High-risk Percutaneous Coronary Intervention Research Articles

Management of Percutaneous Coronary Intervention Complications: Algorithms From the 2018 and 2019 Seattle Percutaneous Coronary Intervention Complications Conference.

Complications of percutaneous coronary intervention (PCI) may have significant impact on patient survival and healthcare costs. PCI procedural complexity and patient risk are increasing, and operators must be prepared to recognize and treat complications, such as perforations, dissections, hemodynamic collapse, no-reflow, and entrapped equipment. Unfortunately, few resources exist to train operators in PCI complication management. Uncertainty regarding complication management could contribute to the undertreatment of patients with high-complexity coronary disease. We, therefore, coordinated the Learning From Complications: How to Be a Better Interventionalist courses to disseminate the collective experience of high-volume PCI operators with extensive experience in chronic total occlusion and high-risk PCI. From these conferences in 2018 and 2019, we developed algorithms that emphasize early recognition, effective treatment, and team-based care of PCI complications. We think that an algorithmic approach will result in a logical and systematic response to life-threatening complications. This construct may be useful for operators who plan to perform complex PCI procedures.

Deploying Mechanical Circulatory Support Via the Axillary Artery in Cardiogenic Shock and High-Risk Percutaneous Coronary Intervention

We sought to study the feasibility of axillary artery as alternative access for mechanical circulatory support (MCS) in cardiogenic shock and high-risk percutaneous coronary intervention (HR-PCI) patients with severe occlusive peripheral artery disease (PAD). In patients with severe PAD, the iliofemoral artery may be so diseased preventing deployment of MCS, precluding the use of lifesaving therapy. In such circumstances, the axillary artery may be a viable access site. Records of all patients presenting with cardiogenic shock or HR-PCI requiring MCS through axillary artery access at our institution from January 2016 to September 2018 were examined. Demographics, clinical, procedural, and outcomes data were collected on all patients. A total of 48 patients presented with cardiogenic shock (60%) or HR-PCI (40%) requiring MCS via axillary artery due to prohibitive PAD (mean age 66 ± 11 years). Admission diagnoses were non-ST segment elevation myocardial infarction (38%), unstable angina (23%), ST segment elevation myocardial infarction (19%), and cardiac arrest (21%). Time from axillary access to activation of Impella was 11.9 ± 4 minutes. Four patients required concomitant Impella RP for right ventricular support due to biventricular cardiogenic shock. Twenty-two patients died before Impella was explanted due to multiorgan failure, stroke, and infection. None of the patients who died had vascular complications related to axillary access. Axillary artery appears to be a viable alternative access for large bore devices in patients with prohibitive PAD. As experience of the field with this approach grows, it may be the default access for deployment of large bore sheaths in the future.

Six months follow-up of protected high-risk percutaneous coronary intervention with the microaxial Impella pump: results from the German Impella registry.

Percutaneous coronary intervention (PCI) represents an important alternative to coronary bypass surgery for the treatment of patients with complex coronary artery disease and high perioperative risk. Protected percutaneous coronary intervention applies temporary percutaneous ventricular assist devices to mitigate potential hemodynamic compromise in high-risk patients. The Impella system is currently the most commonly used device for protected percutaneous coronary intervention and showed improved hemodynamic parameters in earlier trials. This study was designed as a retrospective, observational multi-center registry conducted in ten hospitals in Germany. We included consecutive patients undergoing protected high-risk percutaneous coronary intervention with Impella support. The primary endpoint was defined as the occurrence of a major adverse cardiac event defined as all-cause mortality, ST-elevation myocardial infarction, or stroke during a postprocedural 180-day follow-up period. In total, 157 patients (80.3% male; mean age 71.8 ± 10.8 years) were included in the present study, and 180-day follow-up was complete for 149 patients (94.9%). At baseline, the patients had a median left ventricular ejection fraction of 39.0% (interquartile range, 25.0-50.0%). The median SYNergy between PCI with TAXUS and Cardiac Surgery-Score I was 33.0 (interquartile range, 24.0-40.5) and the median EuroSCORE II was 7.2% (interquartile range, 3.2-17.1%). During postprocedural follow-up, 34 patients (22.8%) suffered a major adverse cardiac event. All-cause mortality was 18.1% (27 patients). Nine patients (6.0%) sustained a ST-elevation myocardial infarction, while 4 patients (2.7%) had a stroke. Patients undergoing protected high-risk percutaneous coronary intervention with Impella support showed an acceptable 180-day clinical outcome regarding major adverse cardiac event and mortality.

Outcomes of Impella-supported high-risk nonemergent percutaneous coronary intervention in a large single-center registry.

We aimed to evaluate the early and one-year outcomes of Impella-supported high-risk nonemergent percutaneous coronary intervention (PCI). The evidence for the use of mechanical circulatory support (MCS) devices in high-risk nonemergent PCI is limited and nonconclusive. We performed a single-center retrospective study including all patients who underwent high-risk nonemergent PCI supported by Impella 2.5/CP at our institution between January 2009 and June 2018. This patient population was propensity score matched with subjects undergoing PCI with no MCS. The primary endpoint was major adverse cardiac events (MACE: all-cause death, myocardial infarction [MI], and target lesion revascularization) at one-year follow-up. Two-hundred fifty patients undergoing Impella-supported nonemergent PCI were matched to 250 controls. The two groups were well balanced in terms of clinical and angiographic characteristics. Left main PCI was performed more frequently among Impella-supported patients (26% vs. 11%, p < .001), who also had numerically higher prevalence of rotational atherectomy use (44% vs. 37%, p = .10) and a higher number of vessels treated (1.8 ± 0.8 vs. 1.3 ± 0.6, p < .001), compared with controls. Impella-supported patients suffered a higher incidence of periprocedural MI (14.0% vs. 6.4%, p = .005), major bleeding (6.8% vs. 2.8%, p = .04), and need for blood transfusions (11.2% vs. 4.8%, p = .008). However, at one-year follow-up there were no differences in the rates of MACE (31.2% vs. 27.4%, p = .78) or any of its individual components between Impella-supported patients and controls. Although Impella-supported patients suffer a higher incidence of periprocedural adverse events (partially linked to more aggressive PCI), the incidence of one-year MACE was similar between the Impella and control group.

Rotational Atherectomy for Severely Calcified Lesions in Patients With Left Ventricular Systolic Dysfunction: One-Year Outcomes From aSingle-Center Registry Analysis

BackgroundHigh-risk percutaneous coronary intervention (PCI) in patients with left ventricular (LV) systolic dysfunction has been proven to induce reverse LV remodeling. However, the impact of high-risk PCI focusing on rotational atherectomy (RA) in patients with severe LV systolic dysfunction has not been completely addressed. MethodsAmong 4339 consecutive patients who underwent PCI, 178 patients with 192 lesions were treated with RA. The reduced ejection fraction (EF) group (LVEF ≤35%) included 25 patients, the mid-range EF group (LVEF 36–50%) included 44 patients, and the preserved EF group (LVEF >50%) included 109 patients. The primary outcome was a composite of cardiac death, non-fatal myocardial infarction, target-vessel revascularization, and ischemic stroke. ResultsThe cumulative 1-year incidence of the primary outcome was similar among the three groups (reduced EF, 29%; mid-range EF, 25%; preserved EF, 26%; p = 0.95). After adjusting for confounding factors, the incidence of the primary outcome in the reduced EF group (hazard ratio [HR], 1.07; 95% confidence interval [CI], 0.43–2.37; p = 0.87) and the mid-range EF group (HR, 0.99; 95% CI, 0.47–1.94; p = 0.97) was similar to that in the preserved EF group. LVEF was significantly improved in the reduced EF and mid-range EF groups compared with the preserved EF group (absolute change in LVEF: 13.6 ± 11.3%, 9.0 ± 10.1%, and −0.7 ± 7.8%, respectively; p < 0.0001). ConclusionsReduced EF was not associated with increase in the primary outcome in patients undergoing RA. This seemed to result from the improved LV function after PCI. Summary for annotated table of contentsThis single center analysis study investigated 1-year composite outcome of cardiac death, non-fatal myocardial infarction, target-vessel revascularization, and ischemic stroke in patients with severe LV systolic dysfunction undergoing RA compared with that in patients with preserved LV function. The cumulative 1-year incidence of the composite outcome was similar among the three groups (reduced EF, 29%; mid-range EF, 25%; preserved EF, 26%; p = 0.95). LVEF was significantly improved in the reduced EF and mid-range EF groups compared with the preserved EF group (absolute change in LVEF: 13.6 ± 11.3%, 9.0 ± 10.1%, and −0.7 ± 7.8%, respectively; p < 0.0001).

Increased Mean Platelet Volume is Associated with Decreased Survival in Patients Supported with Impella

Increased mean platelet volume (MPV) has been associated with elevated risk of stroke and myocardial infarction in the general population and stroke/pump thrombosis in Heartmate II recipients. It has been proposed that contact with foreign surfaces and centrifugation promote prothrombotic states with platelet activation and increased MPV. An association between MPV and outcomes of patients treated with percutaneous short-term circulatory devices has not been investigated. This was a retrospective study of 67 patients who received percutaneously inserted ventricular assist device (pVAD) support for high risk percutaneous coronary interventions. Mean platelet volume (MPV) was measured by impedance technology with Sysmex XN-10 hematological analyzer and expressed in femtoliters (fL). Average MPV (aMPV) and percentage change from admission (∆MPV%) were calculated. All patients experienced rise in MPV during the hospital stay (10.7+/-0.9 pre-pVAD, 10.8+/-0.8 in 24hrs post pVAD, and 11.1+/-1 fL at 7d, p<0.0001). However, MPV increase was more pronounced in the 24 patients (34.5%) who expired in the hospital (Figure A) and the ∆MPV% was significantly higher in expired patients (7.7+/-7.8 vs. 4.6+/-4.9% in survivors, p=0.026). When adjusted for clinical variables (age, gender, and histories of atrial fibrillation, hypertension, coronary artery disease, and congestive heart failure), every 1% increase in ∆MPV% was associated with 11% increased odds of dying in patients undergoing high risk PCI with pVAD support (OR 1.111, 95%CI 1.015-1.216, p=0.022). This pilot study indicates that rise in MPV is associated with increased mortality in PCI patients treated with pVAD. Simple and widely available MPV measurements may be useful in identifying high risk patients and estimating prognosis, which may aid in proper resource allocation. More studies on this subject are necessary.

The clinical case of the first high risk percutaneus coronary intervention under use of the PulseCath iVAC 2L left ventricular assist device in Russia

Percutaneous left ventricular assist devices are necessary to maintain blood circulation in patients with cardiogenic shock after high risk percutaneous coronary interventions. The PulseCath iVAC 2L is a new device that can be implanted percutaneously via the femoral artery. The device consists of an extracorporeal membrane pump and a catheter, which is inserted into the left ventricle through the aorta. The pump is connected to the console of the intra-aortic balloon counterpulsator generating a pulsatile blood flow.

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.

Organoprotective Effects of Extracorporeal Membrane Oxygenation and Intra-Aortic Balloon Pump in High-Risk Percutaneous Coronary Intervention in Patients with Acute Coronary Syndrome

Purpose of the study: to evaluate the organoprotective effects of veno-arterial extracorporeal membrane oxygenation and intra-aortic balloon pump during high-risk percutaneous coronary intervention in acute coronary syndrome.Materials and methods. Patients required mechanical circulatory support (n=51) were divided into two study groups: patients who received mechanical circulatory support by veno-arterial extracorporeal membrane oxygenation (ECMO) (Group 1, n=29) during high-risk percutaneous coronary intervention, and Group 2 patients who received mechanical circulatory support by intra-aortic balloon pump (IABP) during high-risk percutaneous coronary intervention (Group 2, n=22). The dynamics of instrumental parameters and laboratory markers of organ damage were evaluated by electrocardiography, echocardiography, determining troponin I, creatine phosphokinases and creatinine levels, NGAL, venous blood saturation to compare the organoprotective properties of mechanical circulation support in the intra- and postoperative period.Results. The following values of the parameters were found the next day after the intervention: troponin I — 0.18 (0.1; 2.3) ng/ml in the ECMO group and 1.64 (0.92; 2.36) ng/ml in the IABP group (P=0.045); serum NGAL —139.4 (88.1; 166.7) ng/ml in the ECMO group and 212.3 (102; 279) in the IABP group (P=0.027); renal dysfunction (stages R, I, F according to RIFLE) — 2 (6.8%) observations in the ECMO group and 7 (31.8%) in the IABP group (P=0.021); multiple organ failure (2 or more points according to SOFA) — 3 (10.3%) cases in the ECMO group and 12 (54.5%) in the IABP group (P=0.001).Conclusion. Veno-arterial ECMO in comparison with IABP has a more pronounced organoprotective effect by achieving better hemodynamic stability, which, in turn, prevents hypoxia and the subsequent development of organ dysfunction. In addition, in conditions of veno-arterial ECMO, better completeness and quality of revascularization is ensured, and hospital mortality is also reduced.

TEMPORARY TREND AND OUTCOME OF MECHANICAL CIRCULATORY SUPPORT IN ELECTIVE HEMODYNAMICALLY STABLE HIGH RISK PERCUTANEOUS CORONARY INTERVENTION

Mechanical circulatory support (MCS) might reduce procedural complications and mortality in high risk percutaneous coronary intervention (HRPCI). Although, Impella is the only device with FDA approval for use in HRPCI, there is no published randomized trial available to suggest an improvement in

IN-HOSPITAL OUTCOMES OF IMPELLA VERSUS IABP IN MULTIVESSEL PERCUTANEOUS CORONARY INTERVENTION: NATIONAL INPATIENT DATABASE ANALYSIS

Impella is a mechanical circulatory support device indicated in severe cardiogenic shock and high-risk percutaneous coronary intervention. And IABP is commonly used during PCI in acute coronary syndrome to improve coronary perfusion. We investigated the in-hospital outcomes of IABP and Impella in

IMPELLA ASSISTED HIGH RISK PERCUTANEOUS CORONARY INTERVENTION-AN ANALYSIS OF RISK FACTORS ASSOCIATED WITH 30-DAY MORTALITY

To date, there are no defined risk factors for 30-day mortality after Impella protected high-risk percutaneous coronary intervention (HR-PCI). Retrospective analysis of all Impella protected HR-PCI at a single center was performed. All patients had Impella placed electively at the beginning of the

Extremely high-risk percutaneous coronary intervention in an elderly patient with multiple comorbidities and good general condition

Extremely high-risk percutaneous coronary intervention in an elderly patient with multiple comorbidities and good general condition

Observational multicentre registry of patients treated with IMPella mechanical circulatory support device in ITaly: the IMP-IT registry

The aim of this study was to investigate nationwide trends and clinical outcomes of the Impella device for cardiogenic shock (CS) and high-risk percutaneous coronary intervention (HR-PCI). The IMP-IT study was a multicentre observational national registry which enrolled all patients treated with Impella 2.5, Impella CP, Impella 5.0 and Impella RP, both for CS and HR-PCI indications, across 17 Italian centres from 2004 to June 2018. A total of 406 patients were included: 229 had CS (56.4%) and 177 underwent HR-PCI (43.6%). The use of Impella increased significantly during the study period (average annual percent change 39.8%, 95% confidence interval: 30.4 to 49.9; p<0.0001) for both indications. The Impella 2.5 was the most commonly used device (N=242; 59.6%). Rates of in-hospital and one-year all-cause death in patients with CS were 46.9% and 57.0%, respectively; 18.5% underwent left ventricular assist device implantation or heart transplant at one year. Rates of in-hospital and one-year all-cause death in patients who underwent HR-PCI were 5.7% and 15.6%, respectively. Rates of device-related complications were 37.1% and 10.7% in the setting of CS and HR-PCI, respectively. Use of the Impella for CS and HR-PCI is increasing substantially in Italy, despite relatively high rates of device-related complications.

Temporary percutaneous ventricular assist devices for cardiogenic shock and high-risk percutaneous coronary intervention: a systematic literature review

Percutaneous ventricular assist devices (pVADs) are frequently used for the treatment of patients with cardiogenic shock (CS) due to acute myocardial infarction (AMI) and as a support in percutaneous coronary intervention (PCI) for high-risk patients. CS is a clinical condition characterized by inadequate tissue perfusion due to cardiac dysfunction and for 80% of cases it is caused by AMI with left ventricular insufficiency. CS is responsible for about 50% of deaths in patients with myocardial infarction. Usually, PCIs do not require hemodynamic support, which could be however necessary in patients undergoing high-risk PCI. Presently, available pVADs in Europe are Impella 2.5, Impella CP, HeartMate PHP, TandemHeart, PulseCath iVAC2L. The aim of this review is to evaluate the efficacy and safety of pVADs in patients with refractory CS complicating AMI or undergoing high-risk PCI. We systematically searched for randomized controlled trials (RCTs) and controlled observational studies in PubMed, Embase and PubMed CENTRAL databases until September 2018. We included studies comparing pVADs with intra-aortic balloon pumps (IABP) or medical therapy in patients with CS complicating AMI or undergoing high-risk PCI. Researchers independently assessed records' eligibility, inclusion and methodological quality of included studies. If possible, data of included studies was combined in a meta-analysis. Risk ratio (RR) and 95% confidence interval (CI) were calculated using a random effects model. Overall, 8 studies were included. Five studies (3 RCTs and 2 observational studies) evaluated pVADs in patients with SC complicating AMI. Meta-analyses showed that 30-day mortality did not differ between patients treated with pVADs and the control group (RR 1.05, 95% CI 0.84-1.31). However, risk of major bleeding was 2 times higher in patients treated with pVADs compared to controls. Three studies evaluated pVADs in patients undergoing high-risk PCI. Due to the lack of data, it was not possible to combine study results in a meta-analysis. One RCT reported no difference in 30- and 90-day mortality between patients randomized to Impella or IABP. Two non-randomized controlled studies reported no difference in terms of in-hospital all-cause mortality between the two groups. Our meta-analysis suggests similar results in terms of efficacy and safety between pVADs and control (IABP and medical therapy) for the treatment of patients with CS complicating AMI or undergoing high-risk PCI.

Circulatory support with larger volume intra-aortic balloon pump vs. standard volume or no-balloon pump during high-risk percutaneous coronary interventions. A randomised study.

IntroductionPercutaneous coronary intervention in high-risk patients (HRPCI) is associated with increased risk of periprocedural complications such as hypotension and shock. Mechanical circulatory support devices may the bridge patient safely throughout the procedure and are often used in this setting.AimWe assessed the outcomes of patients subjected to HRPCI and supported with intra-aortic balloon pump (IABP) of larger volume (MEGA) compared to standard volume (STRD) or no balloon support at all (CTRL).Material and methodsIn this single-centre, open-label, randomised, controlled trial, HRPCI patients were randomly assigned to three groups: MEGA, STRD, and CTRL in a 1 : 1 : 1 scheme. Screening failure patients were assigned to the registry (REG). Composite haemodynamic endpoint (CHEP) was assessed during the procedure and major adverse cardiac even (MACE)/safety endpoints up to 1-year follow-up (FU).ResultsA total of 36 patients were randomised (13 MEGA, 14 STRD, and 9 CTRL). The incidence of in-hospital MACE was observed in 23.1% of MEGA, 7.1% of STRD and 33.3% of CTRL (p = 0.25) patients; MACE at FU in 50.0%, 35.7%, and 55.6% (p = 0.61); major bleeding in 46.2%, 28.6%, and 22.2%, (p = 0.45); and CHEP in 15.4%, 50.0%, and 44.4%, respectively (p = 0.13). On per-treatment (PT) analysis (16 MEGA, 10 STRD, and 21 CTRL), including 11 patients from REG, in-hospital MACE was observed in 18.8% of MEGA, 10.0% of STRD, and 23.8% of CTRL (p = 0.64) patients; MACE at FU in 53.3%, 20.0%, and 57.1% (p = 0.12); major bleeding in 37.5%, 20.0%, and 33.3% (p = 0.62); and CHEP in 15.5%, 50.0%, and 52.4%, respectively (p = 0.023).ConclusionsLarger volume intra-aortic balloon pump might be effective at reducing haemodynamic instability during HRPCI without a statistically significant effect on safety endpoints or MACE.

Mechanical circulatory support during high-risk percutaneous coronary intervention in a young male patient.

Mechanical circulatory support during high-risk percutaneous coronary intervention in a young male patient.

A Review of Bleeding Risk with Impella-supported High-risk Percutaneous Coronary Intervention.

Complex, high-risk percutaneous coronary intervention (HR-PCI) is increasingly being performed, often with mechanical circulatory support (MCS), though to date, there are limited randomised data on the efficacy of MCS for HR-PCI. The majority of MCS is provided by intra-aortic balloon pumps, but increasingly Impella® (Abiomed, Danvers, MA, USA) heart pumps are being used. While the Impella pumps provide greater increases in cardiac output, these devices require large bore access, which has been associated with an increased risk of bleeding and vascular complications. Decisions regarding the use of Impella are often based on risk-benefit considerations, with Impella-related bleeding risk being a major factor that can impact decisions for planned use. While bleeding risk related to large bore access is a concern, published data on the risk have been quite variable. Thus, the goal of this article is to provide a comprehensive review of reports describing bleeding and vascular complications for Impella-supported HR-PCI.

859 Outcomes for High-Risk Percutaneous Coronary Intervention (PCI) in Patients Referred from a Rural Centre to Metropolitan Sites

859 Outcomes for High-Risk Percutaneous Coronary Intervention (PCI) in Patients Referred from a Rural Centre to Metropolitan Sites

Dynamic Change of Coronary Microcirculation During Cardiocirculatory Support by the Impella

The use of the Impella device (ABIOMED, Danvers, Massachusetts) is becoming widespread in patients presenting with cardiogenic shock and those undergoing high-risk percutaneous coronary intervention (PCI). The DTU-STEMI (Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction -