Systematic Assessment of Shock Severity in Postoperative Cardiac Surgery Patients.

BACKGROUND: The Society for Cardiovascular Angiography and Interventions (SCAI) shock classification has been shown to provide robust mortality risk stratification in a variety of cardiovascular patients. OBJECTIVES: This study sought to evaluate the SCAI shock classification in postoperative cardiac surgery intensive care unit (CSICU) patients. METHODS: This study retrospectively analyzed 26,792 postoperative CSICU admissions at a heart center between 2012 and 2022. Patients were classified into SCAI shock stages A to E using electronic health record data. Moreover, the impact of late deterioration (LD) as an additional risk modifier was investigated. RESULTS: The proportions of patients in SCAI shock stages A to E were 24.4%, 18.8%, 8.4%, 35.5%, and 12.9%, and crude hospital mortality rates were 0.4%, 0.6%, 3.3%, 4.9%, and 30.2%, respectively. Similarly, the prevalence of postoperative complications and organ dysfunction increased across SCAI shock stages. After multivariable adjustment, each higher SCAI shock stage was associated with increased hospital mortality (adjusted OR: 1.26-16.59) compared with SCAI shock stage A, as was LD (adjusted OR: 8.2). The SCAI shock classification demonstrated a strong diagnostic performance for hospital mortality (area under the receiver operating characteristic: 0.84), which noticeably increased when LD was incorporated into the model (area under the receiver operating characteristic: 0.90). CONCLUSIONS: The SCAI shock classification effectively risk-stratifies postoperative CSICU patients for mortality, postoperative complications, and organ dysfunction. Its application could, therefore, be extended to the field of cardiac surgery as a triage tool in postoperative care and as a selection criterion in research.

Mechanistic assessment and ablation of left ventricular assist device related ventricular tachycardia in patients with severe heart failure.

Aims: Left-ventricular-assist-devices (lvad) are an established treatment for patients with severe heart failure with reduced ejection fraction (HF) and reduce mortality. However, HF patients have significant substrate for ventricular tachycardia (VT) and the lvad itself might be pro-arrhythmogenic. We investigated the mechanism of VT in lvad-patients in relation to the underlying etiology and provide in silico and ex-vivo data for ablation in these HF patients. Methods and Results: We retrospectively analyzed invasive electrophysiological (EP) studies of 17 patients with VT and lvad. The mechanism of VT was determined using electroanatomical, entrainment and activation time mapping. Ischemic cardiomyopathy was present in 70% of patients. VT originated from the lvad region in >30%. 1/6 patients with VT originating from the lvad region had episodes before lvad implantation, while 7/11 patients with VT originating from other regions had episodes before implantation. Number and time of radiofrequency (RF)-ablation lesions were not different between VTs originating from the lvad or other regions. Long-term freedom from VT was 50% upon ablation in patients with VT originating from the lvad region and 64% if ablation was conducted in other regions. To potentially preemptively mitigate lvad related VT in patients undergoing lvad implantation, we obtained in silico derived data and performed ex-vivo experiments targeting ventricular myocardium. Of the tested settings, application of 25 W for 30 s was safe and associated with optimal lesion characteristics. Conclusion: A significant percentage of patients with lvad undergoing VT ablation exhibit arrhythmia originating in close vicinity to the device and recurrence rates are high. Based on in silico and ex-vivo data, we propose individualized RF-ablation in selected patients at risk for/with lvad related VT.

The DZHK research platform: maximisation of scientific value by enabling access to health data and biological samples collected in cardiovascular clinical studies.

The German Centre for Cardiovascular Research (DZHK) is one of the German Centres for Health Research and aims to conduct early and guideline-relevant studies to develop new therapies and diagnostics that impact the lives of people with cardiovascular disease. Therefore, DZHK members designed a collaboratively organised and integrated research platform connecting all sites and partners. The overarching objectives of the research platform are the standardisation of prospective data and biological sample collections among all studies and the development of a sustainable centrally standardised storage in compliance with general legal regulations and the FAIR principles. The main elements of the DZHK infrastructure are web-based and central units for data management, LIMS, IDMS, and transfer office, embedded in a framework consisting of the DZHK Use and Access Policy, and the Ethics and Data Protection Concept. This framework is characterised by a modular design allowing a high standardisation across all studies. For studies that require even tighter criteria additional quality levels are defined. In addition, the Public Open Data strategy is an important focus of DZHK. The DZHK operates as one legal entity holding all rights of data and biological sample usage, according to the DZHK Use and Access Policy. All DZHK studies collect a basic set of data and biosamples, accompanied by specific clinical and imaging data and biobanking. The DZHK infrastructure was constructed by scientists with the focus on the needs of scientists conducting clinical studies. Through this, the DZHK enables the interdisciplinary and multiple use of data and biological samples by scientists inside and outside the DZHK. So far, 27 DZHK studies recruited well over 11,200 participants suffering from major cardiovascular disorders such as myocardial infarction or heart failure. Currently, data and samples of five DZHK studies of the DZHK Heart Bank can be applied for.

Periareolar endoscopic minimally invasive cardiac surgery: postoperative scar assessment analysis.

OBJECTIVES: The standard approach for minimally invasive cardiac surgery (MICS) for repair of the atrioventricular valves is a right lateral minithoracotomy. In this study, we report our experience with a periareolar endoscopic approach, which aims at an optimal cosmetic outcome while preserving optimal clinical outcomes. METHODS: All patients underwent periareolar endoscopic MICS using high-definition three-dimensional endoscopic visualization without additional rib-spreading. Patients presented with degenerative and/or functional mitral regurgitation. Patients undergoing concomitant tricuspid valve surgery, cryo-ablation, patent foramen ovale closure, left atrial appendage occlusion and/or left atrial myxoma extirpation were included. This descriptive article analysed the aesthetic and functional outcome of the periareolar scar using 5 most common and clinimetrically sound scar assessment scales. For statistical analysis of the scar assessment grading scales, box and whisker plots were calculated depicting median, interquartile range and high and low range data points. RESULTS: Median scar assessment scale scores for n = 100 male patients (response rate 100/109; 91.7%) were 2 [1, 4], 7.5 [6, 9], 11 [8, 14], 3 [2, 3] and 10 [9, 11] for the Vancouver scar scale, Manchester scar scale, patient scar assessment scale, Stony brook scar evaluation scale and Dermatology Quality of Life Index scale, respectively. Ninety-seven patients received mitral valve repair, 7 mitral valve replacement, whereas 5 had left atrial myxoma extirpation. Concomitant tricuspid annuloplasty, cryo-ablation, left atrial appendage occlusion and patent foramen ovale closure surgery were performed in 12, 29, 5 and 8 patients, respectively. Median procedure, cardiopulmonary bypass and cross-clamp times were 169.5 [154.3, 189.3], 111.5 [97, 127], and 68.5 [58.8, 81] min, respectively. CONCLUSIONS: Periareolar endoscopic MICS is safe and cosmetically appealing. It is feasible and allows for complex mitral valve repair, mitral valve replacement and concomitant surgery. Data from 5 scar assessment scales suggest that this technique delivers patient-satisfying results regarding functional and cosmetic outcomes.

Comparison of feasibility and results of frailty assessment methods prior to left ventricular assist device implantation.

AIMS: Assessing frailty and sarcopenia is considered a valuable cornerstone of perioperative risk stratification in advanced heart failure patients. The lack of an international consensus on a diagnostic standard impedes its implementation in the clinical routine. This study aimed to compare the feasibility and prognostic impact of different assessment tools in patients undergoing continuous-flow left ventricular assist device (cf-LVAD) implantation. METHODS AND RESULTS: We prospectively compared feasibility and prognostic values of six frailty/sarcopenia assessment methods in 94 patients prior to cf-LVAD implantation: bioelectrical impedance analysis (BIA), computed tomography (CT)-based measurement of two muscle areas/body surface area [erector spinae muscle (TMESA/BSA) and iliopsoas muscle (TPA/BSA)], physical performance tests [grip strength, 6 min walk test (6MWT)] and Rockwood Clinical Frailty Scale (RCFS). Six-month mortality and/or prolonged ventilation time >95 h was defined as the primary endpoint. BIA and CT showed full feasibility (100%); physical performance and RCFS was limited due to patients' clinical status (feasibility: 87% grip strength, 62% 6MWT, 88% RCFS). Phase angle derived by BIA showed the best results regarding the prognostic value for 6 month mortality and/or prolonged ventilation time >95 h (odds ratio (OR) 0.66 [95% confidence interval (CI): 0.46-0.92], P = 0.019; area under the curve (AUC) 0.65). It provided incremental value to the clinical risk assessment of EuroSCORE II: C-index of the combined model was 0.75 [95% CI; 0.651-0.848] compared with C-index of EuroSCORE II alone, which was 0.73 (95% CI: 0.633-0.835). Six-month survival was decreased in patients with reduced body cell mass derived by BIA or reduced muscle area in the CT scan compared with patients with normal values: body cell mass 65% (95% CI: 51.8-81.6%) vs. 83% (95% CI: 74.0-93.9%); P = 0.03, TMESA/BSA 65% (95% CI: 51.2-82.2%) vs. 82% (95% CI: 73.2-93.0%); P = 0.032 and TPA/BSA 66% (95% CI: 53.7-81.0%) vs. 85% (95% CI: 75.0-95.8%); P = 0.035. CONCLUSIONS: Bioelectrical impedance analysis parameters and CT measurements were shown to be suitable to predict 6-month mortality and/or prolonged ventilation time >95 h in patients with advanced heart failure prior to cf-LVAD implantation. Phase angle had the best predictive capacity and sarcopenia diagnosed by reduced body cell mass in BIA or muscle area in CT was associated with a decreased 6 month survival.

Computed Tomography-Based Assessment of Transvalvular Pressure Gradient in Aortic Stenosis.

Background: In patients with aortic stenosis, computed tomography (CT) provides important information about cardiovascular anatomy for treatment planning but is limited in determining relevant hemodynamic parameters such as the transvalvular pressure gradient (TPG). Purpose: In the present study, we aimed to validate a reduced-order model method for assessing TPG in aortic stenosis using CT data. Methods: TPGCT was calculated using a reduced-order model requiring the patient-specific peak-systolic aortic flow rate (Q) and the aortic valve area (AVA). AVA was determined by segmentation of the aortic valve leaflets, whereas Q was quantified based on volumetric assessment of the left ventricle. For validation, invasively measured TPGcatheter was calculated from pressure measurements in the left ventricle and the ascending aorta. Altogether, 84 data sets of patients with aortic stenosis were used to compare TPGCT against TPGcatheter. Results: TPGcatheter and TPGCT were 50.6 ± 28.0 and 48.0 ± 26 mmHg, respectively (p = 0.56). A Bland-Altman analysis revealed good agreement between both methods with a mean difference in TPG of 2.6 mmHg and a standard deviation of 19.3 mmHg. Both methods showed good correlation with r = 0.72 (p < 0.001). Conclusions: The presented CT-based method allows assessment of TPG in patients with aortic stenosis, extending the current capabilities of cardiac CT for diagnosis and treatment planning.

Myocardial Work Assessment for the Prediction of Prognosis in Advanced Heart Failure.

Objectives: The aim of this study was to investigate whether echocardiographic assessment of myocardial work is a predictor of outcome in advanced heart failure. Background: Global work index (GWI) and global constructive work (GCW) are calculated by means of speckle tracking, blood pressure measurement, and a normalized reference curve. Their prognostic value in advanced heart failure is unknown. Methods: Cardiopulmonary exercise testing and echocardiography with assessment of GWI and GCW was performed in patients with advanced heart failure caused by ischemic heart disease or dilated cardiomyopathy (n = 105). They were then followed up repeatedly. The combined endpoint was all-cause death, implantation of a left ventricular assist device, or heart transplantation. Results: The median patient age was 54 years (interquartile range [IQR]: 48-59.9). The mean left ventricular ejection fraction was 27.8 ± 8.2%, the median NT-proBNP was 1,210 pg/ml (IQR: 435-3,696). The mean GWI was 603 ± 329 mmHg% and the mean GCW was 742 ± 363 mmHg%. The correlation between peak oxygen uptake and GWI as well as GCW was strongest in patients with ischemic cardiomyopathy (r = 0.56, p = 0.001 and r = 0.53, p = 0.001, respectively). The median follow-up was 16 months (IQR: 12-18.5). Thirty one patients met the combined endpoint: Four patients died, eight underwent transplantation, and 19 underwent implantation of a left ventricular assist device. In the multivariate Cox regression analysis, only NYHA class, NT-proBNP and GWI (hazard ratio [HR] for every 50 mmHg%: 0.85; 95% CI: 0.77-0.94; p = 0.002) as well as GCW (HR for every 50 mmHg%: 0.86; 95% CI: 0.79-0.94; p = 0.001) were identified as independent predictors of the endpoint. The cut-off value for predicting the outcome was 455 mmHg% for GWI (AUC: 0.80; p < 0.0001; sensitivity 77.4%; specificity 71.6%) and 530 mmHg% for GCW (AUC: 0.80; p < 0.0001; sensitivity 74.2%; specificity 78.4%). Conclusions: GWI and GCW are powerful predictors of outcome in patients with advanced heart failure.

Assessment of 10-Year Left-Ventricular-Remodeling by CMR in Patients Following Aortic Valve Replacement.

Aims: Aortic valve replacement (AVR) may result in reverse cardiac remodeling. We aimed to assess long-term changes in the myocardium following AVR by Cardiac Magnetic Resonance Imaging (CMR). Methods: We prospectively observed the long-term left ventricular (LV) function and structure of 27 patients with AVR [n = 19 with aortic stenosis (AS); n = 8 with aortic regurgitation (AR)] by CMR. Patients underwent CMR before, as well as 1, 5, and 10 years after AVR. We evaluated clinical parameters, LV volumes, mass, geometry, ejection fraction (EF), global myocardial longitudinal strain (MyoGLS), global myocardial circular strain (MyoGCS), hemodynamic forces (HemForces), and Late Gadolinium Enhancement (LGE). Results: The median of LVMI, EDVI, and ESVI decreased in both groups. Patients with AR had higher initial values of EDVI and ESVI and showed a more prominent initial reduction. In AS, MyoGLS improved already after 1 year and remained constant afterward, whereas, in AR no improvement of MyoGLS was found. MyoGCS remained unchanged in the AS group but deteriorated in the AR group over 10 years. Ejection fraction (EF) was higher in AS patients compared to AR 10 years post-AVR. Late gadolinium enhancement (LGE) could be found more frequently in AS patients. Conclusion: CMR was well suited to investigate myocardial changes over a 10-year follow up period in patients with aortic valve disease. Regarding the long-term functional changes following AVR, patients with AR seemed to benefit less from AVR compared to AS patients. Fibrosis was more common in AS, but this did not reflect functional evolution in these patients. Close monitoring seems indispensable to avoid irreversible structural damage of the heart and to perform AVR at an appropriate stage.

Disproportionate mitral regurgitation: another myth? A critical appraisal of echocardiographic assessment of functional mitral regurgitation.

The contradictory findings of recent prospective randomized controlled trials assessing the impact of percutaneous edge-to-edge repair in patients with functional or secondary mitral regurgitation have triggered a lively discussion about an "integrated" echocardiographic approach for grading severity of mitral regurgitation. In the MITRA-FR trial, the COAPT trial and the REDUCE-FMR trial echocardiographic assessment of the severity of mitral regurgitation was consistent with principles set forth by the current echocardiographic guidelines and analysed in its best settings by expert international leaders in the field of echocardiography. However, serious inconsistencies appeared in the presented echocardiographic assessments regarding cardiac output and regurgitant fraction. A new term "disproportionate functional mitral regurgitation" was introduced describing a situation where the increase of effective regurgitant orifice area exceeds the enlargement of the left ventricular end-diastolic volumes. Further discussion resulted in the idea of a "new conceptional framework" for distinguishing "proportionate" and "disproportionate" functional mitral regurgitation. The aim of this viewpoint is to dispute conclusions based on the term "disproportionate" mitral regurgitation. A "disproportionate" FMR is highly questionable because disproportionateness of flow in communication vessels cannot exist. In addition, a proposal of echocardiographic assessment based on a conventional comprehensive transthoracic echocardiography is given to avoid obvious hemodynamic contradictions.

Validity of visual assessment of aortic valve morphology in patients with aortic stenosis using two-dimensional echocardiography.

The diagnostic value of a visual assessment of aortic valve (AV) morphology for grading aortic stenosis (AS) remains unclear. A visual score (VS) for assessing the AV was developed and its reliability with respect to Doppler measurements and the calcium score (ctCS) derived by multislice computed tomography was evaluated. 99 Patients with AS of various severity and 38 patients without AS were included in the analysis. Echocardiographic studies were evaluated using the new VS which includes echogenicity, thickening, localization of lesions and leaflet mobility, with a total score ranging from 0 to 11. The association of VS with ctCS and the severity of AS was analyzed. There was a significant correlation of VS with AV hemodynamic parameters and with ctCS. The cut-off value for the detection of AS of any grade was a VS of 6 (sensitivity 95%, specificity 85% for women; sensitivity 85%, specificity 88% for men). A VS of 9 for women and of 10 for men was able to predict severe AS with a high specificity (96% in women and 94% in men, AUC 0.8 and 0.86, respectively). The same cut-off values were identified for the detection of ctCS of ≥ 1600 AU and ≥ 3000 AU with a specificity of 77% and 82% (AUC 0.69 and 0.81, respectively). Assessment of aortic valve morphology can serve as an additional diagnostic tool for the detection of AS and an estimation of its severity.

Characteristics of Contemporary Randomized Clinical Trials and Their Association With the Trial Funding Source in Invasive Cardiovascular Interventions.

Importance: Changes in evidence-based practice and guideline recommendations depend on high-quality randomized clinical trials (RCTs). Commercial device and pharmaceutical manufacturers are frequently involved in the funding, design, conduct, and reporting of trials, the implications of which have not been recently analyzed. Objective: To evaluate the design, outcomes, and reporting of contemporary randomized clinical trials of invasive cardiovascular interventions and their association with the funding source. Design, Setting, and Participants: This cross-sectional study analyzed published RCTs between January 1, 2008, to May 31, 2019. The trials included those involving coronary, vascular and structural interventional cardiology, and vascular and cardiac surgical procedures. Main Outcomes and Measures: We assessed (1) trial characteristics, (2) finding of a statistically significant difference in the primary end point favoring the experimental intervention, (3) reporting of implied treatment advantage in trials without significant differences in primary end point, (4) existence of major discrepancies between registered and published primary outcomes, (5) number of patients whose outcomes would need to switch from a nonevent to an event to convert a significant difference in primary end point to nonsignificant, and (6) association with funding source. Results: Of the 216 RCTs analyzed, 115 (53.2%) reported having commercial sponsorship. Most trials had 80% power to detect an estimated treatment effect of 30%, and 128 trials (59.3%) used composite primary end points. The median (interquartile range [IQR]) sample size was 502 (204-1702) patients, and the median (IQR) follow-up duration was 12 (1.0-14.4) months. Overall, 123 trials (57.0%) reported a statistically significant difference in the primary outcome favoring the experimental intervention; reporting strategies that implied an advantage were identified in 55 (65.5%) of 84 trials that reported nonsignificant differences. Commercial sponsorship was associated with a statistically significantly greater likelihood of favorable outcomes reporting (exponent of regression coefficient ß, 2.80; 95% CI, 1.09-7.18; P = .03) and with the reporting of findings that are inconsistent with the trial results. Discrepancies between the registered and published primary outcomes were found in 82 trials (38.0%), without differences in trial sponsorship. A median (IQR) number of 5 (2.8-12.5) patients experiencing a different outcome would have change statistically significant results to nonsignificant. Commercial sponsorship was associated with a greater number of patients (exponent of regression coefficient ß, 1.29; 95% CI, 1.00-1.66; P = .04). Conclusions and Relevance: These results suggest that contemporary RCTs of invasive cardiovascular interventions are relatively small and fragile, have short follow-up, and have limited power to detect large treatment effects. Commercial support appeared to be associated with differences in trial design, results, and reporting.

Assessment of Global Longitudinal and Circumferential Strain Using Computed Tomography Feature Tracking: Intra-Individual Comparison with CMR Feature Tracking and Myocardial Tagging in Patients with Severe Aortic Stenosis.

In this study, we used a single commercially available software solution to assess global longitudinal (GLS) and global circumferential strain (GCS) using cardiac computed tomography (CT) and cardiac magnetic resonance (CMR) feature tracking (FT). We compared agreement and reproducibility between these two methods and the reference standard, CMR tagging (TAG). Twenty-seven patients with severe aortic stenosis underwent CMR and cardiac CT examinations. FT analysis was performed using Medis suite version 3.0 (Leiden, The Netherlands) software. Segment (Medviso) software was used for GCS assessment from tagged images. There was a trend towards the underestimation of GLS by CT-FT when compared to CMR-FT (19.4 ± 5.04 vs. 22.40 ± 5.69, respectively; p = 0.065). GCS values between TAG, CT-FT, and CMR-FT were similar (p = 0.233). CMR-FT and CT-FT correlated closely for GLS (r = 0.686, p < 0.001) and GCS (r = 0.707, p < 0.001), while both of these methods correlated moderately with TAG for GCS (r = 0.479, p < 0.001 for CMR-FT vs. TAG; r = 0.548 for CT-FT vs. TAG). Intraobserver and interobserver agreement was excellent in all techniques. Our findings show that, in elderly patients with severe aortic stenosis (AS), the FT algorithm performs equally well in CMR and cardiac CT datasets for the assessment of GLS and GCS, both in terms of reproducibility and agreement with the gold standard, TAG.

Echocardiographic assessment of functional mitral regurgitation: opening Pandora's box?

Two recent trials of transcatheter mitral-valve repair in patients with functional mitral regurgitation (FMR) presented opposing results for the MitraClip® compared to medical therapy alone. The conflicting results gave rise to intensive discussions about assessment of mitral valve regurgitation (MR). A recent editorial viewpoint provided a potential explanation presenting a new pathophysiologic concept. However, the echocardiographic characterization of both trials' patients is inconsistent and the discussed concepts appear to suffer from plausibility weaknesses. It is well conceivable that limitations in the echocardiographic assessment of the trial patients introduced a bias regarding the selection of patients with severe (or less severe) MR that may be a more plausible explanation for the differences in outcome. We here illustrate our viewpoint regarding the two MitraClip trials and also illustrate the difficulties in assessing functional MR properly. It may indeed be "opening Pandora's box", but we will also make an attempt to provide a solution.

Frailty is a predictor of short- and mid-term mortality after elective cardiac surgery independently of age.

OBJECTIVES: Assessment of perioperative risk of elderly patients in cardiac surgery is difficult, and most of the common risk scores show over- or underestimation. Two frailty scores, the comprehensive assessment of frailty (CAF) score and the Frailty predicts death One yeaR after CArdiac Surgery Test (FORECAST), were developed as additional tools to estimate the preoperative mortality risk, taking into consideration the frailty status of elderly patients. METHODS: Four hundred and fifty patients who were referred for elective cardiac surgery were included. All the patients were assessed with the CAF test and the FORECAST. Thirty-day and 1-year mortality were evaluated by telephone interview. Univariate and bivariate logistic regression were performed to test the predictive power of the tests on mortality. Correlation of the scores with age was calculated with Spearman ranks. Three commensurate groups were built for each of the frailty scores and the outcome was compared between the groups. All analyses were performed for Society of Thoracic Surgeons (STS) and European System for Cardiac Operative Risk Evaluation (EuroSCORE) accordingly. RESULTS: A total of 227 male and 223 female patients were included. Thirty-day mortality was 6.1%, and 1-year mortality was 13.3%. Logistic regression showed that both scores are able to predict 30-day as well as 1-year mortality. Bivariate logistic regression showed that both frailty scores give relevant additional information to the STS and EuroSCORE for the prediction of 1-year mortality. The frailty scores were only weakly correlated with age in contrast to STS and EuroSCORE and therefore can be used as indicator of the biological age of patients besides the numerical age. Survival up to 1 year was relevantly reduced in the group of patients with the higher frailty scores. CONCLUSIONS: CAF and FORECAST are additional tools to evaluate elderly patients adequately before elective cardiac surgery, and showed an association with short- and mid-term mortality independently of age.

Transvenous lead extractions: comparison of laser vs. mechanical approach.

AIMS: In this retrospective study we compared different lead extraction techniques. METHODS AND RESULTS: Between January 2009 and December 2012 we performed transvenous lead extraction procedures on 206 leads in 122 patients. Mean implant duration (MID) was 69.6 months (1-384 months). Leads with lead implant duration ≥ 12 months were assigned to groups according to the extraction technique: Group A: no extraction tool; Group B: laser approach; and Group C: mechanical approach. Overall clinical success was 93.3%. Group A showed a significantly lower MID [38.1 (19-122) months] compared with Groups B and C [83.1 (13-168) months; P < 0.0001 vs. 95.4 (12-384) months; P < 0.0001]. Mean implant duration between Groups B and C did not differ significantly (P = 0.28). Clinical and complete procedural success was 100% in Group A. Clinical success rate was higher in Group C than in Group B (97.0 vs. 76.9%, P = 0.018). Complete procedural success did not differ significantly between Groups B and C (88.9 vs. 76.9%; P = 0.132). In Groups B and C, absence of complete procedural success occurred in long implanted leads (MID 107.8 ± 36.4 and 137.6 ± 89.2 months). Relative costs per extracted lead were 49% higher in Group B than in Group C. CONCLUSION: In case of long implanted leads a laser and a mechanical approach are comparable in complete procedural success and safety. Clinical success and cost effectiveness analysis favours the mechanical approach. Regardless of the extraction technique efficacy and safety optimization has to focus on long implanted leads.

On cell separation with topographically engineered surfaces.

BACKGROUND: Topographical modifications of the surface influence several cell functions and can be exploited to modulate cellular activities such as adhesion, migration and proliferation. These complex interactions are cell-type specific, therefore engineered substrates featuring patterns of two or more different topographies may be used to obtain the selective separation of different cell lineages. This process has the potential to enhance the performance of biomedical devices promoting, for example, the local coverage with functional tissues while demoting the onset of inflammatory reactions. FINDINGS & CONCLUSIONS: Here we present a computational tool, based on Monte Carlo simulation, which decouples the contribution of cell proliferation and migration and predicts the cell-separation performance of topographically engineered substrates. Additionally, we propose an optimization procedure to shape the topographically engineered areas of a substrate and obtain maximal cell separation.

Assessment of inflammatory response to transfemoral transcatheter aortic valve implantation compared to transapical and surgical procedures: a pilot study.

AIMS: Surgical aortic valve replacement (AVR) has been associated with systemic inflammatory reactions. Yet, the role of inflammation following transcatheter aortic valve implantation (TAVI) has not been fully elucidated. METHODS AND RESULTS: In a total of 40 patients evaluated by the 'heart team,' this retrospective study assessed levels of high-sensitive C-reactive protein (hs-CRP) and leukocyte counts following 'uneventful' AVR and TAVI. Four groups of matched patients were compared (AVR; transapical and transfemoral Edwards SAPIEN [TA ES and TF ES, respectively]; and transfemoral Medtronic CoreValve [TF CV]). A postprocedural increase of both hs-CRP levels and leukocyte counts was observed (P<.001) with peak levels 48 hours after the procedures. Comparing treatment groups, hs-CRP levels at 48 hours were significantly higher following AVR and TA ES compared to TF ES and TF CV (P<.04). Leukocyte counts at 48 hours were higher following TA ES compared to TF ES and TF CV (P<.03). Multivariate analysis incorporating both hs-CRP levels and leukocyte counts confirmed significant differences for all measurements over time (P<.001). Furthermore, the treatment group significantly influenced postprocedural hs-CRP levels and leukocyte counts (P<.001). CONCLUSION: Both AVR and TAVI evoke a postprocedural inflammatory response. Higher hs-CRP levels and leukocyte counts following AVR and apical TAVI suggest less inflammation following femoral procedures.

One-year follow-up of patients undergoing elective cardiac surgery assessed with the Comprehensive Assessment of Frailty test and its simplified form.

Assessment of perioperative risk of elderly patients in cardiac surgery is demanding. Most of the commonly used cardiac surgery risk scores over-or underestimate individual risk. Therefore, we recently developed a 'frailty score', the comprehensive assessment of frailty (CAF) score that showed a good prediction of 30-day mortality. The aim of the study was to evaluate the ability of the new score predicting one-year outcome. CAF was preoperatively applied to 400 patients ≥ 74 years that were admitted to cardiac surgery between September 2008 and January 2010. For 213 of these patients one-year follow-up was assessed by telephone interview until April 2010. One hundred and ten male and 103 female patients were included. Twenty-five percent underwent isolated coronary revascularization, 35% isolated valve procedures and 26% underwent combined procedures. One-year mortality was 12.2%. Patients who died within one year had a median frailty score of 16 [5;33] compared to 11 [3;33] to the one-year survivors (P=0.001). A new, easily applicable score ('Frailty predicts death One yeaR after Elective Cardiac Surgery Test') was built out of the basic score and showed a promising ability to predict one-year mortality. CAF is a new additional tool to assess prognosis of elderly patients before cardiac surgical interventions. The 'CAF' score facilitates prediction of mid-term outcome of high-risk elderly patients.

Combining cardiac magnetic resonance and computed tomography coronary calcium scoring: added value for the assessment of morphological coronary disease?

To investigate prospectively, in patients with suspicion of coronary artery disease (CAD), the added value of coronary calcium scoring (CS) as adjunct to cardiac magnetic resonance (CMR) for the diagnosis of morphological coronary stenosis in comparison to catheter angiography (CA). Sixty consecutive patients (8 women; 64 ± 10 years) referred to CA underwent CMR (1.5 T) including perfusion and late gadolinium-enhancement imaging as well as CS with computed tomography. Diagnostic performance was evaluated for CMR and CS separately, and for both methods combined, with CA as reference standard. Best CS threshold combined with a specificity >90% to predict significant stenosis in patients without abnormalities on CMR was determined from receiver operator characteristics (ROC) analysis. Abnormal CMR results were considered to indicate significant stenosis regardless of CS; CS above threshold reclassified patients to have CAD regardless of CMR. CA identified 104/960 (11%) coronary segments with coronary artery stenosis >50% in 36/60 (60%) patients. ROC revealed an area-under-the-curve of 0.83 (95%CI: 0.68-0.99) with the best CS threshold of 495 Agatston score (sensitivity 50%). CMR depicted 128/960 (13%) myocardial segments with abnormalities in 31/60 (52%) patients. Sensitivity, specificity, negative (NPV) and positive predictive value (PPV) of CMR were 78, 88, 72 and 90%. When adding CS to CMR, sensitivity and NPV increased to 89 and 83%, while specificity and PPV slightly decreased to 83 and 89%. Accuracy of the combined approach (87%) was significantly (P < 0.05) higher than that of CMR (82%) alone. Adding CS to CMR improves the accuracy for the detection of morphological CAD.

Comprehensive assessment of frailty for elderly high-risk patients undergoing cardiac surgery.

OBJECTIVE: Cardiosurgical operative risk can be assessed using the logistic European system for cardiac operative risk evaluation (EuroSCORE) and the Society of Thoracic Surgeons (STS) score. Factors other than medical diagnoses and laboratory values such as the 'biological age' are not included in these scores. The aim of the study was to evaluate an additional assessment of frailty in routine cardiac surgical practice. METHODS: 'The comprehensive assessment of frailty' test was applied to 400 patients≥74 years who were admitted to our centre between September 2008 and January 2010. For comparison, the STS score and the EuroSCORE were calculated. The primary end point was the correlation of Frailty score to 30-day mortality. A total of 206 female and 194 male patients were included. RESULTS: Median Frailty score was 11 [7,15]. Median of logistic EuroSCORE was 8.5% [5.8%; 13.9%]. Median of STS score was 3.3% [2.1%; 5.1%]. There were low-to-moderate albeit significant correlations of Frailty score with STS score and EuroSCORE (p<0.05). There was also a significant correlation between Frailty score and observed 30-day mortality (p<0.05). Patients received isolated coronary artery bypass grafting (CABG) (n=90), isolated valve surgery (n=128), trans-catheter valve implantation (n=59) or combined procedures (n=123). CONCLUSIONS: The comprehensive assessment of frailty is an additional tool to evaluate elderly patients adequately before cardiac surgical interventions. The Frailty score combines characteristics of the Fried criteria [1], of patient phenotype, of his physical performance and laboratory results. Further analysis on a larger patient population is warranted. A combination of the new Frailty score and the traditional scoring systems may facilitate a more accurate risk scoring in elderly high-risk patients scheduled for conventional cardiac surgery or trans-catheter aortic valve replacement.