Clinical and Angiographic Outcomes of Elective Paclitaxel-Coated Balloon Angioplasty in Comparison with Drug-Eluting Stents for De Novo Coronary Lesions in Large Vessels.

We retrospectively examined the feasibility of paclitaxel-coated balloon (PCB) angioplasty for de novo stenosis in large coronary vessels (LV; pre- or postprocedural reference vessel diameter ≥ 2.75 mm) in comparison with placement of drug-eluting stents (DESs).Consecutive de novo stenotic lesions in the LV electively and successfully treated with either PCB (n = 73) or DESs (n = 81) from January 2016 to December 2018 at our center were included. The primary endpoint was the incidence of target lesion failure (TLF), including cardiac death, nonfatal myocardial infarction, and target vessel revascularization. The impact of PCB on TLF was examined using Cox proportional hazards models by including 39 variables. The secondary endpoint, angiographic restenosis, defined as a follow-up percent diameter stenosis > 50, was examined in angiographic follow-up lesions after PCB angioplasty (n = 56) and DES placement (n = 53). This retrospective investigation was conducted in July 2022.The mean PCB size and length were 3.23 ± 0.42 and 18.4 ± 4.3 mm, respectively. The TLF frequency in the PCB group (6.8% during the mean observational interval of 1536 ± 538 days) was not significantly different from that in the DES group (14.6%, 1344 ± 606 days, P = 0.097). PCB was not a significant predictor of TLF in the univariate analysis (hazard ratio: 0.424; 95%CI: 0.15-1.21; P = 0.108). There was no angiographic restenosis after PCB angioplasty.The present observational single-center study showed that PCB for de novo stenosis in the LV had no significant adverse impact on TLF and had favorable angiographic outcomes.

Clinical Outcomes of Patients with Chronic Kidney Disease Undergoing Percutaneous Coronary Interventions with a Novel Dynamic Coronary Roadmap System.

Dynamic coronary roadmap (DCR) is a novel technology that creates a real-time overlay of the coronary arteries in percutaneous coronary intervention (PCI) and has the potential to reduce the contrast volume. However, the efficacy of DCR in terms of clinical outcomes in patients with chronic kidney disease (CKD) remains to be fully elucidated.This single center retrospective study enrolled 275 patients with CKD who underwent PCI, and divided them into a DCR group (n = 124) and Non-DCR group (n = 151). Propensity score matching was performed to minimize the differences in baseline characteristics in 113 patient pairs. The primary endpoint was a composite outcome of all-cause death, hospitalization for heart failure, nonfatal myocardial infarction, or the introductory rate of dialysis within 2 years. The secondary endpoints were contrast medium volume, the incidence of contrast-induced acute kidney injury (CI-AKI), and the introductory rate of dialysis within 2 years.Although there was no significant difference in the success rate (DCR group: 99.1% versus Non-DCR group: 98.2%; P = 0.561), contrast volume (92.20 mL versus 115.97 mL; P = 0.002) was significantly lower in the DCR group. CI-AKI incidence was 0.9% versus 6.2% in the DCR and Non-DCR groups, respectively (P = 0.031). The composite outcome defined as primary endpoint occurred in 10 patients in the DCR group and 20 patients in the Non-DCR group (8.8% versus 17.7%; P = 0.049).From the perspective of acute and long-term clinical outcomes, DCR use may be effective for patients with CKD.

Mid-term follow-up results after implementing a new strategy for the diagnosis and management of periprosthetic joint infections.

BACKGROUND: Periprosthetic joint infections (PJIs) represent one of the most serious complications associated with joint replacement surgeries, a complication also of modern orthopedic surgery despite the efforts that occurred in this field. Frequently PJIs lead to prolonged morbidity, increased costs and mortality. METHODS: We are conducting a single-center observational cohort ongoing study in the Academic Emergency Hospital Sibiu, Romania, study in which sonication of the retrieved and as a rapid method of bacteria detection, molecular identification of bacteria by 16S rRNA beacon-based fluorescent in situ hybridization (bbFISH) are used. RESULTS: A total of 61 patients were enrolled in this study. The diagnosis of aseptic loosening was established in 30 cases (49.1%) and the diagnosis of periprosthetic joint infection was established at 31 patients (50.8%). The mean follow-up period in the subgroup of patients diagnosed with periprosthetic joint infections was 36.06 ± 12.59 months (range: 1-54). The 25-months Kaplan-Meier survival rate as the end point, as a consequence of the period of enrollment and a different follow-up period for each type of surgical procedure, was 75% after debridement and implant retention, 91.7% after one-stage exchange, 92.3% after two-stage exchange, and 100% after three-stage exchange. There were no significant differences in survival percentage. CONCLUSIONS: Our study has good results similar to previously published data. We cannot recommend one strategy of managing prosthetic joint infections over the other. Definitely, there is a need for prospective randomized controlled trials.

A systematic review of follow-up results of additively manufactured customized implants for the pelvic area.

INTRODUCTION: While 3D printing of bone models for preoperative planning or customized surgical templating has been successfully implemented, the use of patient-specific additively manufactured (AM) implants is a newer application not yet well established. To fully evaluate the advantages and shortcomings of such implants, their follow-up results need to be evaluated. AREA COVERED: This systematic review provides a survey of the reported follow-ups on AM implants used for oncologic reconstruction, total hip arthroplasty both primary and revision, acetabular fracture, and sacrum defects. EXPERT OPINION: The review shows that Titanium alloy (Ti4AL6V) is the most common type of material system used due to its excellent biomechanical properties. Electron beam melting (EBM) is the predominant AM process for manufacturing implants. In almost all cases, porosity at the contact surface is implemented through the design of lattice or porous structures to enhance osseointegration. The follow-up evaluations show promising results, with only a small number of patients suffering from aseptic loosening, wear, or malalignment. The longest reported follow-up length was 120 months for acetabular cages and 96 months for acetabular cups. The AM implants have proven to serve as an excellent option to restore premorbid skeletal anatomy of the pelvis.

Prognostic Impacts of CHADS2, CHA2DS2-VASc, and CHA2DS2-VASc-HS Scores on Clinical Outcomes After Elective Drug-Eluting Stent Placement for De Novo Coronary Stenosis.

Background: The prognostic impact of CHADS2, CHA2DS2-VASc, and CHA2DS2-VASc-HS scores on clinical outcomes after drug-eluting stent (DES) placement has not been fully elucidated. Methods and Results: The present study was a retrospective, non-randomized, single-center, and lesion-based study. Target lesion failure (TLF), comprising cardiac death, non-fatal myocardial infarction, and target vessel revascularization, occurred in 7.1% of 872 consecutive de novo coronary lesions in 586 patients. These patients were electively and exclusively treated by DESs from January 2016 to January 2022 until July 2022 with a mean (±SD) observational interval of 411±438 days. Multivariate Cox proportional hazard analysis revealed that CHA2DS2-VASc-HS scores ≥7 (hazard ratio [HR] 1.800; 95% CI 1.06-3.05; P=0.029) was a significant predictor of cumulative TLF among 24 variables evaluated. CHADS2 scores ≥2 (HR 3.213; 95% CI 1.32-7.80; P=0.010) and CHA2DS2-VASc scores ≥5 (HR 1.980; 95% CI 1.10-3.55; P=0.022) were also significant in the multivariate analysis. Pairwise comparisons of receiver operating characteristic curves for CHADS2 score ≥2, CHA2DS2-VASc score ≥5, and CHA2DS2-VASc-HS score ≥7 showed they were equivalent in terms of predicting the incidence of TLF, with areas under the curve of 0.568, 0.575, and 0.573, respectively. Conclusions: All 3 cardiocerebrovascular thromboembolism risk scores were strong predictors of the incidence of cumulative mid-term TLF after elective DES placement, with cut-off values of 2, 5, and 7, respectively, and equivalent prognostic impacts.

Midterm safety and efficacy of elective drug-coated balloon angioplasty in comparison to drug-eluting stents for unrestrictive de novo coronary lesions: A single center retrospective study.

BACKGROUND: The safety and efficacy of elective drug-coated balloon (DCB) angioplasty for unrestrictive de novo coronary stenosis in daily practice is not fully understood, especially in comparison to those of drug-eluting stents (DESs). METHODS: A total of 588 consecutive de novo coronary stenotic lesions electively and successfully treated with either DCB (n = 275) or DESs (n = 313) between January 2016 and December 2019 at our medical center were included. The primary safety endpoint was the incidence of target lesion failure (TLF), comprising cardiac death, non-fatal myocardial infarction, and target vessel revascularization. The secondary angiographic efficacy endpoint was angiographic restenosis frequency, defined as a follow-up percent diameter stenosis of >50. The endpoints were compared after baseline adjustment using propensity score matching. In addition, the frequency and predictors of late lumen enlargement (LLE), defined as minus late luminal loss, were examined in 201 crude angiographic follow-up lesions after DCB angioplasty. RESULTS: A total of 31 baseline parameters were adjusted to analyze 177 lesions in each group. The TLF frequencies (DCB group: 9.6 % during a mean observational interval of 789 ±â€¯488 days vs. DES group: 10.2 %, 846 ±â€¯484 days, p = 0.202) and cumulative TLF-free ratios of both groups were not significantly different (p = 0.892, log-rank test). The angiographic restenosis frequency in the DCB group (6.3 %, n = 128) was not significantly different from that of the DES group (10.1 %, n = 100, p = 0.593). LLE was observed in 45.3 % of entire lesions, and a type-A dissection was a significant predictor of LLE among 23 variables (odds ratio: 3.02, 95 % CI: 1.31-6.95, p = 0.010). CONCLUSIONS: The present single-center retrospective study revealed statistically equivalent midterm clinical safety and angiographic efficacy among both elective DCB angioplasty and DESs placements in the treatment of unrestrictive de novo coronary lesions. In our daily practice environment, LLE was achieved in approximately half after DCB angioplasty.

Human mesenchymal stem cells treatment for severe COVID-19: 1-year follow-up results of a randomized, double-blind, placebo-controlled trial.

BACKGROUND: The long-term consequences of human umbilical cord-derived mesenchymal stem cell (UC-MSC) treatment for COVID-19 patients are yet to be reported. This study assessed the 1-year outcomes in patients with severe COVID-19, who were recruited in our previous UC-MSC clinical trial. METHODS: In this prospective, longitudinal, cohort study, 100 patients enrolled in our phase 2 trial were prospectively followed up at 3-month intervals for 1 year to evaluate the long-term safety and effectiveness of UC-MSC treatment. The primary endpoint was an altered proportion of whole-lung lesion volumes measured by high-resolution CT. Other imaging outcomes, 6 min walking distance (6-MWD), lung function, plasma biomarkers, and adverse events were also recorded and analyzed. This trial was registered with ClinicalTrials.gov (NCT04288102). FINDINGS: MSC administration improved in whole-lung lesion volume compared with the placebo with a difference of -10.8% (95% CI: -20.7%, -1.5%, p = 0.030) on day 10. MSC also reduced the proportion of solid component lesion volume compared with the placebo at each follow-up point. More interestingly, 17.9% (10/56) of patients in the MSC group had normal CT images at month 12, but none in the placebo group (p = 0.013). The incidence of symptoms was lower in the MSC group than in the placebo group at each follow-up time. Neutralizing antibodies were all positive, with a similar median inhibition rate (61.6% vs. 67.6%) in both groups at month 12. No difference in adverse events at the 1-year follow-up and tumor markers at month 12 were observed between the two groups. INTERPRETATION: UC-MSC administration achieves a long-term benefit in the recovery of lung lesions and symptoms in COVID-19 patients. FUNDING: The National Key R&D Program of China, the Innovation Groups of the National Natural Science Foundation of China, and the National Science and Technology Major Project.

Role of Echocardiography in the Diagnosis and Interventional Management of Atrial Septal Defects.

This review centers on the usefulness of echo-Doppler studies in the diagnosis of ostium secundum atrial septal defects (ASDs) and in their management, both in children and adults. Transthoracic echocardiography can easily identify the secundum ASDs and also differentiate secundum ASDs from other kinds of ASDs, such as ostium primum ASD, sinus venosus ASD and coronary sinus ASD, as well as patent foramen ovale. Preliminary selection of patients for device occlusion can be made by transthoracic echocardiograms while final selection is based on transesophageal (TEE) or intracardiac (ICE) echocardiographic studies with optional balloon sizing of ASDs. TEE and ICE are extremely valuable in guiding device implantation and in evaluating the position of the device following its implantation. Echo-Doppler evaluation during follow-up is also useful in documenting improvements in ventricular size and function, in assessing the device position, in detecting residual shunts, and in identifying rare device-related complications. Examples of echo images under each section are presented. The reasons why echo-Doppler is very valuable in diagnosing and managing ASDs are extensively discussed.

Tetralogy of Fallot in the nascent open-heart surgical era in a tertiary hospital in south-west Nigeria: lessons learnt.

BACKGROUND: Tetralogy of Fallot (TOF) is the leading cyanotic congenital heart disease. We commenced open-heart surgery at the Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC), Ile-Ife, Nigeria in 2016. OBJECTIVES: To review the incidence, pattern, management and treatment outcomes of TOF at the OAUTHC. METHODS: A retrospective audit was undertaken of hospital records, including echocardiograms of patients with TOF seen from January 2016 to February 2020 at the Paediatric Cardiology Unit, OAUTHC. RESULTS: Seventy-two patients (37 boys and 35 girls) aged 0.17-22 years had TOF. Thirty-three (45.8%) had surgery; 31 (93.9%) corrective surgery and two (6.1%) a modified Blalock-Taussig shunt. Complications following surgery included cardiac dysfunction, post-transfusion malaria, pulmonary regurgitation, pericardial effusion and death (15%). Thirty-nine (54.2%) patients had conservative medical management. Complications included polycythaemia and thrombotic stroke, and 14 (35.9%) patients died. CONCLUSIONS: TOF is associated with significant morbidity and mortality in developing countries. Early and safe corrective surgery is desirable.

The midterm results of coronary endarterectomy in patients with diffuse coronary artery disease.

BACKGROUND: Diffuse coronary artery disease is a challenge for both percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). Coronary artery endarterectomy (CE) coupled with CABG is an alternative method to achieve complete revascularization. The mid- and long-term results of CE are largely questionable. The aim is to evaluate the early and mid-term graft patency of concomitant coronary artery endarterectomy and CABG. METHODS: A total of 304 patients who had undergone concomitant CE and CABG for diffuse coronary artery disease were identified from our database. A total of 238 patients (1) with complete operative records, (2) with good graft flow during surgery, (3) who were discharged, (4) with a one-year/ three-year follow-up were included in our study. The follow-up information was obtained directly from our out-patient department and by telephone contact. The categorical and continuous values were analyzed by Chi Square test and student's test respectively. RESULTS: CE was performed on 238 patients who represented a total of 269 target coronary vessels. The mean age of the patients was 67.8 ± 6.8 years old; male to female patient ratio was 170:68. The mean intensive care unit stay was 1.7 ± 8 days, and mean post-operative length of hospital stay was 11 ± 3 days. The average follow up time was 41.8 ± 21.4 months. At follow-up, the overall graft patency was 78.4% at one year and 69.8% at three years. The left coronary graft patency rate was significantly higher than the right coronary graft patency rate (87.4% vs 73.1% at one-year and 78.2% vs 64.8% at three years). There was no significant difference in graft patency rates between the on-pump CE + CABG vs off-pump CE + CABG groups at one year (80.0% vs 76.9%) and at three years (92.3% vs 91.7%). At the one-year follow up, 92.3% of grafts showed grade A patency in the on-pump group versus 91.7% in the off-pump group; 7.7% of grafts showed grade B patency in the on-pump group versus 8.3% in the off-pump group. At the three-year follow up, 80.6% of grafts showed grade A patency in the on-pump group versus 77.4% in the off-pump group; 19.4% of grafts showed grade B patency in the on-pump group versus 22.6% in the off -pump group. The Predictors of better graft patency are use of LIMA graft, CE on LAD, and intra-operative graft flow meter and PI. CONCLUSIONS: In patients with diffuse coronary disease, CE is a safe and feasible technique for a select group of patients with excellent mid-term survival rates and graft patency rates. CE produces better overall results when performed on the LAD, and grafted over with the LIMA. Similar outcomes are obtained with both on-pump and off-pump surgery. For a select group of patients, coronary endarterectomy (CE) offers an alternative choice of coronary artery reconstruction and complete coronary revascularization.

First Tarsometatarsal Joint Derotational Arthrodesis for Flexible Hallux Valgus: Results from Follow-Up of 3-8 Years.

PURPOSE: We report 3- to 8-year follow-up results for the first tarsometatarsal joint derotational arthrodesis. METHODS: A total of 70 patients (88 feet) with symptomatic flexible hallux valgus were operated between 2003 and 2009. In all, 66 patients (94.3%) with 84 (95.5%) feet were enrolled in retrospective analysis; of those, 58 (87.9%) patients with 76 (90.5%) feet were followed for a mean of 5.1 (range: 3.0-8.3) years. Preoperative, 6 week postoperative, and late follow-up weightbearing radiographs were evaluated along with clinical examination and questionnaires. RESULTS: The mean hallux valgus angle improved 13.4° (95% confidence interval: 11.6-15.1, p < .001) at the latest follow-up, while the mean intermetatarsal angle correction was 4.5° (95% confidence interval: 3.7-5.2, p < .001). There were three (4.0%) nonunions, and seven (9.2%) feet needed reoperation during follow-up. CONCLUSION: First tarsometatarsal joint derotational arthrodesis is an effective procedure for correcting flexible hallux valgus deformity and provides a satisfactory long-term outcome.

Long-term angiographic outcomes of sirolimus- and paclitaxel-eluting stent placement in diabetes, long lesions, and small vessels.

We conducted a lesion-based retrospective sub-analyses of diabetes mellitus (DM), diffuse long lesions (stented segment ≥40 mm; LLs), and small vessels (SVs; reference diameter ≤2.6 mm) in patients who received sirolimus- (SESs) or paclitaxel-eluting stents (PESs) for nonrandom treatment of de novo native coronary stenosis in a clinical practice setting. During the period from May 2007 to February 2009, 490 of 682 PES-treated and 293 of 386 SES-treated lesions were angiographically followed up within 1500 days of PCI, and the retrospective investigation was conducted in April 2013. The frequencies of target lesion revascularization (TLR; any recurrent PCI including both marginal stent restenosis) and binary in-stent restenosis (percentage diameter of in-stent stenosis >50%) upon follow-up angiography, evaluated by adjusting 25 baseline variables using propensity score matching analysis, after placement of SESs and PESs were the following: DM (n = 124 per arm), 14.5 vs. 15.3% (p = 0.842), and 14.5 vs. 16.1% (0.856); LLs (n = 81), 16.0 vs. 21.0% (0.433), and 12.3 vs. 22.2% (0.117); SVs (n = 107), 11.2 vs. 29.9% (<0.001), and 11.2 vs. 30.8% (<0.001), respectively. The p values of log-rank tests for the cumulative TLR-free ratios after SES and PES placement were 0.504 in DM, 0.625 in LLs, and <0.001 in SVs group, respectively. Thus, compared to PES, SES showed the equivalent efficacy for DM, the tendency to be superior for LLs due to approximately 24-45% reductions in TLR and binary restenosis rates, and the promising superiority for SVs on the angiographic outcomes during a long-term observational interval.

Radiological Follow-up Results of Cemented Vertebrae after Vertebroplasty

STUDY DESIGN: A retrospective study. OBJECTIVES: To assess radiological follow-up results, including progression of bone cement augmented vertebrae, of patients who underwent percutaneous vertebroplasty (PVP). SUMMARY OF LITERATURE REVIEW: There are few studies of radiological follow-up results that include progression of bone cement augmented vertebrae after PVP, regardless of good clinical results. MATERIALS AND METHODS: Between January 2000 and August 2007, 253 patients were treated with PVP for osteoporotic compression fracture. Among them, 81 patients died during follow-up and 101 patients (157 vertebrae) were available for follow-up over 7 years. We analyzed the radiologic outcomes, focusing on augmented bone cement feature and progressive change with adjacent vertebrae. RESULTS: The mean follow-up period was 7.9 years. Anterior body height in the last follow-up was improved about 0.3 mm compared with the preprocedural value, but this improvement was not statistically significant. The focal kyphotic angle was reduced from 12.3° at the preprocedural state to 11.7° at the postprocedural state but this change was also not statistically significant (p>0.05). Out of the 101 cases, we observed 7 cases of radiolucent line with decreased bone density in the adjacent area of bone cement and 5 cases of bone cement cracks accompanied with vertebral collapse were observed. Eleven patients (10.8%) had a solid spontaneous fusion, and 8 patients (7.9%) had partially fused with adjacent vertebrae. CONCLUSIONS: The bone cement augmented vertebrae showed stable radiologic progression without significant changes in vertebral height or kyphotic angle. After percutaneous vertebroplasty, unpredictable spontaneous fusion with proximal adjacent vertebrae developed at a higher rate than 10% rate.

The Long-term Follow-up Results of Patients with Partially Accommodative Esotropia after Conventional Surgery

PURPOSE: To evaluate the changes of clinical features after long-term follow-up observation on patients with partially accommodative esotropia who had undergone conventional surgery. METHODS: Thirty-five patients who maintained orthophoria for at least one year duration after surgery were evaluated. The amount of surgery was measured based on the near angle of deviation after full hyperopic correction. The comparison was made based on the best corrected visual acuity, refractive errors, degree of stereopsis and ocular positions before and after surgery. RESULTS: The mean spherical equivalent was +4.46 D before surgery and +3.66 D at the final examination. Among a total of 70 eyes, the best corrected visual acuity of 0.6 or less was seen in 16 before surgery, and in 12 at the final examination. The average angle of deviation was 50.14 PD before correction and 34.43 PD after correction. The Titmus stereotest after surgery was 80 sec of arc in 6, and even 40 sec of arc in 2 out of the 35 patients. At the final examination, 29 of the 35 patients revealed stable orthophoria, but exophoria, in a range of 15-25 PD, developed in 6 patients. Of these 6, 4 had anisometropic amblyopia, and 1 had bilateral high hyperopia of 8.0 D with refractive amblyopia. CONCLUSIONS: Long-term follow-up observation is essential after surgery for partially accommodative esotropia due to fear of the gradual development of consecutive exotropia, particularly in amblyopia cases, even though acceptable initial postoperative orthophoria has been achieved.

Immediate Survival, Complication and Follow up Results of Patients with Aortic Dissection

BACKGROUND: The purpose of this study is to evaluate the immediate survival, complication and follow-up results of aortic dissection and to analyze the risk factors that determine the prognosis after aortic dissection. METHODS: 29 patients(M : 12, Age : 59.0+/-11 yrs) with aortic dissection were reviewed retrospectively. Any dissection involving the ascending aorta was classified as proximal dissection and the dissection was considered to be acute if time from clinical onset of the dissection to admission was less than 2 weeks. The immediate survival rate and follow-up results of aortic dissection was compared by type, onset and mode of treatment. RESULTS: 1) The studied patient were 29(Acute onset : 24, Proximal type : 14) and 17 patients(Proximal type : 14) were surgically treated. 2) Five of 10 patients with proximal dissection and 4 of 12 patients with distal dissection, who were managed by medical treatment, died, and 1 of 4 patients with proximal dissection and none of 3 patients with distal dissection, who were managed by surgical treatment, died at hospital. There was no significant statistical difference in mortality according to type, onset and mode of treatment. 3) Nine of 14 patients with proximal dissection and 8 of 15 patients with distal dissection had one or more complications. 4) The cause of death could be established in 10 patients. The most frequent cause of death was aortic rupture including cardiac tamponade(4 of 6 patients for proximal dissection, 2 of 3 patients for distal dissection). 5) The most of death, 8 of 10 deaths occurred within 2 weeks of onset of disease. there was a good life expectancy for the discharged patient regardless of type, onset and mode of treatment. CONCLUSION: These data showed that there was equivalent outcomes in patients with aortic dissection regardless of type, onset and mode of treatment. But these data would not be applied to general population with aortic dissection because of limited number of the study.