The paramount of three-dimensional echocardiography in percutaneous closure of large oval perimembranous ventricular septal defect: a case report.

Background: Ventricular septal defect (VSD) is the most common type of congenital heart abnormality with perimembranous VSD (pmVSD) accounting for ∼70% of all VSD. Nowadays, transcatheter closure is the first choice for suitable pmVSD. However, there was no report about closing the large oval-shaped VSD percutaneously. Case summary: A 34-year-old male with known VSD was referred for transcatheter closure after failed attempts in other hospital. Patient had been diagnosed with VSD at a young age, but he was lost to follow-up. He presented with shortness of breath due to heart failure and pulmonary hypertension. The initial measurement of the defect was 6-7 mm by transthoracic echocardiography (TTE), transoesophageal echocardiography (TEE), and LV angiography. However, re-measurement using TEE and 3D echocardiography revealed that the VSD is oval with diameters of 18 mm × 6 mm. Initially, device No. 12/14 was used, but it was dislodged on two attempts. The operator then decided to upsize the device size to No. 16/18 that was successful. The patient's condition was good, and 6 months follow-up after the procedure showed good outcomes without any residual defect or arrhythmia. Discussion: In this study, we would like to highlight the rarity of large oval pmVSD that almost failed to be closed with the conventional measurement with echocardiography and fluoroscopy. Transoesophageal echocardiography especially 3D can be the new modality of choice that might be superior to fluoroscopy to decide the right device size in some cases such as oval-shaped pmVSD.

Right ventricular outflow tract stenting for late presenter unrepaired Fallot physiology: a single-center experience.

Objectives: The purpose of this study was to assess the clinical outcome after right ventricular outflow tract (RVOT) stenting in late presenter patient with unrepaired Fallot physiology. Background: In younger patients, RVOT stenting is an alternative to mBTT shunt; however, there have been few reports of this palliative technique in late presenter population, including adults. Methods: This was a single-center, retrospective study of nonrandomized, palliated Fallot patients. Clinical outcomes such as left ventricular ejection fraction and saturation were measured in 32 individuals following RVOT stenting in adults (n = 10) and children (n = 22). The Statistical Package for Social Science (SPSS) 26.0 software was used to analyze the statistical data. Results: During the procedure, the average stent diameter and length were 8.84 ± 1.64 mm and 35.46 ± 11.23 mm, respectively. Adult patients received slightly longer stents than pediatric patients (43.60 ± 11.64 mm vs. 31.77 ± 9.07 mm). Overall, patients' saturation increased from 58.56 ± 19.03% to 91.03 ± 8.98% (p < 0.001), as did their left ventricular ejection fraction (LVEF) from 64.00 ± 18.21% to 75.09 ± 12.98% (p = 0.001). Three patients improved their LVEF from 31 to 55%, 31 to 67%, and 26 to 50%. The median length of stay was 8 (2-35) days, with an ICU stay of 2 (0-30) days. The median time from RVOT stent palliation to total repair was 3 months (range: 1 month-12 months). Conclusions: RVOT stenting is a safe and effective method for increasing saturation and ejection fraction not only in newborn infants but also in late presenters, including adults with unrepaired Fallot physiology.

A young woman with acute coronary syndrome and antiphospholipid syndrome. Is it the antiphospholipid syndrome or COVID-19 vaccination or classical risk as the risk factor? a case report.

BACKGROUND: Acute coronary syndrome (ACS) in young women is poorly understood due to underdiagnosis and undertreatment. One of the possible risk factors for ACS in young women is antiphospholipid syndrome (APS). Coronavirus disease 2019 (COVID-19) vaccination also emerged as one of the possible risk factors for ACS during the COVID-19 pandemic. CASE PRESENTATION: Our patient, a 39-year-old Batak woman with dyslipidemia and family history of cardiovascular disease, experienced chest pain slightly improved at rest accompanied by autonomic symptoms. She was diagnosed with non-ST-elevation myocardial infarction (NSTEMI) based on her clinical features, dynamic electrocardiogram changes, troponin elevation, and multislice computed tomography angiography confirmed with diagnostic catheterization. The patient was managed by percutaneous coronary intervention with implantation of drug-eluting stents. On follow-up, the patient was diagnosed with APS based on history of preeclampsia with severe features in the first and third pregnancy, spontaneous abortion in the second pregnancy, history of transient ischemic attack, moderately positive lupus anticoagulant on two occasions with an interval of 12 weeks, and ACS. Further investigation revealed a history of COVID-19 vaccination with Sinovac four and six weeks before presentation. The patient was recommended for lifelong warfarin and short-term dual antiplatelet (aspirin and ticagrelor). CONCLUSIONS: Young women are not completely immune to ACS as evident in this case of ACS in a young woman with classical risk factors (dyslipidemia and family history of cardiovascular disease) and APS. Further studies are required to fill the knowledge gap on whether COVID-19 vaccination had any contribution to the ACS in the young woman.

Pulmonary reperfusion injury in post-palliative intervention of oligaemic cyanotic CHD: a new catastrophic consequence or just revisiting the same old story?

Pulmonary reperfusion injury is a well-recognised clinical entity in the setting pulmonary artery angioplasty for pulmonary artery stenosis or chronic thromboembolic disease, but not much is known about this complication in post-palliative intervention of oligaemic cyanotic CHD. The pathophysiology of pulmonary reperfusion injury in this population consists of both ischaemic and reperfusion injury, mainly resulting in oxidative stress from reactive oxygen species generation, followed by endothelial dysfunction, and cytokine storm that may induce multiple organ dysfunction. Other mechanisms of pulmonary reperfusion injury are "no-reflow" phenomenon, overcirculation from high pressure in pulmonary artery, and increased left ventricular end-diastolic pressure. Chronic hypoxia in cyanotic CHD eventually depletes endogenous antioxidant and increased the risk of pulmonary reperfusion injury, thus becoming a concern for palliative interventions in the oligaemic subgroup. The incidence of pulmonary reperfusion injury varies depending on multifactors. Despite its inconsistence occurrence, pulmonary reperfusion injury does occur and may lead to morbidity and mortality in this population. The current management of pulmonary reperfusion injury is supportive therapy to prevent deterioration of lung injury. Therefore, a general consensus on pulmonary reperfusion injury is necessary for the diagnosis and management of this complication as well as further studies to establish the use of novel and potential therapies for pulmonary reperfusion injury.

Transesophageal echocardiography-guided percutaneous closure of multiple muscular ventricular septal defects with pulmonary hypertension using single device: A case report.

Background: Surgery is typically used to correct challenging ventricular septal defects (VSDs), such as VSD with pulmonary hypertension and multiple defects. In this case report, we would like to highlight the feasibility of multiple defects VSD closure with single device percutaneously using zero-fluoroscopy technique. Case presentation: A 7-year-old child was referred with the main symptom of shortness of breath. She started experiencing repeated respiratory tract infections, feeding issues, and failure to thrive at the age of six months. Her body weight was only 18 kg. TEE revealed several muscular VSD with 2-3 mm and 12 mm diameters, 3 mm spacing between VSD, L to R shunt, AR (-), and TR mild with septal leaflet tricuspid prolapse. Following right heart catheterization (Qp:Qs 3.5, PVRi 5.23WUmsq, PVR 4.55 WU, PVR/SVR 0.16), we made the decision to correct the defect using an Amplatzer Septal Occluder (AGA) No. 16 mm using transjugular method. Full device deployment was successfully performed with several episodes of PVC storm and severe bradycardia. One and a half years after the procedure, her TVG dropped to only 18 mmHg, her visible indicators of PH subsided, and the PA dilator treatment was discontinued. Her body weight had increased to 28 kg, and she had no complaints. Conclusions: Our experience demonstrated that percutaneous closure of multiple VSD with a single device is possible, even with pulmonary hypertension.

The outcomes of fetal aortic valvuloplasty in critical aortic stenosis: A systematic review and meta-analysis.

BACKGROUND: Critical aortic stenosis that appears in mid-gestation tends to develop to growth retardation of left ventricle, known as hypoplastic left heart syndrome (HLHS). Despite better clinical management of HLHS, the morbidity and mortality rates of univentricular circulation patients remain high. In this paper, we sought to perform a systematic review and meta-analysis to know the outcomes of fetal aortic valvuloplasty in critical aortic stenosis patients. METHODS: This systematic review and meta-analysis was conducted according to the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) statement. A systematic search on fetal aortic valvuloplasty procedure for critical aortic stenosis was performed through PubMed, Scopus, EBSCOhost, ProQuest, and Google Scholar. The primary endpoint of each group was overall mortality. We used R software (version 4.1.3) to estimate the overall proportion of each outcome using random-effects model of proportional meta-analysis. RESULTS: A total of 389 fetal subjects from 10 cohort studies were included in this systematic review and meta-analysis. Fetal aortic valvuloplasty (FAV) was successfully performed in 84% of patients. It revealed a successful conversion to biventricular circulation rate of 33% with a mortality rate of 20%. Bradycardia and pleural effusion requiring treatment were two most common fetal complications, whereas maternal complication reported was only placental abruption in one patient. CONCLUSIONS: FAV has a high technical success rate with the ability to achieve biventricular circulation and a low rate of procedure-related mortality if carried out by experienced operators.

A retrograde approach for transcatheter valvotomy procedure in infants with pulmonary atresia intact ventricular septum (PA-IVS): retrograde versus antegrade approach.

INTRODUCTION: This study evaluates the retrograde approach compared to the antegrade approach in infants with PA-IVS who underwent transcatheter pulmonary valvotomy procedure at National Cardiovascular Center Harapan Kita, Jakarta, Indonesia. MATERIAL AND METHOD: This is a single-centre retrospective study conducted from January 2017 to June 2019 consisting of infants undergoing transcatheter pulmonary valvotomy procedures from our centre. RESULTS: Among 3733 records of cardiac catheter procedure in paediatric patients during the last 3 years, there were 12 subjects with PA-IVS, where five subjects were done by antegrade approach and seven by retrograde approach. The retrograde approach is shown to excel the antegrade approach in terms of procedural time by 58.64 minutes (CI 95 % 32.97-84.29, p = 0.008) and PA-RV crossing time by 27 minutes (CI 95 % 14.01-39.99, p = 0.02). There was no significant difference in contrast used (120.23 ± 25.77 versus 150.27 ± 39.26 ml/BSA, p = 0.518), and right ventricle to pulmonary artery systolic pressure gradient after valvotomy (39.571 ± 5.814 versus 53.52 ± 29.15, p = 0.329) between the retrograde and the antegrade approach. CONCLUSION: The retrograde approach offered shorter procedural time and comparably satisfying results than the antegrade approach. The shorter procedural time was preferred due to the shorter duration of general anaesthesia, which may decrease the risk of neurodevelopmental deficits in the patient.

The Risk Factors of Acute Coronary Syndrome in Young Women: A Systematic Review and Meta-Analysis.

BACKGROUND: Acute coronary syndrome (ACS) has been one of the leading causes of mortality in the world. Despite common understanding regarding ACS as an older population's or man's disease, the number of young women affected by this condition is increasing. Many studies have assessed the risk factors of ACS, but only a few studies focused on this subpopulation. Therefore, this systematic review and meta-analysis aim to evaluate the risk factors predisposing to ACS in the young women population. METHODS: Nine online databases were screened from the date of inception to September 2021, where the acquired studies were evaluated using the PRISMA statement. The inclusion criteria were a case control study with women age cut-off of <50 years. The risk factors of acute coronary syndrome were analyzed using a random-effect model, expressed as summary statistics of odds ratio (OR) for categorical variable and standard mean difference (SMD) for continuous data with normal distribution, with 95% confidence interval (CI). Quality assessment was conducted using the STROBE statement. RESULTS: Seven studies with the total of 7042 patients met the inclusion criteria of this metaanalysis. Diabetes mellitus, high BMI, obesity, hypercholestrolemia, hypertension, smoking, and family history significantly increased acute coronary syndrome risk in young women. Other risks such as heavy alcohol consumption, oral contraceptive use, and postmenopausal state were associated with higher risk of ACS. CONCLUSION: The independent risk factors which are strongly related to ACS in young women were diabetes mellitus, hypertension, and hypercholesterolemia with odd ratios of 6.21, 5.32, and 4.07. Other risk factors which may be associated with an increased risk of ACS in young women were heavy alcohol consumption, oral contraceptive use, and postmenopausal state. Health promotion and effective intervention on this specific population regarding these risk factors can decrease young female cardiovascular morbidity and mortality as well as improved quality of life of women.

Clinical outcomes of COVID-19 infection in congenital heart disease: A single-center experience in Indonesia.

Background: Congenital heart disease (CHD) patients are thought to be vulnerable to COVID-19 complications. In this study, we would like to assess the outcomes and clinical characteristics in COVID-19 CHD patients. Method: A single-center, observational study was conducted in National Cardiovascular Center Harapan Kita (NCCHK). This study included patients with CHD who were hospitalized for COVID-19. The extracted data were baseline characteristics, clinical findings, supportive examination findings, complications, outcomes, and length of stay of the patients. The data were then analyzed using SPSS 26.0 software. Result: Twenty-six patients with CHD and COVID-19 infection were included in our study. There were 24 resolved cases and 2 deaths, four patients experienced complications such as renal insufficiency (1), sepsis (2), and multiorgan failure (1). The median length of stay was 13 days. The most common symptoms experienced by the patients were breathlessness (65.4%), cough (57.7%), and fever (42.3%). Conclusion: We observed a relatively mild COVID-19 clinical course despite prior research showing that patients with cardiovascular comorbidities, such as CHD, have a higher case-fatality rate. This could be because of the smaller sample size, non-standardized diagnosis, severity, treatment, and age group.

Impact of older age at Fontan completion on mid-term survival.

BACKGROUND: The optimum age of Fontan completion remains unknown. Currently, the majority of centers worldwide are performing Fontan completion at 2-4 years of age. In Indonesia, lack of awareness and limited resources probably explain why patients seek treatment at advanced stage. This study aimed to evaluate the impact of older age at Fontan completion on mid-term survival. RESULTS: A single-center retrospective cohort study was performed on 261 patients who underwent Fontan completion between 2008 and 2019 and survived to discharge. The patients were followed up until April 2020, with a median follow-up period of 3 years (range 0-12 years). The median age was 5 years (range 2-24 years). The survival rates of patients with the age at operation ≤ 6 years and > 6 years were 92.1% and 82.8%, respectively. A subgroup analysis showed that the survival rates for age < 4 years, 4-6 years (reference age), 6-8 years, 8-10 years, 10-18 years, and > 18 years were 85.7%, 94.8%, 85.4%, 78.8%, 85.7%, and 66.7%, respectively. Age at Fontan completion of > 6 years (HR 3.84; p = 0.020) was associated with a lower 12-year survival rate. The age at operation of 8-10 years (HR 6.79; p = 0.022) and > 18 years (HR 15.30; p = 0.006) had the worst survival rates. CONCLUSIONS: An older age at Fontan completion (> 6 years) significantly reduced mid-term survival rate. The age at Fontan of 8-10 years and > 18 years had higher risk of mid-term death than age of 4-6 years.

Echocardiography-Guided Percutaneous Patent Ductus Arteriosus Closure: 1-Year Single Center Experience in Indonesia.

Introduction: Since the first successful percutaneous closure under transesophageal echocardiographic (TEE) guidance, many centers explored transcatheter procedures without fluoroscopy. This single-center study is aimed to show the feasibility and safety of percutaneous patent ductus arteriosus (PDA) closure under echocardiography-only guidance during our 1-year experience. Methods: Patients with PDA were recruited for percutaneous PDA closure guided by either fluoroscopy or echocardiography-only in National Cardiovascular Center Harapan Kita (ClinicalTrials.gov Identifier: NCT05321849, clinicaltrials.gov/ct2/show/NCT05321849). Patients were evaluated clinically and radiologically using transthoracic echocardiography (TTE) at 6, 24, and 48 h after the procedure. The primary endpoint was the procedural success. Secondary endpoints were the procedural time and the rate of adverse events. Results: A total of 60 patients underwent transcatheter PDA closure, 30 patients with fluoroscopy and 30 patients with echocardiography guidance. All patients had successful PDA closure. There were only residual shunts, which were disappeared after follow-up in both groups, but one patient with a fluoroscopy-guided procedure had moderate tricuspid regurgitation with suspected thrombus in the tricuspid valve. The procedural time was not significantly different between the fluoroscopy and echocardiography groups.

Reversed Potts Shunt Outcome in Suprasystemic Pulmonary Arterial Hypertension: A Systematic Review and Meta-Analysis.

BACKGROUND: Reversed Potts shunt has been a prospective approach to treat suprasystemic pulmonary hypertension, particularly when medication treatment fails to reduce right ventricular afterload. OBJECTIVE: This meta-analysis aims to review the clinical, laboratory, and hemodynamic parameters after a reversed Potts shunt in suprasystemic pulmonary hypertension patients. METHODS: Six electronic databases were searched from the date of inception to August 2021, where the obtained studies were evaluated according to the PRISMA statement. The effects of shunt creation were evaluated by comparing preprocedural to postprocedural or follow-up parameters, expressed as a mean difference of 99% confidence interval. Quality assessment was conducted using the STROBE statement. RESULTS: Seven studies suited the inclusion criteria which were included in this article. A reduction in upper and lower limb oxygen saturation [Upper limb: St. Mean difference -0.55, 99% CI -1.25 to 0.15; P=0.04; I2=6%. Lower limb: St. Mean difference -4.45, 99% CI -7.37 to -1.52; P<0.00001; I2=65%]. Reversed Potts shunt was shown to improve WHO functional class, 6-minute walk distance, NTpro-BNP level, and hemodynamic parameters including tricuspid annular plane systolic excursion, interventricular septal curvature, and end-diastolic right ventricle/left ventricle ratio. CONCLUSION: Reversed Potts shunt cannot be said to be relatively safe, although it allows improvement in the clinical and functional status in patients with suprasystemic PAH. Reversed Potts shunt procedure may be the last resort for drug-resistant pulmonary hypertension as it is considered a high-risk procedure performed on patients with extremely poor conditions.

Pharmacology Management in Improving Exercise Capacity of Patients with Fontan Circulation: A Systematic Review and Meta-analysis.

BACKGROUND: The Fontan procedure is currently the mainstay therapy for single functional ventricles. However, with prolonged follow-up duration, various complications have been observed that seriously influence the quality of life of patients. OBJECTIVES: The aim of this meta-analysis is to compare the effectiveness of pharmacologic agents in improving exercise capacity in patients with Fontan circulation. METHODS: This meta-analysis was conducted according to the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) statement and has been registered in the International Prospective Register for Systematic Reviews database with registration no. 282352. Quality assessments of the included studies were assessed using the Strengthening Reporting of Observational Studies in Epidemiology (STROBE) statement. RESULTS: Twelve studies met the predetermined inclusion criteria and were included in this metaanalysis. This meta-analysis found that treatment with bosentan significantly improved New York Heart Association Functional Class (NYHA FC) in Fontan patients (standard mean difference - 0.59, 95% CI -0.94 - -0.25; P=0.0008; I2 = 1%). However, the use of bosentan (P=0.66) and sildenafil (P=0.13) did not show a significant improvement in the maximum rate of oxygen consumption (VO2 max). CONCLUSION: This meta-analysis shows that people with Fontan circulation may benefit from using bosentan as it decreases postexercise heart rate and improves NYHA FC and 6-minute walking test results. Therefore, indirectly improving exercise capacity. Nonetheless, considerable work is required to strengthen our knowledge in improving the exercise capacity of Fontan patients.

Association between Right Ventricle-Pulmonary Artery Coupling with In-Hospital Outcome after Triple Valve Surgery in Rheumatic Heart Disease.

Context: Triple valve surgery (TVS) is a relatively higher in-hospital mortality rate than any isolated valve surgery. In advanced-stage valvular heart disease, maladaptation may occur, creating RV-PA uncoupling. Aims To evaluate whether RV-PA coupling is associated with the in-hospital outcome of patients after TVS. Settings and Design: From the medical records, clinical and echocardiography data were collected and compared between the survived and patients with in-hospital mortality groups. Methods and Material: Patients with the rheumatic multivalvular disease who underwent triple valve surgery were included in the study. Statistical and analysis used Uni and bivariate analysis assessed any association between the RV-PA coupling using TAPSE/PASP and other clinical variables with the in-hospital mortality post TVS. Result: From 269 patients, the in-hospital mortality rate was 10 %. The median value of TAPSE/PASP ratio in all group is 0.41 (0.02-5.79). Impaired RV-PA coupling which value < 0.36 occurs in 38.3 % population. By multivariate analysis, independent predictors of in-hospital mortality were TAPSE/PASP < 0.36 (OR 3.46, 95 % CI 1.21 - 9.89; P 0.02), age (OR 1.04, 95 % CI 1.003-1.094; P 0.035), CPB duration, (OR 1.01, 95 % CI 1.003-1.017; P 0.005). Conclusion: RV-PA uncoupling assessed by TAPSE / PASP ratio < 0.36 is associated with the in-hospital mortality in patients post triple valve surgery. Other factors associated with the outcome were older age and longer CPB machine duration.

A Comparative Effectiveness Systematic Review and Meta-analysis of Drugs for the Prophylaxis of Junctional Ectopic Tachycardia.

BACKGROUND: Junctional Ectopic Tachycardia (JET) is an arrhythmia originating from the AV junction, which may occur following congenital heart surgery, especially when the intervention is near the atrioventricular junction. OBJECTIVE: The aim of this systematic review and meta-analysis is to compare the effectiveness of amiodarone, dexmedetomidine, and magnesium in preventing JET following congenital heart surgery. METHODS: This meta-analysis was conducted according to the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) statement, where 11 electronic databases were searched from the date of inception to August 2020. The incidence of JET was calculated with the relative risk of 95% Confidence Interval (CI). Quality assessment of the included studies was assessed using the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement. RESULTS: Eleven studies met the predetermined inclusion criteria and were included in this meta-analysis. Amiodarone, dexmedetomidine, and magnesium significantly reduced the incidence of postoperative JET [Amiodarone: risk ratio 0.34; I2= 0%; Z=3.66 (P=0.0002); 95% CI 0.19-0.60. Dexmedetomidine: risk ratio 0.34; I2= 0%; Z=4.77 (P<0.00001); 95% CI 0.21-0.52. Magnesium: risk ratio 0.50; I2= 24%; Z=5.08 (P<0.00001); 95% CI 0.39-0.66]. CONCLUSION: All three drugs have shown promising results in reducing the incidence of JET. Our systematic review found that dexmedetomidine is better in reducing the length of ICU stays as well as mortality. In addition, dexmedetomidine also has the least pronounced side effects among the three. However, it should be noted that this conclusion was derived from studies with small sample sizes. Therefore, dexmedetomidine may be considered as the drug of choice for preventing JET.

Balloon pulmonary valvuloplasty in neonates with critical pulmonary stenosis: Jugular or femoral.

BACKGROUND: Critical pulmonary stenosis (PS) is one of the life-threatening congenital heart diseases which present during the neonatal period with cyanosis. Surgical valvotomy was once the procedure of choice for critical PS; however, balloon pulmonary valvuloplasty (BPV) has now become the standard treatment. Although the procedure is usually simple, crossing the pulmonary valve from the femoral vein can be difficult, especially when severe tricuspid regurgitation and right atrium dilatation are present. In such patients, the maneuver can be simplified by using the right internal jugular vein approach. However, many operators are reluctant to use this approach because of unfamiliarity with the technique, potential complications, and paucity of reports. Until now, there is no literature describing BPV using the transjugular approach in neonates, also none directly comparing the transfemoral and transjugular approaches. OBJECTIVE: We compared transjugular with the transfemoral approach in terms of procedure time and complications. MATERIALS AND METHODS: This was a retrospective cohort study. Participants were neonates with critical PS undergoing BPV in the National Cardiovascular Center Harapan Kita from 2013 to 2018. RESULTS: Of 15 neonates undergoing BPV, eight were done using the transjugular approach and seven using the femoral approach. Mean age and weight in both groups was similar. In all eight patients using transjugular approach, crossing the pulmonary valve was consistently quick and easy. The total procedural time, pulmonary crossing time, and fluoro time was significantly shorter using the transjugular approach (65 ± 8 vs. 108 ± 17.8 min, P < 0.05; 22 ± 3.1 vs. 45 ± 14.8 min, P < 0.01; 29 ± 13 vs. 67 ± 35 min, P < 0.05). There were no complications relating to vascular access. Moreover, the BPV procedure itself demonstrated comparable results in both groups. CONCLUSION: BPV using the transjugular approach is safe and effective to relieve critical PS in neonates compared to the transfemoral approach.