Publications by authors named "Federico Pappalardo"

195 Publications

Metabolomic profile of patients with left ventricular assist devices: a pilot study.

Ann Cardiothorac Surg 2021 Mar;10(2):240-247

Anesthesia and Intensive Care, IRCCS ISMETT, UPMC Italy, Palermo, Italy.

Background: Metabolomic profiling has important diagnostic and prognostic value in heart failure (HF). We investigated whether left ventricular assist device (LVAD) support has an impact on the metabolomic profile of chronic HF patients and if specific metabolic patterns are associated with the development of adverse events.

Methods: We applied untargeted metabolomics to detect and analyze molecules such as amino acids, sugars, fatty acids and other metabolites in plasma samples collected from thirty-three patients implanted with a continuous-flow LVAD. Data were analyzed at baseline, i.e., before implantation of the LVAD, and at long-term follow-up.

Results: Our results reveal significant changes in the metabolomic profile after LVAD implant compared to baseline. In detail, we observed a pre-implant reduction in amino acid metabolism (aminoacyl-tRNA biosynthesis) and increased galactose metabolism, which reversed over the course of support [median follow-up 187 days (63-334 days)]. These changes were associated with improved patient functional capacity driven by LVAD therapy, according to NYHA functional classification of HF (NYHA class I-II: pre-implant =0% of the patients; post-implant =97% of the patients; P<0.001). Moreover, patients who developed adverse thromboembolic events (n=4, 13%) showed a pre-operative metabolomic fingerprint mainly associated with alterations of fatty acid biosynthesis and mitochondrial beta-oxidation of short-chain saturated fatty acids.

Conclusions: Our data provide preliminary evidence that LVAD therapy is associated with changes in the metabolomic profile of HF and suggest the potential use of metabolomics as a new tool to stratify LVAD patients in regard to the risk of adverse events.
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http://dx.doi.org/10.21037/acs-2020-cfmcs-117DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8033252PMC
March 2021

Weaning from Impella and mobilization of Impella patients.

Eur Heart J Suppl 2021 Mar 27;23(Suppl A):A41-A45. Epub 2021 Mar 27.

Department of Anesthesia and Intensive Care, IRCCS ISMETT, UPMC Italy, Via Ernesto Tricomi 5, 90127 Palermo, Italy.

Weaning of patients from Impella is complex and includes evaluation of the underlying disease, which is essential for estimating the potential for heart recovery. Monitoring during the weaning phase with echocardiography and pulmonary artery catheters will be discussed, as well as the use of intravenous and oral heart failure drugs. Patients who are candidates for weaning must be stable, without inotropes, and must have recovered from acute end-organ damage. Coronary artery disease and valvular heart diseases should be appropriately addressed before weaning to take the maximum advantage of haemodynamic stability provided by the support and to maximize the possibility of weaning. Tips and tricks for the mobilization of Impella patients will also be discussed.
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http://dx.doi.org/10.1093/eurheartj/suab008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8005888PMC
March 2021

Escalation and de-escalation of mechanical circulatory support in cardiogenic shock.

Eur Heart J Suppl 2021 Mar 27;23(Suppl A):A35-A40. Epub 2021 Mar 27.

Department of Anesthesia and Intensive Care, IRCCS ISMETT, UPMC Italy, Via Ernesto Tricomi 5, 90127 Palermo, Italy.

Cardiogenic shock (CS) is a clinical entity that includes a wide spectrum of different scenarios. Mechanical circulatory support (MCS) plays a fundamental role in the contemporary treatment of CS, and is a key element in determining optimal treatment in this complex population. Cardiac support with mechanical devices should allow reduction and complete weaning from inotropes. Persistence of elevated left ventricular (LV) filling pressures, pulmonary congestion, metabolic decompensation, and end-organ damage during current MCS are criteria for MCS escalation. Precise diagnosis of the underlying cause of right ventricular () is fundamental for undertaking the correct escalation strategy. In the setting of both MCS escalation and de-escalation, it is important to select a strategy in relation to long-term perspectives (bridge-to-recovery, bridge-to-LV assist device, or bridge-to-heart transplantation). Small retrospective studies have demonstrated that the BiPella approach is feasible, reduces cardiac filling pressures and improves cardiac output across a range of causes of CS. Simultaneous LV and RV device implantation and lower RV afterload may be associated with better outcomes in biventricular CS, but prospective studies are still required.
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http://dx.doi.org/10.1093/eurheartj/suab007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8005884PMC
March 2021

Pump flow setting and assessment of unloading in clinical practice.

Eur Heart J Suppl 2021 Mar 27;23(Suppl A):A23-A26. Epub 2021 Mar 27.

Department of Anesthesia and Intensive Care, IRCCS ISMETT, UPMC Italy, Via Ernesto Tricomi, 5, 90127 Palermo, Italy.

The rationale for mechanical circulatory support (MCS) in cardiogenic shock is to restore cardiac output in selected patients when critically low or in case of refractory cardiac arrest. Furthermore, an MCS device that moves blood from either the left atrium or the left ventricle to the systemic circulation will potentially unload the ventricle. These devices are used alone or in combination with venoarterial extracorporeal membrane oxygenation (VA-ECMO). If a left-sided Impella device is used, it should be run at the highest possible performance level during treatment while avoiding suction events. When combined with VA-ECMO, the Impella device should be run at a lower performance level, ensuring sufficient left ventricular emptying but avoiding suction. Continuous monitoring is pivotal and patients managed outside the catheterization laboratory should be monitored with an arterial line, a central venous catheter, frequent use of pulmonary artery catheters and regular imaging by transthoracic echocardiogram.
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http://dx.doi.org/10.1093/eurheartj/suab004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8005883PMC
March 2021

Intensive care unit management of percutaneous mechanical circulatory supported patients: the role of imaging.

Eur Heart J Suppl 2021 Mar 27;23(Suppl A):A15-A22. Epub 2021 Mar 27.

Department of Anesthesia and Intensive Care, IRCCS ISMETT, UPMC Italy, Via Ernesto Tricomi 5, 90127 Palermo, Italy.

The clinical management of patients on Impella support requires multimodality monitoring and imaging. Upon intensive care unit admission, echocardiography is essential to ensure correct pump positioning/guide repositioning, to monitor acute myocardial infarction/device-related cardiac complications and to evaluate baseline left and right ventricular function. Over time, the echocardiographic assessment of myocardial viability has become an essential target for guiding mechanical circulatory support escalation and long-term strategies. The recognition and grading of any valvular dysfunction and damage in Impella patients are challenging, as the device interferes with the colour Doppler signal, and the loading conditions of the left ventricle are modified by the pump. Valvular disease in such patients is often secondary, and correct identification is pivotal for future therapeutic strategies. The emerging use of newer techniques, including speckle-tracking echocardiography, is of increasing interest in the imaging of critically ill patients.
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http://dx.doi.org/10.1093/eurheartj/suab003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8005892PMC
March 2021

STATUS QUO 2020: what have we learned so far in temporary mechanical circulatory support? Use of Impella beyond the cathlab: open issues and clinical needs.

Eur Heart J Suppl 2021 Mar 27;23(Suppl A):A1-A2. Epub 2021 Mar 27.

Department of Cardiology, Odense University Hospital and Cardiac Intensive Care Unit, Heart Center, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej, DK - 2100 Copenhagen, Denmark.

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http://dx.doi.org/10.1093/eurheartj/suab005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8005881PMC
March 2021

Endocrine Challenges in Patients with Continuous-Flow Left Ventricular Assist Devices.

Nutrients 2021 Mar 5;13(3). Epub 2021 Mar 5.

Department of Anesthesia and Intensive Care, IRCCS-ISMETT (Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione), 90133 Palermo, Italy.

Heart failure (HF) remains a leading cause of morbidity, hospitalization, and mortality worldwide. Advancement of mechanical circulatory support technology has led to the use of continuous-flow left ventricular assist devices (LVADs), reducing hospitalizations, and improving quality of life and outcomes in advanced HF. Recent studies have highlighted how metabolic and endocrine dysfunction may be a consequence of, or associated with, HF, and may represent a novel (still neglected) therapeutic target in the treatment of HF. On the other hand, it is not clear whether LVAD support, may impact the outcome by also improving organ perfusion as well as improving the neuro-hormonal state of the patients, reducing the endocrine dysfunction. Moreover, endocrine function is likely a major determinant of human homeostasis, and is a key issue in the recovery from critical illness. Care of the endocrine function may contribute to improving cardiac contractility, immune function, as well as infection control, and rehabilitation during and after a LVAD placement. In this review, data on endocrine challenges in patients carrying an LVAD are gathered to highlight pathophysiological states relevant to this setting of patients, and to summarize the current therapeutic suggestions in the treatment of thyroid dysfunction, and vitamin D, erythropoietin and testosterone administration.
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http://dx.doi.org/10.3390/nu13030861DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7999433PMC
March 2021

Timing of Impella implantation and outcomes in cardiogenic shock or high-risk percutaneous coronary revascularization.

Catheter Cardiovasc Interv 2021 Apr 1. Epub 2021 Apr 1.

Division of cardiology, Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.

Objective: To evaluate the role of the microaxial percutaneous mechanical circulatory support device (Impella® pump) implantation pre-percutaneous coronary intervention (PCI) versus during/after PCI in cardiogenic shock (CS) and high-risk PCI populations.

Background: A better understanding of the safety and effectiveness of the Impella and the role of timing of this support initiation in specific clinical settings is of utmost clinical relevance.

Methods: A total of 365 patients treated with Impella 2.5/CP in the 17 centers of the IMP-IT Registry were included. Through propensity-score weighting (PSW) analysis, 1-year clinical outcomes were assessed separately in CS and HR-PCI patients, stratified by timing of Impella support.

Results: Pre-procedural insertion was associated with an improvement in 1-year survival in patients with CS due to acute myocardial infarction (AMI) treated with PCI (p = .04 before PSW, p = .009 after PSW) and HR-PCI (p < .01 both before and after PSW). Among patients undergoing HR-PCI, early Impella support was also associated with a lower rate of the composite of mortality, re-hospitalization for heart failure, and need for left-ventricular assist device/heart transplantation at 1-year (p = .04 before PSW, p = .01 after PSW). Furthermore, Impella use during/after PCI was associated with an increased in-hospital life-threatening and severe bleeding among patients with AMI-CS receiving PCI (7 vs. 16%, p = .1) and HR-PCI (1 vs. 9%, p = .02).

Conclusions: Our findings suggested a survival benefit and reduced rates of major bleeding when a pre-PCI Impella implantation instead of during-after procedure was used in the setting of HR-PCI and AMI-CS.
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http://dx.doi.org/10.1002/ccd.29674DOI Listing
April 2021

Impact of CytoSorb on kinetics of vancomycin and bivalirudin in critically ill patients.

Artif Organs 2021 Mar 9. Epub 2021 Mar 9.

Department of Anesthesia and Intensive Care, IRCCS ISMETT, UPMC Italy, Palermo, Italy.

CytoSorb is a promising tool to treat severe inflammatory status with multiple mechanisms in the acute care setting. Its effect on drugs is, however, poorly documented in vivo, although removal of small molecules might translate into decreased blood levels of life-saving medications. The aim of this study was to assess the impact of CytoSorb on vancomycin and bivalirudin clearance in a large population of critically ill patients. We performed a single-center analysis of CytoSorb treatments performed between January 2018 and March 2019 in critically ill patients admitted to our intensive care unit. A total of 109 CytoSorb treatments were performed in 89 patients. A decrease in lactate dehydrogenase (P = .007), troponin T (P = .022), and creatine phosphokinase (P = .013) was reported during treatment. Vancomycin dose required significant adjustments during treatment (P < .001), but no significant change was necessary after the first 3 days. Similarly, the requirements of bivalirudin significantly changed over days (P < .001), but no dose adjustment was needed after the first 3 days of treatment. No differences in terms of vancomycin and bivalirudin dose need was observed between patients on extracorporeal membrane oxygenation and those who were not (P = .6 and P = .6, respectively), between patients with and without continuous veno-venous hemofiltration (P = .9 and P = .9, respectively), and between CytoSorb responders or not (P = .4 and P = .7, respectively). CytoSorb is effective in mitigating the systemic inflammatory response and safe with respect to vancomycin and bivalirudin administration. These preliminary data further support the use of CytoSorb as adjunct therapy in critically ill patients.
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http://dx.doi.org/10.1111/aor.13952DOI Listing
March 2021

Outcome Prediction in Patients with Severe COVID-19 Requiring Extracorporeal Membrane Oxygenation-A Retrospective International Multicenter Study.

Membranes (Basel) 2021 Feb 27;11(3). Epub 2021 Feb 27.

Department of Medicine III (Interdisciplinary Medical Intensive Care), Medical Center, Faculty of Medicine, University of Freiburg, Hugstetter Strasse 55, 79106 Freiburg, Germany.

The role of veno-venous extracorporeal membrane oxygenation therapy (V-V ECMO) in severe COVID-19 acute respiratory distress syndrome (ARDS) is still under debate and conclusive data from large cohorts are scarce. Furthermore, criteria for the selection of patients that benefit most from this highly invasive and resource-demanding therapy are yet to be defined. In this study, we assess survival in an international multicenter cohort of COVID-19 patients treated with V-V ECMO and evaluate the performance of several clinical scores to predict 30-day survival.

Methods: This is an investigator-initiated retrospective non-interventional international multicenter registry study (NCT04405973, first registered 28 May 2020). In 127 patients treated with V-V ECMO at 15 centers in Germany, Switzerland, Italy, Belgium, and the United States, we calculated the Sequential Organ Failure Assessment (SOFA) Score, Simplified Acute Physiology Score II (SAPS II), Acute Physiology And Chronic Health Evaluation II (APACHE II) Score, Respiratory Extracorporeal Membrane Oxygenation Survival Prediction (RESP) Score, Predicting Death for Severe ARDS on V‑V ECMO (PRESERVE) Score, and 30-day survival.

Results: In our study cohort which enrolled 127 patients, overall 30-day survival was 54%. Median SOFA, SAPS II, APACHE II, RESP, and PRESERVE were 9, 36, 17, 1, and 4, respectively. The prognostic accuracy for all these scores (area under the receiver operating characteristic-AUROC) ranged between 0.548 and 0.605.

Conclusions: The use of scores for the prediction of mortality cannot be recommended for treatment decisions in severe COVID-19 ARDS undergoing V-V ECMO; nevertheless, scoring results below or above a specific cut-off value may be considered as an additional tool in the evaluation of prognosis. Survival rates in this cohort of COVID-19 patients treated with V‑V ECMO were slightly lower than those reported in non-COVID-19 ARDS patients treated with V-V ECMO.
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http://dx.doi.org/10.3390/membranes11030170DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7997249PMC
February 2021

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

J Card Surg 2021 Apr 5;36(4):1344-1351. Epub 2021 Feb 5.

Department of Cardiac Surgery, Leipzig Heart Center, Leipzig, Germany.

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.
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http://dx.doi.org/10.1111/jocs.15401DOI Listing
April 2021

MitraBridge and left ventricular assist device: Crossing dangerous bridges.

J Heart Lung Transplant 2021 Apr 21;40(4):316-317. Epub 2021 Jan 21.

Division of Cardiology, New York Presbiterian Hospital, Columbia University, New York, New York.

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http://dx.doi.org/10.1016/j.healun.2021.01.004DOI Listing
April 2021

Multitarget Approach to Cardiogenic Shock after Acute Myocardial Infarction: Extracorporeal Life Support (ECLS) and Beyond.

Membranes (Basel) 2021 Jan 27;11(2). Epub 2021 Jan 27.

Cardiothoracic Center, Department of Anesthesia and Intensive Care, Istituto Clinico Sant'Ambrogio, 20149 Milan, Italy.

Cardiogenic shock following acute myocardial infarction is associated with high mortality, substantially unchanged for the previous 20 years. Several approaches have been sought to achieve a therapeutic breakthrough, from myocardial revascularization strategies to the use of mechanical circulatory support. Many issues are, as yet, unresolved. Systemic inflammation seems to play a key role but is still lacking in effective therapies, and is potentially compounded by the death spiral of hypoperfusion and/or artificial devices. In this review, a multitarget approach to cardiogenic shock following acute myocardial infarction is proposed.
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http://dx.doi.org/10.3390/membranes11020087DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7911652PMC
January 2021

Early Findings after Implementation of Veno-Arteriovenous ECMO: A Multicenter European Experience.

Membranes (Basel) 2021 Jan 22;11(2). Epub 2021 Jan 22.

Department of Intensive Care, Erasme Hospital, Université Libre de Bruxelles, Route de Lennik, 808, B-1070 Brussels, Belgium.

Extracorporeal membrane oxygenation (ECMO) is increasingly used to treat cardiopulmonary failure in critically ill patients. Peripheral cannulation may be complicated by a persistent low cardiac output in case of veno-venous cannulation (VV-ECMO) or by differential hypoxia (e.g., lower PaO in the upper than in the lower body) in case of veno-arterial cannulation (VA-ECMO) and severe impairment of pulmonary function associated with cardiac recovery. The treatment of such complications remains challenging. We report the early effects of the use of veno-arterial-venous (V-AV) ECMO in this setting.

Methods: Retrospective analysis including patients from five different European ECMO centers (January 2013 to December 2016) who required V-AV ECMO. We collected demographic data as well as comorbidities and ECMO characteristics, hemodynamics, and arterial blood gas values before and immediately after (i.e., within 2 h) V-AV implementation.

Results: A total of 32 patients (age 53 (interquartiles, IQRs: 31-59) years) were identified: 16 were initially supported with VA-ECMO and 16 with VV-ECMO. The median time to V-AV conversion was 2 (1-5) days. After V-AV implantation, heart rate and norepinephrine dose significantly decreased, while PaO and SaO significantly increased compared to baseline values. Lactate levels significantly decreased from 3.9 (2.3-7.1) to 2.8 (1.4-4.4) mmol/L ( = 0.048). A significant increase in the overall ECMO blood flow (from 4.5 (3.8-5.0) to 4.9 (4.3-5.9) L/min; < 0.01) was observed, with 3.0 (2.5-3.2) L/min for the arterial and 2.8 (2.1-3.6) L/min for the venous return flows.

Conclusions: In ECMO patients with differential hypoxia or persistently low cardiac output syndrome, V-AV conversion was associated with improvement in some hemodynamic and respiratory parameters. A significant increase in the overall ECMO blood flow was also observed, with similar flow distributed into the arterial and venous return cannulas.
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http://dx.doi.org/10.3390/membranes11020081DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7912524PMC
January 2021

Validation of Prognostic Scores in Extracorporeal Life Support: A Multi-Centric Retrospective Study.

Membranes (Basel) 2021 Jan 24;11(2). Epub 2021 Jan 24.

Department of Internal Medicine II, University Hospital Regensburg, 93053 Regensburg, Germany.

Multiple prognostic scores have been developed for both veno-arterial (VA) and veno-venous (VV) extracorporeal membrane oxygenation (ECMO), mostly in single-center cohorts. The aim of this study was to compare and validate different prediction scores in a large multicenter ECMO-population.

Methods: Data from five ECMO centers included 300 patients on VA and 329 on VV ECMO support (March 2008 to November 2016). Different prognostic scores were compared between survivors and non-survivors: APACHE II, SOFA, SAPS II in all patients; SAVE, modified SAVE and MELD-XI in VA ECMO; RESP, PRESET, ROCH and PRESERVE in VV ECMO. Model performance was compared using receiver-operating-curve analysis and assessment of model calibration. Survival was assessed at intensive care unit discharge.

Results: The main indication for VA ECMO was cardiogenic shock; overall survival was 51%. ICU survivors had higher Glasgow Coma Scale scores and pH, required cardiopulmonary resuscitation (CPR) less frequently, had lower lactate levels and shorter ventilation time pre-ECMO at baseline. The best discrimination between survivors and non-survivors was observed with the SAPS II score (area under the curve [AUC] of 0.73 (95% CI 0.67-0.78)). The main indication for VV ECMO was pneumonia; overall survival was 60%. Lower PaCO, higher pH, lower lactate and lesser need for CPR were observed among survivors. The best discrimination between survivors and non-survivors was observed with the PRESET score (AUC 0.66 (95% CI 0.60-0.72)).

Conclusion: The prognostic performance of most scores was moderate in ECMO patients. The use of such scores to decide about ECMO implementation in potential candidates should be discouraged.
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http://dx.doi.org/10.3390/membranes11020084DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7912316PMC
January 2021

Early intra-aortic balloon pump in acute decompensated heart failure complicated by cardiogenic shock: Rationale and design of the randomized Altshock-2 trial.

Am Heart J 2021 03 16;233:39-47. Epub 2020 Dec 16.

Department of Anesthesia and Intensive Care, IRCCS ISMETT, UPMC Italy, Palermo, Italy.

Background: Cardiogenic shock (CS) is a systemic disorder associated with dismal short-term prognosis. Given its time-dependent nature, mechanical circulatory support may improve survival. Intra-aortic balloon pump (IABP) had gained widespread use because of the easiness to implant and the low rate of complications; however, a randomized trial failed to demonstrate benefit on mortality in the setting of acute myocardial infarction. Acute decompensated heart failure with cardiogenic shock (ADHF-CS) represents a growing resource-intensive scenario with scant data and indications on the best management. However, a few data suggest a potential benefit of IABP in this setting. We present the design of a study aimed at addressing this research gap.

Methods And Design: The Altshock-2 trial is a prospective, randomized, multicenter, open-label study with blinded adjudicated evaluation of outcomes. Patients with ADHF-CS will be randomized to early IABP implantation or to vasoactive treatments. The primary end point will be 60 days patients' survival or successful bridge to heart replacement therapy. The key secondary end point will be 60-day overall survival; 60-day need for renal replacement therapy; in-hospital maximum inotropic score, maximum duration of inotropic/vasopressor therapy, and maximum sequential organ failure assessment score. Safety end points will be in-hospital occurrence of bleeding events (Bleeding Academic Research Consortium >3), vascular access complications and systemic (noncerebral) embolism. The sample size for the study is 200 patients.

Implications: The Altshock-2 trial will provide evidence on whether IABP should be implanted early in ADHF-CS patients to improve their clinical outcomes.
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http://dx.doi.org/10.1016/j.ahj.2020.11.017DOI Listing
March 2021

Transition From Temporary to Durable Circulatory Support Systems.

J Am Coll Cardiol 2020 12;76(25):2956-2964

Department of Cardiovascular and Thoracic Surgery, Heart and Diabetes Center NRW, Bad Oeynhausen, Germany.

Background: The decision to implant durable mechanical circulatory systems (MCSs) in patients on extracorporeal life support (ECLS) is challenging due to expected poor outcomes in these patients.

Objectives: The aim of this study was to identify outcome predictors that may facilitate future patient selection and decision making.

Methods: The Durable MCS after ECLS registry is a multicenter retrospective study that gathered data on consecutive patients who underwent MCS implantation after ECLS between January 2010 and August 2018 in 11 high-volume European centers. Several perioperative parameters were collected. The primary endpoint was survival at 1 year after durable MCS implantation.

Results: A total of 531 durable MCSs after ECLS were implanted during this period. The average patient age was 53 ± 12 years old. ECLS cannulation was peripheral in 87% of patients and 33% of the patients had history of cardiopulmonary resuscitation before ECLS implantation. The 30-day, 1-year, and 3-year actuarial survival rates were 77%, 53%, and 43%, respectively. The following predictors for 1-year outcome have been observed: age, female sex, lactate value, Model of End-Stage Liver Disease XI score, history of atrial fibrillation, redo surgery, and body mass index >30 kg/m. On the basis of this data, a risk score and an app to estimate 1-year mortality was created.

Conclusions: The outcome in patients receiving durable MCS after ECLS remains limited, yet preoperative factors may allow differentiating futile patients from those with significant survival benefit.
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http://dx.doi.org/10.1016/j.jacc.2020.10.036DOI Listing
December 2020

Impella 5.0 supported oncological surgery as bridge to LVAD.

ESC Heart Fail 2021 Feb 7;8(1):167-170. Epub 2020 Nov 7.

Advanced Heart Failure and Mechanical Circulatory Support Program, San Raffaele Scientific Institute, Milan, Italy.

We describe the case of a 58-year-old man presenting with myocardial infarction complicated by cardiogenic shock, treated with Impella CP which was escalated to an axillary 5.0 due to lack of cardiac recovery. Weaning from Impella 5.0 failed, and the patient was evaluated for heart transplantation (HTx) or left ventricular assist device (LVAD). HTx was excluded because of a rectal adenocarcinoma. The patient underwent colorectal surgery while on Impella. Perioperative course was uneventful. After 61 days of Impella, when the LVAD implantation was scheduled, the patient died due to K. pneumoniae infection.
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http://dx.doi.org/10.1002/ehf2.12758DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7835545PMC
February 2021

Inflow cannula obstruction of the HeartWare left ventricular assist device: what do we really know?

Cardiovasc Pathol 2021 Jan - Feb;50:107299. Epub 2020 Oct 17.

Università Vita Salute San Raffaele, Milano, Italy; Anesthesia and Intensive Care, San Raffaele Scientific Institute, Milano, Italy. Electronic address:

In the setting of HeartWare left ventricular assist device (HVAD, Medtronic) implantation, pre-pump blood flow obstruction has been described due to intraventricular thrombus formation occluding the inflow cannula. This phenomenon often evolves in suboptimal pump performance, and requires prompt management to prevent its progression. However, to date, effective strategies and tools for the diagnosis and management of this complication are poorly described. We report a case of HVAD inflow cannula obstruction that drove later in-pump thrombosis and, eventually, complete cannula occlusion, and discuss gap of knowledge and limitations of currently available diagnostic and therapeutic tools in this scenario. Furthermore, we reinforce the value of time-frequency analysis of the HVAD log files to early identify abnormal pump operation associated with inflow cannula obstruction despite unremarkable trends of pump parameters.
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http://dx.doi.org/10.1016/j.carpath.2020.107299DOI Listing
December 2020

Thrombotic Risk of Rotor Speed Modulation Regimes of Contemporary Centrifugal Continuous-flow Left Ventricular Assist Devices.

ASAIO J 2020 Oct 15. Epub 2020 Oct 15.

Univeristà Vita Salute San Raffaele, Milano, Italy.

Contemporary centrifugal continuous-flow left ventricular assist devices (LVADs) incorporate dynamic speed modulation algorithms. Hemocompatibility of these periodic unsteady pump operating conditions has been only partially explored. We evaluated whether speed modulation induces flow alterations associated with detrimental prothrombotic effects. For this aim, we evaluated the thrombogenic profile of the HeartWare ventricular assist device (HVAD) Lavare Cycle (LC) and HeartMate3 (HM3) artificial pulse (AP) via comprehensive numerical evaluation of (i) pump washout, (ii) stagnation zones, (iii) shear stress regimens, and (iv) modeling of platelet activation status via the platelet activity state (PAS) model. Data were compared between different simulated operating scenarios, including: (i) constant rotational speed and pump pressure head, used as reference; (ii) unsteady pump pressure head as induced by cardiac pulsatility; and (iii) unsteady rotor speed modulation of the LC (HVAD) and AP (HM3). Our results show that pump washout did not improve across the different simulated scenarios in neither the HVAD nor the HM3. The LC reduced but did not eliminate flow stagnation (-57%) and did not impact metrics of HVAD platelet activation (median PAS: +0.4%). The AP reduced HM3 flow stagnation by up to 91% but increased prothrombotic shear stress and simulated platelet activation (median PAS: +124%). Our study advances understanding of the pathogenesis of LVAD thrombosis, suggesting mechanistic implications of rotor speed modulation. Our data provide rationale criteria for the future design optimization of next generation LVADs to further reduce hemocompatibility-related adverse events.
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http://dx.doi.org/10.1097/MAT.0000000000001297DOI Listing
October 2020

Transcatheter Mitral Valve Repair in Cardiogenic Shock and Mitral Regurgitation: A Patient-Level, Multicenter Analysis.

JACC Cardiovasc Interv 2021 01 14;14(1):1-11. Epub 2020 Oct 14.

Department of Cardiac Surgery, San Raffaele Scientific Institute, Milan, Italy.

Objectives: The aim of this study was to evaluate the outcome of transcatheter mitral valve repair (TMVr) in patients with cardiogenic shock and significant mitral regurgitation (MR).

Background: Patients in cardiogenic shock with severe MR have a poor prognosis in the setting of conventional medical therapy. Because of its favorable safety profile, TMVr is being increasingly used as an acute therapy in this population, though its efficacy remains unknown.

Methods: A multicenter, collaborative, patient-level analysis was conducted. Patients with cardiogenic shock and moderate to severe (3+) or severe (4+) MR who were not surgical candidates were treated with TMVr. The primary outcome was in-hospital mortality. Secondary outcomes included 90-day mortality, heart failure (HF) hospitalization, and the combined event rate of 90-day mortality and HF hospitalization following dichotomization by TMVr device success.

Results: Between January 2011 and February 2019, 141 patients across 14 institutions met the inclusion criteria. In-hospital mortality occurred in 22 patients (15.6%), at 90 days in 38 patients (29.5%), and at one year in 55 patients (42.6%). Median length of hospital stay following TMVr was 10 days (interquartile range: 6 to 20 days). HF hospitalization occurred in 26 patients (18.4%) at a median of 73 days (interquartile range: 26 to 546 days). When stratified by TMVr procedural results, successful TMVr reduced rates of in-hospital mortality (hazard ratio [HR]: 0.36; 95% confidence interval [CI]: 0.13 to 0.98; p = 0.04), 90-day mortality (HR: 0.36; 95% CI: 0.16 to 0.78; p = 0.01), and the composite of 90-day mortality and HF hospitalization (HR: 0.41; 95% CI: 0.19 to 0.90; p = 0.03).

Conclusions: TMVr may improve short- and intermediate-term mortality in high-risk patients with cardiogenic shock and moderate to severe MR. Randomized studies are needed to definitively establish MR as a therapeutic target in patients with cardiogenic shock.
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http://dx.doi.org/10.1016/j.jcin.2020.08.037DOI Listing
January 2021

Left Ventricular Unloading Is Associated With Lower Mortality in Patients With Cardiogenic Shock Treated With Venoarterial Extracorporeal Membrane Oxygenation: Results From an International, Multicenter Cohort Study.

Circulation 2020 Dec 9;142(22):2095-2106. Epub 2020 Oct 9.

German Center for Cardiovascular Research (DZHK), partner site Hamburg/Lübeck/Kiel, Germany (B.S., P.M.B., A.B., S. Blankenberg, S.D., M.E., I.E., D.F., N.F., T.G., P.K., C.N., D.W.).

Background: Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is increasingly used to treat cardiogenic shock. However, VA-ECMO might hamper myocardial recovery. The Impella unloads the left ventricle. This study aimed to evaluate whether left ventricular unloading in patients with cardiogenic shock treated with VA-ECMO was associated with lower mortality.

Methods: Data from 686 consecutive patients with cardiogenic shock treated with VA-ECMO with or without left ventricular unloading using an Impella at 16 tertiary care centers in 4 countries were collected. The association between left ventricular unloading and 30-day mortality was assessed by Cox regression models in a 1:1 propensity score-matched cohort.

Results: Left ventricular unloading was used in 337 of the 686 patients (49%). After matching, 255 patients with left ventricular unloading were compared with 255 patients without left ventricular unloading. In the matched cohort, left ventricular unloading was associated with lower 30-day mortality (hazard ratio, 0.79 [95% CI, 0.63-0.98]; =0.03) without differences in various subgroups. Complications occurred more frequently in patients with left ventricular unloading: severe bleeding in 98 (38.4%) versus 45 (17.9%), access site-related ischemia in 55 (21.6%) versus 31 (12.3%), abdominal compartment in 23 (9.4%) versus 9 (3.7%), and renal replacement therapy in 148 (58.5%) versus 99 (39.1%).

Conclusions: In this international, multicenter cohort study, left ventricular unloading was associated with lower mortality in patients with cardiogenic shock treated with VA-ECMO, despite higher complication rates. These findings support use of left ventricular unloading in patients with cardiogenic shock treated with VA-ECMO and call for further validation, ideally in a randomized, controlled trial.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.048792DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7688081PMC
December 2020

Mechanical circulatory support for ventricular tachycardia ablation: New tools for old patients.

Int J Cardiol 2020 11 3;319:94-95. Epub 2020 Jun 3.

Department of Anesthesia and Intensive Care, Cardiothoracic Center, Istituto Clinico Sant'Ambrogio, Milan, Italy; Chair of Cardiac Surgery, Postgraduate in Cardiac Surgery, University of Milan, Italy.

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http://dx.doi.org/10.1016/j.ijcard.2020.05.063DOI Listing
November 2020

Pressure and flow properties of dual-lumen cannulae for extracorporeal membrane oxygenation.

Perfusion 2020 11 5;35(8):736-744. Epub 2020 Jun 5.

Workgroup on Innovation and Technology in ECLS, EuroELSO, Newcastle upon Tyne, UK.

Introduction: In the last decade, dual-lumen cannulae have been increasingly applied in patients undergoing extracorporeal life support. Well-performing vascular access is crucial for efficient extracorporeal membrane oxygenation support; thus, guidance for proper cannulae size is required. Pressure-flow charts provided by manufacturers are often based on tests performed using water, rarely blood. However, blood is a shear-thinning and viscoelastic fluid characterized by different flow properties than water.

Methods: We performed a study evaluating pressure-flow curves during standardized conditions using human whole blood in two commonly available dual-lumen cannulae used in neonates, pediatric, and adult patients. Results were merged and compared with the manufacturer's corresponding curves obtained from the public domain.

Results: The results showed that using blood as compared with water predominantly influenced drainage flow. A 10-80% higher pressure-drop was needed to obtain same drainage flow (hematocrit of 26%) compared with manufacturer's water charts in 13-31 Fr bi-caval dual-lumen cannulae. The same net difference was found in cavo-atrial cannulae (16-32 Fr), where a lower drainage pressure was required (Hct of 26%) compared with the manufacturer's test using blood with an Hct of 33%. Return pressure-flow data were similar, independent whether pumping blood or water, to the data reported by manufacturers.

Conclusion: Non-standardized testing of pressure-flow properties of extracorporeal membrane oxygenation dual-lumen cannulae prevents an adequate prediction of pressure-flow results when these cannulae are used in patients. Properties of dual-lumen cannulae may vary between sizes within same cannula family, in particular concerning the drainage flow.
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http://dx.doi.org/10.1177/0267659120926009DOI Listing
November 2020

Bedside insertion of impella percutaneous ventricular assist device in patients with cardiogenic shock.

Int J Cardiol 2020 10 28;316:26-30. Epub 2020 May 28.

Department of Anesthesia and Intensive Care, IRCCS ISMETT, UPMC Italy, Via E. Tricomi 5, Palermo, Italy.

Background Bedside insertion of Impella percutaneous ventricular assistant device (pVAD) (Abiomed, Danvers, MA) under transesophageal echocardiographic (TEE) guidance is an attractive strategy enabling lifesaving treatment in patients with cardiogenic shock and who cannot to be transported promptly to the catheterization laboratory (Cathlab). Methods In this retrospective, single-center study, we reviewed all consecutive patients supported with Impella pVAD for CS. We compared the characteristics and outcomes of those who underwent Impella pVAD insertion under fluoroscopic guidance (Fluoro group) in the Cathlab with those who underwent insertion under TEE guidance at bedside (TEE group). Results: Between February 2013 and April 2018, a total of 150 consecutive patients with CS were supported with Impella. Fifty-five (38%) were in TEE group and 95 (62%) in Fluoro group. Impella insertion was successful in all the patients. At the time of Impella insertion patients among the TEE group had higher incidence of refractory hemodynamic collapse (87% vs 53%; p < 0.001) and venoarterial extracorporeal membrane oxygenation (62% vs 35%, p=0.002). In-hospital mortality was significantly higher in the TEE group (55% vs. 31%, p=0.04). Rates of Impella-related complications were not different between the two groups, except for higher requirement for renal replacement therapy in the TEE group (35% vs 17%; p = 0.004). Conclusions Emergent Impella insertion with TEE guidance is feasible, safe and effective in critically ill patients with cardiogenic shock.
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http://dx.doi.org/10.1016/j.ijcard.2020.05.080DOI Listing
October 2020

Mechanical circulatory support for Takotsubo syndrome: a systematic review and meta-analysis.

Int J Cardiol 2020 10 28;316:31-39. Epub 2020 May 28.

Cardiac Arrest Center, Advanced Heart Failure Unit, Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany. Electronic address:

Background: Cardiogenic shock occurs in 10%-15% of patients with Takotsubo syndrome (TS). For several reasons catecholamines, and especially inotropes, should be avoided in TS. Temporary mechanical circulatory support (MCS) appears attractive as bridge-to-recovery, but prospective studies are lacking. Here we analyze the available literature on MCS use in patients with TS.

Methods And Results: PubMed/Medline was systematically screened until December 2019. 18 studies reporting pooled data of 5629 TS patients, of whom 227 had received MCS, were considered for a qualitative synthesis. 81 articles from 2003 through 2019 reporting individual data of 93 MCS cases were included in a meta-analysis. Median age was 57 (IQR: 43-68) years, 83.9% were women, and a physical trigger could be identified in 74.1% of cases. Median left ventricular ejection fraction (LVEF) before MCS was 20% (IQR: 15-25) and comparable between groups defined by MCS device. An apical TS type was present in 76.1% of cases. The overall number of publications on MCS for TS increased over time, as did those using veno-arterial extracorporeal membrane oxygenation (V-A ECMO) and Impella, while those using intra-aortic balloon pump declined. MCS-related complications were not regularly reported. Median time on MCS was 3 (IQR: 2-7) days, with an overall survival of 94.6%.

Conclusions: MCS for TS-related shock is increasingly reported, with a growing use of V-A ECMO and Impella. Currently available clinical data support this approach. Prospective studies are needed to evaluate safety and efficacy of different devices as well as timing of MCS in this special patient population.
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http://dx.doi.org/10.1016/j.ijcard.2020.05.033DOI Listing
October 2020

Reply to the letter to the editor "Implication of Impella 5.0 therapy as a bridge tool from VA-ECMO to durable LVAD therapy".

J Crit Care 2020 12 4;60:348. Epub 2020 May 4.

IRCCS, San Raffaele Scientific Institute, Milan, Italy.

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http://dx.doi.org/10.1016/j.jcrc.2020.04.013DOI Listing
December 2020