Right disc thrombosis of the new Gore Cardioform ASD Occluder.

BACKGROUND: The GCA is a well performing device in terms of efficacy despite complex anatomies (aortic rim <5 mm and ASD diameter >17 mm) with a good safety profile. AIMS: To evaluate atrial septal defect (ASD) features impacting on right disc device thrombosis in patients who underwent Gore Cardioform ASD Occluder (GCA) implantation. METHODS: A total of 44 consecutive patients undergoing percutaneous ASD with GCA device from January 2020 to September 2022 at our tertiary care Center were evaluated. The minimum follow-up was 6 months. RESULTS: The patients were stratified in two groups according to a cut-off value of ASD diameter equal to 20 mm at sizing balloon, derived from ROC analysis (AUC = 0.894; p = 0.024). Baseline characteristics were comparable between groups in terms of age, sex, weight, height, and interatrial septum dimensions. Patients with ASD > 20 mm (n = 9) had a higher ASD/device dimension ratio, both at echocardiography (p = 0.009) and at sizing balloon (p = 0.001), longer fluoroscopic time (p = 0.022), and higher incidence of device thrombosis (0.006). Right disc thrombosis was observed in three patients of the ASD > 20 mm group, always in the inferior portion of the right disc. On univariate analysis, ASD diameter at sizing balloon (OR 1.360; p = 0.036) was the only positive predictor of device thrombosis. CONCLUSIONS: Right disc thrombosis of the GCA device may be under-recognized at follow-up, hence deserving clinical attention, especially in those patients with larger ASD diameters.

Transcatheter Pulmonary Valve Implantation in Repaired Tetralogy of Fallot and Anomalous Left Coronary Artery Origin.

We describe a rare and extremely challenging case of transcatheter pulmonary valve implantation in repaired tetralogy of Fallot and anomalous origin of the left main coronary artery from the right coronary sinus. Procedural planning based on advanced multimodality imaging and 3-dimensional technology proved to be the key to procedural success.

Outcomes of transcatheter pulmonary SAPIEN 3 valve implantation: an international registry.

BACKGROUND AND AIMS: Transcatheter pulmonary valve implantation (TPVI) is indicated to treat right-ventricular outflow tract (RVOT) dysfunction related to congenital heart disease (CHD). Outcomes of TPVI with the SAPIEN 3 valve that are insufficiently documented were investigated in the EUROPULMS3 registry of SAPIEN 3-TPVI. METHODS: Patient-related, procedural, and follow-up outcome data were retrospectively assessed in this observational cohort from 35 centres in 15 countries. RESULTS: Data for 840 consecutive patients treated in 2014-2021 at a median age of 29.2 (19.0-41.6) years were obtained. The most common diagnosis was conotruncal defect (70.5%), with a native or patched RVOT in 50.7% of all patients. Valve sizes were 20, 23, 26, and 29 mm in 0.4%, 25.5%, 32.1%, and 42.0% of patients, respectively. Valve implantation was successful in 98.5% [95% confidence interval (CI), 97.4%-99.2%] of patients. Median follow-up was 20.3 (7.1-38.4) months. Eight patients experienced infective endocarditis; 11 required pulmonary valve replacement, with a lower incidence for larger valves (P = .009), and four experienced pulmonary valve thrombosis, including one who died and three who recovered with anticoagulation. Cumulative incidences (95%CI) 1, 3, and 6 years after TPVI were as follows: infective endocarditis, 0.5% (0.0%-1.0%), 0.9% (0.2%-1.6%), and 3.8% (0.0%-8.4%); pulmonary valve replacement, 0.4% (0.0%-0.8%), 1.3% (0.2%-2.4%), and 8.0% (1.2%-14.8%); and pulmonary valve thrombosis, 0.4% (0.0%-0.9%), 0.7% (0.0%-1.3%), and 0.7% (0.0%-1.3%), respectively. CONCLUSIONS: Outcomes of SAPIEN 3 TPVI were favourable in patients with CHD, half of whom had native or patched RVOTs.

Safety and efficacy of the Amplatzer™ Trevisio™ intravascular delivery system: Post-approval study results.

BACKGROUND: The Amplatzer™ Trevisio™ Intravascular Delivery System (Trevisio DS; Abbott Laboratories, Chicago, IL, USA) facilitates the delivery of Amplatzer™ Occluders and features an ultraflexible tip, which improves assessment of occluder position before release. AIMS: To assess the safety and efficacy of the Trevisio DS for transcatheter closure of patent foramen ovale and atrial septal defect. METHODS: The Amplatzer™ Trevisio™ Intravascular Delivery System Post-Approval Study was a prospective, postmarket, single-arm, multicentre, observational study of the Trevisio DS. Enrolled patients were indicated for transcatheter closure of patent foramen ovale or atrial septal defect. In all procedures, the Trevisio DS was used to deliver Amplatzer™ Occluders. Technical success was defined as successful deployment and release of at least one occluder. Device- or procedure-related serious adverse events were tracked until discharge or day 7, whichever occurred earlier. RESULTS: The study enrolled 144 patients with patent foramen ovale and 107 patients with atrial septal defect at 22 European sites; 53 patients with atrial septal defect (49.6%) were aged<18years. The rate of technical success was 98.4% (97.2% for atrial septal defect, 99.3% for patent foramen ovale). There was one serious adverse event (0.4%), an acute periprocedural device embolization that occurred after occluder release in a patient with atrial septal defect; the device was retrieved percutaneously. This was determined by the implanter to be unrelated to the performance of the Trevisio DS. CONCLUSIONS: The Trevisio DS exhibited a high rate of technical success and an excellent safety profile during transcatheter closure of patent foramen ovale and atrial septal defect.

Cervical aortic arch in the pediatric population: a meta-analysis of individual patient's data.

Background: This is the first meta-analysis to analyze all reports of published pediatric cases of cervical aortic arch (CAA) by highlighting the clinical characteristics and treatment outcomes using the reported individual data of the patients. The aim of the study is to investigate the clinical features and surgical outcomes of such a rare disease in the pediatric population. Methods: A comprehensive search was conducted in various academic databases, including PubMed, ScienceDirect, SciELO, DOAJ, and Cochrane Library, until June 2022 for case reports describing the presence of cervical aortic arch in the pediatric age. Case reports and series were included if the following criteria were met: (1) description of the cervical aortic arch; (2) patient of pediatric age; and (3) published in the English language. All other types of publications that lacked patient-specific information were excluded from the analysis. This systematic review was conducted in accordance with the PRISMA guidelines. The primary outcome measure of the analysis was early and late mortality. Results: The literature search identified 2,272 potentially eligible articles, 72 of which met our inclusion criteria with 96 patients including the author's institutional case. At a median of 365 (90-730) days, the overall cohort registered a 7.3% (7/96) mortality rate. In the subset of patients who underwent surgery, the mortality rate was also 7.3% (4/55), and the mortality rate following surgery to treat only CAA was 2.4% (1/42). Dyspnea was identified as an independent determinant of mortality by employing the univariable Firth bias-reduced logistic regression method. Conclusion: Cervical aortic arch is a rare congenital heart disease that poses treatment challenges due to the high anatomical variability, diverse clinical presentations, and the presence of other concomitant diseases. The surgical treatment appears to be a safe and effective approach for resolving the symptoms, although it needs to be tailored individually for each patient. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=346826, Identifier: CRD42022346826.

Solving Intraoperative Complications During Endovascular Repair of Late Contained Ruptured Aortic Pseudoaneurysm After Surgical De-coarctation: Case Report and Systematic Review of Literature.

AIM: We present a case of successful endovascular repair of late ruptured aortic anastomotic pseudoaneurysm following previous left subclavian artery-descending thoracic aorta bypass and concomitant emergency thoracic endovascular aortic repair (TEVAR) of complicated endovascular aortic de-coarctation never previously described is also presented. A review of the intraoperative, 30-day, and follow-up morbidity, mortality, and complications of TEVAR as endovascular treatment of late aneurysm/pseudoaneurysms after surgical aortic de-coarctation was also performed. METHODS: The systematic review was performed in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement and following PICO model. A literature search was conducted on MEDLINE, PubMed, EMBASE, Cochrane Library, Google Scholar, Science Direct, and Web of Science using the words "tevar of late complication of aortic coarctation surgical repair" and "endovascular repair of anastomotic pseudoaneurysm in coarctation" up to June 17, 2022. Data were extracted from study documents about study design, patient's demographics and comorbidities, details about primary surgical repair, type of late complication, time between open surgery and occurrence of complications, details of the secondary endovascular procedure with technical success, early, and follow-up mortality and morbidity. RESULTS: A total of 18 papers were included with 78 patients (48 men, 69.5%). The most frequent type of primary open surgical repair was patch aortoplasty (46, 58.9%). Focusing on aneurysm and pseudoaneurysm as late complications, most of the patients were asymptomatic (45, 57.7%). All patients underwent TEVAR, 14 of them (17.9%) in urgent/emergent setting. The technical success was 98.7%, with 1 intraoperative death due to rupture of the aorta. In total, 31 patients out of 78 (39.7%) showed different complications in the immediate postoperative time, with type II endoleak being the most observed (8/31, 25.8%). The mean follow-up time was about 2 years (26.5 months, range 3-92). Overall, 30-day mortality was 2.6%. Complications occurred in 30 patients (39.4%), 23 of them resolved during the follow-up period. CONCLUSIONS: With the limit of low-quality data, TEVAR can be considered a safe and effective option for the treatment of late complications after open surgery for aortic coarctation, even in urgent settings. CLINICAL IMPACT: Different specialists have to face the technical complexities and risks related to treatment of late complications after surgical de-coartaction, which can be either surgical or endovascular, and depend on patient's ages. Although covered stents appear to have some protection from the development of stent fractures, doesn't provide complete protection from late aneurysm formation. In this setting, TEVAR may represent a valuable option, combining the advantages of the covered stent with those of a device that can cover a wider range of aortic length, especially in adult patients. This study shows thoracic endovascular repair can be considered a safe and effective option in clincal practice for the treatment of late complications after open surgery for AC, even in urgent settings.

Adults with tetralogy of Fallot show specific features of cerebral small vessel disease: the BACH San Donato study.

Life expectancy in adults with congenital heart disease (ACHD) has increased. As these patients grow older, they experience aging-related diseases more than their healthy peers. To better characterize this field, we launched the multi-disciplinary BACH (Brain Aging in Congenital Heart disease) San Donato study, that aimed at investigating signs of brain injury in ACHD. Twenty-three adults with repaired tetralogy of Fallot and 23 age- and sex-matched healthy controls were prospectively recruited and underwent brain magnetic resonance imaging. White matter hyperintensities (WMHs) were segmented using a machine-learning approach and automatically split into periventricular and deep. Cerebral microbleeds were manually counted. A subset of 14 patients were also assessed with an extensive neuropsychological battery. Age was 41.78 ± 10.33 years (mean ± standard deviation) for patients and 41.48 ± 10.28 years for controls (p = 0.921). Albeit not significantly, total brain (p = 0.282) and brain tissue volumes (p = 0.539 for cerebrospinal fluid, p = 0.661 for grey matter, p = 0.793 for white matter) were lower in ACHD, while total volume (p = 0.283) and sub-classes of WMHs (p = 0.386 for periventricular WMHs and p = 0.138 for deep WMHs) were higher in ACHD than in controls. Deep WMHs were associated with poorer performance at the frontal assessment battery (r = -0.650, p = 0.012). Also, patients had a much larger number of microbleeds than controls (median and interquartile range 5 [3-11] and 0 [0-0] respectively; p < 0.001). In this study, adults with tetralogy of Fallot showed specific signs of brain injury, with some clinical implications. Eventually, accurate characterization of brain health using neuroimaging and neuropsychological data would aid in the identification of ACHD patients at risk of cognitive deterioration.

Case report: Personalized transcatheter approach to mid-aortic syndrome by in vitro simulation on a 3-dimensional printed model.

An 8-year-old girl, diagnosed with mid-aortic syndrome (MAS) at the age of 2 months and under antihypertensive therapy, presented with severe systemic hypertension (>200/120 mmHg). Computed tomography (CT) examination revealed aortic aneurysm between severe stenoses at pre- and infra-renal segments, and occlusion of principal splanchnic arteries with peripheral collateral revascularization. Based on CT imaging, preoperative three-dimensional (3D) anatomy was reconstructed to assess aortic dimensions and a dedicated in vitro planning platform was designed to investigate the feasibility of a stenting procedure under fluoroscopic guidance. The in vitro system was designed to incorporate a translucent flexible 3D-printed patient-specific model filled with saline. A covered 8-zig 45-mm-long Cheatham-Platinum (CP) stent and a bare 8-zig, 34-mm-long CP stent were implanted with partial overlap to treat the stenoses (global peak-to-peak pressure gradient > 60 mmHg), excluding the aneurysm and avoiding risk of renal arteries occlusion. Percutaneous procedure was successfully performed with no residual pressure gradient and exactly replicating the strategy tested in vitro. Also, as investigated on the 3D-printed model, additional angioplasty was feasible across the frames of the stent to improve bilateral renal flow. Postoperative systemic pressure significantly reduced (130/70 mmHg) as well as dosage of antihypertensive therapy. This is the first report demonstrating the use of a 3D-printed model to effectively plan percutaneous intervention in a complex pediatric MAS case: taking full advantage of the combined use of a patient-specific 3D model and a dedicated in vitro platform, feasibility of the stenting procedure was successfully tested during pre-procedural assessment. Hence, use of patient-specific 3D-printed models and in vitro dedicated platforms is encouraged to assist pre-procedural planning and personalize treatment, thus enhancing intervention success.

Primary Arterial Switch Operation for Late Presentation of Transposition of the Great Arteries With Intact Ventricular Septum.

Transposition of the great arteries (TGA) with intact ventricular septum (IVS) are subject to neonatal arterial switch operation (ASO) to avoid deconditioning of the left ventricle (LV). Often an early repair is not feasible in developing countries where late referral is frequent. We aim to explore ASO outcomes in late TGA-IVS and compare "unfavorable candidates" (LV myocardial mass <35gr/m2 unfavorable geometry. banana-like LV shape) with other late TGA-IVS. Single-center retrospective study on late TGA-IVS who underwent primary ASO between 2015 and 2018. We divide patients into 2 groups: unfavorable candidates and favorable candidates TGA. We report categorical variables as number and percentage and continuous variables as median with interquartile range. Differences were assessed with Chi-squared or Fisher exact tests, Wilcoxon sign-rank, and Wilcoxon-rank sum tests. 45 TGA-IVS were referred with a median age of 35 days. Pre-operative echocardiography identified banana-like LV shape in 66.7%; unfavorable LV geometry in 47.6% and LV mass <35gr/m2 in 51%. Only 1 death occurred related to myocardial ischemia. Five patients (11%) required ECMO for LV dysfunction, with unfavorable candidates having a higher but not significant use (18.7% vs 6.9%, P = 0.33). At discharge, echocardiography demonstrated significant LV mass improvement compared to pre-operative (58.6 vs 33.8 gr/m2, P < 0.0001) with no significant echocardiographic difference between unfavorable and favorable late-TGA. Primary ASO in late presenter TGA-IVS can be performed safely with low mortality having a low threshold to ECMO. Significantly unconditioned LV are amenable with primary ASO with good LV mass recovery.

Impact of hard lockdown on interventional cardiology procedures in congenital heart disease: a survey on behalf of the Italian Society of Congenital Heart Disease.

The Coronavirus disease 2019 (COVID-19) pandemic has thoroughly and deeply affected the provision of healthcare services worldwide. In order to limit the in-hospital infections and to redistribute the healthcare professionals, cardiac percutaneous intervention in Pediatric and Adult Congenital Heart Disease (ACHD) patients were limited to urgent or emergency ones. The aim of this article is to describe the impact of the COVID-19 pandemic on Pediatric and ACHD cath laboratory activity during the so-called 'hard lockdown' in Italy. Eleven out of 12 Italian institutions with a dedicated Invasive Cardiology Unit in Congenital Heart Disease actively participated in the survey. The interventional cardiology activity was reduced by more than 50% in 6 out of 11 centers. Adolescent and ACHD patients suffered the highest rate of reduction. There was an evident discrepancy in the management of the hard lockdown, irrespective of the number of COVID-19 positive cases registered, with a higher reduction in Southern Italy compared with the most affected regions (Lombardy, Piedmont, Veneto and Emilia Romagna). Although the pandemic was brilliantly addressed in most cases, we recognize the necessity for planning new, and hopefully homogeneous, strategies in order to be prepared for an upcoming new outbreak.

Left ventricular restrictive physiology in kids with atrial septal defects: Something unexpected!

Atrial septal defect (ASD) associated with left ventricular (LV) diastolic dysfunction (DD) is rare in children. DD is common in elderly patients undergoing ASD closure. Restrictive physiology among children undergoing percutaneous ASD closure is something unexpected that has not been described before in the literature. Hence, we report a child referred to our center for ASD closure in whom an LV DD has been unmasked with a balloon occlusion test and has been managed with pharmacological preconditioning and subsequent ASD closure with good outcome. Albeit rare, LV DD can occur in children undergoing ASD closure.

Long-term follow-up after recanalisation of aortic arch atresia.

AIMS: Aortic arch atresia (AAA) is one of the rarest obstructive defects. The presence of this anomaly in adult age is uncommon. The typical anatomic feature consists of a complete occlusion of the membranous obstruction resulting in an acquired atresia without flow continuity between the proximal and distal segments. This feature is important in determining the feasibility of percutaneous intervention. The aim of the present study was to share long-term follow-up data of adult patients with AAA requiring percutaneous interventions for the management of this rare anomaly involving five different centres. METHODS AND RESULTS: Retrospective data of 19 patients (12 males, 63.2%, mean age 32.2±18.9 years) diagnosed with AAA treated in five different centres between 1999 and 2017 were collected. All patients underwent percutaneous recanalisation by (1) radiofrequency (RF) system (five patients, 26.3%), (2) extra-stiff guidewire (12 patients, 63.2%), and (3) transseptal needle (two patients, 10.5%). All procedures were subsequently followed by covered stent implantation. Two patients developed complications during the procedure and one of them died. Over a median follow-up of 4.94 years, four (21%) patients were able to be weaned from medications for hypertension. All the patients underwent reassessment for recurrence or restenosis during the follow-up. Seven (36.8%) patients underwent successful stent dilatation with a balloon. After the intervention, one patient experienced a late complication; however, one patient died due to an unknown cause believed to be unrelated to the previous recanalisation procedure. CONCLUSIONS: Percutaneous treatment of AAA is feasible with good long-term survival. This study reports the largest case series so far available in the literature.

Right and left ventricle native T1 mapping in systolic phase in patients with congenital heart disease.

BACKGROUND: T1 mapping is emerging as a powerful tool in cardiac magnetic resonance (CMR) to evaluate diffuse fibrosis. However, right ventricular (RV) T1 mapping proves difficult due to the limited wall thickness in diastolic phase. Several studies focused on systolic T1 mapping, albeit only on the left ventricle (LV). PURPOSE: To estimate intra- and inter-observer variability of native T1 (nT1) mapping of the RV, and its correlations with biventricular and pulmonary function in patients with congenital heart disease (CHD). MATERIAL AND METHODS: In this retrospective, observational, cross-sectional study we evaluated 36 patients with CHD, having undergone CMR on a 1.5-T scanner. LV and RV functional evaluations were performed. A native modified look-locker inversion recovery short-axis sequence was acquired in the systolic phase. Intra- and inter-reader reproducibility were reported as complement to 100% of the ratio between coefficient of reproducibility and mean. Spearman ρ and Mann-Whitney U-test were used to compare distributions. RESULTS: Intra- and inter-reader reproducibility was 84% and 82%, respectively. Median nT1 was 1022 ms (interquartile range [IQR] 1108-972) for the RV and 947 ms (IQR 986-914) for the LV. Median RV-nT1 was 1016 ms (IQR 1090-1016) in patients with EDVI ≤100 mL/m2 and 1100 ms (IQR 1113-1100) in patients with EDVI >100 mL/m2 (P = 0.049). A significant negative correlation was found between RV ejection fraction and RV-nT1 (ρ = -0.284, P = 0.046). CONCLUSION: Systolic RV-nT1 showed a high reproducibility and a negative correlation with RV ejection fraction, potentially reflecting an adaptation of the RV myocardium to pulmonary valve/conduit (dys)-function.

Right ventricular strain in repaired Tetralogy of Fallot with regards to pulmonary valve replacement.

PURPOSE: To assess right ventricular (RV) myocardial strain both globally and segmentally through feature-tracking cardiac magnetic resonance (CMR) in patients with Tetralogy of Fallot (ToF), with regards to pulmonary valve replacement (PVR). METHODS: After Ethics Committee approval, we retrospectively included 46 consecutive ToF patients who had two CMR examinations performed at our institution between March 2014 and June 2019. We divided patients into those who had not undergone PVR between the two CMR examinations (Group-0), and those who had (Group-1). Ventricular volumes were quantified on cine sequences, and strain was calculated through feature-tracking, using the previously traced segmentations. RV longitudinal and radial strain were assessed both globally and separately for the septum and free wall. Variations were normalized for intercurrent years, differences were appraised with t-tests or Mann-Whitney U. RESULTS: 30 patients belonged to Group-0 and 16 to Group-1. Median age was 22 years (interquartile range [IQR] 17-29 years) in Group-0, and 21 years (IQR 16-29 years) in Group-1. No significant differences were reported in RV strain between groups (p ≥ 0.254) except for RV septal radial strain, significantly higher (p = 0.010) in Group-0 (24.2 %, IQR 10.1-52.4 %) than in Group-1 (6.0 %, IQR -3.3-23.3 %) at the second CMR. Both global and segmental RV strains decreased over time in both groups, and yearly variations did not differ significantly (p ≥ 0.081) between groups. CONCLUSIONS: While PVR performed at the appropriate timing eases the burden on the RV allowing for a reduction in volumes, RV strain seems to continuously deteriorate as in patients who do not undergo PVR.

Lombardy regional urgent reorganization for congenital cardiac patients following the Covid-19 pandemic.

OBJECTIVE: By the end of February 2020, the COVID-19 pandemic infection had spread in Northern Italy, with thousands of patients infected. In Lombardy, the most affected area, the majority of public and private hospitals were dedicated to caring for COVID-19 patients and were organized following the 'Hub-and-Spoke' model for other medical specialties, like cardiac surgery and interventional procedures for congenital cardiac disease (CHD). Here, we report how the congenital cardiac care system was modified in Lombardy and the first results of this organization. METHODS: We describe a modified 'Hub-and-Spoke' model - that involves 59 birthplaces and three specialized Congenital Cardiac Centers -- and how the hub center organized his activity. We also reported the data of the consecutive cases hospitalized during this period. RESULTS: From 9 March to 15 April, we performed: a total of 21 cardiac surgeries, 4 diagnostic catheterizations, 3 CT scans, and 2 CMR. In three cases with prenatal diagnosis, the birth was scheduled. The spoke centers referred to our center six congenital cardiac cases. The postop ExtraCorporeal Membrane Oxygenation support was required in two cases; one case died. None of these patients nor their parents or accompanying person was found to be COVID-19-positive; 2 pediatric intensivists were found to be COVID-19-positive, and needed hospitalization without mechanical ventilation; 13 nurses had positive COVID swabs (4 with symptoms), and were managed and isolated at home. CONCLUSION: Our preliminary data suggest that the model adopted met the immediate needs with a good outcome without increased mortality, nor COVID-19 exposure for the patients who underwent procedures.

DATA in BRIEF of: Interventional Cardiac Catheterization in Neonatal Age: Results in a Multi-centre Italian Experience.

A comprehensive description of morbidity and mortality as well as risk factors of interventional cardiac catheterization performed in neonatal age was reported in our paper recently published on the International Journal of Cardiology (IJCA28502; PII: S0167-5273(20)30384-3; DOI: 10.1016/j.ijcard.2020.04.013). Eight Italian high-volume centres of Paediatric Cardiology were involved in this observational, retrospective data collection and analysis. In this dataset, clinical and procedural characteristics of 1423 newborns submitted to 1551 interventional cardiac catheterization procedures were analyzed. Primary outcomes were considered procedure and in-hospital mortality as well as major adverse event and procedural failure rates. Secondary outcomes were considered minor adverse events and need for blood transfusion. Targets of this data analysis were: 1) to evaluate the overall major risk factors of interventional cardiac catheterization; 2) to identify the most hazardous interventional procedures; 3) to assess possible trends of individual procedures as well as their outcome over time; 4) to find possible relationships between the volume activity of any centre and the procedure and follow-up outcome. In particular, this Data in Brief companion paper aims to report the specific statistic highlights of the multivariable analysis (binary logistic regression) used to assess the impact of any potential risk factors on the type of procedure over a short-term follow-up.