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Introduction Limb ischemia is a severe complication of peripheral veno-arterial extracorporeal life support (V-A ECLS). Several techniques have been developed to prevent this, but it remains a major and frequent adverse event (incidence: 10–30%). In 2019, a new cannula with bidirectional flow (retrograde towards the heart and antegrade towards the distal limb) has been introduced. A single-centre experience with this cannula in patients undergoing peripheral V-A ECLS is herewith reported. Methods This prospective observational study included adults (≥18 years) undergoing V-A ECLS from January 2021 to October 2022 with the use of a bidirectional femoral artery cannula. Primary outcome was limb ischemia requiring intervention during cardio-circulatory support. Secondary outcomes were compartment syndrome, limb amputation, cannulation site bleeding, need for other surgical intervention due to cannula related complications, duplex ultrasound parameters from the femoral vessels, and in-hospital survival. Results Twenty-two consecutive patients were included. During extracorporeal life support (ECLS) support, limb ischemia requiring intervention occurred in one patient (4.5%) and no patients developed a compartment syndrome, or required a fasciotomy or amputation. Significant bleeding was reported in two patients (9%) due to slight cannula dislodgement, easily solved with cannula repositioning. In-hospital survival was 63.6%. Conclusions The bidirectional cannula is associated with a low risk for limb ischemia-related complications compared to current literature, and apparently represents a safe alternative to dedicated distal perfusion cannula. Further studies are warranted to confirm these preliminary findings.

BACKGROUND: In patients receiving venovenous (VV) extracorporeal membrane oxygenation (ECMO) packed red blood cell (PRBC) transfusion thresholds are usually higher than in other patients who are critically ill. Available guidelines suggest a restrictive approach, but do not provide specific recommendations on the topic. The main aim of this study was, in a short timeframe, to describe the actual values of haemoglobin and the rate and the thresholds for transfusion of PRBC during VV ECMO.METHODS: PROTECMO was a multicentre, prospective, cohort study done in 41 ECMO centres in Europe, North America, Asia, and Australia. Consecutive adult patients with acute respiratory distress syndrome (ARDS) who were receiving VV ECMO were eligible for inclusion. Patients younger than 18 years, those who were not able to provide informed consent when required, and patients with an ECMO stay of less than 24 h were excluded. Our main aim was to monitor the daily haemoglobin concentration and the value at the point of PRBC transfusion, as well as the rate of transfusions. The practice in different centres was stratified by continent location and case volume per year. Adjusted estimates were calculated using marginal structural models with inverse probability weighting, accounting for baseline and time varying confounding.FINDINGS: Between Dec 1, 2018, and Feb 22, 2021, 604 patients were enrolled (431 [71%] men, 173 [29%] women; mean age 50 years [SD 13·6]; and mean haemoglobin concentration at cannulation 10·9 g/dL [2·4]). Over 7944 ECMO days, mean haemoglobin concentration was 9·1 g/dL (1·2), with lower concentrations in North America and high-volume centres. PRBC were transfused on 2432 (31%) of days on ECMO, and 504 (83%) patients received at least one PRBC unit. Overall, mean pretransfusion haemoglobin concentration was 8·1 g/dL (1·1), but varied according to the clinical rationale for transfusion. In a time-dependent Cox model, haemoglobin concentration of less than 7 g/dL was consistently associated with higher risk of death in the intensive care unit compared with other higher haemoglobin concentrations (hazard ratio [HR] 2·99 [95% CI 1·95-4·60]); PRBC transfusion was associated with lower risk of death only when transfused when haemoglobin concentration was less than 7 g/dL (HR 0·15 [0·03-0·74]), although no significant effect in reducing mortality was reported for transfusions for other haemoglobin classes (7·0-7·9 g/dL, 8·0-9·9 g/dL, or higher than 10 g/dL).INTERPRETATION: During VV ECMO, there was no universally accepted threshold for transfusion, but PRBC transfusion was invariably associated with lower mortality only when done with haemoglobin concentration of less than 7 g/dL.FUNDING: Extracorporeal Life Support Organization.

BACKGROUND: Extracorporeal membrane oxygenation (ECMO) has been widely used in patients with COVID-19, but uncertainty remains about the determinants of in-hospital mortality and data on post-discharge outcomes are scarce. The aims of this study were to investigate the variables associated with in-hospital outcomes in patients who received ECMO during the first wave of COVID-19 and to describe the status of patients 6 months after ECMO initiation.METHODS: EuroECMO-COVID is a prospective, multicentre, observational study developed by the European Extracorporeal Life Support Organization. This study was based on data from patients aged 16 years or older who received ECMO support for refractory COVID-19 during the first wave of the pandemic-from March 1 to Sept 13, 2020-at 133 centres in 21 countries. In-hospital mortality and mortality 6 months after ECMO initiation were the primary outcomes. Mixed-Cox proportional hazards models were used to investigate associations between patient and management-related variables (eg, patient demographics, comorbidities, pre-ECMO status, and ECMO characteristics and complications) and in-hospital deaths. Survival status at 6 months was established through patient contact or institutional charts review. This study is registered with ClinicalTrials.gov, NCT04366921, and is ongoing.FINDINGS: Between March 1 and Sept 13, 2020, 1215 patients (942 [78%] men and 267 [22%] women; median age 53 years [IQR 46-60]) were included in the study. Median ECMO duration was 15 days (IQR 8-27). 602 (50%) of 1215 patients died in hospital, and 852 (74%) patients had at least one complication. Multiorgan failure was the leading cause of death (192 [36%] of 528 patients who died with available data). In mixed-Cox analyses, age of 60 years or older, use of inotropes and vasopressors before ECMO initiation, chronic renal failure, and time from intubation to ECMO initiation of 4 days or more were associated with higher in-hospital mortality. 613 patients did not die in hospital, and 547 (95%) of 577 patients for whom data were available were alive at 6 months. 102 (24%) of 431 patients had returned to full-time work at 6 months, and 57 (13%) of 428 patients had returned to part-time work. At 6 months, respiratory rehabilitation was required in 88 (17%) of 522 patients with available data, and the most common residual symptoms included dyspnoea (185 [35%] of 523 patients) and cardiac (52 [10%] of 514 patients) or neurocognitive (66 [13%] of 512 patients) symptoms.INTERPRETATION: Patient's age, timing of cannulation (FUNDING: None.

Patients undergoing explantation of left ventricular assist devices (LVADs) after improvement of myocardial function remain a minority. Nevertheless, considering the growing population of LVAD patients, increasing demand for new explantation strategies is expected. Herein, we present a retrospective review of seven patients undergoing HeartMate3 explantation with the use of a custom-made apical ring plug in four medical centers. The primary outcome was status at intensive care unit discharge. Secondary outcomes included perioperative complications and transfusions. Six out of seven patients were males. The median age at explantation and time on LVAD support was 35 years (range:13-73) and 10 months (range:9-24), respectively. No technical difficulties were experienced during plug implantation via a conventional sternotomy or through a left lateral thoracotomy, either with or without cardiopulmonary bypass. Perioperative transfusions ranged from 0 to 3 units/patient. No re-operations for bleeding, hemorrhagic, embolic, or plug-related infective events were observed. Heparin was started 6 hours after surgery as a bridge to oral anticoagulation (international normalized ratio: 2-2.5). All patients were discharged alive from intensive care unit. This novel plug device for HeartMate3 explantation was successfully and safely implanted in this first patient series. Notwithstanding, its use should still be considered off-label and larger studies are required to investigate its long-term results.

Purpose of reviewCoronavirus disease 2019 (COVID-19) pandemic changed the way we had to approach hospital- and intensive care unit (ICU)-related resource management, especially for demanding techniques required for advanced support, including extracorporeal membrane oxygenation (ECMO).Recent findingsAvailability of ICU beds and ECMO machines widely varies around the world. In critical conditions, such a global pandemic, the establishment of contingency capacity tiers might help in defining to which conditions and subjects ECMO can be offered. A frequent reassessment of the resource saturation, possibly integrated within a regional healthcare coordination system, may be of help to triage the patients who most likely will benefit from advanced techniques, especially when capacities are limited.SummaryIndications to ECMO during the pandemic should be fluid and may be adjusted over time. Candidacy of patients should follow the same prepandemic rules, taking into account the acute disease, the burden of any eventual comorbidity and the chances of a good quality of life after recovery; but the current capacity of healthcare system should also be considered, and frequently reassessed, possibly within a wide hub-and-spoke healthcare system.

OBJECTIVES: Historically, females were described as suffering from worse outcomes after left ventricular assist device (LVAD) implantation. However, females' preoperative conditions are unique, making direct comparisons with males challenging. This study aimed to select through propensity score (PS) matching two preoperatively comparable populations of females and males and test if any real sex-related difference exists regarding survival and adverse events after LVAD implantation.METHODS: This retrospective single-center observational study investigated patients who received LVAD implantation between 2010 and 2018. PS matching was applied to balance preoperative heterogeneity between males and females. Primary endpoint was survival at follow-up. Secondary endpoints included perioperative outcomes and LVAD-related adverse events.RESULTS: 92 fully comparable females(n=46) and males(n=46) were selected after PS matching (median age:57 years, min-max:18-75). 26.1% of patients required preoperative mechanical circulatory support. Females needed more intraoperative fresh frozen plasma (pCONCLUSIONS: After reducing preoperative heterogeneity between females and males, survival after LVAD implantation does not differ based on sex. However, differences might exist in terms of higher transfusions and strokes in females. Reducing preoperative sex disparities and developing intraoperative and anticoagulation strategies which acknowledge sex-related variations might help abolishing differences in LVAD outcomes.

BACKGROUND: Among patients referred for cardiac surgeries, atrial fibrillation (AF) is a common comorbidity and a risk factor for post-operative arrhythmias (such as sinus node dysfunction or atrioventricular heart blocks), including those requiring permanent pacemaker (PPM) implantation.OBJECTIVE: The current study aimed to evaluate the prevalence and long-term survival of post-operative PPM implantation in patients with pre-operative AF who underwent valve surgery with or without concomitant procedures.METHODS: Presented analysis pertains to the HEIST (HEart surgery In atrial fibrillation and Supraventricular Tachycardia) registry. During study period 11,949 patients underwent valvular (aortic, mitral or tricuspid valve replacement or repair) surgery and/or surgical ablation (SA) and were stratified according to post-operative PPM status.RESULTS: Permanent pacemaker implantation after surgery was necessary in 2.5% of patients, with a significant variation depending on the type of surgery (from 1.1% in mitral valve repair to 3.3% in combined mitral and tricuspid valve surgery). In a multivariate logistic regression model, tricuspid intervention (PCONCLUSION: In patients with pre-operative AF, the need for PPM implantation after valve surgery or SA is not an infrequent outcome, with SA not affecting its prevalence but actually improving long-term survival.

Background: Atrial fibrillation (AF) is a relatively common comorbidity among patients referred for coronary artery bypass grafting (CABG) and is associated with poorer prognosis. However, little is known about how surgical technique influences survival in this population. Aim: The current analysis aimed to determine whether total arterial revascularization (TAR) is associated with improved long-term outcomes in patients with preoperative AF. Methods: We analyzed patients' data from the HEIST (HEart surgery In atrial fibrillation and Supraventricular Tachycardia) registry. The registry, to date, involves five tertiary high-volume centers in Poland. Between 2006 and 2019, 4746 patients presented with preoperative AF and multivessel coronary artery disease and underwent CABG. We identified cases of TAR and used propensity score matching to determine non-TAR controls. Median follow-up was 4.1 years (interquartile range [IQR], 1.9-6.8 years). Results: Propensity matching resulted in 295 pairs of TAR vs. non-TAR. The mean (standard deviation [SD]) number of distal anastomoses was 2.5 (0.6) vs. 2.5 (0.6) (P = 0.94), respectively. Operative and 30-day mortality was not different between TAR and non-TAR patients (hazard ratio [HR] and 95% confidence intervals [CIs], 0.17 (0.02-1.38); P = 0.12 and 0.74 [0.40-1.35]; P = 0.33, respectively). By contrast, TAR was associated with nearly 30% improved late survival: HR, 0.72 (0.55-0.93); P = 0.01. This benefit was sustained in subgroup analyses, yet most pronounced in low-risk patients (

LARC is managed by multimodal treatments whose intensity can be highly modulated. In this context, we need surrogate endpoints to help predict long-term outcomes and better personalize treatments. A previous study identified 2yDFS as a stronger predictor of OS than pCR in LARC patients undergoing neoadjuvant RT. The aim of this pooled analysis was to assess the role of pCR and 2yDFS as surrogate endpoints for OS in a larger cohort. The pooled and subgroup analyses were performed on large rectal cancer randomized trial cohorts who received long-course RT. Our analysis focused on the evaluation of OS in relation to the pCR and 2-year disease status. A total of 4600 patients were analyzed. Four groups were identified according to intermediate outcomes: 12% had both pCR and 2yDFS (the better); 67% achieved 2yDFS but not pCR (the good); 1% had pCR but not 2yDFS; and 20% had neither pCR nor 2yDFS (the bad). The pCR and 2yDFS were favorably associated with OS in the univariate analysis, and 2yDFS maintained a statistically significant association in the multivariate analysis independently of the pCR status. The combination of the pCR and 2yDFS results in a strong predictor of OS, whereas failure to achieve 2yDFS carries a poor prognosis regardless of the pCR status. This new stratification of LARC patients could help design predictive models where the combination of 2yDFS and pCR should be employed as the primary outcome.

Background Patients receiving left ventricle assist devices (LVADs) as bridge to recovery remain a minority with 1%-5% of LVADs explanted after improvement of myocardial function. Nevertheless, considering the growing population of patients supported with LVADs, an increasing demand of new explantation strategies is expected in the near future. A novel plug for LVAD explantation has been developed and its biocompatibility profile needs to be proved. This study tested the biocompatibility of this novel plug in an in vivo ovine model. Methods Six adult Blackhead Persian female sheep received plug implantation on the cardiac apex via minimally invasive approach and were clinically observed up to 90 days. Echocardiography was performed to detect thrombus formation or further plug-related complications. After the observation period, euthanasia was performed and samples including the plug and the surrounding tissues were obtained to be analyzed with correlative light and electron microscopy. Organ necrosis, ischemia and peripheral embolism were investigated. Results Three animals survived surgery and completed the follow-up time without experiencing clinical complications. Echocardiographic controls excluded the presence of an intracavitary thrombus in the left ventricle (LV). Autopsy confirmed no signs of local infection, LV thrombus or peripheral embolism. Light and electron microscopy revealed an intact epithelium covering a layer of connective tissue on the plug surface facing the heart lumen. Conclusions This novel apical plug for LVAD explantation allows for endothelial and connective tissue growth on its ventricular side within 90 days from surgery. Further studies are required to fully demonstrate the biocompatibility of this apical plug and investigate the optimal anticoagulation regimen to be applied after implantation.

OBJECTIVE: Myocardial damage occurs in up to 25% of coronavirus disease 2019 (COVID-19) cases. While veno-venous extracorporeal life support (V-V ECLS) is used as respiratory support, mechanical circulatory support (MCS) may be required for severe cardiac dysfunction. This systematic review summarizes the available literature regarding MCS use rates, disease drivers for MCS initiation, and MCS outcomes in COVID-19 patients. METHODS: PubMed/EMBASE were searched until October 14, 2021. Articles including adults receiving ECLS for COVID-19 were included. The primary outcome was the rate of MCS use. Secondary outcomes included mortality at follow-up, ECLS conversion rate, intubation-to-cannulation time, time on ECLS, cardiac diseases, use of inotropes, and vasopressors. RESULTS: Twenty-eight observational studies (comprising both ECLS-only populations and ECLS patients as part of larger populations) included 4218 COVID-19 patients (females: 28.8%; median age: 54.3 years, 95%CI: 50.7-57.8) of whom 2774 (65.8%) required ECLS with the majority (92.7%) on V-V ECLS, 4.7% on veno-arterial ECLS and/or Impella, and 2.6% on other ECLS. Acute heart failure, cardiogenic shock, and cardiac arrest were reported in 7.8%, 9.7%, and 6.6% of patients, respectively. Vasopressors were used in 37.2%. Overall, 3.1% of patients required an ECLS change from V-V ECLS to MCS for heart failure, myocarditis, or myocardial infarction. The median ECLS duration was 15.9 days (95%CI: 13.9-16.3), with an overall survival of 54.6% and 28.1% in V-V ECLS and MCS patients. One study reported 61.1% survival with oxy-right ventricular assist device. CONCLUSION: MCS use for cardiocirculatory compromise has been reported in 7.3% of COVID-19 patients requiring ECLS, which is a lower percentage compared to the incidence of any severe cardiocirculatory complication. Based on the poor survival rates, further investigations are warranted to establish the most appropriated indications and timing for MCS in COVID-19.

Background and Objective: Resuscitative therapies for respiratory and cardiac failure are lifesaving and extended by using extracorporeal life support (ECLS) as mechanical circulatory support (MSC). This review informs the debate to identify the life-threatening thoracic emergencies in which patients may be cannulated for ECLS support.Methods: An advanced search was performed in PubMed, Embase, Google Scholar, and references query, assessed in June 2022, identified 761 records. Among them, 74 publications in English were included in the current narrative review.Key Content and Findings: ECLS is an additional tool for organ support in life-threatening thoracic emergencies. It provides bridging to recovery or to decision about destination as definitive therapy, intervention, or surgery. Non-traumatic emergencies include mediastinal mass, acute lung injury (ALI), aspiration, embolisms, acute and chronic heart failure. However, based on the current evidence, trauma, and especially blunt thoracic trauma, is one of the main indications for ECLS use in thoracic emergencies, among others in chest wall fractures, blunt and penetrating lung injuries. ECLS use is always individualized to patient's needs, injury pattern and kind of organ failure, circulatory arrest inclusive, depending on if respiratory or cardiac and circulatory support is needed. Further, ECLS offers the possibility for fast volume resuscitation and rewarming, thus preventing the lethal of trauma: hypothermia, hypoperfusion and acidosis. Anticoagulation may be omitted for some hours or days. Interdisciplinary cooperation between the intensivists, surgeons, anesthesiologists, emergency medical services, an appropriately organized and trained staff, equipment resources and logistical planning are essential for successful outcomes.Conclusions: ECLS use in selected life-threatening thoracic emergencies is increasing. The summarized findings appeal to policymakers, and we hope that our summary of recommendations may impact clinical practice and research.

Objectives: Extracorporeal membrane oxygenation (ECMO) for postcardiotomy cardiogenic shock has been increasingly used without concomitant mortality reduction. This study aims to investigate determinants of in-hospital and postdischarge mortality in patients requiring postcardiotomy ECMO in the Netherlands.Methods: The Netherlands Heart Registration collects nationwide prospective data from cardiac surgery units. Adults receiving intraoperative or postoperative ECMO included in the register from January 2013 to December 2019 were studied. Survival status was established through the national Personal Records Database. Multivariable logistic regression analyses were used to investigate determinants of in-hospital (3 models) and 12-month postdischarge mortality (4 models). Each model was developed to target specific time points during a patient's clinical course.Results: Overall, 406 patients (67.2% men, median age, 66.0 years [interquartile range, 55.0-72.0 years]) were included. In-hospital mortality was 51.7%, with death occurring in a median of 5 days (interquartile range, 2-14 days) after surgery. Hospital survivors (n = 196) experienced considerable rates of pulmonary infections, respiratory failure, arrhythmias, and deep sternal wound infections during a hospitalization of median 29 days (interquartile range, 17-51 days). Older age (odds ratio [OR], 1.02; 95% CI, 1.0-1.04) and preoperative higher body mass index (OR, 1.08; 95% CI, 1.02-1.14) were associated with in-hospital death. Within 12 months after discharge, 35.1% of hospital survivors (n = 63) died. Postoperative renal failure (OR, 2.3; 95% CI, 1.6-4.9), respiratory failure (OR, 3.6; 95% CI, 1.3-9.9), and re-thoracotomy (OR, 2.9; 95% CI, 1.3-6.5) were associated with 12-month postdischarge mortality.Conclusions: In-hospital and postdischarge mortality after postcardiotomy ECMO in adults remains high in the Netherlands. ECMO support in patients with higher age and body mass index, which drive associations with higher in-hospital mortality, should be carefully considered. Further observations suggest that prevention of re-thoracotomies, renal failure, and respiratory failure are targets that may improve postdischarge outcomes.

OBJECTIVES: Postcardiotomy extracorporeal membrane oxygenation (ECMO) can be initiated intraoperatively or postoperatively based on indications, settings, patient profile, and conditions. The topic of implantation timing only recently gained attention from the clinical community. We compare patient characteristics as well as in-hospital and long-term survival between intraoperative and postoperative ECMO. METHODS: The retrospective, multicenter, observational Postcardiotomy Extracorporeal Life Support (PELS-1) study includes adults who required ECMO due to postcardiotomy shock between 2000 and 2020. We compared patients who received ECMO in the operating theater (intraoperative) with those in the intensive care unit (postoperative) on in-hospital and postdischarge outcomes. RESULTS: We studied 2003 patients (women: 41.1%; median age: 65 years; interquartile range [IQR], 55.0-72.0). Intraoperative ECMO patients (n = 1287) compared with postoperative ECMO patients (n = 716) had worse preoperative risk profiles. Cardiogenic shock (45.3%), right ventricular failure (15.9%), and cardiac arrest (14.3%) were the main indications for postoperative ECMO initiation, with cannulation occurring after (median) 1 day (IQR, 1-3 days). Compared with intraoperative application, patients who received postoperative ECMO showed more complications, cardiac reoperations (intraoperative: 19.7%; postoperative: 24.8%, P = .011), percutaneous coronary interventions (intraoperative: 1.8%; postoperative: 3.6%, P = .026), and had greater in-hospital mortality (intraoperative: 57.5%; postoperative: 64.5%, P = .002). Among hospital survivors, ECMO duration was shorter after intraoperative ECMO (median, 104; IQR, 67.8-164.2 hours) compared with postoperative ECMO (median, 139.7; IQR, 95.8-192 hours, P

Coronavirus disease 2019 (COVID-19) radically modified the organization of healthcare systems with shutdown of routine activities and outpatient clinics. Herein, we report our institutional experience with a Telemonitoring and Care Program (TC-Program) to monitor and support left ventricular assist device (LVAD) patients during COVID-19 outbreak. This single-arm cohort study analyzed 156 patients who entered the TC-Program at our institution between April and August 2020. The TC-Program was based on routine phone calls to patients and a 24/7 emergency line. In November 2020, patients were asked for feedback on the TC-Program and checked for survival, transplant, or explant. The primary endpoint was the rate of TC-Program-driven interventions. Patients (males: 82.8%) were 61 years old (interquartile range [IQR]: 53.0-67.5) and on LVAD support for 1,266 days (IQR: 475-2,211). Patients were included in the TC-Program for a median time of 99 days (min:15, max:120) and received a median number of six phone calls (min:1, max:14). Twenty-three patients (14.7%) were referred for clinical evaluation after phone contact. Two patients (1.27%) were diagnosed with COVID-19: one of them died after intensive care, and one remained paucisymptomatic and recovered. Three patients asked to exit the program considering it not useful while the others gave high rates in terms of usefulness (median: 9, IQR: 8-10), information (median: 9, IQR: 8-10), good medical care (median: 9, IQR: 8-10), and psychologic support (median: 8, IQR: 7-10). A TC-Program based on the four ICSA principles (Inform, Care, Support, and Adapt) is feasible in LVAD patients and can be rapidly implemented during the COVID-19 pandemic.

Background Health-related quality of life (HRQOL) measurement has become an important health care outcome even in oncological pediatric scenario. During radiation therapy care path, pediatric patients and their relatives may suffer from emotional and psychosocial distress not only related to cancer diagnosis, but also due to the procedure and the required daily routine. Despite the high prevalence of psychosocial consequences in this setting, instruments that inquire pediatric HRQOL and healthcare satisfaction have rarely been studied in Italy. Purpose of this study was to investigate reliability and linguistic validation of the PedsQL™ healthcare satisfaction Hematology/Oncology module from its original English version to Italian language. Methods Three phases standard procedure of cross-culture adaptation were used to create Italian version of PedsQL™ healthcare satisfaction Hematology/Oncology module. Forward translations and backward translations were performed. Finally, a pilot-testing for understandability of the 'pre-final' version was conducted with parents of children attending our Radiotherapy Center using two methodologies of Cognitive Interviewing (“Thinkaloud Interviews” and “Respondent Debriefing”), in order to obtain the final Italian version of the PedsQL™ healthcare satisfaction Hematology/Oncology module. Results Twenty-five parents (2 father, 23 mothers) were recruited during their children’s radiotherapy treatment and the grammatically and conceptually acceptable pre-final version of the PedsQL™ Healthcare Satisfaction Hematology/Oncology Module was administered. The questionnaire was well understood reflecting its linguistic adaptation. Compliance with questionnaire administration was optimal. All subjects stated that the questions were interesting to express their opinion, most of them reported that all the questions of each section were clearly comprehensible and easy to understand, suggesting minimal changes that were double-checked with back translation. Furthermore, six of them spontaneously asked to complete the questionnaire in order to review the assistance received during radiotherapy. Conclusion Our Italian version of the PedsQL™ 3.0 Healthcare Satisfaction Hematology/Oncology Module seems to be a valid and functional instrument to indagate Healthcare Satisfaction.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) remains the preferred strategy for high-risk or elderly individuals with aortic valve (AV) stenosis who are not considered to be optimal surgical candidates. Recent evidence suggests that low-risk patients may benefit from TAVI as well. The current study evaluates midterm survival in low-risk patients undergoing elective surgical AV replacement (SAVR) versus TAVI.METHODS: The Aortic Valve Replacement in Elective Patients From the Aortic Valve Multicenter Registry (AVALON) compared isolated elective transfemoral TAVI or SAVR with sternotomy or minimally invasive approach in low-risk individuals performed between 2015 and 2019. Propensity score matching was conducted to determine SAVR controls for TAVI group in a 1-to-3 ratio with 0.2 caliper.RESULTS: A total of 2393 patients undergoing elective surgery (1765 SAVR and 629 TAVI) with median European System for Cardiac Operative Risk Evaluation II (EuroSCORE II) score 1.81 (interquartile range [IQR], 1.36 to 2.53]) were initially included. Median follow-up was 2.72 years (IQR, 1.32-4.08; max 6.0). Propensity score matching returned 329 TAVI cases and 593 SAVR controls. Thirty-day mortality was 11 out of 329 (3.32%) in TAVI and 18 out of 593 (3.03%) in SAVR (risk ratio, 1.10; 95% CI, 0.52-2.37; P = .801) groups, respectively. At 2 years, survival curves began to diverge in favor of SAVR, which was associated with 30% lower mortality (hazard ratio, 0.70; 95% CI, 0.496-0.997; P = .048).CONCLUSIONS: Our data did not demonstrate a survival difference between TAVI and SAVR during the first 2 postprocedure years. After that time, SAVR is associated with improved survival. Extended observations from randomized trials in low-risk patients undergoing elective surgery are warranted to confirm these findings and draw definitive conclusions.

Background: Peripartum cardiomyopathy (PPCM) is a rare cause of heart failure (HF), presenting with left ventricular (LV) systolic dysfunction either at the end of pregnancy or in the months following delivery. In rare cases, PPCM leads to severe impairment of LV function, refractory cardiogenic shock or advanced HF. LV assist devices (LVAD) have been shown to be a feasible treatment option in advanced HF. However, little is known about long-term outcomes and prognosis of PPCM patients undergoing LVAD implantation. Methods: A retrospective analysis of data from PPCM patients undergoing LVAD implantation in two tertiary centers with respect to long-term outcomes was performed. Results: Twelve patients of median age 30 (18–39) years were included. Eight patients were experiencing cardiogenic shock (INTERMACS 1) at implantation. Seven patients were implanted within 1 month of their PPCM diagnosis. Median duration of LVAD support was 19 (2–92) months with median follow up of 67 (18–136) months (100% complete). In-hospital and 1-year mortality were 0% and 8.3%, respectively. Two patients died on LVAD support, four patients were successfully bridged to transplantation, two patients are still on LVAD, and four were successfully weaned due to sufficient LV recovery (one died after LV function deteriorated again). Conclusion: LVAD treatment of decompensated end-stage PPCM is feasible. Early LVAD provision led to hemodynamic stabilization in our cohort and facilitated safe LV recovery in one third of these young female patients.

An intra-cavitary left ventricular (LV) thrombus is a relative contraindication to LV assist device (LVAD) implantation based on increased thromboembolic risks. Herein, we present our experience with LVAD patients with or without preoperative diagnosis of LV-thrombus. We retrospectively investigated 563 patients who received LVAD implantation between 2004 and 2018. Diagnosis of LV-thrombus was verified with computed tomography scan, magnetic resonance imaging, echocardiography, or intraoperative LV inspection. The primary endpoint was 30-day survival free of stroke and pump thrombosis. Overall, 72 patients (12.8%) had a diagnosis of LV-thrombus. They were younger (51 years; IQR:41-59), affected by severely reduced ejection fraction (15%; IQR:10-20), more often presenting with dilated cardiomyopathy (61.8%) and INTERMACS profile 1 (33.3%). Preoperative atrial fibrillation was frequent in patients without LV-thrombus (38.9%). Conventional sternotomy was the preferred approach in LV-thrombus patients (77.8%), based on more HMII implantations in these patients (41.7%). Survival free of strokes and pump thrombosis at 30 days was comparable (P = .5751) between patients with (83.3%) or without LV-thrombus (80.9%). LVAD implantation in patients with preoperative LV-thrombus is safe and feasible. When managed through correct diagnostic and intraoperative strategies including accurate inspection of the LV cavity, these patients show similar 30-day outcomes compared to patients without LV-thrombus.

This study evaluated the ability of T2 mapping magnetic resonance imaging at 3 T, in addition to morphological sequences, to assess efficacy of platelet-rich plasma (PRP) injections, characterizing qualitatively and quantitatively the grade of knee cartilage repair in patients with patellofemoral chondropathy. We retrospectively studied 34 patients (22 men, 12 women, mean age 41.8 years, including 22 men) with patellofemoral knee chondropathy, who underwent intra-articular PRP injections and completed a clinical and instrumental follow-up. As control group, we evaluated 34 patients who underwent non-operative therapy. All patients were submitted to clinical (using VAS and WOMAC index) and imaging studies with 3 T magnetic resonance with cartilage analysis with T2 mapping sequences for cartilage analysis before and after treatment. In the study group, mean pre-treatment T2 relaxation time values were 44.2 ± 2.5 ms, considering all articular cartilage compartments, with significant reduction at the follow-up (p p p p

OBJECTIVES The HeartMate 3 left ventricular assist device was first implanted in 2014 and received the Conformité Européenne mark in 2015. Since then, several trials demonstrated its high haemocompatibility associated with good survival and low adverse events rates. Herein, we report our institutional experience with patients supported with HeartMate 3 for 5 years. METHODS This prospective cohort study included patients receiving a HeartMate 3 implantation in 2014 as part of the HeartMate 3 Conformité Européenne Mark clinical trial. Patients had follow-up visits every 3 months while on left ventricular assist device support, and all patients completed the 5-year follow-up. The primary end point was survival at 5 years. Secondary end points included adverse events, health status and quality of life. RESULTS Eight patients (men: 75%) aged 59 years (min–max: 52–66 years) were enrolled. At 5 years, survival was 100%. Patients remained on support for a median time of 1825 days (min–max: 101–1825 days); 2 patients successfully received cardiac transplants. No right heart failure, haemolysis, pump thrombosis, pump malfunction or neurological events occurred in any patients. A driveline infection was observed in 6 patients (0.25 events/patient-year). Compared to baseline, a significant improvement in quality of life and in New York Heart Association functional class was noted after the implant and for the whole follow-up time. A slight decline in kidney function and in the 6-min walk test results occurred after 3 years. CONCLUSIONS This study reports the longest single-centre follow-up of the HeartMate 3, showing excellent haemocompatibility over time with high survival and low complication rates at 5 years.

ObjectiveThe Awake Extracorporeal Life Support (ECLS) practice combined with physiotherapy is increasing. However, available evidence for this approach is limited, with unclear indications on timing, management, and protocols. This review summarizes available literature regarding Awake ECLS and physiotherapy application rates, practices, and outcomes in adults, providing indications for future investigations.MethodsFour databases were screened from inception to February 2021, for studies reporting adult Awake ECLS with/without physiotherapy. Primary outcome was hospital discharge survival, followed by Extracorporeal Membrane Oxygenation (ECMO) duration, extubation, Intensive Care Unit stay.ResultsTwenty-nine observational studies and one randomized study were selected, including 1,157 patients (males n = 611/691, 88.4%) undergoing Awake ECLS. Support type was reported in 1,089 patients: Veno-Arterial ECMO (V-A = 39.6%), Veno-Venous ECMO (V-V = 56.8%), other ECLS (3.6%). Exclusive upper body cannulation and femoral cannulation were applied in 31% versus 69% reported cases ( n = 931). Extubation was successful in 63.5% ( n = 522/822) patients during ECLS. Physiotherapy details were given for 676 patients: exercises confined in bed for 47.9% ( n = 324) patients, mobilization until standing in 9.3% ( n = 63) cases, ambulation performed in 42.7% ( n = 289) patients. Femoral cannulation, extubation and V-A ECMO were mostly correlated to complications. Hospital discharge survival observed in 70.8% ( n = 789/1114).ConclusionAwake ECLS strategy associated with physiotherapy is performed regardless of cannulation approach. Ambulation, as main objective, is achieved in almost half the population examined. Prospective studies are needed to evaluate safety and efficacy of physiotherapy during Awake ECLS, and suitable patient selection. Guidelines are required to identify appropriate assessment/evaluation tools for Awake ECLS patients monitoring.

OBJECTIVE: Preoperative atrial fibrillation (AF) increases risk of stroke, heart failure, and all-cause mortality after cardiac surgery. Despite encouraging results and guideline recommendations, surgical ablation (SA) for AF concomitant with other heart surgery remains low. In the current study we aimed to address the long-term mortality after SA concomitant with cardiac surgery.METHODS: This report pertains to the HEart surgery In atrial fibrillation and Supraventricular Tachycardia (HEIST) registry. We identified 20,765 adult patients (62% male) with preoperative AF who underwent conventional sternotomy heart surgery between 2010 and 2021 in 8 tertiary centers in Poland, Netherlands, and Italy. We used Cox proportional hazards models for computations and propensity score matching to minimize differences in baseline characteristics.RESULTS: Of included patients, 2755 (13.4%) underwent SA for AF. The highest rates of SA were observed for mitral interventions (mitral valve repair or replacement and tricuspid intervention, 25.2%), lowest for isolated coronary artery bypass grafting (6.2%). Patients in the SA group were younger (mean age 64.5 ± 9.0 years vs 68.7 ± 16.0 years; P < .001) and lower risk (mean European System for Cardiac Operative Risk Evaluation [EuroSCORE] II, 4.1 vs 5.7; P < .001). During the 11-year study period, there was a mortality reduction associated with SA (hazard ratio, 0.57; 95% CI, 0.52-0.62; P < .001). After propensity matching, 2750 pairs with similar baseline characteristics were identified. SA was associated with 16% mortality decline (hazard ratio, 0.84; 95% CI, 0.75-0.94; P = .003).CONCLUSIONS: In this multicenter, retrospective, propensity matched study, SA concomitant with other cardiac surgery was associated with improved long-term survival regardless of baseline surgical risk.