PATIENT AUTONOMY AND INFORMED CONSENT
Thorough, patient-centered counseling is essential. Surgeons must be familiar with alternative and supplementary therapies and the services available at their institutions in order to provide well informed guidance and receive truly informed consent. Many hospitals have developed specialized ‘Bloodless Medicine’ services to assist with patient education, informed consent, preoperative optimization, perioperative management, and care coordination for any patients declining blood products [3▪]. These teams may include Jehovah's Witness representatives, hematologists, anesthesiologists and other specialists, who can be a great resource.
Though patients may refuse whole blood or packed red blood cells, the governing council of the Jehovah's Witnesses allows use of fractionated blood derivatives, leaving it up to the patient's own discretion . Informed consent discussions should include the patient's wishes regarding the use of whole blood or their primary components (red blood cells, platelets, plasma) versus blood derivatives (albumin, cryoprecipitate, fibrinogen, clotting factor concentrates and immunoglobulins). This should be clearly documented and made known to all care providers. Many patients accept technologies like intraoperative cell salvage that collects and processes blood before transfusing it back into the patient. However, some believe that once blood has left the body, it may not be transfused. Others believe that as long as blood remains within tubing that is continuously connected to the patient's body, as with hemodialysis and cardiac bypass, its use is allowed.
Given the complexity of this decision-making process, these conversations should ideally take place early and not under duress. Patients must be given the opportunity to make decisions with comprehensive information free from coercion from the medical team, family members or others. Patient confidentiality is of utmost importance. Having made their decisions well in advance, patients may carry documentation with them. However, it is important to verbally confirm these wishes to ensure that the carrier continues to hold these beliefs as documented and that they carry the document of their own free will. Whenever discordance among family members exists, patients may desire to keep transfusions confidential. Finally, many patients’ wishes are nuanced, and some may express a desire to accept transfusion only in the case of life-threatening anemia. For example, some patients may accept transfusion if two independent clinicians agree that death is likely without transfusion. Some patients, particularly those whose refusal of transfusion stems from a fear of infectious disease or adverse transfusion reaction, may be willing to accept transfusion if donated by friends and family members or if they are given the opportunity to bank their own blood in advance of a procedure for potential autologous donation. In patients with preexisting anemia, donating one's own blood may not be a viable option.
WHEN INTERVENTION IS NECESSARY
Whether to operate is always an important decision, but even more so when a patient refuses blood transfusion. Various factors have been identified that significantly increase mortality risk in severely anemic Jehovah's Witness patients not accepting transfusion. Age at least 45, acute admission and Hgb less than 8 g/dl were found to have the highest mortality risk. Other risk factors include hypertension and cardiac disease. These parameters and the patient's pathology will help determine whether the patient is a surgical candidate .
In hemodynamically stable adults, the American Association of Blood Banks recommends transfusion at a Hgb of 7 and 8 g/dl for patients undergoing orthopedic or cardiac surgery or with preexisting cardiovascular disease. These guidelines do not apply to patients with acute coronary syndrome or severe thrombocytopenia. There is insufficient evidence to apply the guidelines to chronic, transfusion-dependent anemia .
A 2002 study of 300 postoperative patients treated at a single institution between 1981 and 1994 who refused blood transfusion and had postoperative Hgb 8 g/dl or less, showed that the odds of death increased 2.5 times for each 1 g decrease in the Hgb level. The overall mortality rate in this study was 16%, and 11.5% for gynecologic procedures . A 2014 update including 293 patients, of which 288 were Jehovah's Witnesses, receiving care at a single institution with an established Bloodless Medicine and Surgery program between 2003 and 2012 showed an overall mortality rate of 8.2 and 2.5% for gynecologic and obstetric procedures. The mortality rate was 1.5% in patients with Hgb 7.1–8.0 g/dl and rose to 19.4% in patients with Hgb 4.1–5.0 g/dl and 50% in patients with Hgb 2.1–3.0 g/dl. The adjusted odds ratio of mortality for each 1 g decrease in Hgb was 1.82 . Though mortality rates of 0–1.5% are reported among these two studies at Hgb of 7.1–8.0 g/dl, the rates of serious morbidity, including sepsis, cardiac arrhythmia, congestive heart failure, myocardial infarction, pneumonia and deep wound infections, was 9.4–22.6% [6,8].
Emergent versus nonemergent presentation
For patients with acute, active bleeding, urgent surgical intervention may be unavoidable and rapid intervention is the most important way to reduce blood loss. Preoperative uterine artery embolization (UAE) may be considered if readily available and care should be coordinated with interventional radiology. If surgical intervention is deemed necessary and appropriate, the procedure should be performed minimally invasively if possible, to reduce blood loss and complication risk .
For nonemergent patients, proper timing and preoperative work-up and optimization is important. Patients who do not desire future childbearing may consider early definitive surgical intervention for adenomyosis or symptomatic fibroid uterus. Hysterectomy should be preferred over myomectomy to minimize blood loss. For patients with infertility or desiring fertility preservation, early myomectomy may be preferable to conservative medical treatment. Fibroids in unfavorable anatomic locations, such as cervical fibroids, cornual fibroids or broad ligament fibroids may benefit from early surgical removal even if they are not highly symptomatic. Removing such fibroids before they become very large may decrease risk of excessive blood loss. On the other hand, in perimenopausal patients, the decision may be made to pursue medical management or alternative therapies to avoid the risks of surgery in patients who may soon experience natural cessation of vaginal bleeding.
Major surgery for gynecologic malignancy can incur significant blood loss with postop transfusion rates up to 32% . Jehovah's Witness patients undergoing surgery for gynecologic cancer have significantly worse postoperative outcomes if they received abdominal versus minimally invasive surgery with significantly higher blood loss, length of stay, ICU admission and death. Almost a third of those undergoing laparotomy have their procedures stopped prematurely secondary to bleeding or bleeding risk and half of patients with epithelial ovarian cancer have suboptimal cytoreduction [11▪▪]. Given these findings, minimally invasive procedures should be performed whenever feasible and neoadjuvant chemotherapy followed by interval debulking surgery may be more appropriate for patients who refuse blood transfusion. In addition to the immediate risks that patients must accept when refusing blood products, they must also be counseled that, for surgical treatment of malignancy, the refusal may impact their postoperative cytoreductive status and overall prognosis [11▪▪].
In patients who refuse surgery or for whom the risk of surgical intervention is considered unacceptably high, alternative therapies are available. These therapies may also be performed as temporizing measures with surgical management planned after medical optimization. Multiple interventions may be employed, either concurrently or in a step-wise fashion. Early evaluation and active management are key.
Uterine artery embolization
UAE is safe and effective for treatment of fibroids, improving bulk symptoms and heavy bleeding . However, successful UAE depends on fibroid location and blood supply [13,14]. UAE has a lower risk of major complications but an increased risk of re-intervention 2 and 5 years later compared with surgery . UAE has also shown promise for treatment of adenomyosis, with a recent study showing decrease in symptoms of 83% of patients and even greater effects in patients with both fibroids and adenomyosis . The impact of UAE on conception and obstetric complications remains controversial. Studies show conflicting evidence that UAE leads to decreased fertility and increased rates of miscarriage, preterm delivery, intra-uterine growth restriction, malpresentation, abnormal placentation, and/or postpartum hemorrhage. However, because UAE does not remove fibroid tissue completely, these outcomes may be secondary to the continued existence of fibroids, not the intervention itself. As a result, some still consider UAE an option in those desiring future childbearing . However, pregnancy outcomes following UAE are significantly worse than those following myomectomy .
Endometrial ablation has long been used as a treatment for heavy menstrual bleeding. Multiple Food and Drug Administration (FDA)-approved devices utilize various forms of energy, with or without hysteroscopic resection, to remove or desiccate the endometrium down to its basalis layer. Compared with nonresectoscopic techniques, resection did not significantly decrease menstrual bleeding but did increase operative time and complications . Though, many new technologies have been developed in an attempt to improve outcomes, a 2019 Cochrane review found no significant difference in efficacy for heavy menstrual bleeding [19▪▪].
Complications associated with endometrial ablation including uterine perforation, burns, painful obstructed menses, hematometra and infection. Long-term failure requiring re-operation within 4–5 years is between 18 and 38% . Rates of endometrial ablation failure are the highest in younger women, women with larger uteri, submucous myomas and history of C-section. Ablation has significantly higher treatment failures and complication rates when compared with both levonorgestrel intrauterine system (LNG-IUS) and hysterectomy. Women with a history of tubal ligation and existing dysmenorrhea are at risk for postablative pain [21▪▪]. A recent decision analysis model found that the LNG-IUS was superior to hysterectomy and ablation in both cost and quality-of-life outcome measures. Though hysterectomy was more expensive than ablation, it showed superior quality of life outcomes and provides definitive treatment . Ablation is also limited by uterine size and contour. Though certain ablation systems are FDA approved for use in the presence of submucosal fibroids, hysteroscopic resection may be preferred to ablation with fibroids in situ. Ablation is contraindicated in women who desire future fertility and should not be used in women with endometrial hyperplasia or malignancy. Use in women at high risk for endometrial cancer is controversial.
Thermal ablative treatment of fibroids
Thermal ablative technologies heat fibroid tissue using various methods including lasers, radiofrequency and microwave energy, and ultrasound or magnetic resonance-guided high-intensity focused ultrasound energy. Fibroid tissue is heated until necrosis is achieved, and though they may reduce in size, they do not disappear. Reintervention is often required .
It is important to optimize blood counts before surgery by minimizing blood loss and maximizing hematopoiesis.
Minimizing blood loss
Menstrual suppression can be beneficial in surgical preparation for all patients, particularly those who refuse transfusion. Medical therapy to reduce menstrual bleeding in premenopausal women include a variety of hormonal and nonhormonal options and include oral, intramuscular, transdermal, transvaginal, and intrauterine options. Hormonal options include estrogen–progestin regimens, progestin-only regimens and gonadotropin-releasing hormone analogues (GnRH-a). Continuous use of combined hormonal contraceptives has been shown to be well tolerated with few side effects and can be considered in those without contraindications . Oral norethindrone acetate reduces menstrual bleeding by 87% . GnRH-a use significantly improves preoperative Hgb in patients with fibroids undergoing hysterectomy or myomectomy . The LNG-IUS has been found to be more effective than combined hormonal contraceptives, tranexamic acid (TXA) and long-course oral progestins . LNG-IUS is also effective in women with uterine fibroids [26,28]. The choice of which hormonal regimen to be used should be individualized based on patient history that may preclude use of certain medications, side effects, compliance and patient preference for route of administration in addition to cost of the medication.
Nonhormonal options include NSAIDs and TXA. TXA functions by stabilizing clot formation via inhibition of fibrinolysis. The recommended dosing varies by indication and, for menorrhagia, is 1300 mg orally three times daily for a maximum of 5 days during menses. A reduction of up to 56% of mean blood loss has been shown when used for the first 5 days of menses [29,30]. Although theoretical consideration for thrombosis exists when using an antifibrinolytic agent, population-based studies have not evidenced an association with TXA use and increased thrombosis risk .
It is also important to maximize new blood production. Anemia can result from various deficiencies, and repleting iron, folate and vitamin B12 is recommended. Iron can be repleted either orally or intravenously. Advantages of intravenous administration include less gastrointestinal side effects and shortening the time to full repletion.
Recombinant human erythropoietin has been an option for most Jehovah's Witnesses who have normal erythropoietin production, regardless of the cause . However, in one case series of 76 patients, erythropoietin use was not associated with increased hemoglobin recovery at any time within 28 days of administration . In another retrospective study from New Zealand, 91 Jehovah's Witnesses who received erythropoietin were compared with 57 who did not, and treatment was not associated with shorter duration of severe anemia or a reduction in mortality [34▪]. The FDA has warned that in patients with renal failure, erythropoiesis-stimulating agents (ESA's) can increase risk of death and serious cardiovascular events. In patients with certain cancers, there is increased risk of tumor progression and decreased overall survival. Perioperative patients not receiving prophylactic anticoagulation have increased risk of deep venous thromboses .
Some Jehovah's Witnesses may accept synthetic or semisynthetic preparations of hemoglobin, also known as hemoglobin-based oxygen carriers (HBOC), which are administered via infusion. However, given serious adverse events and continuing concerns about toxicity, no HBOC product has been approved by the FDA . Some products may be available for administration under FDA emergency provisions or as part of clinical trials enrolling patients with life-threatening anemia for whom blood is not an option [37,38].
Needless to say, a clearly documented comprehensive informed consent and shared decision-making process is of utmost importance. In preparation for surgery, the patient's advanced directive should be completed and included in the medical record, including identification of a healthcare proxy. Surgeons should have immediate access to the healthcare proxy in the event of life-threatening emergency. The healthcare proxy should be present in the hospital waiting room at the time of surgery, if at all possible, or otherwise easily reachable.
Clinical care must incorporate patients as part of multidisciplinary medical and surgical care. Various teams including anesthesia, surgery, hematology, nursing, social work, and administrators should be made aware of the patient's wishes to be able to provide synchronous care . Medical and administrative efforts in the form of a bloodless medicine and surgery program can be instrumental in helping to reduce morbidity and mortality. Consulting such a program if it exists is always recommended.
Arranging for the availability of cell salvage equipment and coordinating with the cell salvage team should be done as early as possible. As there is a possibility that patients or healthcare proxies may alter their initial decision to decline blood transfusion, a blood type and screen may still be obtained so as to be prepared in the event that a transfusion is requested. The same antibiotic and VTE prophylaxis protocols and precautions for preventing complications should be kept.
INTRAOPERATIVE MEDICAL INTERVENTIONS
To decrease surgical blood loss, preemptive and intraoperative pharmacologic and hemostatic agents can be employed . Multiple options are available including uterotonics, such as ergometrine, oxytocin, and misoprostol, injection of intra-myometrial vasopressin or bupivacaine with epinephrine, and antifibrinolytic agents, such as tranexamic acid [36,40▪▪,41,42].
In a 2008 systematic review, multiple modalities were proven helpful in reducing hemorrhage during myomectomy. Vaginal misoprostol works by increasing in myometrial contractions, reducing uterine blood flow and decreasing intraoperative blood loss. Intramyometrial vasopressin and bupivacaine with epinephrine create areas of local vasoconstriction, reducing blood flow around the surgical site (see Table 1) . The addition of rectal misoprostol, placed 30 min before myomectomy, has an additive effect in reducing blood loss [44▪]. Preoperative and prophylactic intravenous TXA (100 mg/ml) has been shown to significantly decrease blood loss in abdominal myomectomy compared with placebo .
Topical hemostatic agents accelerate hemostasis while avoiding tissue necrosis and devascularization that occurs with use of electrosurgery. In other specialties, hemostatic agents have been shown to shorten operative times and decrease the need for blood transfusion in the perioperative period. The largest benefit arises from use in areas with generalized small vessel bleeding (i.e. ovarian cystectomies and myomectomies) or bleeding near important structures where application of thermal energy or further dissection can illicit more harm. Types of topical hemostatic agents include absorbable agents such as oxidized regenerated cellulose and microfibrillar collagen that have the capacity to create a framework for natural platelet aggregation and can be bactericidal, as well as microporous polysaccharides and gelatins that can form platelet plugs and matrices when they absorb blood. Biologic topical hemostatic agents include topical thrombin, topical thrombin mixed with gelatin and fibrin sealants that can contain coagulation factors [45▪▪,46–48].
Autologous red blood cell transfusion is associated with fewer complications and lower costs than allogenic transfusion [38,49–51]. In brief, the cell salvage process involves collecting all intraoperative blood loss through dedicated suction, mixing it with anticoagulant to prevent clotting, spinning it to separate red blood cells from plasma, filtering and washing to remove debris, and finally collecting red cells for transfusion if necessary . Cell salvage has proven useful in orthopedics and cardiovascular surgery [52,53]. Application to gynecologic surgery has suggested that women undergoing complicated myomectomies [defined as uterine size >15 weeks gestation, prolonged operative time (>120 min), multiple myomas (>5) or intraoperative blood loss of >1000 ml) are more likely to derive the cost-benefit of cell salvage because of a higher likelihood of reinfusion . However, most studies published have small sample sizes [46–48]. For patients unwilling to accept allogenic blood transfusion, cell salvage should be offered, especially when there is risk of increased blood loss and high likelihood of reinfusion of autologous blood. Cell salvage can be used in both laparoscopy and laparotomy.
Surgical technique is central to any successful operation and adherence to avascular planes allows identification and ligation of necessary vascular pedicles, particularly if performed in alternate locations, as when ligating the uterine vessels at their origin in the retroperitoneum. Alternatively, once isolated, vascular pedicles can be temporarily controlled with the use of vessel loops, tourniquets, bulldog clamps or removable hemoclips. Intramyometrial vasopressin has been shown to reduce blood loss more effectively than tourniquet in abdominal myomectomy  and 400 μg of vaginal misoprostol 1 h preoperatively leads to comparable blood loss compared with tourniquets [55▪]. Isolation and ligation of the uterine artery prior to myomectomy was found to be superior to tourniquet in reducing blood loss during myomectomy .
Uterine artery embolization can be performed preoperatively when significant blood loss is anticipated. Preoperative UAE performed hours to days prior to both laparoscopic and open myomectomy has been shown to allow a safe and effective procedure without significant difference in blood loss or need for transfusion despite greater fibroid burden [57,58].
Maintaining a clear visual field with working suction is critical so that any active bleeding can be safely identified and controlled. Surgeons may consider upsizing from a 5 to a 10 mm cannula or even adding a secondary suction device for improved visualization.
Prolonged operative times can contribute to increased blood loss. Thus, operating efficiently while maintaining quality is the goal. Advanced energy devices like bipolar vessel sealers decrease time spent in traditional clamping, cutting and tying of pedicles. Complex surgical cases and those with trainee involvement can take longer and consideration should be made as to which cases are better suited to primary attending or senior surgeon involvement when in an academic teaching hospital.
Finally, understanding one's limitations when it comes to specific disease, route of surgery, or overall technical difficulty of a case cannot be overlooked. It is important that the surgeon be comfortable operating on a patient who refuses blood transfusion. If not, the patient should be referred to a surgeon who can perform the procedure at a medical center that routinely cares for these patients. Patients must be informed preoperatively of the potential need to perform a definitive extirpative procedure, such as oophorectomy or hysterectomy instead of a more conservatively planned ovarian cystectomy or myomectomy in order to stop bleeding. Ultimately, one must always be prepared to convert to an alternate route of surgery, such as a laparotomy for improved exposure and control of the surgical field.
Benjamin Franklin once said, ‘An ounce of prevention is worth a pound of cure.’ When patients refuse blood transfusion, early and aggressive preoperative optimization is key. When surgery is required, choice of proper procedure and timing is important. We have discussed many ways to preemptively maintain hemostasis, the surgical landscape can quickly change, and strategies must be incorporated to reduce blood loss during active bleeding. In caring for any patient that refuses blood transfusion, providers must engage in respectful, patient-centered decision-making and comprehensive, multidimensional care.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
REFERENCES AND RECOMMENDED READING
Papers of particular interest, published within the annual period of review, have been highlighted as:
- ▪ of special interest
- ▪▪ of outstanding interest
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Highlights the particular challenges of caring for women with gynecologic cancer who refuse blood transfusion and the high rate of adverse outcomes in Jehovah's Witness patients. Not only are surgical outcomes poorer, surgical prognosis is also often adversely affected because of the inability to achieve optimal cytoreduction or even complete major surgery because of bleeding or bleeding risk. The article highlights these and other specific concerns when it comes to gynecologic cancer and the importance of considering minimally invasive surgery and neoadjuvant surgery in this population.
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Cochrane review comparing safety, efficacy and acceptability of endometrial ablation techniques for heavy menstrual bleeding. Despite development of new devices and technologies, the review showed no significant difference in bleeding or patient satisfaction. Newer devices did show lower risk of equipment failure and greater ease of use leading to lower risk of adverse events including uterine perforation, fluid overload, cervical lacerations and hematometra than older techniques.
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Though case reports of successful use of erythropoietin (particularly high-dose recombinant human erythropoietin) report successful treatment of anemia in Jehovah's Witness patients, this article adds to the literature that shows that low-dose erythropoietin does not improve short-term anemia in patients who do not accept blood transfusion and does not decrease mortality. Erythropoietin is not without risk and should be used thoughtfully.
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Tranexamic acid (TXA) is being used increasingly in obstetrics to prevent or treat postpartum hemorrhage. This systematic review includes four studies of women undergoing myomectomy – three focusing on abdominal myomectomy and one focusing on hysteroscopic myomectomy. TXA was shown to significantly reduce intraoperative and postoperative blood loss in abdominal myomectomy but not in hysteroscopic myomectomy where postoperative hemoglobin was actually lower when compared with patients treated with oxytocin. As use of TXA increases, more studies are needed.
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This single-blinded randomized controlled trial compared the efficacy of intramyometrial vasopressin alone to intramyometrial vasopressin with preoperative rectal misoprostol in reducing blood loss in laparoscopic myomectomy. The study showed significant reduction in blood loss and significantly higher postop hemoglobin with the addition of preop rectal misoprostol.
45▪▪. Ito TE, Martin AL, Henderson EF, et al. Systematic review of topical hemostatic agent use in minimally invasive gynecologic surgery. JSLS
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A useful systematic review of topical agents that can be used to gain hemostasis in minimally invasive gynecologic surgery. Includes helpful summary tables and covers all commonly used agents.
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55▪. Afolabi MA, Ezeoke GG, Saidu R, et al. Comparing perioperative vaginal misoprostol with intraoperative pericervical hemostatic tourniquet in reducing blood loss during abdominal myomectomy: A randomized controlled trial. J Turk Ger Gynecol Assoc
This randomized controlled trial compared the efficacy of single dose 400 μg preoperative vaginal misoprostol to intraoperative pericervical tourniquet in women undergoing abdominal myomectomy. The study showed comparable results and no statistically significant difference in intraoperative blood loss and transfusion between the two groups.
56. Helal AS, Abdel-Hady el-S, Refaie E, et al. Preliminary uterine artery ligation versus pericervical mechanical tourniquet in reducing hemorrhage during abdominal myomectomy. Int J Gynaecol Obstet
57. Schnapauff D, Russ M, Kröncke T, et al. Analysis of presurgical uterine artery embolization (PUAE) for very large uterus myomatosus; patient's desire to preserve the uterus; case series and literature review. Fortschr Röntgenstr
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Keywords:Copyright © 2019 YEAR Wolters Kluwer Health, Inc. All rights reserved.
blood transfusion; Jehovah's Witness; preoperative optimization