Publications by authors named "Saskia Houterman"

83 Publications

Interpectoral-pectoserratus plane (PECS II) block in patients undergoing trans-axillary thoracic outlet decompression surgery; A prospective double-blind, randomized, placebo-controlled clinical trial.

J Clin Anesth 2022 Jul 27;82:110939. Epub 2022 Jul 27.

Faculty of Health, Medicine and Life Sciences, Department of Epidemiology, CAPHRI School for Public Health and Primary Care, Maastricht University, Universiteitssingel 40, 6229 ER Maastricht, the Netherlands; Department of Vascular Surgery, Catharina hospital, Michelangelolaan 2, 5623 EJ Eindhoven, the Netherlands. Electronic address:

Study Objective: To investigate if an interpectoral-pectoserratus plane (PECS II) block decreases postoperative pain, postoperative nausea and vomiting and improves quality of recovery in patients with neurogenic thoracic outlet syndrome (NTOS) undergoing trans-axillary thoracic outlet decompression surgery.

Design: A prospective single center double blinded randomized placebo-controlled trial.

Setting: Perioperative period; operating room, post anesthesia care unit (PACU) and hospital ward.

Patients: Seventy patients with NTOS, undergoing trans-axillary thoracic outlet decompression surgery.

Interventions: Patients were randomized to an interventional arm, receiving the block with 40 ml ropivacaine 0.5% (concentration was adjusted if the patient's weight was <66 kg), and a placebo group, receiving a sham block with 40 ml NaCl 0.9%. The interpectoral-pectoserratus plane block was performed ultrasound guided; the first injection below the pectoral minor muscle and the second below the pectoral major muscle. The hospitals' pharmacist prepared the study medication and was the only person able to see the randomization result. The study was blinded for patients, researchers and medical personnel.

Measurements: Primary outcome parameters were postoperative pain, measured by numeric rating scale on the PACU (start and end) and on the ward on postoperative day (POD) 0 and 1, and postoperative morphine consumption, measured on the PACU and on the ward during the first 24 h. Secondary outcome parameters were postoperative nausea and vomiting, and quality of recovery.

Main Results: There was no statistically significant difference in NRS on the PACU at the start (ropivacaine 4.9 ± 3.2 vs placebo 6.2 ± 3.0, p = .07), at the end (ropivacaine 4.0 ± 1.7 vs placebo 3.9 ± 1.7, p = .77), on the ward on POD 0 (ropivacaine 4.6 ± 2.0 vs placebo 4.6 ± 2.0, p = 1.00) or POD 1 (ropivacaine 3.9 ± 1.8 vs placebo 3.6 ± 2.0, p = .53). There was no difference in postoperative morphine consumption at the PACU (ropivacaine 11.0 mg ± 6.5 vs placebo 10.8 mg ± 4.8, p = .91) or on the ward (ropivacaine 11.6 mg ± 8.5 vs placebo 9.6 mg ± 9.4, p = .39).

Conclusions: The interpectoral-pectoserratus plane block is not effective for postoperative analgesia in patients with NTOS undergoing trans-axillary thoracic outlet decompression surgery.
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http://dx.doi.org/10.1016/j.jclinane.2022.110939DOI Listing
July 2022

Surgical repair of post-infarction ventricular free-wall rupture in the Netherlands: data from a nationwide registry.

Ann Cardiothorac Surg 2022 May;11(3):310-318

Department of Cardiothoracic Surgery, Heart and Vascular Centre, Maastricht University Medical Centre, Maastricht, The Netherlands.

Background: Ventricular free-wall rupture (VFWR) is an infrequent but catastrophic complication of acute myocardial infarction (AMI). Most reports about outcome after surgical treatment are single-center experiences. We examined the early and mid-term outcomes after surgical repair of post-AMI VFWR using the Netherlands Heart Registration (NHR) database.

Methods: We included data from NHR patients (>18 years old) who underwent surgery for post-AMI VFWR between 2014 and 2019. The primary end-point was in-hospital mortality. Secondary outcomes included postoperative complications and mid-term survival.

Results: The study included 148 patients (54.7% male, mean age 66.5±11.1 years). Critical preoperative status was found in 62.6% of subjects. In-hospital mortality was 31.1% (46 of 148). Multivariable analysis identified female sex [odds ratio (OR), 5.49; 95% confidence interval (CI): 2.24-13.46] and critical preoperative status (OR, 4.06; 95% CI: 1.36-12.13) as independent predictors of in-hospital mortality. The overall median postoperative follow-up was 2.2 (interquartile range, 0.7-3.8) years. Overall survival rates at three and five years were 58.9% and 55.7%, respectively. Among hospital survivors, only 15 (14.7%) patients died during follow-up, with a five-year survival rate of 80.8%.

Conclusions: In-hospital mortality after surgical repair of post-AMI VFWR is considerable. Female sex and preoperative critical status are independent predictors of early postoperative (in-hospital) death. Logistic EuroSCORE I can reliably predict in-hospital mortality (optimal cut-off >33%). Mid-term follow-up of patients surviving in-hospital course shows excellent results.
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http://dx.doi.org/10.21037/acs-2021-ami-10DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9207691PMC
May 2022

Reliability and validity of the standardized elevated arm stress test in the diagnosis of neurogenic thoracic outlet syndrome.

J Vasc Surg 2022 May 11. Epub 2022 May 11.

Department of Vascular Surgery, Catharina Hospital, Eindhoven, The Netherlands; CAPHRI School for Public Health and Primary Care, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands. Electronic address:

Objective: We developed a standardized elevated arm stress test (sEAST) meter to standardize patients' posture and measure additional grip and fatigue parameters. In the present prospective cohort study, we aimed to determine the reliability and validity of the sEAST in the diagnosis of neurogenic thoracic outlet syndrome (NTOS).

Methods: Patients evaluated for NTOS between October 2018 and February 2020 were included and performed the sEAST. The patients were classified into a proven NTOS group or a symptomatic control group using the reporting standards for NTOS and the outcome of thoracic outlet decompression surgery. Healthy persons were recruited as an asymptomatic control group. The test-retest reliability, area under the receiver operating characteristic curve, and positive and negative predictive values were calculated for each sEAST parameter.

Results: A total of 426 patients with suspected NTOS and 147 healthy controls had performed the sEAST. The validity analysis was performed with data from 111 patients with proven NTOS, 94 symptomatic controls, and 147 asymptomatic controls. The reporting standards were inconclusive for 116 patients; 77 patients had been excluded because thoracic outlet decompression surgery had not been performed or was unsuccessful, and 28 because they had arterial or venous thoracic outlet syndrome. The area under the receiver operating characteristic curve for the proven NTOS group compared with the asymptomatic control and symptomatic control groups ranged from 0.59 to 0.77 and 0.54 to 0.63, respectively. The positive predictive value ranged from 46% to 65% and the negative predictive value from 51% to 66%. The test-retest reliability analysis for 80 patients with multiple sEAST measurements showed moderate to good (0.52-0.87) intraclass correlation coefficient values for the duration and grip strength parameters. However, the grip fatigue parameters demonstrated poor (0.46-0.16) intraclass correlation coefficient values.

Conclusions: The sEAST showed good test-retest reliability for the duration and grip strength parameters. However, the discriminative value of all sEAST parameters was low for NTOS diagnostics. The good test-retest reliability of the sEAST parameters indicates that they could be valuable outcome measures for comparison in a diagnostic care pathway.
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http://dx.doi.org/10.1016/j.jvs.2022.03.885DOI Listing
May 2022

Reliability and validity of the elevated arm stress test in the diagnosis of neurogenic thoracic outlet syndrome.

J Vasc Surg 2022 May 10. Epub 2022 May 10.

Department of Neurology, Catharina Hospital, Eindhoven, The Netherlands. Electronic address:

Objectives: The objective of this retrospective analysis of prospectively collected data was to assess the test-retest reliability and validity of the elevated arm stress test (EAST) as measured by the duration in a cohort of patients with suspected neurogenic thoracic outlet syndrome (NTOS).

Methods: Patients evaluated for NTOS between January 2017 and September 2018 were identified. Test-retest reliability by the intraclass correlation coefficient was determined for duration of the EAST. For the validity analysis, patients were classified in a proven NTOS group or a symptomatic control group without NTOS using the Society for Vascular Surgery reporting standards and the outcome of thoracic outlet decompression surgery. A receiver operating characteristic curve was made for the duration of EAST. The area under the curve, and positive and negative predictive values were calculated for the EAST.

Results: In total, 428 patients with suspected NTOS were retrospectively analyzed. Of these patients, 61 were excluded because no EAST data was available. Another 101 patients were excluded because of inconclusive reporting standards, arterial or venous TOS, or because thoracic outlet decompression surgery was not performed or had a negative result. The validity analysis in the remaining 266 patients showed an area under the curve for the duration of the EAST of 0.62 (95% confidence interval, 0.55-0.69). The positive predictive value of the duration ranged between 65% and 66%, and the negative predictive value between 53% and 58%. For the test-retest reliability analysis, 118 patients were excluded because they performed only one measurement in a 100-day time period. Analysis in the remaining 148 patients showed an intraclass correlation coefficient value of 0.65 (95% confidence interval, 0.55-0.74) for duration.

Conclusions: The EAST measured by the duration showed a moderate test-retest reliability, but the discriminative value was low in the diagnosis of NTOS. The outcome of the EAST measured by the duration should be used with caution.
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http://dx.doi.org/10.1016/j.jvs.2022.03.883DOI Listing
May 2022

Surgery Versus Continued Conservative Treatment for Neurogenic Thoracic Outlet Syndrome: the First Randomised Clinical Trial (STOPNTOS Trial).

Eur J Vasc Endovasc Surg 2022 May 7. Epub 2022 May 7.

Department of Vascular Surgery, Catharina Hospital, Eindhoven, The Netherlands; CAPHRI School for Public Health and Primary Care, Faculty of Health, Medicine and Life Sciences, Maastricht University, The Netherlands. Electronic address:

Objective: Neurogenic thoracic outlet syndrome (NTOS) is one of the most controversial clinical entities in medicine. Several major case series have shown promising results of surgery; however, solid scientific evidence is lacking. The aim of this trial was to objectify the effect of thoracic outlet decompression (TOD).

Methods: A single centre (high volume, tertiary TOS centre), non-blinded, randomised controlled trial was conducted with parallel group design. Patients with a diagnosis of NTOS refractory to conservative therapy were randomised to one of two intervention arms, receiving either a transaxillary thoracic outlet decompression (TA-TOD) or continued conservative treatment. After three months, the conservative treated group was also offered a TA-TOD. The primary outcome was change in Disability of the Arm, Shoulder and Hand (DASH) questionnaire score. Secondary outcomes were changes in Cervical Brachial Symptoms Questionnaire (CBSQ), TOS disability scale, and quality of life scores. Outcomes were assessed at baseline, three, six, and 12 months after inclusion.

Results: Fifty patients were enrolled in this trial: 25 in the TA-TOD group and 25 in the continued conservative treatment group. Follow up was completed in 24 and 22 patients, respectively. At three months, there was a statistically significant difference in DASH scores (TA-TOD: mean 45.15, 95% confidence interval [CI] 38.08 - 52.21; conservative treatment: mean 64.92, 95% CI 57.54 - 72.30; p < .001). All patients in the conservative treatment group applied for surgery three months after randomisation. After surgery of the conservative treatment group, there was no statistically significant difference between the groups for all primary and secondary outcome measures.

Conclusions: TA-TOD for NTOS is effective in patients who do not respond to conservative treatment. Trial register number: NL63986.100.17.
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http://dx.doi.org/10.1016/j.ejvs.2022.05.003DOI Listing
May 2022

Risk factors for PTSD diagnosis in young victims of recent sexual assault.

Eur J Psychotraumatol 2022 5;13(1):2047293. Epub 2022 Apr 5.

National Psychotrauma Center for Children and Youth, University Medical Center Utrecht, Utrecht, Netherlands.

Background: Sexual assault is associated with a high risk of developing PTSD. Little is known about the PTSD onset in children who have recently been victimized by sexual assault. It is important to identify children at risk for PTSD after sexual assault to prevent chronic problems and revictimization.

Objective: The first aim of this study was to describe the development of post-traumatic stress symptoms in the four weeks after sexual assault. The second aim was to analyse whether pre-assault factors, assault-related factors, social support, and post-traumatic stress, measured at two weeks post-assault, were associated with an indication of PTSD.

Method: From January 2019 to March 2021, data were collected of victims aged 8-17 years ( = 51; mean age = 15.00;  = 1.78) who had contacted a Sexual Assault Centre. Severity of post-traumatic stress symptoms was measured at two and four weeks post-assault. The study was designed to use a multivariate logistic regression analysis. The study included female victims only.

Results: Most of the victims (58.8%) showed a decline in the severity of post-traumatic stress symptoms in the four weeks after sexual assault. However, 27.4% showed an increase and 13.7% showed no change in symptoms. More than two-thirds of the children (70.6%) showed severe post-traumatic stress symptoms at four weeks post-assault, i.e. had an indication of PTSD. Since only one significant difference was found, the multivariate analysis was not executed. A significant difference was found between severity of symptoms at two weeks and an indication of PTSD at four weeks ((49) = -5.79;  < .001).

Conclusion: Children with high levels of post-traumatic stress at two weeks post-assault are at risk for PTSD indication at four weeks post-assault. Further research is needed to determine whether early trauma-based treatment for children with high post-traumatic stress symptoms can prevent the development of PTSD.
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http://dx.doi.org/10.1080/20008198.2022.2047293DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8986203PMC
April 2022

Evaluating corrected carotid flow time as a non-invasive parameter for trending cardiac output and stroke volume in cardiac surgery patients.

J Ultrasound 2022 Apr 9. Epub 2022 Apr 9.

Department of Anesthesiology, Catharina Hospital, Eindhoven, The Netherlands.

Purpose: The corrected carotid flow time (ccFT) is derived from a pulsed-wave Doppler signal at the common carotid artery. Several equations are currently used to calculate ccFT. Its ability to assess the intravascular volume status non-invasively has recently been investigated. The purpose of this study was to evaluate the correlation and trending ability of ccFT with invasive cardiac output (CO) and stroke volume (SV) measurements.

Methods: Eighteen cardiac surgery patients were included in this prospective observational study. ccFT measurements were obtained at three time points: after induction of anesthesia (T1), after a passive leg raise (T2), and post-bypass (T3). Simultaneously, CO and SV were measured by calibrated pulse contour analysis. Three different equations (Bazett, Chambers, and Wodey) were used to calculate ccFT. The correlation and percentage change in time (concordance) between ccFT and CO and between ccFT and SV were evaluated.

Results: Mean ccFT values differed significantly for the three equations (p < 0.001). The correlation between ccFT and CO and between ccFT and SV was highest for Bazett's (ρ = 0.43, p < 0.0001) and Wodey's (ρ = 0.33, p < 0.0001) equations, respectively. Concordance between ΔccFT and ΔCO and between ΔccFT and ΔSV was highest for Bazett's (100%) and Wodey's (82%) equations, respectively. Subgroup analysis demonstrated that correlation and concordance between SV and ccFT improved when assessed within limited heart rate (HR) ranges.

Conclusion: The use of different ccFT equations leads to variable correlation and concordance rates between ccFT and CO/SV measurements. Bazett's equation acceptably tracked CO changes in time, while the trending capability of SV was poor.
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http://dx.doi.org/10.1007/s40477-022-00678-zDOI Listing
April 2022

Using real-world data to monitor and improve quality of care in coronary artery disease: results from the Netherlands Heart Registration.

Neth Heart J 2022 Apr 7. Epub 2022 Apr 7.

Netherlands Heart Registration, Utrecht, The Netherlands.

Worldwide, quality registries for cardiovascular diseases enable the use of real-world data to monitor and improve the quality of cardiac care. In the Netherlands Heart Registration (NHR), cardiologists and cardiothoracic surgeons register baseline, procedural and outcome data across all invasive cardiac interventional, electrophysiological and surgical procedures. This paper provides insight into the governance and processes as organised by the NHR in collaboration with the hospitals. To clarify the processes, examples are given from the percutaneous coronary intervention and coronary artery bypass grafting registries. Physicians who are mandated by their hospital to instruct the NHR to process their data are united in registration committees. The committees determine standard sets of variables and periodically discuss the completeness and quality of data and patient-relevant outcomes. In the case of significant variation in outcomes, processes of healthcare delivery are discussed and good practices are shared in a non-competitive and safe setting. To create new insights for further improvement in patient-relevant outcomes, quality projects are initiated on, for example, multivessel disease treatment, cardiogenic shock and diagnostic intracoronary procedures. Moreover, possibilities are explored to expand the quality registries through additional relevant indicators, such as resource use before and after the procedure, by enriching NHR data with other existing data resources.
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http://dx.doi.org/10.1007/s12471-022-01672-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8988537PMC
April 2022

Redo surgery for neurogenic thoracic outlet syndrome is useful.

J Vasc Surg 2022 08 31;76(2):531-537.e1. Epub 2022 Mar 31.

Department of Vascular Surgery, Catharina Hospital, Eindhoven, The Netherlands; CAPHRI School for Public Health and Primary Care, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands. Electronic address:

Objectives: Surgery for neurogenic thoracic outlet syndrome (NTOS) has shown good outcome in numerous case series. However, 5% to 30% of patients will have persistent or recurrent symptoms, caused by incomplete first rib resection, reattachment of residual scalene muscle, fibrous scarring around the brachial plexus, or a wrong NTOS diagnosis. In patients with a sound diagnosis of recurrent or persisting NTOS, not responding to conservative measures, a secondary procedure can be considered. We report the results of redo thoracic outlet decompression surgery through the supraclavicular approach (SC-REDO-TOD) for persistent or recurrent NTOS.

Methods: A retrospective review of a prospective database was performed. Every patient referred from September 2016 until January 2020 was eligible for inclusion. In an SC-REDO-TOD, we perform complete (cartilage-cartilage) resection of the first rib, any bony and fibrous anomalies, complete anterior and middle scalenectomy, and complete neurolysis of the brachial plexus (complete anatomical decompression of the brachial plexus). Clinical outcomes were assessed by questionnaires including the Disability of Arm, Shoulder and Hand (DASH), Cervico-Brachial Symptoms Questionnaire (CBSQ), and TOS (thoracic outlet syndrome) Disability scale.

Results: In total, 45 patients had a SC-REDO-TOD. The median duration of hospital admission after SC-REDO-TOD was 1.41 days (interquartile range, 1.00 day). In total, 30 (66.66%) of 45 patients had recurrent NTOS, and 15 (33.33%) of 45 patients had persisting NTOS. Postoperative complications were seen in eight patients (18.18%). One patient had postoperative complications with permanent impairment (Horner syndrome). Seven patients had postoperative complications with full recovery (three patients had a chylous leakage that was treated with a median-chain triglycerides diet for 6 weeks, three patients had transient phrenic nerve palsy with full recovery <6 weeks, and one patient had a discrete Horner syndrome that resolved in 6 weeks). The median time of follow-up was 19.50 months (interquartile range, 14.00 months) and the response rate to the questionnaires was 91.11% at 6 months and 64.44% at 12 months. We found a positive and statistically significant difference for DASH score, CBSQ score, and TOS Disability Scale score comparing scores for all patients. (DASH score: P < .001; CBSQ score: P < .001; TOS Disability Scale: P < .001). Patients with first rib remnants showed a significant better response (lower DASH, CBSQ and TOS Disability Scale scores) compared with patients without first rib remnants (DASH score: P = .004; CBSQ score: P ≤ .014; TOS Disability Scale: P = .009).

Conclusions: SC-REDO-TOD after a previous NTOS surgery shows good results with a low risk of permanent impairment. Patients with NTOS with first rib remnants after primary surgery seem to benefit the most from SC-REDO-TOD surgery.
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http://dx.doi.org/10.1016/j.jvs.2022.03.863DOI Listing
August 2022

Incidence and Predictors of Permanent Pacemaker Implantation after Transcatheter Aortic Valve Procedures: Data of The Netherlands Heart Registration (NHR).

J Clin Med 2022 Jan 23;11(3). Epub 2022 Jan 23.

Department of Cardio-Thoracic Surgery, Heart and Vascular Centre, Maastricht University Medical Centre (MUMC), 6202 AZ Maastricht, The Netherlands.

Atrioventricular conduction disturbance leading to permanent pacemaker (PM) implantation is a frequent and relevant complication after transcatheter aortic valve implantation (TAVI). We aimed to evaluate the rate of post-TAVI permanent PM implantation over time and to identify the predictive factors for post-TAVI PM. The data were retrospectively collected by the Netherlands Heart Registration (NHR). In total, 7489 isolated TAVI patients between 2013 and 2019 were included in the final analysis. The primary endpoint was a permanent PM implantation within 30 days following TAVI. The incidence of the primary endpoint was 12%. Post-TAVI PM showed a stable rate over time. Using multivariable logistic regression analysis, age (OR 1.01, 95% CI 1.00-1.02), weight (OR 1.00, 95% CI 1.00-1.01), creatinine serum level (OR 1.15, 95% CI 1.01-1.31), transfemoral TAVI approach (OR 1.34, 95% CI 1.11-1.61), and TAVI post-dilatation (OR 1.58, 95% CI 1.33-1.89) were shown to be independent predictors of PM. Male sex (OR 0.80, 95% CI 0.68-0.93) and previous aortic valve surgery (OR 0.42, 95% CI 0.26-0.69) had a protective effect on post-TAVI PM. From a large national TAVI registry, some clinical and procedural factors have been identified as promoting or preventing post-TAVI PM. Further efforts are required to identify high-risk patients for post-TAVI PM and to reduce the incidence of this important issue.
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http://dx.doi.org/10.3390/jcm11030560DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8836997PMC
January 2022

Preoperative anaemia and outcome after elective cardiac surgery: a Dutch national registry analysis.

Br J Anaesth 2022 Apr 12;128(4):636-643. Epub 2022 Jan 12.

Department of Anaesthesiology, Intensive Care and Pain Medicine, Amphia Hospital, Breda, The Netherlands. Electronic address:

Background: Previous studies have shown that preoperative anaemia in patients undergoing cardiac surgery is associated with adverse outcomes. However, most of these studies were retrospective, had a relatively small sample size, and were from a single centre. The aim of this study was to analyse the relationship between the severity of preoperative anaemia and short- and long-term mortality and morbidity in a large multicentre national cohort of patients undergoing cardiac surgery.

Methods: A nationwide, prospective, multicentre registry (Netherlands Heart Registration) of patients undergoing elective cardiac surgery between January 2013 and January 2019 was used for this observational study. Anaemia was defined according to the WHO criteria, and the main study endpoint was 120-day mortality. The association was investigated using multivariable logistic regression analysis.

Results: In total, 35 484 patients were studied, of whom 6802 (19.2%) were anaemic. Preoperative anaemia was associated with an increased risk of 120-day mortality (adjusted odds ratio [aOR] 1.7; 95% confidence interval [CI]: 1.4-1.9; P<0.001). The risk of 120-day mortality increased with anaemia severity (mild anaemia aOR 1.6; 95% CI: 1.3-1.9; P<0.001; and moderate-to-severe anaemia aOR 1.8; 95% CI: 1.4-2.4; P<0.001). Preoperative anaemia was associated with red blood cell transfusion and postoperative morbidity, the causes of which included renal failure, pneumonia, and myocardial infarction.

Conclusions: Preoperative anaemia was associated with mortality and morbidity after cardiac surgery. The risk of adverse outcomes increased with anaemia severity. Preoperative anaemia is a potential target for treatment to improve postoperative outcomes.
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http://dx.doi.org/10.1016/j.bja.2021.12.016DOI Listing
April 2022

UGT1A1 genotype-guided dosing of irinotecan: A prospective safety and cost analysis in poor metaboliser patients.

Eur J Cancer 2022 02 5;162:148-157. Epub 2022 Jan 5.

Department of Clinical Pharmacy, Catharina Hospital, Eindhoven, the Netherlands; Department of Clinical Pharmacy and Toxicology, Leiden University Medical Centre, Leiden, the Netherlands. Electronic address:

Aim: To determine the safety, feasibility, pharmacokinetics, and cost of UGT1A1 genotype-guided dosing of irinotecan.

Patients And Methods: In this prospective, multicentre, non-randomised study, patients intended for treatment with irinotecan were pre-therapeutically genotyped for UGT1A1∗28 and UGT1A1∗93. Homozygous variant carriers (UGT1A1 poor metabolisers; PMs) received an initial 30% dose reduction. The primary endpoint was incidence of febrile neutropenia in the first two cycles of treatment. Toxicity in UGT1A1 PMs was compared to a historical cohort of UGT1A1 PMs treated with full dose therapy, and to UGT1A1 non-PMs treated with full dose therapy in the current study. Secondary endpoints were pharmacokinetics, feasibility, and costs.

Results: Of the 350 evaluable patients, 31 (8.9%) patients were UGT1A1 PM and received a median 30% dose reduction. The incidence of febrile neutropenia in this group was 6.5% compared to 24% in historical UGT1A1 PMs (P = 0.04) and was comparable to the incidence in UGT1A1 non-PMs treated with full dose therapy. Systemic exposure of SN-38 of reduced dosing in UGT1A1 PMs was still slightly higher compared to a standard-dosed irinotecan patient cohort (difference: +32%). Cost analysis showed that genotype-guided dosing was cost-saving with a cost reduction of €183 per patient.

Conclusion: UGT1A1 genotype-guided dosing significantly reduces the incidence of febrile neutropenia in UGT1A1 PM patients treated with irinotecan, results in a therapeutically effective systemic drug exposure, and is cost-saving. Therefore, UGT1A1 genotype-guided dosing of irinotecan should be considered standard of care in order to improve individual patient safety.
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http://dx.doi.org/10.1016/j.ejca.2021.12.009DOI Listing
February 2022

Effect of minimally invasive mitral valve surgery compared to sternotomy on short- and long-term outcomes: a retrospective multicentre interventional cohort study based on Netherlands Heart Registration.

Eur J Cardiothorac Surg 2022 05;61(5):1099-1106

Department of Cardiothoracic Surgery, Maastricht University Medical Center, Maastricht, Netherlands.

Objectives: Minimally invasive mitral valve surgery (MIMVS) has been performed increasingly for the past 2 decades; however, large comparative studies on short- and long-term outcomes have been lacking. This study aims to compare short- and long-term outcomes of patients undergoing MIMVS versus median sternotomy (MST) based on real-world data, extracted from the Netherlands Heart Registration.

Methods: Patients undergoing mitral valve surgery, with or without tricuspid valve, atrial septal closure and/or rhythm surgery between 2013 and 2018 were included. Primary outcomes were short-term morbidity and mortality and long-term survival. Propensity score matching analyses were performed.

Results: In total, 2501 patients were included, 1776 were operated through MST and 725 using an MIMVS approach. After propensity matching, no significant differences in baseline characteristics persisted. There were no between-group differences in 30-day mortality (1.1% vs 0.7%, P = 0.58), 1-year mortality (2.6% vs 2.1%, P = 0.60) or perioperative stroke rate (1.1% vs 0.6%, P = 0.25) between MST and MIMVS, respectively. An increased rate of postoperative arrhythmia was observed in the MST group (31.3% vs 22.4%, P < 0.001). A higher repair rate was found in the MST group (80.9% vs 76.3%, P = 0.04). No difference in 5-year survival was found between the matched groups (95.0% vs 94.3%, P = 0.49). Freedom from mitral reintervention was 97.9% for MST and 96.8% in the MIMVS group (P = 0.01), without a difference in reintervention-free survival (P = 0.30).

Conclusions: The MIMVS approach is as safe as the sternotomy approach for the surgical treatment of mitral valve disease. However, it comes at a cost of a reduced repair rate and more reinterventions in the long term, in the real-world.
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http://dx.doi.org/10.1093/ejcts/ezab507DOI Listing
May 2022

Correlation of Carotid Doppler Blood Flow With Invasive Cardiac Output Measurements in Cardiac Surgery Patients.

J Cardiothorac Vasc Anesth 2022 04 5;36(4):1081-1091. Epub 2021 Oct 5.

Department of Anesthesiology, Catharina Hospital, Eindhoven, The Netherlands.

Objective: Carotid Doppler ultrasound has been a topic of recent interest, as it may be a promising noninvasive hemodynamic monitoring tool. In this study, the relation between carotid artery blood flow and invasive cardiac output (CO) was evaluated.

Design: A prospective, observational study.

Setting: A single-institution, tertiary referral hospital.

Participants: Eighteen elective cardiac surgery patients.

Interventions: CO was measured by calibrated pulse contour analysis. Simultaneously, carotid artery pulsed-wave Doppler measurements were obtained in the operating room in three clinical settings: after induction of anesthesia (T1), after a passive leg raise maneuverer (T2), and at the end of surgery (T3).

Measurements And Main Results: Correlation and trending between carotid artery blood flow and invasive CO were evaluated. Furthermore, two Bland-Altman plots were constructed to evaluate the level of agreement between carotid artery-derived CO and invasive CO measurements. Carotid artery blood flow correlated moderately with invasive CO (ρ = 0.67, 95% confidence interval 0.56-0.76, p < 0.05). Concordance between the percentage change of carotid artery blood flow and invasive CO from T1 to T3 was 72%. The level of agreement between carotid artery-derived CO and invasive CO was ±2.29; ±2.57 L/min, with a bias of 0.1; -0.54 L/min, and mean error of 50% and 48%, for the two Bland-Altman analyses, respectively. Intraexamination precision was acceptable.

Conclusions: In cardiac surgery patients, carotid artery blood flow correlated moderately with invasive CO measurements. However, the trending ability of carotid artery blood flow was poor, and carotid artery-derived CO tended not to be interchangeable with invasive CO.
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http://dx.doi.org/10.1053/j.jvca.2021.09.043DOI Listing
April 2022

Sex Difference in Long-Term Survival After Coronary Artery Bypass Grafting Is Age-Dependent.

J Cardiothorac Vasc Anesth 2022 05 5;36(5):1288-1295. Epub 2021 Sep 5.

Department of Cardiothoracic Surgery, Catharina Hospital, Eindhoven, the Netherlands. Electronic address:

Objectives: Women undergoing coronary artery bypass grafting (CABG) demonstrate higher rates of postoperative morbidity and mortality than men. The aim of this study was to compare the patient profile and long-term outcomes of men and women undergoing isolated CABG.

Design: A retrospective patient record study and propensity score-matched analysis.

Setting: This single-center study was performed at Catharina Hospital in Eindhoven, The Netherlands.

Participants: The study comprised 17,483 patients, of whom 13,564 (77.6%) were men and 3,919 (22.4%) were women.

Interventions: Coronary artery bypass grafting was performed between January 1998 and December 2015.

Measurements And Main Results: The mean follow-up period was 8.8 ± 5.0 years. Women were older than men (67.7 ± 9.4 years v 63.9 ± 9.6 years, p < 0.001) and had lower preoperative hemoglobin levels. Early mortality (30-day) (2.8% v 1.9%; p < 0.001) and one-year mortality (5.2% v 3.8%; p < 0.001) rates were significantly higher in women than in men. Women demonstrated worse long-term survival than men only in the population younger than 70 years. After propensity score matching, female sex was not identified as an independent risk factor for long-term survival.

Conclusions: In the patient population, propensity score-matched analysis showed that female sex was not an independent risk factor for long-term survival after CABG. Poorer survival in women after CABG only was observed in patients <70 years of age.
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http://dx.doi.org/10.1053/j.jvca.2021.08.104DOI Listing
May 2022

Cancer worry after facial nonmelanoma skin cancer resection and reconstruction: A 1-year prospective study.

Psychooncology 2022 02 14;31(2):238-244. Epub 2021 Sep 14.

Department of Plastic and Reconstructive Surgery, Catharina Hospital, Eindhoven, The Netherlands.

Objective: Nonmelanoma skin cancer (NMSC) is one of the most diagnosed cancers in the world, with the number of new occurrences rising every year. Most patients with facial skin cancer experience cancer-related worry. Yet, little is known about their worry during the period after cancer treatment. This study aimed to assess the long-term change of cancer worry after surgical treatment in patients with NMSC.

Methods: Patients undergoing surgery for facial NMSC between December 2017 and March 2020 were asked to complete the FACE-Q Skin Cancer-Cancer Worry scale before (baseline), 3-month, and 1-year post-surgery.

Results: A total of 151 patients completed the baseline and 3-month, and 99 (65.6%) the 1-year post-operative survey. A significant decrease in cancer worry score was seen between baseline and 3-month post-surgery (p < 0.001). No difference was found between the 3-month and 1-year post-surgery scores (p = 0.78). Less improvement in cancer worry was seen for patients who had one facial skin cancer in their medical history (p = 0.001) and patients who had a history of facial surgery (p < 0.001).

Conclusion: Post-surgery patients still experience cancer worry. Therefore, targeted counseling might be of value when coping with cancer-related concerns. Patients with a history of facial NMSC and patients with a history of facial surgery might benefit from additional counseling.
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http://dx.doi.org/10.1002/pon.5810DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9255639PMC
February 2022

Prediction models in gynaecology: Transparent reporting needed for clinical application.

Eur J Obstet Gynecol Reprod Biol 2021 Oct 9;265:190-202. Epub 2021 Sep 9.

Department of Obstetrics and Gynaecology, Catharina Hospital, Eindhoven, the Netherlands; Women's Clinic, Ghent University Hospital, Ghent, Belgium.

The clinical application of prediction models is increasing within the field of gynaecology and obstetrics. This is mostly due to the fact that clinicians and patients prefer individualized counselling and person specific, more objective outcome assessment. To prevent using inadequate models, it is important to construct and perform prediction model studies correctly. Therefore, the TRIPOD statement (the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis) was developed. The aim of this review is to obtain an overview of the existing published prediction models for benign gynaecology and to investigate to what extent these studies meet the TRIPOD criteria. We performed a literature search in the databases PubMed, Embase and Cochrane Library from inception to August 2020. Searching the cross-references of the relevant studies within our search identified additional articles. Publications were included if the aim of the study was to develop a multivariable prediction model within the field of benign gynaecology. Two independent reviewers extracted the data. Analysis of the studies was performed by using a checklist derived from the TRIPOD criteria. Based on our search, 2487 studies were selected, including potential duplications. Eventually, a total of twenty-two studies were selected. 91% of these studies handled their predictors by univariable analysis before developing a multivariable prediction model. Fifteen studies described having missing data, but not all of them (9%) handled these missing data. Four different internal validation methods were used in twenty studies. Fifteen studies (68%) had prediction models with a C-index ≥ 0.7, which indicates a good model. Half of the studies (50%) did not measure the calibration, overall performance was described in two studies (9%). External validation was performed in 9% of the studies. The correct development of a prediction model within benign gynaecology and subsequent transparent reporting of the model development is important to facilitate clinical use. Without transparent reporting, wrong assumptions can be made leading to incorrect application of a specific prediction model. This overview shows that excepting carrying out an external validation, only one article met all the criteria. Therefore, we strongly recommend use of the TRIPOD criteria for developing and validating a prediction model (study). In addition, prior to publication, content experts should critically and statistically review the prediction model. If too many criteria are not met, refusing publication should be considered.
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http://dx.doi.org/10.1016/j.ejogrb.2021.08.013DOI Listing
October 2021

Incidence and predictors of permanent pacemaker implantation after surgical aortic v alve replacement: Data of the Netherlands Heart Registration (NHR).

J Card Surg 2021 Oct 11;36(10):3519-3527. Epub 2021 Jul 11.

See addendum for Cardiothoracic Surgery Registration Committee members of the Netherlands Heart Registration.

Objective: Permanent pacemaker implantation (PPI) after surgical aortic valve replacement (SAVR) remains a frequent complication. Predictors, however, have been mainly investigated in single-center studies. Therefore, nationwide data were used to identify patients-and procedural risk factors for postoperative PPI.

Materials And Methods: Data were retrospectively collected from the Netherlands Heart Registration (NHR). Patients enrolled in the NHR undergoing isolated SAVR from 2013 to 2019 were analyzed. Primary endpoint was in-hospital PPI during hospitalization after SAVR.

Results: From the NHR database, 5600 patients with symptomatic aortic valve stenosis were included in the study. Crude incidence of post-SAVR PPI was 4.0%. Backward regression analysis identified previous cardiac surgery (odds ratio [OR]: 1.80; 95% confidence interval [CI]: 1.18-2.76), extra-corporeal circulation time (OR: 1.01; 95% CI: 1.00-1.01), vasopressor use (OR: 2.66; 95% CI: 1.79-3.96) and in-hospital cardiac conduction abnormalities (OR: 4.48; 95% CI: 3.36-5.98) as potential predictors for PPI. Across the time, PPI after SAVR significantly increased (OR: 1.11; 95% CI: 1.03-1.21).

Conclusions: From this nationwide analysis, PPI after SAVR remains a low but increasingly frequent complication. Several predictive factors for postoperative PPI after SAVR have been identified and might be useful for patient informed consent about potential adverse event rate.
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http://dx.doi.org/10.1111/jocs.15803DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8518121PMC
October 2021

Outcome and Predictors for Mortality in Patients with Cardiogenic Shock: A Dutch Nationwide Registry-Based Study of 75,407 Patients with Acute Coronary Syndrome Treated by PCI.

J Clin Med 2021 May 11;10(10). Epub 2021 May 11.

Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, 1105 AZ Amsterdam, The Netherlands.

It is important to gain more insight into the cardiogenic shock (CS) population, as currently, little is known on how to improve outcomes. Therefore, we assessed clinical outcome in acute coronary syndrome (ACS) patients treated by percutaneous coronary intervention (PCI) with and without CS at admission. Furthermore, the incidence of CS and predictors for mortality in CS patients were evaluated. The Netherlands Heart Registration (NHR) is a nationwide registry on all cardiac interventions. We used NHR data of ACS patients treated with PCI between 2015 and 2019. Among 75,407 ACS patients treated with PCI, 3028 patients (4.1%) were identified with CS, respectively 4.3%, 3.9%, 3.5%, and 4.3% per year. Factors associated with mortality in CS were age (HR 1.02, 95%CI 1.02-1.03), eGFR (HR 0.98, 95%CI 0.98-0.99), diabetes mellitus (DM) (HR 1.25, 95%CI 1.08-1.45), multivessel disease (HR 1.22, 95%CI 1.06-1.39), prior myocardial infarction (MI) (HR 1.24, 95%CI 1.06-1.45), and out-of-hospital cardiac arrest (OHCA) (HR 1.71, 95%CI 1.50-1.94). In conclusion, in this Dutch nationwide registry-based study of ACS patients treated by PCI, the incidence of CS was 4.1% over the 4-year study period. Predictors for mortality in CS were higher age, renal insufficiency, presence of DM, multivessel disease, prior MI, and OHCA.
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http://dx.doi.org/10.3390/jcm10102047DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8151113PMC
May 2021

Does postoperative cognitive decline after coronary bypass affect quality of life?

Open Heart 2021 04;8(1)

Department of Cardiothoracic Surgery, University Medical Centre Groningen, Groningen, The Netherlands.

Objective: This study aimed to explore the influence of coronary artery bypass grafting (CABG) on both postoperative cognitive dysfunction and quality of life (QoL) and the association between the two patient-related outcomes.

Methods: In a prospective, observational cohort study, patients with elective, isolated CABG were included. Cognitive function was assessed using the Cogstate computerised cognitive test battery preoperatively, 3 days and 6 months after surgery. QoL was measured preoperatively and at 6 months using the RAND-36 questionnaire including the Physical Component Score (PCS) and the Mental Component Score (MCS). Regression analysis, with adjustment for confounders, was used to evaluate the association between postoperative cognitive dysfunction and QoL.

Results: A total of 142 patients were included in the study. Evidence of persistent cognitive dysfunction was observed in 33% of patients after 6 months. At 6 months, the PCS had improved in 59% and decreased in 21% of patients, and the MCS increased in 49% and decreased in 29%. Postoperative cognitive changes were not associated with QoL scores.

Conclusions: Postoperative cognitive dysfunction and decreased QoL are common 6 months after surgery, although cognitive function and QoL were found to have improved in many patients at 6 months of follow-up. Impaired cognitive function is not associated with impaired QoL at 6 months.

Trial Registration Number: NCT03774342.
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http://dx.doi.org/10.1136/openhrt-2020-001569DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8070880PMC
April 2021

Feasibility and Outcomes of a Multidisciplinary Care Pathway for Neurogenic Thoracic Outlet Syndrome: A Prospective Observational Cohort Study.

Eur J Vasc Endovasc Surg 2021 Jun 31;61(6):1017-1024. Epub 2021 Mar 31.

Department of Vascular Surgery, Catharina Hospital, Eindhoven, the Netherlands; CAPHRI School for Public Health and Primary Care, Faculty of Health, Medicine and Life Sciences, Maastricht University, the Netherlands. Electronic address:

Objective: The North American Society for Vascular Surgery (SVS) reporting standards for neurogenic thoracic outlet syndrome (NTOS) were published in 2016 to produce consistency in the diagnosis and treatment of NTOS, but outcomes resulting from following these standards are not yet available. The results of a standardised multidisciplinary care pathway for NTOS based on the North American SVS reporting standards for NTOS are reported.

Methods: Patients referred between August 2016 and December 2019 with suspected NTOS were evaluated in this single center prospective cohort study. Diagnosis and treatment were performed according to a care pathway based on the North American SVS reporting standards. The outcome of surgically treated patients was determined by the Derkash score, thoracic outlet syndrome disability scale (TDS), Cervical Brachial Score Questionnaire (CBSQ), Disability of the Arm Shoulder and Hands Dutch language version (DASH-DLV) and Short Form-12 (SF-12) at three, six, 12, and 24 months.

Results: Of 856 referred patients, 476 (55.6%) patients were diagnosed with NTOS. Dedicated physiotherapy was successful in 186 patients (39.1%). Surgical treatment was performed in 290 (60.9%) patients of whom 274 were included in the follow up. At a mean follow up of 16.9 ± 9.2 months, significant improvement (p < .001) in TDS, CBSQ, DASH-DLV, and SF-12 scores was seen in the surgical group between baseline and all follow up intervals. Derkash outcome after surgical intervention was excellent in 83 (30.3%), good in 114 (41.6%), fair in 43 (15.7%), and poor in 34 (12.4%) of the patients. Complications occurred in 16 (5.8%) patients, and 32 (10.4%) patients experienced recurrent or persistent NTOS complaints.

Conclusion: A multidisciplinary care pathway based on the North American SVS reporting standards for NTOS helped to confirm the diagnosis in 56% of patients referred, and guided the selection of patients who might benefit from thoracic outlet decompression surgery after unsuccessful dedicated physiotherapy. Intermediate follow up showed good outcomes in the majority of surgically treated patients.
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http://dx.doi.org/10.1016/j.ejvs.2021.02.048DOI Listing
June 2021

Clinical validation of a computerized algorithm to determine mean systemic filling pressure.

J Clin Monit Comput 2022 02 31;36(1):191-198. Epub 2021 Mar 31.

Department of Intensive Care, Erasmus MC University Medical Centre, Rotterdam, The Netherlands.

Mean systemic filling pressure (Pms) is a promising parameter in determining intravascular fluid status. Pms derived from venous return curves during inspiratory holds with incremental airway pressures (Pms-Insp) estimates Pms reliably but is labor-intensive. A computerized algorithm to calculate Pms (Pmsa) at the bedside has been proposed. In previous studies Pmsa and Pms-Insp correlated well but with considerable bias. This observational study was performed to validate Pmsa with Pms-Insp in cardiac surgery patients. Cardiac output, right atrial pressure and mean arterial pressure were prospectively recorded to calculate Pmsa using a bedside monitor. Pms-Insp was calculated offline after performing inspiratory holds. Intraclass-correlation coefficient (ICC) and assessment of agreement were used to compare Pmsa with Pms-Insp. Bias, coefficient of variance (COV), precision and limits of agreement (LOA) were calculated. Proportional bias was assessed with linear regression. A high degree of inter-method reliability was found between Pmsa and Pms-Insp (ICC 0.89; 95%CI 0.72-0.96, p = 0.01) in 18 patients. Pmsa and Pms-Insp differed not significantly (11.9 mmHg, IQR 9.8-13.4 vs. 12.7 mmHg, IQR 10.5-14.4, p = 0.38). Bias was -0.502 ± 1.90 mmHg (p = 0.277). COV was 4% with LOA -4.22 - 3.22 mmHg without proportional bias. Conversion coefficient Pmsa ➔ Pms-Insp was 0.94. This assessment of agreement demonstrates that the measures Pms-Insp and the computerized Pmsa-algorithm are interchangeable (bias -0.502 ± 1.90 mmHg with conversion coefficient 0.94). The choice of Pmsa is straightforward, it is non-interventional and available continuously at the bedside in contrast to Pms-Insp which is interventional and calculated off-line. Further studies should be performed to determine the place of Pmsa in the circulatory management of critically ill patients. ( www.clinicaltrials.gov ; TRN NCT04202432, release date 16-12-2019; retrospectively registered).Clinical Trial Registration www.ClinicalTrials.gov , TRN: NCT04202432, initial release date 16-12-2019 (retrospectively registered).
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http://dx.doi.org/10.1007/s10877-020-00636-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8011774PMC
February 2022

Update and, internal and temporal-validation of the FRANCE-2 and ACC-TAVI early-mortality prediction models for Transcatheter Aortic Valve Implantation (TAVI) using data from the Netherlands heart registration (NHR).

Int J Cardiol Heart Vasc 2021 Feb 23;32:100716. Epub 2021 Jan 23.

Erasmus University Medical Center, the Netherlands.

Background: The predictive performance of the models FRANCE-2 and ACC-TAVI for early-mortality after Transcatheter Aortic Valve Implantation (TAVI) can decline over time and can be enhanced by updating them on new populations. We aim to update and internally and temporally validate these models using a recent TAVI-cohort from the Netherlands Heart Registration (NHR).

Methods: We used data of TAVI-patients treated in 2013-2017. For each original-model, the best update-method (model-intercept, model-recalibration, or model-revision) was selected by a closed-testing procedure. We internally validated both updated models with 1000 bootstrap samples. We also updated the models on the 2013-2016 dataset and temporally validated them on the 2017-dataset. Performance measures were the Area-Under ROC-curve (AU-ROC), Brier-score, and calibration graphs.

Results: We included 6177 TAVI-patients, with 4.5% observed early-mortality. The selected update-method for FRANCE-2 was model-intercept-update. Internal validation showed an AU-ROC of 0.63 (95%CI 0.62-0.66) and Brier-score of 0.04 (0.04-0.05). Calibration graphs show that it overestimates early-mortality. In temporal-validation, the AU-ROC was 0.61 (0.53-0.67).The selected update-method for ACC-TAVI was model-revision. In internal-validation, the AU-ROC was 0.63 (0.63-0.66) and Brier-score was 0.04 (0.04-0.05). The updated ACC-TAVI calibrates well up to a probability of 20%, and subsequently underestimates early-mortality. In temporal-validation the AU-ROC was 0.65 (0.58-0.72).

Conclusion: Internal-validation of the updated models FRANCE-2 and ACC-TAVI with data from the NHR demonstrated improved performance, which was better than in external-validation studies and comparable to the original studies. In temporal-validation, ACC-TAVI outperformed FRANCE-2 because it suffered less from changes over time.
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http://dx.doi.org/10.1016/j.ijcha.2021.100716DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7843396PMC
February 2021

Recent trends in aortic valve interventions: Data of the Netherlands heart registration.

J Card Surg 2021 Feb 23;36(2):573-581. Epub 2020 Dec 23.

Netherlands Heart Registration, Utrecht, the Netherlands.

Background And Aim Of The Study: Transcatheter aortic valve implantation (TAVI) has evolved from bailout for inoperable patients to an alternative to surgical aortic valve replacement (SAVR) in higher-risk groups. The aim of this study is to describe these clinical trends in TAVI and SAVR in patients with aortic valve disease.

Methods: We analyzed data of the Netherlands Heart Registration (NHR) up to 2018 to explore the trends in TAVI and SAVR among 14 cardiac centers in the Netherlands.

Results: Between 2013 and 2017, a total of 7432 isolated SAVR and 5929 TAVI procedures have been performed. A 43.9% increase in the total number of procedures was observed, mainly due to the considerable increase in the number of TAVI procedures. In 2017, there was a decrease in the number of SAVR procedures. In the TAVI group, 30- and 120-day mortality decreased significantly from 7.2% and 10.6% in 2013 to 3.4% and 5.7% in 2017, respectively. In the SAVR group, 30- and 120-day mortality decreased from 1.7% and 2.9% in 2013 to 1.2% and 1.7% in 2017, respectively. Outcomes showed a significant decrease in vascular complications after TAVI. The risk profile of TAVI patients has changed over time.

Conclusions: The recent developments in TAVI have contributed to the increasing numbers of aortic valve interventions in the Netherlands. Mortality rates after SAVR and TAVI decreased as did the rate of complications after TAVI. Furthermore, a trend towards decrease of preoperative risk was observed.
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http://dx.doi.org/10.1111/jocs.15265DOI Listing
February 2021

Complications in pulmonary vein isolation in the Netherlands Heart Registration differ with sex and ablation technique.

Europace 2021 02;23(2):216-225

Department of Cardiology and Cardiac Surgery, Amsterdam University Medical Centres, University of Amsterdam, Amsterdam, The Netherlands.

Aims: Pulmonary vein isolation (PVI) has become a cornerstone of the invasive treatment of atrial fibrillation. Severe complications are reported in 1-3% of patients. This study aims to compare complications and follow-up outcome of PVI in patients with atrial fibrillation.

Methods And Results: The data were extracted from the Netherlands Heart Registration. Procedural and follow-up outcomes in patients treated with conventional radiofrequency (C-RF), multielectrode phased RF (Ph-RF), or cryoballoon (CB) ablation from 2012 to 2017 were compared. Subgroup analysis was performed to identify variables associated with complications and repeat ablations. In total, 13 823 patients (69% male) were included. The reported complication incidence was 3.6%. Patients treated with C-RF developed more cardiac tamponades (C-RF 0.8% vs. Ph-RF 0.3% vs. CB 0.3%, P ≤ 0.001) and vascular complications (C-RF 1.7% vs. Ph-RF 1.2% vs. CB 1.3%, P ≤ 0.001). Ph-RF was associated with fewer bleeding complications (C-RF: 1.0% vs. Ph-RF: 0.4% vs. CB: 0.7%, P = 0.020). Phrenic nerve palsy mainly occurred in patients treated with CB (C-RF: 0.1% vs. Ph-RF: 0.2% vs. CB: 1.5%, P ≤ 0.001). In total, 18.4% of patients were referred for repeat ablation within 1 year. Female sex, age, and CHA2DS2-VASc were independent risk factors for cardiac tamponade and bleeding complications, with an adjusted OR for female patients of 2.97 (95% CI 1.98-4.45) and 2.02 (95% CI 1.03-4.00) respectively.

Conclusion: The reported complication rate during PVI was low. Patients treated with C-RF ablation were more likely to develop cardiac tamponades and vascular complications. Female sex was associated with more cardiac tamponade and bleeding complications.
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http://dx.doi.org/10.1093/europace/euaa255DOI Listing
February 2021

Dabigatran trough concentrations in very elderly patients.

Eur J Hosp Pharm 2021 07 25;28(4):231-233. Epub 2020 Sep 25.

Geriatrics, Catharina Hospital, Eindhoven, The Netherlands.

Objectives: The aim of this observational study was to explore dabigatran concentrations in elderly and very elderly patients in a real-life population. Patients aged >75 years receiving dabigatran have a significantly higher risk of gastrointestinal bleeding compared withthose receiving warfarin. High trough concentrations have an important impact on this bleeding risk.

Methods: We measured dabigatran trough concentrations in 75 patients with atrial fibrillation, divided into age categories <75, ≥75 to 84 and ≥85 years. The most important exclusion criteria were use of interacting medication and severe renal failure. We analysed absolute trough concentrations and concentrations normalised for dose.

Results: Trough concentrations were considerably higher in the highest age category. Dose-normalised medians were 0.66, 0.83 and 1.20 ng/mL/mg in the <75, ≥75-84 and ≥85 age groups, respectively (p=0.004).

Conclusion: Clinicians should be aware of higher dabigatran concentrations in elderly patients despite dose reduction.
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http://dx.doi.org/10.1136/ejhpharm-2020-002456DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8239269PMC
July 2021

Acute isotonic hyponatremia after single dose histidine-tryptophan-ketoglutarate cardioplegia: an observational study.

Perfusion 2021 Jul 5;36(5):440-446. Epub 2020 Aug 5.

Department of Anaesthesiology, Catharina Hospital, Eindhoven, The Netherlands.

Introduction: Histidine-tryptophan-ketoglutarate cardioplegia is used for prolonged myocardial protection in complex cardiac surgery. Administration leads to acute hyponatremia in a majority of patients, because of its low sodium concentration (15 mmol/L). However, histidine-tryptophan-ketoglutarate solution's osmolality is slightly hypertonic (310 mOsm/kg). Hypothesized was that acute hyponatremia will be induced, which does not need to be corrected with hypertonic saline.

Methods: Cardiac surgery patients who received histidine-tryptophan-ketoglutarate cardioplegia were included in this prospective single center study. Serial blood samples were taken from each patient at five different time points: after induction of anesthesia (T1) and 10 minutes (T2), 6 hours (T3), 12 hours (T4), and 18 hours (T5) after administration of histidine-tryptophan-ketoglutarate cardioplegia, respectively. Blood samples were analyzed for sodium concentration, osmolality, and acid-base balance.

Results: Twenty-five patients were included. Median blood sodium levels decreased from 140 [138-141] at T1 to 128 [125-130] mmol/L at T2 (p < 0.001). At T3, T4, and T5, median blood sodium concentrations were 136 [134-138], 139 [137-140], and 140 [137-142] mmol/L, respectively. Median osmolality was 289 [286-293] at T1 and increased to 296 [291-299] mOsm/kg (p < 0.001) at T2. At T3, T4, and T5, osmolality was 298 [292-302], 298 [294-304], and 300 [297-306] mOsm/kg, respectively. Median pH decreased from 7.38 [7.36-7.40] at T1 to 7.30 [7.27-7.32] at T2 (p < 0.001).

Conclusion: Administration of histidine-tryptophan-ketoglutarate cardioplegia during cardiac surgery leads to acute moderate to severe hyponatremia, which resolves spontaneously in the first 18 hours perioperatively. Correction with hypertonic saline is not necessary.
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http://dx.doi.org/10.1177/0267659120946952DOI Listing
July 2021

Survival and quality of life after transcatheter aortic valve implantation relative to the general population.

Int J Cardiol Heart Vasc 2020 Jun 22;28:100536. Epub 2020 May 22.

Department of Cardiology, Catharina Hospital, Eindhoven, the Netherlands.

Background: Little is known about survival and quality of life (QoL) of patients treated by transcatheter aortic valve implantation (TAVI) compared to the age- and sex-matched general population. In this study we compared subgroups of the National Heart Registration TAVI cohort to the Dutch age- and sex-matched population at the level of survival and QoL.

Methods And Results: From the Netherlands Heart Registration (NHR) the TAVI cohort (5489 patients, period 2013-2017) was extracted. These data were compared to the national Dutch population data collected from the national statistics office, Statistics Netherlands (CBS). Subgroups were defined according to sex and age (<65, 65-80 and >80). For QoL analyses the age subgroups <65, 65-75 and >75 were used. Long term survival was significantly higher in the general population compared to the TAVI population. Elderly TAVI patients (>80 years) had the same survival as the age-matched general population (46vs43% at 5 years, respectively). Survival in women was better than in men in both the general population and the TAVI cohort. Patients treated by TAVI, aged 65 years and older had a comparable QoL to that of the general population.

Conclusions: This study shows that TAVI patients aged 80 years and older have a similar long-term survival as an age-matched general population. However, because of lower survival in under 80 TAVI patients, the overall long term survival of all TAVI patients is worse than that of the general population in the Netherlands. This study also suggests that QoL after TAVI treatment is comparable to QoL in the general population.
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http://dx.doi.org/10.1016/j.ijcha.2020.100536DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7251765PMC
June 2020

External validation of existing prediction models of 30-day mortality after Transcatheter Aortic Valve Implantation (TAVI) in the Netherlands Heart Registration.

Int J Cardiol 2020 Oct 22;317:25-32. Epub 2020 May 22.

Department of Medical Informatics, Amsterdam UMC - Location AMC, University of Amsterdam, the Netherlands.

Background: Several mortality prediction models (MPM) are used for predicting early (30-day) mortality following transcatheter aortic valve implantation (TAVI). Little is known about their predictive performance in external TAVI populations. We aim to externally validate established MPMs on a large TAVI dataset from the Netherlands Heart Registration (NHR).

Methods: We included data from NHR-patients who underwent TAVI during 2013-2017. We calculated the predicted mortalities per MPM. We assessed the predictive performance by discrimination (Area Under Receiver Operating-characteristic Curve, AU-ROC); the Area Under Precision-Recall Curve, AU-PRC; calibration (using calibration-intercept and calibration-slope); Brier Score and Brier Skill Score. We also assessed the predictive performance among subgroups: tertiles of mortality-risk for non-survivors, gender, and access-route.

Results: We included 6177 TAVI-patients with an observed early-mortality rate of 4.5% (n = 280). We applied seven MPMs (STS, EuroSCORE-I, EuroSCORE-II, ACC-TAVI, FRANCE-2, OBSERVANT, and German-AV) on our cohort. The highest AU-ROCs were 0.64 (95%CI 0.61-0.67) for ACC-TAVI and 0.63 (95%CI 0.60-0.67) for FRANCE-2. All MPMs had a very low AU-PRC of ≤0.09. ACC-TAVI had the best calibration-intercept and calibration-slope. Brier Score values ranged between 0.043 and 0.063. Brier Skill Score ranged between -0.47 and 0.004. ACC-TAVI and FRANCE-2 predicted high mortality-risk better than other MPMs. ACC-TAVI outperformed other MPMs in different subgroups.

Conclusion: The ACC-TAVI model has relatively the best predictive performance. However, all models have poor predictive performance. Because of the poor discrimination, miscalibration and limited accuracy of the models there is a need to update the existing models or develop new TAVI-specific models for local populations.
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http://dx.doi.org/10.1016/j.ijcard.2020.05.039DOI Listing
October 2020

Interfascial Plane Blocks Reduce Postoperative Pain and Morphine Consumption in Thoracic Outlet Decompression.

Ann Vasc Surg 2020 Jul 16;66:301-308. Epub 2019 Dec 16.

Department of Anaesthesiology, Catharina Hospital, Eindhoven, the Netherlands.

Background: Postoperative analgesia in patients undergoing transaxillary thoracic outlet decompression (TATOD) is challenging because of the invasive surgery, the complex innervation of the axillary region, and the preoperative use of opioids by many patients. Commonly, postoperative pain is managed with additional opioids that introduce well-known sideeffects. To investigate the analgesic efficacy of 2 novel regional anesthesia techniques, we performed a retrospective study comparing the combined pectoral block type 1 and erector spinae block (PECS 1 + ESB) and the pectoral block type 2 (PECS 2) and systemic intravenous opioids regimen (no block) in patients undergoing TATOD.

Materials And Methods: We performed 10 PECS 1 + ESB and 10 PECS 2 blocks in patients undergoing TATOD. Twenty patients were randomly selected as controls. The primary endpoint was pain. Secondary endpoints were opioid use, nausea, and vomiting.

Results: Postoperative maximal numeric rating scale scores on recovery were significantly lower in patients receiving either a PECS 1 + ESB or a PECS 2 block compared with controls without block (no block: median 6.00, interquartile range [IQR] 3.00; PECS 1 + ESB: median 4.50, IQR 4.00; PECS 2: median 4.00, IQR 5.00; P = 0.031). Postoperative intravenous morphine consumption was 43% lower in the PECS 1 + ESB group and 56% lower in the PECS 2 group compared with the group with no block (oral morphine equivalents; no block: mean 16.05 ± SD 6.79 mg; PECS 1 + ESB mean 9.05 ± SD 6.24 mg; PECS 2: mean 7.00 ± SD 6.16; P = 0.03 and P = 0.003, respectively). There was no statistical difference in both nausea and vomitus (no block 45% nausea and 30% vomitus, PECS 1 + ESB 40% nausea and 20% vomitus, PECS 2 10% nausea and 0% vomitus, P = 0.17 and P = 0.14, respectively).

Conclusions: There was a significant reduction in postoperative pain and opioid consumption for patients treated with either the PECS 1 + ESB block or PECS 2.
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http://dx.doi.org/10.1016/j.avsg.2019.12.005DOI Listing
July 2020
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