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Article: Impella as unloading strategy during VA-ECMO: systematic review and meta-analysis.

Fiorelli, Francesca / Panoulas, Vasileios

2021 Volume 22, Issue 4, Page(s) 1503–1511

Abstract: Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is used as mechanical circulatory support in cardiogenic shock (CS). It restores peripheral perfusion, at the expense of increased left ventricle (LV) afterload. In this setting, Impella can be ... ...

Abstract	Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is used as mechanical circulatory support in cardiogenic shock (CS). It restores peripheral perfusion, at the expense of increased left ventricle (LV) afterload. In this setting, Impella can be used as direct unloading strategy. Aim of this meta-analysis was to investigate efficacy and safety of LV unloading with Impella during ECMO in CS. A systematic search on Medline, Scopus and Cochrane Library was performed using as combination of keywords: extracorporeal membrane oxygenation, Impella, percutaneous micro axial pump, ECPELLA, cardiogenic shock. We aimed to include studies, which compared the use of ECMO with and without Impella (ECPELLA vs. ECMO). Primary endpoint was short-term all-cause mortality; secondary endpoints included major bleeding, haemolysis, need for renal replacement therapy (RRT) and cerebrovascular accident (CVA). Five studies met the inclusion criteria, with a total population of 972 patients. The ECPELLA cohort showed improved survival compared to the control group (RR (Risk Ratio): 0.86; 95% CI (Confidence Interval): 0.76, 0.96;
MeSH term(s)	Extracorporeal Membrane Oxygenation/adverse effects ; Heart Ventricles ; Heart-Assist Devices ; Humans ; Shock, Cardiogenic/diagnosis ; Shock, Cardiogenic/therapy ; Stroke
Language	English
Publishing date	2021-12-22
Publishing country	Singapore
Document type	Meta-Analysis ; Systematic Review
ZDB-ID	2108910-3
ISSN	1530-6550
ISSN	1530-6550
DOI	10.31083/j.rcm2204154
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Zs.A 6410: Show issues

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Article: Recognizing patients as candidates for temporary mechanical circulatory support along the spectrum of cardiogenic shock.

Montisci, Andrea / Panoulas, Vasileios / Chieffo, Alaide / Skurk, Carsten / Schäfer, Andreas / Werner, Nikos / Baldetti, Luca / D'Ettore, Nicoletta / Pappalardo, Federico

European heart journal supplements : journal of the European Society of Cardiology

2023 Volume 25, Issue Suppl I, Page(s) I3–I10

Abstract: A growing body of evidence indicates that the benefits of temporary mechanical circulatory support (tMCS) in patients with cardiogenic shock (CS) is dependent on its aetiology and timing of implantation. As such, appropriate diagnosis, screening, ... ...

Abstract	A growing body of evidence indicates that the benefits of temporary mechanical circulatory support (tMCS) in patients with cardiogenic shock (CS) is dependent on its aetiology and timing of implantation. As such, appropriate diagnosis, screening, selection, and treatment is crucial to achieving good outcomes with tMCS. Here, the latest guidance on CS phenotypes and diagnostics for correctly identifying tMCS candidates is discussed. This includes comprehensive overviews of patient screening with attention given to differences in CS presentation between the sexes, and contraindications for mechanical circulatory support.
Language	English
Publishing date	2023-12-13
Publishing country	England
Document type	Journal Article
ZDB-ID	1463769-8
ISSN	1554-2815 ; 1520-765X
ISSN (online)	1554-2815
ISSN	1520-765X
DOI	10.1093/eurheartjsupp/suad127
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Article: From medical therapy to mechanical support: strategies for device selection and implantation techniques.

Bertoldi, Letizia F / Montisci, Andrea / Westermann, Dirk / Iannaccone, Mario / Panoulas, Vasileios / Werner, Nikos / Mangner, Norman

European heart journal supplements : journal of the European Society of Cardiology

2023 Volume 25, Issue Suppl I, Page(s) I11–I18

Abstract: Cardiogenic shock (CS) is a complex clinical syndrome with a high risk of mortality. The recent, rapid development of temporary mechanical circulatory support (tMCS) has altered CS treatment. While catecholamines remain the cornerstone of CS therapy, ... ...

Abstract	Cardiogenic shock (CS) is a complex clinical syndrome with a high risk of mortality. The recent, rapid development of temporary mechanical circulatory support (tMCS) has altered CS treatment. While catecholamines remain the cornerstone of CS therapy, tMCS usage has increased. According to shock severity, different treatment strategies including catecholamines alone, catecholamines and tMCS, or multiple tMCS might be used. State-of-the-art implantation techniques are necessary to avoid complications linked to the invasive nature of tMCS. In particular, bleeding and access-site complications might counteract the potential haemodynamic benefit of a percutaneous ventricular assist device. In this review, we describe the role of catecholamines in CS treatment and present the different tMCS devices with an explanation on how to use them according to CS aetiology and severity. Finally, an overview of the best practice for device implantation is provided.
Language	English
Publishing date	2023-12-13
Publishing country	England
Document type	Journal Article
ZDB-ID	1463769-8
ISSN	1554-2815 ; 1520-765X
ISSN (online)	1554-2815
ISSN	1520-765X
DOI	10.1093/eurheartjsupp/suad128
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Article ; Online: Surgical explant of a right ventricular assist device with sternum-sparing technique.

Monteagudo-Vela, Maria / Panoulas, Vasileios / Riesgo-Gil, Fernando / Simon, Andre

European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery

2019 Volume 58, Issue 1, Page(s) 193–195

Abstract: The use of long-term mechanical assist devices for isolated right ventricular failure is rare. Herein, we describe our protocol for successful recovery of the right ventricle and subsequent explantation of a right ventricular assist device using a ... ...

Abstract	The use of long-term mechanical assist devices for isolated right ventricular failure is rare. Herein, we describe our protocol for successful recovery of the right ventricle and subsequent explantation of a right ventricular assist device using a sternum-sparing technique and insertion of a titanium plug to occlude the coring defect of the inflow cannula.
MeSH term(s)	Device Removal ; Heart Failure/surgery ; Heart Ventricles/diagnostic imaging ; Heart Ventricles/surgery ; Heart-Assist Devices ; Humans ; Sternum/surgery
Language	English
Publishing date	2019-11-16
Publishing country	Germany
Document type	Journal Article
ZDB-ID	639293-3
ISSN	1873-734X ; 1010-7940 ; 1567-4258
ISSN (online)	1873-734X
ISSN	1010-7940 ; 1567-4258
DOI	10.1093/ejcts/ezz352
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Zs.A 2303: Show issues

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Article ; Online: A detailed explantation assessment protocol for patients with left ventricular assist devices with myocardial recovery.

Monteagudo Vela, María / Rial Bastón, Verónica / Panoulas, Vasileios / Riesgo Gil, Fernando / Simon, Andre

Interactive cardiovascular and thoracic surgery

2020 Volume 32, Issue 2, Page(s) 298–305

Abstract: Objectives: Left ventricular assist device (LVAD) implantation for end-stage heart failure patients has been on the rise, providing a reliable long-term option. For some LVAD patients, longer term LV unloading leads to recovery; hence, the need for ... ...

Abstract	Objectives: Left ventricular assist device (LVAD) implantation for end-stage heart failure patients has been on the rise, providing a reliable long-term option. For some LVAD patients, longer term LV unloading leads to recovery; hence, the need for evaluating potential myocardial recovery and weaning eligibility has emerged. Methods: All patients who underwent contemporary LVAD explantation at our institution between 2009 and 2020 were included in the study. Patients in New York Heart Association I, left ventricular ejection fraction >40%, a cardiac index >2.4 l/min and a peak oxygen intake >50% predicted underwent a 4-phase weaning assessment. A minimally invasive approach using a titanium plug was the surgery of choice in the most recent explants. Kaplan-Meier curves were used to estimate the survival at 1 and 5 years. Results: Twenty-six patients (17 HeartMate II, 9 HeartWare) underwent LVAD explantation after a median 317 days of support [IQ (212-518)], range 131-1437. Mean age at explant was 35.8 ± 12.7 years and 85% were males. Idiopathic dilated cardiomyopathy was the underlying diagnosis in 70% of cases. Thirteen (48%) patients were on short-term mechanical circulatory support and 60% required intensive care unit admission prior to the LVAD implantation. At 1 year, Kaplan-Meier estimated survival was 88%, whereas at 6 years, it was 77%. The average left ventricular ejection fraction at 1 year post-explant was 44.25% ± 8.44. Conclusions: The use of a standardized weaning protocol (echocardiographic and invasive) and a minimally invasive LVAD explant technique minimizes periprocedural complications and leads to good long-term device-free survival rates.
MeSH term(s)	Adult ; Cardiomyopathy, Dilated/physiopathology ; Device Removal ; Echocardiography ; Heart Failure/physiopathology ; Heart-Assist Devices ; Humans ; Kaplan-Meier Estimate ; Male ; Middle Aged ; New York ; Stroke Volume ; Treatment Outcome ; Ventricular Function, Left
Language	English
Publishing date	2020-11-20
Publishing country	England
Document type	Journal Article
ZDB-ID	2095298-3
ISSN	1569-9285 ; 1569-9293
ISSN (online)	1569-9285
ISSN	1569-9293
DOI	10.1093/icvts/ivaa259
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Zs.A 5730: Show issues

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Article ; Online: Comparison of mid-term mortality after surgical, supported or unsupported percutaneous revascularization in patients with severely reduced ejection fraction: A direct and network meta-analysis of adjusted observational studies and randomized-controlled.

Iannaccone, Mario / Barbero, Umberto / Franchin, Luca / Montabone, Andrea / De Filippo, Ovidio / D'ascenzo, Fabrizio / Boccuzzi, Giacomo / Panoulas, Vasileios / Hill, Jonathan / Brilakis, Emmanouil S / Chieffo, Alaide

International journal of cardiology

2023 Volume 396, Page(s) 131428

Abstract: Introduction: The optimal revascularization strategy in patients with heart failure with reduced ejection fraction (HFrEF) remains to be elucidated. The aim of this paper is to compare the mid-term mortality rate among patients with severely reduced ... ...

Abstract	Introduction: The optimal revascularization strategy in patients with heart failure with reduced ejection fraction (HFrEF) remains to be elucidated. The aim of this paper is to compare the mid-term mortality rate among patients with severely reduced ejection fraction (EF) and complex coronary artery disease who underwent coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI) with Impella support, or without. Methods: Randomized control trials and propensity-adjusted observational studies including patients with ischemic cardiomyopathy (ICM) and severe EF reduction undergoing revascularization were selected. Different revascularization strategies (CABG, supported PCI, and PCI without Impella) were compared in pairwise and network meta-analysis. The primary endpoint was mid-term mortality (within the first year after revascularization). Results: Fifteen studies, mostly observational (17,841 patients; 6779 patients treated with CABG, 8478 treated with PCI without Impella, and 2584 treated with Impella-supported PCI) were included in this analysis. The median age was 67.8 years (IQR 65-70.1), 21.2% (IQR 16.4-26%) of patients were female sex, and a high prevalence of cardiovascular risk factors was noted across the entire population. At pairwise analysis, CABG and PCI without Impella showed similar one-year all-cause mortality (10.6% [IQR 7.5-12.6%] vs 12% [IQR 8.4-11.5%]) RR 0.85 CI 0.67-1.09, while supported PCI reduced one-year all-cause mortality compared to PCI without Impella (9.4% [IQR 5.7-12.5%] vs 10.6% [IQR 8.9-10.7%]) RR 0.77 CI 0.6-0.89. At network meta-analysis, supported PCI showed better results (RR 0.75, 95% CI 0.59-0.94) compared to CABG. Conclusion: Our analysis found that supported PCI may have a benefit over standard PCI in patients in direct comparison, and over CABG from indirect comparison, and with HFrEF undergoing revascularization. Further RCTs are needed to confirm this result. (PROSPERO CRD42023425667).
MeSH term(s)	Humans ; Female ; Aged ; Male ; Heart Failure ; Percutaneous Coronary Intervention/methods ; Network Meta-Analysis ; Stroke Volume ; Coronary Artery Disease/diagnosis ; Coronary Artery Disease/surgery ; Treatment Outcome ; Observational Studies as Topic
Language	English
Publishing date	2023-10-09
Publishing country	Netherlands
Document type	Meta-Analysis ; Journal Article
ZDB-ID	779519-1
ISSN	1874-1754 ; 0167-5273
ISSN (online)	1874-1754
ISSN	0167-5273
DOI	10.1016/j.ijcard.2023.131428
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Zs.A 1673: Show issues

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Article ; Online: Ten-year improved survival in patients with multi-vessel coronary disease and poor left ventricular function following surgery: A retrospective cohort study.

Cummings, Ian G / Lucchese, Gianluca / Garg, Sheena / Soni, Manish / Majid, Akbar F / Marczin, Nandor / Panoulas, Vasileios / Raja, Shahzad G

International journal of surgery (London, England)

2020 Volume 76, Page(s) 146–152

Abstract: Objective: Patients with multi-vessel coronary artery disease and poor left ventricular (LV) function (ejection fraction [EF] < 30%) requiring revascularization are considered 'high-risk'. Limited long-term survival data exists comparing percutaneous ... ...

Abstract	Objective: Patients with multi-vessel coronary artery disease and poor left ventricular (LV) function (ejection fraction [EF] < 30%) requiring revascularization are considered 'high-risk'. Limited long-term survival data exists comparing percutaneous coronary intervention (PCI) with second-generation drug-eluting stents (DES) versus surgery for this cohort of patients. Methods: We retrospectively reviewed our data for 321 patients with EF < 30% who underwent multi-vessel revascularization from January 2005 to December 2015 using Cox regression analyses and inverse probability treatment weighted (IPTW) methods. We stratified patients that underwent surgical revascularization into on-pump coronary artery bypass grafting (CABG) and off-pump CABG and analyzed all-cause mortality at 10 years compared to PCI. Results: 214 patients underwent CABG (n [on-pump CABG] = 94; n [off-pump CABG] = 120) and 107 patients had PCI with second generation DES. PCI with DES had higher 10-year mortality compared with on-pump CABG (Hazard ratio [HR] = 1.86, 95% confidence interval [CI] = 1.46-2.42; p < 0.001) and off-pump CABG (HR = 2.32, 95% CI = 1.75-3.15; p < 0.001). This was confirmed in IPTW analyses. When adjusting for both measured and unmeasured factors using instrumental variable analyses, PCI with DES had higher 10-year mortality compared with on-pump CABG (Δ = 13.5, 95% CI = 3.2-24.5; p = 0.012) and off-pump CABG (Δ = 16.1, 95% CI = 5.9-25.8; p < 0.001). Conclusion: Surgical revascularization, preferably off-pump CABG, results in better long-term survival compared with PCI using second generation DES for patients with multi-vessel coronary artery disease and poor left ventricular function. Randomized controlled trials in this patient group should be undertaken.
MeSH term(s)	Aged ; Cohort Studies ; Coronary Artery Bypass ; Coronary Artery Bypass, Off-Pump ; Coronary Artery Disease/surgery ; Drug-Eluting Stents ; Female ; Humans ; Male ; Middle Aged ; Percutaneous Coronary Intervention ; Proportional Hazards Models ; Retrospective Studies ; Treatment Outcome ; Ventricular Function, Left
Language	English
Publishing date	2020-03-13
Publishing country	England
Document type	Journal Article
ZDB-ID	2212038-5
ISSN	1743-9159 ; 1743-9191
ISSN (online)	1743-9159
ISSN	1743-9191
DOI	10.1016/j.ijsu.2020.03.008
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Zs.A 6502: Show issues

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Article ; Online: Outcomes of heart transplantation in patients bridged with Impella 5.0: Comparison with native chest transplanted patients without preoperative mechanical circulatory support.

Monteagudo-Vela, María / Panoulas, Vasileios / García-Saez, Diana / de Robertis, Fabio / Stock, Ulrich / Simon, Andre Rudiger

Artificial organs

2020 Volume 45, Issue 3, Page(s) 254–262

Abstract: The Impella (Abiomed, Danvers, MA, USA) has become an important adjunct treatment modality in bridging patients with end-stage heart failure to recovery or orthotopic heart transplantation (HTx). We compared the outcome of patients directly bridged to ... ...

Abstract	The Impella (Abiomed, Danvers, MA, USA) has become an important adjunct treatment modality in bridging patients with end-stage heart failure to recovery or orthotopic heart transplantation (HTx). We compared the outcome of patients directly bridged to HTx with the Impella 5.0 versus patients without mechanical circulatory support (MCS). Patients with no previous sternotomy or MCS, who were transplanted between September 2014 and March 2019 were included in this retrospective analysis. Impella 5.0 was implanted using surgical access and transesophageal echocardiography guidance. Forty-two out of 155 transplanted patients fulfilled the insertion criteria. Eight (19%) were bridged with Impella 5.0 to HTx. Recipient and donor baseline characteristics were comparable in both groups. There were no significant differences in survival between the groups at 30-day (94% no MCS vs. 87.5% Impella group, P = .47) or 6 months (94% vs. 87.5%, P = .51). Patients on Impella 5.0 showed a significant recovery of hemodynamic parameters and end-organ function. Average duration of support to HTx was 16 ± 17 days. Impella 5.0, when used in suitable patients in a timely fashion can be a good strategy for bridging patients to HTx. The axillary approach allows for early extubation and mobilization. Outcomes of patients bridged to HTx with Impella 5.0 in acute cardiogenic shock are comparable to those of patients with no MCS.
MeSH term(s)	Adult ; Aged ; Echocardiography, Transesophageal ; Female ; Follow-Up Studies ; Heart Failure/etiology ; Heart Failure/mortality ; Heart Failure/surgery ; Heart Transplantation/statistics & numerical data ; Heart-Assist Devices/statistics & numerical data ; Humans ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Prosthesis Implantation/methods ; Prosthesis Implantation/statistics & numerical data ; Retrospective Studies ; Shock, Cardiogenic/complications ; Shock, Cardiogenic/mortality ; Shock, Cardiogenic/surgery ; Treatment Outcome ; United Kingdom/epidemiology ; Young Adult
Language	English
Publishing date	2020-10-15
Publishing country	United States
Document type	Comparative Study ; Journal Article
ZDB-ID	441812-8
ISSN	1525-1594 ; 0160-564X
ISSN (online)	1525-1594
ISSN	0160-564X
DOI	10.1111/aor.13816
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Zs.A 1463: Show issues

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Article: Association of individual aortic leaflet calcification on paravalvular regurgitation and conduction abnormalities with self-expanding trans-catheter aortic valve insertion.

Mahon, Ciara / Davies, Allan / Gambaro, Alessia / Musella, Francesca / Costa, Ana Luisa / Panoulas, Vasileios / Nicol, Edward / Duncan, Alison / Davies, Simon / Mirsadraee, Saeed

Quantitative imaging in medicine and surgery

2021 Volume 11, Issue 5, Page(s) 1970–1982

Abstract: Background: Complication rates of paravalvular aortic regurgitation (PVR) and permanent pacemaker insertion remain high in patients undergoing trans-catheter aortic valve insertion for severe aortic stenosis. The spatial distribution of calcium between ... ...

Abstract	Background: Complication rates of paravalvular aortic regurgitation (PVR) and permanent pacemaker insertion remain high in patients undergoing trans-catheter aortic valve insertion for severe aortic stenosis. The spatial distribution of calcium between individual aortic valve leaflets, and its potential role in these complications is gaining interest. We aimed to assess the accuracy of individual aortic valve leaflet calcium quantification, and to determine its effect on the frequency of these complications. Methods: This was a retrospective study of 251 patients who underwent trans-catheter aortic valve insertion using the Evolut RTM valve. The off-line Terarecon software platform was used for Agatston scoring the short axis views. Results: There was a correlation between the sum of the individual leaflet and the total aortic valve calcium score. There was a univariate association between an increase [per 100 Agatston unit (AU)] in both right coronary leaflet (RCL) and left coronary leaflet (LCL) calcium with the risk of PVR. There was an association between an increase in LCL calcium score (per 100 AU) and need for post-implantation balloon aortic valvuloplasty (BAV). There was no association between individual leaflet calcification on the risk of permanent pacemaker insertion. Conclusions: This study supports the idea that a quantifiable and reproducible method of individual valve leaflet calcification score may serve as an independent risk factor for paravalvular regurgitation, beyond visual assessment of asymmetry. However, the same may not be true of spatial calcium distribution and permanent pacemaker implantation (PPI).
Language	English
Publishing date	2021-04-06
Publishing country	China
Document type	Journal Article
ZDB-ID	2653586-5
ISSN	2223-4306 ; 2223-4292
ISSN (online)	2223-4306
ISSN	2223-4292
DOI	10.21037/qims-20-1122
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Article ; Online: Clinical Indications of IMPELLA Short-Term Mechanical Circulatory Support in a Tertiary Centre.

Monteagudo Vela, María / Simon, Andre / Riesgo Gil, Fernando / Rosenberg, Alex / Dalby, Miles / Kabir, Tito / García Saez, Diana / Panoulas, Vasileios

Cardiovascular revascularization medicine : including molecular interventions

2019 Volume 21, Issue 5, Page(s) 629–637

Abstract: Introduction: The Impella family of devices are short-term mechanical circulatory support (MCS) pumps that hold promise in treating patients with acute cardiogenic shock, acting as bridge to recovery, transplant or durable left ventricular assist device. ...

Abstract	Introduction: The Impella family of devices are short-term mechanical circulatory support (MCS) pumps that hold promise in treating patients with acute cardiogenic shock, acting as bridge to recovery, transplant or durable left ventricular assist device. We assessed the clinical utility, indications and outcomes of the Impella family of devices in a tertiary centre. Methods: In the current study we present our initial 2-year experience with different Impella types. We explored the indications for device implantation, initial hemodynamic and biochemical response and mid-term survival. Results: A total of 57 patients underwent Impella implantation; 36 Impella CP, 14 Impella 5.0 and 7 Impella RP. Mean age was 54.2 ± 15.2 whereas 78.9% were males. The main indications for left sided MCS included cardiogenic shock secondary to ACS, decompensated dilated or ischemic end stage cardiomyopathy and myocarditis. Mean LVEF pre-Impella implantation was 23 ± 13.7%. PCI was performed in 24 (54.5%) patients. Main indication for Impella RP was RV failure following LVAD implantation. The median duration of support was 5 days (IQR 1 to 10.5 days). 24 h following Impella implantation, there was significant improvement in all hemodynamic parameters as well as renal and liver function. Patients presenting with INTERMACS I had a 30-day survival of 40% whereas patients with INTEMACS 2 or above had a 30-day survival of 82.4%. Conclusions: The Impella short-term mechanical assist device provides immediate improvement in hemodynamic parameters and end organ function recovery. Patient outcomes are heavily influenced by the stage of shock and the timely insertion of MCS.
MeSH term(s)	Adult ; Aged ; Device Removal ; Female ; Heart Transplantation ; Heart-Assist Devices ; Humans ; Male ; Middle Aged ; Prosthesis Design ; Prosthesis Implantation/adverse effects ; Prosthesis Implantation/instrumentation ; Prosthesis Implantation/mortality ; Recovery of Function ; Retrospective Studies ; Risk Factors ; Shock, Cardiogenic/diagnosis ; Shock, Cardiogenic/mortality ; Shock, Cardiogenic/physiopathology ; Shock, Cardiogenic/therapy ; Stroke Volume ; Tertiary Care Centers ; Time Factors ; Treatment Outcome ; Ventricular Function, Left
Language	English
Publishing date	2019-12-06
Publishing country	United States
Document type	Journal Article
ZDB-ID	2212113-4
ISSN	1878-0938 ; 1553-8389
ISSN (online)	1878-0938
ISSN	1553-8389
DOI	10.1016/j.carrev.2019.12.010
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Zs.A 5562: Show issues

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