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.     

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 Circulatory Assist Devices for High-Risk Coronary Intervention

A unifying definition of what constitutes high-risk percutaneous coronary intervention remains elusive. This reflects the existence of several recognized patient, anatomic, and procedural characteristics that, when combined, can contribute to elevating risk. The relative inability to withstand the adverse hemodynamic sequelae of dysrhythmia, transient episodes of ischemia-reperfusion injury, or distal embolization of atherogenic material associated with coronary intervention serve as a common thread to tie this patient cohort together. This enhanced susceptibility to catastrophic hemodynamic collapse has triggered the development of percutaneous cardiac assist devices such as the intra-aortic balloon pump, Impella (Abiomed Inc., Danvers, Massachusetts), TandemHeart (CardiacAssist, Inc., Pittsburgh, Pennsylvania), and extracorporeal membranous oxygenation to provide adjunctive mechanical circulatory support. In this state-of-the-art review, we discuss the physiology underpinning their application. Thereafter, we examine the results of several randomized multicenter trials investigating their use in high-risk coronary intervention to determine which patients would benefit most from their implantation and whether there is a signal to delineate whether they should be used in an elective pre-procedure, standby, rescue, or routine post-procedure fashion.     

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.     

The science behind percutaneous hemodynamic support: A review and comparison of support strategies

Patients in a variety of cardiovascular disease states may benefit from temporary percutaneous cardiac support, including those in acute decompensated heart failure, fulminant myocarditis, acute myocardial infarction with or without cardiogenic shock and those undergoing high‐risk percutaneous coronary intervention. The ideal percutaneous cardiac support device is safe, easy to use and versatile enough to meet the needs of various clinical situations and patient cohorts. In addition, it should provide maximal hemodynamic support and protection against myocardial ischemia. With these goals in mind, the scientific principles that govern hemodynamic effectiveness and myocardial protection as they pertain to acute support devices are reviewed. © 2012 Wiley Periodicals, Inc.     

Reversible coronary artery kinking caused by cardiopulmonary support

Cardiopulmonary support is utilized to provide optimal hemodynamic stability in high risk patients undergoing percutaneous transluminal coronary angioplasty. This report describes a patient undergoing supported angioplasty in whom multiple new severe stenoses were noted following coronary dilation and that were completely reversed by discontinuing cardiopulmonary support. © Wiley-Liss, Inc.     

Percutaneous support of the failing left and right ventricle—recommendations for the use of mechanical device therapy

Patients in cardiogenic shock and acute heart failure show high mortality and morbidity despite aggressive and invasive methods such as percutaneous coronary intervention and the use of mechanical support devices. Percutaneous implantation of active hemodynamic support is often the only option for hemodynamic stabilization of patients in cardiogenic shock. Therefore, current guidelines support the use of these devices. Standardized protocols and clinical algorithms for the use of these support devices decrease mortality in these patients. The aim of this review is an overview of current therapies of cardiogenic shock with special focus on mechanical support devices and the suggestion of a clinical algorithm for the differential use of current devices as well as the hemodynamic monitoring of such patients in order to reduce mortality in cardiogenic shock.     

经皮机械循环支持设备治疗急性心肌梗死并发心源性休克研究进展

当前急诊经皮冠脉介入治疗技术日趋成熟规范，新型抗血小板药物广泛应用，主动脉球囊反搏泵（IABP）逐渐普及，但急性心肌梗死并发心源性休克患者死亡率仍居高不下。对此，包括Impella、TendemHeart和ECMO在内的经皮机械循环支持设备可通过提供较之IABP更强的血流动力学支持而有望改善心源性休克患者预后。尽管现有临床证据较少，仍不足以充分证明应用经皮机械循环支持设备救治的临床获益，同时应用后血管和全身并发症不容忽视，但随着技术的进步和临床应用经验的日益增加，经皮机械循环支持设备有望成为心梗并发心源性休克患者成功救治的关键所在。     

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.     

Percutaneous support devices for high risk or complicated coronary angioplasty

Indications for coronary angioplasty have expanded to include patients with unstable acute ischemic syndromes, severe multivessel coronary artery disease and impaired left ventricular function. Several mechanical approaches have been developed as adjuncts to high risk coronary angioplasty to improve patient tolerance of coronary balloon occlusion and maintain hemodynamic stability in the event of complications. These percutaneous techniques include intraaortic balloon counterpulsation, anterograde transcatheter coronary perfusion, coronary sinus retroperfusion, cardiopulmonary bypass, Hemopump left ventricular assistance and partial left heart bypass. The intraaortic balloon pump provides hemodynamic support and ameliorates ischemia by decreasing myocardial work; it may be inserted for periprocedural complications or before angioplasty in patients with ischemia or hypotension. Anterograde distal coronary artery perfusion may be accomplished passively through an autoperfusion catheter or by active pumping of oxygenated blood or fluorocarbons through the central lumen of an angioplasty catheter. Synchronized coronary sinus retroperfusion produces pulsatile blood flow via the cardiac veins to the coronary bed distal to a stenosis. Both perfusion techniques limit development of ischemic chest pain and myocardial dysfunction in patients undergoing prolonged balloon inflations. Percutaneous cardiopulmonary bypass provides complete systemic hemodynamic support which is independent of intrinsic cardiac function or rhythm and has been employed prophylactically in very high risk patients before coronary angioplasty or emergently for abrupt closure. These and newer support devices, while associated with significant complications, may ultimately improve the safety of coronary angioplasty and allow its application to those who would otherwise not be candidates for revascularization.     

Percutaneous cardiopulmonary bypass support in the catheterization laboratory: technique and complications

A safe and easily applied technique of percutaneous cardiopulmonary bypass support has been developed for use in the cardiac catheterization laboratory. The importance of this technique lies in its ability to maintain hemodynamic stability during high risk interventional procedures regardless of intrinsic cardiac function. Venous and arterial cannulas (18F) are inserted percutaneously over a stiff guide wire after sequential dilatation with 12F and 14F dilators. Bypass flow rates of up to 5 L/min can be achieved. This technique can be applied to support patients with cardiac arrest, hemodynamic collapse after abrupt closure during coronary angioplasty, and cardiogenic shock, as well as those undergoing high-risk elective coronary angioplasty. This form of support also permits transport of the patient to the operating room in a stable condition after an unsuccessful angioplasty. The complications are mostly related to cannula removal and can be minimized by the use of a proper technique. Although the ultimate role of this new technique remains to be completely defined, it appears that it will expand the patient population for whom coronary interventions can be applied.     

Inter-hospital transfer of critically-ill patients for urgent cardiac surgery after placement of an intra-aortic balloon pump.

METHODS: To assess the safety and feasibility of transfer of patients requiring urgent cardiac surgery, from a hospital without onsite cardiac surgical facilities, after insertion of an intra-aortic balloon pump (IABP) to maintain clinical and hemodynamic stability, a retrospective review of all cardiac charactheterizations was performed. Sixty-two patients required IABPs, among whom 24 were transported to a surgical center from the outskirts of Lisbon to the city center in an ambulance accompanied by a physician, a nurse and paramedical personnel. RESULTS: Patients who required hemodynamic support with IABPs usually had unstable angina with critical coronary lesions requiring immediate surgical intervention, hypotensive patients with mechanical complications after an AMI, and patients with AMI who did not receive thrombolytic therapy, and with coronary lesions not amenable to percutaneous coronary intervention. All patients reached the surgical center alive, and no patient had either hemodynamic or electrical instability during transport. CONCLUSIONS: Surface transport of patients requiring emergency cardiac surgery after insertion of IABPs is safe, feasible and may provide circulatory and clinical stability in a subset of critically-ill patients.     

The use of a sentinel cerebral protection system during Impella CP removal in a patient with left ventricular thrombus

Percutaneous mechanical circulatory support (pMCS) devices are commonly being utilized for hemodynamic support in patients undergoing high‐risk percutaneous coronary interventions or stabilization for those in cardiogenic shock. Left ventricular (LV) to ascending aorta (Ao) rotodynamic pumps such as the Impella devices allow for rapid hemodynamic stabilization or support in such instances. The use of such devices is contraindicated in patients with known LV thrombus. However, it remains unclear on how to manage patients who develop an LV thrombus while on prolonged Impella support. While there are currently no cerebral embolic protection devices (CEPDs) approved for use in conjunction with LV to Ao pMCS devices or other short‐term mechanical support devices, there is a theoretical benefit for the use of such technology in the right circumstances. We present a case describing the use of the sentinel cerebral protection system (SCPS) in a patient who developed LV thrombus while on Impella CP support. The use of the SCPS in this patient suggests a potential role for CEPD in prevention of thromboembolism while on Impella support.     

Predictors of long-term outcome following percutaneous coronary intervention in patients with type 2 diabetes mellitus

OBJECTIVES: Diabetes has a major impact on the long-term outcome following percutaneous coronary intervention, being a major risk factor for restenosis. We aimed at assessing the clinical, hemodynamic and angiographic factors that predict outcome in this high-risk group. METHODS: Diabetic patients who underwent percutaneous coronary intervention during the period 1996-2000 were identified retrospectively, and their medical records, hemodynamic data and angiograms studied at the time of their procedure. Angiographic data were analyzed to determine procedural factors, quantitative angiographic results of their percutaneous coronary intervention and severity and extent scores of coronary artery disease. Clinical follow-up was obtained in 99.7% to a mean time of 782+/-153 days after percutaneous coronary intervention. RESULTS: A total of 327 consecutive diabetic patients underwent percutaneous coronary intervention on 389 lesions. The overall procedural success rate was 96.2%; however, during follow-up, 40.2% of patients had an adverse cardiac event. The strongest independent predictors of adverse outcome were presence of renal disease, need for medical diabetic treatment, and the extent of coronary artery disease as assessed by the extent score, but not the duration of diabetes or glycemic control. Other factors, which are often predictive of short-term outcome in a general population, such as vessel diameter, lesion length, and severity of coronary artery disease, were not predictive of outcome. CONCLUSIONS: In patients with type 2 diabetes mellitus, the extent of the coronary arteries involved with atheroma as well as systemic factors such as renal involvement are the best predictors of long-term outcome following percutaneous coronary intervention.     

Improvement in hemodynamics with a new, larger-volume (50 cc) intra-aortic balloon for high-risk percutaneous coronary intervention

A primary cause of adverse outcomes among high-risk patients undergoing percutaneous coronary intervention (PCI) may be a diminished capacity to tolerate the hemodynamic and ischemic insults that can occur during the procedure. A common means of mechanical support during PCI has been the intra-aortic balloon pump (IABP). We describe successful periprocedural mechanical support with a new, 50 cc IABP in a patient with both severe left ventricular dysfunction and extensive coronary arteriosclerosis, for whom PCI with stenting was indicated. The prophylactic use of this 50 cc IABP, which traditionally would be contraindicated because of the patient's height (162.6 cm), markedly increased the diastolic aortic pressure (by approximately 110 mmHg) over the baseline level, while promptly reducing left-sided heart pressures. This finding appears to exceed the average diastolic augmentation reported for smaller-volume balloons. Although the role of the IABP in high-risk PCI remains controversial, further research is warranted to clarify and compare this new 50 cc IABP to smaller-volume balloons, and ascertain whether the observed hemodynamic benefits can translate into improved clinical outcomes among patients requiring mechanical support during PCI.     

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.     

Cardiopulmonary support for complex angioplasty

The role of cardiopulmonary support (CPS) in interventional procedures is currently in evolution. The authors review the clinical applications and technical considerations involved in CPS including discussion of indications, hemodynamic effects, complications, and prophylactic versus stand-by techniques. Use of the technique in high risk percutaneous transluminal coronary angioplasty patients is discussed.     

When the Complex Meets the High-Risk: Mechanical Cardiac Support Devices and Percutaneous Coronary Interventions in Severe Coronary Artery Disease

Coronary artery disease (CAD) remains a leading cause of mortality and morbidity worldwide. Few practice guidelines directly address the issue of revascularization in patients with CAD at higher risk of periprocedural complications. It remains a challenge to appropriately identify the subset of patients with CAD who will require short-term use of mechanical cardiocirculatory support devices (MCSDs) when high-risk (HR) percutaneous coronary intervention (PCI) is required. Issues of the complexity (coronary anatomy and high burden of comorbidities) and risk status (hemodynamic precarity or compromise) need to be considered when considering revascularization in patients. This review will focus on the evolving concept of protected PCI in patients with CAD, and how a balanced, integrated heart-team approach remains the path to optimal patient-centred care in the setting of HR-PCI supported with MCSD.     

Percutaneous ventricular assist device to rescue a patient with profound shock from a thrombosed prosthetic mitral valve

The TandemHeart is a percutaneous ventricular assist device that has been approved to provide hemodynamic support in high-risk patients undergoing cardiac procedures, including percutaneous coronary interventions and aortic balloon valvuloplasty. Limited data exists for its role in stabilizing cardiogenic shock secondary to prosthetic valve dysfunction. In conclusion, we report the first case, to our knowledge, of profound cardiogenic shock secondary to an acutely thrombosed mechanical mitral valve in which the use of the TandemHeart was instrumental in rescuing a critically ill young female who made a full recovery.     

Providing Macro- and Microcirculatory Support with the Lifebridge System During High-risk PCI in Cardiogenic Shock

High-risk percutaneous procedures are necessary in patients with contraindications to surgery in whom the inherent risk of the underlying disease is very high. Circulatory support may be provided with an intra-aortic balloon pump. If active cardiac support is required different devices have been successfully used. We report the case of a 75-year-old patient admitted in cardiogenic shock with a severe coronary three-vessel disease with distal left main stenosis. The ejection fraction was 23%. The high-risk PCI of the distal left main coronary artery and left circumflex artery PCI as the main supplying vessel was supported by Lifebridge (Lifebridge Medizintechnik GmbH, Ampfing, Germany), a new portable mechanical circulatory support system. During the procedure we evaluated the macro- and microcirculation. The complex procedure succeeded with a flow of 2-2.5l providing both adequate macro- and microcirculation.