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Benefits, Costs of Robotic Diaphragmatic Hernia Repair Weighed
By ETHAN COVEY
Arecently published study has found that the costs associated with robotic diaphragmatic hernia repair may outweigh any potential clinical benefits compared with laparoscopic surgery.
The findings add interesting context to ongoing discussions about the increased role of technology in surgical procedures (J Am Coll Surg 2021;233[1]:9-19.e2).
“We set out to study robotic and laparoscopic approaches to diaphragmatic hernia repair [DHR] with the hypothesis that there would be a benefit within the first year postoperatively, related to the improved visualization and dexterity the robot provides,” said lead author Sujay Kulshrestha, MD, a surgeon at Loyola University Medical Center, in Maywood, Ill.
The retrospective analysis included information from 2011 to 2018 on patients who underwent transabdominal DHR, and associated inpatient and outpatient encounters within 12 months after the operation. Data were gathered from the Healthcare Cost and Utilization Project State Inpatient and State Ambulatory Surgery and Services Databases for Florida.
Of 8,858 identified patients who underwent DHR surgery, 67.3% were treated by laparoscopic DHR, 17.2% by open DHR, and 15.5% by robotic-assisted DHR. The overall rate of robotic DHR increased from 5% in 2011 to 26.4% in 2018.
Generally, patients who underwent open procedures were older, more likely to be male, had higher comorbidity scores, and were more likely to have Medicare or Medicaid insurance than those who underwent laparoscopic or robotic DHR.
The researchers found that of the three surgical approaches, open procedures were associated with the worst outcomes. Recipients of open DHR had a longer index hospital length of stay and were less likely to be discharged home than those undergoing laparoscopic or robotic DHR.
However, when compared with laparoscopic surgery, robotic DHR did not fare well.
The median length of stay for patients treated by robotic DHR was longer than for those undergoing laparoscopic DHR, and robotic DHR was associated with the highest overall index hospitalization costs. Upon matched analysis, there were no differences in the overall rate of post-index hospital-based encounters between surgical approaches.
“Our results did not identify a tangible clinical or financial benefit that outweighed robotic DHR’s up-front costs,” Dr. Kulshrestha said. “This points to the possible need to expand the follow-up period for research to better understand global effects of these operations—a lot of the complications we identified were beyond the first 90 days after the index operation.”
Shanu N. Kothari, MD, the vice chair of medical staff affairs at the USC School of Medicine in Greenville, S.C., also pointed to the need for longer-term data. “The follow-up was one year, so truly long-term follow-up data remains to be determined.”
Dr. Kulshrestha concurred. “In terms of future directions, similar studies with extended follow-up could help identify late postoperative complications, or provide an understanding of what operations are clinically beneficial and cost-effective for prioritizing limited time at a robotic console.”
Dr. Kothari also noted that the currently high costs of robotic DHR will likely decrease, potentially making the approach more affordable and leveling existing differences in pricing between institutions. “With a variety of robotic platforms in various iterations of development, I would presume that the charges related to robotic platforms will continue to go down with time,” he said.
Most concerning, according to Dr. Kothari, was the higher rate—17.2%—of patients who still underwent open DHR, and the fact that frequently they were the sickest individuals. “These are exactly the risk factors of patients who would benefit the most from a minimally invasive approach, whether it be laparoscopic or robotic,” he said. “The tendency, even in an urgent setting, to do open surgery ‘because it is faster and better for the patient’ is unfounded by studies including this one. These patients spend an extended time in the hospital, are more likely to go to an extended care facility, and in this analysis, the charges were equivalent to the use of a robotic platform.”
Dr. Kothari added that the true impact of these various approaches over time is unknown, especially as reoperation rates in the study were very low. “The real question that remains unanswered is the following: What is the financial burden of symptomatic diaphragmatic hernias on health care expenditures and, what, if anything, can we as surgeons do to minimize recurrence rates?” he said. ■
—Shanu N. Kothari, MD
KCENTRA® (Prothrombin Complex Concentrate [Human]) For Intravenous Use, Lyophilized Powder for Reconstitution Initial U.S. Approval: 2013 BRIEF SUMMARY OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Kcentra safely and effectively. See full prescribing information for Kcentra.
WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS
Patients being treated with Vitamin K antagonists (VKA) therapy have underlying disease states that predispose them to thromboembolic events. Potential benefits of reversing VKA should be weighed against the potential risks of thromboembolic events, especially in patients with the history of a thromboembolic event. Resumption of anticoagulation should be carefully considered as soon as the risk of thromboembolic events outweighs the risk of acute bleeding. • Both fatal and non-fatal arterial and venous thromboembolic complications have been reported with Kcentra in clinical trials and post marketing surveillance. Monitor patients receiving Kcentra for signs and symptoms of thromboembolic events. • Kcentra was not studied in subjects who had a thromboembolic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the prior 3 months. Kcentra may not be suitable in patients with thromboembolic events in the prior 3 months.
------------------------------------INDICATIONS AND USAGE----------------------------------
Kcentra, Prothrombin Complex Concentrate (Human), is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with: • acute major bleeding or • need for an urgent surgery/invasive procedure.
-----------------------------DOSAGE AND ADMINISTRATION--------------------------------For intravenous use after reconstitution only.
• Kcentra dosing should be individualized based on the patient’s baseline International Normalized Ratio (INR) value, and body weight. • Administer Vitamin K concurrently to patients receiving Kcentra to maintain factor levels once the effects of Kcentra have diminished. • The safety and effectiveness of repeat dosing have not been established and it is not recommended. • Administer reconstituted Kcentra at a rate of 0.12 mL/kg/min (~3 units/kg/min) up to a maximum rate of 8.4 mL/min (~210 units/min).
Pre-treatment INR 2–< 4 4–6 > 6
Dose* of Kcentra (units† of Factor IX) / kg body weight 25 35 50
Maximum dose‡ (units of Factor IX) Not to exceed 2500 Not to exceed 3500 Not to exceed 5000
* Dosing is based on body weight. Dose based on actual potency is stated on the vial, which will vary from 20 31 Factor IX units/mL after reconstitution. The actual potency for 500 vial ranges from 400-620 units/vial. The actual potency for 1000 unit vial ranges from 800-1240 units/vial. † Units refer to International Units. ‡ Dose is based on body weight up to but not exceeding 100 kg. For patients weighing more than 100 kg, maximum dose should not be exceeded.
---------------------------------DOSAGE FORMS AND STRENGTHS--------------------------
• Kcentra is available as a white or slightly colored lyophilized concentrate in a single-use vial containing coagulation Factors II, VII, IX and X, and antithrombotic Proteins C and S.
--------------------------------------CONTRAINDICATIONS ------------------------------------
Kcentra is contraindicated in patients with: • Known anaphylactic or severe systemic reactions to Kcentra or any components in Kcentra including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin. • Disseminated intravascular coagulation. • Known heparin-induced thrombocytopenia. Kcentra contains heparin.
----------------------------------WARNINGS AND PRECAUTIONS----------------------------
• Hypersensitivity reactions may occur. If necessary, discontinue administration and institute appropriate treatment. • Arterial and venous thromboembolic complications have been reported in patients receiving Kcentra. Monitor patients receiving Kcentra for signs and symptoms of thromboembolic events. Kcentra was not studied in subjects who had a thrombotic or thromboembolic (TE) event within the prior 3 months. Kcentra may not be suitable in patients with thromboembolic events in the prior 3 months. • Kcentra is made from human blood and may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
-----------------------------------ADVERSE REACTIONS----------------------------------------
• The most common adverse reactions (ARs) (frequency 2.8%) observed in subjects receiving Kcentra were headache, nausea/vomiting, hypotension, and anemia. (6) • The most serious ARs were thromboembolic events including stroke, pulmonary embolism, and deep vein thrombosis.
