Contemporary Evidence in Protected Percutaneous Coronary Intervention: A Case-Based Review

Decades have passed since studies comparing coronary artery bypass grafting (CABG) with medical therapy for multivessel coronary disease indicated a survival advantage of surgery in the subset of patients with significant left ventricular impairment.1–3 These investigations changed the prevailing clinical impression such that severe left ventricular (LV) dysfunction might be an indication for revascularization as opposed to a relative contraindication. Although the studies might currently be deemed obsolete by many measures, they continue to inform societal guidelines with regard to CABG and LV dysfunction.4,5 Recently, the long-term outcomes after the Surgical Treatment for Ischemic Heart Failure (STICH) trial have reinforced the potential benefits of surgical revascularization in patients with congestive heart failure and an ejection fraction of <35%.6 Over the intervening period, numerous trials have compared percutaneous coronary intervention (PCI) with CABG in patients with stable angina and multivessel disease. Aside from diabetes mellitus, the trials by and large have demonstrated equivalence in the end points of death and myocardial infarction. So can one extrapolate equivalence for PCI with CABG in patients with LV dysfunction? The short answer is no. There is scant direct evidence from randomized trials comparing the 2 methods of revascularization because patients with congestive heart failure or severe LV dysfunction have typically been underrepresented or excluded.7–9 Article, see p 2132 Acknowledging the lack of a large randomized evidence base, there are theoretical reasons why PCI might perform less well than CABG in patients with LV dysfunction. PCI, by its nature, addresses short segments of severe stenosis. However surgery will also address the intervening disease that might progress to become culprit lesions in the future.10 This disadvantage of PCI is likely to be particularly important in patients with limited LV reserve who over the longer term …

Aim. To analyze the multicenter international experience of high-risk protected percutaneous coronary intervention (PCI) procedures using the transaortic temporary pulsatile mechanical circulatory support (MCS) device iVAC 2L (PulseCath B. V., Amsterdam, the Netherlands).Material and methods. The pilot prospective-retrospective international multi-center observational study included patients with multivessel and/or complex coronary lesions, indications for coronary revascularization and refusal of the heart team from coronary artery bypass grafting and unprotected PCI due to a high risk of complications. PCI was performed with a temporary MCS using the iVAC 2L device in five clinics in Russia and Belarus.Results. From February 2023 to February 2024, 24 patients were included in the study. The median age was 69,0 years (interquartile range (IQR): 63,5-71,8); 87,5% were men. Twenty patients (83,3%) underwent elective PCI and four patients (16,7%) due to acute coronary syndrome (ACS) as follows: three with non-ST-segment elevation myocardial infarction and one with ST-segment elevation myocardial infarction (STEMI). The patient with STEMI underwent PCI against the background of acute heart failure (AHF). The median MCS time was 66,0 min (IQR: 43,0-98,0). Technical success of PCI was achieved in 100% of patients. The median initial and residual SYNTAX scores were 35,0 (IQR: 25,6-41,4) and 8,0 (IQR: 5,0-17,5), respectively. The median left ventricular ejection fraction before PCI and 7 days after was 44,0% (IQR: 31,0-54,0) and 48,0% (IQR: 36,5-53,5), respectively. In two cases (8,3%), major bleeding from the access site of the MCS device was observed. There were 2 fatal outcomes as follows: during elective PCI due to progression of acute left ventricular failure and in the late period due to septic shock after emergency PCI.Conclusion. PCI with MCP by the iVAC 2L device is an applicable and relatively safe tactic of coronary revascularization in patients with a high risk of complications, including in the conditions of ACS and AHF.

Part 7: The Era of Reperfusion

The intra-aortic balloon pump (IABP) was first introduced into clinical practice in 1968.1 Early experimental and clinical trials suggested that intra-aortic balloon counterpulsation could provide circulatory assistance to a failing left ventricle.2,3 Counterpulsation—balloon inflation during diastole and deflation in systole—augments the intrinsic Windkessel effect, whereby potential energy stored in the aortic root during systole is converted to kinetic energy with the elastic recoil of the aortic root. Counterpulsation leads to a decline in afterload, a reduction in cardiac work, and therefore myocardial oxygen requirements of the ventricle. Augmentation of diastolic pressure when the balloon is fully inflated together with reduction in left ventricular (LV) filling pressures contribute to improved coronary perfusion (Figures 1 and 2).4 This proposed improvement in myocardial energetics has been further supported by a significant reduction in systemic lactate.5 These physiological enhancements are thought to be of particular benefit after acute myocardial infarction (AMI), supported by animal studies, which have shown a reduction in infarct size when counterpulsation is used.6,7 Figure 1. Coronary perfusion. Coronary flow is predominantly diastolic and further enhanced by counterpulsation, which augments diastolic blood flow and thus coronary perfusion. In addition, aortic recoil during diastole further improves efficiency of the left ventricle. Figure 2. Systemic arterial pressure waveform on introduction of intra-aortic balloon pump–assisted diastolic augmentation. The intra-aortic balloon pump inflates at the dicrotic notch, leading to peak-augmented diastolic pressure. As the balloon deflates, assisted end diastolic pressure is seen to be lower than unassisted end diastolic pressure and assisted systolic pressure is lower than unassisted systolic pressure. Peak diastolic augmentation should be greater than the unassisted systolic pressure and both assisted pressures should be less than the unassisted pressures. Intra-aortic balloon counterpulsation was initially used as a means of supporting patients undergoing surgical revascularization. Percutaneous delivery …

ABSTRACTBackgroundThe therapeutic management of patients with multivessel disease and severe left ventricular dysfunction is complex and controversial.AimsThe aim of this study was to analyze the clinical outcomes and the changes in left ventricular ejection fraction (LVEF) in patients with severe left ventricular dysfunction and at least one chronic total occlusion (CTO) undergoing percutaneous coronary intervention (PCI) with hemodynamic support provided by Impella.MethodsRetrospective, multicenter study enrolling patients with severe left ventricular dysfunction and severe coronary artery disease with at least one CTO who required percutaneous mechanical circulatory support with Impella, from January 2019 to December 2023. The primary endpoints were the incidence of MACE (composite of cardiovascular death, acute myocardial infarct, and target lesion revascularization) at 90 days. The secondary endpoint was changes in LVEF and functional class during the same period.ResultsA total of 27 patients (34 CTOs) were included in the study. The mean SYNTAX score was 35 ± 11. The median J‐CTO score of 2 (1–3). At 90 day of follow‐up, there were three MACE (11%), two cardiovascular deaths and one TLR; three vascular complications were related to access for the Impella device (only one required invasive treatment); and LVEF improved significantly after revascularization (delta LVEF: 10% [CI 95% 6, 15]). A total of 81% of patients improved their angina or dyspnea status at 90 days.ConclusionsIn high‐risk patients with severe left ventricular dysfunction with complex coronary disease including CTO, PCI with mechanical circulatory support using the Impella device is associated with favorable safety and efficacy outcomes at short‐term follow‐up.

Although there is not uniform definition of high-risk percutaneous coronary intervention (PCI), patients with severe three-vessel disease, left main disease, single remaining patent vessel and/or depressed left ventricular ejection fraction are considered a high-risk population. In this setting, periprocedural hemodynamic instability represents a serious issue. Percutaneous mechanical circulatory support (MCS) devices may improve both safety and efficacy of high-risk PCI. Indeed, MCS help to maintain coronary perfusion pressure and reduce myocardial workload, providing the operator sufficient time to reach the target of complete revascularization. The most used MCS are intra-aortic balloon pump and Impella. There are a plenty of data in literature about the efficacy and safety of the use of MCS in high-risk PCI performed through the femoral access. However, there is a paucity of data about the use of MCS in transradial high-risk PCI. Radial over femoral access has been showed to reduce bleeding complications and therefore may further improve the outcome of high-risk PCI. Herein we report a case of transradial high-risk PCI supported by the Impella 2.5 L and review the available data on this topic.

Persistent Challenges in Defining High-Risk Percutaneous Coronary Intervention.

This editorial refers to ‘Management and outcomes in patients with moderate or severe functional mitral regurgitation and severe left ventricular dysfunction’, by Z. Samad et al ., on page doi:10.1093/eurheartj/ehv343. The management of patients with severe secondary (also called functional) mitral regurgitation (MR) and left ventricular (LV) dysfunction is a topic of interest because it concerns many patients who have a poor prognosis,1–3 and the data currently available on the impact of different treatments are somewhat discordant.4–9 Therefore current recommendations for interventions in both the European and US guidelines are restrictive, with a low level of evidence.10–13 The study by Samad is an important one in the field.14 The study population results from the merging of two large databases from Duke University putting together a record of 1441 patients with moderate to severe functional MR and LV dysfunction. The first goal of this contemporary study was to describe current practices. It confirmed that medical management is the most popular strategy, which was used in 75% of patients. Percutaneous coronary intervention was used in 8%, coronary bypass surgery (CABG) in 6%, CABG plus mitral valve surgery in 7%, and finally mitral valve surgery in isolation in 4% of cases. This is the basis for the choice of medical treatment as a comparator with MitraClip …

Randomized trials have largely demonstrated that percutaneous coronary intervention (PCI) with sirolimus-eluting (SES) and paclitaxel-eluting stents (PES) results in a significant reduction in the occurrence of angiographic restenosis and revascularization compared with bare metal stents (BMS).1–4 The benefit of drug-eluting stents (DES) also has been confirmed in “real-world” scenarios. In this setting, when the analysis was focused on high-risk patient and lesion subgroups, a benefit still existed despite the presence of restenosis.5–7 These expanded indications do not yet cover many other types of complex lesions for which only registries or randomized trials, not yet published, are available so far (Tables 1 through 7⇓⇓⇓⇓⇓⇓). This topic is discussed in detail in this review. An important clarification is that the lack of proof is most probably due to the difficulty in performing randomized trials in high-risk groups using BMS as controls. It will be no surprise to find that the field in which DES perform best compared with BMS is likely to be complex lesions and patients8 (Figure 1). View this table: TABLE 1. DES in Unprotected Left Main Stenosis View this table: TABLE 2. DES in Bifurcation Lesions View this table: TABLE 3. DES in Chronic Total Occlusions View this table: TABLE 4. DES in Small-Vessel Disease and Long Lesions View this table: TABLE 5. DES in SVGs View this table: TABLE 6. DES in Acute MI View this table: TABLE 7. DES in Multivessel Disease Figure 1. Lesion complexity and stent performance in the BMS and DES eras. Adapted from Edelman et al.8 Current American Heart Association/American College of Cardiology (AHA/ACC) and European Society of Cardiology (ESC) guidelines consider the presence of a stenosis in the unprotected left main coronary artery (LMCA) a class IIa or IIb indication, respectively, for PCI if coronary artery bypass grafting (CABG) is not a viable option.9,10 Moreover, according to the AHA/ACC 2005 guidelines, in …

The management and outcomes of patients with functional moderate/severe mitral regurgitation and severe left ventricular (LV) systolic dysfunction are not well defined. We sought to determine the characteristics, management strategies, and outcomes of patients with moderate or severe mitral regurgitation (MR) and LV systolic dysfunction. For the period 1995-2010, the Duke Echocardiography Laboratory and Duke Databank for Cardiovascular Diseases databases were merged to identify patients with moderate or severe functional MR and severe LV dysfunction (defined as LV ejection fraction ≤ 30% or LV end-systolic diameter > 55 mm). We examined treatment effects in two ways. (i) A multivariable Cox proportional hazards model was used to assess the independent relationship of different treatment strategies and long-term event (death, LV assist device, or transplant)-free survival among those with and without coronary artery disease (CAD). (ii) To examine the association of mitral valve (MV) surgery with outcomes, we divided the entire cohort into two groups, those who underwent MV surgery and those who did not; we used inverse probability weighted (IPW) propensity adjustment to account for non-random treatment assignment. Among 1441 patients with moderate (70%) or severe (30%) MR, a significant history of hypertension (59%), diabetes (28%), symptomatic heart failure (83%), and CAD (52%) was observed. Past revascularization in 26% was noted. At 1 year, 1094 (75%) patients were treated medically. Percutaneous coronary intervention was performed in 114 patients, coronary artery bypass graft (CABG) surgery in 82, CABG and MV surgery in 96, and MV surgery alone in 55 patients. Among patients with CAD, compared with medical therapy alone, the treatment strategies of CABG surgery [hazard ratio (HR) 0.56, 95% confidence interval (CI) 0.42-0.76] and CABG with MV surgery (HR 0.58, 95% CI 0.44-0.78) were associated with long-term, event-free survival benefit. Percutaneous intervention treatment produced a borderline result (HR 0.78, 95% CI 0.61-1.00). However, the relationship with isolated MV surgery did not achieve statistical significance (HR 0.64, 95% CI 0.33-1.27, P = 0.202). Among those with CAD, following IPW adjustment, MV surgery was associated with a significant event-free survival benefit compared with patients without MV surgery (HR 0.71, 95% CI 0.52-0.95). In the entire cohort, following IPW adjustment, the use of MV surgery was associated with higher event-free survival (HR 0.69, 95% CI 0.53-0.88). In patients with moderate or severe MR and severe LV dysfunction, mortality was substantial, and among those selected for surgery, MV surgery, though performed in a small number of patients, was independently associated with higher event-free survival.

Background/Introduction In high-risk patients, percutaneous coronary intervention (PCI) with Impella mechanical circulatory support has become an important part of the revascularization strategy. However, data regarding the impact of age in patients undergoing Impella-supported PCI are limited. Purpose The aim of this study was to describe the characteristics and outcomes of Impella mechanical circulatory support in patients ≥75 years of age undergoing high-risk PCI. Methods Using the PROTECT III study, a prospective, multicenter, FDA-audited cohort of the Catheter-based Ventricular Assist Device (cVAD) registry, we compared baseline characteristics and clinical outcomes of patients ≥75 years of age with those of patients &amp;lt;75 years of age treated with Impella-supported high-risk PCI. Rates of major adverse cardiovascular and cerebral events (MACCE), defined as the composite of all-cause death, myocardial infarction (MI), stroke/transient ischemic attack, and revascularization, were assessed at 30 days and 90 days, and mortality was assessed to 1 year. A multivariable Cox regression model (including covariates significant in univariable analysis) was used to examine associations between age and clinical outcomes. Results A total of 1237 patients (26.8% female) were included in the analysis; of whom 493 (39.9%) were ≥75 years of age. Patients ≥75 years of age had lower body mass index (27 kg/m² vs. 30 kg/m²), a lower prevalence of diabetes (49% vs. 61%) and prior MI (37% vs. 43%), and lower estimated glomerular filtration rates (eGFR, 60 vs. 74 mL/min/1.73 m²). They more often suffered from severe valvular heart disease (17% vs. 7%), and more frequently underwent left main PCI (58% vs. 39%). Left ventricular ejection fraction was higher in patients ≥75 years of age (37.7±15.9% vs. 32.0±14.5%). (p&amp;lt;0.05 for all comparisons). Baseline SYNTAX scores did not differ among groups. Rates of death and MACCE did not differ between age groups at either 30 days or 90 days (Figure 1). Mortality at 1 year was 24.0% in patients ≥75 years of age and 17.9% in those &amp;lt;75 years of age. Age ≥75 years was associated with an increased risk of mortality at 1 year (unadjusted HR 1.40, 95% CI 1.05-1.86, p=0.02) and the association remained significant after multivariable adjustment (adjusted HR 1.99, 95% CI 1.24-3.18, p=0.004; Figure 2). Conclusion(s) This study demonstrates that increased age ≥75 years was not associated with a higher risk of mortality or MACCE at 30 or 90 days following protected PCI with Impella mechanical circulatory support, suggesting that protected high-risk PCI in elderly patients is safe and feasible. However, age ≥75 years remained an independent predictor for 1-year mortality after protected PCI.30-day and 90-day MACCE1-year All-cause death

Total revascularization of coronary disease at the time of primary percutaneous coronary intervention.

Background Referral for high-risk percutaneous coronary intervention (PCI) is a progressively growing trend. Percutaneous Mechanical Circulatory Support (MCS), may protect the myocardium and reduce the risk of major adverse events. Clinical data on Left Ventricular (LV) unloading by pneumatically driven Percutaneous Left Ventricular Assist Devices (pVAD's) is currently scarce. Purpose Describe the unloading pattern produced by a pneumatically driven pulsatile pVAD on LV haemodynamics through real-time Pressure-volume (PV) analysis with a conductance catheter positioned in the left ventricle. Methods 19 patients undergoing high-risk PCI treated with MCS were monitored with PV loops and pulmonary artery catheterization throughout the intervention. Results When activated on 1:1 assist ratio, the mean output produced by the pVAD was 1.36±0.13L/min. Compared to pre-implantation, 1:1 support produced a significant reduction in End-systolic Wall Stress (ΔWSes: −11.95%, p&lt;0.01) and PV area (ΔPVA: −16.67%, p&lt;0.01). Contractility did not significantly change (ΔV100: +29.48%, p=0.073; End-systolic Elastance, ΔEes: 1.24%, p=0.86). Effective Arterial Elastance (Ea), representing afterload, decreased (ΔEa: −12.05%, p&lt;0.05). Total Arterial Compliance (ΔTAC: +31.59, p&lt;0.01) increased and Ventricular-arterial Coupling (ΔEa/Ees: −9.79%, p=0.06) non-significantly improved. Mean arterial pressure non-significantly decreased (ΔMAP: −6.66%, p=0.06) and global Cardiac Output remained stable (ΔCO: −0.06%, p=0.37). When the pVAD was removed after the PCI these changes were reversed (Figure 1). Image 1 Conclusion High-risk PCI with pneumatic MCS may result in LV unloading and reduced myocardial oxygen consumption. Further insights will be released in the PULSE trial (Clinicaltrials.gov NCT03200990).

Selecting a revascularization strategy in patients with multivessel disease (MVD) and severely reduced left ventricular ejection fraction (LVEF) remains a challenge. PCI with Impella 2.5 may facilitate high-risk PCI, however long-term results comparing unprotected versus protected PCI are currently unknown. We sought to evaluate the outcome of patients undergoing protected compared to unprotected percutaneous coronary intervention (PCI) in the setting of MVD and severely reduced LVEF.We included patients with MVD and severely reduced LVEF (≤35%) in this retrospective, single-centre study. Patients that underwent unprotected PCI before the start of a dedicated protected PCI program with Impella 2.5 were compared to patients that were treated with protected PCI after the start of the program. The primary endpoint was defined as major adverse cardiac and cerebrovascular events (MACCE) during a 1-year follow-up. The secondary endpoints consisted of in-hospital MACCE and adverse events.A total of 61 patients (mean age 70.7 ± 10.9 years, 83.6% male) were included in our study, of which 28 (45.9%) underwent protected PCI. The primary endpoint was reached by 26.7% and did not differ between groups (P = .90). In-hospital MACCE (P = 1.00) and in-hospital adverse events (P = .12) also demonstrated no significant differences. Multivariate logistic regression identified procedural success defined as complete revascularization and absence of in-hospital major clinical complications as protective parameter for MACCE (OR 0.17, 95% CI 0.04–0.70, P = .02).Patients with MVD and severely depressed LVEF undergoing protected PCI with Impella 2.5 demonstrate similar in-hospital and one-year outcomes compared to unprotected PCI.

Surgical collateralization: The hidden mechanism for improving prognosis in chronic coronary syndromes