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Lead dwell time10 years is a recognized predictor for transvenous lead extraction (TLE) failure and complications. Data on the efficacy and safety of TLE using the bidirectional rotational mechanical sheaths in patients with very old leads are lacking. In this multicenter study, we reported the outcomes of transvenous rotational mechanical lead extraction in patients with leads implanted for ≥10 years.A total of 441 leads (median: 159 months [135-197]; range: 120-487) in 189 consecutive patients were removed with the Evolution RL sheaths (Cook Medical, Bloomingtom, IN, USA) and mechanical ancillary tools supporting the procedures.The main indication for TLE was infection in 74% of cases. Complete procedural success rate, clinical success rate, per lead were 94.8% and 98.2%, respectively. Failure of lead extraction was seen in 1.8% of leads. The additional use of a snare via the femoral approach was required in 9% of patients. Lead dwell time was the only predictor of incomplete led removal (odds ratio: 1.009; 95% confidence interval [CI]: 1.003-1.014; p = .002). Four major complication (2%) were encountered. During a mean time follow-up of 31 ± 27 months, 21 patients (11%) died. No procedure-related mortality occurred. Predictors of mortality included severe left ventricular systolic dysfunction (hazard ratio [HR]: 8.06; 95% CI: 2.99-21.73; p = .001), TLE for infection (HR: 8.0; 95% CI: 1.04-62.5; p = .045), diabetes (HR: 3.7; 95% CI: 1.48-9.5; p = .005), and previous systemic infection (HR: 3.1; 95% CI: 1.17-8.24; p = .022). Incomplete lead removal or failure lead extraction did not impact on survival during follow-up.Our findings demonstrated that the use of bidirectional rotational TLE mechanical sheaths combined with different mechanical tools and femoral approach allows reasonable success and safety in patients with very old leads at experienced specialized centers.

We investigated the efficacy, safety, and versatility of the AngioVac (AngioDynamics, Latham, NY) system for the treatment of intravascular and intracardiac masses of different origins. We prospectively enrolled all consecutive patients treated with the AngioVac system between July-2016 and November-2021 at our institution. Three configurations of the device were adopted in 44 patients: a venous-venous circuit in 21 cases (47.7%), a venous-arterial ECMO-like configuration in 20 (45.5%), and a venous-arterial-arterial circuit with 2 centrifugal pumps for left-sided cardiac masses in 3 (6.8%). Successful removal of the mass was achieved in 41 patients (93.2%), while in the other cases conversion to full sternotomy was necessary. Intraoperative complications occurred in 3 cases (6.8%), including 1 death, 1 pulmonary embolization, and 1 cardiac perforation. The AngioVac system is a valid, safe, and versatile option for the treatment of intravascular masses also in patients with prohibitive surgical risk.

We aimed to identify prognostic laboratory markers during extracorporeal life support (ECLS) in patients with primary refractory cardiogenic shock (RCS) and to create a preliminary specific mortality score. All 208 consecutive subjects admitted for primary RCS and treated with ECLS between January-2009 and December-2018 were retrospectively analyzed. Multivariate regression analysis on laboratory markers during the first nine days of ECLS was used to develop a 'Refractory End-stage Shock CUred with Ecls' (RESCUE) score. Serum creatinine (OR=3.72, 95%CI:2.01-6.88), direct bilirubin (OR=1.40, 95%CI:1.05-1.8), and platelet count (OR=0.62, 95%CI:0.42-0.94) were independent predictors of in-hospital mortality and were included in the score. The mean AUC was 0.763 (95%CI:0.698-0.828) in the development cohort and 0.729 (95%CI:0.664-0.794) in the bootstrap internal validation cohort. The RESCUE score represents a novel promising instrument to predict early mortality during the first critical days of ECLS and to help in properly guiding the therapeutic decision-making process.

BACKGROUND Recent studies have shown that Evolution RL bidirectional rotational mechanical sheath (Cook Medical,USA) is an effective and safe technique for transvenous lead extraction (TLE). We reported our experience with the bidirectional rotational mechanical tools using a multidisciplinary approach highlighting the value of a joint cardiac surgeon and electrophysiologist collaboration. METHODS The study population comprised 84 patients (77%male;mean age 65±18 years) undergoing TLE.After multidisciplinary evaluation, a combined procedure was considered. RESULTS The main indication for TLE was infection in 54 cases (64%).Overall,152 leads were extracted with a mean implant duration of 94±63 months (range 12-421).Complete procedural success rate, clinical success rate, and lead removal with clinical success rate were 91.6 % (77/84),97.6% (82/84), and 98.6%(150/152), respectively.Eighteen combined procedure were performed in 12 patients (14%), such as "hybrid approach" (n = 2) or TLE concomitant to:1) transcatheter aspiration procedure for large vegetation (n = 8); 2) left ventricular assistance device implantation as bridge to cardiac transplantation (n = 1); 3) permanent pacing with epicardial leads (n = 6); 4) tricuspid valve replacement (n = 1).One major complication (1.2%) and 11 (13%) minor complications were encountered.No injury to the superior vena cava occurred and no procedure-related deaths were reported. During a mean time follow-up of 21±18 months, 17 patients (20%) died.They were more often diabetics (P = 0.02), and they underwent TLE more often for infection (P = 0.004). CONCLUSIONS Our results support the finding that excellent outcomes can be achieved in performing TLE of chronically implanted leads by using the Evolution RL bidirectional rotational mechanical sheath and a multidisciplinary team approach involving both electrophysiologist and cardiac surgeon as first line operators. This article is protected by copyright. All rights reserved.

We report a case of a 77-years-old man admitted to our department because of facial plethora, prominent venous collateral over the anterior chest wall, marked swelling of the head and upper extremities. His medical history was notable diabetes, non-Hodgkin lymphoma (NHL), eradicated HCV, AV block, for which he underwent placement of a dual-chamber pacemaker 4 years earlier. A superior vena cava (SVC) syndrome lead-related was documented on angio-CT scan and phlebography. After a multidisciplinary team discussion, a treatment strategy was designed to consist of transvenous lead extraction, SVC reconstruction and epicardial pacing placement. At 5 months follow-up, he was completely relieved of symptoms. Conclusion Lead-associated SVC syndrome is a rare condition and there is no standard management protocol. Data are lacking and we need at least a registry to make the treatment homogeneous. In this specific patient, a hybrid procedure based on lead extraction and reconstruction of superior vena cava was safe and effective for the relief of symptoms and maintenance of SVC patency. Heparin alone will not lead to the resolution of the disease if the disease is at an advanced stage. Learning outcomes Patients with lead-induced superior vena cava syndrome often required a multidisciplinary approach. A hybrid procedure based on transvenous lead extraction and reconstruction of superior vena cava is safe and effective to achieve relief of symptoms, maintenance of SVC patency, and adequate pacing.

Background: The present study evaluates outcomes of LVAD patients, taking into account the device strategy and the INTERMACS profile. Methods: We included 192 LVAD-patients implanted between January 2012 and May 2021. The primary and secondary end-points were survival and major adverse events between Profiles 1–3 vs. Profile 4, depending on implantation strategies (Bridge-to-transplant-BTT; Bridge-to-candidacy-BTC; Destination-Therapy-DT). Results: The overall survival was 67% (61–75) at 12 months and 61% (54–70) at 24 months. Profile 4 patients showed significantly higher survival (p = 0.018). Incidences of acute right-ventricular-failure (RVF) (p = 0.046), right-ventricular-assist-device (RVAD) implantation (p = 0.015), and continuous-venovenous-hemofiltration (CVVH) (p = 0.006) were higher in Profile 1–3 patients, as well as a longer intensive care unit stays (p = 0.050) and in-hospital-mortality (p = 0.012). Twelve-month and 24-month survival rates were higher in the BTT rather than in BTC (log-rank = 0.410; log-rank = 0.120) and in DT groups (log-rank = 0.046). In the BTT group, Profile 1–3 patients had a higher need for RVAD support (p = 0.042). Conclusions: LVAD implantation in elective patients was associated with better survival and lower complications incidence. LVAD implantation in BTC patients has to be considered before their conditions deteriorate. DT should be addressed to elective patients in order to guarantee acceptable results.

When approaching infected lead removal in cardiac device-related infective endocarditis (CDRIE), a surgical consideration for large (>20 mm) vegetations is recommended. We report our experience with the removal of large CDRIE vegetations using the AngioVac system, as an alternative to conventional surgery. We retrospectively reviewed all infected lead extractions performed with a prior debulking using the AngioVac system, between October 2016 and April 2022 at our institution. A total of 13 patients presented a mean of 2(1) infected leads after a mean of 5.7(5.7) years from implantation (seven implantable cardioverter-defibrillators, four cardiac resynchronization therapy-defibrillators, and two pacemakers). The AngioVac system was used as a venous–venous bypass in six cases (46.2%), venous–venous ECMO-like circuit (with an oxygenator) in five (38.5%), and venous–arterial ECMO-like circuit in two cases (15.4%). Successful (>70%) aspiration of the vegetations was achieved in 12 patients (92.3%) and an intraoperative complication (cardiac perforation) only occurred in 1 case (7.7%). Subsequent lead extraction was successful in all cases, either manually (38.5%) or using mechanical tools (61.5%). The AngioVac system is a promising effective and safe option for large vegetation debulking in CDRIE. Planning the extracorporeal circuit design may represent the optimal strategy to enhance the tolerability of the procedure and minimize adverse events.

AngioVac system (AngioDynamics) has already proved to be a useful tool in the treatment of thrombotic and endocarditic formations concerning the venous district. Herein, the AngioVac aspiration system combined with the bidirectional rotational Evolution mechanical sheath lead extraction was used for an effective and safety cardiac-device-related-infective-endocarditis removal in a grown-up congenital heart disease patient through a totally peripheral approach.

Left-ventricular-assist-device (LVAD) implantation in patients with antiphospholipid-syndrome (APS) is considered a high-risk procedure and its indication still represents an open challenge. Herein, we report a 63-year-old man with APS and end-stage heart failure, for whom a HeartMate3-LVAD and a continuous rheologic profile monitoring with a multiparametric assessment resulted the optimal therapeutic strategy.

We investigated the synergistic effect of the new cone-bearing design of Jarvik 2000 (Jarvik Heart Inc., NY) together with a minimally-invasive approach to outcomes of LVAD patients.We retrospectively reviewed all patients from 5 institutions involved in the Jarvik 2000 Italian Registry, from October 2008 to October 2016. Patients were divided into three groups according to pump design and implantation technique: pin-bearing design and conventional approach (Group 1); cone-bearing and conventional approach (Group 2); cone-bearing and minimally-invasive implantation (Group 3).A total of 150 adult patients with end-stage heart failure were enrolled: 26 subjects in Group 1, 74 in Group 2, and 50 in Group 3. Nineteen patients (73%) in Group 1, 51 (69%) in Group 2, and 36 (72%) in Group 3 were discharged. During follow-up, 22 patients underwent transplantation, while in 3 patients the LVAD was explanted. The overall 1-year survival was 58 ± 10%, 64 ± 6%, and 74% ± 7% in Groups 1, 2, and 3, respectively (p = 0.034). The competing-risks-adjusted cumulative incidence rate for adverse events was 42.1 [27-62.7] per 100 patient-years in Group 1, 35.4 [25.3-48.2] in Group 2, and 22.1 [12.4-36.4] in Group 3 (p = 0.046 for Group 1 vs. 3).The association of the modern cone-bearing configuration of Jarvik 2000 and minimally invasive surgery improved survival and minimized the risk for cardiovascular events, as a result of combining technology and technique.

(1) Objectives: The aim of this study was to investigate the impact of the prolonged use of continuous-flow left ventricular assist devices (LVADs) on heart transplant (HTx) candidates. (2) Methods: Between January 2012 and December 2019, we included all consecutive patients diagnosed with end-stage heart failure considered for HTx at our institution, who were also eligible for LVAD therapy as a bridge to transplant (BTT). Patients were divided into two groups: those who received an LVAD as BTT (LVAD group) and those who were listed without durable support (No-LVAD group). (3) Results: A total of 250 patients were analyzed. Of these, 70 patients (28%) were directly implanted with an LVAD as BTT, 11 (4.4%) received delayed LVAD implantation, and 169 (67%) were never assisted with an implantable device. The mean follow-up time was 36 ± 29 months. In the multivariate analysis of survival before HTx, LVAD implantation showed a protective effect: LVAD vs. No-LVAD HR 0.01 (p < 0.01) and LVAD vs. LVAD delayed HR 0.13 (p = 0.02). Mortality and adverse events after HTx were similar between LVAD and No-LVAD (p = 0.65 and p = 0.39, respectively). The multi-state survival analysis showed a significantly higher probability of death for No-LVAD vs. LVAD patients with (p = 0.03) or without (p = 0.04) HTx. (4) Conclusions: The use of LVAD as a bridge to transplant was associated with an overall survival benefit, compared to patients listed without LVAD support.

Continuous flow left ventricular assist devices (LVADs) have become a valuable therapy for end-stage heart failure. In vitro research highlighted a role of outflow cannula position on the pattern of blood flow in the aorta. However, the clinical effects of the alterations of flow remain unclear. We investigate short- and long-term outcomes of patients implanted with Jarvik 2000 LVAD, according to the ascending (Group 1) versus descending (Group 2) outflow graft connection to the aorta in a multicenter study. From May 2008 to October 2014, 140 consecutive end-stage heart failure patients underwent Jarvik 2000 LVAD implantation in 17 Italian centers. According with a preliminary multivariate analysis, we selected the 90 patients implanted in the four high-volume centers to avoid bias (Group 1 n = 39, Group 2 n = 51). Among the groups, no differences were recorded in the hospital mortality and the main complications occurring after LVAD implantation were similar. In multivariable analysis, the ascending aorta outflow cannula position and higher creatinine at discharge were significant predictors for long-term survival. Postimplant hemolysis was more pronounced in descending aorta outflow graft anastomosis. Outflow graft anastomosis to the ascending aorta is associated with better long-term survival, independent of age and perfusion techniques, reflecting the previous in vitro results.

Background Subcutaneous implantable cardioverter defibrillator (S-ICD) is a suitable alternative for transvenous ICD (TV-ICD) patients who have undergone transvenous lead extraction (TLE). Limited data are available on the outcome of S-ICD patients implanted after TLE. We assessed the safety, efficacy, and outcome of S-ICD implantation after TLE of TV-ICD. Methods The study population consisted of 36 consecutive patients with a median age of 52 (44–66) years who underwent S-ICD implantation after TLE of TV-ICD. Results Indications for TLE were infection (63.9%) and lead malfunction (36.1%). During a median follow-up of 31 months, 3 patients (8.3%) experienced appropriate therapy and 7 patients (19.4%) experienced complications including inappropriate therapy (n = 4; 11.1%), isolated pocket erosion (n = 2; 5.5%), and ineffective therapy (n = 1; 2.8%). No lead/hardware dysfunction was reported. Premature device explantation occurred in 4 patients (11%). Eight patients (22.2%) died during follow-up, six of them (75%) because of refractory heart failure (HF). There were no S-ICD-related deaths. Predictors of mortality included NYHA class ≥ 2 (HR 5.05; 95% CI 1.00–26.38; p = 0.04), hypertension (HR 22.72; 95% CI 1.05–26.31; p = 0.02), diabetes (HR 10.64; 95% CI 2.05–55.60; p = 0.001) and ischemic heart disease (HR 5.92; 95% CI 1.17–30.30; p = 0.01). Conclusion Our study provides evidences on the use of S-ICD as an alternative after TV-ICD explantation for both infection and lead failure. Mortality of S-ICD patients who underwent TV-ICD explantation does not appear to be correlated with the presence of a prior infection, S-ICD therapy (appropriate or inappropriate), or S-ICD complications but rather to worsening of HF or other comorbidities.

Background: In this study, we assessed the mid-term outcomes of patients who received a heart donation from a marginal donor (MD), and compared them with those who received an organ from a standard donor (SD). Methods: All patients who underwent HTx between January 2012 and December 2020 were enrolled at a single institution. The primary endpoints were early and long-term survival of MD recipients. Risk factors for primary graft failure (PGF) and mortality in MD recipients were also analyzed. The secondary endpoint was the comparison of survival of MD versus SD recipients. Results: In total, 238 patients underwent HTx, 64 (26.9%) of whom received an organ from an MD. Hospital mortality in the MD recipient cohort was 23%, with an estimated 1 and 5-year survival of 70% (59.2–82.7) and 68.1% (57.1–81), respectively. A multivariate analysis in MD recipients showed that decreased renal function and increased inotropic support of recipients were associated with higher mortality (p = 0.04 and p = 0.03). Cold ischemic time (p = 0.03) and increased donor inotropic support (p = 0.04) were independent risk factors for PGF. Overall survival was higher in SD than MD (85% vs. 68% at 5 years, log-rank = 0.008). However, risk-adjusted mortality (p = 0.2) and 5-year conditional survival (log-rank = 0.6) were comparable. Conclusions: Selected MDs are a valuable resource for expanding the cardiac donor pool, showing promising results. The use of MDs after prolonged ischemic times, increased inotropic support of the MD or the recipient and decreased renal function are associated with worse outcomes.

Objective To analyze Italian Cardiac Surgery experience during the pandemic of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) identifying risk factors for overall mortality according to coronavirus disease 2019 (COVID‐19) status. Methods From February 20 to May 31, 2020, 1354 consecutive adult patients underwent cardiac surgery at 22 Italian Centers; 589 (43.5%), patients came from the red zone. Based on COVID‐19 status, 1306 (96.5%) were negative to SARS‐CoV‐2 (COVID‐N), and 48 (3.5%) were positive to SARS‐CoV‐2 (COVID‐P); among the COVID‐P 11 (22.9%) and 37 (77.1%) become positive, before and after surgery, respectively. Surgical procedures were as follows: 396 (29.2%) isolated coronary artery bypass grafting (CABG), 714 (52.7%) isolated non‐CABG procedures, 207 (15.3%) two associate procedures, and three or more procedures in 37 (2.7%). Heart failure was significantly predominant in group COVID‐N (10.4% vs. 2.5%, p = .01). Results Overall in‐hospital mortality was 1.6% (22 cases), being significantly higher in COVID‐P group (10 cases, 20.8% vs. 12, 0.9%, p

Aims Recent studies have shown that evolution RL bidirectional rotational mechanical sheath (Cook Medical, USA) is an effective and safe technique for transvenous lead extraction (TLE). We reported our experience with the bidirectional rotational mechanical tools using a multidisciplinary approach highlighting the value of a joint cardiac surgeon and electrophysiologist collaboration. Methods and results The study population comprised 84 patients (77% male; mean age 65 ± 18 years) undergoing TLE. After multidisciplinary evaluation, a combined procedure was considered. The main indication for TLE was infection in 54 cases (64%).Overall, 152 leads were extracted with a mean implant duration of 94 ± 63 months (range: 6–421). Complete procedural success rate, clinical success rate, and lead removal with clinical success rate were 91.6% (77/84), 97.6% (82/84), and 98.6% (150/152), respectively. Eighteen combined procedures were performed in 12 patients (14%), such as ‘hybrid approach’ (n = 2) or TLE concomitant to: (i) transcatheter aspiration procedure for large vegetation (n = 8); (ii) left ventricular assistance device implantation as bridge to cardiac transplantation (n = 1); (iii) permanent pacing with epicardial leads (n = 6); and (iv) tricuspid valve replacement (n = 1).One major complication (1.2%) and 11 (13%) minor complications were encountered. No injury to the superior vena cava occurred and no procedure-related deaths were reported. During a mean time follow-up of 21 ± 18 months, 17 patients (20%) died. They were more often diabetics (P = 0.02), and they underwent TLE more often for infection (P = 0.004). Conclusions Our results support the finding that excellent outcomes can be achieved in performing TLE of chronically implanted leads by using the evolution RL bidirectional rotational mechanical sheath and a multidisciplinary team approach involving both electrophysiologist and cardiac surgeon as first line operators.

Left ventricular assist device implantation is an established treatment for patients with end-stage heart failure. The HeartMate 3 (Abbott Laboratories, Abbott Park, IL) is a continuous-flow centrifugal pump, recently introduced in the clinic, that has shown greater hemocompatibility compared with similar devices of previous generations. Nevertheless, anticoagulation is still required after HeartMate 3 implant to avoid pump dysfunction. Hereafter, we describe the case of a patient candidate to left ventricular assist device implantation for end-stage heart failure presenting a concomitant cerebrovascular lesion, accidentally found during preoperative assessment, that would have contraindicated the procedure (for the prohibitive risk of cerebral hemorrhage), unless a step by step problem-solving approach was adopted.

CentriMag® extracorporeal VAD support could represent a more physiological choice than conventional ECMO in primary cardiogenic shock. We therefore evaluated the outcome of patients with primary cardiogenic shock who were supported with CentriMag® extracorporeal VAD implantation versus conventional ECMO. We retrospectively reviewed all extracorporeal life supports implanted for primary cardiogenic shock between January 2009 and December 2018 at our institution. Among 212 patients, 143 cases (67%) were treated exclusively with ECMO (Group 1) and 69 cases (33%) with extracorporeal VAD implantation (Group 2, 48 of whom as conversion of ECMO). ECLS mean duration was 8.37 ± 8.43 days in Group 1 and 14.25 ± 10.84 days in Group 2 (p = 0.001), while the mean rates of the highest predicted flow were 61.21 ± 16.01% and 79.49 ± 18.42% (p = 0.001), respectively. Increasing mechanical support flow was related to in-hospital mortality and overall mortality in Group 1 (HR 11.36, CI 95%: 2.19–44.20), but not in Group 2 (HR 1.48, CI 95%: 0.32–6.80). High-flow ECMO patients had lower survival with respect to high-flow extracorporeal VAD patients (p = 0.027). In the setting of high-flow mechanical circulatory support, CentriMag® extracorporeal VAD optimized patient survival, granting long-term assistance and physiological circulation patterns.

Background and Aims: Right ventricle failure (RVF) can be a fatal complication following left ventricle assist device (LVAD) implant. Careful intra and postoperative management is becoming increasingly important. Unfortunately, the attempts are limited to the prediction and not to the treatment. There are no data on Ketogenic parenteral nutrition (KPN) for the targeted treatment of RVF. The aim of our retrospective observational case-control study is to determine whether KPN may play a role as additional treatment to conventional therapy after LVAD implantation.Material and Methods: This is a retrospective single center analysis of a case series on prospectively collected data. From February 2012 to April 2021, 192 patients have been implanted with an LVAD. All the patients were managed with optimal medical and surgical therapy. One-hundred-seven patients were treated with additional KPN as adjuvant therapy against and in prevention of acute RVF (KPN-Group), defined according to International Society Heart and Lung Transplantation (ISHLT) guidelines. The remaining 85 patients, managed without KPN, constituted our control group (No-KPN-Group).Results: In KPN-Group acute-RVF occurred in 31 patients (29%), while causing death in 14 patients (13%). In the No-KPN-Group acute-RVF was observed in 32 patients (37.6%), while causing death in 20 patients (23.5%). According to echocardiographic and hemodynamic results, the majority of KPN-Group patients responded with RV function improvement (range 4–60% of TAPSE increase, p Conclusion: KPN was well tolerated. A complete recovery of the RV function was achieved in the majority of the patients and results lasted beyond the duration of KPN. Future research to understand the underlying mechanism, and identification of suitable patients and treatment duration is necessary.

Background Surgical aortic valve replacement (SAVR) is still the gold standard for treating aortic valve stenosis (AVS). Its effectiveness has been extensively examined in terms of perioperative mortality, but its impact on overall health has received much less attention. Aims To assess the physical performance, cognitive status, and health-related quality of life of elderly patients undergoing SAVR, in the short, medium and long term. Methods This single-center prospective study enrolled patients aged > 70 years who underwent isolated SAVR for severe AVS. Data were collected on each participant’s clinical status, physical performance, cognitive status, mood, and health-related quality of life. This multidimensional geriatric assessment was performed before surgery (T0), and again at 45 days (T1), 3 months (T2), 6 months (T3), and 12 months (T4) post-surgery. Baseline (T0) and follow-up (T2-T4) data were compared separately for patients grouped by gender using paired t-tests. Results Data from a total of 35 patients were analyzed. Compared with the baseline (T0), nutritional status worsened at T1, then gradually improved through to T4. Physical performance, mood, and health-related quality of life improved significantly after surgery. Cognitive function showed no change through to T3, but then deteriorated at T4. Conclusions Our results show that SAVR in patients over 70 years of age has a positive impact on nutrition, mood, and health-related quality of life. Cognitive function was not negatively affected in the short and medium term, although it deteriorated in the long term. SAVR also had a positive impact on the physical performance of our sample.

Left ventricular assist device (LVAD) therapy is a well accepted and effective strategy to treat advanced heart failure. The miniaturized third-generation centrifugal pumps HeartWare HVAD (Medtronic, Dublin, Ireland) and HeartMate 3 (Abbott, Illinois, USA) are the two most commonly implanted systems in the contemporary era. Their design has allowed clinicians to pioneer several alternate and less invasive implantation techniques to tackle a broad spectrum of clinical scenarios. A brief review and discussion of alternative surgical techniques for both inflow and outflow cannula insertion, in the contemporary LVAD surgery era, are herein reported.

The hepatic rupture durig pregnancy is a catastrophic clinical issue associated with high fetal and maternal mortality. We describe the case of hepatic hemangioma rupture complicated by massive thrombosis of the inferior vena cava successfully treated by using AngioVac aspiration system. Although an aggressive surgical strategy is recommended, a multidisciplinary approach using modern devices can represent a new frontier in the treatment of these patients.

An increased need of extracorporeal membrane oxygenation (ECMO) support is going to become evident as treatment of SARS-CoV-2 respiratory distress syndrome. This is the first report of the Italian Society for Cardiac Surgery (SICCH) on preliminary experience with COVID-19 patients receiving ECMO support. Data from 12 Italian hospitals participating in SICCH were retrospectively analyzed. Between March 1 and September 15, 2020, a veno-venous (VV) ECMO system was installed in 67 patients (94%) and a veno-arterio-venous ECMO in four (6%). Five patients required VA ECMO after initial weaning from VV ECMO. Thirty (42.2%) patients were weaned from ECMO, while 39 (54.9%) died on ECMO, and six (8.5%) died after ECMO removal. Overall hospital survival was 36.6% (n = 26). Main causes of death were multiple organ failure (n = 14, 31.1%) and sepsis (n = 11, 24.4%). On multivariable analysis, predictors of death while on ECMO support were older age (p = 0.048), elevated pre-ECMO C-reactive protein level (p = 0.048), higher positive end-expiratory pressure on ventilator (p = 0.036) and lower lung compliance (p = 0.032). If the conservative treatment is not effective, ECMO support might be considered as life-saving rescue therapy for COVID-19 refractory respiratory failure. However warm caution and thoughtful approaches for timely detection and treatment should be taken for such a delicate patients population.

Background: Atrial fibrillation (AF) is a well-established post-cardiac surgery complication. Orthotopic heart transplantation (OHT) represents a peculiar condition where surgical thoracic veins isolation and autonomic denervation occur. This study aims at investigating AF incidence in OHT in order to define its risk factors and to evaluate its prognostic impact. Methods: 278 patients affected by OHT were recruited in our Cardiac Surgery Unit and retrospectively analyzed, using clinical, surgical and instrumental data. Results: The patients cohort showed 45 post-operative (16.5%) and 20 late AF cases (7.2%). Only paroxysmal AF episodes were observed. Elderly donors and acute rejection resulted as risk factors in patients with post-operative AF episodes, who presented higher all-cause mortality at 11 years post-OHT (p

Background Propensity score matching is a statistical method that is often used to make inferences on the treatment effects in observational studies. In recent years, there has been widespread use of the technique in the cardiothoracic surgery literature to evaluate to potential benefits of new surgical therapies or procedures. However, the small sample size and the strong dependence of the treatment assignment on the baseline covariates that often characterize these studies make such an evaluation challenging from a statistical point of view. In such settings, the use of propensity score matching in combination with oversampling and replacement may provide a solution to these issues by increasing the initial sample size of the study and thus improving the statistical power that is needed to detect the effect of interest. In this study, we review the use of propensity score matching in combination with oversampling and replacement in small sample size settings. Methods We performed a series of Monte Carlo simulations to evaluate how the sample size, the proportion of treated, and the assignment mechanism affect the performances of the proposed approaches. We assessed the performances with overall balance, relative bias, root mean squared error and nominal coverage. Moreover, we illustrate the methods using a real case study from the cardiac surgery literature. Results Matching without replacement produced estimates with lower bias and better nominal coverage than matching with replacement when 1:1 matching was considered. In contrast to that, matching with replacement showed better balance, relative bias, and root mean squared error than matching without replacement for increasing levels of oversampling. The best nominal coverage was obtained by using the estimator that accounts for uncertainty in the matching procedure on sets of units obtained after matching with replacement. Conclusions The use of replacement provides the most reliable treatment effect estimates and that no more than 1 or 2 units from the control group should be matched to each treated observation. Moreover, the variance estimator that accounts for the uncertainty in the matching procedure should be used to estimate the treatment effect.

We describe massive thrombus formation completely occluding an aortic bioprosthesis in a patient with venoarterial extracorporeal membrane oxygenation and apical venting. The thrombus was surgically removed and the patient recovered with no complications. Timely identification and immediate surgical removal of thrombi may allow patient recovery with no severe complications.

OBJECTIVES The aim of this study was to evaluate short- and long-term clinical outcomes, including the perceived health-related quality of life, in patients younger than 65 years having undergone aortic valve replacement either with biological or mechanical valve prostheses. METHODS Between 2002 and 2013, 242 consecutive patients RESULTS No significant difference in survival was found between the 2 groups (mechanical versus biological: 100% vs 96.6% at 1 year, 98.2% vs 93.1% at 5 years and 92.3% vs 83.4% at 10 years after surgery, P = 0.091). For all the interviewed patients (n = 161, 66.5%), perceived quality of life at the latest follow-up was excellent. Need for reoperation was higher in the bioprosthetic group (8% vs 0%, P = 0.995), whereas the rate of major bleedings was higher in the mechanical valve group (3% vs 20%, P = 0.094). The mean and maximum transvalvular pressure gradients were 20.5 ± 9.7 and 37.4 ± 17.5 mmHg in the biological group and 14.8 ± 4.8 and 26.6 ± 9.2 mmHg in the mechanical group (P = 0.014). CONCLUSIONS No significant differences were found between biological and mechanical valves in terms of patients’ survival, clinical outcomes and quality of life. Mean and maximum transvalvular pressure gradients were significantly higher in the biological group. The majority of patients would opt for the same prosthesis type, if asked to choose again.

Evolution RL sheath with its bidirectional rotational mechanism is an effective and safe technique for transvenous lead extraction of chronically implanted leads. However, data about powered mechanical sheath through jugular vein are lacking. Our report suggest that bidirectional rotational mechanical sheath may represent an effective and safe approach for removal of chronically implanted jugular lead.

Chronological age represents the main factor in donor selection criteria for organ transplantation, however aging is very heterogeneous. Defining the biological aging of individual organs may contribute to supporting this process. In this study we examined the biological age of the heart [right (RA)/left atrium (LA)] and peripheral blood leucocytes in the same subject, and compared these to assess whether blood mirrors cardiac biological aging. Biological aging was studied in 35 donors (0.4–72 years) by exploring mitotic and non-mitotic pathways, using telomere length (TL) and age-dependent methylation changes in certain CpG loci (DNAmAge). Heart non-mitotic DNAmAge was strongly younger than that of both blood (− 10 years, p p p ≤ 0.01). Finally, blood and heart TL (p p

The AngioVac System has already proved to be effective and safe in the treatment of thrombotic and endocarditic formations concerning the venous district and the tricuspid valve. We describe an innovative use of the AngioVac System to treat a left-sided heart mass. In a high-surgical-risk patient, we used a micro-invasive transapical access and a modified extracorporeal membrane oxygenation circuit to remove the mass from the mitral bioprosthesis without having to replace it. Further experiences are required to confirm the safety of this technique in high-risk patients.

Myocarditis is an inflammatory disease of the myocardium, due to several causes, often underdiagnosed, and it may be responsible for acute (or even fulminant) or chronic heart failure. In this scenario, the first aim of the cardiac surgeon becomes saving the patients’ life (“bridge to life”), obtaining their clinical stabilization, and allowing diagnosis. For this purpose, mechanical circulatory support (MCS) devices are widely used in cardiac surgery with the intent to treat acute and chronic heart failure, not responsive to medical therapies. The extracorporeal circulatory support allows critical patients to gain and maintain hemodynamic stability until a partial or complete cardiac function is restored (short-term). If myocardial recovery is not achievable, other surgical options (long-term) are available. Heart transplant remains the optimal therapeutic solution, but it is not always available due to shortage of compatible donors, especially in pediatric recipients. Myocarditis, due to any causes, does not represent a contraindication for transplantation, but in some forms (e.g., acute infection, giant cell myocarditis, etc.) this option needs to be accurately evaluated. Finally, long-term devices (included biventricular support as total artificial heart) may be considered to bridge patients to transplant or less frequently as destination therapy.

In this work we aimed to evaluate the evolution of our surgical experience with the implantation of a continuous flow left ventricular assist device (LVAD), from the original full sternotomy approach to less invasive surgical strategies including mini-sternotomy and/or mini-thoracotomies. We reviewed all consecutive patients implanted with a continuous flow LVAD at our Institute. To exclude the possible bias related to the device used, out of 91 collected LVADs implants, we selected only those patients (n = 42) who received, between 2012 and 2015, the HeartWare HVAD. The analysis focused on the surgical approach used for the LVAD implant. Most of the patients (95%) were affected by dilated or ischemic cardiomyopathy, with an INTERMACS class I-II in the majority of cases (77%). The LVAD implant was performed through a full sternotomy in 10 patients (24%); the remaining 32 cases (76%) were managed with minimally invasive procedures. These were left mini-thoracotomy with upper mini-sternotomy (20 patients, 62%), right and left mini-thoracotomy (7 patients, 22%), and a recently developed left mini-thoracotomy with outflow graft anastomosis to the left axillary artery (5 patients, 16%). The most common adverse event on device was right heart failure (26%). Eighteen patients (43%) were transplanted. Overall estimated 24 months survival (on device or after transplant) was 68 ± 7%. The causal analysis, adjusted by propensity score weighting baseline data and sample size, showed that left mini-thoracotomy with outflow anastomosis to the left axillary artery resulted in a significantly reduced rate of post implant right heart failure (P < 0.01), and mechanical ventilation time (P = 0.049). To conclude, in our series, by applying mini-invasive implant techniques in the majority of cases, mid-term survival of continuous flow LVADs in severely compromised patients was satisfactory. In the adjusted analysis, the left anterior mini-thoracotomy with outflow anastomosis to the left axillary artery showed the most favorable results.

The SARS-CoV-2 pandemic is nowadays an international emergency and the North-Italian regions have faced a high rate of infection and case fatality. A logistic and structural rearrangement has been required to ensure COVID-19-free areas, to save human and economic resources, and to solve all incoming urgencies. Herein, we report the Padova experience in heart transplantation and mechanical circulatory support implantation for severe INTERMACS class patients with satisfactory results during COVID-19 pandemic.

The formation of thrombotic deposits affects the functionality of mechanical prosthetic heart valves; as a consequence, mechanical valves thrombosis needs early diagnosis to prevent thromboembolic events. This paper compares the acoustic signals produced by two commercial bileaflet mechanical heart valves in the closing phase to detect the presence of thrombi. The closing sounds were recorded in vitro by means of a phonocardiographic device under different hydrodynamic conditions. Thrombotic deposits of different weight and shape were applied onto the valve leaflet and the annular housing, until the movement of one leaflet was completely blocked. From the acoustic signals, the corresponding spectra were calculated and four diagnostic frequency bands were identified: their comparison allowed detecting malfunctioning valves because of the presence of thrombotic formations.

Purpose Hemocompatibility represents the goal for left ventricular assist devices (LVADs). Currently, third generation-fully-magnetically-levitated LVAD (HeartMate 3, HM3) has shown high hemocompatibility. Aim of this retrospective study was to evaluate safety and effectiveness of anticoagulant therapy alone after HM3 implantation. Methods Patients were monitored by clinical evaluation, classical laboratory, thromboelastometry (ROTEM) and aggregometry (Multiplate) in the postoperative period and at follow-up. Based on therapeutic options, our population (=25 patients, from November 2015 to March 2018) was divided in: Group A (=15 patients, 60%) with antiplatelet+anticoagulant medications and Group B (=10 patients, 40%) with anticoagulant medication alone. Primary outcome was freedom from clinical thromboembolic and/or hemorrhagic events. For the assessment of asymptomatic neurologic events, patients were explored with MiniMental-State-Examination (MMSE) and Brief-Neuropsychological-Examination 2 (ENB2). Results Mean age was 61.5 ± 5.6 years and 4 patients (16%) were in INTERMACS profile 1, 15 (60%) in profile 2-3 and 6 (24%) in profile 4. Bleeding occurred in 10 patients (Group A=9, 40% vs Group B=1, 10%, p=0.0177). In particular, cerebral hemorrhage in 1 (Group A), gastrointestinal bleeding in 5 (Group A), late onset chest bleeding in 2 (Group A), minor bleeding in 6 (5 Group A, 1 Group B). No thromboembolic events were reported. At follow-up ENB2 showed significant improvement of patients’ neuropsychological performance (p=0.006), whereas MMSE results remained stable (p=0.1). Conclusion Heartmate 3 is a highly hemocompatible device. This study suggests that anticoagulation alone is a safe and effective therapy as it prevents both thrombotic and hemorrhagic events.

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Background In addition to the Evolution RL sheath, tools by Cook Medical (Bloomington, IN, USA), supporting lead extraction (LE), are available. Data on their use are not reported in detail in previous studies. Moreover, data regarding outcome are lacking. The aim was to evaluate the safety and effectiveness of the Evolution sheath (Evolution RL and Evolution Shortie, Cook Medical) by using a stepwise approach with the available extraction tools and the outcome. Methods A total of 393 leads in 198 consecutive patients were removed with the Evolution RL sheath and ancillary tools using a stepwise approach. Results The main indication for LE was infection in 125 (63.1%) cases. The mean implant duration was 95.4 ± 59.7 months. According to our stepwise approach, the Evolution Shortie RL sheath was used in all cases and complete LE was achieved in 24 (12.2%) cases. The Evolution RL was used in 174 (87.8%) cases and the SteadySheath Evolution tissue stabilization sheath (Cook Medical) in 87 (44%) because of tenacious fibrosis anchored targeted leads. Compression coil (OneTie, Cook Medical) was used in 141 (71%) cases. Complete procedural success rate, clinical success rate, and lead removal with clinical success rate were 97%, 99%, and 99.5%, respectively. One major complication (0.5%) and 10 (5%) minor complications were encountered. During a mean time follow-up of 12 ± 9 months, 14 (7%) patients died. Predictors of mortality included impaired renal function (HR 5.7; 95% CI 1.9-17.6; P = 0.002), extraction because of infection (hazard ratio [HR] 4.0; 95% confidence interval [CI] 1-18.1; P = 0.045), and diabetes (HR 3.2; 95% CI 1.1-9.8; P = 0.036). Conclusions Lead extraction using the Evolution RL bidirectional rotational mechanical sheath and ancillary tools in a systematic stepwise approach was effective and safe.

AIMS We analysed the outcomes with the use of a new-generation continuous-flow left ventricular assist device (CF-LVAD) as a bridge-to-transplant (BTT). MATERIALS AND METHODS We included all patients implanted with an intrapericardial CF-LVAD as BTT, between January 2012 and December 2016. Primary outcomes were overall survival, survival on waiting list and postheart transplant (HTx) survival. The outcomes after HTx were compared with those of a contemporary cohort of patients transplanted without previous CF-LVAD (No-LVAD group, n = 73). RESULTS We included 53 patients with a median age of 52 years (interquartile range: 43-59 years). Seventy-two percent were in INTERMACS profile 1-2 before implant; all entered the HTx waiting list after receiving the CF-LVAD. HTx was performed in 42 (79%) cases (LVAD group). Overall estimated survival (considering both pre-HTx and post-HTx) was 89% [95% confidence interval (CI) 81-98%] at 1 year and 80% (CI 70-92%) at 2 years. The estimated survival on waiting list was 91% (CI 80-100%) at 6 months, whereas the 1-year estimated post-HTx survival was 88% (CI 79-98%). The Kaplan-Meier curves of survival after HTx of LVAD versus No-LVAD group were comparable (log-rank P = 0.54), as well as the rates of post-HTx adverse events. A multivariable model of survival after HTx, accounting for the most relevant patient characteristics, identified LVAD use as a significant protective factor [LVAD versus No-LVAD hazard ratio 0.22 (CI 0.06-0.91)]. CONCLUSION The use of new-generation intrapericardial CF-LVADs as a BTT resulted, in our series, in satisfactory pre-HTx and post-HTx outcomes.