (OR 4.21, CI 1.50-12.17), vaginal bleeding (OR 5.96, CI 1.44-24.6), and learning to cope with symptoms (OR 3.36, CI 2.21-5.11). Factors associated with unsuccessful HT discontinuation included trouble sleeping (OR 0.40, CI 0.26-0.61) and mood swings or depression (OR 0.63, CI 0.42-0.92).ConclusionsDoctor advice is strongly associated with successful HT discontinuation. Symptom management, particularly sleep and mood disturbances, may help women discontinue HT.

Published
2014

5. Depressive symptoms and menopausal burden in the midlife

Author

Reed, Susan D, Ludman, Evette J, Newton, Katherine M, Grothaus, Louis C, LaCroix, Andrea Z, Nekhlyudov, Larissa, Spangler, Leslie, Jordan, Luesa, Ehrlich, Kelly, and Bush, Terry

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Clinical Sciences, Health Sciences, Contraception/Reproduction, Clinical Research, Mental Health, Depression, Estrogen, Aging, Reproductive health and childbirth, Good Health and Well Being, Aged, Cross-Sectional Studies, Dyspareunia, Female, Hot Flashes, Humans, Menopause, Middle Aged, Odds Ratio, Postmenopause, Sweating, Paediatrics and Reproductive Medicine, Obstetrics & Reproductive Medicine, Biomedical and clinical sciences, Health sciences
Abstract

ObjectiveThe goal of this study was to assess whether menopausal symptoms were more common and/or more severe among women with depressive symptoms.MethodsA cross-sectional survey of 1358 women, ages 45-70, at two large integrated health plans (Seattle; Boston) was performed. Information on demographics, medical and reproductive history, medication use, menopausal experience and depressive symptoms (PHQ-8) were collected. Women taking HT were excluded. Logistic regression models adjusted for age and body mass index tested the associations between menopausal symptoms (hot flushes, night sweats, vaginal dryness and dyspareunia) and presence of moderate/severe depressive symptoms.Results770 women were included; 98 (12.7%) had moderate/severe depressive symptoms and 672 (87.3%) had no/mild depressive symptoms. Women with moderate/severe depressive symptoms were almost twice as likely to report recent vasomotor symptoms (hot flashes and or night sweats) vs. women with no/mild depressive symptoms (adjusted odds ratio (aOR) 1.67, 95%CI 1.04-2.68), and to report them as severe (aOR 1.63, 95%CI 0.95-2.83). A higher symptom burden was observed despite the fact that 20% of women with moderate/severe depressive symptoms (vs. 4.6% no/mild depressive symptoms) were using an SSRI or SNRI, medications known to improve vasomotor symptoms. The percentage of women with menopausal symptoms, and the percentage with severe vasomotor symptoms were linearly associated with the depressive symptom score.ConclusionsDepressive symptoms "amplified" the menopausal experience, or alternatively, severe vasomotor symptoms worsened depressive symptoms.

Published
2009

6. How the Women’s Health Initiative (WHI) Influenced Physicians’ Practice and Attitudes

Author

Bush, Terry M, Bonomi, Amy E, Nekhlyudov, Larissa, Ludman, Evette J, Reed, Susan D, Connelly, Maureen T, Grothaus, Lou C, LaCroix, Andrea Z, and Newton, Katherine M

Subjects
Reproductive Medicine, Health Services and Systems, Biomedical and Clinical Sciences, Health Sciences, Estrogen, Behavioral and Social Science, Aging, Clinical Research, 7.3 Management and decision making, Management of diseases and conditions, Generic health relevance, Good Health and Well Being, Attitude, Estrogen Replacement Therapy, Female, Humans, Interviews as Topic, Male, Physicians, Professional Practice, Women's Health, Clinical Sciences, General & Internal Medicine, Clinical sciences, Health services and systems, Public health
Abstract

BackgroundThe landmark Women's Health Initiative (WHI) Postmenopausal Hormone Therapy Trial published in 2002 showed that the health risks of combination hormone therapy (HT) with estrogen and progestin outweighed the benefits in healthy postmenopausal women. Dissemination of results had a major impact on prescriptions for, and physician beliefs about HT. No study has fully examined the influence of the widely publicized WHI on physicians' practice and attitudes or their opinions of the scientific evidence regarding HT; in addition, little is known about how physicians assist women in their decisions regarding HT.Design and participantsWe conducted in-depth telephone interviews with family practitioners, internists, and gynecologists from integrated health care delivery systems in Washington State (n = 10 physicians) and Massachusetts (n = 12 physicians). Our objectives were to obtain qualitative information from these physicians to understand their perspectives on use of HT, the scientific evidence regarding its risks and benefits, and counseling strategies around HT use and discontinuation.ApproachWe used Template Analysis to code transcribed telephone interviews and identify themes.ResultsPhysicians were conflicted about the WHI results and its implications. Seven themes identified from in-depth interviews suggested that the WHI (1) was a ground-breaking study that changed clinical practice, including counseling; (2) was not applicable to the full range of patients seen in clinical practice; (3) raised concerns over the impact of publicized health information on women; (4) created uncertainty about the risks and benefits of HT; (5) called for the use of decision aids; (6) influenced discontinuation strategies; and (7) provided an opportunity to discuss healthy lifestyle options with patients. As a result of the WHI, physicians reported they no longer prescribe HT for prevention and were more likely to suggest discontinuation, although many felt women should be in charge of the HT decision.ConclusionsPhysicians varied in their opinions of HT and the scientific evidence (positive and negative). Whereas the WHI delineated the risks and benefits of HT, physicians reported that decision aids are needed to guide discussions with women about menopause and HT. Better guidance at the time of WHI study publication might have been valuable to ensure best practices.

Published
2007

7. The Herbal Alternatives for Menopause (HALT) Study: background and study design

Author

Newton, Katherine M, Reed, Susan D, Grothaus, Lou, Ehrlich, Kelly, Guiltinan, Jane, Ludman, Evette, and LaCroix, Andrea Z

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Complementary and Integrative Health, Prevention, Nutrition, Clinical Research, Estrogen, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Cimicifuga, Complementary Therapies, Double-Blind Method, Estrogens, Conjugated (USP), Female, Hot Flashes, Humans, Medroxyprogesterone Acetate, Menopause, Middle Aged, Phytotherapy, Plant Preparations, Soybean Proteins, Clinical Sciences, Paediatrics and Reproductive Medicine, Obstetrics & Reproductive Medicine, Biomedical and clinical sciences, Health sciences
Abstract

We designed a randomized double-blind randomized trial to examine the short and long-term effects of alternative approaches commonly used to manage menopause symptoms. Women were randomly assigned to: (1) black cohosh 160 mg daily; (2) multibotanical (50 mg black cohosh, alfalfa, chaste tree, dong quai, false unicorn, licorice, oats, pomegranate, Siberian ginseng, boron) four capsules daily; (3) multibotanical plus telephone counseling to increase dietary soy; (4) conjugated equine estrogen 0.625 mg +/- 2.5 mg medroxyprogesterone acetate; or (5) placebo. Working with a skilled CAM provider helped us choose interventions that reflected naturopathic practices worthy of study. Mass mailing, with careful tracking and rapid responses to recruitment rates, was an effective and cost-effective recruitment strategy. Creativity was necessary to construct methods for blinding capsules and the dietary soy intervention. Independent testing of herbal products was vital to confirming their constituents. The Data and Safety and Monitoring Committee, and project officers at the funding agency, were critical partners in designing responses to unanticipated Women's Health Initiative findings published during the HALT trial. Careful monitoring of adverse events may provide much needed information about side effects of herbal products and supplements. Despite inherent challenges, the study of alternative therapies for menopause symptoms is a rewarding and important area deserving of further inquiry.

Published
2005

8. Clinical Characteristics and Outcomes From Percutaneous Coronary Intervention of Last Remaining Coronary Artery: An Analysis From the British Cardiovascular Intervention Society Database

Author

Shoaib, A, Rashid, M, Kontopantelis, E, Sharp, A, Fahy, EF, Nolan, J, Townend, J, Ludman, P, Ratib, K, Azam, ZA, Ahmad, A, McEntegart, M, Mohamed, MO, Kinnaird, T, Mamas, MA, (BCIS), British Cardiovascular Intervention Society, and (NICOR), National Institute for Cardiovascular Outcomes Research

Subjects
Male, medicine.medical_specialty, British cardiovascular intervention society, Time Factors, Databases, Factual, medicine.medical_treatment, Health Status, Coronary Vessels/diagnostic imaging, Comorbidity, Coronary Artery Disease, Risk Assessment, Percutaneous Coronary Intervention, Risk Factors, Internal medicine, medicine, Humans, Myocardial infarction, Vascular Patency, Percutaneous Coronary Intervention/adverse effects, Aged, Retrospective Studies, business.industry, Age Factors, Percutaneous coronary intervention, Coronary anatomy, Middle Aged, medicine.disease, RC666, R1, Coronary Vessels, United Kingdom, medicine.anatomical_structure, Treatment Outcome, Conventional PCI, Cardiology, Female, Cardiology and Cardiovascular Medicine, business, RA, Coronary Artery Disease/diagnostic imaging, Artery
Abstract

Background: Patients with complex high-risk coronary anatomy, such as those with a last remaining patent vessel (LRPV), are increasingly revascularized with percutaneous coronary intervention (PCI) in contemporary practice. There are limited data on the outcomes of these high-risk procedures. Methods: We analyzed a large longitudinal PCI cohort (2007–2014, n=501 841) from the British Cardiovascular Intervention Society database. Clinical, demographic, procedural, and outcome data were analyzed by dividing patients into 2 groups; LRPV group (n=2432) and all other PCI groups (n=506 691). Results: Patients in the LRPV PCI group were older, had more comorbidities, and higher prevalence of moderate-severe left ventricular systolic dysfunction. Mortality was higher in the LRPV PCI group during hospital admission (12 % versus 1.5 %, P P P P P P P Conclusions: In this contemporary cohort, patients who had PCI to their LRPV had a higher-risk profile and more adverse clinical outcomes, irrespective of the vessel treated.

Published
2020
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9. Association of different antiplatelet therapies with mortality after primary percutaneous coronary intervention

Author

Olier, I, Sirker, A, Hildick-Smith, DJR, Kinnaird, T, Ludman, P, de Belder, MA, Baumbach, A, Byrne, J, Rashid, M, Curzen, N, Mamas, MA, and British Cardiovascular Intervention Society and the National Ins

Subjects
Male, Ticagrelor, medicine.medical_specialty, Prasugrel, Antiplatelet drug, medicine.medical_treatment, 030204 cardiovascular system & hematology, Coronary Restenosis, 03 medical and health sciences, Percutaneous Coronary Intervention, 0302 clinical medicine, P2Y12, Internal medicine, medicine, Humans, cardiovascular diseases, 030212 general & internal medicine, Myocardial infarction, QA, Aged, Retrospective Studies, Postoperative Care, Dose-Response Relationship, Drug, business.industry, Incidence, Percutaneous coronary intervention, Middle Aged, RC666, medicine.disease, Clopidogrel, R1, United Kingdom, Survival Rate, Conventional PCI, ST Elevation Myocardial Infarction, Female, Cardiology and Cardiovascular Medicine, business, Prasugrel Hydrochloride, Platelet Aggregation Inhibitors, Follow-Up Studies, medicine.drug
Abstract

ObjectivesPrasugrel and ticagrelor both reduce ischaemic endpoints in high-risk acute coronary syndromes, compared with clopidogrel. However, comparative outcomes of these two newer drugs in the context of primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) remains unclear. We sought to examine this question using the British Cardiovascular Interventional Society national database in patients undergoing primary PCI for STEMI.MethodsData from January 2007 to December 2014 were used to compare use of P2Y12 antiplatelet drugs in primary PCI in >89 000 patients. Statistical modelling, involving propensity matching, multivariate logistic regression (MLR) and proportional hazards modelling, was used to study the association of different antiplatelet drug use with all-cause mortality.ResultsIn our main MLR analysis, prasugrel was associated with significantly lower mortality than clopidogrel at both 30 days (OR 0.87, 95% CI 0.78 to 0.97, P=0.014) and 1 year (OR 0.89, 95% CI 0.82 to 0.97, P=0.011) post PCI. Ticagrelor was not associated with any significant differences in mortality compared with clopidogrel at either 30 days (OR 1.07, 95% CI 0.95 to 1.21, P=0.237) or 1 year (OR 1.058, 95% CI 0.96 to 1.16, P=0.247). Finally, ticagrelor was associated with significantly higher mortality than prasugrel at both time points (30 days OR 1.22, 95% CI 1.03 to 1.44, P=0.020; 1 year OR 1.19 95% CI 1.04 to 1.35, P=0.01).ConclusionsIn a cohort of over 89 000 patients undergoing primary PCI for STEMI in the UK, prasugrel is associated with a lower 30-day and 1-year mortality than clopidogrel and ticagrelor. Given that an adequately powered comparative randomised trial is unlikely to be performed, these data may have implications for routine care.

Published
2018
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10. Temporal trends in relative survival following percutaneous coronary intervention

Author

Hulme, WJ, Sperrin, M, Martin, GP, Curzen, N, Ludman, P, Kontopantelis, E, Mamas, MA, and British Cardiovascular Intervention Society and the National Ins

Subjects
Adult, Male, British cardiovascular intervention society, Time Factors, Adolescent, medicine.medical_treatment, Population, Coronary Artery Disease, Cardiovascular Medicine, State Medicine, quality in health care, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Age Distribution, Percutaneous Coronary Intervention, Older patients, Patient age, medicine, Humans, In patient, 030212 general & internal medicine, Registries, Mortality, Sex Distribution, education, Aged, Aged, 80 and over, education.field_of_study, Wales, Relative survival, business.industry, Research, Percutaneous coronary intervention, General Medicine, Middle Aged, RC666, Survival Analysis, 3. Good health, England, Conventional PCI, Female, coronary intervention, business, 030217 neurology & neurosurgery, Demography
Abstract

ObjectivePercutaneous coronary intervention (PCI) has seen substantial shifts in patient selection in recent years that have increased baseline patient mortality risk. It is unclear to what extent observed changes in mortality are attributable to background mortality risk or the indication and selection for PCI itself. PCI-attributable mortality can be estimated using relative survival, which adjusts observed mortality by that seen in a matched control population. We report relative survival ratios and compare these across different time periods.MethodsNational Health Service PCI activity in England and Wales from 2007 to 2014 is considered using data from the British Cardiovascular Intervention Society PCI Registry. Background mortality is as reported in Office for National Statistics life tables. Relative survival ratios up to 1 year are estimated, matching on patient age, sex and procedure date. Estimates are stratified by indication for PCI, sex and procedure date.Results549 305 procedures were studied after exclusions for missing age, sex, indication and mortality status. Comparing from 2007 to 2008 to 2013–2014, differences in crude survival at 1 year were consistently lower in later years across all strata. For relative survival, these differences remained but were smaller, suggesting poorer survival in later years is partly due to demographic characteristics. Relative survival was higher in older patients.ConclusionsChanges in patient demographics account for some but not all of the crude survival changes seen during the study period. Relative survival is an under-used methodology in interventional settings like PCI and should be considered wherever survival is compared between populations with different demographic characteristics, such as between countries or time periods.

Published
2019
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11. Efficacy and safety of tenecteplase in combination with enoxaparin, abciximab, or unfractionated heparin: the ASSENT-3 randomised trial in acute myocardial infarction

Author

Van de Werf, F., Armstrong, P. W., Granger, C., Wallentin, L., Adgey, A. A. J., Aylward, P., Binbrek, A. S., Califf, R., Cassim, S., Diaz, R., Fanebust, R., Fioretti, P. M., Huber, K., Husted, S., Lindahl, B., Lopez-Sendon, J. L., Makijarvi, M., Meyer, J., Navarro Robles, J., Pfisterer, M., Seabra-Gomes, R., Soares-Piegas, L., Sugrue, D., Tendera, M., Theroux, P., Toutouzas, P., Vahanian, A., Verheugt, F., Sarelin, H., Goetz, G., Bluhmki, E., Daclin, V., Danays, T., Houbracken, K., Kaye, J., Reilly, P., Hacke, W., von Kummer, R., Lesaffre, E., Bogaerts, K., Peeters, C., Fox, K. A. A., Brower, R., Hirsh, J., Maggioni, A., Tijssen, J., Weaver, D., Beernaert, A., Beysen, N., Broos, K., De Prins, E., D'Hollander, K., Dupon, L., Fomyna, N., Fransen, A., Genesse, D., Goffin, L., Hendrickx, R., Jansen, B., Jorissen, F., Luys, C., Luyten, A., Marschal, C., Moreira, M., Munsters, K., Salerno, R., Schoovaerts, C., Sinnaeve, P., Schildermans, C., Vandenberghe, K., Vandeschoot, K., Van Gucht, H., Van Rompaey, P., Vlassak, S., Watzeels, M., Wittockx, H., Galan, K., Humeniuk, L., Seidel, A., Molina, M., Hafley, G., Alexander, J., Pascual, A., Bestilny, S., Temple, T., Ahuad Guerrero, R., Albisu, J. P., Bassani Arrieta, C. A., Bono, J., Caccavo, A., Cagnolatti, A., Cartasegna, L. R., Castellanos, R., Chekerdemian, S., Covelli, G., Cuello, J. L., Cuneo, C. A., Fernandez, A., Ferrara, C., Ferro-Queirel, E., Gambarte, A., Garcia-Duran, R., Hasbani, E., Hrabar, A., Keller, L., Lobo Marquez, L. L., Luciardi, H., Macin, S. M., Marinig, A., Marzetti, E., Muntaner, J., Nordaby, R., Orlandini, A. D., Piombo, A. C., Pomposiello, J. C., Quijano, R. A., Amerena, J., Aroney, G., Buckmaster, N., Carroll, P., Fitzpatrick, M., Newman, R., Rowe, M., Singh, B., Thomson, A., Winter, C., Eber, B., Gaul, G. B., Klein, W., Leisch, F., Mayr, H., Mlczoch, J., Niessner, H., Pachinger, O., Pall, H., Pichler, M., Roggla, G., Schaflinger, E., Schreiber, W., Slany, J., Traindl, O., Zenker, G., Beckers, J., Bekaert, I., Berthe, C., Bodur, G., Carlier, B., Carlier, M., Carpentier, J., Celen, H., Charlier, F., Clement, A., Coenen, A., Crochelet, L., De Keyser, F., De Man, F., de Meester, A., Dendale, P., Dhondt, E., Dhooghe, G., El Allaf, D., Elshot, S., Emmerechts, C., Foret, F., Gatera, E., Geraedts, J., Gerardy, A. C., Gysbrechts, M., Hallemans, R., Hellemans, S., Herssens, H., Huygens, L., Janssens, L., Lalmand, J., Maamar, R., Marechal, P., Mertens, D., Michel, P., Morandini, E., Nannan, M., Nguyen, D., Odeurs, W., Peerenboom, P., Pirenne, B., Quinonez, M., Raymenants, E., Renard, M., Silance, P. G., Standaert, A. M., Striekwold, H., Thiels, H., Valadi, D., van Brabandt, H., Van Dormael, M., Van Iseghem, P., Van Walleghem, U., Vanden Bosch, H., Vandenbossche, J. L., Vermylen, J., Verstraete, S., Vo Ngoc, P., Willems, P., Zenner, R., Campos de Albuquerque, D., Coutinho, M., de Camargo Carvalho, A. C., Fernandes Manenti, E. R., Ferreira Azevedo, A., Golin, V., Gun, C., Marin Neto, J. A., Marino, R. L., Miranda Abrantes, J. A., Nicolau, J. C., Porto Alegre Dancini, E. M., Rabelo, A., Ramos, R. F., Rizzi Coelho, O., Alexander, D., Bata, I. R., Bhargava, R. K., Bogaty, P., D'Amours, G., Darcel, I., Finnie, K. J. C., Fowlis, R., Gupta, M. K., Henderson, M., Howlett, M. K., Javier, J. J., Kieu, C. V., Kumar, G., Lebouthillier, P., Leduc, F., Lepage, S., Mcavinue, T., Mcgillen, J. E., Mcmeekin, J. D., Morse, J. W., Pistawka, K., Raimondo, E. F., Sandrin, F., Smith, H., Smylie, P. C., Tran, K., Turabian, M., Wagner, K. R., Winkler, L. H., Woo, K. S., Falstie-Jensen, N., Lind Rasmussen, S., Lomholt, P., Markenvard, J., Nielsen, H., Petersen, J., Romer, F., Ahonen, J., Huttunen, M., Kokkonen, L., Luukkonen, J., Mantyla, P., Melin, J., Mustonen, J., Valli, J., Voutilainen, S., Agraou, B., Allam, S., Baradat, G., Battistella, P., Bazin, P., Bouvier, J. -M., Destrac, S., Fouche, R., Fournier, P. -Y., Funck, F., Garnier, H., Grall, J. -Y., Gully, C., Lallement, P. -Y., Loiselet, P., Mycinsky, C., Page, A., Parisot, M., Range, G., Rocher, R., Tafani, C., Thisse, J. -Y., Tibi, T., Tissot, M., Wahl, P., Backenkohler, U., Bavastro, P., Beckmann-Hiss, H., Behnke, M., Bermes, M., Bernsmeier, R., Bethge, K. P., Bethge, H., Block, M., Burkhardt, W., Cieslinski, G., Claus, G., Deetjen, A., Diefenbach, A., Diehm, C., Dietz, A., Dippold, W. G., Eichner, A., Erckenbrecht, J. F., Gawlick, L., Gerber, V., Goppel, L., Gottwik, M., Grosch, B., Hammer, B., Hanheide, M., Hanrath, P., Haspel, J., Hennersdorf, F., Hermanns, M., Hoffmeister, H. M., Holzapfel, P., Hubner, H., Jansen, W., Jung, S., Kaddatz, J., Kienbock, H., Klein, H. H., Konz, K. H., Kulschbach, M., Leschke, M., Liebau, G., Linnartz, M., Lockert, G., Loesbrock, R., Lollgen, H., Ludwig, N., Mudra, H., Munzer, K., Nebel, B., Nellessen, U., Neu, C., Olbrich, H. G., Pfeffer, A., Pfeiffer, P., Plate, V., Pollock, B., Rapp, H., Rommele, U., Sauer, K., Scheffler, N., Schlotterbeck, K., Schmidt-Salzmann, A., Schnitzler, G., Schumann, H., Schuster, C. J., Schuster, P., Schweizer, P., Seitz, K., Simon, R., Spes, C., Szabo, S., Terhardt-Kasten, E., Theuerkauf, B., Tigges, R., Tinnappel, J., Topp, H., Trockel, P., Unland, N., Veth, V., Vom Dahl, J., Vossbeck, G., Weindel, K., Weib, D., Wiewel, D., Wirtz, P., Zipp, C., Apostolou, T., Chalkidis, C., Exadaktylos, N., Foussas, S., Hatseras, D., Karas, S., Karydis, K., Lambrou, S., Louridas, G., Manolis, A., Nanas, J., Novas, I., Panagiotidou, T., Papadopoulos, C., Papakonstantinou, D., Papasteriadis, E., Pavlidis, P., Pyrgakis, V., Skoufas, P., Stavrati, A., Tyrologos, A., Vardas, P., Vrouchos, G., Zacharoulis, A., Zarifis, J., Brown, A., Daly, K., Fennell, W., Horgan, J., Mccann, H., Mcdonald, K., O'Reilly, M., Sullivan, P., Altamura, G., Ambrosio, G., Auteri, A., Aveta, P., Azzarito, M., Badano, L. P., Barbiero, M., Barletta, C., Biscosi, C., Boccanelli, A., Bottero, M., Brizio, E., Brunazzi, M. C., Brunelli, C., Bugatti, U., Capozi, A., Capucci, A., Carfora, A., Caronna, A., Carrone, M., Casazza, F., Cauticci, A., Ceci, V., Ciconte, V., Circo, A., Ciricugno, S., Comito, F., Cornacchia, D., Corsini, G., D'Andrea, F., De Rosa, P., De Simone, M., Del Citerna, F., Del Pinto, M., Dell'Ali, C., Della Casa, S., Della Monica, R., Delogu, G., Di Biase, M., Di Chiara, A., Di Guardo, G., Di Marco, S., Di Mario, F., Di Napoli, T., Di Palma, F., Fadin, B. M., Fazzari, M., Ferraiuolo, G., Fiaschetti, R., Fontanelli, A., Fresco, C., Gambelli, G., Gasbarri, F., Gemelli, M., Giani, P., Gigantino, A., Giomi, A., Giorgi, G., Greco, C., Gregorio, G., Guagnozzi, G., Guiducci, U., Guzzardi, G., Izzo, A., La Rosa, A., Leone, F., Leone, G., Lo Bianco, F., Locuratolo, N., Maggiolini, S., Malinconico, M., Mancone, C., Mangiameli, S., Marchi, S. M., Maresta, A., Mauri, F., Mazzini, C. A., Michisanti, M., Miracapillo, G., Modena, M. G., Morgagni, G. L., Mossuti, E., Nascimbeni, F., Negrelli, M., Notaristefano, A., Pardi, S., Peci, P., Pettinati, G., Pietropaolo, F., Pirelli, S., Pretolani, M., Prinzi, D., Proietti, F., Raganelli, L., Rapino, S., Re, F., Ricci, R., Rinaldi, G., Rusticali, G., Severi, S., Spallarossa, P., Tartagni, F., Terrosu, P., Tortorella, G., Tota, F., Tritto, I., Tuccilo, B., Turco, V., Uscio, G., Valagussa, F., Vergoni, W., Verzuri, M. S., Vetrano, A., Villani, R., Zanini, R., Boisante, L., Niclou, R., Alcocer, L., Castro, A., Fragoso, J., Gonzalez, V., Gonzalez-Pacheco, H., Hernandez-Santamaria, I., Huerta, R., Huerta, D., Martinez, A., Mendoza, M., Moguel, R., Navarro, J., Portos, J. M., Rodriguez, I., Sierra, L., Valencia, S., Vazquez, A., Arnold, A. E. R., Boehmer, A. G., de Graaf, J. J., Funke Kupper, A. J., Gobel, E. J. A. M., Janus, C. L., Linssen, G. C. M., Sedney, M. I., Slegers, L. C., Spierenburg, H. A. M., Strikwerda, S., Tans, J. G. M., Twisk, S. P. M., van der Heijden, R., van Kalmthout, P. M., Verheugt, F. W. A., Holt, E., Skogsholm, A., Thorshaug, R., Thybo, N. K., Wang, H., Maciejewicz, J., Piotrowski, W., Pluta, W., Ruminski, W., Skura, M., Smielak-Korombel, W., Carranca, J., Carvalho, M., Catarino, C., Cunha, D., Ferreira, D., Ferreira, J., Ferreira da Costa, A. F., Lopes de Carvalho, J., Martins, L., Mourao, L., Oliveira Carrageta, M., Prazeres de Sa, E., Puig, J., Ramalho Dos Santos, M. J. J., Resende, M., Seabra Gomes, R., Baig, M. M. E., Bayat, J., Benjamin, J. D., Ranjith, N., Routier, R., Wittmer, H., Abizanda Campos, R., Alonso Garcia, M. A., Amaro Cendon, A., Arboleda Sanchez, J. A., Blanco Varela, J., Bruguera I Cortada, J., Carpintero Avellaneda, J. L., Caturla Such, J., Civeira Murillo, E., Fernandez Aviles, F., Fernandez Fernandez, R., Figueras Bellot, J., Fiol Sala, M., Froufe Sanchez, J., Garcia Calabozo, R., Garcia Palacios, J. L., Gonzalez Maqueda, I., Kallmeyer Martin, C., Lopez Sendon, J. L., Manzano Ramirez, A., Marine Rebull, J., Monton Rodriguez, A., Pique Gilart, M., Reina Toral, A., Rodriguez Llorian, A., Ruano Marco, M., Sanchez Miralles, A., Sanjose Garagarza, J. M., Santalo Bel, M., Torres Ruiz, J. M., Valentin Segura, V., Ahlstrom, P., Ahremark, U., Bandh, S., Bellinetto, A., Dahlberg, A., Hansen, O., Hurtig, U., Jonasson, L., Karlsson, J. E., Larsson, L. E., Moller, B., Ohlin, H., Persson, H., Sandstedt, L., Soderberg, S., Svennberg, L., Swahn, E., Tygesen, H., Broccard, A. F., Estlinbaum, W., Follath, F., Frutiger, A., Hess, N., Maggiorini, M., Marti, D., Muller, P., Rickenbacher, P., Schaller, M. D., Weinbacher, M., Abdulali, S., Ahmad, G., George, S., Ghazi, A., Rao, K. N., Bishop, A., Bridges, A., Canepa-Anson, R., Cave, M., Clarck, R., Cooper, I., de Belder, A., Farrer, M., Kendall, J. M., Ludman, P., Mattu, R., Mcglinchey, P., Moriarty, A. J., Muthusamy, S., Nee, P. A., Nolan, J., Papouchado, M., Rose, E. L., Shahi, M., Stephens, J., Trevelyan, J., Abdul-Karim, A., Adler, L., Arunasalam, S., Avington, D., Baron, S., Beel, T., Bellamy, B., Bennett, J., Berndt, T., Berrick, A., Bersin, R. M., Bethala, V., Bharath, S., Bouchard, A., Boulet, J. E., Bowerman, R., Boyek, T., Brar, R. S., Brodell, G., Bryant, B., Buckner, J. K., Cage, J., Cannon, J. D., Carducci, B., Carr, K., Chang, M., Chelliah, N., Chin, W. L., Chin, J., Church, D. H., Clark, R., Coulis, L., Dadkhah, S., Dearing, B., Defranco, A., Dharawat, M., Dharawat, R., Dhruva, N., Dicola, J., Dykstra, G., Eisenberg, S., El-Bialy, A., Fera, S., Ford, K., Foreman, R. D., Friedman, S., Friedman, V., Garibian, G., Gelormini, J., Geninatti, M. R., Genovese, R., Ghazi, F., Gilchrist, I., Gitler, B., Glover, R., Gonzalez, J., Goulah, R., Graham, B., Gray, R., Grodman, R., Habib, G. B., Hack, T., Hamroff, G., Hanna, G., Hart, M., Haught, H., Hawkins, J., Hempel, R., Hiremath, Y., Hiser, W., Holland, E., Jaffe, N., Jamal, N., James, K. F., Kalla, S., Kates, M., Kemper, A. J., Kennedy, J. J., Kerut, E. K., Killpack, M., King, J., T. Y., Ko, Kollar, K., Kontos, M., Kugelmassluu, A., Kumar, A., Kutscher, A. H., Lambrecht, C., Lancaster, L., Layden, J., Lazar, A., Lebow, M., Lee, C., Lee, A. B., Lehr, J., Levin, F. L., Levitt, R., Levy, R. M., Lieberman, A., Litman, G. I., Lui, H., Luu, M. Q., Macdonald, G., Madyoon, H., Mancherje, C., Marmulstein, M., Mclaurin, B. T., Mcnellis, M., Mendelson, R., Micale, P. J., Miller, M. J., Miller, M. S., Miller, J., Millman, A., Millsaps, R., Minor, S., Modica, J., Morse, H., Moskovits, N., Nester, B. A., Newton, A. S., Niazi, I., Niederman, A., Oatfield, R., Painter, J. A., Pamfilis, S. M., Pamulapati, K. M., Patel, N., Payne, R., Pearson, C., Peizner, D. S., Petrovich, L., Piriz, J., Pollack, M., Pollock, S., Popkave, A., Puma, J. A., Quesada, R., Quigley-Malcolm, D., Raby, K., Ravindran, K., Rees, A. P., Reiner, J., Rivera, E., Rogers, F., Rosenthal, A., Rowe, W. W., Ryan, P. F., Ryman, K., Salacata, A., Santolin, C., Saucedo, J., Savage, R., Savage, W., Schumacher, R., Segarra, S., Sharkey, S., Shonkoff, D., Silver, M., Silver, S. L., Singh, G., Sinyard, R. D., Sporn, D., Srivastava, N. K., Stomel, R., Suresh, D. P., Tallman, M., Togioka, T., Varma, S., Verant, R. P., Wallach, R., Weinberg, M., Weinberg, D., Weinstein, J. M., Wesley, G., Westerman, J. H., Wheeling, J., Whitaker, J., Widmer, M., Yasin, M., and Zakrzewski, M. J.

Subjects
Male, medicine.medical_specialty, Abciximab, Ischemia, Myocardial Infarction, Tenecteplase, Injections, Immunoglobulin Fab Fragments, Reperfusion therapy, Fibrinolytic Agents, Recurrence, Internal medicine, medicine, Humans, Myocardial infarction, Enoxaparin, Aged, Intention-to-treat analysis, Chi-Square Distribution, business.industry, Heparin, Antibodies, Monoclonal, General Medicine, Middle Aged, medicine.disease, Survival Analysis, Regimen, Treatment Outcome, Anesthesia, Tissue Plasminogen Activator, Cardiology, Drug Therapy, Combination, Female, business, Platelet Aggregation Inhibitors, medicine.drug
Abstract

BACKGROUND: Current fibrinolytic therapies fail to achieve optimum reperfusion in many patients. Low-molecular-weight heparins and platelet glycoprotein IIb/IIIa inhibitors have shown the potential to improve pharmacological reperfusion therapy. We did a randomised, open-label trial to compare the efficacy and safety of tenecteplase plus enoxaparin or abciximab, with that of tenecteplase plus weight-adjusted unfractionated heparin in patients with acute myocardial infarction. METHODS: 6095 patients with acute myocardial infarction of less than 6 h were randomly assigned one of three regimens: full-dose tenecteplase and enoxaparin for a maximum of 7 days (enoxaparin group; n=2040), half-dose tenecteplase with weight-adjusted low-dose unfractionated heparin and a 12-h infusion of abciximab (abciximab group; n=2017), or full-dose tenecteplase with weight-adjusted unfractionated heparin for 48 h (unfractionated heparin group; n=2038). The primary endpoints were the composites of 30-day mortality, in-hospital reinfarction, or in-hospital refractory ischaemia (efficacy endpoint), and the above endpoint plus in-hospital intracranial haemorrhage or in-hospital major bleeding complications (efficacy plus safety endpoint). Analysis was by intention to treat. FINDINGS: There were significantly fewer efficacy endpoints in the enoxaparin and abciximab groups than in the unfractionated heparin group: 233/2037 (11.4%) versus 315/2038 (15.4%; relative risk 0.74 [95% CI 0.63-0.87], p=0.0002) for enoxaparin, and 223/2017 (11.1%) versus 315/2038 (15.4%; 0.72 [0.61-0.84], p

Published
2001

12. Impact of COVID-19 Pandemic on Mechanical Reperfusion for Patients With STEMI

Author

Giuseppe De Luca, Pierre Deharo, Pierfrancesco Agostoni, Gabriele Gabrielli, Francisco Bosa Ojeda, Ylitalo Antti, Lisette Okkels Jensen, Bor Wilbert, Luigi Vignali, Fortunato Scotto Di Uccio, Dariusz Dudek, Marco Boccalatte, Monica Verdoia, Edouard Benit, Gianni Casella, Heidi Lehtola, Alessandra Scoccia, Tim Kinnaird, Massimo Siviglia, Raul Moreno, Vladimir Ganyukov, Arpad Lux, Mika Laine, Adrian P. Banning, Santiago Camacho-Freiere, Guido Parodi, José Moreu, Michał Kidawa, Miha Cercek, Victor Becerra, Stephane Manzo, Elvin Kedhi, Marija Vavlukis, Filippo Zilio, Ciro De Simone, Nikola Bakraceski, Xavier Carrillo, Giuseppe Uccello, Maurizio Menichelli, Gerard Rourai Ferrer, Dimitrios Alexopoulos, Benjamin Faurie, Jurriën M. ten Berg, Lucia Marinucci, Juan Sanchis Forés, Giovanni Amoroso, Sébastien Levesque, Bernardo Tuccillo, Enrico Fabris, Peter Ludman, Rui Campante Teles, Wojtek Wojakowski, Leonardo Spedicato, Lucian Calmac, Yves Cottin, Maurits T. Dirksen, Petr Kala, Thomas W Johnson, Xacobe Flores Rios, Gianluca Caiazzo, Clemens van Birgelen, Francesco Versaci, Alexander Ijsselmuiden, Luca Donazzan, Kees-Jan Royaards, Adriaan O. Kraaijeveld, Alejandro Gutierrez Barrios, Gennaro Galasso, Vincenzo Guiducci, Julinda Mehilli, Giuseppe Cirrincione, Andrea Santucci, Giuliana Cortese, José Luis Díez Gil, Iñigo Lozano Martínez-Luengas, Bruno Scheller, Periklis Davlouros, Tomas Kovarnik, Arturo García-Touchard, Pieter C. Smits, De Luca, G., Verdoia, M., Cercek, M., Jensen, L. O., Vavlukis, M., Calmac, L., Johnson, T., Ferrer, G. R., Ganyukov, V., Wojakowski, W., Kinnaird, T., van Birgelen, C., Cottin, Y., Ijsselmuiden, A., Tuccillo, B., Versaci, F., Royaards, K. -J., Berg, J. T., Laine, M., Dirksen, M., Siviglia, M., Casella, G., Kala, P., Diez Gil, J. L., Banning, A., Becerra, V., De Simone, C., Santucci, A., Carrillo, X., Scoccia, A., Amoroso, G., Lux, A., Kovarnik, T., Davlouros, P., Mehilli, J., Gabrielli, G., Rios, X. F., Bakraceski, N., Levesque, S., Cirrincione, G., Guiducci, V., Kidawa, M., Spedicato, L., Marinucci, L., Ludman, P., Zilio, F., Galasso, G., Fabris, E., Menichelli, M., Garcia-Touchard, A., Manzo, S., Caiazzo, G., Moreu, J., Fores, J. S., Donazzan, L., Vignali, L., Teles, R., Benit, E., Agostoni, P., Bosa Ojeda, F., Lehtola, H., Camacho-Freiere, S., Kraaijeveld, A., Antti, Y., Boccalatte, M., Deharo, P., Martinez-Luengas, I. L., Scheller, B., Alexopulos, D., Moreno, R., Kedhi, E., Uccello, G., Faurie, B., Gutierrez Barrios, A., Di Uccio, F. S., Wilbert, B., Smits, P., Cortese, G., Parodi, G., Dudek, D., banning, adrian/0000-0002-2842-7861, GUIDUCCI, VINCENZO/0000-0002-0833-2785, vavlukis, marija/0000-0002-4479-6691, Bor, Willem L/0000-0002-3253-5961, DAVLOUROS, PERIKLIS/0000-0002-1439-1992, Uccello, Giuseppe/0000-0002-6163-8468, Kidawa, Michal/0000-0002-5000-6561, [De Luca, Giuseppe] Univ Piemonte Orientale, Div Cardiol, Azienda Osped Univ Maggiore Carita, Novara, Italy, [Verdoia, Monica] Osped Inferm Biella, ASL Biella, Div Cardiol, Biella, Italy, [Cercek, Miha] Univ Med Ctr, Ctr Intens Internal Med, Ljubljana, Slovenia, [Jensen, Lisette Okkels] Odense Univ Hosp, Div Cardiol, Odense, Denmark, [Vavlukis, Marija] Ss Cyril & Methodius Univ, Med Fac, Univ Clin Cardiol, Skopje, North Macedonia, [Calmac, Lucian] Clin Emergency Hosp Bucharest, Bucharest, Romania, [Johnson, Tom] Univ Hosp Bristol NHSFT, Bristol Heart Inst, Div Cardiol, Bristol, Avon, England, [Johnson, Tom] Univ Bristol, Bristol, Avon, England, [Ferrer, Gerard Rourai] Hosp Univ Bellvitge, Heart Dis Inst, Intervent Cardiol Unit, Barcelona, Spain, [Ganyukov, Vladimir] State Res Inst Complex Issues Cardiovasc Dis, Div Cardiol, Kemerovo, Russia, [Wojakowski, Wojtek] Med Univ Silezia, Div Cardiol, Katowice, Poland, [Kinnaird, Tim] Univ Hosp Wales, Div Cardiol, Cardiff, Wales, [van Birgelen, Clemens] Thoraxctr Twente, Dept Cardiol, Med Spectrum Twente, Enschede, Netherlands, [Cottin, Yves] Univ Hosp, Div Cardiol, Dijon, France, [IJsselmuiden, Alexander] Amphia Hosp, Div Cardiol, Breda, Netherlands, [Tuccillo, Bernardo] Osped Mare, Div Cardiol, Naples, Italy, [Di Uccio, Fortunato Scotto] Osped Mare, Div Cardiol, Naples, Italy, [Versaci, Francesco] Osped Santa Maria Goretti, Div Cardiol, Latina, Italy, [Royaards, Kees-Jan] Maasstad Ziekenhuis, Div Cardiol, Rotterdam, Netherlands, [Smits, Pieter] Maasstad Ziekenhuis, Div Cardiol, Rotterdam, Netherlands, [Ten Berg, Jurrien] St Antonius Hosp, Div Cardiol, Nieuwegein, Netherlands, [Wilbert, Bor] St Antonius Hosp, Div Cardiol, Nieuwegein, Netherlands, [Laine, Mika] Helsinki Univ Cent Hosp, Div Cardiol, Helsinki, Finland, [Dirksen, Maurits] Northwest Clin, Div Cardiol, Alkmaar, Netherlands, [Siviglia, Massimo] Osped Riuniti Reggio Calabria, Div Cardiol, Reggio Di Calabria, Italy, [Casella, Gianni] Osped Maggiore Bologna, Div Cardiol, Bologna, Italy, [Kala, Petr] Masaryk Univ, Univ Hosp Brno, Med Fac, Brno, Czech Republic, [Diez Gil, Jose Luis] H Univ & Politecn La Fe, Valencia, Spain, [Banning, Adrian] John Radcliffe Hosp, Oxford, England, [Becerra, Victor] Hosp Clin Univ Virgen Victoria, Malaga, Spain, [De Simone, Ciro] Clin Villa Fiori, Div Cardiol, Acerra, Italy, [Santucci, Andrea] Osped Santa Maria Misericordia, Perugia, Italy, [Carrillo, Xavier] Hosp Germans Triasi Pujol, Badalona, Spain, [Scoccia, Alessandra] Osped St Anna, Div Cardiol, Ferrara, Italy, [Amoroso, Giovanni] Onze Lieve Vrouwe Gasthuis OLVG, Amsterdam, Netherlands, [Lux, Arpad] Mastricht Univ, Med Ctr, Maastricht, Netherlands, [Kovarnik, Tomas] Charles Univ Hosp, Prague, Czech Republic, [Davlouros, Periklis] Patras Univ Hosp, Invas Cardiol & Congenital Heart Dis, Patras, Greece, [Mehilli, Julinda] Ludwig Maximilians Univ Munchen, Univ Hosp Munich, Munich, Germany, [Gabrielli, Gabriele] Azienda Osped Univ, Intervent Cardiol Unit, Osped Riuniti, Ancona, Italy, [Rios, Xacobe Flores] Complexo Hosp Univ La Coruna, La Coruna, Spain, [Bakraceski, Nikola] Ctr Cardiovasc Dis, Ohrid, North Macedonia, [Levesque, Sebastien] CHU Poitiers, Univ Hosp, Poitiers, France, [Cirrincione, Giuseppe] Osped Civ Arnas, Div Cardiol, Palermo, Italy, [Guiducci, Vincenzo] AUSL IRCCS, Reggio Emilia, Italy, [Kidawa, Michal] Med Univ Lodz, Cent Hosp, Lodz, Poland, [Spedicato, Leonardo] Osped Santa Maria Misericordia, Div Cardiol, Udine, Italy, [Marinucci, Lucia] Osped Riuniti Marche Nord, Div Cardiol, Azienda Osped, Pesaro, Italy, [Ludman, Peter] Univ Hosp Birmingham, Birmingham, W Midlands, England, [Zilio, Filippo] Osped Santa Chiara, Trento, Italy, [Galasso, Gennaro] Osped San Giovanni Dio Ruggi Aragona, Div Cardiol, Salerno, Italy, [Fabris, Enrico] Univ Ospedali Riuniti, Azienda Osped, Trieste, Italy, [Menichelli, Maurizio] Osped F Spaziani, Div Cardiol, Frosinone, Italy, [Garcia-Touchard, Arturo] Hosp Puerta Hierro, Div Cardiol, Majadahonda, Spain, [Manzo, Stephane] Paris 07 Univ, CHU Lariboisiere, AP HP, Div Cardiol,INSERM,UMRS 942, Paris, France, [Caiazzo, Gianluca] Osped G Moscati, Div Cardiol, Aversa, Italy, [Moreu, Jose] Complejo Hosp Toledo, Div Cardiol, Toledo, Spain, [Sanchis Fores, Juan] Hosp Clin Univ Valencia, Div Cardiol, Valencia, Spain, [Donazzan, Luca] Osped S Maurizio Bolzano, Div Cardiol, Bolzano, Italy, [Vignali, Luigi] Azienda Osped Sanitaria, Intervent Cardiol Unit, Parma, Italy, [Teles, Rui] Hosp Santa Cruz, Div Cardiol, CHLO Carnaxide, Lisbon, Portugal, [Benit, Edouard] Jessa Ziekenhuis, Div Cardiol, Hasselt, Belgium, [Agostoni, Pierfrancesco] Ziekenhuis Netwerk Antwerpen ZNA Middelheim, Div Cardiol, Antwerp, Belgium, [Bosa Ojeda, Francisco] Hosp Univ Canarias, Div Cardiol, Santa Cruz De Tenerife, Spain, [Lehtola, Heidi] Oulu Univ Hosp, Div Cardiol, Oulu, Finland, [Camacho-Freiere, Santiago] Juan Ramon Jimenez Hosp, Div Cardiol, Huelva, Spain, [Kraaijeveld, Adriaan] UMC Utrecht, Div Cardiol, Utrecht, Netherlands, [Antti, Ylitalo] Univ Hosp, Heart Ctr, Div Cardiol, Turku, Finland, [Boccalatte, Marco] Osped Santa Maria Grazie, Div Cardiol, Pozzuoli, Italy, [Deharo, Pierre] Aix Marseille Univ, CHU Timone, Div Cardiol, Marseille, France, [Lozano Martinez-Luengas, Inigo] Hosp Cabuenes, Div Cardiol, Gijon, Spain, [Scheller, Bruno] Univ Saarland, Div Cardiol Clin & Expt Intervent Cardiol, Homburg, Germany, [Alexopoulos, Dimitrios] Attikon Univ Hosp, Div Cardiol, Athens, Greece, [Moreno, Raul] Hosp Paz, Div Cardiol, Madrid, Spain, [Kedhi, Elvin] St Jan Hosp, Div Cardiol, Brugge, Belgium, [Uccello, Giuseppe] Osped A Manzoni Lecco, Div Cardiol, Lecce, Italy, [Faurie, Benjamin] Grp Hosp Mutualiste Grenoble, Div Cardiol, Grenoble, France, [Gutierrez Barrios, Alejandro] Hosp Puerta Mar, Div Cardiol, Cadiz, Spain, [Cortese, Giuliana] Univ Padua, Dept Stat Sci, Padua, Italy, [Parodi, Guido] Azienda Osped Univ Sassari, Sassari, Italy, [Dudek, Dariusz] Jagiellonian Univ Med Coll, Inst Cardiol, Krakow, Poland, RS: Carim - H01 Clinical atrial fibrillation, and Cardiologie

Subjects
Male, Internationality, medical decision-making, medicine.medical_treatment, 030204 cardiovascular system & hematology, Rate ratio, COVID-19 (coronavirus), Settore MED/06, 0302 clinical medicine, Pandemic, Percutaneous Coronary Intervention/statistics & numerical data, Medicine, Viral, 030212 general & internal medicine, Myocardial infarction, Registries, Acute myocardial-infarction, Original Investigation, STEMI, ST-segment elevation myocardial infarction, Middle Aged, 3. Good health, Europe, fibrinolysis, Female, COVID-19, primary angioplasty, STEMI, Aged, Humans, Percutaneous Coronary Intervention, Retrospective Studies, ST Elevation Myocardial Infarction, Coronavirus Infections, Pandemics, Pneumonia, Viral, Cardiology and Cardiovascular Medicine, Editorial Comment, ACUTE MYOCARDIAL-INFARCTION, medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), Primary angioplasty, IRR, incidence rate ratio, Europe/epidemiology, 03 medical and health sciences, Betacoronavirus, cardiovascular diseases, Mortality, PCI, percutaneous coronary intervention, DES, drug-eluting stent(s), business.industry, ST Elevation Myocardial Infarction/mortality, PPCI, primary PCI, SARS-CoV-2, MORTALITY, Percutaneous coronary intervention, Retrospective cohort study, Pneumonia, medicine.disease, Confidence interval, ST-segment elevation myocardial infarction, CI, confidence interval, Emergency medicine, COVID-19, STEMI, primary angioplasty, ACS, acute coronary syndrome, business
Abstract

Background The fear of contagion during the coronavirus disease-2019 (COVID-19) pandemic may have potentially refrained patients with ST-segment elevation myocardial infarction (STEMI) from accessing the emergency system, with subsequent impact on mortality. Objectives The ISACS-STEMI COVID-19 registry aims to estimate the true impact of the COVID-19 pandemic on the treatment and outcome of patients with STEMI treated by primary percutaneous coronary intervention (PPCI), with identification of “at-risk” patient cohorts for failure to present or delays to treatment. Methods This retrospective registry was performed in European high-volume PPCI centers and assessed patients with STEMI treated with PPPCI in March/April 2019 and 2020. Main outcomes are the incidences of PPCI, delayed treatment, and in-hospital mortality. Results A total of 6,609 patients underwent PPCI in 77 centers, located in 18 countries. In 2020, during the pandemic, there was a significant reduction in PPCI as compared with 2019 (incidence rate ratio: 0.811; 95% confidence interval: 0.78 to 0.84; p, Central Illustration

Published
2020
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13. The 2011-2012 pilot European Society of Cardiology Sentinel Registry of Transcatheter Aortic Valve Implantation: 12-month clinical outcomes

Author

Georg Nickenig, Javier Goicolea, Francesco Romeo, Carlos Macaya, Gerhard Schuler, Martine Gilard, Eduardo Alegria Barrero, Peter Wenaweser, Marian Zembala, Carlo Di Mario, Roberta Serdoz, Petr Kala, Cécile Laroche, Stephan Windecker, Geneviève Derumeaux, Bernard D. Prendergast, Susanna Price, Erwin Schroeder, Bernard Iung, Ottavio Alfieri, Hélène Eltchaninoff, Adam Witkowski, Peter Ludman, Thomas Snow, Michele Pighi, Michael Schlüter, Haim D. Danenberg, Gian Paolo Ussia, Manel Sabaté, Neil Moat, Pepe Zamorano, Roberto Corti, Gianni Dall'Ara, Gilard, Martine, Schlüter, Michael, Snow, Thomas M., Dall'Ara, Gianni, Eltchaninoff, Helene, Moat, Neil, Goicolea, Javier, Ussia, Gian Paolo, Kala, Petr, Wenaweser, Peter, Zembala, Marian, Nickenig, Georg, Price, Susanna, Barrero, Eduardo Alegria, Iung, Bernard, Zamorano, Pepe, Schuler, Gerhard, Corti, Roberto, Alfieri, Ottavio, Prendergast, Bernard, Ludman, Peter, Windecker, Stephan, Sabate, Manel, Witkowski, Adam, Danenberg, Haim, Schroeder, Erwin, Romeo, Francesco, Macaya, Carlo, Derumeaux, Geneviève, Laroche, Cécile, Pighi, Michele, Serdoz, Roberta, Di Mario, Carlo, Gilard, M, Schlüter, M, Snow, Tm, Dall'Ara, G, Eltchaninoff, H, Moat, N, Goicolea, J, Ussia, Gp, Kala, P, Wenaweser, P, Zembala, M, Nickenig, G, Price, S, Alegria Barrero, E, Iung, B, Zamorano, P, Schuler, G, Corti, R, Prendergast, B, Ludman, P, Windecker, S, Sabate, M, Witkowski, A, Danenberg, H, Schroeder, E, Romeo, F, Macaya, C, Derumeaux, G, Laroche, C, Pighi, M, Serdoz, R, and Di Mario, C.

Subjects
Male, Registrie, Aortic valve, Cardiac Catheterization, Aortic stenosi, Survival, medicine.medical_treatment, 030204 cardiovascular system & hematology, Prosthesis, Transcatheter aortic valve implantation (TAVI), Postoperative Complications, 0302 clinical medicine, Risk Factors, 80 and over, Registries, 030212 general & internal medicine, Cardiac catheterization, Aged, 80 and over, Heart Valve Prosthesis Implantation, aortic stenosis, registry, survival, transcatheter aortic valve implantation (TAVI), Aged, Aortic Valve, Aortic Valve Stenosis, Female, Follow-Up Studies, Heart Valve Prosthesis, Humans, Pilots, Treatment Outcome, Transcatheter Aortic Valve Replacement, Pilot, Atrial fibrillation, 3. Good health, medicine.anatomical_structure, Aortic valve stenosis, Cardiology, Cardiology and Cardiovascular Medicine, Human, Registry, medicine.medical_specialty, Logistic euroscore, Transcatheter aortic, Vascular access, Follow-Up Studie, 03 medical and health sciences, Internal medicine, medicine, business.industry, Risk Factor, medicine.disease, Aortic Valve Stenosi, Surgery, Heart Valve Prosthesi, Postoperative Complication, business
Abstract

AIMS Our aim was to assess one-year outcomes of patients enrolled in the pilot European Sentinel Registry of Transcatheter Aortic Valve Implantation (TAVI). METHODS AND RESULTS One-year outcomes of 4,571 patients (81.4±7.2 years, 2,291 [50.1%] male) receiving TAVI with the SAPIEN XT (57.3%) or CoreValve prosthesis at 137 European centres were analysed using Kaplan-Meier and Cox proportional hazards regression techniques. At one year, 3,341 patients were alive, 821 had died, and 409 were lost to follow-up. Of 2,125 patients who underwent functional assessment, 1,916 (90%) were in New York Heart Association (NYHA) Class I/II at one year, with functional improvement from baseline noted in 1,682 patients (88%). One-year survival based on 4,564 patients was estimated at 79.1%. Independent baseline predictors of mortality were increasing age and logistic EuroSCORE, the presence of NYHA III/IV, chronic obstructive pulmonary disease, and atrial fibrillation. Female gender was associated with a 4% survival benefit at one year. Vascular access routes other than transfemoral were associated with poorer survival. Procedural failure and major periprocedural complications had an adverse impact on survival. CONCLUSIONS Contemporary European experience attests to the effectiveness of routine TAVI in unselected elderly patients.

Published
2016
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14. Local and general anaesthesia do not influence outcome of transfemoral aortic valve implantation

Author

Hélène Eltchaninoff, Martine Gilard, Eduardo Alegria Barrero, Francesco Romeo, Carlo Di Mario, Bernard Iung, Georg Nickenig, Manel Sabaté, Peter Wenaweser, Alessio Mattesini, Javier Goicolea, Petr Kala, Adam Witkowski, Marian Zembala, Geneviève Derumeaux, Thomas Snow, Stephan Windecker, Ottavio Alfieri, Rodrigo Estévez-Loureiro, Peter Ludman, Susanna Price, Neil Moat, Cécile Laroche, Carlos Macaya, Gerhard Schuler, Gian Paolo Ussia, Luigi Tavazzi, Bernard D. Prendergast, Gianni Dall'Ara, José Luis Zamorano, Haim D. Danenberg, Erwin Schroeder, Dall'Ara, G, Eltchaninoff, H, Moat, N, Laroche, C, Goicolea, J, Ussia, Gp, Kala, P, Wenaweser, P, Zembala, M, Nickenig, G, Snow, T, Price, S, Alegria Barrero, E, Estevez Loureiro, R, Iung, B, Luis Zamorano, J, Schuler, G, Alfieri, Ottavio, Prendergast, B, Ludman, P, Windecker, S, Sabate, M, Gilard, M, Witkowski, A, Danenberg, H, Schroeder, E, Romeo, F, Macaya, C, Derumeaux, G, Mattesini, A, Tavazzi, L, Di Marioa, C., Dall'Ara, Gianni, Eltchaninoff, Helene, Moat, Neil, Laroche, Cécile, Goicolea, Javier, Ussia, Gian Paolo, Kala, Petr, Wenaweser, Peter, Zembala, Marian, Nickenig, Georg, Snow, Thoma, Price, Susanna, Barrero, Eduardo Alegria, Estevez-Loureiro, Rodrigo, Iung, Bernard, Zamorano, José Lui, Schuler, Gerhard, Prendergast, Bernard, Ludman, Peter, Windecker, Stephan, Sabate, Manel, Gilard, Martine, Witkowski, Adam, Danenberg, Haim, Schroeder, Erwin, Romeo, Francesco, MacAya, Carlo, Derumeaux, Genevieve, Mattesini, Alessio, Tavazzi, Luigi, and Di Mario, Carlo

Subjects
Male, Registrie, Aortic valve, medicine.medical_specialty, Aortic valve stenosi, Population, Pilot Projects, Anesthesia, General, Anaesthesia, Transcatheter Aortic Valve Replacement, medicine, Humans, Pilot Project, General anaesthesia, Registries, education, Stroke, Outcome, Aged, Aged, 80 and over, Transcatheter aortic valve implantation, education.field_of_study, business.industry, Mortality rate, Incidence (epidemiology), Confounding, Aortic Valve Stenosis, medicine.disease, 3. Good health, Surgery, Treatment Outcome, medicine.anatomical_structure, Aortic valve stenosis, Anesthesia, Female, Cardiology and Cardiovascular Medicine, business, Anesthesia, Local, Human
Abstract

Background: There is great variability for the type of anaesthesia used during TAVI, with no clear consensus coming from comparative studies or guidelines. We sought to detect regional differences in the anaesthetic management of patients undergoing transcatheter aortic valve implantation (TAVI) in Europe and to evaluate the relationship between type of anaesthesia and in-hospital and 1 year outcome. Methods: Between January 2011 and May 2012 the Sentinel European TAVI Pilot Registry enrolled 2807 patients treated via a transfemoral approach using either local (LA-group, 1095 patients, 39%) or general anaesthesia (GA-group, 1712 patients, 61%). Results: A wide variation in LA use was evident amongst the 10 participating countries. The use of LA has increased over time (from a mean of 37.5% of procedures in the first year, to 57% in last 6 months, p < 0.01). MI, major stroke aswell as in-hospital death rate (7.0% LAvs 5.3% GA, p = 0.053) had a similar incidence between groups, confirmed in multivariate regression analysis after adjusting for confounders. Dividing our population in tertiles according to the Log-EuroSCORE we found similar mortality under LA, whilst mortality was higher in the highest risk tertile under GA. Survival at 1 year, compared by Kaplan-Meier analysis, was similar between groups (log-rank: p = 0.1505). Conclusions: Selection of anaesthesia appears to be more influenced by national practice and operator preference than patient characteristics. In the absence of an observed difference in outcomes for either approach, there is no compelling argument to suggest that operators and centres should change their anaesthetic practice. (C) 2014 Elsevier Ireland Ltd. All rights reserved.

Published
2014

15. The 2011-12 pilot European Sentinel Registry of Transcatheter Aortic Valve Implantation: in-hospital results in 4,571 patients

Author

Adam Witowski, Neil Moat, Hélène Eltchaninoff, Peter Wenaweser, Martine Gilard, Marian Zembala, Carlo Di Mario, Haim D. Danenberg, Eduardo Alegria Barrero, Bernard Iung, Petr Kala, Georg Nickenig, Roberto Corti, Carlos Macaya, Bernard D. Prendergast, Gerhard Schuler, Francesco Romeo, Ottavio Alfieri, Gian Paolo Ussia, Peter Ludman, Thomas Snow, Luigi Tavazzi, Aldo P. Maggioni, Erwin Schroeder, Manel Sabaté, Pepe Zamorano, Javier Goicolea, Stephan Windecker, Geneviève Derumeaux, Service de cardiologie, Université Paris Diderot - Paris 7 (UPD7)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Optimisation des régulations physiologiques (ORPHY (EA 4324)), Université de Brest (UBO)-Centre Hospitalier Régional Universitaire de Brest (CHRU Brest)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), Dipartimento di Ingegneria Strutturale e Geotecnica (DISG), Università degli Studi di Roma 'La Sapienza' = Sapienza University [Rome], Service de Cardiologie, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Université Paris Diderot - Paris 7 (UPD7)-AP-HP - Hôpital Bichat - Claude Bernard [Paris]-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Università degli Studi di Roma 'La Sapienza' [Rome], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Università degli Studi di Roma 'La Sapienza' = Sapienza University [Rome] (UNIROMA), Guerrero, François, Di Mario, C, Eltchaninoff, H, Moat, N, Goicolea, J, Ussia, Gp, Kala, P, Wenaweser, P, Zembala, M, Nickenig, G, Barrero, Ea, Snow, T, Iung, B, Zamorano, P, Schuler, G, Corti, R, Alfieri, Ottavio, Prendergast, B, Ludman, P, Windecker, S, Sabate, M, Gilard, M, Witowski, A, Danenberg, H, Schroeder, E, Romeo, F, Macaya, C, Derumeaux, G, Maggioni, A, and Tavazzi, L.

Subjects
Male, Cardiac Catheterization, Time Factors, [SDV.MHEP.PHY] Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO], Pilot Projects, Settore MED/11 - Malattie dell'Apparato Cardiovascolare, Comorbidity, 030204 cardiovascular system & hematology, Cardiac Catheters, Age Factors, Aged, Aged, 80 and over, Aortic Valve Stenosis, Chi-Square Distribution, Clinical Competence, Equipment Design, Europe, Female, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation, Hospital Mortality, Humans, Logistic Models, Multivariate Analysis, Odds Ratio, Patient Selection, Prospective Studies, Prosthesis Design, Risk Assessment, Risk Factors, Treatment Outcome, Registries, 0302 clinical medicine, 80 and over, 030212 general & internal medicine, Myocardial infarction, Prospective cohort study, Stroke, valvular heart disease, 3. Good health, Cardiology and Cardiovascular Medicine, medicine.medical_specialty, 03 medical and health sciences, medicine, [SDV.MHEP.PHY]Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO], Mitral regurgitation, business.industry, Odds ratio, medicine.disease, Surgery, business, Chi-squared distribution
Abstract

International audience; Aims: The aim of this prospective multinational registry is to assess and identify predictors of in-hospital outcome and complications of contemporary TAVI practice. Methods and results: The Transcatheter Valve Treatment Sentinel Pilot Registry is a prospective independent consecutive collection of individual patient data entered into a web-based case record form (CRF) or transferred from compatible national registries. A total of 4,571 patients underwent TAVI between January 2011 and May 2012 in 137 centres of 10 European countries. Average age was 81.4±7.1 years with equal representation of the two sexes. Logistic EuroSCORE (20.2±13.3), access site (femoral approach: 74.2%), type of anaesthesia and duration of hospital stay (9.3±8.1 days) showed wide variations among the participating countries. In-hospital mortality (7.4%), stroke (1.8%), myocardial infarction (0.9%), major vascular complications (3.1%) were similar in the SAPIEN XT and CoreValve (p=0.15). Mortality was lower in transfemoral (5.9%) than in transapical (12.8%) and other access routes (9.7%; p

Published
2013

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