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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.

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.

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.

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.

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.

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.

An increasing number of patients with end-stage heart failure are being treated with continuous-flow left ventricular assist devices (cf-LVADs). These patients provide new challenges to the staff in exercise-based cardiac rehabilitation (CR) programs. Even though experience remains limited, it seems that patients supported by cf-LVADs may safely engage in typical rehabilitative activities, provided that some attention is paid to specific aspects, such as the presence of a short external drive line. In spite of initial physical deconditioning, CR allows progressive improvement of symptoms such as fatigue and dyspnea. Intensity of rehabilitative activities should ideally be based on measured aerobic capacity and increased appropriately over time. Regular, long-term exercise training results in improved physical fitness and survival rates. Appropriate adjustment of cf-LVAD settings, together with maintenance of adequate blood volume, provides maximal output, while avoiding suction effects. Ventricular arrhythmias, although not necessarily constituting an immediate life-threatening situation, deserve treatment as they could lead to an increased rate of hospitalization and poorer quality of life. Atrial fibrillation may worsen symptoms of right ventricular failure and reduce exercise tolerance. Blood pressure measurements are possible in cf-LVAD patients only using a Doppler technique, and a mean blood pressure ≤80 mmHg is considered "ideal." Some patients may present with orthostatic intolerance, related to autonomic dysfunction. While exercise training constitutes the basic rehabilitative tool, a comprehensive intervention that includes psychological and social support could better meet the complex needs of patients in which cf-LVAD may offer prolonged survival.

Background The role of extracorporeal life support (ECLS) in primary cardiogenic shock (PCS) is well established. In this study, we evaluated the impact of etiology on outcomes. Methods Between January 2009 and March 2013, we implanted a total of 249 patients with ECLS; we focused on 64 patients for whom peripheral ECLS was the treatment for PCS. Of these, 37 cases (58%) were “acute” (mostly acute myocardial infarction: 39%); 27 (42%) had an exacerbation of “chronic” heart failure (dilated cardiomyopathy: 30%; post-ischemic cardiomyopathy: 9%; and congenital: 3%). Results In the group with chronic etiology, 23 patients were bridged to a left ventricular assist device (52%) or heart transplantation (33%). In the group with acute etiology, ECLS was used as a bridge-to-transplantation in 3 patients (8%), a bridge-to-bridge in 9 (24%), and a bridge-to-recovery in 18 (49%). One patient in each group was bridged to conventional surgery. Recovery of cardiac function was achieved in only the group with acute primary cardiogenic shock (18 vs 0 patients, P = .0001). A mean flow during support of ≤60% of the theoretic flow (body surface area × 2.4) was a predictor of successful weaning (P = .02). Median duration of ECLS support was 7 days (range: 2-11.5 days). Nine patients (14%) died during support; 30-day overall survival was 80% (51 of 64 patients); and 59% of patients were discharged, in whom survival at 48 months was 90%. Thirty-day survival was correlated with duration of ECLS support. Conclusions In “chronic” heart failure, ECLS represents a bridge to a ventricular assist device or heart transplantation, whereas in “acute” settings, it offers a considerable chance of recovery, and is often the only required therapy.

Background: The aim of our study was to compare 2 surgical and anesthetic approaches during ventricular assist device implantation. Methods: 68 patients (50.4 ± 17.1 years old) were supported with the HeartWare® HVAD (32 patients) and the Jarvik 2000 VAD (36 patients) between January 2010 and August 2016. Two surgical techniques were applied: a minimally invasive approach with the aid of paravertebral-block (mini-invasive group, 41 patients) and a standard-surgical-approach with the aid of general anesthesia (27 patients). Results: The minimally invasive approach allowed faster postoperative recovery by significantly reducing the duration of surgery (pConclusions: Minimally invasive approaches play a substantial role in VAD surgery by facilitating faster recovery, which is important for patients at very high risk.

Hemorrhagic and thrombotic complications largely contribute to the morbidity and mortality associated with VADs [1].

According to the INTERMACS registry, “low profiles” define the highest severity in the spectrum of advanced heart failure.

Mechanical circulatory support devices have been increasingly used for long-term support. We reviewed outcomes in all patients supported with a SynCardia total artificial heart (TAH) for more than 1 year to assess its safety in long-term support. As of December 2011, all 47 patients who received the TAH from 10 centers worldwide were included in this retrospective study. Clinical data were collected on survival, infections, thromboembolic and hemorrhagic events, device failures, and antithrombotic therapy. The mean age of patients was 50 ± 1.57 years, the median support time was 554 days (range 365-1373 days). The primary diagnosis was dilated cardiomiopathy in 23 patients, ischemic in 15, and "other" in 9. After a minimum of 1 year of support, 34 patients (72%) were successfully transplanted, 12 patients (24%) died while on device support, and 1 patient (2%) is still supported. Five patients (10%) had a device failure reported. Major complications were as follows: systemic infections in 25 patients (53%), driveline infections in 13 patients (27%), thromboembolic events in 9 patients (19%), and hemorrhagic events in 7 patients (14%). SynCardia TAH has proven to be a reliable and effective device in replacing the entire heart. In patients who reached a minimum of 1 year of support, device failure rate is acceptable and only in two cases was the leading cause of death. Infections and hemorrhagic events were the major causes of death. Patients who remain supported beyond 1 year are still likely to survive to transplantation.

Recombinant activated factor VII (rFVIIa) is currently approved for treating or preventing hemorrhage in patients with hemophilia, Glanzmann's thrombasthenia, or congenital FVII deficiency. Its "off-label" use for massive bleeding in the setting of trauma or surgery has been increasing because of demonstrated efficacy. However, the use of rFVIIa also carries a high thrombo-embolic risk. This is particularly true in cardiac surgery patients, especially those treated with mechanical circulatory support. We describe the case of a patient treated with a biventricular assist device in our center, in whom severe bleeding was treated in a targeted manner, using rotational thromboelastometry to guide administration and dosing of rFVIIa. A comprehensive review of the emerging literature on the use of rFVIIa postventricular assist device implantation accompanies the case to highlight the need for careful selection of prohemostatic agents in this high-risk group.

Carvajal syndrome is a variant of Naxos disease characterized by a predominant left ventricular involvement, wooly or curly hair, and palmoplantar keratoderma or similar skin disorders. We describe the clinical and therapeutic course of a 14-year old boy affected by this syndrome, in whom a progressive biventricular failure developed at 13 years of age. The patient was hospitalized in the pediatric department 3 months earlier after the onset of cardiac arrhythmias and he critically worsened with signs and symptoms of biventricular cardiac failure. Over massive inotropic agent infusion, the patient was transferred to our intensive-care-unit in order to be haemodinamically stabilized with a ventricular assist device (VAD) and thereafter transplanted.

Purpose ECMO for the treatment of refractory cardiogenic shock (RCS) has demonstrated dubious results after 9 days of support. Short-term continuous-flow ventricular assist devices (STCF-VADs) could represent a more physiological choice. We therefore evaluate the outcome of patients that needed prolonged support and underwent STCF-VAD implantation compared to conventional ECMO. Methods Between January 2009 and December 2017, 196 extracorporeal life support (ECLS) were implanted in our centre for primary RCS; we selected the 106 patients that exceed the 9 days of ECLS. 45 cases (42%) were treated exclusively with ECMO implantation (Group 1), while 61 cases (58%) underwent left ventricular or biventricular continuous-flow ventricular assist device STCF-VAD implantation (Group 2). Among these last patients, in 44 cases the STCF-VAD was intended as upgrade of ECMO support. Results The duration of ECLS was 17±9 days in the Group 1 and 14±9 days in the Group 2 (p=0.07), while the mean rates of the maximal theoretic flow were 62±15% and 81±21% (p Conclusion In the purview of prolonged ECLS and full hemodynamic support, STCF-VAD has proved to enhance the early survival respect single-stage ECMO in patients with primary RCS.

We describe a modified implantation technique for the HeartWare ventricular assist device. We access the apex through a left minithoracotomy. The outflow graft is tunneled through a small incision in the fourth intercostal space and then subcutaneously to the subclavian region. After division of the left axillary artery, an end-to-end anastomosis is performed to the proximal part, and the distal vessel is connected end-to-side through a fenestration in the outflow graft. We believe that this technique, particularly suitable for redo scenarios or severely calcified aorta, achieves a more direct blood flow into the aorta and reduces cerebrovascular events while avoiding excessive flow to the arm.

A 41-year-old-male with diagnosis of dilated cardiomyopathy was referred to our hospital for heart failure, despite standard medical therapy, to evaluate indications for heart transplantation or mechanical cardiac support. Pre-Operative contrast computer tomography (CT) scan diagnosed pulmonary thrombosis of the left branch of the pulmonary artery. Treatment with low molecular weight heparin was established and the next day a thrombus-arteriectomy and Heartware (Heartware, Framingham, MA, USA) left ventricular assist device (LVAD) implantation were performed simultaneously. The patient was discharged home with oral anticoagulant and antiplatelet therapy, according to our center's VAD protocol. Currently, the patient has been assisted with the LVAD for the past 24 months. The CT scan confirmed the absence of pulmonary artery thrombosis.

Limited options do exist for mechanical circulatory support as a bridge to transplantation in the pediatric population. This is especially true when it comes to intracorporeal technologies. We describe our successful experience with the use of HeartWare ventricular assist devices (HeartWare, Inc., Framingham, MA, USA) in three patients