Second Victims among German Emergency Medical Services Physicians (SeViD-III-Study).

BACKGROUND: Patient care in the prehospital emergency setting is error-prone. Wu's publications on the second victim syndrome made very clear that medical errors may lead to severe emotional injury on the caregiver's part. So far, little is known about the extent of the problem within the field of prehospital emergency care. Our study aimed at identifying the prevalence of the Second Victim Phenomenon among Emergency Medical Services (EMS) physicians in Germany. METHODS: Web-based distribution of the SeViD questionnaire among n = 12.000 members of the German Prehospital Emergency Physician Association (BAND) to assess general experience, symptoms and support strategies associated with the Second Victim Phenomenon. RESULTS: In total, 401 participants fully completed the survey, 69.1% were male and the majority (91.2%) were board-certified in prehospital emergency medicine. The median length of experience in this field of medicine was 11 years. Out of 401 participants, 213 (53.1%) had experienced at least one second victim incident. Self-perceived time to full recovery was up to one month according to 57.7% (123) and more than one month to 31.0% (66) of the participants. A total of 11.3% (24) had not fully recovered by the time of the survey. Overall, 12-month prevalence was 13.7% (55/401). The COVID-19 pandemic had little effect on SVP prevalence within this specific sample. CONCLUSIONS: Our data indicate that the Second Victim Phenomenon is very frequent among prehospital emergency physicians in Germany. However, four out of ten caregivers affected did not seek or receive any assistance in coping with this stressful situation. One out of nine respondents had not yet fully recovered by the time of the survey. Effective support networks, e.g., easy access to psychological and legal counseling as well as the opportunity to discuss ethical issues, are urgently required in order to prevent employees from further harm, to keep healthcare professionals from leaving this field of medical care and to maintain a high level of system safety and well-being of subsequent patients.

[Further Development of Maturity Levels of Quality and Risk Management System at the University Hospital Schleswig-Holstein]. / Weiterentwicklung der Reifegrade des Qualitäts ­ und Risikomanagementsystems am Universitätsklinikum Schleswig-Holstein.

INTRODUCTION: Following upon our publication "Maturity Levels of Quality and Risk Management at the University Hospital Schleswig-Holstein" in 2018, we present the further development of the maturity model. Quality and risk management in hospitals is not only required by law but also plays a significant role in an optimized patient- and process-oriented health care. METHODS: A questionnaire-based self-assessment was carried out by 46 clinical units of the UKSH (location Kiel and Lübeck) for the analysis of nine quality criteria overall. Four of these criteria (quality assurance (QS), critical incident reporting system (CIRS), complaint management (BM) and process management (PM)) were already analysed in 2016 and were extended to the five new aspects, namely audits and on-site inspections, responsibilities, morbidity and mortality conferences, hygiene training and surgical safety checklist. Every quality item was graded into four categories from "A" (fully implemented) to "D" (not implemented at all). RESULTS: The comparison of the results for quality criteria QS, CIRS, BM, PM and the overall maturity level between 2016 and 2020 demonstrated statistically significant improvements in 2020 concerning the criteria QS (p=0.013), CIRS (p=0.026), PM (p=0.000) and the overall maturity levels (p=0.019). The criteria BM did not show any statistically significant improvement. The five newly added quality criteria demonstrated maturity levels "A" (fully implemented) and "B" (largely implemented) the following: audits and on-site inspections (100%), responsibilities (95.6%), morbidity and mortality conferences (65.2%), hygiene training (95.6%), and surgical safety checklist (100%). CONCLUSION: An integrated quality and risk management has already been a firm element of UKSH for years. Nevertheless, review of effectiveness of the initiated targeted measures is still a challenge. This is the reason why it is necessary to develop effective and resource-saving approaches for the evaluation of measures and the identification of potential for improvement. The recognised potential for improvement should be risk-prioritized and completely exploited using sustainable measures. Following this principle, we designed a qualitative model of maturity levels for the evaluation of our quality and risk management system at the UKSH in 2016, whose further development we demonstrate here.

The Universal and Primary Prevention of Foetal Alcohol Spectrum Disorders (FASD): A Systematic Review.

Foetal alcohol spectrum disorder (FASD) comprises multiple neurodevelopmental disorders caused by alcohol consumption during pregnancy. With a global prevalence rate of 7.7 per 1000 population, FASD is a leading cause of prenatal developmental disorders. The extent of physical, mental, and social consequences for individuals with FASD can be vast and negatively affect their social environment, daily life, school, relationships, and work. As treatment for FASD is labour- and cost-intensive, with no cure available, prevention is key in reducing FASD prevalence rates. As most systematic reviews conducted so far have focused on specific FASD risk groups, we investigated the effectiveness of universal FASD prevention and primary preventive strategies. We identified a total of 567 potentially pertinent records through PubMed, Cochrane Library, EBSCO, PubPsych, and DAHTA published from 2010 to May 2020, of which 10 studies were included in this systematic review. Results showed a substantial heterogeneity in the studies' quality, although all preventive measures, except one, proved effective in both increasing knowledge and awareness of FASD, as well as decreasing the risk of an alcohol exposed pregnancy. Limiting factors such as small sample sizes and a lack of behavioural change testing require further studies to support existing evidence for FASD prevention and its implementation, as well as detecting the best course of action for FASD prevention when creating and implementing prevention and intervention approaches.

Minimally Invasive Direct Coronary Artery Bypass in High-Risk Patients with Multivessel Disease.

BACKGROUND: High-risk patients with multivessel disease (MVD) including a complex stenosis of the left anterior descending coronary may not be ideal candidates for guideline compliant therapy by coronary artery bypass grafting (CABG) regarding invasiveness and perioperative complications. However, they may benefit from minimally invasive direct coronary artery bypass (MIDCAB) grafting and hybrid revascularization (HCR). METHODS: A logistic European system for cardiac operative risk evaluation score (logES) >10% defined high risk. In high-risk patients with MVD undergoing MIDCAB or HCR, the incidence of major adverse cardiac and cerebrovascular events (MACCEs) after 30 days and during midterm follow-up was evaluated. RESULTS: Out of 1,250 patients undergoing MIDCAB at our institution between 1998 and 2015, 78 patients (logES: 18.5%; age, 76.7 ± 8.6 years) met the inclusion criteria. During the first 30 days, mortality and rate of MACCE were 9.0%; early mortality was two-fold overestimated by logES. Complete revascularization as scheduled was finally achieved in 64 patients (82.1%). Median follow-up time reached 3.4 (1.2-6.5) years with a median survival time of 4.7 years. Survival after 1, 3, and 5 years was 77, 62, and 48%. CONCLUSION: In high-risk patients with MVD, MIDCAB is associated with acceptable early outcome which is better than predicted by logES. Taking the high-risk profile into consideration, midterm follow-up showed satisfying results, although scheduled HCR was not realized in a relevant proportion. In selected cases of MVD, MIDCAB presents an acceptable alternative for high-risk patients.

Enhancing patient safety by integrating ethical dimensions to Critical Incident Reporting Systems.

BACKGROUND: Critical Incident Reporting Systems (CIRS) provide a well-proven method to identify clinical risks in hospitals. All professions can report critical incidents anonymously, low-threshold, and without sanctions. Reported cases are processed to preventive measures that improve patient and staff safety. Clinical ethics consultations offer support for ethical conflicts but are dependent on the interaction with staff and management to be effective. The aim of this study was to investigate the rationale of integrating an ethical focus into CIRS. METHODS: A six-step approach combined the analysis of CIRS databases, potential cases, literature on clinical and organizational ethics, cases from ethics consultations, and experts' experience to construct a framework for CIRS cases with ethical relevance and map the categories with principles of biomedical ethics. RESULTS: Four main categories of critical incidents with ethical relevance were derived: (1) patient-related communication; (2) consent, autonomy, and patient interest; (3) conflicting economic and medical interests; (4) staff communication and corporate culture. Each category was refined with different subcategories and mapped with case examples and exemplary related ethical principles to demonstrate ethical relevance. CONCLUSION: The developed framework for CIRS cases with its ethical dimensions demonstrates the relevance of integrating ethics into the concept of risk-, quality-, and organizational management. It may also support clinical ethics consultations' presence and effectiveness. The proposed enhancement could contribute to hospitals' ethical infrastructure and may increase ethical behavior, patient safety, and employee satisfaction.

Impact of Patient-Prosthesis Mismatch following Aortic Valve Replacement on Long-Term Survival and Quality of Life.

BACKGROUND: The impact of patient-prosthesis mismatch (PPM) after aortic valve replacement (AVR) on long-term survival and quality of life (QoL) remains controversial. The objective of this study was to evaluate the impact of PPM on long-term survival and QoL in a large cohort of patients treated with isolated stented biological AVR in a single-center experience. METHODS: We analyzed data of 632 consecutive patients following isolated stented biological AVR between 2007 and 2012 at our institution. We evaluated the QoL (393 evaluable patients) using the Short Form 12-item Health Survey (SF-12) questionnaire via telephone call and the impact of PPM on long-term survival (533 evaluable patients) by Kaplan-Meier's estimate. RESULTS: Severe PPM (<0.65 cm2/m2) had a negative impact on physical component summary (PCS) score (SF-12) compared with patients with moderate or no PPM (p = 0.014), while the mental component summary (MCS) score (SF-12) was not affected by the degree of PPM (p = 0.133). Long-term survival was not different among the three different PPM groups investigated (p = 0.75). CONCLUSION: Severity of PPM demonstrated no influence on long-term survival and MCS score (SF-12), but it was associated with a lower PCS score (SF-12) in patients with severe PPM.

Sex-specific outcome after minimally invasive direct coronary artery bypass for single-vessel disease.

OBJECTIVES: Female gender is reported as an independent risk factor for a poor outcome after coronary artery bypass grafting. We analysed the influence of gender on surgical outcome in patients with single-vessel disease undergoing minimally invasive direct coronary artery bypass (MIDCAB). METHODS: From January 1998 to December 2016, a total of 607 consecutive patients with single-vessel disease (31.9% women) underwent MIDCAB at our institution. Major adverse cardiac and cerebrovascular events (MACCE) were recorded during a median follow-up period of 8.0 years. Survival time was estimated for all patients and after applying propensity score matching (138 women vs 138 men). Multivariable Cox regression analysis identified risk factors predicting a long-term mortality rate. RESULTS: In women, a longer surgical time (125 vs 113 min; P < 0.001) and a higher transfusion rate were recorded (13.0% vs 5.1%; P = 0.001) with similar rates of in-hospital deaths (1.0% vs 0.5%; P = 0.60) and MACCE (1.5% vs 0.7%; P = 0.39). Survival and MACCE-free survival during the follow-up period did not differ significantly between genders (P = 1.0, P = 0.36). Survival and MACCE-free survival rates after 5 years were 94% and 90% in women compared to 91% and 86% in men. Propensity score matching demonstrated improved long-term survival rates in women (P = 0.029). Insulin-dependent diabetes mellitus, postoperative atrial fibrillation and prolonged intensive care unit stay were associated with long-term deaths for both genders, whereas obesity, former myocardial infarction and preoperative atrial fibrillation were significant risk factors in men. CONCLUSIONS: Female patients showed no adverse outcomes after MIDCAB, although risk factors were gender-specific. Overall, MIDCAB demonstrated excellent short- and long-term results as a treatment for single-vessel disease in both genders.

Combination of National Quality Assurance Data Collection With a Standard Operating Procedure in Community-Acquired Pneumonia: A Win-Win Strategy?

PURPOSE: The primary contact for German physicians with national quality assurance in community-acquired pneumonia (CAP) is frequently experienced as time-consuming obligatory documentation. Since the regular feedback loop stretches up to 18 months, the immediate impact on quality is perceived as rather low. Ultimately, a method leading to increase in the quality of data collection, clarification on expected clinical treatment standards, and improvement in the acceptance and feedback mechanism is needed. METHODS: We developed a form merging data collection for quality indicators with a standard operating procedure (SOP) in CAP and implemented it in the daily routine of a university's department for internal medicine. Fulfillment of quality indicators before and after the implementation of the new form was measured. RESULTS: Critical parameters such as the documentation of breathing rate and clinical parameters at discharge strongly improved after implementation of the intervention. Uncritical parameters showed slight improvement or stable results at a high level. CONCLUSION: The combination of collection of quality data with a clinical SOP and context information may improve the impact of quality measures by increasing acceptance, quality of data capture, short-loop feedback, and possibly quality of care.

A retrospective study of conscious sedation versus general anaesthesia in patients scheduled for transfemoral aortic valve implantation: A single center experience.

OBJECTIVES: The current 2017 ESC/EACTS guidelines recommend transcatheter aortic valve implantations (TAVIs) as the therapy of choice for inoperable patients with severe symptomatic aortic stenosis. Most of the TAVIs worldwide are performed under general anaesthesia (GA). Although conscious sedation (CS) concepts are increasingly applied in Europe, it is still a matter of debate which concept is associated with highest amount of safety for this high-risk patient population. The aim of this single center, before-and-after study was to investigate feasibility and safety of CS compared with GA with respect to peri-procedural complications and 30-day mortality in patients scheduled for transfemoral TAVI (TF-TAVI). METHODS: From March 2012 until September 2014, patients scheduled for the TF-TAVI procedure were included in a prospective, observational manner. From the 200 patients finally included, 107 procedures were performed under GA, using either an endotracheal tube or a laryngeal mask, and balanced anaesthesia. CS was performed in 93 patients using low-dose propofol and remifentanil. RESULTS: Conversion to GA was needed 4 times due to procedural-related complications (4.3%), in one patient due to ongoing agitation (1.1%). The CS-group showed significantly shorter key time courses: anaesthesia time (105 [95-120] minutes vs 115 [105-140] minutes, P-value = 0.009, Mann-Whitney-U-test) and length of stay in the intensive care unit (1.6 [1.0-1.5] d vs 2.1 [1.0-2.0] d, P-value = 0.002, Mann-Whitney-U-test). The lowest mean arterial pressure was significantly higher in the CS-group compared with the GA-group (74.3 mmHg vs 55.2 mmHg, P-value <0.0001, t-test). CS was associated with less requirements of norepinephrine (0.1 µg/kg vs 2.3 µg/kg, P-value <0.0001, Mann-Whitney-U-test). CONCLUSIONS: Our single-center data demonstrate that CS is a feasible and safe alternative, especially with respect to a higher degree of intra-procedural haemodynamic stability, and a reduced length of stay in the intensive care unit.

Outcomes after transaortic transcatheter aortic valve implantation: long-term findings from the European ROUTE†.

OBJECTIVES: There is lack of data regarding the longer-term outcomes of patients undergoing transaortic (TAo) transcatheter aortic valve implantation (TAVI). We aimed to provide a contemporary snapshot of the types and frequencies of events in the year following TAo-TAVI. METHODS: The Registry of the Utilization of the TAo-TAVI approach using the Edwards SAPIEN Valve (ROUTE) is a multicentre, European, prospective, observational registry of aortic stenosis patients undergoing TAo-TAVI. Patients were grouped according to the composite end point death, myocardial infarction, stroke/transient ischaemic attack, major vascular complications, life-threatening bleeding, acute kidney injury (AKI) and/or cardiovascular rehospitalization. RESULTS: Two hundred and fifty-three patients with a mean age of 81.5 ± 5.8 years were included, of whom 89 (35.2%) patients met the composite end point (the event group) and 164 (64.8%) patients did not (the event-free group). New York Heart Association (NYHA) class III/IV (85.2% vs 71.8%, P = 0.017), Canadian Cardiovascular Society angina class III/IV (22.6% vs 11.4%; P = 0.021), pulmonary disease (32.6% vs 18.9%; P = 0.015) and renal insufficiency (15.7% vs 3.0%; P < 0.001) were more common in the event group. At 1 year, the most common event was death (19.1%), followed by AKI stage II or III (14.7%). The baseline renal insufficiency was the strongest independent predictor of composite end point achievement [odds ratio (OR) 7.55, 95% confidence interval (CI) 2.33-24.56], followed by NYHA class III/IV (OR 2.316, 95% CI 1.06-5.06) and pulmonary disease (OR 2.91, 95% CI 1.45-5.85). Pulmonary disease was also an independent predictor of 1-year mortality (OR 3.01, 95% CI 1.34-6.75). CONCLUSIONS: Long-term outcomes after TAo-TAVI appear to be similar to those for TAVI via other non-transfemoral access routes. Awareness of characteristics associated with poorer outcomes may aid patient selection and identification of those requiring closer post-procedural monitoring. CLINICAL TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier: NCT01991431.

[Maturity Levels of Quality and Risk Management at the University Hospital Schleswig-Holstein]. / Reifegrade des Qualitäts- und Risikomanagementsystems am Universitätsklinikum Schleswig-Holstein.

INTRODUCTION: Quality and risk management in hospitals are not only required by law but also for an optimal patient-centered and process-optimized patient care. To evaluate the maturity levels of quality and risk management at the University Hospital Schleswig-Holstein (UKSH), a structured analytical tool was developed for easy and efficient application. METHODS: Four criteria concerning quality management - quality assurance (QS), critical incident reporting system (CIRS), complaint management (BM) and process management (PM) - were evaluated with a structured questionnaire. Self-assessment and external assessment were performed to classify the maturity levels at the UKSH (location Kiel and Lübeck). Every quality item was graded into four categories from "A" (fully implemented) to "D" (not implemented at all). First of all, an external assessment was initiated by the head of the department of quality and risk management. Thereafter, a self-assessment was performed by 46 clinical units of the UKSH. Discrepancies were resolved in a collegial dialogue. Based on these data, overall maturity levels were obtained for every clinical unit. RESULTS: The overall maturity level "A" was reached by three out of 46 (6.5%) clinical units. No unit was graded with maturity level "D". 50% out of all units reached level "B" and 43.5% level "C". The distribution of the four different quality criteria revealed a good implementation of complaint management (maturity levels "A" and "B" in 78.3%), whereas the levels for CIRS were "C" and "D" in 73.9%. Quality assurance and process management showed quite similar distributions for the levels of maturity "B" and "C" (87% QS; 91% PM). DISCUSSION: The structured analytical tool revealed maturity levels of 46 clinical units of the UKSH and defined the maturity levels of four relevant quality criteria (QS, CIRS, BM, PM). As a consequence, extensive procedures were implemented to raise the standard of quality and risk management. In future, maturity levels will be reevaluated every two years. This qualitative maturity level model enables in a simple and efficient way precise statements concerning presence, manifestation and development of quality and risk management.

Transaortic transcatheter aortic valve implantation as a first-line choice or as a last resort? An analysis based on the ROUTE registry.

OBJECTIVES: Transaortic transcatheter aortic valve implantation (TAo-TAVI) is a recently developed alternative to transapical (TA) or transfemoral (TF) TAVI. We aimed to analyse the effectiveness and safety of TAo-TAVI as a first line approach and to compare it to patients receiving TAo-TAVI as a last resort, which is current practice. METHODS: ROUTE is a prospective, multicentre registry to assess the clinical outcomes of TAo-TAVI. Patients without contraindications for TA- and TF-TAVI (TAo-first) were compared to patients with contraindications for both of these access routes (TAo-last). Outcome analysis was based on VARC II defined clinical end-points. RESULTS: Three hundred and one patients were included, of which 224 patients met TAo-first and 77 TAo-last criteria. The valve was delivered and catheter retrieved successfully in all patients. In the TAo-first group, rates of conversion to open surgery and requirement for a second valve were low and not different compared to TAo-last patients (1% vs. 3%, P = 0.46 and 1% vs. 3%, P = 0.46, respectively). This was also true for the rate of paravalvular regurgitation (≥ moderate: 4% vs. 3%). All-cause mortality at 30-days was 6% vs. 5% ( P = 0.76), rates of stroke 2% vs. 0% ( P = 0.24), pacemaker implantation (11% vs. 4%, P = 0.093), and life-threatening bleeding 4% vs. 3% ( P = 0.70). Valve safety (both 85%, P = 0.98) and clinical efficacy (80% vs. 82%; P = 0.73) did not differ between groups. CONCLUSIONS: Although comparative data to TA and TF procedures were not available in the present analysis, findings suggest that TAo may be considered not only as a last resort strategy when classical access routes are deemed unfeasible, but also as a potential first-line option, with only low rates of paravalvular regurgitation and permanent pacemaker implantation. CLINICALTRIALS.GOV: NCT01991431.

Prevention of surgical site sternal infections in cardiac surgery: a two-centre prospective randomized controlled study.

OBJECTIVES: Surgical site infection (SSI) of the sternum is a devastating complication in cardiac surgery. The aim of this prospective randomized controlled two-centre clinical study was to compare the use of a gentamicin-collagen sponge (Genta-Coll® resorb) and of a cyanoacrylate-based microbial skin sealant (InteguSeal®) on the SSI rate of the sternum. METHODS: We analysed data from 996 consecutive patients following isolated coronary artery bypass grafting between 2012 and 2014. The patients were randomized into three groups: standard group (S-group), Genta-Coll group (G-group) and InteguSeal group (I-group). The primary study end-point was to analyse the incidence of superficial and deep sternal SSI. The secondary study end-point was to determine independent risk factors for an increased SSI rate. RESULTS: Of the 996 patients investigated, 332 patients were in S-group, 336 patients in G-group and 328 patients in I-group. The mean age was 67.7 ± 9.4 years, 18.6% were women and the overall SSI rate was 6.2% with 2.2% deep sternal wound infections. SSI rates were 8.3% (S-group), 5.4% (G-group) and 4.9% (I-group) (P 0.16). Multiple regression analysis demonstrated a preoperative body mass index (BMI) of >30 kg/m2 (P 0.047), re-thoracotomy for postoperative bleeding (P < 0.001) and sternum instability (P < 0.001) as independent predictors for an increased SSI rate. CONCLUSIONS: The application of InteguSeal® or Genta-Coll® resorb had no significant influence on the incidence of the sternal SSI rate in 996 consecutive cardiac surgery patients but demonstrated a trend towards a benefit from using these prophylactic approaches. Multiple regression analysis demonstrated a preoperative BMI of >30 kg/m2, re-thoracotomy for bleeding and sternum instability as independent predictors for an increased sternal SSI rate.

Transaortic transcatheter aortic valve implantation: experience from the Kiel study.

OBJECTIVES: To evaluate the efficacy and safety of Edwards SAPIEN-XT or SAPIEN-3 transcatheter heart valves via transaortic (TAo) access. METHODS: A total of 100 consecutive patients with severe symptomatic aortic stenosis undergoing TAo-transcatheter aortic valve implantation (TAVI) were included in this observational registry (November 2012-December 2014). Periprocedural and post-procedural outcomes were assessed. RESULTS: Of these 100 patients, 1 received a Medtronic CoreValve. Therefore, this patient was subsequently removed from the analysis. Ninety-nine consecutive TAo-TAVI patients received a balloon-expandable transcatheter heart valve (Sapien). The SAPIEN-XT valve was implanted in 53 patients and the SAPIEN-3 valve in 46 patients. Fluoroscopy time was shorter in the SAPIEN-3 cases (5.6 ± 2.5 vs 8.1 ± 5.1 min, SAPIEN-XT; P = 0.004), with fewer patients requiring dilatation after the operation (20.5% SAPIEN-3 vs 64.2% SAPIEN-XT; P < 0.0001). There were no other significant differences in procedural characteristics between the two valves. All-cause 30-day mortality was 5.1% overall, with comparable outcomes for the two valves (5.7 and 4.4% for SAPIEN-XT and SAPIEN-3 valves, respectively; OR: 1.32; 95% CI: 0.21-8.27; P = 1.0). New atrial fibrillation (13.1%) and acute kidney injury (11.1%) were the most common complications during the 30 days post-procedure. The number of new pacemakers was low (6.1%), with no differences found between the two valve groups. A comparison of 100 TAo- and 42 TA-TAVI implanted in the same period demonstrated similar results in short- (P = 0.31) and long-term (P = 0.99) mortality rates. CONCLUSIONS: The efficacy and safety of the Edwards SAPIEN-XT or SAPIEN-3 heart valves via TAo access were demonstrated by high procedural success and low complication rates. The data indicate that this approach is a viable alternative to established access routes.

Preprocedural but not periprocedural high-sensitive Troponin T levels predict outcome in patients undergoing transcatheter aortic valve implantation.

AIM: Risk assessment of patients undergoing transcatheter aortic valve implantation (TAVI) remains difficult. Biomarkers have been shown to provide potential prognostic information. Here, we aimed to analyze whether the biomarker high-sensitivity Troponin T (hsTNT) could be used to improve risk stratification. METHOD: We prospectively enrolled 267 patients undergoing TAVI. Biomarkers (hsTNT and NTproBNP) were measured 1 day before, and 3 and 7 days postprocedure. All possible prognostic factors upon survival time were analyzed by Cox regression analysis. RESULTS: A total of 259 patients (mean age 82±6.1 years) were available for complete follow-up. The median Logistic EuroSCORE (Log ES) and Log ES II were 21.16% (Q1=13.92; Q3=34.27) and 6.42% (Q1=3.89; Q3=11.07), respectively. Median follow-up was 290 (Q1=88; Q3=529) days. A total of 71 deaths occurred during follow-up, and the 30-day mortality was 5.8%. Median baseline hsTNT was 27.4 pg/mL (Q1=16.2; Q3=46 pg/mL). From all potential mortality-associated factors, only preprocedural hsTNT level (P=.001), elevated Log ES (P=.03) as well as acute kidney injury (P<.001) and chronic obstructive pulmonary disease (COPD) (P=.039) emerged as independent prognostic parameters for adverse outcome. We also tested whether the Valve Academic Research Consortium-2 (VARC-II) cutoff for myocardial damage (hsTNT peak value exceeding 15× the upper reference limit + at least 50% increase) was of prognostic relevance. At 72-hours post-TAVI, 36.2% of the patients matched these VARC-II criteria of myocardial damage. However, these patients did not display a difference in survival compared to patients without significant myocardial injury. CONCLUSION: Elevated preprocedural hsTNT represents an independent risk predictor of all-cause death while periprocedural hsTNT elevation failed to show prognostic relevance.

Short- and long-term follow-up after minimally invasive direct coronary artery bypass in octogenarians.

OBJECTIVES: Demographic changes lead to a rising incidence of octogenarians undergoing surgical revascularization of coronary artery disease. Minimally invasive direct coronary artery bypass (MIDCAB) represents a surgical treatment with reduced trauma and without the use of cardiopulmonary bypass. The aim of this study was to evaluate short- and long-term outcomes after MIDCAB in octogenarians. METHODS: Between 1998 and 2012, 1060 patients underwent MIDCAB at our department. Among them, 72 patients (6.8%) were older than 80 years at the time of operation. Incidence of major adverse cardiac and cerebrovascular events (MACCEs) was compared between octogenarians [median age 82 (81; 85) years, 63.9% male] and younger MIDCAB patients [median age 64 (56; 70) years, 70.7% male] after 30 days and during follow-up. The impact of demographics and preoperative comorbidities on mortality during follow-up was analysed. RESULTS: At baseline, the elderly group presented with a statistically significant higher logistic EuroSCORE I (9.2 vs 2.2%, P < 0.001). Within 30 days, octogenarians showed a mortality rate of 5.6% (younger patients 0.8%, P = 0.006) and an MACCE rate of 5.6% (younger patients 1.3%, P = 0.024). The median follow-up time of 30-day survivors was 5.5 (2.9; 7.6) years and follow-up completeness reached 96.9%. In the elderly group, 1-, 3- and 5-year survival rates were 89, 78 and 63% in comparison with 97, 94 and 90% in the younger group (P < 0.001), respectively. The estimated median survival time in octogenarians was 6.7 (CI 4.854; 8.629) years. Logistic regression showed preoperative renal impairment, peripheral arterial occlusive disease and pulmonary hypertension to have a stronger impact on mortality during follow-up than age above 80 years. CONCLUSIONS: MIDCAB represents a safe treatment option in octogenarians and is associated with a good perioperative outcome and satisfying long-term results in octogenarians.

Elevated growth differentiation factor 15 levels predict outcome in patients undergoing transcatheter aortic valve implantation.

AIMS: Transcatheter aortic valve implantation (TAVI) has emerged as a treatment of aortic stenosis in patients at high surgical risk. However, risk stratification in this elderly population is challenging, as patients at extreme risk might not benefit from TAVI. While several clinical criteria have been proposed for estimating the outcome, prediction of individual risk remains difficult. Therefore, our aim was to assess the prognostic value of the biomarker growth differentiation factor 15 (GDF15). METHODS AND RESULTS: Over a 2.9-year period, we prospectively enrolled 217 patients undergoing TAVI. Clinical parameters, risk scores, and biomarkers (NT-proBNP and GDF15) were measured at baseline. The primary endpoint was survival time; prognostic factors were analysed by Cox regression analysis. Mean age of study participants was 81.8 ± 6.0 years. Median Logistic EuroSCORE was 20.1 (Q1-Q3 13.6-32.6). Thirty-day mortality was 6.9%; 30.4% of the patients died during follow-up [median 349 days (Q1-Q3 106-660)]. Median pre-procedural GDF15 values were 2256 pg/mL (1585-3082). High GDF15 levels were associated with numerous factors that could contribute to poor outcome. Analyses comparing the upper quartile with the lower three quartiles for biomarker levels revealed a hazard ratio (HR) of increased GDF15 for adverse outcome of 2.4 [95% confidence interval (CI) 1.5-3.9, P < 0.001]. Of note, in multiple analyses, elevated GDF15 levels were superior to NT-proBNP for predicting negative outcome (adjusted HR of GDF15 1.97, 95% CI 1.2-3.3; P = 0.009). CONCLUSION: Elevated GDF15 levels were superior to NT-proBNP for TAVI risk stratification and provided additional prognostic information. Thus, patient selection for TAVI may benefit from measurement of GDF15.

Laser scoop desobliteration: a method for minimally invasive remote recanalization of chronically occluded superficial femoral arteries.

Stenosis and occlusion of the superficial femoral artery (SFA) are most common in arterial occlusive disease. There are numerous interventional, surgical, and combined approaches to reconstitute maximum blood supply to the lower limb; however, despite intense clinical research, the long-term success rates are still poor. We present the first results with a catheter prototype for laser-based minimal invasive endarterectomy, called laser scoop desobliteration (LSD). The tip of a glass fiber containing a catheter was modified with a spatula head design and connected to an ultraviolet laser. It was tested in cadavers fixed with the Thiel embalming technique preserving tissue consistency, flexibility, and plasticity. After longitudinal arteriotomy of the SFA, a circular dissection between media and adventitia was performed. Then the LSD catheter was inserted and propagated with a progress of 1 mm∕s. Afterward, the atheroma core, which showed a plain surface without substantial attaching tissue debris, was removed. Histological examination of the vessel wall showed that the dissection was performed at the media/adventitia interface. In summary, the constructed LSD catheter allowed a rapid and easy way to perform an endarterectomy, thereby offering an innovative approach in the treatment of chronic occluded SFA.

Comparison of different resection tools for human calcified aortic valves.

OBJECTIVE: Symptomatic severe aortic valve stenosis is a disease primarily found in patients of advanced age. The standard therapy is the aortic valve replacement. Transcatheter aortic valve implantation (TAVI) is a treatment for patients ineligible for conventional aortic valve replacement. To minimize the incidence of TAVI-related complications, such as paravalvular leakage, pacemaker necessity, and ostial coronary occlusion, our research group works on the development of resection tools for aortic valves. The aim of this study was to investigate ex vivo different resection tools for human calcified aortic valves concerning cross-section morphology. METHODS: With the use of 12 human calcified aortic leaflets, the effect of laser scalpel, punching device, and scissors on cross-section morphology was investigated. Scanning electron microscopy and histological analyses were applied to evaluate the cutting surface area. RESULTS: The cross-section areas created by a laser scalpel were smooth, regular, and uniform, whereas these areas were rough, irregular, and inhomogeneous when using the scissors or the punching device. Quantitative analysis of the cutting edges demonstrated significant differences between the three resection tools. The best results were obtained for the laser scalpel compared with the punching device (P < 0.001) and for the laser scalpel compared with the scissors (P < 0.05), whereas the scissors compared with the punching device showed no significant differences (P > 0.05). CONCLUSIONS: Laser cutting of human calcified aortic valves demonstrated the best results concerning homogeneous cross-section morphology compared with the punching device and the scissors and seems to be a promising tool for aortic valve resection during TAVI procedures in the future.

Off-pump coronary artery bypass prevents visceral organ damage.

OBJECTIVES: Visceral malperfusion after coronary artery bypass grafting (CABG) results in high morbidity and mortality. This study was designed to evaluate the effect of CABG performed by surgical techniques on visceral perfusion and function. METHODS: Pigs (n = 28) were studied in four groups: I. Sham; II. Off-pump coronary artery bypass grafting (OPCAB): 1 h stabilizer with 40 min intracoronary shunt; III. Extracorporeal circulation (ECC): 1 h ECC with 40 min aortic cross-clamping and cardioplegic arrest; IV. Impella: 1 h left ventricular blood-pump support and stabilizer with 40 min intracoronary shunt. A left internal mammary to left anterior descending coronary artery bypass was performed in Groups II-IV. All animals were observed for a further 240 min. During the experiment haemodynamics, creatinine clearance, intestinal fatty acid binding protein (iFABP), pancreatic (lipase and amylase) and liver enzymes (α-glutathione s-transferase, glutamate-oxaloacetate transaminase (GOT), gamma-glutamyl transferase (GGT), glutamate dehydrogenase and glutamate-pyruvate transaminase (GPT)) were measured. Visceral perfusion (VP) was assessed in both kidneys, intestine, pancreas, liver and spleen with 15 µm fluorescent microspheres. RESULTS: During OPCAB surgery, VP decreased slightly. Renal functional parameters, iFABP, pancreatic and liver enzymes remained unchanged. ECC and Impella led to significantly reduced renal, pancreatic and intestinal blood flow (P < 0.05). Creatinine clearance, pancreatic and liver (GPT, GGT) enzymes were significantly decreased only after ECC (P < 0.05). ECC and Impella resulted in a significantly increased iFABP level (P < 0.05). GOT was elevated significantly after surgery in Groups II, III and IV (P < 0.05). CONCLUSIONS: CABG with ECC or Impella leads to impaired visceral blood flow and function. OPCAB minimizes these procedure associated alterations.