Journal: European Journal of Cardio-Thoracic Surgery

Abbreviation

Eur J Cardiothorac Surg

Publisher

Oxford University Press

Journal Volumes

ISSN

1010-7940
1873-734X

Description

Filters

Reset filters

Search Results

Publications 1 - 10 of 52
  • Randomized Trials in Cardiac Surgery: Why and How
    Item type: Review Article
    Gaudino, Mario; Siepe, Matthias; Williams, Bryan; et al. (2025)
    European Journal of Cardio-Thoracic Surgery
    OBJECTIVES Randomized clinical trials (RCTs) are the gold standard for comparative effectiveness. However, they face unique challenges in cardiac surgery. The objective of this work is to summarize the challenges of RCTs in cardiac surgery, describe efforts employed in recent years to mitigate these impediments and outline the future opportunities for increased RCT adoption in the specialty. METHODS This review was conducted as an expert analysis on the existing state of RCTs in cardiac surgery based on expert discussion at a dedicated session during the 2024 Annual Meeting of the European Association for Cardio-Thoracic Surgery (EACTS). Different trial-support infrastructures, such as the Randomized Comparison of the Clinical Outcomes of Single versus Multiple Arterial Grafts (ROMA) Network, the Cardiothoracic Surgical Trials Network (CTSN), the Global Cardiovascular Research Funders Forum (GCRFF) and the UK Model, and their respective mechanisms for overcoming RCT barriers were described in detailed. Models were selected due to specific author involvement and knowledge. Future directions were postulated based on current trends. RESULTS Despite heterogeneous structures, the described models largely aimed to increased cardiac RCTs through improved trial participation, either via increased trainees, expanded stakeholders or focused patient recruitment, facilitating funding and fostering wider collaboration. CONCLUSIONS RCTs are a key component for clinical advancement yet have been underutilized in cardiac surgery. Recent endeavours have reduced the multifactorial barriers associated with cardiac surgery RCTs and intentional future efforts are necessary for continued cardiac advancement.
  • Classic hemiarch versus hemiarch and hybrid noncovered open stenting for acute DeBakey type I dissection-a propensity score-matched analysis
    Item type: Journal Article
    Pitts, Leonard; Montagner, Matteo; Kofler, Markus; et al. (2025)
    European Journal of Cardio-Thoracic Surgery
    OBJECTIVES This study investigates early and midterm outcomes after surgery for acute DeBakey type I dissection between classic hemiarch replacement and additional open noncovered stenting of the aortic arch. METHODS Patients who underwent surgery for acute DeBakey type I dissection receiving solely hemiarch replacement (2015–2022) or additional open noncovered stenting of the aortic arch (2018–2022) using the ‘Ascyrus Medical Dissection Stent’ (AMDS) were included. After propensity score matching, the groups were compared in terms of clinical and radiological outcomes. RESULTS A total of 261 patients (155 hemiarch, 106 AMDS) were included. After matching, the cohort comprised 2 balanced groups with 108 patients (54 each group): 30-day mortality was 19% in the hemiarch group versus 15% in the AMDS group [P = 0.61, odds ratio (OR) = 0.77 (confidence interval (CI) 0.27–2.12)]. New postoperative stroke [P = 0.99, OR = 0.98 (CI 0.11–8.43)] and revision for malperfusion did not differ [P = 0.38, OR = 1.70 (CI 0.53–5.99)]. The incidence of new distal anastomotic entries was significantly lower in the AMDS group with 17% vs 45% in the hemiarch group [P = 0.028, OR = 0.35 (CI 0.13–0.87)]. True lumen expansion was significantly improved in the aortic arch [P = 0.006, OR = 3.15 (CI 1.41–7.34)] and stented portion of the descending aorta [P < 0.001, OR = 8.51 (CI 3.65–21.24)] as well as false lumen thrombosis in the aortic arch [P = 0.048, OR = 2.24 (CI 1.02–5.07)]. Two-year survival did not differ (P = 0.170). CONCLUSIONS Additional AMDS implantation shows similar clinical outcomes, reduces the risk for new distal anastomotic entries and may be associated with superior positive aortic remodelling in the aortic arch and stented portion of the descending aorta. Long-term results regarding aortic remodelling and reintervention rate are highly needed.
  • The arch remodelling stent for DeBakey I acute aortic dissection: experience with 100 implantations
    Item type: Journal Article
    Montagner, Matteo; Kofler, Markus; Seeber, Fabian; et al. (2022)
    European Journal of Cardio-Thoracic Surgery
    OBJECTIVES A novel hybrid non-covered stent was developed to treat malperfusion and prevent aneurysm formation following hemiarch procedure for DeBakey I acute aortic dissection (AAD). The present analysis investigates the performance of the device in 100 consecutive implantations. METHODS Between 2018 and 2021, 100 patients underwent surgical repair of DeBakey I AAD with implantation of a non-covered stent in the arch and descending aorta. The primary entry tear was located in the root or the ascending aorta. Clinical and imaging data were collected and analysed retrospectively. The endpoints of the study were 30-day mortality, neurological outcome and need of additional procedures due to postoperative malperfusion. Technical success was assessed in the first postoperative computed tomography in regard to the induction of false lumen thrombosis in the descending aorta. RESULTS The median age was 61 (54–73) years. Preoperative malperfusion was present in 46 (46%) patients. The primary arterial cannulation strategy was the right axillary artery and an open distal anastomosis was performed in a median caudal circulatory arrest of 40 (34–52) min. In 48% of cases, a 55–40 tapered stent was implanted. The 30-day mortality was 18%, and the operation-related new postoperative neurological deficit was present in 8%. Technical success was achieved in 76% of patients. CONCLUSIONS The novel non-covered stent can be safely applied to complement aortic repair with the hemiarch procedure for DeBakey I AAD. The expansion of the true lumen through the device may prevent postoperative malperfusion and induces positive vascular remodelling with the thrombosis of the false lumen.
  • Retrospective 1-year outcome follow-up in 200 patients supported with HeartMate 3 and HeartWare left ventricular assist devices in a single centre
    Item type: Journal Article
    Mueller, Marcus; Hoermandinger, Christoph; Richter, Gregor; et al. (2020)
    European Journal of Cardio-Thoracic Surgery
    OBJECTIVES Various trials have assessed the outcome and reliability of the HeartWare HVAD (HW) and HeartMate 3 (HM3) left ventricular assist devices. A direct comparison of clinical outcomes and of the complication profile of these 2 left ventricular assist devices is lacking. We present a retrospective analysis of patients supported with HM3 and HW as a left ventricular assist device. METHODS Preoperative data, complications and outcomes including a 1-year follow-up of patients supported with the HM3 and HW in a single centre were retrospectively analysed. Both pumps were implanted on- or off-pump, employing standard and minimally invasive techniques. For logistic reasons, the 2 device types were implanted in an alternating manner, thereby reducing the systematic bias for pump selection. We considered this to be an appropriate approach, as no differences in respect of survival or the complication profile of the two device types have been demonstrated. Anticoagulation was similar in patients with both pumps according to our anticoagulation protocol, with a target international normalized ratio of 2.5–3.0, a home monitoring system and blood pressure management with a mean arterial target pressure of 70–80 mmHg. RESULTS Between October 2015 and April 2017, 100 patients underwent implantation of the HW and 100 patients underwent implantation of the HM3. The median time on the device was 0.98 years (range 0–2.23 years). The median age was 58.5 (51–65) versus 57 (49–64) years (P = 0.456); the number of male patients was 87 versus 88 (P = 0.831). Of the HW patients, 73% were rated as having an INTERMACS level I or II, compared to 57% of the HM3 patients (P = 0.018). There were no further differences in preoperative data. A total of 14 patients had pre-, intra- or post-pump blood flow obstruction in the HW group versus 4 in the HM3 group [hazard ratio (HR) 2.5 (0.7–8.8), P = 0.103]. There were no differences regarding gastrointestinal bleeding [HR 1.25 (0.56–2.64), P = 0.624] or driveline infection (0.68 vs 0.8 events per patient-year, P = 0.0789). The incidence of ischaemic stroke was similar in both groups [HR 0.72 (0.25–2.09), P = 0.550]. Cerebral bleeding was more frequent in patients supported with HW [HR 6.79 (1.43–32.20), P = 0.016]. The incidence of cerebrovascular accidents, on the other hand, was similar in both groups [HR 1.85 (0.83–4.19), P = 0.13]. The incidence of haemocompatibility-related adverse events, however, was significantly higher in the HW group (113 points corresponding to 1.28 events per patient-year versus 69 points corresponding to 0.7 events per patient-year, P < 0.001). The 1-year survival was similar in both groups [62.2%, 95% confidence interval (CI) (0.53–0.73) vs 66.7%, 95% CI (0.58–0.767), P = 0.372]. CONCLUSIONS Our data show that the complication profile differs between the 2 pumps, but that early survival is comparable.
  • Reply to Condello et al.
    Item type: Other Journal Item
    Van Praet, Karel M.; Kofler, Markus; Falk, Volkmar; et al. (2022)
    European Journal of Cardio-Thoracic Surgery
  • Predictors of mid-term outcomes in patients undergoing implantation of a ventricular assist device directly after extracorporeal life support
    Item type: Journal Article
    Tsyganenko, Dmytro; Gromann, Tom Wolfgang; Schoenrath, Felix; et al. (2019)
    European Journal of Cardio-Thoracic Surgery
    Objectives: Extracorporeal life support (ECLS) can be applied as a bridge to diagnosis and decision-making for further treatment with long-term left ventricular assist devices (LVADs). Methods: From January 2012 to January 2018, 714 adult patients were treated with ECLS in our institution. During the same period, 618 patients received an LVAD for long-term support. Of them, 100 patients were further supported with a long-term LVAD. We retrospectively analysed the datasets of these 100 consecutive patients with the goal of developing an algorithm to predict outcomes for a rational use of long-term ventricular assist device therapy in this setting. Results: The mean age of the 100 patients was 54.1 ± 11.6 years, and 72 were men. Twenty-nine patients had a BMI of >30 kg/m². In 33 patients, a temporary right ventricular assist device was necessary postoperatively. The 30-day, 1-year and 2-year survival after ventricular assist device implantation was 62.0% [95% confidence interval (CI) 53.2–72.3], 43.0% (95% CI 34.3–53.9) and 37.1% (95% CI 28.2–48.7%), respectively. Penalized multivariable logistic regression analysis showed following predictors for 1-year mortality: bilirubin increase per mg/dl [odds ratio (OR) 1.41, 95% CI 1.12–1.77], C-reactive protein increase per mg/dl (OR 1.11, 95% CI 1.05–1.19), ECLS duration >7 days (OR 4.90, 95% CI 1.66–14.41), BMI >30 kg/m² (OR 1.41, 95% CI 1.05–8.52) and female gender (OR 3.06, 95% CI 1.02–9.23). On the basis of these data, a nomogram to estimate 1-year mortality after LVAD implantation was created. Conclusion: After stabilization of patients experiencing cardiogenic shock using ECLS, LVAD implantation can be performed with elevated mortality in an otherwise futile situation. Liver dysfunction, inflammatory status and obesity increase the risk for mid-term mortality.
  • Magnetically powered microrobots: a medical revolution underway?
    Item type: Other Journal Item
    Chautems, Christophe; Zeydan, Burak; Charreyron, Samuel; et al. (2017)
    European Journal of Cardio-Thoracic Surgery
  • ESC/EACTS guideline for chronic coronary syndrome-invasive treatment perspectives important for daily practice
    Item type: Other Journal Item
    Doenst, Torsten; Borger, Michael; Falk, Volkmar; et al. (2024)
    European Journal of Cardio-Thoracic Surgery
  • Enhanced recovery after minimally invasive cardiac surgery following a zero ICU concept-a propensity score-matched analysis
    Item type: Journal Article
    Pitts, Leonard; Dini, Martina; Goecke, Simon; et al. (2024)
    European Journal of Cardio-Thoracic Surgery
    OBJECTIVES This study investigates our enhanced recovery after minimally invasive cardiac surgery program “enhanced recovery after minimally invasive cardiac surgery” (ERMICS) following a ‘Zero ICU’ concept compared to standard-of-care treatment in terms of safety and clinical efficacy. METHODS All patients who underwent minimally invasive mitral valve surgery for primary severe mitral valve regurgitation between 2021 and 2023 were included. Propensity score matching (2:1) was performed between patients who received standard-of-care treatment and those who underwent ERMICS. Patients treated with the ERMICS approach were transferred to the peripheral ward instead of the intensive care unit on the day of surgery (Zero ICU). Separate primary end-points were safety (mortality, stroke), postoperative ventilation time and hospital length of stay. RESULTS A total of 611 patients (566 standard of care vs 45 ERMICS) were included in the study. After 2:1 matching, the cohort comprised 135 patients (90 standard of care vs 45 ERMICS) and were well balanced in terms of pre- and intraoperative variables. Thirty-day mortality was 0% in both groups. Postoperative ventilation time [P = 0.018, odds ratio (OR) < 0.01, confidence interval (CI) < 0.001], postoperative pain (P = 0.005, OR = 0.36, CI 0.18–0.74) and hospital length of stay (P = 0.049, OR = 0.28, CI 0.08–0.98) was significantly lower in ERMICS patients, while postoperative complications did not differ. CONCLUSIONS Our ERMICS ‘Zero ICU’ concept is safe and leads to significantly shorter postoperative ventilation time and hospital length of stay for patients undergoing minimally invasive mitral valve surgery for primary severe mitral valve regurgitation.
  • Reply to Jasinski et al.
    Item type: Other Journal Item
    Christ, Torsten; Sündermann, Simon H.; Falk, Volkmar; et al. (2022)
    European Journal of Cardio-Thoracic Surgery
Publications 1 - 10 of 52