Introduction: Percutaneous dilatational tracheostomy (PDT) is a safe and cost-effective alternative to surgical tracheostomy. Cirrhotic patients often require ICU admission and prolonged mechanical ventilation. Patients with liver cirrhosis (LC) are known to have coagulopathy and relatively safe and simple procedures such as tracheostomy may be associated with high complication rates, specifically high bleeding rates. Current guidelines are unable to make a specific recommendation on the safety of PDT among cirrhotic patients. We aimed to evaluate the safety of PDT in critically ill patients with LC. Methods: A retrospective chart review identified critically ill patients who underwent PDT between January 2012 and March 2023. The study group was defined as all patients with a diagnosis of LC. The primary outcome was early (7-day) bleeding, categorized as minor or major. Secondary outcomes were PDT-related and 30-day all-cause mortality. Propensity score matching was performed to adjust the imbalances between the groups. Results: A total of 1,628 were included in the analysis. Thirty-three of them (2.0%) had LC. In the LC group, only 1 patient (3.0%, 95% CI: 0.0–15.8%) developed early bleeding. Intra-operative, early, late bleeding, and PDT-related mortality rates did not differ significantly between those with LC and those without. Conclusion: This retrospective cohort study indicates that PDT can be safely performed in critically ill cirrhotic patients, without significantly increasing the risk of bleeding complications.

Percutaneous dilatational tracheostomy (PDT) is increasingly acknowledged as a safe and cost-effective alternative to surgical tracheostomy for selected critically ill patients requiring prolonged mechanical ventilation [1]. Cirrhotic patients often develop severe complications requiring ICU admission. Though some studies reported improving outcomes in patients with cirrhosis admitted to ICUs, their prognosis remains poor, with high morbidity and mortality rates [2]. Patients with liver cirrhosis (LC) are known to have coagulopathy with higher postoperative complication rates of various procedures, including relatively safe and simple procedures such as tracheostomy [3, 4]. PDT has been shown to be associated with lower rates of complications when compared to open technique among patients with LC [4]. However, current guidelines are unable to make a specific recommendation on the safety of PDT among cirrhotic patients due to the paucity of clinical evidence [1, 5]. In the current study, we aimed to evaluate the safety of PDT in critically ill patients with LC.

This retrospective cohort study was approved by the Institutional Review Board of Rambam Health Care Center, Haifa, Israel. The need for informed consent was waived. A chart review identified critically ill patients who underwent PDT between January 2012 and March 2023. The study group was defined as all patients with an admission diagnosis of LC (ICD-10 codes K70.3, K74.4, K74.5, K74.6) [6]. The diagnosis was confirmed during the chart review. Patients with acute liver failure were excluded. The modality of LC diagnosis and the presumed etiology of cirrhosis were also extracted. Among the non-cirrhotic patients, the absence of cirrhosis was confirmed during the chart review.

All the PDTs were performed using the modified Ciaglia technique [1]. Patients with platelet count <50,000/μL or an INR >1.5 were treated with platelets and fresh frozen plasma (FFP), respectively, immediately before the procedure at the discretion of the attending physician. Patients receiving therapeutic anticoagulation (IV heparin with aPTT goal of 70–100 s or SC enoxaparin 1 mg/kg bd) or dual anti-platelets therapy were excluded. Pharmacological thromboprophylaxis was suspended for 12 h before and after the procedure.

The primary outcome was early (7-day) bleeding, categorized as minor (requiring direct pressure, dressing change, or bedside sutures) or major (requiring exploration in an operating room, urgent therapeutic bronchoscopy due to airway compromise, hemoglobin decrease ≥2 g/dL, transfusion ≥2 packed red cells units) [7, 8]. Secondary endpoints were PDT-related and 30-day all-cause mortality.

Categorical variables were reported with frequencies and percentages and continuous variables were reported as means with standard deviation. We used Student’s t test for continuous parameters and the χ2 test for categorical variables. A p value of less than 0.05 was considered statistically significant. We used all the available data from our databases within the study time frame. Propensity score matching was performed to adjust the imbalances of covariates between the groups. Analysis was conducted with MedCalc Statistical Software version 14.8 (MedCalc, Ostend, Belgium).

A total of 1,628 were included in the analysis. Thirty-three of them (2.0%) had LC (Table 1) with Model for End-stage Liver Disease (MELD) scores ranging between 7 and 34. The predominant etiologies for LC were alcohol-related liver disease (10/33), nonalcoholic steatohepatitis (10/33), and viral hepatitis (7/33). The diagnosis of LC was confirmed either by ultrasound elastography (22/33) or liver biopsy (11/33). Nineteen of these patients (57.6%) had class B disease according to Child-Pugh classification and 12 (36.4%) had class C disease. Detailed information regarding the 33 patients with LC is provided in supplementary Table 1 (for all online suppl. material, see https://doi.org/10.1159/000539106).

Table 1.

Clinical and laboratory characteristics of the study cohorta

No cirrhosis (n = 1,595)Cirrhosis (n = 33)p value
Age (SD), years 60.3 (18.3) 63.5 (11.2) 0.32 
Male gender, n (%) 1,065 (66.8) 21 (63.6) 0.71 
Charlson Comorbidity Index 
 0, n (%) 148 (9.3) 0 (0.0) 0.04 
 1, n (%) 115 (7.3) 2 (6.1) 
 2, n (%) 161 (10.2) 0 (0.0) 
 ≥3, n (%) 1161 (73.2) 31 (93.9) 
Admission diagnosis 
 Medical, n (%) 637 (40.0) 22 (66.7) 0.02 
 Neurological, n (%) 256 (16.1) 3 (9.1) 
 Surgical, n (%) 106 (6.7) 1 (3.0) 
 Trauma, n (%) 400 (25.1) 2 (6.1) 
 Other, n (%) 194 (12.2) 5 (15.2)  
BMI (SD), kg/m2 27.3 (6.3) 27.7 (5.3) 0.74 
Mechanical ventilation duration before tracheostomy (SD), days 13.6 (11.9) 17.0 (7.5) 0.1 
Aspirin treatment within 5 days before procedure, n (%) 211 (13.2) 6 (18.2) 0.41 
Platelets count (SD), KmcL 312.3 (176.1) 169.8 (113.9) <0.001 
INR (SD) 1.1 (0.2) 1.2 (0.3) <0.001 
aPTT (IQR), s 29.6 (6.7) 31.3 (6.6) 0.15 
MELD score 
 ≤9, n (%) 1,155 (72.4) 14 (42.4) <0.001 
 10–19, n (%) 362 (22.7) 9 (27.3) 
 20–29, n (%) 51 (3.2) 7 (21.2) 
 ≥30, n (%) 27 (1.7) 3 (9.1) 
Child-Pugh classification, n (%) 
 Class A (5–6 points) 2 (6.1) 
 Class B (7–9 points) 19 (57.6) 
 Class C (10–15 points) 12 (36.4) 
Intraoperative bleeding, n (%) 20 (1.3) 0 (0.0) 0.52 
Early bleeding 
 Minor, n (%) 79 (5.0) 1 (3.0) 0.61 
 Major, n (%) 5 (0.3) 0 (0.0) 0.75 
Late bleeding, n (%) 4 (0.3) 0 (0.0) 0.77 
PDT-related mortality, n (%) 10 (0.6) 0 (0.0) 0.65 
30-day all-cause mortality, n (%) 383 (24.0) 12 (36.4) 0.26 
No cirrhosis (n = 1,595)Cirrhosis (n = 33)p value
Age (SD), years 60.3 (18.3) 63.5 (11.2) 0.32 
Male gender, n (%) 1,065 (66.8) 21 (63.6) 0.71 
Charlson Comorbidity Index 
 0, n (%) 148 (9.3) 0 (0.0) 0.04 
 1, n (%) 115 (7.3) 2 (6.1) 
 2, n (%) 161 (10.2) 0 (0.0) 
 ≥3, n (%) 1161 (73.2) 31 (93.9) 
Admission diagnosis 
 Medical, n (%) 637 (40.0) 22 (66.7) 0.02 
 Neurological, n (%) 256 (16.1) 3 (9.1) 
 Surgical, n (%) 106 (6.7) 1 (3.0) 
 Trauma, n (%) 400 (25.1) 2 (6.1) 
 Other, n (%) 194 (12.2) 5 (15.2)  
BMI (SD), kg/m2 27.3 (6.3) 27.7 (5.3) 0.74 
Mechanical ventilation duration before tracheostomy (SD), days 13.6 (11.9) 17.0 (7.5) 0.1 
Aspirin treatment within 5 days before procedure, n (%) 211 (13.2) 6 (18.2) 0.41 
Platelets count (SD), KmcL 312.3 (176.1) 169.8 (113.9) <0.001 
INR (SD) 1.1 (0.2) 1.2 (0.3) <0.001 
aPTT (IQR), s 29.6 (6.7) 31.3 (6.6) 0.15 
MELD score 
 ≤9, n (%) 1,155 (72.4) 14 (42.4) <0.001 
 10–19, n (%) 362 (22.7) 9 (27.3) 
 20–29, n (%) 51 (3.2) 7 (21.2) 
 ≥30, n (%) 27 (1.7) 3 (9.1) 
Child-Pugh classification, n (%) 
 Class A (5–6 points) 2 (6.1) 
 Class B (7–9 points) 19 (57.6) 
 Class C (10–15 points) 12 (36.4) 
Intraoperative bleeding, n (%) 20 (1.3) 0 (0.0) 0.52 
Early bleeding 
 Minor, n (%) 79 (5.0) 1 (3.0) 0.61 
 Major, n (%) 5 (0.3) 0 (0.0) 0.75 
Late bleeding, n (%) 4 (0.3) 0 (0.0) 0.77 
PDT-related mortality, n (%) 10 (0.6) 0 (0.0) 0.65 
30-day all-cause mortality, n (%) 383 (24.0) 12 (36.4) 0.26 

BMI, body mass index; INR, international normalized ratio; PTT, activated partial thromboplastin time; MELD, Model for End-stage Liver Disease; PDT, percutaneous dilatational tracheostomy; SD, standard deviation.

Statistically significant values (p ≤ 0.05) are given in bold and italics.

aThere were no missing values.

In the LC group, only 1 patient (3.0%, 95% CI: 0.0–15.8%) developed early mild bleeding successfully treated with packing. This 69-year-old male had class C Child-Pugh alcoholic cirrhosis (MELD score of 20), normal perioperative INR (1.11), and moderate thrombocytopenia (69,000 per μL). Intra-operative, early, and late bleeding rates did not differ significantly between those with LC and those without (0.0 vs. 1.3%, p = 0.52; 3.0 vs. 5.3%, p = 0.57; and 0.0 vs. 0.6%, p = 0.77, respectively). In the LC group, 2 patients (6.1%) required perioperative thrombocyte transfusion and three (9.1%) required FFP transfusion. In the LC group, there were no cases of PDT-related mortality. Thirty-day all-cause mortality was slightly higher in the LC group compared to patients without liver disease, although these differences did not reach a statistical significance level (36.4 vs. 24.0%, p = 0.26). Six of the 12 deaths (50%) in the LC group were liver disease related. All these patients had class C liver disease according to Child-Pugh classification. After the incorporation of the propensity score, the results did not change significantly (Table 2).

Table 2.

Clinical and laboratory characteristics of the matched cohort

No cirrhosis (n = 29)Cirrhosis (n = 29)p value
Age (SD), years 64.6 (9.9) 64.2 (10.3) 0.86 
Male gender, n (%) 16 (55.2) 18 (62.1) 0.60 
Charlson Comorbidity Index 
 0, n (%) 0 (0.0) 0 (0.0) 0.37 
 1, n (%) 0 (0.0) 1 (3.4) 
 2, n (%) 1 (3.4) 0 (0.0) 
 ≥3, n (%) 28 (96.6) 28 (96.6) 
Admission diagnosis 
 Medical, n (%) 20 (69.0) 20 (69.0) 1.00 
 Neurological, n (%) 2 (6.9) 2 (6.9) 
 Surgical, n (%) 1 (3.4) 1 (3.4) 
 Trauma, n (%) 1 (3.4) 1 (3.4) 
 Other, n (%) 5 (3.4) 5 (3.4)  
BMI (SD), kg/m2 27.4 (6.4) 28.4 (5.0) 0.52 
Mechanical ventilation duration before tracheostomy (SD), days 16.9 (7.5) 17.2 (7.2) 0.87 
Aspirin treatment within 5 days before procedure, n (%) 9 (31.0) 5 (17.2) 0.22 
Platelets count (SD), μL 185.3 (107.4) 165.9 (98.2) 0.48 
INR (SD) 1.1 (0.2) 1.2 (0.3) 0.11 
aPTT (IQR), s 29.0 (6.9) 30.7 (6.1) 0.34 
MELD score 
 ≤9, n (%) 11 (37.9) 
 10–19, n (%) 9 (31.0) 
 20–29, n (%) 7 (24.1) 
 ≥30, n (%) 2 (6.9) 
Intraoperative bleeding, n (%) 0 (0.0) 0 (0.0) 1.00 
Early bleeding 
 Minor, n (%) 1 (3.4) 1 (3.4) 1.00 
 Major, n (%) 0 (0.0) 0 (0.0) 1.00 
Late bleeding, n (%) 0 (0.0) 0 (0.0) 1.00 
PDT-related mortality, n (%) 0 (0.0) 0 (0.0) 1.00 
30-days all-cause mortality, n (%) 11 (37.9) 11 (37.9) 1.00 
No cirrhosis (n = 29)Cirrhosis (n = 29)p value
Age (SD), years 64.6 (9.9) 64.2 (10.3) 0.86 
Male gender, n (%) 16 (55.2) 18 (62.1) 0.60 
Charlson Comorbidity Index 
 0, n (%) 0 (0.0) 0 (0.0) 0.37 
 1, n (%) 0 (0.0) 1 (3.4) 
 2, n (%) 1 (3.4) 0 (0.0) 
 ≥3, n (%) 28 (96.6) 28 (96.6) 
Admission diagnosis 
 Medical, n (%) 20 (69.0) 20 (69.0) 1.00 
 Neurological, n (%) 2 (6.9) 2 (6.9) 
 Surgical, n (%) 1 (3.4) 1 (3.4) 
 Trauma, n (%) 1 (3.4) 1 (3.4) 
 Other, n (%) 5 (3.4) 5 (3.4)  
BMI (SD), kg/m2 27.4 (6.4) 28.4 (5.0) 0.52 
Mechanical ventilation duration before tracheostomy (SD), days 16.9 (7.5) 17.2 (7.2) 0.87 
Aspirin treatment within 5 days before procedure, n (%) 9 (31.0) 5 (17.2) 0.22 
Platelets count (SD), μL 185.3 (107.4) 165.9 (98.2) 0.48 
INR (SD) 1.1 (0.2) 1.2 (0.3) 0.11 
aPTT (IQR), s 29.0 (6.9) 30.7 (6.1) 0.34 
MELD score 
 ≤9, n (%) 11 (37.9) 
 10–19, n (%) 9 (31.0) 
 20–29, n (%) 7 (24.1) 
 ≥30, n (%) 2 (6.9) 
Intraoperative bleeding, n (%) 0 (0.0) 0 (0.0) 1.00 
Early bleeding 
 Minor, n (%) 1 (3.4) 1 (3.4) 1.00 
 Major, n (%) 0 (0.0) 0 (0.0) 1.00 
Late bleeding, n (%) 0 (0.0) 0 (0.0) 1.00 
PDT-related mortality, n (%) 0 (0.0) 0 (0.0) 1.00 
30-days all-cause mortality, n (%) 11 (37.9) 11 (37.9) 1.00 

BMI, body mass index; INR, international normalized ratio; PTT, activated partial thromboplastin time; MELD, Model for End-stage Liver Disease; PDT, percutaneous dilatational tracheostomy; SD, standard deviation.

Statistically significant values (p ≤ 0.05) are given in bold and italics.

This retrospective cohort study indicates that PDT can be performed safely in critically ill cirrhotic patients, without significantly increasing the risk of bleeding complications or mortality. Perioperative thrombocytes and/or FFP transfusion may be required in a small proportion of these patients.

Although an ICD-10-based retrospective analysis of the National Inpatient Sample revealed that PDT is associated with fewer complications and less hemorrhaging at the tracheostomy site compared to the open approach, only 1 previous study has directly addressed the safety of PDT in patients with liver disease [4, 9]. Notably, this study predominantly focused on patients with acute liver failure and patients after liver transplantation. Only 19 patients suffered from chronic liver disease. The patients were followed for 72 h, and the authors found only 1 case of severe bleeding (1.7%) and 12 cases of mild bleeding (20%). Most of these patients suffered from severe coagulopathy defined as INR >1.5 or platelet count <50,000/μL. These results are in concordance with our findings.

The limitations of our study include its retrospective design, the relatively small number of patients in the LC group, and the fact that most of these patients had mild to moderate severity of liver insufficiency (MELD score of 18/33 patients was <20). Further large-scale, prospective studies are necessary to validate the safety of PDT in this unique population.

The study was approved by the Institutional Review Board at Rambam Health Care Center, Haifa, Israel (approval number: 0143-21-RMB). The need for informed consent was waived by the RHCC Institutional Review Board.

The authors have no conflicts of interest to declare.

No funding sources to be reported.

R.N., F.M., Y.Sh, and D.E. contributed to conceptualization and methodology; R.N, F.M., O.S., N.G., and D.E. contributed to data collection and to data analysis and visualization; R.N., F.M., and D.E. contributed to writing – original draft preparation; R.N., F.M., Y.Sh, and D.E. contributed to writing – review and editing; and R.N. and F.M. equally contributed as first authors.

The data presented in this study are available on request from the corresponding author. The data are not publicly available for privacy reasons. Further inquiries can be directed to the corresponding author.

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