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Acute type A aortic dissection (ATAAD) is a dramatic emergency exhibiting a mortality of 50% within the first 48 hours if not operated. This study found an absolute value of cosine-like seasonal variation pattern for Germany with significantly fewer ATAAD events (Wilcoxon test) for the warm months of June, July, and August from 2005 to 2015. Many studies suspect a connection between ATAAD events and weather conditions. Using ERA5 reanalysis data and an objective weather type classification in a contingency table approach showed that for Germany, significantly more ATAAD events occurred during lower temperatures (by about 4.8 K), lower water vapor pressure (by about 2.6 hPa), and prevailing wind patterns from the northeast. In addition, we used data from a classification scheme for human-biometeorological weather conditions which was not used before in ATAAD studies. For the German region of Berlin and Brandenburg, for 2006 to 2019, the proportion of days with ATAAD events during weather conditions favoring hypertension (cold air advection, in the center of a cyclone, conditions with cold stress or thermal comfort) was significantly increased by 13% (Chi-squared test for difference of proportions). In contrast, the proportion was decreased by 19% for conditions associated with a higher risk for patients with hypotension and therefore a lower risk for patients with hypertension (warm air advection ahead of warm fronts, conditions with no thermal stress or heat stress, in the center of a cyclone with thermal stress). As many studies have shown that hypertension is a risk factor for ATAAD, our findings support the hypothesized relation between ATAAD and hypertension-favoring weather conditions. [ABSTRACT FROM AUTHOR]

Background The microbial etiology of prosthetic valve infective endocarditis (PVE) can be difficult to identify. Our aim was to investigate the benefit of molecular imaging technique fluorescence in situ hybridization (FISH) combined with 16S rRNA-gene polymerase chain reaction (PCR) and sequencing (FISHseq) for the analysis of infected prosthetic heart valves. Methods We retrospectively evaluated the diagnostic outcome of 113 prosthetic valves from 105 patients with suspected PVE, treated in 2003–2013 in the Department of Cardiac Surgery, Charité University Medicine Berlin. Each prosthetic valve underwent cultural diagnostics and was routinely examined by FISH combined with 16S rRNA gene PCR and sequencing. We compared classical microbiological culture outcomes (blood and valve cultures) with FISHseq results and evaluated the diagnostic impact of the molecular imaging technique. Results Conventional microbiological diagnostic alone turned out to be insufficient, as 67% of preoperative blood cultures were noninformative (negative, inconclusive, or not obtained) and 67% of valve cultures remained negative. FISHseq improved the conventional cultural diagnostic methods in PVE in 30% of the cases and increased diagnostic accuracy. Of the valve culture–negative PVE cases, FISHseq succeeded in identifying the causative pathogen in 35%. Conclusions FISHseq improves PVE diagnostics, complementing conventional cultural methods. In addition to species identification, FISH provides information about the severity of PVE and state of the pathogens (eg, stage of biofilm formation, activity, and localization on and within the prosthetic material). As a molecular imaging technique, FISHseq enables the unambiguous discrimination of skin flora as contaminant or infectious agent. [ABSTRACT FROM AUTHOR]

Background: Functional mitral regurgitation (FMR) is one of the most common heart valve diseases that is a sequel of left ventricular remodelling. Although mitral valve annuloplasty is a standard treatment of FMR, the recurrence of FMR is a major drawback and occurs in 10–50% of patients. The REFORM-MR registry aims to investigate the effectiveness of standardized papillary muscle relocation and ring annuloplasty and to identify the risk factors associated with recurrent FMR. Methods: REFORM-MR is a prospective, multicenter registry that enrols consecutive FMR patients across five sites in Germany. All patients with FMR and restricted movement of leaflets during systole (i.e., type IIIb mitral regurgitation) undergoing standardized subannular repair in combination with mitral valve annuloplasty are included in the study. The primary objective is to examine the effect of combined papillary muscle relocation and ring annuloplasty on the recurrence of FMR at 2 years postoperatively. The secondary objectives are MACCE rate, reinterventions on the mitral valve and cardiac-related mortality in the study cohort. Echocardiography core-lab and MRI core-lab will provide anonymized analysis of the imaging data in the REFORM-MR registry. Student's t-test or Mann–Whitney U test for continuous variables and the Chi-Square or Fisher exact test for categorical variables are used for group comparisons. Kaplan–Meier analyses is performed for survival and safety outcomes. Results: As of May 2021, a total of 97 patients were enrolled across five sites in Germany. Conclusions: The results of this study will help define the outcomes of combined papillary muscle relocation and ring annuloplasty in the FMR treatment in a multicentre setting and to improve the understanding of the limitations of subannular repair procedures while treating patients with type III FMR. Trial registration clinicaltrials.gov Identifier: NCT03470155. [ABSTRACT FROM AUTHOR]

Background: Nearly 1000 permanent ventricular assist devices (VADs) are implanted in patients with severe congestive heart failure in Germany each year. VADs are miniaturized centrifugal pumps that generate continuous blood flow; they are powered and controlled through a cable that passes through the skin. Para-corporeal systems are only rarely implanted, usually in children. Methods: In this selective review of the literature, including guidelines and registry data, we discuss the indications, therapeutic effects, and complications of permanently implantable cardiac support systems. Results: The optimal time for VAD implantation cannot be precisely defined. A comparative assessment of the various available systems is not possible, as no randomized trials have been performed on this topic. Registry data indicate that 69% to 81% of patients survive one year after VAD implantation, which is significantly better than the natural course of (conservatively treated) severe congestive heart failure. The distance patients are able to walk is 129 to 220 m longer at six months, depending on the system implanted. Scores on the EQ-5D health status questionnaire are 28 to 37 points better at six months. The potential severe complications include infection, right-heart failure, hemorrhage, pump thrombosis, stroke, and death. Conclusion: A VAD system can be implanted as an alternative to cardiac transplantation or as a bridging treatment until the patient can be listed for transplantation and receive the transplant. Because of the organ shortage in Germany, only a minority of VAD patients ever receive a transplant. [ABSTRACT FROM AUTHOR]

Surgical aortic valve replacement is still considered the first-line treatment for patients suffering from severe aortic valve stenosis. In recent years, transcatheter aortic valve implantation (TAVI) has emerged as an alternative for selected high-risk patients. According to the latest results of the German external quality assurance program, mandatory by law, the initially very high mortality and procedural morbidity have now decreased to approximately 6 and 12%, respectively. Especially in Germany, the number of patients treated by TAVI has increased exponentially. In 2013, a total of 10.602 TAVI procedures were performed. TAVI is claimed to be minimally invasive. This is true concerning the access, but it does not describe the genuine complexity of the procedure, defined by the close neighborhood of the aortic valve to delicate intracardiac structures. Hence, significant numbers of life-threatening complications may occur and have been reported. Owing to the complexity of TAVI, there is a unanimous concordance between cardiologists and cardiac surgeons in the Western world demanding a close heart team approach for patient selection, intervention, handling of complications, and pre- as well as postprocedural care, respectively. The prerequisite is that TAVI should not be performed in centers with no cardiac surgery on site. This is emphasized in all international joint guidelines and expert consensus statements. Today, a small number of patients undergoTAVI procedures in German hospitals without a department of cardiac surgery on site. To be noted, most of these hospitals perform less than 20 cases per year. Recently, the German Cardiac Society (DGK) published a position paper supporting this practice pattern. Contrary to this statement and concerned about the safety of patients treated this way, the German Society for Thoracic and Cardiovascular Surgery (DGTHG) still fully endorses the European (ESC/EACTS) and other actual international guidelines and consensus statements. Only the concomitance of departments for cardiac surgery and cardiology on site can provide optimal TAVI care. This commentary by the DGTHG delineates the data and resources upon which its opinion is based. [ABSTRACT FROM AUTHOR]

Background: Prosthetic valve endocarditis is the most severe form of infective endocarditis. This study assessed the risks and challenges of surgery for aortic prosthetic valve endocarditis.Methods: In total, 116 consecutive patients (98 males, age 65.2±12.7years), who underwent redo-surgery for active aortic prosthetic valve endocarditis between 2000 and 2014, were reviewed. Cox regression analysis was used to identify factors for aortic root destructions as well as for morbidity and mortality. Median follow-up was 3.8 years (0-13.9 years).Results: Aortic root destructions (42 limited and 29 multiple lesions) were associated with early prosthetic valve endocarditis and delayed diagnosis (≥14 d), but not with mortality. There were 16 (13.8%) early (≤30 d) and 32 (27.6%) late (>30 days) deaths. Survival at 1, 5, and 10 years was 72±4.3%, 56±5.4%, and 46±6.4%, respectively. The cumulative incidence of death, reinfection, and reoperation was 19.0% at 30days and 36.2% at 1year. Delayed diagnosis, concomitant procedures, and EuroSCORE II >20% were predictors for early mortality and need for mechanical circulatory support, age >70years, and critical preoperative state were predictors for late mortality. In their absence, survival at 10 years was 70±8.4%. Reinfections and reoperations occurred more frequently if ≥1 risk factor for endocarditis and aortic root destructions were present. At 10 years, freedom from reinfection and reoperation was 89±4.2% and 91±4.0%.Conclusions: The risks of death, reinfection, and reoperation are significant within the first year after surgery for aortic prosthetic valve endocarditis. Early diagnosis and aortic root destructions are the most important challenges, but advanced age, critical preoperative state, and the need for mechanical circulatory support determine long-term survival. [ABSTRACT FROM AUTHOR]

Based on a voluntary registry, founded by the German Society for Thoracic and Cardiovascular Surgery (DGTHG) in 1980, a well-defined but limited dataset of all cardiac and vascular surgery procedures performed in 77 German heart surgery departments is reported annually. For the year 2023, a total of 168,841 procedures were submitted to the registry. Of these operations, 100,606 are defined as heart surgery procedures in a classical sense. The unadjusted in-hospital survival rate for the 28,996 isolated coronary artery bypass grafting procedures (relationship on-/off-pump 2.8:1) was 97.6%; 97.7% for the 39,859 isolated heart valve procedures (23,727 transcatheter interventions included); and 99.2% for 19,699 pacemaker/implantable cardioverter defibrillator procedures. Concerning short and long-term mechanical circulatory support, a total of 2,982 extracorporeal life support/extracorporeal membrane oxygenation implantations and 772 ventricular assist device implantations (left/right ventricular assist device, BVAD, total artificial heart) were reported. In 2023, 324 isolated heart transplantations, 248 isolated lung transplantations, and 2 combined heart-lung transplantations were performed. This annually updated registry of the DGTHG represents nonrisk adjusted voluntary public reporting and encompasses acute data for nearly all heart surgical procedures in Germany. It constitutes trends in heart medicine and represents a basis for quality management (e.g., benchmark) for all participating institutions., Competing Interests: None declared., (Thieme. All rights reserved.)

Objectives: The objective of the present study was to model the effects of a reduced number of treatment centres for acute type A aortic dissection on preclinical transportation distance and time. We examined whether treatment in selected centres in Germany would be implementable with respect to time to treatment., Methods: For our transportation model, the number of aortic dissections and respective mean annual volume were collected from the annual quality reports (2015-2017) of all German cardiac surgery centres (n = 76). For each German postal code, the fastest and shortest routes to the nearest centre were calculated using Google Maps. Furthermore, we analysed data from the German Federal Statistical Office from January 2005 to December 2015 to identify all surgically treated patients with acute type A aortic dissection (n = 14 102) and examined the relationship between in-hospital mortality and mean annual volume of medical centres., Results: Our simulation showed a median transportation distance of 27.13 km and transportation time of 35.78 min for 76 centres. Doubling the transportation time (70 min) would allow providing appropriate care with only 12 medical centres. Therefore, a mean annual volume of >25 should be obtained. High mean annual volume was associated with significantly lower in-hospital mortality rates (P < 0.001). A significantly lower mortality rate of 14% was observed (P < 0.001) if a mean annual volume of 30 was achieved., Conclusions: Operationalizing the volume-outcome relationship with fewer but larger medical centres results in lower mortality, which outweighs the disadvantage of longer transportation time., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: This study aimed to develop a patient-centred approach to the burden of acute type A aortic dissection (ATAAD) through modelling. The main objective was to identify potential improvements in managing this life-threatening cardiovascular condition and to provide evidence-based recommendations to optimise outcomes., Design: We developed a predictive model along patient pathways to estimate the burden of ATAAD through the years of life lost (YLLs) metric. The model was created based on a systematic review of the literature and was parameterised using demographic data from the German healthcare environment. The model was designed to allow interactive simulation of different scenarios resulting from changes in key impact factors., Setting: The study was conducted using data from the German healthcare environment and results from the literature review., Participants: The study included a comprehensive modelling of ATAAD cases in Germany but did not directly involve participants., Interventions: There were no specific interventions applied in this study based on the modelling design., Primary and Secondary Outcome Measures: The single outcome measure was the estimation of YLL due to ATAAD in Germany., Results: Our model estimated 102 791 YLL per year for ATAAD in Germany, with 62 432 and 40 359 YLL for men and women, respectively. Modelling an improved care setting yielded 93 191 YLL or 9.3% less YLL compared with the current standard while a worst-case scenario resulted in 113 023 or 10.0% more YLL. The model is accessible at https://acuteaorticdissection.com/ to estimate custom scenarios., Conclusions: Our study provides an evidence-based approach to estimating the burden of ATAAD and identifying potential improvements in the management of pathways. This approach can be used by healthcare decision-makers to inform policy changes aimed at optimising patient outcomes. By considering patient-centred approaches in any healthcare environment, the model has the potential to improve efficient care for patients suffering from ATAAD., Competing Interests: Competing interests: AM is a shareholder of x-cardiac and receives consulting fees from Edwards and Pfizer as well as travel grants from Abbott, Edwards, and Medtronic. All other authors declare no competing interests., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Among low-risk patients with severe, symptomatic aortic stenosis who are eligible for both transcatheter aortic-valve implantation (TAVI) and surgical aortic-valve replacement (SAVR), data are lacking on the appropriate treatment strategy in routine clinical practice., Methods: In this randomized noninferiority trial conducted at 38 sites in Germany, we assigned patients with severe aortic stenosis who were at low or intermediate surgical risk to undergo either TAVI or SAVR. Percutaneous- and surgical-valve prostheses were selected according to operator discretion. The primary outcome was a composite of death from any cause or fatal or nonfatal stroke at 1 year., Results: A total of 1414 patients underwent randomization (701 to the TAVI group and 713 to the SAVR group). The mean (±SD) age of the patients was 74±4 years; 57% were men, and the median Society of Thoracic Surgeons risk score was 1.8% (low surgical risk). The Kaplan-Meier estimate of the primary outcome at 1 year was 5.4% in the TAVI group and 10.0% in the SAVR group (hazard ratio for death or stroke, 0.53; 95% confidence interval [CI], 0.35 to 0.79; P<0.001 for noninferiority). The incidence of death from any cause was 2.6% in the TAVI group and 6.2% in the SAVR group (hazard ratio, 0.43; 95% CI, 0.24 to 0.73); the incidence of stroke was 2.9% and 4.7%, respectively (hazard ratio, 0.61; 95% CI, 0.35 to 1.06). Procedural complications occurred in 1.5% and 1.0% of patients in the TAVI and SAVR groups, respectively., Conclusions: Among patients with severe aortic stenosis at low or intermediate surgical risk, TAVI was noninferior to SAVR with respect to death from any cause or stroke at 1 year. (Funded by the German Center for Cardiovascular Research and the German Heart Foundation; DEDICATE-DZHK6 ClinicalTrials.gov number, NCT03112980.)., (Copyright © 2024 Massachusetts Medical Society.)

The evolution and progress in cardiovascular medicine and substantial changes in the German health care system require both a reflection of the principles of patient-centered care in general and an update of the criteria that define a department of cardiac surgery in Germany. This position paper lists the core requirements for a cardiac surgical department with regard to infrastructure, facilities, necessary staff, and standard of care (processes). This standard may be used by hospitals and health care providers to ensure the safety and quality of cardiac surgical departments in Germany., Competing Interests: None declared., (Thieme. All rights reserved.)

Objectives: We aimed to define and assess risk-specific adverse outcomes after transcatheter aortic valve implantation (TAVI) in an all-comers patient population based on German administrative claims data., Methods: Administrative claims data of patients undergoing transvascular TAVI between 2017 and 2019 derived from the largest provider of statutory health-care insurance in Germany were used. Patients' risk profile was assessed using the established Hospital Frailty Risk (HFR) score and 30-day adverse events were evaluated. Multivariable logistic regression models were applied to investigate the relation of patients' risk factors to clinical outcomes and, subsequently, of clinical outcomes to mortality., Results: A total of 21,430 patients were included in the analysis. Of those, 51% were categorized as low-, 37% as intermediate-, and 12% as high-risk TAVI patients according to HFR score. Whereas low-risk TAVI patients showed low rates of periprocedural adverse events, TAVI patients at intermediate or high risk suffered from worse outcomes. An increase in HFR score was associated with an increased risk for all adverse outcome measures. The strongest association of patients' risk profile and outcome was present for cerebrovascular events and acute renal failure after TAVI. Independent of patients' risk, the latter showed the strongest relation with early mortality after TAVI., Conclusions: Differentiated outcomes after TAVI can be assessed using claims-based data and are highly dependent on patients' risk profile. The present study might be of use to define risk-adjusted outcome margins for TAVI patients in Germany on the basis of health-insurance data., (© 2022. The Author(s).)

High-quality care of cardiac surgical patients requires the employment and recruiting of qualified medical professionals with minimal fluctuation of staff members. This aspect becomes increasingly difficult due to the current shortage of skilled professionals as well as the present framework conditions of the German Healthcare System. The implementation of physician assistants (PA) in cardiac surgery departments may augment existing human resource concepts in an innovative and sustainable manner, tailored to meet department specific requirements. Long-term experiences from Anglo-American countries prove that the implementation of a PA system may stabilize or potentially even improve medical treatment quality. At the same time, cardiac surgical residents may be relieved from routine tasks, releasing additional time resources for a solid and diverse specialist training. Furthermore, positive effects on economic aspects of an institution may be possible. The required delegation of medical tasks to allied health professionals already has a legal basis in Germany, while a specific legal framework tailored to physician assistants does not exist yet. In this context, it is an important aspect that medical associations define a reliable catalog of tasks that may be delegated to physician assistants. Under evaluation of medical, legal and economic aspects and in a structured manner, this position paper defines medical tasks of physician assistants in cardiac surgery., Competing Interests: Disclosure The authors report no conflicts of interest in this work., (Thieme. All rights reserved.)

Objectives: Short-term mechanical circulatory support is a life-saving treatment for acute cardiogenic shock (CS). This multicentre study investigates the preoperative predictors of 30-day mortality in CS patients treated with Impella 5.0 and 5.5 short-term left ventricular assist devices., Methods: Data of patients in CS (n = 70) treated with the Impella 5 (n = 63) and 5.5 (n = 7) in 2 centres in Berlin between October 2016 and October 2019 were collected retrospectively., Results: CS was caused by acute myocardial infarction (n = 16), decompensated chronic heart failure (n = 41), postcardiotomy syndrome (n = 5) and acute myocarditis (n = 8). Before implantation 12 (17%) patients underwent cardiopulmonary resuscitation and 32 (46%) patients were ventilated. INTERMACS level 1, 2 and 3 was established in 35 (50%), 29 (41%) and 6 (9%) of patients, respectively. The mean preoperative lactate level was 4.05 mmol/l. The median support time was 7 days (IR= 4-15). In 18 cases, the pump was removed for myocardial recovery, in 22 cases, durable left ventricular assist devices were implanted, and 30 patients died on support. The overall 30-day survival was 51%. Statistical analysis showed that an increase in lactate per mmol/l [odds ratio (OR) 1.217; P = 0.015] and cardiopulmonary resuscitation before implantation (OR 16.74; P = 0.009) are predictors of 30-day survival. Based on these data, an algorithm for optimal short-term mechanical circulatory support selection is proposed., Conclusions: Impella treatment is feasible in severe CS. Severe organ dysfunction, as well as the level and duration of shock predict early mortality. An algorithm based on these parameters may help identify patients who would benefit from Impella 5+ support., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objective: We sought to investigate the procedural and hemodynamic outcome after valve-in-valve transcatheter aortic valve replacement (VinV-TAVR) for different surgical (SBV) and transcatheter (TAVR) bioprosthetic valves., Methods and Results: 223 patients (76 ± 11years, STS-Score 8.3 ± 10.1) suffering from SBV failure treated with VinV-TAVR were enrolled at 6 centers across Germany. At time of the intervention, the majority of patients were in NYHA-class ≥ III (88%, n = 180). Failure mode of the SBVs was either stenosis, regurgitation (AR) or a combination of both in 85 (38%), 76 (34%) and 62 (28%) patients, respectively. 138 (62%) patients were treated with first generation TAVR valves (Edwards Sapien XT or CoreValve). Second generation valves were implanted in 85 (38%) patients (Sapien 3, Medtronic CoreValve Evolut, SJM-Portico, JenaValve). VinV-TAVR was associated with high procedural success rate, conversion to surgery was necessary in 3 (2%) patients. After VinV-TAVR procedure, 4 (2%) patients suffered from ≥ moderate AR. In 6 (3%) patients a second valve was implanted due to mispositioning of the first valve and subsequent severe paravalvular AR. Coronary obstruction was observed in 4 (2%) patients. Major bleeding and cerebrovascular complications (according to VARC) were reported in 3 (1%) and 4 (2%) patients at 30 days. Post-interventionally, 44/178 (25%) patients evidenced a mean pressure gradient (mPG) ≥ 20 mmHg. Residual stenosis was not associated with increased mortality (HR 0.39; 95% CI 0.13-1.22; p = 0.11)., Conclusion: In VinV-TAVR for SBV-failure is a safe procedure resulting in hemodynamic improvement in the majority of patients. Residual stenosis is a common finding which can be observed in 1/4 of patients undergoing VinV-TAVR. However, this condition is not associated with increased 1-year-mortality.

Objective: Patients with infective endocarditis undergoing cardiac surgery are a high-risk population. Few data on incidence and predictors of need for high-dose inotropic support in this setting are currently available., Design: Retrospective study., Setting: Tertiary-care hospital., Participants: Ninety consecutive patients undergoing cardiac surgery for infective endocarditis., Interventions: None., Measurements and Main Results: Baseline, intraoperative and outcome data were collected. Stepwise multiple logistic regression analysis was performed to identify preoperative predictors of postoperative hemodynamic support. High-dose postoperative inotropic support was defined as inotropic score >10 (calculated as dobutamine dose (in µg/kg/min) + dopamine dose (in µg/kg/min) + (epinephrine dose [in µg/kg/min] × 100) + (norepinephrine dose [in µg/kg/min] × 100) + (milrinone dose [in µg/kg/min] × 10) + (vasopressin dose [in U/kg/min] × 10 000) + (levosimendan dose [in µg/kg/min] × 50) or need for mechanical circulatory support at intensive care unit admission. Postoperative high-dose inotropic or mechanical circulatory support was required in 57 cases (61%). Stepwise multiple logistic regression identified 5 variables independently associated with need for postoperative circulatory support: male sex (odds ratio [OR] = 10.9), surgery duration (OR for every minute increase = 1.01), impairment of kidney function (eGFR <60 mL/min/m 2 - OR = 19), preoperative new-onset heart failure (defined by clinical, imaging and laboratory parameters - OR = 5.30), and low preoperative platelet count (for every 1×10 3 /μl increase - OR = 0.99)., Conclusions: Patients undergoing cardiac surgery for infective endocarditis are at high risk for postoperative hemodynamic instability. Preoperative organ failure is an important determinant for postoperative hemodynamic instability., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Transcatheter caval valve implantation is under evaluation as a treatment option for inoperable patients with severe tricuspid regurgitation (TR). The procedure involves the catheter-based implantation of bioprosthetic valves in the inferior vena cava and superior vena cava to treat symptoms associated with TR. This study is the first to evaluate the feasibility, safety, and efficacy of this interventional concept., Methods and Results: Twenty-five patients (mean age, 73.9±7.6 years; women, 52.0%) with severe symptomatic TR despite optimal medical treatment deemed unsuitable for surgery were treated with caval valve implantation under a compassionate clinical use program. Technical feasibility defined as procedural success, hemodynamic effect defined as venous pressure reduction, and safety defined as periprocedural adverse events were evaluated, with clinical follow-up at discharge and up to 12 months. The functional impact was evaluated by assessment of New York Heart Association class at the time of hospital discharge. The total number of valves implanted in the caval position was 31. Patients were treated with single (inferior vena cava-only; n=19; 76.0%) or bicaval valve implantation (inferior vena cava+superior vena cava; n=6; 24.0%). Either balloon-expandable valves (Sapien XT/3: n=18; 72.0%) or self-expandable valves (TricValve: n=6; 24.0%; Directflow: n=1; 4.0%) were used. Procedural success was achieved in 96% (n=24). Early and late valve migration requiring surgical intervention occurred in 1 patient each. Thirty-day and in-hospital mortality were 8% (2 of 25) and 16% (4 of 25). Causes of in-hospital mortality included respiratory (n=1) or multiple organ failure (n=3) and were not linked to the procedure. Mean overall survival in the study cohort was 316±453 days (14-1540 days)., Conclusions: Caval valve implantation for the treatment of severe TR and advanced right ventricular failure is associated with a high procedural success rate and seems safe and feasible in an excessive-risk cohort. The study demonstrates hemodynamic efficacy with consistent elimination of TR-associated venous backflow and initial clinical improvement. These results encourage further trials to determine which patients benefit most from this interventional approach., (© 2018 American Heart Association, Inc.)

Surgical aortic valve replacement is still considered the first-line treatment for patients suffering from severe aortic valve stenosis. In recent years, transcatheter aortic valve implantation (TAVI) has emerged as an alternative for selected high-risk patients. According to the latest results of the German external quality assurance program, mandatory by law, the initially very high mortality and procedural morbidity have now decreased to approximately 6 and 12%, respectively. Especially in Germany, the number of patients treated by TAVI has increased exponentially. In 2013, a total of 10.602 TAVI procedures were performed. TAVI is claimed to be minimally invasive. This is true concerning the access, but it does not describe the genuine complexity of the procedure, defined by the close neighborhood of the aortic valve to delicate intracardiac structures. Hence, significant numbers of life-threatening complications may occur and have been reported. Owing to the complexity of TAVI, there is a unanimous concordance between cardiologists and cardiac surgeons in the Western world demanding a close heart team approach for patient selection, intervention, handling of complications, and pre- as well as postprocedural care, respectively. The prerequisite is that TAVI should not be performed in centers with no cardiac surgery on site. This is emphasized in all international joint guidelines and expert consensus statements. Today, a small number of patients undergo TAVI procedures in German hospitals without a department of cardiac surgery on site. To be noted, most of these hospitals perform less than 20 cases per year. Recently, the German Cardiac Society (DGK) published a position paper supporting this practice pattern. Contrary to this statement and concerned about the safety of patients treated this way, the German Society for Thoracic and Cardiovascular Surgery (DGTHG) still fully endorses the European (ESC/EACTS) and other actual international guidelines and consensus statements. Only the concomitance of departments for cardiac surgery and cardiology on site can provide optimal TAVI care. This commentary by the DGTHG delineates the data and resources upon which its opinion is based., (Georg Thieme Verlag KG Stuttgart · New York.)

Objectives: This study was designed to delineate the role of implantable cardioverter defibrillator (ICD) therapy for the primary and secondary prevention of sudden cardiac death in patients listed for heart transplantation., Setting: Retrospective observational multicentre study., Patients: 1089 consecutive patients listed for heart transplantation in two tertiary heart transplant centres were enrolled. Of 550 patients (51%) on the transplant list with an ICD, 216 had received their ICD for the primary prevention of sudden cardiac death and 334 for secondary prevention. 539 patients did not receive an ICD., Intervention: Treatment with or without an ICD was left to the discretion of the heart failure specialist., Main Outcome Measure: All-cause mortality., Results: ICDs appear to be associated with a reduction in all-cause mortality in patients implanted with the device for primary and secondary prevention compared to those without an ICD despite a median time on the waiting list of only 8 months (estimated 1-year: 88±3% vs. 77±3% vs. 67±3%; p=0.0001). A Cox regressional hazard model (corrected for age, sex, underlying heart disease, atrial fibrillation, cardiac resynchronisation therapy, New York Heart Association (NYHA) class, ejection fraction, co-medication and year of listing) suggested an independent beneficial effect of ICDs that was most pronounced in patients who had received an ICD for primary prevention (HR 0.4, 95% CI 0.19 to 0.85; p=0.016)., Conclusions: ICD implantation appears to be associated with an immediate and sustained survival benefit for patients awaiting heart transplantation.

Objective: Live broadcasting of cardiac surgical procedures has an educational intention. There is an ongoing debate whether live surgery increases risk. Aim of this study was to evaluate the outcomes of patients who underwent a cardiac surgical procedure during live broadcasting., Methods: A total of 250 cardiac operations were performed during 32 live broadcastings at four different clinical sites between 1999 and 2009. Data on patient characteristics, intra-operative procedures and patient short- and long-term outcome were collected and analyzed. All participating centers complied with the rules for the conduct of live surgery developed by the European Association of Cardiovascular and Thoracic Surgery (EACTS) Techno College Committee., Results: Primary educational focus was the mitral valve in 126 cases, aortic valve including transcatheter valve implantations in 34, coronary artery bypass grafting (CABG) in 29, congenital in 26, aortic (ascending, arch, and descending) in 15, atrial fibrillation in 13, and heart failure in seven. Mean EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 8.7 ± 11.5 (range: 0.8-72). Thirty-day mortality was 1.2% (3/250): reasons for death were multi-organ failure in two and respiratory failure in one patient, respectively. Stroke rate was 2.4% (6/250). Five patients (2%) required cardiac re-operations within 30 days. The rate of mitral valve repair was 96% (121) and compares favourably with repair rates presented in national registries. Mean follow-up of all patients was 3.7 ± 2.8 years with an estimated survival of 92% (95% confidence interval (CI): 87-95%) at 5 years., Conclusions: Based on this large experience there is no evidence for an excess perioperative risk for patients operated under the conditions of live broadcasting., (Copyright © 2010 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.)

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.

Objective: Aortic surgical procedures requiring hypothermic circulatory arrest are associated with altered hemostasis and increased bleeding. In a randomized clinical trial, we evaluated effects of thromboelastometrically guided algorithm on transfusion requirements., Methods: Fifty-six consecutive patients (25 with acute type A dissection) undergoing aortic surgery with hypothermic circulatory arrest were enrolled in a randomized trial during a 6-month period. Patients were randomly allocated to treatment group (n = 27) with thromboelastometrically guided transfusion algorithm or control group (n = 29) with routine transfusion practices (clinical judgment-guided transfusion followed by transfusion according to coagulation test results). Primary end point was cumulative allogeneic blood units (red blood cells, fresh-frozen plasma, and platelets) transfused., Results: Transfusion of allogeneic blood was significantly reduced in the thromboelastometry group: median 9.0 units (interquartile range, 2.0-30.0 units) versus. 16.0 units (9.0-23.0 units, P = .02). Most significant decrease was in the use of fresh-frozen plasma (3.0 units, 0-12.0 units, vs 8.0 units, 4.0-18.0 units, P = .005). Postoperative blood loss (890 mL/d, 600-1250 mL/d vs 950 mL/d, 650-1400 mL/d, p = 0.5) and rate of surgical re-exploration (19% vs 24%, P = .7) were similar between groups. Thromboelastometrically guided algorithm significantly decreased need for massive perioperative transfusion (odds ratio, 0.45; 95% confidence interval, 0.2-0.9; P = .03) in multivariable logistic regression analysis., Conclusions: Thromboelastometrically guided transfusion is associated with a decreased use of allogeneic blood units and reduced incidence of massive transfusion in patients undergoing aortic surgery with circulatory arrest., (Copyright © 2010 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

Background: The SYNTAX score was introduced to measure the complexity of coronary artery disease. Although a high SYNTAX score is indicative of a worse long-term outcome after percutaneous coronary intervention (PCI), it remains unclear whether it is also true for coronary artery bypass grafting (CABG)., Methods: We analyzed 200 consecutive CABG patients who underwent operations in 2002. Demographic and intraoperative data, perioperative outcomes, and 5-year outcomes were obtained. The SYNTAX score was calculated retrospectively by reviewing the original diagnostic angiograms. After excluding patients who had undergone CABG or PCI treatment within 6 months before surgery, we included 154 patients in the study. Patients were partitioned into tertiles according to the SYNTAX score (low, < or =18; intermediate, >18-26; high, >26). Cox regression analysis was used to identify baseline and procedural predictors for the combined end point of 5-year major adverse cardiac and cerebrovascular events (MACCE) and its components. Cumulative event rates were estimated by Kaplan-Meier methods., Results: The mean (+/-SD) age was 66.6 +/- 8.5 years, the mean ejection fraction was 56.4% +/- 13.6%, and the mean logistic EuroSCORE was 4.2% +/- 4.7%. The SYNTAX score ranged between 2 and 52. The overall survival rate was 94.8% at 1 year and 84.1% at 5 years. The rate of freedom from MACCE was 92.9% and 78.0% at 1 and 5 years, respectively. Only a higher EuroSCORE, a New York Heart Association class of III to IV, and smoking could be identified with Cox regression as risk factors for MACCE during follow-up. The overall survival and MACCE rates of the 3 SYNTAX score subgroups were not significantly different., Conclusions: Complex coronary pathology as measured by the SYNTAX score did not affect the long-term outcome after CABG in this study.

Very little medical virtual reality systems which are developed are applied in real surgical scenarios. One reason for this is that the system solutions resulting from research projects often address a single research question and are not embedded in an overall design. This paper presents a DICOM based approach on standardizing data structures, i.e. surface meshes, which are required for supporting surgical workflows by virtual reality applications.

Surgical telemanipulators are obviously used in cardiac surgery to provide the surgeon in a confined space the same stereoscopic vision, full dexterity, unimpaired hand-eye alignment and tactile feedback as in open surgery. This is the basic concept that enables the controlled fine soft tissue manipulation that is needed in bypass grafting and valve surgery. In 2005, a total of 2984 cardiac procedures were performed worldwide using the da Vinci system. This includes totally endoscopic coronary artery bypass grafting (TECAB), mitral valve repair (MVR) procedures, ASD closure and cardiac tissue ablation for atrial fibrillation.

Since the introduction of off-pump coronary artery bypass grafting (OPCAB) for coronary multivessel disease there was growing interest to evaluate the impact of OPCAB surgery compared to conventional coronary artery bypass grafting (CCAB) with cardiopulmonary bypass and cardioplegic arrest. However, subsequent prospective randomized studies and meta-analyses comparing OPCAB and CCAB surgery were performed on low-risk patients or mixed-risk populations. They usually failed to demonstrate a significant benefit of OPCAB surgery on early mortality or perioperative major cardiac and cerebrovascular events. In recent years, efforts were made to analyze the meaning of beating-heart concepts for patients with specific cardiac and extracardiac risks like ischemic cardiomyopathy, older age, renal failure, acute coronary syndrome, left main stenosis and others. For these subsets of patients several mono- and multicenter studies are available today. Even if most of them were nonrandomized and thus failed to reach evidence level A according to the AHA/ACC (American Heart Association/American College of Cardiology) definition, they still allow analyzing interim results for each specific perioperative risk factor. Particularly multi-risk patients and patients with severely reduced left ventricular function seem to benefit in terms of perioperative mortality and major morbidity by avoiding cardiopulmonary bypass and cardioplegic arrest. Analyzing early results and long-term follow-up of 364 patients with severely reduced ejection fraction<20%, the authors found a long-term benefit for patients when using OPCAB strategies particularly due to reduced perioperative mortality. Moreover, for most subsets of patients with significant extracardiac risk factors the incidence or perioperative stroke was reduced. In patients with preoperative renal and pulmonary dysfunction a decrease of corresponding organ failure was found for OPCAB strategy. For most risk populations transfusion requirements were significantly lower in OPCAB compared to CCAB surgery. In none of the patients an unfavorable outcome of beating-heart surgery compared to CCAB was shown. For emergency patients with an acute coronary syndrome presenting stable and unstable hemodynamics the authors found a clinical benefit by using beating-heart strategies. Particularly in patients with cardiogenic shock, cardiopulmonary bypass was often required to guarantee adequate perioperative organ perfusion. However, these patients seemed to benefit from avoiding global cardiac ischemia and maintaining native coronary blood flow. Follow-up results were comparable for these patients. In conclusion, beating-heart coronary artery bypass grafting seems to be advantageous in various risk populations and should be considered for patients with more than average risks for cardiopulmonary bypass and cardioplegic arrest.

For better integration of surgical assist systems into the operating room, a common communication and processing plattform that is based on the users needs is needed. The development of such a system, a Surgical Picture Aquisition and Communication System (S-PACS), according the systems engineering cycle is oulined in this paper. The first two steps (concept and specification) for the engineering of the S-PACS are discussed.A method for the systematic integration of the users needs', the Quality Function Deployment (QFD), is presented. The properties of QFD for the underlying problem and first results are discussed. Finally, this leads to a first definition of an S-PACS system.

Objective: Reoperations are associated with an increased surgical risk due to adhesions. We prospectively evaluated a bioresorbable membrane after surgery for congenital heart defects over a 3.5-year period., Methods: The surgical membrane (CV Seprafilm, Genzyme, Cambridge, Mass) was applied in 350 of 1024 patients; 30 of them underwent reoperation and were evaluated in comparison to 10 random reoperated patients. Adhesions were evaluated using a subjective scoring system [1 (lowest tenacity) to 5 (highest tenacity)] and extent in percent at different regions of the heart., Results: Patients were operated for atrioventricular septal defect (69), tetralogy of Fallot (65), functional single ventricle (75), valve surgery (48), ventricular septal defect (20), subaortic stenosis (17), hypoplastic left heart syndrome (17), and other diagnoses (39). Application of the surgical membrane was safe in all patients, without any infections. At reoperation patients received Glenn (14), total cavopulmonary connection (6), and others (10). Overall mortality was 2/350 (0.57%). There was a remarkable reduction in tenacity score (3.3 vs 4.3) and in the extent of adhesions (77.7% vs 86%). Duration of reoperation was significantly reduced., Conclusions: A bioresorbable surgical membrane leads to a significant reduction in the tenacity and amount of adhesions. It is recommended for general use whenever repeat operation is anticipated in congenital as well as in adult cardiac surgery.