Impact of therapeutic and prophylactic anticoagulation after soft tissue tumor resection and microsurgical defect coverage in patients with high-risk coagulopathies or vascular diseases

doi:10.21203/rs.3.rs-2751836/v1

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Impact of therapeutic and prophylactic anticoagulation after soft tissue tumor resection and microsurgical defect coverage in patients with high-risk coagulopathies or vascular diseases

https://doi.org/10.21203/rs.3.rs-2751836/v1

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Introduction: The wide resection and microsurgical free flap coverage are main pillars of the multimodal treatment of soft tissue malignancies. In the challenging subpopulation of patients with preexisting hypercoagulabilities or documented vascular diseases, perioperative bridging anticoagulation is advised, which is considered by some surgeons as challenging. The authors investigate the outcomes and complication in this subpopulation shedding light on prophylactic and therapeutic anticoagulation.

Material and Methods: A retrospective, monocentric evaluation of all patients with malignant soft tissue tumors undergoing tumor resection and defect reconstruction was performed from 2005 to 2021 in a comprehensive cancer care center for soft tissue tumors. The main inclusion criterium was preoperative anticoagulation therapy due to documented cardiovascular comorbidities or coagulopathies. Bridging was performed with an alternative anticoagulation regimen, either prophylactic or therapeutic. The demographics, bridging regimens, outcomes and complications are reported and compared between the two bridging groups.

Results: Out of 240 soft tissue tumor patients receiving reconstructive microsurgical coverage 26 patients received 29 free flaps. Of these, 13 patients received prophylactic bridging (PB) while the other 13 received therapeutic bridging (TB). The flap survival rate was 85.7% in the PB and 66.7% in TB (p = 0.39). Overall postoperative complications were slightly greater in the therapeutic anticoagulation cohort, however, with no significant preference for a complication type.

Conclusion Therapeutic bridging of high-risk patients with hypercoagulopathies or vascular diseases increases the overall surgical sites complications. When a clear systemic benefit of therapeutic anticoagulation is not present, a surgery related benefit is highly questionable.

Coagulopathy

free flaps

anticoagulation

tumor resection

Surgical Oncology

Oncologic reconstructive microsurgery with free flaps includes covering post-resection defects by autologous tissue from a donor site and transplanting it to another anatomical site under microsurgical anastomosis of the flap vessels. Reconstructive free flap surgery for defect reconstruction¹ is considered safe and with very high success rates > 95% ². Nevertheless, as the surgery is very delicate requiring specialized microsurgical training, multimorbid tumor patients with preexisting cardiovascular diseases and hypercoagulable conditions may be attributed to higher complication rates^3–6 with longer hospital stays and requiring revision or failure of the free flaps⁷. Vascular complications like thrombosis, post-operative bleeding, vascular circulatory disorders^{8, 9} are therefore considered relative contraindications in some centers¹⁰. On the contrary, these risk factors are not reported to be relevant contraindications in high volume centers for replantation and other free tissue transfer surgeries^{11, 12}.

Clear evidence is therefore lacking. These patients may therefore be bridged with different anticoagulation regimens to minimize complications. The bridging can either be prophylactic or therapeutic, which is commonly according to the hospital specific regimes including unfractionated heparin, low-molecular-weight heparin or aspirin. Preoperatively, the anti-coagulation is commonly adjusted, which entails the risk of perioperative complications, like vascular circulatory disturbance, venous congestion and even flap loss ¹³.

Other clinical studies have already demonstrated that when performing flap surgery, bridging with antithrombotic medication can lead to an increased incidence of various complications such as hematoma¹⁴, heparin-induced thrombocytopenia¹⁵, pulmonary edema or even thrombosis¹⁶. However, unfractionated Heparin and low-molecular weight fractions of heparin (LMWH) can improve microcirculatory perfusion, as indicated by increased flap survival, only LMWH improved anastomotic patency while minimizing hemorrhage¹⁷. Some studies also even showed that the use of therapeutic anticoagulation has no significant positive influence on the survival of free flaps^18–21.

Several hypercoagulable disorders, like the common factor V Leiden, have been associated with a higher risk of venous thromboembolism, and such conditions are often considered a relative contraindication or a red flag to microsurgical reconstruction. They may also be advised to continue or change their anticoagulation during the surgery and postoperatively ². This may pose an increased risk of bleeding.

The purpose of this study is therefore to investigate the extent of the complications experienced in patients with high-risk preexisting coagulopathies and cardiovascular disease undergoing soft tissue tumor resection with free flap reconstruction, highlighting the rationale behind therapeutic and prophylactic anticoagulation regimens.

Approval was granted by the local institutional ethics committee (registration number: 21-1563) and was performed in accordance with the affirmation of the Helsinki Declaration. A retrospective, monocentric study was conducted with data was extracted from the electronic charts, the operation records and the inpatient files.

Included were patients with soft tissue tumors undergoing tumor resection and microsurgical defect reconstruction with free flaps between November of 2005 and February of 2021 (Fig. 1). In a second step, all patients were then selected for documented, preexisting hypercoagulabilities and vascular diseases requiring preoperative anticoagulation therapy. According to the standard operating procedure, they all received bridging peri- and postoperatively with an alternative anticoagulant. These regimens were divided into a prophylactic group (PG) and a therapeutic group (TG). The decision whether prophylactic or therapeutic was chosen on a case-by-case basis solely by the postoperative instructions of the surgeon.

Exclusion criteria were missing records or unconfirmed diagnosis (e.g. pathology report, other type of malignancy). The parameters retrieved included demographic data (age, gender, BMI, comorbidities, ASA classification score), type of malignancy, anticoagulation data (underlying disease, hypercoagulability data, administered perioperative anticoagulation regimen), surgical data (free flap performed, ischemia time, length of hospitalization), Revisions and complications intraoperatively and postoperatively. Complications included venous or arterial flap thrombosis, total flap failure, partial flap necrosis, flap survival, delayed wound healing, seroma (donor site), hematoma and bleedings (donor site, tumor excision site), lymphatic fistula, postoperative bleeding and revision surgeries. Furthermore, major adverse thromboembolic events, such as deep venous thrombosis and stroke were evaluated.

All patient parameters were entered into an Excel sheet (Microsoft Corporation, USA). Statistical analyses included Fishers Exact tests the prophylactic and therapeutic anticoagulation. All tests were two-tailed and a p-value of less than p ≤ 0.05 was considered statistically significant. Statistical analysis and plots were calculated using GraphPad Prism® (GraphPad Prism, version 8.4.3, San Diego, California, USA).

Patient Characteristics

240 soft tissue tumor patients received reconstructive microsurgical coverage between 2005 and 2021. Out of these, 26 patients were treated preoperatively with ongoing anticoagulation due to hypercoagulopathies or vascular diseases. They received 29 free flaps (Tables 1 and 2), with 13 patients in each cohort being treated by 14 free flap surgeries in the PG and 15 free flap surgeries in the TG due to revision surgeries. Both groups were comparable as to age, gender, BMI, ASA score, type of tumors and comorbidities except for arterial hypertension, which was diagnosed in 38.5% of the TG vs. 92.3% of the PG group (p < 0.05). Most soft tissue tumors were squamous skin cancers or sarcomas (57.7% & 38.5%). Out of the skin cancers 14 were located at the scalp.

The majority of patients had a history of venous thrombosis (12/26, 46.2%) and atrial fibrillation (11/26, 42.3%), which were the underlying rationale for the therapeutic anticoagulation. In the TG, 7 out of 13 patients (53.8%) had a history of thrombosis compared to 5 out of 13 patients (53.8%) in the PG (p = 0.69). 3 patients (3/13, 23.1%) in the TG had an artificial vessel graft compared to none in the prophylactic anticoagulation group (p = 0.22) which necessitated the application of acetylsalicylic acid (ASS) (Table 3).

Anticoagulation Protocol

The perioperative anticoagulation was administered in accordance with the department’s standard operating procedure (SOP). Therapeutic anticoagulation is prescribed to bridge ongoing oral anticoagulation with Vitamine k antagonists in high risk patients (high CHADS2 score). Enoxaparine (low-molecular weight heparin) subcutaneously or heparine perfusor i.v were administered. A heparine perfusor dose of 15 000 IE/d is prophylactic, while 25 000 IE are considered therapeutic. The INR value was monitored every 6 hours. As for enoxaparin, only an administered dose of 0.6 or 0.8 ml twice daily, depending on the patient’s weight and renal function, are considered to be therapeutic. Based on the administered regimen, the patients were retrospectively subdivided into the therapeutic (TG) or prophylactic (PG) group (Table 3). Out of these 13 patients, 6 also received once a day 100 mg of ASS, mostly to arterial stents.

Intraoperative complications

Interestingly, only in the TG did intraoperative thrombosis occur (4 arterial and 1 venous, p < 0.05) accounting to 30.8% of the cases (Fig. 2). All cases of intraoperative thrombosis were salvaged after anastomotic revision. The number of anastomotic revisions ranged from one to three. No revisions were necessary in the prophylactic group. Two of these patients developed postoperative flap thrombosis with flap loss. One Patient had intraoperatively an arterial and a venous flap thrombosis, with a postoperative flap loss due to recurrent postoperative thrombosis of the flap.

Postoperative complications and outcome

Overall, flap survival was 79.3% (23/29), with a higher number of flap loss in the TG (30.8% vs 15.4%), yet not statistically significant (p = 0.39) (Table 4). One patient required the use of 2 consecutive free flap reconstructions and lost both due to postoperative thromboembolic events. This rate of flap loss refers to this high risk and multimorbid study population.

Some patients developed postoperative arterial as well as venous flap thrombosis. In the flaps that received postoperative a prophylactic anticoagulation approach two flaps developed a thrombotic event (n = 2/14, 14.3%). In detail, one patient had arterial and venous flap thrombosis. One Patient had only venous flap thrombosis. Both flaps were salvageable in emergency exploration surgery and revision of anastomosis.

Furthermore, the number of overall postoperative complications was significantly greater in the TG, even though there was not any significant difference in each complication type (Fig. 2). Although, there was a higher number of revision surgeries in the TG with 46.4% vs. 33.3%, p = 0.05 (Fig. 3), some patients received multiple revision surgeries (61.5% of the TG vs. 38.5% of the PG, p = 0.43).

The rate of major postoperative bleeding or hematoma was comparable, however only within the TG a surgical evacuation was required (3 out of 4 patients in the TG). Additionally, there was a tendency to delayed wound healing in the TG (5/7, 38.5%) vs. (1/13, 7.7%) the PG (p = 0.16). In the whole cohort one patient developed a deep venous thrombosis (1/26, 3.8%) and one patient suffered a stroke (1/26, 3.8%). Both incidents were limited to the therapeutic anticoagulation (each 1/13, 7.7%).

Out of the 29 flaps 24 full patient records included ischemia times (Fig. 4). Overall, even though not significantly, the ischemia time (min.) in the flaps that were lost was greater than the ischemia time of the successful flaps (mean 96.33 min vs. 74.00 min, p = 0.08). Overall, the inpatient stay (days) did not differ significantly in the prophylactic group (mean 22.85 days) when comparing it to the therapeutic anticoagulation group (mean 25.46 days, p = 0.96).

Anticoagulation bridging is administered due to preexisting hypercoagulabilities, cardiovascular diseases, history of thromboembolism and genetic hypercoagulabilities like factor-V-Leiden or thrombophilia. Effective anticoagulation can lower the risk of thromboembolism by 66%. On the other hand, the risk of perioperative cardiovascular complications depends on the comorbidities and the duration of the surgical procedure²². With an age peak of soft tissue tumor patients undergoing free flap reconstruction in the older population (over 70), a higher prevalence of comorbidities with ongoing anticoagulation exists. Anticoagulation protocols differ among institutes, guidelines and disciplines^{23, 24}. There is currently no consensus on peri-operative management regarding anticoagulation and postoperative monitoring of free flaps [3]. Our study confirms a higher-than-average intraoperative flap thrombosis rate in the study population for patients treated from soft-tissue malignancies. Even the group treated by a therapeutic regimen (TG), did not show a decrease in the risk of postoperative flap thrombosis. In contrary, all intraoperative thrombosis appeared in this group, which were salvageable. Wang et al have investigated multiple anticoagulation protocols and still observed a higher flap thrombosis rate in hypercoagulable patients²⁴. A recent study focusing on microsurgical breast reconstruction came to the same conclusion¹². Although, there was a higher number of revision surgeries in the TG with 46.4% vs. 33.3%, p = 0.05, some patients received multiple revision surgeries (61.5% of the TG vs. 38.5% of the PG, p = 0.43). Possibly, high-risk patients will require several revisions due to individual risk factors aside from the anticoagulation regimen (smoking history, arterial hypertension). The fact, that arterial hypertension was higher in the PG raises the question, whether multimorbid TG patients received a higher internal medicine care due to their risk factors. However, both groups were comparable in their comorbidities except for hypertension, which was higher in the PG. A further finding of this study was the higher number of revision surgeries in the TG, mainly due to the flap-related thrombosis or partial necrosis. While a higher hematoma/bleeding complication are expected in the TG as in previous studies, we did not observe any difference in our study ²⁵. However, there is large evidence in the surgery supporting prophylactic anticoagulation in low- to mid-risk patients, as the risk of bleeding decreases, while maintaining a similar prophylactic effect^{12, 26}. High risk patients can benefit from bridging therapy with therapeutic-dose heparin, after the vitamin k-antagonist were stopped for 5 days prior to surgery^{27, 28}. However, the risk of bleeding under therapeutic anticoagulation in large surgeries is estimated to be 3%. Free flap surgeries are considered large procedures which provide best defect coverage, offering fast recovery replacing like-with-like and especially for oncologic patients, offering best prerequisite for fast adjuvant therapies like radiation therapy. The overall flap loss rate reported in further studies was about 4% ²⁹. Flap monitoring has a great importance in postoperative control, as it helps to detect blood flow problems at an early stage. Numerous monitoring methods are available: Surface Doppler, implantable Doppler, infrared spectroscopy, laser Doppler, indocyanine green, fluorometer, as well as the older methods of tissue sampling, temperature monitoring, and clinical evaluation (recapillarization, puncture in the flap). Successful flap revisions can be significantly increased by early detection. At our institution we rely strongly in implantable doppler probes implanted distal to the venous anastomosis. A survey showed that the large proportion of microsurgeons do not use pre-operative (79.71%) or intra-operative (56.52%) anticoagulation routinely ³⁰.

This study carries the limitations of retrospective, single center design and the variable anticoagulation protocols administered to the patients, as requested by their surgeon. Each reconstruction was done by an experienced surgeon. Although these limitations provide insight for further investigation and study design, it seems that perioperative application of prophylactic anticoagulation may be sufficient for the reconstructive microsurgical results. Therapeutic bridging should be considered very carefully, and if chosen, these patients need intensive attention and monitoring during their hospitalization. They tended to require more revision surgeries, flap thrombosis and a greater amount of delayed wound healing. Skillful surgical technique, proper patient selection, careful preoperative planning, and meticulous postoperative care would be more important to determine the outcome in free flap surgery than would the pharmacologic treatment.

According to this review, the antithrombotics—including aspirin, heparin or low-molecular weight heparin, had no significant effects on free flap survival and increased the incidence of hematoma. The patients not receiving any antithrombotics showed a comparable free flap survival rate with lower risks of bleeding complications compared with those receiving antithrombotics. Although prospective randomized studies would be required, the results suggest that the therapeutic pharmacologic anticoagulation for bridging needs to be questioned.

Funding: None.

Ethical approval: The study was registered under the following approval of the local ethics committee 21-1563

Conflict of interest statement: The authors have no commercial, proprietary or financial interest to declare in relation to the content of this article, to the products or companies described in this article.

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Tables are available in Supplementary Files section.

No competing interests reported.

TABLE11.jpg
Table 1. Patients’ Demographics and Type of Malignancy. The whole patient cohort consisted of 26 patients which had a history of anticoagulation and underwent surgical treatment of soft tissue tumors and plastic surgical defect coverage with free flaps. These patients were subdiveded into 2 different postoperativ anticoagulation regimes. The average length of inpatient stay was 22.9 ± 13.9 (prophylactic) and 25.5 ± 19.3 (therapeutic) days. Both patient groups did not differ significantly with respect to gender (p = 0.54), age (p = 0.17), type of soft tissue tumor (p = 0.14), ASA score (p = 0.59), current nicotine cosumtion (p = 0.48), as well as pre-existing medical conditions (see Table 1 for details). Notably, we observed a larger proportion of arterial hypertension in the prophylactic anticoagulation group (p = 0.01). The majority of soft tissue tumors in all patients were skin cancers (n=15, 57.7%). Out of these skin cancers 14 were located at the scalp which implied the use of plastic surgical defect coverage of the scalp. 1 skin cancer patient had the indication for defect coverage of the lateral right knee. 10 patients had the indication for plastic surgical defect coverage after sarcoma resection (38.5%) of which 4 sarcomas were located on the lower limb, 3 in the trunk region, and 3 at the scalp. Additionally, one patient was treated with primary breast reconstruction (3.8%) for a invasive ductal carcinoma. All together the 26 patients received 29 free flaps of which the majoity consisted of latissimus doris flaps (n=13, 44.8%). The cohort that received a prophylactic AK underwent 14 free flap surgeries of which 6 consisted of latissimus dorsi flaps (42.9%) and in the therapeutic AK group out of the 15 flaps 7 also consisted of latissimus dorsi flaps (46.7%). See Table 1 for details about the other type of flaps.
TABLE21.jpg
Table 2. Perioperative complications and postoperative outcome All outcome parameters are presented in Table 2. Overall, flap survival was 75.9% (22/29). The flap survival rate was 85.7% (12/14) and 66.7% (10/15) for the groups prophylactic and therapeutic anticoagulation, respectively (p = 0.39). In the whole cohort two partial flap necrosis were noticed (6.9%). Two total (14.3%) flap losses and no partial flap necrosis occurred, in group prophylactic, whereas 5 total (33.3%) flap losses and two partial (13.3%) flap necrosis occurred in group therapeutic (p = 0.39 and 0.48; Tabl. 2). In total, intraoperative thrombotic events occured in 4 patients (13.8%), all cases of intraoperative thrombosis were salvaged after anastomotic revision. In total, postoperative thrombotic events occured in 7 flaps out of 29 (24.1%). Some patients developed postoperative arterial as well as venous flap thrombosis. In total, 5 (71.4%) of the 7 flaps that developed postoperative thrombosis ended in total flap loss. 2 flaps (28.6%) were salvageable in emergency exploration surgery and revision of anastomosis. In total, 7 (24.1%) total flap losses were recorded. One patient had 2 total flap losses. Overall 5 (71.4%) of these occured in the therapeutic anticoagulation group and 2 (28.6%) in the prophylactic anticoagulation group. 2 flap losses occured without any postoperative thrombosis. The rate of major postoperative bleeding was 7.7% and 15.5% (p = >0.99) in the prophylactic and therapeutic anticoagulation group. In the prophylactic anticoagulation group out of the 3 recorded hematomas 0 required surgical evacuation and out of the 4 recorded total hematomas in the therapeutic anticoagulation group 3 patients (23.1%) required surgical evacuation (p = 0.22).
TABLE31.jpg
Table 3. Anticoagulation Data.
TABLE41.jpg
Table 4. Complications and Revision Surgeries.

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Impact of therapeutic and prophylactic anticoagulation after soft tissue tumor resection and microsurgical defect coverage in patients with high-risk coagulopathies or vascular diseases

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Abstract

Figures

Introduction

Patients And Methods

Results

Patient Characteristics

Anticoagulation Protocol

Intraoperative complications

Postoperative complications and outcome

Discussion

Conclusions

Declarations

References

Tables

Additional Declarations

Supplementary Files

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