What is the Incidence of Bone Cement Implantation Syndrome in Elderly patients Undergoing Cemented Stem Hemiarthroplasty ? An Evaluation of 40 Patients

Abstract

Introduction:

To study the incidence of bone cement implantation syndrome in elderly patients undergoing cemented stem hip arthroplasty with the use of pulse lavage.

Materials and Methods

40 consecutive patients undergoing cemented stem hip arthroplasty enrolled in the study and intra-operative vitals post induction and post cementing were recorded at 5, 10 and 15 min.

Results

Study depicted an incidence of 32.5%. The incidence of grade 1, 2 ,3 was 22.5%,7.5% and 2.5%, respectively. There was a significant correlation between increased age and those patients suffering from BCIS grade 2 and 3 (p = 0.016). There was no correlation drawn between the comorbidities of the patients and the presence of the condition. However, all the patients with a history of dementia, myocardial infarction and stroke developed the syndrome. A significant correlation was drawn with patients suffering from left ventricular failure (p-value 0.03) pre-operatively. The severity of bone cement implantation syndrome was associated with a significant increase in pre-operative neutrophils (p-value 0.037) and hyponatremia (p-value 0.042) compared to patients with a mild condition, indicated the need for optimisation of the patient. A severe case leading to cardio-pulmonary collapse post cementing was recorded.

Conclusions

BCIS is a commonly occurring under-reported phenomenon in the elderly, leading to significant intra-operative complications. Pre-operative risk assessment along with good coordination between anaesthetist and surgeon is imperative.

Introduction

In elderly patients, arthroplasty is preferred over osteosynthesis in femoral neck fractures for better outcomes and longivity [1]. Adequate fixation, cemented or uncemented depends on multiple parameters and remains controversial keeping in mind the comorbidities of the patient, the quality of the bone and current walking status. In 1953, Sir John Charnley introduced the use of poly-methyl methacrylate (PMMA) bone cement, which has ever since played a vital role in the orthopaedic intervention [2]. The cement creates an adequate hold between the implant and irregular bone surfaces [3]. Cemented hemiarthroplasty as opposed to uncemented has lower risk or re-operation rate and better long-term viability [4, 5]. However, on the other hand cemented arthroplasty is commonly associated with an entity known as bone cement implantation syndrome (BCIS). This BCIS is characterized by hypoxia, hypotension or both and/or unexpected loss of consciousness occurring around the time of cementing. BCIS has been underreported for several years and it took until 2009 for a proper classification and grading of the syndrome [6]. Donaldson and colleagues recently proposed a severity classification of BCIS:

Grade 1—moderate hypoxia (arterial oxygen saturation < 94%) or hypotension (decrease in systolic arterial pressure (SAP) > 20%).

Grade 2—severe hypoxia (arterial oxygen saturation < 88%) or hypotension (decrease in SAP > 40%) or unexpected loss of consciousness.

Grade 3—cardiovascular collapse requiring cardiopulmonary resuscitation.

Pathophysiology of BCIS is not fully known but it is suspected that due to increased intramedullary pressure because of the cement there is a release of emboli during cementing and prosthesis insertion [7]. Several studies have corroborated this using intraoperative trans-esophageal echocardiography, depicting an increase in the embolic load in the form of “snow flurries or embolic showers” during cementing. Intra-operative BCIS should be treated with resuscitation and supportive care along with good communication between the operating surgeon and anaesthetist. [8]

Pulsed lavage is a form of mechanical hydrotherapy using a pressurized, pulsed solution to irrigate and debride wounds of necrotic tissues. Meticulous high volume and high-pressure pulsatile lavage reduces both pulmonary physiological derangements and fat emboli along with other debris [9].

Despite a high incidence of BCIS in cemented arthroplasty, there is a lacuna in studies amongst the Indian population, other than a few case reports. Hence, the present observational study is planned to identify the incidence of BCIS in cemented stem arthroplasty for hip fractures with intra-operative use of pulse lavage using the severity classification of BCIS in elderly patients.

Material and Methods

Study Setting

The present prospective observational study was conducted in the Department of Orthopaedics in collaboration with the Department of Anaesthesia and Intensive Care at Government Medical College and Hospital Sector 32, Chandigarh after ethical approval and informed consent was taken from all patients. Inclusion Criteria consisted of patients older than 65 years, American Society of Anaesthesiologists (ASA) physical status I-III and patients undergoing cemented stem arthroplasty. Exclusion Criteria consisted of patients suffering from polytrauma and pathological fracture. A minimum of 40 consecutive patients were enrolled in this study.

Preparation of the Patient

History including mechanism of injury, date of injury, ambulatory status, coexisting diseases along the history of medications being consumed on a regular basis by the patient were noted. Baseline investigations, chest X-ray, electrocardiogram and echocardiography (ECHO) findings were recorded. The plan of cemented hemiarthroplasty was made keeping in mind the bone quality and previous walking status by the team.

Operative Procedure

Patients were operated on with cemented stem hip arthroplasty in the lateral position. Thorough saline wash with pulsatile lavage was used for the femoral canal. Two packets of medium viscosity cement (Simplex) were used by manually mixing the cement. Retrograde introduction of cement with a cement gun along with the insertion of a cement restrictor was carried out for all patients. The anaesthesia team was informed at the time of cementing. Following parameters: heart rate (HR); NIBP(non-invasive blood pressure) ( [SBP], [DBP], [MAP]); SpO₂; were recorded at baseline,5, 10, 15 min after induction as well as 5,10, 15 min after implantation of bone cement and on arrival to post-operative unit. The lowest SBP recorded within 15 min after cementation was used to score the severity of BCIS on comparing with the mean induction values. Each patient was classified as having no BCIS (grade 0) or grade 1, 2 or 3 BCIS, according to Donaldson and colleagues' classification [6]. The post-operative Intensive Care Unit (ICU) stay along with ambulatory status and 1 month mortality was recorded.

Observations and Results

Forty-five patients were assessed for eligibility in the present observational study. (Fig. 1 consort flow diagram).

Fig. 1.

CONSORT Flow diagram

Population Characteristics

The mean age was 75.62 ± 7.33, 60% of patients between 71 and 80 years. 28 (70%) of the participants were female. 25 (62.5%) of the participants were walking with support pre-injury. 67.5% of the participants belonged to ASA grade 2 and 32.5% were ASA 3 grade. Figure 2 depicts the list of comorbidities of the patients. Indication for surgery amongst the 40 elderly patients was a fracture neck of the femur requiring arthroplasty. Post-surgery, 27.5% (11) patients were walking without support, 52.5%(21) patients were walking with support, 12.5%(5) patients were bedridden and 10%(4) required ICU admission.

Fig. 2.

comorbidities of the enrolled patients in%

Incidence

32.5% (13/40) of the participants suffered from BCIS intra-operatively based on Donaldson et al. [6] The patients diagnosed with BCIS were further classified into mild (grade 1) and moderate to severe (grade 2 and 3) based on the grading system, 69.2% (9/13) of the participants had BCIS Grade: mild and 30.8% (4/13) of the participants suffered BCIS Grade: moderate-severe. 41.7% male and 28.6% female patients suffered from the condition. 33.3% (5/15) of the patients walking without support, 32% (8/25) walking with support pre-operatively suffered from BCIS. No correlation was found between age and the condition. 25.9% (7/27) patients of ASA 2 and 46.2% (6/13) of ASA 3 suffered the condition. No significance was found between BCIS and any comorbidity or medications however, all patients of previous stroke, myocardial infarction (MI), arrhythmias and dementia developed BCIS. Significant correlation was drawn between affected patients and their pre-operative ECHO findings, depicting left ventricular failure (LVF) primarily, other than age-related changes (p value = 0.03). No significance was found between the duration of symptoms or pre-operative blood work and patients suffering from the condition.

Mild vs Moderate-Severe:

The mean age of the mild group was 73.56 ± 5.20 and moderate-severe 84.50 ± 7.59 years, depicting a significant difference between mild and moderate-severe groups in terms of age (p value = 0.016). No significance was found between ASA grade or gender and BCIS severity. All patients suffering from BCIS grade moderate-severe were walking with support before injury(4). Patients with mild conditions were operated on within 11.50 (10.54) days as compared to 23 (24.58) days in case of moderate/severe grade of BCIS although, no significance was found. In patients suffering from mild BCIS the mean pre-operative neutrophils were 68.56 ± 13.04 and mod-severe was 83.67 ± 4.69 with p value 0.037, depicting significance. A significant correlation was drawn (p-value 0.042) between the severity of the syndrome and low sodium pre-operatively (133.250 mEq/L with normal range 135–145 mEq/L) as compared to patients with mild BCIS (142.11 mEq/L).

Intra-operative findings: The intra-operative positive findings between patients with and without BCIS along with mild vs moderate-severe BCIS are visible in Tables 1, 2, 3

Table 1.

BCIS and BP post cementing T4 = 5 min after cementing, T5 = 10 min after cementing, T6 = 15 min after cementing

SBP (mmHg) (T4)	BCIS		Wilcoxon-Mann–Whitney U Test
	Present	Absent	W	p value
Mean (SD)	95.92 (17.33)	116.74 (13.19)	52.500	< 0.001**
Median (IQR)	101 (92–102)	116 (110–121.5)
Range	59–130	98–154
SBP (mmHg) (T5)
Mean (SD)	101.54 (18.43)	117.07 (15.66)	84.500	0.009
Median (IQR)	98 (88–115)	116 (107.5–126.5)
Range	70–137	87–153
SBP (mmHg) (T6)
Mean (SD)	104.54 (20.29)	120.11 (16.44)	96.000	0.022
Median (IQR)	102 (97–120)	120 (106–134.5)
Range	65–135	93–148
DBP (mmHg) (T4)
Mean (SD)	54.31 (11.28)	66.26 (10.95)	74.500	0.004
Median (IQR)	51 (44–66)	67 (56.5–73)
Range	38–71	49–92

Bold values indicate the statistically significant p values

Table 2.

BCIS and saturation T0 = pre-induction, T1 = 5 min after induction, T2 = 10 min after induction, T3 = 15 min after induction, T4 = 5 min after cementing, T5 = 10 min after cementing, T6 = 15 min after cementing, T7 = post-operative anaesthesia care unit

SPO2	BCIS Present					BCIS Absent					p-value
	Mean	SD	95% CI		Range	Mean	SD	95% CI		Range
			Lower	Upper				Lower	Upper
T4	95.31	6.37	91.85	98.77	83–100	99.19	1.14	98.75	99.62	96–100	0.00**
T5	94.85	8.56	90.19	99.50	69–100	98.89	1.45	98.34	99.44	95–100	0.02*
T6	96.85	4.47	94.42	99.28	86–100	98.85	1.54	98.27	99.43	95–100	0.04*

^**Highly significant at 0.01 and * significant at 0.05 level

Bold values indicate the statistically significant p values

Table 3.

BCIS grade and saturation T0 = pre-induction, T7 = post-operative anaesthesia care unit reaching significance at T0 and T7 significant

SpO2 (%) (T0)	BCIS Grade		Wilcoxon-Mann–Whitney U Test
	Mild	Moderate-Severe	W	p value
Mean (SD)	98.33 (1.41)	94.50 (3.32)	30.500	0.059
Median (IQR)	99 (97–99)	94 (93.25–95.25)
Range	96–100	91–99
SpO2 (%) (T7)
Mean (SD)	99.33 (1.32)	97.00 (1.83)	32.500	0.022
Median (IQR)	100 (99–100)	97 (95.75–98.25)
Range	96–100	95–99

P value Significant at 0.05 level, SpO2 at T0 approaching significance and T7 P = 0.022

Bold values indicate the statistically significant p values

Intra-Operative BCIS grade 3: 92-year-old patient suffered from cardio-pulmonary collapse. 10 min following cementing intra-operatively patient’s heart rate was unrecordable followed by 43 beats/minutes and systolic blood pressure of 78 mmhg. The patient expired within 48 h of procedure in the ICU. Figure 3 depicts Intra-operative findings.

Fig. 3.

Operative images of patients suffering from BCIS Grade 3, a Pre-operative x-ray with fracture neck of femur, bPost induction vitals, c ECG showing atrial fibrillation, d Unrecordable saturation, e Unrecordable heart rate

Post-operatively: Post-surgical procedure, 18.2% (2/11) of patients walking with support, 33.3% (7/21) walking with support and 60% (3/5) of bedridden patients suffered from BCIS. 50% (2/4) of the patients requiring ICU admission suffered from BCIS. 1 patient expired post-surgery. 10.0% (4/40) of the participants expired within 3 month follow-up.

Discussion

In our study, the patients undergoing cemented hip arthroplasty were diagnosed with the presence or absence of BCIS and further severity was classified based on Donaldson’s criteria [6]. The incidence ranges from 26 to 74% due to the lack of uniform BCIS diagnostic criteria [10–13]. A retrospective study carried out by Olsen and colleagues' of 1016 patients resulted in an incidence of 28% and a recent study reported an incidence of 37% among 208 patients [10, 14]. Our prospective study depicted an incidence of 32.5% ranging from mild to severe BCIS. The incidence of grade 1, 2, 3 BCIS was 22.5%,7.5% and 2.5%, respectively, slightly more than the previous data recorded as 21%,5.1% and 1.7% respectively [10]. Our study showed a slight increase in incidence as previously BCIS was under reported due to lack of consensus on its definition and our study was only carried out in the elderly age group more than 65 years whereas previous data was collected from various retrospective hip registries, which included patients of all age groups [10]. There was a significant correlation between increased age and those patients suffering from BCIS grade 2 and 3 (p = 0.016). It is known that old age is a risk factor for BCIS and a recent study reported age older than 75 years as an independent risk factor for severity [10, 12, 15]. Park et al. in 2015 depicted that patients older than 65 years of age are bound to experience some degree of BCIS and patients aged more than 85 years, experience significant cardiorespiratory changes which further corroborated our study findings. [16]

No significant correlation was found between pre-injury walking status and with the presence of BCIS and severity, however, all the patients suffering from moderate to severe BCIS had been walking with support before the operative procedure. This further indicated the predisposition to develop moderate to severe BCIS in patients using support for ambulation. A retrospective study of 142 cases in 2020 has drawn correlation between pre-injury non-ambulatory status of the patient and the predisposition to develop BCIS grade 2 or 3 (OR 11.83 at 95% CI 1.1–131.8 with p value < 0.05) [17].

There was no correlation drawn between comorbidities of the patients and the presence or absence of BCIS. However, all the patients with the history of dementia, myocardial infarction and stroke developed BCIS, depicting poor cardiopulmonary reserve. A recent retrospective study further reported the significance of the history of cardiac arrhythmia with the predisposition to develop BCIS (OR = 5.7,95% CI 95% 1.1–28.9, p = 0.04) [17]. No significant correlation was drawn between the history of medication and the incidence of BCIS, although previous studies have drawn correlation between the severity of BCIS with the use of diuretics, angiotensin-converting enzyme inhibitors, beta blockers and warfarin [10]. A significant correlation was drawn between patients with LVF and the presence of the syndrome (p-value 0.03). A previous study by Byrick et al. noted that a sudden and severe increase in pulmonary artery pressure because of increased embolic load may lead to right ventricular failure and further dilation of the right ventricle. The dilated right ventricle leads to a shift in the interventricular septum towards the left side causing decreased left ventricular compliance and ultimately reduced cardiac output [18]. This may explain why patients with already compromised left ventricles are more predisposed to developing BCIS. A positive correlation was found between various leukocyte mediators pre-operatively and the severity of BCIS with a significant increase in neutrophils (p-value 0.037) and consequently a decrease in lymphocytes (p-value 0.020) in patients developing moderate to severe BCIS. Byrick et al. indicated that the embolic load in the canal is a time-limited phenomena, not only mechanical but also mediator related, leading to increased vascular tone [18]. Our study correlates with the mediator pathogenesis model of BCIS and a positive correlation was devised between severity and inflammatory mediators, although more studies with an increased sample size need to be done to explore this relation as it may help in the treatment. A significant correlation was drawn (p-value 0.042) between the severity of the syndrome and low sodium pre-operatively (133.250 mEq/L with normal range 135–145 mEq/L) as compared to patients with mild BCIS (142.11 mEq/L). This further indicates the need for optimisation of patients, to reduce risk. A meta-analysis by Leung et al. analysed 964 263 adults undergoing major surgery, depicting that preoperative hyponatremia is associated with an increased risk of 30 day mortality, especially in non-emergency surgery. Hyponatremia was even associated with a greater risk of intra-operative major coronary event, further corroborating our findings with an increased risk to develop severe cardio-pulmonary collapse [19].

Significant decrease in SBP was found in patients with the presence of BCIS at 5,10 and 15 min after cementing, with a highly significant decrease in SBP at T4(5 min after cementing). A significant decrease in DBP was found 5 min after cementing. Furthermore, a significant decrease in oxygen saturation was found 5, 10, and 15 min after cementing with a highly significant decrease in saturation at T4 (5 min after cementing). This was corroborative with previous studies done regarding intra-operative findings of BCIS which resulted in significant hypotension and hypoxia on insertion of cement. [20]

The SBP of patients with moderate to severe BCIS was consistently lower compared to mild cases pre-operatively and the heart rate was consistently higher from induction to cementing, although did not reach significance. Even the low saturation at pre-induction was approaching significance in moderate to severe BCIS. No study has been done to analyse pre-cementing vitals, which may act as predictors to develop severe BCIS in elderly patients undergoing cemented arthroplasty.

One patient suffered from cardio-pulmonary collapse (BCIS grade 3). The patient was of 92 years of age with a positive history of previous stroke, MI, hypertension, artheroscelrosis and atrial fibrillation. The patient was on regular beta blockers, diuretics, antiplatelets, calcium antagonists and ACE inhibitors. The patient had pre-operative hyponatremia (125 mEq/L) and suffered from severe LVF 0.10 min following cementing intra-operatively patient’s heart rate became unrecordable. The patient expired within 48 h of the procedure in the ICU. Thus, the patient was initially also at high risk to develop BCIS according to the history of comorbidities of the patient, concomitant with findings of previous study results of high-risk candidates. [10]

According to our study, 10% of patients suffered from 3 month mortality and no significant correlation was drawn between the presence and severity of the condition. Previous studies have reported an increased risk of early mortality (< 48 h) and 1 month mortality in moderate to severe BCIS as 28% and 47%, respectively. [10, 14] Rassir et al. recently reported an increased 30 day mortality in moderate to severe cases with a hazard ratio of 3.46 [12].

Limitations of the study include the low sample size which may not fully highlight the presence of BCIS. 10% of patients suffered from early mortality, the reasons for which were not fully elaborated as patients were discharged in stable condition. The study concentrated on regarding BCIS as an intraoperative condition and hence a lack of detailed follow-up after discharge is also a limitation. Previous studies have reported retrospective data and this study aims to provide an insight in elderly patients undergoing arthroplasty in a prospective manner.

Summary and Conclusion

Thus, BCIS is a common intra-operative condition, which is underreported and goes undiagnosed. It primarily occurs in elderly individuals with poor cardio-respiratory reserve and the severity increases with an increase in the age group. The option of uncemented prosthesis should not be ruled out in high-risk individuals. Intra-operative monitoring of the patient’s status requires teamwork in the operation theatre by the anaesthesia team and the surgical team to reduce morbidity and mortality of elderly patients undergoing cemented arthroplasty in high-risk individuals. Future prospective studies should be performed with a larger sample size to further identify key factors in predicting the condition, patient optimisation before surgery and further intraoperative management. The long-term follow-up of lower grades of BCIS after surgery is also necessary to evaluate patient response and outcomes in comparison to patients without BCIS.

Declarations

Conflict of Interest

On behalf of all authors, the corresponding author states that there is no conflict of interest.

Ethical Approval

This article does not contain any studies with human or animal subjects performed by any of the authors

Informed Consent

For this type of study informed consent is not required