Browsing by Author "Barbagelata, Alejandro"
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Item Open Access Continuation versus discontinuation of renin-angiotensin system inhibitors in patients admitted to hospital with COVID-19: a prospective, randomised, open-label trial.(The Lancet. Respiratory medicine, 2021-01-07) Cohen, Jordana B; Hanff, Thomas C; William, Preethi; Sweitzer, Nancy; Rosado-Santander, Nelson R; Medina, Carola; Rodriguez-Mori, Juan E; Renna, Nicolás; Chang, Tara I; Corrales-Medina, Vicente; Andrade-Villanueva, Jaime F; Barbagelata, Alejandro; Cristodulo-Cortez, Roberto; Díaz-Cucho, Omar A; Spaak, Jonas; Alfonso, Carlos E; Valdivia-Vega, Renzo; Villavicencio-Carranza, Mirko; Ayala-García, Ricardo J; Castro-Callirgos, Carlos A; González-Hernández, Luz A; Bernales-Salas, Eduardo F; Coacalla-Guerra, Johanna C; Salinas-Herrera, Cynthia D; Nicolosi, Liliana; Basconcel, Mauro; Byrd, James B; Sharkoski, Tiffany; Bendezú-Huasasquiche, Luis E; Chittams, Jesse; Edmonston, Daniel L; Vasquez, Charles R; Chirinos, Julio ABackground
Biological considerations suggest that renin-angiotensin system inhibitors might influence the severity of COVID-19. We aimed to evaluate whether continuing versus discontinuing renin-angiotensin system inhibitors (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers) affects outcomes in patients admitted to hospital with COVID-19.Methods
The REPLACE COVID trial was a prospective, randomised, open-label trial done at 20 large referral hospitals in seven countries worldwide. Eligible participants were aged 18 years and older who were admitted to hospital with COVID-19 and were receiving a renin-angiotensin system inhibitor before admission. Individuals with contraindications to continuation or discontinuation of renin-angiotensin system inhibitor therapy were excluded. Participants were randomly assigned (1:1) to continuation or discontinuation of their renin-angiotensin system inhibitor using permuted block randomisation, with allocation concealed using a secure web-based randomisation system. The primary outcome was a global rank score in which participants were ranked across four hierarchical tiers incorporating time to death, duration of mechanical ventilation, time on renal replacement or vasopressor therapy, and multiorgan dysfunction during the hospitalisation. Primary analyses were done in the intention-to-treat population. The REPLACE COVID trial is registered with ClinicalTrials.gov, NCT04338009.Findings
Between March 31 and Aug 20, 2020, 152 participants were enrolled and randomly assigned to either continue or discontinue renin-angiotensin system inhibitor therapy (continuation group n=75; discontinuation group n=77). Mean age of participants was 62 years (SD 12), 68 (45%) were female, mean body-mass index was 33 kg/m2 (SD 8), and 79 (52%) had diabetes. Compared with discontinuation of renin-angiotensin system inhibitors, continuation had no effect on the global rank score (median rank 73 [IQR 40-110] for continuation vs 81 [38-117] for discontinuation; β-coefficient 8 [95% CI -13 to 29]). There were 16 (21%) of 75 participants in the continuation arm versus 14 (18%) of 77 in the discontinuation arm who required intensive care unit admission or invasive mechanical ventilation, and 11 (15%) of 75 participants in the continuation group versus ten (13%) of 77 in the discontinuation group died. 29 (39%) participants in the continuation group and 28 (36%) participants in the discontinuation group had at least one adverse event (χ2 test of adverse events between treatment groups p=0·77). There was no difference in blood pressure, serum potassium, or creatinine during follow-up across the two groups.Interpretation
Consistent with international society recommendations, renin-angiotensin system inhibitors can be safely continued in patients admitted to hospital with COVID-19.Funding
REPLACE COVID Investigators, REPLACE COVID Trial Social Fundraising Campaign, and FastGrants.Item Open Access Dengue Myocarditis: A Case Report and Major Review.(Global heart, 2023-01) Cristodulo, Roberto; Luoma-Overstreet, Gracia; Leite, Fernando; Vaca, Manuel; Navia, Michelle; Durán, Gustavo; Molina, Fernando; Zonneveld, Bozorg; Perrone, Sergio Víctor; Barbagelata, Alejandro; Kaplinsky, EdgardoDengue is a viral disease transmitted by the bite of a female arthropod, prevalent primarily in tropical and subtropical regions. Its manifestations include asymptomatic infections, dengue fever, and a severe form called hemorrhagic dengue or dengue shock syndrome. Atypical manifestations can also occur, called expanded dengue syndrome. We describe the case of a 43-year-old man with an unusual presentation of dengue, demonstrating a workup suggestive of myocardial and pericardial damage. Symptoms and markers indicative of cardiac compromise improved after five days on anti-inflammatory treatment. Dengue myocarditis is considered an uncommon complication of dengue, although its reported incidence is likely an underestimation. In general, most cases of dengue myocarditis are self-limited, with only a minority at risk of progressing to heart failure. In order to improve recognition and prevent progression, healthcare providers should maintain a high degree of suspicion regarding potential cardiac complications in patients with dengue.Item Open Access Feasibility of combining serial smartphone single-lead electrocardiograms for the diagnosis of ST-elevation myocardial infarction.(American heart journal, 2019-12-27) Muhlestein, Joseph Boone; Anderson, Jeffrey L; Bethea, Charles F; Severance, Harry W; Mentz, Robert J; Barsness, Gregory W; Barbagelata, Alejandro; Albert, David; Le, Viet T; Bunch, T Jared; Yanowitz, Frank; May, Heidi T; Chisum, Benjamin; Ronnow, Brianna S; Muhlestein, Joseph Brent; Duke University Cooperative Cardiovascular Society (DUCCS) investigatorsBACKGROUND:The rate-limiting step in STEMI diagnosis often is the availability of a 12-lead electrocardiogram (ECG) and its interpretation. The potential may exist to speed the availability of 12-lead ECG information by using commonly available mobile technologies. We sought to test whether combining serial smartphone single-lead ECGs to create a virtual 12-lead ECG can accurately diagnose STEMI. METHODS:Consenting patients presenting with symptoms consistent with a possible STEMI had contemporaneous standard 12-lead and smartphone '12-lead equivalent' ECG (produced by electronically combining serial single-lead ECGs) recordings obtained. Matched ECGs were evaluated qualitatively and quantitatively by a panel of blinded readers and classified as STEMI/STEMI equivalent (LBBB), Not-STEMI, or uninterpretable. Interpretable ECG pairs were graded as showing good, fair, or poor correlation. RESULTS:Two hundred four subjects (age = 60 years, males = 57%, STEMI activation = 45%) were enrolled from 5 international sites. Smartphone ECG quality was graded as good in 151 (74.0%), fair in 32 (15.7%), poor in 8 (3.9%), and uninterpretable in 13 (6.4%). A STEMI/STEMI equivalent diagnosis was identified by standard 12-lead ECG in 57/204 (27.9%) recordings. For all interpretable pairs of smartphone ECGs compared with standard ECGs (n = 190), the sensitivity, specificity, and positive and negative predictive values for STEMI/STEMI equivalent by smartphone were 0.89, 0.84, 0.70 and 0.95, respectively. CONCLUSIONS:A '12-lead equivalent' ECG obtained from multiple serial single-lead ECGs from a smartphone can identify STEMI with good correlation to a standard 12-lead ECG. This technology holds promise to improve outcomes in STEMI by enhancing the reach and speed of diagnosis and thereby early treatment.Item Open Access Randomized elimination and prolongation of ACE inhibitors and ARBs in coronavirus 2019 (REPLACE COVID) Trial Protocol.(Journal of clinical hypertension (Greenwich, Conn.), 2020-10) Cohen, Jordana B; Hanff, Thomas C; Corrales-Medina, Vicente; William, Preethi; Renna, Nicolas; Rosado-Santander, Nelson R; Rodriguez-Mori, Juan E; Spaak, Jonas; Andrade-Villanueva, Jaime; Chang, Tara I; Barbagelata, Alejandro; Alfonso, Carlos E; Bernales-Salas, Eduardo; Coacalla, Johanna; Castro-Callirgos, Carlos Augusto; Tupayachi-Venero, Karen E; Medina, Carola; Valdivia, Renzo; Villavicencio, Mirko; Vasquez, Charles R; Harhay, Michael O; Chittams, Jesse; Sharkoski, Tiffany; Byrd, James Brian; Edmonston, Daniel L; Sweitzer, Nancy; Chirinos, Julio ASevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for coronavirus disease 2019 (COVID-19), is associated with high incidence of multiorgan dysfunction and death. Angiotensin-converting enzyme 2 (ACE2), which facilitates SARS-CoV-2 host cell entry, may be impacted by angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs), two commonly used antihypertensive classes. In a multicenter, international randomized controlled trial that began enrollment on March 31, 2020, participants are randomized to continuation vs withdrawal of their long-term outpatient ACEI or ARB upon hospitalization with COVID-19. The primary outcome is a hierarchical global rank score incorporating time to death, duration of mechanical ventilation, duration of renal replacement or vasopressor therapy, and multiorgan dysfunction severity. Approval for the study has been obtained from the Institutional Review Board of each participating institution, and all participants will provide informed consent. A data safety monitoring board has been assembled to provide independent oversight of the project.Item Open Access Smartphone 12-lead ECG-Exciting but must be handled with care.(American heart journal, 2020-08) Muhlestein, Joseph Brent; Muhlestein, Joseph Boone; Anderson, Jeffrey L; Bethea, Charles F; Severance, Harry W; Mentz, Robert J; Barsness, Gregory W; Barbagelata, Alejandro; Albert, David; Le, Viet T; Bunch, T Jared; Yanowitz, Frank; May, Heidi T; Chisum, Benjamin; Ronnow, Brianna S; Duke University Cooperative Cardiovascular Society (DUCCS) investigatorsItem Open Access Smartphone ECG for evaluation of ST-segment elevation myocardial infarction (STEMI): Design of the ST LEUIS International Multicenter Study.(Journal of electrocardiology, 2018-03) Barbagelata, Alejandro; Bethea, Charles F; Severance, Harry W; Mentz, Robert J; Albert, David; Barsness, Gregory W; Le, Viet T; Anderson, Jeffrey L; Bunch, T Jared; Yanowitz, Frank; Chisum, Benjamin; Ronnow, Brianna S; Muhlestein, Joseph BIn patients experiencing an ST-elevation myocardial infarction (STEMI), rapid diagnosis and immediate access to reperfusion therapy leads to optimal clinical outcomes. The rate-limiting step in STEMI diagnosis is the availability and performance of a 12-lead ECG. Recent technology has provided access to a reliable means of obtaining an ECG reading through a smartphone application (app) that works with an attachment providing all 12-leads of a standard ECG system. The ST LEUIS study was designed to validate the smartphone ECG app and its ability to accurately assess the presence or absence of STEMI in patients presenting with chest pain compared with the gold standard 12-lead ECG. We aimed to support the diagnostic utility of smartphone technology to provide a timely diagnosis and treatment of STEMI. The study will take place over 12months at five institutions. Approximately 60 patients will be enrolled per institution, for a total recruitment of 300 patients.Item Open Access Smartphone ECG for evaluation of STEMI: Results of the ST LEUIS Pilot Study(Journal of Electrocardiology, 2015-01-01) Muhlestein, Joseph Boone; Le, Viet; Albert, David; Moreno, Fidela Ll; Anderson, Jeffrey L; Yanowitz, Frank; Vranian, Robert B; Barsness, Gregory W; Bethea, Charles F; Severance, Harry W; Ramo, Barry; Pierce, John; Barbagelata, Alejandro; Muhlestein, Joseph Brent© 2015 Elsevier Inc. All rights reserved.Background 12-lead ECG is a critical component of initial evaluation of cardiac ischemia, but has traditionally been limited to large, dedicated equipment in medical care environments. Smartphones provide a potential alternative platform for the extension of ECG to new care settings and to improve timeliness of care. Objective To gain experience with smartphone electrocardiography prior to designing a larger multicenter study evaluating standard 12-lead ECG compared to smartphone ECG. Methods 6 patients for whom the hospital STEMI protocol was activated were evaluated with traditional 12-lead ECG followed immediately by a smartphone ECG using right (VnR) and left (VnL) limb leads for precordial grounding. The AliveCor™ Heart Monitor was utilized for this study. All tracings were taken prior to catheterization or immediately after revascularization while still in the catheterization laboratory. Results The smartphone ECG had excellent correlation with the gold standard 12-lead ECG in all patients. Four out of six tracings were judged to meet STEMI criteria on both modalities as determined by three experienced cardiologists, and in the remaining two, consensus indicated a non-STEMI ECG diagnosis. No significant difference was noted between VnR and VnL. Conclusions Smartphone based electrocardiography is a promising, developing technology intended to increase availability and speed of electrocardiographic evaluation. This study confirmed the potential of a smartphone ECG for evaluation of acute ischemia and the feasibility of studying this technology further to define the diagnostic accuracy, limitations and appropriate use of this new technology.Item Open Access The left bundle-branch block puzzle in the 2013 ST-elevation myocardial infarction guideline: from falsely declaring emergency to denying reperfusion in a high-risk population. Are the Sgarbossa Criteria ready for prime time?(American heart journal, 2013-09) Cai, Qiangjun; Mehta, Nilay; Sgarbossa, Elena B; Pinski, Sergio L; Wagner, Galen S; Califf, Robert M; Barbagelata, AlejandroPrompt and accurate identification of ST-elevation myocardial infarction (STEMI) in the presence of left bundle-branch block (LBBB) remains difficult. The 2004 STEMI guideline recommended emergent reperfusion therapy to patients with suspected ischemia and new or presumably new LBBB. These recommendations have led to frequent false catheterization laboratory activation and inappropriate fibrinolytic therapy because most patients with suspected ischemia and new or presumably new LBBB do not have acute coronary artery occlusion on angiography. The new 2013 STEMI guideline makes a drastic change by removing previous recommendations. Therefore, patients with suspected ischemia and new or presumably new LBBB would no longer be treated as STEMI equivalent. The new guideline fails to recognize that some patients with suspected ischemia and LBBB do have STEMI, and denying reperfusion therapy could be fatal. The Sgarbossa electrocardiography criteria are the most validated tool to aid in the diagnosis of STEMI in the presence of LBBB. A Sgarbossa score of ≥3 has a superb specificity (98%) and positive predictive value for acute myocardial infarction and angiography-confirmed acute coronary occlusion. Thus, we propose a diagnosis and triage algorithm incorporating the Sgarbossa criteria to quickly and accurately identify, among patients presenting with chest pain and new or presumably new LBBB, those with acute coronary artery occlusion. This is a high-risk population in which reperfusion therapy would be denied by the 2013 STEMI guideline. Our algorithm will also significantly reduce false catheterization laboratory activation and inappropriate fibrinolytic therapy, the inevitable consequence of the 2004 STEMI guideline.