Real-world use of the Impella 2.5 circulatory support system in complex high-risk percutaneous coronary intervention: The USpella Registry

Objectives: We report on the real-world, multicenter experience of the Impella 2.5 circulatory support system during high-risk PCI, a subset of the larger USpella Registry. Background: Standard of care for most patients with compromised ventricular function with multivessel or high-risk coronary lesions has been coronary artery bypass grafting. In poor operative candidates, high-risk PCI is increasingly considered, despite an increased risk for periprocedural hemodynamic compromise. Methods: 175 consecutive patients who underwent high-risk PCI with prophylactic support of the Impella 2.5 were evaluated. The primary safety endpoint was the incidence of major adverse cardiac events (MACE) at 30 days. Secondary endpoints included safety and efficacy related to the device and patient outcomes, including survival at 12 months. Results: Overall angiographic revascularization was successful in 99% of patients and in 90% of those with multivessel revascularization, resulting in a reduction of the mean SYNTAX score post-PCI from 36 ± 15 to 18 ± 15 (P < 0.0001) and an improvement of the ejection fraction (from 31 ± 15% to 36 ± 14%, P < 0.0001). In 51% of patients, the functional status improved by one or more NYHA class (P < 0.001). At 30-day follow-up, the rate of MACE was 8%, and survival was 96%, 91%, and 88% at 30 days, 6 months, and 12 months, respectively. Conclusions: The use of Impella 2.5 in high-risk PCI appeared feasible and safe in the real-world setting. The utilization of the Impella 2.5 was successful, resulting in favorable short- and midterm angiographic, procedural and clinical outcomes. ? 2012 Wiley Periodicals, Inc.     

Mechanical left ventricular unloading during high risk coronary angioplasty: First use of a new percutaneous transvalvular left ventricular assist device

A new catheter mounted, transvalvular left ventricular assist device has been designed for percutaneous transfemoral access. The device, the Hemopump? [14 French (Fr.) outer diameter], is based on a mixed flow rotary pump and is capable of flow rates of 1.5–2.2 1/min. The pump is inserted using a specialized 16 Fr. femoral introducer sheath. The first application of the percutaneous Hemopump? in man was performed in two patients with hemodynamic compromise during high risk coronary angioplasty. In these patients, Hemopump? support resulted in hemodynamic stabilization (increase in aortic pressure from 60/42 to 87/61 and from 80/60 to 100/70 mm Hg, respectively) and marked left ventricular unloading (decrease in pulmonary capillary wedge pressure from 25 to 10 and from 14 to 10 mm Hg) during balloon inflation. In both patients, percutaneous transluminal coronary angioplasty (PTCA) could be accomplished successfully. Using the system for periods of about 2 hr in each patient, we observed no vascular, hemorrhagic, or embolic complications. In both patients, only a minor increase in both plasma free hemoglobin and lactate dehydrogenase levels was noted. Our preliminary experiences suggest that the percutaneous Hemopump? is safe and effective and may be a powerful alternative to other devices used for supported angioplasty.     

Left ventricular unloading and concomitant total cardiac output increase by the use of percutaneous Impella Recover LP 2.5 assist device during high-risk coronary intervention.

A number of techniques have been proposed for circulatory support during high-risk percutaneous coronary interventions (PCI), but no single approach has achieved wide acceptance so far. We report on a patient with severe left ventricular (LV) impairment who underwent a PCI with the use of a new left ventricular assist device, the Impella Recover LP 2.5 system. The effects on global cardiac output were determined by thermodilution (TD) and LV pressure-volume loops obtained by conductance catheter. The activation of the pump resulted in a rapid and sustained unloading effect of the LV. At the same time, the continuous expulsion of blood into ascending aorta throughout the cardiac cycle produced by the pump resulted in an increase of systemic overall CO, measured by the TD technique, of 1.43 L/min. The procedure was uncomplicated and the patient remained uneventful at follow-up. Our single experience gives new input for future trials to assess the effect of the Impella Recover LP 2.5 assist device on outcome in this subset of patients.     

Successful high‐risk percutaneous coronary intervention with the use of minimal extracorporeal circulation system

Minimal extracorporeal circulation (MECC) represents a contemporary system which integrates several advances in cardiopulmonary bypass technology in a single circuit. We challenged the efficacy of the MECC system to support the circulation in elective high‐risk percutaneous coronary intervention (PCI). A 78‐year‐old patient with complex coronary disease who would have been otherwise rejected for interventional therapy underwent PCI with rotablation on MECC support. The MECC system provided hemodynamic support at a flow of 1.8 L min^?1 m^?2 while perfusion pressure was kept at a minimum of 70 mm Hg. This allowed for successful angioplasty of the left main stem and a chronically occluded right coronary artery, which otherwise produced significant hemodynamic compromise. This case illustrates that mechanical circulatory support with the MECC system could provide a stable environment and a “safety net” for carrying out complex percutaneous coronary intervention in high‐risk patients. © 2012 Wiley Periodicals, Inc.     

Periprocedural myocardial infarction in patients undergoing complex versus noncomplex percutaneous coronary intervention

Background

Limited data are available on the risk of periprocedural myocardial infarction (MI) in patients undergoing complex versus noncomplex percutaneous coronary intervention (PCI).

Methods

We assessed the risk of periprocedural MI according to the fourth Universal definition of myocardial infarction (UDMI) and several other criteria among patients undergoing elective PCI in a prospective, single-center registry. Complex PCI included at least one of the following: 3 coronary vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, treatment of chronic total occlusion, and use of rotational atherectomy.

Results

Between 2017 and 2021, we included 1010 patients with chronic coronary syndrome, of whom 226 underwent complex PCI (22.4%). The rate of periprocedural MI according to the fourth UDMI was significantly higher in complex compared to noncomplex PCI patients (26.5% vs. 14.5%, p < 0.001). Additionally, periprocedural MI was higher in the complex PCI group using SCAI (4% vs. 1.1%, p = 0.009), ARC-2 (13.7% vs. 8.0%, p = 0.013), ISCHEMIA (5.8% vs. 1.7%, p = 0.002), and EXCEL criteria (4.9% vs. 2.0%, p = 0.032). SYNTAX periprocedural MI occurred at low rates in both groups (0.9% vs. 0.6%, p = 0.657). Complex PCI was an independent predictor of the fourth UDMI periprocedural MI (odds ratio [OR] 1.54, 95% confidence interval [CI]: 1.04–2.27, p = 0.031).

Conclusions

In patients with chronic coronary syndrome undergoing elective PCI, complex PCI is associated with a significantly higher risk of periprocedural MI using multiple definitions. These findings highlight the importance of considering upfront this risk in the planning of complex PCI procedures.     

Feasibility of complex coronary intervention in combination with percutaneous aortic valve implantation in patients with aortic stenosis using percutaneous left ventricular assist device (TandemHeart®)

Coronary atherosclerosis is a common finding in patients with severe aortic stenosis. Indeed, aortic stenosis is associated with risk factors similar those of coronary atherosclerosis such as older age, hypertension, diabetes, hypercholesterolemia and smoking. In light of the evolution of percutaneous aortic valve implantation (PAVI) and ongoing improvements in techniques of PCI, a combined approach using PCI and PAVI can be proposed for patients with complex coronary artery and aortic valve disease. This report describes the feasibility of the combination of percutaneous coronary intervention and percutaneous aortic valve implantation with peripheral left ventricular assist device (TandemHeart) support in 3 elderly patients with complex coronary altery disease and aortic stenosis considered too high risk for conventional surgical therapy. © 2009 Wiley‐Liss, Inc.     

First‐in‐human robotic percutaneous coronary intervention for unprotected left main stenosis

The safety and feasibility of robotically‐assisted percutaneous coronary intervention (PCI) for simple coronary lesions has been demonstrated. The CorPath robotic system (Corpath 200, Corindus, Waltham, MA) consists of a robotic arm mounted on the cardiac catheterization table that consists of a drive housing a single‐use sterile cassette, which is connected to the guiding catheter. While sitting in the nonsterile, radiation‐shielded cockpit, the operator remotely controls delivery and removal of coronary guidewires, angioplasty balloons, and stents. The database for the ongoing PRECISION registry was queried at a single center and results of unprotected left main robotic PCI procedures are reported. Of 102 robotic PCI procedures performed at this center, 6 were unprotected left main lesions (age 69 ± 14 years; 67% male). All 6 subjects underwent successful PCI (fluoroscopy time 26.8 ± 11.4 min;1.8 stents and 2.2 vessels treated/patient) with three requiring hemodynamic support (two with percutaneous left ventricular assistance using the Impella 2.5 (Abiomed, Danvers, MA) and one with intraaortic balloon pump counterpulsation). This report demonstrates the feasibility of performing robotically assisted unprotected left main PCI with or without hemodynamic support. © 2016 Wiley Periodicals, Inc.