Outcome of percutaneous HeartMate3 decommissioning: A single-centre experience.

OBJECTIVES: To highlight the role of percutaneous left ventricular assist device (LVAD) decommissioning as a safe procedure after myocardial recovery in patients with advanced heart failure. BACKGROUND: The HeartMate3 LVAD (Abbott, Chicago, IL, USA) is designed to provide circulatory support with enhanced hemocompatibility for patients with advanced heart failure. Most VADs are used as a bridge to heart transplantation; however, in certain cases, myocardial function recovers, and VADs can be explanted after the patient is weaned. Although surgical explantation remains the gold standard, minimally invasive percutaneous decommissioning has been described as a successful alternative. In this study, we present our experience, one-year outcomes, and adverse events associated with percutaneous LVAD decommissioning. METHODS: We conducted a retrospective review of data from six consecutive patients who underwent percutaneous LVAD decommissioning. RESULTS: Six patients were enrolled in the study. For all six patients, HM3 decommissioning was completed at least 6 months ago. No technical complications were documented. No strokes were observed within the study period, and the ejection fraction improved. The mean follow-up duration was 18 ± 8.5 months, and the survival rate was 100%. CONCLUSION: Percutaneous HeartMate3 decommissioning appears to be safe. In particular, the survival after the procedure was 100%, and no events, especially thromboembolic ones, occurred.

Single-center experience of LVAD implantation in patients with sickle-cell trait: A retrospective analysis.

BACKGROUND: The most worrisome complications in patients supported by left ventricular assist device (LVAD) are pump thrombosis, embolism, and bleeding. The actual rate of these events in patients with sickle-cell disease (SCD) has not well investigated. The aim of our study is to evaluate the outcomes of LVAD implantation in patients with sickle-cell hemoglobinopathy at our institution. METHODS: This retrospective, observational, single-center study was conducted on patients with sickle-cell trait (SCT), who underwent LVAD implantation using the HeartMate3 LVAD. RESULTS: LVAD devices were implanted in four patients with SCT. All procedures were performed successfully. All patients had uneventful post-implant course. Overall, the mean follow-up time was 25 months (range 21-28 months) and showed an unremarkable post-implant course. There was a significant improvement in hematological markers over the follow-up period. CONCLUSIONS: Despite the limited numbers of patients enrolled in this study, our findings indicate that LVAD surgery is safe in SCD patients and offers remarkable clinical improvement. Further studies are needed to provide more evidence regarding this type of patients undergoing LVAD implantation.

A Retrospective Analysis of Treatment Outcomes Following Guided Bone Regeneration at Sites Exhibiting Severe Alveolar Ridge Atrophy.

ABSTRACT: Severely atrophic alveolar ridges represent a great challenge for implant-prosthetic rehabilitations. The aim of this study was to clinically and histologically evaluate horizontal and vertical bone gain, as well as implant survival/success rate after guided bone regeneration (GBR) for the reconstruction of large bone defects. Fourteen subjects (7 males and 7 females; mean age: 48.9 ±â€Š14.1) were enrolled in the study. They were selected according to specific inclusion criteria and all patients required GBR procedures for placing implants in severe atrophic jaws (bone height ≤6 mm). Guided bone regeneration was performed using dense polytetrafluoroethylene nonresorbable titanium-reinforced membranes associated with particulate heterologous bone grafts. Implant placement was performed 6 months after surgery at the same time as the removal of the membrane. Furthermore, a biopsy sample from the grafted sites was collected to conduct a histological analysis of the regenerated bone. Forty-seven dental implants were placed and followed up after prosthetic loading. Seventeen sites, 8 in the maxilla and 9 in the mandible, were suitable for the GBR procedure. The healing period was uneventful in 13 sites. The average value of vertical bone regeneration was 5.88 ±â€Š1.17 mm. Postloading follow-up ranged from 24 to 59 months. During the follow-up, clinical and radiographic exams showed no significant bone resorption and, in each case, the criteria for implants' survival were respected with no signs of any complications. Histological analysis of the bone biopsy samples revealed residual graft particulate in close contact with newly formed bone. Guided bone regeneration is a reliable technique for reconstruction of severe atrophic ridges. Larger long-term follow-up studies are needed to evaluate the condition of the bone grafted over time and its ability to support functional loading of the implants.

Relation of Prolonged Pacemaker Dependency After Cardiac Surgery to Mortality.

Permanent pacemaker implantation (PPI) represents a rare complication after cardiac surgery, with no uniform agreement on timing and no information on follow-up. A multicenter retrospective study was designed to assess pacemaker dependency (PMD) and long-term mortality after cardiac surgery procedures. Between 2004 and 2016, PPI-patients from 18 centers were followed. Time-to-event data were evaluated with semiparametric regression Cox models and semiparametric Fine and Gray model for competing risk framework. Of 859 (0.90%) PPI-patients, 30% were pacemaker independent (PMI) at 6 months. PMD showed higher mortality compared with PMI (10-year survival 80.1% ± 2.6% and 92.2% +2.4%, respectively, log-rank p-value < 0.001) with an unadjusted hazard ratio for death of 0.36 (95% CI 0.20 to 0.65, p< 0.001 favoring PMI) and an adjusted hazard ratio of 0.19 (95% CI 0.08 to 0.45, p< 0.001 with PMD as reference). Crude cumulative incidence function of restored PMI rhythm at follow-up at 6 months, 1 year and 12 years were 30.5% (95% CI 27.3% to 33.7%), 33.7% (95% CI 30.4% to 36.9%) and 37.2% (95% CI 33.8% to 40.6%) respectively. PMI was favored by preoperative sinus rhythm with normal conduction (SR) (HR 2.37, 95% CI 1.65 to 3.40, p< 0.001), whereas coronary artery bypass grafting and aortic valve replacement were independently associated with PMD (HR 0.63, 95% CI 0.45 to 0.88, p = 0.006 and HR 0.807, 95% CI 0.65 to 0.99, p = 0.047 respectively). Time-to-implantation was not associated with increased rate of PMI. Although 30% of PPI-patients are PMI after 6 months, PMD is associated with higher mortality at long term.

Assessing the development and implementation of the Global Trigger Tool method across a large health system in Sicily.

Background: The Institute for Healthcare Improvement (IHI) has proposed a new method, the Global Trigger Tool (IHI GTT), to detect and monitor adverse events (AEs) and provide information to implement improvement. In 2015, the Sicilian Health System adopted IHI GTT to assess the number, types and severity levels of AEs. The GTT was implemented in 44 of 73 Sicilian public hospitals and 18,008 clinical records (CRs) were examined. Here we present the standardized application of the GTT and the preliminary results of 14,706 reviews of CRs. Methods: IHI GTT was adapted, developed and implemented to the local context. Reviews of CRs were conducted by 199 professionals divided into 71 review teams consisting of three individuals: two of whom had clinical knowledge and expertise, and a physician to authenticate the AE. The reviewers entered data into a dedicated IT-platform. All 44 of the public hospitals were included, with approximately 300,000 yearly inpatient admissions out of a population of approximately 5 million. In total, 14,706 randomized CRs of inpatients from medicine, surgery, obstetric and ICU wards, from June 2015 to June 2018 were reviewed. Results: In 975 (6.6%) CRs at least one AE was found. Approximately 20,000 patients of the 300,000 discharged each year in Sicily have at least one AE. In 5,574 (37.9%) CRs at least one trigger was found. A total of 1,542 AEs were found. The analysis of ROC curve shows that the presence of two triggers in a CR indicates with high probability the presence of an AE. The most frequent type of AE was in-hospital related infection. Conclusions: The GTT is an efficient method to identify AEs and to track improvement of care. The analysis and monitoring of some triggers is important to prevent AEs. However, it is a labor-intensive method, particularly if the CRs are paper-based.

A predictive model for early mortality after surgical treatment of heart valve or prosthesis infective endocarditis. The EndoSCORE.

BACKGROUND: The aim of this large retrospective study was to provide a logistic risk model along an additive score to predict early mortality after surgical treatment of patients with heart valve or prosthesis infective endocarditis (IE). METHODS: From 2000 to 2015, 2715 patients with native valve endocarditis (NVE) or prosthesis valve endocarditis (PVE) were operated on in 26 Italian Cardiac Surgery Centers. The relationship between early mortality and covariates was evaluated with logistic mixed effect models. Fixed effects are parameters associated with the entire population or with certain repeatable levels of experimental factors, while random effects are associated with individual experimental units (centers). RESULTS: Early mortality was 11.0% (298/2715); At mixed effect logistic regression the following variables were found associated with early mortality: age class, female gender, LVEF, preoperative shock, COPD, creatinine value above 2mg/dl, presence of abscess, number of treated valve/prosthesis (with respect to one treated valve/prosthesis) and the isolation of Staphylococcus aureus, Fungus spp., Pseudomonas Aeruginosa and other micro-organisms, while Streptococcus spp., Enterococcus spp. and other Staphylococci did not affect early mortality, as well as no micro-organisms isolation. LVEF was found linearly associated with outcomes while non-linear association between mortality and age was tested and the best model was found with a categorization into four classes (AUC=0.851). CONCLUSIONS: The following study provides a logistic risk model to predict early mortality in patients with heart valve or prosthesis infective endocarditis undergoing surgical treatment, called "The EndoSCORE".

[Hospital mortality at a cardiosurgical unit in Torino: international comparisons and time trend]. / Mortalità ospedaliera in una unità di cardiochirurgia di Torino: confronti internazionali e andamento temporale.

OBJECTIVE: To compare hospital mortality in a cardiac surgery unit with external data and to assess changes in time (patients undergoing surgery in two different periods). MATERIALS AND METHODS: Data on risk factors for hospital mortality were collected from clinical records (retrospectively for the first period and prospectively for the second) for all patients undergoing open heart surgery at the Heart Surgery Unit of the University of Turin (Italy) during 1991 and 1995 (n = 1794) and 1999 (n = 892). Comparisons of in-hospital mortality, expressed as Standardized Mortality Ratios (SMR), were adjusted for risk factors defined according to EuroSCORE (European System for Cardiac Operative Risk Evaluation). RESULTS: In the first and second period, complete information on all the 17 EuroSCORE items was available for 58.3% and 89.6% patients respectively. After exclusion of patients with one or more missing data, observed and expected numbers of death were found to be very similar, with SMRs ranging between 0.82 (isolated bypass in the second period) and 1.06 ("other" surgery in the first period). Mortality was higher among patients with missing data, but at least in 1999 the latter had a limited impact on the overall estimates. Compared to the first period, mortality was reduced during 1999 (from 5.9% to 5.4%), in particular for isolated bypass (from 4.4% to 3.4%). CONCLUSIONS: In the unit under investigation, hospital mortality following heart surgery was similar to that predicted from EuroSCORE and seemed to be lower in 1999 than in 1991-95, particularly for isolated bypass. Incompleteness of data on individual risk factors may have been a source of bias, especially when data were collected retrospectively.