| Literature DB >> 36071754 |
Eric Lim1, Jean-Marc Baste2, Michael Shackcloth3.
Abstract
Background: Reinforced staple lines are less susceptible to leaks or bleeding and may consequently reduce morbidity and complications during or after surgery. However, their safety and benefits as well as the best form of reinforcement are still under debate. This study evaluates the safety of a stapler with pre-attached buttressing material based on adverse events (AEs) in thoracic surgery.Entities:
Keywords: Surgical stapler; adverse events (AEs); prospective studies; staple line reinforcement; thoracic surgery
Year: 2022 PMID: 36071754 PMCID: PMC9442509 DOI: 10.21037/jtd-22-220
Source DB: PubMed Journal: J Thorac Dis ISSN: 2072-1439 Impact factor: 3.005
Figure 1Endo GIA™ Tri-Staple™ technology with Reinforced Reload (Medtronic) with preloaded buttress material (Used with the permission of Medtronic).
Baseline demographics
| Parameter | Overall (n=40) |
|---|---|
| Age, mean ± SD, years | 65±10 |
| Female, n (%) | 20 (50.0) |
| FEV1, mean ± SD, % | 82±20 |
| BMI, mean ± SD | 27.9±5.9 |
| ASA class, n (%) | |
| Class 1 | 2 (5.0) |
| Class 2 | 15 (37.5) |
| Class 3 | 20 (50.0) |
| Unknown | 3 (7.5) |
| Tobacco use, n (%) | |
| Current smoker | 11 (27.5) |
| Former smoker | 20 (50.0) |
| Non-smoker | 9 (22.5) |
| Duration smoking†, years, median [IQR] | 43 [29–52] |
| Duration since patient stopped smoking‡, years, median [IQR] | 7 [1–10] |
| Co-morbidities, n (%) | 38 (95.0) |
| Cardiovascular | 5 (12.5) |
| Diabetes mellitus type II | 3 (7.5) |
| Gastrointestinal | 5 (12.5) |
| Hypertension | 15 (37.5) |
| Musculoskeletal | 4 (10.0) |
| Renal | 1 (2.5) |
| Respiratory (lung) | 26 (65.0) |
| Respiratory (other) | 2 (5.0) |
| Other | 22 (55.0) |
†, duration of smoking only applies to former and current smokers for whom starting age and/or quitting age were available; ‡, duration since patient stopped smoking only applies to former smokers for whom quitting age was available. SD, standard deviation; FEV1, forced expiratory volume in 1 second; BMI, body mass index; ASA, American Society of Anesthesiologists; IQR, interquartile range.
Perioperative data
| Parameter | Unimpaired lung function (n=33) | Impaired lung function (n=7) | Overall (n=40) |
|---|---|---|---|
| Procedure, n (%) | |||
| Lobectomy | 19 (57.6) | 3 (42.9) | 22 (55.0) |
| Wedge resection | 7 (21.2) | 3 (42.9) | 10 (25.0) |
| Combined lobectomy and wedge resection | 2 (6.1) | 1 (14.3) | 3 (7.5) |
| Other† | 5 (15.2) | 0 (0.0) | 5 (12.5) |
| Operative time, median [IQR], minutes | 165 [105–190] | 155 [85–171] | 158 [100–184] |
| ICU stay, n (%) | 13 (39.4) | 3 (42.9) | 16 (40.0) |
| SSI class, n (%) | |||
| Class I‡ | 33 (100.0) | 7 (100.0) | 40 (100.0) |
| Hemostasis (intraoperative) | |||
| Total EBL, median [IQR], mL | 50 [0–225] | 20 [0–330] | 40 [0–212] |
| Total EBL ≥50 mL, n (%) | 17 (51.5) | 3 (42.9) | 20 (50.0) |
| EBL ≥50 mL at staple line, n (%) | 1 (3.0) | 0 (0.0) | 1 (2.5) |
| Bleeding with staple line intervention, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Transfusion required, n (%) | 2 (6.1) | 0 (0.0) | 2 (5.0) |
| Leak, n (%) | |||
| Leak test performed | 26 (78.8) | 7 (100.0) | 33 (82.5) |
| Leak detected | 3/26 (11.5) | 0 (0.0) | 3 (9.1) |
| Leak addressed before closure | 2/3 (66.7) | n/a | 2/3 (66.7) |
| Staple line, n (%) | |||
| Staple line visualized | 32 (97.0) | 7 (100.0) | 39 (97.5) |
| Buttress visualized in place | 33 (100.0) | 7 (100.0) | 40 (100.0) |
| Any bleeding observed at staple line | 2 (6.1) | 0 (0.0) | 2 (5.0) |
| Perioperative intervention§ | 5 (15.2) | 0 (0.0) | 5 (12.5) |
| Pre-discharge reintervention¶ | 2 (6.1) | 0 (0.0) | 2 (5.0) |
†, other procedures include combined pleural biopsy and wedge resection, combined lobectomy and lymphadenectomy, VATS biopsy, resection of posterior mediastinal mass, and lobectomy that was converted to thoracotomy; ‡, class I surgical site infections are defined as clean wounds (non-traumatic wound, noninflamed, no break in technique, no entry of the infection into the gastrointestinal, genitourinary or respiratory tract or oropharynx); §, perioperative interventions include pressure to resolve a minor staple line bleeding, a drain for a leak, a resection of additional lung tissue to release a reinforced reload that got stuck and could no longer be opened (the only device-related adverse event), and two other interventions to address a leak and a bleed that occurred away from the buttressed staple line; ¶, pre-discharge reinterventions were the insertion of a drain to address the air leak that developed postoperatively and the exchange of the drain type. IQR, interquartile range; ICU, intensive care unit; SSI, surgical site infection; EBL, estimated blood loss; VATS, video-assisted thoracoscopic surgery.
Postoperative outcomes
| Parameter | Unimpaired lung function (n=33) | Impaired lung function (n=6) | Overall (n=39) |
|---|---|---|---|
| Length of stay, median [IQR], days | 4 [2–6] | 6 [3–7] | 4 [2–6] |
| Total postoperative EBL, median [IQR], mL | 50 [0–120] | 60 [45–125] | 50 [0–135] |
| Postoperative EBL ≥50 mL, n (%) | 17 (51.5) | 4 (66.7) | 21 (53.8) |
| Postoperative leak†, n (%) | 3 (9.1) | 0 (0.0) | 3 (7.7) |
| Drain | |||
| Drain used, n (%) | 31 (94%) | 6 (100.0) | 37 (94.9) |
| Volume, median [IQR], mL | 400 [100–1,013] | 400 [244–631] | 400 [100–935] |
| Duration, median [IQR], days | 3 [1–4] | 3 [1–5] | 3 [1–4] |
| Readmission (any)‡, n (%) | 3 (9.1) | 0 (0.0) | 3 (7.7) |
†, duration of postoperative leaks were 4, 5 and 14 days. Only the leak lasting 14 days was considered a prolonged air leak (i.e., lasting >7 days); ‡, reasons for readmission were mild (infection, n=1) or moderate (swelling n=1, pain n=1). IQR, interquartile range; EBL, estimated blood loss.
Safety data
| Parameter | Open | VATS | Overall |
|---|---|---|---|
| AEs, n | 1 | 33 | 34 |
| Classification, n (%) | |||
| Mild† | 1/1 (100) | 20/33 (61) | 21/34 (62) |
| Moderate‡ | NA | 13/33 (39) | 13/34 (38) |
| Timing, n (%) | |||
| In hospital | NA | 25/33 (76) | 25/34 (74) |
| Post-discharge | 1/1 (100) | 8/33 (24) | 9/34 (26) |
| Procedure-related, n (%) | 1/1 (100) | 19/33 (58) | 20/34 (59) |
| Possible device involvement, n (%) | 0/1 (0) | 1/33 (3) | 1/34 (3) |
| Related to bleeding, n (%) | 0/1 (0) | 4/33 (12) | 4/34 (12) |
| Related to leaks, n (%) | 0/1 (0) | 3/33 (9) | 3/34 (9) |
| Related to infection, n (%) | 1/1 (100) | 4/33 (12) | 5/34 (15) |
| AEs by patient, n (%) | |||
| Any AE | 1/9 (11) | 16/31 (52) | 17/40 (43) |
| More than 1 AE | 0/9 (0) | 8/31 (26) | 8/40 (20) |
| AE in hospital | 0/9 (0) | 12/31 (39) | 12/40 (30) |
| AE post-discharge§ | 1/9 (11) | 5/30 (17) | 6/39 (15) |
| Death | 0/9 (0) | 0/31 (0) | 0/40 (0) |
†, awareness of event, but easily tolerated; ‡, discomfort enough to cause some interference with activities of daily living; §, note post-discharge total number of patients is decreased due to loss of one patient to follow-up. VATS, video-assisted thoracoscopic surgery; AE, adverse event.