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.

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.

Comparison of Efficacy and Cost of Iodine Impregnated Drape vs. Standard Drape in Cardiac Surgery: Study in 5100 Patients.

We sought to examine the efficacy in preventing surgical site infection (SSI) in cardiac surgery, using two different incise drapes (not iodine-impregnated and iodine-impregnated). A cost analysis was also considered. Between January 2008 and March 2015, 5100 consecutive cardiac surgery patients, who underwent surgery in our Institute, were prospectively collected. A total of 3320 patients received a standard not iodine-impregnated steri-drape (group A), and 1780 patients received Ioban(®) 2 drape (group B). We investigated, by a propensity matched analysis, whether the use of standard incise drape or iodine-impregnated drape would impact upon SSI rate. Totally, 808 patients for each group were matched for the available risk factors. Overall incidence of SSI was significantly higher in group A (6.5 versus 1.9 %) (p = 0.001). Superficial SSI incidence was significantly higher in group A (5.1 vs 1.6 %) (p = 0.002). Deep SSI resulted higher in group A (1.4 %) than in group B (0.4 %), although not significantly (p = 0.11). Consequently, the need for vacuum-assisted closure (VAC) therapy use resulted 4.3 % in group A versus 1.2 % in group B (p = 0.001). Overall costs for groups A and B were 12.494.912 € and 11.721.417 €, respectively. The Ioban(®) 2 offered totally 773.495 € cost savings compared to standard steri-drape. Ioban 2 drape assured a significantly lower incidence of SSI. Additionally, Ioban(®) 2 drape proved to be cost-effective in cardiac surgery.

Nitinol flexigrip sternal closure system and standard sternal steel wiring: insight from a matched comparative analysis.

OBJECTIVE: We sought to assess the efficiency of two different sternal closure techniques in preventing sternal wound instability in high-risk patients. MATERIALS AND METHODS: Between January 2009 and February 2012, 2068 consecutive cardiac patients were prospectively collected in our database. The 561 patients in whom the thermoreactive nitilium clips (Flexigrip) have been used (group A) were matched 1 : 1 with 561 patients who received a standard parasternal wiring technique (group B) on 10 available risk factors known to affect sternal wound healing (age, age >75 years, sex, diabetes mellitus, cardiac procedure, obesity, re-intervention, cross-clamp, and total operative times). The study was completed with a cost analysis. RESULTS: The two groups were well matched, although different for bilateral internal thoracic harvesting, chronic obstructive pulmonary disease, renal insufficiency, and congestive heart failure, which were significantly more frequent in group A. At 30 days of follow-up, the association of wound complication and sternal instability was significantly less frequent in group A versus group B (0.2 versus 1.6%) (P = 0.04). Overall incidence of sternal wound complication was lower in group A (2 versus 3.5%) (P = 0.28). In the presence of wound infection, a sternal wound instability was never observed in group A (P = 0.06). Overall costs were €8,701,854 and €9,243,702 in groups A and B, respectively; thus the Flexigrip closure technique offered a €541,848 cost saving. CONCLUSIONS: Flexigrip use in high-risk patients showed a lower incidence of sternal wound instability with no need for sternal re-wiring in any case, even in the presence of wound infection.

Impact of vacuum-assisted closure therapy on outcomes of sternal wound dehiscence†.

OBJECTIVES: Sternal wound dehiscence (SWD) after cardiac surgery is a rare but serious condition associated with considerable costs and morbidity. We sought to evaluate the results of the introduction of vacuum-assisted closure (VAC) therapy in the management of sternal wound dehiscence, compared with those of previous conventional treatments. METHODS: We retrospectively collected 7148 patients who underwent cardiac surgery at our institution between January 2002 and June 2012. A total of 152 (2.1%) patients had a sternal wound dehiscence: 107 were treated with conventional treatments (Group A) and 45 were managed with VAC therapy (Group B). Patients were stratified according to preoperative risk factors and type of sternal wound dehiscence (superficial or deep; infected or not) and compared by means of a propensity-matched analysis. A cost analysis was also performed. RESULTS: Forty-five patients of each group matched for all preoperative risk factors and type of sternal wound dehiscence. SWD-related mortality rate was significantly lower in Group B (11 vs 0%; P = 0.05). Incidence of mediastinitis (P < 0.0001), sepsis (P = 0.04), delayed SWD infection (P = 0.05), other complication (P = 0.05), surgical sternal revision (P = 0.04) and surgical superficial revision (P < 0.0001) were all significantly lower in Group B. Mean patient cost was 31 106€ in Group A and 24 383€ in Group B, thus achieving a mean saving of 6723€ per patient. CONCLUSIONS: In our experience, the use of VAC therapy for the management of SWD was considerably effective in decreasing mortality (SWD related), incidence of complications and need for surgical procedures; thus, leading to a significant reduction of costs.

Nitinol flexigrip sternal closure system and chest wound infections: insight from a comparative analysis of complications and costs.

BACKGROUND: We sought to assess the efficiency of two different sternal closure techniques in preventing sternal wound complications (SWC). A cost analysis was also considered. METHODS: Between January 2008 and April 2010, 1,644 consecutive cardiac surgery patients who underwent cardiac surgery in our institute were prospectively collected. A total of 1,072 patients received a standard parasternal wiring technique (group A), and 572 patients received a new method of sternal closure based on the use of thermoreactive nitillium clips (Flexigrip; Praesidia SRL, Bologna, Italy [group B]). We investigated, by a propensity matched analysis, whether the use of standard or nitinol clip closure would impact on sternal wound outcome. RESULTS: In all, 464 patients of each group were matched for 17 available risk factors. Overall incidence of SWC was significantly higher in group A (4.1% versus 1.7%; p=0.03). Sternal surgical revision to treat a thoracic instability was required in a significantly higher number of patients in group A (9 patients, 1.9%) and in none of group B (p=0.004). The incidence of sternal instability, secondary to wound infection, was significantly lower in group B (p=0.05). Overall costs were €7,407,296 and €6,896,432 in group A and group B, respectively. Thus, nitinol clip closure technique offered a €510,864 cost saving compared with standard steel wiring technique. CONCLUSIONS: The Flexigrip assured a lower incidence of SWC. The use of the nitinol clip favored an improved sternal closure technique preventing mediastinitis. Additionally, the nitinol clip system proved to be cost effective in cardiac surgery.