Clinical expert consensus document on the use of percutaneous left ventricular assist support devices during complex high-risk indicated PCI: Italian Society of Interventional Cardiology Working Group Endorsed by Spanish and Portuguese Interventional Cardiology Societies

doi:10.1016/j.ijcard.2019.05.065

International Journal of Cardiology

Volume 293, 15 October 2019, Pages 84-90

https://doi.org/10.1016/j.ijcard.2019.05.065 Get rights and content

Highlights

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PCI may be the only option in an increasing number of patients with complex CAD.
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Percutaneous LVAD may effectively support long lasting and/or complicated PCI.
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pLVAD use should be assessed by a multiparametric/disciplinary evaluation.
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This report aim to advise practical suggestions on pLVAD use during high-risk PCI.

Abstract

Percutaneous coronary intervention (PCI) is establishing as the last remaining revascularization option in an increasing number of patients affected by complex coronary artery disease not suitable for surgery. Over the past decade, percutaneous left ventricular assist device (pLVAD) has increasingly replaced intra-aortic balloon pump to provide hemodynamic support during such non-emergent complex high-risk indicated procedures (CHIP) averting the risk of circulatory collapse and of adverse events in long lasting and/or complicated procedures. This review article aims to report the key factors to define CHIP, to summarize the available pLVAD which have CE mark for temporary mechanical LV support and to discuss the rationale of their use in this subset of patients. Based on the expertise of the Italian Society of Interventional Cardiology working group, with the endorsement from Spanish and Portuguese Society of Interventional Cardiology working groups, it will provide several practical suggestions in regards to the use of pLVAD in different clinical CHIP scenarios.

Section snippets

Introduction and objective

Over the past decades the indication for percutaneous coronary interventions (PCI) has progressively widened to involve those patients with high-risk characteristics requiring advanced technologies and longer procedure times. Although the guidelines recommend coronary artery bypass grafting (CABG) for patients with high complexity coronary artery disease (CAD), PCI can represent the last remaining revascularization option in an increasing number of patients not suitable for surgery [1].

Definition of high-risk and protected PCI and the role of the Heart Team

The definition of CHIP has been evolving in the most recent years. There is a growing consensus that in order to define PCI complexity several factors have to be taken into account: hemodynamic status of the patient (shock or severely depressed left-ventricular function), patient clinical characteristics and comorbidities and complexity of coronary anatomies/lesions [3]. High-risk clinical characteristics and comorbidities are defined as: advanced age (>75 years), diabetes mellitus, heart

CE MARK pLVAD and current available evidences

The available pLVAD with CE mark for high surgical risk patients with complex CAD and significantly reduced LVEF are described in details in the Supplementary appendix.

Clinical need and device selection

The physiologic effects of an LV-aortic support, as Impella device, are: first, the unloading of the left ventricle, reducing LV end-diastolic pressure and LV wall tension and decreasing LV work and myocardial oxygen demand (Fig. 2); secondly, it increases the mean arterial pressure, diastolic pressure, cardiac output and thus cardiac power out-put, leading to improved systemic perfusion and increased coronary flow. Differently, the active deflation of the IABP immediately before the onset of

Unprotected left main and severe coronary artery disease (SYNTAX score > 22)

According to current ESC guidelines patients with LM disease and SYNTAX score > 22 have a class IIa recommendation for PCI [1]. A high proportion of patients with distal LM have also MVD and left ventricle dysfunction [13] adding additional risk to the procedure. The higher the syntax score in the context of LM disease, the stronger the indication for myocardial revascularization (either CABG or PCI) over medical treatment [2]. To this regard, although PCI has a class III, level of evidence B

Conclusions

Currently available CE mark pLVADs have shown different efficacy and safety in non-emergent CHIP patients and their specific use should be evaluated on the basis of patient characteristics and clinical conditions assessed by a multidisciplinary team. However, because of the paucity of data, in order to further validate pLVAd in this setting, RCTs and national and international registries with larger number of patients and longer clinical follow up are warranted.

Acknowledgments

None.

Funding

None.

Declaration of Competing Interest

AC and GT received speakers fees from Abiomed and GADA, FB and CT received speaker's fees from Abiomed, Abbott and Medtronic; FP, CB, RG, GM, EN, FR, BCA, ORL, RM, RS, AF, JBS, APDP, GM, GE have no conflicts to declare.

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Cited by (45)

Predictors of Adverse Outcome in High-Risk Percutaneous Coronary Interventions Patients
2023, Canadian Journal of Cardiology
Identifying high-risk percutaneous coronary intervention (PCI) patients is challenging. We aimed to evaluate which high-risk patients are prone to adverse events.
We performed a retrospective study including consecutive high-risk PCIs from 2005 to 2018 in a large tertiary medical centre. Patients with unprotected left main (LM) disease, last patent coronary vessel, or 3-vessel coronary artery disease with left ventricular ejection fraction < 35% were included. A predictive 30-day major adverse cardiac events (MACE) score consisting of any myocardial infarction, all-cause death, or target-vessel revascularisation was constructed.
From 2005 to 2018, a total of 1890 patients who underwent PCI met the predefined high-risk PCI criteria. Mortality rate was 8.8% at 30 days and 20.7% at 1 year, and 30-day MACE rate was 14.2% and 33.5% at 1 year. Predictors of short-term MACE were New York Heart Association functional class (NYHA) 4 (hazard ratio [HR] 6.65; P < 0.001), systolic blood pressure (SBP) < 90 mm Hg (HR 4.93; P < 0.001), creatinine > 1.3 mg/dL (HR 3.57; P < 0.001), hemoglobin < 11.0 g/dL (HR 3.07; P < 0.001), pulmonary artery systolic pressure > 50 mm Hg (HR 2.06; P < 0.001), atrial fibrillation (HR 1.74; P < 0.001), and LM disease (HR 2.04; P < 0.001) or last patent vessel (HR 1.70; P = 0.002). A score constructed from these parameters reached a sensitivity of 90% and a specificity of 81% with areas under the receiver operating characteristic curve of 0.92 for MACE and 0.94 with 89% sensitivity and 87% specificity for all-cause mortality.
Specific features such as LM lesion or last patent conduit, pulmonary hypertension, atrial fibrillation, anemia, and renal failure, along with low SBP and NYHA 4, aid risk stratification and consideration of further treatment measures.
Contexte : Il s’avère difficile de cerner les interventions coronariennes percutanées (ICP) associées à un risque élevé. Notre objectif était donc d’évaluer quels patients sont susceptibles de subir des événements indésirables après une ICP.
Nous avons réalisé une étude rétrospective incluant des ICP consécutives associées à un risque élevé et réalisées entre 2005 et 2018 dans un grand centre médical tertiaire. Les patients présentant une sténose du tronc commun non protégé de l’artère coronaire gauche, une lésion touchant le dernier vaisseau coronaire perméable ou une maladie coronarienne tritronculaire avec fraction d’éjection ventriculaire gauche < 35 % ont été inclus. Un score prédictif d’événements cardiovasculaires indésirables majeurs (ECIM) à 30 jours comprenant l’infarctus du myocarde, le décès toutes causes confondues ou la revascularisation du vaisseau cible a été établi.
De 2005 à 2018, un nombre total de 1 890 patients ayant subi une ICP répondaient aux critères prédéfinis d’ICP associée à un risque élevé. Le taux de mortalité était de 8,8 % à 30 jours et de 20,7 % à 1 an, et le taux d’ECIM était de 14,2 % à 30 jours et de 33,5 % à 1 an. Les facteurs permettant de prédire la survenue d’ECIM à court terme étaient la classe fonctionnelle 4 de la New York Heart Association (NYHA) (rapport des risques instantanés [RRI] : 6,65; P < 0,001), une pression artérielle systolique (PAS) < 90 mmHg (RRI : 4,93; P < 0,001), un taux de créatinine > 1,3 mg/dL (RRI : 3,57; P < 0,001), un taux d’hémoglobine < 11,0 g/dL (RRI : 3,07; P < 0,001), une pression artérielle pulmonaire systolique > 50 mmHg (RRI : 2,06; P < 0,001), la fibrillation auriculaire (RRI : 1,74; P < 0,001), la sténose du tronc commun de l’artère coronaire gauche (RRI : 2,04; P < 0,001) ou une lésion touchant le dernier vaisseau perméable (RRI : 1,70; P = 0,002). Le score établi à partir de ces paramètres a atteint une sensibilité de 90 % et une spécificité de 81 % avec une aire sous la courbe de la fonction d’efficacité du récepteur (ASC-ROC) de 0,92 pour les ECIM, ainsi qu’une sensibilité de 89 % et une spécificité de 87 % pour la mortalité toutes causes confondues avec une ASC-ROC de 0,94.
Des caractéristiques particulières, telles que la sténose du tronc commun de l’artère coronaire gauche ou une lésion touchant le dernier vaisseau perméable, l’hypertension pulmonaire, la fibrillation auriculaire, l’anémie et l’insuffisance rénale, ainsi qu’une faible PAS et la classe 4 de la NYHA, facilitent la stratification des risques et l’examen des mesures thérapeutiques supplémentaires à adopter.
Validation of UK-BCIS CHIP Score to Predict 1-Year Outcomes in a Contemporary United States Population
2023, JACC: Cardiovascular Interventions
A complex high-risk indicated percutaneous coronary intervention (CHIP) score was recently developed from the British Cardiovascular Intervention Society (BCIS) database to define CHIP cases and their risk of in-hospital major adverse cardiac or cerebrovascular events (MACCE).
The authors sought to apply this score to a contemporary U.S. population for the prediction of adverse events at 1 year following percutaneous coronary intervention (PCI).
Consecutive patients undergoing PCI at a large tertiary care center between 2011 and 2020 were considered for inclusion. Patients were categorized into 4 groups based on their BCIS-CHIP score (0, 1-2, 3-4, ≥5). In each category, we assessed the 1-year risk of MACCE, a composite of all-cause death, myocardial infarction, and stroke. Secondary outcomes were the individual components of MACCE, and major bleeding at 1 year.
Among 20,799 patients included, MACCE at 1 year occurred in 1.7% patients with score 0 (reference), 3.0% with score 1 or 2 (HR: 1.72; 95% CI: 1.32-2.24), 6.1% with score 3 or 4 (HR: 3.60; 95% CI: 2.78-4.66), and 12.0% with score ≥5 (HR: 7.40; 95% CI: 5.75-9.51). Each point increase of the BCIS-CHIP score conferred a 28.0% increase of MACCE risk. The BCIS-CHIP score demonstrated good discrimination for the prediction of 1-year MACCE (C-index 0.70). The risk of secondary outcomes also progressively increased with higher score values.
In a large PCI registry, the BCIS-CHIP score had a good predictive value for MACCE at 1 year. The utilization of this score can facilitate an accurate risk stratification of patients undergoing PCI.
Radial vs Femoral Access in ACS Patients Undergoing Complex PCI Is Associated With Consistent Bleeding Benefit and No Excess of Risks
2022, Canadian Journal of Cardiology
Citation Excerpt :
Several studies have recently focused on patients undergoing complex interventions. However, the vast majority of those studies mainly investigated on the optimal revascularisation and/or antithrombotic strategies,8,9,18,19 with significant heterogeneity in the definition of complex PCI. A small number of studies analysed the role of access site selection, in the context of patients with chronic coronary syndrome (CCS) undergoing PCI of CTO, heavily calcified lesions, left main, or complex bifurcations.11
The comparative effectiveness of transradial (TRA) compared with transfemoral (TFA) access in acute coronary syndrome (ACS) patients undergoing complex percutaneous coronary intervention (PCI) remains unclear.
Among 8404 ACS patients in the Minimising Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX (MATRIX)—Access trial, 5233 underwent noncomplex (TRA: n = 2590; TFA: n = 2643) and 1491 complex (TRA: n = 777; TFA: n = 714) PCI. Co-primary outcomes were major adverse cardiovascular events (MACE, the composite of all-cause mortality, myocardial infarction, or stroke) and the composite of MACE and Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding (net adverse cardiovascular events [NACE]) at 30 days.
Rates of 30-day MACE (HR 0.94, 95% CI 0.72-1.22) or NACE (HR 0.89, 95% CI 0.69-1.14) did not significantly differ between groups in the complex PCI group, whereas both primary end points were lower (HR 0.84, 95% CI 0.70-1.00; HR 0.83, 95% CI 0.70-0.98; respectively) with TRA among noncomplex PCI patients, with negative interaction testing (P_int = 0.473 and 0.666, respectively). Access-site BARC type 3 or 5 bleeding was lower with TRA, consistently among complex (HR 0.18, 95% CI 0.05-0.63) and noncomplex (HR 0.41, 95% CI 0.20-0.85) PCI patients, whereas the former group had a greater absolute risk reduction of 1.7% (number needed to treat: 59) owing to their higher absolute risk.
Among ACS patients, PCI complexity did not affect the comparative efficacy and safety of TRA vs TFA, whereas the absolute risk reduction of access-site major bleeding was greater with TRA compared with TFA in complex as opposed to noncomplex PCI.
L'efficacité comparative de l'accès transradial (ATR) par rapport à l'accès transfémoral (ATF) chez les patients souffrant d'un syndrome coronarien aigu (SCA) et subissant une intervention coronarienne percutanée (ICP) complexe reste incertaine.
Parmi les 8404 patients atteints de SCA participant à l'essai MATRIX (Minimising Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX), 5233 ont subi une ICP non complexe (ATR : n = 2590; ATF : n = 2643) et 1491 une ICP complexe (ATR : n = 777; ATF : n = 714). Les principaux indicateurs de résultats étaient les événements cardiovasculaires indésirables majeurs (ECIM, composite de la mortalité toutes causes confondues, de l'infarctus du myocarde ou de l'accident vasculaire cérébral) et le composite des ECIM et des hémorragies de type 3 ou 5 selon le score du Bleeding Academic Research Consortium (BARC) (événements cardiovasculaires indésirables nets [ECIN]) à 30 jours.
Les taux d'ECIM (Rapport des risques instantanés (RRI) 0,94, IC à 95 % 0,72-1,22) ou d'ECIN (RRI 0,89, IC à 95 % 0,69-1,14) à 30 jours n'ont pas différé de manière significative entre les groupes dans le groupe ICP complexe, alors que les deux critères d'évaluation primaires étaient inférieurs (RRI 0,84, IC à 95 % 0,70-1,00; RRI 0,83, IC à 95 % 0,70-0,98; respectivement) via l'ATR chez les patients ICP non complexes, avec un test d'interaction négatif (P_int = 0,473 et 0,666, respectivement). Les hémorragies de type 3 ou 5 du BARC au niveau du site d'accès étaient plus faibles via l'ATR, de manière constante chez les patients ayant subi une ICP complexe (RRI 0,18, IC à 95 % 0,05-0,63) et non complexe (RRI 0,41, IC à 95 % 0,20-0,85), alors que le premier groupe présentait une réduction du risque absolu plus importante de 1,7 % (nombre nécessaire à traiter : 59) en raison de son risque absolu plus élevé.
Chez les patients atteints de SCA, la complexité de l'ICP n'a pas eu d'incidence sur l'efficacité et la sécurité comparatives de l'ATR par rapport à l'ATF, tandis que la réduction du risque absolu d'hémorragie majeure au point d'accès était plus importante avec l'ATR qu'avec l'ATF dans les ICP complexes que dans les ICP non complexes.
Imaging for Temporary Mechanical Circulatory Support Devices
2022, Journal of Cardiothoracic and Vascular Anesthesia
Citation Excerpt :
Temporary MCS devices have been used successfully for high-risk percutaneous coronary interventions (left main equivalent, chronic total occlusion), ablative ventricular arrhythmias procedures, and transcatheter valvular interventions . This has been described specifically with the Tandem Heart, Impella (left-sided), and VA ECMO.9-13 To decompress the left ventricle.
Heart failure is an important cause of mortality and morbidity in the world. Changes in organ allocation for solid thoracic (lung and heart) transplantation has increased the number of patients on mechanical circulatory support. Temporary mechanical support devices include devices tht support the circulation directly or indirectly such as extracorporeal membrane oxygenation (ECMO) and temporary support for right-sided failure, left-sided failure or biventricular failure. Most often, these devices are placed percutaneously and require either guidance with echocardiography, continuous radiography (fluoroscopy) or both. Furthermore, these devices need imaging in the intensive care unit to confirm continued accurate placement. This review contains the imaging views and nuances of the temporary assist devices (including ECMO) at the time of placement and the complications that can be associated with each individual device.
Haemodynamic support during high-risk percutaneous coronary intervention
2022, Archives of Cardiovascular Diseases
Defining Percutaneous Coronary Intervention Complexity and Risk: An Analysis of the United Kingdom BCIS Database 2006-2016
2022, JACC: Cardiovascular Interventions
Citation Excerpt :
It is interesting to observe that use of planned LV support was the factor most strongly associated with in-hospital MACCE, presumably reflecting the underlying comorbidity of the patient such as low EF and multivessel disease including the left main stem. Although guidelines support the use of mechanical LV support during high-risk PCI, the observed reduction in the prevalence of use of planned LV support is likely driven by increasing operator comfort in high-risk PCI over time, a lack of robust clinical evidence supporting their use, cost, and concerns regarding the safety and morbidity of the devices themselves (8,31,32). The inclusion of both anatomical and patient characteristics as markers of risk in our analysis acknowledges that both influence patient outcomes.
The authors used the BCIS (British Cardiovascular Intervention Society) database to define the factors associated with percutaneous coronary intervention (PCI) procedural complexity.
Complex high-risk indicated percutaneous coronary intervention (CHIP-PCI) is an emerging concept that is poorly defined.
The BCIS (British Cardiovascular Intervention Society) database was used to study all PCI procedures in the United Kingdom 2006-2016. A multiple logistic regression model was developed to identify variables associated with in-hospital major adverse cardiac or cerebrovascular events (MACCE) and to construct a CHIP score. The cumulative effect of this score on patient outcomes was examined.
A total of 313,054 patients were included. Seven patient factors (age ≥80 years, female sex, previous stroke, previous myocardial infarction, peripheral vascular disease, ejection fraction <30%, and chronic renal disease) and 6 procedural factors (rotational atherectomy, left main PCI, 3-vessel PCI, dual arterial access, left ventricular mechanical support, and total lesion length >60 mm) were associated with increased in-hospital MACCE and defined as CHIP factors. The mean CHIP score/case for all PCIs increased significantly from 1.06 ± 1.32 in 2006 to 1.49 ± 1.58 in 2016 (P < 0.001 for trend). A CHIP score of 5 or more was present in 2.5% of procedures in 2006 increasing to 5.3% in 2016 (P < 0.001 for trend). Overall in-hospital MACCE was 0.6% when the CHIP score was 0 compared with 1.2% with any CHIP factor present (P < 0.001). As the CHIP score increased, an exponential increase in-hospital MACCE was observed. The cumulative MACCE for procedures associated with a CHIP score 4+ or above was 3.2%, and for a CHIP score 5+ was 4.4%. All other adverse clinical outcomes were more likely as the CHIP score increased.
Seven patient factors and 6 procedural factors were associated with adverse in-hospital MACCE and defined as CHIP factors. Use of a CHIP score might be a future target for risk modification.

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