Safety of Calcium-Channel Blockers During Radial Cardiac Catheterization in Patients With Acute Myocardial Infarction or Systolic Heart Failure.

OBJECTIVES: The aim of this study was to evaluate the safety of calcium-channel blockers (CCBs) during radial artery catheterization in two populations with a contraindication to their use. BACKGROUND: Cardiac catheterization performed via the radial approach has become increasingly common worldwide, but adoption has been slow in the United States. One possible explanation is concern over radial artery vasospasm, which can complicate procedures. Spasmolytic drugs, typically intra-arterial CCBs, are used to prevent spasm, but their safety is not well established in high-risk populations, such as those with ST-segment elevation myocardial infarction (STEMI) or systolic heart failure (HF), in which CCB may be contraindicated. METHODS: Consecutive STEMI and HF patients undergoing cardiac catheterization over a 1-year period were prospectively evaluated. All operators in our laboratory use the radial approach unless contraindicated. All patients received CCB immediately after sheath insertion. The primary outcome of interest was change in blood pressure immediately after CCB. Procedural outcomes were also evaluated. RESULTS: A total of 184 patients were included in the study (54 with STEMI and 129 with HF). There was a significant drop in systolic blood pressure (SBP) and diastolic blood pressure (DBP) following verapamil administration (P<.001 for both), but no change in HR (P>.99). SBP decreased more than 20 mm Hg in 15.7% of patients, none of whom required initiation of vasopressors. In regression analysis, only baseline SBP correlated significantly with the change in blood pressure. CONCLUSIONS: Patients with STEMI or HF can safely tolerate intra-arterial CCB during radial catheterization.

Infections in Patients with a Total Artificial Heart Are Common but Rarely Fatal.

Patients who received a total artificial heart (TAH) at Virginia Commonwealth University (VCU) between January 1, 2010 and December 31, 2011 were identified from the VCU Mechanical Circulatory Support Clinical Database. Retrospective data extraction from the medical records was performed from the time of TAH implantation until heart transplantation or death. Infections were classified as confirmed or suspected. Twenty-seven men and five women, mean age 49.5 years (range 24-68 years) received a TAH. The mean duration of TAH support was 225 days (range 1-1,334 days). Of the 32 patients, 4 (12.5%) died and 28 (87.5 %) underwent heart transplantation. Causes of death were pneumonia (n = 1), TAH malfunction (n = 1), refractory cardiogenic shock (n = 1), and respiratory failure (n = 1). Seventy documented and 13 suspected infections developed in 25 patients (78%). The most common sources of infection were urinary tract (n = 26), respiratory tract (n = 18), and bloodstream (n = 11). There were five pump infections and two driveline infections. The number of infections per patient ranged from 0 to 10. Sixteen different pathogens were identified; the most common were: Klebsiella pneumoniae (n = 15), coagulase-negative Staphylococci (n = 10), Enterococcus species (n = 9), and Enterobacter species (n = 8). Mortality directly attributable to infection was infrequent.

Impact of INTERMACS Profile on Clinical Outcomes for Patients Supported With the Total Artificial Heart.

BACKGROUND: Insufficient data delineate outcomes for Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1 patients with the total artificial heart (TAH). METHODS: We studied 66 consecutive patients implanted with the TAH at our institution from 2006 through 2012 and compared outcome by INTERMACS profile. INTERMACS profiles were adjudicated retrospectively by a reviewer blinded to clinical outcomes. RESULTS: Survival after TAH implantation at 6 and 12 months was 76% and 71%, respectively. INTERMACS profile 1 patients had decreased 6-month survival on the device compared with those in profiles 2-4 (74% vs 95%, log rank: P = .015). For the 50 patients surviving to heart transplantation, the 1-year posttransplant survival was 82%. There was no difference in 1-year survival when comparing patients in the INTERMACS 1 profile with less severe profiles (79% vs 84%; log rank test P = .7; hazard ratio [confidence interval] 1.3 [0.3-4.8]). CONCLUSIONS: Patients implanted with the TAH as INTERMACS profile 1 had reduced survival to transplantation compared with less sick profiles. INTERMACS profile at the time of TAH implantation did not affect 1-year survival after heart transplantation.

Surveillance Endomyocardial Biopsy in the Modern Era Produces Low Diagnostic Yield for Cardiac Allograft Rejection.

BACKGROUND: The changing epidemiology of cardiac allograft rejection has prompted many to question the yield of surveillance endomyocardial biopsy (EMB) in heart transplantation (HT) patients. We sought to determine the yield of EMB in the modern era. METHODS: We evaluated 2597 EMBs in 182 consecutive HT patients who survived to their first EMB. The EMBs were categorized as asymptomatic or clinically driven and were compared based on era of antiproliferative therapy use at our center (early azathioprine era: 1990-2000 vs modern mycophenolate era: 2000-2011). RESULTS: In the modern era, patients had a higher prevalence of risk factors for developing rejection (≥ International Society of Heart and Lung Transplantation grade 2R); however, the frequency of rejection was decreased at all times (0-6 months: 60.2% vs 21.5%, P < 0.001, 6-12 months: 26.8% vs 1.8%, P < 0.001, 12-36 months: 32.3% vs 10.5%, P = 0.006). The yield of asymptomatic EMB decreased in the modern era between 0 and 6 months (10.9% vs 3.12%), 6 to 12 months (17% vs 0%), and years 2 to 3 (6.1% vs 1.5%). In the early era, the odds ratio of rejection during asymptomatic EMB compared to a clinically driven EMB was 0.47 (95% confidence interval, 0.31-0.71) and was decreased in the modern era (0.17 [0.07-0.42], P = 0.04). The probability of detecting rejection on asymptomatic EMB was significantly reduced in the modern era, even after adjustment for tacrolimus and induction therapy (1% vs 8%, P < 0.001). CONCLUSIONS: The clinical yield of surveillance EMB has decreased in the modern era. The EMB in asymptomatic patients longer than 6 months after HT warrants further scrutiny.

The total artificial heart.

The total artificial heart (TAH) is a form of mechanical circulatory support in which the patient's native ventricles and valves are explanted and replaced by a pneumatically powered artificial heart. Currently, the TAH is approved for use in end-stage biventricular heart failure as a bridge to heart transplantation. However, with an increasing global burden of cardiovascular disease and congestive heart failure, the number of patients with end-stage heart failure awaiting heart transplantation now far exceeds the number of available hearts. As a result, the use of mechanical circulatory support, including the TAH and left ventricular assist device (LVAD), is growing exponentially. The LVAD is already widely used as destination therapy, and destination therapy for the TAH is under investigation. While most patients requiring mechanical circulatory support are effectively treated with LVADs, there is a subset of patients with concurrent right ventricular failure or major structural barriers to LVAD placement in whom TAH may be more appropriate. The history, indications, surgical implantation, post device management, outcomes, complications, and future direction of the TAH are discussed in this review.

Mechanical circulatory support devices in the ICU.

The medical community has used implantable mechanical circulatory support devices at increasing rates for patients dying from heart failure and cardiogenic shock. Newer-generation devices offer a more durable and compact option when compared with bulky early-generation devices. This article is a succinct introduction and overview of the hemodynamic principles and complications after device implantation for ICU clinicians. We review the concepts of device physiology, clinical pearls for perioperative management, and common medical complications after device implantation.

Anticoagulation in transradial percutaneous coronary intervention.

Transradial percutaneous coronary intervention (PCI) is associated with significant reductions in access site complications and major bleeding as compared with the transfemoral approach. Bivalirudin is now the most commonly used anticoagulant for transradial PCI in the United States, while weight adjusted unfractionated heparin remains the most common choice outside the United States. A growing number of reports suggest that transradial intervention may offer improved outcomes across a variety of clinical situations, including those at the highest risk of bleeding complications, such as those with acute myocardial infarction. The following review provides an overview of the studies evaluating anticoagulation in transradial PCI and a rationale for the combination of the transradial approach to coronary interventions with an optimal anticoagulant strategy to reduce both access site and nonaccess site-related bleeding.

Right ventricular dysfunction: lessons learned from mechanical circulatory assist devices.

Congestive heart failure represents a disease process of epidemic proportions in the United States, with 900,000 annual hospitalizations for New York Heart Association class III to IV symptoms. The inexorable deterioration of this group of patients has, until recently, been delayed by pharmacotherapy and by the use of automated implantable cardioverter defibrillators and cardiac resynchronization therapy. The authors propose that a major component of the downhill course of New York Heart Association class IV left heart failure is secondary to right heart failure and present the major predictors of right ventricular dysfunction. This, together with the limited availability of heart transplant donors, has led to the development of the left ventricular assist devices and the total artificial heart. Contrasting and comparing these devices have permitted insight into the importance of right ventricular function in the pathophysiology of heart failure, especially in the decision to proceed with left ventricular assist device placement, which is limited by right heart dysfunction or biventricular replacement with the total artificial heart.

Persistent anemia after implantation of the total artificial heart.

BACKGROUND: The total artificial heart (TAH) replaces the heart with 2 pneumatic pumps and 4 tilting disk mechanical valves. It was hypothesized that patients receiving TAH support have persistent hemolysis that resolves after heart transplantation (HT). METHODS AND RESULTS: Hematocrit (HCT) was compared in patients on TAH to left ventricular assist device (LVAD) support for bridge to HT. Data were compared with t tests. The TAH (n = 36; mean age 47 ± 13 years) and LVAD patients (n = 14; mean age 53 ± 12 years) were supported for a median of 83 (interquartile range [IQR] 43-115) and 106 days (IQR 84-134), respectively. Hematocrit was similar between the TAH and LVAD patients (34 ± 6% vs 37 ± 5%; P = .07) at baseline. After placement, TAH patients had lower HCT at 2 (20 ± 2% vs 24 ± 3%), 4 (22 ± 3% vs 26 ± 3%), 6 (22 ± 4% vs 30 ± 4%), and 8 weeks (23 ± 4% vs 33 ± 5%; P < .001 for all). There were no differences in HCT at 1 (30 ± 4% vs 29 ± 7%; P = .42) and 3 months (35 ± 7% vs 35 ± 4%; P = .98) after removal of the devices for HT. TAH patients had undetectable haptoglobin in 96% of assessments, increased lactate dehydrogenase (1,128 ± 384 units/L), and detectable plasma free hemoglobin in 40% of measurements (21 ± 15 mg/dL). High sensitivity C-reactive protein (52 ± 50 mg/dL) was elevated, and reticulocyte production index was decreased (1.6 ± 0.6). CONCLUSIONS: Patients implanted with a TAH have persistent anemia that resolves only after HT. The association of hemolysis, ineffective erythropoiesis, and inflammation with the TAH warrants further study.

Evaluating heart failure after implantation of mechanical circulatory support devices.

The medical community has seen an explosive rise in the utilization of implantable mechanical circulatory support devices for late-stage cardiomyopathy. Care for these complex patients requires a basic understanding of device physiology and potential complications. This review focuses on an algorithm that incorporates a careful clinical history and examination with diagnostic modalities for the evaluation of a patient who is failing therapy with a continuous-flow left ventricular assist device, as well as the general management and optimization of patients implanted with an artificial heart.

Implantable mechanical circulatory support: demystifying patients with ventricular assist devices and artificial hearts.

Engineering advancements have expanded the role for mechanical circulatory support devices in the patient with heart failure. More patients with mechanical circulatory support are being discharged from the implanting institution and will be seen by clinicians outside the immediate surgical or heart-failure team. This review provides a practical understanding of device design and physiology, general troubleshooting, and limitations and complications for implantable left ventricular assist devices (pulsatile-flow and continuous-flow pumps) and the total artificial heart.

Antithrombotic therapy for the CardioWest temporary total artificial heart.

The CardioWest temporary total artificial heart serves as a viable bridge to orthotopic heart transplantation in patients who are experiencing end-stage refractory biventricular heart failure. This device is associated with a low, albeit still substantial, risk of thrombosis. Platelet interactions with artificial surfaces are complex and result in continuous activation of contact proteins despite therapeutic anticoagulation. We searched the medical literature (publication dates, January 1962-October 2009) in order to evaluate means of mitigating adverse events that have occurred after implantation of the CardioWest temporary total artificial heart.We conclude that the use of a multitargeted antithrombotic approach, involving anticoagulation (bivalirudin and warfarin) and antiplatelet therapy (dipyridamole and aspirin), can mitigate the procoagulative effects of mechanical circulatory assist devices, particularly those that are associated with the CardioWest temporary total artificial heart. Careful monitoring with use of a variant multisystem approach, involving efficacy tests (thrombelastography and light transmittance aggregometry), safety tests (laboratory analyses), and warfarin genomics, may maximize the therapeutic actions and minimize the bleeding risks that are associated with the multitargeted antithrombotic approach. The development and monitoring of individualized antithrombotic regimens require that informed health professionals appreciate the complexities and grasp the hazards that are associated with these therapies.

Induction immunosuppression for orthotopic heart transplantation: a review.

OBJECTIVES: To describe the appropriateness and safety of induction immunosuppression for patients at risk for fatal rejection, and to describe the safety and effectiveness profiles of the induction regimens available in the United States. DATA SOURCES: MEDLINE/PubMed database, EMBASE database, Google Scholar; references from pertinent articles were also reviewed to identify additional data. STUDY SELECTION: A systematic literature review from January 1, 1980, through June 30, 2008, was performed. Included articles ranged from case series to prospective randomized controlled double-blind placebo-controlled trials that detailed the following topics with respect to induction immunosuppression: risk of fatal rejection, renal sparing, malignancy, OKT3, rabbit or equine antithymocyte globulin, daclizumab, basiliximab, and alemtuzumab. RESULTS: Patients at highest risk for fatal rejection experienced a survival benefit from induction immunosuppression, whereas all other patients experienced no benefit or harm. Most of the early data detail positive experiences with polyclonal antibody regimens. Several newer trials compare the use of polyclonal strategies with the use of anti-CD25 targeted monoclonal antibodies. Few researchers have assessed the usefulness of an anti-CD52 approach. Overall, induction therapy remains a poorly studied and widely variable practice among the major US heart transplant centers. CONCLUSION: At present, the unrestricted use of induction for all patients does not seem prudent. Induction should be individualized for each patient on the basis of a well-designed protocol, careful analysis of the transplant center's demographics, and the effectiveness and safety profiles of the regimens used.

Bi-ventricular circulatory support with the Abiomed AB5000 system in a patient with idiopathic refractory ventricular fibrillation.

A 45-year-old man had life-threatening recurrent idiopathic ventricular fibrillation and persistent cardiogenic shock develop. The episodes of ventricular fibrillation were refractory to aggressive medical management; therefore an Abiomed AB5000 bi-ventricular support system was implanted for arrhythmia control. The device was able to maintain hemodynamic stability during the following 2 weeks. The patient was discharged from the hospital with fully recovered cardiac function.

Primary cutaneous fungal infections in solid organ transplantation: a case series.

Cutaneous fungal infections in solid-organ transplant patients present in a variety of nonspecific ways, requiring a high index of suspicion to diagnose correctly. In the present series of four transplant recipients, subsequent primary cutaneous fungal infections presented as papules, plaques, ulcers and subcutaneous nodules. Transplantations included one cardiac, two renal and one renal-pancreatic transplant. Fungal infections were limited to the skin; there was no evidence of disseminated disease in any case. The pathogens isolated were Scedosporium apiospermum (Pseudallescheria boydii), Alternaria species, Aspergillus fumigatus, and a coelomycete in the Coniothyrium-Microsphaeropsis complex of dark molds. Individuals were successfully treated with surgical debridement, antifungal agents, and reduction of immunosuppressive therapy. All patients and allografts survived. Accurate diagnosis, aggressive surgery and appropriate antifungal therapy, combined with close outpatient follow-up, optimize the likelihood of a cure in a transplant population.

One-year outcome after combined coronary artery bypass grafting and transmyocardial laser revascularization for refractory angina pectoris.

Long-term outcomes after coronary artery bypass graft surgery (CABG) plus transmyocardial revascularization (TMR) are largely unknown. We report the results of 30-day and 3-, 6-, and 12-month clinical follow-up after CABG plus TMR in a consecutive series of patients with refractory angina pectoris and > or = 1 myocardial ischemic area not amenable to CABG. All patients who underwent CABG plus TMR (n = 169) (mean age 63 +/- 10 years, 70% men, 51% with previous CABG, 82% were deemed inoperable at other heart surgery centers due to small vessels or diffuse disease) between March 1996 and February 2000 were clinically followed and end points of interest (survival, stroke, acute myocardial infarction, and revascularization) and angina class were recorded at 30 days and 3, 6, and 12 months after CABG. At 1 year, actuarial survival and event-free survival were 85% and 81%, respectively. At the end of the first year after the procedure, 7 patients (4%) had angina class III/IV versus 152 patients (90%) at baseline (p <0.001). Predictors of major adverse cardiac events were advanced age (odds ratio [OR] 3.4, 95% confidence intervals [CI] 1.2 to 9.4, p = 0.01), prolonged intensive care unit stay (OR 3.3, CI 1.1 to 9.7, p <0.001), new-onset atrial fibrillation (OR 2.8, CI 1.1 to 7.0, p = 0.02), and in-hospital myocardial infarction (OR 1.5, CI 1.3 to 1.7, p <0.001). Thus, procedural success at 30 days and overall event-free and actuarial survival in a high-risk population setting shows that CABG plus TMR is a safe revascularization option for patients with intractable angina pectoris.