Robert M. Adamson

Outcomes in Advanced Heart Failure Patients with Left Ventricular Assist Devices for Destination Therapy

Background—The HeartMate II (HMII) destination therapy (DT) trial demonstrated significant improvements in outcomes in continuous-flow left ventricular assist devices compared with patients implanted with the pulsatile-flow HeartMate XVE. The primary hypothesis of the current study is that trial patients enrolled after the initial data cohort would have better clinical outcomes. Methods and Results—Two hundred eighty-one patients who underwent HMII for DT from May 2007 to March 2009 (Mid Trial [MT] group) were compared with the initial 133 HMII patients from March 2005 to May 2007 (Early Trial [ET] group). Patient entry criteria were the same during the 2 time periods. Survival, adverse events, and quality of life were compared between the 2 groups. Baseline characteristics were similar between the groups. Compared with the ET group, patients in the MT group had reduced adverse event rates for bleeding requiring transfusions (1.66 versus 1.13 events per patient-year, P<0.001), sepsis (0.38 versus 0.27, P=0.025), device-related infections (0.47 versus 0.27, P<0.001), and hemorrhagic stroke (0.07 versus 0.03, P=0.01). Other event rates were similar between groups including ischemic stroke (0.06 versus 0.05 events per patient-year, P=0.57). Survival at 1 year in the MT group was 73% versus 68% in the ET group (P=0.21). Additionally, there was a significant reduction in deaths caused by hemorrhagic stroke (P=0.01). Quality of life improvements were significant in both the groups (P<0.001). Conclusions—The benefit of DT therapy with the HMII is confirmed in subsequent trial patients, with improved adverse event rates and a strong trend for improvements in survival. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00121485.

Algorithm for the diagnosis and management of suspected pump thrombus

Pump thrombosis is a dreaded complication of long-term implantable ventricular assist devices. No guidance exists regarding the diagnosis and management of this entity despite its significant morbidity. After considerable thought and deliberation, a group of leading investigators in the field of mechanical support propose an algorithm for the diagnosis and management of this vexing entity based on clinical symptoms and serologic and imaging studies.

Improved patient survival after cardiac arrest using a cardiopulmonary support system

A portable cardiopulmonary bypass system that can be rapidly deployed in a nonsurgical setting using nursing staff was used in 38 patients with cardiovascular collapse refractory to ACLS protocol. Percutaneous or cutdown cannulation sites were: femoral vein-femoral artery (n = 18), right internal jugular vein-femoral artery (n = 2), right atrium-ascending aorta (n = 12), or a combination approach (n = 4). Two patients could not be cannulated. Patient diagnoses were pulmonary emboli (n = 3), failed coronary angioplasty (n = 7), myocardial infarction with cardiogenic shock (n = 5), trauma (n = 7), aortic stenosis (n = 2), postcardiotomy deterioration (n = 10), deterioration after cardiac transplantation (n = 2), cardiomyopathy with shock (n = 1), and ruptured ascending aortic dissection (n = 1). Ninety-five percent of patients (36 of 38) were successfully resuscitated to a stable rhythm. Eight diagnostic procedures (coronary angiography, n = 4; pulmonary angiography, n = 3; and aortography, n = 1) were performed while patients were on cardiopulmonary support. Early deaths resulted from massive hemorrhage (n = 8), inability to cannulate (n = 2), and irreversible myocardial injury (n = 10). Sixty-six percent (24 of 36) of patients successfully cannulated underwent conversion to standard cardiopulmonary bypass with attendant operative procedure or placement of ventricular assist device or total artificial heart. Fifty percent (18 of 36) of patients cannulated were successfully weaned from cardiopulmonary support, and 17% (6/36) are long-term survivors.(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical strategies and outcomes in advanced heart failure patients older than 70 years of age receiving the HeartMate II left ventricular assist device: a community hospital experience.

OBJECTIVES The primary objective of this study was to determine outcomes in left ventricular assist device (LVAD) patients older than age 70 years. BACKGROUND Food and Drug Administration approval of the HeartMate II (Thoratec Corporation, Pleasanton, California) LVAD for destination therapy has provided an attractive option for older patients with advanced heart failure. METHODS Fifty-five patients received the HeartMate II LVAD between October 5, 2005, and January 1, 2010, as part of either the bridge to transplantation or destination therapy trials at a community hospital. Patients were divided into 2 age groups: ≥ 70 years of age (n = 30) and < 70 years of age (n = 25). Outcome measures including survival, length of hospital stay, adverse events, and quality of life were compared between the 2 groups. RESULTS Pre-operatively, all patients were in New York Heart Association functional class IV refractory to maximal medical therapy. Kaplan-Meier survival for patients ≥ 70 years of age (97% at 1 month, 75% at 1 year, and 70% at 2 years) was not statistically different from patients <7 0 years of age (96% 1 month, 72% at 1 year, and 65% at 2 years, p = 0.806). Average length of hospital stay for the ≥ 70-year age group was 24 ± 15 days, similar to that of the < 70-year age group (23 ± 14 days, p = 0.805). There were no differences in the incidence of adverse events between the 2 groups. Quality of life and functional status improved significantly in both groups. CONCLUSIONS The LVAD patients ≥ 70 years of age have good functional recovery, survival, and quality of life at 2 years. Advanced age should not be used as an independent contraindication when selecting a patient for LVAD therapy at experienced centers.

Pump Replacement for Left Ventricular Assist Device Failure Can Be Done Safely and Is Associated With Low Mortality

BACKGROUND Although continuous-flow left ventricular assist devices (LVAD) are durable and reliable, device replacement will be inevitable in some patients. We evaluated the incidence and outcomes of pump replacement procedures with the HeartMate II (Thoratec Corporation, Pleasanton, CA) LVAD. METHODS Data were obtained from 1,128 patients implanted from March 2005 to January 2010 with the HeartMate II during the clinical trials for bridge to transplant and destination therapy. The operative mortality associated with the replacement procedure was determined. RESULTS The mean duration of HeartMate II support was 568 ± 535 days (cumulative duration: 1,755 patient-years, longest: 6.5 years). A total of 72 (6.4%) patients underwent 79 LVAD replacements (0.045 events/patient-year) of which 2 were in the initial operation and 77 in separate procedures. Reasons for replacement were percutaneous lead damage (36 events, 3.0%), device thrombosis (25 events, 2.1%), infection (7 events, 0.6%), and miscellaneous other (11 events, 0.9%). The median time to pump replacement was 428 days (range 0 to 1,474). Of the 77 replacement procedures, there were 5 (6.5%) operative deaths within 30 days. The causes of death were device thrombosis, right heart failure, multisystem organ failure, and bleeding. One year after exchange (median 2.1 years after initial implant), 30% had died, 5% were transplanted, and 65% were ongoing and alive. CONCLUSIONS HeartMate II device failure requiring pump replacement is infrequent, but when required can be done safely. These data continue to provide encouraging evidence supporting HeartMate II use for long-term circulatory support.

Emergency resuscitation using portable extracorporeal membrane oxygenation

Manual cardiopulmonary resuscitation is currently the standard treatment for cardiac arrest patients both in and out of the hospital. Accumulated experimental and anecdotal clinical evidence suggests enhanced survival in patients with extreme circulatory decompensation who have been emergently supported with portable cardiopulmonary bypass. Long-term survival is possible even when application is delayed, but early institution of support after cardiac arrest in selected patients offers the best survival advantages. In our hospital this has been achieved by training a team of in-house personnel to emergently prepare, apply, and temporarily manage cardiopulmonary bypass until personnel with greater specialty training arrive. Machinery needed to perform emergency cardiopulmonary bypass is currently available in all hospitals with open heart surgery programs. Simple support is often therapeutic but can also serve as a bridge to definitive diagnostic and other therapeutic procedures. Commercial units are becoming more biocompatible and easier to use, making both wider application and more prolonged support likely in the future.

Cost reduction by combined carotid endarterectomy and coronary artery bypass grafting

A significant cost reduction is likely if patients who require coronary artery bypass grafting with significant carotid stenosis have simultaneous carotid endarterectomy and bypass grafting, provided risk is not increased. To investigate this issue, we retrospectively identified cases from February 1977 to May 1994 with first-time isolated carotid endarterectomy, coronary bypass, or combined procedures. In the isolated carotid endarterectomy population, median age was 69 years and 58% (85/146) were male, as compared with 68 years and 68% (68/100) male in the combined group; median age of the coronary bypass cohort was 65 years and 76% (381/500) male. A significantly higher percentage of patients in the coronary bypass versus combined group were in New York Heart Association functional class IV. In the combined group there was a significantly higher incidence of older age, diabetes, hypertension, hyperlipidemia, renal failure, and congestive heart failure. There was no difference among the three groups with respect to hospital mortality (0%, 3.4%, and 4.0%, respectively) and permanent stroke (0.7%, 1.2%, and 0%, respectively). Hospital costs were

Effects of Exercise During Long-term Support With a Left Ventricular Assist Device Results of the Experience With Left Ventricular Assist Device With Exercise (EVADE) Pilot Trial

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Comparison of functional capacity in patients with end-stage heart failure following implantation of a left ventricular assist device versus heart transplantation: results of the experience with left ventricular assist device with exercise trial.

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Aortic valve closure associated with HeartMate left ventricular device support: Technical considerations and long-term results

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