Protected Percutaneous Coronary Intervention Research Articles

Structured Weaning From the Impella Left Ventricular Micro-Axial Pump in Acute Myocardial Infarction With Cardiogenic Shock and Protected Percutaneous Coronary Intervention: Experience From a Non-Cardiac Surgical Centre

The Impella (Abiomed, Danvers, MA, USA) temporary percutaneous left ventricular assist device is increasingly used as mechanical circulatory support in patients with acute myocardial infarction-cardiogenic shock (AMICS) or those undergoing high-risk protected percutaneous coronary intervention (PCI). The optimal weaning regimen remains to be defined. We implemented a structured weaning protocol in a series of 10 consecutive patients receiving Impella support for protected PCI or AMICS treated with PCI in a high volume non-cardiac surgery centre. Weaning after revascularisation was titrated to native heart recovery using both haemodynamic and echocardiographic parameters. Ten patients (eight male, two female; aged 43-70 years) received Impella support for AMICS (80%) or protected PCI (20%). Cardiogenic shock was of Society for Cardiac Angiography & Interventions grade C-E of severity in 80%, and median left ventricular end-diastolic pressure was 31 mmHg. Protocol implementation allowed successful weaning in eight of 10 patients with a median support time of 29 hours (range, 4-48 hours). Explantation was associated with an increase in heart rate (81 vs 88 bpm; p=0.005), but no significant change in Cardiac Index (2.9 vs 2.9 L/min/m2), mean arterial pressure (79 vs 82 mmHg), vasopressor requirement (10% vs 10%), or serum lactate (1.0 vs 1.0). Median durations of intensive care and hospital stay were 3 and 6 days, respectively. At 30 days, the mortality rate was 20%, with median left ventricular ejection fraction of 40%. A structured and dynamic weaning protocol for patients with AMICS and protected PCI supported by the Impella device is feasible in a non-cardiac surgery centre. Larger studies are needed to assess generalisability of such a weaning protocol.

Characteristics and outcomes of elderly patients undergoing protected percutaneous coronary intervention with impella mechanical circulatory support

Abstract 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 <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<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 <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

Abstract 18976: In-Hospital Outcomes in Patients Undergoing Protected Left Main Percutaneous Coronary Intervention With Percutaneous Left Ventricle Assist Device Protection

Introduction: Left main disease (LMCA) is a known risk factor for patients’ poor outcomes. Percutaneous revascularization of LMCA in heart failure patients is associated with a particularly high periprocedural risk. Percutaneously introduced left ventricle assist devices (pLVAD) are a potential tool to improve patient outcomes in these high-risk procedures. Hypothesis: Our study aimed to assess short-term clinical outcomes of protected left main percutaneous coronary intervention with the use of a pLVAD. Methods: A prospective registry of patients with chronic heart failure, undergoing protected LMCA PCI included 66 patients, 89% male, the median age of 71.5 y.o, 40 (60.6%) after prior myocardial infarction, 31 (47%) after prior PCI and 12 (18.2%) after CABG, with CTO RCA in 17 (25.6%) of cases. Percutaneous LVAD was used in all patients, 72% access site was the right femoral artery, additional plaque modification techniques were used in 46 (69.7%) patients, IVL was applied in 25 (37.9%) of cases and high-speed rotational or orbital atherectomy was used in 21 (31.2%) of cases. Median of 3 [2;4] DES was implanted. Results: During the in-hospital follow-up, a significant improvement of the left ventricle ejection fraction was observed (median LVEF 30% post PCI vs22% at baseline, p<0.001) as well as a significant decrease of NTproBNP levels (765 [IQR: 194, 6,370] at discharge vs 7113 pg/ml [IQR:1,945, 15,646] at baseline, p=0.01]. There was 1 in-hospital death due to cardiogenic shock. A safety monitoring revealed 11 hematomas, including 3 cases that needed vascular surgery. Bleeding according to BARC 3a was recorded in 17/66 (28%) and BARC 3b in 3/66 (5%) of cases. Conclusions: Percutaneous LVAD support is a feasible method to perform protected left main PCI with a good safety profile when applied by experienced operators A significant improvement of the LVEF can be observed after left main revascularization Further research is needed to confirm the presented results.

P303 ECMO–PROTECTED HIGH RISK PCI IN UNUSUAL CLINICAL AND ANATOMICAL SCENARIO

Abstract Background Non–emergent complex high–risk indicated procedure (CHIP) identify complex PCI according with clinical, anatomical and procedural features and prevent intraprocedural hemodynamic compromise represents a major issue. The aortic valve bypass (AVB) has been an uncommon surgical option performed by creating a heterotopic second left ventricular output bypassing native stenotic aortic valve with flow redistribution between the native left ventricular outflow tract and the apical–aortic bypass. AVB was phased out in “TAVI–era”. Case Report A 78 years–old obese and hypertensive male, with pulmonary fibrosis and previous AVB for severe aortic stenosis judged at unacceptable high surgical risk 10 years before, was admitted to the emergency department for chest pain and palpitation. Patient was in Killip class I. ECG showed rapid atrial fibrillation without ST–segment elevation. Atrial tachyarrhythmia, chest pain and palpitation spontaneously simultaneously resolved. A type 2 NSTEMI–ACS was suspected according to clinical features and pathological Hs–troponin. Multimodality imaging documented normal systolic function, normally operating AVB, paradoxical low flow severe native aortic valve stenosis, a chronic type B aortic dissection from distal anastomosis of AVB retrogradely extended to left subclavian artery origin and a wide aneurysm of the abdominal aorta (Fig. 1). Coronary angiography documented severely calcific multivessel disease. Prompt and complete revascularization was considered mandatory and a surgical redo was discarded. The use of an intraprocedural hemodynamic support was advisable, but anatomical context represented substantial contraindication to IABP and Impella. Heart Team decided to perform VA–ECMO–protected–PCI. After lesion preparation double kissing crush was performed on LMCA and single stents were implanted in proximal LAD and proximal RCA (Fig. 2). Despite signs of transient hemodynamic instability the patient tolerated the procedure thanks to the ECMO support. Complete myocardial revascularization was obtained without complications and the subsequent clinical course was uneventful. Discussion In this CHIP patient, hemodynamic support was vital to allow a safe complete myocardial revascularization. ECMO is a demanding system, not routinely used for “protected PCI”; however, the case here reported underlines that ECMO can be a feasible option, prerequisite in uncommon cases where other standard tMCS are contraindicated.

The Role of the Percutaneous Impella Pump in Anesthesia and Intensive Care

The use of temporary mechanical circulatory support (tMCS) devices and in particular the increasing use of the Impella device family has gained significant interest over the last two decades. Nowadays, its use plays a well-established key role in both the treatment of cardiogenic shock, and as a preventive and protective therapeutic option during high-risk procedures in both cardiac surgery and cardiology, such as complex percutaneous interventions (protected PCI). Thus, it is not surprising that the Impella device is more and more present in the perioperative setting and especially in patients on intensive care units. Despite the numerous advantages such as cardiac resting and hemodynamic stabilization, potential adverse events exist, which may lead to severe, but preventable complications, so that adequate education, early recognition of such events and a subsequent adequate management are crucial in patients with tMCS. This article provides an overview especially for anesthesiologists and intensivists focusing on technical basics, indications and contraindications for its use with special focus on the intra- and postoperative management. Furthermore, troubleshooting for most common complications for patients on Impella support is provided.

Standardized pre-procedural clinical workup for protected percutaneous coronary intervention.

In addition to appropriate patient screening, pre-procedural preparation is essential to optimize both technical success and patient outcome for protected percutaneous coronary intervention (PCI). A critical component of optimization is the identification and preparation of a suitable femoral access site. Here, we describe several options for both imaging and image-guided access to optimize the approach.

Specific clinical vignettes in high-risk protected percutaneous coronary intervention.

There are several cardiac- and patient-related factors that come into play when considering patients for protected percutaneous coronary intervention (PCI). Cardiac factors include complexity/location of coronary lesions, the degree of left or right ventricular impairment, the presence of valvular lesions, and ventricular arrhythmias. Patient related factors include comorbidities that would render the patient at a higher risk of death should cardiogenic shock ensue during the procedure. Comorbidities include chronic lung disease (chronic obstructive airways disease, asthma, pulmonary fibrosis), renal or liver impairment, other cardiovascular diseases (such as previous cerebrovascular accident or transient ischemic attack, peripheral arterial disease, carotid stenosis), diabetes, frailty and advanced age. Here, we present three very different cases where left ventricular support was deemed appropriate to reduce peri-procedural risk and optimize outcomes.

What is known in pre-, peri-, and post-procedural anticoagulation in micro-axial flow pump protected percutaneous coronary intervention?

Interest in the use of percutaneous left ventricular assist devices (p-LVADs) for patients undergoing high-risk percutaneous coronary intervention (PCI) is growing rapidly. The Impella™ (Abiomed Inc.) is a catheter-based continuous micro-axial flow pump that preserves haemodynamic support during high-risk PCI. Anticoagulation is required to counteract the activation of the coagulation system by the patient's procoagulant state and the foreign-body surface of the pump. Excessive anticoagulation and the effect of dual antiplatelet therapy (DAPT) increase the risk of bleeding. Inadequate anticoagulation leads to thrombus formation and device dysfunction. The precarious balance between bleeding and thrombosis in patients with p-LVAD support is often the primary reason that patients' outcomes are jeopardized. In this chapter, we will discuss anticoagulation strategies and anticoagulant management in the setting of protected PCI. This includes anticoagulant therapy with unfractionated heparin, direct thrombin inhibitors, DAPT, purge blockage prevention by bicarbonate-based purge solution, and monitoring by activated clotting time, partial thromboplastin time, as well as anti-factor Xa levels. Here, we provide a standardized approach to the management of peri-interventional anticoagulation in patients undergoing protected PCI.

Optimized patient selection in high-risk protected percutaneous coronary intervention.

Percutaneous mechanical circulatory support (pMCS) is increasingly used in patients with poor left-ventricular (LV) function undergoing elective high-risk percutaneous coronary interventions (HR-PCIs). These patients are often in critical condition and not suitable candidates for coronary artery bypass graft surgery. For the definition of HR-PCI, there is a growing consensus that multiple factors must be considered to define the complexity of PCI. These include haemodynamic status, left-ventricular ejection fraction, clinical characteristics, and concomitant diseases, as well as the complexity of the coronary anatomy/lesions. Although haemodynamic support by percutaneous LV assist devices is commonly adopted in HR-PCI (protected PCI), there are no clear guideline recommendations for indication due to limited published data. Therefore, decisions to use a nonsurgical, minimally invasive procedure in HR-PCI patients should be based on a risk-benefit assessment by a multidisciplinary team. Here, the current evidence and indications for protected PCI will be discussed.

A new iteration for the single-access large-bore technique during Impella supported complex and high-risk coronary intervention: a case report

BackgroundComplex and high-risk coronary intervention (CHIP-PCI) and PCI in cardiogenic shock complicating acute coronary syndrome (ACS) are increasingly performed under mechanical circulatory support—so-called protected PCI. Among the available options, Impella Cardiac Power (CP) heart pump (Abiomed) is percutaneously inserted over the femoral artery and typically requires a second arterial access to perform PCI, which further enhances the risk of vascular and bleeding complications. The single-access technique allows Impella CP placement and PCI performance through the same vascular access. When a 7 Fr system is desirable, only a long and entirely hydrophilic coated sheath has been previously used, which is not available in Europe.Case summaryA 85-year-old patient admitted with non ST-elevation - acute coronary syndrome (NSTE-ACS), severely reduced left ventricular function and three-vessel coronary artery disease underwent single-access CHIP-PCI under Impella CP support. After a failed attempt to insert a standard 7 Fr long femoral sheath alongside the Impella catheter, we successfully introduced a 7.5 Fr sheathless guiding catheter and delivered the planned percutaneous treatment with the benefits conferred by a 7 Fr—rather than 6—lumen catheter, without the need for an additional arterial access.DiscussionThis is, to the best of our knowledge, the first case of CHIP-PCI performed under Impella support utilizing the single-access technique with a 7.5 Fr sheathless guiding catheter. Beyond advantages of the single-access technique in sparing time and avoiding vascular complications associated with gaining a second arterial access, the lower outer diameter of the sheathless catheter compared with standard 7 Fr sheaths may allow improved limb perfusion and lower chance of interference with the Impella CP catheter.

High-Risk Percutaneous Coronary Intervention of Native Coronary Arteries Without Mechanical Circulatory Support in Acute Coronary Syndrome Without Cardiogenic Shock

Widespread utilization of mechanical circulatory support (MCS) for high-risk percutaneous coronary intervention (PCI) remains controversial, with a lack of randomized supporting evidence and associated risk of device-related complications. We investigated whether high-risk PCI of native coronary arteries without elective MCS in patients with acute coronary syndrome (ACS) is safe and feasible. We performed a single-center, retrospective analysis for ACS patients meeting American College of Cardiology high-risk criteria: unprotected left main disease, last remaining conduit, ejection fraction <35%, 3-vessel coronary artery disease, severe aortic stenosis, or severe mitral regurgitation. Patients with cardiogenic shock and those undergoing PCI of the bypass grafts were excluded. Major in-hospital and 30-day cardiovascular outcomes were assessed. From 2003 through 2018, 499 patients (847 lesions) with unstable angina pectoris (UAP), 1218 patients (1807 lesions) with non-ST-elevation myocardial infarction (NSTEMI), and 868 patients (1260 lesions) with ST-segment elevation myocardial infarction (STEMI) underwent high-risk PCI. Procedural success was achieved in 97.2% of UAP, 98.3% of NSTEMI, and 96.6% of STEMI patients. In-hospital and 30-day all-cause mortality were as follows: UAP, 2%; NSTEMI, 2.1%; and STEMI 4.7%. Bailout intra-aortic balloon pump was required in 1.6% of UAP, 3.1% of NSTEMI, and 10.3% of STEMI patients. Major complications for UAP, NSTEMI, and STEMI were, respectively: target lesion revascularization (2.3%, 1.4%, and 1.5%), stroke or transient ischemic attack (0.8%, 0.6%, and 1.3%), acute renal failure (8.2%, 7.2%, and 10.2%), major bleeding (1.6%, 3.1%, and 8.5%). In conclusion, our results show that high-risk PCI without elective MCS is safe and feasible in most ACS patients, challenging professional societies' current recommendations. A randomized trial comparing unprotected versus protected high-risk PCI for non-shock ACS patients is warranted.

Coronary artery bypass grafting under sole Impella 5.0 support for patients with severely depressed left ventricular function

Selection of the ideal surgical procedure for coronary revascularization in patients with severe cardiac dysfunction at times may represent a challenge. In recent years, with the advent of surgical large microaxial pumps, e.g., Impella 5.0 (Abiomed Inc., Boston, USA), specific support and effective unloading of the left ventricle has become available. In the interventional field, good results have been achieved with smaller microaxial pumps in the setting of so-called protected percutaneous coronary intervention. In this study, we would like to share our early experience with surgical coronary revascularization under the sole support of Impella 5.0, omitting the use of heart–lung machine in three cases of severe cardiac dysfunction due to complex ischemic heart disease. Effective circulatory support intraoperatively and postoperatively speaks in favor of this technique in selected patients.

Feasibility and Safety of High-Risk Percutaneous Coronary Intervention Without Mechanical Circulatory Support.

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One stent versus two stents for distal LM PCI: insights from the experience of a high volume center

Abstract Introduction Distal left main (LM) PCIremains a challenge. One of the most debated issues is whether to use a single vs 2 stent provisional strategy. While most studies and guidelines favour a single stent strategy, the recent DK-CRUSH V trial has shown better results with a 2 stent strategy. Objective To evaluate the performance of a single vs dual stent strategy for LM PCI in a real-world population setting. Methods Single-center procedural prospective registry of patients (pts) submitted to LM PCI from 2015–2018, with retrospective event analysis. Demographic, clinical data and procedure characteristics were analysed. Results were obtained with χ2 test, T student test, Kaplan-Meier survival analysis, logistic and Cox regression. Results 100 pts (73 men; 69±11 years) were included. Co-morbidities were very frequent (85 had hypertension, 54 had diabetes, 71 had dyslipidemia and 39 were past smokers). 32 had reduced LVEF (&amp;lt;40%) and 45 previous CABG. The decision to proceed to PCI vs surgery was undertaken individually by the local HeartTeam. Most of the procedures (57) were in an acute coronary syndrome setting (11 in STEMI, 7 with cardiogenic shock). The anatomical distribution of the lesions was: distal in 69 pts (61 involved the LAD and or Cx ostium), mid shaft in 7 pts, ostial in 18 pts and diffuse in 6 pts. Protected left main PCI encompassed 41% of the procedures. The complication rate was 7%. During a mean follow-up of 866±400 days, there were 4 peri-procedural deaths, 1-year mortality rate of 10% and 22 pts died overall. In pts submitted to distal LM PCI, a single stent was used in 49 pts (66%) versus a 2 stent approach in 23 pts (31%). The only significant difference between these groups were diabetes (66% in the single stent vs 32% in the 2 stent group, p=0.006) and protected LM (51% in the single stent vs 26.1% in the two stent group, p=0.046). While a 2 stent strategy was associated with higher mortality by Kaplan Meyer analysis (LogRank = 11.07, p=0.001), it was not an independent predictor of mortality in Cox regression. Cox univariate analysis identified LVEF &amp;lt;40% (OR 2.2, CI 1.01–4.9, p=0.047) and complications (OR 3.1, CI 1.4 – 6.9, p=0.004) as the only predictors of death. In multivariate analysis, only the latter was an independent predictor of mortality (OR 2.6, IC 1.1–5.9, p=0.028). The use of a 2 stent strategy was significantly associated with complications (χ2=5.1 p=0.024)) and was the only independent predictor of it (OR 3.8, IC 1.1–12.8, p=0.03). This was true even in the subgroup of protected LM PCI. Conclusion In a real-world setting of challenging LM PCI cases, a single stent strategy for distal LM PCI performed better. The use of 2 stents was an independent predictor of complications, strongly associated with increased risk of death. While a LM PCI must be undertaken on an individual basis, a single stent provisional strategy, whenever feasible, seems to be the best option. Funding Acknowledgement Type of funding source: Public hospital(s). Main funding source(s): Hospita Santa Maria

Sex sub analysis from observational multicenter registry of patients treated with Impella mechanical circulatory support device in Italy: the IMP-IT women

Abstract Background Women-specific data on safety, effectiveness, and outcomes for mechanical support in the setting of cardiogenic shock (CS) and high-risk percutaneous coronary intervention (HR-PCI) are still unsettled. The IMP-IT study was a multicenter observational national registry that 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 centers from 2004 to June 2018 Purpose To analyze the characteristics of female population enrolled in IMP-IT registry and to assess differences in presentation, timing to interventions and outcomes between men and women. Methods The Women-IMP-IT study is a multicenter observational national registry focusing on female population enrolled in IMP-IT study. Baseline, procedural and hemodynamics characteristics, such as outcome were collected. Differences between men and women were examined. Results Mean age of female population was 66.9±16.1 years, Body mass index was 26.3±5.5 kg/m2. There was a higher rate of cardiogenic shock (66.7% vs. 49.1%; p=0.06), NSTEMI (18% vs 9%, p=0.03) and acute myocarditis (9.6% vs 1.4%, p=0.01) in women vs men, associated with a lower rate of protected PCI (33.3% vs 50.9%, p=0.06). We did not observed a statistically difference in device related complications (27.4% vs 23.3%; p=0.50), respectively in women compared to men. In particular, no differences were observed in access site bleedings (10.8% vs 9%; p=0.70) and life threatening or severe bleeding (15.3% vs 11.4%; p=0.40). At one year, all-cause death rate was 45.1% in women vs 30.1% in men (p=0.016), and cardiac death rate was 42.5% in women and 27.5% in men (p=0.013). At 1-year no significant difference was observed in the rate of myocardial infarction (3.7% vs 2.3%; p=0.44), stroke (3.7% vs 2.6%; p=0.70), heat-failure hospitalization (7.7% vs 7.5%; p=1.0), need for left ventricular assist device or heart transplantation (1.3% vs 5.5%; p=0.21). Conclusions In our series, use of Impella is CS and HR-PCI is increasing in female population. Sex-differences in mortality are mostly explained by clinical differences at presentation. Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): EAPCI Education and Training Grants

Design, concept and first in-vitro results of the percutaneous, pulsatile left ventricular assist device-PERKAT LV

Abstract Introduction A very high morbidity and mortality is associated with cardiogenic shock due to left ventricular failure despite encouraging developments in interventional cardiology. Patients suffering from cardiogenic shock often require temporary mechanical circulatory support to stabilize organ perfusion. In addition, an increasing number of patients with complex multi-vessel diseases cannot undergo surgical myocardial revascularization as recommended by recent guidelines due to their comorbidities. Those patients could benefit from a protected PCI approach using a temporary mechanical assist device. The available LVAD systems have specific advantages and disadvantages. Purpose It was our aim to develop a percutaneous, pulsatile assist device that unloads the left ventricle in a physiologic way. Methods The PERKAT-LV (“PERkutane KATheterpumptechnologie”) device consists of a self-expanding nitinol pump chamber which is covered by foils. Those foils carry multiple outflow valves at the proximal part of the pump chamber. A flexible suction tube with a pigtail-shaped tip and inflow holes are attached to its distal part. The system is designed for 16F percutaneous implantation via the femoral artery. Pulling back the outer sheath unfolds the nitinol chamber in the descending aorta while the flexible suction tube bypasses the aortic arch and ascending aorta with its tip in the left ventricle. In the second implantation step, a standard IABP balloon is placed into the pumping chamber and is connected to an external IABP console. Balloon deflation generates a blood flow from the left ventricle into PERKAT LV. During balloon inflation, blood leaves the system through the outflow foil valves in the descending aorta. Positioning and schematic drawing of PERKAT-LV is demonstrated in Figure 1. Results Preliminary in-vitro studies using a prototype of the PERKAT LV device were performed. It was tested in different afterload settings (0, 40, 80 and 120 mmHg) using a standard 30 ccl IABP balloon and varying inflation/deflations rates (70, 80, 90, 100, 110 and 120/min). We detected flow rates ranging from 2.0 to 3.0 L/min depending on the afterload setting and inflation/deflation rate. Conclusion The novel percutaneously implantable and pulsatile working PERKAT-LV device offers left ventricular unloading and circulatory support of up to 3.0 L/min in a first feasibility study. At the moment, the system is extensively studied under in vitro conditions. First in vivo evaluation will follow in the near future. Based on the current results, we believe that the system is a promising novel approach for percutaneous application of temporary left ventricular mechanical support. Figure 1 Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): German Federal Ministry of Education and Research

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.

Safety and Efficacy of a Percutaneously Inserted Ventricular Support Device Purge Solution Heparin 25 U/mL.

The Impella is a percutaneous ventricular assist device (pVAD) that provides temporary hemodynamic support to patients with cardiogenic shock or for protected percutaneous coronary intervention. The manufacturer recommends a 50-U/mL concentration of heparin purge solution (or 25 U/mL as an alternative), with systemic heparin to maintain therapeutic anticoagulation during device support. Concomitant use of systemic heparin with the purge solution may increase the risk of bleeding. The primary objective of this study was to describe the prevalence of thrombosis and bleeding using a less-concentrated heparin purge solution (25 U/mL) in combination with systemic heparin therapy. This was a retrospective observational cohort study of patients who required at least 12 hours of pVAD support and received 25-U/mL concentration of heparin purge solution between January 1, 2014, and May 31, 2017. The primary end points were the rate of thrombotic and bleeding events. Secondary end points included the percentage of time within the therapeutic activated partial thromboplastin time (aPTT) range. Descriptive statistics were utilized for data analysis. Of the 161 patients screened, 100 met inclusion criteria; 63% of patients experienced a bleeding event, with Bleeding Academic Research Consortium (BARC) type 3a being the most common. Median percentages of subtherapeutic and supratherapeutic aPTT values were similar between the bleeding and nonbleeding groups. Two patients experienced thrombotic events. Based on our findings, the device thrombosis rate was 2% and the rate of major bleeding (BARC 3a and higher) was 35%. This study provides descriptive outcomes data of a lower-concentration heparin purge solution.

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.

P962Follow-up of protected high-risk percutaneous coronary intervention with microaxial Impella pump. Results from the retrospective German Impella Registry

Abstract Background Percutaneous coronary intervention (PCI) presents a relevant alternative to coronary bypass surgery for the treatment of patients with complex coronary artery disease and high perioperative risk. By temporary implantation of a percutaneous ventricular assist devices (pVAD) interventionalists attempt to anticipate the hemodynamic risk of those high-risk patients in a so-called protected PCI. The Impella® system presents the currently most common device for protected PCI and could show hemodynamic stability in earlier trials. Methods This study is a retrospective, observational multi-center registry of ten hospitals in Germany. We included patients undergoing protected high-risk PCI with Impella® support. The primary endpoint was defined as major adverse cardiac events (MACE) during a 180-day follow-up and consisted of all-cause mortality, myocardial infarction (MI) and stroke. Results Six of the participating hospitals performed a follow-up. In total, 157 patients (80.3% male; mean age 71.8±10.8 years) were included in the present study. Prior to PCI, median left ventricular ejection fraction was 39.0% (25.0%-50.0%) and median SYNTAX-Score I was 33.0 (24.0–40.5). The 180-day follow-up was available for 149 patients (94.9%). Eight patients (5.1%) were lost to follow-up. During the follow-up period, 34 patients (22.8%) suffered from a MACE. A total of 27 patients (18.1%) died. Nine patients (6.0%) sustained a MI, while 4 patients (2.7%) had a stroke. Kaplan-Meier curves for primary endpoint Conclusions Patients undergoing protected high-risk PCI with Impella® support show a good 180-day clinical outcome regarding rates of MACE and mortality. However, a head-to-head comparison of Impella supported patients to protected PCI with other pVADs is pending. Acknowledgement/Funding S.B., N.W., F.A.-R., J.-M.S., A.S., R.S., I.A. receive consulting fees/honoraria from Abiomed (Danvers, MA, USA).