The role of Impella in high-risk percutaneous coronary intervention

Percutaneous coronary intervention (PCI) has been increasingly performed in patients with severely depressed left ventricular function and complex coronary lesions, including multivessel disease.Mechanical ventricular assist devices play an increasingly important role in high-risk PCI. Impella CP^® (Abiomed, Inc.) is a new percutaneous left ventricular assist device, designed for short-term circulatory support. It is a promising option for hemodynamic support in high-risk procedures and can potentially reduce PCI-related complications.The authors present two case reports of high-risk PCI using the Impella CP^® device.In the setting of low coronary flow reserve, severely depressed left ventricular function and potential hemodynamic instability, the Impella CP^® device has made it possible to maintain hemodynamic stability during procedures, without being associated with vascular complications.     

Avoiding hemodynamic collapse during high‐risk percutaneous coronary intervention: Advanced hemodynamics of impella support

The rate of performing primary percutaneous coronary intervention in patients with complex coronary artery disease is increasing. The use of percutaneous mechanical circulatory support devices provides critical periprocedural hemodynamic support. Mechanical support has increased the safety and efficacy of interventional procedures in this high‐risk patient population. Predicting patient response to the selected intervention can be clinically challenging. Here we demonstrate a case where complete hemodynamic collapse during PCI was avoided by mechanical support provided by the Impella device. Further, we employ a comprehensive cardiovascular model to predict ventricular function and patient hemodynamics in response to the procedure. New computational tools may help interventionists visualize, understand, and predict the multifaceted hemodynamic aspects of these high risk procedures in individual patients. © 2016 Wiley Periodicals, Inc.     

Percutaneous left ventricular assist device: "TandemHeart" for high-risk coronary intervention.

Patients undergoing percutaneous coronary intervention (PCI) with severely compromised left ventricular systolic function and complex coronary lesions, including multivessel disease, left main disease, or bypass graft disease, are at higher risk of adverse outcomes from hemodynamic collapse. The TandemHeart percutaneous ventricular assist device may provide circulatory support during high-risk PCI. We implanted the TandemHeart device in eight patients who underwent high-risk PCI. The patients were considered to be at exceptionally high risk for decompensation due to procedural complexity combined with underlying LV dysfunction. The mean ejection fraction was 30% +/- 9% and five patients were turned down for surgical revascularization. Seven patients underwent multivessel PCI, including three patients who underwent unprotected left main coronary artery PCI. There was 100% procedural success. The TandemHeart was removed immediately post-PCI with no groin complications. Six patients are event- and symptom-free at 189 +/- 130 days; one patient died 10 days post-PCI after lower extremity bypass surgery and another developed acute renal failure postprocedure, requiring hemodialysis. Our initial clinical experience with the TandemHeart ventricular assist device demonstrates that hemodynamic support can be rapidly achieved percutaneously during high-risk PCI, with excellent procedural success in highly complex and critically ill patients.     

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.     

Mechanical circulatory support with impella to facilitate percutaneous coronary intervention for post‐TAVI bilateral coronary obstruction

One of the potential complications of transcatheter aortic valve implantation (TAVI) is coronary obstruction (CO), which can occur by displacement of heavily calcified native valve cusps against the coronary ostium. Treatment mandates immediate percutaneous coronary intervention (PCI) to restore coronary flow and improve hemodynamics and if unsuccessful, urgent implementation of circulatory support, commonly extracorporeal, with subsequent surgical revascularization. We report a case of post‐TAVI CO for which successful emergent deployment of Impella percutaneous mechanical circulatory support to restore hemodynamic stability facilitated definitive treatment with bilateral PCI. Impella support represents an expeditious, effective, and widely available therapy to complement and facilitate PCI in the treatment of CO complicating TAVI, and may diminish requirement for urgent coronary artery bypass surgery. © 2015 Wiley Periodicals, Inc.     

Novel technique of performing multivessel PCI through an Impella sheath

A 69‐year‐old woman with diabetes was found to have multi‐vessel coronary artery disease and underwent 5‐vessel coronary artery bypass grafting. Patient had persistent cardiogenic shock postoperatively despite intra‐aortic balloon pump and escalating pressor requirements. Electrocardiogram showed new ischemic changes and the patient was urgently taken to the catheterization lab for coronary angiography and placement of an Impella CP for higher degree of hemodynamic support via the left femoral artery. Due to limitations in vascular access the Impella CP sheath was utilized for vascular access for diagnostic angiography and coronary intervention concurrently with ongoing Impella CP support. The first obtuse marginal had severe proximal disease and was treated with percutaneous coronary intervention (PCI) with a drug eluting stent. To our knowledge, this case is the first in which successful diagnostic angiography as well as multi‐vessel PCI was performed via an Impella sheath while concurrently using the percutaneous mechanical circulatory support system of the Impella CP. Multiple guide catheters and a pigtail catheter were successfully passed via the Impella CP sheath to perform PCI. This novel method of vascular access could be an important tool to use in high‐risk patients with limitations in access sites and decrease potential bleeding complications by limiting the number of arterial punctures.     

Percutaneous left ventricular support devices

Patients undergoing percutaneous coronary intervention (PCI) who have severely compromised left ventricular systolic function and complex coronary lesions including multivessel disease, left main disease, or bypass graft disease are at higher risk of adverse outcomes from hemodynamic collapse. The TandemHeart percutaneous left ventricular assist device and the Impella Recover LP 2.5 System may provide rapid circulatory support in high-risk PCI patients and in those who have cardiogenic shock. Identification of patients who are at high risk for severe hemodynamic compromise and most likely to benefit from mechanical circulatory support is crucial to derive the most benefit from this therapy. Multicenter randomized clinical trials are needed to clearly define the role of these two devices in providing circulatory support in a variety of clinical settings.     

Percutaneous left main coronary disease treatment without on‐site surgery back‐up in patients with acute coronary syndromes

Background : Best revascularization strategy in patients with acute coronary syndromes (ACS) and unprotected left main (ULM) coronary disease is still debate reflecting lack of convincing data. Objectives : To assess clinical feasibility and efficacy of ULM percutaneous coronary intervention (PCI) in patients with ACS and describe the practice of a center without on‐site surgical back‐up over a 7‐year period. Methods : Data on high‐risk patients with ACSs undergoing percutaneous ULM treatment were prospectively collected in an independent registry. Primary end‐points of this study were immediate and long‐term outcomes expressed as target lesion failure (TLF, composite of cardiac death, myocardial infarction (MI), and target lesion revascularization). Results : Between January 2003 and January 2010, 200 consecutive patients were included in this study. Angiographic success was obtained in 95% of patients but procedural success was 87% primarily affected by an 11% of in‐hospital cardiac mortality. At median follow‐up of 26 months (IQ 10–47), the overall TLF rate was 28.5%, with 16.0% of cardiac death, 7.0% of MI, and 10.5% of clinically driven target lesion revascularization rates. Cumulative definite/probable stent thrombosis was 3.5%. Elevated EuroSCORE value and pre‐procedural hemodynamic instability were the strongest predictors of TLF. Temporal trend analysis showed progressive but not significant improvement for both immediate (P = 0.110) and long‐term (P = 0.073) outcomes over the study period. Conclusions : This single‐center study based on current clinical practice in patient with ULM disease and ACS confirmed PCI as feasible revascularization strategy in absence of on‐site cardio‐thoracic support. Nevertheless, the outcome of these high‐risk patients is still hampered by a sensible in‐hospital mortality rate. © 2011 Wiley Periodicals, Inc.     

Multivessel percutaneous coronary intervention without contrast agents

Contrast‐induced nephropathy (CIN) following coronary angiography is associated with significant morbidity and mortality. Contrast media volume is the key risk factor for CIN in patients with chronic kidney disease undergoing coronary angiography and interventions. Very often, coronary interventions are avoided in such high‐risk patients because of possible significant adverse clinical outcomes. We present a case demonstrating use of intravascular ultrasound (IVUS) to guide multivessel percutaneous coronary intervention (PCI) performed without any contrast administration in a patient with extreme risk for CIN. With the availability of advanced imaging of the coronary arteries such as high definition IVUS, contrast free PCI is a feasible approach and is associated with significant advantages of reducing or eliminating the development of CIN following PCI. This case report highlights the key practical aspects of performing contrast‐free PCI and the challenges associated with such approach. © 2015 Wiley Periodicals, Inc.     

Single-center experience with the TandemHeart percutaneous ventricular assist device to support patients undergoing high-risk percutaneous coronary intervention

We describe our experience of patients, from December 2005 through May 2007 who underwent percutaneous coronary intervention (PCI) with severely depressed left ventricle systolic function and complex coronary lesions. The complex coronary lesions included multiple vessel coronary artery disease, left main (LM) coronary artery disease, calcified coronary lesions and bypass graft disease. All patients were clinically assessed to be at too high of a risk for circulatory collapse without maximal hemodynamic support while they underwent high-risk PCI. The TandemHeart percutaneous ventricular assist device (THpVAD) may be able to provide the necessary circulatory support required to enhance procedural success and patient safety during high-risk PCI. METHODS AND RESULTS: We implanted the THpVAD in 6 patients who underwent high-risk PCI. There was unanimity among several physicians in our institution that each patient was an exceptionally high risk for circulatory collapse due to the anticipated procedural complexity. The average ejection fraction was 33% (range 15-65%). Five of the patients were considered to be at an unacceptably high risk for coronary artery bypass surgery. All 6 patients underwent multivessel PCI. Five of the 6 underwent unprotected LM PCI. One patient of the 5 underwent vein-graft PCI as well as a debulking procedure with rotational atherectomy and PCI of the LM. We had a 100% success rate with implantation of the THpVAD. Five of the 6 patients were alive at 30 days post procedure. One patient died 3 days after the procedure due to multiorgan failure. A vascular surgeon performed the removal of the devices with no associated complications. CONCLUSIONS: Our clinical experiences with the TandemHeart pVAD demonstrated that hemodynamic support could be achieved safely, efficiently and effectively by way of a percutaneous route in anticipation of high-risk PCI.     

Procedural Strategies to Reduce the Incidence of Contrast-Induced Acute Kidney Injury During Percutaneous Coronary Intervention

Contrast-induced acute kidney injury (CI-AKI) is a potentially serious complication following coronary angiography and percutaneous coronary intervention (PCI). The incidence of CI-AKI is particularly high in patients with advanced chronic kidney disease (defined as an estimated glomerular filtration rate <30 ml/min/1.73 m²). Although much effort has been dedicated to the identification and implementation of preventive measures for this complication at the pre-intervention stage, much less has been investigated on the procedural strategies and techniques to decrease the risk of CI-AKI during PCI. The mainstay of such approaches relies on the minimization of contrast volume by means of specific strategies or dedicated devices. Invasive imaging, such as intravascular ultrasound or non–contrast-based optical coherence tomography, is another pillar of any ultra-low-contrast-volume PCI protocol. Finally, an array of miscellaneous ancillary measures can be implemented to decrease the risk of CI-AKI, which includes the use of radial access, remote ischemic conditioning, and hemodynamic support in high-risk patients. The present review analyzes the technical aspects as well as the scientific evidence supporting these novel techniques, with the goal to improve the outcomes of patients at high risk for CI-AKI undergoing PCI.     

Patient preferences for coronary artery bypass graft surgery or percutaneous intervention in multivessel coronary artery disease

Objectives: Determine if patients prefer multivessel percutaneous coronary intervention (mv‐PCI) over coronary artery bypass graft surgery (CABG) for treatment of symptomatic multivessel coronary artery disease (mv‐CAD) despite high 1‐year risk. Background: Patient risk perception and preference for CABG or mv‐PCI to treat medically refractory mv‐CAD are poorly understood. We hypothesize that patients prefer mv‐PCI instead of CABG even when quoted high mv‐PCI risk. Methods: 585 patients and 31 physicians were presented standardized questionnaires with a hypothetical scenario describing chest pain and medically refractory mv‐CAD. CABG or mv‐PCI was presented as treatment options. Risk scenarios included variable 1‐year risks of death, stroke, and repeat procedures for mv‐PCI and fixed risks for CABG. Participants indicated their preference of revascularization method based on the presented risks. We calculated the odds that patients or physicians would favor mv‐PCI over CABG across a range of quoted risks of death, stroke, and repeat procedures. Results: For nearly all quoted risks, patients preferred mv‐PCI over CABG, even when the risk of death was double the risk with CABG or the risk of repeat procedures was more than three times that for CABG (P < 0.0001). Compared to patients, physicians chose mv‐PCI less often than CABG as the risk of death and repeat procedures increased (P < 0.001 and P = 0.004, respectively). Conclusion: Patients favor mv‐PCI over CABG to treat mv‐CAD, even if 1‐year risks of death and repeat procedures far exceed risk with CABG. Physicians are more influenced by actual risk and prefer mv‐PCI less than patients despite similarly quoted 1‐year risks. © 2013 Wiley Periodicals, Inc.     

First Canadian experience with high-risk percutaneous coronary intervention with assistance of a percutaneously deployed left ventricular assist device

Mechanical assist devices play an increasing role in high-risk percutaneous coronary intervention (PCI) in highly complex and critically ill patients. The Impella Recover LP 2.5 is a minimally invasive left ventricular assist device that is inserted percutaneously via a 13 Fr sheath. The device is engineered to provide a significant increase in cardiac output in patients with severe left ventricular impairment as well as in patients undergoing high-risk coronary intervention, and may provide substantive circulatory support when severe hemodynamic compromise occurs. It can potentially be maintained in situ for five to seven days. Canada's first implantations of an Impella device providing circulatory support in patients undergoing complex, high-risk PCI are reported. Larger studies will be required to identify whether a survival benefit or improvement in left ventricular function can be achieved when using the Impella device to support patients undergoing high-risk PCI or those in cardiogenic shock.     

Primary percutaneous coronary intervention for inferior ST‐segment elevation myocardial infarction in a patient supported by the HeartWare left ventricular assist device

A 63‐year‐old man with an ischaemic cardiomyopathy, supported by the HeartWare left ventricular assist device (LVAD), presented with ventricular tachycardia and inferior ST‐elevation myocardial infarction (STEMI) with associated acute right ventricular (RV) dysfunction. He underwent primary percutaneous coronary intervention with balloon angioplasty and placement of three drug‐eluting stents in the proximal‐to‐mid right coronary artery. Post‐procedure, ventricular arrhythmias abated, RV systolic dysfunction resolved and RV size normalised. Percutaneous coronary intervention (PCI) facilitated by the use of miniaturised percutaneous LVAD has become an increasingly available treatment option for high‐risk patients. PCI in patients on established full mechanical circulatory support is not a common occurrence. Indeed, to our knowledge, this is the first case of primary percutaneous coronary intervention on an LVAD‐supported heart reported in the medical literature. The case raises several specific issues that are of peculiar interest to clinicians involved in the care of patients supported by mechanical assist devices who experience an acute coronary syndrome requiring emergent revascularisation.     

A first‐in‐man study of the reitan catheter pump for circulatory support in patients undergoing high‐risk percutaneous coronary intervention

Objectives : To investigate the safety of a novel percutaneous circulatory support device during high‐risk percutaneous coronary intervention (PCI). Background : The Reitan catheter pump (RCP) consists of a catheter‐mounted pump‐head with a foldable propeller and surrounding cage. Positioned in the descending aorta the pump creates a pressure gradient, reducing afterload and enhancing organ perfusion. Methods : Ten consecutive patients requiring circulatory support underwent PCI; mean age 71 ± 9; LVEF 34% ± 11%; jeopardy score 8 ± 2.3. The RCP was inserted via the femoral artery. Hemostasis was achieved using Perclose? sutures. PCI was performed via the radial artery. Outcomes included in‐hospital death, MI, stroke, and vascular injury. Hemoglobin (Hb), free plasma Hb (fHb), platelets, and creatinine (cre) were measured pre PCI and post RCP removal. Results : The pump was inserted and operated successfully in 9/10 cases (median 79 min). Propeller rotation at 10,444 ± 1,424 rpm maintained an aortic gradient of 9.8 ± 2 mm Hg. Although fHb increased, there was no significant hemolysis (4.7 ± 2.4 mg/dl pre vs. 11.9 ± 10.5 post, P = 0.04, reference 20 mg/dl). Platelets were unchanged (pre 257 ± 74 × 10⁹ vs. 245 ± 63, P = NS). Renal function improved (cre pre 110 ± 27 μmol/l vs. 99 ± 28, P = 0.004). The RCP was not used in one patient following femoral introducer sheath related aortic dissection. All PCI procedures were successful with no deaths or strokes, one MI, and no vascular complications following pump removal. Conclusions : The RCP can be used safely in high‐risk PCI patients. This device may be an alternative to other percutaneous systems when substantial cardiac support is needed. © 2009 Wiley‐Liss, Inc.     

Complex robotic‐enhanced percutaneous coronary intervention

A remote‐controlled, robotic system was developed to address procedural challenges and occupational hazards associated with traditional percutaneous coronary intervention (PCI). The PRECISE (Percutaneous Robotically Enhanced Coronary Intervention) Study demonstrated the safety and feasibility of the robotic system. We report four cases of complex coronary interventions demonstrating the capabilities of robotic‐enhanced PCI to treat multilesion, multivessel coronary disease, saphenous venous graft disease, and an ST‐elevation myocardial infarction. The robotic system offers enhanced visibility, precise measurement, accurate stent positioning, improved ergonomics, and superior operator protection from radiation. © 2013 Wiley Periodicals, Inc.     

Revascularization strategies for patients with stable coronary artery disease

Patients with coronary artery disease who have prognostically significant lesions or symptoms despite optimum medical therapy require mechanical revascularization with coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI) or both. In this review, we will evaluate the evidence‐based use of the two revascularization approaches in treating patients with coronary artery disease. CABG has been the predominant mode of revascularization for more than half a century and is the preferred strategy for patients with multivessel disease, especially those with diabetes mellitus, left ventricular systolic dysfunction or complex lesions. There have been significant technical and technological advances in PCI over recent years, and this is now the preferred revascularization modality in patients with single‐vessel or low‐risk multivessel disease. Percutaneous coronary intervention can also be considered to treat complex multivessel disease in patients with increased risk of adverse surgical outcomes including frail patients and those with chronic obstructive pulmonary disease. Improvements in both CABG (including total arterial revascularization, off‐pump CABG and ‘no‐touch’ graft harvesting) and PCI (including newer‐generation stents, adjunctive pharmacotherapy and intracoronary imaging) mean that they will continue to challenge each other in the future. A ‘heart team’ approach is strongly recommended to select an evidence‐based, yet individualized, revascularization strategy for all patients with complex coronary artery disease. Finally, optimal medical therapy is important for all patients with coronary artery disease, regardless of the mode of revascularization.     

Coronary artery bypass grafting versus percutaneous coronary intervention in patients with noninsulin treated type 2 diabetes mellitus: A meta‐analysis of randomized controlled trials

Background

The outcomes and prognosis of revascularization by either coronary artery bypass grafting (CABG) surgery or percutaneous coronary intervention (PCI) in patients with noninsulin‐treated type 2 diabetes mellitus (NITDM) have not yet been well established.

Methods

Randomized controlled trials (RCTs) were identified by searching Pubmed, EMBASE, and Cochrane library from inception until May 2016. Heterogeneity was evaluated, and the pooled hazard ratio (HR) was calculated by using a fixed‐effect model. A random‐effect model was used when statistically significant heterogeneity was observed (I² ≥ 50%). All data analyses were carried out by using RevMan 5.3 and STATA software 12.0.

Results

A total of 4 RCTs involving 5 studies, consisting of 2270 patients with noninsulin‐treated type 2 diabetes mellitus, were identified. Compared with CABG‐treated patients, PCI‐treated patients had significantly higher all‐cause mortality (HR 1.39; 95% CI 1.01 to 1.91; P = .04), myocardial infarction (HR 2.14; 95% CI 1.40 to 3.27; P = .0004), repeated revascularization (HR 2.52; 95% CI 1.77 to 3.57; P < .00001), and major adverse cardiovascular and cerebrovascular events (HR 1.50; 95% CI 1.20‐1.87; P = .0004). However, PCI was associated with lower incidence of stoke (HR 0.47; 95% CI 0.24 to 0.90; P = .02).

Conclusions

In NITDM patients, our study suggests that CABG surgery is associated with reduced risk of mortality and morbidity, although with increased incidence of stroke compared with percutaneous coronary intervention. The decision if to have percutaneous coronary intervention or CABG surgery should factor the risk for stroke of the patients when considering CABG over percutaneous coronary intervention. Adequately powered RCTs are needed to confirm the results of this meta‐analysis.     

Comparison of the predictive value of EuroSCORE,SYNTAX score,and clinical SYNTAX score for outcomes of patients undergoing percutaneous coronary intervention for unprotected left main coronary artery disease

Objectives : We aimed to assess the prognostic values of the EuroSCORE, SYNTAX score, and the novel Clinical SYNTAX score (CSS) for 30‐day and 1‐year outcomes in patients undergoing left main (LM) percutaneous coronary intervention (PCI). Background : PCI has become an alternative treatment for LM coronary artery disease, and risk scoring system might be beneficial for pre‐PCI risk stratification. Methods and Results : We enrolled 198 consecutive patients with unprotected LM disease undergoing PCI (mean age 71.5 ± 10.7 years). The CSS was calculated by multiplying the SYNTAX Score to (age/left ventricular ejection fraction +1 for each 10 mL the estimated glomerular filtration rate <60 mL/min per 1.73 m²). The endpoints were 30‐day, and 1‐year all‐cause death and major adverse cardiovascular events (MACE), which were defined as all‐cause death, nonfatal MI, and clinical‐driven target vessel revascularization. Comparing with the SYNTAX score, the predictive accuracy of CSS for 30‐day and 1‐year all‐cause death and MACE were significantly higher (c‐statistics, CSS versus SYNTAX score: P < 0.01 for 30‐day and 1‐year all‐cause death; P < 0.05 for 30‐day and 1‐year MACE, respectively). Furthermore, in the multivariate Cox regression analysis, both EuroSCORE and CSS were identified as the independent predictors of 30‐day and 1‐year all‐cause death and MACE, but the SYNTAX score was not. Conclusions : In the general practice among a high‐risk population undergoing LM PCI, EuroSCORE and CSS might be independent predictors for 30‐day and 1‐year all‐cause death and MACE. Furthermore, the CSS had a superior discriminatory ability in predicting the 30‐day and 1‐year clinical outcomes comparing with the SYNTAX score. © 2012 Wiley Periodicals, Inc.