Corrigendum: Five-Year Outcome After Continuous Flow LVAD With Full-Magnetic (HeartMate 3) Versus Hybrid Levitation System (HeartWare): A Propensity-Score Matched Study From an All-Comers Multicentre Registry.

[This corrects the article DOI: 10.3389/ti.2023.11675.].

Five-Year Outcome After Continuous Flow LVAD With Full-Magnetic (HeartMate 3) Versus Hybrid Levitation System (HeartWare): A Propensity-Score Matched Study From an All-Comers Multicentre Registry.

Despite the withdrawal of the HeartWare Ventricular Assist Device (HVAD), hundreds of patients are still supported with this continuous-flow pump, and the long-term management of these patients is still under debate. This study aims to analyse 5 years survival and freedom from major adverse events in patients supported by HVAD and HeartMate3 (HM3). From 2010 to 2022, the MIRAMACS Italian Registry enrolled all-comer patients receiving a LVAD support at seven Cardiac Surgery Centres. Out of 447 LVAD implantation, 214 (47.9%) received HM3 and 233 (52.1%) received HVAD. Cox-regression analysis adjusted for major confounders showed an increased risk for mortality (HR 1.5 [1.2-1.9]; p = 0.031), for both ischemic stroke (HR 2.08 [1.06-4.08]; p = 0.033) and haemorrhagic stroke (HR 2.6 [1.3-4.9]; p = 0.005), and for pump thrombosis (HR 25.7 [3.5-188.9]; p < 0.001) in HVAD patients. The propensity-score matching analysis (130 pairs of HVAD vs. HM3) confirmed a significantly lower 5 years survival (81.25% vs. 64.1%; p 0.02), freedom from haemorrhagic stroke (90.5% vs. 70.1%; p < 0.001) and from pump thrombosis (98.5% vs. 74.7%; p < 0.001) in HVAD cohort. Although similar perioperative outcome, patients implanted with HVAD developed a higher risk for mortality, haemorrhagic stroke and thrombosis during 5 years of follow-up compared to HM3 patients.

Non-intrusive PODI-ROM for patient-specific aortic blood flow in presence of a LVAD device.

Left ventricular assist devices (LVADs) are used to provide haemodynamic support to patients with critical cardiac failure. Severe complications can occur because of the modifications of the blood flow in the aortic region. In this work, the effect of a continuous flow LVAD device on the aortic flow is investigated by means of a non-intrusive reduced order model (ROM) built using the proper orthogonal decomposition with interpolation (PODI) method based on radial basis functions (RBF). The full order model (FOM) is represented by the incompressible Navier-Stokes equations discretized by using a Finite Volume (FV) technique, coupled with three-element Windkessel models to enforce outlet boundary conditions in a multi-scale approach. A patient-specific framework is proposed: a personalized geometry reconstructed from Computed Tomography (CT) images is used and the individualization of the coefficients of the three-element Windkessel models is based on experimental data provided by the Right Heart Catheterization (RHC) and Echocardiography (ECHO) tests. At FOM level, we also consider the pre-surgery configuration in order to further validate the predictive capabilities of the model in several contexts. The ROM has been tested by considering a parametric setting with respect to the LVAD flow, which is a crucial parameter of the problem. We consider a parameter range that covers typical clinical values. The accuracy of the ROM is assessed against results obtained with the FOM both for primal, velocity and pressure, and derived quantities, wall shear stress (WSS). Finally, we briefly discuss the efficiency of our ROM approach.

Prediction of right ventricular failure after left ventricular assist device implantation: role of vasodilator challenge.

AIMS: Pulmonary artery pulsatility index (PAPi) is an indicator of right ventricular (RV) function and an independent predictor of right ventricular failure (RVF) following left ventricular assist device (LVAD) implantation. Administration of vasodilator challenge during right heart catheterization (RHC) could reduce RV workload allowing a better assessment of its functional reserve. METHODS AND RESULTS: Patients undergoing LVAD implantation at our Institution between May 2013 and August 2021 were enrolled. Only patients who had undergone RHC and vasodilator challenge with sodium nitroprusside were analyzed. We collected all available clinical, instrumental, and haemodynamic parameters, at baseline and after nitroprusside infusion and evaluated potential associations with post-LVAD RVF. Of the 54 patients analyzed, 19 (35%) developed RVF after LVAD implantation. Fractional area change (FAC) (OR: 0.647, CI: 0.481-0.871; P = 0.004), pulmonary artery systolic pressure (PASP) (OR: 0.856, CI: 0.761-0.964; P = 0.010), and post-sodium nitroprusside (NTP) PAPi (OR: 0.218, CI: 0.073-0.653; P = 0.006) were independent predictors of post-LVAD RVF. The model combining FAC, PASP, and post-NTP PAPi demonstrated a predictive accuracy of 90.7%. Addition of post-NTP PAPi significantly increased the predictive accuracy of the European Registry for Patients with Mechanical Circulatory Support right-sided heart failure risk score [79.4 vs. 70.4%; area under the curve (AUC): 0.841 vs. 0.724, P = 0.022] and the CRITT score (79.6% vs. 74%; AUC: 0.861 vs. 0.767 P = 0.033). CONCLUSION: Post-NTP PAPi has observed to be an independent predictor of RVF following LVAD implantation. Dynamic assessment of PAPi using a vasodilator challenge may represent a method of testing RV functional reserve in candidates for LVAD implantation. Larger and prospective studies are needed to confirm this hypothesis.

Does the distance between residency and implanting center affect the outcome of patients supported by left ventricular assist devices? A multicenter Italian study on radial mechanically assisted circulatory support (MIRAMACS) analysis.

BACKGROUND: Patients with LVAD require continuous monitoring and care, and since Implanting Centers (ICs) are more experienced in managing LVAD patients than other healthcare facilities, the distance between patient residency and IC could negatively affect the outcomes. METHODS: Data of patients discharged after receiving an LVAD implantation between 2010 and 2021 collected from the MIRAMACS database were retrospectively analyzed. The population was divided into two groups: A (n = 175) and B (n = 141), according to the distance between patient residency and IC ≤ or >90 miles. The primary endpoint was freedom from Adverse Events (AEs), a composite outcome composed of death, cerebrovascular accident, hospital admission because of GI bleeding, infection, pump thrombosis, and right ventricular failure. Secondary endpoints were incidences of mortality and complications. All patients were followed-up regularly, according to participating center protocols. RESULTS: Baseline clinical characteristics and indications for LVAD did not differ between the two groups. The mean duration of support was 25.5 ± 21 months for Group A and 25.7 ± 20 months for Group B (p = 0.79). At 3 years, freedom from AEs was similar between Group A and Group B (p = 0.36), and there were no differences in rates of mortality and LVAD-related complications. CONCLUSIONS: Distance from the IC does not represent a barrier to successful outcomes as long as regular and continuous follow-up is provided.

A Redo Percutaneous Emergency Intervention of Left Ventricular Assist Device Graft Occlusion.

In patients with advanced heart failure (HF), left ventricular assist devices (LVADs) have demonstrated to be effective in improving the quality of life and reducing further hospitalizations. Although uncommon, LVAD outflow graft obstruction (OGO) is a potentially life-threatening complication and percutaneous treatment has been proposed as a standard intervention strategy in such cases. We report the case of a 69 year old man admitted due to LVAD failure causing unstable HF. Past medical history included percutaneous intervention on the outflow graft with stent implantation one year before. The patient was under chronic treatment with vitamin K antagonists (VKA). Emergent percutaneous angiography was performed, showing recurrent OGO due to thrombosis located at a kinking site, distally to the previously treated segment. Using distal anchoring technique, a balloon-expandable 10 × 79 mm endoprosthesis (GORE® Viabahn® VBX) was effectively positioned and post-dilated. Final angiography confirmed the patency of the stent implanted one-year before. Despite the procedure succeeding in restoring LVAD function, the patient died due to septic shock ten days after. Our case suggests that recurrent OGO can be effectively treated with percutaneous redo and that long-term stent patency can be achieved with a standard antithrombotic treatment, despite further thrombotic events in other segments of the graft are still possible (especially at the kinking site). Moreover, other noncardiac conditions as infective complications, can dramatically impact the clinical course and lead to unfavorable outcomes.

A new hemodynamic index to predict late right failure in patients implanted with last generation centrifugal pump.

BACKGROUND: Right ventricular failure (RVF) is a severe event that increases perioperative mortality after left ventricle assist device (LVAD) implantation. Right ventricular (RV) function is particularly affected by the LVAD speed by altering RV preload and afterload as well as the position of the interventricular septum. However, there are no studies focusing on the relationship between pump speed optimization and risk factors for the development of late RVF. METHODS: Between 2015 and 2019, 50 patients received LVAD implantation at San Camillo Hospital in Rome. Of these, 38 who underwent pump speed optimization were included. Post-optimization hemodynamic data were collected. We assessed a new Hemodynamic Index (HI), calculated as follows:  HI = MAP × PCWP CVP × RPM set RPM max , to determine the risk of late RVF, which was defined as the requirement for rehospitalization and inotropic support. RESULTS: Ten patients had late RVF after LVAD implantation. Five patients required diuretic therapy and speed optimization. Three patients required inotropic support with adrenaline 0.05 µg/kg/min. Two patients needed prolonged continuous venovenous hemofiltration and high dose inotropic support. Multivariate analysis revealed that a low HI (odds ratio 11.5, 95% confidence interval, 1.85-65.5, p [.003]) was an independent risk factor for late RVF after LVAD implantation. CONCLUSION: We demonstrated a low HI being a significant risk factor for the development of RVF after LVAD implantation. We suggest implementing HI as a decision support tool for goal-direct optimization of the device aiming to reduce the burden of late-onset RVF during the follow-up.

Fast myocardial recovery ensured by the combined use of V-A ECMO and IMPELLA CP in cardiogenic shock related to a pheochromocytoma crisis.

BACKGROUND: Pheochromocytoma is a rare catecholamine-secreting tumor derived from chromaffin cells in the adrenal glands. An excessive stimulation of cardiac myocytes, when pheochromocytoma 'crisis' occurs, lead to myocardial damage with cardiogenic shock. AIM OF THE STUDY: We present the case of a A 28-year old female patient admitted with signs of severe cardiogenic shock. She was successfully supported with extracorporeal membrane oxygenation (ECMO) combined with IMPELLA CP heart pump (Abiomed Danvers, MA), for left ventricular unloading. Mechanical circulatory support (MCS) was used to favour myocardial recovery and avoid cardiac remodeling. RESULTS: A very fast recovery was observed. The ECMO was discontinued after four days. The IMPELLA-CP was safely removed after six days. A completely myocardial recovery was observed. CONCLUSIONS: Use of MCS might find an indication in case of PCC as a bridge to myocardial recovery.

Hutchinson-Gilford Progeria Syndrome and Severe Aortic Stenosis: A New Hope for Treatment.

Hutchinson-Gilford progeria syndrome is an autosomal dominant, rare, fatal pediatric segmental premature aging disease. Cardiovascular and cerebrovascular diseases constitute the major cause of morbidity and mortality. Patients with the syndrome and severe aortic valve stenosis have been described in the literature, and for all of them a strategy of conservative management has been followed. We describe the first successful treatment of a 23-year-old Hutchinson-Gilford progeria syndrome patient with severe aortic stenosis who underwent transapical transcatheter aortic valve replacement.

Percutaneous Aortic Valve Closure in Patient With Left Ventricular Assist Device and Dilated Aortic Annulus.

Percutaneous transcatheter intervention for aortic regurgitation secondary to implantation of a continuous-flow left ventricular assist device remains challenging, because of the minimal global experience with these procedures. Two treatment options are available: transcatheter aortic valve replacement, which is not always feasible when a dilated aortic annulus is present, and percutaneous aortic valve occlusion. We report a successful percutaneous closure of the aortic valve using an oversized Amplatzer patent foramen ovale multifenestrated device (St Jude Medical, Saint Paul, MN) to treat aortic regurgitation associated with dilated aortic annulus in a patient with a continuous-flow left ventricular assist device.

Minimally invasive treatment of multiple valve disease: A modified approach through a right lateral minithoracotomy.

BACKGROUND AND AIM OF THE STUDY: Today there is little experience with minimally invasive treatment of multiple valve disease and no standard techniques have been provided yet. We report our early experience with combined aortic and mitral valve surgery with or without tricuspid surgery through a right lateral minithoracotomy (RmT), describing the technical aspects of our approach. METHODS: From April 2017 to April 2019 thirty patients with mitro-aortic valve disease or with triple valve pathology underwent surgery through a 3 to 4 cm lateral RmT into the third intercostal space. Cardiopulmonary bypass was established through femoral vessels cannulation. Surgery on the mitral valve (MV) was performed first and sutures put into the mitral annulus. Aortic valve replacement (AVR) was performed next. Then, the selected ring or prosthetic valve was implanted in a mitral position throughout previously placed sutures. Finally, if required, tricuspid valve surgery was performed. RESULTS: In combined with AVR, MV replacement was performed in 20 patients (66%), and MV repair in 10 patients (34%). Concomitant tricuspid annuloplasty was performed in five patients (17%). There was no conversion to full sternotomy. Postoperatively, one patient died. Postoperative echocardiography showed no perivalvular leakage in aortic or in the mitral position. No residual mitral regurgitation was observed in patients who underwent MV repair. CONCLUSIONS: Minimally invasive surgery of double and triple valve disease is feasible. Our approach through a lateral RmT allows optimal visualization of the aortic, mitral, and tricuspid valves, simplifies the surgical procedure and allows excellent results also in complex MV repair procedures.

Acute DeBakey Type I aortic dissection without intimal tear in the arch: is total arch replacement the right choice?

OBJECTIVES: Surgical management of acute DeBakey Type I aortic dissection without intimal tear in the aortic arch is controversial. This study compared short- and long-term outcomes of total arch replacement (TAR) versus limited ascending aorta/hemiarch replacement (no-TAR) in a consecutive series of patients. METHODS: Between January 1998 and December 2015, 220 consecutive patients were operated for DeBakey Type I acute aortic dissection; 135 cases did not exhibit an intimal entry tear in the aortic arch and were subsequently selected to comprise the primary study cohort. A secondary subgroup analysis was made within these 135 cases, which comprised patients who received antegrade cerebral perfusion as the neuroprotective strategy of choice (n = 45). RESULTS: Mean follow-up period was 5 ± 4 years. Among the patients selected, 21 (16%) underwent TAR. Thirty-day mortality was higher in the TAR group (38% vs 21%, P = 0.04). Postoperative complication rates were similar between the groups (61% vs 73%, P = 0.31). Long-term mortality and late aortic reintervention rates were also similar (7% vs 30%, P = 0.36 and 27% vs 14%, P = 0.32, respectively). From the subgroup of patients with antegrade cerebral perfusion, 14 (31%) underwent TAR and 31 (69%) had no-TAR. Mean follow-up-time was 3 ± 2 years. Thirty-day mortality was higher in the TAR group (50% vs 16%, P < 0.01), postoperative complications, long-term mortality and late aortic reintervention rates were similar (64% vs 69%, P = 0.73; 0% vs 19%, P = 0.22; 29% vs 8%, P = 0.17, respectively). CONCLUSIONS: TAR was associated with higher 30-day mortality compared with the less extensive hemiarch replacement. In the long term, TAR showed a trend of improved survival and higher reintervention rate.

Early and late outcomes after surgical repair of congenital supravalvular aortic stenosis: a European Congenital Heart Surgeons Association multicentric study.

OBJECTIVES: Our goal was to evaluate the early and late results of the surgical management of congenital supravalvular aortic stenosis (SVAS). METHODS: We performed a retrospective, multicentre study using data from the European Congenital Heart Surgeons Association. Exclusion criteria were age >18 years, operation before 1990 and redo supravalvular aortic stenosis operations. Multivariate Cox regression analysis was performed to detect independent predictors of adverse events. RESULTS: Of a total of 301 patients (male/female = 194/107; median age 3.9 years, range 13 days-17.9 years), 17.6% had a prior surgical or interventional procedure. Pulmonary artery stenosis was present in 41.5% and coronary anomalies in 13.6%. The operation consisted of a single patch repair in 36.7%, a pantaloon-shaped patch in 36.7%, a 3-patch technique in 14.3% and other techniques in 11.7%. Postoperative complications occurred in 14.9%, and the early mortality rate was 5%. At a median follow-up of 13 years (interquartile range 3.5-7.8; follow-up completed 79.1%), there were 10 late deaths (4.2%). A surgical reoperation or an interventional cardiology procedure occurred in 12.6% and 7.2%, respectively. No significant differences in outcomes between the techniques were found. Age at repair <12 months and pulmonary artery stenosis were associated with an increased risk of early (P = 0.0001) and overall mortality (P = 0.025), respectively. Having an operation after 2005 and co-existing pulmonary artery stenosis were significant predictors of late reintervention (P = 0.0110 and P = 0.001, respectively). CONCLUSIONS: Surgical repair of congenital stenosis is an effective procedure with acceptable surgical risk and good late survival, but late morbidity is not negligible, especially in infants and when associated pulmonary artery stenosis is present.

Coronary Artery Bypass Grafting in Elderly Patients: Insights from a Comparative Analysis of Total Arterial and Conventional Revascularization.

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.

Analysis of early and long-term outcomes of acute type A aortic dissection according to the new international aortic arch surgery study group recommendations.

To evaluate predictors of early and long-term outcomes of surgical repair of acute Type A aortic dissection. Retrospective single-centre study evaluating patients surgically treated between 1998 and 2013. Clinical follow-up was performed. Complications were classified according to the International Aortic Arch Surgery Study Group recommendations. Statistical analysis included univariate and multivariate analysis of preoperative and operative data. One hundred eighty-five patients were evaluated. The follow-up was complete for 180 patients (97 %). Mean age was 63 years, 82 % had a DeBakey type I aortic dissection, 18 % a type II. Eleven patients (6 %) died intraoperatively, 119 of the remaining (68 %) had postoperative complications. Thirty-day mortality was 21 % (38 patients). Average ICU and hospital stay were 6 and 14 days, respectively. During a mean follow-up time of 6 ± 4 years we observed 44 deaths (31 %). Twenty patients (14 %) needed late thoracic aorta reoperation. Results from the multivariate analysis are as follows. Thirty-day mortality was associated with abdominal pain at presentation (p < 0.01). The incidence of postoperative complications was related to older age at intervention (p < 0.01) and longer cross-clamp time (p < 0.01). Mortality at follow-up was significantly increased by older age at intervention (p < 0.01), with a logarithmic growth after 60 years, female sex (p < 0.01), preoperative limb ischemia (p = 0.02) and DHCA (p < 0.01). The surgical results of type A aortic dissection are affected by age at intervention with a logarithmic increase of late mortality in patients older than 60 years.

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.

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.

Cardiomyocytes in vitro adhesion is actively influenced by biomimetic synthetic peptides for cardiac tissue engineering.

Scaffolds for tissue engineering must be designed to direct desired events such as cell attachment, growth, and differentiation. The incorporation of extracellular matrix-derived peptides into biomaterials has been proposed to mimic biochemical signals. In this study, three synthetic fragments of fibronectin, vitronectin, and stromal-derived factor-1 were investigated for the first time as potential adhesive sequences for cardiomyocytes (CMs) compared to smooth muscle cells. CMs are responsive to all peptides to differing degrees, demonstrating the existence of diverse adhesion mechanisms. The pretreatment of nontissue culture well surfaces with the (Arginine-Glycine-Aspartic Acid) RGD sequence anticipated the appearance of CMs' contractility compared to the control (fibronectin-coated well) and doubled the length of cell viability. Future prospects are the inclusion of these sequences into biomaterial formulation with the improvement in cell adhesion that could play an important role in cell retention during dynamic cell seeding.