Percutaneous Coronary Intervention In High-risk Patients Research Articles

Invasiveness of previous treatment for peripheral arterial disease and risk of adverse cardiac events after coronary stenting

Patients with peripheral arterial disease (PADs), undergoing percutaneous coronary intervention (PCI), have higher adverse event risks. The effect of invasiveness of PADs treatment on PCI outcome is unknown. This study assessed the impact of the invasiveness of previous PADs treatment (invasive or non-invasive) on event risks after PCI with contemporary drug-eluting stents. This post-hoc analysis pooled 3-year patient-level data of PCI all-comer patients living in the eastern Netherlands, previously treated for PADs. PADs included symptomatic atherosclerotic lesion in the lower or upper extremities; carotid or vertebral arteries; mesenteric arteries or aorta. Invasive PADs treatment comprised endarterectomy, bypass surgery, percutaneous transluminal angioplasty, stenting or amputation; non-invasive treatment consisted of medication and participation in exercise programs. Primary endpoint was (coronary) target vessel failure: composite of cardiac mortality, target vessel-related myocardial infarction, or clinically indicated target vessel revascularization. Of 461 PCI patients with PADs, information on PADs treatment was available in 357 (77.4%) patients; 249 (69.7%) were treated invasively and 108 (30.3%) non-invasively. Baseline and PCI procedural characteristics showed no between-group difference. Invasiveness of PADs treatment was not associated with adverse event risks, including target vessel failure (20.5% vs. 16.0%; HR: 1.30, 95%-CI 0.75–2.26, p = 0.35), major adverse cardiac events (23.3% vs. 20.4%; HR: 1.16, 95%-CI 0.71–1.90, p = 0.55), and all-cause mortality (12.1% vs. 8.3%; HR: 1.48, 95%-CI 0.70–3.13, p = 0.30). In PADs patients participating in PCI trials, we found no significant relation between the invasiveness of previous PADs treatment and 3-year outcome after PCI. Consequently, high-risk PCI patients can be identified by consulting medical records, searching for PADs, irrespective of the invasiveness of PADs treatment.Graphical abstractComparison of patients with non-invasive and invasive PADs treatment. PADs peripheral arterial disease, PCI percutaneous coronary intervention.

Influence of left ventricular ejection fraction in patients undergoing contemporary pLVAD-supported high-risk PCI

Left ventricular (LV) systolic dysfunction worsens outcomes in patients undergoing percutaneous coronary intervention (PCI). The objective of this study, therefore, was to evaluate outcomes of pLVAD-supported high-risk PCI (HRPCI) patients according to LV ejection fraction (LVEF). Patients from the PROTECT III study undergoing pLVAD-supported HRPCI were stratified according to baseline LVEF: severe LV dysfunction (LVEF <30%), mild and moderate LV dysfunction (LVEF ≥30% to <50%), or preserved LV function (LVEF ≥50%). Major adverse cardiovascular and cerebrovascular events (MACCE: composite of all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization), and PCI-related complications were assessed at 90 days and mortality was assessed at 1-year. From March 2017 to March 2020, 940 patients had evaluable baseline LVEF recorded in the study database. Patients with preserved LV function were older, more frequently presented with myocardial infarction, and underwent more left main PCI and atherectomy. Immediate PCI-related coronary complications were infrequent (2.7%, overall), similar between groups (P=0.98), and not associated with LVEF. Unadjusted 90-day MACCE rates were similar among LVEF groups; however, as a continuous variable, LVEF was associated with both 90-day MACCE (adj.HR per 5% 0.89, 95% CI [0.80, 0.98], P=0.018) and 1-year mortality (adj.HR per 5% 0.84 [0.78, 0.90], P <0.0001). Patients who underwent pLVAD-supported HRPCI exhibited low incidence of PCI-related complications, regardless of baseline LVEF. However, LVEF was associated with 90-day MACCE and 1-year mortality.

Predictors of Adverse Outcome in High-Risk Percutaneous Coronary Interventions Patients.

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.

Zero Contrast and Ultra-Low Contrast Percutaneous Coronary Intervention

Contrast-induced acute kidney injury (AKI) is a common complication following percutaneous coronary intervention (PCI) in patients with a background of chronic kidney disease (CKD). This complication can lead to short- and long-term dialysis requirements. There has been some interest in recent years in performing PCI in high-risk patients with minimal use of contrast to avoid this complication. We reviewed a case series of eight cases where ultra-low-contrast PCI was performed and a further case of zero-contrast PCI, which were primarily performed under the guidance of intravascular imaging. Pre- and post-renal functions were recorded, and clinical outcomes were measured based on the survival rate and the need for revascularisation in the culprit vessel. A step-by-step description of how to perform the procedure safely and effectively is provided. There were no procedural complications encountered in this cohort. The renal function remained stable 1 week after the procedure. The procedure was technically successful in all cases based on intravascular and angiographic measures. Patients were followed up for a minimum of 6 months and no adverse clinical events were recorded. A description of the procedural steps is provided based on current experience and review of the literature. Ultra-low-contrast PCI is feasible and safe in a carefully selected group of patients in centres with experience in the use of intravascular imaging.

Immediate and early percutaneous coronary intervention in very high-risk and high-risk non-ST segment elevation myocardial infarction patients.

BackgroundThe European Society of Cardiology (ESC) guidelines for the management of acute coronary syndromes in patients presenting without persistent ST‐segment elevation (non‐ST‐segment elevation myocardial infarction [NSTEMI]) has recommended immediate (<2 h) percutaneous coronary intervention (PCI) in very‐high risk patients and early (<24 h) PCI in high‐risk patients.HypothesisTo examine the ESC NSTEMI guidelines adherence in a nationwide survey in Israel using the Acute Coronary Syndrome Israeli Survey (ACSIS). We hypothesized that adherence to the guidlines' recommnded PCI timing in NSTEMI pateints will be inadequate, partly due to the inconsistent evidence regarding its effect on clinical outcomes.MethodsAll NSTEMI patients who underwent PCI during the ACSIS surveys in 2016 and 2018 were included in the analysis.ResultsOut of 1793 NSTEMI patients, 1643 (92%) patients underwent PCI, and door to balloon time was documented in 1078 of them. One hundred and fifty‐six (14.5%) patients and 922 (85.5%) patients were defined as very high‐risk and high‐risk NSTEMI patients, respectively. Of the very high‐risk NSTEMI patients, only 10 (6.4%) underwent immediate coronary angiography, and 50 (32.1%) underwent early coronary angiography. Acute heart failure 139 (89.1%) was the main reason for including NSTEMI patients in the very high‐risk category. Of the high‐risk patients, early coronary angiography was performed in only 405 (43.9%) patients. Patients in whom coronary angiography was postponed were older and had more comorbidities.ConclusionsDespite guidelines recommendations for immediate and early PCI in very high‐risk and high‐risk NSTEMI patients, respectively, most patients do not undergo immediate or early PCI according to contemporary guidelines. Further studies are needed to better understand the reasons for guidelines' nonadherence in those high‐risk patients.

PCI in Patients With Heart Failure: Current Evidence, Impact of Complete Revascularization, and Contemporary Techniques to Improve Outcomes

Coronary artery disease (CAD) is the most common cause of left ventricular systolic dysfunction (LVSD) and heart failure (HF). Revascularization with coronary artery bypass grafting (CABG) reduces all-cause mortality compared with medical therapy alone for these patients. Despite this, CABG is performed in a minority of patients with HF, partly due to patient unwillingness or inability to undergo major cardiac surgery and partly due to physician reluctance to refer for surgery due to high operative risk. Percutaneous coronary intervention (PCI) is a less-invasive method of revascularization that has the potential to reduce periprocedural complications compared with CABG in patients with HF. Recent advances in PCI technology and technique have made it realistic to achieve more complete revascularization with PCI in high-risk patients with HF, although no randomized controlled clinical trials (RCTs) of PCI in HF compared with either medical therapy or CABG have been performed. In this review, we discuss the currently available evidence for PCI in HF and the association between the extent of revascularization and clinical outcomes in HF. We also review recent advances in PCI technology and techniques with the potential to improve clinical outcomes in HF. Finally, we discuss emerging clinical trial evidence of revascularization in HF and the large, persistent evidence gaps that should be addressed with future clinical trials of revascularization in HF.

Ticagrelor Monotherapy After PCI in High-Risk Patients With Prior MI: A Prespecified TWILIGHT Substudy.

The aim of this study was to evaluate if patients with prior myocardial infarction (MI) could benefit from ticagrelor monotherapy in terms of bleeding reduction without any compromise in ischemic event prevention. Patients with history of MI who undergo percutaneous coronary intervention (PCI) remain at risk for recurrent ischemic events. The optimal antithrombotic strategy for this cohort remains debated. In this prespecified analysis of the randomized TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients after Coronary Intervention) trial, the authors evaluated the impact of history of MI on treatment effect of ticagrelor monotherapy versus ticagrelor plus aspirin in patients undergoing PCI with drug-eluting stent with at least 1clinical and 1 angiographic high-risk feature and free from adverse events at 3months after index PCI. The primary endpoint was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding, and the key secondary endpoint was the composite of all-cause death, MI, or stroke, both at 12months after randomization. A total of 1,937 patients (29.7%) with and 4,595 patients (70.3%) without prior MI were randomized to ticagrelor and placebo or ticagrelor and aspirin. At 1 year after randomization, patients with prior MI experienced higher rates of death, MI, or stroke (5.7% vs 3.2%; P< 0.001) but similar BARC types 2 to 5 bleeding (5.0% vs 5.5%; P=0.677) compared with patients without prior MI. Ticagrelor monotherapy consistently reduced the risk for the primary bleeding outcome in patients with (3.4% vs 6.7%; HR: 0.50; 95%CI: 0.33-0.76) and without (4.2% vs 7.0%; HR: 0.58; 95%CI: 0.45-0.76; Pinteraction=0.54) prior MI. Rates of the key secondary ischemic outcome were not significantly different between treatment groups irrespective of history of MI (prior MI, 6.0% vs 5.5% [HR: 1.09; 95%CI: 0.75-1.58]; no prior MI, 3.1% vs 3.3% [HR: 0.92; 95%CI: 0.67-1.28]; Pinteraction=0.52). Ticagrelor monotherapy is associated with significantly lower risk for bleeding events compared with ticagrelor plus aspirin, without any compromise in ischemic prevention, among high-risk patients with history of MI undergoing PCI. (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention [TWILIGHT]; NCT02270242).

High Risk PCI Patients Still Missing Out on Cardiac Rehabilitation Referral – a Prospective, Multisite Study of 41,739 Patients From the Victorian Cardiac Outcomes Registry

Despite level I evidence and guideline recommendations, uptake of cardiac rehabilitation (CR) is suboptimal. The aim of this study was to identify contemporary trends and predictors of CR referral of percutaneous coronary intervention (PCI) patients in Victoria, Australia.

Outcome of Impella 2.5 use in patients undergoing Percutaneous Coronary Intervention in Henan, China: a case series.

Acute myocardial infarction (AMI) complicated by cardiogenic shock (AMI-CS) or heart failure is associated with an unacceptably high in-hospital mortality of 33%-55% and a lost chance to accept PCI (Percutaneous Coronary Intervention). The aim of the study was to find out whether percutaneous hemodynamic support device Impella 2.5 improves prognosis of high-risk PCI patients or not. This study was a case series involving six patients who underwent a Left Ventricular Assist Device (LVAD, Impella 2.5, Abiomed, Danvers, MA) implantation after suffering from AMI with a very low ejection fraction and acute heart failure. The clinical experience and outcomes of the patients are hereby discussed. All PCI procedures were safely completed under LVAD support. The hemodynamic parameters of all patients improved clinically over the next 30 days and following 12 months after Impella insertion except in two patients, of which one patient (Case number 6) died 4 days post-Impella protected PCI procedure due to acute left ventricle heart failure with cardiogenic shock and pulmonary oedema; and another one died at 12 months after Impella protected PCI procedure (Case number 4) due to decompensated heart failure and infected pneumonia. Percutaneous hemodynamic support is favorable and feasible during high risk Percutaneous Coronary Intervention (PCI). A bigger study is needed to substantiate the claims of the current study.

Prognostic irrelevance of plaque vulnerability following plaque sealing in high-risk patients with type 2 diabetes: an optical coherence tomography study

BackgroundType 2 diabetes mellitus (T2DM) is associated with an increased cardiovascular risk related at least in part to a more vulnerable plaque phenotype. However, patients with T2DM exhibit also an increased risk following percutaneous coronary intervention (PCI). It is unknown if plaque vulnerability of a treated lesion influences cardiovascular outcomes in patients with T2DM. In this study, we aimed to assess the association of plaque morphology as determined by optical coherence tomography (OCT) with cardiovascular outcome following PCI in high-risk patients with T2DM.Methods81 patients with T2DM and OCT-guided PCI were recruited. Pre-interventional OCT and systematic follow-up of median 66.0 (IQR = 8.0) months were performed.ResultsDuring follow-up, 24 patients (29.6%) died. The clinical parameters age (HR 1.16 per year, 95% CI 1.07–1.26, p < 0.001), diabetic polyneuropathy (HR 3.58, 95% CI 1.44–8.93, p = 0.006) and insulin therapy (HR 3.25, 95% CI 1.21–8.70, p = 0.019) predicted mortality in T2DM patients independently. Among OCT parameters only calcium-volume-index (HR 1.71 per 1000°*mm, 95% CI 1.21–2.41, p = 0.002) and lesion length (HR 1.93 per 10 mm, 95% CI 1.02–3.67, p = 0.044) as parameters describing atherosclerosis extent were significant independent predictors of mortality. However, classical features of plaque vulnerability, such as thickness of the fibrous cap, the extent of the necrotic lipid core and the presence of macrophages had no significant predictive value (all p = ns).ConclusionClinical parameters including those describing diabetes severity as well as OCT-parameters characterizing atherosclerotic extent but not classical features of plaque vulnerability predict mortality in T2DM patients following PCI. These data suggest that PCI may provide effective plaque sealing resulting in limited importance of local target lesion vulnerability for future cardiovascular events in high-risk patients with T2DM.

Patient Selection for Protected Percutaneous Coronary Intervention: Who Benefits the Most?

The evolution of percutaneous coronary intervention (PCI) enables a complete revascularization of complex coronary lesions. However, simultaneously, patients are presenting nowadays with higher rates of comorbidities, which may lead to a lower physiologic tolerance for complex PCI. To avoid hemodynamic instability during PCI and achieve safe complete revascularization, protected PCI using mechanical circulatory support devices has been developed. However, which patients would benefit from the protected PCI is still in debate. Hence, this review provides practical approaches for the selection of patients by outlining current clinical data assessing utility of protected PCI in high-risk patients.

Pragmatic trial comparing routine versus no routine functional testing in high-risk patients who underwent percutaneous coronary intervention: Rationale and design of POST-PCI trial

Although the need to detect restenosis has diminished in the contemporary practice of percutaneous coronary intervention (PCI) with drug-eluting stents (DES), the surveillance of ischemia owing to restenosis or disease progression deserves attention in high-risk PCI settings. It is unknown whether follow-up strategy of routine noninvasive functional testing potentially reduces the risk of major cardiovascular events in high-risk PCI patients. The POST-PCI study is an investigator-initiated, multicenter, prospective randomized trial comparing the effectiveness of two follow-up strategies in patients with high-risk anatomic or clinical characteristics who underwent PCI. Study participants were randomly assigned to either (1) the routine noninvasive stress testing (exercise electrocardiography, nuclear stress imaging, or stress echocardiography) at 12 months post-PCI or (2) the standard-care without routine testing. In the routine stress testing group, depending on the testing results, all clinical decisions regarding subsequent diagnostic or therapeutic procedures were at the treating physician's discretion. The primary endpoint was a composite outcome of death from any causes, myocardial infarction, or hospitalization for unstable angina at 2 years post-PCI. More than 1700 high-risk PCI patients have been randomized over 2.0 years at 11 major cardiac centers in Korea. This pragmatic POST-PCI trial will provide valuable clinical evidence on the effectiveness of follow-up strategy of routine noninvasive stress testing in high-risk PCI patients.

Impella support and acute kidney injury during high-risk percutaneous coronary intervention: The Global cVAD Renal Protection Study.

Protection against acute kidney injury (AKI) has been reported with the use of Impella during high-risk percutaneous coronary intervention (HR-PCI). We sought to evaluate this finding by determining the occurrence of AKI during Impella-supported HR-PCI in patients from the Global cVAD Study and compare this incidence with their calculated AKI risk at baseline. In this prospective, multicenter study, we enrolled 314 consecutive patients. We included 223 patients that underwent nonemergent HR-PCI supported with Impella 2.5 or Impella CP and excluded those requiring hemodialysis prior to HR-PCI (19) and those with insufficient data (72). The primary outcome was AKI postprocedurally at 48 hr versus the predicted risk of AKI according to Mehran risk score. Logistic regression analysis determined predictors of AKI. Overall, 4.9% (11) of Impella-supported patients developed AKI (exclusively stage 1) at 48 hr versus a predicted rate of 21.9%, representing a 77.6% lower AKI rate (p < .0001). In this study, no Impella-supported patients required renal replacement therapy. Estimated glomerular filtration rate (ml/min/1.73 m2 ) alone predicted AKI (adjusted odds ratio [AOR]: 4.915; 95% confidence intervals [CI]: 1.02-23.53, p = .046), and increasing contrast had insignificant effects on AKI during high-risk PCI (AOR: 1.15; 95% CI: 0.87-1.51, p = .332). In patients not protected from AKI, the postprocedure incidence of AKI was not significantly greater and did not correlate with chronic kidney disease severity. The incidence of AKI was lower during HR-PCI than expected from current risk models. Although further exploration of this finding is warranted, these data support a new protective strategy against AKI during HR-PCI.

Prognostic significance of prior ischemic stroke in patients with coronary artery disease undergoing percutaneous coronary intervention.

To investigate the long-term outcomes of percutaneous coronary intervention (PCI) in patients with previous ischemic stroke. Ischemic stroke and coronary artery disease (CAD) are leading causes of death that often coexist with each other. With the increased use of PCI in high-risk patients with CAD, the association between prior ischemic stroke and cardiovascular/cerebrovascular events in patients with CAD undergoing PCI has been a topic of interest. We enrolled 10,300 consecutive patients who had undergone PCI from January 2013 to December 2013 and classified them into the prior ischemic stroke group (n = 1,106) and no prior ischemic stroke group (n = 9,194). The primary outcome was major adverse cardiovascular and cerebrovascular events (MACCEs) during follow-up. The secondary endpoints included each component of the primary endpoint and stent thrombosis (ST). Overall, 10.7% patients had a history of ischemic stroke. At a median 29-month follow-up, MACCEs following PCI occurred with 2-year incidences of 15.4% in the prior ischemic stroke group and 11.7% in the no prior ischemic stroke group. Cox regression analysis demonstrated that prior ischemic stroke was independently associated with a higher risk of MACCEs (adjusted hazard ratio [HR] = 1.294; 95% confidence interval [CI]: 1.100-1.522; P = 0.002), recurrent stroke (adjusted HR = 2.463; 95% CI: 1.729-3.507; P = 0.000), and ST (adjusted HR = 1.787; 95% CI: 1.075-2.971; P = 0.025). A high residual syntax score and low renal function were independent risk factors for MACCEs. Increased concern and active treatment strategies are needed in patients undergoing PCI who have a history of ischemic stroke.

A systematic literature review and meta-analysis of impella devices used in cardiogenic shock and high risk percutaneous coronary interventions

Background: To perform a meta-analysis on pooled survival and complications rates of Impella® heart pumps (Abiomed Inc., Danvers, USA) use in cardiogenic shock and high-risk coronary percutaneous coronary intervention (PCI). Methods and Findings: Articles were searched in Medline, Medline In-Process, EMBASE and the CENTRAL bibliographic databases on the 30th April, 2017. Prospective and retrospective studies with ≥10 patients supported with Impella. Survival and complication rates were pooled. The literature review identified 33 articles. Data on patient characteristics, indication of support, type of Impella device and outcomes were extracted. A random effect was used to pool the various outcomes. Low heterogeneity (I2 ≤0.25) results are presented. A total of 2,827 patients (40.5% cardiogenic shock, 59.5% high-risk PCI) were included (mean age 64.9±11.4, male 74.6%). In the cardiogenic shock indication, survival rate to 90 and 180 days was 62.6% and 58.3%, respectively; the rates of hemolysis and device malfunction were 8.8% and 2.5%, respectively. In the high-risk PCI indication, the 30 day major adverse cardiac and cerebrovascular event (MACCE) rate was 15.3% with a 30 day survival, stroke, myocardial infarction and repeat revascularization rates of 92.2%, 0.3%, 13.5% and 1.6%, respectively. Hemolysis and device malfunction affected respectively 0.7% and 1.4% of the high-risk PCI patients. Conclusions: This is the largest meta-analysis summarizing the literature outcome data of Impella heart pumps. The present study demonstrates very encouraging survival in cardiogenic shock patients and very good 30 day outcomes in patients undergoing prophylactic support for high-risk PCI.

Hemodynamics and its predictors during Impella-protected PCI in high risk patients with reduced ejection fraction

BackgroundPercutaneous ventricular-assistance by Impella (IMP) represents an emerging strategy to manage patients with reduced left-ventricular (LV) ejection-fraction (EF) undergoing percutaneous-coronary-intervention (PCI). The hemodynamic behave during IMP-protected PCI has been scarcely investigated. MethodsWe reviewed the IMP console's function and hemodynamic data (which are continuously recorded during assistance) in a consecutive series of 37 patients who underwent elective IMP-protected PCI in two high-volume centers. All patients had multivessel disease and impaired LVEF. Coronary artery disease burden was graded using the British-Cardiovascular-Intervention-Society jeopardy-score (BCIS-JS) score. IMP motor speed and pressure signals (systolic blood pressure, SBP, and mean blood pressure, MBP) were analyzed. Primary hemodynamic end-points were “critical systolic blood pressure (SBP) drop” (SBP decrease ≥ 20 mm Hg reaching ≤90 mm Hg values) and “critical mean blood pressure (MBP) drop” (MBP decrease reaching ≤60 mm Hg). ResultsOver mean assistance duration of 254 ± 549 min, no IMP motor drop occurred. During PCI, SBP and MBP significantly decreased but all patients had SBP values >78 mm Hg.Critical SBP and MBP drops occurred in 10.8% of patients. Among all baseline and procedural characteristics, BCIS-JS was the only significant predictor of SBP drop (p = 0.001) while BCIS-JS and LV end-diastolic volume significantly predicted MBP drop (p = 0.001 for both). ConclusionsIn patients with reduced EF undergoing IMP-protected PCI, a significant pressure decrease occurs during PCI but pressure is systematically maintained at levels warranting vital organ perfusion. Critical pressure drops during PCI occur in some patients with higher jeopardized myocardium and left ventricular diastolic volumes.

Feasibility and safety of combined percutaneous coronary intervention among high-risk patients with severe aortic stenosis undergoing transcatheter aortic valve implantation: a systematic review and meta-analysis.

Recent reports indicated that percutaneous coronary intervention (PCI) may be correlated with increased mortality in patients undergoing transcatheter aortic valve implantation (TAVI). Therefore, we performed a meta-analysis to determine the feasibility and safety of combined PCI in high-risk patients with severe aortic stenosis undergoing TAVI. A comprehensive literature search was performed using PubMed, Embase and the Cochrane Central Register of Controlled trials through June 2016. Five clinical trials including 1634 patients were identified. The pooled analysis revealed no significant differences in 30-day all-cause mortality [odds ratio (OR) 1.25, 95% confidence interval (CI) 0.52-3.05; P = 0.62], 30-day cardiovascular mortality rate (OR 1.59, 95% CI 0.52-4.88; P = 0.41) and 1-year mortality rate (OR 1.16, 95% CI 0.85-1.59; P = 0.34) among the patients assigned to TAVI and those undergoing TAVI+PCI. The incidence of myocardial infarction (OR 2.96, 95% CI 1.03-8.45; P = 0.04) was slightly higher in the TAVI+PCI group. Other complications, such as stroke, kidney injury, bleeding and vascular complications, were not significantly increased in the TAVI+PCI group. Patients treated with a staged procedure of TAVI and PCI but not simultaneous TAVI+PCI showed higher 30-day all-cause mortality as compared to those undergoing isolated TAVI. Combined TAVI+PCI showed similar rates of death from any cause at 30 days and 1 year as compared to isolated TAVI. Except for myocardial infarction, the rate of operative complications in the TAVI+PCI group was not detrimental as compared to the isolated TAVI group. The simultaneous treatment of significant coronary artery lesions may be preferred in selected patients undergoing TAVI.

Transradial Artery Access in Percutaneous Coronary Intervention for ST-Segment Elevation Myocardial Infarction and Cardiogenic Shock.

Early revascularization is the gold standard for management of patients with ST-elevation myocardial infarction (STEMI) and cardiogenic shock (CS). The use of transradial artery access (TRA) in percutaneous coronary intervention (PCI) has increased in recent years and has emerged as a safe and effective approach to PCI in high-risk patients, with advantages in reduced major bleeding events, other peri-procedural complications, and all-cause mortality when compared with transfemoral artery access (TFA). Multiple randomized clinical trials have demonstrated these advantages of TRA vs. TFA PCI in STEMI patients. Although there remains a lack of dedicated randomized trials in CS, observational data suggest benefits on the same endpoints as in STEMI with TRA vs. TFA PCI in CS. This review summarizes the existing literature on the use of TRA compared to TFA for STEMI and CS patients; the reduction of major bleeding events, other peri-procedural complications, and mortality associated with TRA in STEMI and CS; and technical considerations and challenges in the care of these high-risk patient populations.

The Role of Mechanical Circulatory Support During Percutaneous Coronary Intervention in Patients Without Severely Depressed Left Ventricular Function

Currently, there are no data on the use of mechanical circulatory support (MCS) in patients without severely depressed left ventricular ejection fraction (LVEF) during high-risk percutaneous coronary intervention (PCI). We analyzed data from the global catheter-based ventricular assist device (cVAD) registry on the clinical use of MCS in high-risk PCI in patients without severely depressed LVEF, defined as LVEF > 35%. Patients without cardiogenic shock from the catheter-based ventricular assist device registry, who underwent elective or urgent PCI with an Impella 2.5 or Impella CP, were included. Patients who received MCS after the start of the PCI were excluded. A total of 891 patients were included, of whom 661 had LVEF ≤ 35% and 230 had LVEF > 35%. Patients with LVEF > 35% compared with patients with LVEF ≤ 35% were older (72.12 ± 11.70 years vs 68.68 ± 11.01 years; p <0.001), had more extensive coronary artery disease with more diseased vessels (1.90 ± 0.71 vs 1.73 ± 0.79; p = 0.005), more multivessel intervention (1.74 ± 0.69 vs 1.55 ± 0.73; p <0.001), and more use of rotational atherectomy (21.21% vs 14.90%; p = 0.046), respectively. Additionally, they had a high prevalence of high-risk clinical features such as renal failure (24.89%) and diabetes mellitus (45.37%). Despite these high-risk features, the major adverse cardiovascular and cerebral event rates were favorable overall, with no differences between the 2 groups (3.48% vs 4.54%; p = 0.574). Despite having LVEF > 35%, this selected group of patients had severe co-morbidities and complex angiographic features; hence, PCI with hemodynamic support was deemed necessary. In addition, PCI with elective MCS was feasible and safe in this patient population.

The effectiveness and safety of the Impella ventricular assist device for high-risk percutaneous coronary interventions: A systematic review.

Small randomized controlled trials (RCTs) and observational studies have examined the effectiveness and safety of the Impella device, a percutaneous left ventricular assist device, in the setting of high-risk percutaneous coronary intervention (PCI). However, data are sparse and results are conflicting. Our objective was to evaluate the effectiveness and safety of the Impella device in high-risk patients undergoing PCI via a systematic review of the literature. We searched Medline, EMBASE, and the Cochrane Library for RCTs and observational studies that evaluated the Impella device in high-risk patients undergoing PCI. Inclusion was restricted to studies in which ≥10 patients received the Impella device; both uncontrolled and controlled (versus intra-aortic-balloon pump [IABP]) studies were included. A total of 20 studies (4 RCTs, 2 controlled observational studies, and 14 uncontrolled observational studies; 1,287 patients) were included, with follow-up ranging from 1 to 42 months. The use of Impella resulted in improved procedural and hemodynamic characteristics in controlled and uncontrolled studies. In controlled studies, the 30-day rates of all-cause mortality and MACE were similar across groups. In most uncontrolled studies, the 30-day rates of all-cause mortality were generally low (range: 3.7%-10%), though rates of MACE were slightly higher (range: 5%-20%). The Impella device was found to improve procedural and hemodynamic parameters, but only limited randomized data are available regarding clinical outcomes associated with its use. Large, multicenter RCTs are needed to definitively establish the effectiveness of the Impella device among high-risk PCI patients.