Andreas Brieke

PREVENtion of HeartMate II Pump Thrombosis Through Clinical Management: The PREVENT multi-center study

BACKGROUND Recommended structured clinical practices including implant technique, anti-coagulation strategy, and pump speed management (PREVENT [PREVENtion of HeartMate II Pump Thrombosis Through Clinical Management] recommendations) were developed to address risk of early (<3 months) pump thrombosis (PT) risk with HeartMate II (HMII; St. Jude Medical, Inc. [Thoratec Corporation], Pleasanton, CA). We prospectively assessed the HMII PT rate in the current era when participating centers adhered to the PREVENT recommendations. METHODS PREVENT was a prospective, multi-center, single-arm, non-randomized study of 300 patients implanted with HMII at 24 participating sites. Confirmed PT (any suspected PT confirmed visually and/or adjudicated by an independent assessor) was evaluated at 3 months (primary end-point) and at 6 months after implantation. RESULTS The population included 83% men (age 57 years ± 13), 78% destination therapy, and 83% Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Profile 1-3. Primary end-point analysis showed a confirmed PT of 2.9% at 3 months and 4.8% at 6 months. Adherence to key recommendations included 78% to surgical recommendations, 95% to heparin bridging, and 79% to pump speeds ≥9,000 RPMs (92% >8,600 RPMs). Full adherence to implant techniques, heparin bridging, and pump speeds ≥9,000 RPMs resulted in a significantly lower risk of PT (1.9% vs 8.9%; p < 0.01) and lower composite risk of suspected thrombosis, hemolysis, and ischemic stroke (5.7% vs 17.7%; p < 0.01) at 6 months. CONCLUSIONS Adoption of all components of a structured surgical implant technique and clinical management strategy (PREVENT recommendations) is associated with low rates of confirmed PT.

Decision Making for Destination Therapy Left Ventricular Assist Devices “There Was No Choice” Versus “I Thought About It an Awful Lot”

Background—Destination therapy left ventricular assist devices (DT LVADs) are one of the most invasive medical interventions for end-stage illness. How patients decide whether or not to proceed with device implantation is unknown. We aimed to understand the decision-making processes of patients who either accept or decline DT LVADs. Methods and Results—Between October 2012 and September 2013, we conducted semistructured, in-depth interviews to understand patients’ decision-making experiences. Data were analyzed using a mixed inductive and deductive approach. Twenty-two eligible patients were interviewed, 15 with DT LVADs and 7 who declined. We found a strong dichotomy between decision processes with some patients (11 accepters) being automatic and others (3 accepters, 7 decliners) being reflective in their approach to decision making. The automatic group was characterized by a fear of dying and an over-riding desire to live as long as possible: “[LVAD] was the only option I had…that or push up daisies…so I automatically took this.” By contrast, the reflective group went through a reasoned process of weighing risks, benefits, and burdens: “There are worse things than death.” Irrespective of approach, most patients experienced the DT LVAD decision as a highly emotional process and many sought support from their families or spiritually. Conclusions—Some patients offered a DT LVAD face the decision by reflecting on a process and reasoning through risks and benefits. For others, the desire to live supersedes such reflective processing. Acknowledging this difference is important when considering how to support patients who are faced with this complex decision.

Implantable cardioverter-defibrillator shocks in patients with a left ventricular assist device

BACKGROUND Left ventricular assist device (LVAD) use is becoming increasingly common for patients with end-stage heart failure. However, the rate of implantable cardioverter-defibrillator (ICD) shocks and the effect of these shocks on outcomes in patients with LVADs remain unknown. METHODS Medical records were reviewed from patients with both an ICD and a LVAD from September 2000 to February 2009. The association between ICD shocks and survival while receiving device support was assessed using Cox proportional hazards modeling. RESULTS Thirty-three of 61 patients with a LVAD also had an ICD and form the basis of this report. The mean duration of LVAD support was 238 days. One or more ICD shocks were delivered to 14 patients (42%) with 8 (24%) receiving appropriate shocks for ventricular arrhythmias and 6 (18%) receiving inappropriate shocks. No patients received both appropriate and inappropriate shocks. When compared with receiving no ICD shock, receiving any ICD shock or an appropriate ICD shock were both associated with an increase in the risk of death (hazard ratio [HR] 4.5, 95% confidence interval [CI] 1.2 to 17.3, p = 0.027, and HR 5.3, 95% CI 1.3 to 22.6, p = 0.023, respectively); receipt of an inappropriate shock showed a non-significant trend for an increased risk of death (HR 3.2, 95% CI 0.7 to 16.1, p = 0.151). CONCLUSIONS ICD shocks are common after implantation of LVADs, with nearly equal numbers of appropriate and inappropriate shocks. ICD shocks are associated with higher mortality. Larger studies are needed for assessing the independent relationship of ICDs to a variety of clinical outcomes in patients with LVADs.

Restless Legs Syndrome Induced by Escitalopram : Case Report and Review of the Literature

Restless legs syndrome (RLS) is a sensorimotor disorder characterized by distressing sensations deep inside the limbs, typically occurring at bedtime or rest. These paresthesias involve an irresistible urge to move the limb, which provides temporary relief but at the expense of sleep and quality of life. The pathophysiology of RLS has been related to dopaminergic pathway dysfunction, thereby aligning it closely with depression from both pathophysiologic and treatment perspectives. Certain antidepressant drugs, including the selective serotonin reuptake inhibitors (SSRIs) and serotonin‐norepinephrine reuptake inhibitors (SNRIs), may induce or exacerbate RLS. We describe the case of a 34‐year‐old woman with no history of RLS who came to the emergency department with acute decompensated heart failure. After 7 days of hospitalization, she was waitlisted to receive a heart transplant. Her mood became depressed, and she requested a psychiatric consultation; escitalopram 10 mg at bedtime was started. Within 2 days of starting therapy, she developed very severe (determined by a score based on an RLS symptom rating scale) RLS symptoms, warranting the discontinuation of escitalopram. Within 2 days of stopping therapy, her RLS symptoms improved considerably (rated as mild). One week later, the patient was rechallenged with a lower dose of escitalopram, and her very severe RLS symptoms reappeared. Within 2 days of stopping escitalopram, her RLS symptoms again improved, with complete resolution 1 week later. Using the Naranjo adverse drug reaction probability scale, which assesses the probability of a drug causing an adverse event, the patients score was 9, indicating a definite adverse drug reaction. Although published case reports have linked fluoxetine, sertraline, citalopram, paroxetine, and mirtazapine to RLS, this is the first report, to our knowledge, of escitalopram as a cause of RLS. Based on this case and additional data published with other SSRIs and SNRIs, we believe that escitalopram should be added to the list of agents that can induce RLS.

Left ventricular assist device as bridge to transplantation does not adversely affect one-year heart transplantation survival.

OBJECTIVE Left ventricular assist devices are increasingly used as a bridge to transplantation. It remains unclear whether the use of pretransplant left ventricular assist devices adversely affects short-term survival after cardiac transplantation. METHODS A retrospective review of 317 consecutive patients undergoing cardiac transplantation at an academic center between 1986 and 2006 was undertaken. Left ventricular assist devices were used pretransplant in 23 of these 317 patients, and 294 patients did not require left ventricular assist device support. Patients with a left ventricular assist device were supported with a Heartmate VE or Heartmate XVE (Thoratec Corp, Pleasanton, Calif). Kaplan-Meier survival estimates were compared between the left ventricular assist device group and the non-left ventricular assist device group using the log-rank test. In addition, occurrence of death was analyzed between the 2 groups with a chi-square analysis. The results are expressed as 1-year survival with 95% confidence intervals in parentheses. RESULTS The 1-year survival for all 317 patients was 0.86 (0.82-0.90). The patient survival for the group without a left ventricular assist device before cardiac transplant was 0.87 (0.83-0.90), and the survival for the group with a left ventricular assist device as bridge to transplantation was 0.83 (0.67-0.98; P = .77). For the deaths that occurred in all 317 patients, 19% of the patients without left ventricular assist devices died within 30 days of transplant, whereas 80% of the patients with left ventricular assist devices died within 30 days of transplant (P < .01). CONCLUSION When used as a bridge to transplantation, left ventricular assist devices do not compromise 1-year survival after cardiac transplantation. Of the patients who die after transplantation, patients bridged with left ventricular assist devices are at higher risk for death within 30 days of transplant. These data suggest that left ventricular assist devices as a bridge to transplantation should be considered for appropriately selected patients awaiting cardiac transplantation.

Effect of left ventricular assist device placement on preexisting implantable cardioverter-defibrillator leads.

BACKGROUND The left ventricular assist device (LVAD) is a therapy for patients with end-stage heart failure, many of whom have a preexisting implantable cardioverter-defibrillator (ICD). We investigated whether the implantation of a LVAD affects ICD function. METHODS AND RESULTS Patients implanted with a LVAD between September 2000 and February 2009 were studied. Right ventricular (RV), right atrial, and left ventricular lead impedance, sensing, and capture thresholds were recorded before and after LVAD placement and subsequent lead-related interventions were noted. Of the 61 patients receiving a LVAD, data were collected from 30 patients who had preexisting ICDs. Significant pre-post differences were noted for all RV lead parameters: sensing amplitude decreased from 9.2+/-3.1 to 5.7+/-3.6 millivolts (P < .001); impedance decreased from 479+/-118 to 418+/-94 ohms (P=.008); and threshold increased from 4.3+/-6.7 to 11.0+/-16.8 microjoules (P=.021). As a result of alterations in lead parameters, 4 patients (13%) required lead revisions and 6 patients (20%) required ICD testing. CONCLUSIONS Differences in ICD lead function were observed after LVAD placement resulting in clinically significant interventions. These data suggest that ICD interrogation be performed post-LVAD placement and that patients be counseled for the potential need for lead revisions and ICD testing when consented for a LVAD.

Influence of Donor Cocaine Use on Outcome After Cardiac Transplantation: Analysis of the United Network for Organ Sharing Thoracic Registry

Heart transplantation from donors with a history of cocaine abuse remains controversial. Therefore, we examined the consequence of donor cocaine-use history on all-cause mortality and the development of coronary artery disease after heart transplantation. Using the United Network for Organ Sharing Thoracic Registry we identified 9,217 first-time heart-only adult transplant recipients between January 1999 and December 2003, and then divided this cohort into sub-groups based on the reported history of donor cocaine use. Multivariate analysis revealed no difference in mortality or development of coronary artery disease at 1 and 5 years between transplant recipients who received an organ from donors with a history of cocaine use when compared with donors having no history of cocaine use.

Activated partial thromboplastin time overestimates anti-coagulation in left ventricular assist device patients

Patients with continuous-flow left ventricular assist devices (LVADs) require long-term systemic anti-coagulation after implantation to prevent thrombotic events. Thrombosis of an LVADmay result in cerebrovascular accidents, device exchange or death. Over the past several years, there has been a reported increase in the risk of device thrombosis in the United States, without a clear explanation for the increase. Proper anticoagulation management in patients with an LVAD is essential for thrombosis prevention. Unfractionated heparin (UFH) is often used to bridge LVAD patients early after surgical implantation or when oral anti-coagulation is sub-therapeutic. Due to its mechanism of action, the activated partial thromboplastin time (aPTT) reflects the function of heparin’s effects on the intrinsic pathways of the coagulation cascade, whereas the anti-factor Xa (anti-Xa) assay measures heparin’s impact on anti-thrombin. The aPTT is currently the most commonly used laboratory test for monitoring UFH. A large number of variables can affect the aPTT, rendering the patient receiving UFH at risk of supraor sub-therapeutic anticoagulation. Routine monitoring of UFH using the anti-Xa assay has been reported to provide a more accurate reflection of anti-coagulation. Since the 1990s, the American College of Chest Physicians and the College of American Pathologists have recommended that aPTT goals be titrated to a corresponding anti-Xa level according to individual institutions. It is currently unknown whether the aPTT and anti-Xa levels reflect the same level of anti-coagulation in LVAD patients. Due to a higher-than-expected LVAD thrombosis rate at our institution, we hypothesized that the aPTT may not adequately reflect the level of anti-coagulation with UFH in LVAD patients; therefore, we simultaneously measured the aPTT and anti-Xa activity in both LVAD recipients and patients admitted with acute decompensated heart failure (ADHF). We performed a prospective, single-center quality improvement project that included all hospitalized patients receiving

Concomitant surgical cryoablation for refractory ventricular tachycardia and left ventricular assist device placement: a dual remedy but a recipe for thrombosis?

BackgroundVentricular tachycardia (VT) can persist following placement of a left ventricular assist device (LVAD). The optimal management strategy for VT during the peri-LVAD period is unknown.Case PresentationsTwo case reports are presented that describe epicardial and endocardial VT ablation performed during LVAD placement. Subsequently, both patients developed LVAD thrombosis, a known and dreaded complication of LVADs, requiring re-operation.ConclusionsWhile LVAD thrombosis is likely multifactorial and remains an area of active research, these two cases should increase awareness of the possible risks of VT ablation—especially endocardial ablation—during LVAD placement. Further research is needed to understand the effects of VT ablation during the peri-LVAD period.

Driving with a driveline: A survey of current practice patterns for allowing a patient supported with a left ventricular assist device to drive

The authors thank Dr Angelo Graffigna and Chiara Dalpiaz (Anesthesiology and Intensive Care Unit, Santa Chiara Hospital, Trento, Italy) for their clinical efforts and logistic support. Further thanks to Dr Marco Lanfranconi, Stefano Pelenghi, and Tiziano Colombo (Cardiac Surgery Unit, Niguarda Hospital, Milano, Italy), who performed cardiac retrieval and transplantation, and to Dr Aldo Cannata, Giuseppe Bruschi (Cardiac Surgery Unit, Niguarda Hospital, Milano, Italy) and Maria Frigerio (Cardiology Unit, Niguarda Hospital, Milano, Italy), and to Roberto Paino (Anesthesiology and Intensive Care Unit, Niguarda Hospital, Milano, Italy) for their technical help and postoperative care. None of the authors has a financial relationship with a commercial entity that has an interest in the subject of the presented manuscript or other conflicts of interest to disclose.