Reduce Driveline Trauma Through Stabilization and Exit Site Management: 30 Days Feasibility Results from the Multicenter RESIST Study.

The percutaneous lead management kit (PLMK) was developed for the HeartMate 2 (HM2) left ventricular assist device (LVAD) to reduce trauma at the exit site and to maintain a clean environment. REduce Driveline Trauma through StabIlization and Exit Site ManagemenT (RESIST) was a multicenter, prospective, nonrandomized study designed to evaluate the feasibility of the PLMK for managing the HM2 driveline exit site. Fifty patients were enrolled at five sites at a median of 495 days post-HM2 implant; 92% (46 of 50) of patients used the PLMK for a minimum of 30 days. At 30 days, more patients found the PLMK to be extremely comfortable (80% vs. 37%, p < 0.001) and extremely effective at stabilizing the driveline (82% vs. 40%, p < 0.001) compared with each center's standard of care. Frequency of dressing changes was 6-7 days or higher for 85% of the patients with PLMK. Three patients developed driveline infection while on PLMK (6%, 0.15 events per patient year), and 35 patients continued to use the PLMK after 6 months. The PLMK is easy to use, increases patient comfort, and increases driveline stability with a dressing change frequency of 6-7 days.

Safety of Prothombin Complex Concentrate to Control Excess Bleeding During Continuous Flow LVAD Insertion.

In cardiovascular surgery, hemostatic complexities require the provision of blood products to control bleeding as well as the use of a number of hemostatic agents, some of which cause significant morbidity. Among these agents is prothrombin complex concentrates (PCC), however there is no clear consensus on PCC use in cardiovascular surgery. To investigate the safety of PCC in patients undergoing left ventricular assist device (LVAD) placement, we reviewed our single institution experience to examine the incidence of thromboembolic events and a variety of hospital markers including morbidity and mortality. A retrospective review was conducted of patients who underwent LVAD placement between January 2010 and October 2012. Patients who received intraoperative PCC constituted the PCC group (n = 41) and those who did not constituted the non-PCC group (n = 27). The overall incidence of thromboembolic events at 3 months postoperative was 12 (29.3%) in the PCC group compared with six (22.2%) in the non-PCC group, respectively (p > 0.05). Morbidity did not differ between groups and one patient in the PCC group died. The intraoperative use of PCC in LVAD insertion does not appear to be associated with a significant increase in thromboembolic events; however, larger randomized trials are needed to confirm these findings.

Chest compressions may be safe in arresting patients with left ventricular assist devices (LVADs).

INTRODUCTION: The number of patients with left ventricular assist devices (LVADs) is increasing each year. Despite a lack of evidence, many emergency medical systems and hospitals have recommended against performing chest compressions in these patients. This deviation from conventional resuscitation algorithms is secondary to concern that chest compressions could dislodge the LVAD. OBJECTIVE: To assess whether cannula dislodgment occurred in LVAD patients receiving chest compressions. METHODS: We retrospectively analyzed the outcomes of all LVAD patients who received chest compressions for cardiac arrest over a four year period in a large urban hospital. Eight cases were reviewed for both cannula integrity and outcomes. RESULTS: Using autopsy and adequate flow through device as proxy for intact inflow/outflow cannulas, none of the eight patients receiving chest compressions had cannula dislodgment. Four of the 8 patients had return of neurologic function. CONCLUSIONS: In this small retrospective case series, standard chest compressions in patients with LVADs did not cause cannula dislodgment. More research is necessary to determine the utility of chest compressions in the LVAD population.

Emergency physician-initiated extracorporeal cardiopulmonary resuscitation.

CONTEXT: Extracorporeal cardiopulmonary resuscitation (ECPR) refers to emergent percutaneous veno-arterial cardiopulmonary bypass to stabilize and provide temporary support of patients who suffer cardiopulmonary arrest. Initiation of ECPR by emergency physicians with meaningful long-term patient survival has not been demonstrated. OBJECTIVE: To determine whether emergency physicians could successfully incorporate ECPR into the resuscitation of patients who present to the emergency department (ED) with cardiopulmonary collapse refractory to traditional resuscitative efforts. DESIGN: A three-stage algorithm was developed for ED ECPR in patients meeting inclusion/exclusion criteria. We report a case series describing our experience with this algorithm over a 1-year period. RESULTS: 42 patients presented to our ED with cardiopulmonary collapse over the 1-year study period. Of these, 18 patients met inclusion/exclusion criteria for the algorithm. 8 patients were admitted to the hospital after successful ED ECPR and 5 of those patients survived to hospital discharge neurologically intact. 10 patients were not started on bypass support because either their clinical conditions improved or resuscitative efforts were terminated. CONCLUSION: Emergency physicians can successfully incorporate ED ECPR in the resuscitation of patients who suffer acute cardiopulmonary collapse. More studies are necessary to determine the true efficacy of this therapy.

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.

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

BACKGROUND: Aortic valve integrity is crucial for optimal left ventricular assist device (LVAD) support. Pre-existing native aortic insufficiency, aortic valve incompetence acquired during support, as well as previously placed prosthetic aortic valves present unique problems for these patients. METHODS: We reviewed and analyzed data for 28 patients who underwent left ventricular outflow tract closure associated with HeartMate I (n =12) and HeartMate II (n = 16) LVAD insertion or exchange. Indications for valve closure, surgical technique, LVAD function, survival rates and complications were retrospectively analyzed. Survival rates were compared with those of HeartMate LVAD patients (n = 104) who did not undergo aortic valve closure. RESULTS: Indications for closure included native aortic valve insufficiency (10 patients), aortic valve deterioration after prolonged LVAD support (8 patients) and previously placed mechanical (9 patients) or bioprosthetic aortic prostheses (1 patient). There were 2 operative and 5 late deaths (mean 227 days post-operatively). Of the deaths, none were due to aortic valve closure. Actuarial survival was 78% at 1 year and 53% at 3 years, which was statistically better than for our patients with an intact aortic outflow (61% at 1 year, 45% at 3 years; p < 0.05). Five patients had transplants, 1 patient was successfully bridged to recovery, and 15 patients remain on LVAD support. No patient with outflow closure developed regurgitation, embolization or compromised LVAD support. CONCLUSION: Outflow tract closure in LVAD-supported patients is safe, often necessary and well tolerated.

A 20-year experience with urgent percutaneous cardiopulmonary bypass for salvage of potential survivors of refractory cardiovascular collapse.

OBJECTIVE: In-hospital cardiac arrest or refractory shock carries a high mortality despite the use of advanced resuscitative measures. We have implemented an in-hospital, nurse-based, continuously available, percutaneous, venoarterial cardiopulmonary bypass system, also known as extracorporeal life support (ECLS), as an adjunct to resuscitation when initial measures are ineffective. METHODS: In 1986, a system for the rapid initiation of ECLS, was created in which trained critical care nurses primed an ECLS circuit and in-house physicians percutaneously placed required cannulas. From a prospective registry, we assessed long-term survival (LTS) (> or =30 days, cardiopulmonary support weaned), short-term survival (<30 days, CPS weaned), or death on CPS. RESULTS: One hundred fifty patients (age, 57 +/- 17 years) were urgently started on CPS for cardiac arrest (n = 127; witnessed, n = 124; unwitnessed, n = 3) and refractory shock (n = 23). Sixty-nine patients were weaned from CPS, and 81 could not be weaned. Overall, 39 (26.0%) patients achieved LTS with a subsequent Kaplan-Meier median survival of 9.5 years. Duration of CPS was 32 +/- 38 hours for LTS and 21 +/- 38 hours for non-LTS. LTS occurred in 29 (23.4%) of 124 patients started on CPS for witnessed cardiac arrest and 11 (47.8%) of 23 for refractory shock (P < .05). Among patients with CPS initiated in the cardiac catheterization laboratory, LTS was seen in 24 (50.0%) of 48 versus 15 (14.7%) of 102 in patients with CPS initiated in other locations (P < .001). Cardiopulmonary resuscitation times greater than or equal to 30 minutes were associated with lower LTS (P < .05). The most common cause of death during CPS was refractory cardiac dysfunction (39.5%), and the most common cause associated with short-term survival was neurologic/pulmonary dysfunction (53.6%). Seven patients were bridged to a left ventricular assist device, and 1 subsequently underwent heart transplantation. Multivariate analysis revealed only cardiac catheterization laboratory site of initiation as a significant independent predictor of LTS (P < .01). When dividing the 20-year experience in tertiles, recent recipients have had more common prearrest insertion. Rates of long-term survival have not changed. CONCLUSION: Of patients started on CPS, 46% were weaned, and 26.0% were long-time survivors. Rapid initiation of CPS permits LTS for some inpatients with cardiovascular collapse when initial advanced resuscitation fails. Strategies to improve end-organ function associated with use of CPS should lead to greater LTS. This practical application of inexpensive available technology should be more widely used.

Portable rapid response extracorporeal life support: a center's 20-year experience with a registered nurse-run program.

If advanced cardiac life support therapy fails to revive a patient, extracorporeal life support (ECLS) becomes a critical bridge that maintains total systemic circulation and oxygenation during cardiac arrest or severe respiratory failure and allows time to establish a treatment plan. Improved patient outcomes depend on a shorter time period from the start of advanced cardiac life support to the initiation of ECLS. An in-house critical care nurse response team facilitates rapid initiation of ECLS, often in less than 20 minutes, at any time in any area of the hospital. Since 1986, Sharp Memorial Hospital has placed 176 patients on ECLS, using a registered nurse team with a survival rate greater than 30 days of 27.7%. The system used for rapid and mobile initiation of ECLS maintains perfusion to the vital organs via a centrifugal flow pump, using a hollow-fiber membrane oxygenator and percutaneous cannulas. Team members prime the system while the ECLS-trained first-response physicians place cannulae. All elements of program development, team education, and ongoing program maintenance are critical to successful outcomes for patients.

The next treatment option: using ventricular assist devices for heart failure.

Ventricular assist devices (VADs) are becoming more commonplace in the hospital and community settings as the number of patients living with heart failure increases. Patients being discharged after hospitalization for heart failure rose from 399 000 in 1979 to 1 099 000 in 2004, an increase of 175%. Patients with heart failure become severely debilitated finding activities of daily living including eating, bathing, and walking a great effort. Patients with end-stage heart failure are often sent home on inotropic therapies and referred to hospice care. The use of VADs for these patients can dramatically improve both the quality and the length of life. VADs can be broadly categorized as being either continuous flow (fluid dynamic) or pulsatile (volume displacement) and either can be used as short- or long-term support devices. The critical care nurse is in a unique position to educate patients with chronic heart failure on options available to improve their quality of life including VAD therapy. VADs are available for destination therapy for those not meeting transplant criteria, offering a longer quality of life. As centers gain more experience and referrals are made earlier in the disease process, VAD patient care will be more streamlined decreasing length of stay.

Case series: clinical management of persistent mechanical assist device driveline drainage using vacuum-assisted closure therapy.

Percutaneous driveline lead and pocket sites are potential sources of drainage that can lead to infection. Some patients experience a slower closure of tissue growth into the driveline. The management of chronically open and or draining driveline wounds is a challenge. The KCI vacuum-assisted closure (VAC) device is a noninvasive negative-pressure therapy that promotes the healing of wounds not responding to conventional treatment. Vacuum-assisted closure therapy has proven safe, effective, and cost efficient by decreasing the number of dressing changes and length of stay. The left ventricular assist device (LVAD) team initiated VAC therapy in 3 patients. The tunneling method allowed the wound to heal from the inside out. The dressing was changed every 3 days, and the size and depth of the wound was monitored. Patients may be sent home using a portable VAC device until wound closure is obtained, which decreases the hospital length of stay. Our experience with three patients suggests the VAC device can be used for draining and tunneling LVAD driveline-site wounds and may prevent fistula formation. It is especially useful for patients with ascites that may be draining along the driveline tract. The sites showed increased granulation, decreased drainage, and a reduced bacterial burden after having the device in place.

Assessment of recurrent heart failure associated with left ventricular assist device dysfunction.

BACKGROUND: Patients with advanced heart failure may require long-term support with an intracorporeal left ventricular assist device (LVAD) before cardiac transplant, while awaiting myocardial recovery, or during destination therapy. Compared with the diagnosis of native heart dysfunction, there is less experience with the assessment of recurrent heart failure after LVAD placement. METHODS: Ten patients (9 men, 1 woman; age, 58 +/- 11 years) were studied after LVAD placement. Six patients were studied because of recurrent heart failure; the remaining 4 had other indications for study and are reported here as controls. Cardiac catheterization, including LVAD and cannulae catheterization, and angiography were performed. RESULTS: Inflow cannula valve regurgitation by LVAD angiography was found in 3 cases. Patients with regurgitation had a mean increased resting LVAD rate of 105 beats/min (range, 90-120); LVAD output exceeded forward cardiac output (LVAD - thermodilution cardiac output = +3.7 liters/min [0.6-6.4]). Inflow cannula obstruction identified with a filling phase pressure gradient between the left ventricle and the LVAD was found in 3 additional patients. Patients with obstruction had decreased resting LVAD rates (50 beats/min, all patients); LVAD output was less than the forward cardiac output (LVAD - thermodilution cardiac output = -2.3 liters/min [-0.8 to -3.5]). Compared with those with inflow valve regurgitation, patients with cannula obstruction had higher pulmonary capillary wedge pressures; phasic left ventricular pressure variation was reduced. Patients with cannula dysfunction underwent surgical intervention, and 4 of 6 were long-term survivors. CONCLUSIONS: When heart failure recurs after LVAD placement, abnormalities of the inflow cannula are common. Cardiac catheterization can confirm the diagnosis before surgical intervention. Hemodynamic coupling between the left ventricle and the LVAD is increased with inflow valve regurgitation and reduced with cannula obstruction.

Nutrition assessment and management of left ventricular assist device patients.

Nutrition evaluation and support is an integral component of left ventricular assist device (LVAD) therapy. Malnutrition in the LVAD patient contributes to a host of post-operative problems, such as infection and limited functional capacity, which compromise long-term outcomes. Comprehensive pre-operative evaluation of the LVAD patient should include a nutrition assessment and formalized plan to initiate and advance nutrition support while addressing the metabolic imbalances associated with heart failure. An interdisciplinary approach, including a nutrition support team, is desirable to manage these patients effectively. This article reviews essential aspects regarding nutrition management of these patients.

Multicenter experience: prevention and management of left ventricular assist device infections.

Implantable left ventricular assist devices (LVADs) have demonstrated clinical success in both the bridge-to-transplantation and destination-therapy patient populations; however, infection remains one of the most common causes of mortality during mechanical circulatory support. Thus, serious LVAD infections may negate the benefits of LVAD implantation, resulting in decreased quality of life, increased morbidity and mortality, and increased costs associated with implantation. Prevention of device-related infection is crucial to the cost-effective use of mechanical circulatory support devices. Therefore, adherence to evidence-based infection control and prevention guidelines, meticulous surgical technique and optimal postoperative surgical site care form the foundation for LVAD associated infection prevention.

Management of adult patients with a left ventricular assist device.

The number of left ventricular assist device (LVAD) implantations is growing as a result of increased waiting periods for cardiac transplantation and the decreased availability of organ donors. Furthermore, the Food and Drug Administration (FDA) has approved permanent LVAD support. After an acute hospitalization, patients with LVADs may need prolonged convalescence in a healthcare facility because they have complex medical needs and are physically disabled. Admission criteria need to be developed as essential patient and nursing competencies need to be defined as a part of a successful LVAD program in an acute rehabilitation center. Acute rehabilitation centers can help patients with LVADs transition to a home setting.