Psychological assessment of patients on the heart transplant waiting list: A single center experience.

OBJECTIVE: To analyze the data of the psychological assessment, focusing attention on the quality of life and the psychological status of patients who are listed for heart transplant. METHODS: All heart failure patients listed for heart transplant at the Cardiac Surgery Unit of Bari University, Italy, were evaluated from September to November 2023, by administering the Symptom Checklist-90-R (SCL-90-R) and the Short Form Health Survey 36 (SF-36). RESULTS: Overall, 27 patients were studied. Mean age was 60 years, 88% were males. One third of the patients showed a clinically significant overall mental distress. The symptoms leading to domains such as somatization (55.55%), anxiety (40.74%) and depression (33.33%) were frequently observed. The majority of the population studied (96.30%) showed low levels of perceived physical health status, while 59,62% of them presented levels of perceived physical health status below normal ranges. CONCLUSIONS: Heart transplant candidates show elements of overall mental distress and low quality of life related to physical health status.

Can a "broken heart" successfully be transplanted? A brief report.

A 59-year-old woman, with dilated ischemic cardiomyopathy, was urgently admitted to our Intensive Care Unit for cardiogenic shock. ECMO VA was implanted and placed on the national emergency waitlist for transplantation. A potential donation was identified ten days later. The donor was a 58-year-old woman, with no cardiovascular risk factors, had died of a rupture of a cerebral aneurysm with left ventricle dysfunction due to Takotsubo syndrome. Brain injuries such as hemorrhage, trauma and stroke have been extensively documented in literature to cause a surge in stress hormones, such as catecholamines. Such a surge can have a direct effect on the heart, resulting in a transient myocardial dysfunction commonly referred to as "Takotsubo cardiomyopathy" or "broken heart syndrome". Many studies have shown that hearts that are dysfunctional at the start of transplant screening, with normal contractile function at the time of organ retrieval, have similar outcomes to hearts that do not have dysfunction. In our case, the transplanted heart, at the time of sampling, still had moderate dysfunction (EF 40%) which completely disappeared after the transplant.

A comparison of intracardiac echocardiography and transesophageal echocardiography for guiding device closure of ostium secundum atrial septal defect: A 15-year experience.

BACKGROUND AND AIM: Our aim was to evaluate the fluoroscopy time (FT), procedure time (PT) safety and efficacy when using intracardiac echocardiography (ICE) in comparison to transesophageal echocardiography (TEE) guidance for transcatheter closure of Ostium Secundum Atrial Septal Defect (OS-ASD). METHOD: Ninety patients (n = 90) diagnosed with OS-ASD underwent transcatheter closure between March 2006 and October 2021. Fifty-seven patients were treated under ICE guidance, while 33 patients were treated under TEE guidance. RESULTS: Mean age was 43 ± 15 years and 42 ± 10 years in the ICE and TEE groups, respectively. The majority of patients had a centrally placed defect. Median FT was 8.40 min versus 11.70 min (p < .001) in the ICE group compared to the TEE group, respectively. Median PT was 43 min versus 94 min (p < .001) in the ICE group compared to the TEE group, respectively. Both ICE and TEE provided high quality images. All interventions were completed successfully, except for one patient in the ICE group who experienced a device migration, the development of atrial tachycardia in one patient and atrial fibrillation in two patients in the ICE group which spontaneously cardioverted. There were no other complications. CONCLUSION: This study on a consistent cohort of patients with OS-ASD undergoing percutaneous closure suggests that use of ICE is safe and efficacious. Compared to TEE, ICE demonstrated significantly shorter FT and PT, decreasing the entire duration of the procedure and x-ray exposure. No relevant differences were observed in terms of success rate and complications.

Heart transplant in a Sars-CoV-2 positive recipient: Management protocol of the world's first case.

The advent of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in China at the end of 2019 has developed into a global outbreak, and COVID- 19 is an ongoing major public health issue. During the pandemic, transplant programs had to devise strategies to deal with the possibility of COVID-19-positive donors and recipients. We describe the case of a heart transplant recipient who tested positive with the SARS- CoV2 swab upon admission to our Unit of Cardiac Surgery when a suitable donor became available. Given his clinical status of end-stage heart failure and the absence of imaging and clinical signs suggestive of COVID-19, and his having been vaccinated with three doses, we decided to proceed with the transplant.

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.

Oversampling and replacement strategies in propensity score matching: a critical review focused on small sample size in clinical settings.

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

Frozen Elephant Trunk to Exclude the Kommerell Diverticulum Associated with Double Aortic Arch in Adult Redo Patient.

Kommerell diverticulum can be associated to several types of vascular rings, including double aortic arch. Surgical indications for vascular rings and Kommerell diverticulum include bulging symptoms onto trachea and esophagus too. Moreover, the aneurysmal enlargement over time can eventually cause acute aortic syndromes. Management of this pathology in adulthood is challenging and many techniques have been proposed, notably hybrid solutions. Herein, we report the case of a patient, who underwent redo surgery with frozen elephant trunk technique, caused by persisting symptoms after a previous operation of vascular ring interruption.

From bench to bedside: Impact of left ventricular assist device outflow conduit anastomosis position on outcome.

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.

Biventricular assistance with 2 hm3 in a small chest patient: extra-pericardial implant.

We describe the clinical course and treatment of a 53-year-old female, with small chest dimensions, referred to our institution for a primary cardiogenic shock. The patient underwent an on-pump left ventricular assist-device (VAD) implantation with the aid of immediate post-operative paracorporeal right-VAD assistance for an acute right ventricular failure. After two unsuccessful weaning attempts, she underwent extrapericardial HM 3 RVAD implantation.

Fulminant myocarditis parvovirus B19 related in a young woman.

We present the case of a 18-year-old female with fulminant lymphocytic myocarditis caused by Parvovirus B19 (PVB19), successfully treated using temporary LVAD. In the literature there is no consensus on the surgical strategy. While some surgeons prefer to use a single device supporting only the LV, others prefer to start immediately with a biventricular supporting. At pre-procedural ultrasound evaluation, her anatomical features were not suitable for a percutaneous device such as the Impella. Thus, a temporary paracorporeal continuous flow LVAD was inserted. The heart recovery allowed LVAD removal 9 days after the implant.

How to evaluate the outflow tract of LVAD after minimally invasive implantation by 3D CT-scan.

During a minimally invasive implantation technique, the outflow graft of left ventricular assist device (LVAD) is tunnelled blindly through the pericardium or left pleura, with an inability to assess for twisting or malposition. Three-dimensional computed tomography scan (CT-scan) has a role in qualitative evaluation of the different outflow tract configurations. The different surgical minimally invasive approaches include: (a) mini-sternotomy and left mini-thoracotomy, (b) right mini-thoracotomy and left mini-thoracotomy, (c) subclavian artery access and left mini-thoracotomy. The outflow graft could be anastomosed to the left axillary artery or the ascending aorta. CT-scan reconstruction using syngo InSpace4D (Siemens, Muenchen, Germany) was used to provide fast segmentation and high-resolution images. The 3D reconstructions permit an evaluation of different anastomosis configurations and to assess the route of outflow graft.

COVID-19 infection in left ventricular assist device patients.

We describe two cases of favorable and unexpected recovery in positive patients with coronavirus disease 2019, suffering from multiorgan comorbidity and already assisted with the left ventricular assist device. We have observed that, although in the presence of more comorbidities, when the maintenance of a valid support of the cardiovascular function is guaranteed, the possibility of successfully overcoming the severe acute respiratory syndrome coronavirus 2 infection is still alive.

Use of rapid-deployment aortic valve prosthesis and patch reconstruction in complex endocarditis.

We describe the case of a 59-year-old female affected by aortic extensive endocarditis with communication between aortic annulus and right cavities, treated with double pericardial patch reconstruction and rapid-deployment aortic valve prosthesis implantation.

Left ventricle reconstruction and heartmate3 implantation. The "double patch technique".

BACKGROUND: HeartMate 3 is a left ventricular assist device, composed of a centrifugal pump. It can be applied as a myocardial recovery, a bridge to transplant, or a destination therapy, in the treatment of patients with left ventricular heart failure. METHODS: Herein we describe a technique applied against a giant aneurysmal dilatation, which combines a surgical device implantation and a left ventricular reconstruction using a double patch. RESULTS: The patch minimizes thrombotic risk thanks to its internal bovine pericardium layer, which is in contact with blood. CONCLUSIONS: The outlined technique is relatively reproducible and safe in a selected group of patients, as it employs a high-quality device and enables the restoration of an appropriate ventricular geometry.

Presentation Mode of Glycans Affect Recognition of Human Serum anti-Neu5Gc IgG Antibodies.

Recognition of carbohydrates by antibodies can be affected by antigen composition and density. This had been investigated in a variety of controllable multivalent systems using synthetic carbohydrate antigens, yet such effects on anticarbohydrate antibodies in circulating human serum have not been fully addressed thus far. All humans develop a polyclonal and diverse response against carbohydrates containing a nonhuman sialic acid form, N-glycolylneuraminic acid (Neu5Gc). This red meat-derived monosaccharide is incorporated into a diverse collection of human glycans resulting in circulating anti-Neu5Gc antibodies in human sera. Such antibodies can cause exacerbation of diseases mediated by chronic inflammation such as cancer and atherosclerosis. We aimed to evaluate how different presentation modes of Neu5Gc-glycans can affect the detection of anti-Neu5Gc IgGs in human serum. Here, we compare serum IgG recognition of Neu5Gc-containing glycoproteins, glycopeptides, and synthetic glycans. First, Neu5Gc-positive or Neu5Gc-deficient mouse strains were used to generate glycopeptides from serum glycoproteins. Then we developed a reproducible ELISA to screen human sera against Neu5Gc-positive glycopeptides for detection of human serum anti-Neu5Gc IgGs. Finally, we evaluated ELISA screens against glycopeptides in comparison with glycoproteins, as well as against elaborated arrays displaying synthetic Neu5Gc-glycans. Our results demonstrate that the presentation mode and diversity of Neu5Gc-glycans are critical for detection of the full collection of human serum anti-Neu5Gc IgGs.

Generation of cattle knockout for galactose-α1,3-galactose and N-glycolylneuraminic acid antigens.

Two well-characterized carbohydrate epitopes are absent in humans but present in other mammals. These are galactose-α1,3-galactose (αGal) and N-glycolylneuraminic acid (Neu5Gc) which are introduced by the activities of two enzymes including α(1,3) galactosyltransferase (encoded by the GGTA1 gene) and CMP-Neu5Gc hydroxylase (encoded by the CMAH gene) that are inactive in humans but present in cattle. Hence, bovine-derived products are antigenic in humans who receive bioprosthetic heart valves (BHVs) or those that suffer from red meat syndrome. Using programmable nucleases, we disrupted (knockout, KO) GGTA1 and CMAH genes encoding for the enzymes that catalyse the synthesis of αGal and Neu5Gc, respectively, in both male and female bovine fibroblasts. The KO in clonally selected fibroblasts was detected by polymerase chain reaction (PCR) and confirmed by Sanger sequencing. Selected fibroblasts colonies were used for somatic cell nuclear transfer (SCNT) to produce cloned embryos that were implanted in surrogate recipient heifers. Fifty-three embryos were implanted in 33 recipients heifers; 3 pregnancies were carried to term and delivered 3 live calves. Primary cell cultures were established from the 3 calves and following molecular analyses confirmed the genetic deletions. FACS analysis showed the double-KO phenotype for both antigens confirming the mutated genotypes. Availability of such cattle double-KO model lacking both αGal and Neu5Gc offers a unique opportunity to study the functionality of BHV manufactured with tissues of potentially lower immunogenicity, as well as a possible new clinical approaches to help patients with red meat allergy syndrome due to the presence of these xenoantigens in the diet.

A comparison of quality of life and psychological distress in heart transplantation patients at adult and pediatric ages.

BACKGROUND: The aim of the current study was to evaluate and compare the quality of life (QOL) and psychological status of adult patients who underwent heart transplant (HTx) at pediatric or adult ages. METHODS: The population consisted of two groups: patients who received HTx after 18 years old and pediatrics who received HTx between the age of 1 and 18 years. At the time of the study, all patients were over 18 years old. QOL data were collected from patients using 36-item Short-Form Health Survey (SF-36) and psychological distress by the Symptom checklist 90-revised questionnaire (SCL-90-R). RESULTS: A total of 232 HTx patients were evaluated; 217 were transplanted at an adult age and 15 at a pediatric one. QOL improved significantly in pediatrics patients in the general health perceptions subscale and physical pain subscale than adult patients. The Global Index of the psychological distress did not differ in the two groups, but the pediatric patients registered statistically significant higher scores on the interpersonal sensitivity symptom subscale (adult group 36 ± 0.42 vs pediatric group 81 ± 0.79), the hostility subscale (adult group m 39 ± 0.44 vs pediatric group 73 ± 0.76) and the paranoid ideation subscale (adult group 46 ± 0.46 vs pediatric group 96 ± 1.02). CONCLUSION: The pediatric heart recipients showed better quality of life, but they show marked sensitivity, hostility and paranoid ideation which increases the risk of mental distress and therefore their adherence to medical treatment.

Multicenter experience with the Evolution RL mechanical sheath for lead extraction using a stepwise approach: Safety, effectiveness, and outcome.

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.

Bilateral mini-thoracotomy approach for minimally invasive implantation of HeartMate 3.

Left ventricular assist devices (LVADs) are an established option for the treatment of end-stage heart failure. Last-generation devices are characterized by a miniaturized pump size, allowing for intra-pericardial placement. This feature enabled the introduction of less-invasive implantation techniques, which have been linked to many favorable effects. The HeartMate 3 LVAD is a continuous-flow centrifugal pump, recently introduced for clinical use. Here, we describe the minimally invasive implantation of the HeartMate 3 through a bilateral mini-thoracotomy.