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.].

Outcome of patients supported with the HeartMate 3 after extracorporeal life support: On behalf of the Durable Mechanical Circulatory Support After Extracorporeal Life Support Study Group.

OBJECTIVES: The Durable Mechanical Circulatory Support System After Extracorporeal Life Support registry is a multicenter registry of patients who were bridged from extracorporeal life support to a durable mechanical circulatory support system. Although numerous studies have highlighted the favorable outcomes after implantation of the HeartMate 3 (Abbott), the objective of our study is to examine the outcomes of patients who received HeartMate 3 support after extracorporeal life support. METHODS: Data of patients undergoing HeartMate 3 implantation from January 2016 to April 2022 at 14 centers were collected and evaluated. Inclusion criteria were patients with extracorporeal life support before HeartMate 3 implantation. The outcome was reported and compared with patients receiving other types of pumps. RESULTS: A total of 337 patients were bridged to durable mechanical circulatory support system after extracorporeal life support in the study period. Of those patients, 140 were supported with the HeartMate 3. The other types of pumps included 170 HeartWare HVADs (Medtronic) (86%), 14 HeartMate II devices (7%), and 13 (7%) other pumps (7%). Major postoperative complications included right heart failure requiring temporary right ventricular assist device in 60 patients (47%). Significantly lower postoperative stroke (16% vs 28%, P = .01) and pump thrombosis (3% vs 8%, P = .02) rates were observed in the patients receiving the HeartMate 3. The 30-day, 1-year, and 3-year survivals in patients receiving the HeartMate 3 were 87%, 73%, and 65%, respectively. CONCLUSIONS: In this critically ill patient population, the survivals of patients who were transitioned to the HeartMate 3 are deemed acceptable and superior to those observed when extracorporeal life support was bridged to other types of durable mechanical circulatory support systems.

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.

Management of harlequin syndrome under ECPELLA support: A report of two cases and a proposed approach.

The use of ECPELLA in patients with severe lung disease may result in an unfavorable phenomenon of differential hypoxia. The simultaneous evaluation of three arterial blood samples from different arterial line (right radial artery, left radial artery, ECMO arterial line) in patients at risk of Harlequin syndrome (also called differential hypoxemia (DH)) can localize the "mixing cloud" along the aorta. Focusing the attention on the "mixing cloud" position instead of on isolated flows of Veno-Arterial Extracorporeal Membrane Oxygenation (VA ECMO) and Impella CP makes the decision making easier about how to modify MCSs flows according to the clinical context. Herein, we present two cases in which ECPELLA configuration was used to treat a cardiogenic shock condition and how the ECPELLA-induced hypoxia was managed.

Stroke Complications in Patients Requiring Durable Mechanical Circulatory Support Systems After Extracorporeal Life Support.

Stroke is one of the leading complications following durable mechanical circulatory support (MCS) implantation. The aim of this multicenter study was to investigate stroke complications in patients requiring durable MCS following extracorporeal life support (ECLS). Data of 11 high volume MCS centers were collected and evaluated to identify patients who underwent durable MCS implantation after ECLS support between January 2010 and August 2018. The primary outcome was stroke following durable MCS implantation. Univariate and multivariate logistic regression analyses were performed to determine predictors of stroke. Overall, 531 patients met the inclusion criteria. Only patients who were supported with continuous flow pumps were included in this study accounting for 495 patients (median age 54 years old [interquartile range 47-60]). A total of 136 patients (27%) developed postoperative stroke on device during the follow-up (48% ischemic and 52% hemorrhagic) after a median durable MCS support of 320 [32-1,000] days, accounting for 0.17 events per patient-year. Of 133 patients with known date of stroke, a total of 47 (10%) developed stroke during the first 30 days (64% ischemic and 36% hemorrhagic), and 86 patients developed stroke after 30 days (38% ischemic and 62% hemorrhagic) of durable MCS support (late stroke). Survival rate was significantly lower in patients with hemorrhagic stroke ( p = 0.00091). Stroke appears to be a common complication in patients transitioned to durable MCS support after ECLS. Hemorrhagic stroke is a more common type of late stroke and is associated with inferior outcomes.

Clinical and Prognostic Role of Noninvasive Hemodynamic Assessment in Left Ventricular Assist Device Carriers.

Persistence of heart failure symptoms or suboptimal hemodynamic is a frequent condition in LVAD carriers, associated with adverse outcome. Invasive hemodynamic optimization was associated with a better outcome. Our group recently validated an echocardiographic protocol to noninvasively assess hemodynamics of LVAD patients. Aim of this prospective study was to investigate its utility in clinical practice and its prognostic role. From February 2016 to February 2019 fifty-five LVAD carriers (HVAD/HM3 34/21; age 61 ± 10 years, 89% males; INTERMACS profile at LVAD implantation ≤3 68%). A two-phased protocol was performed. First, the patient underwent clinical evaluation. Second, an echo-Doppler blinded to clinical data was performed. Clinical and echo-Doppler evaluation both identified patients with "optimal hemodynamic profile" (normal left and right estimated atrial pressures) versus other profiles. clinical evaluation overestimated the presence of an optimal profile compared with echo-Doppler (83% vs. 59%). The presence of overt heart failure identified patients with the highest risk of adverse outcomes (death or hospitalization for HF at 6 months: HR 15, 95% CI, 5.5-39, P < 0.001). An optimal profile by echo-Doppler was associated with a better outcome among patients without overt heart failure (death or hospitalization for HF at 6 months: HR 0.08, 95% CI, 0.01.5-0.64, P < 0.02). After echo-Doppler, the clinician modified treatment in 46 cases (37%). Noninvasive evaluation of hemodynamics by echo-Doppler adds significant prognostic information in LVAD patients without overt HF and is a valuable tool to tailor treatment in the outpatient follow-up of LVAD carriers. Visual abstract: http://links.lww.com/ASAIO/A783.

Pulmonary Artery Catheter Monitoring in Patients with Cardiogenic Shock: Time for a Reappraisal?

Cardiogenic shock represents one of the most dramatic scenarios to deal with in intensive cardiology care and is burdened by substantial short-term mortality. An integrated approach, including timely diagnosis and phenotyping, along with a well-established shock team and management protocol, may improve survival. The use of the Swan-Ganz catheter could play a pivotal role in various phases of cardiogenic shock management, encompassing diagnosis and haemodynamic characterisation to treatment selection, titration and weaning. Moreover, it is essential in the evaluation of patients who might be candidates for long-term heart-replacement strategies. This review provides a historical background on the use of the Swan-Ganz catheter in the intensive care unit and an analysis of the available evidence in terms of potential prognostic implications in this setting.

Transversus thoracic plane block and rectus sheath block for left ventricular assist device implantation via full median sternotomy: A case report.

BACKGROUND: Traditionally, pain management after left ventricular assist device (LVAD) implantation via median sternotomy have been based on intravenous opioids but, in the era of enhanced recovery after surgery, a multimodal opioid-sparing analgesia could represent a valid alternative reducing opioids related side effects. CASE REPORT: We described the successfully use of an opioid-sparing regimen for pain management after LVAD implantation via median sternotomy based on two ultrasound-guided fascial plane wall blocks. Bilateral ultrasound-guided transversus thoracic plane block was performed to manage sternotomy pain; additionally, unilateral left ultrasound-guided rectus sheath block was performed to provide somatic pain relief for left abdominal wall structures superficial to the peritoneum within which the LVAD driveline was inserted. The patient was extubated on Day 1 and good quality analgesia (numerical rating scale <3) was obtained, without using nonsteroidal antiinflammatory drugs or opioids. The patient was discharged from Intensive Care Unit on Day 3 and during hospitalization (lasted 24 days) there was no need for rescue analgesia administration.

Prognostic implications of pulmonary artery catheter monitoring in patients with cardiogenic shock: A systematic review and meta-analysis of observational studies.

PURPOSE: To investigate the impact of pulmonary artery catheter (PAC) monitoring on survival of cardiogenic shock(CS), in the light of the controversies in available evidence. MATERIALS AND METHODS: MEDLINE, EMBASE, Cochrane library and Web of Science were systematically screened to identify most relevant studies on patients with CS comparing PAC use to non-use during hospital stay. Short-term mortality was the primary endpoint and the use of Mechanical Circulatory Support (MCS) devices was the secondary one. RESULTS: Six observational studies including 1,166,762 patients were selected. The most frequent etiology of CS was post-myocardial infarction (75% [95% CI 55-89%] in PAC-group and 81%[95% CI 47-95%] in non-PAC group). Overall, PAC was used in 33%(95% CI 24-44%) of cases. Pooling data adjusted for confounders, a significant association between the PAC-group and a reduction in short-term mortality emerged when compared to the non-PAC group (36%[95% CI 27-45%] vs 47%[95% CI 35-59%];AdjustedOR 0.71, 95% CI 0.59-0.87, p < 0.01). MCS use was significantly higher in PAC vs non-PAC group (59% [95% CI 54-65%]) vs 48% [95% CI 43-53%]);OR 1.60 [95% CI 1.27-2.02, p < 0.01]). CONCLUSIONS: PAC was associated with lower incidence of short-term mortality in CS pooling adjusted observational studies. Prospective studies are needed to confirm our hypothesis and better clarify the mechanisms of this potential prognostic benefit.

Short term outcomes of Impella circulatory support for high-risk percutaneous coronary intervention a systematic review and meta-analysis.

OBJECTIVE: Aim of this study is to evaluate short term safety and efficacy of Impella in high risk percutaneous coronary intervention (HR-PCI) population. BACKGROUND: While several studies demonstrated the clinical significance of Impella in HR-PCI, few data exist about its impact on short term outcome. METHODS: All studies reporting short term outcomes of PCI with any Impella device were included. The primary endpoint was either in-hospital or 30-day mortality, while vascular complications, post-procedural stroke, post-procedural dialysis and bleeding complications were assessed as secondary outcomes. RESULTS: Nine studies with 7448 patients were included. Median age was 69.5 years old (67-73), with a mean ejection fraction of 29.7% (20%-39%) and a Syntax score of 30.2 (25. 5-33, interquartile [IQR]). Impella 2.5 was the most commonly used axial flow pump used to support these PCIs (88.7%). In-hospital death was observed in 5.09% of patients (95% confidence interval [CI] 3.69-6.49, I2  = 78%), while vascular complications in 2.53% of patients (1.07-4.00, I2  = 89%) and post-procedural stroke in 2.77% of patients (0.50-6.05, I2  = 98%). Major bleeding occurred in 5.98% of patients (3.66-8.31, I2  = 90%) and post-procedural dialysis in 4.44% of patients (1.50-7.37, I2  = 93% all CI 93%). CONCLUSION: Use of Impella in high risk PCI appears to have an acceptable rate of complication, especially regarding vascular complications and major bleedings.

Extracorporeal life support programme for out-of-hospital cardiac arrest during competitive sport events: the experience of the Volleyball Men's World Championship Final Six in Turin (Italy).

The high incidence of out-of-hospital cardiac arrest refractory to standard resuscitation protocols, despite precompetitive screening, demonstrated the need for a prehospital team to provide an effective system for life support and resuscitation at the Volleyball Men's World Championship. The evolution of mechanical circulatory support suggests that current advanced cardiovascular life support protocols no longer represent the highest standard of care at competitive sporting events with large spectator numbers. Extracorporeal life support (ECLS) improves resuscitation strategies and offers a rescue therapy for refractory cardiac arrest that can no longer be ignored. We present our operational experience of an out-of-hospital ECLS cardiopulmonary resuscitation team at an international sporting event.

Comparison of ECMO vs ECpella in Patients With Non-Post-Pericardiotomy Cardiogenic Shock: An Updated Meta-Analysis.

INTRODUCTION: The impact of Impella and ECMO (ECPELLA) in cardiogenic shock (CS) remains to be defined. The aim of this meta-analysis is to evaluate the benefit of ECPELLA compared to VA-ECMO in patients with non post-pericardiotomy CS. METHODS: All studies reporting short term outcomes of ECpella or VA ECMO in non post-pericardiotomy CS were included. The primary endpoint was 30-day mortality. Vascular and bleeding complications and LVAD implantation/heart transplant within 30-days were assessed as secondary outcomes. RESULTS: Of 407 studies identified, 13 observational studies (13,682 patients, 13,270 with ECMO and 412 with ECpella) were included in this analysis. 30-day mortality was 55.8% (51.6-59.9) in the VA-ECMO group and 58.3% (53.5-63.0) in the ECpella group. At meta-regression analysis the implantation of IABP did not affect mortality in the ECMO group. The rate of major bleeding in patients on VA-ECMO and ECpella support were 21.3% (16.9-26.5) and 33.1% (25.9-41.2) respectively, while the rates of the composite outcome of LVAD implantation and heart transplantation within 30-days in patients on VA-ECMO and ECpella support were 14.4% (9.0-22.2) and 10.8%. When directly compared in 3 studies, ECpella showed a positive effect on 30-day mortality compared to ECMO (OR: 1.81: 1.039-3.159). CONCLUSION: Our data suggest that ECpella may reduce 30-day mortality and increase left ventricle recovery, despite increased of bleeding rates.

Left ventricular assist device implants in patients on extracorporeal membrane oxygenation: do we need cardiopulmonary bypass?

OBJECTIVES: Implanting a durable left ventricular assist device (LVAD) in a patient on extracorporeal life support (ECLS) is challenging. The goal of this study was to compare the results of patients from a European registry who had a durable LVAD implanted with or without transition from ECLS to cardiopulmonary bypass (CPB). METHODS: A total of 531 patients on ECLS support who had an LVAD implant between January 2010 and August 2018 were analysed; after 1:1 propensity score matching, we identified and compared 175 patients in each group. RESULTS: The duration of preoperative ECLS was 7 [standard deviation (SD) 6] vs 7 (SD 6) days in patients with or without CPB (P = 0.984). The surgical time was longer in the CPB group [285 (SD 72) vs 209 [SD 75] min; P ≤ 0.001). The postoperative chest tube output was comparable [1513 (SD 1311) vs 1390 (SD 1121) ml; P = 0.3]. However, re-exploration for bleeding was necessary in 41% vs 29% of patients with or without CPB (P = 0.01) and a significantly higher number of packed red blood cells and fresh frozen plasma [8 (SD 8) vs 6 (SD 4) units; P = 0.001 and 6 (SD 7) vs 5 (SD 5) units; P = 0.03] were administered to patients operated on with CPB. A postoperative mechanical right ventricular support device was necessary in 50% vs 41% of patients (P = 0.08). The stroke rate was not significantly different (P 0.99). No difference in survival was observed. CONCLUSIONS: Omitting CPB for an LVAD implant in patients on ECLS is safe and results in shorter operating time, less re-exploration for bleeding and fewer blood products. However, no survival benefit is observed.

Impact of extra-corporeal life support (ECLS) cannulation strategy on outcome after durable mechanical circulation support system implantation on behalf of durable MCS after ECLS Study Group.

BACKGROUND: The literature on outcomes of patients requiring durable mechanical circulatory support (MCS) after extra-corporeal life support (ECLS) is limited. The aim of this study was to investigate the impact of preoperative ECLS cannulation on postoperative outcome after durable MCS implantation. METHODS: The durable MCS after ECLS registry is a multicenter retrospective study that gathered data on consecutive patients who underwent durable MCS implantation after ECLS between January 2010 and August 2018 in eleven high volume European centers. Patients who underwent the implantation of total artificial heart, pulsatile pumps, or first-generation pumps after ECLS were excluded from the analysis. The remaining patients were divided into two groups; central ECLS group (cECLS) and peripheral ECLS group (pECLS). A 1:1 propensity score analysis was performed to identify two matched groups. The outcome of these two groups was compared. RESULTS: A total of 531 durable MCS after ECLS were implanted during this period. The ECLS cannulation site was peripheral in 87% (n=462) and central in 13% (n=69) of the patients. After excluding pulsatile pumps and total artificial heart patients, a total of 494 patients remained (pECLS =434 patients, cECLS =60 patients). A 1:1 propensity score analysis resulted in 2 matched groups (each 55 patients) with median age of 54 years (48-60 years) in cECLS group and 54 years (43-60 years) in pECLS group. HeartWare HVAD (Medtronic, Minneapolis, MN) was implanted in the majority of the patients (cECLS =71% vs. pECLS =76%, P=0.67). All postoperative morbidities were comparable between the groups. The thirty-day, one year and long-term survival was comparable between the groups (P=0.73). CONCLUSIONS: The cannulation strategy of ECLS appears to have no impact on the post-operative outcome after durable MCS implantation.

Conventional and alternative sites for left ventricular assist device inflow and outflow cannula placement.

Left ventricular assist device (LVAD) therapy is a well accepted and effective strategy to treat advanced heart failure. The miniaturized third-generation centrifugal pumps HeartWare HVAD (Medtronic, Dublin, Ireland) and HeartMate 3 (Abbott, Illinois, USA) are the two most commonly implanted systems in the contemporary era. Their design has allowed clinicians to pioneer several alternate and less invasive implantation techniques to tackle a broad spectrum of clinical scenarios. A brief review and discussion of alternative surgical techniques for both inflow and outflow cannula insertion, in the contemporary LVAD surgery era, are herein reported.

Impact of a surgical approach for implantation of durable left ventricular assist devices in patients on extracorporeal life support.

BACKGROUND: The aim of this study was to evaluate the impact of the surgical approach on the postoperative outcome in patients who underwent left ventricular assist device (LVAD) implantation after having received veno-arterial extracorporeal life support (va-ECLS) using data from a European registry (ECLS-VAD). Five hundred and thirty-one patients were included. METHODS: A propensity score-adjusted outcome analysis was performed, resulting in 324 patients in the full sternotomy (FS) group and 39 in the less invasive surgery (LIS) group. RESULTS: The surgery lasted in median 236 min in the FS group versus 263 min in the LIS group (p = 0.289). The median chest tube output during the first 24 h was similar in both groups. Patients who underwent implantation with an FS required more blood products during the first 24 postoperative hours (median 16 vs. 12, p = 0.033). The incidence of revision due to bleeding was also higher (35.5 vs. 15.4%, p = 0.016). A temporary postoperative right ventricular assist device was necessary in 45.1 (FS) versus 23.1% (LIS) of patients, respectively (p = 0.067). No stroke occurred in the LIS group during the first 30 days after surgery (7.4% in the FS group). The incidence of stroke and of renal, hepatic, and respiratory failure during the follow-up was similar in both groups. The 30-day and one-year survival were similar in both groups. CONCLUSION: LIS for implantation of a durable LVAD in patients on va-ECLS implanted for cardiogenic shock is associated with less revision due to bleeding, less administration of blood products and absence of perioperative stroke, with no impact on survival.