Importance:Cutibacterium acnes, traditionally considered a contaminant, is increasingly recognized as a relevant pathogen of prosthetic valve endocarditis, particularly in men. It is hypothesized that intraoperative transfer from incised hair follicles at the sternal wound margin occurs despite current standard disinfection protocols. Objective:To evaluate whether additional intraoperative hygiene measures reduce surgical site contamination with C acnes during cardiac surgery. Design, Setting, and Participants:This multicenter, parallel-group, blinded randomized clinical trial was conducted from October 28, 2024, to March 3, 2025, at 1 university hospital and 1 university-affiliated teaching hospital in Munich, Germany. Participants were male patients undergoing first-time cardiac surgery. Patients and laboratory personnel were blinded to group assignments. The analysis was based on a per-protocol design. Six patients were excluded after randomization due to incorrect sampling (n = 4) or incorrectly performed intervention procedures (n = 2). Intervention:The intervention group received additional hygiene measures after sternotomy, including changing outer gloves, disinfecting sternal wound margins with iodine, and covering them with sterile absorption pads. The control group received usual care, which included a glove change after sternotomy without additional skin margin treatment. Main Outcomes and Measures:The primary outcome was perioperative C acnes contamination, measured by the number of culture-positive swabs, amount of growth on agar, and pathogen identification via matrix-assisted laser desorption-ionization time of flight mass spectrometry. Results:Among 124 male patients (mean [SD] age, 68.5 [9.9] years) included in the analysis, C acnes was detected significantly less frequently in the intervention group (9 of 62 [14.5%]) compared with the control group (38 of 62 [61.3%]; risk ratio [RR], 0.24 [95% CI, 0.13-0.45]; P < .001), representing a relative risk reduction of 76%. Regarding growth intensity in the pericardium, the intervention group showed 100% negative or thioglycolate-only growth, whereas 27 patients (43.5%) in the control group exhibited agar growth (1+ to 3+). Overall bacterial contamination was similarly reduced (10 of 62 [16.1%] vs 44 of 62 [71.0%]; RR, 0.23 [95% CI, 0.13-0.41]; P < .001). Chest hair density was identified as a risk factor for contamination (odds ratio, 1.16 [95% CI, 1.02-1.31]; P = .02). Conclusions and Relevance:In this randomized clinical trial of 124 male patients undergoing cardiac surgery, additional intraoperative hygiene measures targeting the wound margin significantly reduced C acnes transfer to the surgical site. These simple, low-cost strategies should be considered for implementation in standard surgical protocols to potentially prevent prosthetic valve endocarditis. Trial Registration:German Clinical Trials Register: DRKS00035169.

Importance Cutibacterium acnes , traditionally considered a contaminant, is increasingly recognized as a relevant pathogen of prosthetic valve endocarditis, particularly in men. It is hypothesized that intraoperative transfer from incised hair follicles at the sternal wound margin occurs despite current standard disinfection protocols. Objective To evaluate whether additional intraoperative hygiene measures reduce surgical site contamination with C acnes during cardiac surgery. Design, Setting, and Participants This multicenter, parallel-group, blinded randomized clinical trial was conducted from October 28, 2024, to March 3, 2025, at 1 university hospital and 1 university-affiliated teaching hospital in Munich, Germany. Participants were male patients undergoing first-time cardiac surgery. Patients and laboratory personnel were blinded to group assignments. The analysis was based on a per-protocol design. Six patients were excluded after randomization due to incorrect sampling (n = 4) or incorrectly performed intervention procedures (n = 2). Intervention The intervention group received additional hygiene measures after sternotomy, including changing outer gloves, disinfecting sternal wound margins with iodine, and covering them with sterile absorption pads. The control group received usual care, which included a glove change after sternotomy without additional skin margin treatment. Main Outcomes and Measures The primary outcome was perioperative C acnes contamination, measured by the number of culture-positive swabs, amount of growth on agar, and pathogen identification via matrix-assisted laser desorption–ionization time of flight mass spectrometry. Results Among 124 male patients (mean [SD] age, 68.5 [9.9] years) included in the analysis, C acnes was detected significantly less frequently in the intervention group (9 of 62 [14.5%]) compared with the control group (38 of 62 [61.3%]; risk ratio [RR], 0.24 [95% CI, 0.13-0.45]; P < .001), representing a relative risk reduction of 76%. Regarding growth intensity in the pericardium, the intervention group showed 100% negative or thioglycolate-only growth, whereas 27 patients (43.5%) in the control group exhibited agar growth (1+ to 3+). Overall bacterial contamination was similarly reduced (10 of 62 [16.1%] vs 44 of 62 [71.0%]; RR, 0.23 [95% CI, 0.13-0.41]; P < .001). Chest hair density was identified as a risk factor for contamination (odds ratio, 1.16 [95% CI, 1.02-1.31]; P = .02). Conclusions and Relevance In this randomized clinical trial of 124 male patients undergoing cardiac surgery, additional intraoperative hygiene measures targeting the wound margin significantly reduced C acnes transfer to the surgical site. These simple, low-cost strategies should be considered for implementation in standard surgical protocols to potentially prevent prosthetic valve endocarditis. Trial Registration German Clinical Trials Register: DRKS00035169

Background and aim of the study: During the COVID-19 pandemic in Bavaria, surgical ICU resources were reallocated, and elective procedures were postponed, impacting the management of infective endocarditis (IE). This study evaluated early surgical outcomes in patients with native valve endocarditis (NVE) and prosthetic valve endocarditis (PVE) before and during the pandemic. Methods: We retrospectively analyzed 94 patients (66% male) treated pre-pandemic (August 2018–March 21, 2020) and 84 patients (76% male) treated during the pandemic (March 22, 2020–November 2021). NVE cases comprised 78% pre-pandemic and 68% during the pandemic, while PVE cases increased from 22% to 32%. Preoperative characteristics, surgical urgency, postoperative complications, and in-hospital mortality were assessed. Explanted valves underwent histological, microbiological, and molecular analyses, including fluorescence in situ hybridization (FISH) with 16S rRNA PCR/sequencing. Results: During the pandemic, preoperative NYHA class III-IV increased significantly (NVE: 49% to 74%; PVE: 29% to 70%; all p<0.05). Urgent surgeries became more frequent (NVE: 27% to 49%, p=0.017; PVE: 20% to 52%, p=0.034), and the interval from diagnosis to surgery in PVE patients was prolonged (11 vs. 16 days, p=0.038). More complex procedures, including double-valve surgeries, were required (9.5% vs. 37%, p=0.022). Postoperatively, re-thoracotomy rates increased in NVE cases (OR: 9.106, p<0.001), while odds ratios for stroke, sepsis, and prolonged ICU stay in PVE patients trended higher but lacked statistical significance. Conclusion: The pandemic led to diagnostic delays, worsened preoperative conditions, and increased surgical urgency in IE patients, underscoring the need for resilient healthcare strategies to maintain timely surgical care during future crises.

Background For clinicians treating patients with infective endocarditis (IE), identifying the causative microorganisms poses a critical diagnostic challenge. Standard techniques including blood and heart valve cultures often yield inconclusive results. According to the recent 2023 Duke-ISCVID Criteria, molecular methods represent potent tools to enhance this aspect of IE diagnostics and guide subsequent therapeutic strategies.Methods We retrospectively analyzed data from 124 consecutive patients who underwent heart valve surgery due to suspected IE at M & uuml;nchen Klinik Bogenhausen. The standard diagnostic pathway, which included blood culture, valve culture, histopathological analysis, and polymerase chain reaction (PCR)/sequencing, was compared with the enhanced diagnostic pathway, which included fluorescence in situ hybridization + PCR/sequencing (FISHseq) instead of PCR/sequencing alone. The aim of this study was to assess the added value of combining standard diagnostics with molecular methods such as PCR/sequencing or FISHseq for the diagnosis of IE and the potential impact on therapy.Results Standard diagnostic methods and PCR/sequencing yielded inconclusive results in 57/124 cases (46.0%). FISHseq provided an added value for diagnostics in 79/124 cases (63.7%) and potentially would have impacted therapy in 95/124 (76.6%) of cases. By adding data through direct visualization and characterization of microorganisms, FISHseq reduced the number of inconclusive cases by 86.0%.Conclusions The comparison of 2 molecular diagnostic tools for IE from the same heart valve emphasizes the value of molecular methods including molecular imaging by FISH for IE diagnostics and supports the 2023 Duke-ISCVID Criteria.

OBJECTIVES The German CArdioSurgEry Atrial Fibrillation Registry is a prospective, multicentric registry analysing outcomes of patients undergoing surgical ablation for atrial fibrillation as concomitant or stand-alone procedures. This data sub-analysis of the German CArdioSurgEry Atrial Fibrillation Registry aims to describe the in-hospital and 1-year outcomes after concomitant surgical ablation, based on 2 different ablation approaches, epicardial and endocardial surgical ablation.METHODS Between January 2017 and April 2020, 17 German cardiosurgical units enrolled 763 consecutive patients after concomitant surgical ablation. In the epicardial group, 413 patients (54.1%), 95.6% underwent radiofrequency ablation. In the endocardial group, 350 patients (45.9%), 97.7% underwent cryoablation. 61.5% of patients in the epicardial group and 49.4% of patients in the endocardial group presenting with paroxysmal atrial fibrillation. Pre-, intra- and post-operative data were gathered.RESULTS Upon discharge, 32.3% (n = 109) of patients after epicardial surgical ablation and 24.0% (n = 72) of patients after endocardial surgical ablation showed recurrence of atrial fibrillation. The in-hospital mortality rate was low, 2.2% (n = 9) in the epicardial and 2.9% (n = 10) in the endocardial group. The overall 1-year procedural success rate was 58.4% in the epicardial and 62.2% in the endocardial group, with significant symptom improvement in both groups. The 1-year mortality rate was 7.7% (n = 30) in epicardial and 5.0% (n = 17) in the endocardial group.CONCLUSIONS Concomitant surgical ablation is safe and effective with significant improvement in patient symptoms and freedom from atrial fibrillation. Adequate cardiac rhythm monitoring should be prioritized for higher quality data acquisition. Atrial fibrillation (AF) is the most common abnormal rhythm of the heart, occurring in 5-41% of the patients who undergo cardiac surgery, depending on the underlying disease [1].

OBJECTIVES:The study aimed to review a multicentre experience of patients undergoing surgical intervention for infective endocarditis caused by Cutibacterium acnes and to analyse the diagnostic challenges and operative results. METHODS:We retrospectively reviewed 8812 patients undergoing cardiac surgery for endocarditis at 12 cardiac surgical departments across Germany. The overall population was divided based on the type of endocarditis (i.e. native and prosthetic valve endocarditis). Primary outcomes were in-hospital mortality, 1- and 5-year survival. RESULTS:Cutibacterium acnes caused endocarditis in 269 patients (3.1%). Median age was 65 years (54-72 years) and 237 (88.1%) were male. We observed significantly higher rates of native valve endocarditis in patients aged 21-40, whereas prosthetic valve endocarditis was more frequent in all other age groups (P < 0.001). The median EuroSCORE II of the cohort was 10.7 (5.0-29.6), with it being significantly higher in the prosthetic valve endocarditis group (P < 0.001). Blood culture-negative infective endocarditis was initially reported in 54.3% of the patients. The in-hospital mortality was comparable between the groups (P = 0.340). Survival at 1 and 5 years was significantly higher in the native valve endocarditis group (P < 0.001). CONCLUSIONS:Cutibacterium acnes causes native valve endocarditis, especially in younger patients. The incidence of endocarditis caused by C.acnes is alarming and is at par with well-known endocarditis pathogens such as the HACEK group. The pathogen has a low virulence and presents with a rather indolent course. The diagnosis of C.acnes endocarditis is challenging and requires a multimodal specialized approach. Surgical treatment is associated with acceptable outcomes.

Objectives: Degeneration of mitral prostheses/rings may be treated by redo surgery, and, recently, by transcatheter valve-in-valve/ring implantation. This multicenter registry presents results of transcatheter valve-in-valve and repeat surgery for prostheses/rings degeneration. Methods: Data provided by 10 German heart centers underwent propensity score-matched retrospective analysis. The primary endpoint was 30-day/midterm mortality. Perioperative outcome was assessed according to the Mitral Valve Academic Research Consortium criteria. Further, the influence of moderate or greater tricuspid regurgitation (TR) on 30-day/midterm mortality was analyzed. Results: Between 2014 and 2019, 273 patients (79 transcatheter mitral valve-in-valve [TM-ViV] and 194 redo mitral valve replacement [Re-MVR]) underwent repeat procedure for mitral prosthesis/ring degeneration. Propensity score matching distinguished 79 patient pairs. European System for Cardiac Operative Risk Evaluation (EuroSCORE) II-predicted risk was 15.7 +/- 13.7% in the TM-ViV group and 15.0% +/- 12.7% in the Re-MVR group (P = .5336). TM-ViV patients were older (74.73 vs 72.2 years; P = .0030) and had higher incidence of atrial fibrillation (54 vs 40 patients; P = .0233). Severe TR incidence was similar (17.95% in TM-ViV vs 14.10%; P = .1741). Sixty-eight TM-ViV patients previously underwent mitral valve replacement, whereas 41 Re-MVR patients underwent valve repair (P < .0001). Stenosis was the leading degeneration mechanism in 42 TM-ViV versus 22 Re-MVR patients (P < .0005). The 30-day/midterm mortality did not differ between groups. Moderate or greater TR was a predictor of total (odds ratio [OR], 4.36; P = .0011), 30-day (OR, 3.76; P = .0180), and midterm mortality (OR, 4.30; P = .0378), irrespective of group. Conclusions: In both groups, observed mortality was less than predicted. Redo surgery enabled treatment of concomitant conditions, such as atrial fibrillation or TR. TR was shown to be a predictor of total, 30-day, and midterm mortality in both groups.

Background Mycobacterium chelonae is a rare cause of infective endocarditis that is difficult to diagnose and treat. After we found M chelonae in a series of patients, we aimed to investigate its role in cardiovascular prosthesis dysfunction and contamination of bioprostheses as a possible cause of infection. Methods In this collaborative microbiological study, we report on nine patients treated in three cardiovascular surgical departments in Germany, who were found to have M chelonae infection after receiving BioIntegral bioprostheses. We performed fluorescence in-situ hybridisation (FISH) combined with broad-range 16S rRNA gene amplification and sequencing (FISHseq) on samples of native cardiovascular tissue and explanted bioprosthetic material, as well as on 12 unused BioIntegral prostheses. We confirmed FISHseq findings with histological examination by staining for acid-fast bacilli, and M chelonae was differentiated from M abscessus by molecular techniques. Findings Between Dec 1, 2020, and Feb 28, 2022, we identified M chelonae in BioIntegral bioprostheses from three initial patients treated in Berlin that were explanted following dysfunction or suspected endocarditis, visualising morphologically intact FISH-positive mycobacteria. Despite negative mycobacterial culture, we also detected M chelonae in all 12 unused BioIntegral prostheses. The competent authorities in the EU prompted an alert, leading to the identification of six additional patients between March 1, 2022, and July 31, 2023. To find other cases of M chelonae endocarditis, we reviewed the FISHseq results of 1237 cardiovascular samples that were analysed between Jan 1, 2015, and Aug 31, 2022, including 295 samples from 228 bioprostheses supplied by other manufacturers. M chelonae was only detected in six of 41 patients who had received BioIntegral products. Interpretation Bioprostheses manufactured by BioIntegral Surgical might be colonised by M chelonae, which can lead to implant dysfunction. These infections are likely to be missed by conventional routine diagnostics and should be considered in patients with BioIntegral implants and suspected infection or dysfunction. Cases should be reported to public health and regulatory authorities. Routine safety testing of bioprostheses during manufacture should be reconsidered. Funding German Federal Ministry of Education and Research.

The coronavirus disease (COVID-19) pandemic had a significant impact on global health, leading to changes in the allocation of medical resources and delayed treatment of non-COVID-19 patients. This study aimed to examine the effects of the global pandemic on cardiac surgical procedures and patient outcomes within a tertiary care center. Two cohorts were compared in this study: the cohort that was treated before the pandemic (2019/2020 cohort) and the cohort that was treated after the implementation of lockdown measures (2020/2021 cohort). Preoperative cardiac status, including the severity of symptoms and history of cardiac decompensation, was evaluated. Rates of urgent and emergent cases and postoperative complications were analyzed. The 2020/2021 cohort experienced a 21.50

Infective endocarditis (IE) is associated with extremely high surgical mortality. During the SARS-CoV-2 pandemic, hospitals restructured their intensive care units and outpatient services to prioritize COVID-19 care, which may have affected the outcomes of patients requiring urgent procedures. This study aimed to evaluate the impact of the pandemic on surgical outcomes of IE patients in Southern Germany.This observational, community-based study compared two cohorts of surgical candidates: a pandemic cohort from March 2020 to November 2021 (n = 84) and a pre-pandemic cohort from August 2018 to March 2020 (before the lockdown, n = 94). Preoperative status and postoperative in-hospital complications were analyzed and compared between the groups.The pandemic cohort experienced longer symptom onset to diagnosis intervals (14.5 versus 8 days, p = 0.529). A higher incidence of definite IE was observed after the lockdown according to the modified Duke criteria (82.1% versus 68.1%, p = 0.035). Patients presented with more severe symptoms post-lockdown (NYHA Class III: 50% versus 33%; Class IV: 22.6% versus 11.7%, p = 0.001). Postoperative complications, such as re-thoracotomy due to bleeding and hemofiltration for acute renal failure, were significantly more frequent after the lockdown (p < 0.05). However, in-hospital survival rates did not differ significantly between the groups.The COVID-19 pandemic and related lockdown measures were associated with delayed diagnoses and worse perioperative outcomes for surgical IE patients, highlighting the need for improved management strategies during public health crises.

OBJECTIVES The CArdioSurgEry Atrial Fibrillation (CASE-AF) registry is a prospective, multicentre study for collecting and analysing real-world data of surgical atrial fibrillation (AF) treatment. This study aimed to evaluate outcomes of surgery for long-standing persistent AF at 1 year.METHODSIn total, 17 centres consecutively include all eligible patients with continuous AF lasting for >= 1 year. Exclusion criteria are missing informed consent or age <18 years. For patient-reported outcomes measures, the European Heart Rhythm Association score was used. No presence of AF (based on ECG findings including Holter ECG and/or implanted devices), no re-ablation, no further cardioversion and no rehospitalization due to AF after a 3-month blanking period defined no AF recurrence at 1 year.RESULTS From January 2017 to January 2020, a total of 1115 patients were enrolled in CASE-AF. Of them, 202 patients (mean age 69.7 +/- 7.8 years, 27.2% female) underwent surgical ablation of long-standing persistent AF (study cohort), mostly accompanied by left atrial appendage closure (n = 180 [89%], resection n = 75 [42%]) and predominantly performed as concomitant (n = 174 [86%]) and left atrial only procedure (n = 144 [71%]). Early mortality (30 days) was 2.0% and morbidity was low. At follow-up (median 14.4 months, interquartile range, 12.7-17.6 months, 100% complete), 106 patients (56%) had no AF recurrence and 93% of them were asymptomatic. AF recurrence was accompanied by AF-related rehospitalization (n = 12, P = 0.003), direct current shock cardioversion (n = 23, P < 0.001), AF ablation (n = 7, P = 0.003) and stroke (n = 3, P = 0.059). Multivariable analysis identified cryoablation, predominantly performed endocardially including additional left atrial (74%) and biatrial (42%) lesions, as a significant factor for freedom from AF recurrence (odds ratio 2.7, 95% confidence interval 1.07-6.79, P = 0.035).CONCLUSIONS According to CASE-AF, surgical ablation of long-standing persistent AF is most effective when concomitantly performed using endocardial cryoablation. Ongoing follow-up allows further elucidation of efficacious treatment strategies.

OBJECTIVES With the expansion of transcatheter aortic valve replacement (TAVR) into intermediate and low risk, the number of TAVR procedures is bound to rise and along with it the number of cases of infective endocarditis following TAVR (TIE). The aim of this study was to review a multicentre experience of patients undergoing surgical intervention for TIE and to analyse the underlying indications and operative results. METHODS We retrospectively identified and analysed 69 patients who underwent cardiac surgery due to TIE at 9 cardiac surgical departments across Germany. The primary outcome was operative mortality, 6-month and 1-year survival. RESULTS Median age was 78 years (72-81) and 48(69.6%) were male. The median time to surgical aortic valve replacement was 14 months (5-24) after TAVR, with 32 patients (46.4%) being diagnosed with early TIE. Cardiac reoperations were performed in 17% of patients and 33% underwent concomitant mitral valve surgery. The main causative organisms were: Enterococcus faecalis (31.9%), coagulase-negative Staphylococcus spp. (26.1%), Methicillin-sensitive Staphylococcus aureus (15.9%) and viridians group streptococci (14.5%). Extracorporeal life support was required in 2 patients (2.9%) for a median duration of 3 days. Postoperative adverse cerebrovascular events were observed in 13 patients (18.9%). Postoperatively, 9 patients (13.0%) required a pacemaker and 33 patients (47.8%) needed temporary renal replacement therapy. Survival to discharge was 88.4% and survival at 6 months and 1 year was found to be 68% and 53%, respectively. CONCLUSIONS Our results suggest that TIE can be treated according to the guidelines for prosthetic valve endocarditis, namely with early surgery. Surgery for TIE is associated with acceptable morbidity and mortality rates. Surgery should be discussed liberally as a treatment option in patients with TIE by the 'endocarditis team' in referral centres.

IntroductionIn Infective Endocarditis (IE), early diagnosis of the causative microorganism is crucial for correct antibiotic therapy, which improves the patients’ outcome.ObjectivesWe studies the impact of biofilm formation in IE samples.Materials & methodsWe used Fluorescence in situ Hybridization (FISH) combined with 16S rRNA-gene PCR and sequencing to visualize and identify the infectious agents in native as well as prosthetic valves and to study any biofilm formation. The signal intensity of the fluorescence-labelled FISH probes correlates to a high ribosome content of the bacteria indicating metabolic activity at the time point of surgery. We developed a spacer FISH assay for the detection of the 16S-23S intergenic spacer region that is only present in actively transcribing cells to detect the activity of bacterial cells more precisely on a single cell level.ResultsFISH visualized bacteria in the heart valves ranging from single cells to highly organized biofilms. Interestingly, we found FISH positive bacteria in culture negative samples and samples from patients under antibiotic therapy. Using the spacer FISH, we visualized positive microbial cells in heart valves of patients under adequate therapy. Preliminary data point to a correlation between the biofilm state and treatment inefficiency.ConclusionFISH/PCR not only allows timely identification of the pathogens in IE, but also biofilm-staging and visualization of the effect of antimicrobial therapy at time of surgery. The technique provides crucial information for successful targeted antibiotic therapy, and it might guide therapeutical decisions in relation to biofilm state in the future.

The Trifecta aortic valve has excellent hemodynamic performance as result of an expansive valve design with a bovine pericardial sheet externally mounted on a titanium stent. We report 2 cases of early Trifecta valve degeneration, both caused by partial rupture of one of the leaflet cusps 3 and 4 years post-implant. Post discharge, both patients had routinely performed echocardiography check-ups, without signs of valve failure. Transesophageal echocardiography performed during emergency hospital readmission due to severe dyspnea revealed transvalvular aortic regurgitation without signs of endocarditis. Urgent redo-surgery was successful in both cases, replacing the Trifecta prosthesis with a different bovine bioprosthesis.

Objective: It has been reported that balloon aortic valvuloplasty immediately before transfemoral or transapical transcatheter aortic valve implantation has mostly little to no clinical value. We aimed to provide data on the need for balloon aortic valvuloplasty in patients undergoing transaortic transcatheter aortic valve implantation. Methods: Patients undergoing transaortic transcatheter aortic valve implantation with the Edwards SAPIEN XT (Nyon, Switzerland) or 3 transcatheter heart valve were prospectively included at 18 sites across Europe. In the present analysis, we compare the periprocedural and 30-day outcomes of patients undergoing conventional (thorn balloon aortic valvuloplasty) versus direct (-balloon aortic valvuloplasty) transaortic transcatheter aortic valve implantation. Results: Of the 300 patients enrolled, 222 underwent conventional and 78 underwent direct transaortic transcatheter aortic valve implantation. Peak and mean transvalvular gradients were improved in both groups with no significant difference between groups. Procedural duration, contrast agent volume, and requirement for postdilation were also comparable. A trend toward fewer periprocedural complications was evident in the direct group (3.9% vs 11.3%; P = .053), with significantly lower rates of permanent pacemaker implantation (0% vs 5.0%; P = .034). Balloon aortic valvuloplasty omission had no significant effect on any of the 30-day safety and efficacy outcomes, including Valve Academic Research Consortium-2 composite end points (early safety events: 22.7% vs 17.4%, odds ratio, 1.17, 95% confidence interval, 0.53-2.62; clinical efficacy events: 20.5% vs 18.7%, odds ratio, 1.14, 95% confidence interval, 0.51-2.55). Conclusions: For many patients, balloon aortic valvuloplasty predilation seems to have little clinical value in transaortic transcatheter aortic valve implantation using a balloon expandable transcatheter valve and may result in a higher rate of periprocedural complications, particularly in terms of permanent pacemaker implantation.

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.

OBJECTIVES: In infective endocarditis (IE), identification of the causative organism and consecutive treatment are crucial for patient survival. Although the macroscopic aspect resembles infected tissue, standard diagnostic tests often fail to allow one to identify bacteria. Fluorescence in situ hybridization (FISH) is a molecular, culture-independent technique that allows one to identify and visualize microorganisms within tissue and to recognize their morphology, number and activity. We analysed the diagnostic benefit of FISH/polymerase chain reaction (PCR) by comparing its results to those of standard diagnostic tests. METHODS: From September 2015 to April 2018, 128 patients underwent first-time or redo valve surgery to treat IE. Patients were designated according to the modified Duke criteria as definite (n=61), possible (n=34) or rejected (n=33) IE. Tissue specimens obtained intraoperatively were analysed using FISH/PCR in addition to undergoing standard diagnostic testing and PCR alone. RESULTS: We used blood cultures to detect microorganisms in 67/128 patients; valve cultures, in 34/128; PCR, in 67/128; histopathological diagnosis showed IE in 72/128 cases. We were able to detect microorganisms in 103/128 cases using FISH/PCR, with 55/61 in definite IE. Furthermore, we were able to identify 26 cases of bacterial biofilm using FISH/PCR, despite antibiotic treatment of 61 in the definite, 13 in the possible and 1 in the rejected group, including 8/33 patients in the rejected group with active bacteria. In all cases, the patient's therapy was altered. CONCLUSIONS: FISH/PCR was used to identify microorganisms in cases in which standard diagnostic tests failed to provide sufficient results for various reasons. Furthermore, FISH/PCR enabled us to identify bacterial biofilms and to differentiate between active versus degraded bacteria, thus indicating the impact of treatment. Therefore, we suggest FISH/PCR as an additional diagnostic tool in IE alongside standard diagnostic tests.

OBJECTIVES Transaortic (TAo) access for transcatheter aortic valve implantation (TAVI) is an alternative to the conventional transfemoral or transapical routes. Data comparing the characteristics and outcomes of TAo-TAVI using the SAPIEN XT and SAPIEN 3 heart valves are scarce. The objective of the current analysis was to provide such information. METHODS ROUTE is an international, prospective, observational registry. Patients with severe calcific aortic stenosis scheduled for TAo-TAVI with an Edwards SAPIEN XT or a SAPIEN 3 heart valve were consecutively enrolled at 22 centres across Europe between February 2013 and February 2015. Periprocedural, in-hospital and 30-day complication rates were assessed. RESULTS Of the 301 patients included, 126 (41.9%) received a SAPIEN 3 and 175 (58.1%) a SAPIEN XT. The SAPIEN 3 was associated with shorter procedure time (101 ± 35 vs 111 ± 40 min; P = 0.031) and a lower quantity of contrast agent used (87 ± 43 vs 112 ± 50 ml; P < 0.001). Balloon dilation was performed less often before (68.0% vs 78.3%; P = 0.045) and after implantation (13.6% vs 30.1%; P = 0.001). No statistically significant differences between the valve types were documented for overall (4.1% SAPIEN 3 vs 7.6% SAPIEN XT; P = 0.21), TAVI-related (0.8% vs 4.7%; P = 0.084) and cardiovascular mortality (2.4% vs 5.9%; P = 0.158). Major vascular complications were less frequent (0.8% vs 5.3%; P = 0.049), and there was a lower rate of moderate-to-severe paravalvular regurgitation (0.8% vs 5.1%; P = 0.050) in the SAPIEN 3 group. CONCLUSIONS Both the SAPIEN XT and SAPIEN 3 were safely implanted via the TAo route, though the SAPIEN 3 may be associated with a higher procedural success rate and improved prognosis. ClinicalTrials.gov Identifier NCT01991431.

ObjectivesWe present 1-year outcomes of the post-market registry of a next-generation transcatheter heart valve used for aortic regurgitation (AR). BackgroundTranscatheter aortic valve replacement (TAVR) is routine in high-risk patients with aortic stenosis but is not recommended for AR. The JenaValve (JenaValve Technology GmbH, Munich, Germany) overcomes technical challenges in AR patients through a leaflet clipping mechanism. MethodsThe JenaValve EvalUation of Long Term Performance and Safety In PaTients with SEvere Aortic Stenosis oR Aortic Insufficiency (JUPITER) Registry is a European study to evaluate safety and effectiveness of this THV. From 2012-2015, 30 patients with AR were enrolled. ResultsMean age was 74.49.3 years. Procedural success was 96.7% (29/30). One patient was converted to open surgery. No annular rupture or coronary ostia obstruction occurred. Mortality at 30 days was 10.0% (3/30). Combined safety endpoint was met in 13.3% (4/30). Paravalvular regurgitation was not present/trivial in 84.6% (22/26) and mild in 15.4% (4/26). Rate of permanent pacemaker implantation was 3.8% (1/26). One-year Kaplan-Meier survival was 79.9%, one-year combined efficacy was 73.1% (19/30). No further strokes were observed during 1 year of follow-up. ConclusionsThe JenaValve overcomes technical challenges of TAVR in AR through a clipping mechanism. We report satisfactory outcomes of a multicenter registry using the JenaValve for predominant AR, as rate of THV embolization, residual AR and permanent pacemaker implantation was low. One-year results using the JenaValve for AR encourage its use for this indication.

Objectives Despite encouraging late outcomes, the use of bilateral internal thoracic artery (BITA) grafting for myocardial revascularization in diabetic patients remains controversial because of an increased risk of sternal wound complications. In the present study, early- and long-term outcomes of the use of left-sided BITA versus single internal thoracic artery (SITA) grafting in young (< 65 years of age) diabetic patients were reviewed retrospectively. Methods A total of 250 propensity score pair-matched diabetic patients, operated on between February 2000 and December 2011, receiving either BITA (n = 125) or SITA (n = 125) grafting were analyzed retrospectively. In each group, 104 patients were males, and mean age was 60.1 ± 5.3 years. Follow-up was 2.1 to 14.8 years (mean, 9.3 ± 3.5 years) and complete for 100%. Results Incidence of deep sternal wound infection was 2.4 versus 3.2% (p = 0.722). Rethoracotomy due to bleeding occurred in 4.8 versus 3.2% (p = 0.608). The 5-, 10-, and 14-year estimates of survival were 93.4, 76.6, and 67.5% (BITA) versus 89.5, 81.5, and 32.8% (SITA); p = 0.288. Freedom from reangiography/intervention (60.5 vs. 63.9%) during follow-up was comparable (p = 0.507) as well as infarction rate (93.8 vs. 95.1%, p = 0.833) and redoes (p = 0.672, exclusively valve surgery) were comparable. Freedom from thromboembolic or cerebrovascular events did not show any significant differences (94.0 vs. 94.0%, p = 0.78). Multivariate analysis identified poor ejection fraction as predictor for decreased long-term survival. Neither age nor gender or urgency had an influence on long-term mortality. Conclusion Left-sided BITA grafting may be performed routinely even in diabetic patients without increased incidence of postoperative wound-healing complications. Survival rates after 5, 10, and 14 years were comparable for BITA and SITA grafting.