Surgical reconstruction for unilateral iliac artery lesions in patients younger than 50 years

Background: To evaluate safety, short and long-term graft patency, clinical success rates, and factors associated with patency, limb salvage and mortality after surgical reconstruction in patients younger than 50 years of age who had undergone unilateral iliac artery bypass surgery. Patients and methods: From January 2000 to January 2010, 65 consecutive reconstructive vascular operations were performed in 22 women and 43 men of age < 50 years with unilateral iliac atherosclerotic lesions and claudication or chronic limb ischemia. All patients were followed at 1, 3, 6, and 12 months after surgery and every 6 months thereafter. Results: There was in-hospital vascular graft thrombosis in four (6.1 %) patients. No in-hospital deaths occurred. Median follow-up was 49.6 ± 33 months. Primary patency rates at 1-, 3-, 5-, and 10-year were 92.2 %, 85.6 %, 73.6 %, and 56.5 %, respectively. Seven patients passed away during follow-up of which four patients due to coronary artery disease, two patients due to cerebrovascular disease and one patient due to malignancy. Limb salvage rate after 1-, 3-, 5-, and 10-year follow-up was 100 %, 100 %, 96.3 %, and 91.2 %, respectively. Cox regression analysis including age, sex, risk factors for vascular disease, indication for treatment, preoperative ABI, lesion length, graft diameter and type of pre-procedural lesion (stenosis/occlusion), showed that only age (beta - 0.281, expected beta 0.755, p = 0.007) and presence of diabetes mellitus during index surgery (beta - 1.292, expected beta 0.275, p = 0.026) were found to be significant predictors of diminishing graft patency during the follow-up. Presence of diabetes mellitus during index surgery (beta - 1.246, expected beta 0.291, p = 0.034) was the only variable predicting mortality. Conclusions: Surgical treatment for unilateral iliac lesions in patients with premature atherosclerosis is a safe procedure with a low operative risk and acceptable long-term results. Diabetes mellitus and age at index surgery are predictive for low graft patency. Presence of diabetes is associated with decreased long-term survival.

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Clinical results of the Metha short hip stem: a perspective for younger patients?

Orthopedic Reviews ◽

10.4081/or.2013.e34 ◽

2013 ◽

Vol 5 (4) ◽

pp. 34 ◽

Cited By ~ 30

Author(s):

Fritz Thorey ◽

Claudia Hoefer ◽

Nima Abdi-Tabari ◽

Matthias Lerch ◽

Stefan Budde ◽

...

Keyword(s):

Bone Ingrowth ◽

Long Term Results ◽

Harris Hip Score ◽

Femoral Revision ◽

Term Survival ◽

Younger Patients ◽

The Mean ◽

Short Stems

In recent years, various uncemented proximal metaphyseal hip stems were introduced for younger patients as a bone preserving strategy. Initial osteodensitometric analyses of the surrounding bone of short stems indicate an increase of bone mass with secondary bone ingrowth fixation as a predictor of long-term survival of these types of implants. We report the outcome of 151 modular Metha short hip stem implants in 148 patients between March 2005 and October 2007. The mean follow-up was 5.8±0.7 years and the mean age of the patients was 55.7±9.8 years. Along with demographic data and co-morbidities, the Harris Hip Score (HHS), the Hip dysfunction and Osteoarthritis Outcome Score (HOOS), and also the results of a patient-administered questionnaire were recorded pre-operatively and at follow-up. The mean HHS increased from 46±17 pre-operatively to 90±5 the HOOS improved from 55±16 pre-operatively to 89±10 at the final follow-up. A total of three patients have been revised, two for subsidence with femoral revision and one for infection without femoral revision (Kaplan Meier survival estimate 98%). The radiological findings showed no radiolucent lines in any of the patients. The modular Metha short hip stem was implanted in younger patients, who reported an overall high level of satisfaction. The clinical and radiographic results give support to the principle of using short stems with metaphyseal anchorage. However, long-term results are necessary to confirm the success of this concept in the years to come.

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Open Surgical versus Minimally Invasive in Situ Femorodistal Bypass: Long-term Results

Journal of Endovascular Therapy ◽

10.1177/152660280301000122 ◽

2003 ◽

Vol 10 (1) ◽

pp. 117-120 ◽

Cited By ~ 1

Author(s):

Nomdo S. Renken ◽

Cees H.A. Wittens ◽

Peter M.T. Pattynama ◽

Nico A.J.J. Du Bois ◽

Lukas C. van Dijk

Keyword(s):

Minimally Invasive ◽

Limb Salvage ◽

Long Term Results ◽

Open Technique ◽

Treatment Groups ◽

Closed Technique ◽

Open Versus

Purpose: To compare long-term patency and limb survival rates for the classical in situ surgical bypass procedure versus a minimally invasive technique for femorodistal revascularization. Methods: From May 1992 to June 1994, a prospective multicenter study was undertaken at 4 centers to evaluate the open versus closed technique for femorodistal bypass grafting. Of 97 patients enrolled in the trial, 73 patients (49 men; mean age 71 years) were assigned to the long-term follow-up protocol and prospectively randomized to the open (n = 38) or closed (n = 35) procedure. The classical open technique is characterized by a long incision over the length of the bypass graft, while the minimally invasive procedure involves only two short incisions over each anastomosis site (the side branches are closed with a coaxial embolization catheter system). Graft patency was evaluated with duplex imaging periodically throughout the 4-year observation period. Results: There was no statistically significant difference between the treatment groups with respect to age, sex, hypertension, ischemic heart disease, or smoking. However, the open group had a significantly greater incidence of diabetes (p = 0.037). Over a median 4.7-year follow-up (range 0.3–6.4), 9 (12%) patients (3 open and 6 closed) were lost to follow-up: 2 died and 7 refused the duplex examination. No significant differences in 4-year patency, limb salvage, or survival was demonstrated between the open versus closed treatment groups; 4-year secondary patency was 62% versus 64%, respectively, and limb salvage was 72% versus 86%. Conclusions: The closed technique for femorodistal in situ bypass procedures yields favorable long-term outcomes compared to the traditional open technique.

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Dynamic cranioplasty for brachycephaly in Apert syndrome: long-term follow-up study

Journal of Neurosurgery ◽

10.3171/jns.2001.94.5.0757 ◽

2001 ◽

Vol 94 (5) ◽

pp. 757-764 ◽

Cited By ~ 10

Author(s):

José Guimarães-Ferreira ◽

Fredrik Gewalli ◽

Pelle Sahlin ◽

Hans Friede ◽

Py Owman-Moll ◽

...

Keyword(s):

Cell Mass ◽

Apert Syndrome ◽

Long Term Results ◽

Safe Procedure ◽

Content Type ◽

Skull Shape ◽

The Mean ◽

Fine Print

Object. Brachycephaly is a characteristic feature of Apert syndrome. Traditional techniques of cranioplasty often fail to produce an acceptable morphological outcome in patients with this condition. In 1996 a new surgical procedure called “dynamic cranioplasty for brachycephaly” (DCB) was reported. The purpose of the present study was to analyze perioperative data and morphological long-term results in patients with the cranial vault deformity of Apert syndrome who were treated with DCB. Methods. Twelve patients have undergone surgery performed using this technique since its introduction in 1991 (mean duration of follow-up review 60.2 months). Eleven patients had bicoronal synostosis and one had a combined bicoronal—bilambdoid synostosis. Perioperative data and long-term evolution of skull shape visualized on serial cephalometric radiographs were analyzed and compared with normative data. Changes in mean skull proportions were evaluated using a two-tailed paired-samples t-test, with differences being considered significant for probability values less than 0.01. The mean operative blood transfusion was 136% of estimated red cell mass (ERCM) and the mean postoperative transfusion was 48% of ERCM. The mean operative time was 218 minutes. The duration of stay in the intensive care unit averaged 1.7 days and the mean hospital stay was 11.8 days. There were no incidences of mortality and few complications. An improvement in skull shape was achieved in all cases, with a change in the mean cephalic index from a preoperative value of 90 to a postoperative value of 78 (p = 0.000254). Conclusions. Dynamic cranioplasty for brachycephaly is a safe procedure, yielding high-quality morphological results in the treatment of brachycephaly in patients with Apert syndrome.

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Long-Term Results of Surgical Treatment of Popliteal Artery Aneurysms

International Surgery ◽

10.9738/intsurg-d-14-00301.1 ◽

2016 ◽

Vol 103 (5-6) ◽

pp. 315-322

Author(s):

Kimihiro Igari ◽

Toshifumi Kudo ◽

Takahiro Toyofuku ◽

Takehisa Iwai ◽

Yoshinori Inoue

Keyword(s):

Limb Salvage ◽

Popliteal Artery ◽

Surgical Repair ◽

Graft Patency ◽

Primary Patency ◽

Long Term Results ◽

Open Surgical Repair ◽

Autologous Vein ◽

Medial Approach

The aim of this study was to evaluate the long-term outcomes of the surgical repair of popliteal artery aneurysms (PAAs), and to analyze the factors associated with graft patency. Between January 1980 and December 2013, 45 limbs were subjected to open surgical repair at Tokyo Medical and Dental Hospital. We retrospectively examined the patients' clinical characteristics, clinical symptoms, and aneurysm-related anatomy. Surgical procedures were performed through a posterior or medial approach using autologous vein or prosthetic graft. Surgical outcomes were evaluated by postoperative mortality, postoperative morbidity, graft patency, and limb salvage. During the study period, 45 limbs (35 patients; mean age, 60 years) underwent open surgical repair. A total of 25 limbs were treated through a posterior approach using 23 autologous vein grafts (AVGs) and 2 expanded polytetrafluoroethylene (ePTFE) grafts. The other 20 limbs were treated through a medial approach using 13 AVGs and 7 ePTFE grafts. During the mean follow-up period of 65 months, the primary patency rates at 1, 3, and 5 years were 88.0%, 75.7%, and 75.7%, respectively, and the limb salvage rates at 1, 3, and 5 years were 97.1%, 91.4%, and 91.4%, respectively. In the univariate analysis, the ligation and bypass grafting affected the primary patency rate significantly, and the ePTFE graft was associated with a poor primary patency in the multivariate analysis (hazard ratio, 17.8). The use of resection or endoaneurysmorrhaphy for PAAs and graft interposition with an AVG might be more effective for the open repair of PAAs.

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Elective and Emergent Endovascular Treatment of Subclavian Artery Aneurysms and Injuries

Journal of Endovascular Therapy ◽

10.1177/152660280301000113 ◽

2003 ◽

Vol 10 (1) ◽

pp. 58-65 ◽

Cited By ~ 29

Author(s):

Maria Schoder ◽

Manfred Cejna ◽

Thomas Hölzenbein ◽

Georg Bischof ◽

Fritz Lomoschitz ◽

...

Keyword(s):

Stent Graft ◽

Subclavian Artery ◽

Artery Aneurysm ◽

Graft Patency ◽

Long Term Results ◽

Stent Grafts ◽

Central Venous ◽

Luminal Narrowing

Purpose: To demonstrate our short and long-term results after transbrachial treatment of subclavian artery aneurysms and injuries with stent-grafts in elective and emergency settings. Methods: Ten of 12 consecutive patients (6 men; mean age 63.8 years, range 38–80) were treated electively with commercially prepared endografts delivered via a transbrachial access to repair a subclavian artery aneurysm (n = 3) or an injury from a misplaced central venous catheter (n = 7). Two patients required emergency treatment for a ruptured atherosclerotic aneurysm in one and an unintentional arterial puncture during placement of a central venous access in the other. Stent-graft patency during follow-up was assessed by physical examination with comparison of brachial blood pressures in all patients; computed tomography angiography (CTA) was performed in available patients. Results: Successful deployment of stent-grafts with sealing of the lesion was achieved in all cases. There were 2 (17%) procedural complications. One patient developed an access-site hematoma that required surgical revision. The second patient, who had a right subclavian injury, suffered an embolic cerebral infarction. The primary stent-graft patency during follow-up (mean 11.6 months) was 100%. CTA examinations in 7 patients at a mean 18 months showed strut dislocation at the thoracic outlet without luminal narrowing in 1 patient. A 50% intraluminal narrowing due to compression between the clavicle and the first rib occurred in another patient. Six patients with a mean follow-up of 23 months (range 0.3–4.5 years) are still alive with patent stent-grafts. Conclusions: Endovascular stent-graft treatment of subclavian artery aneurysms and injuries is a less invasive alternative to surgical repair. Long-term results must still be confirmed in further studies.

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Hyperlipidemia and mortality associated with diabetes mellitus co-existence in Chinese peritoneal dialysis patients

Lipids in Health and Disease ◽

10.1186/s12944-020-01405-5 ◽

2020 ◽

Vol 19 (1) ◽

Author(s):

Xin Wei ◽

Yueqiang Wen ◽

Qian Zhou ◽

Xiaoran Feng ◽

Fen Fen Peng ◽

...

Keyword(s):

Diabetes Mellitus ◽

Peritoneal Dialysis ◽

Cox Regression ◽

Dialysis Patients ◽

Term Survival ◽

Risk Of Mortality ◽

Subgroup Analyses ◽

All Cause Mortality

Abstract Background To evaluate associations between diabetes mellitus (DM) coexisting with hyperlipidemia and mortality in peritoneal dialysis (PD) patients. Methods This was a retrospective cohort study with 2939 incident PD patients in China from January 2005 to December 2018. Associations between the DM coexisting with hyperlipidemia and mortality were evaluated using the Cox regression. Results Of 2939 patients, with a median age of 50.0 years, 519 (17.7%) died during the median of 35.1 months. DM coexisting with hyperlipidemia, DM, and hyperlipidemia were associated with 1.93 (95% CI 1.45 to 2.56), 1.86 (95% CI 1.49 to 2.32), and 0.90 (95% CI 0.66 to 1.24)-time higher risk of all-cause mortality, compared with without DM and hyperlipidemia, respectively (P for trend < 0.001). Subgroup analyses showed a similar pattern. Among DM patients, hyperlipidemia was as a high risk of mortality as non-hyperlipidemia (hazard ratio 1.02, 95%CI 0.73 to 1.43) during the overall follow-up period, but from 48-month follow-up onwards, hyperlipidemia patients had 3.60 (95%CI 1.62 to 8.01)-fold higher risk of all-cause mortality than those non-hyperlipidemia (P interaction = 1.000). Conclusions PD patients with DM coexisting with hyperlipidemia were at the highest risk of all-cause mortality, followed by DM patients and hyperlipidemia patients, and hyperlipidemia may have an adverse effect on long-term survival in DM patients.

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Does combined dose intensification radiotherapy improve disease control in resectable retroperitoneal sarcoma? Long-term results of a phase I/II trial.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.10050 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. 10050-10050

Author(s):

Myles JF Smith ◽

Paul F Ridgway ◽

Charles N Catton ◽

Amanda Cannell ◽

Brian O'Sullivan ◽

...

Keyword(s):

Phase I ◽

Disease Control ◽

Retroperitoneal Sarcoma ◽

Long Term Results ◽

Low Grade ◽

Term Survival ◽

Primary Disease ◽

Upper Abdomen

10050 Background: Late failure is a challenging problem in retroperitoneal sarcoma (RPS) and reported 10 yr overall survival (OS) rates range from 20-30%. Use of preoperative external beam radiotherapy (XRT) in the management of RPS remains controversial. No RCT and very few prospective trials of any type have been completed. We investigated the effects of preop XRT plus dose escalation with early postop brachytherapy (BT) on long term survival and recurrence in RPS. Methods: From 06/96 to 10/00, 40 patients (25 female) with resectable RPS were entered onto a phase I/II trial of preop XRT (50 Gy) plus postop BT (20-25 Gy). As previously reported, BT to the upper abdomen was associated with significant grade III-V postop toxicity, and from 12/98 on, BT was applied only to cases where the “field at risk” excluded the upper abdomen. Kaplan Meier survival curves were constructed; OS and recurrence free survival (RFS) were compared by log rank (SPSS 19.0). Results: Median age at study entry was 58 (38-70) yrs. Twenty nine patients presented to our center with primary disease (73%), and 22 (55%) had high grade tumors. All patients had preop XRT and total gross resection, while half (n=19) received BT. As of 12/2011, median follow-up time is 108 mos. For the entire study cohort, OS at 5 and 10 yrs were 70% and 65%, respectively; RFS at 5 and 10 yrs were 65% and 58%, respectively. RFS at 5 yrs was reduced in high vs. low grade RPS (50% vs. 83%, p=0.028), but by 10 yrs. was similar in high and low grade tumors (50% vs. 67%, p=ns). RFS was reduced in patients who presented with recurrent vs. primary disease (27% vs. 69% at 10 yrs., p=0.018), as was OS (36% vs. 76% at 10 yrs., p=0.034). Neither OS nor RFS was improved in the cohort of patients who received BT compared to the cohort who did not: at 10 yrs. RFS was 53% +BT and 62% -BT, while OS was 53% and 76%, respectively, p=ns. Conclusions: In this prospective study with mature follow-up, long term OS and RFS in patients who underwent combined preop XRT plus resection of RPS compare favorably with those reported in retrospective institutional and population-based series. Postoperative BT did not contribute to disease control.

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Surgical Aortic Mitral Curtain Replacement: Systematic Review and Metanalysis of Early and Long-Term Results

Journal of Clinical Medicine ◽

10.3390/jcm10143163 ◽

2021 ◽

Vol 10 (14) ◽

pp. 3163

Author(s):

Ilaria Giambuzzi ◽

Giorgia Bonalumi ◽

Michele Di Mauro ◽

Maurizio Roberto ◽

Silvia Corona ◽

...

Keyword(s):

Infective Endocarditis ◽

Pacemaker Implantation ◽

Early Mortality ◽

Long Term Results ◽

High Complexity ◽

Long Term Outcomes ◽

Term Survival ◽

Double Valve Replacement

The Commando procedure is challenging, and aims to replace the mitral valve, the aortic valve and the aortic mitral curtain, when the latter is severely affected by pathological processes (such as infective endocarditis or massive calcification). Given the high complexity, it is seldomly performed. We aim to review the literature on early (hospitalization and up to 30 days) and long-term (at least 3 years of follow-up) results. Bibliographical research was performed on PubMed and Cochrane with a dedicated string. Papers regarding double valve replacement or repair in the context of aortic mitral curtain disease were included. The metaprop function was used to assess early survival and complications (pacemaker implantation, stroke and bleeding). Nine papers (540 patients, median follow-up 41 (IQR 24.5–51.5) months) were included in the study. Pooled proportion of early mortality, stroke, pacemaker implant and REDO for bleeding were, respectively 16.2%, 7.8%, 25.1% and 13.1%. The long-term survival rate ranged from 50% to 92.2%. Freedom from re-intervention was as high as 90.9% when the endocarditis was not the first etiology and 78.6% in case of valvular infection (one author had 100%). Freedom from IE recurrences reached 85% at 10 years. Despite the high mortality, the rates of re-intervention and infective endocarditis recurrences following the Commando procedure are satisfactory and confirm the need for an aggressive strategy to improve long-term outcomes.

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Impact of diabetes mellitus on long-term survival after transcatheter mitral valve edge-to-edge repair

European Heart Journal ◽

10.1093/eurheartj/ehab724.1640 ◽

2021 ◽

Vol 42 (Supplement_1) ◽

Author(s):

M Geyer ◽

V H Schmitt ◽

K Keller ◽

S Born ◽

K Bachmann ◽

...

Keyword(s):

Diabetes Mellitus ◽

Mitral Valve ◽

Cox Regression ◽

Regression Analyses ◽

Term Survival ◽

Long Term Survival ◽

Short And Long Term ◽

Artery Disease

Abstract Introduction Diabetes mellitus (DM) represents a notable risk factor after surgical and interventional procedures but data on the influence of DM on long-term survival after Transcatheter Edge-to-edge Repair (TEER) for Mitral valve Regurgitation (MR) are sparse. Purpose To compare the outcome of patients with and without DM after TEER. Methods Retrospective monocentric assessment of patients after successful treatment of MR by TEER (exclusion of combined forms of transcatheter repair) between 06/2010 and 03/2018. Patients were stratified for DM at baseline and observed regarding mortality during follow-up. Cox regression analyses were performed for survival analyses. Results 627 patients (47.0% females, 88.2% aged ≥70 years) and among these 174 subjects with DM (27.3%) were included with a median follow-up period of 486 days [IQR 157–916 days]). Within the investigation period, 20 patients (3.2%) were lost to follow-up. Patients with DM more often presented severe comorbidities like obesity (27.3% vs. 9.2%, p<0.001), arterial hypertension (91.4% vs. 83.7%, p=0.013), renal insufficiency (63.8% vs. 43.9%, p<0.001), coronary artery disease (77.0% vs. 59.8%, p<0.001) or peripheral artery disease (14.4% vs. 8.4%, p=0.026) and had a higher median logistic Euroscore I (29.4% [20.0/43.0] vs. 25.0% [16.7/36.6], p=0.001) as well as reduced systolic function (LVEF 35% [30/50] vs. 45% [30/55], p<0.001). No statistical differences in short- and long-term survival were detected between patients with and without DM (in-hospital mortality 1.7 vs. 2.6%, p=0.771; at 30-days 5.0 vs. 6.0%, p=0.842, 1-year 28.7 vs. 25.0%, p=0.419, 3-years 49.2 vs. 44.1%, p=0.554, 5-years 69.0 vs. 68.3%, p=0.497). By calculating cox regression analyses, DM was not predictive for a higher mortality, even after adjustment for other risk factors (HR 1-year 1.17 [95% CI 0.80–1.71], p=0.419; HR long-term 1.13 [95% CI 0.86–1.49], p=0.373) in the total cohort, as well as after stratification for the underlying mitral valve pathology (functional MR: 1-year HR 0.99 [95% CI 0.01–1.62], p=0.969, long-term HR 0.903 [95% CI 0.63–1.29, p=0.571; primary MR: 1-year HR 1.48 [95% CI 0.66–3.35, p=0.344, long-term HR1.66 [95% CI 0.89–3.09], p=0.110). Conclusions Even though DM-patients presented with a more vulnerable clinical profile, no relevant differences in short- and long-term mortality after TEER for MR were found. Although being factored in most common risk scores, DM could not be associated with an adverse prognosis after transcatheter therapy of MR. FUNDunding Acknowledgement Type of funding sources: None.

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Outcomes after surgical resection of primary cardiac sarcomas

Patologiya krovoobrashcheniya i kardiokhirurgiya ◽

10.21688/1681-3472-2021-2-69-79 ◽

2021 ◽

Vol 25 (2) ◽

pp. 69

Author(s):

S. S. Babeshko ◽

Yu. P. Samurganov ◽

K. O. Barbukhatti ◽

V. A. Porkhanov

Keyword(s):

Local Recurrence ◽

Surgical Resection ◽

Conflict Of Interest ◽

Right Atrium ◽

Radical Resection ◽

Long Term Results ◽

Survival Duration ◽

Term Survival

Aim. To assess the immediate and long-term results of surgical treatment of patients with primary cardiac sarcomas.Methods. In the period from 2013 to 2020, five patients (two men and three women) of different age groups (from 10 to 54 years old) with primary cardiac sarcomas various localisations had been operated at our hospital. In all the patients, the operation was performed from the median sternotomy with cardiopulmonary bypass, normothermia and crystalloid cardioplegia.Results. The average age of the patients was 32 ± 12 years. Two patients had leiomyosarcoma (of right atrium and pulmonary artery), two had angiosarcoma of the right atrium and one was diagnosed with pleomorphic left atrial sarcoma. Only in two patients, the lesion was limited to one chamber; in other cases, the tumour exhibited aggressive infiltrative growth and invasion into the inferior vena cava, myocardium of the left ventricle, contralateral cardiac chambers, pericardium and parietal pleura. Three patients underwent radical surgery with R0 resection, two others underwent cytoreductive surgery with R2 resection owing to the prevalence of the process and the technical impossibility of radical resection. We did not record any in-hospital mortality. Postoperative chemotherapy was administered to four patients. At follow up, (median 18.8 ± 11.7 month), one patient was alive (follow-up 35 months) and was undergoing chemotherapy owing to local recurrence of the disease. One patient with pulmonary leiomyosarcoma underwent re-operation because of local recurrence 1 year after the primary surgery. All the patients died because of disease progression. The average postoperative survival duration in those who died was 14.8 ± 8.1 month.Conclusion. Despite effective early results, long-term survival and tumour-free course were disappointing owing to the initial prevalence of the disease course, the complexity of surgical procedures and the impossibility of radical resection in two cases. However, a multimodality treatment of this pathology, including radical surgical resection of the tumour (R0) along with the modern neoadjuvant and adjuvant chemotherapy, and in some cases, radiotherapy, can improve the survival duration.Received 18 December 2020. Revised 4 March 2021. Accepted 10 March 2021.Funding: The study did not have sponsorship.Conflict of interest: Authors declare no conflict of interest.

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