Tulio Caldonazo

Tulio Caldonazo

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Previous Organizations / Institutes

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Tulio Caldonazo has a total of 330 co-authors. Here are the top co-authors by number of shared publications:


Latest Publications

  • Open Access

    Secondary TEVAR After Frozen Elephant Trunk: Indications and Timing

    by Dimitrios E. Magouliotis, Beatrice Bacchi, Arian Arjomandi Rad, Andrew Xanthopoulos, Tulio Caldonazo, Michele D’Alonzo, Massimo Baudo, Francesco Cabrucci, Francesca Maria di Muro

    Frozen elephant trunk (FET) stabilizes the arch and proximal descending aorta, but complete distal remodeling is achieved in only a subset of patients with aortic dissection. Persistent false lumen perfusion, aortic growth, and distal stent graft-induced new entry lead to secondary thoracic endovascular aortic repair (TEVAR), and reported distal reintervention rates range from about 13% at 5 years in pooled data to 33% in a center with routine staging. This narrative review examines the indications for and timing of secondary TEVAR after FET. PubMed was searched to September 2026, and 97 publications were included. Evidence obtained in patients treated with FET is distinguished from evidence extrapolated from primary type B dissection and from the authors’ interpretation. We summarize the predictors of incomplete remodeling, including stent graft length, residual re-entry location, chronicity, aortic diameter at the distal stent level, early remodeling trajectory, and heritable aortopathy, and we contrast planned completion with surveillance-based reactive TEVAR, including technical aspects and spinal cord protection. Direct evidence on timing after FET is limited to retrospective series and one pilot randomized trial of TEVAR 1 to 3 months after type I repair; most data on the time-dependent loss of flap plasticity come from primary type B dissection. No universal timing rule is supported. We propose a phenotype-driven approach, not yet validated, in which timing is referenced to dissection onset and individualized to aortic anatomy, disease progression, and clinical condition.

  • Open Access

    Butyrylcholinesterase Activity as a Mortality Marker in ICU Patients: An Individual Participant Data Meta-Analysis

    by Ricardo Esper Treml, Iago T. C. Grillo, Anna Hrabovska, Tomas Fazekas, Florian Espeter, Karsten Schmidt, Tulio Caldonazo, Felipe S. Passos, Paulo Ricardo Gessolo Lins, Thais Dimidega, et al.

    OBJECTIVES: To determine whether butyrylcholinesterase (BChE) activity independently predicts in-hospital mortality in critically ill adults and to derive a prognostic threshold from patient-level data. DATA SOURCES: Six databases (PubMed, MEDLINE, Embase, Scopus, Web of Science, Cochrane CENTRAL) were searched from inception to data lock. The protocol was registered with PROSPERO (CRD42024558631); reporting followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses of individual participant data (IPD). STUDY SELECTION: Eligible studies were observational cohorts of critically ill adults measuring BChE by the Ellman or Worek method. Six prospective European and South American ICU cohorts contributed 482 adults (92.9% with sepsis; in-hospital mortality, 39%). Risk of bias was appraised with the Quality in Prognosis Studies tool. DATA EXTRACTION: Deidentified IPD from corresponding authors and one public repository were checked for integrity, harmonized, and converted to U/L. Variables included demographics, sepsis status, severity indices (Sequential Organ Failure Assessment, Acute Physiology and Chronic Health Evaluation II), and biochemical markers. DATA SYNTHESIS: Analyses included receiver operating characteristic curves (DeLong area under the curve [AUC], bias-corrected bootstrap), multivariable logistic regression, generalized estimating equation models, Kaplan-Meier and Cox regression, and random-effects meta-analysis (Hartung–Knapp). Admission BChE was lower among non-survivors, with moderate discrimination (pooled AUC, 0.72; 95% CI, 0.65–0.83; DeLong AUC, 0.671; 95% CI, 0.644–0.697). Higher Day-1 BChE was independently associated with lower mortality (odds ratio [OR] per 100 U/L, 0.979; 95% CI, 0.967–0.990; p < 0.001), with a significant ICU day interaction ( p = 0.029) and attenuation by Day 4. BChE below 1615 U/L predicted higher mortality (hazard ratio, 1.69; 95% CI, 1.11–2.59; log-rank p = 0.015). Meta-analysis confirmed the inverse association (pooled OR per 1 sd , 0.22; 95% CI, 0.06–0.73; p = 0.023). CONCLUSIONS: BChE enzymatic activity was an integrative, time-dependent prognostic marker of in-hospital mortality, particularly in sepsis. Reduced ICU admission levels and persistently suppressed trajectories identified higher-risk patients. BChE may complement organ dysfunction scores; the 1615 U/L threshold is exploratory and requires prospective external validation.

  • Open Access

    Outcomes of reoperative versus primary cardiac surgery: a systematic review and meta-analysis

    by Leo Consoli, Ilias G. Koziakas, Mir W. Majeed, Eren Cetinel, Pawel Lajczak, Hristo Kirov, Torsten Doesnt, Tulio Caldonazo

    Background: Cardiovascular diseases are lifelong and progressive conditions that can recur after primary surgery. The procedural risks and prognosis of patients requiring reoperations are not well-defined. Materials and Methods: We searched MEDLINE, EMBASE, and the Cochrane Library for eligible studies. Analysis was performed using a random-effects meta-analysis for the main (short-term mortality) and additional (short-term adverse events and long-term mortality) endpoints. Binary endpoints were pooled using odds ratios (ORs) or hazard ratios (HRs) with 95% confidence intervals (CIs). A two-tailed P -value < 0.05 was considered statistically significant. We used R Studio for all analyses. Results: We included 34 studies ( n = 148 149). Reoperative surgery was associated with higher odds of in-hospital mortality in coronary bypass grafting (OR 2.45; 95% CI 1.90–3.15; P < 0.001) and in valve surgery (OR 2.08; 95% CI 1.84–2.35; P < 0.001), but not in aortic surgery (OR 1.40; 95% CI 0.94–2.14; P = 0.13). Long-term mortality was higher in the subgroups of valve surgery (HR 1.88; 95% CI 1.52–2.32; P < 0.001) and aortic surgery (HR 1.50; 95% CI 1.20–1.86; P < 0.001), but not in coronary bypass (HR 1.30; 95% CI 0.82–2.05; P = 0.32). Redo valve surgery was associated with more adverse events, while findings in coronary bypass and aortic surgery were borderline. Conclusion: Redo cardiac surgery is generally associated with worse in-hospital outcomes and worse long-term mortality.

  • Open Access

    T2-sparing vs T2-including sympathectomy for hyperhidrosis: a meta-analysis on compensatory sweating

    by Lucas Monteiro Delgado, Paula Duarte D’AMbrosio, Rachid Eduardo Noleto da Nobrega Oliveira, Keith Mortman, Túlio Caldonazo, Felipe S. Passos, Marcelo Albuquerque Barbosa Martins, Deepti Sreepathi, Adriana-Simoneta Pimienta-Ibarra, Paulo Manuel-Pêgo Fernandes, et al.

    Background: Sympathectomy is the definitive treatment for primary hyperhidrosis, offering high success rates. However, compensatory sweating (CS) remains a frequent and distressing complication. The level of ganglionic resection, particularly the inclusion of T2, may influence CS incidence, but evidence remains inconsistent. Methods: A systematic search of PubMed, Embase, and the Cochrane Library was conducted up to July 2025, to identify studies comparing T2-sparing versus T2-including sympathectomy for primary hyperhidrosis. Pooled odds ratios (ORs) and 95% confidence intervals (CIs) were calculated using random-effects models. Heterogeneity was assessed using the I2 statistic. For outcomes with significant heterogeneity, leave-one-out sensitivity analyses were performed. Results: Eleven studies involving 3,090 patients were included. Of these, 47.2% underwent T2-sparing sympathectomy and 52.8% underwent T2-including procedures. T2-sparing sympathectomy was associated with a significantly lower incidence of overall CS (OR 0.38; 95% CI 0.21–0.67; p = 0.0009; I2 = 65%) and severe CS (OR 0.43; 95% CI 0.28–0.64; p < 0.0001; I2 = 19%). Subgroup analyses confirmed consistent results across both randomized and non-randomized studies, as well as across short-term (≤ 12 months) and long-term (> 12 months) follow-up periods. Sensitivity analyses confirmed the robustness of the findings. No publication bias was detected. Conclusions: T2-sparing sympathectomy was associated with a significantly lower incidence of CS. These findings support avoiding T2 when feasible to minimize postoperative morbidity. Further prospective studies are needed to confirm these results.

  • Open Access

    Development efficiency and mortality after coronary artery bypass grafting: a national causal inference analysis

    by Gabriel K. Martins, Arthur D. Botelho, Leo Consoli, Iago T. Grillo, Felipe S. Passos, Ricardo E. Treml, Tulio Caldonazo

    Background: We evaluated whether development efficiency, the component of the Human Development Index independent of GDP per capita and income inequality, is associated with in-hospital mortality after coronary artery bypass grafting (CABG) in Brazil, and whether this association is mediated by access to elective surgery. Methods: We conducted a retrospective ecological panel study using administrative data on CABG hospitalizations within the Brazilian Unified Health System from 2008 to 2024. State-year observations were linked to socioeconomic indicators. Development efficiency was defined as the residual of HDI after regression on GDP per capita and the Gini coefficient. Associations with in-hospital mortality were examined using volume-weighted multilevel models. Absolute causal effects and mediation through urgency status were estimated using g-computation and parametric causal mediation analysis. Results: The final analytic panel included 379 state-year observations. A 1–standard deviation increase in development efficiency was associated with a reduction in predicted in-hospital mortality from 6.8% to 5.7% (absolute risk reduction − 1.1% points; p < 0.001). At the population level, this corresponds to approximately one fewer observed death per 91 procedures in states with higher versus lower development efficiency. Mediation analysis indicated that 95.5% of the total effect was attributable to the natural direct effect, while only 4.5% was mediated through urgency status, with no significant indirect effect. Conclusions: Development efficiency is an independent and clinically meaningful determinant of survival after CABG in Brazil. Higher income-independent HDI performance is associated with substantial absolute mortality reductions, driven predominantly by direct system-level pathways rather than changes in urgency profile. Strengthening health-system efficiency and perioperative capacity may therefore yield meaningful gains in cardiac surgical outcomes.

  • Open Access

    The Impact of Pre‐Transplant Ventricular Assist Device Support on Survival After Heart Transplantation in Pediatric Patients: A Systematic Review and Meta‐Analysis of Reconstructed Time‐To‐Event Data

    by Johannes Fischer, Silas Schwegmann, Richard Plem, Ayodeji Arobo, Abdullah Almehandi, Felipe S. Passos, Hristo Kirov, Torsten Doesnt, Gunter Kerst, Tsvetomir Loukanov, et al.

    Objectives: Heart transplantation is the gold standard therapy for pediatric end‐stage heart failure. Ventricular assist devices (VADs) have improved waitlist survival, but their effect on post‐transplant outcomes remains uncertain. This study aimed to evaluate the impact of pre‐transplant VAD support on outcomes in pediatric heart transplant recipients. Methods: We performed a systematic review and a meta‐analysis using three different databases to compare outcomes in pediatric heart transplant recipients with and without pre‐transplant VAD support. The primary outcome was long‐term survival. Secondary outcomes were postoperative stroke, hospital length of stay (LOS), and post‐transplantation rejection. Results: A total of 3247 studies were identified, of which five were included in the analysis. There was no significant difference in long‐term survival among patients who survived to transplantation between the groups (HR 0.963; 95% CI 0.84 to 1.10; p = 0.582). However, the postoperative stroke rate was significantly higher in the VAD group (OR 2.17; 95% CI 1.63 to 2.89; p < 0.0001), while no significant differences were observed in hospital LOS (SMD −0.09; 95% CI −0.33 to 0.14; p = 0.4375) or post‐transplant rejection (OR 1.18; 95% CI 1.00 to 1.39; p = 0.0505). Conclusions: Pre‐transplant VAD support was associated with non‐inferior survival despite greater baseline severity among patients who survived to transplantation, enabling access to transplantation, but at the cost of higher VAD‐related complications, particularly stroke, with no differences in hospital LOS or rejection.

  • Open Access

    Impact of Obesity on Outcomes after Minimally Invasive Mitral Valve Surgery: A Systematic Review and Meta-Analysis

    by Paul C. Onyeji, Sonise Momplaisir-Onyeji, Abhigyan Majumdar, Przemysław Nowakowski, Felipe S. Passos, Hristo Kirov, Ricardo Esper Treml, Torsten Doenst, Sophie Tkebuchava, Tulio Caldonazo

  • Open Access

    Outcomes after using cerebral embolic protection devices during transcatheter aortic valve replacement: an updated meta-analysis

    by Mohamed Saad Sayed, Amro K. AlQurm, Waleed Mohaned Rasheed, Kenda Yousef Abedal- Kareem, Saeb M. Albsoul, Sara K. AlQurm, Shatha M. Ramadneh, Jude N. Haddad, Obadah Aqtash, Tulio Caldonazo

    Background: Cerebral embolic protection (CEP) devices have been developed to reduce periprocedural embolization through transcatheter aortic valve replacement (TAVR), yet their clinical benefit remains uncertain. This study aimed to systematically evaluate the efficacy and safety of CEP devices during TAVR using evidence restricted to randomized controlled trials (RCTs). Methods: We conducted a systematic review and meta-analysis following PRISMA guidelines. MEDLINE, Embase, Web of Science, Scopus, and Cochrane CENTRAL were searched through July 2025 for RCTs comparing CEP devices vs. no protection in patients undergoing TAVR. The primary outcome was the all-cause stroke. Random-effects model was applied for the primary analysis. Results: Nine RCTs comprising 11,696 patients (6,000 patients in CEP, 5,696 patients in control) were analyzed. CEP use did not significantly reduce the overall risk of all-cause stroke ( RR 0.92; 95% CI 0.73–1.14; p = 0.43 ). The results were consistent across different subgroups, either Sentinel (filter device) ( RR 0.88; 95% CI 0.70–1.11; I 2 = 0.00%) or TriGuard (deflection device) ( RR 1.40; 95% CI 0.67–2.94; I 2 = 0.00%) (P interaction = 0.50). Similarly, no significant differences between the two groups were observed for the risk of all-cause mortality, disabling stroke, non-disabling stroke, cardiovascular mortality, transient ischemic attack, major adverse cardiovascular and cerebrovascular events, major bleeding, major vascular complications, or acute kidney injury. Conclusions: Among patients undergoing TAVR, CEP devices could not reduce the risk of stroke compared with the control group. Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO/view/CRD420251114450 , CRD420251114450.

  • Open Access

    Pulsed Field Ablation Versus High-Power Short-Duration Ablation for Atrial Fibrillation—A Meta-Analysis of Reconstructed Time-to-Event Data

    by Pedro B. Bregion, Felipe S. Passos, Stefano Schena, Luca Fazzini, Hristo Kirov, Camilla S. Rossi, Torsten Doenst, Antonino Di Franco, Tulio Caldonazo

    Background: Pulsed field ablation (PFA) has shown promising results for atrial fibrillation (AF), with efficacy comparable to established ablation techniques. High-power short-duration (HPSD) ablation has also emerged as a potential alternative. However, the relative superiority between these approaches remains uncertain. We performed a systematic review and meta-analysis to address this gap. Methods: Three databases were searched. The primary outcome was freedom from AF recurrence. Secondary outcomes included tamponade and other complications, procedure and fluoroscopy durations. Time-to-event data were reconstructed, and a random-effects model was employed. Given variability in post-ablation blanking periods across studies, landmark analyses were performed using a 3-month cut-off to account for the potential under-detection of early recurrence events. Results: Eight studies (1369 patients [PFA: 642; HPSD: 727]) were included. PFA was associated with greater freedom from AF recurrence (HR 0.751; 95% CI 0.57 to 0.99; p = 0.044). Landmark analyses showed no difference in the 0–3 month period; a significant benefit of PFA was observed thereafter (HR 0.72; 95% CI 0.54 to 0.98; p = 0.033). There were no significant differences between groups in the incidence of tamponade (p = 0.73) or overall complications (p = 0.99). PFA was associated with shorter procedure duration (MD 37.05; 95% CI 27.69 to 46.41; p < 0.01), whereas fluoroscopy duration was significantly shorter in the HPSD group (MD −9.04; 95% CI −11.71 to −6.37; p < 0.001). Conclusion: PFA was associated with a lower risk of AF recurrence compared to HPSD, particularly beyond the late post-ablation period, with similar rates of complications. Although PFA was associated with shorter procedure duration, HPSD demonstrated reduced fluoroscopy time.