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Background Guidelines recommending antibiotic prophylaxis at emergency cholecystectomy for cholecystitis were based on low-quality evidence. The aim of this trial was to demonstrate that omitting antibiotics is not inferior to their prophylactic use. Methods This multicentre, randomized, open-label, non-inferiority clinical trial randomly assigned adults with mild-to-moderate acute calculous cholecystitis (immediate cholecystectomy indicated) to 2 g cefazolin administered before incision or no antibiotic prophylaxis. The primary endpoint was a composite of all postoperative infectious complications in the first 30 days after surgery. Secondary endpoints included all individual components of the primary endpoint, other morbidity, and duration of hospital stay. Results Sixteen of 226 patients (7.1 per cent) in the single-dose prophylaxis group and 29 of 231 (12.6 per cent) in the no-prophylaxis group developed postoperative infectious complications (absolute difference 5.5 (95 per cent c.i. −0.4 to 11.3) per cent). With a non-inferiority margin of 10 per cent, non-inferiority of no prophylaxis was not proven. The number of surgical-site infections was significantly higher in the no-prophylaxis group (5.3 versus 12.1 per cent; P = 0.010). No differences were observed in the number of other complications, or duration of hospital stay. Conclusion Omitting antibiotic prophylaxis is not recommended.

Minimally invasive mitral valve surgery (MIMVS) has become the standard approach for mitral valve pathology in many centres. The anterolateral mini thoracotomy access is beneficial in reoperative surgery by avoiding repeat sternotomy associated risks. The aim of this study is to analyse the safety of this technique. All patients undergoing reoperative MIMVS between 2008 and 2019 were studied retrospectively. Primary endpoint was 30-day major complications and mortality; secondary outcome was long term survival, reoperation rate and rate of more than moderate recurrent regurgitation. 146 Patients underwent reoperative MIMVS with a mean age of 68 ± 8 years. The composite outcome of 30-day major complication and mortality was 29.5%. 30-Day mortality was 6.2% and stroke rate 3.4%. Survival for the whole cohort was 89.7 ± 2.5% at 1-year, 71.6 ± 4.3% at 5 year and 50.9 ± 5.9% at 8-year follow up. Cox regression analysis revealed reduced left ventricular function (HR 2.8; 95%CI 1.5 - 5.0), GFR60 (HR 2.1; 95%CI 1.2 - 3.7) and active endocarditis (HR 6.4; 95%CI 2.7 - 15.4) as variables associated with reduced long-term survival. The cumulative incidence of re-operation after mitral valve replacement was 11.3 ± 3.2% at 5-year and for repair 16.2 ± 7.5% at 5-year. The cumulative incidence of more than moderate recurrent regurgitation after mitral valve repair was 25.4 ± 9.0% at 3-year. Minimally invasive access in reoperative mitral valve surgery in the current study showed similar 30-day mortality and stroke rate compared to repeat sternotomy results reported in literature.

OBJECTIVES Longer aortic cross-clamp (ACC) time is associated with decreased early survival after cardiac surgery. Because maximum follow-up in previous studies on this subject is confined to 28 months, it is unknown whether this adverse effect is sustained far beyond this term. We aimed to determine whether longer ACC time was independently associated with decreased late survival after isolated aortic valve replacement in patients with severe aortic stenosis during 25 years of follow-up. METHODS In this retrospective cohort study, multivariable analysis was performed to identify possible independent predictors of decreased late survival, including ACC and cardiopulmonary bypass (CPB) time, in a cohort of 456 consecutive patients with severe aortic stenosis, who had undergone isolated aortic valve replacement between 1990 and 1993. RESULTS Mean follow-up was 25.3 ± 2.7 years. Median (interquartile range) and mean ACC times were normal: 63.0 (20.0) and 64.2 ± 16.1 min, respectively. Age, operative risk scores and New York Heart Association class were similar in patients with ACC time above, versus those with ACC time below the median. Longer ACC time was independently associated with decreased late survival: hazards ratio (HR) 1.01 per minute increase of ACC time (95% confidence interval [CI] 1.00–1.02; P = 0.012). Longer CPB time was not associated with decreased late survival (HR 1.00 per minute increase of CPB time [95% CI 1.00–1.00; P = 0.30]). CONCLUSIONS Longer ACC time, although still within normal limits, was independently associated with decreased late survival after isolated aortic valve replacement in patients with severe aortic stenosis.

BACKGROUND: Approximately 15% of saphenous vein grafts (SVGs) occlude during the first year after coronary artery bypass graft surgery (CABG) despite aspirin use. The POPular CABG trial (The Effect of Ticagrelor on Saphenous Vein Graft Patency in Patients Undergoing Coronary Artery Bypass Grafting Surgery) investigated whether ticagrelor added to standard aspirin improves SVG patency at 1 year after CABG. METHODS: In this investigator-initiated, randomized, double-blind, placebo-controlled, multicenter trial, patients with ≥1 SVGs were randomly assigned (1:1) after CABG to ticagrelor or placebo added to standard aspirin (80 or 100 mg). The primary outcome was SVG occlusion at 1 year, assessed with coronary computed tomography angiography, in all patients who had primary outcome imaging available. A generalized estimating equation model was used to perform the primary analysis per SVG. The secondary outcome was 1-year SVG failure, which was a composite of SVG occlusion, SVG revascularization, myocardial infarction in myocardial territory supplied by a SVG, or sudden death. RESULTS: Among 499 randomized patients, the mean age was 67.9±8.3 years, 87.1% were male, the indication for CABG was acute coronary syndrome in 31.3%, and 95.2% of procedures used cardiopulmonary bypass. Primary outcome imaging was available in 219 patients in the ticagrelor group and 224 patients in the placebo group. The SVG occlusion rate in the ticagrelor group was 9.6% (44 of 457 SVGs) versus 10.1% in the placebo group (50 of 497 SVGs; odds ratio, 0.87 [95% CI, 0.49–1.55]; P =0.64). SVG failure occurred in 32 patients (12.9%) in the ticagrelor group versus 32 patients (13.0%) in the placebo group (hazard ratio, 1.04 [95% CI, 0.63–1.69]). CONCLUSIONS: In this randomized, placebo-controlled trial, the addition of ticagrelor to standard aspirin did not reduce SVG occlusion at 1 year after CABG. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02352402. URL: https://eudract.ema.europa.eu/ ; Unique identifier: 2014-002142-50.

BACKGROUND: The effect of single as compared with dual antiplatelet treatment on bleeding and thromboembolic events after transcatheter aortic-valve implantation (TAVI) in patients who do not have an indication for long-term anticoagulation has not been well studied. METHODS: In a randomized, controlled trial, we assigned a subgroup of patients who were undergoing TAVI and did not have an indication for long-term anticoagulation, in a 1:1 ratio, to receive aspirin alone or aspirin plus clopidogrel for 3 months. The two primary outcomes were all bleeding (including minor, major, and life-threatening or disabling bleeding) and non-procedure-related bleeding over a period of 12 months. Most bleeding at the TAVI puncture site was counted as non-procedure-related. The two secondary outcomes were a composite of death from cardiovascular causes, non-procedure-related bleeding, stroke, or myocardial infarction (secondary composite 1) and a composite of death from cardiovascular causes, ischemic stroke, or myocardial infarction (secondary composite 2) at 1 year, with both outcomes tested sequentially for noninferiority (noninferiority margin, 7.5 percentage points) and superiority. RESULTS: A total of 331 patients were assigned to receive aspirin alone and 334 were assigned to receive aspirin plus clopidogrel. A bleeding event occurred in 50 patients (15.1%) receiving aspirin alone and in 89 (26.6%) receiving aspirin plus clopidogrel (risk ratio, 0.57; 95% confidence interval [CI], 0.42 to 0.77; P = 0.001). Non-procedure-related bleeding occurred in 50 patients (15.1%) and 83 patients (24.9%), respectively (risk ratio, 0.61; 95% CI, 0.44 to 0.83; P = 0.005). A secondary composite 1 event occurred in 76 patients (23.0%) receiving aspirin alone and in 104 (31.1%) receiving aspirin plus clopidogrel (difference, -8.2 percentage points; 95% CI for noninferiority, -14.9 to -1.5; P

BaCKgrouNd: The effect of prosthesis-patient mismatch (PPM) on late survival after aortic valve replacement (aVr) in patient with symptomatic severe aortic stenosis (AS) remains unclear. Also, late follow-up in previous studies is confined to only one decade. We aimed to determine the effect of PPM on late survival after isolated aVr for symptomatic severe as during 25 years of follow-up. MeThods: in this retrospective cohort study, Kaplan-Meier survival analysis was performed to determine late survival in 404 consecutive patients with moderate PPM (N.=86), severe (N.=11), or no/mild PPM (N.=307) after isolated aVr for symptomatic severe as during a mean follow-up of 25.0±2.9 years. Moderate, severe, and no/mild PPM were defined as indexed effective orifice area of >0.65≤0.85, ≤0.65, and >0.85 cm 2/m 2, respectively. Multivariable analysis was performed to identify possible independent predictors of decreased late survival, including moderate or severe PPM. RESULTS: Late survival of patients with severe PPM was worse in comparison with those with no/mild PPM: 7.4±2.6 (95% confidence interval 2.2-12.5) vs. 13.6±0.5 (95% confidence interval 12.6-14.6) years, respectively; P=0.020. Late survival of patients with moderate PPM was similar to those with no/mild PPM. Severe PPM was an independent predictor of decreased late survival: hazards ratio 4.002 (95% confidence interval 1.869-8.569); P

Introduction and hypothesis Chronic pelvic pain (CPP) is a common multifactorial condition affecting 6 to 27% of women aged 18–50 years worldwide. This study was conducted to review and meta-analyse the current literature on the reduction of chronic pelvic pain after botulinum toxin A (BTA) injection. Method In July 2021 we performed a systematic search in PubMed and EMBASE to assess the benefits of BTA injection in pelvic floor muscles in women with chronic pelvic pain. Primary outcome was reduction in visual analogue scale (VAS) after treatment. Secondary outcomes evaluated were: reduction of dyspareunia, pelvic floor resting pressure and quality of life. Identified reports were assessed on quality of reporting and risk of bias. Standardized mean difference (SMD) was used to combine and analyse outcomes of the included studies. Results Eight studies with 289 participants were considered eligible to be included in this systematic review and meta-analysis. After recalculating SMD into VAS scores (0–100), long-term follow-up (24–26 weeks) showed a significant 15-point improvement in VAS scores (95% CI: 8.8–21.5) for non-menstrual pelvic pain and a 13-point improvement (95% CI: 2.1–24.0) for dyspareunia. BTA injection had a significant effect on pelvic floor resting pressure and quality of life. Conclusion There is limited scientific evidence on the effectiveness of BTA injections in pelvic floor muscles in women with chronic pelvic pain. The available studies show that BTA injections significantly reduce pain levels and improve quality of life at 6 months follow-up. Prospero ID CRD42018105204.

ObjectiveNon-dialytic conservative care is argued to be a reasonable treatment alternative for dialysis in selected older patients with advanced chronic kidney disease. We evaluated patient-relevant outcomes including health-related quality of life in a previous study. However, the scoring algorithm we used to calculate the physical and mental component summary scores of the Short Form-36 (SF-36) turned out to differ from comparable studies on this topic. The aim of this critical appraisal was to reanalyze the SF-36 summary scores in our patient cohort (≥ 70 years) using the more widely used scoring algorithm.ResultsPatients on conservative care (n = 23) had lower physical and mental component summary scores compared to patients not yet started on dialysis (n = 39), but similar compared to patients on dialysis (n = 34). These findings were similar to our original findings and did not change the conclusions. Several scoring algorithms are used for the SF-36 summary scores. Researchers should be aware of this fact and should use the same scoring algorithm across similar studies in a specific field to increase comparability. Using the more widely used scoring algorithm, the recalculated SF-36 summary scores of our patient cohort can now be compared to other studies.

Glycoprotein IIb/IIIa inhibitors (GPI) are still used in patients with ST-segment elevation myocardial infarction (STEMI) who undergo primary percutaneous coronary intervention (PCI), although discussion about its clinical benefit is ongoing.GPI use was analyzed in this subanalysis of the POPular Genetics trial, which randomized STEMI patients to CYP2C19 genotype-guided treatment (clopidogrel or ticagrelor) or standard treatment with ticagrelor/prasugrel. The composite thrombotic endpoint consisted of cardiovascular death, myocardial infarction (MI), definite stent thrombosis, and stroke at 30 days. The combined bleeding endpoint consisted of Platelet Inhibition and Patient Outcomes (PLATO) major and minor bleeding at 30 days. Univariable and multivariable analyses in addition to a propensity score-matched (PSM) analysis were conducted.In total, 2378 patients, of whom 1033 received GPI and 1345 did not, were included. In multivariable analysis, GPI administration was associated with fewer thrombotic events (hazard ratio [HR] 0.22, 95% confidence interval [CI] 0.09-0.55) and MIs (HR 0.24, 95% CI 0.08-0.73). Furthermore, GPI administration was associated with an increase in bleedings (HR 2.02, 95% CI 1.27-3.19), driven by minor bleedings (HR 2.32, 95% CI 1.43-3.76), without a significant difference in major bleedings (HR 0.69, 95% CI 0.19-2.57). In the PSM analysis, no significant association was found.In STEMI patients undergoing primary PCI, GPI administration was associated with a reduction in thrombotic events at a cost of an increase in (mostly minor) bleedings in multivariable analysis, while propensity score analysis did not show significant associations.

Background: Guidelines favor ticagrelor or prasugrel over clopidogrel in patients with myocardial infarction. However, the POPular Genetics trial (Patient Outcome After Primary Percutaneous Coronary Intervention [PCI]) showed that in patients with primary PCI, a CYP2C19 genotype–guided strategy was associated with a lower bleeding risk without increasing thrombotic risk, compared with routine ticagrelor/prasugrel treatment. Nevertheless, optimal P2Y 12 inhibitor treatment in specific CYP2C19 genetic subgroups is still a subject of debate. Methods: A prespecified subanalysis of the POPular Genetics trial was performed, using patients in whom CYP2C19 *2, *3, and *17 genotypes was determined. Two different analyses were planned. The first assessed the effect of the CYP2C19 *17 allele in clopidogrel-treated patients. The second compared the effect of clopidogrel in noncarriers of a loss-of-function allele with ticagrelor/prasugrel–treated patients, irrespective of CYP2C19 genotype. Main outcomes were a thrombotic outcome (cardiovascular death, myocardial infarction, stent thrombosis, and stroke) and a bleeding outcome (PLATO [Platelet Inhibition and Patient Outcomes] major and minor bleeding) after 12 months. Results: A total of 2429 patients were used for analyses. In the first analysis, the CYP2C19 *17 polymorphism was not found to have a significant influence on thrombotic (adjusted hazard ratio, 0.95 [95% CI, 0.45–2.02]) or bleeding outcomes (adjusted hazard ratio, 0.74 [95% CI, 0.48–1.18]). In the second analysis, clopidogrel was associated with a lower number of bleeding events compared with ticagrelor/prasugrel (9.9% versus 11.7%, adjusted hazard ratio, 0.74 [95% CI, 0.56–0.96]), without a significant increase in thrombotic events (3.4% versus 2.5%, adjusted hazard ratio, 1.14 [95% CI, 0.68–1.90]). Conclusions: In patients with primary PCI not carrying a CYP2C19 loss-of-function allele, the use of clopidogrel compared with ticagrelor or prasugrel was associated with lower bleeding rates, without an increase in thrombotic events. No effect on clinical outcomes was found for the CYP2C19 *17 polymorphism. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01761786. URL: https://www.trialregister.nl/ ; Unique identifier: NL2872.

Multiple non-invasive tests are performed to diagnose coronary artery disease (CAD), but all are limited to either anatomical or functional assessments. Computed tomography derived Fractional Flow Reserve (CT-FFR) based on patient-specific lumped parameter models is a new test combining both characteristics simulating invasive FFR. This study aims to evaluate the added value of CT-FFR over other non-invasive tests to diagnose CAD. Patients with clinical suspicion of angina pectoris between 2010 and 2011 were included in this cross-sectional study. All underwent stress electrocardiography (X-ECG), SPECT, CT coronary angiography (CCTA) and CT-FFR. Invasive coronary angiography (ICA) and FFR were used as reference standard. Five models mimicking the clinical workflow were fitted and the area under receiver operating characteristic (AUROC) curve was used for comparison. 44% of the patients included in the analysis had a FFR of ≤ 0.80. The basic model including pre-test-likelihood and X-ECG had an AUROC of 0.79. The SPECT-strategy had an AUROC of 0.90 (p = 0.008), CCTA-strategy of 0.88 (p

Invasive fractional flow reserve (FFR) adoption remains low mainly due to procedural and operator related factors as well as costs. Alternatively, quantitative flow ratio (QFR) achieves a high accuracy mainly outside the intermediate zone without the need for hyperaemia and wire-use. We aimed to determine the diagnostic performance of QFR and to evaluate a QFR–FFR hybrid strategy in which FFR is measured only in the intermediate zone. This retrospective study included 289 consecutive patients who underwent invasive coronary angiography and FFR. QFR was calculated for all vessels in which FFR was measured. The QFR–FFR hybrid approach was modelled using the intermediate zone of 0.77–0.87 in which FFR-measurements are recommended. The sensitivity, specificity, and accuracy on a per vessel-based analysis were 84.6%, 86.3% and 85.6% for QFR and 88.0%, 92.9% and 90.3% for the QFR–FFR hybrid approach. The diagnostic accuracy of QFR–FFR hybrid strategy with invasive FFR measurement was 93.4% and resulted in a 56.7% reduction in the need for FFR. QFR has a good correlation and agreement with invasive FFR. A hybrid QFR–FFR approach could extend the use of QFR and reduces the proportion of invasive FFR-measurements needed while improving accuracy.

Aims: Natriuretic peptides are helpful in detecting chronic heart failure (HF) in primary care, however there are a lack of data evaluating thresholds recommended by clinical guidelines. This study assesses the diagnostic accuracy of N-terminal pro-B-type natriuretic peptide (NT-proBNP) using combined individual patient data from two studies in the UK and The Netherlands. Methods and results: Random effects methods were used to estimate the performance characteristics of NT-proBNP thresholds recommended by the European Society of Cardiology (ESC) and the UK National Institute for Health and Care Excellence (NICE) guidelines. New onset HF was diagnosed in 313 of 1073 (29.2%) participants. Age, sex and atrial fibrillation-adjusted NT-proBNP was a better predictor of HF with reduced ejection fraction (HFrEF) than preserved ejection fraction (HFpEF), with area under receiver operating characteristic curve of 0.82 95% CI (0.78 to 0.86) vs. 0.71 (0.66 to 0.75). In persons aged 70 years and over, the ESC threshold at 125ng/L for detection of all-cause HF had summary negative predictive value (NPV) of 84.9% (81.6 to 88.2), positive predictive value (PPV) 68.1% (63.1 to 73.3), sensitivity 74.9% (69.5 to 80.3) and specificity 80.1% (76.9 to 83.4); the NICE threshold at 400ng/L had summary NPV of 74.7% (72.1 to 77.2), PPV 81.8% (73.3 to 89.5), sensitivity 43.5% (37.2 to 49.8) and specificity 94.5% (92.3 to 96.7). Conclusion: NT-proBNP is better at detecting HFrEF than HFpEF in a primary care setting. In persons aged 70 and over, the ESC threshold of 125ng/L is more accurate at detecting and excluding HF than the higher level suggested in NICE guidelines. More prospective data are required to establish the optimal NP threshold for detecting chronic HF in general practice.

ObjectiveMinimally invasive surgery is increasingly adopted as an alternative to conventional sternotomy for mitral valve pathology in many centres worldwide. A systematic safety analysis based on a comprehensive list of pre-specified 30-day complications defined by the Mitral Valve Academic Consortium (MVARC) criteria is lacking. The aim of the current study was to systematically analyse the safety of minimally invasive mitral valve surgery in our centre based on the MVARC definitions.MethodsAll consecutive patients undergoing minimally invasive mitral valve surgery through right mini-thoracotomy in our institution within 10 years were studied retrospectively. The primary outcome was a composite of 30-day major complications based on MVARC definitions.Results745 patients underwent minimally invasive mitral valve surgery (507 repair, 238 replacement), with a mean age of 62.9±12.3 years. The repair was successful in 95.8%. Overall 30-day mortality was 1.2% and stroke rate 0.3%. Freedom from any 30-day major complications was 87.2%, and independent predictors were left ventricular ejection fraction 2(OR 1.98; 95% CI 1.17 to 3.26).ConclusionsMinimally invasive mitral valve surgery is a safe technique and is associated with low 30-day mortality and stroke rate.

Aims To identify risk factors for composite outcome of mortality, stroke or myocardial infarction in patients with severe carotid stenosis undergoing staged carotid artery stenting (CAS) with subsequent cardiac surgery. Methods and results In this prospective observational study, we enrolled 643 consecutive patients with both symptomatic (i.e., with history of stroke) and asymptomatic severe carotid artery disease, who required cardiac surgery. Generally, cardiac surgery was planned 30 days after the CAS procedure. The composite outcome consisted of death, stroke and myocardial infarction. The composite outcome rate was 26.3% at 5 years and 47% at 8 years after CAS. Age ≥ 80 years (hazard ratio [HR] = 1.89; 95%CI, 1.18-3.03; P = 0.008), history of stroke (HR = 1.66, 1.16-2.37; P = 0.006), chronic obstructive pulmonary disease (HR = 1.86; 1.07-3.24; P = 0.03) and kidney disease (HR = 1.83, 1.11-3.04; P = 0.02) were independent risk factors for the composite outcome during long-term follow-up. Conclusions In this study with staged CAS followed by cardiac surgery, we confirm previously reported event-free survival rates and identify several risk factors for the composite outcome. Future studies are needed to confirm the importance of the identified risk factors and to assess their predictive ability.

Background Conservative care is argued to be a reasonable treatment alternative for dialysis in older patients with advanced chronic kidney disease (CKD). However, comparisons are scarce and generally focus on survival only. Comparative data on more patient-relevant outcomes are needed to truly foster shared decision-making on an individual level, and cost comparison is needed to assess value of care. Methods We conducted a retrospective observational single-center cohort study in 366 patients aged ≥70 years with advanced CKD, who chose dialysis (n = 240) or conservative care (n = 126) after careful counselling by a multidisciplinary team in a non-academic teaching hospital in The Netherlands. Using a value-based health care approach (value = outcomes/cost): survival, health-related quality of life—cross-sectionally assessed with the Kidney Disease Quality of Life Short Form™—treatment burden, and treatment costs were evaluated. Results The overall survival benefit of patients on a dialysis pathway compared with patients on conservative care diminished or lost significance in patients aged ≥80 years or with severe comorbidity. There were no differences between patients managed conservatively and dialysis patients on physical and mental health summary scores (all P > 0.1). Patients on conservative care had 352.7 hospital free days per year versus 282.7 in patients on a dialysis pathway, calculated from treatment decision (adjusted incidence rate ratio: 1.15, 95% confidence interval: 1.09 to 1.21, P

Objectives: The aim of this study was to determine predictors of very late stent thrombosis (VLST; >1 year after stenting), and to evaluate whether addition of these predictors to the dual antiplatelet therapy (DAPT) score would improve the ability to identify patients at high risk of VLST who might benefit from DAPT. Background: VLST is a severe complication of percutaneous coronary intervention (PCI). Extended knowledge about the predictors of VLST is needed to prevent this life-threatening complication. Recent data showed a reduction in VLST after treatment with prolonged DAPT. The DAPT study developed a prediction score to identify patients after PCI who might benefit from prolonged DAPT duration. Methods: The Dutch stent thrombosis study is a multi-center case-control study. Consecutive patients with definite VLST were included between 2007 and 2014. Baseline characteristics from the index PCI were collected. Independent predictors of VLST were identified and added to the DAPT score to develop the VLST score. Results: In total, 155 VLST cases and 155 matched controls were included. Suboptimal result of stenting, right coronary artery as target vessel, and diffuse coronary artery ectasia were independent predictors of VLST, and added to the DAPT score. The power of the VLST score to identify patients who experienced VLST was increased (AUC, 95%CI; DAPT score: 0.64, 0.57-0.70; VLST score: 0.70, 0.63-0.76, P = 0.010). Conclusions: Addition of newly identified independent predictors of VLST resulted in a prediction model with a higher ability to identify patients at high risk of VLST who might benefit from prolonged DAPT.

Aims Thoracoscopic surgical ablation has evolved into a successful strategy for symptomatic atrial fibrillation (AF) refractory to other therapy. More widespread referral is limited by the lack of information on potential complications. Our aim was to systematically evaluate 30-day complications of totally thoracoscopic surgical ablation. Methods and results We retrospectively studied consecutive patients undergoing totally thoracoscopic surgical ablation at a referral centre in the Netherlands (2007–2016). Patients received pulmonary vein isolation, with additional lesion lines as needed, and left atrial appendage exclusion. The primary outcomes were freedom from any complications and freedom from irreversible complications at 30-days. Secondary outcomes included intra- and post-operative complications according to severity. Included were 558 patients with median age 62 years (interquartile range 56–68 years), 70% male and 53% with a previous failed catheter ablation. The cohort consisted of 43% paroxysmal AF, 47% persistent AF, and 10% long-standing persistent AF. Freedom from any 30-day complication was 88.2%, and from complications with life-long affecting consequences 97.5%. The intra-operative complication rate was 2.3% with no strokes or death observed. The median hospital length of stay was 4 days. The percentage of patients with major and minor complications at 30-days was 3.2% and 8.1%, respectively, with one patient dying of an ischaemic stroke. The only patient groups with excess complications were women aged ≥70 years and patients with a history of congestive heart failure. Conclusions Totally thoracoscopic ablation is associated with a low complication rate in a referral centre and may be a useful alternative to other rhythm control strategies.

Objectives: The PRISON-IV trial showed inferior outcome in patients with chronic total occlusions (CTOs) treated with the ultrathin-struts (60 μm for stent diameter ≤3 mm, 81μm >3 mm) hybrid-sirolimus eluting stents (SES) compared with everolimus eluting stents (EES, 81 μm). The aim of this study is to investigate if the use of smaller stents (≤3 mm) was responsible for the inferior outcome reported in the trial. Methods: In the PRISON-IV trial 330 patients with CTO lesion were randomized 1:1 to receive either hybrid-SES or EES. The hybrid-SES failed to reach the non-inferiority primary endpoint of in-segment late lumen loss (LLL) at 9-month angiographic follow-up. In this sub-analysis, we divided the population according to the different size of stents implanted in those receiving only stents with diameter ≤3 mm (Group-A, 178 patients), only stents >3 mm (Group-B, 59 patients), and those receiving stents of both sizes (Group-C, 93 patients). Results: Baseline and procedural characteristics were comparable in the three groups. At angiographic follow-up, most of the adverse outcomes occurred in Group A, with higher incidence of binary restenosis in the Hybrid-SES versus EES (10.3% vs 1.3%, P = 0.03) and augmented in-stent diameter stenosis (26.04 ± 18.59% vs 21.24 ± 12.84, P = 0.06). Similarly, optical coherence tomography (OCT), which was performed in 60 patients at follow-up, documented a mild trend toward lower values of minimum in stent area in Hybrid-SES arm of Group A (4.4 ± 1.02mm2 vs 5.0 ± 1.28mm2, respectively, P = 0.16). Conclusions: The present analysis suggests that the inferior performance of the ultra-thin hybrid-SES in CTO-PCI is particularly pronounced when smaller stent (≤3 mm diameter) are adopted, if compared with EES.

Introduction Optimal left ventricular (LV) lead position in patients undergoing cardiac resynchronization therapy(CRT) is crucial to achieve an optimal effect on hemodynamics. Due to various difficulties, up to 30% of transvenous LV lead placements fail, or a suboptimal position is achieved. Surgical epicardial LV lead placement could be performed at a position anticipated to be the optimal site. This could have a more favorable effect, which may be expressed by increased improvement in left ventricular ejection fraction(LVEF) and cardiac perfusion. The objective of this trial is to compare transvenous versus epicardial LV lead placement in CRT in a randomized fashion Methods and results : 52 patients were randomized to either epicardial or transvenous approach. All patients received an ICD with CRT. Patients were followed for 6 months after device implant. Primary endpoint was the degree of change in cardiac perfusion measured by myocardial perfusion scintigraphy. LVEF equally improved in both groups, from 24% to 36% in the transvenous group versus 25% to 35% in the epicardial group (p = 0.797). Cardiac perfusion, expressed as summed stress score(SSS), improved in both groups without a significant difference as well (p = 0.727). Complication rate was similar, respectively 6 and 7 patients had any complication. Admission time was significantly longer in the epicardial group with 2 (2-7) versus 3 (2-32) days (p

Essentials Platelet reactivity is correlated with thrombotic risk after percutaneous coronary intervention (PCI). Hematocrit (HCT) is associated with platelet reactivity as measured with the VerifyNow P2Y12 assay. We tested a formula proposed to correct VerifyNow measurements for HCT in 978 PCI patients. Correcting platelet reactivity for HCT did not improve the prediction of thrombotic events after PCI. SummaryBackground High on-treatment platelet reactivity is predictive for the occurrence of atherothrombotic events following percutaneous coronary interventions (PCIs). A low hematocrit (HCT) value is associated with higher platelet reactivity values, expressed in P2Y12 reaction units (PRU), as measured with the VerifyNow P2Y12 assay. However, it is suggested that this is only an in vitro phenomenon. Objective To determine whether adjusting PRU for HCT improves the predictive value for thrombotic events following PCI. Material and methods The VerifyNow P2Y12 assay was performed in clopidogrel-treated patients undergoing non-urgent PCI included in a prospective cohort study. PRU values were corrected for HCT with a formula proposed in recent literature. Receiver operating characteristic (ROC) curves were made to determine the optimal cut-off values to predict the occurrence of the primary endpoint, a composite of all-cause death and non-fatal myocardial infarction, stent thrombosis and ischemic stroke, during 1 year of follow-up. The chi-squared test was performed to determine whether correcting PRU for HCT improved the prediction of the primary endpoint. Results A total of 978 patients were analyzed. A negative correlation between PRU and HCT was observed (R2 = 0.104). The optimal cut-off value for the corrected PRU was 215. ROC analyses showed that prediction of the primary endpoint did not differ for the corrected PRU (area under the curve, 0.61; sensitivity, 0.57; specificity, 0.64) and the uncorrected PRU (area under the curve, 0.61; sensitivity, 0.69; specificity, 0.53). Conclusion Correcting PRU for HCT does not improve the prediction of thrombotic events following PCI.

OBJECTIVE This study aims to determine frequency and reasons for prematurely discontinuing or switching antiplatelet therapy in elderly patients admitted with non-ST-elevation acute coronary syndrome (NSTE-ACS). METHOD Patients of 75 years or older admitted with suspected NSTE-ACS were included between 2013 and 2016. Information was extracted from the patients' medical files. RESULTS A total of 544 patients were included, 17.3% discontinued aspirin within one year, predominantly (57%) within 30 days. The most common reason was the start of a (non-vitamin-K) oral anticoagulant [(N)OAC], either combined with a P2Y12-inhibitor (43%) or as monotherapy (16%). The P2Y12-inhibitor was discontinued in 31.2% of patients within one year, of which 46% within 30 days. The most common reason was undergoing coronary artery bypass grafting (CABG; 22%). Switching of clopidogrel seldom occurred; however, ticagrelor was switched in 50/179 patients mainly due to dyspnoea (42%). Independent predictors for prematurely discontinuing antiplatelet therapy were undergoing CABG [odds ratio (OR) 3.257 (95% confidence interval [CI] 1.836-5.779)], need for (N)OAC [OR 2.167 (95% CI 1.423-3.300)] and type II ACS as final diagnosis [OR 3.793 (95% CI 1.721-8.361)]. Undergoing percutaneous coronary intervention [OR 0.393 (95% CI 0.243-0.634)] and use of clopidogrel [OR 0.441(95% CI 0.293-0.662)] were independent predictors of continuing antiplatelet therapy. CONCLUSION In elderly patients of at least 75 years with NSTE-ACS, antiplatelet therapy is frequently discontinued prematurely, most often within 30 days. Main reasons for discontinuing are need for (N)OAC, undergoing CABG or type II ACS as final diagnosis and suffering from dyspnoea while on ticagrelor.

It is unknown whether patients undergoing primary percutaneous coronary intervention (PCI) benefit from genotype-guided selection of oral P2YWe conducted a randomized, open-label, assessor-blinded trial in which patients undergoing primary PCI with stent implantation were assigned in a 1:1 ratio to receive either a P2YFor the primary analysis, 2488 patients were included: 1242 in the genotype-guided group and 1246 in the standard-treatment group. The primary combined outcome occurred in 63 patients (5.1%) in the genotype-guided group and in 73 patients (5.9%) in the standard-treatment group (absolute difference, -0.7 percentage points; 95% confidence interval [CI], -2.0 to 0.7; P0.001 for noninferiority). The primary bleeding outcome occurred in 122 patients (9.8%) in the genotype-guided group and in 156 patients (12.5%) in the standard-treatment group (hazard ratio, 0.78; 95% CI, 0.61 to 0.98; P = 0.04).In patients undergoing primary PCI, a

The incidence of geriatric ankle fractures is rising and the potential for complications is high in this population. Little is known about factors associated with increased postoperative complications after surgical fixation of ankle fractures in older-age patients. The purpose of this retrospective cohort study was to assess the epidemiology and risk factors for complications after surgically treated ankle fractures in geriatric patients. All patients who were 65 years or older and had a surgically treated ankle fracture were included. Pilon fractures, patients who were initially treated conservatively or who had less than 1 month of follow-up were excluded. Postoperative complications, demographic-, fracture- and surgical data of 282 patients were recorded from two level 2 trauma centers between 2012 and 2017. A total of 87 (30.9%) patients developed a complication, of which wound related complications were most frequently reported. Superficial and deep wound infections were observed in 27 (9.6%) and 18 (6.4%) patients, respectively. Multivariate regression analysis demonstrated increased age to be an independent predictive variable for the occurrence of postoperative complications (odds ratio 1.04; 95% confidence interval 1.00-1.09), while cast immobilization for more than 2 weeks was a protective factor for the development of wound related complications (odds ratio 0.34; 95% confidence interval 0.17-0.66). In conclusion, the incidence of postoperative complications among geriatric patients after surgical treatment of ankle fractures is high and patients should be informed accordingly.

High on-treatment platelet reactivity (HPR) on P2Y12-inhibitors in patients treated with dual antiplatelet therapy is strongly associated with adverse ischaemic events. Studies have shown conflicting results with regard to the correlation and agreement between the different tests. Several assays are available to establish HPR. A composite advice based on more than one test might be a better way to identify HPR patients. To compare HPR rates and agreement between individual platelet function tests and a panel of three tests In our large percutaneous coronary intervention centre, all patients who suffered a stent thrombosis were invited back to a dedicated clinic. Platelet function testing was performed in all patients and matched control patients. HPR rates were compared between individual tests and with a composite comprised of three tests. A total of 242 patients were included, of whom in 193 patients all tests were available. HPR rates ranged from 14.6% [VerifyNow cut-off >235 platelet reactivity units (PRU)] to 49.7% (Vasodilator-Stimulated Phosphoprotein Assay). HPR according to the composite advice (≥2 out of 3 tests indicating HPR) was present in 29.8% of patients. The best correlation with the composite advice was observed with light transmittance aggregometry (kappa = 0.78) and VerifyNow (lower cut-off >208 PRU; kappa = 0.68). VerifyNow with cut-off more than 235 PRU identified the smallest proportion of patients with HPR, whereas Vasodilator-Stimulated Phosphoprotein Assay seemed to 'over-identify' HPR. In this real life patient cohort, a large variability was observed between four different platelet function tests. The use of a composite advice based on three tests is a promising alternative.

AIMS: Treatment strategies of high-risk patients with mitral regurgitation (MR) differ between disease based on functional and disease based on degenerative origin. In the present study, we aimed to evaluate the effect of surgical, percutaneous, or conservative treatment of MR according to MV mechanism, for high-risk patients. METHODS AND RESULTS: Survival outcomes of MitraClip, surgical, or conservative strategies were compared for 688 high-risk patients with functional MR and 275 with degenerative MR. Cox regression and propensity analyses were used to correct for differences in baseline characteristics. For functional MR, conservative treatment proved to have a higher mortality hazard when compared to MitraClip treatment (hazard ratio [HR] 1.79, 95% confidence interval [CI]: 1.34 to 2.39, p

The POPular Risk Score was developed for the selective intensification of P2YIn a single-center prospective cohort study, patients with a high risk score were treated with prasugrel and patients with a low risk score with clopidogrel. The risk score-guided cohort was compared with a historic cohort of clopidogrel-treated patients. The endpoint consisted of all-cause death, myocardial infarction, stroke, or stent thrombosis during 1 year of follow-up. TIMI major and minor bleeding events were also analyzed.The guided cohort contained 1127 patients, 26.9% of whom were switched to prasugrel according to the POPular Risk Score. The historic cohort contained 893 patients. The incidence of the combined thrombotic endpoint was significantly lower in the guided cohort as compared with the historic cohort (8.4% versus 3.7%, p 0.001). This strategy was safe with respect to bleeding (4.0% versus 1.3%, p 0.001, for TIMI major or minor bleeding). Results were comparable after multivariate and propensity score matched and weighted analysis.Selective intensification of P2Y

Item does not contain fulltext BACKGROUND: The aim of this study was to determine perioperative factors influencing neurologic outcome in a single-center cohort of patients undergoing elective aortic arch operations. METHODS: From January 2005 to June 2015, 791 consecutive patients received open aortic arch operations with either antegrade selective cerebral perfusion (ASCP) (636 patients [80.4%]) or deep hypothermic circulatory arrest (DHCA) (155 patients [19.6%]). Main indications were degenerative aneurysm (85%) and chronic postdissection aneurysm (9.1%). RESULTS: Hospital mortality (30 days) was 5.3%. Permanent neurologic dysfunction (PND) was observed in 42 patients (5.3%). Significant risk factors for PND appeared to be femoral artery cannulation (p = 0.003), progressive cardiopulmonary bypass (p = 0.001), circulatory arrest (p = 0.001), and ASCP time (p = 0.011). ASCP, in contrast to DHCA, was protective against PND (odds ratio [OR], 0.37; p = 0.003). Temporary neurologic dysfunction (TND) was observed in 49 patients (6.2%). Preoperative transient ischemic attack (TIA) (p = 0.001), progressive EuroSCORE (p = 0.001), left ventricular ejection fraction (LVEF) less than 50% (p = 0.003), and the use of femoral artery cannulation (p = 0.049) showed correlation in the univariate analysis. Stepwise logistic regression indicated TIA (p = 0.002; OR, 3.24) and the EuroSCORE (p = 0.003; OR, 1.23) as independent predictors of TND. CONCLUSIONS: Contemporary elective aortic arch repair can be achieved with low mortality and a low incidence of neurologic dysfunction. ASCP was confirmed to be the safest method of cerebral protection. The extent of aortic arch replacement (apart from the frozen elephant trunk [FET] procedure) was not related to increased rates of TND or PND.

Objectives The aim of this study was to investigate the efficacy and safety of the hybrid ultrathin-strut sirolimus-eluting stent (SES) with biodegradable polymer compared with the thin-strut everolimus-eluting stent (EES) with durable polymer in successfully recanalized chronic total occlusions (CTOs). Background The introduction of drug-eluting stents revolutionized the treatment of CTOs. However, limited data are available on new-generation drug-eluting stents with biodegradable polymer in CTOs. Methods In this multicenter trial, patients were randomized, after successful CTO recanalization, to either SES or EES. The primary noninferiority endpoint was in-segment late lumen loss (noninferiority margin 0.2 mm). Secondary endpoints included in-stent late lumen loss and clinical endpoints. Results Overall, 330 patients were included. At 9 months, angiography was available in 281 patients (85%). Duration of occlusion ≥3 months was 92.5%, with mean stent length of 52.4 ± 28.1 mm versus 52.3 ± 26.5 mm in the SES and EES groups. The primary noninferiority endpoint, in-segment late lumen loss, was not met for SES versus EES (0.13 ± 0.63 mm vs. 0.02 ± 0.47 mm; p = 0.08, 2-sided; difference 0.11 mm; 95% confidence interval: −0.01 to 0.25 mm; pnoninferiority = 0.11, 1-sided). In-stent late lumen loss was comparable between SES and EES (0.12 ± 0.59 mm vs. 0.07 ± 0.46 mm; p = 0.52). The incidence of in-stent and in-segment binary restenosis was significantly higher with SES compared with EES (8.0% vs. 2.1%; p = 0.028), with comparable rates of reocclusions (2.2% vs. 1.4%; p = 0.68). Clinically indicated target lesion and target vessel revascularization (9.2% vs. 4.0% [p = 0.08] and 9.2% vs. 6.0% [p = 0.33]), target vessel failure (9.9% vs. 6.6%; p = 0.35), and definite or probable stent thrombosis (0.7% vs. 0.7%; p = 1.00) were comparable between the SES and EES groups. Conclusions This randomized trial failed to show noninferiority of hybrid SES relative to EES in terms of in-segment late lumen loss in successfully recanalized CTOs. Furthermore, a statistically significantly higher rate of binary restenosis was found with SES.

Gaseous microemboli (GME) may originate from the extracorporeal circuit and enter the arterial circulation of the patient. GME are thought to contribute to cerebral deficit and to adverse outcome after cardiac surgery. The arterial filter is a specially designed component for removing both gaseous and solid microemboli. Integration of an arterial filter with an oxygenator is a contemporary concept, reducing both prime volume and foreign surface area. This study aims to determine the air-handling properties of four contemporary oxygenator devices with an integrated arterial filter. Two oxygenator devices, the Capiox FX25 and the Fusion, showed significant increased volume of GME reduction rates (95.03 ± 3.13% and 95.74 ± 2.69%, respectively) compared with both the Quadrox-IF (85.23 ± 5.84%) and the Inspire 6F M (84.41 ± 12.93%). Notably, both the Quadrox-IF and the Inspire 6F M as well as the Capiox FX 25 and the Fusion showed very similar characteristics in volume and number reduction rates and in detailed distribution properties. The Capiox FX25 and the Fusion devices showed significantly increased number and volume reduction rates compared with the Quadrox-IF and the Inspire 6F M devices. Despite the large differences in design of all four devices, our study results suggest that the oxygenator devices can be subdivided into two groups based on their fibre design, which results in screen filter (Quadrox-IF and Inspire 6F M) and depth filter (Capiox FX25 and Fusion) properties. Depth filter properties, as present in the Capiox FX25 and Fusion devices, reduced fractionation of air and may ameliorate GME removal.

Aims: The PRISON IV trial investigated the next-generation sirolimus-eluting stent (SES) with ultra-thin struts and biodegradable polymer against the second-generation everolimus-eluting stent (EES) with thin struts and durable polymer in patients with successfully recanalised chronic total occlusions (CTO). In this study, we examined the secondary optical coherence tomography endpoints. Methods and results: The main PRISON IV trial randomised 330 patients to either SES or EES. At nine months, 281 (85%) patients underwent repeat angiography. Of these, 60 consecutive patients received optical coherence tomography divided over both stent groups. The mean number of struts analysed was 750±337 and 633±358 in SES and EES patients, respectively (p=0.07). The minimal lumen area, minimal stent area, maximal neointima area and neointimal thickness were comparable between the groups (4.8±2.1 and 4.4±1.5 mm2; 5.3±1.8 and 5.3±1.4 mm2; 2.5±2.0 and 2.2±1.5 mm2; 0.7±1.7 and 0.4±0.2 mm). The percentage of uncovered struts was higher with EES (6.2±7.5% and 11.9±13.4%, p=0.04), whereas the percentage of malapposed struts and mean number of coronary evaginations were significantly higher with SES (2.9±4.0% and 1.2±2.4%, p=0.02; 18.5±17.7 and 5.3±3.1, p=0.004). Conclusions: The optical coherence tomography findings of this substudy demonstrated improved strut coverage with ultra-thin strut SES with bioresorbable polymer compared to thin-strut EES with durable polymer in CTO. On the other hand, SES showed a higher rate of stent strut malappositon and coronary evaginations. The clinical relevance of these findings remains to be demonstrated.

The purpose of this study was to update the current evidence regarding the efficacy and safety of the totally thoracoscopic maze (TT-maze) procedure for the treatment of atrial fibrillation (AF). Fourteen studies published between 2011 and 2016 and comprising 1171 patients were included as follows: 545 (46%) patients had paroxysmal AF (pAF), 268 (23%) persistent AF (persAF) and 358 (31%) longstanding persistent AF (LSPAF). Fixed- and random-effect models were used to calculate the pooled overall freedom from atrial arrhythmias. The 1- and 2-year pooled overall antiarrhythmic drug (AAD) free (off-AAD) success rates were 78% (95% confidence interval (CI): 72-83%, n = 13) and 77% (95% CI: 64-86%, n = 6), respectively. The 1- and 2-year pooled on-AAD success rates were 84% (95% CI: 78-89%, n = 5) and 85% (95% CI: 78-90%, n = 3), respectively. Subanalysis regarding the different types of AF revealed a 1-year pooled off-AAD success rate of 81% (95% CI: 73-86%, n = 7) for pAF, 63% (95% CI: 57-69%, n = 5) for persAF and 67% (95% CI: 52-79%, n = 3) for LSPAF. The overall in-hospital complication rate was

This study examines the application of near-infrared spectroscopy to noninvasively detect critical limb ischemia using regional hemoglobin oxygen saturation in percentage values and regional hemoglobin oxygen saturation limb-to-arm ratios. The regional hemoglobin oxygen saturation values and regional hemoglobin oxygen saturation limb-to-arm ratios were calculated in 61 patients with critical limb ischemia (group A). Measurements were performed in rest at four fixed spots at the most affected lower limb and at a reference spot at both upper arms. Similar measurements were performed in the left lower limb of 30 age-matched control patients without peripheral arterial disease (group B). The regional hemoglobin oxygen saturation values and regional hemoglobin oxygen saturation limb-to-arm ratios were significantly different at all measured spots between the groups (all p

During cardiopulmonary bypass (CPB), gaseous microemboli (GME) are released into the patients' arterial bloodstream. Gaseous microemboli may contribute to the adverse outcome after cardiac surgery. Recently, two oxygenator models with or without integrated arterial filter (IAF) were designed and only differ in size, leading to a change of 20% in surface area of the hollow fibers and 25% in blood velocities. The aim of this study was to assess the air removal characteristics of the inspire oxygenators with or without IAF. Sixty-eight patients were randomly assigned to four different groups: optimized adult and full adult and an additional IAF. Gaseous microemboli reduction rates were measured with a bubble counter. The number of GME reduction rates showed no differences. However, both models reduced significantly less volume of GME (optimized adult: 40.6% and full adult: 50.3%) compared with both models with IAF (88.7% and 88.5%, respectively). No significant differences of reduction rates were found between both devices without IAF and also not between both models with IAF. In conclusion, the larger inspire oxygenator tends to remove more GME. No effect from size of oxygenator device with integrated screen filter on GME reduction was observed. The inspire oxygenators with IAF may be considered as an adequate GME filter.

OBJECTIVES: Risk stratification for chest pain patients at the emergency department is recommended in several guidelines. The history, ECG, age, risk factors, and troponin (HEART) score is based on medical literature and expert opinion to estimate the risk of a major adverse cardiac event. We aimed to assess the predictive effects of the 5 HEART components and to compare performances of the original HEART score and a model based on regression analysis. METHODS: We analyzed prospectively collected data from 2388 patients, of whom 407 (17%) had a major adverse cardiac event within 6 weeks (acute myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft, significant stenosis with conservative treatment and death due to any cause). RESULTS: Univariate regression analysis showed the same ordering of predictive effects as used in the HEART score. Based on multivariable logistic regression analysis, an adjusted score showed slightly better calibration and discrimination (c statistic HEART, 0.83, HEART-adj, 0.85). In comparison to HEART, HEART-adj proved in a decision curve analysis clinically useful for decision thresholds over 25%. Nevertheless, the original HEART classified patients better than HEART-adj (net reclassification improvement = 14.1%). CONCLUSION: The previously chosen weights of the 5 elements of the HEART score are supported by multivariable statistical analyses, although some improvement in calibration and discrimination is possible by adapting the score. The gain in clinical usefulness is relatively small and supports the use of either the original or adjusted HEART score in daily practice.

This study aims to determine whether genetic variants that influence CYP3A4 expression are associated with platelet reactivity in clopidogrel-treated patients undergoing elective percutaneous coronary intervention (PCI), and to evaluate the influence of statin/fibrate co-medication on these associations. A study cohort was used containing 1124 consecutive elective PCI patients in whom CYP3A4*22 and PPAR-α (G209A and A208G) SNPs were genotyped and the VerifyNow P2Y12 platelet reactivity test was performed. Minor allele frequencies were 0.4% for CYP3A4*22/*22, 6.8% for PPAR-α G209A AA, and 7.0% for PPAR-α A208G GG. CYP3A4*22 was not associated with platelet reactivity. The PPAR-α genetic variants were significantly associated with platelet reactivity (G209A AA: −24.6 PRU [−44.7, −4.6], p = 0.016, A208G GG: −24.6 PRU [−44.3, −4.8], p = 0.015). Validation of these PPAR-α results in two external cohorts, containing 716 and 882 patients, respectively, showed the same direction of effect, although not statistically significant. Subsequently, meta-analysis of all three cohorts showed statistical significance of both variants in statin/fibrate users (p = 0.04 for PPAR-a G209A and p = 0.03 for A208G), with no difference in statin/fibrate non-users. In conclusion, PPAR-α G209A and A208G were associated with lower platelet reactivity in patients undergoing elective PCI who were treated with clopidogrel and statin/fibrate co-medication. Further research is necessary to confirm these findings.

BackgroundDistal forearm fractures are common in children. The reference standard to diagnose these fractures is by conventional radiography, which exposes these patients to harmful radiation. Ultrasound (US) seems to be a good alternative. However, emergency physicians (EPs) in the Netherlands have limited experience in using US for diagnosing fractures in children.ObjectiveThe primary objective was to determine the accuracy of US, performed by a Dutch EP, compared with conventional radiography, in diagnosing distal forearm fractures in children. As a secondary objective, differences in pain scores during the performance of both US and plain radiography were determined.MethodsChildren, aged between 0 and 14 years old, suspected of having a distal forearm fracture were enrolled at the Emergency Department. US and radiographic findings were compared. Statistics for accuracy were calculated. Pain scores were recorded during US and radiography and compared as well. All participating operators received an hour-long pretrial training.Results100 patients were enrolled. The mean age was 9.5 years (SD, 3.6), and 50% were women. Overall diagnostic accuracy was 92% (95% CI 85%-96%). The sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios for US were 95% (95% CI 87% to 99%), 86% (95% CI 71% to 95%), 92% (95% CI 83% to 97%), 91% (95% CI 76% to 98%), 6.86 (95% CI 3.04 to 15.51) and 0.05 (95% CI 0.02 to 0.17), respectively. The pain scores during US and radiographic imaging were 3.3 and 4.6, respectively (pConclusionsIn this study, we showed that US is an accurate method for diagnosing distal forearm fractures in children. The main advantages are that it is radiation-free and rapidly practicable, and that patients experience it as less painful than radiography. Moreover, this study has proven that with minimal experience in US, good diagnostic accuracy can be achieved after brief training.

Aims: Our objectives were to compare effectiveness and long-term prognosis after epicardial thoracoscopic atrial fibrillation (AF) ablation vs. endocardial catheter ablation, in patients with prior failed catheter ablation or high risk of failure. Methods and results: Patients were randomized to thoracoscopic or catheter ablation, consisting of pulmonary vein isolation with optional additional lines (2007–2010). Patients were reassessed in 2016/2017, and those without documented AF recurrence underwent 7-day ambulatory electrocardiography. The primary rhythm outcome was recurrence of any atrial arrhythmia lasting >30 s. The primary clinical endpoint was a composite of death, myocardial infarction, or cerebrovascular event, analysed with adjusted Cox proportional hazard ratios (HRs). One hundred and 24 patients were randomized with 34% persistent AF and mean age 56 years. Arrhythmia recurrence was common at mean follow-up of 7.0 years, but substantially lower with thoracoscopic ablation: 34/61 (56%) compared with 55/63 (87%) with catheter ablation [adjusted HR 0.40, 95% confidence interval (CI) 0.25–0.64; P

Contains fulltext : 215769.pdf (Publisher’s version ) (Closed access) BACKGROUND: Three techniques of magnetic resonance imaging (MRI)-based targeted biopsy (TB) of the prostate exist. There is no superiority regarding diagnostic efficacy of prostate cancer (PCa) detection. OBJECTIVE: To compare adverse events (AEs) among three TB techniques and to evaluate the effect on urinary and erectile function. DESIGN, SETTING, AND PARTICIPANTS: Post hoc analysis of a multicentre randomised controlled trial among men with negative systematic biopsy (SB) and suspicion of PCa. INTERVENTION: In 234 patients, 3-T multiparametric MRI demonstrated PIRADS>/= 3 lesions, and patients were randomised 1:1:1 for TB: transrectal in-bore MRI TB (MRI-TB), transperineal MRI-transrectal ultrasound (TRUS) fusion TB (FUS-TB), and transrectal cognitive TRUS TB (COG-TB). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: AEs (Clavien-Dindo) were compared using Pearson chi-square test. Univariate logistic regression tests were performed for the number of cores, biopsy approach, and usage of anticoagulants. The participants filled in baseline and 30-d postbiopsy International Prostate Symptom Score (IPSS) and International Index of Erectile Function (IIEF-5) questionnaires. The delta between measurements was compared using one-way analysis of variance. RESULTS AND LIMITATIONS: There were significant differences in minor AEs: 53% in MRI-TB, 71% in FUS-TB, and 85% in COG-TB (p

Postoperative coagulopathic bleeding is common in cardiac surgery and associated with increased morbidity and mortality. Platelet function is affected by multiple factors, including patient and procedural characteristics. Point-of-care (POC) multiple electrode aggregometry (MEA) can rapidly detect and quantify platelet dysfunction and could contribute to optimal patient blood management. In patients undergoing CABG and heart valve surgery platelet function was assessed using POC MEA at four different perioperative timepoints in response to stimulation with four specific receptor agonists (ADP, AA, COL, TRAP). Postoperative bleeding was recorded during 24 h after surgery. Regression analyses were performed to establish associations between perioperative platelet function and postoperative blood loss. Ninety-nine patients were included in the study. Fifty-nine patients (60%) were on antiplatelet therapy (APT) at time of surgery. ADP- and AA-induced platelet aggregation declined during CPB and after decannulation from CPB, with a maximum decrease of 55% for ADP (35 vs. 77 AU at baseline

OBJECTIVES: It is unclear whether postoperative infections can be prevented by treating asymptomatic bacteriuria, or whether, on the other hand, such treatment will increase the risk of more serious infection by pathogenic bacteria different from the ones causing bacteriuria. This study aimed to support future treatment decisions for preoperative cardiothoracic surgery patients with asymptomatic bacteriuria, by examining current preoperative practice, in relation to postoperative outcome. METHODS: A retrospective cohort study was conducted. All patients who underwent cardiothoracic surgery in 2011–2013 using extracorporeal circulation in St. Antonius Hospital Nieuwegein, and who preoperatively had nitrituria and/or leucocyturia were included. Exclusion criteria were C-reactive protein level higher than 10 mg/l, emergency surgery, critical preoperative state and/or antibiotic treatment because of other infections. Outcomes were postoperative infections and length of stay. Furthermore, we compared culture results of preoperative urine with postoperative infection sites in order to study the hypothesis of haematogenous spread. RESULTS: One thousand and two patients with leucocyturia or nitrituria were eligible, of whom 3.9% had been treated with antibiotics preoperatively (AB+). Of the 96.1% of patients who had not been treated (AB−), 8.3% had an infection postoperatively, compared with 5.1% in the treatment (AB+) group. This was not statistically significant {odds ratio, corrected for EuroSCORE, 0.53 [95% confidence interval (CI) 0.12–2.24, P= 0.39]}. Length of stay, corrected for EuroSCORE, between the treated (AB+) and the non-treated (AB−) group did not differ, with a hazard ratio of 1.05 (95% CI 0.63–1.75, P= 0.85). As regards bacterial culture results, none of patients not treated with antibiotics preoperatively (AB−) seemed to have a postoperative infection due to haematogenous spread of bacteria from the urinary tract present preoperatively. CONCLUSIONS: The risk of haematogenous spread of bacteria seems to be non-existent in this large cohort of non-treated patients, under our local clinical practice. Based on this current, best available evidence, it seems therefore safe not to treat patients with asymptomatic bacteriuria prior to cardiothoracic surgery. This could also imply that it is safe not to perform routine preoperative urine testing.

Background Mean follow-up in previous studies on the effect of prosthesis–patient mismatch on long-term survival after aortic valve replacement (AVR) is confined to a maximum of one decade. This retrospective longitudinal cohort study was performed to determine the effect on long-term survival of prosthesis–patient mismatch after AVR with a mean follow-up of almost two decades. Methods Kaplan-Meier survival analysis was used to determine long-term survival after AVR in a cohort of 673 consecutive patients, divided into 163 patients (24.2%) with prosthesis–patient mismatch (indexed effective orifice area ≤0.85 cm 2 /m 2 ) and 510 patients (75.8%) without prosthesis–patient mismatch (indexed effective orifice area >0.85 cm 2 /m 2 ). Effective orifice area values of the prosthetic valves were retrieved from the literature or obtained from the charts of the prosthetic valve manufacturers. Cox multiple regression analysis was used to identify possible independent predictors, including prosthesis–patient mismatch, of decreased long-term survival. Results Median sizes of the implanted mechanical (n = 430) and biologic (n = 243) prostheses were 25 and 23 mm, respectively. Mean follow-up after AVR was 17.8 ± 1.8 years. Prosthesis–patient mismatch was not an independent predictor of decreased long-term survival (hazard ratio, 0.828; 95% confidence interval, 0.669 to 1.025; p = 0.083). Severe prosthesis–patient mismatch (indexed effective orifice area ≤0.65 cm 2 /m 2 ), occurring in only 17 patients (2.5%), showed an insignificant trend toward decreased long-term survival (hazard ratio, 1.68; 95% confidence interval, 0.97 to 2.91; p = 0.066). Conclusions Prosthesis–patient mismatch was not an independent predictor of decreased long-term survival after AVR.

OBJECTIVES: The totally thoracoscopic left atrial Maze (TT-Maze) is a relatively new surgical solution for the treatment of atrial fibrillation (AF). The procedure consists of a complete left atrial Maze, which is performed by video-assisted thoracoscopy with the use of radiofrequency ablation. We describe our rhythm results as well as our learning curve experience of the TT-Maze. METHODS: To evaluate the learning curve, all consecutive patients who underwent a TT-Maze and were operated by one surgeon (Bart P. Van Putte) were included in the study. The endpoint of surgery was sinus rhythm with a bidirectional block of the box and pulmonary veins. RESULTS: A total of 83 patients were included. Fifty percent of the patients had paroxysmal AF. The mean indexed left atrial volume was 44 ± 15 ml/m 2 and 38% of the patients had a previous catheter ablation for AF. During a mean follow-up of 10.9 ± 4.9 months, there were no major events. At latest follow-up, 82% of the patients did not have a single registration of AF or other atrial tachyarrhythmias longer than 30 s. Patients without AF were also free from anti-arrhythmic drugs in 90% of the cases, free from coumadins or direct oral anticoagulants in 63% of the cases and free from both in 58% of the cases. CONCLUSIONS: After almost 1-year follow-up, the TT-Maze is proved to be a successful, safe and reproducible strategy for the treatment of all types of AF including patients with enlarged left atria and previously failed catheter ablation.

ObjectiveTo assess whether laparoscopic cholecystectomy is superior to percutaneous catheter drainage in high risk patients with acute calculous cholecystitis.DesignMulticentre, randomised controlled, superiority trial.Setting11 hospitals in the Netherlands, February 2011 to January 2016.Participants142 high risk patients with acute calculous cholecystitis were randomly allocated to laparoscopic cholecystectomy (n=66) or to percutaneous catheter drainage (n=68). High risk was defined as an acute physiological assessment and chronic health evaluation II (APACHE II) score of 7 or more.Main outcome measuresThe primary endpoints were death within one year and the occurrence of major complications, defined as infectious and cardiopulmonary complications within one month, need for reintervention (surgical, radiological, or endoscopic that had to be related to acute cholecystitis) within one year, or recurrent biliary disease within one year.ResultsThe trial was concluded early after a planned interim analysis. The rate of death did not differ between the laparoscopic cholecystectomy and percutaneous catheter drainage group (3% v 9%, P=0.27), but major complications occurred in eight of 66 patients (12%) assigned to cholecystectomy and in 44 of 68 patients (65%) assigned to percutaneous drainage (risk ratio 0.19, 95% confidence interval 0.10 to 0.37; Pv 5%, Pv 5 days, PConclusionLaparoscopic cholecystectomy compared with percutaneous catheter drainage reduced the rate of major complications in high risk patients with acute cholecystitis.Trial registrationDutch Trial Register NTR2666.

Background— Survival outcome after MitraClip treatment, compared with surgical or conservative treatment, is not well defined. We examined survival after MitraClip treatment in a large multicenter real-life setting. Methods and Results— We retrospectively formed matched high-risk surgically and conservatively treated control cohorts to compare to a high-risk MitraClip cohort. One thousand thirty-six patients were included in 4 Dutch centers, of which 568 were treated with the MitraClip. The observed survival at 5-year follow-up in our MitraClip cohort was low (39.8%) but was comparable to our conservative cohort (40.5%). Observed 5-year survival for our surgical cohort was 76.3%. However, there were significant differences between the baseline characteristics of the 3 studied cohorts, with the MitraClip cohort having the highest comorbidity burden. After adjusting for baseline differences by using Cox regression, the MitraClip and surgical cohorts showed similar survival ratios (hazard ratio, 0.92; 95% confidence interval, 0.67–1.26; P =0.609), whereas both showed a lower mortality hazard when compared with conservative treatment (hazard ratio, 0.61; 95% confidence interval, 0.49–0.77; P P Conclusions— This matched analysis suggests a lower mortality hazard for MitraClip intervention in a high-risk population with symptomatic mitral regurgitation when compared with conservative management alone.

SummaryPatients exhibiting high on-clopidogrel platelet reactivity (HPR) are at an increased risk of atherothrombotic events following percutaneous coronary interventions (PCI). The use of concomitant medication which is metabolised by the hepatic cytochrome P450 system, such as phenprocoumon, is associated with HPR. We assessed the level of platelet reactivity on clopidogrel in patients who received concomitant treatment with acenocoumarol (another coumarin derivative). Patients scheduled for PCI were included in a prospective, single centre, observational registry. Patients who were adequately pre-treated with clopidogrel were eligible for this analysis, which included 1,582 patients, of whom 104 patients (6.6 %) received concomitant acenocoumarol treatment. Platelet reactivity, as measured with the VerifyNow P2Y12 assay and expressed in P2Y12 Reaction Units (PRU), was significantly higher in patients on concomitant acenocoumarol treatment (mean PRU 229 ± 88 vs 187 ± 95; p< 0.001). In patients with concomitant acenocoumarol use, the proportion of patients with HPR was higher, defined as PRU > 208 (57.7 % vs 41.1 %; p=0.001) and PRU236 (49.0 % vs 31.4 %; p< 0.001). In multivariable analysis, concomitant acenocoumarol use was independently associated with a higher PRU and the occurrence of HPR defined as PRU236 (OR 2.00, [1.07–3.79]), but not with HPR defined as PRU > 208 (OR 1.37, [0.74–2.54]). PRU also was significantly increased after 1:1 propensity matching (+28.2; p< 0.001). As this was an observational study, confounding by indication cannot be excluded, although multivariable analyses and propensity matching were performed. The impact of the findings from this hypothesis-generating study on clinical outcome requires further investigation.

Item does not contain fulltext AIMS: To investigate the optimal periprocedural antithrombotic strategy in patients on long-term oral anticoagulation (OAC) who require percutaneous coronary intervention with stenting. METHODS AND RESULTS: The WOEST study was a randomised controlled trial which recruited 573 patients on long-term OAC who underwent PCI. The periprocedural treatment strategy was left to the operator's discretion. To assess the safety and feasibility of uninterrupted oral anticoagulation (UAC) and bridging therapy (BT), bleeding complications and MACCE were assessed in patients treated according to UAC (n=241) and BT (n=322) regimen. After 30 days, as well as after one year, there were no significant differences in bleeding complications (HR 1.14, 95% CI: 0.77-1.69, p=0.51, and HR 1.26, 95% CI: 0.94-1.69, p=0.12, respectively) and MACCE. MACCE tended to be less frequent in the UAC group (respectively HR 0.48, 95% CI: 0.15-1.51, p=0.21, and HR 0.72, 95% CI: 0.46-1.14, p=0.16). Additionally, adjustment with a propensity score revealed no significant differences. Periprocedural INR was not associated with bleeding or MACCE. CONCLUSIONS: In the WOEST study, UAC was not associated with an increase of bleeding or MACCE compared to bridging therapy. This is the largest study up to now to support the current guidelines. The WOEST trial is registered with ClinicalTrials.gov, number NCT00769938.

Objectives To estimate the incidence of stent thrombosis (ST) after early discontinuation of clopidogrel. Background Premature discontinuation of clopidogrel is the strongest risk factor for ST. In contrast, recent studies suggest that shorter dual antiplatelet therapy (DAPT) can be discontinued as soon as 3 months after stenting. However, these studies included very few ACS patients and were not powered for ST. Hence, little is known about the occurrence of ST in high-risk populations when DAPT is discontinued early. Methods This is a subanalysis of The Dutch ST Registry 437 ST cases (mainly first-generation DES and BMS). Acute coronary syndrome was the indication for index-PCI in 74% of the patients. Clopidogrel discontinuation rates in ST patients and matched controls were used to calculate the absolute incidence of ST after early clopidogrel discontinuation. Results The overall rate of ST after cessation of clopidogrel was 4.6% (95%CI: 3.9-5.4%), as compared to 1.7% (95%CI: 1.5-1.9%) in patients who did not discontinue clopidogrel. The incidence of ST was 35.4% when clopidogrel was discontinued in the first 30 days after index-PCI declining to 11.7% when clopidogrel was discontinued in the first 180 days. Conclusions This dedicated ST registry shows that ST rates were very high when clopidogrel was discontinued before 6 months after index-PCI and therefore suggests that clopidogrel discontinuation in the first 6 months after ACS should be avoided.

Antiplatelet therapy plays a pivotal role in patients with an ST-segment elevation myocardial infarction (STEMI) to prevent further atherothrombotic events, such as stent thrombosis. Although the risk of stent thrombosis is highest in the first hours after primary percutaneous coronary intervention (pPCI), little is known about when an adequate level of platelet inhibition is achieved following a clopidogrel or ticagrelor loading dose in STEMI patients. Patients presenting with STEMI in whom pPCI was performed and who were loaded with 600 mg clopidogrel or 180 mg ticagrelor were eligible for enrolment in this nonrandomized, open label, single-center study. Platelet reactivity was measured before PCI, 6 and 24 hours after loading dose and after 2, 7, and 14 days, using the VerifyNow P2Y12 assay as well as 20 µmol/L adenosine diphosphate stimulated light transmittance aggregometry (LTA). We analyzed the time until a VerifyNow result of

Objectives: The PLATO trial revealed superiority of ticagrelor over clopidogrel for the prevention of atherothrombotic events in patients with acute coronary syndrome. However, adverse events such as bleeding, dyspnea, and bradycardia were frequently reported, potentially leading to excess early ticagrelor discontinuation (ETD), later confirmed in the PEGASUS trial. We here evaluated the incidence and causes for ETD in a real-world patient cohort in a high-volume nonacademic percutaneous coronary intervention center in the Netherlands. Methods: In a retrospective single-center registry, all patients discharged from the hospital with a new ticagrelor prescription were screened for ETD. Follow-up data were obtained using the hospital electronic patient file records and confirmed by telephone contact with the patient and/or general practitioner, if necessary, to complement the data. Results: Ticagrelor was prescribed in 354 patients between December 2011 and December 2012. The follow-up data were available in 301 patients with a mean follow-up duration of 330 days. ETD or switching to another antiplatelet agent occurred in 73 patients (24.3%), mostly due to dyspnea (11.6%), bleeding (3.7%), or planned major surgery (2.7%). Conclusions: Almost one quarter of ticagrelor patients were discontinued prematurely or switched to another antiplatelet agent within 1 year, mostly due to dyspnea or bleeding.