A rocky month for anesthesia reimbursement policy

 

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December has been a tumultuous month for anesthesia pay policy, as provider and public outrage has spurred two payers to reverse controversial reimbursement policies.

On Dec. 5, Anthem Blue Cross Blue Shield announced it would rescind a planned update to its anesthesia reimbursement policy. The update proposed a new payment structure tied to CMS physician work time values, under which claims exceeding predetermined time limits would be denied.

The policy faced sharp criticism from the American Society of Anesthesiologists, which issued a statement Nov. 14 decrying the plan’s lack of consideration for the individualized nature of anesthesia care. The ASA warned the policy would “arbitrarily pre-determine the time allowed for anesthesia care,” potentially resulting in denied payments for complex or prolonged cases and risking patient safety.

On Dec. 4, social media outrage erupted when posts about Anthem’s policy went viral on the platform X. The widespread backlash prompted policymakers to intervene, leading to Anthem’s reversal the following day.

“It’s very interesting that Anthem’s policy was so egregious in how it attempted to not pay for anesthesia services that even had friends and family members who are not in the medical field texting me regarding this ridiculous policy,” Gerald Szelagowski, MD, anesthesiologist at Lima, Ohio-based Buckeye Anesthesia Services and Consultants, told Becker’s. “When the general public, who have no knowledge of how anesthesia time is billed, is reaching out to members of the medical community concerned, that tells you how far Anthem is going to go in order to increase profits.”

The controversy surrounding reimbursement policies was further amplified by broader scrutiny of insurance practices following the tragic murder of UnitedHealthcare CEO Brian Thompson. This incident cast a spotlight on decision-making within the insurance industry, fueling public anger and calls for accountability.

“It is the right thing to do, but I’m concerned about the decision-making process that led to this policy. My assumption is the recent murder of the UnitedHealthcare CEO and the subsequent outrage regarding commercial insurance companies had more to do with the reversal than anything else,” Mike MacKinnon, DNP, CRNA, owner of Mackinnon Anesthesia, told Becker’s. “At least the timing suggests that’s the case, as they announced this policy in the second week of November and not until it hit the news again after the CEO murder was another light shed on this issue and they decided to reverse. My guess is this was to avoid more negative press ‘eyes’ on them.”

Then, on Dec. 16, Kaiser Foundation Health Plan announced it had reversed an anesthesia reimbursement policy introduced in Washington state in November.

The now-rescinded plan required anesthesia services to include specific modifiers identifying who performed the service for reimbursement. Additionally, the policy reduced payments for QZ services — those rendered by certified registered nurse anesthetists — to 85% of the physician fee schedule.

“As one of the largest not-for-profit healthcare providers in the country, Kaiser Permanente’s mission is to provide high-quality, affordable care to our members and the communities we serve,” a Kaiser spokesperson said in a statement shared with Becker’s. “While we will continue our focus on keeping care affordable for our members, we will not implement changes in reimbursement rates for anesthesia services provided by CRNAs. We have returned to previous reimbursement rate levels, retroactive to November 1, 2024.”

The reversal came after the American Association of Nurse Anesthesiology strongly opposed the policy, describing it in a Dec. 10 statement as discriminatory. The AANA argued that the policy unfairly targeted CRNAs based on their licensure while not affecting other anesthesia providers delivering the same services.

Now, another insurance company — Ohio-based health insurance provider Medical Mutual — plans to reduce CRNA reimbursements to 85% beginning Jan. 24.

The AANA issued a statement expressing disapproval for the policy, calling it “a blatant, dangerous, and self-serving attack on CRNAs and the patients they seek to care for,” according to a Dec. 19 news release.

“CRNAs are often the only anesthesia providers in the rural communities across the nation, including rural communities in Ohio where Medical Mutual is headquartered,” the AANA said in its statement. “The attempt by insurers to restrict their practice, underscores the critical need for the Department of Health and Human Services (HHS) to enforce the nondiscrimination provision, and is why AANA continues its litigation in the United States District Court for the Northern District of Ohio to compel HHS to enforce the law.”

The push to cut anesthesia reimbursements is not new. Medicare’s average anesthesia rate for 2023 was $21.88, a 5.5% decline from 2019, according to an analysis by Coronis Health. Another analysis, from VMG Health, found that Medicare reimbursements for anesthesia services decreased from $22.2730 per unit in 2019 to $21.1249 in 2023 under CMS’ final rule.

“Many facilities and ASCs already provide stipends to maintain anesthesia services due to insufficient reimbursement rates. Additional cuts could have increased these stipends, straining resources further for hospitals and ASCs,” Megan Friedman, DO, anesthesiologist and director of Los Angeles-based Pacific Coast Anesthesia Consultants, told Becker’s. “This financial burden would only compound the existing workforce shortage, with 78% of facilities reporting difficulties in anesthesia staffing and over half of anesthesia providers nearing retirement age.”

Effectiveness of Ventilation via an Endotracheal Tube in Pharynx Versus a Facemask in Patients With Potentially Difficult Airway

AUTHORS: Markham, Travis MD et al

Anesthesia & Analgesia 140(2):p 280-289, February 2025.

BACKGROUND:

The difficult airway is frequently encountered across many scenarios. The extreme form is a “cannot intubate and cannot oxygenate” scenario, which lacks a reliable rescue technique. Previous case reports or studies with small sample sizes indicate the feasibility and efficiency of an endotracheal tube in the pharynx (TTIP) to ventilate patients. We hypothesize that ventilation via TTIP is an effective rescue technique for failed mask ventilation.

METHOD:

One hundred forty-seven patients with potentially difficult airways were randomly assigned to the sequence (Tube first) of tube first ventilation via TTIP for 1 minute after induction, followed by via mask ventilation for 1 minute or in reverse sequence (Mask first). The ventilation was done with pressure control mode, a peak inspiratory airway pressure of 20 cmH2O, an inspiratory to expiratory time ratio of 1:2, and a respiratory rate of 10 breaths/min.

RESULTS:

A total of 136 patients underwent final analysis. The overall success rate (primary outcome) of ventilation via TTIP and mask, defined as the presence of expired carbon dioxide, was 93.4% (127/136) and 84.6% (115/136), respectively (P = .02). The success rate, 85.7% (6/7), of mask ventilation rescuing a failed TTIP ventilation and 100% (13/13) of TTIP rescuing a failed mask ventilation were comparable (P = .35).

CONCLUSIONS:

The success rates of TTIP and mask ventilation are comparable. Ventilation via TTIP could be an alternative rescue technique for managing a difficult airway.

KEY POINTS

  • Question: Can an endotracheal tube in pharynx (TTIP) ventilation be an effective rescue technique for failed mask ventilation?
  • Findings: The success rate of TTIP ventilation is comparable with that of facemask ventilation in adult patients with potentially difficult airways.
  • Meaning: TTIP is a potential alternative for managing difficult airways.

Comparative Effectiveness of Analgesia for Early Pain Management After Pediatric Tonsillectomy

AUTHORS: Deng, Xialin MSc et al

Anesthesia & Analgesia December 2024.

BACKGROUND:

Timely and effective analgesia after tonsillectomy in children is crucial, but there is currently no consensus on the optimal analgesics. This analysis aimed to identify the most effective for this surgery.

METHODS:

We conducted a systematic review and network meta-analysis (random-effects model) of randomized controlled trials comparing analgesics for pediatric tonsillectomy. We searched relevant studies in PubMed, Embase, Cochrane Library, and Web of Science databases from database inception until June 30, 2023. Children (≤18 years old) who underwent tonsillectomy with or without adenoidectomy were eligible for inclusion. Primary outcomes encompassed pain score and postoperative complications; secondary outcomes included postoperative supplementary analgesia, functional evaluation, and sedation score.

RESULTS:

In total 82 randomized controlled trials involving 6110 patients were included, forming the primary network that comprised comparative data for 16 different interventions (including placebo) across 6 types of analgesics. The integrated analysis revealed that nonsteroidal anti-inflammatory drugs except ketoprofen had no significant effects in relieving postoperative pain (mean difference [MD], −2.96; 95% confidence interval [CI], −5.59 to −0.32; P = .10). Local anesthetic infiltration (bupivacaine: MD, −2.76; 95% CI, −3.88 to −1.64, P = .01; ropivacaine: MD, −2.49; 95% CI, −4.25 to −0.73, P = .02; lidocaine: MD, −1.86; 95% CI,-3.52 to −0.2, P = .02; levobupivacaine: MD, −1.06; 95% CI, −2.00 to −0.12, P = .01), analgesics (morphine: MD, −2.07; 95% CI, −3.14 to −1.00; P = .02), and glucocorticoids (dexamethasone: MD, −0.45; 95% CI, −0.73 to −0.16; P = .01) were effective in relieving pain after pediatric tonsillectomy. In reducing incidence of postoperative complications, dexamethasone was superior to bupivacaine (relative risk [RR], 0.60; 95% CI, 0.43–0.83; P = .02). Regarding the number of patients needing rescue analgesic, levobupivacaine was superior to lidocaine (RR, 0.51; 95% CI, 0.32–0.81; P = .01). In rescue analgesia requirement, morphine outperformed lidocaine (RR, 0.44; 95% CI, 0.25–0.75; P = .01) and ropivacaine (RR, 0.54; 95% CI, 0.32–0.91; P = .01) in efficacy but not different from bupivacaine (P = .10) and levobupivacaine (P = .12).

CONCLUSIONS:

Based on these results, we would recommend local bupivacaine infiltration or local levobupivacaine infiltration for older children and dexamethasone injection for younger children for early analgesia after tonsillectomy. However, clinicians should choose the optimal analgesic based on the individual child’s condition and clinical situation.

Abstract

Associations Between Social Determinants of Health and Opioid-Use Disorder Among Chronic Pain Patients From a Multi-Institutional Dataset

AUTHORS: Do, Veena M. BS et al

Anesthesia & Analgesia December 2024.

BACKGROUND:

This study examined the association between opioid-use disorder (OUD)-related diagnoses (eg, opioid dependence) and social determinants of health (SDoH) among patients with chronic pain.

METHODS:

A cross-sectional study was performed using the All of Us dataset (including >70,000 patients) to measure associations between SDoH and OUD using population- and individual-level surveys. Mixed-effects multivariable regression models (random effect being zip code) were conducted for each of the key SDoH domains. The odds ratio (OR) and 95% confidence interval (CI) were reported.

RESULTS:

There were 71,727 participants identified to have chronic pain, of which 7272 (10.1%) had OUD. Using data from all participants with population-level survey data available (n = 71,684), the Area Deprivation Index was associated with increased odds of OUD (OR, 5.70, 95% CI, 2.34–13.83, P < .001). Being unemployed (OR, 1.91, 95% CI, 1.59–2.31, P < .001) was associated with OUD. Chronic pain patients with a college degree or greater had lower odds of having OUD (OR, 0.48, 95% CI, 0.39–0.59, P < .001). Responses to questions related to delayed medical care (OR, 1.42, 95% CI, 1.20–1.69, P < .001) and inability to afford medical care (OR, 1.37, 95% CI, 1.16–1.63, P < .001) were associated with an increased odds of OUD. Chronic pain patients who were never married or without a partner (OR, 1.49, 95% CI, 1.28–1.73, P < .001) had higher odds of OUD.

CONCLUSIONS:

The study revealed a significantly greater social disadvantage metric in chronic pain individuals with OUD.

KEY POINTS

Research Question: What are the social determinants of health factors associated with opioid-use disorder (OUD) among patients with chronic pain?

Findings: The study revealed a significantly greater social disadvantage metric in chronic pain individuals with OUD.

Meaning: Future studies should target social determinants of health for potentially preventing OUD among chronic pain patients.

Discover The Best Anesthesiologist Opportunity in New Mexico

If you’re an anesthesiologist searching for a balanced lifestyle and rewarding work, you’ll want to check out this opportunity. Our all-anesthesiologist group is seeking a dedicated team member to join our collaborative practice.

Position Highlights:

  • Zero Call for 3 Weeks: Enjoy three weeks of no call duty, followed by one week of call. Even during your call week, there’s no daytime work—just coverage after 7 PM, so you may not work the entire week.
  • Competitive Compensation: Earn a $500,000 annual salary plus a comprehensive benefits package.
  • Work-Life Balance: Enjoy 8 weeks of vacation each year to recharge and relax.
  • Team-Based Approach: Join a cohesive group of 4 full-time anesthesiologists and 1 vacation relief provider, managing 3 operating rooms.

This role provides the perfect mix of professional fulfillment and personal freedom, with a supportive environment and a predictable schedule.

Interested?
Let’s connect! Contact Dr. Rob at 660-596-2224 or drrob@anesthesiaexperts.com for more details or to apply. Feel free to pass this along to any colleagues who might be interested.

This is a rare opportunity—don’t miss your chance to join a team that values your skills and respects your time!

Join Our New CRNA Team in Riverdale, GA!

We’re excited to announce the formation of a new anesthesia group in Riverdale, GA, located just 10 minutes from the Atlanta Airport. We’re seeking dedicated CRNAs to join our collaborative care team, which will include 4 full-time CRNAs and 2 anesthesiologists managing 4 operating rooms.  This is a 25% independent practice and doing own blocks!

Position Highlights:

  • Case Mix: Bread-and-butter cases – no heads, hearts, trauma, or OB.
  • Call Schedule: Call is from home with only a 10% chance of being called back.
  • Work Environment: Enjoy a supportive and collegial workplace.

This is an excellent opportunity to be part of a close-knit team and establish yourself in a fantastic community near Atlanta.

Interested?
Please reach out to Dr. Rob at 660-596-2224 or drrob@anesthesiaexperts.com. Feel free to share this opportunity with anyone who might be interested!

We look forward to hearing from you!

Association of General Anesthesia for Cesarean Delivery with Postpartum Depression and Suicidality

AUTHORS: Guglielminotti, Jean MD, PhD et al

Anesthesia & Analgesia December 2024.

BACKGROUND:

Compared to neuraxial anesthesia, general anesthesia (GA) for cesarean delivery is associated with an increased risk of postpartum depression (PPD) requiring hospitalization. However, obstetric complications occurring during childbirth (eg, stillbirth) are associated with both increased use of GA and increased risk of PPD, and may account for the reported association between GA and PPD. This study assessed the association of GA for cesarean delivery with PPD requiring hospitalization, outpatient visit, or emergency department (ED) visit, accounting for obstetric complications.

METHODS:

This retrospective cohort study included women who underwent a cesarean delivery in New York State between January 2009 and December 2017. Women were followed for 1 year after discharge for readmission, outpatient visit, or ED visit. The primary outcome was PPD requiring readmission, outpatient visit, or ED visit. The 2 secondary outcomes were (1) PPD requiring readmission, and (2) suicidality. Obstetric complications included severe maternal morbidity, blood transfusion, postpartum hemorrhage, preterm birth, and stillbirth. Adjusted hazard ratios (aHRs) and 95% confidence intervals (CIs) of PPD, PPD requiring readmission, and suicidality associated with GA were estimated using the propensity score matching and the overlap propensity score weighting methods.

RESULTS:

Of the 325,840 women included, 19,513 received GA (6.0%; 95% CI, 5.9–6.1). Complications occurred in 43,432 women (13.3%) and the GA rate for these women was 9.7% (95% CI, 9.4–10.0). The incidence rate of PPD was 12.8 per 1000 person-years, with 24.5% requiring hospital readmission, and was higher when an obstetric complication occurred (17.1 per 1000 person-years). After matching, the incidence rate of PPD was 15.5 per 1000 person-years for women who received neuraxial anesthesia and 17.5 per 1000 person-years for women who received GA, yielding an aHR of 1.12 (95% CI, 0.97–1.30). Use of GA was associated with a 38% increased risk of PPD requiring hospitalization (aHR: 1.38; 95% CI, 1.07–1.77) and with a 45% increased risk of suicidality (aHR 1.45; 95% CI, 1.02–2.05). Results were consistent when using the overlap propensity score weighting.

CONCLUSIONS:

Use of GA for cesarean delivery is independently associated with a significantly increased risk of PPD requiring hospitalization and suicidality. It underscores the need to avoid using GA whenever appropriate and to address the potential mental health issues of patients after GA use, specifically by screening for PPD and providing referrals to accessible mental health providers as needed.

The Impact of Medicaid Expansion on Congenital Heart Surgery Outcomes: Data From the Society of Thoracic Surgeons Database

AUTHORS: Ross, Faith J. MD, MS et al

Anesthesia & Analgesia December 2024.

BACKGROUND:

The Affordable Care Act expanded Medicaid eligibility and increased public insurance coverage for children across the United States. As only a subset of states adopted expansion of coverage, disparities in insurance coverage between expansion and nonexpansion states emerged. We examined the association between Medicaid expansion and cardiac surgery outcomes to understand the impact of Medicaid expansion in a medically complex pediatric population. We hypothesized that expansion of Medicaid eligibility would be associated with greater improvement in surgical outcomes.

METHODS:

The Society of Thoracic Surgeons Congenital Heart Surgery Database was used to evaluate perioperative outcomes for children 0 to 18 years undergoing cardiac surgery between January 2010 and December 2019. We used a difference-in-differences (DiD) design to estimate the impact of Medicaid expansion on surgical outcomes by comparing changes in outcomes between individuals in expansion states and those in nonexpansion states, both before and after the expansion. Outcomes included operative mortality, major complications and postoperative length of stay (PLOS).

RESULTS:

The interaction between Medicaid expansion and time period post- vs preexpansion was not significant for any of the outcome variables. The odds ratio (OR) for mortality related to the Medicaid expansion was 1.12 (confidence interval [CI], 0.95–1.32, P = .161). For major complications, the OR was 0.99 (CI, 0.90–1.09, P = .770). For PLOS, the incidence rate ratio was 1.02 (CI, 0.99–1.05, P = .141).

CONCLUSIONS:

There was an overall decline in congenital heart surgery mortality over time; however, states that expanded Medicaid eligibility did not experience a greater improvement in mortality relative to states that did not expand eligibility. Similarly, there was no significant difference in major complications or PLOS related to Medicaid expansion. Further studies are needed to examine long-term outcomes and the larger spectrum of accessibility to congenital cardiac care which may benefit from insurance coverage.

Association Between Arterial Hyperoxia and Mortality in Pediatric and Adult Patients Undergoing Extracorporeal Membrane Oxygenation

AUTHORS: Gu, Wan-Jie MD, PhD et al

Anesthesia & Analgesia December 2024.

BACKGROUND:

In patients receiving extracorporeal membrane oxygenation (ECMO) support, the association between arterial hyperoxia and outcomes is unclear. We performed a systematic review and meta-analysis to determine the association between arterial Po2 (Pao2) and mortality in patients with ECMO.

METHODS:

The meta-analysis followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 statement and registered in International Prospective Register of Systematic Reviews (PROSPERO; CRD42023467361). We systematically searched PubMed and Embase databases up to September 2023 for randomized trials or observational studies that investigated the association between Pao2 and mortality in pediatric and adult patients receiving venovenous ECMO (VV-ECMO), venoarterial ECMO (VA-ECMO), and extracorporeal cardiopulmonary resuscitation (ECPR). The predefined outcome was 28-day mortality. We synthesized the data using a random-effects model, calculating odds ratios (OR) and corresponding 95% confidence intervals (CI).

RESULTS:

Thirteen cohort studies (17,766 participants) were included. All studies used categorical Pao2 cutoff, with varying thresholds ranging from ≥100 mm Hg to ≥300 mm Hg. When compared with patients with normoxia, elevated Pao2 levels at all studied thresholds were consistently associated with increased mortality (≥300 mm Hg: OR 1.56, 95% CI, 1.31–1.85, P < .01; ≥200 mm Hg: OR 1.43, 95% CI, 1.10–1.87, P < .01; ≥150 mm Hg: OR 1.51, 95% CI, 1.15–1.98, P < .01; and ≥100 mm Hg: OR 1.44, 95% CI, 1.03–2.02, P = .03). A sensitivity analysis focusing on studies reporting adjusted OR yielded similar results. We observed this association in both adult and pediatric populations.

CONCLUSIONS:

In critically ill patients on VV- or VA-ECMO, increased Pao2 values were associated with increased 28-day mortality in ECMO patients. Our results should be interpreted with caution given observational nature of included studies. Further randomized trials are warranted to validate these results.

Erythrocytes and Platelets Autotransfusion in High Hemorrhagic Risk Cardiac Surgery

AUTHORS: Aouifi, Abdellah MD et al 

Anesthesia & Analgesia December 2024.

Intraoperative cell salvage (IOCS) allows the collection, treatment, and retransfusion of shed blood from the surgical field and cardiopulmonary bypass (CPB) collector during cardiac surgery. This technique has been shown to reduce the need for allogeneic blood products in many surgical specialties.

Centrifugation-based IOCS devices enable red blood cell (RBC) reinfusion, whereas platelets and other coagulation factors are largely eliminated during processing. Although this technique permits reducing RBC transfusion exposure, it does not reduce the need for allogeneic platelet transfusion.

Knowing the role of platelets in surgical bleeding and considering the risks associated with platelet transfusion the SAME device (i-SEP) was developed to save and wash both RBC and platelets with a recovery rate of 86.1% and 52.4%, respectively. The SAME device was developed based on a noncentrifugal recovery of cells from shedded blood, using membrane filtration technology. This technique preserves a higher number of platelets and avoids cell alteration due to centrifugation process.

The SAME Erythrocytes and Platelets Innovative Autotransfusion (SEPIA) registry was created to compare routine cell-salvage solutions with the same device in patients undergoing hemorrhagic surgeries throughout France. Herein we report our pilot experience from the first institution enrolling patients in the SEPIA registry.

METHODS

From January to June 2023, we prospectively gathered data from 104 patients who underwent cardiac surgical procedures with high-bleeding risk at the Infirmerie Protestante (Lyon). 52 were treated with a new filtration-based IOCS device (SAME, i-SEP), and 52 with a standard IOCS device (Xtra, LivaNova). Patients were included in the SEPIA registry, a postmarketing clinical registry gathering data from the IOCS devices (laboratory on reinfusion bags), in addition to allogeneic transfusion data, laboratory results, postoperative follow-up data, and adverse events. Sepia was registered in the French Health Data Hub and was considered nonhuman-subject research, as it requires no patient-impacting procedures. All patients consented to data collection after being informed.

The decision for which device to use was solely based on the availability of the respective devices. Perioperative management and transfusion guidelines did not differ between the 2 devices, and a standardized transfusion algorithm based on TEG (Haemonetics) was used.

Statistical Analysis

Data are expressed as means ± standard deviation (SD), or numbers and percentages (%). Continuous outcomes were compared with unpaired Student t test or Mann-Whitney U test. The alpha risk was set at 5%. Statistical analysis was performed with EasyMedStat (version 3.35).

RESULTS

Demographics, surgical characteristics, and autotransfusion data are reported in the Table. The nature of surgeries, procedures, and CPB durations were comparable between both groups. Almost all patients were treated with Tranexamic Acid (SAME: 96% vs Xtra: 100%). Although the treated blood volumes were lower in the same group, these patients had higher reinfused blood volumes compared to the Xtra group. Lower hematocrits were found in the SAME group. However, the SAME treated bags contained 4 times higher platelet content than the Xtra bags.

Table. – Preliminary Data on SEPIA Registry: Population Characteristics, Cell-Salvage Processing Performances, and Quality Control Results on Reinfusion Bags

Parameters Xtra
(n = 52)
SAME
(n = 52)
Sex [female, n (%)] 10 (19%) 19 (37%)
Age (yr) 68 ± 9 66 ± 12
Height (cm) 173 ± 9 171 ± 10
Weight (kg) 83 ± 17 80 ± 17
BMI 27.9 ± 5.4 27.4 ± 5.9
Surgery characteristics
 Isolated CABG 7 6
 Single non-CABG 7 16
 Combined procedures 38 30
 Aortic procedures 19 21
 Procedure duration (incision-closing, min) 151 ± 45 157 ± 39
 Cardiopulmonary bypass time (min) 100 ± 33 98 ± 33
 Aortic cross clamping time (min) 77 ± 28 73 ± 25
Autotransfusion
 Number of cycles (n) 3.2 ± 1.0 4.2 ± 2.0**
 Treated blood volume (mL) 2704 ± 804 2069 ± 831***
 Returned blood volume (mL) 685 ± 244 794 ± 353*
 Returned blood hematocrit (%) 57.1 ± 6.5 40.7 ± 3.3***
Quality control on reinfusion bags
 Number of analyzed bags 24 27
 Hemoglobin (g/dL) 18.4 ± 2.8 15.3 ± 1.6***
 Red blood cells concentration (106/mcl) 6.2 ± 0.9 5.0 ± 0.7***
 Platelet concentration (103/mcl) 35 ± 31 139 ± 360***
 Leukocyte concentration (103/mcl) 11 ± 6 12 ± 5
Data are presented as means ± standard deviations unless otherwise indicated.Abbreviations: CABG, coronary artery bypass graft; SEPIA: SAME Erythrocytes and Platelets Innovative Autotransfusion.
When statistically significant between groups:
*P <.05,
**P < .01,
***P < .001.

Hemoglobin levels were comparable between both groups (Figure A), whereas patients’ platelet counts tended to be higher in the SAME group, especially at the end of surgery and during the first 2 postoperative days (Figure B), without reaching significance.

F1
Figure.: 

Evolution of hemoglobin (A) and platelet (B) concentrations in patients (excluding patients’ data after allogeneic RBC or platelet transfusion) and number of transfused patients (C) and products (D) over their hospital stay with both autotransfusion devices (mean ± standard deviation).

Patients treated with SAME were exposed to allogeneic platelet transfusion, plasma, and RBC (Figure C) less frequently. Additionally, a smaller quantity of allogeneic blood products was used in SAME group compared to Xtra group (Figure D).

Fibrinogen concentrate was administered per-operatively in 4 patients in each group and was less frequently used postoperatively in SAME group than Xtra group (respectively in 7 (13%) and 11 (21%) patients). Patients received no prothrombin complex concentrates nor recombinant activated factor VII.

Postoperative drainage cumulated more volume in Xtra group than SAME group, respectively at 12, 24, and 48 hours postoperative: 541 ± 354, 718 ± 388, 904 ± 470 mL vs 424 ± 225, 613 ± 296, and 790 ± 398 mL.

DISCUSSION

Our pilot analysis of the SEPIA registry suggests improved hemostasis in the patients treated with SAME, both on single parameters such as allogeneic transfusions, and on a multistaged definition for perioperative bleeding (UDPB). Comparing these data with previously published analyses our study confirms the performance of the SAME device on hematocrit, RBC, platelets, and leukocyte salvage.

In highly hemorrhagic approaches, blood salvage has always been a major concern. Even if the cell saver devices allow salvage of RBCs, platelets are nearly completely lost due to the centrifugation-based recovery process. In dealing with a novel technology, we faced some issues in our early experience. The initial software was not intuitive and only a few nurses could manage the device. We also faced massive clotting in the reservoir with 1 patient due to an intentional pause of the recycling process for about 10 minutes. This experience helped to modify the software by introducing an alarm after 3 minutes of pause in the filtration cycle, avoiding any recurrence of accidental clotting. Finally, if the cycle of cell recovery is longer when compared to a cell saver (7–10 minutes for the SAME device vs 5min for the cell saver), a fast reinfusion is possible and already possible within the software in case of an immediate need for massive volume reinfusion.

Concerning low hematocrit levels in the SAME device, its reinfusion bags provided higher volume along with lower hemoglobin concentrations due to the device’s cell salvaging process, but the overall amount of reinfused hemoglobin was comparable between the 2 groups, whereas platelet concentrations were higher for the SAME device.

Although postoperative levels of hemoglobin and platelets were not significantly different between groups, the SAME device allowed for lower exposure to allogeneic blood products, and a notably lower number of allogeneic platelet transfusions.

These results encourage further data collection and they may be used to estimate the number of patients to be included in the multicentric SEPIA registry to demonstrate the advantage of SAME in terms of reducing platelet transfusions and improving hemostasis in patients undergoing high-bleeding-risk cardiac surgery while confirming the safety of SAME across a large number of institutions.