Graftmaster savior: Injury to a patent LIMA during pericardiectomy, when a covered stent came to the rescue.

A 71-year-old male with multivessel coronary artery disease who underwent bypass with saphenous vein grafts to a Marginal branch and distal RCA and LIMA to LAD in 1988, DM II, atrial fibrillation on Coumadin, TIA, obstructive sleep apnea and pulmonary hypertension was referred to our institution after extensive dyspnea evaluation with a diagnosis of constrictive pericarditis for pericardiectomy. He had normal left ventricular function, moderate mitral and tricuspid regurgitation. Coronary angiography revealed ostial LAD CTO, patent LIMA to mid LAD, second Marginal branch CTO with left-to-left collaterals and mid RCA CTO with left-to-right collaterals. Vein grafts to the Marginal branch and distal RCA were occluded. The pericardium was heavily calcified on CT of the chest. The LIMA was inadvertently injured leading to acute STEMI and ventricular fibrillation arrest treated with defibrillation once. Surgical repair was unsuccessful. A Graftmaster covered stent was successful deployed with restoration of TIMI III flow to the LAD territory. Pericardiectomy was completed via both the median resternotomy and left thoracotomy. Triple therapy with Aspirin, Clopidogrel, and Coumadin was initiated and maintained for 3 months without hemorrhagic or thrombotic complications. He has continued to do well in follow-up on Clopidogrel and Coumadin.

Steroid treatment resolves acute respiratory failure in patient transferred for ECMO.

INTRODUCTION: Space-consuming mediastinal tumors can create respiratory failure. METHODS: We are reporting on a case of mediastinal lymphoma, which created respiratory failure in our patient. IV steroid therapy was used in our patient, who presented with end-stage respiratory failure. RESULTS: Conservative management of our patient was possible without the application of ECMO. CONCLUSIONS: In the right patient population, IV steroid treatment can avoid further deterioration of end-stage respiratory failure.

Clinical Experience With Sternotomy Versus Subcostal Approach for Exchange of HeartMate II Left Ventricular Assist Device.

BACKGROUND: The safety and efficacy of exchanging the HeartMate II (Thoratec Corp, Pleasanton, CA) left ventricular assist device (LVAD) through a less invasive subcostal approach remains unclear. METHODS: We reviewed the records of 17 patients who underwent exchange of their HeartMate II device at our institution since 2007. We divided the cohort into devices exchanged through a subcostal (SC) approach versus a median sternotomy (MS) approach and obtained data pertaining to the short- and long-term outcomes. RESULTS: Nine patients had pump exchange through an MS approach versus 8 patients who underwent an SC approach. The mean duration of support with the first pump was 540 ± 450 days. The reason for exchange was electromechanical failure (7 patients), thrombosis (8 patients), and infection (2 patients). There were no 30-day perioperative deaths with either approach. Compared with sternotomy, patients who underwent an SC approach had significantly shorter operative times (131 vs 222 minutes; p = 0.001) and lower reoperation rates for bleeding (0 vs 44.4%; P = 0.05) and required fewer transfused blood products (packed red cells, 3.5 units vs 7.1 units; p < 0.05; cryoprecipitate, 50.7 mL vs 209.3 mL; p = 0.01; and platelets, 292 mL versus 762 mL; p < 0.05). Additionally, patients who underwent an SC approach had shorter postoperative stays in the intensive care unit (ICU) (5 days vs 13.8 days; p < 0.05) and shorter total hospital stays (16.4 days vs 27.2 days; p < 0.05). Long-term survival after mean follow-up of 260 days for the SC group and 232 days for the sternotomy group was 75% and 33%, respectively. CONCLUSIONS: Exchange of the HeartMate II pump can be accomplished with low morbidity and mortality and good long-term outcomes through a less invasive SC approach.

Severity of end-organ damage as a predictor of outcomes after implantation of left ventricular assist device.

The optimal timing of left ventricular assist device (LVAD) implantation in the management of advanced heart failure remains controversial. We hypothesize that in patients with cardiogenic shock, the severity of end-organ dysfunction as determined by the sequential organ failure assessment (SOFA) score is a determinant of outcomes after LVAD implantation. We determined the preoperative SOFA score and short- and long-term outcomes of 97 consecutive patients who received HeartMate II or HeartWare LVAD at our institution since January 2007. Kaplan-Meier analysis was used to compare long-term survival across SOFA score subgroups. The overall 30 day mortality was 10.1%, with no significant difference among SOFA score subgroups. Patients with scores ≥9 had significantly longer hospital stay (26 ± 6 vs. 18 ± 10 days, p = 0.03). One-year survival for SOFA scores 0-2, 3-5, 6-8, and ≥9 was 94%, 75%, 64%, and 29%, respectively. SOFA score was significantly lower in survivors at 6, 9, 12, 24, and 36 months. SOFA score did not predict adverse outcomes of bleeding, cerebrovascular events, infection, or pump exchange. These results show that preoperative SOFA score is a powerful predictor of outcomes after LVAD implantation. Long-term outcomes can be significantly improved by early intervention before emergence of end-organ dysfunction.

Ambulatory extra-aortic counterpulsation in patients with moderate to severe chronic heart failure.

OBJECTIVES: The study sought to assess feasibility, safety, and potential efficacy of a novel implantable extra-aortic counterpulsation system (C-Pulse) in functional class III and ambulatory functional class IV heart failure (HF) patients. BACKGROUND: 30% to 40% of HF patients suffer from poor functional status and quality of life (QoL) but are not in need of end-stage treatments. We undertook a multicenter single-arm study to assess the C-Pulse System in such patients. METHODS: New York Heart Association (NYHA) functional class III or ambulatory functional class IV HF patients were eligible. Safety was assessed continuously through 12 months. Efficacy measurements included changes from baseline to 6 and 12 months in NYHA functional class, Minnesota Living with Heart Failure (MLWHF) and Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, 6-min walk distance (6MWD), and exercise peak oxygen consumption (pVO2; 6 months only). RESULTS: Twelve men and 8 women (56.7 ± 7 years, 34 to 71 years of age) with ischemic (n = 7) or nonischemic (n = 13) cardiomyopathy were implanted. There was no 30-day mortality and no neurological events or myocardial infarctions through 12 months. At 6 months, there were 3 deaths (1 device-related). One-year survival was 85%. At 6 months, C-Pulse produced improvements in NYHA functional class (3.1 ± 0.3 to 1.9 ± 0.7, p = 0.0005), MLWHF (63.6 ± 19.9 to 40.2 ± 23.2, p = 0.0005), and KCCQ scores (43.6 ± 21.1 to 65.6 ± 21.5, p = 0.0002), but not 6MWD (275.5 ± 64.0 to 296.4 ± 104.9, p = NS) or pVO2 (14.5 ± 3.6 to 13.1 ± 4.4, p = NS). Improvements continued at 12 months, with 6MWD change becoming statistically significant (336.5 ± 91.8, p = 0.0425). CONCLUSIONS: Use of C-Pulse in this population is feasible, appears safe, and improves functional status and QoL. A prospective, multicenter, randomized controlled trial is underway. (C-Pulse IDE Feasability Study-A Heart Assist System; NCT00815880).

Intracardiac echocardiography for diagnosis and management of left ventricular assist device inlet obstruction.

Left ventricular assist devices (LVADs) have become more important in the management of patients with advanced heart failure. New generation rotary blood pumps demonstrated survival benefits and improved functional status and quality of life in these patients. Although a variety of relevant advances have been achieved in the field of device technology, the risk of severe complications remains. In this report, we describe the application of intracardiac echocardiography in the management of postoperative LVAD complications.

Drive-line infections and sepsis in patients receiving the HVAD system as a left ventricular assist device.

BACKGROUND: Drive-line infections and sepsis lead to significant morbidity and even mortality in patients with ventricular assist devices (VADs). The HeartWare HVAD system is unique compared with other VAD systems in that it has a thin, flexible drive-line and is implanted directly into the pericardial space without the need for a pump pocket. We reviewed 332 patients receiving the HVAD in the pivotal ADVANCE Bridge to Transplant (BTT) trial and Continued Access Protocol (CAP) to determine the incidence of drive-line infections and sepsis. METHODS: Summary statistics of outcomes and Kaplan-Meier freedom-from-event analyses were performed. The Cochran-Mantel-Haenszel test for homogeneity was used to determine whether there was any site effect on rates of either drive-line exit-site or sepsis infections. RESULTS: Drive-line exit-site infections occurred in 16.9% (56 of 332) of patients (0.25 event per patient-year [EPPY]). These infections were primarily treated with antibiotics and most occurred >30 days post-implant (88%, or 66 of 75 drive-line infections). Sepsis occurred in 17.2% (57 of 332) of patients (0.23 EPPY), and sepsis events occurred more frequently >30 days post-implant (86%, or 60 of 70 sepsis events). Of patients with sepsis, 17.5% (10 of 57) died due to sepsis-related neurologic events (7 of 10) and multisystem organ failure (2 of 10) and cardiopulmonary failure (1 of 10), whereas there were no deaths related to drive-line infections. In addition, 17.5% (10 of 57) of patients had a stroke event while under treatment for sepsis (7 hemorrhagic and 3 ischemic strokes), and 3.5% (2 of 57 patients with sepsis) had a device exchange for VAD thrombus (4 days before and 1 day after sepsis diagnosis). Patients with drive-line infections or sepsis had a larger body mass index compared to those without infection (29.4 vs 27.6 kg/m(2), p = 0.015), and were more frequently diabetic (43.7% vs 31.2%, p = 0.034). Although there was no negative impact on survival in patients with drive-line exit-site infections, there was a trend for reduced survival in patients with sepsis events when compared to those patients without sepsis. CONCLUSIONS: The incidence of drive-line infection and sepsis was low in patients receiving the HVAD pump. Despite a trend toward reduced survival in patients with sepsis events, the overall survival of patients with either drive-line infections or sepsis was excellent.

Takotsubo's syndrome after mitral valve repair and rescue with extracorporeal membrane oxygenation.

We report a case of Takotsubo's syndrome in a 37-year-old woman after mitral valve repair for severe mitral regurgitation triggered by a severe protamine reaction that was likely associated with immune-mediated coronary hypersensitivity (Kounis' syndrome) and made worse by resuscitation with high doses of catecholamines. The patient recovered fully after a 4-day course of extracorporeal membrane oxygenation therapy (ECMO).

End-organ recovery is key to success for extracorporeal membrane oxygenation as a bridge to implantable left ventricular assist device.

Preexisting organ dysfunctions are known factors of death after placement of implantable mechanical circulatory support (MCS). Extracorporeal membrane oxygenation (ECMO) may able to stabilize organ function in patients with cardiogenic shock before MCS implantation. Between 2008 and 2012, 17 patients with cardiogenic shock were supported with ECMO before implantable MCS placement. Patient's end-organ functions were assessed by metabolic, cardiac, hepatic, renal, and respiratory parameters. Survival data after MCS implantations were analyzed for overall survival to discharge, complications, and breakpoint in days on ECMO to survival. Before MCS implantation, lactate, hepatic, and renal functions were improved and pulmonary edema was resolved. The interval between ECMO initiation and MCS placement was 12.1 ± 7.9 days. Overall survival rate to discharge after left ventricular assist device/total artificial heart placement was 76%. The survival of patients transitioned from ECMO to MCS within 14 days was 92% and was significantly better than the survival of patients from ECMO to MCS supported longer than 14 days, 25%, p < 0.05. ECMO support can immediately stabilize organ dysfunction in patients with cardiogenic shock. After improvement of organ function, MCS implantation should be done without delay, since the patients supported for longer than 14 days with ECMO had inferior survival compared to national data.

Comparison of hemolysis between CentriMag and RotaFlow rotary blood pumps during extracorporeal membrane oxygenation.

The purpose of this investigation was to compare the hemolysis levels for patients on extracorporeal membrane oxygenation (ECMO) incorporating two different rotary blood pumps (CentriMag [CMAG] and RotaFlow [RF]) in identical circuits otherwise. The difference between the two pumps is the cost. One is 20-30 times less expensive than the other. A retrospective analysis of all patients placed on ECMO from June 2008 through May 2012 was done to evaluate hemolysis. Daily plasma hemoglobin (pHb), lactate dehydrogenase (LDH), and lactate levels were collected on all patients. Values were compared between those patients who received a CMAG and those who received an RF. Patients had to be on ECMO for more than 2 days to be included in the study. Linear mixed effects models were fit to the data to assess differences over time for each continuous outcome. Forty patients were placed on ECMO incorporating CMAG, whereas 40 patients received an RF. There were no significant statistical differences between CMAG and RF groups when comparing days on support (8.7 ± 5.0; 8.4 ± 5.7), age (44.8 ± 18.3; 46.1 ± 16.0), body surface area (2.03 ± 0.36; 1.96 ± 0.31), gender (male: 58%, female: 42%; male: 55%, female: 45%), etiology, type of support (veno-arterial [VA)]: 78%, veno-venous [VV)]: 22%; VA: 82%, VV: 18%) and pre-ECMO LDH levels (4004.0 ± 3583.2; 3603.7 ± 3354.1). There were also no significant differences between the CMAG and RF groups when comparing the mean values for daily pHb levels (5.7 ± 3.6; 5.7 ± 4.2), lactate levels (2.8 ± 1.9; 3.0 ± 2.1), and LDH levels (2656.3 ± 1606.8; 2688.6 ± 1726.1) or daily lactate, LDH, and pHb levels for the first 10 days of support. From our investigation, there is no difference between the CMAG and the RF blood pumps in regard to the creation of hemolysis during ECMO. The difference in cost of the devices does not correlate with the performance and outcomes.

Changes in the functional status measures of heart failure patients with mechanical assist devices.

Continuous-flow left ventricular assist devices (cfLVADs) have been proven safe and effective for bridge-to-transplant and destination therapy (DT) in patients with advanced heart failure. However, the fixed pump speed of these devices may lack response to activity and oxygen demand, thereby limiting exercise tolerance. The objective of this observational study was to describe exercise capacity as measured by peak oxygen consumption (peak VO2) that may be expected during support with a cfLVAD. Peak VO2 was measured in patients (mean age: 58.3 ± 11.7 years; 66.7% ischemic and 33.3% DT) before cfLVAD support (11.2 ± 3.0 ml/kg/min, n = 25), between 3 and 6 months (12.7 ± 3.5 ml/kg/min, n = 31), at 1 year (10.7 ± 2.6 ml/kg/min, n = 16), and longer than 1 year (11.2 ± 1.7 ml/kg/min, n = 10). There was no statistical improvement in peak VO2 at any time point after implantation. In addition, ventilatory efficiency remained poor after LVAD implantation at all time points. Although studies have shown an increase in survival and patient's quality of life, exercise capacity as measured by cardiopulmonary exercise testing remains low during cfLVAD support.

The RECOVER I: a multicenter prospective study of Impella 5.0/LD for postcardiotomy circulatory support.

OBJECTIVES: Cardiogenic shock after cardiac surgery is accompanied by a high mortality rate. Early institution of hemodynamic support with a versatile, easy to insert left ventricular assist device might help bridge patients to recovery or to the next therapy, and improve the outcomes. METHODS: Patients developing cardiogenic shock or low cardiac output syndrome after being weaned off cardiopulmonary bypass were enrolled in a prospective single-arm feasibility study (RECOVER I). The primary safety endpoint was the frequency of major adverse events (death, stroke) at 30 days or discharge, whichever was longer. The primary efficacy endpoint was survival of the patient to implementation of the next therapy, which included recovery at 30 days after device removal and bridge-to-other-therapy. RESULTS: Sixteen patients provided informed consent and were enrolled in the study. Hemodynamics improved immediately after the initiation of mechanical support: cardiac index, 1.65 versus 2.7 L/min/m(2) (P = .0001); mean arterial pressure, 71.4 versus 83.1 mm Hg (P = .01); and pulmonary artery diastolic pressure, 28.0 versus 19.8 mm Hg (P < .0001). The pump provided an average of 4.0 ± 0.6 L/min of flow for an average duration of 3.7 ± 2.9 days (range, 1.7-12.6). The primary safety endpoint occurred in 2 patients (13%; 1 stroke and 1 death). For the primary efficacy endpoint, recovery of the native heart function was obtained in 93% of the patients discharged, with bridge-to-other-therapy in 7%. Survival to 30 days, 3 months, and 1 year was 94%, 81%, and 75%, respectively. CONCLUSIONS: The use of the Impella 5.0/left direct device is safe and feasible in patients presenting with postcardiotomy cardiogenic shock. The device was rapidly inserted, enabled early support, and yielded favorable outcomes.

Hemolysis and Pulmonary Insufficiency following Right Ventricular Assist Device Implantation.

We report a case of severe hemolysis and pulmonary valve insufficiency (PI) following right ventricular support using a paracorporeal pneumatic pump (Abiomed, Danvers, MA, USA). We speculate that the high velocity jet of blood emanating from the outflow cannula caused turbulence above the pulmonary valve, leading to PI and hemolysis. Despite the growing number of implanted ventricular assist devices, we could find no report in the literature describing pulmonary valve insufficiency secondary to right ventricular assist device (RVAD) placement. Fortunately, in this case, right ventricular function recovered sufficiently after seven days of support, allowing explantation of the device and resolution of PI and hemolysis.

Development of aortic insufficiency in patients supported with continuous flow left ventricular assist devices.

Development of aortic insufficiency (AI) in patients supported with continuous flow left ventricular assist devices (LVAD) can adversely affect pump performance. In this study, we examined the incidence of new AI after LVAD implant at our institution. Pre- and postoperative echocardiograms of 66 patients who received HeartMate II or Heartware LVAD at our institution since June 2008 were reviewed for presence of new AI. Median LVAD support duration was 221 days. New AI developed in 6 patients (9.5%) after a median time of 374.5 days of support. There were no cases of severe or symptomatic AI. There was no significant difference between the AI incidence between HeartMate II and Heartware recipients. For patients who remained on LVAD support at 6 and 12 months, freedom from AI was 100% and 68.4%, respectively. Age, destination therapy status, and duration of support were predictors of new AI after LVAD implant. In conclusion, AI develops frequently during long-term support with continuous flow LVADs, particularly in those supported for longer than 6 months. As we move to the era of long-term LVAD support and destination therapy, further studies with longer follow-ups are required to determine the progression and clinical significance of AI in these patients.

Technique for insertion of HeartMate II left ventricular assist device inflow cannula.

During implantation of the HeartMate II left ventricular assist device, the inflow cannula is typically inserted in such a way that the sewing ring is placed within the ventricular cavity in contact with the endocardium. We describe a novel implantation technique in which the sewing ring is secured to the left ventricular epicardium, thus avoiding the complication of bleeding from the exposed cut surface of apical myocardium. In addition, the shortened intraventricular segment of the inflow cannula protects against inflow occlusion by the interventricular septum.

The new role of the perfusionist in adult extracorporeal life support.

Adult and pediatric extracorporeal life support (ECLS) has been transformed by the European(1) and Australian( 2) experiences with a reduction of the circuit to its most basic form (Figure 1). Many factors have converged at this point in time to allow us to offer this support. The availability in the U.S.A. of an advanced oxygenator (Quadrox(D)) (Maquet Inc., Bridgewater, NJ), long-term centrifugal pumps and circuit coatings offers us the means to provide ECLS. The other equally important factor is the intensivist trained in extracorporeal therapies. Once the intensive care unit registered nurse (ICU RN) is trained to safely and effectively manage both the patient and ECLS circuit, this support may be offered. The perfusionist is in an unique position to educate and mentor the ICU RN in ECLS. There is, perhaps, no one in a better position to explain this equipment and its uses in an interdisciplinary-oriented pediatric and adult ECLS program than a perfusionist.

A passively suspended Tesla pump left ventricular assist device.

The design and initial test results of a new passively suspended Tesla type left ventricular assist device blood pump are described. Computational fluid dynamics (CFD) analysis was used in the design of the pump. Overall size of the prototype device is 50 mm in diameter and 75 mm in length. The pump rotor has a density lower than that of blood and when spinning inside the stator in blood it creates a buoyant centering force that suspends the rotor in the radial direction. The axial magnetic force between the rotor and stator restrain the rotor in the axial direction. The pump is capable of pumping up to 10 L/min at a 70 mm Hg head rise at 8,000 revolutions per minute (RPM). The pump has demonstrated a normalized index of hemolysis level below 0.02 mg/dL for flows between 2 and 9.7 L/min. An inlet pressure sensor has also been incorporated into the inlet cannula wall and will be used for control purposes. One initial in vivo study showed an encouraging result. Further CFD modeling refinements are planned and endurance testing of the device.