Abstract
Abstract
Background:
An increasing number of end-stage heart failure patients are supported with left ventricular assist device (LVAD) implantation and must be maintained on consistent anticoagulation. These patients are experiencing prolonged survival and, in some, there is development of new biliary disease. However, safety and outcomes of this procedure in this unique patient group is not well reported.
Methods:
This was a retrospective single-center review. All adult patients supported on an implanted, continuous flow LVAD from 2007 to 2016 were screened. Baseline characteristics, laboratory values, and operative details were collected through retrospective chart review and an institutional LVAD registry.
Results:
Of the 798 patients screened, 5 (0.63%) underwent laparoscopic cholecystectomy after LVAD implantation. In 4 patients (80%), the indication for surgery was symptomatic cholelithiasis and 1 patient (20%) had symptomatic acalculous cholecystitis. The average time from LVAD implantation to laparoscopic cholecystectomy was 254 ± 158 days. Average (corrected) preoperative international normalized ratio (INR) was 1.34 ± 0.30. Average preoperative hemoglobin was 11.28 ± 2.41 g/dL. All patients were on warfarin preoperatively and admitted before their operations for bridging with a heparin drip. Average postoperative change in hemoglobin was −1.16 ± 1.97 g/dL. The only major postoperative complication in this cohort was the development of an abdominal wall hematoma in 1 patient requiring operative evacuation. The average length of stay was 13.2 ± 4.6 days. Three patients (60%) took an average of 12 days to reach therapeutic INR.
Conclusions:
Laparoscopic cholecystectomies can be performed safely in LVAD patients. Prolonged hospital stay is mainly owing to time required to reach a therapeutic INR postoperatively. Level of Evidence: II, prognostic.
Background
Orthotopic heart transplant remains the gold standard for treatment of end-stage heart failure. However, a growing number of patients require mechanical circulatory support until transplant, or if ineligible for transplant, long-term support as destination therapy. Implantable left ventricular assist devices (LVADs) are the most common form of long-term support. Data from the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure trial showed that the use of LVADs prolongs life in heart failure patients compared with pharmacologic interventions alone. 1 Consequently, as the number of these patients increases over time, they may be diagnosed with other comorbidities that require operative intervention. There are important considerations when evaluating noncardiac surgical interventions in this unique patient cohort, such as the position of the LVAD driveline, perioperative management of complex anticoagulation regimens, and fluid resuscitation in a hemodynamically sensitive patient.2,3
Laparoscopic cholecystectomy is the standard of care for treatment of symptomatic gallstones and acalculous cholecystitis. It is common for patients who have undergone cardiac surgery to experience biliary tract disease, which may be secondary to hypoperfusion and gallbladder stasis. 4 Thus, the objective of this study was to describe the outcomes and management of LVAD patients undergoing laparoscopic cholecystectomy at a single institution.
Methods
Study population and inclusion criteria
To address the research purpose, the investigators designed and implemented a retrospective single-center review. Institutional Review Board (IRB) approval including a waiver of consent was granted. The study population consisted of all consecutive adult patients (age >18 years) who were supported on an implanted, continuous flow LVAD from January 1, 2007 to December 31, 2016; all patients who underwent laparoscopic cholecystectomy after LVAD implantation were included in this study. Baseline characteristics, such as gender, age, and medical comorbidities were collected from a retrospective chart review and from a prospectively collected institutional LVAD registry. All laparoscopic cholecystectomies were performed under general anesthesia with endotracheal intubation. LVAD settings and performance were monitored by a certified clinical perfusionist during the entire operation. Postoperatively, patients were admitted to a telemetry floor under the heart failure cardiology service. Postoperative laboratories were checked routinely on postoperative day 1 or as indicated.
Hematologic laboratory test results, such as hemoglobin and international normalized ratio (INR), were collected through chart review. In addition, the type of anticoagulation regimen, the use of intraoperative and postoperative blood transfusions, the use of perioperative and postoperative antibiotics, and any postoperative complications were collected through chart review.
Technical considerations during laparoscopic cholecystectomy
All laparoscopic cholecystectomies were performed in a similar manner. Before induction of anesthesia, an arterial line was placed in all patients. After induction of anesthesia, the driveline insertion site was covered with a sterile dressing and the abdomen was otherwise prepped and draped in standard manner. Pneumoperitoneum in all cases was achieved through open (Hasson) technique (Fig. 1). Using a 5 mm 30° laparoscope and three additional subcostal ports, the gallbladder was retracted, the peritoneal reflections were taken down, and the structures entering the gallbladder were identified to give a critical view of safety. The remainder of the gallbladder was dissected off the gallbladder fossa using the electrocautery and removed in a specimen bag. Port sites were closed using monofilament suture and skin glue.

Diagram of torso showing recommended placement of laparoscopic ports in a patient supported by LVAD. The driveline's course, which can vary, must be noted by the surgeon before and after insufflation so it can be avoided. LVAD, left ventricular assist device.
Statistical analysis
Continuous variables are presented as mean ± standard deviation, and compared using Student's t-test. Categorical variables are presented as proportions and percentages, and compared using chi-squared test or Fisher's exact test as appropriate. Statistical significance was established at P < .05. Statistical analysis was performed using SPSS (IBM, Armonk, NY).
Results
A total of 798 patients with LVADs were screened using our institution's LVAD registry. Five (0.63%) patients were found to have undergone laparoscopic cholecystectomy after LVAD implantation. Table 1 provides patient demographics. Four patients (80%) had heart failure of ischemic origin. Two patients (40%) had a history of previous stroke or transient ischemic attack. All 5 patients were men, with an average age of 67 ± 4.4 years. The average time from LVAD implantation to laparoscopic cholecystectomy was 254.4 ± 158.0 days. Table 2 provides the indications for laparoscopic cholecystectomy in this patient cohort. For 4 patients (80%), the indication was symptomatic cholelithiasis, and 1 patient (20%) had symptomatic acalculous cholecystitis.
Patient Demographics
BSA, bovine serum albumin; LVAD, left ventricular assist device.
Indications for Laparoscopic Cholecystectomy
CT, computed tomography; RUQ, right upper quadrant.
Table 3 gives the coagulation parameters for all LVAD patients who underwent laparoscopic cholecystectomy. The average preoperative hemoglobin was 11.3 ± 2.4 g/dL, whereas the average preoperative INR was 1.38 ± 0.38. The average postoperative change in hemoglobin was −1.16 ± 1.97 g/dL and the average postoperative change in INR was 0.08 ± 0.54. Five units of preoperative fresh frozen plasma (FFP) were administered to 1 patient with a preoperative INR of 2.0. One patient received 5 mg vitamin K preoperatively.
Coagulation Labs for All Laparoscopic Cholecystectomy Patients
INR, international normalized ratio; SD, standard deviation.
All patients were on warfarin preoperatively and admitted before their operations for holding of warfarin and bridging with a heparin infusion. The only major postoperative complication in this cohort was the development of an abdominal wall hematoma in 1 patient, which was treated with drainage in the operating room and postoperative transfusion of 2 U of packed red blood cells. The other 4 patients did not receive any intraoperative or postoperative transfusions. The average length of stay was 13.2 ± 4.6 days. Three patients (60%) took an average of 12 days to reach therapeutic INR after their laparoscopic cholecystectomies that was the main driver for prolonged hospitalization. Enoxaparin is not favored for bridging in our LVAD patients because of high rates of bleeding.
Discussion
Approximately 2500 people undergo implantation of LVAD each year. 5 Although these devices were originally developed as a bridge to transplant, an increasing number of patients are treated with LVAD as destination therapy (not listed for heart transplant). Five-year survival for a patient with a durable LVAD as destination therapy has increased to 35%. 5 As the pool of patients with LVADs grows, common general surgical problems will arise in this population. The most morbid complication of LVAD therapy remains thrombosis formation on the pump's many nonepithelialized surfaces, mandating warfarin anticoagulation in all patients. Aspirin is recommended for thrombosis prevention as well.
These patients must be monitored closely during and after cholecystectomy because they are highly susceptible to changes in intravascular volume. An anesthesiologist with expertise in management of heart failure should be involved in the case. A cardiologist with experience in the management of heart failure should be consulted before surgery to optimize medical therapy. A perfusionist should be separately tasked with monitoring pump function during the case, especially during induction of anesthesia (i.e., responsibility for monitoring the LVAD should not be placed on the anesthesiology team). Continuous hemodynamic optimization with judicious adjustments to intravascular fluid volume, and the use of inotropic and vasoactive agents is mandatory. Practitioners should remember that VADs are dependent upon fluid/volume status, as they do not adapt output on a Starling curve but can only pump the volume delivered to them. Therefore, factors that decrease preload will directly affect pump flow and decrease output. These can include the following: drugs, hypovolemia (from either dehydration or hemorrhage), positioning, increased abdominal pressures (e.g., from insufflation), loss of preload (from induction of anesthesia), and loss of sympathetic tone.
Maintenance of a consistent anticoagulation regimen in the LVAD patient population is integral to preventing pump thrombosis. However, if urgent operative intervention is necessary, use of prothrombin complex concentrate (PCC) has been shown to be a safe method for rapid anticoagulation reversal. A retrospective review of 31 LVAD patients presenting with intracranial hemorrhage showed that there was no difference in the rate of postreversal thromboembolic events between the patients who received PCC and those who received traditional vitamin K antagonists. 6 In addition, time to anticoagulation reversal was shorter and FFP requirements were lower in patients who received PCC. Thus, PCC can be considered as a reliable, efficacious alternative to traditional reversal methods in this patient population. As previously mentioned, enoxaparin is not utilized at our institution for bridging subtherapeutic INRs in the LVAD patient population. Use of enoxaparin in LVAD patients has been shown to be associated with increased incidence in major bleeding episodes during the bridging period. 7
The general surgeon faced with gallbladder disease in a patient with an LVAD should not be deterred from operating laparoscopically by the presence of an LVAD. LVADs have been described as “the most sophisticated, expensive, and potentially dangerous devices that have ever been implanted in humans.” 8 For this reason, multidisciplinary teams have been formed to care for patients with LVADs and a surgeon absolutely must avail himself or herself of these resources to make a plan for holding anticoagulation, medical optimization, and postoperative resumption of anticoagulation. In the operating room, the general surgeon should (1) ensure adequate support from perfusion services, (2) carefully protect the driveline from injury and contamination, and (3) take extra measures to ensure hemostasis because prompt resumption of anticoagulation is essential to preserve the LVAD. In doing so, surgeons can offer patients with an LVAD a safe and effective laparoscopic cholecystectomy.
Footnotes
Disclosure Statement
The authors report no proprietary or commercial interest in any product mentioned or concept discussed in this article.
