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Extracorporeal membrane oxygenation (ECMO) is increasingly employed to support patients affected by refractory cardiogenic shock. When patients cannot be weaned from ECMO because of severe heart dysfunction, heart transplantation (HTx) or implantation of a durable mechanical circulatory support should be considered. Traditionally, the use of ECMO as a direct bridge to HTx was burdened by high mortality. However, during these last years, the widespread employment of ECMO increased centers’ experience in the management of this device, and new allocation policies provided the highest priority level for ECMO HTx candidates. Therefore, these factors could have mitigated the negative outcomes previously reported. The aim of this chapter is to describe the role of ECMO as a direct bridge to HTx, analyzing results of this strategy, and how to determine candidacy and risk stratification among the severely ill population of patients supported by this mechanical circulatory support.

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.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).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).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.

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 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.

Gastrointestinal bleeding (GIB) can occur in patients after left ventricular assist device (LVAD) implantation. In cases of recurrent GIB, the management of anticoagulation treatment represents a challenging situation in which the risk of bleeding recurrence and the need for long-term anticoagulation must be balanced. This case series describes the successful management of anticoagulation in three patients with recurrent GIB using fondaparinux. To our knowledge, these are the first reported cases of recurrent GIB in which a single dose of subcutaneous fondaparinux was used instead of oral anticoagulation. None of the patients presented with signs of pump thrombosis or arterial embolism. If confirmed by larger studies, the substitution of oral anticoagulation with subcutaneous, single-dose fondaparinux could represent a safe alternative treatment in a select group of patients with recurrent GIB., Piani, et al. Fondaparinux as Alternative Anticoagulant Treatment in Patients with Left Ventricular Assist Devices and Recurrent Gastrointestinal Bleeding: Case Series. The VAD Journal. 2022; 8(1):e2022814. https://doi.org/10.11589/vad/e2022814

Bridge to heart transplantation (HTx) with ECMO is associated with poor outcome, but patient status, according to different levels of multiorgan compromise, is generally not considered. The aim of this study was to analyze the prognostic value of acute physiology, age, and chronic health evaluation IV (APACHE IV) score in this setting. Thirty-two patients underwent HTx bridged with ECMO at our institution between 2005 and 2017; they were divided into two groups, according to a cutoff value of APACHE IV score obtained by Receiver operating characteristic curve analysis for 30-day mortality. Kaplan-Meyer survival curves were plotted, and compared through the log-Rank test. Cox regression model was used to estimate which factors were associated with overall survival. The 30-day mortality prediction of the APACHE IV score showed an AUC of 0.98 [95% C.I. 0.84-0.99], with a cutoff value corresponding to a score value of 47 (specificity of 84.6% and sensitivity of 100%) in order to discriminate between a group with low probability (Group A, patients with an APACHE IV score47), and a group with high probability (Group B, patients with an APACHE IV score ≥47) of 30-day mortality. Median follow up was 26.9 months (range: 0.03-143.8). On overall, patients bridged with ECMO showed a high early mortality (18.7%30 days, n = 6). All deaths occurred in Group B, where 30-day mortality was 60%. Survival probability among Group B patients was 26.6% at both 1 and 5 years. Conversely, in Group A no early mortality was reported, and the estimated survival was 89.7% at 1 year and 81.5% at 5 years, respectively. Mortality correlated at univariate analysis with recipient age, APACHE IV score and female sex, while the multivariate Cox regression analysis showed that only an APACHE IV score (HR 1.23 [1.08-1.39, 95% C.I.]) and female sex (HR 6.68 [1.42-31.43, 95% C.I.]) had an adverse impact on survival. This study shows that the APACHE IV score could be considered a powerful predictor of survival in patients bridged by ECMO to HTx, and can account for a better selection of patients on ECMO support at time of listing.

We report the use of extra-corporeal cardiopulmonary support (ECLS), in a case of complicating refractory severe cardiogenic shock, in a patient with Tako-tsubo cardiomyopathy (TC). Tako-tsubo cardiomyopathy syndrome is characterized by left ventricular (LV) wall motion abnormalities, usually without coronary artery disease, mimicking the diagnosis of acute coronary syndrome. This ventricular dysfunction is typically reversible in the acute phase, though it can progress into refractory cardiogenic shock with limited therapeutic options available. Here, we report for the first time in a Tako-tsubo patient with refractory cardiogenic shock, the use of ECLS treatment in order to unload the heart, sustain circulation and end-organ perfusion, and promote potential ventricular recovery. Extra-corporeal life support allowed inotropic drug weaning while maintaining end-organ function and supported the patient until myocardial recovery. The patient recovered completely, and a normal LV ejection fraction was documented by 2D echocardiography on day 7. From our experience, ECLS can be an appropriate treatment for severe refractory cardiogenic shock in patients with TC. Extra-corporeal life support was an effective ultimate solution.

Background Left ventricular assist device (LVAD) implantation improves survival and quality of life in patients with advanced heart failure (HF). Despite these advantages, LVADs are not free from risks. Among all adverse events (AE), pump thrombosis and bleeding, especially of the gastrointestinal (GI) tract, have been reported to occur with increasing frequency in some CF-LVADs. The INCOR LVAD system is a third-generation, continuous flow, axial pump with active magnetic levitation, avoiding the potential downsides of mechanical bearings. Methods The aim of this retrospective study was to review the Italian clinical experience with the INCOR LVAD and to determine the prevalence of GI bleeding and pump thrombosis. All patients implanted between January 2006 and May 2012 were considered eligible. Results The total population consisted of 42 patients. LVAD indication was BTT in 36 (86%) and DT in 6 (14%) patients; 31 patients (74%) were INTERMACS class 1 or 2. Mean support time was 525 ± 570 days. The 1-year and 2-year survival rates were 74% and 60%, respectively. The most frequent AE was driveline infection (0.33 events PPY) followed by stroke with consequence (0.17 events PPY), sepsis (0.07 events PPY), and right HF (0.05 events PPY). No episodes of pump thrombosis or GI bleeding were observed. Conclusions In this cohort of high-risk, advanced HF patients, the INCOR LVAD provided effective support with improved survival. Moreover, the absence of GI bleeding and pump thrombosis demonstrates a favorable characteristic of this device. Further prospective studies are needed to confirm these data.

Objective: The aim of this study was to evaluate the feasibility, safety and outcome of skeletonized bilateral internal mammary arteries (BIMA) in patients with unstable angina (UA) undergoing non-elective myocardial revascularization. Methods: Between January 1997 and December 2003, 758 patients, mean age 62G12 years, underwent non-elective coronary artery bypass grafting (CABG) for unstable angina. Two hundred and five (27%) were operated emergently and 503 (73%) urgently. BIMA were employed in 320 (42%) patients (Group B) and isolated left IMA and/or saphenous vein grafts in the remaining 438 (58%) patients (Group M). Results: In-hospital mortality (BZ5.9% and MZ5.3%), and perioperative myocardial infarction (BZ2.2%; MZ1.96%) were similar between the two groups (PZns). Actuarial survival at 1, 3 and 7 years was 98.7, 97.5 and 96.2% in B and 99, 94.3 and 88.4% in M (P!0.05 at 7 years follow-up). At 7 years follow-up, the event-free cardiac survival (92 vs. 87%, PZ0.021), angina-free survival (98.6 vs. 94%, PZ0.039), reoperation-free cardiac survival (98 vs. 95%, PZ0.04) and infarct-free cardiac survival (98.7 vs. 96%, PZ0.05) were better in Group B. Multivariate analysis identified ageO65 years (PZ0.02), LVEF!35% (PZ0.01), O1 ischemic irreversible area (PZ0.03) as independent predictors for late deaths, while the use of the LIMA (PZ0.006) and both mammary arteries (PZ0.001) decreased the risk of late deaths. Conclusions: The use of BIMA in non-elective CABG for UA is safe and effective. Mid-term outcome, however, are superior with improved freedom from cardiac death, from coronary reintervention and from myocardial infarction. Q 2005 Elsevier B.V. All rights reserved.

Although the myocardium contains progenitor cells potentially capable of regenerating tissue upon lethal ischaemic injury, their actual role in post-infarction heart healing is negligible. Therefore, transplantation of extra-cardiac stem cells is a promising therapeutic approach for post-infarction heart dysfunction. Paracrine cardiotropic factors released by the grafted cells, such as the cardiotropic hormone relaxin (RLX), may beneficially influence remodelling of recipient hearts. The current study was designed to address whether grafting of mouse C2C12 myoblasts, genetically engineered to express green fluorescent protein (C2C12/GFP) or GFP and RLX (C2C12/RLX), are capable of improving long-term heart remodelling in a rat model of surgically induced chronic myocardial infarction. One month after myocardial infarction, rats were treated with either culture medium (controls), or C2C12/GFP cells, or C2C12/RLX cells plus exogenous RLX, or exogenous RLX alone. The therapeutic effects were monitored for 2 further months. Cell transplantation and exogenous RLX improved the main echocardiographic parameters of cardiac function, increased myocardial viability (assessed by positron emission tomography), decreased cardiac sclerosis and myocardial cell apoptosis and increased microvascular density in the post-infarction scar tissue. These effects were maximal upon treatment with C2C12/RLX plus exogenous RLX. These functional and histopathological findings provide further experimental evidence that myoblast cell grafting can improve myocardial performance and survival during post-infarction heart remodelling and dysfunction. Further, this study provides a proof-of-principle to the novel concept that genetically engineered grafted cells can be effectively employed as cell-based vehicles for the local delivery of therapeutic cardiotropic substances, such as RLX, capable of improving adverse heart remodelling.

Total arterial myocardial revascularization (TAMR) is advisable because of the excellent long-term patency of arterial conduits. We present early and midterm outcomes of five different surgical configurations for TAMR. Between January 1998 and May 2004, 112 patients (aged 56.5 +/- 4.5 years, 20% female) with three-vessel disease underwent TAMR. The internal mammary arteries (IMAs) were harvested in a sketelonized fashion. The surgical techniques for TAMR consisted in Y or T composite grafts (n = 88, 78%) constructed between the in situ right IMA (RIMA) and the free left IMA (LIMA) graft (n = 58) or the radial artery (n = 30) (RA) in three different configurations. The other techniques consisted in T- and inverted T-graft (n = 24, 22%) constructed between the RA conduit and the free LIMA graft in two different configurations. The mean follow-up time was 40 +/- 23 months. Postoperative angiographic control was performed in 76/111 (70%) patients. Overall, 472 arterial anastomoses (average 4.2 per patient) were performed. One (0.9%) patient, undergoing the inverted T-graft technique, died on postoperative day 2. Another patient (0.9%), undergoing the lambda-graft technique using both IMAs and RA, suffered a new myocardial infarction probably due to RA conduit vasospasm. One week after surgery, after the transthoracic echocardiographic Doppler with adenosine provocative test, the coronary flow reserve (CFR) at the LIMA and RIMA main stems were 2 +/- 0.4 and 2.4 +/- 0.3, respectively. At 12-month follow-up, after adenosine provocative test, the CFRs at the LIMA and RIMA stems were significantly higher than the values at 1 week after surgery within the same group; (LIMA)CFR (1 week) 2.4 +/- 0.3 (12 months) vs 2 +/- 04 (1 week), P = 0.002; (RIMA)CFR 2.58 +/- 0.4 vs 2.4 +/- 0.3, P = 0.001. The CFR at the RIMA main stem was higher in all measurements within the same group than in the LIMA main stem, but not significantly. In one patient undergoing the lambda-graft technique using both IMAs, the RIMA was found to have a string sign. Postoperative angiography in 50 patients showed that the patency rate for the LIMA was 100%, for the RIMA 97.3%, and for the RA 96.7%. Angiography at 3-year follow-up in 76 patients documented excellent patency rates of the LIMA (97.4%), RIMA (95%), and RA (87%). Survival at 7 years was 92.5%, event-free survival 89.3%, and freedom from angina 94%. Total arterial myocardial revascularization using different surgical configurations is safe and effective. The use of composite arterial grafts provides excellent clinical and angiographic results, with a low rate of angina recurrence and late cardiac events. These configurations allow for complete arterial revascularization.

Surgical revascularization employing bilateral internal mammary arteries (IMAs) is an excellent procedure in elective surgery, but its role in urgent/emergent procedures is still debating. This retrospective study evaluates the feasibility, safety and surgical early outcomes of employing double skeletonized IMAs in patients with unstable angina (UA) undergoing urgent/emergent revascularization.From January 1997 to May 2004, 824 patients (491 males, 333 females, mean age 64 +/- 12 years) underwent urgent revascularization for UA. Bilateral IMAs were employed in 346 (42%) patients (group B) and isolated and/or saphenous vein grafts in the remaining 478 (58%) patients (group M). There were no significant differences in preoperative risk factors between the two groups (mean EuroSCORE value).Postoperative stay was free from complications in 87% of patients of group B and 91% of group M. In-hospital mortality (group B 5.9%, group M 5.3%, p = NS) and perioperative myocardial infarction (group B 2.2%, group M 1.96%, p = NS), mean coronary care unit stay and total hospital stay were similar in both groups. Actuarial survival at 1, 3, 5 and 7 years was respectively 98.7, 97.5, 96.9 and 96.1% in group B and 99, 93.4, 92.1 and 88.4% in group M (p0.05). At a mean follow-up of 6.6 years the event-free survival (p = 0.021) and reoperation-free cardiac survival (p = 0.003) were better in group B. Multivariate analysis identified that age65 years (p = 0.01), congestive heart failure (p = 0.001), left ventricular ejection fraction35% (p = 0.03), and1 ischemic irreversible area (p = 0.02) are negative predictors for reoperation-free cardiac survival. The employment of the left IMA (p = 0.006) and of both IMAs (p = 0.001) were positive predictors for the overall survival and reoperation-free cardiac survival.Our results show that the use of skeletonized bilateral IMAs is associated with an acceptable risk and a lower incidence of postoperative complications in patients with UA, improving late outcomes in this group of patients.

Mitral valve regurgitation (MVR), occurring as a result of myocardial ischemia and global left ventricular (LV) dysfunction, predicts a poor outcome in terms of survival and morbidity. Between 1995 and 2003, 180 consecutive patients with impaired LV function and chronic ischemic MVR underwent cardiac surgery. Fifty-four patients (group I), MVR (grade III-IV) underwent simultaneous MV surgery and coronary artery bypass grafting (CABG); 40 patients (group II), MVR (grade II-III), and 86 patients (group III), MVR (grade I-II), underwent CABG alone. In group I, MV repair was performed in 36 patients (group IA) and MV replacement in 18 (group IB). The incidence of hospital death was similar between groups. The actuarial event-free survival was significantly lower in group than in groups II and III (P = 0.0045) and I (P = 0.038). The overall actuarial survival was significantly higher in group IA than in group IB (P = 0.027). Postoperatively, the LV ejection fraction (P < 0.001), LV end-diastolic diameter (P < 0.001), LV end-systolic diameter (P < 0.01), and cardiac index (P < 0.001) improved significantly in group I. The regurgitation fraction decreased significantly in Groups I and III after surgery (P < 0.001 and P = 0.003, respectively). Both MV repair and replacement that preserves subvalvular apparatus in patients with end-stage ischemic myocardiopathy offer an acceptable outcome. Mitral valve repair simultaneous to CABG improves significantly the LV function and its geometry. In patients with mild to moderate mitral regurgitation, CABG alone may be performed with good overall survival, but with lower event-free survival than those undergoing concomitant mitral valve repair.

The advantages and the safety aspects of ministernotomy, in aortic valve replacement, are presently under investigation. The aim of this study was to compare the postoperative results between ministernotomy access and standard total sternotomy access.Between January 1997 and July 2002, 98 patients underwent elective aortic valve replacement. They were divided into two groups: group Gm (49 patients) undergoing a ministernotomy approach ("reversed C" or "reversed L") and group Gs (49 patients) undergoing conventional total sternotomy.The length of the skin incision was significantly shorter in group Gm (p0.001). The total operative time was significantly longer in group Gm (p = 0.02), but no significant differences were found in the cardiopulmonary bypass and aortic cross-clamping times. Mean mediastinal drainage, incidence of bleeding800 ml, mechanical ventilation time, intensive care unit stay and hospital stay were significantly greater in group Gs. Five days after the surgical procedure, spirometric analysis demonstrated a significant reduction in total lung capacity, and in maximum expiratory and inspiratory pressures in group Gs compared with group Gm (p = 0.003, p = 0.001, p = 0.01, respectively).Our results showed that in addition to cosmetic advantages, ministernotomy is also associated with a better outcome in terms of sternal stability, blood loss and transfusions, and postoperative pain. Ministernotomy also improved the recovery of respiratory function, with a shorter mechanical ventilation time and allowed an earlier hospital discharge.