AirSeal^® iFS: Insufflation Backed by Clinical Data

Authors: M Grieco, F Tirelli, et al.

Focus of Study: TaTME

Publication Type: Consecutive, Retrospective

Key Takeaways:

The low pressure group showed:

• Decreased occurrence of post-op ileus
• Shorter time to solid oral feeding

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Authors: A Akingboye, M Hamid, et al.

Focus of Study: Lap Colorectal Surgery

Publication Type: Prospective

Key Takeaways:
AirSeal at 8mmHg group experienced:

• Improved intraoperative lung compliance and peak inspiratory pressures
• Decreased post-op pain over 5 days both at rest and on exertion
• Low IAP was associated with an earlier time to pass flatus post-op

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Authors: Q Denost, S Celarier, et al.

Focus of Study: Lap & Robotic Colectomy

Publication Type: Prospective, Randomized

Key Takeaways:

AirSeal at 7mmHg group experienced:

• Reduced LOS (1 day)
• Lower post-operative pain scores /li>
• Improved post-operative patient mobilization (sitting and walking)

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Authors: V Obias, J Paull, et al.

Focus of Study: Robotic LAR and Right Hemicolectomy

Publication Type: Retrospective

Key Takeaways:

AirSeal group showed:

• Significantly shorter (20.8%) Low Anterior Resection procedure times (232 min vs. 293 min)
• Significantly lower EBL (28.2%) in Low Anterior Resection procedures (150cc vs. 209cc)

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Authors: B Ramshaw, B Forman, et al.

Focus of Study: Lap Ventral Hernia

Publication Type: CQI

Key Takeaways:

• Patients in AirSeal + Exparel group had a shorter length of stay in hospital
• Procedures in AirSeal + Exparel group were 25% shorter in duration (101 minutes vs. 135 minutes)

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Authors: B Ramshaw, V Vetrano, et al.

Focus of Study: Lap Inguinal Hernia

Publication Type: CQI

Key Takeaways:

Patients in the group with AirSeal at low pressure and Exparel:

• Were 7.81 times more likely to be discharged on the day of surgery
• Were 80.5% less likely to develop a new type of groin pain after surgery

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Authors: N de'Angelis, F Brunetti, et al.

Focus of Study: Lap Cholecystectomy

Publication Type: Consecutive, Prospective

Key Takeaways:

• Low stable pneumoperitoneum pressure with AirSeal in sickle cell disease (SCD) patients is associated with a significantly reduced incidence of post-operative SCD-related morbidity
• AirSeal allowed for rapid ambulation/return to regular diet without increasing the total cost per patient

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Authors: D Telem, R Kikhia, et al.

Focus of Study: Lap Cholecystectomy

Publication Type: CQI

Key Takeaways:

• Patients in the AirSeal group had a LOS that was 34.7% shorter (19.6 vs 30 hours) than patients in the SI group

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Authors: B Needleman, J Rydlewicz, et al.

Focus of Study: Roux-en-Y (Gastric Bypass)

Publication Type: Retrospective, Randomized

Key Takeaways:

The AirSeal group:

• Saved 12.3 minutes on average, which saves about $345 per case on OR time
• Had a mean EBL of 34.6cc compared to the VersaStep group which had a mean EBL of 45cc

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Authors: W Richards, P Saway, et al.

Focus of Study: Lap General and Bariatric Surgery

Publication Type: Consecutive, Prospective

Key Takeaways:

The AirSeal group showed:

• Trends toward lower pain scores at discharge or 24 hours
• Statistically lower PIP (peak inspiratory pressure)
• Statistically lower etCO₂

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Authors: J Huang, C Foley, et al.

Focus of Study: Robotic Gynecology

Publication Type: Prospective, Consecutive

Key Takeaways:

• Each reduction in intraabdominal pressure corresponded to a significant decrease in initial pain scores and LOS
• Patients in the AirSeal 8 & 10mmHg groups had significantly shorter lengths of stay compared to the high-pressure groups (12 & 15mmHg)
• Each reduction in intraabdominal pressure corresponded to a significant decrease in Peak Inspiratory Pressures (PIP)
• Each reduction in intraabdominal pressure corresponded to a significant decrease in Tidal Volume (TV)

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Authors: J-L Benifla, J Sroussi, et al.

Focus of Study: Lap Gynecology

Publication Type: Prospective, Randomized

Key Takeaways:

Patients in the AirSeal group:

• Experienced both a lower incidence and severity of post-operative pain
• Had lower maximal peak airway pressure
• Had lower maximal etCO₂
• Had a lower maximal systolic blood pressure
• Twice as many patients in the AirSeal group were discharged on the day of surgery (46.7% vs. 23.3%)

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Authors: A Buda, G Di Martino, et al.

Focus of Study: Laparoscopic Hysterectomy, BSO, Sentinel Node Biopsy

Publication Type: Multicenter, Retrospective

Key Takeaways:

AirSeal patients showed:

• Lower incidence of post-operative shoulder pain
• Lower severity of global pain at 4, 8, and 24 hours/li>
• Significantly lower etCO₂
• Significantly lower Peak Airway Pressure
• Significantly lower systolic blood pressure
• Significantly faster recovery
• 98% of patients were discharged within 2 days vs. 75% of patients in the standard group

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Authors: I Boualaoui, E Bey, et al.

Focus of Study: Lap/Robotic Sacrocolpopexy

Publication Type: Retrospective, Single-center

Key Takeaways:

The AirSeal group showed:

• 1. A statistically significant difference in the mean operating time (110 minutes in the AirSeal group vs. 121 minutes in the Standard Insufflation group)
• Trend towards shorter LOS
• Trend towards lower post-op pain

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Authors: G Miyano, K Morita, et al.

Focus of Study: Laparoscopic Toupet Fundoplication

Publication Type: Single Subject Case Study

Key Takeaways:

• With the AirSeal iFS, there was no disruptive loss of pneumoperitoneum, which saves time and allows the operator to focus without distraction
• The AirSeal iFS contributed to the successful completion of LTF in a 1.8kg infant

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Authors: S Siddiqui, M Faizan, et al.

Focus of Study: Partial Nephrectomy

Publication Type: Systematic review, Meta-analysis

Key Takeaways:

• AirSeal significantly lowers etCO₂ in patients undergoing LPN, which can therefore impact recovery and complication rates

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Authors: M Covotta, C Claroni, et al.

Focus of Study: Robotic Cystectomy

Publication Type: Prospective, Parallel

Key Takeaways:

Patients in the AirSeal group showed:

• Lower inspiratory plateau pressure (Pplat)
• Lower minute volume (MV)
• Lower etCO₂
• Significantly higher static compliance (Cstat)

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Authors: W Zhi, Y Wang, et al.

Focus of Study: Robot-Assisted Radical Prostatectomy

Publication Type: Meta-analysis

Key Takeaways:

• AirSeal results in shorter operative time, reduced hospital stays, and fewer major complications

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Authors: N Vasdev, N Martin, et al.

Focus of Study: Robot-Assisted Radical Cystectomy

Publication Type: Prospective, Consecutive

Key Takeaways:

The 12mmHg AirSeal group:

• Had a 40 min shorter operative time and 1-day shorter LOS than the 15mmHg group
• Had fewer patients with ileus (10% vs. 30%) compared to the 15mmHg group
• Passed flatus 1 day earlier and stooled 1.5 days earlier than 15mmHg group
• The study found that patients in the 15mmHg AirSeal group had a higher risk of paralytic ileus post robotic cystectomy and robotic intracorporeal urinary diversion

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Authors: G Fan, Y Chen, et al.

Focus of Study: Robotic Partial Nephrectomy

Publication Type: Systematic, Meta-analysis

Key Takeaways:

AirSeal group showed:

• Significantly lower rates of subcutaneous emphysema
• 12hr post-op pain scores significantly lower

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Authors: W Xu, M Wei, et al.

Focus of Study: Robotic Partial Nephrectomy

Publication Type: Randomized Controlled Trial

Key Takeaways:

AirSeal group showed:

• Significantly lower subcutaneous emphysema rate than the conventional group
• Significantly lower etCO₂, PaCO₂ at the end of the operation, lower tidal volumes and frequency of scope cleaning
• Significantly lower post-op pain scores at 8hr, 12hr, and at time of discharge

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Authors: F Forte, S Sorrenti, et al.

Focus of Study: Lap Partial Nephrectomy

Publication Type: Retrospective

Key Takeaways:

AirSeal group showed:
• Lower operative time (107.5 min in AirSeal group vs. 120 min in SI group)
• Lower complication rates
• Decreased perioperative blood loss (1.45g/dL vs 2.2g/dL)
• Reduced warm ischemia time (18 min vs. 20 min)

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Authors: J Landman, P Bucur, et al.

Focus of Study: Lap Renal & Peri-Renal Surgery

Publication Type: Prospective, Randomized

Key Takeaways:

Patients in the AirSeal group:

• Had a pneumoperitoneum that was far more stable or less variable than patients in the Standard Insufflation group
• Had a lower etC0₂ after 10 minutes of insufflation than patients in the SI group

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Authors: B Desroches, J Porter, et al.

Focus of Study: Robotic Partial Nephrectomy

Publication Type: Prospective, Randomized, Multicenter

Key Takeaways:

• Patients in the 12mmHg AirSeal group developed SCE less often than patients in both the AirSeal 15mmHg and SI 15mmHg groups
• There was no difference in SCE rates between patients in AirSeal 15mmHg and SI 15mmHg groups
• Peak airway pressure was lower in both AirSeal groups VS. SI group
• etCO₂ was lower in the AirSeal 12mmHg group than both the AirSeal 15mmHg and SI 15mmHg groups

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Authors: T Feng, J Porter, et al.

Focus of Study: Partial Nephrectomy

Publication Type: Prospective, Randomized, Controlled trial

Key Takeaways:

• AirSeal insufflation at 12mmHg was associated with a reduced risk of developing subcutaneous emphysema
• Pain was decreased in both AirSeal groups compared to standard insufflation

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Authors: R Abaza, M Ferroni

Focus of Study: Robotic Prostatectomy

Publication Type: Prospective, Consecutive

Key Takeaways:

The 6mmHg group showed:

• Patients had lower max pain scores between 5 and 12 hours
• Fewer overall complications
• The mean LOS was shorter (0.57 vs 1 day)
• 43.3% of patients were discharged on the day of surgery
• Fewer patients returned to the ER within 30 days
• Fewer patients were readmitted within 30 days

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Authors: M Yezdani, S Yu, et al.

Focus of Study: Robotic Prostatectomy

Publication Type: Single-site, Perspective

Key Takeaways:

AirSeal group showed:
• Significantly less operative time (146min vs. 167min)
• Reduction in intraoperative blood loss (132ml vs. 215ml)
• Pain scores at 6-12 hours post-op were significantly lower (3.3 vs. 4.1) than the SI group

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Authors: D Lee, Mohammed S, et al.

Focus of Study: Robotic Prostatectomy

Publication Type: Consecutive, Prospective

Key Takeaways:

• Procedures in AirSeal group were 12.6% shorter in duration
• Patients in AirSeal group had fewer episodes of nausea (2% vs 10%)
• Trend toward less pain in the AirSeal group within the first 24 hours after surgery

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Authors: A Mottrie, G Vandenbroucke, et al.

Focus of Study: Robot-assisted Radical Prostatectomy (RARP)

Publication Type: Prospective, single center

Key Takeaways:

• Central venous pressure and mean airway pressure showed improvements when AirSeal was used

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Authors: Y Lu, Q Zou, et al.

Focus of Study: Minimally Invasive Urological Surgery

Publication Type: Meta-analysis

Key Takeaways:

AirSeal resulted in:

• Significantly lower Clavien-Dindo III-IV complications
• Significantly reduced general and shoulder pain at 12-24h post-op
• Reduced LOS

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Authors: R Abaza, M Ferroni

Focus of Study: Robotic Prostatectomy

Publication Type: Randomized, Double-blinded, Controlled trial

Key Takeaways:

The 6mmHg group showed:

• Significantly lower post-op pain scores
• Improved ventilation - reduced etCO₂ & PIP, reduced MAP

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Authors: M Rohloff, T Maatman, et al.

Focus of Study: Robotic Prostatectomy

Publication Type: Prospective, randomized, Double blinded trial

Key Takeaways:

Patients in the AirSeal at 12mmHg group:

• Had a significantly shorter LOS
• Showed lower occurrence of post-operative ileus (decreased from 12% to 5%)

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Authors: F Annino, L Topazio, et al.

Focus of Study: Robotic Partial Nephrectomy

Publication Type: Prospective, Consecutive

Key Takeaways:

The AirSeal group showed:

• Procedures were 10.8% shorter in duration
• Warm ischemia time was 38.9% shorter
• A significant increase in the number of cases performed as “zero ischemia” (clampless) was observed in the AirSeal group (20 vs 4 cases)

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Authors: R Abaza, O Martinez, et al.

Focus of Study: Robotic Prostatectomy

Publication Type: Consecutive, Retrospective

Key Takeaways:

• Patient charges were significantly lower for patients that were discharged on the day of surgery with no increase in readmissions or emergency visits

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Authors: A El-Hajj, C Ayoub, et al.

Focus of Study: Robotic Prostatectomy

Publication Type: Single-tertiary center study

Key Takeaways:

AirSeal was associated with:

• Shorter operative times by 12.3 minutes
• Shorter length of hospital stay by 0.5 days
• Lower odds of Clavien-Dindo complications

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Authors: K Bedani, S Razdan, et al.

Focus of Study: Robotic Urologic Surgery

Publication Type: Meta-analysis

Key Takeaways:

The AirSeal group showed:

• Lower inspiratory plateau pressure, lower minute volume, lower ETCO₂, lower CO₂ elimination rate, higher static compliance
• Improved cardiopulmonary parameters
• Some studies showed decreased complication rates at low pressure

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Authors: L Kavoussi, R Wimhofer, et al.

Focus of Study: Robotic Prostatectomy

Publication Type: Single-site, Retrospective

Key Takeaways:

• Mean operative time decreased by 23.2 min in AirSeal group vs. SI group

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Authors: H Katoh, Y Ikeda, et al.

Focus of Study: Total Endoscopic Hemithyroidectomy

Publication Type: Retrospective

Key Takeaways:

• The AirSeal system significantly reduced the frequency of scope cleaning (p=0.016)
• Time to disappearance of SCE around surgical cavity was significantly shorter in the AirSeal group (p=0.019)
• When suctioning mist/smokes produced by an energy device, AirSeal prevented narrowing working space and greatly contributed to wide and clear visibility

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