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Objectives: The main aim was a systematic evaluation of the current evidence on outcomes for patients undergoing right ventricular assist device (RVAD) implantation following left ventricular assist device (LVAD) implantation. Methods: This systematic review was registered on PROSPERO (CRD42019130131). Reports evaluating in-hospital as well as follow-up outcome in LVAD and LVAD/RVAD implantation were identified through Ovid Medline, Web of Science and EMBASE. The primary endpoint was mortality at the hospital stay and at follow-up. Pooled incidence of defined endpoints was calculated by using random effects models. Results: A total of 35 retrospective studies that included 3260 patients were analyzed. 30 days mortality was in favour of isolated LVAD implantation 6.74% (1.98–11.5%) versus 31.9% (19.78–44.02%) p = 0.001 in LVAD with temporary need for RVAD. During the hospital stay the incidence of major bleeding was 18.7% (18.2–19.4%) versus 40.0% (36.3–48.8%) and stroke rate was 5.6% (5.4–5.8%) versus 20.9% (16.8–28.3%) and was in favour of isolated LVAD implantation. Mortality reported at short-term as well at long-term was 19.66% (CI 15.73–23.59%) and 33.90% (CI 8.84–59.96%) in LVAD respectively versus 45.35% (CI 35.31–55.4%) p ⩽ 0.001 and 48.23% (CI 16.01–80.45%) p = 0.686 in LVAD/RVAD group respectively. Conclusion: Implantation of a temporary RVAD is allied with a worse outcome during the primary hospitalization and at follow-up. Compared to isolated LVAD support, biventricular mechanical circulatory support leads to an elevated mortality and higher incidence of adverse events such as bleeding and stroke. [ABSTRACT FROM AUTHOR]

Background: Closed‐chest transapical valve implantations (aortic, mitral, and tricuspid) and cardiac structural procedures requiring large‐sized introducer sheaths cannot be safely performed with the available technology. We tested a self‐expanding apical closure device in a closed‐chest animal model, using large‐sized introducer sheaths and human‐sized animals to establish the technique for future tests in humans. Methods: Six human‐sized pigs (mean weight: 89.7 ± 3.7 kg) received general anesthesia, intubation, and full heparinization (15,000 IU/animal; expected activated clotting time >200 s). Under fluoroscopy and multimodality imaging guidance with next‐generation fusion imaging prototypes, a 15‐cm long needle and a standard guidewire were percutaneously inserted under the xiphoidal aponeurosis and into the ventricular apex. After the exchange with a stiff guidewire, a 21‐Fr introducer sheath for transapical procedures (outer diameter: 25‐Fr) was placed in the left ventricle through the apex. The self‐expanding closure device was inserted and deployed under fluoroscopic guidance while the 21‐Fr sheath was gently removed. Hemodynamic conditions were monitored for 30 min and then the chest was opened to inspect the closure device and quantify the blood loss in the pericardium. Animals were killed and the hearts were removed and inspected. Results: All six apical closure devices were successfully deployed without adverse events. No death, hemodynamic collapse, or cardiac tamponade occurred during the 30‐min observational period (mean systolic and diastolic pressures: 88 ± 11 and 58 ± 13 mmHg, respectively; mean heart rate: 60 ± 11 beats per minutes). Pre‐ and postdeployment (after protamine administration) mean activated clotting time was 541 ± 263 and 217 ± 62 s, respectively. The plugs provided good sealing with a mean of 27.2 ± 13.86 ml of blood lost in the pericardium. Postmortem inspection showed good plug fixation without myocardial damage. Conclusion: This self‐expanding apical closure device successfully sealed the percutaneous access sites made with large‐sized introducer sheaths in human‐sized animals. This preclinical study suggests that transapical valve and structural procedures requiring large‐sized introducer sheaths can be performed percutaneously. [ABSTRACT FROM AUTHOR]

Objective: Aorto-esophageal fistula (AEF) is a rare condition consisting in a fistula between the aorta and the esophagus. The thoracic endovascular aortic repair (TEVAR) has become an accepted treatment for initial AEF management, but large series are not available and outcomes are questionable. This study aims at evaluating the current evidence of TEVAR in AEF., Methods: A search on PubMed/MEDLINE and EMBASE was conducted up to June 2023. Data on article type, patients' demographics, cause and type of AEF, clinical presentation, time from clinical presentation to TEVAR, strategies, mortality, and follow-up were analyzed., Results: 106 reports published between 1997 and 2023 were deemed eligible for this study (92 case reports; 14 case-series). A total of 163 patients (mean age: 58.9±16.5 years), diagnosed with AEF and treated with TEVAR (with or without staged surgical repair of the esophagus or the aorta) were included. A thoracic aortic aneurysm (34.4%) was the most common cause of AEF, followed by esophageal cancer (25.2%), foreign body in esophagus (13.5%) and post-TEVAR complication (9.8%). Primary AEF were 129 (79.1%), and secondary AEF were 34 (20.9%). TEVAR alone was performed 80 times (49.1%), while TEVAR with staged esophageal or aortic surgery 83 times (50.9%). The overall 30-day mortality was 11.7% (n=19): 18.8% in TEVAR alone and 4.8% in TEVAR with staged surgery, respectively (p=0.006). Mean follow-up time was 12.3±14.7 months. The overall 6-month mortality was 34.4% (n=56): 48.8% in TEVAR alone and 20.5% in TEVAR with staged surgery (p<0.001). Bleeding for recurrence of AEF and sepsis were the main causes of death., Conclusions: In case of AEF, TEVAR can be urgently performed for bleeding management and hemodynamic control. TEVAR alone is a valuable yet not definitive procedure. Instead, TEVAR followed by surgical repair may provide better outcomes and should be recommended, when possible., Clinical Impact: This review summarizes the published papers on endovascular aortic repair for the treatment of aorto-esophageal fistulae. The clinicians can find several important details on how to manage the presence of an esophageal fistulae wich represents a potential life-threatening problem for the patients. The implantation of a thoracic endovascular aortic prosthesis represents a fast and reliable procedure in case of emergency but a second step surgical repair provides better outcomes and should be recommended in suitable patients., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.