Evidence-Based Classification for Post-bariatric Weight Regain from a Benchmark Registry Cohort of 18,403 Patients and Comparison with Current Criteria.

INTRODUCTION: There is a need for a standardized, evidence-based classification of post-bariatric weight-regain, to investigate and compare revision procedures and to advice and treat patients in an evidence-based way. METHODS: We used standard deviations (SD) of the highest (1-2 years) and latest (> 2 years) percentage total weight loss (%TWL) results after primary bariatric surgery from the Dutch Audit for Treatment of Obesity (DATO) bariatric registry as benchmarks for (above) average (≥ - 1SD), poor (- 1SD to - 2SD) and insufficient (< - 2SD) weight loss. Weight regain maintaining (above) average weight loss was called grade 1, weight regain towards poor weight loss grade 2, towards insufficient weight loss grade 3, with subgrades 2a/3a for below average weight loss from the start, and 2b/3b for weight regain from (above) average to below average weight loss. Patient characteristics and diabetes improvement/impairment were compared. Sensitivity and specificity of 14 existing weight regain criteria were calculated. RESULTS: We analyzed 93,465 results from 38,830 patients (77.1% gastric bypass, 22.5% sleeve gastrectomy). The - 1SD thresholds for early and late weight loss approximated 25%TWL and 20%TWL, the - 2SD threshold for late weight loss 10%TWL. Weight regain could be analyzed for 18,403 patients (2.5-5.2 years follow-up). They regained mean 6.7 kg (5.4%TWL), with 66.8% grade 1 weight regain, 7.2% grade 2a, 7.4% grade 2b, 2.1% grade 3a, and 0.6% grade 3b. There were significant differences in comorbidities, gender, age, weight regain, diabetes impairment, and diabetes improvement across grades. Weight regain criteria from literature were extremely divers. None had high sensitivity. CONCLUSION: The DATO classification for post-bariatric weight regain combines the extent of weight regain with evidence-based endpoints of weight loss. It differentiated weight regain maintaining (above) average weight loss, two intermediate grades, gradual weight regain with below average weight loss from the start (primary non-response) and steep weight regain towards insufficient weight loss (secondary non-response). The classification is superior to existing criteria and well supported by evidence.

Long-term outcome of superficialis-to-profundus tendon transfer in patients with clenched fist due to spastic hemiplegia.

BACKGROUND: Spastic hemiplegia is a common feature after stroke, which can result in a clenched fist deformity with secondary hygienic problems and pain. Operative treatment can improve these problems, although literature about its long-term effects is lacking. PURPOSE: To determine whether Superficialis-to-Profundus tendon (StP-) transfer procedure leads to permanent improvement of hygiene and reduction of pain in patients with clenched fist due to spastic hemiplegia following stroke. METHOD: Patients who underwent a StP-transfer in 2003-2005 were evaluated on skin condition, upper extremity joint mobility, resting position and muscle tone and with VAS scores on hygiene maintenance and pain in the hand. RESULTS: Six patients (mean age 54 years; duration after stroke 10 years) were included. Indications to operate were hygienic problems only (3) or combined with pain (3). The average follow-up period was 19 months. After 6 weeks of post-operative splinting, no standard follow-up was applied. Serious post-operative complications were not reported. At follow-up no hygienic problems were present and pain was decreased in all except one patient. All hands could passively be fully opened. In resting position, flexion was seen in the MCP-joints (60-90 degrees). Muscle tone was raised in flexors of the wrist and fingers and m. adductor pollicis (Ashworth 1-2). Given the same pre- and post-operative circumstances, all patients would agree to have the surgery over again. CONCLUSION: Even 19 months after the StP-transfer for clenched fist, all operated hands could still be fully opened and there was a permanent improvement of hygiene and pain reduction.

Effect of vascular freezing on the histopathology of dissected small vessels in the rat: vascular freezing does induce intimal hyperplasia in arteries and veins.

Intimal hyperplasia is the primary response of a vessel wall after injury. It may be the single most significant factor affecting long-term patency. The purpose of this study was to find out whether freeze injury, inflicted on rat microvessels, would be followed by intimal hyperplasia. Toward this aim, we exposed the superficial femoral vessels in the rat. On one side they were frozen using liquid nitrogen spray. The other side was dissected as the control. Vessel segments, harvested immediately and after 1, 2, 3, and 5 months, were studied light microscopically for the occurrence and content of intimal hyperplasia. In the arteries a considerable intimal hyperplasia was found within a 4-week interval, persisting for at least 5 months, as a result of the freeze injury. In the veins, the intimal hyperplasia was much less marked but was nevertheless demonstrable. These findings are not in agreement with earlier studies, in which freezing of injured rat microarteries with liquid nitrogen spray was followed by complete regeneration of the vessel wall, without intimal hyperplasia taking place. The factors contributing to these differences are discussed. It is concluded that freezing of a vessel wall is followed by intimal hyperplasia, which is part of the normal healing process.

Microcirculatory changes following different temperature washouts in a free flap model.

In spite of the extensive experimental work on vascular washout in free flap surgery, an optimal temperature for the washout solution has not been established. This study was designed to determine the effect of the washout solution temperature on the degree to which the microcirculation is cleared of blood. The cremaster muscle flap in the rat was used, in which the microcirculation can be directly viewed and the presence of blood and perfusion parameters within various vessels can be measured during and after washout. Washout was started with a single, high-pressure infusion and continued at 130 mmHg for 15 minutes. The temperature of the washout solution was either 2-3, 20-22, or 35 degrees C. In all three groups, washout cleared the microcirculation almost completely within the first minute. However, we observed that a cold or room temperature washout cleared the microcirculation more completely than a warm washout did. The temperature of the washout solution did not effect post washout capillary perfusion and/or arterial diameters.

Do leukocytes contribute to impaired microvascular tissue perfusion after arterial repair?

Impaired capillary perfusion may result in flap failure. Platelet emboli, polymorphonuclear leukocytes (PMNs), and/or vasospasm have been identified as possible causes. This study investigates the role of PMNs in causing impaired capillary perfusion in a free flap model. PMN concentrations were depleted using antineutrophil serum. The cremaster muscles of 20 Sprague-Dawley rats were isolated on a single neurovascular pedicle and after a simulated technically poor arterial anastomosis upstream and reperfusion, capillary perfusion was measured each hour for 6 hours. Even though the number of PMNs was significantly reduced in the animals treated with antineutrophil serum, capillary perfusion was not changed compared with controls. These results demonstrate that depleting circulating PMNs does not protect capillary perfusion in our model. These findings suggest that reduced capillary perfusion downstream from an anastomotic repair is not mediated by the presence of PMNs in the microcirculation.

Lack of nitric oxide contributes to vasospasm during ischemia/reperfusion injury.

Vasospasm can be a complication after free tissue transfer and replant operations. Recent studies suggest that vasospasm may be due to endothelium dysfunction, resulting in impairment of nitric oxide production. The present experiment was designed to investigate acute responses of the microcirculation of skeletal muscle to local interarterial infusion of sodium nitroprusside (a direct donor of nitric oxide and thus an endothelium-independent vasodilator) or acetylcholine chloride (which stimulates endothelium release of endogenous nitric oxide) during reperfusion after 4 hours of warm ischemia. Male Sprague-Dawley rats, each weighing 100 to 120 gm, were anesthetized with sodium pentobarbitone and were surgically prepared with vascular isolated and denervated cremaster muscles that were subjected to 4 hours warm ischemia and 2 hours of reperfusion. Sodium nitroprusside (10(-3) M), acetylcholine chloride (10(-4) M), or normal saline (eight rats for each group) were administered by local infusion (0.1 ml/hour) through the femoral artery into the natural blood flow of the cremaster. The arterial tree in the cremaster was observed and arteriole diameters (A1-A4) were measured using intravital microscopy. The number of arteriole branches having temporary stoppage of flow were counted in each cremaster. The results from this study show that local infusion of sodium nitroprusside, but not acetylcholine chloride, prevents ischemia/reperfusion vasoconstriction in A3 and A4 arterioles and thus improves microvascular blood flow. Generalized vasoconstriction caused by topically applied norepinephrine (10(-6) M) to sham ischemia cremasters could be completely reversed by the local infusion of 10(-4) M acetylcholine chloride. These results indicate that vasospasm after ischemia/reperfusion may be related to temporary endothelial cell dysfunction, resulting in the inability to produce sufficient nitric oxide during early reperfusion. Vascular smooth muscle, however, is responsive to locally administered sodium nitroprusside infusion (which is thought to provide exogenous nitric oxide).

Effect of low dose aspirin on thrombus formation at arterial and venous microanastomoses and on the tissue microcirculation.

In free flap/replantation surgery, failure is usually associated with thrombotic occlusion of a microvascular anastomosis (risk zone I) or, on occasion, flow impairment in the microcirculation of the transferred or replanted tissue (risk zone II). The objective of this study is to describe the effect of low dose aspirin on blood flow at both risk zones in microvascular surgery. Risk zone I: In rat femoral arteries and veins, thrombus formation was measured at the anastomoses using transillumination and videomicroscopy. Forty male Wistar rats were assigned in equal numbers to four groups: either arterial or venous injury with either aspirin (5 mg/kg systemically) or saline treatment. We found that aspirin significantly reduces thrombus formation at the venous anastomosis (p = 0.001). Risk zone II: In the isolated rat cremaster muscle downstream from an arterial anastomosis, we measured capillary perfusion, arteriolar diameters, and the appearance of platelet emboli for 6 hours in the muscle microcirculation. Sixteen male Wistar rats in two equal groups received either aspirin (5 mg/kg systemically) or saline. We found that in aspirin-treated animals, capillary perfusion is significantly (p = 0.002) improved, whereas arteriolar diameters and emboli only slightly increased. In conclusion, low dose aspirin inhibits anastomotic venous thrombosis and improves microcirculatory perfusion in our rat model. These studies provide quantitative data confirming and clarifying the beneficial effects of low dose aspirin in microvascular surgery.

Anatomy of the feeding blood vessels of the cremaster muscle in the rat.

Since the early seventies over 300 studies have used the cremaster muscle as a flap model, yet little has been reported on the upstream feeding vessels of this muscle. The purpose of this study was to investigate the anatomy of the cranial feeding vessels of the left and right cremaster muscle in Sprague-Dawley rats. An additional aim was to compare these results with the anatomy of the feeding vessels of the cremaster muscle in another strain (Wistar). To permit identification of the cranial feeding vessels, the pedicle was dissected very carefully and thereafter perfused with green dye, which was administered through a cannula placed in the distal femoral artery. In Sprague-Dawley rats it was found that the cremaster muscle in only 30% of the animals received its total blood supply through the superior external pudendal artery. In Wistar rats the same was true in less than 45%. The cremaster muscle of the rest of the animals appeared to receive its blood either in part or in total from the hypogastric trunk. We suggest that the name pudic-epigastric trunk be abandoned.

Microsurgery without a microscope: laboratory evaluation of a three-dimensional on-screen microsurgery system.

In microvascular surgery, procedures may be both technically and physically demanding. Precise movements sustained over long hours in addition to typically compromised surgeon and assistant positioning lead quickly to physical and mental fatigue. Many of the positioning problems encountered are related to the fact that the eyes of the surgeon must be continually fixed to the microscope eyepieces. This study explores a possible solution: a microscope system that eliminates the need to view the operative field through the microscope eyepieces. A Three-dimensional On-screen Microsurgical System (TOMS) was used and contrasted with conventional operative microvascular surgery in the laboratory setting. The surgeon's comfort, his ability to instruct microsurgical technique, pertinent technological performance, and the procedure itself were evaluated using a standardized questionnaire. Based on data collected in this study, we conclude that divorcing the surgeon's eyes from the microscope eyepieces using the TOMS may make prolonged microvascular procedures less physically demanding and may increase the comfort level of both the surgeon and his assistant, although refinements to the technology are required.

Cold (0 degree C) ischaemic tolerance of latissimus dorsi free flaps in rats: a macroscopic and morphological study.

The purpose of this study was to define the cold (0 degree C) ischaemic tolerance (CIT) of the latissimus dorsi free flap in inbred rats. Flaps were isolated, stored at 0 degree C for periods of time ranging from 0 to 120 hr and then revascularised and reperfused for 14 days. Thereafter the CIT was assessed macroscopically, and by light microscopy. Electron microscopy was performed in flaps after 0 and 24 hr of reperfusion following a cold ischaemic interval ranging from 0 to 120 hr. From this preliminary study, it was concluded that the CIT was 48-72 hr.

The benefit of a single-passage perfusion with a hypertonic citrate solution on the cold ischemia tolerance of epigastric free flaps in Dark-Agouty rats.

In this study the effectiveness of a single-passage perfusion with hypertonic citrate solution on the cold ischemia tolerance in epigastric free flaps in Dark-Agouty rats was investigated. In the control group a significant decline in survival percentage was observed when the storage time was extended from 72 hours to 96 hours. A single (pressure controlled) passage perfusion with hypertonic citrate solution was able to prevent this decline.

Neither desferrioxamine nor lipoic acid enhances the cold ischaemic tolerance of epigastric free flaps in rats.

This study was designed to test the ability of pre- and postischaemic administration of desferrioxamine (DFX), a combination of a preischaemic single passage perfusion with hypertonic citrate solution (HCA) and postischaemic administration of DFX, and pre- and postischaemic administration of lipoic acid (LA) to enhance the cold (0 degree C) ischaemia tolerance in epigastric free flaps in inbred rats. The ischaemic intervals varied between 0 and 120 hr. The area of flap survival 2 weeks after revascularisation as a percentage of original flap size was recorded as an exponent of ischaemic tolerance. None of the treatment regimens was able to increase flap area survival. Histologically, there were no major differences between the different treatment regimens.

Non-revascularized epigastric free flap: no all-or-none survival pattern.

We have previously shown that the epigastric flap in Dark Agouty rats, measuring approximately 6 x 4 cm with borders related to well-defined anatomical structures, does not exhibit an all-or-none survival pattern. This study was designed to investigate the survival pattern of non-revascularized epigastric flaps in three other rat strains (Sprague-Dawley, Brown-Norway, and Lewis). In concordance with our earlier observations, but in contrast to reports by many other groups, in none of the used strains was an all-or-none survival pattern observed. Survival varying from 2 to 30% (mean, 12%) of the original flap, without significant differences between the strains, was found. The locations of survival exhibited a clear pattern, probably owing to the fat pad in the subcutis and revascularisation from the recipient wound edges.

Survival characteristics of the epigastric free flap in DA-rats.

Epigastic flaps measuring approximately 6 x 4 cm with borders related to well-defined anatomical structures were isografted (Dark Agouty to Dark Agouty inbred rats) with or without anastomosing their epigastric pedicle, after various periods of ischaemia, ranging from 0 to 120 h. During the ischaemic insult the flaps were stored at 0 degrees C in a hypertonic citrate solution. The non-revascularized flaps exhibited survival percentages varying from 2 to 34% (mean, 16%) of the original flap,. independent of the storage interval. The flaps that were revascularized after ischaemia had a 100% survival when transplanted immediately after isolation and following 48 h of cold storage. Mean survival percentages of 78% after 72 h of ischaemia, 32% after 96 h, and 4% after 120 h of ischaemia were found. It is concluded that the model described in this study is suitable for free flap research, because of its delineated borders. However, when the area of flap survival is lower than 30% in revascularized flaps there is a distinct likelihood that the flaps have survived regardless of the pedicle as simple Wolfe or composite grafts. Results must therefore be interpreted with great care.