Early postoperative tachyarrhythmias in adult congenital heart surgery: an eight-year review at a tertiary university hospital in Thailand
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Key findings
• The study reported a 12.9% incidence of postoperative tachyarrhythmias after congenital heart surgery, predominantly atrial fibrillation and atrial flutter, with older age and left atrial enlargement as significant risk factors. Approximately half of the cohort were diagnosed with septal defects, emphasizing the prevalence and impact of these conditions that are often detected late, particularly in developing countries.
What is known and what is new?
• Arrhythmia is a common complication in adult congenital heart disease driven by both structural changes and surgical interventions. Tachyarrhythmias following adult congenital heart surgery are well-recognized and many contributing factors are unmodifiable.
• This study provides insights into the incidence, characteristics, and risk of tachyarrhythmia after congenital heart surgery. We underscore a substantial number of undetected septal defects that required late intervention.
What is the implication, and what should change now?
• This study underscores the urgent need for early detection and timely intervention of septal defects. It calls for enhanced screening measures and improved healthcare policies to reduce postoperative complications in this population.
Introduction
Congenital heart disease (CHD) represents a wide range of structural cardiac abnormalities present at birth, requiring varying degrees of surgical intervention across a patient’s lifespan. Advances in surgical techniques and postoperative care have markedly improved the survival rates of individuals with CHD, leading to a growing number of adults living with surgically corrected or palliated conditions. Complications from surgically treated CHD may emerge years after the initial procedure, and reoperations may be required due to residual defects, conduit degeneration, or heart failure (1). Some CHDs, such as atrial septal defects (ASDs) and ventricular septal defects (VSDs), may be first diagnosed in adulthood, thus contributing to an increase in the number of adults undergoing congenital heart surgery.
Tachyarrhythmias represent a common and significant post-surgical complication (2), impacting both the morbidity and long-term survival of these patients (3). The predisposition to arrhythmias in CHD patients is often multifactorial, including underlying heart disease, residual postoperative states, or sequelae from previous interventions (4). Hemodynamic shifts and scarring of atrial and ventricular tissues also contribute significantly to the heightened arrhythmic risk.
Despite considerable data on arrhythmia-related adult CHD (5,6), research focusing specifically on postoperative tachyarrhythmias following adult congenital heart surgeries is sparse. Given that tachyarrhythmias are more prevalent than bradyarrhythmias and have distinct etiologies, this study aimed to elucidate the incidence, characteristics, and risk factors associated with early postoperative tachyarrhythmias after surgeries for adult CHD. We present this study in accordance with the STROBE reporting checklist (7) (available at https://jtd.amegroups.com/article/view/10.21037/jtd-24-771/rc).
Methods
Study design and population
This study was designed as a single-center retrospective cohort analysis conducted at Siriraj Hospital. The study was conducted in accordance with the Declaration of Helsinki (as revised in 2013). The protocol was reviewed and approved by the Siriraj Institutional Review Board (IRB) (Si 990/2020), and given the retrospective nature of the study, informed consent from participants was waived by the IRB. The cohort included adult patients aged 18 years and older who underwent elective cardiac surgery using cardiopulmonary bypass (CPB) for the treatment of adult CHD from March 2013 to November 2020. Patients with arrhythmias prior to surgery were excluded.
Data collection
Data were extracted from medical records including demographic information, comorbidities, diagnoses, procedures, echocardiogram results, medications, CPB details, type and volume of blood products used, laboratory values, respiratory support details, and lengths of stay in the intensive care unit (ICU) and hospital. The Wernovsky inotrope score was calculated using the formula: dopamine dose (mcg/kg/min) + dobutamine dose (mcg/kg/min) + 100 × epinephrine dose (mcg/kg/min) to assess the level of inotropic support needed post-surgery (8).
Arrhythmias definition and classification
Early postoperative tachyarrhythmia was defined as any new-onset tachyarrhythmia that occurred in-hospital following adult congenital heart surgery and necessitated significant intervention, such as antiarrhythmic medication or electrical cardioversion/defibrillation. Tachyarrhythmias were classified into two main categories: supraventricular and ventricular.
Supraventricular tachyarrhythmias included supraventricular tachycardia (SVT), which encompasses atrial tachycardia (AT), atrial flutter (AFL), and atrioventricular nodal reentrant tachycardia (AVNRT); atrial fibrillation (AF); and unspecified SVT for those not classified under specific subtypes (9). Ventricular tachyarrhythmias included sustained monomorphic ventricular tachycardia (VT) and polymorphic VT (10).
Detection and documentation of tachyarrhythmias were performed using continuous electrocardiographic monitoring connected to a central monitoring station with memory capabilities. Data on the onset, type, and treatment of arrhythmias were collected. Treatment decisions were made by the cardiac ICU management team based on standard clinical guidelines.
Statistical analysis
The reported incidence of tachyarrhythmias following surgery for adult CHD ranged from 6% to 28% (6,11). Based on an assumed 25% incidence of postoperative tachyarrhythmia, the sample size calculation indicated that a minimum of 288 patients was required to achieve a 95% confidence interval (CI) with a margin of error of 10%.
Categorical variables were presented as numbers and percentages. Continuous data normality was assessed using the Shapiro-Wilk test. Variables with a normal distribution were expressed as mean and standard deviation (SD), while those not normally distributed were reported as median and interquartile range (IQR). For between-group comparisons, categorical variables were analyzed using the chi-square test or Fisher’s exact test, and continuous variables were assessed with the independent Student’s t-test or Mann-Whitney U test as appropriate. A P value of <0.05 was considered statistically significant.
Variables from the univariable analysis with a P value of <0.2 were included in the multivariable analysis. In the regression model, age was categorized in 5-year increments. Collinearity among variables was assessed using the Pearson pairwise correlation coefficient, with those showing an r>0.7 indicating multicollinearity and thus removed from the analysis. Multivariable logistic regression with a backward variable selection procedure was used to determine the final model. The model’s fit was evaluated using the Hosmer-Lemeshow goodness-of-fit test, where a P value of >0.05 suggested a good fit. The predictive accuracy of the model was assessed using the area under the receiver operating characteristic (AUROC) curve. Our dataset had a minor degree of missing data, which was addressed using multiple imputation using the Markov chain Monte Carlo technique. All statistical analyses were conducted using PASW Statistics for Windows, Version 18.0 (SPSS Inc., Chicago, IL, USA). Graphs were created with GraphPad Prism version 10 (Boston, MA, USA).
Results
Patient demographics and surgical indications
We included 311 patients who met the inclusion criteria, consisting of 108 males (34.7%) with a median age of 34 years (range, 18–78 years). The primary surgical indication was a newly diagnosed septal defect in 170 patients (54.7%), which comprised 129 ASD (41.5%) and 41 VSD (13.2%). Additionally, 91 patients (29.3%) were treated for post-repair sequelae, predominantly severe pulmonary regurgitation (PR) after tetralogy of Fallot (TOF) correction in 69 cases (22.2%) (Table 1).
Table 1
| Characteristics | Values |
|---|---|
| Male | 108 (34.7) |
| Age (years) | 34.0 (24.0, 48.0) |
| Primary diagnosis | |
| ASD | 129 (41.5) |
| Severe PR post-TOF repair | 69 (22.2) |
| VSD | 41 (13.2) |
| Valvular abnormality | 12 (3.9) |
| AVSD | 11 (3.5) |
| TOF | 11 (3.5) |
| Single ventricle post-repair | 6 (1.9) |
| PAPVR/TAPVR | 5 (1.6) |
| Conduit stenosis post-repair | 5 (1.6) |
| PA VSD MAPCAs post-repair | 4 (1.3) |
| ALCAPA/ARCAPA | 3 (1.0) |
| Ebstein’s anomaly | 3 (1.0) |
| ccTGA post-repair | 3 (1.0) |
| Coarctation of aorta | 2 (0.6) |
| DORV post-repair | 2 (0.6) |
| TGA post-repair | 2 (0.6) |
| Cor triatriatum | 1 (0.3) |
| Coronary AV fistula | 1 (0.3) |
| Ruptured sinus of Valsalva | 1 (0.3) |
Data are presented as n (%) or median (IQR). ASD, atrial septal defect; PR, pulmonic regurgitation; TOF, tetralogy of Fallot; VSD, ventricular septal defect; AVSD, atrioventricular septal defect; PAPVR, partial anomalous of pulmonary venous return; TAPVR, total anomalous pulmonary venous return; PA, pulmonary atresia; MAPCAs, major aortopulmonary collaterals; ALCAPA, anomalous left coronary artery from pulmonary artery; ARCAPA, anomalous right coronary artery from pulmonary artery; ccTGA, congenitally-corrected transposition of great artery; DORV, double outlet right ventricle; TGA, transposition of great artery; AV, arteriovenous; IQR, interquartile range.
Incidence and characteristics of early postoperative tachyarrhythmias
A total of 40 patients (12.9%), aged 20 to 78 years, developed significant postoperative tachyarrhythmias requiring intervention due to symptomatic or hemodynamic instability. These arrhythmias included AF (n=27; 67.5%), AFL (n=6; 15.0%), AVNRT (n=1; 2.5%), unspecified SVT (n=4; 10.0%), VT (n=1; 2.5%), and polymorphic VT (n=1; 2.5%) (Figure 1).
The median onset of tachyarrhythmias was 29.5 h after surgery, ranging from within the first hour after ICU admission to the fifth postoperative day. Most tachyarrhythmias occurred within the first 72 h post-surgery, with a significant clustering on the first two postoperative days (n=33; 82.5%) (Figure 2). Patients with septal defects predominantly experienced AF and AFL, whereas those undergoing surgery for post-repair complications exhibited a broader array of arrhythmias.
Hemodynamically stable tachyarrhythmias were more commonly observed and effectively managed using amiodarone, beta-blocker, adenosine, and electrolyte correction, per individual patient indications. Six patients required cardioversion due to hemodynamic instability; one of these escalated to cardiac arrest and was successfully resuscitated. Most postoperative tachyarrhythmias are resolved by hospital discharge or at follow-up. However, four patients required further interventions, including placement of automated implantable cardioverter-defibrillators (AICD) and undergoing radiofrequency catheter ablation (RFCA), as detailed in Table 2.
Table 2
| ID | Gender | Age (years) | Diagnosis | Operation | Type of tachyarrhythmia | Onset (h) |
Treatment | MV duration (h) | ICU stay (h) |
Hospital stay (days) | Post-discharge intervention |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | F | 24 | Severe PR with LPA stenosis | PVR, LPA plasty, TV annuloplasty | Unstable polymorphic VT | 7 | Defibrillation, amiodarone, magnesium | 40 | 168 | 26 | AICD |
| 2 | M | 78 | Ruptured SoV | Aneurysm repair | AFL | 13 | Cardioversion, amiodarone | 86 | 95 | 16 | EPS, RFCA |
| 3 | M | 27 | Large ASD secundum | ASD closure | AFL | 35 | Amiodarone | 5 | 26 | 6 | EPS, RFCA |
| 4 | F | 61 | Large ASD secundum | ASD closure | AFL | 35 | Amiodarone | 4 | 22 | 7 | EPS, RFCA |
MV, mechanical ventilation; ICU, intensive care unit; PR, pulmonary regurgitation; LPA, left pulmonary artery; PVR, pulmonic valve replacement; TV, tricuspid valve; VT, ventricular tachycardia; AICD, automated implantable cardioverter-defibrillator; SoV, sinus of Valsalva; AFL, atrial flutter; EPS, electrophysiologic study; RFCA, radiofrequency catheter ablation; ASD, atrial septal defect.
Risk factors associated with early postoperative tachyarrhythmias
Table 3 provides patients’ clinical characteristics and operative data stratified by early postoperative arrhythmias. In the univariable analysis, older age was a prominent risk factor as patients with arrhythmias had a median age of 46 years compared to 31 for those without (P<0.001). The presence of left atrial enlargement also significantly increased the risk of arrhythmias (40.0% in the arrhythmia group vs. 17.7% in the non-arrhythmia group; P=0.003). Additionally, patients with tachyarrhythmias had longer hospital stays (median 7 vs. 6 days; P<0.001) and a trend toward longer mechanical ventilation time, although not statistically significant (12.0 vs. 7.3 h; P=0.050).
Table 3
| Characteristics | Total (n=311) | Tachyarrhythmia | P value | |
|---|---|---|---|---|
| Yes (n=40) | No (n=271) | |||
| Age (years) | 34.0 (24.0, 48.0) | 46.0 (33.0, 58.0) | 31.0 (23.0, 47.0) | <0.001 |
| Male | 108 (34.7) | 13 (32.5) | 95 (35.1) | 0.86 |
| Body weight (kg) | 55.0 (47.0, 63.0) | 55.5 (46.3, 62.8) | 55.0 (47.0, 63.0) | 0.91 |
| BMI (kg/m2) | 21.5 (19.3, 24.2) | 22.4 (20.2, 24.9) | 21.2 (19.0, 24.2) | 0.26 |
| Resternotomy | 79 (25.4) | 6 (15.0) | 73 (26.9) | 0.12 |
| History of CHF | 16 (5.1) | 2 (5.0) | 14 (5.2) | 0.97 |
| Preoperative TTE | ||||
| LVEF (%) | 64.0 (57.0, 70.0) | 65.0 (56.3, 72.8) | 64.0 (57.0, 70.0) | 0.83 |
| RAE | 234 (75.2) | 34 (85.0) | 200 (73.8) | 0.17 |
| RVE | 257 (82.6) | 36 (90.0) | 221 (81.5) | 0.26 |
| LAE | 64 (20.6) | 16 (40.0) | 48 (17.7) | 0.003 |
| LVE | 15 (4.8) | 3 (7.5) | 12 (4.4) | 0.42 |
| Medication(s) | ||||
| ACEI/ARB | 49 (15.8) | 8 (20.0) | 41 (15.1) | 0.48 |
| Beta-blocker | 61 (19.6) | 12 (30.0) | 49 (18.1) | 0.09 |
| Diuretics | 111 (35.7) | 18 (45.0) | 93 (34.3) | 0.22 |
| Sildenafil | 30 (9.6) | 4 (10.0) | 26 (9.6) | 0.94 |
| Anesthetic maintenance | ||||
| Isoflurane | 130 (41.8) | 18 (45.0) | 112 (41.3) | 0.73 |
| Sevoflurane | 99 (31.8) | 17 (42.5) | 82 (30.3) | 0.15 |
| Propofol | 80 (25.7) | 5 (12.5) | 75 (27.7) | 0.051 |
| Adjunct dexmedetomidine | 18 (5.8) | 1 (2.5) | 17 (6.3) | 0.49 |
| Operative time (min) | 185.0 (135.0, 235.0) | 175.0 (145.0, 255.0) | 185.0 (130.0, 235.0) | 0.67 |
| CPB time (min) | 82.0 (57.0, 113.0) | 72.5 (54.5, 114.5) | 83.0 (57.0, 112.0) | 0.63 |
| AoX time (min) | 54.0 (36.0, 77.0) | 49.0 (33.0, 75.0) | 55.0 (36.0, 77.5) | 0.66 |
| Lowest core temperature (°C) | 32.5 (31.9, 33.3) | 32.6 (32.0, 33.6) | 32.5 (31.9, 33.3) | 0.58 |
| Type of cardioplegia | 0.53 | |||
| Cold blood | 292 (93.9) | 36 (90.0) | 256 (94.5) | |
| Delnido | 15 (4.8) | 3 (7.5) | 12 (4.4) | |
| Custodiol | 4 (1.3) | 1 (2.5) | 3 (1.1) | |
| Intraoperative Mg | 151 (48.6) | 18 (45.0) | 142 (52.4) | 0.40 |
| Laboratory findings | ||||
| Na (mEq/L) | 141.0 (139.0, 142.0) | 141.0 (138.0, 143.8) | 141.0 (138.0, 142.0) | 0.41 |
| K (mEq/L) | 3.8 (3.5, 4.0) | 3.9 (3.6, 4.1) | 3.8 (3.5, 4.0) | 0.20 |
| Mg (mmol/L) | 3.5 (2.7, 4.1) | 3.3 (2.9, 4.1) | 3.5 (2.7, 4.1) | 0.63 |
| Ca (mmol/L) | 4.2 (4.0, 4.5) | 4.2 (4.0, 4.6) | 4.2 (4.0, 4.5) | 0.74 |
| HCO3 (mEq/L) | 22.0 (21.0, 24.0) | 22.0 (20.3, 24.0) | 22.0 (21.0, 24.0) | 0.66 |
| pH | 7.4±0.1 | 7.4±0.1 | 7.4±0.1 | 0.75 |
| Inotrope score | 1.0 (0, 6.0) | 2.0 (1.0, 5.0) | 1.0 (0, 5.0) | 0.11 |
| Vasopressor-inotrope score | 2.0 (0, 6.0) | 3.0 (1.0, 8.0) | 2.0 (0, 6.0) | 0.09 |
| RBC (mL) | 350.0 (0, 766.0) | 428.5 (260.3, 824.8) | 350.0 (0, 742.6) | 0.51 |
| FFP (mL) | 462.0 (0, 899.0) | 458.0 (0, 710.8) | 463.0 (0, 932.8) | 0.70 |
| Platelet (mL) | 0 (0, 314.0) | 0 (0, 293.8) | 0 (0, 315.0) | 0.24 |
| Cryoprecipitate (mL) | 0 (0, 100.0) | 0 (0, 0) | 0 (0, 107.8) | 0.30 |
| Total RBC and blood product (mL) | 1,037.0 (292.5, 1,930.0) | 1,034.0 (294.0, 1,856.0) | 1,037.0 (292.5, 1,939.5) | 0.89 |
| Mechanical ventilatory time (h) | 8.0 (4.7, 15.8) | 12.0 (4.3, 19.4) | 7.3 (4.8, 45.1) | 0.050 |
| ICU stay (h) | 22.0 (20.1, 25.5) | 23.5 (21.7, 47.9) | 21.8 (20.0, 25.0) | 0.12 |
| Hospital stay (days) | 6.0 (5.0, 7.0) | 7.0 (6.0, 9.8) | 6.0 (5.0, 7.0) | <0.001 |
Data are presented as n (%), median (IQR), or mean ± SD. BMI, body mass index; CHF, congestive heart failure; TTE, transthoracic echocardiogram; LVEF, left ventricular ejection fraction; RAE, right atrial enlargement; RVE, right ventricular enlargement; LAE, left atrial enlargement; LVE, left ventricular enlargement; ACEI, angiotensin-converting enzyme inhibitor; ARB, angiotensin receptor blocker; CPB, cardiopulmonary bypass; AoX, aortic cross-clamp; RBC, red blood cell; FFP, fresh frozen plasma; ICU, intensive care unit; IQR, interquartile range; SD, standard deviation.
The multivariable analysis further quantified age as a risk factor, with each 5-year increment increasing arrhythmia odds by 26% [adjusted odds ratio (OR) =1.26; 95% CI: 1.12–1.42; P<0.001]. Left atrial enlargement was associated with an increased risk of tachyarrhythmias (adjusted OR =2.78; 95% CI: 1.31–5.85; P=0.007) (Table 4). Intraoperative propofol use suggested a protective trend, though not statistically significant. The model demonstrated good fit (Hosmer Lemeshow P=0.51) and a satisfactory predictive accuracy with an AUROC of 0.752 (95% CI: 0.671–0.833; P<0.001), indicating a robust model for predicting early postoperative tachyarrhythmias (Figure 3).
Table 4
| Characteristics | Adjusted OR (95% CI) | P value |
|---|---|---|
| Age (per 5-year increment) | 1.26 (1.12, 1.42) | <0.001 |
| Left atrial enlargement | 2.78 (1.31, 5.85) | 0.007 |
| Intraoperative propofol use | 0.43 (0.16, 1.17) | 0.10 |
OR, odds ratio; CI, confidence interval.
Discussion
This study evaluated early postoperative tachyarrhythmias in 311 patients undergoing adult congenital heart surgery at a tertiary university hospital. We observed a notable incidence of tachyarrhythmias (12.9%), predominantly occurring within the first 72 h post-surgery, with AF being the most common arrhythmia (67.5%) in our cohort.
The incidence of postoperative arrhythmias, including both bradyarrhythmia and tachyarrhythmia, in prior studies has ranged from approximately 8% to 32% (3,6,11), with tachyarrhythmias specifically reported between 6% and 28% (6,11). Our findings align with these ranges, although the variability can largely be attributed to differences in cardiac diagnoses, surgical complexities, and the definitions of arrhythmia employed in these studies (i.e., requiring supportive measures, antiarrhythmic medication).
We demonstrated that patients with septal defects frequently developed AF and AFL, while those with post-TOF repair exhibited a broader range of tachyarrhythmias, including AF, AFL, AVNRT, and both monomorphic and polymorphic VTs. The chronic volume overload and increased atrial stretch from septal defects lead to structural and electrical remodeling of the atrium, making patients more susceptible to supraventricular arrhythmias. In contrast, post-TOF repair patients often have residual hemodynamic abnormalities and right ventricular volume overload, resulting in right atrial and ventricular enlargement. Surgical scars and myocardial fibrosis further contribute to arrhythmogenic substrates, increasing the risk for both supraventricular and ventricular arrhythmias (12).
Not surprisingly, adult patients showed a higher incidence of postoperative tachyarrhythmias compared to the pediatric population (13-15). This is consistent with our observations that increasing age is associated with a higher likelihood of atrial or ventricular arrhythmias potentially due to age-related physiological changes and chronic hemodynamic stress (16,17). Additionally, our study demonstrated that AF was the most common arrhythmia post-surgery, unlike in the pediatric CHD population where junctional ectopic tachycardia (JET) prevails. The pediatric atrial myocardium’s resistance to hemodynamic stress potentially makes early postoperative AF rare in children (18).
Studies have shown that 10% of patients over 40 years old who have not undergone closure of septal defect developed AF (19,20). This increased incidence is likely associated with the presence of cardiovascular comorbidities such as systemic hypertension and obesity (21), rendering older patients more susceptible to postoperative AF. However, AF can present at younger ages in the CHD population compared to the general population (22). Early percutaneous or surgical closure of ASD can prevent this outcome (19,20), suggesting the importance of timely intervention.
The duration of atrial volume overload is a critical factor promoting atrial fibrosis, subsequently linked to atrial arrhythmias in patients with CHD (23). The additional surgical stress from cardiac operations exacerbates the likelihood of postoperative tachyarrhythmias due to factors such as systemic inflammatory response to CPB, activation of the complement cascade, direct mechanical irritation to the pericardium and myocardium, atrioventricular node swelling, atriotomy or ventriculotomy, and electrolyte disturbance (24-26).
Although tachyarrhythmias following adult congenital heart surgery are well-documented and many contributing factors were unmodifiable, our study highlights the significant number of previously undetected septal defects necessitating late intervention. These patients faced a higher risk of postoperative tachyarrhythmias, stroke, and heart failure (27), leading to extended treatment, hospital stays, and additional cardiac procedures. These findings underscore the crucial need for early detection and intervention of septal defects.
The retrospective nature of this study and its single-institution design may limit the generalizability of our findings. For example, the high volume of TOF repairs with transannular patches at our center might have introduced a selection bias, resulting in a patient cohort with a high incidence of severe PR. Multicenter studies are needed to validate and expand our understanding of the implications of postoperative tachyarrhythmias in the adult CHD population.
Conclusions
Our study reported a notable incidence of postoperative arrhythmias following adult congenital heart surgery, identifying AF as the predominant type, with septal defects being the most frequently encountered adult CHD condition. Older age and left atrial enlargement were independent risk factors. Importantly, our study shows a considerable number of late-detected septal defects requiring late interventions, underscoring the importance of early detection and management, particularly in developing countries where delayed diagnoses can lead to more complex outcomes. This emphasizes the need for improved screening and healthcare policies to mitigate postoperative complications in this population.
Acknowledgments
The authors express their gratitude to Dr. Paweena Chungsomprasong, a pediatric cardiologist at Siriraj Hospital, for a thorough review of the manuscript.
Funding: None.
Footnote
Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://jtd.amegroups.com/article/view/10.21037/jtd-24-771/rc
Data Sharing Statement: Available at https://jtd.amegroups.com/article/view/10.21037/jtd-24-771/dss
Peer Review File: Available at https://jtd.amegroups.com/article/view/10.21037/jtd-24-771/prf
Conflicts of Interest: Both authors have completed the ICMJE uniform disclosure form (available at https://jtd.amegroups.com/article/view/10.21037/jtd-24-771/coif). The authors have no conflicts of interest to declare.
Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki (as revised in 2013). This study was approved by Siriraj Institutional Review Board (Si 990/2020) with an exemption of informed consent, given the retrospective nature of the study.
Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.
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