Hypothermic oxygenated perfusion of the donor heart in heart transplantation: the short-term outcome from a randomised, controlled, open-label, multicentre clinical trial.

BACKGROUND: Static cold storage (SCS) remains the gold standard for preserving donor hearts before transplantation but is associated with ischaemia, anaerobic metabolism, and organ injuries, leading to patient morbidity and mortality. We aimed to evaluate whether continuous, hypothermic oxygenated machine perfusion (HOPE) of the donor heart is safe and superior compared with SCS. METHODS: We performed a multinational, multicentre, randomised, controlled, open-label clinical trial with a superiority design at 15 transplant centres across eight European countries. Adult candidates for heart transplantation were eligible and randomly assigned in a 1:1 ratio. Donor inclusion criteria were age 18-70 years with no previous sternotomy and donation after brain death. In the treatment group, the preservation protocol involved the use of a portable machine perfusion system ensuring HOPE of the resting donor heart. The donor hearts in the control group underwent ischaemic SCS according to standard practices. The primary outcome was time to first event of a composite of either cardiac-related death, moderate or severe primary graft dysfunction (PGD) of the left ventricle, PGD of the right ventricle, acute cellular rejection at least grade 2R, or graft failure (with use of mechanical circulatory support or re-transplantation) within 30 days after transplantation. We included all patients who were randomly assigned, fulfilled inclusion and exclusion criteria, and received a transplant in the primary analysis and all patients who were randomly assigned and received a transplant in the safety analyses. This trial was registered with ClicalTrials.gov (NCT03991923) and is ongoing. FINDINGS: A total of 229 patients were enrolled between Nov 25, 2020, and May 19, 2023. The primary analysis population included 204 patients who received a transplant. There were no patients who received a transplant lost to follow-up. All 100 donor hearts preserved with HOPE were transplantable after perfusion. The primary endpoint was registered in 19 (19%) of 101 patients in the HOPE group and 31 (30%) of 103 patients in the SCS group, corresponding to a risk reduction of 44% (hazard ratio 0·56; 95% CI 0·32-0·99; log-rank test p=0·059). PGD was the primary outcome event in 11 (11%) patients in the HOPE group and 29 (28%) in the SCS group (risk ratio 0·39; 95% CI 0·20-0·73). In the HOPE group, 63 (65%) patients had a reported serious adverse event (158 events) versus 87 (70%; 222 events) in the SCS group. Major adverse cardiac transplant events were reported in 18 (18%) and 33 (32%) patients in the HOPE and SCS group (risk ratio 0·56; 95% CI 0·34-0·92). INTERPRETATION: Although there was not a significant difference in the primary endpoint, the 44% risk reduction associated with HOPE was suggested to be a clinically meaningful benefit. Post-transplant complications, measured as major adverse cardiac transplant events, were reduced. Analysis of secondary outcomes suggested that HOPE was beneficial in reducing primary graft dysfunction. HOPE in donor heart preservation addresses the existing challenges associated with graft preservation and the increasing complexity of donors and heart transplantation recipients. Future investigation will help to further elucidate the benefit of HOPE. FUNDING: XVIVO Perfusion.

Ex vivo heart perfusion: an updated systematic review.

Due to the discrepancy between patients awaiting a heart transplant and the availability of donor hearts, strategies to expand the donor pool and improve the transplant's success are crucial. This review aims to summarize current knowledge on the ex vivo heart preservation (EVHP) experience as an alternative to standard cold static storage (CSS). EVHP techniques can improve the preservation of the donor's heart before transplantation and allow for pre-transplant organ evaluation.

Evaluation of tricuspid valve regurgitation following transvenous rotational mechanical lead extraction.

AIMS: Transvenous lead extraction (TLE) is potentially complicated by significant tricuspid valve regurgitation increase (TRI). However, there are limited data on the effect of the bidirectional rotational mechanical sheaths on significant TRI. The aim of the present study was to investigate the rate of significant changes in tricuspid regurgitation (TR) severity following mechanical rotational TLE and their outcomes. METHODS AND RESULTS: In 158 patients (mean age 66 ± 16.9 years) undergoing mechanical rotational TLE, acute changes in TR severity were assessed by echocardiography evaluation. A significant acute TRI was defined as an increase of at least one grade with a post-extraction severity at least moderate. A total of 290 leads were extracted (mean implant duration, 93 ± 65 months). Significant TRI was noted in 5.7% of patients, and it was linked to tricuspid valve damage, TLE infection indication, and longer lead implant duration. Univariate predictors of significant TRI included implant duration of all leads [odds ratio (OR) 1.01; 95% confidence interval (CI) 1.003-1.018; P = 0.001] and right ventricular leads (OR 1.01; 95% CI 1.004-1.017; P = 0.002). Severe increase of TR following TLE was an independent predictor of mortality [hazard ratio (HR) 5.20; 95% CI 1.44-18.73; P = 0.012 ] along with severe systolic dysfunction (HR 2.37; 95% CI 1.01-5.20; P = 0.032), and systemic infection (HR 2.28; 95% CI 1.06-4.89; P = 0.035). CONCLUSION: Significant TRI was detected in 5.7% of patients following transvenous rotational mechanical lead extraction. The duration of lead implantation emerged as the sole predictor of significant TRI. Physicians engaged in TLE should exercise greater vigilance for this potential complication.

The Mitris RESILIA Valve: New Skin for a Proven Design.

By incorporating the best features of the Carpentier-Edwards PERIMOUNT Magna Mitral Ease valve (Edwards Lifesciences Corporation, Irvine, California) and INSPIRIS RESILIA tissue (Edwards Lifesciences Corporation, Irvine, California), the mitris valve inherits the advantages of the remarkable hemodynamic performance of the former and the durability of the latter. In this paper, we will summarize the process that led to the creation of this new valve and report on the first implant's feasibility and first impression. The mitris valve has an overall implantability profile, overlapping the previous generation with no added challenges, but compared to the PERIMOUNT Magna Mitral Ease valve, the mitris valve boasts a more pliable saddle-shaped sewing cuff that is specifically tailored to fit the complex structure of the mitral valve with a lower stent height. This could be particularly beneficial in the context of double-valve replacement, as it may prevent any disturbance to the bioprosthesis located in the aortic position in small annulus. This could also prevent some rare but unpleasant complications such as left ventricle outflow obstruction or rupture of the atrioventricular sulcus. In addition, it could allow for better adherence to the saddle-shaped annulus of the mitral valve with the possibility of less stress (and therefore fibrosis) on the valve tissue, while further reducing the degeneration time. Furthermore, thanks to the possibility of being temporarily adjusted inwards, it is possible to ensure greater implantability compared to the previous generation of Magna Edwards mitral valves. Thanks to INSPIRIS technology, which prevents the generation of free aldehydes that promote oxidation and calcification of pericardial tissue, it is possible to assume that the durability will probably also improve. This reinforces the trustworthiness of the mitris valve.

Surgery for Active Infective Endocarditis on Mitral Valve: Anatomical, Surgical, and Disease Factors as Long-Term Outcome Modifiers.

Background and Objectives: Determinants of long-term outcomes after surgery for native mitral valve endocarditis have not been thoroughly investigated. The aim of this study was to assess anatomical, disease, and surgical risk factors for long-term mortality and need of reintervention, in patients undergoing mitral valve surgery for active endocarditis. Materials and Methods: Patients who underwent surgery for active native mitral valve endocarditis at three academic centres, between 2000 and 2022, were analysed. The primary outcome was long-term survival. The secondary outcome was the freedom from mitral reoperation. Survival curves were constructed with Kaplan-Meier methodology. Multivariable Cox regression was used to identify demographic, anatomical, disease, and surgical factors associated with late mortality and reoperation. Results: 335 consecutive patients with active mitral endocarditis were analysed. Two hundred and one patients (70.5%) had infection confined to the valve cusp whereas 89 (25.6%) had invasive disease extended to the annulus and surrounding tissues. Preoperative neurological events occurred at the diagnosis in 52 cases. Streptococci were the most common causative organisms followed by Staphylococcus aureus, Coagulase-negative Staphylococcus, and Enterococcus. Valve repair was performed in 108 patients (32.2%). Survival at 5 and 10 years was 70.1% and 59.2%, respectively. Staphylococcus emerged as an independent predictor of late mortality, along with age, chronic obstructive pulmonary disease, and previous cardiac surgery. Survival was considerably reduced in patients with S. aureus compared with those without (log rank p < 0.001). The type of surgery (repair vs. replacement) did not emerge as a risk factor for late mortality and reoperation. Seventeen patients underwent mitral reoperation during the follow-up. The 5- and 10-year freedom from reoperation was 94.7% and 91.8%, respectively. Conclusions: Active mitral valve endocarditis remains a life-threatening disease with impaired survival. While lesion characteristics influenced surgical decision-making and intraoperative management, their impact on long-term survival and freedom from reintervention appears to be moderated by other factors such as infecting pathogens and patient comorbidities.

Outcomes of transvenous lead extraction of very old leads using bidirectional rotational mechanical sheaths: Results of a multicentre study.

INTRODUCTION: Lead dwell time >10 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Prevalence, risk factors, and clinical effect of coronary artery disease in patients with asymptomatic bilateral carotid stenosis.

OBJECTIVE: In the present report, we have described the prevalence, risk factors, and clinical effects of coronary artery disease (CAD) for patients with asymptomatic bilateral carotid stenosis. METHODS: We conducted a single-center, retrospective cohort study of consecutive patients referred for bilateral carotid stenosis >70% (2014-2021). All the patients had undergone systematic coronary angiography. Depending on the anatomic and clinical characteristics, the patients had undergone combined carotid endarterectomy (CEA) plus coronary artery bypass grafting, coronary percutaneous intervention followed by CEA or carotid artery stenting (CAS), or staged bilateral CEA with cardiac best medical therapy. The cumulative 30-day stroke/myocardial infarction (MI) rate after cardiac and bilateral carotid interventions and long-term survival and freedom from cardiovascular mortality were assessed. RESULTS: A total of 167 patients with bilateral carotid stenosis >70% had undergone preoperative coronary angiography, identifying severe CAD in 108 patients (65.1%). Echocardiographic abnormalities (odds ratio [OR], 2.07; 95% confidence interval [CI], 1.03-5.78; P = .04) and prior coronary intervention (OR, 11.94; 95% CI, 2.99-63.81; P = .001) were significantly associated with severe CAD. CAD was treatable in 91 patients (84%) and untreatable in 17 (16%). The cumulative MI rate was 4.8%; 5.6% for the patients with severe CAD and 1.7% for those without severe CAD (P = .262). The cumulative stroke rate was 1.8%; 1.8% for those with severe CAD and 1.7% for those without severe CAD (P = 1.00). The overall stroke/MI rate was 6.6%; 8.3% for those with severe CAD and 3.3% for patients without severe CAD (P = .33). Patients with severe CAD deemed untreatable for coronary bypass or percutaneous intervention had a higher risk of perioperative stroke/MI (OR, 1.24; 95% CI, 1.00-2.83; P = .04). At 10 years, overall survival was 67.1% (95% CI, 57%-79%), and freedom from cardiovascular mortality was 78.5% (95% CI, 69%-89%). Patients with untreatable CAD maintained a higher risk of 10-year mortality (hazard ratio, 5.5; 95% CI, 1.6-19.9; P < .01). CONCLUSIONS: In the present study, the prevalence of CAD in patients with bilateral carotid stenosis was high, especially for those with abnormal echocardiographic findings. CAD was potentially treatable in 80% of patients, and staged or simultaneous CAD treatment was performed with an acceptable stroke/MI complication rate for these patients. The presence of untreatable CAD was associated with worsened early and long-term outcomes, questioning the benefit of carotid interventions for this subset of patients.

Outcomes of transvenous lead extraction in octogenarians using bidirectional rotational mechanical sheaths.

BACKGROUND: Outcomes of transvenous lead extraction (TLE) are well reported in the general population, However, data on safety, efficacy of TLE in octogenarians with a long lead dwell time, using powered extraction tools are limited. The aim of this multicenter study was to evaluate the safety, effectiveness of TLE in octogenarians using the bidirectional rotational mechanical sheaths and mid-term outcome after TLE. METHODS: The study population comprised 83 patients (78.3% male; mean age 85 ± 3 years; [range 80-94 years]) with 181 target leads. All the leads (mean implant duration 112 ± 77 months [range 12-377]) were extracted exclusively using the Evolution RL sheaths (Cook Medical, Bloomington, IN, USA). RESULTS: The main indication for TLE was infection in 84.3% of cases. Complete procedural success rate, clinical success rate, per lead were 93.9% and 98.3%, respectively. Failure of lead extraction was seen in 1.7% of leads. The additional use of a snare was required in 8.4% of patients. Major complications occurred in one patient (1.2%). Thirty-day mortality after TLE was 6%. During a mean time follow-up of 22 ± 21 months, 24 patients (29%) died. No procedure-related mortality occurred. Predictors of mortality included ischemic cardiomyopathy (HR 4.35; 95% CI 1.87-10.13; p = .001), left ventricularejection fraction ≤35% (HR 7.89; 95% CI 3.20-19.48; p < .001), and TLE for systemic infection (HR 4.24; 95% CI 1.69-10.66; p = .002). CONCLUSIONS: At experienced centers bidirectional rotational mechanical sheaths combined with different mechanical tools and femoral approach allowreasonable success and safety in octogenarian with long lead dwell time. Patient's age should not influence the decision to extract or not the leads, although the 30-day and mid-term mortality are significant, especially in the present of specific comorbidities.

Covalently Grafted Peptides to Decellularized Pericardium: Modulation of Surface Density.

The covalent functionalization of synthetic peptides allows the modification of different biomaterials (metallic, polymeric, and ceramic), which are enriched with biologically active sequences to guide cell behavior. Recently, this strategy has also been applied to decellularized biological matrices. In this study, the covalent anchorage of a synthetic peptide (REDV) to a pericardial matrix decellularized via Schiff base is realized starting from concentrated peptide solutions (10-4 M and 10-3 M). The use of a labeled peptide demonstrated that as the concentration of the working solution increased, the surface density of the anchored peptide increased as well. These data are essential to pinpointing the concentration window in which the peptide promotes the desired cellular activity. The matrices were extensively characterized by Water Contact Angle (WCA) analysis, Differential Scanning Calorimetry (DSC) analysis, geometric feature evaluation, biomechanical tests, and preliminary in vitro bioassays.

The valuable interaction among cardiac surgeon and electrophysiologist for transvenous rotational mechanical lead extraction.

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 a 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 procedures 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 = .02), and they underwent TLE more often for infection (p = .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.

Technology and technique for left ventricular assist device optimization: A Bi-Tech solution.

BACKGROUND: 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. METHODS: 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). RESULTS: 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). CONCLUSIONS: 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.

Surgical aortic valve replacement in elderly patients: effects on physical performance, cognitive function and health-related quality of life.

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.

Transapical mitral valve repair procedures: Primetime for microinvasive mitral valve surgery.

INTRODUCTION: Nowadays micro-invasive-procedures (off-pump, beating-heart) for mitral valve repair (MVRe) are abruptly expanding with the potential to be adopted as a valuable alternative to surgery. In the present manuscript, the authors review the available technologies intended to treat mitral regurgitation (MR) through transapical approach, including annuloplasty and chordal-repair options. ANNULOPLASTY: To date, Valcare Amend is the only transapical MV ring to have been implanted in patients. The device allows for stabilization of the annulus through a complete semirigid d-shaped ring. The first-in-human successful procedure was performed in 2016 by our Group and subsequent clinical experience included a total of 14 implanted patients. Currently, the technology is under clinical trial evaluation to validate the efficacy and safety profile of the device. CHORDAL REPAIR: Beating-heart chordal implantation via transapical approach is a current feasible, safe and reproducible option. Neochord DS1000 is the most widely used technology in the field, with a solid procedural experience and good results in well-selected patients. Its clinical use has been validated in Europe since 2012, while it is still under clinical investigation in the United States. Harpoon MVRe system is a novel technology, recently CE-mark approved for clinical use. DISCUSSION AND CONCLUSIONS: Transapical micro-invasive technologies are current viable therapies to treat MR in selected patients. Although there are still several limitations that preclude an extensive use of such procedures, their results are promising in well-selected patients. Embracing transcatheter MVRe therapies should guide the cardiac surgeon through the new revolution of micro-invasive MV tailored repair.

The black root: Aortic valve sparing in alkaptonuria.

We report an unusual case of black discoloration of an aortic root aneurysm and aortic valve cusps due to homogentisic acid deposition in a patient suffering from alkaptonuria. The patient underwent a valve-sparing aortic root replacement after careful and objective evaluation of the valve cusps. Despite alkaptonuria is classically associated with aortic valve stenosis and replacement, in the present case, the affected valve cusps were suitable for repair. To our knowledge, this is the first reported case of aortic valve-sparing procedure performed in a patient with alkaptonuria.

Prognostic value of SARS-CoV-2 on patients undergoing cardiac surgery.

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 < .001). Multivariable analysis identified COVID-P condition as a predictor of in-hospital mortality together with emergency status. In the COVID-P subgroup, the multivariable analysis identified increasing age and low oxygen saturation at admission as risk factors for in-hospital mortality. CONCLUSION: As expected, SARS-CoV-2 infection, either before or soon after cardiac surgery significantly increases in-hospital mortality. Moreover, among COVID-19-positive patients, older age and poor oxygenation upon admission seem to be associated with worse outcomes.

Long-Term Outcomes in Heart Transplanted Patients with Anderson-Fabry Disease: Effectiveness of a Combined Medical and Surgical Therapy.

BACKGROUND: Transplantation in the management of end-stage organ failure in patients with Anderson- Fabry disease is still a matter of debate due to a lack of data regarding long-term outcomes and prognosis. OBSERVATIONS: Most of the cases in the literature did not receive enzyme-replacement therapy (ERT), or received it only years after transplantation. Based on our experience, we describe here the long-term results of heart transplant in combination with early ERT. CONCLUSIONS: Transplantation combined with lifelong ERT should be considered to offer patients a chance of good long-term outcomes and quality of life.

Porcine Small Intestinal Submucosa (SIS) as a Suitable Scaffold for the Creation of a Tissue-Engineered Urinary Conduit: Decellularization, Biomechanical and Biocompatibility Characterization Using New Approaches.

Bladder cancer (BC) is among the most common malignancies in the world and a relevant cause of cancer mortality. BC is one of the most frequent causes for bladder removal through radical cystectomy, the gold-standard treatment for localized muscle-invasive and some cases of high-risk, non-muscle-invasive bladder cancer. In order to restore urinary functionality, an autologous intestinal segment has to be used to create a urinary diversion. However, several complications are associated with bowel-tract removal, affecting patients' quality of life. The present study project aims to develop a bio-engineered material to simplify this surgical procedure, avoiding related surgical complications and improving patients' quality of life. The main novelty of such a therapeutic approach is the decellularization of a porcine small intestinal submucosa (SIS) conduit to replace the autologous intestinal segment currently used as urinary diversion after radical cystectomy, while avoiding an immune rejection. Here, we performed a preliminary evaluation of this acellular product by developing a novel decellularization process based on an environmentally friendly, mild detergent, i.e., Tergitol, to replace the recently declared toxic Triton X-100. Treatment efficacy was evaluated through histology, DNA, hydroxyproline and elastin quantification, mechanical and insufflation tests, two-photon microscopy, FTIR analysis, and cytocompatibility tests. The optimized decellularization protocol is effective in removing cells, including DNA content, from the porcine SIS, while preserving the integrity of the extracellular matrix despite an increase in stiffness. An effective sterilization protocol was found, and cytocompatibility of treated SIS was demonstrated from day 1 to day 7, during which human fibroblasts were able to increase in number and strongly organize along tissue fibres. Taken together, this in vitro study suggests that SIS is a suitable candidate for use in urinary diversions in place of autologous intestinal segments, considering the optimal results of decellularization and cell proliferation. Further efforts should be undertaken in order to improve SIS conduit patency and impermeability to realize a future viable substitute.

Total Endovascular Aortic Arch Repair: From Dream to Reality.

The gold-standard therapy for the treatment of aortic arch pathologies is conventional open surgery. Recently, total endovascular aortic arch replacement with branched stent-grafts has been introduced into clinical practice with the aim of reducing invasiveness especially in selected high-risk patients. The aim of this review is to describe the two most commonly used branched devices for endovascular arch stent-grafting: Nexus (Endospan, Herzlia, Israle) and RelayBranch (Terumo Aortic, Glasgow, United Kingdom). Nexus is a CE-certified off-the-shelf, single branch, double stent graft system. It consists of two different components: a main module for the aortic arch and the descending aorta with a side-branch for the brachiocephalic artery (BCA), and a curved module for the ascending aorta that lands into the sino-tubular junction and connects to the main module through a side-facing self-protecting sleeve. Nexus may be used in urgent-emergency cases and also in patients with only one suitable supra-aortic target vessel but, on the other hand, it makes cerebral blood flow dependent on one source vessel only. The RelayBranch Thoracic Stent-Graft System is a custom made, double branched endograft with a wide window on its superior portion to accommodate two inner tunnels for BCA and left common carotid artery connection; bilateral cervical accesses are generally used to advance guidewires for catheterization of the inner tunnels in a retrograde fashion. RelayBranch can be customized on every patient's specific anatomy and provides a double blood source for the brain, but it cannot be used in urgent-emergency conditions. Therefore, in order to optimize outcomes, the choice of the most appropriate device should be made considering pros and cons of each system and patient's anatomy by an experienced aortic team. In conclusion, total endovascular aortic arch exclusion is a promising reality in selected high-risk patients.

Totally peripheral approach for ICD lead vegetation removal in a GUCH patient.

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.

Surgical redo versus transseptal or transapical transcatheter mitral valve-in-valve implantation for failed mitral valve bioprosthesis.

BACKGROUND: Redo surgical mitral valve replacement (SMVR) is the current standard of care for patients with failed bioprosthetic mitral valve (MV). Transcatheter mitral valve-in-valve replacement (TMViV) is arising as an alternative to SMVR in high risk patients. We sought to evaluate procedural safety, early and mid-term outcomes of patients who underwent transseptal TMViV (TS-TMViV), transapical TMViV (TA-TMViV), or redo-SMVR. METHODS: We identified patients with failed bioprosthetic MV who underwent TS-TMViV, TA-TMViV, or SMVR at four Italian Centers. Clinical and echocardiographic data were codified according to Mitral Valve Academic Research Consortium definition (MVARC), except for significant valve stenosis. RESULTS: Between December 2012 and September 27, 2019 patients underwent TS-TMViV, 22 TA-TMViV, and 29 redo-SMVR. TS-TMViV and TA-TMViV patients presented higher mean age and surgical risk scores compared with SMVR group (77.8 ± 12 years, 77.3 ± 7.3 years, 67.8 ± 9.4 years, p < .001; STS PROM 8.5 ± 7.2; 8.9 ± 4.7; 3.6 ± 2.6, p < .001). TS-TMViV procedure was associated with shorter intensive care unit time and total length of stay (LOS) compared with TA-TMViV and SMVR group. There were no differences in MVARC procedural success at 30-days (74.1, 72.7, and 51.7%, p = .15) and one-year all-cause mortality between groups (14.8, 18.2, and 17.2%, p = 1.0). MV mean gradient was similar between TS-TMViV, TA-TMViV, and SMVR groups at 30 days and 12 months. CONCLUSIONS: For the selected patients, TS-TMViV and TA-TMViV are to be considered a valid alternative to redo-SMVR with comparable 1-year survival. TS-TMViV is the less invasive strategy and has the advantage of shortening the LOS compared with TA-TMViV.