Body mass index and pulmonary vein isolation: real-world data on outcomes and quality of life.

AIMS: Increasing numbers of overweight and obese patients undergo pulmonary vein isolation (PVI), despite the association between higher body mass index (BMI) and adverse PVI outcomes. Evidence on complications and quality of life in different bodyweight groups is limited. This study aims to clarify the impact of BMI on repeat ablations, periprocedural complications, and changes in quality of life. METHODS AND RESULTS: This multi-centre study analysed prospectively collected data from 15 ablation centres, covering all first-time PVI patients in the Netherlands from 2015 to 2021. Patients were categorized by BMI: normal weight (18.5-24.9 kg/m2), overweight (25-29.9 kg/m2), and obesity (≥30 kg/m2). Quality of life was assessed using the Atrial Fibrillation Effect on QualiTy-of-life questionnaire at baseline and 1-year post-PVI. Among 20 725 patients, 30% were of normal weight, 47% overweight, and 23% obese. Within the first year after PVI, obese patients had a higher incidence of repeat ablations than normal-weighing and overweight patients (17.8 vs. 15.6 and 16.1%, P < 0.05). Obesity was independently associated with repeat ablations (odds ratio 1.15; 95% confidence interval 1.01-1.31, P = 0.03). This association remained apparent after 3 years. Complication rates were 3.8% in normal weight, 3.0% in overweight, and 4.6% in obese, with weight class not being an independent predictor. Quality of life improved in all weight groups post-PVI but remained lowest in obese patients. CONCLUSION: Obesity is independently associated with a higher rate of repeat ablations. Pulmonary vein isolation is equally safe in all weight classes. Despite lower quality of life among obese individuals, substantial improvements occur for all weight groups after PVI.

Gender is Independently Associated With Red Blood Cell and Platelet Transfusion in Patients Undergoing Coronary Artery Bypass Grafting: Data From the Netherlands Heart Registration.

OBJECTIVES: The aim of this study was to evaluate the incidence of transfusions, including red blood cells (RBC), platelets, and fresh frozen plasma (FFP) during and after coronary artery bypass grafting (CABG) in the Netherlands. Furthermore, the authors aimed to identify the impact of sex on blood product transfusion. DESIGN: A retrospective multicenter cohort study. Data were collected from January 2013 to December 2021 from the Netherlands Heart Registration (NHR) database. SETTING: The NHR receives its data from 16 heart centers in the Netherlands. PARTICIPANTS: Patients older than 18 years who underwent CABG in the Netherlands. INTERVENTIONS: Coronary artery bypass grafting with extracorporeal circulation or off-pump coronary artery bypass grafting. MEASUREMENTS AND MAIN RESULTS: The incidence of blood transfusion, defined as transfusions intraoperatively and during the length of the hospital admission after CABG. In addition, a differentiation was made according to the type of transfusion (packed RBC, platelets, and FFP). In the overall cohort (N = 42,388), the number of patients who received a transfusion of any type was 27.0% (n = 11,428). Women received more often RBC transfusions compared with men (45.4% v 15.6%, respectively, p < 0.001). There was a significant difference between the 2 sexes regarding platelet transfusion (women 10.0% v men 11.1%, p = 0.005) but not in FFP transfusion. Female sex was independently associated with RBC transfusion, using the multivariate logistic regression analysis. CONCLUSIONS: The incidence of any blood transfusion was 27.0%, and was higher in women than in men. The female sex was independently associated with receiving RBC during and after CABG.

Building a patient-centred nationwide integrated cardiac care registry: intermediate results from the Netherlands.

This paper presents an overview of the development of an integrated patient-centred cardiac care registry spanning the initial 5 years (September 2017 to December 2022). The Netherlands Heart Registration facilitates registration committees in which mandated cardiologists and cardiothoracic surgeons structurally evaluate quality of care using real-world data. With consistent attendance rates exceeding 60%, a valuable network is supported. Over time, the completeness level of the registry has increased. Presently, four out of six quality registries show over 95% completeness in variables that are part of the quality policies of cardiology and cardiothoracic surgery societies. Notably, 93% of the centres voluntarily report outcomes related to open heart surgery and (trans)catheter interventions publicly. Moreover, outcomes after implantable cardioverter-defibrillator and pacemaker procedures are transparently reported by 26 centres. Multiple innovation projects have been initiated by the committees, signalling a shift from publishing outcomes transparently to collaborative efforts in sharing healthcare processes and investigating improvement initiatives. The next steps will focus on the entire pathway of cardiac care for a specific medical condition instead of focusing solely on the outcomes of the procedures. This redirection of focus to a comprehensive assessment of the patient pathway in cardiac care ultimately aims to optimise outcomes for all patients.

Embedding routine health care data in clinical trials: with great power comes great responsibility.

Randomised clinical trials (RCTs) are vital for medical progress. Unfortunately, 'traditional' RCTs are expensive and inherently slow. Moreover, their generalisability has been questioned. There is considerable overlap in routine health care data (RHCD) and trial-specific data. Therefore, integration of RHCD in an RCT has great potential, as it would reduce the effort and costs required to collect data, thereby overcoming some of the major downsides of a traditional RCT. However, use of RHCD comes with other challenges, such as privacy issues, as well as technical and practical barriers. Here, we give a current overview of related initiatives on national cardiovascular registries (Netherlands Heart Registration, Heart4Data), showcasing the interrelationships between and the relevance of the different registries for the practicing physician. We then discuss the benefits and limitations of RHCD use in the setting of a pragmatic RCT from a cardiovascular perspective, illustrated by a case study in heart failure.

Appearance-related psychosocial distress after facial non-melanoma skin cancer surgery: A 1-year prospective study.

OBJECTIVE: Patients undergoing Mohs Micrographic Surgery (MMS) for facial non-melanoma skin cancer (NMSC) experience appearance-related psychosocial distress due to its post-surgical esthetic changes. However, little is known about its development over a longer follow-up period. This study prospectively assessed appearance-related psychosocial distress in patients undergoing MMS for facial NMSC over a 1-year follow up period. METHODS: Patients who had MMS for facial NMSC between September 2020 and October 2021 were invited to answer the FACE-Q Skin Cancer - appearance-related psychosocial distress scale preoperatively, 2 weeks, 6 months, and 1 year after surgery. RESULTS: A total of 217 patients completed the questionnaire at baseline. In addition, 158 (72.8%), 139 (64.1%), and 120 (55.3%) questionnaires were successfully answered 2 weeks, 6 months, and 1 year after surgery, respectively. Patients with a peripheral lesion presented higher appearance-related psychosocial distress scores at baseline than patients with a central lesion (p = 0.02). There was a decreasing trend in appearance-related psychosocial distress over time, but without a significant result (baseline-2-week; p = 0.73, 2-week-6-month; p = 0.80, 6-month-1-year; p = 0.17, baseline-1-year; p = 0.23). Patients with secondary intention healing and graft reconstruction methods experienced more appearance-related psychosocial distress over time than patients with primary wound closures (p = 0.03). CONCLUSIONS: Patients still experience appearance-related psychosocial distress 1 year after MMS. These patients may benefit from targeted counseling. Additionally, predictors of more appearance-related psychosocial distress, such as secondary intention healing and graft reconstruction methods, may benefit from additional psychological care.

Long-term Outcome of Reexploration for Bleeding After Coronary Artery Bypass Grafting.

OBJECTIVES: This study aimed to determine the influence of reexploration for bleeding and blood product requirement after coronary artery bypass grafting (CABG) on long-term mortality. DESIGN: A retrospective cohort study. SETTING: A single-center institution. PARTICIPANTS: All patients who underwent CABG between January 1998 and December 2019 were included. INTERVENTIONS: The parameters were analyzed to assess the association between reexploration for bleeding and long-term mortality. MEASUREMENTS AND MAIN RESULTS: The primary endpoint was all-cause mortality up to the end of follow-up (June 1, 2021). The secondary endpoints were 30-day mortality, duration of admission, blood product transfusion, postoperative use of an intra-aortic balloon pump, deep sternal wound infection, myocardial infarction, and neurologic complications. The Cox proportional hazards model was used to assess the association between reexploration and blood product use and all-cause mortality. Median follow-up was 9.7 years (IQR 5.1-14.6). In total, 576 out of 21,346 (2.7%) patients were reexplored for bleeding. Thirty-day mortality was 6.2% v 1.6% for the reexplored versus not reexplored patients. Reexploration for bleeding was not significantly correlated with long-term mortality (hazard ratio [HR] 1.029; p = 0.068). On the other hand, blood product transfusion (HR = 1.135; p < 0.001), and in particular, packed red blood cell (pRBC) transfusion (HR = 1.139; p < 0.001), was significantly associated with higher long-term mortality. After multivariate Cox regression using ≥5 pRBC transfused as a cut-off point, reexploration for bleeding was not significantly associated with long-term mortality (HR 0.982; p = 0.813). Receiving ≥5 pRBCs was significantly associated with higher long-term mortality (HR 1.249; p < 0.001). CONCLUSION: Reexploration for bleeding was significantly associated with higher 30-day mortality but not with long-term mortality. Poorer long-term mortality was attributed to patient characteristics and higher use of postoperative blood products.

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

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.

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

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.

Redo surgery for neurogenic thoracic outlet syndrome is useful.

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.

Development and validation of a prediction model for early mortality after transcatheter aortic valve implantation (TAVI) based on the Netherlands Heart Registration (NHR): The TAVI-NHR risk model.

BACKGROUND: The currently available mortality prediction models (MPM) have suboptimal performance when predicting early mortality (30-days) following transcatheter aortic valve implantation (TAVI) on various external populations. We developed and validated a new TAVI-MPM based on a large number of predictors with recent data from a national heart registry. METHODS: We included all TAVI-patients treated in the Netherlands between 2013 and 2018, from the Netherlands Heart Registration. We used logistic-regression analysis based on the Akaike Information Criterion for variable selection. We multiply imputed missing values, but excluded variables with >30% missing values. For internal validation, we used ten-fold cross-validation. For temporal (prospective) validation, we used the 2018-data set for testing. We assessed discrimination by the c-statistic, predicted probability accuracy by the Brier score, and calibration by calibration graphs, and calibration-intercept and calibration slope. We compared our new model to the updated ACC-TAVI and IRRMA MPMs on our population. RESULTS: We included 9144 TAVI-patients. The observed early mortality was 4.0%. The final MPM had 10 variables, including: critical-preoperative state, procedure-acuteness, body surface area, serum creatinine, and diabetes-mellitus status. The median c-statistic was 0.69 (interquartile range [IQR] 0.646-0.75). The median Brier score was 0.038 (IQR 0.038-0.040). No signs of miscalibration were observed. The c-statistic's temporal-validation was 0.71 (95% confidence intervals 0.64-0.78). Our model outperformed the updated currently available MPMs ACC-TAVI and IRRMA (p value < 0.05). CONCLUSION: The new TAVI-model used additional variables and showed fair discrimination and good calibration. It outperformed the updated currently available TAVI-models on our population. The model's good calibration benefits preprocedural risk-assessment and patient counseling.

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

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.

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

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.

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

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.

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

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.

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

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.

Does concomitant tricuspid valve surgery increase the risks of minimally invasive mitral valve surgery? A multicentre comparison based on data from The Netherlands Heart Registration.

OBJECTIVES: Mitral valve (MV) disease is often accompanied by tricuspid valve (TV) disease. The indication for concomitant TV surgery during primary MV surgery is expected to increase, especially through a minimally invasive surgical (MIS) approach. The aim of the current study is to investigate the safety of the addition of TV surgery to MV surgery in MIMVS in a nationwide registry. METHODS: Patients undergoing atrioventricular valve surgery through sternotomy or MIS between 2013 and 2018 were included. Patients undergoing MV surgery only through sternotomy or MIS were used as comparison. Primary outcomes were short-term morbidity and mortality and long-term survival. Propensity score matching was used to correct for potential confounders. RESULTS: The whole cohort consisted of 2698 patients. A total of 558 patients had atrioventricular double valve surgery through sternotomy and 86 through MIS. As a comparison, 1365 patients underwent MV surgery through sternotomy and 689 patients through MIS. No differences in 30- and 120-day mortality were observed between the groups, both unmatched and matched. 5-year survival did not differ for double atrioventricular valve surgery through either sternotomy or MIS in the matched population (90.1% vs. 95.3%, Log-Rank p = .12). A higher incidence of re-exploration for bleeding (n = 12 [15.2%] vs. n = 3 [3.8%], p = .02) and new onset arrhythmia (n = 35 [44.3%] vs. n = 13 [16.5%], p < .001) was observed in double valve surgery through MIS. Median length of hospital stay (LOHS) was longer in the minimally invasive double valve group (9 days [6-13]) compared with sternotomy (7 days [6-11]; p = .04). CONCLUSION: No differences in short-term mortality and 5-year survival were observed when tricuspid valve was added to MV surgery in MIS or sternotomy. The addition of tricuspid valve surgery is associated with higher incidence of re-exploration for bleeding, new onset arrhythmia. A longer LOHS was observed for MIS compared to sternotomy.

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

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 âž” 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).

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

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.

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

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.

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

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.