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2. Intermittent intravenous paracetamol versus continuous morphine in infants undergoing cardiothoracic surgery: a multi-center randomized controlled trial

Author

Zeilmaker-Roest, Gerdien, de Vries-Rink, Christine, van Rosmalen, Joost, van Dijk, Monique, de Wildt, Saskia N., Knibbe, Catherijne A. J., Koomen, Erik, Jansen, Nicolaas J. G., Kneyber, Martin C. J., Maebe, Sofie, Van den Berghe, Greet, Haghedooren, Renata, Vlasselaers, Dirk, Bogers, Ad J. J. C., Tibboel, Dick, and Wildschut, Enno D.

Published
2024
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3. Cardiac Resynchronization Therapy for Adult Patients With a Failing Systemic Right Ventricle: A Multicenter Study.

Author

Kharbanda, Rohit K, Moore, Jeremy P, Lloyd, Michael S, Galotti, Robert, Bogers, Ad JJC, Taverne, Yannick JHJ, Madhavan, Malini, McLeod, Christopher J, Dubin, Anne M, Mah, Douglas Y, Chang, Philip M, Kamp, Anna N, Nielsen, Jens C, Aydin, Alper, Tanel, Ronn E, Shah, Maully J, Pilcher, Thomas, Evertz, Reinder, Khairy, Paul, Tan, Reina B, Czosek, Richard J, Shivkumar, Kalyanam, and de Groot, Natasja MS

Subjects
Heart Ventricles, Humans, Transposition of Great Vessels, Treatment Outcome, Retrospective Studies, Adult, Middle Aged, Female, Male, Heart Failure, Cardiac Resynchronization Therapy, cardiac resynchronization therapy, congenital heart disease, heart failure, pacing, systemic right ventricle, Cardiovascular, Heart Disease, Cardiorespiratory Medicine and Haematology
Abstract

Background The objective of this international multicenter study was to investigate both early and late outcomes of cardiac resynchronization therapy (CRT) in patients with a systemic right ventricle (SRV) and to identify predictors for congestive heart failure readmissions and mortality. Methods and Results This retrospective international multicenter study included 13 centers. The study population comprised 80 adult patients with SRV (48.9% women) with a mean age of 45±14 (range, 18-77) years at initiation of CRT. Median follow-up time was 4.1 (25th-75th percentile, 1.3-8.3) years. Underlying congenital heart disease consisted of congenitally corrected transposition of the great arteries and dextro-transposition of the great arteries in 63 (78.8%) and 17 (21.3%) patients, respectively. CRT resulted in significant improvement in functional class (before CRT: III, 25th-75th percentile, II-III; after CRT: II, 25th-75th percentile, II-III; P=0.005) and QRS duration (before CRT: 176±27; after CRT: 150±24 milliseconds; P=0.003) in patients with pre-CRT ventricular pacing who underwent an upgrade to a CRT device (n=49). These improvements persisted during long-term follow-up with a marginal but significant increase in SRV function (before CRT; 30%, 25th-75th percentile, 25-35; after CRT: 31%, 25th-75th percentile, 21-38; P=0.049). In contrast, no beneficial change in the above-mentioned variables was observed in patients who underwent de novo CRT (n=31). A quarter of all patients were readmitted for heart failure during follow-up, and mortality at latest follow-up was 21.3%. Conclusions This international experience with CRT in patients with an SRV demonstrated that CRT in selected patients with SRV dysfunction and pacing-induced dyssynchrony yielded consistent improvement in QRS duration and New York Heart Association functional status, with a marginal increase in SRV function.

Published
2022

17. Effect of routine preoperative screening for aortic calcifications using noncontrast computed tomography on stroke rate in cardiac surgery: the randomized controlled CRICKET study

Author

Knol, Wiebe G., Simon, Judit, Den Harder, Annemarie M., Bekker, Margreet W. A., Suyker, Willem J. L., de Heer, Linda M., de Jong, Pim A., Leiner, Tim, Merkely, Béla, Pólos, Miklós, Krestin, Gabriel P., Boersma, Eric, Koudstaal, Peter J., Maurovich-Horvat, Pál, Bogers, Ad J. J. C., and Budde, Ricardo P. J.

Published
2022
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18. CeRebrUm and CardIac Protection with ALlopurinol in Neonates with Critical Congenital Heart Disease Requiring Cardiac Surgery with Cardiopulmonary Bypass (CRUCIAL): study protocol of a phase III, randomized, quadruple-blinded, placebo-controlled, Dutch multicenter trial

Author

Stegeman, Raymond, Nijman, Maaike, Breur, Johannes M. P. J., Groenendaal, Floris, Haas, Felix, Derks, Jan B., Nijman, Joppe, van Beynum, Ingrid M., Taverne, Yannick J. H. J., Bogers, Ad J. J. C., Helbing, Willem A., de Boode, Willem P., Bos, Arend F., Berger, Rolf M. F., Accord, Ryan E., Roes, Kit C. B., de Wit, G. Ardine, Jansen, Nicolaas J. G., and Benders, Manon J. N. L.

Published
2022
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35. Sex-related differences in the clinical course of aortic root and ascending aortic aneurysms:the DisSEXion Study

Author

Notenboom, Maximiliaan L., de Keijzer, Adine R., Veen, Kevin M., Gokalp, Arjen, Bogers, Ad J. J. C., Heijmen, Robin H., van Kimmenade, Roland R. J., Geuzebroek, Guillaume S. C., Mokhles, M. Mostafa, Bekkers, Jos A., Roos-Hesselink, Jolien W., Takkenberg, Johanna J. M., Notenboom, Maximiliaan L., de Keijzer, Adine R., Veen, Kevin M., Gokalp, Arjen, Bogers, Ad J. J. C., Heijmen, Robin H., van Kimmenade, Roland R. J., Geuzebroek, Guillaume S. C., Mokhles, M. Mostafa, Bekkers, Jos A., Roos-Hesselink, Jolien W., and Takkenberg, Johanna J. M.

Abstract

Background and Aims To explore male-female differences in aneurysm growth and clinical outcomes in a two-centre retrospective Dutch cohort study of adult patients with ascending aortic aneurysm (AscAA). Methods Adult patients in whom imaging of an AscAA (root and/or ascending: >= 40 mm) was performed between 2007 and 2022 were included. Aneurysm growth was analysed using repeated measurements at the sinuses of Valsalva (SoV) and tubular ascending aorta. Male-female differences were explored in presentation, aneurysm characteristics, treatment strategy, survival, and clinical outcomes. Results One thousand eight hundred and fifty-eight patients were included (31.6% female). Median age at diagnosis was 65.4 years (interquartile range: 53.4-71.7) for females and 59.0 years (interquartile range: 49.3-68.0) for males (P < .001). At diagnosis, females more often had tubular ascending aortic involvement (75.5% vs. 70.2%; P = .030) while males more often had SoV involvement (42.8% vs. 21.6%; P < .001). Maximum absolute aortic diameter, at any location, at diagnosis did not differ between females (45.0 mm) and males (46.5 mm; P = .388). In females, tubular ascending growth was faster (P < .001), whereas in males, SoV growth was faster (P = .005), corrected for covariates. Unadjusted 10-year survival was 72.5% [95% confidence interval (CI) 67.8%-77.6%] for females and 78.3% (95% CI 75.3%-81.3%) for males (P = .010). Twenty-three type A dissections occurred, with an incidence rate of 8.2/1000 patient-years (95% CI 4.4-14.1) in females and 2.4/1000 patient-years (95% CI 1.2-4.5) in males [incidence rate ratio females/males: 3.4 (95% CI 1.5-8.0; P = .004)]. Conclusions In patients having entered a diagnostic programme, involvement of aortic segments and age- and segment-related growth patterns differ between women and men with AscAA, particularly at an older age. Unravelling of these intertwined observations will provide a deeper understanding of AscAA progression an

Published
2024

36. Long-term surgical outcomes of congenital supravalvular aortic stenosis:a systematic review, meta-analysis and microsimulation study

Author

Meccanici, Frederike, Notenboom, Maximiliaan L., Meijssen, Jade, Smit, Vernon, Van De Woestijne, Pieter C., Van Den Bosch, Annemien E., Helbing, Willem A., Bogers, Ad J.J.C., Takkenberg, Johanna J.M., Roos-Hesselink, Jolien W., Meccanici, Frederike, Notenboom, Maximiliaan L., Meijssen, Jade, Smit, Vernon, Van De Woestijne, Pieter C., Van Den Bosch, Annemien E., Helbing, Willem A., Bogers, Ad J.J.C., Takkenberg, Johanna J.M., and Roos-Hesselink, Jolien W.

Abstract

OBJECTIVES: Congenital supravalvular aortic stenosis (SVAS) is a rare form of congenital outflow tract obstruction and long-term outcomes are scarcely reported. This study aims to provide an overview of outcomes after surgical repair for congenital SVAS. METHODS: A systematic review of published literature was conducted, including observational studies reporting long-term clinical outcome (>2 years) after SVAS repair in children or adults considering >20 patients. Early risks, late event rates and time-to-event data were pooled and entered into a microsimulation model to estimate 30-year outcomes. Life expectancy was compared to the age-, sex- and origin-matched general population. RESULTS: Twenty-three publications were included, encompassing a total of 1472 patients (13 125 patient-years; pooled mean follow-up: 9.0 (6.2) years; median follow-up: 6.3 years). Pooled mean age at surgical repair was 4.7 (5.8) years and the most commonly used surgical technique was the single-patch repair (43.6%). Pooled early mortality was 4.2% (95% confidence interval: 3.2-5.5%) and late mortality was 0.61% (95% CI: 0.45-0.83) per patient-year. Based on microsimulation, over a 30-year time horizon, it was estimated that an average patient with SVAS repair (mean age: 4.7 years) had an observed life expectancy that was 90.7% (95% credible interval: 90.0-91.6%) of expected life expectancy in the matched general population. The microsimulation-based 30-year risk of myocardial infarction was 8.1% (95% credible interval: 7.3-9.9%) and reintervention 31.3% (95% credible interval: 29.6-33.4%), of which 27.2% (95% credible interval: 25.8-29.1) due to repair dysfunction. CONCLUSIONS: After surgical repair for SVAS, 30-year survival is lower than the matched-general-population survival and the lifetime risk of reintervention is considerable. Therefore, lifelong monitoring of the cardiovascular system and in particular residual stenosis and coronary obstruction is recommended.

Published
2024

37. Long term outcome after surgical ASD-closure at young age:Longitudinal follow-up up to 50 years after surgery

Author

Kauling, Robert M, Pelosi, Chiara, Cuypers, Judith A A E, van den Bosch, Annemien E, Hirsch, Alexander, Carvalho, João G, Bowen, Daniel J, Kardys, Isabella, Bogers, Ad J J C, Helbing, Wim A, Roos-Hesselink, Jolien W, Kauling, Robert M, Pelosi, Chiara, Cuypers, Judith A A E, van den Bosch, Annemien E, Hirsch, Alexander, Carvalho, João G, Bowen, Daniel J, Kardys, Isabella, Bogers, Ad J J C, Helbing, Wim A, and Roos-Hesselink, Jolien W

Abstract

OBJECTIVES: To describe the clinical outcome and quality of life up to 50 years after surgical atrial septal defect (ASD) closure at young age. Primary outcome is defined as MACE (all-cause mortality, cardiac re-interventions, ischemic stroke, endocarditis, heart failure and symptomatic arrhythmia).METHODS: Single-center, longitudinal cohort-study evaluating 135 consecutive patients who underwent ASD-closure before the age of 15 years between 1968 and 1980. Participants were invited for extensive cardiac evaluation and assessment of quality-of-life every 10 years.RESULTS: Eighty patients (86%) of 93 eligible survivors were included in this study (mean age 52 ± 5 years (range 41-63), 40% male). Median follow-up since surgery was 45 years (range 40-51). Cumulative survival after 50 years was 86% and comparable to the normal Dutch population. Cumulative event-free survival after 45 and 50-years was 59% and 46% respectively (re-intervention in 6, symptomatic arrhythmia in 25, and pacemaker implantation in 10 patients). Right ventricular ejection fraction on CMR was diminished in 6%. Exercise capacity was normal in 77%. There was no pulmonary hypertension. NT-proBNP was elevated in 61%. Quality of life was comparable with the general population. No predictors for late events were identified.CONCLUSION: Long-term survival after surgical ASD-closure in childhood is good and not statistically different at 50 years compared to the normal Dutch population. Re-intervention rate is low, there is no pulmonary hypertension. Right ventricular function was diminished in 6%, exercise capacity was good and stable over time with quality of life comparable to the general population. However, supraventricular tachycardia is common.

Published
2024

38. Intermittent intravenous paracetamol versus continuous morphine in infants undergoing cardiothoracic surgery: a multi-center randomized controlled trial

Author

Intensive care patientenzorg, Cluster A, Zeilmaker-Roest, Gerdien, de Vries-Rink, Christine, van Rosmalen, Joost, van Dijk, Monique, de Wildt, Saskia N., Knibbe, Catherijne A.J., Koomen, Erik, Jansen, Nicolaas J.G., Kneyber, Martin C.J., Maebe, Sofie, Van den Berghe, Greet, Haghedooren, Renata, Vlasselaers, Dirk, Bogers, Ad J.J.C., Tibboel, Dick, Wildschut, Enno D., Intensive care patientenzorg, Cluster A, Zeilmaker-Roest, Gerdien, de Vries-Rink, Christine, van Rosmalen, Joost, van Dijk, Monique, de Wildt, Saskia N., Knibbe, Catherijne A.J., Koomen, Erik, Jansen, Nicolaas J.G., Kneyber, Martin C.J., Maebe, Sofie, Van den Berghe, Greet, Haghedooren, Renata, Vlasselaers, Dirk, Bogers, Ad J.J.C., Tibboel, Dick, and Wildschut, Enno D.

Published
2024

39. Intermittent intravenous paracetamol versus continuous morphine in infants undergoing cardiothoracic surgery:a multi-center randomized controlled trial

Author

Zeilmaker-Roest, Gerdien, de Vries-Rink, Christine, van Rosmalen, Joost, van Dijk, Monique, de Wildt, Saskia N., Knibbe, Catherijne A.J., Koomen, Erik, Jansen, Nicolaas J.G., Kneyber, Martin C.J., Maebe, Sofie, Van den Berghe, Greet, Haghedooren, Renata, Vlasselaers, Dirk, Bogers, Ad J.J.C., Tibboel, Dick, Wildschut, Enno D., Zeilmaker-Roest, Gerdien, de Vries-Rink, Christine, van Rosmalen, Joost, van Dijk, Monique, de Wildt, Saskia N., Knibbe, Catherijne A.J., Koomen, Erik, Jansen, Nicolaas J.G., Kneyber, Martin C.J., Maebe, Sofie, Van den Berghe, Greet, Haghedooren, Renata, Vlasselaers, Dirk, Bogers, Ad J.J.C., Tibboel, Dick, and Wildschut, Enno D.

Abstract

Background: To determine whether intermittent intravenous (IV) paracetamol as primary analgesic would significantly reduce morphine consumption in children aged 0–3 years after cardiac surgery with cardiopulmonary bypass. Methods: Multi-center, randomized, double-blinded, controlled trial in four level-3 Pediatric Intensive Care Units (PICU) in the Netherlands and Belgium. Inclusion period; March 2016–July 2020. Children aged 0–3 years, undergoing cardiac surgery with cardiopulmonary bypass were eligible. Patients were randomized to continuous morphine or intermittent IV paracetamol as primary analgesic after a loading dose of 100 mcg/kg morphine was administered at the end of surgery. Rescue morphine was given if numeric rating scale (NRS) pain scores exceeded predetermined cutoff values. Primary outcome was median weight-adjusted cumulative morphine dose in mcg/kg in the first 48 h postoperative. For the comparison of the primary outcome between groups, the nonparametric Van Elteren test with stratification by center was used. For comparison of the proportion of patients with one or more NRS pain scores of 4 and higher between the two groups, a non-inferiority analysis was performed using a non-inferiority margin of 20%. Results:In total, 828 were screened and finally 208 patients were included; parents of 315 patients did not give consent and 305 were excluded for various reasons. Fourteen of the enrolled 208 children were withdrawn from the study before start of study medication leaving 194 patients for final analysis. One hundred and two patients received intermittent IV paracetamol, 106 received continuous morphine. The median weight-adjusted cumulative morphine consumption in the first 48 h postoperative in the IV paracetamol group was 5 times lower (79%) than that in the morphine group (median, 145.0 (IQR, 115.0–432.5) mcg/kg vs 692.6 (IQR, 532.7–856.1) mcg/kg; P < 0.001). The rescue morphine cons

Published
2024

43. Population Pharmacokinetics and Target Attainment of Allopurinol and Oxypurinol Before, During, and After Cardiac Surgery with Cardiopulmonary Bypass in Neonates with Critical Congenital Heart Disease.

Author

Chu, Wan-Yu, Nijman, Maaike, Stegeman, Raymond, Breur, Johannes M. P. J., Jansen, Nicolaas J. G., Nijman, Joppe, van Loon, Kim, Koomen, Erik, Allegaert, Karel, Benders, Manon J. N. L., Dorlo, Thomas P. C., Huitema, Alwin D. R., Beynum, Ingrid M. van, ten Cate, Floris E. Udink, Helbing, Willem A., Taverne, Yannick J. H. J., de Boode, Willem P., Bogers, Ad J. C. C., Joosten, Koen F. M., and van de Woestijne, Pieter C.

Subjects
SURGICAL complications, XANTHINE oxidase, CONGENITAL heart disease, CARDIOPULMONARY bypass, CARDIAC surgery
Abstract

Background: The CRUCIAL trial (NCT04217421) is investigating the effect of postnatal and perioperative administration of allopurinol on postoperative brain injury in neonates with critical congenital heart disease (CCHD) undergoing cardiac surgery with cardiopulmonary bypass (CPB) shortly after birth. Objective: This study aimed to characterize the pharmacokinetics (PK) of allopurinol and oxypurinol during the preoperative, intraoperative, and postoperative phases in this population, and to evaluate target attainment of the current dosing strategy. Methods: Nonlinear mixed-effects modeling was used to develop population PK models in 14 neonates from the CRUCIAL trial who received up to five intravenous allopurinol administrations throughout the postnatal and perioperative periods. Target attainment was defined as achieving an allopurinol concentration >2 mg/L in at least two-thirds of the patients during the first 24 h after birth and between the start and 36 h after cardiac surgery with CPB. Results: A two-compartment model for allopurinol was connected to a one-compartment model for oxypurinol with an auto-inhibition effect on the conversion, which best described the PK. In a typical neonate weighing 3.5 kg who underwent cardiac surgery at a postnatal age (PNA) of 5.6 days, the clearance (CL) of allopurinol and oxypurinol at birth was 0.95 L/h (95% confidence interval 0.75–1.2) and 0.21 L/h (0.17–0.27), respectively, which subsequently increased with PNA to 2.97 L/h and 0.41 L/h, respectively, before CPB. During CPB, allopurinol and oxypurinol CL decreased to 1.38 L/h (0.9–1.87) and 0.12 L/h (0.05–0.22), respectively. Post-CPB, allopurinol CL increased to 2.21 L/h (1.74–2.83), while oxypurinol CL dropped to 0.05 L/h (0.01–0.1). Target attainment was 100%, 53.8%, and 100% at 24 h postnatally, 24 h after the start of CPB, and 36 h after the end of cardiac surgery, respectively. The combined concentrations of allopurinol and oxypurinol maintained ≥ 90% inhibition of xanthine oxidase (IC90XO) throughout the postnatal and perioperative period. Conclusions: The minimal target concentration of allopurinol was not achieved at every predefined time interval in the CRUCIAL trial; however, the dosing strategy used was deemed adequate, since it yielded concentrations well exceeding the IC90XO. The decreased CL of both compounds during CPB suggests influence of the hypothermia, hemofiltration, and the potential sequestration of allopurinol in the circuit. The reduced CL of oxypurinol after CPB is likely attributable to impaired kidney function. [ABSTRACT FROM AUTHOR]

Published
2024
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