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1.
Vestn Oftalmol ; 140(2): 72-77, 2024.
Article Ru | MEDLINE | ID: mdl-38742501

The modern treatment strategy for keratoconus (KC) involves sequential application of medical technologies aimed at stabilizing pathological changes in the cornea and restoring visual acuity. PURPOSE: This study compares the effect of implantation of intrastromal corneal ring segment (ICRS) and fitting of individual scleral rigid contact lenses (RCLs) on visual functions in patients with stage II-III KC after previously performed corneal collagen cross-linking. MATERIAL AND METHODS: The Helmholtz National Medical Research Center of Eye Diseases examined and treated 34 patients (69 eyes) aged 18 to 33 years with stage II-III KC. The study included patients who had previously undergone standard corneal collagen cross-linking. Depending on the type of optical correction, the patients were divided into two groups: patients in group 1 underwent ICRS implantation using a femtosecond laser; patients in group 2 were fitted with individual scleral RCLs. RESULTS: Improvement in clinical and functional parameters was observed in both groups. A higher clinical and functional result was achieved in group 2. CONCLUSION: For patients with stable stage II-III KC, it is advisable to recommend fitting of individual scleral RCLs for visual rehabilitation.


Contact Lenses , Keratoconus , Sclera , Visual Acuity , Humans , Keratoconus/surgery , Keratoconus/diagnosis , Keratoconus/physiopathology , Keratoconus/therapy , Female , Male , Adult , Sclera/surgery , Prosthesis Implantation/methods , Prosthesis Implantation/instrumentation , Treatment Outcome , Corneal Topography , Prostheses and Implants , Young Adult , Prosthesis Fitting/methods , Adolescent , Corneal Stroma/surgery
2.
Methodist Debakey Cardiovasc J ; 20(3): 49-56, 2024.
Article En | MEDLINE | ID: mdl-38765211

For patients with existing venous thromboembolisms (VTEs), anticoagulation remains the standard of care recommended across multiple professional organizations. However, for patients who developed a deep venous thrombosis (DVT) and/or a pulmonary embolism and cannot tolerate anticoagulation, inferior vena cava (IVC) filters must be considered among other alternative treatments. Although placement of a filter is considered a low-risk intervention, there are important factors and techniques that surgeons and interventionalists should be aware of and prepared to discuss. This overview covers the basics regarding the history of filters, indications for placement, associated risks, and techniques for difficult removal.


Device Removal , Prosthesis Design , Prosthesis Implantation , Pulmonary Embolism , Vena Cava Filters , Venous Thrombosis , Humans , Pulmonary Embolism/prevention & control , Venous Thrombosis/prevention & control , Venous Thrombosis/therapy , Risk Factors , Prosthesis Implantation/instrumentation , Prosthesis Implantation/adverse effects , Treatment Outcome , Venous Thromboembolism/prevention & control , Venous Thromboembolism/diagnosis , Vena Cava, Inferior/diagnostic imaging , Risk Assessment , Anticoagulants/therapeutic use , Anticoagulants/adverse effects
3.
Int J Cardiol ; 407: 132113, 2024 Jul 15.
Article En | MEDLINE | ID: mdl-38697398

BACKGROUND: Axillary vein puncture (AVP) is a valid alternative to Subclavan vein puncture for leads insertion in cardiac implantable electronic device implantation, that may reduce acute and delayed complications. Very few data are available about ICD recipients. A simplified AVP technique is described. METHODS: All the patients who consecutively underwent "de novo" ICD implantation, from March 2006 to December 2020 at the University of Verona, were considered. Leads insertion was routinely performed through an AVP, according to a simplified technique. Outcome and complications have been retrospectively analyzed. RESULTS: The study population consisted of 1711 consecutive patients. Out of 1711 patients, 38 (2.2%) were excluded because they were implanted with Medtronic Sprint Fidelis lead. Out of 1673 ICD implantations, 963 (57.6%) were ICD plus cardiac resynchronization therapy, 434 (25.9%) were dual-chamber defibrillators, and 276 (16.5%) were single-chamber defibrillators, for a total of 3879 implanted leads. The AVP success rate was 99.4%. Acute complications occurred in 7/1673 (0.42%) patients. Lead failure (LF) occurred in 20/1673 (1.19%) patients. Comparing the group of patients with lead failure with the group without LF, the presence of three leads inside the vein was significantly associated with LF, and the multivariate analysis confirmed three leads in place as an independent predictor of LF. CONCLUSION: AVP, according to our simplified technique, is safe, effective, has a high success rate, and a very low complication rate. The incidence of LF was exceptionally low. The advantages of AVP are maintained over time in a population of ICD recipients.


Axillary Vein , Defibrillators, Implantable , Punctures , Humans , Defibrillators, Implantable/adverse effects , Male , Female , Retrospective Studies , Aged , Middle Aged , Axillary Vein/diagnostic imaging , Prosthesis Implantation/methods , Prosthesis Implantation/adverse effects , Prosthesis Implantation/instrumentation , Treatment Outcome , Time Factors
4.
J Orthop Surg Res ; 19(1): 273, 2024 May 02.
Article En | MEDLINE | ID: mdl-38698477

BACKGROUND: Talar malignant tumor is extremely rare. Currently, there are several alternative management options for talus malignant tumor including below-knee amputation, tibio-calcaneal arthrodesis, and homogenous bone transplant while their shortcomings limited the clinical application. Three-dimensional (3D) printed total talus prosthesis in talus lesion was reported as a useful method to reconstruct talus, however, most researches are case reports and its clinical effect remains unclear. Therefore, the current study was to explore the application of 3D printed custom-made modular prosthesis in talus malignant tumor. METHODS: We retrospectively analyzed the patients who received the 3D printed custom-made modular prosthesis treatment due to talus malignant tumor in our hospital from February 2016 to December 2021. The patient's clinical data such as oncology outcome, operation time, and volume of blood loss were recorded. The limb function was evaluated with the Musculoskeletal Tumor Society 93 (MSTS-93) score, The American Orthopedic Foot and Ankle Society (AOFAS) score; the ankle joint ranges of motion as well as the leg length discrepancy were evaluated. Plain radiography and Tomosynthesis-Shimadzu Metal Artefact Reduction Technology (T-SMART) were used to evaluate the position of prosthesis and the osseointegration. Postoperative complications were recorded. RESULTS: The average patients' age and the follow-up period were respectively 31.5 ± 13.1 years; and 54.8 months (range 26-72). The medium operation time was 2.4 ± 0.5 h; the intraoperative blood loss was 131.7 ± 121.4 ml. The mean MSTS-93 and AOFAS score was 26.8 and 88.5 respectively. The average plantar flexion, dorsiflexion, varus, and valgus were 32.5, 9.2, 10.8, and 5.8 degree respectively. One patient had delayed postoperative wound healing. There was no leg length discrepancy observed in any patient and good osseointegration was observed on the interface between the bone and talus prosthesis in all subjects. CONCLUSION: The modular structure of the prosthesis developed in this study seems to be convenient for prosthesis implantation and screws distribution. And the combination of solid and porous structure improves the initial stability and promotes bone integration. Therefore, 3D printed custom-made modular talus prosthesis could be an alternative option for talus reconstruction in talus malignant tumor patients.


Bone Neoplasms , Printing, Three-Dimensional , Prosthesis Design , Talus , Humans , Talus/surgery , Talus/diagnostic imaging , Male , Adult , Female , Bone Neoplasms/surgery , Bone Neoplasms/diagnostic imaging , Retrospective Studies , Middle Aged , Young Adult , Prosthesis Implantation/methods , Prosthesis Implantation/instrumentation , Adolescent , Ankle Joint/surgery , Ankle Joint/diagnostic imaging , Osseointegration , Treatment Outcome , Range of Motion, Articular , Prostheses and Implants
5.
Catheter Cardiovasc Interv ; 103(6): 909-916, 2024 May.
Article En | MEDLINE | ID: mdl-38584525

BACKGROUND: Utilization of right ventricular mechanical circulatory support (RV-MCS) devices has been limited by a lack of recognition of RV failure as well as a lack of availability and experience with RV-MCS. AIMS: We report a single-center experience with the use of percutaneous RV-MCS and report predictors of adverse outcomes. METHODS: This was a single-center retrospective cohort study. Data from consecutive patients who received RV-MCS for any indication between June 2015 and January 2022 were included. Data on baseline comorbidities, hemodynamics, and laboratory values were collected. The primary outcome was in-hospital mortality analyzed as a logistic outcome in a multivariable model. These variables were further ranked by their predictive value. RESULTS: Among 58 consecutive patients enrolled, the median age was 66 years, 31% were female and 53% were white. The majority of the patients (48%) were hospitalized for acute on chronic heart failure. The majority of the patients were SCAI SHOCK Stage D (67%) and 34 (64%) patients had MCS placed within 24 h of the onset of shock. Before placement of RV-MCS, median central venous pressure (CVP) and RV stroke work index were 20 mmHg and 8.9 g m/m2, respectively. Median serum lactate was 3.5 (1.6, 6.2) mmol/L. Impella RP was implanted in 50% and ProtekDuo in the remaining 50%. Left ventricular MCS was concomitantly used in 66% of patients. Twenty-eight patients (48.3%) died. In these patients, median serum lactate was significantly higher (4.1 [2.3, 13.0] vs. 2.2 [1.4, 4.0] mmol/L, p = 0.007) and a trend toward higher median CVP (24 [18, 31] vs. 19 [14, 24] mmHg, p = 0.052). In the multivariable logistic model, both serum lactate and CVP before RV-MCS placement were independent predictors of in-hospital mortality. Serum lactate had the highest predictive value. CONCLUSION: In our real-world cohort, 52% of patients treated with RV-MCS survived their index hospitalization. Serum lactate at presentation and CVP were the strongest predictors of in-hospital mortality.


Heart Failure , Heart-Assist Devices , Hospital Mortality , Recovery of Function , Ventricular Dysfunction, Right , Ventricular Function, Right , Humans , Female , Male , Retrospective Studies , Aged , Heart Failure/physiopathology , Heart Failure/mortality , Heart Failure/therapy , Heart Failure/diagnosis , Treatment Outcome , Middle Aged , Risk Factors , Time Factors , Ventricular Dysfunction, Right/physiopathology , Ventricular Dysfunction, Right/mortality , Ventricular Dysfunction, Right/etiology , Ventricular Dysfunction, Right/therapy , Ventricular Dysfunction, Right/diagnostic imaging , Risk Assessment , Prosthesis Implantation/instrumentation , Prosthesis Implantation/adverse effects , Prosthesis Implantation/mortality , Biomarkers/blood
6.
Catheter Cardiovasc Interv ; 103(7): 1165-1170, 2024 Jun.
Article En | MEDLINE | ID: mdl-38648353

This paper presents the novel use of a temporary percutaneous ventricular assist device (pVAD) in a 51-year-old man with an implanted durable left ventricular assist device (d-LVAD). The pre-existing left ventricular assist device was unable to successfully unload the left ventricle, and the addition of the temporary pVAD achieved successful unloading as well as a decrease in pulmonary artery pressures without compromising the function of the right ventricle allowing safe UNOS listing for orthotopic heart transplantation.


Heart Failure , Heart-Assist Devices , Prosthesis Design , Recovery of Function , Ventricular Function, Left , Humans , Male , Middle Aged , Treatment Outcome , Heart Failure/physiopathology , Heart Failure/therapy , Ventricular Function, Right , Arterial Pressure , Pulmonary Artery/physiopathology , Pulmonary Artery/diagnostic imaging , Prosthesis Implantation/instrumentation
7.
J Cardiovasc Electrophysiol ; 35(5): 1041-1045, 2024 May.
Article En | MEDLINE | ID: mdl-38462703

INTRODUCTION: Transsubclavian venous implantation of the Aveir leadless cardiac pacemaker (LCP) has not been previously reported. METHODS AND RESULTS: Three cases of transsubclavian implantation of the Aveir LCP are reported. Two cases were postbilateral orthotopic lung transplant, without appropriate femoral or jugular access due to recent ECMO cannulation and jugular central venous catheters. In one case, there was strong patient preference for same-day discharge. Stability testing confirmed adequate fixation and electrical testing confirmed stable parameters in all cases. All patients tolerated the procedure well without significant immediate complications. CONCLUSIONS: We demonstrate the feasibility of transsubclavian implantation of the Aveir LCP.


Cardiac Pacing, Artificial , Jugular Veins , Pacemaker, Artificial , Humans , Male , Middle Aged , Jugular Veins/surgery , Female , Aged , Treatment Outcome , Equipment Design , Prosthesis Implantation/instrumentation , Prosthesis Implantation/adverse effects
8.
Respiration ; 103(6): 344-352, 2024.
Article En | MEDLINE | ID: mdl-38531338

INTRODUCTION: Endoscopic lung volume reduction with endobronchial valves has been widely recognized for treating hyperinflation in advanced chronic obstructive pulmonary disease and emphysema patients. The main challenges include the technical complexity of upper lobe implantation and the number of endobronchial valves required. These issues might be addressed by placing larger diameter valves in the lobar bronchus. This study evaluated the feasibility, efficiency, and safety of the new valve PulmValve (model PV-13) in porcine models. METHODS: Six PV-13 valves were bronchoscopically implanted into the caudal lobe bronchus of six healthy pigs. The procedure time, valve deployment, and removability were recorded. Follow-up examinations included blood tests, chest CT scans, and bronchoscopy at 30 min, 14 days, 28 days, and 84 days post-procedure, with necropsy and pathological evaluations after the final follow-up examination. RESULTS: The successful in vivo deployment and removal of PV-13 valves was established, with a median procedure time of 6.5 min. The distal lung volume reduction was evident at 30 min post-operation and was persistently monitored on day 84. No migration or malfunction of any PV-13 valves was detected, but a mild angle deviation was found in 3 cases. Coughing was observed in four pigs within the first 7 days and localized granulation tissue was observed in all pigs. No cases of pneumothorax, diffuse pneumonia, or hemoptysis were detected. CONCLUSIONS: In this study, we report the successful implantation and removal of a new valve PulmValve in a short operation time. Complete lobar atelectasis was induced without device migration, malfunction, or severe complications. Further studies are warranted to evaluate the long-term, sustained effects and potential benefits in human patients.


Bronchoscopy , Feasibility Studies , Animals , Swine , Bronchoscopy/methods , Pneumonectomy/methods , Pulmonary Valve/surgery , Pulmonary Valve/diagnostic imaging , Prosthesis Implantation/methods , Prosthesis Implantation/instrumentation , Prosthesis Design , Female , Tomography, X-Ray Computed
9.
Artif Organs ; 48(6): 655-664, 2024 Jun.
Article En | MEDLINE | ID: mdl-38459775

OBJECTIVES: Right ventricular failure following implantation of a durable left ventricular assist device (LVAD) is a major driver of mortality. Reported survival following biventricular (BiVAD) or total artificial heart (TAH) implantation remains substantially inferior to LVAD alone. We report our outcomes with LVAD and BiVAD HeartMate 3 (HM3). METHODS: Consecutive patients undergoing implantation of an HM3 LVAD between November 2014 and December 2021, at The Alfred, Australia were included in the study. Comparison was made between the BiVAD and LVAD alone groups. RESULTS: A total of 86 patients, 65 patients with LVAD alone and 21 in a BiVAD configuration underwent implantation. The median age of the LVAD and BiVAD groups was 56 years (Interquartile range 46-62) and 49 years (Interquartile range 37-55), respectively. By 4 years after implantation, 54% of LVAD patients and 43% of BiVAD patients had undergone cardiac transplantation. The incidence of stroke in the entire experience was 3.5% and pump thrombosis 5% (all in the RVAD). There were 14 deaths in the LVAD group and 1 in the BiVAD group. The actuarial survival for LVAD patients at 1 year was 85% and BiVAD patients at 1 year was 95%. CONCLUSIONS: The application of HM 3 BiVAD support in selected patients appears to offer a satisfactory solution to patients requiring biventricular support.


Heart Failure , Heart-Assist Devices , Humans , Middle Aged , Male , Female , Heart Failure/surgery , Heart Failure/mortality , Heart Failure/therapy , Adult , Retrospective Studies , Treatment Outcome , Heart Transplantation/methods , Australia/epidemiology , Prosthesis Implantation/instrumentation , Prosthesis Implantation/adverse effects , Prosthesis Implantation/methods
10.
J Cardiovasc Transl Res ; 17(2): 252-264, 2024 04.
Article En | MEDLINE | ID: mdl-38300356

This study aims to associate the incidence of postoperative vasoplegia and short-term survival to the implantation of various left ventricular assist devices differing in hemocompatibility and flow profiles. The overall incidence of vasoplegia was 25.3% (73/289 patients) and 30.3% (37/122), 25.0% (18/72), and 18.9% (18/95) in the axial flow (AXF), centrifugal flow (CF), and centrifugal flow with artificial pulse (CFAP) group, respectively. Vasoplegia was associated with longer intensive care (ICU) and hospital length of stay (LOS) and mortality. ICU and in-hospital LOS and 1-year mortality were the lowest in the CFAP group. Post hoc analysis resulted in a p-value of 0.43 between AXF and CF; 0.35 between CF and CFAP; and 0.06 between AXF and CFAP. Although there is a trend in diminished incidence of vasoplegia, pooled logistic regression using flow profile and variables that remained after feature selection showed that flow profile was not an independent predictor for postoperative vasoplegia.


Heart-Assist Devices , Length of Stay , Prosthesis Design , Vasoplegia , Ventricular Function, Left , Humans , Vasoplegia/physiopathology , Vasoplegia/etiology , Vasoplegia/diagnosis , Male , Female , Middle Aged , Time Factors , Treatment Outcome , Incidence , Risk Factors , Adult , Aged , Heart Failure/physiopathology , Heart Failure/mortality , Heart Failure/diagnosis , Heart Failure/therapy , Prosthesis Implantation/instrumentation , Prosthesis Implantation/adverse effects , Prosthesis Implantation/mortality , Retrospective Studies , Hospital Mortality , Risk Assessment
11.
Vasc Endovascular Surg ; 58(5): 559-566, 2024 Jul.
Article En | MEDLINE | ID: mdl-38196287

INTRODUCTION AND IMPORTANCE: Long-term mechanical complications after inferior vena cava (IVC) filter placement include embedded or tilted filters, erosion of the vena cava, filter thrombosis. In the setting of caval thrombosis, patients may subsequently develop venous hypertension and post-thrombotic syndrome (PTS). Here we present three unique cases of IVC filter complications and surgical management. CASE PRESENTATION: A 30-year-old female presented with acute abdominal pain, revealing a duodenal perforation caused by an IVC filter eroding into her duodenum. A 42-year-old female with an IVC filter in place for 20 years due to a prior pulmonary embolism underwent laser-assisted retrieval of the filter due to concerns of caval adherence. A 48-year-old male with a history of DVT, venous stasis ulcer, and an IVC filter presented for filter retrieval. CLINICAL FINDINGS AND INVESTIGATIONS: The surgical techniques described in this report include complicated IVC filter retrieval, performed in cases of filter complications including migration, fracture, duodenal perforation and IVC thrombosis resulting in PTS. One case, requiring open retrieval, is explained and the surgical technique is provided. There are images and videos of these procedures to enrich the learning experience. INTERVENTION AND OUTCOMES: The surgical techniques described in this report include complicated inferior vena cava filter retrieval, performed in cases of filter complications including migration, fracture, duodenal perforation and IVC thrombosis. One case, requiring open retrieval, is explained and the surgical technique is provided. There are images and videos of these procedures to enrich the learning experience. RELEVANCE AND IMPACT: Endovascular retrieval of long-term complicated IVC filters is challenging, but it can be a safely performed in many patients. However, open surgery may be necessary in selected patients.


Device Removal , Foreign-Body Migration , Vena Cava Filters , Vena Cava, Inferior , Venous Thrombosis , Humans , Vena Cava Filters/adverse effects , Male , Middle Aged , Female , Adult , Treatment Outcome , Foreign-Body Migration/etiology , Foreign-Body Migration/diagnostic imaging , Foreign-Body Migration/surgery , Vena Cava, Inferior/diagnostic imaging , Vena Cava, Inferior/injuries , Vena Cava, Inferior/surgery , Venous Thrombosis/etiology , Venous Thrombosis/diagnostic imaging , Venous Thrombosis/therapy , Intestinal Perforation/etiology , Intestinal Perforation/surgery , Intestinal Perforation/diagnostic imaging , Prosthesis Implantation/instrumentation , Prosthesis Implantation/adverse effects , Time Factors , Prosthesis Design , Phlebography
12.
Ann Med ; 55(1): 965-972, 2023 12.
Article En | MEDLINE | ID: mdl-36883206

OBJECTIVE: Patients with ureteral calculi and systemic inflammatory response syndrome (SIRS) often require emergency drainage, and percutaneous nephrostomy (PCN) and retrograde ureteral stent insertion (RUSI) are the most commonly used methods. Our study aimed to identify the best choice (PCN or RUSI) for these patients and to examine the risk factors for progression to urosepsis after decompression. METHODS: A prospective, randomized clinical study was performed at our hospital from March 2017 to March 2022. Patients with ureteral stones and SIRS were enrolled and randomized to the PCN or RUSI group. Demographic information, clinical features and examination results were collected. RESULTS: Patients (n = 150) with ureteral stones and SIRS were enrolled into our study, with 78 (52%) patients in the PCN group and 72 (48%) patients in the RUSI group. Demographic information was not significantly different between the groups. The final treatment of calculi was significantly different between the two groups (p < .001). After emergency decompression, urosepsis developed in 28 patients. Patients with urosepsis had a higher procalcitonin (p = .012) and blood culture positivity rate (p < .001) and more pyogenic fluids during primary drainage (p < .001) than patients without urosepsis. CONCLUSION: PCN and RUSI were effective methods of emergency decompression in patients with ureteral stone and SIRS. Patients with pyonephrosis and a higher PCT should be carefully treated to prevent the progression to urosepsis after decompression.Key messageIn this study, we evaluate the best choice (PCN or RUSI) for patients who have ureteral stones and SIRS and to examine the risk factors for progression to urosepsis after decompression. This study found that PCN and RUSI were effective methods of emergency decompression. Pyonephrosis and higher PCT were risk factors for patients to develop to urosepsis after decompression.


Nephrostomy, Percutaneous , Prosthesis Implantation , Pyonephrosis , Systemic Inflammatory Response Syndrome , Ureteral Calculi , Humans , Decompression, Surgical/methods , Procalcitonin/blood , Prospective Studies , Prosthesis Implantation/instrumentation , Prosthesis Implantation/methods , Pyonephrosis/blood , Pyonephrosis/etiology , Pyonephrosis/surgery , Sepsis/blood , Sepsis/etiology , Sepsis/surgery , Stents , Systemic Inflammatory Response Syndrome/blood , Systemic Inflammatory Response Syndrome/etiology , Systemic Inflammatory Response Syndrome/surgery , Ureteral Calculi/blood , Ureteral Calculi/complications , Ureteral Calculi/surgery
13.
Exp Clin Transplant ; 21(2): 83-92, 2023 02.
Article En | MEDLINE | ID: mdl-36919717

OBJECTIVES: In the past decade, the implantable Doppler probe has been studied widely as a blood flow-monitoring device in reconstructive and transplant surgical specialities. Its utility as an effective postoperative monitoring technique is still debatable, with no clear guidelines in clinical practice. Here, we mapped the current evidence on the usefulness of the implantable Doppler probe as a blood flow-monitoring device. The objective was to present an up-to-date assessment of the benefits and limitations of using implantable Doppler probes in clinical and experimental clinical settings. MATERIALS AND METHODS: We conducted a literature search using the Cochrane Library and Healthcare Databases Advanced Search and using implantable Doppler probe, transplant, graft, and flap as key words. The search yielded 184 studies, with 73 studies included after exclusions. We evaluated, synthesized, and summarized the evidence from the studies in tabular form. RESULTS: There is clinical equipoise regarding the effectiveness of implantable Doppler probe as a flow sensing technique. The main reason is the lack of information and gaps in the evidence regarding the benefits and limitations of using implantable Doppler probes in clinical practice. CONCLUSIONS: The implantable Doppler probe has the potentialto be used as an adjunctpostoperativeblood flow-monitoring device. However, keeping in view of technical limitations, its signals should be interpreted alongside traditional clinical assessment techniques to determine the patency of microvascular anastomosis. Although evidence in this review will inform clinical practice in transplant and reconstructive surgical specialties, a prospective randomized controlled study with a larger patient cohort is required to evaluate the effectiveness of this probe in clinical settings.


Monitoring, Physiologic , Regional Blood Flow , Surgical Flaps , Transplants , Ultrasonography, Doppler , Humans , Blood Circulation , Free Tissue Flaps/blood supply , Free Tissue Flaps/transplantation , Monitoring, Physiologic/instrumentation , Monitoring, Physiologic/methods , Plastic Surgery Procedures/instrumentation , Plastic Surgery Procedures/methods , Postoperative Period , Prospective Studies , Prostheses and Implants , Prosthesis Implantation/instrumentation , Prosthesis Implantation/methods , Surgical Flaps/blood supply , Transplantation/instrumentation , Transplantation/methods , Transplants/blood supply , Ultrasonography, Doppler/instrumentation , Ultrasonography, Doppler/methods
14.
J Laryngol Otol ; 137(3): 263-269, 2023 Mar.
Article En | MEDLINE | ID: mdl-35144697

OBJECTIVE: This study aimed to evaluate the possibilities of artefact reduction using different anatomical implant positions with the Bonebridge bone-conduction hearing implant 602 for a patient with an acoustic neuroma requiring regular diagnostic magnetic resonance imaging of the tumour position. METHOD: Three implant positions and magnetic resonance imaging examinations with and without customised sequences for metal artefact suppression were investigated. The diagnostic usefulness was rated by a radiologist (qualitative evaluation), and the relation between the area of artefact and the total head area was calculated (quantitative evaluation). RESULTS: Following the qualitative analysis, the radiologist rated the superior to middle fossa implant placement significantly better for diagnostic purposes, which is in agreement with the calculated artefact ratio (p < 0.0001). The customised slice-encoding metal artifact correction view-angle tilting metal artifact reduction technique sequences significantly decreased the relative artefact area between 5.13 per cent and 25.02 per cent. The smallest mean artefact diameter was found for the superior to middle fossa position with 6.80 ± 1.30 cm (range: 5.42-9.74 cm; reduction of 18.65 per cent). CONCLUSION: The application of artefact reduction sequencing and special anatomical implant positioning allows regular magnetic resonance imaging in patients with the bone-conduction hearing implant 602 without sacrificing diagnostic imaging quality for tumour diagnosis.


Image Processing, Computer-Assisted , Neuroma, Acoustic , Otologic Surgical Procedures , Prosthesis Implantation , Humans , Artifacts , Bone Conduction , Magnetic Resonance Imaging/methods , Neuroma, Acoustic/diagnostic imaging , Neuroma, Acoustic/surgery , Otologic Surgical Procedures/instrumentation , Otologic Surgical Procedures/methods , Prosthesis Implantation/instrumentation , Prosthesis Implantation/methods
15.
N Engl J Med ; 387(14): 1253-1263, 2022 10 06.
Article En | MEDLINE | ID: mdl-36121045

BACKGROUND: Transcatheter aortic-valve replacement (TAVR) for the treatment of aortic stenosis can lead to embolization of debris. Capture of debris by devices that provide cerebral embolic protection (CEP) may reduce the risk of stroke. METHODS: We randomly assigned patients with aortic stenosis in a 1:1 ratio to undergo transfemoral TAVR with CEP (CEP group) or without CEP (control group). The primary end point was stroke within 72 hours after TAVR or before discharge (whichever came first) in the intention-to-treat population. Disabling stroke, death, transient ischemic attack, delirium, major or minor vascular complications at the CEP access site, and acute kidney injury were also assessed. A neurology professional examined all the patients at baseline and after TAVR. RESULTS: A total of 3000 patients across North America, Europe, and Australia underwent randomization; 1501 were assigned to the CEP group and 1499 to the control group. A CEP device was successfully deployed in 1406 of the 1489 patients (94.4%) in whom an attempt was made. The incidence of stroke within 72 hours after TAVR or before discharge did not differ significantly between the CEP group and the control group (2.3% vs. 2.9%; difference, -0.6 percentage points; 95% confidence interval, -1.7 to 0.5; P = 0.30). Disabling stroke occurred in 0.5% of the patients in the CEP group and in 1.3% of those in the control group. There were no substantial differences between the CEP group and the control group in the percentage of patients who died (0.5% vs. 0.3%); had a stroke, a transient ischemic attack, or delirium (3.1% vs. 3.7%); or had acute kidney injury (0.5% vs. 0.5%). One patient (0.1%) had a vascular complication at the CEP access site. CONCLUSIONS: Among patients with aortic stenosis undergoing transfemoral TAVR, the use of CEP did not have a significant effect on the incidence of periprocedural stroke, but on the basis of the 95% confidence interval around this outcome, the results may not rule out a benefit of CEP during TAVR. (Funded by Boston Scientific; PROTECTED TAVR ClinicalTrials.gov number, NCT04149535.).


Aortic Valve Stenosis , Embolic Protection Devices , Intracranial Embolism , Prosthesis Implantation , Stroke , Transcatheter Aortic Valve Replacement , Acute Kidney Injury/etiology , Aortic Valve/surgery , Aortic Valve Stenosis/surgery , Delirium/etiology , Humans , Intracranial Embolism/etiology , Intracranial Embolism/prevention & control , Ischemic Attack, Transient/etiology , Prosthesis Implantation/instrumentation , Risk Factors , Stroke/etiology , Stroke/prevention & control , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/methods , Treatment Outcome
16.
J Hepatobiliary Pancreat Sci ; 29(7): 817-824, 2022 Jul.
Article En | MEDLINE | ID: mdl-35030302

BACKGROUND/PURPOSE: Although the lumen-apposing metal stent (LAMS) is useful for interventional endoscopic ultrasound (EUS) procedures, there has been some concern about the potential for stent-induced adverse events because of the high lumen-apposing force. A newly designed LAMS with less lumen-apposing force has been developed for use with a physician-controlled electrocautery-enhanced delivery system. The aim of this animal study was to evaluate the feasibility of performing interventional EUS using this newly designed LAMS system. METHODS: Endoscopic ultrasound-guided cystogastrostomy was performed using the novel LAMS three times in a wet simulation model. EUS-guided gastroenterostomy and EUS-guided gallbladder drainage were then performed using the system in four pigs. RESULTS: The LAMS was successfully placed in all three EUS-guided cystogastrostomy procedures using the wet simulation model and in all four EUS-guided gastroenterostomy and gallbladder drainage procedures in the animal model. In the 3 weeks following the procedure, eating behavior was normal in all animals and there were no adverse events. The stents remained patent during this time and were removed without difficulty. The fistula was mature in all cases and a standard upper gastrointestinal endoscope was easily advanced via the fistula to observe the afferent and efferent loops or the lumen of the gallbladder. Necropsy confirmed complete adhesion between the stomach and the wall of the jejunum or gallbladder. CONCLUSIONS: Our study findings demonstrate the feasibility of this new LAMS system and its potential clinical value for interventional EUS.


Anastomosis, Surgical , Electrocoagulation , Endosonography , Prosthesis Implantation , Stents , Ultrasonography, Interventional , Anastomosis, Surgical/instrumentation , Anastomosis, Surgical/methods , Animals , Digestive System Fistula/etiology , Digestive System Fistula/surgery , Drainage/instrumentation , Drainage/methods , Electrocoagulation/instrumentation , Electrocoagulation/methods , Endosonography/instrumentation , Endosonography/methods , Gallbladder/surgery , Jejunum/surgery , Models, Animal , Prosthesis Implantation/instrumentation , Prosthesis Implantation/methods , Stomach/surgery , Swine , Ultrasonography, Interventional/instrumentation , Ultrasonography, Interventional/methods
17.
Bioengineered ; 13(2): 2943-2950, 2022 02.
Article En | MEDLINE | ID: mdl-35038960

Cholangiocarcinoma is a common malignant tumor. Advanced treatment is difficult and the prognosis is poor. It is of great significance to find an effective method to treat cholangiocarcinoma and improve the prognosis of patients. Therefore, 78 patients with cholangiocarcinoma treated in our hospital were divided into group A and group B according to different treatment methods. The clinical effect, bilirubin, tumor size, bile duct patency time, tumor marker level To evaluate the therapeutic effect of I125 seed stent implantation combined with arterial infusion chemoembolization in patients with cholangiocarcinoma. The results showed that I125 seed stent implantation combined with TACE in the treatment of patients with cholangiocarcinoma can play an obvious clinical effect, effectively reduce the level of tumor markers and p53, reduce tumor lesions, improve the survival rate of patients, and play an important role in tumor treatment.


Bile Duct Neoplasms/therapy , Chemoembolization, Therapeutic/methods , Cholangiocarcinoma/therapy , Drug-Eluting Stents , Iodine Radioisotopes/administration & dosage , Adult , Aged , Aged, 80 and over , Bile Duct Neoplasms/diagnosis , Bile Ducts, Intrahepatic/metabolism , Bile Ducts, Intrahepatic/pathology , Bile Ducts, Intrahepatic/surgery , Biomarkers, Tumor/genetics , Biomarkers, Tumor/metabolism , China , Cholangiocarcinoma/diagnosis , Combined Modality Therapy , Female , Humans , Male , Middle Aged , Prognosis , Prosthesis Implantation/instrumentation , Prosthesis Implantation/methods , Retrospective Studies , Treatment Outcome , Tumor Suppressor Protein p53/genetics , Tumor Suppressor Protein p53/metabolism
18.
Isr Med Assoc J ; 24(1): 25-32, 2022 Jan.
Article En | MEDLINE | ID: mdl-35077042

BACKGROUND: Endocardial leads of permanent pacemakers (PPM) and implantable defibrillators (ICD) across the tricuspid valve (TV) can lead to tricuspid regurgitation (TR) or can worsen existing TR with subsequent severe morbidity and mortality. OBJECTIVES: To evaluate prospectively the efficacy of intraprocedural 2-dimentional-transthoracic echocardiography (2DTTE) in reducing/preventing lead-associated TR. METHODS: We conducted a prospective randomized controlled study comparing echocardiographic results in patients undergoing de-novo PPM/ICD implantation with intraprocedural echo-guided right ventricular (RV) lead placement (Group 1, n=56) versus non-echo guided implantation (Group 2, n=55). Lead position was changed if TR grade was more than baseline in Group 1. Cohort patients underwent 2DTTE at baseline and 3 and/or 6 months after implantation. Excluded were patients with baseline TR > moderate or baseline ≥ moderate RV dysfunction. RESULTS: The study comprised 111 patients (74.14 ± 11 years of age, 58.6% male, 19% ICD, 42% active leads). In 98 patients there was at least one follow-up echo. Two patients from Group 1 (3.6%) needed intraprocedural RV electrode repositioning. Four patients (3.5%, 2 from each group, all dual chamber PPM, 3 atrial fibrillation, 2 RV pacing > 40%, none with intraprocedural reposition) had TR deterioration during 6 months follow-up. One patient from Group 2 with baseline mild-moderate aortic regurgitation (AR) had worsening TR and AR within 3 months and underwent aortic valve replacement and TV repair. CONCLUSIONS: The rate of mechanically induced lead-associated TR is low; thus, a routine intraprocedural 2DTTE does not have a significant role in reducing/preventing it.


Echocardiography/methods , Postoperative Complications , Prosthesis Fitting , Prosthesis Implantation , Surgery, Computer-Assisted/methods , Tricuspid Valve Insufficiency , Tricuspid Valve/diagnostic imaging , Aged , Cardiac Pacing, Artificial/methods , Defibrillators, Implantable , Electric Countershock/instrumentation , Female , Humans , Male , Outcome and Process Assessment, Health Care , Pacemaker, Artificial , Postoperative Complications/etiology , Postoperative Complications/prevention & control , Prosthesis Fitting/adverse effects , Prosthesis Fitting/methods , Prosthesis Implantation/adverse effects , Prosthesis Implantation/instrumentation , Prosthesis Implantation/methods , Tricuspid Valve/physiopathology , Tricuspid Valve Insufficiency/diagnosis , Tricuspid Valve Insufficiency/etiology , Tricuspid Valve Insufficiency/prevention & control
19.
Can J Cardiol ; 38(3): 376-383, 2022 03.
Article En | MEDLINE | ID: mdl-34968714

BACKGROUND: Refractory angina is a debilitating condition that affects the quality of life of patients worldwide, who after exhausting standard available therapies are regarded as "no option" patients. Recently, CS (coronary sinus) reducer (Neovasc Reducer) implantation became available and is gaining popularity in the treatment of refractory angina. The effectiveness of this therapy was demonstrated in 1 randomised sham-control trial and numerous uncontrolled prospective studies entailing several hundred patients altogether. We performed a meta-analysis to incorporate the data and elucidate its efficacy and safety. METHODS: A meta-analysis of prospective studies assessing the effects of CS narrowing published in English to June 2021 was performed. The primary outcome was the proportion of patients improving ≥ 1 class in the Canadian Cardiovascular Society (CCS) angina score. Other end points included proportion of patients improving ≥ 2 CCS classes, procedural success, periprocedural complications, changes in Seattle Angina Questionnaire (SAQ) scores, and 6-minute walk test (6MWT). RESULTS: Data from 9 studies including 846 patients were included. An improvement of ≥ 1 CCS class occurred in 76% (95% confidence interval [CI] 73%-80%) of patients. Improvement of ≥ 2 CCS classes was observed in 40% of patients (95% CI 35%-46%). Procedure success was 98%, with no major and 3% nonmajor periprocedural complications. Post procedural SAQ scores and 6MWT distance were significantly improved. CONCLUSIONS: In patients suffering from angina refractory to medical and interventional therapies, Reducer implantation improves symptoms and quality of life with a low complication rate. These results are consistent in 1 randomised trial and multiple prospective uncontrolled studies.


Angina Pectoris , Coronary Sinus , Prosthesis Implantation , Stents , Angina Pectoris/diagnosis , Angina Pectoris/physiopathology , Angina Pectoris/surgery , Cardiac Catheterization/methods , Coronary Sinus/physiopathology , Coronary Sinus/surgery , Equipment Design , Humans , Pain, Intractable/physiopathology , Prosthesis Implantation/adverse effects , Prosthesis Implantation/instrumentation , Prosthesis Implantation/methods , Treatment Outcome
20.
Dig Dis Sci ; 67(1): 315-320, 2022 01.
Article En | MEDLINE | ID: mdl-33742291

BACKGROUND: In patients with severe biliary pancreatitis, delayed cholecystectomy associated with a high risk of recurrence is recommended. The current study aimed to evaluate the effect of common bile duct (CBD) stenting on reducing gallstones migration and recurrence of symptoms in patients with pancreatitis and delayed cholecystectomy candidates. METHODS: To this purpose, the randomized, controlled clinical trial was performed on 40 patients with biliary pancreatitis who were candidates for delayed cholecystectomy. Patients were randomly divided into two groups of A and B that underwent CBD stenting after ERCP and received endoscopic treatment without stenting, respectively. A checklist recorded demographics and complications. Group A was followed up after four weeks to remove the stent and record the complications. Group B underwent MRCP to examine the migration of new gallstones as well as the complications. RESULTS: Of the 40 patients, 20 subjects (11 males and 9 females) were allocated to each group, matched for demographic variables. In the one-month follow-up, only one subject in group A manifested symptoms of gallstone migration and recurrence, while in group B, recurrence was observed in 6 patients (P = 0.037). There was no significant difference in the success rate of ERCP and the incidence of complications between the two groups. CONCLUSION: CBD stenting in patients with biliary pancreatitis and gallstone could reduce the risk of recurrence and remigration of gallstones in delayed cholecystectomy cases.


Cholangiopancreatography, Endoscopic Retrograde , Cholecystectomy/methods , Gallstones , Pancreatitis , Postoperative Complications , Prosthesis Implantation , Cholangiopancreatography, Endoscopic Retrograde/adverse effects , Cholangiopancreatography, Endoscopic Retrograde/instrumentation , Cholangiopancreatography, Endoscopic Retrograde/methods , Female , Gallstones/complications , Gallstones/diagnosis , Gallstones/physiopathology , Gallstones/surgery , Humans , Male , Middle Aged , Pancreatitis/diagnosis , Pancreatitis/etiology , Pancreatitis/prevention & control , Postoperative Complications/diagnosis , Postoperative Complications/etiology , Postoperative Complications/prevention & control , Prosthesis Implantation/adverse effects , Prosthesis Implantation/instrumentation , Prosthesis Implantation/methods , Risk Adjustment/methods , Secondary Prevention/methods , Stents , Time-to-Treatment , Treatment Outcome
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