[The Gelli-Bianco Law: 5-year analysis since its emission]. / Legge Gelli-Bianco: bilancio a 5 anni dalla sua emanazione.

On April 1, 2017, the n. 24/2017 Gelli-Bianco law became effective, its aim being limiting the so-called "defensive medicine" phenomenon. The first bill was neither straightforward nor judicially flawless, thus complying evenly with the law was not obvious. As a consequence, since 2017 there were several attempts to better clarify it, yet its implementation still appears debatable. Ultimately, the Law has not been a real breakthrough in medical liability, as originally intended by the Legislator. The aim of this review is to outline "lights and shadows" of this Law 5 years after its emission.

Impact of preoperative mitral regurgitation on left ventricular assist device patients: propensity score-matched analysis of the EUROMACS dataset.

OBJECTIVES: Mitral regurgitation (MR) is frequently observed in patients undergoing left ventricular assist device implantation. We investigated the impact of preoperative MR on left ventricular assist device patients. METHODS: A retrospective propensity score-matched analysis of adult patients enrolled in the EUROMACS registry between 1 January 2011 and 30 November 2021 was performed. Patients were divided into 2 groups according to the grade of preoperative MR: none-to-mild (MR 0-II) or moderate-to-severe (MR III-IV). RESULTS: Following 1:1 propensity score matching, each group consisted of 914 patients. Incidence of postoperative temporary right ventricular support, reoperation for bleeding and dialysis was similar. MR III-IV demonstrated shorter median intensive care unit stay [14 days (6; 27.8) vs 10 days (5; 22), P = 0.004] and ventilation time [72 h (22, 320) vs 31 h (18, 150), P < 0.001]. Mortality was lower for MR III-IV patients [subdistribution hazard ratio: 0.66, 95% confidence interval (CI): 0.59-0.73, P < 0.001]. The 1-year survival was 68.1% (95% CI: 65.1-71.3%) in MR 0-II and 75% (95% CI: 72.1-78%) in MR III-IV. A lower incidence of total complications [odds ratio (OR): 0.93 (0.89-0.98), P = 0.003] and trend towards a lower risk of neurological dysfunction (subdistribution hazard ratio: 0.79; 95% CI: 0.61-1.01, P = 0.063) and sustained ventricular tachycardia [OR: 0.93 (0.54-1.03), P = 0.074] were demonstrated for MR III-IV. The risk of fatal stroke and pump thrombosis was similar. CONCLUSIONS: Moderate-to-severe MR in patients undergoing left ventricular assist device implantation is associated with better mid-term survival and lower incidence of total major adverse events and complications. The incidence of severe postoperative complications including fatal stroke and device thrombosis was similar.

Extracorporeal Membrane Oxygenation for Graft Dysfunction Early After Heart Transplantation: A Systematic Review and Meta-analysis.

INTRODUCTION: Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is a prevailing option for the management of severe early graft dysfunction. This systematic review and individual patient data (IPD) meta-analysis aims to evaluate (1) mortality, (2) rates of major complications, (3) prognostic factors, and (4) the effect of different VA-ECMO strategies on outcomes in adult heart transplant (HT) recipients supported with VA-ECMO. METHODS AND RESULTS: We conducted a systematic search and included studies of adults (≥18 years) who received VA-ECMO during their index hospitalization after HT and reported on mortality at any timepoint. We pooled data using random effects models. To identify prognostic factors, we analysed IPD using mixed effects logistic regression. We assessed the certainty in the evidence using the GRADE framework. We included 49 observational studies of 1477 patients who received VA-ECMO after HT, of which 15 studies provided IPD for 448 patients. There were no differences in mortality estimates between IPD and non-IPD studies. The short-term (30-day/in-hospital) mortality estimate was 33% (moderate certainty, 95% confidence interval [CI] 28%-39%) and 1-year mortality estimate 50% (moderate certainty, 95% CI 43%-57%). Recipient age (odds ratio 1.02, 95% CI 1.01-1.04) and prior sternotomy (OR 1.57, 95% CI 0.99-2.49) are associated with increased short-term mortality. There is low certainty evidence that early intraoperative cannulation and peripheral cannulation reduce the risk of short-term death. CONCLUSIONS: One-third of patients who receive VA-ECMO for early graft dysfunction do not survive 30 days or to hospital discharge, and one-half do not survive to 1 year after HT. Improving outcomes will require ongoing research focused on optimizing VA-ECMO strategies and care in the first year after HT.

Effect of Preoperative Right Ventricular Dysfunction on Heart Transplantation Outcomes.

BACKGROUND: We investigated if the occurrence of preoperative right ventricular dysfunction is capable of influencing heart transplant results in terms of in-hospital mortality, incidence of primary graft dysfunction, and follow-up mortality. METHODS: We retrospectively analyzed 517 patients who underwent heart transplant between January 2000 and December 2020. We defined right ventricular dysfunction (RVD), as central venous pressure (CVP) > 15 mm Hg and CVP/pulmonary capillary wedge pressure ratio > 0.63. We identified 2 subgroups in our population: 33 patients with preoperative RVD and 484 patients without RVD. RESULTS: In-hospital mortality was 7.9%. Severe early graft failure occurred in 6.6% of patients, with 26 patients (5.1%) needing intra-aortic balloon pump and 17 patients (3.3%) needing extracorporeal membrane oxygenation support. Clinical variables that significantly influenced in-hospital mortality were age, peripheral artery disease, and bilirubin > 1.5 mg/dL, while hemodynamic variables influencing in-hospital mortality were CVP (odds ratio [OR], 1.09 [confidence interval {CI}, 1.03-1.15], P = .004], pulmonary artery systolic pressure (OR, 1.02 [CI, 1.00-1.04], P = .05), CVP/pulmonary capillary wedge pressure ratio (OR, 2.78 [CI, 1.14-6.80], P = .025), pulmonary vascular resistance (OR, 1.15 [CI, 1.01-1.32], P = .042), transpulmonary gradient (TPG) (OR, 1.11 [CI, 1.03-1.18], P = .003) , diastolic transpulmonary gradient (OR, 1.10 [CI, 1.02-1.20], P = .015], together with right ventricular dysfunction (OR, 3.56 [CI, 1.44-8.80], P = .011). On the other hand, clinical variables influencing the incidence of early graft failure were body mass index (calculated as weight in kilograms divided by height in meters squared) > 30, peripheral artery disease, bilirubin > 1.5 mg/dL, Model for End-Stage Liver Disease score excluding international normalized ratio before transplant, and preoperative extracorporeal membrane oxygenation support, while hemodynamic variables were pulmonary arterial systolic pressure (OR, 1.03 [CI, 1.00-1.05], P = .016), TPG (OR, 1.08 [1.01-1.17], P = .03), and right ventricular dysfunction (OR, 3.00 [CI, 1.07-8.40] P = .046). On the multivariable analysis, RVD and TPG were independent predictors of in-hospital mortality, while only TPG was a predictor of early graft failure. Follow-up mortality was 38.7% and was influenced by recipient age, recipient body mass index, and preoperative diabetes. Moreover, 1-, 5-, and 10-year survival of patients with preoperative RVD was significantly worse than patients without RVD (log-rank = 0.001). CONCLUSIONS: In our population, RVD influenced both in-hospital and long-term results after heart transplant. For these reasons, it appears crucially important to optimize preoperative right ventricular function to improve these patients' outcomes.

Is Pulmonary Artery Pulsatility Index (PAPi) a Predictor of Outcome after Pulmonary Endarterectomy?

Background: Pulmonary endarterectomy (PEA) is the gold standard therapy for chronic thromboembolic pulmonary hypertension (CTEPH). Traditionally, pulmonary vascular resistance (PVR) represents the main prognostic factor after surgery. The pulmonary artery pulsatility index (PAPi) has been proposed for the assessment of RV in advanced heart failure, but it has never been applied in CTEPH patients. The aim of the present study is to describe PAPi in patients who underwent PEA, before and after surgery, and to define its predictive impact on postoperative outcomes. Methods: We retrospectively reviewed 188 consecutive adult patients who underwent PEA, between December 2003 and December 2021. PAPi was calculated for 186 patients and reported. Patients were partitioned in two groups using median preoperative PAPi as cutoff value: Group 1 with PAPi ≤ 8.6 (n = 94) and Group 2 with PAPi > 8.6 (n = 92). The propensity-score-matched analysis identified 67 pairs: Early outcomes were compared between two groups. Results: Mean preoperative PAPi was 10.3 ± 7.2. Considering matched populations, no differences emerged in terms of postoperative hemodynamics; Group 1 demonstrated higher 90-day mortality significance (10.4% vs. 3.0%, p = 0.082); the need for mechanical circulatory support (MCS) was similar, but successful weaning was unlikely (25% vs. 85.7%, p = 0.032). Conclusions: Mean PAPi in the CTEPH population is higher than in other diseases. Low PAPi (≤8.6) seems to be associated with lower postoperative survival and successful weaning from MCS.

Reoperations on the ascending aorta and aortic arch: A retrospective series of 453 patients.

OBJECTIVE: The study objective was to analyze the outcomes of reoperative thoracic aortic surgery at our institution from January 1986 to December 2018 to identify specific risk factors for early and late mortality. METHODS: Two groups of patients were identified: aortic root or ascending aorta repair (group 1: proximal repair, 218 patients, 48%) and arch surgery or descending thoracic aorta repair (group 2: distal repair, 235 patients, 52%). Primary end points were 30-day mortality, 10-year survival, and freedom from aortic reoperations. RESULTS: The 30-day mortality (6.4% vs 8.1%) and in-hospital mortality (8.3% vs 11.9%) were similar (P > .05) in the 2 groups. Multivariable analysis identified female gender (odds ratio, 8.60, P < .01), endocarditis (odds ratio, 2.96, P = .04), and cardiopulmonary bypass time (odds ratio, 1.02, P < .01) as risk factors for 30-day mortality. Mean follow-up time was 163 months (confidence interval, 147-179). Long-term survival at 1, 5, and 10 years was 91.2%, 79.4%, and 66.3% in the proximal repair group and 80.7%, 68.8%, the and 55.3% in distal repair group, respectively (P = .03). According to the indication, 1-, 5-, and 10-year survivals were 92.1%, 82.3%, and 68.8% in degenerative aneurysms; 82.7%, 72.4%, and 56.3% in residual dissections; 80.9%, 65.4%, and 50.3% in endocarditis and pseudoaneurysms; 69.2%, 52.7%, and 42.2% in acute type A aortic dissections, respectively (P < .01). Competing risk analysis showed a significantly different cumulative incidence of reoperation at 1, 5, and 10 years between the 2 groups: 0.50%, 0.50%, and 0.90%, respectively, for the proximal repair group, and 0.40%, 4.30%, and 7.70%, respectively, the for distal repair group (P < .01). CONCLUSIONS: In our experience, short- and long-term results of reoperative thoracic aortic surgery were satisfactory in chronic aneurysms but poor in aortic dissections, pseudoaneurysms, and active endocarditis. Reoperative aortic surgery carries a high risk, regardless of the anatomic extension of the procedure.

Therapeutic alternatives in chronic thromboembolic pulmonary hypertension: from pulmonary endarterectomy to balloon pulmonary angioplasty to medical therapy. State of the art from a multidisciplinary team.

Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare disease with a very complex pathophysiology differing from other causes of pulmonary hypertension (PH). It is an infrequent consequence of acute pulmonary embolism that is frequently misdiagnosed. Pathogenesis has been related to coagulation abnormalities, infection or inflammation, although these disturbances can be absent in many cases. The hallmarks of CTEPH are thrombotic occlusion of pulmonary vessels, variable degree of ventricular dysfunction and secondary microvascular arteriopathy. The definition of CTEPH also includes an increase in mean pulmonary arterial pressure of more than 25 mmHg with a normal pulmonary capillary wedge of less than 15 mmHg. It is classified as World Health Organization group 4 PH, and is the only type that can be surgically cured by pulmonary endarterectomy (PEA). This operation needs to be carried out by a team with strong expertise, from the diagnostic and decisional pathway to the operation itself. However, because the disease has a very heterogeneous phenotype in terms of anatomy, degree of PH and the lack of a standard patient profile, not all cases of CTEPH can be treated by PEA. As a result, PH-directed medical therapy traditionally used for the other types of PH has been proposed and is utilized in CTEPH patients. Since 2015, we have been witnessing the rebirth of balloon pulmonary angioplasty, a technique first performed in 2001 but has since fallen out fashion due to major complications. The refinement of such techniques has allowed its safe utilization as a salvage therapy in inoperable patients. In the present keynote lecture, we will describe these therapeutic approaches and results.

Impact of Predicted Heart Mass-Based Donor-Recipient Size Matching on Transplant Outcomes.

BACKGROUND: Currently, guidelines for appropriate donor sizing in recipients mostly focuses on donor-recipient body weight matching. The purpose is to retrospectively determine the impact of predicted heart mass (pHM)-based size matching on heart transplant (HT) outcomes. METHODS: According to our institutional registry, 512 consecutive adult patients underwent HT between January 2000 and August 2020. For each patient, pHM and donor-recipient pHM ratio were calculated. Patients were partitioned into quintiles in terms of pHM ratio: undersizing 2, undersizing 1, reference, oversizing 1, and oversizing 2, with mean pHM donor-recipient ratio of 0.81, 0.96, 1.04, 1.12, and 1.28, respectively. Severe early graft failure and 30-day, 90-day, 1-year, and 10-year mortality were analyzed as outcomes. RESULTS: Recipients of the most oversized group were mostly female (P < .001), had higher preoperative pulmonary vascular resistance (P = .009), had higher rate of mechanical circulatory support (P < .05), and showed a lower United Network for Organ Sharing score (P = .041); the respective donors were younger and more frequently male (P = .001). Ischemic time was similar in all groups (P = .358). Pulmonary vascular resistance (P = .023; odds ratio [OR], 2.38), preoperative mechanical circulatory support (P = .05; OR, 3.06), and United Network for Organ Sharing score (P = .033; OR, 1.76) were identified as risk factors for early mortality. Donor-recipient pHM ratio did not impact early graft failure (P = .871) and early mortality (P = .526). Survival analysis after adjustment for pHM ratio subgroups did not show any difference in outcomes. CONCLUSIONS: A wide range of pHM ratios seems to be safe. A careful allocation of organs, by considering a pHM ratio mismatch, may balance rescue preoperative clinical profiles and preserve HT outcomes.

Multiple organ retrieval in a brain dead left ventricular assist device donor.

Left ventricular assist device (LVAD) support in donors may contribute in preserving proper haemodynamics and systemic perfusion during organ retrieval thus decreasing the risk of multiple organ injury. This is an option to expand the current organ supply. We report on intra-abdominal organs procurement strategy in a selected LVAD recipient who suffered a fatal cerebrovascular accident at the time of COVID-19 pandemic outbreak. The liver and kidneys grafts have been successfully transplanted.

How Would the Authors Treat Their Own Temporary Left Ventricular Failure With Mechanical Circulatory Support?

In the last 20 years, mechanical circulatory supports (MCS) have overturned completely the outcomes and the clinical recovery of patients with isolated acute left ventricle failure (iALVF). This usually occurs more frequently than right-sided heart failure or biventricular dysfunction, and it mainly is caused by acute myocardial infarction. The primary role of MCS is to restore the tissue metabolism to preserve the vital organs' function but, on the other hand, they also have to relieve the workload stress on the heart. In this way, they allow not only the heart to recover from the acute event, but MCS also can stabilize the patient toward cardiac transplantation. The short-term MCS devices currently used in clinical practice are the intraaortic balloon pump, the Impella (Abiomed, Danvers, MA), and venoarterial extracorporeal membrane oxygenation (VA-ECMO), but the choice of the right and tailored device for each patient, as well as the timing to use it, is actually one of the most debated topics of MCS management.

Impact of concomitant cardiac valvular surgery during implantation of continuous-flow left ventricular assist devices: A European registry for patients with mechanical circulatory support (EUROMACS) analysis.

BACKGROUND: We investigated the clinical outcomes after cardiac valvular surgery procedures concomitant (CCPs) with left ventricular assist device (LVAD) implantation compared to propensity score (PS) matched controls using the European Registry for Patients with Mechanical Circulatory Support (EUROMACS) data. METHODS: Between 2006 and 2018, 2760 continuous-flow LVAD patients were identified. Of these, 533 underwent a CCP during the LVAD implant. RESULTS: Cardiopulmonary bypass time (p < 0.001) and time for implant (p < 0.001) were both significantly longer in the LVAD+CCP group. Hospital mortality was comparable between the two groups from the unmatched population (15.7% vs. 14.1%, p = 0.073). Similarly, short-to-mid-term survival was similar in both groups, with 1-year, 3-year, and 5-year survival rates of 67.9%, 48.2%, and 27.7% versus 66.4%, 46.1%, and 26%, respectively (log-rank, p = 0.25). The results were similar in the PS-matched population. Hospital mortality was comparable between the two groups (18.9% vs. 17.4%, p = 0.074). The short-to-mid-term Kaplan-Meier survival analysis was similar for both groups, with 1-year, 3-year, and 5-year survival rates of 63.4%, 49.2%, and 24.7% versus 66.5%, 46%, and 25.1%, respectively (log-rank, p = 0.81). In the unmatched population, LVAD+CCP patients had longer intensive care unit (ICU) stays (p < 0.0001), longer mechanical ventilation time (p = 0.001), a higher rate of temporary right ventricular assist device (RVAD) support (p = 0.033), and a higher rate of renal replacement therapy (n = 35, 6.6% vs. n = 89, 4.0%, p = 0.014). In the PS-matched population, the LVAD+CCP patients had longer ICU stays (p = 0.019) and longer mechanical ventilation time (p = 0.002). CONCLUSIONS: The effect of additive valvular procedures (CCPs) does not seem to affect short-term survival, significantly, based on our registry data analysis. However, the decision to perform CCPs should be balanced with the projected type of surgery and preoperative characteristics. LVAD+CCP patients remain a delicate population and adverse device-related events should be strictly monitored and managed.

Ventricular assist devices implantation: surgical assessment and technical strategies.

Along with the worldwide increase in continuous left ventricular assist device (LVAD) strategy adoption, more and more patients with demanding anatomical and clinical features are currently referred to heart failure (HF) departments for treatment. Thus surgeons have to deal, technically, with re-entry due to previous cardiac surgery procedures, porcelain aorta, peripheral vascular arterial disease, concomitant valvular or septal disease, biventricular failure. New surgical techniques and surgical tools have been developed to offer acceptable postoperative outcomes to all mechanical circulatory support recipients. Several less invasive and/or thoracotomic approaches for surgery combined with various LVAD inflow and outflow graft alternative anastomotic sites for system placement have been reported and described to solve complex clinical scenarios. Surgical techniques have been upgraded with further technical tips to preserve the native anatomy in case of re-entry for heart transplantation, myocardial recovery or device explant. The current continuous-flow miniaturized and intrapericardial devices provide versatility and technical advantages. However, the surgical planning requires a careful multidisciplinary evaluation which must be driven by a dedicated and well-trained Heart Failure team. Biventricular assist device (BVAD) implantation by adoption of the newer radial pumps might be a challenge. However, the results are encouraging thus remaining a valid option. This paper reviews and summarizes LVAD preoperative assessment and current surgical techniques for implantation.

Mechanically Supported Early Graft Failure After Heart Transplantation.

BACKGROUND: The occurrence of early graft failure (EGF) after heart transplantation (Htx) often requires a mechanical circulatory support (MCS) therapy. The aims of our study were to identify risk factors of mechanically supported severe EGF and evaluate their impact on both early and late outcomes. METHODS: Between January 2000 and December 2019, 499 consecutive adult patients underwent Htx at our institution. Severe EGF was defined as the need for extracorporeal life support (ECLS) within 24 hours after surgery. All available recipient and donor variables were retrospectively analyzed. RESULTS: Overall, EGF occurred in 58 (11.6%) patients. Post-Htx peripheral or central ECLS was necessary in 32 (6.4%) cases. Independent predictors of severe EGF were, in the recipient group, preoperative transpulmonary gradient (TPG) >12 mm Hg (odds ratio [OR] 4.1, P = .013), preoperative inotropic score >10 (OR 7.3, P = .0001), and pre-Htx ECLS support (OR 5.2, P = .015), while in the donors, a Eurotransplant donor score ≥17 (OR 8.5, P = .005). The absence of EGF was related with a better survival at 1 year and 5 years (94% and 85%, respectively) compared with EGF requiring ECLS population (36% and 28% at 1 year and 5 years, respectively; P < .001). A five-year conditional survival rate did not differ significantly (85% no EGF vs 83% EGF requiring ECLS). CONCLUSION: Both donor and recipient factors may influence EGF occurrence. Post-Htx ECLS may impact negatively early; however, patients weaned from ECLS eventually benefit from such a rescue treatment with outcomes comparable with Htx patients who did not suffer EGF.

[Surgical treatment of acute aortic syndrome: an update]. / Trattamento chirurgico della patologia aortica acuta: un update.

The term "acute aortic syndrome" describes a variety of acute and emerging aortic pathologies that include intramural hematoma, penetrating aortic ulcer and acute aortic dissection. However, the acute pathology of the thoracic aorta also includes the contained ruptures of aortic aneurysms, traumatic aortic ruptures and iatrogenic aortic dissections. In all these acute situations, in which emerging surgical treatment is often required, decision-making represents a crucial and extremely important phase, which often affects the patient's prognosis, in the short and long term. This review aims to present an update of the surgical treatment of acute aortic syndrome focusing mainly on the correct decision-making, the factors that influence it and the latest novel surgical techniques and strategies.

Veno-venous Extracorporeal Membrane Oxygenation Support in COVID-19 Respiratory Distress Syndrome: Initial Experience.

SARS-CoV-2 may cause severe respiratory failure due to massive alveolar damage. Currently, no adequate curative therapy for Coronavirus Disease 2019 (COVID-19) disease exists. By considering overall impact of COVID-19 pandemic outbreak, an increased need of extracorporeal membrane oxygenation (ECMO) support becomes evident. We report on our preliminary institutional experience with COVID-19 patients receiving venovenous ECMO support.