26 results on '"Rubinshtein R"'
Search Results
2. COVID-19 pandemic and admission rates for and management of acute coronary syndromes in Israel
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Asher, E, primary, Fardman, A, additional, Zahger, D, additional, Orvin, K, additional, Mohsen, M, additional, Tsafrir, O, additional, Rubinshtein, R, additional, Jamal, J, additional, Efraim, R, additional, Kofman, N, additional, Halabi, M, additional, Shacham, Y, additional, Henri Fortis, L, additional, Beigel, R, additional, and Matetzky, S, additional
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- 2021
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3. Acute myocardial infarction in the Covid-19 era: incidence, clinical characteristics and in-hospital outcomes – a multicenter registry
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Fardman, A, primary, Zahger, D, additional, Orvin, K, additional, Kofman, N, additional, Mohsen, J, additional, Tsafrir, O, additional, Asher, E, additional, Rubinshtein, R, additional, Jamal, J, additional, Efraim, R, additional, Halabi, M, additional, Shacham, Y, additional, Fortis, L H, additional, Beigel, R, additional, and Matetzky, S, additional
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- 2021
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4. Normal baseline cardiac autonomic function and increased pupillary parasympathetic tone in patients with vasovagal syncope.
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Nussinovitch U, Barak-Lanciano S, Shavit I, Avivi I, Haber-Kaptsenel E, Palacci H, Chaiat C, and Rubinshtein R
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- Humans, Male, Female, Adult, Case-Control Studies, Young Adult, Middle Aged, Photic Stimulation, Autonomic Nervous System physiopathology, Syncope, Vasovagal physiopathology, Syncope, Vasovagal diagnosis, Heart Rate, Reflex, Pupillary physiology, Parasympathetic Nervous System physiopathology, Pupil physiology, Electrocardiography, Predictive Value of Tests, Heart innervation, Heart physiopathology
- Abstract
It is controversial whether people with vasovagal syncope (VVS) have abnormal autonomic responses at baseline and whether specific diagnostic manoeuvres have a diagnostic value. We investigated whether the pupillary light reflex and cardiac autonomic tests can be used to identify autonomic dysfunction in volunteers with a medical history of VVS. The study groups included 128 healthy volunteers, of whom 31 reported a history of typical VVS. The right pupil was evaluated using an automated, commercial infra-red pupillometer under strict conditions. In addition to miosis and mydriasis kinetics, pupil diameters were measured. Heart rate variability at rest and heart rate changes to standing were quantified with high-resolution electrocardiography and designated software. The demographic and clinical characteristics of both groups were statistically similar. Average constriction velocity (ACV) was significantly higher in VVS patients following a univariate analysis (3.83 ± 0.59 vs. 3.56 ± 0.73 mm/s, p = 0.042) and after correcting for potential confounders (p = 0.049). All other pupillometric and heart rate indices were comparable between groups. Patients with a history of VVS depict pupillary parasympathetic overactivity in response to light stimuli, manifested as increased ACV. The prognostic implications of this finding and the significance of using this simple clinical tool to identify patients who are at risk for developing frequent episodes of VVS or physical injuries following a syncope merits further study., (© 2024 The Authors. Clinical Physiology and Functional Imaging published by John Wiley & Sons Ltd on behalf of Scandinavian Society of Clinical Physiology and Nuclear Medicine.)
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- 2024
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5. Autonomic responses in young females with typical vasovagal syncope.
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Amir B, Lanciano SB, Rubinshtein R, and Nussinovitch U
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- Humans, Female, Adult, Young Adult, Adolescent, Valsalva Maneuver physiology, Syncope, Vasovagal physiopathology, Syncope, Vasovagal diagnosis, Autonomic Nervous System physiopathology, Heart Rate physiology
- Abstract
To determine whether young women who have experienced typical vasovagal syncope (tVVS) have altered autonomic response parameters, based on a battery of autonomic tests and maneuvers. Notably, previous studies including small cohorts and a partial list of tests yielded conflicting results. A total of 91 otherwise healthy women were included and divided according to those who had experienced tVVS (39 patients) or not (52 patients). Heart rate variability was evaluated at rest, under strict conditions, during 5 min of standing and during a deep breathing test. Response to Valsalva maneuver and Ewing maneuver were also quantified and compared. Both groups had similar clinical characteristics at baseline. No significant differences were found between the two groups in any of the autonomic parameters evaluated. Autonomic responses in young women who experienced typical vasovagal syncope at baseline were indistinguishable from those who did not. Thus, using non-tilt test autonomic screening tests does not seem to provide diagnostic benefits, and may not be useful in predicting recurrence in this patient population., (© 2024. The Author(s).)
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- 2024
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6. Percutaneous coronary intervention with ridaforolimus eluting-stents in small vessel coronary artery disease.
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Arow Z, Konigstein M, Vaknin-Assa H, Witberg G, Jonas M, Kerner A, Cafri C, Rubinshtein R, Segev A, Roguin A, Issever MO, Gabarin M, Pereg D, Assali A, and Koifman E
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- Humans, Constriction, Pathologic, Prospective Studies, Prosthesis Design, Treatment Outcome, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease therapy, Coronary Artery Disease etiology, Drug-Eluting Stents, Percutaneous Coronary Intervention
- Abstract
Introduction: The ridaforolimus-eluting stent (RES) system uses a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting ridaforolimus., Aim of Study: To assess the safety and efficacy of small diameter (2.25 mm) RES (EluNIR) in small coronary artery disease., Methods: A prospective, multicenter, single-arm, open-label clinical trial. Clinical follow-up was performed at 30 days, 6 months, and 1 year after the procedure. Target lesions were located in native coronary arteries or bypass graft conduits, with visually estimated diameter of ≥2.25 mm to ≤2.5 mm. The primary endpoint was combined device success, defined as final in-stent residual diameter stenosis <30%, without 30-day major adverse cardiovascular events (MACE)., Results: A total of 81 patients were enrolled in the study. Twenty-three patients (28%) had acute coronary syndrome (ACS) at presentation and 37 (46%) had prior myocardial infarction (MI). Most of the target lesions were located in the circumflex coronary artery (44%) and were classified as B2/C grade according to the American Heart Association/American College of Cardiology classification. The final mean minimal lumen diameter, mean reference vessel diameter, and mean residual percent diameter stenosis were 2.0 ± 0.2 mm, 2.3 ± 0.1 mm, and 14 + 6.6%, respectively. The primary endpoint of device success without 30-day MACE was achieved in 98.8% of the patients. Target lesion failure (TLF) at 6 months was 1.2%. Thirty-day and 1-year MACE rates were 1.2% and 2.5%, respectively., Conclusion: The EluNIR 2.25 mm stent shows excellent results in small coronary artery disease and adds another tool in the treatment of this complex lesion type., (© 2023 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)
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- 2024
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7. First-in-human study of the CAPTIS embolic protection system during transcatheter aortic valve replacement.
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Danenberg H, Vaknin-Assa H, Makkar R, Virmani R, Manevich L, Codner P, Patel V, Finn AV, Landes U, Rubinshtein R, Bar A, Barnea R, Mezape Y, Teichman E, Eli S, Weisz G, and Kornowski R
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- Humans, Aortic Valve diagnostic imaging, Aortic Valve surgery, Prosthesis Design, Treatment Outcome, Risk Factors, Transcatheter Aortic Valve Replacement adverse effects, Aortic Valve Stenosis surgery, Aortic Valve Stenosis complications, Intracranial Embolism etiology, Intracranial Embolism prevention & control, Embolic Protection Devices, Stroke etiology, Embolism etiology, Embolism prevention & control
- Abstract
Background: Stroke and other clinically significant embolic complications are well documented in the early period following transcatheter aortic valve replacement (TAVR). The CAPTIS device is an embolic protection system, designed to provide neurovascular and systemic protection by deflecting debris away from the brain's circulation, capturing the debris and thus avoiding systemic embolisation., Aims: We aimed to study the safety and feasibility study of the CAPTIS complete cerebral and full-body embolic protection system during TAVR., Methods: A first-in-human study investigated the safety, feasibility and debris capturing ability of CAPTIS during TAVR. Patients were followed for 30 days. The primary endpoints were device safety and cerebrovascular events at 72 hours., Results: Twenty patients underwent TAVR using balloon-expandable or self-expanding valve systems. CAPTIS was successfully delivered, positioned, deployed, and retrieved in all cases, and TAVR was successfully completed without device-related complications. No cerebrovascular events were observed. High numbers of debris particles were captured in all patients., Conclusions: The use of the CAPTIS full-body embolic protection system during TAVR was safe, and it captured a substantial number of debris particles. No patient suffered from a cerebrovascular event. A randomised clinical trial is warranted to prove its efficacy.
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- 2023
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8. Coronary Embolism After Transcatheter Aortic Valve Replacement-Case Series and Review of Literature.
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Akuka A, Landes U, Manevich L, Rubinshtein R, and Danenberg HD
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- Humans, Transcatheter Aortic Valve Replacement adverse effects, Embolism epidemiology, Embolism etiology, Coronary Artery Disease, Vascular Diseases, Intracranial Embolism
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Periprocedural systemic embolism is a well-documented complication of transcatheter aortic valve replacement (TAVR). Although the most focus was given to cerebral embolism (which remains unpredictable, difficult to prevent, and a source of increased morbidity and mortality after TAVR), coronary embolism remains less investigated and potentially overlooked. This study provides a case series of 3 patients diagnosed with coronary embolism after TAVR in our institution over a 2-year period (3 of 297 cases, 1%) and a systematic literature review (4 studies; 19 case reports). Overall, coronary embolism associated with TAVR is frequently characterized by proximal vessel occlusion causing ST-elevation myocardial infarction and hemodynamic instability with lower mortality in the acute phase as compared with late coronary embolism. However, it often presents with distal vessel occlusion and minor symptoms that may be overlooked in the periprocedural period. In conclusion, we suggest that TAVR-associated coronary embolism has a much higher prevalence than previously documented. Further studies are warranted to properly assess the prevalence and impact of this phenomenon., Competing Interests: Declaration of Competing Interest Dr. Danenberg serves as a clinical proctor for Medtronic and Edwards Lifesciences. The remaining authors have no competing interests to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)
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- 2023
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9. The impact of on-site cardiac surgical backup on clinical outcomes of acute coronary syndrome-analysis of the ACSIS national registry.
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Moady G, Ovdat T, Rubinshtein R, Eitan A, Daud E, Arow Z, and Atar S
- Abstract
Background: The availability of advanced technologies for mechanical support in hospitals with on-site cardiac surgery (CS), along with the ability to perform urgent coronary artery bypass graft (CABG) surgery, may result in improved clinical outcomes in patients with acute coronary syndrome (ACS)., Methods: We conducted a retrospective analysis of the bi-annually Acute Coronary Syndrome Israeli Survey (ACSIS) registry from the year 2000 to 2020, performed in hospitals with and without CS. Mortality rates and major adverse cardiac and cerebrovascular events (MACCE) rates are reported. We evaluated two periods of the study-early (2000-2010) vs. late (2011-2020). Propensity score matching was performed to reduce bias between the two groups., Results: The study included 16,979 patients (52.3% in the on-site CS group). Patients in the on-site CS group were more likely to undergo percutaneous coronary intervention (PCI), (odds ratio [OR], 1.26 [95% CI, 1.18-1.35]; p < 0.001) and CABG [OR, 1.91 (95%CI, 1.63-2.24); P < 0.001], and patients in hospitals without on-site CS had higher 30-day MACCE [OR, 1.17 (95% CI, 1.07-1.27); p < 0.0005]. Overall, there was no difference in 1-year mortality (hazard ratio [HR], 0.98 [95% CI, 0.89-1.08]; p = 0.71) between the groups. During the late period of the study, patients in the group without on-site CS had lower 30-day mortality [OR, 0.69 (95% CI, 0.49-0.97); P = 0.04], yet with no difference in 1-year mortality [HR, 0.81 (95% CI, 0.65-1.01); p = 0.07]., Conclusions: The availability of on-site CS resulted in variations in treatment modality, yet it did not affect the clinical outcomes of ACS. A trend to a better short-term outcomes was noted in hospitals without CS during the late period of the study, which warrants further investigation., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Moady, Ovdat, Rubinshtein, Eitan, Daud, Arow and Atar.)
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- 2023
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10. When Does a Calcium Score Equate to Secondary Prevention?: Insights From the Multinational CONFIRM Registry.
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Budoff MJ, Kinninger A, Gransar H, Achenbach S, Al-Mallah M, Bax JJ, Berman DS, Cademartiri F, Callister TQ, Chang HJ, Chow BJW, Cury RC, Feuchtner G, Hadamitzky M, Hausleiter J, Kaufmann PA, Leipsic J, Lin FY, Kim YJ, Marques H, Pontone G, Rubinshtein R, Shaw LJ, Villines TC, and Min JK
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- Humans, Male, Middle Aged, Aged, Female, Cohort Studies, Calcium, Secondary Prevention, Risk Assessment methods, Predictive Value of Tests, Disease Progression, Registries, Risk Factors, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease epidemiology, Coronary Artery Disease therapy, Vascular Calcification diagnostic imaging, Vascular Calcification therapy, Vascular Calcification complications, Myocardial Infarction diagnostic imaging, Myocardial Infarction epidemiology, Myocardial Infarction prevention & control, Atherosclerosis
- Abstract
Background: Elevated coronary artery calcium (CAC) scores in subjects without prior atherosclerotic cardiovascular disease (ASCVD) have been shown to be associated with increased cardiovascular risk., Objectives: The authors sought to determine at what level individuals with elevated CAC scores who have not had an ASCVD event should be treated as aggressively for cardiovascular risk factors as patients who have already survived an ASCVD event., Methods: The authors performed a cohort study comparing event rates of patients with established ASVCD to event rates in persons with no history of ASCVD and known calcium scores to ascertain at what level elevated CAC scores equate to risk associated with existing ASCVD. In the multinational CONFIRM (Coronary CT Angiography Evaluation for Clinical Outcomes: An International Multicenter) registry, the authors compared ASCVD event rates in persons without a history of myocardial infarction (MI) or revascularization (as categorized on CAC scores) to event rates in those with established ASCVD. They identified 4,511 individuals without known coronary artery disease (CAC) who were compared to 438 individuals with established ASCVD. CAC was categorized as 0, 1 to 100, 101 to 300, and >300. Cumulative major adverse cardiovascular events (MACE), MACE plus late revascularization, MI, and all-cause mortality incidence was assessed using the Kaplan-Meier method for persons with no ASCVD history by CAC level and persons with established ASCVD. Cox proportional hazards regression analysis was used to calculate HRs with 95% CIs, which were adjusted for traditional cardiovascular risk factors., Results: The mean age was 57.6 ± 12.4 years (56% male). In total, 442 of 4,949 (9%) patients experienced MACEs over a median follow-up of 4 years (IQR: 1.7-5.7 years). Incident MACEs increased with higher CAC scores, with the highest rates observed with CAC score >300 and in those with prior ASCVD. All-cause mortality, MACEs, MACE + late revascularization, and MI event rates were not statistically significantly different in those with CAC >300 compared with established ASCVD (all P > 0.05). Persons with a CAC score <300 had substantially lower event rates., Conclusions: Patients with CAC scores >300 are at an equivalent risk of MACE and its components as those treated for established ASCVD. This observation, that those with CAC >300 have event rates comparable to those with established ASCVD, supplies important background for further study related to secondary prevention treatment targets in subjects without prior ASCVD with elevated CAC. Understanding the CAC scores that are associated with ASCVD risk equivalent to stable secondary prevention populations may be important for guiding the intensity of preventive approaches more broadly., Competing Interests: Funding Support and Author Disclosures Dr Budoff has received grant support from the National Institute of Health and General Electric. Dr Al-Mallah has received support from the American Heart Association, BCBS Foundation of Michigan, and Astellas. Dr Cademartiri has received grant support from GE Healthcare; and has served on the Speakers Bureau of Bracco and as a consultant for Servier. Dr Chow holds the Saul and Edna Goldfarb Chair in Cardiac Imaging Research; and has received research support from TD Bank, AusculSciences, Siemens Healthineers, and Artrya. Dr Hausleiter has received a research grant from Siemens Medical Systems. Dr Kaufmann has received institutional research support from GE Healthcare; and has received grant support from Swiss National Science Foundation. Dr Berman has a consultant agreement with General Electric. Dr Min has served as an employee and retains equity from Cleerly, Inc; has served on the medical advisory board for Arineta; and has received grant support from the National Institutes of Health. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2023
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11. Sex and age-specific interactions of coronary atherosclerotic plaque onset and prognosis from coronary computed tomography.
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van Rosendael SE, Bax AM, Lin FY, Achenbach S, Andreini D, Budoff MJ, Cademartiri F, Callister TQ, Chinnaiyan K, Chow BJW, Cury RC, DeLago AJ, Feuchtner G, Hadamitzky M, Hausleiter J, Kaufmann PA, Kim YJ, Leipsic JA, Maffei E, Marques H, de Araújo Gonçalves P, Pontone G, Raff GL, Rubinshtein R, Villines TC, Chang HJ, Berman DS, Min JK, Bax JJ, Shaw LJ, and van Rosendael AR
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- Humans, Male, Female, Child, Coronary Angiography methods, Tomography, X-Ray Computed, Prognosis, Computed Tomography Angiography methods, Age Factors, Predictive Value of Tests, Plaque, Atherosclerotic diagnostic imaging, Plaque, Atherosclerotic complications, Coronary Stenosis therapy, Coronary Artery Disease therapy
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Aims: The totality of atherosclerotic plaque derived from coronary computed tomography angiography (CCTA) emerges as a comprehensive measure to assess the intensity of medical treatment that patients need. This study examines the differences in age onset and prognostic significance of atherosclerotic plaque burden between sexes., Methods and Results: From a large multi-center CCTA registry the Leiden CCTA score was calculated in 24 950 individuals. A total of 11 678 women (58.5 ± 12.4 years) and 13 272 men (55.6 ± 12.5 years) were followed for 3.7 years for major adverse cardiovascular events (MACE) (death or myocardial infarction). The age where the median risk score was above zero was 12 years higher in women vs. men (64-68 years vs. 52-56 years, respectively, P < 0.001). The Leiden CCTA risk score was independently associated with MACE: score 6-20: HR 2.29 (1.69-3.10); score > 20: HR 6.71 (4.36-10.32) in women, and score 6-20: HR 1.64 (1.29-2.08); score > 20: HR 2.38 (1.73-3.29) in men. The risk was significantly higher for women within the highest score group (adjusted P-interaction = 0.003). In pre-menopausal women, the risk score was equally predictive and comparable with men. In post-menopausal women, the prognostic value was higher for women [score 6-20: HR 2.21 (1.57-3.11); score > 20: HR 6.11 (3.84-9.70) in women; score 6-20: HR 1.57 (1.19-2.09); score > 20: HR 2.25 (1.58-3.22) in men], with a significant interaction for the highest risk group (adjusted P-interaction = 0.004)., Conclusion: Women developed coronary atherosclerosis approximately 12 years later than men. Post-menopausal women within the highest atherosclerotic burden group were at significantly higher risk for MACE than their male counterparts, which may have implications for the medical treatment intensity., Competing Interests: Conflict of interest: None declared., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2023
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12. Assessing the use of a noninvasive monitoring system providing multiple cardio-pulmonary parameters following revascularization in STEMI patients.
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Sharabi I, Merin R, Gluzman Y, Grinshpan R, Shtivelman A, Eisenkraft A, and Rubinshtein R
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Background: Continuous monitoring of ECG, respiratory rate, systolic and diastolic blood pressure, pulse rate, cardiac output, and cardiac index is important in patients with ST-elevation myocardial infarction (STEMI) admitted to the intensive cardiac care unit (ICCU). However, monitoring these parameters in this setting and in these patients using noninvasive, wireless devices has not been conducted so far. We aimed to assess the use of a novel noninvasive continuous monitoring device in STEMI patients admitted to the ICCU., Methods: Participants included STEMI patients that were admitted to the ICCU after primary percutaneous coronary intervention (PPCI). Patients were continuously monitored using a novel wearable chest patch monitor., Results: Fifteen patients with STEMI who underwent PPCI were included in this study. The median age was 52.8 years, the majority were males, and the median body mass index (BMI) was 25.7. Monitoring lasted for 66 ± 16 hours, and included the automatic collection and recording of all vitals, freeing the nursing staff to focus on other tasks. The user experience of nurses as reflected in filled questionnaires showed high satisfaction rates in all aspects., Conclusion: A novel noninvasive, wireless device showed high feasibility in continuously monitoring multiple crucial parameters in STEMI patients admitted to the ICCU after PPCI., Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2023.)
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- 2023
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13. Clustering of clinical and echocardiographic phenotypes of covid-19 patients.
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Shpigelman E, Hochstadt A, Coster D, Merdler I, Ghantous E, Szekely Y, Lichter Y, Taieb P, Banai A, Sapir O, Granot Y, Lupu L, Borohovitz A, Sadon S, Banai S, Rubinshtein R, Topilsky Y, and Shamir R
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- Male, Female, Humans, Echocardiography methods, Prognosis, Phenotype, Cluster Analysis, COVID-19 diagnostic imaging
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We sought to divide COVID-19 patients into distinct phenotypical subgroups using echocardiography and clinical markers to elucidate the pathogenesis of the disease and its heterogeneous cardiac involvement. A total of 506 consecutive patients hospitalized with COVID-19 infection underwent complete evaluation, including echocardiography, at admission. A k-prototypes algorithm applied to patients' clinical and imaging data at admission partitioned the patients into four phenotypical clusters: Clusters 0 and 1 were younger and healthier, 2 and 3 were older with worse cardiac indexes, and clusters 1 and 3 had a stronger inflammatory response. The clusters manifested very distinct survival patterns (C-index for the Cox proportional hazard model 0.77), with survival best for cluster 0, intermediate for 1-2 and worst for 3. Interestingly, cluster 1 showed a harsher disease course than cluster 2 but with similar survival. Clusters obtained with echocardiography were more predictive of mortality than clusters obtained without echocardiography. Additionally, several echocardiography variables (E' lat, E' sept, E/e average) showed high discriminative power among the clusters. The results suggested that older infected males have a higher chance to deteriorate than older infected females. In conclusion, COVID-19 manifests differently for distinctive clusters of patients. These clusters reflect different disease manifestations and prognoses. Although including echocardiography improved the predictive power, its marginal contribution over clustering using clinical parameters only does not justify the burden of echocardiography data collection., (© 2023. The Author(s).)
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- 2023
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14. Treatment of late paravalvular regurgitation after transcatheter aortic valve implantation: prognostic implications.
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Landes U, Hochstadt A, Manevich L, Webb JG, Sathananthan J, Sievert H, Piayda K, Leon MB, Nazif TM, Blusztein D, Hildick-Smith D, Pavitt C, Thiele H, Abdel-Wahab M, Van Mieghem NM, Adrichem R, Sondergaard L, De Backer O, Makkar RR, Koren O, Pilgrim T, Okuno T, Kornowski R, Codner P, Finkelstein A, Loewenstein I, Barbash I, Sharon A, De Marco F, Montorfano M, Buzzatti N, Latib A, Scotti A, Kim WK, Hamm C, Franco LN, Mangieri A, Schoels WH, Barbanti M, Bunc M, Akodad M, Rubinshtein R, and Danenberg H
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- Humans, Aortic Valve diagnostic imaging, Aortic Valve surgery, Prognosis, Treatment Outcome, Transcatheter Aortic Valve Replacement methods, Aortic Valve Stenosis, Heart Valve Prosthesis, Aortic Valve Insufficiency etiology, Aortic Valve Insufficiency surgery
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Aims: Paravalvular regurgitation (PVR) after transcatheter aortic valve implantation (TAVI) is associated with increased morbidity and mortality. The effect of transcatheter interventions to treat PVR after the index TAVI was investigated., Methods and Results: A registry of consecutive patients who underwent transcatheter intervention for ≥ moderate PVR after the index TAVI at 22 centers. The principal outcomes were residual aortic regurgitation (AR) and mortality at 1 year after PVR treatment. A total of 201 patients were identified: 87 (43%) underwent redo-TAVI, 79 (39%) plug closure, and 35 (18%) balloon valvuloplasty. Median TAVI-to-re-intervention time was 207 (35; 765) days. The failed valve was self-expanding in 129 (63.9%) patients. The most frequent devices utilized were a Sapien 3 valve for redo-TAVI (55, 64%), an AVP II as plug (33, 42%), and a True balloon for valvuloplasty (20, 56%). At 30 days, AR ≥ moderate persisted in 33 (17.4%) patients: 8 (9.9%) after redo-TAVI, 18 (25.9%) after plug, and 7 (21.9%) after valvuloplasty (P = 0.036). Overall mortality was 10 (5.0%) at 30 days and 29 (14.4%) at 1 year: 0, 8 (10.1%), and 2 (5.7%) at 30 days (P = 0.010) and 11 (12.6%), 14 (17.7%), and 4 (11.4%) at 1 year (P = 0.418), after redo-TAVI, plug, and valvuloplasty, respectively. Regardless of treatment strategy, patients in whom AR was reduced to ≤ mild had lower mortality at 1 year compared with those with AR persisting ≥ moderate [11 (8.0%) vs. 6 (21.4%); P = 0.007]., Conclusion: This study describes the efficacy of transcatheter treatments for PVR after TAVI. Patients in whom PVR was successfully reduced had better prognosis. The selection of patients and the optimal PVR treatment modality require further investigation., Competing Interests: Conflict of interest J.G.W.: consultant to, and has received research funding from, Edwards Lifesciences, Abbott Vascular, and Boston Scientific. W-K.K.: proctor or speaker fees from Boston Scientific, Abbott, Edwards Lifesciences, Medtronic, Meril Life Sciences. M.A-W.: received speaker's honoraria and/or consultancy fees on his behalf from Boston Scientific and Medtronic. M.B.: consultant for Edwards Lifesciences, Medtronic, and Boston Scientific. L.S.: consultant fees and institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and Symetis. C.H.: Advisory Board Medtronic. J.M. Sinning: speaker honoraria and research grants from Medtronic, Boston Scientific, and Edwards Lifesciences. J.S.: consultant to Edwards Lifesciences. M. Andreas: proctor/consultant/speaker for Edwards, Abbott, and Medtronic, received institutional grants (Edwards, Abbott, Medtronic, and LSI). Dr. M. Guerrero: research grant support from Abbott Vascular and Edwards Lifesciences. F. Castriota: proctor for Medtronic and Boston Scientific. T.N.: consulting or honoraria from Edwards Lifesciences, Medtronic, and Boston Scientific. Consulting and equity with Venus MedTech. T.P.: research grants from Boston Scientific, Edwards Lifesciences, and Biotronik; speaker fees/consultancy fees from Boston Scientific, Medtronic, Abbott, Biotronik, and HighLife SAS. V.C. Babaliaros: consultant to Edwards Lifesciences and equity in transmural system. M.M.: consultant fee from Abbott, Boston, Kardia, and Medtronic. N.V.M.: institutional research grants and consulting fees from Abbott, Boston Scientific, Medtronic, Daiichi Sankyo, and PulseCath BV and institutional research grant support from Edwards Lifesciences. A.L.: institutional research/grant support from Abbott, Boston Scientific, Medtronic, and Edwards Lifesciences; and personal consulting honoraria from Abbott, Edwards Lifesciences and Medtronic. D.H-S.: proctor and advisory to Boston, Medtronic, Edwards Lifesciences, and Abbott. R.M. received grant support from Edwards Lifesciences Corporation; he is a consultant for Abbott Vascular, Cordis, and Medtronic and holds equity in Entourage Medical. All other authors have no conflict of interest to report in relation with this manuscript., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2023
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15. Prognostic Significance of Nonobstructive Left Main Coronary Artery Disease in Patients With and Without Diabetes: Long-Term Outcomes From the CONFIRM Registry.
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Lee J, Shaikh K, Nakanishi R, Gransar H, Achenbach S, Al-Mallah MH, Andreini D, Bax JJ, Berman DS, Cademartiri F, Callister TQ, Chang HJ, Chinnaiyan K, Chow BJW, Cury RC, DeLago A, Feuchtner G, Hadamitzky M, Hausleiter J, Kaufmann PA, Kim YJ, Leipsic JA, Maffei E, Marques H, de Araújo Gonçalves P, Pontone G, Rubinshtein R, Villines TC, Lu Y, Peña JM, Lin FY, Min JK, Shaw LJ, and Budoff MJ
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- Humans, Middle Aged, Aged, Prognosis, Constriction, Pathologic, Coronary Angiography methods, Proportional Hazards Models, Risk Factors, Registries, Coronary Artery Disease complications, Coronary Artery Disease diagnosis, Coronary Artery Disease epidemiology, Diabetes Mellitus epidemiology
- Abstract
Background: Prognostic significance of non-obstructive left main (LM) disease was recently reported. However, the influence of diabetes mellitus (DM) on event rates in patients with and without non-obstructive LM disease is not well-known., Methods: We evaluated 27,252 patients undergoing coronary computed tomographic angiography from the COroNary CT Angiography Evaluation For Clinical Outcomes: An InteRnational Multicenter (CONFIRM) Registry. Cumulative long-term incidence of all-cause mortality (ACM) was assessed between DM and non-DM patients by normal or non-obstructive LM disease (1-49% stenosis)., Results: The mean age of the study population was 57.6±12.6 years. Of the 27,252 patients, 4,434 (16%) patients had DM. A total of 899 (3%) deaths occurred during the follow-up of 3.6±1.9. years. Compared to patients with normal LM, those with non-obstructive LM had more pronounced overall coronary atherosclerosis and more cardiovascular risk factors. After clinical risk factors, segment involvement score, and stenosis severity adjustment, compared to patients without DM and normal LM, patients with DM were associated with increased ACM regardless of normal (HR 1.48, 95% CI 1.22-1.78, p<0.001) or non-obstructive LM (HR 1.46, 95% CI 1.04-2.04, p=0.029), while nonobstructive LM disease was not associated with increased ACM in patients without DM (HR 0.85, 95% CI 0.67-1.07, p=0.165) and there was no significant interaction between DM and LM status (HR 1.03, 95% CI 0.69-1.54, p=0.879)., Conclusion: From the CONFIRM registry, we demonstrated that DM was associated with increased ACM. However, the presence of non-obstructive LM was not an independent risk marker of ACM, and there was no significant interaction between DM and non-obstructive LM disease for ACM., (Copyright © 2022 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.)
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- 2023
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16. Extent of subclinical atherosclerosis on coronary computed tomography and impact of statins in patients with diabetes without known coronary artery disease: Results from CONFIRM registry.
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Shaikh K, Ahmed A, Gransar H, Lee J, Leipsic J, Nakanishi R, Alla V, Bax JJ, Chow BJW, Berman DS, Maffei E, Lin FY, Ahmad A, DeLago A, Pontone G, Feuchtner G, Marques H, Min JK, Hausleiter J, Hadamitzky M, Kaufmann PA, de Araújo Gonçalves P, Cury RC, Kim YJ, Chang HJ, Rubinshtein R, Villines TC, Lu Y, Shaw LJ, Acenbach S, Al Mallah MH, Andreini D, Cademartiri F, Callister TQ, and Budoff MJ
- Subjects
- Adult, Humans, Middle Aged, Tomography, X-Ray Computed, Registries, Hydroxymethylglutaryl-CoA Reductase Inhibitors therapeutic use, Coronary Artery Disease complications, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease drug therapy, Atherosclerosis complications, Atherosclerosis diagnostic imaging, Atherosclerosis drug therapy, Diabetes Mellitus drug therapy, Diabetes Mellitus epidemiology
- Abstract
Background: Absence of subclinical atherosclerosis is considered safe to defer statin therapy in general population. However, impact of statins on atherosclerotic cardiovascular disease in patients with diabetes stratified by coronary artery calcium (CAC) scores and extent of non-obstructive CAD on coronary computed tomography angiography (CCTA) has not been evaluated., Methods: CONFIRM (Coronary CT Angiography EvaluatioN For Clinical Outcomes: An InteRnational Multi-center Registry) study enrolled consecutive adults 18 years of age between 2005 and 2009 who underwent
3 64-detector row CCTA for suspected CAD. The long-term registry includes data on 12,086 subjects who underwent CCTA at 17 centers in 9 countries. In this sub-study of CONFIRM registry, patients with diabetes mellitus (DM) and without diabetes mellitus with normal CCTA or non-obstructive plaque (<50 % diameter stenosis) for whom data on baseline statin use was available were included. CAC score was calculated using Agatston score. The magnitude of non-obstructive coronary artery disease on CCTA was quantified using segment involvement score (SIS). Primary outcome was major cardiovascular events (MACE) which included all-cause mortality, myocardial infarction, and target vessel re-vascularization., Results: A total of 7247 patients (Mean age 56.8 years) with a median follow up of 5 years were included. For DM patients, baseline statin therapy significantly reduced MACE for patients with CAC ≥100 (HR: 0.24; 95 % CI 0.07-0.87; p = 0.03) and SIS≥3 (HR: 0.23; 95 % CI 0.06-0.83; p = 0.024) compared to those not on statin therapy. Among Diabetics with lower CAC (<100) and SIS (≤3) scores, MACE was similar in statin and non-statin groups. In contrast, among non-DM patients, MACE was similar in statin and no statin groups irrespective of baseline CAC (1-99 or ≥100) and SIS., Conclusion: In this large multicenter cohort of patients, the presence and extent of subclinical atherosclerosis as assessed by CAC and SIS identified patients most likely to derive benefit from statin therapy., (Copyright © 2022. Published by Elsevier Inc.)- Published
- 2022
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17. Thoracic Aorta Perforation Treated Conservatively After TAVR in a Patient With Extremely Tortuous Aorta.
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Manevich L, Landes U, Gluzman Y, Welt M, Rubinshtein R, and Danenberg HD
- Abstract
Aortic perforation is a rare complication of transcatheter aortic valve replacement associated with grim outcomes. Tortuous and calcified aortas increase the risk of aortic trauma and perforation. We report a case in which, despite massive thoracic bleeding, avoidance of thoracic aortic surgery resulted in clinical recovery. ( Level of Difficulty: Intermediate. )., Competing Interests: Dr Danenberg serves as a clinical proctor for Medtronic and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2022 Published by Elsevier on behalf of the American College of Cardiology Foundation.)
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- 2022
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18. Outcomes among patients admitted for non-ST-segment myocardial infarction in the pre-pandemic and pandemic COVID-19 era: Israel Nationwide study.
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Asher E, Fardman A, Shmueli H, Orvin K, Oren D, Kofman N, Mohsen J, Moady G, Taha L, Rubinshtein R, Azriel O, Efraim R, Saleem D, Taieb P, Ben-Assa E, Cohen T, Klempfner R, Orlev A, Beigel R, Segev A, and Matetzky S
- Subjects
- Humans, Pandemics, Prospective Studies, Israel epidemiology, COVID-19 epidemiology, Non-ST Elevated Myocardial Infarction epidemiology, Non-ST Elevated Myocardial Infarction therapy, Myocardial Infarction epidemiology, Myocardial Infarction therapy, Percutaneous Coronary Intervention
- Abstract
Background: Since the beginning of the coronavirus disease 2019 (COVID-19) pandemic in 2019, several countries have reported a substantial drop in the number of patients admitted with non-ST-segment myocardial infarction (NSTEMI)., Objective: We aimed to evaluate the changes in admissions, in-hospital management and outcomes of patients with NSTEMI in the COVID-19 era in a nationwide survey., Method: A prospective, multicenter, observational, nationwide study involving 13 medical centers across Israel aimed to evaluate consecutive patients with NSTEMI admitted to intensive cardiac care units over an 8-week period during the COVID-19 outbreak and to compare them with NSTEMI patients admitted at the same period 2 years earlier (control period)., Results: There were 624 (43%) NSTEMI patients, of whom 349 (56%) were hospitalized during the COVID-19 era and 275 (44%) during the control period. There were no significant differences in age, gender and other baseline characteristics between the two study periods. During the COVID-19 era, more patients arrived at the hospital via an emergency medical system compared with the control period (P = 0.05). Time from symptom onset to hospital admission was longer in the COVID-19 era as compared with the control period [11.5 h (interquartile range, IQR, 2.5-46.7) vs. 2.9 h (IQR 1.7-6.8), respectively, P < 0.001]. Nevertheless, the time from hospital admission to reperfusion was similar in both groups. The rate of coronary angiography was also similar in both groups. The in-hospital mortality rate was similar in both the COVID-19 era and the control period groups (2.3% vs. 4.7%, respectively, P = 0.149) as was the 30-day mortality rate (3.7% vs. 5.1%, respectively, P = 0.238)., Conclusion: In contrast to previous reports, admission rates of NSTEMI were similar in this nationwide survey during the COVID-19 era. With longer time from symptoms to admission, but with the same time from hospital admission to reperfusion therapy and with similar in-hospital and 30-day mortality rates. Even in times of crisis, adherence of medical systems to clinical practice guidelines ensures the preservation of good clinical outcomes., (© The Author(s) 2022. Published by Oxford University Press on behalf of International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2022
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19. A validated score to predict one-year and long-term mortality in patients with significant tricuspid regurgitation.
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Hochstadt A, Maor E, Ghantous E, Merdler I, Granot Y, Rubinshtein R, Banai S, Segev A, Kuperstein R, and Topilsky Y
- Abstract
Aims: Most patients with significant (defined as ≥ moderate) tricuspid regurgitation (TR) are treated conservatively. Individual mortality rates are markedly variable. We developed a risk score based on comprehensive clinical and echocardiographic evaluation, predicting mortality on an individual patient level., Methods and Results: The cohort included 1701 consecutive patients with significant TR, half with isolated TR, admitted to a single hospital, treated conservatively. We derived a scoring system predicting 1-year mortality and validated it using k -fold cross-validation and with external validation on another cohort of 5141 patients. Score utility was compared with matched patients without significant TR. One-year mortality rate was 31.3%. The risk score ranged 0-17 points and included 11 parameters: age (0-3), body mass index ≤ 25 (0-1), history of liver disease (0-2), history of chronic lung disease (0-2), estimated glomerular filtration rate (0-5), haemoglobin (0-2), left-ventricular ejection fraction (0-1), right-ventricular dysfunction (0-1), right atrial pressure (0-2), stroke volume index (SVI) (0-1) and left-ventricular end-diastolic diameter (0-1). One-year mortality rates increased from 0 to 100%, as the score increased up to ≥16. Areas under the receiver operating curves were 0.78, 0.70, and 0.73, for the original, external validation, and external validation with SVI measured cohorts. The score remained valid in subpopulations of patients with quantified RV function, quantified TR and isolated TR. Significant TR compared to no TR, affected 1-year mortality stronger with higher scores, with a significantly positive interaction term., Conclusion: We suggest a robust risk score for inpatients with significant TR, assisting risk stratification and decision-making. Our findings underscore the burden of TR providing benchmarks for clinical trial design., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2022
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20. Prognostic significance of plaque location in non-obstructive coronary artery disease: from the CONFIRM registry.
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Han D, Chen B, Gransar H, Achenbach S, Al-Mallah MH, Budoff MJ, Cademartiri F, Maffei E, Callister TQ, Chinnaiyan K, Chow BJW, DeLago A, Hadamitzky M, Hausleiter J, Kaufmann PA, Villines TC, Kim YJ, Leipsic J, Feuchtner G, Cury RC, Pontone G, Andreini D, Marques H, Rubinshtein R, Chang HJ, Lin FY, Shaw LJ, Min JK, and Berman DS
- Subjects
- Computed Tomography Angiography, Coronary Angiography methods, Humans, Predictive Value of Tests, Prognosis, Registries, Risk Assessment methods, Risk Factors, Coronary Artery Disease complications, Coronary Artery Disease diagnostic imaging, Plaque, Atherosclerotic complications, Plaque, Atherosclerotic diagnostic imaging
- Abstract
Aim: Obstructive coronary artery disease (CAD) in proximal coronary segments is associated with a poor prognosis. However, the relative importance of plaque location regarding the risk for major adverse cardiovascular events (MACE) in patients with non-obstructive CAD has not been well defined., Methods and Results: From the Coronary CT Angiography Evaluation for Clinical Outcomes: An International Multicenter (CONFIRM) registry, 4644 patients without obstructive CAD were included in this study. The degree of stenosis was classified as 0 (no) and 1-49% (non-obstructive). Proximal involvement was defined as any plaque present in the left main or the proximal segment of the left anterior descending artery, left circumflex artery, and right coronary artery. Extensive CAD was defined as segment involvement score of >4. During a median follow-up of 5.2 years (interquartile range 4.1-6.0), 340 (7.3%) MACE occurred. Within the non-obstructive CAD group (n = 2065), proximal involvement was observed in 1767 (85.6%) cases. When compared to non-obstructive CAD patients without proximal involvement, those with proximal involvement had an increased MACE risk (log-rank P = 0.033). Multivariate Cox analysis showed when compared to patients with no CAD, proximal non-obstructive CAD was associated with increased MACE risk [hazard ratio (HR) 1.90, 95% confidence interval (CI) 1.47-2.45, P < 0.001] after adjusting for extensive CAD and conventional cardiovascular risk factors; however, non-proximal non-obstructive CAD did not increase MACE risk (HR 1.26, 95% CI 0.79-2.01, P = 0.339)., Conclusions: Independent of plaque extent, proximal coronary involvement was associated with increased MACE risk in patients with non-obstructive CAD. The plaque location information by coronary computed tomography angiography may provide additional risk prediction over CAD extent in patients with non-obstructive CAD., Competing Interests: Conflict of interest: J.K.M. receives funding from the Dalio Foundation, National Institutes of Health, and GE Healthcare; has serves on the scientific advisory board of Arineta and GE Healthcare; and has an equity interest in Cleerly. B.J.W.C. receives research grant support from TD Bank, Artrya, Siemens, and AusculSciences and has an equity interest in GE healthcare. P.A.K.’s nuclear department at the University Hospital Zurich holds research agreement with GE Healthcare. G.P. receives honorarium as speaker and research institutional grant from GE, Bracco, Boehringer, and HeartFlow. All other authors declared no conflict of interest., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)
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- 2022
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21. Dental implant failure rates in patients with self-reported allergy to penicillin.
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Zahra B, Nicholas B, Geoffrey R, Dina Z, Janal MN, and Stuart F
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- Amoxicillin adverse effects, Anti-Bacterial Agents adverse effects, Antibiotic Prophylaxis adverse effects, Dental Restoration Failure, Humans, Penicillins adverse effects, Retrospective Studies, Self Report, Dental Implants adverse effects, Hypersensitivity drug therapy, Hypersensitivity etiology
- Abstract
Background: In a number of previous studies, patients with reported penicillin allergies have been documented to experience higher rates of dental implant failure than those who had not reported this allergy. The authors of this study aimed to determine whether an increased risk of implant failure is associated with patient-reported penicillin allergy and which antibiotic was administered., Methods and Materials: A retrospective study was conducted through chart review of patients who received dental implants at the New York University College of Dentistry. Participants were eligible if they received one or more dental implants at the College and provided at least 1 year of follow-up data., Results: The overall implant failure rate was 12.9%. The failure rate in patients who reported no allergy to penicillin and took amoxicillin was 8.4%, while the failure rate in the allergy-reporting group was 17.1% (adjusted OR = 2.22, 95% CI = 1.44-3.44). The failure rate in allergy-reporting patients who took Clindamycin was also higher than in those who took amoxicillin (19.9%; adjusted OR = 2.9, 95% CI = 1.77-4.47) or any antibiotic other than amoxicillin (20.9%; adjusted OR = 2.77, 95% CI = 1.77-4.32)., Conclusions: Significant findings included a lower implant failure rate in patients taking amoxicillin than in patients taking other antibiotics. There was a significant increase in early implant failure in allergy reporting patients., (© 2022 Wiley Periodicals LLC.)
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- 2022
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22. Aspirin and Statin Therapy for Nonobstructive Coronary Artery Disease: Five-year Outcomes from the CONFIRM Registry.
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Indraratna P, Naoum C, Ben Zekry S, Gransar H, Blanke P, Sellers S, Achenbach S, Al-Mallah MH, Andreini D, Berman DS, Budoff MJ, Cademartiri F, Callister TQ, Chang HJ, Chinnaiyan K, Chow BJW, Cury RC, DeLago A, Feuchtner G, Hadamitzky M, Hausleiter J, Kaufmann PA, Kim YJ, Maffei E, Marques H, Gonçalves PA, Pontone G, Raff GL, Rubinshtein R, Villines TC, Lin FY, Shaw LJ, Narula J, Bax JJ, and Leipsic JA
- Abstract
Purpose: In this cohort study, 5-year data from the Coronary CT Angiography Evaluation for Clinical Outcomes: An International Multicenter Registry (ie, CONFIRM) were examined to identify associations of baseline aspirin and statin use with mortality, major adverse cardiovascular events (MACE), and myocardial infarction (MI) in individuals without substantial (≥50%) stenosis., Materials and Methods: In this prospective cohort study, all participants in the registry underwent coronary CT angiography and were classified as having no detectable coronary plaque or having nonobstructive coronary artery disease (CAD) (1%-49% stenosis). Participants with obstructive (≥50%) stenosis were excluded from analysis. The study commenced in June 2003 and was completed in March 2016. All unadjusted and risk-adjusted analyses utilized the Cox proportional hazard model with hospital sites modeled using shared frailty., Results: A total of 6386 participants with no detectable plaque or with nonobstructive CAD were included (mean age, 56.0 years ± 13.3 [SD], 52% men). The mean follow-up period was 5.66 years ± 1.10. Nonobstructive CAD ( n = 2815, 44% of all participants included in the study) was associated with a greater risk of all-cause mortality (10.6% [298 of 2815] vs 4.8% [170 of 3571], P < .001) compared to those without CAD ( n = 3571, 56%). Baseline aspirin and statin use was documented for 1415 and 1429 participants, respectively, with nonobstructive CAD, and for 1560 and 1565 participants without detectable plaque, respectively. In individuals with nonobstructive CAD, baseline aspirin use was not associated with a reduction in MACE (10.9% [102 of 936] vs 14.7% [52 of 355], P = .06), all-cause mortality (9.6% [95 of 991] vs 10.9% [46 of 424], P = .468), or MI (4.4% [41 of 936] vs 6.2% [22 of 355], P = .18). On multivariate risk-adjusted analysis, baseline statin use was associated with a lower rate of MACE (hazard ratio, 0.59; 95% CI: 0.40, 0.87; P = .007). Neither therapy improved clinical outcomes for participants with no detectable plaque., Conclusion: In participants with nonobstructive CAD, baseline use of statins, but not of aspirin, was associated with improved clinical outcomes. Neither therapy was associated with benefit in participants without plaque. Keywords: Aspirin, Statin, Coronary Artery Disease, CT Angiography, Nonobstructive Coronary Artery DiseaseClinical trial registration no. NCT01443637 Supplemental material is available for this article. © RSNA, 2022See also the commentary by Canan and Navar in this issue., Competing Interests: Disclosures of conflicts of interest: P.I. No relevant relationships. C.N. No relevant relationships. S.B.Z. No relevant relationships. H.G. No relevant relationships. P.B. Consulting fees from Edwards Lifesciences, Neovasc, and Boston Scientific. S.S. No relevant relationships. S.A. No relevant relationships. M.H.A. Grant/contract from Siemens; consulting fees from Philips. D.A. No relevant relationships. D.S.B. Software royalties from Cedars-Sinai Medical Center. M.J.B. No relevant relationships. F.C. No relevant relationships. T.Q.C. No relevant relationships. H.J.C. No relevant relationships. K.C. Executive Committee and Board of Directors, Society for Cardiovascular Computed Tomography (SCCT), unpaid. B.J.W.C. Saul and Edna Goldfarb Chair in Cardiac Imaging; research grants from TD Bank, AusculSciences, Artrya, and CV Diagnostix; board member of SCCT (ended in 2021); stock in GE (equity sold in 2021). R.C.C. Consults for Covera Health, GE Healthcare, and Cleerly (not related to the topic of this article). A.D. No relevant relationships. G.F. No relevant relationships. M.H. No relevant relationships. J.H. Grant/contract from Edwards Lifesciences, payment or honoraria from Abbott Vascular and Edwards Lifesciences, support for meetings and travel from Abbott Vascular and Edwards Lifesciences. P.A.K. University Hospital Zurich holds a research grant with GE Healthcare (unrelated to the present study), Advisory Board for GE Healthcare on the myocardial perfusion tracer Flurpiridaz (unrelated to present study), Vice Chair of the Swiss Society of Nuclear Medicine (unpaid). Y.J.K. No relevant relationships. E.M. No relevant relationships. H.M. No relevant relationships. P.d.A.G. No relevant relationships. G.P. No relevant relationships. G.L.R. No relevant relationships. R.R. Board member of SCCT. T.C.V. No relevant relationships. F.Y.L. Research grant from GE. L.J.S. No relevant relationships. J.N. No relevant relationships. J.J.B. The department of cardiology, Leiden University Medical Center has received unrestricted research grants from Abbott, Edwards Lifesciences, Bayer, Novartis, Boston Scientific, Medtronic, Biotronik, GE Healthcare; payment or honoraria from Speaker Bureau Abbott and Edwards Lifesciences. J.A.L. Unrestricted research grant from GE Healthcare, stock options and consulting fees from HeartFlow and Circle CVI, payment or honoraria from Philips, board of directors of SCCT, deputy editor for Radiology: Cardiothoracic Imaging., (© 2022 by the Radiological Society of North America, Inc.)
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- 2022
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23. Contrast agent volume for coronary computed tomography angiography imaging in current clinical practice.
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Stocker TJ, Bull R, Buls N, Leipsic J, Chow B, Maurovich-Horvat P, Bittencourt MS, Bax JJ, Andreini D, Chen MY, Rubinshtein R, Hadamitzky M, Massberg S, and Hausleiter J
- Subjects
- Computed Tomography Angiography methods, Coronary Angiography methods, Humans, Predictive Value of Tests, Tomography, X-Ray Computed methods, Contrast Media, Coronary Artery Disease diagnostic imaging
- Abstract
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: TJ Stocker, B Chow, P Maurovich-Horvat, JJ Bax, D Andreini, MY Chen, R Rubinshtein, M Hadamitzky and S Massberg report no conflict of interests. R Bull has received speaking fees from Canon Medical outside the submitted work. N Buls has received speaking fees from GE Healthcare outside the submitted work. J Leipsic is a consultant to and holds stock options in HeartFlow and Circle CVI, holds an unrestricted research grant from GE Healthcare and modest speaking fees from Philips Medical Systems outside of the submitted work. MS Bittencourt has received research grant from Sanofi, consultant fees from Bayer and speaker fees from Novonordisk, EMS and Novartis outside the submitted work. J Hausleiter received speaker fees from Abbott Vascular and Edwards Lifesciences outside the submitted work.
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- 2022
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24. Associations between dyspnoea, coronary atherosclerosis, and cardiovascular outcomes: results from the long-term follow-up CONFIRM registry.
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van Rosendael AR, Bax AM, van den Hoogen IJ, Smit JM, Al'Aref SJ, Achenbach S, Al-Mallah MH, Andreini D, Berman DS, Budoff MJ, Cademartiri F, Callister TQ, Chang HJ, Chinnaiyan K, Chow BJW, Cury RC, DeLago A, Feuchtner G, Hadamitzky M, Hausleiter J, Kaufmann PA, Kim YJ, Leipsic JA, Maffei E, Marques H, de Araújo Gonçalves P, Pontone G, Raff GL, Rubinshtein R, Villines TC, Gransar H, Lu Y, Peña JM, Lin FY, Shaw LJ, Narula J, Min JK, and Bax JJ
- Subjects
- Aged, Coronary Angiography methods, Dyspnea, Follow-Up Studies, Humans, Male, Middle Aged, Predictive Value of Tests, Prognosis, Prospective Studies, Registries, Risk Factors, Coronary Artery Disease complications, Coronary Artery Disease diagnostic imaging
- Abstract
Aims: The relationship between dyspnoea, coronary artery disease (CAD), and major cardiovascular events (MACE) is poorly understood. This study evaluated (i) the association of dyspnoea with the severity of anatomical CAD by coronary computed tomography angiography (CCTA) and (ii) to which extent CAD explains MACE in patients with dyspnoea., Methods and Results: From the international COronary CT Angiography EvaluatioN for Clinical Outcomes: An InteRnational Multicenter (CONFIRM) registry, 4425 patients (750 with dyspnoea) with suspected but without known CAD were included and prospectively followed for ≥5 years. First, the association of dyspnoea with CAD severity was assessed using logistic regression analysis. Second, the prognostic value of dyspnoea for MACE (myocardial infarction and death), and specifically, the interaction between dyspnoea and CAD severity was investigated using Cox proportional-hazard analysis. Mean patient age was 60.3 ± 11.9 years, 63% of patients were male and 592 MACE events occurred during a median follow-up duration of 5.4 (IQR 5.1-6.0) years. On uni- and multivariable analysis (adjusting for age, sex, body mass index, chest pain typicality, and risk factors), dyspnoea was associated with two- and three-vessel/left main (LM) obstructive CAD. The presence of dyspnoea increased the risk for MACE [hazard ratio (HR) 1.57, 95% confidence interval (CI): 1.29-1.90], which was modified after adjusting for clinical predictors and CAD severity (HR 1.26, 95% CI: 1.02-1.55). Conversely, when stratified by CAD severity, dyspnoea did not provide incremental prognostic value in one-, two-, or three-vessel/LM obstructive CAD, but dyspnoea did provide incremental prognostic value in non-obstructive CAD., Conclusion: In patients with suspected CAD, dyspnoea was independently associated with severe obstructive CAD on CCTA. The severity of obstructive CAD explained the elevated MACE rates in patients presenting with dyspnoea, but in patients with non-obstructive CAD, dyspnoea portended additional risk., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.)
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- 2022
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25. Impact of Dose Reduction Strategies on Image Quality of Coronary CTA in Real-World Clinical Practice: A Subanalysis of PROTECTION VI Registry Data.
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Stocker TJ, Nühlen N, Schmermund A, Leipsic J, Grove EL, Deseive S, Bax JJ, Maurovich-Horvat P, Otton J, Hadamitzky M, Chen MY, Naoum C, Andreini D, Rubinshtein R, Massberg S, and Hausleiter J
- Subjects
- Aged, Female, Humans, Male, Middle Aged, Prospective Studies, Registries, Computed Tomography Angiography methods, Coronary Angiography methods, Coronary Artery Disease diagnostic imaging, Radiation Dosage, Radiographic Image Interpretation, Computer-Assisted methods
- Abstract
BACKGROUND . Dose reduction strategies for coronary CTA (CCTA) have been underused in clinical practice given concern that the strategies may lower image quality. OBJECTIVE . The purpose of this study was to explore associations between dose reduction strategies and CCTA image quality in real-world clinical practice. METHODS . This subanalysis of the international Prospective Multicenter Registry on Radiation Dose Estimates of Cardiac CT Angiography in Daily Practice in 2017 (PROTECTION VI) study included 3725 patients (2109 men, 1616 women; median age, 59 years) who underwent CCTA for coronary artery evaluation performed at 55 sites in 32 countries. CCTA image sets were reviewed at a core laboratory. A range of patient and scan characteristics, including use of three dose reduction strategies (prospective ECG triggering, low tube potential, and iterative image reconstruction) and image dose, were recorded. A single core laboratory member reviewed all examinations for quantitative image quality measures, including signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR), and reviewed 50% of examinations to assign a qualitative CCTA image quality score and a semiquantitative coronary calcification measure. Multivariable logistic regression models were used to identify predictors of image quality. A second core laboratory member repeated quantitative measures for 100 examinations and the qualitative measure for 383 (approximately 20%) examinations to assess interreader agreement. RESULTS . Independent predictors ( p < .05) of SNR were female sex (effect size, 2.70), lower body mass index (0.38 per 1-unit decrease), stable sinus rhythm (1.71), and scanner manufacturer (variable effect across manufacturers). These factors were also the only independent predictors of CNR. Independent predictors ( p < .05) of CCTA image quality were heart rate (0.17 per 10 beats/min reduction) and coronary calcification (0.15 per coronary calcification grade). None of the three dose-saving strategies or dose-length product was an independent predictor of any image quality measure. Interreader agreement analysis showed intraclass correlation coefficients of 0.874 for SNR and 0.891 for CNR and a kappa value of 0.812 for the qualitative score. CONCLUSION . This large international multicenter study shows that three dose reduction strategies were not associated with decreased CCTA image quality. CLINICAL IMPACT . The dose reduction strategies should be routinely implemented in clinical CCTA.
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- 2021
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26. Preprocedural Coronary CT Angiography Effect on the Likelihood to Restore Flow in Chronic Total Occlusion.
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Rubinshtein R and Danenberg H
- Subjects
- Coronary Angiography, Humans, Predictive Value of Tests, Tomography, X-Ray Computed, Computed Tomography Angiography, Coronary Occlusion diagnostic imaging, Coronary Occlusion therapy
- Abstract
Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Published
- 2021
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