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Background : The present study evaluates outcomes of LVAD patients, taking into account the device strategy and the INTERMACS profile. Methods: We included 192 LVAD-patients implanted between January 2012 and May 2021. The primary and secondary end-points were survival and major adverse events between Profiles 1-3 vs. Profile 4, depending on implantation strategies (Bridge-to-transplant-BTT; Bridge-to-candidacy-BTC; Destination-Therapy-DT). Results: The overall survival was 67% (61-75) at 12 months and 61% (54-70) at 24 months. Profile 4 patients showed significantly higher survival ( p = 0.018). Incidences of acute right-ventricular-failure (RVF) ( p = 0.046), right-ventricular-assist-device (RVAD) implantation ( p = 0.015), and continuous-venovenous-hemofiltration (CVVH) ( p = 0.006) were higher in Profile 1-3 patients, as well as a longer intensive care unit stays ( p = 0.050) and in-hospital-mortality ( p = 0.012). Twelve-month and 24-month survival rates were higher in the BTT rather than in BTC (log-rank = 0.410; log-rank = 0.120) and in DT groups (log-rank = 0.046). In the BTT group, Profile 1-3 patients had a higher need for RVAD support ( p = 0.042). Conclusions: LVAD implantation in elective patients was associated with better survival and lower complications incidence. LVAD implantation in BTC patients has to be considered before their conditions deteriorate. DT should be addressed to elective patients in order to guarantee acceptable results.

(1) Objectives: The aim of this study was to investigate the impact of the prolonged use of continuous-flow left ventricular assist devices (LVADs) on heart transplant (HTx) candidates. (2) Methods: Between January 2012 and December 2019, we included all consecutive patients diagnosed with end-stage heart failure considered for HTx at our institution, who were also eligible for LVAD therapy as a bridge to transplant (BTT). Patients were divided into two groups: those who received an LVAD as BTT (LVAD group) and those who were listed without durable support (No-LVAD group). (3) Results: A total of 250 patients were analyzed. Of these, 70 patients (28%) were directly implanted with an LVAD as BTT, 11 (4.4%) received delayed LVAD implantation, and 169 (67%) were never assisted with an implantable device. The mean follow-up time was 36 ± 29 months. In the multivariate analysis of survival before HTx, LVAD implantation showed a protective effect: LVAD vs. No-LVAD HR 0.01 (p < 0.01) and LVAD vs. LVAD delayed HR 0.13 (p = 0.02). Mortality and adverse events after HTx were similar between LVAD and No-LVAD (p = 0.65 and p = 0.39, respectively). The multi-state survival analysis showed a significantly higher probability of death for No-LVAD vs. LVAD patients with (p = 0.03) or without (p = 0.04) HTx. (4) Conclusions: The use of LVAD as a bridge to transplant was associated with an overall survival benefit, compared to patients listed without LVAD support.

Background: In this study, we assessed the mid-term outcomes of patients who received a heart donation from a marginal donor (MD), and compared them with those who received an organ from a standard donor (SD)., Methods: All patients who underwent HTx between January 2012 and December 2020 were enrolled at a single institution. The primary endpoints were early and long-term survival of MD recipients. Risk factors for primary graft failure (PGF) and mortality in MD recipients were also analyzed. The secondary endpoint was the comparison of survival of MD versus SD recipients., Results: In total, 238 patients underwent HTx, 64 (26.9%) of whom received an organ from an MD. Hospital mortality in the MD recipient cohort was 23%, with an estimated 1 and 5-year survival of 70% (59.2-82.7) and 68.1% (57.1-81), respectively. A multivariate analysis in MD recipients showed that decreased renal function and increased inotropic support of recipients were associated with higher mortality ( p = 0.04 and p = 0.03). Cold ischemic time ( p = 0.03) and increased donor inotropic support ( p = 0.04) were independent risk factors for PGF. Overall survival was higher in SD than MD (85% vs. 68% at 5 years, log-rank = 0.008). However, risk-adjusted mortality ( p = 0.2) and 5-year conditional survival (log-rank = 0.6) were comparable., Conclusions: Selected MDs are a valuable resource for expanding the cardiac donor pool, showing promising results. The use of MDs after prolonged ischemic times, increased inotropic support of the MD or the recipient and decreased renal function are associated with worse outcomes.

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., (© 2021. The Author(s).)

Perceval S is a self-expandable, stent-mounted bioprosthetic valve (BPV), with glutaraldehyde treated bovine pericardium, processed with homocysteic acid as an anti-calcification treatment. The stent is crimpable but the valve insertion is done surgically via a shorter procedure which does not require sutures. OBJECTIVES: MATERIAL AND METHODS: RESULTS: CONCLUSIONS: Collapsing and ballooning do not alter cusp collagen periodicity. Structural valve deterioration with stenosis, due to dystrophic calcification and fibrous tissue overgrowth, seldom occurred in the mid-term. Glutaraldehyde fixed pericardium has the potential to undergo structural valve deterioration with time, similar to well-known BPV failure. This supports the recommendation to pursue improvement of tissue valve treatment with enhanced durability., (Copyright © 2021 Elsevier B.V. All rights reserved.)

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.

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., (© 2020 International Center for Artificial Organs and Transplantation and Wiley Periodicals LLC.)

Introduction: Severe spontaneous bleeding is a significant complication in patients with continuous flow left ventricular assist devices; there is little evidence on endovascular treatment to support its use., Materials and Methods: We observed seven patients (five men, two women, age 43-67 years) with continuous flow left ventricular assist devices on antiaggregant/coagulant therapy, admitted to our hospital for uncorrectable symptomatic anemia; CT-angiography and diagnostic angiography confirmed the presence of atraumatic arterious bleeding from the gastrointestinal tract (six patients), from the intercostal artery and from the bronchial tree (one patient)., Results: All patients where successfully treated via an endovascular approach with superselective embolization of the involved arterial branches with coils and particles., Conclusion: Spontaneous atraumatic bleeding is a frequent complication in patients with continuous flow left ventricular assist devices; endovascular treatment represents a promising alternative to the surgical approach as it is less invasive, easily repeatable and associated to a reduced procedural risk.

The post-auricular (PA) driveline positioning for percutaneous power delivery is a specific feature of the Jarvik 2000 FlowMaker LVAD. We applied several technical refinements to optimise the PA implant. Here, we present and discuss these modifications. We retrospectively reviewed all patients implanted with Jarvik 2000 at our Institution. Different PA implant techniques were described. A machine learning analysis was performed to evaluate the determinants of driveline infection. From December 2008 to December 2017, 62 patients were implanted with Jarvik 2000, at our Institution. The PA connection was managed through the "question mark-shaped" incision in 24 patients (39%) and with the "C-shaped" in 18 (29%), whereas 10 (16%) cases received the "vertical incision" and 10 (16%) the "orthogonal incision". The implant technique resulted highly predictive of driveline infection. The rate of driveline infections was numerically lower among cases managed with the last two techniques. After evolving through different implant techniques, we propose and suggest the "orthogonal incision" to maximise the advantages of the Jarvik 2000 post-auricular driveline.

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., (© 2018 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.)

In this work we aimed to evaluate the evolution of our surgical experience with the implantation of a continuous flow left ventricular assist device (LVAD), from the original full sternotomy approach to less invasive surgical strategies including mini-sternotomy and/or mini-thoracotomies. We reviewed all consecutive patients implanted with a continuous flow LVAD at our Institute. To exclude the possible bias related to the device used, out of 91 collected LVADs implants, we selected only those patients (n = 42) who received, between 2012 and 2015, the HeartWare HVAD. The analysis focused on the surgical approach used for the LVAD implant. Most of the patients (95%) were affected by dilated or ischemic cardiomyopathy, with an INTERMACS class I-II in the majority of cases (77%). The LVAD implant was performed through a full sternotomy in 10 patients (24%); the remaining 32 cases (76%) were managed with minimally invasive procedures. These were left mini-thoracotomy with upper mini-sternotomy (20 patients, 62%), right and left mini-thoracotomy (7 patients, 22%), and a recently developed left mini-thoracotomy with outflow graft anastomosis to the left axillary artery (5 patients, 16%). The most common adverse event on device was right heart failure (26%). Eighteen patients (43%) were transplanted. Overall estimated 24 months survival (on device or after transplant) was 68 ± 7%. The causal analysis, adjusted by propensity score weighting baseline data and sample size, showed that left mini-thoracotomy with outflow anastomosis to the left axillary artery resulted in a significantly reduced rate of post implant right heart failure (P < 0.01), and mechanical ventilation time (P = 0.049). To conclude, in our series, by applying mini-invasive implant techniques in the majority of cases, mid-term survival of continuous flow LVADs in severely compromised patients was satisfactory. In the adjusted analysis, the left anterior mini-thoracotomy with outflow anastomosis to the left axillary artery showed the most favorable results., (© 2018 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.)

Aims: We analysed the outcomes with the use of a new-generation continuous-flow left ventricular assist device (CF-LVAD) as a bridge-to-transplant (BTT)., Materials and Methods: We included all patients implanted with an intrapericardial CF-LVAD as BTT, between January 2012 and December 2016. Primary outcomes were overall survival, survival on waiting list and postheart transplant (HTx) survival. The outcomes after HTx were compared with those of a contemporary cohort of patients transplanted without previous CF-LVAD (No-LVAD group, n = 73)., Results: We included 53 patients with a median age of 52 years (interquartile range: 43-59 years). Seventy-two percent were in INTERMACS profile 1-2 before implant; all entered the HTx waiting list after receiving the CF-LVAD. HTx was performed in 42 (79%) cases (LVAD group). Overall estimated survival (considering both pre-HTx and post-HTx) was 89% [95% confidence interval (CI) 81-98%] at 1 year and 80% (CI 70-92%) at 2 years. The estimated survival on waiting list was 91% (CI 80-100%) at 6 months, whereas the 1-year estimated post-HTx survival was 88% (CI 79-98%). The Kaplan-Meier curves of survival after HTx of LVAD versus No-LVAD group were comparable (log-rank P = 0.54), as well as the rates of post-HTx adverse events. A multivariable model of survival after HTx, accounting for the most relevant patient characteristics, identified LVAD use as a significant protective factor [LVAD versus No-LVAD hazard ratio 0.22 (CI 0.06-0.91)]., Conclusion: The use of new-generation intrapericardial CF-LVADs as a BTT resulted, in our series, in satisfactory pre-HTx and post-HTx outcomes.

Background: Increasing left ventricular assist device (LVAD) pump speed according to the patient's activity is a fascinating hypothesis. This study analyzed the short-term effects of LVAD speed increase on cardiopulmonary exercise test (CPET) performance, muscle oxygenation (near-infrared spectroscopy), diffusion capacity of the lung for carbon monoxide (Dlco) and nitric oxide (Dlno), and sleep quality., Methods: We analyzed CPET, Dlco and Dlno, and sleep in 33 patients supported with the Jarvik 2000 (Jarvik Heart Inc., New York, NY). After a maximal CPET (n = 28), patients underwent 2 maximal CPETs with LVAD speed randomly set at 3 or increased from 3 to 5 during effort (n = 15). Then, at LVAD speed randomly set at 2 or 4, we performed (1) constant workload CPETs assessing O 2 kinetics, cardiac output (CO), and muscle oxygenation (n = 15); (2) resting Dlco and Dlno (n = 18); and (3) nocturnal cardiorespiratory monitoring (n = 29)., Results: The progressive pump speed increase raised peak volume of oxygen consumption (12.5 ± 2.5 ml/min/kg vs 11.7 ± 2.8 ml/min/kg at speed 3; p = 0.001). During constant workload, from speed 2 to 4, CO increased (at rest: 3.18 ± 0.76 liters/min vs 3.69 ± 0.75 liters/min, p = 0.015; during exercise: 5.91 ± 1.31 liters/min vs 6.69 ± 0.99 liters/min, p = 0.014), and system efficiency (τ = 65.8 ± 15.1 seconds vs 49.9 ± 14.8 seconds, p = 0.002) and muscle oxygenation improved. At speed 4, Dlco decreased, and obstructive apneas increased despite a significant apnea/hypopnea index and a reduction of central apneas., Conclusions: Short-term LVAD speed increase improves exercise performance, CO, O 2 kinetics, and muscle oxygenation. However, it deteriorates lung diffusion and increases obstructive apneas, likely due to an increase of intrathoracic fluids. Self-adjusting LVAD speed is a fascinating but possibly unsafe option, probably requiring a monitoring of intrathoracic fluids., (Copyright © 2018 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Different left ventricular assist devices (LVADs) are provided of different driveline exit sites: HeartWare HVAD presents abdominal power-cable-supply, while the Jarvik 2000 LVAD is powered by a retroauricular driveline. We analyzed 93 LVAD-implanted patients from January-2009 to October-2016 (41 HeartWare and 52 Jarvik 2000), hypothesizing a different incidence of infection, according to driveline exit site. The two populations were propensity matched for the demographic data and preoperative variables, and the outcomes were further analyzed. Nine driveline infections (DLIs) were in each LVAD group recorded (22% for HVAD and 17% for Jarvik 2000). The incidence of the complication was similar between groups (p = 0.97), even during time (p = 0.27 within 6 months and p = 0.16 over 6 months of support). Age at implant (p = 0.01), revision for bleeding (p = 0.05), days of postoperative intubation (p = 0.002), and ICU stay (p < 0.001), as well as days on device (p < 0.001) were identified as risk factors for DLIs. The type of device and the driveline exit site were not statistically co-related to infections. Similar infection-freedom survival was identified (p = 0.87). Younger age at implant, revision for bleeding, prolonged mechanical ventilation, delayed rehabilitation, as well as long time LVAD support were identified as risk factors for exit site DLIs. Despite similar incidence of DLIs, the different management and care of the retroauricular exit site makes it more appropriate and comfortable in long-term support.

Background: The aim of our study was to compare 2 surgical and anesthetic approaches during ventricular assist device implantation., Methods: 68 patients (50.4 ± 17.1 years old) were supported with the HeartWare® HVAD (32 patients) and the Jarvik 2000 VAD (36 patients) between January 2010 and August 2016. Two surgical techniques were applied: a minimally invasive approach with the aid of paravertebral-block (mini-invasive group, 41 patients) and a standard-surgical-approach with the aid of general anesthesia (27 patients)., Results: The minimally invasive approach allowed faster postoperative recovery by significantly reducing the duration of surgery (p<0.05), anesthesia (p<0.05), mechanical ventilation (p<0.05), inotropic support (p<0.05), ICU and in-hospital stay (p<0.05), and time to first mobilization (p<0.05). No case of epidural hematoma was observed. Eleven patients died (16%) at 30 days, 3 in the mini-invasive group (7.3%) and 8 in the invasive group (29.6%)., Conclusions: Minimally invasive approaches play a substantial role in VAD surgery by facilitating faster recovery, which is important for patients at very high risk.

Backgrounds: Peak exercise cardiac output (CO) increase is associated with an increase of peak oxygen uptake (VO 2 ), provided that arteriovenous O 2 difference [Δ(Ca-Cv)O 2 ] does not decrease. At anaerobic threshold, VO 2 , is related to CO. We tested the hypothesis that, in heart failure (HF) patients with left ventricular assistance device (LVAD), an acute increase of CO obtained through changes in LVAD pump speed is associated with peak exercise and anaerobic threshold VO 2 increase., Methods: Fifteen of 20 patients bearing LVAD (Jarvik 2000) enrolled in the study successfully performed peak exercise evaluation. All patients had severe HF as shown by clinical evaluation, laboratory tests, echocardiography, spirometry with alveolar-capillary diffusion, and maximal cardiopulmonary exercise testing (CPET). CPETs with non-invasive CO measurements at rest and peak exercise were done on 2days at LVAD pump speed set randomly at 2 and 4., Results: Increasing LVAD pump speed from 2 to 4 increased CO from 3.4±0.9 to 3.8±1.0L/min (ΔCO 0.4±0.6L/min, p=0.04) and from 5.3±1.3 to 5.9±1.4L/min (ΔCO 0.6±0.7L/min, p<0.01) at rest and peak exercise, respectively. Similarly, VO 2 increased from 788±169 to 841±152mL/min (ΔVO 2 52±76mL/min, p=0.01) and from 568±116 to 619±124mL/min (ΔVO 2 69±96mL/min, p=0.02) at peak exercise and at anaerobic threshold, respectively. Δ(Ca-Cv)O 2 did not change significantly, while ventilatory efficiency improved (VE/VCO 2 slope from 39.9±5.4 to 34.9±8.3, ΔVE/VCO 2 -5.0±6.4, p<0.01)., Conclusions: In HF, an increase in CO with a higher LVAD pump speed is associated with increased peak VO 2 , postponed anaerobic threshold, and improved ventilatory efficiency., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

The benefits of total arterial (TAR) versus conventional (CR) revascularization are controversial in the higher-risk cohort of elderly patients. Taking for granted its benefit on long-term survival, we evaluated the effect of TAR on safety (death, myocardial infarction, and stroke) of patients undergoing CABG. Between 2000 and 2009, 487 patients >75 years underwent isolated CABG at our institution (150 TAR and 337 CR). Patients with arterial free-grafts were excluded. After propensity matching, the outcomes of 131 TAR and 127 CR patients were compared. TAR patients had lower incidence of post-operative myocardial infarction (p = 0.025) and stroke (p = 0.005). They also experienced shorter intensive care unit (p = 0.046) and ward stay (p = 0.028), lower output of TnI (p = 0.035), and less wound complications (leg included) (p = 0.0001), while mortality was comparable (p = 0.57). In our cohort of elderly patients with multivessel disease, TAR was associated with lower rates of myocardial infarction, stroke, and shorter hospital stay.

We describe the surgical technique and treatment of a 59-year-old male with cardiogenic shock, who underwent a minimally invasive off-pump ventricular assist device (VAD) implantation with the aid of paravertebral regional analgesia in bilateral mini-thoracotomies as first procedure described in the literature. He was extubated soon after the procedure, in the operating room, with the aim to reduce the right ventricle impairment. These issues are particularly true for patients suffering from pulmonary hypertension and disease, in whom the shortest time of postoperative intubation is fundamental to allow self-inotropic support and recovery of the right ventricle. We illustrate how a minimally invasive implant may improve the clinical outcomes of VAD patients shortening their return time to active life.

The Jarvik 2000 is a left ventricular assist device (LVAD) used as either a bridge-to-transplant or destination therapy with the possibility of retroauricular percutaneous power delivery (pedestal). Percutaneous driveline infection in LVAD is a life-threatening complication that affects both the quality and length of life in patients. With its rigid fixation to the bone, the pedestal and the vascularity of scalp skin promote healing and reduce the risk of driveline infection. We describe a technique to remove the skull-mounted percutaneous pedestal of the Jarvik 2000 after heart transplantation.

Objective: In vitro tests demonstrated that the new cone-bearing configuration of the Jarvik 2000 (Jarvik Heart Inc, New York, NY) left ventricular assist device exhibits better hydraulic efficiency than the previous pin-bearing design. We investigated the long-term outcomes of patients who received the Jarvik 2000 left ventricular assist device, depending on bearing design., Methods: A retrospective review of prospectively collected data from 18 centers included in the Italian Registry was performed. From May 2008 to September 2013, 99 patients with end-stage heart failure were enrolled. Patients were divided into 2 groups according to their Jarvik 2000 suspending mechanism: Group pin included patients with pin bearings (May 2008 to June 2010), and group cone included patients with newer cone bearings (July 2010 to September 2013). The 2 groups did not differ significantly in terms of baseline characteristics., Results: A total of 30 of 39 patients (group pin) and 46 of 60 patients (group cone) were discharged. During follow-up, 6 patients underwent transplantation, and in 1 patient the left ventricular assist device was explanted. The cumulative incidence competing risk of the entire cohort for noncardiovascular-related death was 28% (20%-40%); the cumulative incidence competing risk for cardiovascular-related death was 56% (42%-73%): 71% in group pin versus 26% in group cone (P = .034). The multivariate analyses confirmed that the pin-bearing design was a risk factor for cardiovascular death, along with Interagency Registry for Mechanically Assisted Circulatory Support class. Right ventricular failures and ischemic and hemorrhagic strokes were significantly higher in group pin., Conclusions: Patients with the new pump configuration showed a better freedom from cardiovascular death and lower incidence of fatal stroke and right ventricular failure. Further studies are needed to prove the favorable impact of pump-enhanced fluid dynamics on long-term results., (Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

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.

We describe a modified implantation technique for the HeartWare ventricular assist device. We access the apex through a left minithoracotomy. The outflow graft is tunneled through a small incision in the fourth intercostal space and then subcutaneously to the subclavian region. After division of the left axillary artery, an end-to-end anastomosis is performed to the proximal part, and the distal vessel is connected end-to-side through a fenestration in the outflow graft. We believe that this technique, particularly suitable for redo scenarios or severely calcified aorta, achieves a more direct blood flow into the aorta and reduces cerebrovascular events while avoiding excessive flow to the arm., (Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Therapy with mechanical ventricular assist devices (VADs) in severe heart failure, open to discussion decades ago, is now well established for temporary or long-term support. The typical VAD candidate is very compromised and may not have sufficient resources to tolerate major surgical insults and trauma. Therefore, device implantation through smaller, less traumatic incisions is a desirable goal. The median sternotomy decreases lung volumes and reduces thoracic motion with a significant decrease in functional residual capacity and total lung capacity months later. Minimally invasive cardiac surgery was devised to reduce morbidity because of its potentially less inflammatory response, reduced transfusion requirements and minimal scarring with consequent rapid rehabilitation to normal life activity. Additionally, avoiding cardiopulmonary circulatory support (CPB) even for a short period might reduce the release of inflammatory cytokines and their consequences, as most CPB-related damage happens within the first few minutes. We describe the tricks and traps of minimally invasive approach during VAD implantation, by associating mini-anterior left thoracotomy in the fifth intercostal space with a mini-anterior right thoracotomy in the second intercostal space, without the aid of CPB in paravertebral block regional analgesia combined with mild general anasthesia., (© The Author 2015. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

A 41-year-old-male with diagnosis of dilated cardiomyopathy was referred to our hospital for heart failure, despite standard medical therapy, to evaluate indications for heart transplantation or mechanical cardiac support. Preoperative contrast computer tomography (CT) scan diagnosed pulmonary thrombosis of the left branch of the pulmonary artery. Treatment with low molecular weight heparin was established and the next day a thrombus-arteriectomy and Heartware (Heartware, Framingham, MA, USA) left ventricular assist device (LVAD) implantation were performed simultaneously. The patient was discharged home with oral anticoagulant and antiplatelet therapy, according to our center's VAD protocol. Currently, the patient has been assisted with the LVAD for the past 24 months. The CT scan confirmed the absence of pulmonary artery thrombosis.

Background: The role of extracorporeal life support (ECLS) in primary cardiogenic shock (PCS) is well established. In this study, we evaluated the impact of etiology on outcomes., Methods: Between January 2009 and March 2013, we implanted a total of 249 patients with ECLS; we focused on 64 patients for whom peripheral ECLS was the treatment for PCS. Of these, 37 cases (58%) were "acute" (mostly acute myocardial infarction: 39%); 27 (42%) had an exacerbation of "chronic" heart failure (dilated cardiomyopathy: 30%; post-ischemic cardiomyopathy: 9%; and congenital: 3%)., Results: In the group with chronic etiology, 23 patients were bridged to a left ventricular assist device (52%) or heart transplantation (33%). In the group with acute etiology, ECLS was used as a bridge-to-transplantation in 3 patients (8%), a bridge-to-bridge in 9 (24%), and a bridge-to-recovery in 18 (49%). One patient in each group was bridged to conventional surgery. Recovery of cardiac function was achieved in only the group with acute primary cardiogenic shock (18 vs 0 patients, P = .0001). A mean flow during support of ≤60% of the theoretic flow (body surface area × 2.4) was a predictor of successful weaning (P = .02). Median duration of ECLS support was 7 days (range: 2-11.5 days). Nine patients (14%) died during support; 30-day overall survival was 80% (51 of 64 patients); and 59% of patients were discharged, in whom survival at 48 months was 90%. Thirty-day survival was correlated with duration of ECLS support., Conclusions: In "chronic" heart failure, ECLS represents a bridge to a ventricular assist device or heart transplantation, whereas in "acute" settings, it offers a considerable chance of recovery, and is often the only required therapy., (Copyright © 2015 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Recombinant activated factor VII (rFVIIa) is currently approved for treating or preventing hemorrhage in patients with hemophilia, Glanzmann's thrombasthenia, or congenital FVII deficiency. Its "off-label" use for massive bleeding in the setting of trauma or surgery has been increasing because of demonstrated efficacy. However, the use of rFVIIa also carries a high thrombo-embolic risk. This is particularly true in cardiac surgery patients, especially those treated with mechanical circulatory support. We describe the case of a patient treated with a biventricular assist device in our center, in whom severe bleeding was treated in a targeted manner, using rotational thromboelastometry to guide administration and dosing of rFVIIa. A comprehensive review of the emerging literature on the use of rFVIIa postventricular assist device implantation accompanies the case to highlight the need for careful selection of prohemostatic agents in this high-risk group., (Copyright © 2014 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.)

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.

Background: Much of the morbidity and mortality associated with ventricular assist devices (VADs) is due to haemorrhagic and thrombotic complications. To manage antithrombotic therapy, interactions between the patient and pump should be better understood., Methods: We have compared the Jarvik 2000, an axial flow left ventricular assist device (LVAD), with the HeartWare ventricular assist device (HVAD) centrifugal pump, regarding conventional laboratory findings, thromboelastometric and aggregometric tests., Results: Patients with the Jarvik 2000 experienced a significant reduction in platelet count following implantation, a phenomenon not seen with the HeartWare model. Conversely, we observed that levels of platelet activation, as assessed by a platelet function analyzer, and activation of the coagulation system, as assessed by thromboelastometry, were significantly greater in the HeartWare group., Conclusions: It seems that axial flow pumps, being more destructive on blood cells, tend to reduce platelet numbers. On the other hand, centrifugal flow is associated with a hypercoagulable state, possibly resulting from the activation of the coagulation system in the absence of platelet destruction.

We describe the clinical course and treatment of a 58-year-old male with a primary cardiogenic shock, who underwent a minimally invasive off-pump ventricular-assist-device (VAD) implantation with the aid of paravertebral regional analgesia. He was extubated soon after the procedure, in the operating room, with the aim to reduce the right ventricle impairment. We illustrate how a minimally invasive implant may improve the clinical outcomes of VAD patients shortening their return time to active life.

Carvajal syndrome is a variant of Naxos disease characterized by a predominant left ventricular involvement, wooly or curly hair, and palmoplantar keratoderma or similar skin disorders. We describe the clinical and therapeutic course of a 14-year old boy affected by this syndrome, in whom a progressive biventricular failure developed at 13 years of age. The patient was hospitalized in the pediatric department 3 months earlier after the onset of cardiac arrhythmias and he critically worsened with signs and symptoms of biventricular cardiac failure. Over massive inotropic agent infusion, the patient was transferred to our intensive-care-unit in order to be haemodinamically stabilized with a ventricular assist device (VAD) and thereafter transplanted.

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., (© The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

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., (Copyright © 2012 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: Age-related degenerative heart-valve disease is a health issue in the present era. Octogenarians are frequently affected by concomitant diseases and, with the present lack of resources, the risk/benefit of valvular replacement therapy poses serious medical, economical and political challenge. We analysed the long-term survival of 346 octogenarians who underwent 352 operations between 1 January 1987 and 1 January 2009 and we compared it with the survival of the general population, matched for age, sex and operative year., Methods: The total follow-up was of 1352 years, maximum 15.7 years and was nearly complete except for a single foreigner. Heart diseases, concomitant pathologies, complications and actuarial survival of this study group were compared with 4649 younger counterparts, who received 5416 operations during the same time frame. Octogenarians were sorted by age, sex and operative year and the expected survival was calculated by applying US survival rate and added to the Kaplan-Meier plot for visual comparison., Results: A total of 279 aortic, 38 mitral and 35 mitro-aortic valves were replaced or repaired using 357 bioprostheses, 18 mechanical prostheses, 12 reparative operations and 24 re-operations. A total of 75% of patients were younger than 84 years, 95% were younger than 87 years and 99% younger than 90 years. Sex prevalence was 215 female versus 131 male. Operative (30 days) mortality was 5.5% and overall survival was 84.3% at 1 year, 65.4% at 5 years, 27.3% at 10 years and 5.4% at 15 years. The expected survival of the age-, sex-, operative year-matched population was 26.9% at 10 years and 7.9% at 15 years. Female operative mortality was 5.9% and survival was respectively 86.3%, 70.2%, 27.5% and 9.1%, male mortality was 4.5% and survival was respectively 81%, 56.7%, 28.8% and 0% (p=0.16). Expected female survival was 30% at 10 years and 10% at 15 years versus 22% and 5.6%, respectively, in males. Six octogenarians underwent re-operation, with one death., Conclusions: Despite the highest prevalence of concomitant diseases and the requirement of additional resources for the detection and neutralisation of risk factors, heart-valve operations in octogenarians offer excellent results that compare favourably with the expected survival of the age-, sex- and operative year-matched population, particularly after primary operations., (Copyright 2009 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.)