Novel technique for high-risk coronary protection during implantation of transcatheter aortic valve implants.

Transcatheter aortic valve replacement (TAVR) has become increasingly common as the indications expanded to include valve-in-valve (ViV) applications and a wider patient population with lower surgical risk. Intra-operative coronary arterial occlusion remains a significant source of morbidity, particularly in ViV applications or cases with high-risk anatomy. We present a novel technique for coronary artery protection utilizing a guide extension catheter to secure coronary access during valve deployment and a ViV case demonstration in a patient with prior surgical aortic valve replacement.

Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure that has become an alternative to major cardiac surgery for replacing the aortic valve. A potential serious complication during this procedure is obstruction of the major coronary blood vessels supplying the heart itself. This may occur during deployment of the prosthetic aortic valve, a process which can inadvertently lead to blockage of the opening of the arteries of the heart. We present a novel method for protecting the opening of these arteries during TAVR to reduce the risk of this complication.

Use of the CardioHELP Device for Temporary Hemodynamic Support During High-Risk Percutaneous Coronary Intervention.

BACKGROUND: Temporary extracorporeal membrane oxygenation (ECMO) support for high-risk percutaneous coronary intervention (PCI) has been described in select patients, and data are limited on the CardioHELP device (Maquet). The objective of this study was to assess clinical outcomes in patients undergoing elective, high-risk PCI with CardioHELP support. METHODS: Fifteen consecutive patients receiving the CardioHELP device for elective, high-risk PCI treated at 2 medical centers were included. Patients with cardiogenic shock, cardiac arrest, or non-PCI indications for ECMO were excluded. Baseline demographics, angiographic variables, procedure-related variables, and in-hospital events were collected. RESULTS: Mean age was 71 ± 11 years, 73% were male, mean ejection fraction (EF) was 29 ± 13%, 10 patients (67%) had an EF <30%, and mean SYNTAX I score was 32 ± 11. Multivessel coronary artery disease was present in 14 patients (93%) and unprotected left main coronary artery disease was present in 4 patients (27%). PCI was successful in all patients. In-hospital mortality occurred in 3 patients (20%), 7 patients (47%) received a blood transfusion, and there were no major vascular complications. CONCLUSION: Temporary use of the CardioHELP device for high-risk PCI is associated with acceptable short-term outcome and may be a new option for patients with complex coronary artery disease and left ventricular dysfunction.

Outcomes of Percutaneous Mitral Valve Repair in Systolic Versus Diastolic Congestive Heart Failure.

INTRODUCTION: Percutaneous mitral valve repair with MitraClip device has been approved for treatment of mitral regurgitation in symptomatic patients deemed high risk for surgical repair. This study compares outcomes of Mitraclip in patients with systolic (SHF) versus diastolic heart failure (DHF). METHODS: The study population was extracted from the 2016 Nationwide Readmissions Data (NRD) using International Classification of Diseases, tenth edition, clinical modifications/procedure coding system (ICD-9-CM/PCS) codes for the Mitraclip, SHF, DHF, and procedural complications. Study endpoints included in-hospital all-cause mortality, cardiogenic shock, acute myocardial infarction (AMI), acute kidney injury (AKI), stroke, acute respiratory failure, bleeding, blood transfusion, length of hospital stay (LOS) as well as 30-day readmission rate. RESULTS: A total of 1681 discharges that had Mitraclip during the index hospitalization and had a history of SHF (909) or DHF (772) were included in this analysis. The mean age was 78.5 years and 46.6% were female. SHF group was associated with higher post-procedural cardiogenic shock (7.3% versus 2.0%, p < 0.01), AMI (2.1% versus 0.8%, p = 0.03), AKI (21.0 versus 14.2%, p < 0.01), acute respiratory failure (13.2% versus 9.6%, p = 0.02), and longer LOS (9.6 versus 5.7 days, p < 0.01). There were no significant differences between groups in terms of in-hospital all-cause mortality (3.4% versus 2.3%, p = 0.18), stroke (0.7% versus 1.4%, p = 0.15), bleeding (10.7% versus 8.9%, p = 0.23), need for blood transfusion (5.7% versus 3.6%, p = 0.05), or 30-day readmission rate (15.7% versus 16.1%, p = 0.86). CONCLUSIONS: In comparison to DHF, patients with SHF undergoing the MitraClip had higher in-hospital morbidities and longer LOS but comparable mortality and 30-day readmission rates.

Transcatheter Double Valve-in-Valve Replacement of Aortic and Mitral Bioprosthetic Valves.

Transcatheter aortic valve replacement (TAVR) is an evolving method which has become the treatment of choice in high-risk patients with severe aortic stenosis. Unlike TAVR, the experience with transcatheter mitral valve replacement (TMVR) remains at an early stage because of challenges of valve development and possible complications such as valve displacement and subsequent left ventricular outlet tract (LVOT) obstruction. Here we report a case of transcatheter double valve-in-valve replacement (TDVIVR) in a patient with severe mitral and aortic bioprosthetic valve stenosis, followed by an extensive literature review of the latest techniques and challenges in this field.

The Oxygen Paradox, the French Paradox, and age-related diseases.

A paradox is a seemingly absurd or impossible concept, proposition, or theory that is often difficult to understand or explain, sometimes apparently self-contradictory, and yet ultimately correct or true. How is it possible, for example, that oxygen "a toxic environmental poison" could be also indispensable for life (Beckman and Ames Physiol Rev 78(2):547-81, 1998; Stadtman and Berlett Chem Res Toxicol 10(5):485-94, 1997)?: the so-called Oxygen Paradox (Davies and Ursini 1995; Davies Biochem Soc Symp 61:1-31, 1995). How can French people apparently disregard the rule that high dietary intakes of cholesterol and saturated fats (e.g., cheese and paté) will result in an early death from cardiovascular diseases (Renaud and de Lorgeril Lancet 339(8808):1523-6, 1992; Catalgol et al. Front Pharmacol 3:141, 2012; Eisenberg et al. Nat Med 22(12):1428-1438, 2016)?: the so-called, French Paradox. Doubtless, the truth is not a duality and epistemological bias probably generates apparently self-contradictory conclusions. Perhaps nowhere in biology are there so many apparently contradictory views, and even experimental results, affecting human physiology and pathology as in the fields of free radicals and oxidative stress, antioxidants, foods and drinks, and dietary recommendations; this is particularly true when issues such as disease-susceptibility or avoidance, "healthspan," "lifespan," and ageing are involved. Consider, for example, the apparently paradoxical observation that treatment with low doses of a substance that is toxic at high concentrations may actually induce transient adaptations that protect against a subsequent exposure to the same (or similar) toxin. This particular paradox is now mechanistically explained as "Adaptive Homeostasis" (Davies Mol Asp Med 49:1-7, 2016; Pomatto et al. 2017a; Lomeli et al. Clin Sci (Lond) 131(21):2573-2599, 2017; Pomatto and Davies 2017); the non-damaging process by which an apparent toxicant can activate biological signal transduction pathways to increase expression of protective genes, by mechanisms that are completely different from those by which the same agent induces toxicity at high concentrations. In this review, we explore the influences and effects of paradoxes such as the Oxygen Paradox and the French Paradox on the etiology, progression, and outcomes of many of the major human age-related diseases, as well as the basic biological phenomenon of ageing itself.

The safety and efficacy of peripheral vascular procedures performed in the outpatient setting.

OBJECTIVES: This study sought to evaluate the safety and efficacy of peripheral vascular interventions performed in a private, outpatient catheterization laboratory. BACKGROUND: Peripheral vascular interventions have been traditionally performed in the inpatient setting. However, there has been a recent shift away from hospital-based vascular interventions toward outpatient-based procedures. Data are scarce on the efficacy and safety of such procedures being performed in the outpatient setting. METHODS: We performed a retrospective chart review of the first 500 consecutive procedures that were performed at an outpatient catheterization laboratory from February 2012 through February 2013. We separated the procedures into arteriovenous fistula (AVF)-related procedures, peripheral arterial disease (PAD)-related procedures, and miscellaneous procedures. The primary endpoint was procedure success rate, defined as postintervention residual stenosis of <30% on angiography. The secondary endpoint was procedure-related adverse events. RESULTS: The success rate for AVF-related interventions was 90%, and 93% when including partially successful interventions. The success rate for PAD-related interventions was 82%, and 92% when including partially successful interventions. The procedure success rate for miscellaneous interventions was 89%. Five AVF-related procedures suffered an adverse event (1.49%). Two PAD-related procedures suffered an adverse event (1.3%), while no adverse events were noted among miscellaneous procedures. One patient required immediate postprocedure hospitalization due to iliac artery perforation. CONCLUSION: Peripheral vascular procedures performed in the outpatient setting are safe and effective. A comparison of outcomes between outpatient and inpatient facilities when performing similar peripheral vascular interventions is needed in order to determine whether a transition of further vascular procedures into an outpatient setting is justified.

Improved myocardial perfusion after transmyocardial laser revascularization in a patient with microvascular coronary artery disease.

We report the case of a 59-year-old woman who presented with symptoms of angina that was refractory to medical management. Although her cardiac catheterization revealed microvascular coronary artery disease, her symptoms were refractory to optimal medical management that included ranolazine. After undergoing transmyocardial revascularization, her myocardial ischemia completely resolved and her symptoms dramatically improved. This case suggests that combination of ranolazine and transmyocardial revascularization can be applied to patients with microvascular coronary artery disease.

Treating peripheral arterial disease percutaneously with atherectomy.

PURPOSE: To determine clinical outcomes of patients who underwent percutaneous revascularization (PR) with multiple devices. METHODS: PR cases at a private, tertiary referral hospital were reviewed retrospectively. Limb salvage and patency rates were calculated by the Kaplan Meier method. Historical and procedural factors were analyzed by multivariate Cox proportional hazards models. RESULTS: We identified 66 patients and 87 limbs with 261 lesions, including 38 patients with critical limb ischemia (CLI) (51 limbs, 171 lesions). PR incorporated multiple devices (2.0 ± 1.2 devices/lesion, 2.4 ± 1.6 devices/procedure), including balloon angioplasty (57%), excisional atherectomy (54%), orbital atherectomy (44%), and stenting (13%). Last imaged patency was at 18 ± 13 months and last clinical follow-up was 22 ± 12 months. Thirty-five of 87 limbs had ≥1 repeat PR. In 51 limbs with CLI, limb salvage was 75% at 3 years. Independent predictors of amputation were higher creatinine (P=.01; hazard ratio [HR], 1.4), Rutherford category (P=.03; HR, 3.5), and history of coronary artery bypass graft (CABG) (P=.03; HR, 8.9). Overall patency remained 75% through 3 years. Loss of patency or primary patency (patency without repeat PR) was predicted by higher creatinine, Rutherford category, chronic total occlusion, history of CABG, female gender, current and past smoking. Use of excisional atherectomy maintained overall patency (P=.01; HR, 0.36). CONCLUSIONS: An aggressive approach to PR with frequent use of atherectomy resulted in high rates of limb salvage and patency. Smoking cessation and excisional atherectomy may improve patency rates.

Coronary and intracerebral arterial aneurysms in a young adult with acute coronary syndrome.

A 21-year-old man with no known medical history presented with substernal chest pain. Serial 12-lead electrocardiography showed dynamic ST-segment elevations in the anterolateral leads. Emergent coronary angiography revealed diffuse coronary aneurysmal disease and thrombotic occlusion of the left anterior descending coronary artery. The patient underwent urgent coronary artery bypass grafting. Subsequent imaging showed intracerebral aneurysms that involved his right and left middle cerebral arteries. The incidence, multiple causes, and proposed mechanisms of coronary artery aneurysmal formation are discussed, as is the rare association of these lesions with extracardiac arterial aneurysms.This association between coronary and extracardiac aneurysms is a phenomenon that warrants further study to determine its prevalence and possible causes. Findings could influence recommendations for further screening of patients diagnosed with coronary aneurysmal disease.

Therapeutic hypothermia for acute myocardial infarction and cardiac arrest.

This report focuses on cardioprotection and describes the advantages and disadvantages of various methods of inducing therapeutic hypothermia (TH) with regard to neuroprotection and cardioprotection for patients with cardiac arrest and ST-segment elevation myocardial infarction (STEMI). TH is recommended in cardiac arrest guidelines. For patients resuscitated after out-of-hospital cardiac arrest, improvements in survival and neurologic outcomes were observed with relatively slow induction of TH. More rapid induction of TH in patients with cardiac arrest might have a mild to modest incremental impact on neurologic outcomes. TH drastically reduces infarct size in animal models, but achievement of target temperature before reperfusion is essential. Rapid initiation of TH in patients with STEMI is challenging but attainable, and marked infarct size reductions are possible. To induce TH, a variety of devices have recently been developed that require additional study. Of particular interest is transcoronary induction of TH using a catheter or wire lumen, which enables hypothermic reperfusion in the absence of total-body hypothermia. At present, the main methods of inducing and maintaining TH are surface cooling, endovascular heat-exchange catheters, and intravenous infusion of cold fluids. Surface cooling or endovascular catheters may be sufficient for induction of TH in patients resuscitated after out-of-hospital cardiac arrest. For patients with STEMI, intravenous infusion of cold fluids achieves target temperature very rapidly but might worsen left ventricular function. More widespread use of TH would improve survival and quality of life for patients with out-of-hospital cardiac arrest; larger studies with more rapid induction of TH are needed in the STEMI population.

Impella-assisted balloon aortic valvuloplasty.

The Impella LP 2.5 left ventricular assist device (Abiomed) is safe and effective for assisting high-risk percutaneous interventions. A 77-year-old woman with severe aortic stenosis, severe coronary artery disease, an ejection fraction of 20%, severe peripheral vascular disease, and other comorbidities presented to a private, tertiary referral hospital with shortness of breath that had been worsening over 2 weeks. The patient underwent a successful, Impella-assisted balloon aortic valvuloplasty (BAV) without complications. Impella support may be considered during BAV in high-risk patients with contraindications for a TandemHeart device (CardiacAssist, Inc.).

Treating Refractory Cardiogenic Shock With the TandemHeart and Impella Devices: A Single Center Experience.

BACKGROUND: Patients with cardiogenic shock (CS) are routinely treated with intra-aortic balloon pumps (IABPs). The utility of 2 new percutaneous left ventricular assist devices (PLVADs), the Impella and TandemHeart, is unknown. The objective of this study was to describe the use of PLVADs for patients with CS at our institution. METHODS: All cases involving PLVADs in patients with CS between between January 1, 2008 and June 30, 2010 at a private, tertiary referral hospital were reviewed retrospectively. RESULTS: All 76 cases were identified (50 IABP only, 7 Impella, 19 TandemHeart). Most Impella (5/7) and TandemHeart (10/19) patients were initially treated with an IABP before "upgrading" for increased hemodynamic support. All 76 devices (100%) were initiated successfully. Percutaneous revascularization was attempted in 63 patients with angiographic success in 57 (90%). The incidences of major complications were similar between groups, except bleeding occurred less frequently with the IABP. Mean ejection fraction on presentation was 30.4±16.5% and increased by a mean of 6.6±11.4% (P < 0.001). With the institutional approach of treating patients with CS initially with vasopressors and IABPs, then upgrading to an Impella or TandemHeart device for patients refractory to IABP therapy, the overall mortality rate was 40%. CONCLUSION: The Impella and TandemHeart devices can be initiated successfully in patients with CS, are associated with high rates of angiographic success during high risk percutaneous interventions and may benefit the myocardium during myocardial infarction. Randomized trials are warranted investigating use of the Impella and TandemHeart devices in patients with CS and in patients refractory to conventional IABP therapy.

High-risk percutaneous coronary intervention with the TandemHeart and Impella devices: a single-center experience.

BACKGROUND: Intra-aortic balloon pumps (IABPs) are indicated during high-risk percutaneous coronary intervention (HR-PCI) to reduce major procedural complications. The clinical utility of the newer Impella and TandemHeart devices is not clear. This study determined the baseline characteristics, hemodynamics, and outcomes of patients treated with prophylactic percutaneous left ventricular assist devices (PLVADs) during HR-PCI. METHODS: A retrospective analysis at a private, tertiary referral hospital was conducted of all cases involving prophylactic PLVAD during HR-PCI between January 1, 2008 and June 30, 2010. General practice in this institution involves a tiered approach to PLVAD whereby patients with the least, intermediate, and highest risk of left ventricular failure are treated with an IABP, Impella, or TandemHeart, respectively. RESULTS: Fifty cases were identified (5 IABP, 13 Impella, 32 TandemHeart). Mean ejection fraction was 31 ± 17%. All devices (100%) were initiated successfully. Angiographic success was achieved in 96% (80% IABP, 100% Impella, 97% TandemHeart). Of the 38 patients not in cardiogenic shock, death occurred in 1 (2.6%), recurrent ischemia in 3 (8%), and stroke in 0%. Shortly after device removal, systolic blood pressure (mean increase, +5 ± 22 mmHg) and ejection fraction (mean increase, +7.4 ± 11%; p = 0.0006) increased in all 3 groups, suggesting a beneficial effect on the myocardium. CONCLUSIONS: In patients undergoing HR-PCI with Impella and TandemHeart support, angiographic success was high and major complication rates were low. A tiered approach where patients with the least, intermediate, and highest risk of left ventricular failure are treated with an IABP, Impella, or Tandem- Heart, respectively, theoretically maximizes appropriate hemodynamic support and minimizes complications. Further studies are warranted.

Rotational atherectomy in the drug-eluting stent era: a single-center experience.

BACKGROUND: In heavily calcified lesions, rotational atherectomy (RA) improves procedural success and facilitates stent deployment. Reports on RA in the drug-eluting stent (DES) era are limited. The objective of this study was to determine the presenting characteristics, procedural and in-hospital clinical outcomes of patients who underwent RA at our institution in the DES era. METHODS: Consecutive cases involving RA between January 1, 2004 and December 31, 2009 at a private, tertiary referral hospital were reviewed retrospectively. RESULTS: A total of 158 patients (236 lesions) who underwent RA are described, including 112 patients (158 lesions) with subsequent DES implantation, 19 patients (28 lesions) with bare-metal stent (BMS) implantation, and 27 patients (50 lesions) with no stent. RA was utilized to modify heavily calcified plaque (84%), as bail-out therapy (16%), to preserve the patency of sidebranches (25%) and as debulking therapy for chronic total occlusion (13 lesions) and in-stent restenosis (7 lesions). DES were not placed in 46 patients (23%) due to reference vessel diameter < 2.25 or > 3.75 mm, inability to deliver DES, or desire to avert clopidogrel therapy. Angiographic and procedural success rates were significantly higher in the DES and BMS groups compared with the no stent group (angiographic success: 99.1% for DES versus 95% for BMS versus 63% for no stent; p < 0.05; procedural success: 96.4% for DES versus 95% for BMS versus 63% for no stent; p < 0.05). CONCLUSION: In the DES era, RA remains utilized primarily to modify heavily calcified plaque. In unadjusted analysis, procedural success appears high with subsequent stent placement (DES or BMS) versus RA alone. However, 1 in 4 are not candidates for stent placement, and the lower procedural success rate in this population should be considered prior to embarking on RA.

Left main stent thrombosis complicated by eptifibatide-induced acute thrombocytopenia.

A 57-year-old man with a history of coronary artery disease and placement of an implantable cardioverter-defibrillator presented at our emergency room with an anterior ST-elevation myocardial infarction. Cardiac catheterization revealed an acutely occluded left main coronary artery, which was revascularized successfully with a bare-metal stent. Periprocedurally, the patient received aspirin, clopidogrel, unfractionated heparin, and eptifibatide. The patient was discharged a week later, but he returned to the emergency room the same day with recurrence of severe chest pain. Repeat cardiac catheterization revealed an acutely occluded stent, and the patient underwent repeat bare-metal stent placement and readministration of eptifibatide. On the next day, the patient's platelet count dropped acutely to less than 12,000/mm3. A test for heparin-induced thrombocytopenia antibody was negative. After discontinuation of eptifibatide, the patient's platelet count gradually returned to normal, and he was later discharged from the hospital with no complications. Eptifibatide-induced acute thrombocytopenia is a known but rare adverse effect. We review the handful of case reports in the medical literature, with emphasis on the prevalence, observed clinical course, and recently proposed physiologic mechanisms that probably are responsible for this phenomenon.

Rotational Atherectomy and Stent Implantation for Calcified Left Main Lesions.

BACKGROUND: Left main coronary artery (LMCA) bifurcation and heavily calcified lesions are common and challenging to treat percutaneously. Rotational atherectomy (RA) may be beneficial in this setting to facilitate stent placement though direct supporting evidence is lacking. This study sought to analyze patients who underwent RA of the LMCA. METHODS: Consecutive cases involving RA of the LMCA between 1/1/2004 and 12/31/2009 at a private, tertiary referral hospital were reviewed retrospectively. Medical records, angiograms and clinically driven follow-up were reviewed. RESULTS: Thirty-one cases were identified (20 protected, 11 unprotected), including 23 with stent implantation (21 drug-eluting, 2 bare metal). All 31 lesions had moderate to severe calcification, 84% involved the distal segment. Mean burr-to-vessel ratio was 0.43. Overall angiographic success was 90% (28/31) and was higher with a drug-eluting stent versus no stent (100% vs. 62%; P = 0.0153). In-hospital major adverse cardiovascular events (MACE) occurred in 1 patient (3%). Mid-term MACE occurred in 6 patients (26%) and tended to occur less frequently in patients with protected LMCAs (P = 0.0697). At final follow-up, patients were more likely to be alive and free from angina with a protected LMCA (94% vs. 57% unprotected; P = 0.0564) and with a drug-eluting stent (89% vs. 50% with no stent; P = 0.0281). CONCLUSIONS: RA of the LMCA to facilitate stent implantation appears to be safe and effective with favorable mid-term outcomes. In the setting of severe calcification and distal LMCA involvement RA and drug-eluting stent implantation should be considered.

Review of vascular closure devices.

BACKGROUND: Vascular access-site complications are an important cause of morbidity following catheterization procedures. Manual compression is the "gold standard" in achieving hemostasis of an arteriotomy site; however, manual compression is limited by the need to interrupt anticoagulation, prolonged bed rest, patient discomfort and time demands for healthcare providers. Vascular closure devices (VCDs) improve patient comfort, free medical staff resources and shorten the time needed for hemostasis, ambulation and discharge. However, the safety of VCDs remains in question and they may increase the risks of infection and leg ischemia. Compared with manual compression, the rate of major complications appears to be increased with VasoSeal, decreased with Angio-Seal and decreased in diagnostic cases with Perclose. The safety of VCDs cannot be assumed due to "class effect," and nearly all individual trials are underpowered to detect differences in complication rates, so the safety of other individual VCDs is unclear. In the absence of puncture site-related risk factors, VCDs as a whole appear to have little influence on complication rates, and patients at high baseline risk for bleeding due to clinical factors may benefit from these devices. Screening with femoral angiography prior to VCD placement and avoidance of VCDs in the presence of puncture site-related risk factors might reduce the risk of vascular complications. This review describes the mechanism, efficacy and safety of VCDs including hemostasis pads, the FemoStop, Clamp Ease, Mynx, Duett, FISH, Boomerang, ExoSeal, Starclose, VasoSeal, Angio-Seal and Perclose devices.

When and why do heart attacks occur? Cardiovascular triggers and their potential role.

Coronary heart disease affects 7.6% of the population in the United States, where > 900,000 myocardial infarctions (MIs) occur annually. Approximately half of all MIs have an identifiable clinical trigger. Myocardial ischemia, MI, sudden cardiac death, and thrombotic stroke each occur with circadian variation and peak after waking in the morning. In addition, physical exertion and mental stress are common precipitants of MI. Waking in the morning, physical exertion, and mental stress influence a number of physiologic parameters, including blood pressure, heart rate, plasma epinephrine levels, coronary blood flow, platelet aggregability, and endothelial function. Upregulation of sympathetic output and catecholamines increase myocardial oxygen demand and can decrease myocardial oxygen supply and promote thrombosis. Ischemia ensues when myocardial oxygen demand exceeds supply. Increases in blood pressure and ventricular contractility increase intravascular shear stress and may cause vulnerable atherosclerotic plaques to rupture, forming a nidus for thrombosis that can precipitate MI. Numerous clinical triggers of MI have been identified, including blizzards, the Christmas and New Year's holidays, experiencing an earthquake, the threat of violence, job strain, Mondays for the working population, sexual activity, overeating, smoking cigarettes, smoking marijuana, using cocaine, and particulate air pollution. Avoiding clinical triggers or participating in therapies that prevent clinical triggers from precipitating cardiac events could potentially postpone clinical events by several years and improve cardiovascular morbidity and mortality. Direct or indirect evidence suggests that the risk of triggered MIs is reduced with ß-blockers, aspirin, statins, stress management, and transcendental meditation.

Use of a percutaneous left ventricular assist device for high-risk cardiac interventions and cardiogenic shock.

OBJECTIVE: We sought to describe the use of the TandemHeart percutaneous left ventricular assist device (PVAD) in a group of high-risk patients undergoing complex cardiovascular procedures. BACKGROUND: There is a substantial risk of acute decompensation and death in patients with cardiogenic shock or a reduced cardiac reserve undergoing high-risk cardiovascular interventions. The TandemHeart PVAD provides near-total hemodynamic support in this setting. METHODS: Thirty-seven high-risk patients underwent placement of the TandemHeart PVAD during 38 separate procedures between April 2007 and April 2009. PVAD insertion was considered emergent if a patient was not expected to survive more than 6 hours without PVAD support. Technical success was defined as successful initiation of the PVAD and completion of the intended interventional procedure. RESULTS: All 37 patients were in cardiogenic shock or undergoing complex coronary and valvular interventions with a high probability of hemodynamic collapse. The mean (+/- standard deviation) patient age was 73 +/- 14 years; 97% were in either NYHA class III-IV heart failure or cardiogenic shock; and the mean EuroSCORE was 11 +/- 3.4. Indications for ventricular assist device placement included critical aortic stenosis (n = 8), severe left main coronary stenosis (n = 18), severe multivessel coronary stenosis (n = 19) and severe cardiomyopathy (n = 23). Four patients were being managed for fulminant myocarditis, ventricular free-wall rupture, flail mitral valve or severe paravalvular leak. Despite their critical status and frequent (82%) need for post-procedure blood transfusion, this complex and high-risk patient population tolerated PVAD-supported intervention well and technical success was achieved in all patients. Seventy-one percent of patients survived to hospital discharge with improved functional status. Most deaths occurred in patients not expected to survive due to their moribund status and multiorgan failure. CONCLUSION: This experience demonstrates the utility and effectiveness of TandemHeart PVAD support in patients with advanced disease, critical clinical status and limited therapeutic options.