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1.
Front Cardiovasc Med ; 11: 1408543, 2024.
Article in English | MEDLINE | ID: mdl-38993520

ABSTRACT

Aim: Periprocedural and postinterventional care of patients undergoing closure of patent foramen ovale (PFO) varies significantly across care providers. Same-day discharge (SDD) after transcatheter interventions is an evolving concept. This study aimed to assess the same-day discharge rate and incidence of complications in patients undergoing PFO closure with intracardiac echocardiography (ICE) using the Gore®Cardioform Septal Occluder (GSO) device. The secondary aim was to analyse the efficacy of femoral vein closure with Perclose ProGlide. Methods: Patients who underwent PFO closure with the GSO device at a university hospital in Stockholm, Sweden, were retrospectively included between March 1, 2017, and June 30, 2020, all with cryptogenic stroke as the indication for the procedure. All patients underwent PFO closure with conscious sedation and local anaesthesia. The indication for all patients was a cryptogenic stroke. Periprocedural imaging was performed using ICE and fluoroscopy in all patients. Patient characteristics and periprocedural data were collected from patient charts. Patients were kept on bed rest for 4-6 h post-intervention. Transthoracic echocardiography and clinical examination, including groin status, were performed before discharge. No clinical routine follow-up was performed the day following the intervention. Clinical follow-up was done by phone call two weeks after the procedure, and echocardiographic follow-up was done after 12 months. Data were analysed using linear and logistic regression models. Results: In total, 262 patients were included, of which 246 (94%) had SDD. 166 patients (63%) received the ProGlide™ system for femoral vein access closure. Post-procedural arrhythmias occurred in 17 (6%) patients, and vascular complications in 9 patients (3%). The overall closure rate at follow-up was 98.5%. 25 out of 264 patients (9.5%) had to be readmitted within the first eight weeks after PFO closure, 16 due to atrial fibrillation warranting electric cardioversion, one due to an arteriovenous fistula that was operated, four due to chest pain/pain at the access site, and four patients developed fever. There was no difference in SDD among patients who received ProGlide™ vs. patients who did not receive ProGlide™. Conclusion: SDD appears safe after transcatheter PFO closure with the GSO device with high procedural success rates. Low rates of complications and readmissions make the intervention suitable for this patient-friendly and cost-effective concept.

2.
J Endovasc Ther ; : 15266028241258662, 2024 Jul 24.
Article in English | MEDLINE | ID: mdl-39044646

ABSTRACT

PURPOSE: This trial was designed and aimed to compare safety and efficacy of Obtura™ vascular closure device (VCD) to manual compression (MC) among patients undergoing transfemoral catheterization. MATERIAL AND METHODS: This prospective, randomized, controlled, multicenter trial of Obtura VCD against MC randomized patients in 1:1 (n=268; 134:134) ratio. Safety and efficacy were measured by primary endpoints (time to hemostasis [TTH] and deployment success) and secondary endpoints which included technical success, device-related adverse events, and time to ambulation (TTA). RESULTS: The procedural access using right femoral artery was performed in 95.52% of patients in Obtura VCD versus 96.27% in standard MC method, whereas 2.99% of patients in each group underwent left femoral access. Bilateral access was performed in 1.49% (n=2) versus 0.75% (n=1) in Obtura VCD versus MC, respectively. Both the technical success and deployment success were 100%. Patients in Obtura VCD group had shorter TTH (3.26±3.39 vs 23.95±8.24 minutes; p<0.0001) and TTA (155.44±125.32 vs 723.84±197.98 minutes; p<0.0001) than MC group. No access site complications (re-bleeding, infection, arteriovenous fistula, and transient access site nerve injury) were noted at 2-week, 1-month, and 3-month follow-ups. There were 4 (3%) and 6 (4.5%) cases of hematoma, respectively, in Obtura VCD versus MC and 1 case (0.7%) of post-procedural arterial pseudoaneurysm each in both the groups which were successfully resolved and patients were discharged with no further complications. Further follow-up was without any adverse events. CONCLUSIONS: The study demonstrated favorable safety and efficacy of Obtura™ VCD with a significantly short TTH and TTA compared to MC. CLINICAL IMPACT: In patients undergoing cardiac catheterization, vascular closure devices (VCDs) can achieve hemostasis faster after successful implantation of the device with fewer complications such as bleeding and ambulation can be achieved faster. In terms of effectiveness, Obtura VCD was found to be better than manual compression in achieving early hemostasis and higher technical and deployment success was accomplished. Obtura VCD does not require enlargement of the route through the tissues, uses the same existing arterial sheath as its conduit, and does not cause patients' access sites to feel uncomfortable while it is being deployed.

3.
Front Surg ; 11: 1391533, 2024.
Article in English | MEDLINE | ID: mdl-39035114

ABSTRACT

Abdominal trauma is common in daily life, but a traumatic abdominal wall hernia (TAWH) in children is rare. A TAWH is caused by a huge external force that leads to subcutaneous muscle and fascia rupture, while the skin remains intact. As abdominal pressure increases, the abdominal contents protrude, forming a lump. A TAWH is highly susceptible to missed diagnosis because of other severe injuries. We report a case of a 2-year-old boy with a TAWH who developed a prominent subcutaneous mass on the right side of his abdomen after abdominal trauma; the size of the mass changed significantly with abdominal pressure and crying. In this case, we used a new approach of laparoscopic suture repair technique with the assistance of a fascial closure device and achieved good results. We found that this method offers the advantages of minimally invasive surgery, fast recovery, and no visible surgical incisions. There was no recurrence after 8 months of follow-up.

4.
Article in English | MEDLINE | ID: mdl-39007968

ABSTRACT

BACKGROUND: Pulsed field ablation (PFA) is a novel method of non-thermal cardiac ablation for atrial fibrillation (AF). Its use on patients with pre-existing Watchman devices has not been studied. METHODS: Pulmonary vein isolation (PVI) utilizing PFA was performed in 7 patients with symptomatic AF and implanted Watchman devices. All cases were conducted at a single academic center. RESULTS: Successful PVI in patients with Watchman devices implanted at a median time of 534 days prior to the index ablation procedure (IQR 365 days) was achieved in all cases. No major adverse events (intraprocedural CVA, post-procedural CVA, major or minor bleeding events, device embolization, or cardiac tamponade) were observed. In 6 of 7 patients, a low-dose direct oral anticoagulant (DOAC) strategy was implemented post-PFA. CONCLUSION: We present the first reported case series of PFA in patients with AF and implanted Watchman devices. This study highlights the safety and feasibility of the FARAPULSE PFA system in this patient population.

5.
EJVES Vasc Forum ; 61: 113-115, 2024.
Article in English | MEDLINE | ID: mdl-38884075

ABSTRACT

Introduction: Acute limb ischaemia resulting from foreign body embolisation is an infrequent yet critical complication associated with vascular closure devices (VCDs). Despite the widespread use of VCDs, rare complications such as fragment emboli pose unique challenges, necessitating heightened clinical awareness. This case report presents a case of acute limb ischaemia caused by a VCD malfunction following an endovascular procedure. Report: A 70 year old male who was diagnosed with a severe claudication of the lower extremity (Rutherford III) due to right common iliac stenosis, underwent angioplasty using a FemoSeal (Terumo Ltd., Surrey, UK) to close the right femoral artery access. Two weeks later, the patient presented with acute lower limb ischaemia due to a right popliteal-tibial occlusion. Emergency surgical thrombo-embolectomy was successfully performed from a medial popliteal approach, and the thrombus, which contained a polymer disc from the VCD at its distal end, was completely removed. Discussion: Despite VCDs being proven safe and efficient, rare complications such as fragment emboli can occur, and physicians should be aware of the possible delayed onset of symptoms. Moreover, the radiolucent nature of the polymer disc in a FemoSeal complicates diagnostic imaging. While endovascular approaches exist, open surgery is a safe and effective strategy for retrieving fragments and treating the patient in acute limb ischaemia cases. Conclusion: Physicians should remain vigilant for embolic risks associated with vascular closure devices, even with suitable anatomy and following guidelines, especially considering the trend toward early ambulation and discharge.

6.
Medicina (Kaunas) ; 60(6)2024 Jun 12.
Article in English | MEDLINE | ID: mdl-38929586

ABSTRACT

Background and Objective: Although extracorporeal membrane oxygenation (ECMO) is an essential life-saving technique for patients with refractory cardiopulmonary shock, it can be fatal in certain cases. Case Presentation: A 19-year-old girl treated with ECMO presented with acute limb ischemia 2 days after cannula removal. The decannulation was performed percutaneously by an interventional cardiologist, and the vascular surgery department was consulted after the patient developed symptoms. The first suspected diagnosis was thrombosis due to incorrect use of the closure device. However, the artery had ruptured due to the insertion of a catheter with a cannula that was larger than the patient's artery. Management and Outcome: Fortunately, excessive bleeding due to the size-mismatched cannula was prevented by an unintentional complication of the closing device, which saved the patient's life. She underwent a right common femoral artery thrombectomy and patch angioplasty. Hospital guidelines have changed regarding the surgical removal of ECMO cannulas. Discussion: This report aims to highlight the importance of two aspects that are critical to a successful outcome: individualized cannula selection followed by precise insertion and removal and postoperative evaluation of a patient's final status.


Subject(s)
Cannula , Extracorporeal Membrane Oxygenation , Hemorrhage , Myotonic Dystrophy , Humans , Extracorporeal Membrane Oxygenation/methods , Female , Young Adult , Hemorrhage/etiology , Hemorrhage/therapy , Myotonic Dystrophy/complications , Femoral Artery , Thrombectomy/methods , Adult
7.
Article in English | MEDLINE | ID: mdl-38904848

ABSTRACT

Percutaneous closure of the left atrial appendage may be indicated in patients with contraindications to anticoagulation therapy, for example, after recurrent gastrointestinal bleeding. It is an effective and safe procedure but is not without complications. We present a patient who presented with severe aortic insufficiency due to migration of the left atrial appendage closure device, which required urgent cardiac surgery for its removal.

8.
Article in English | MEDLINE | ID: mdl-38924288

ABSTRACT

INTRODUCTION: Access site complications remain common following atrial fibrillation (AF) catheter ablation. Femoral vascular closure devices (VCDs) reduce time to hemostasis compared with manual compression, although large-scale data comparing clinical outcomes between the two approaches are lacking. METHODS: Two cohorts of patients undergoing AF ablation were identified from 36 healthcare organizations using a global federated research network (TriNetX): those receiving a VCD for femoral hemostasis, and those not receiving a VCD. A 1:1 propensity score matching (PSM) model based on baseline characteristics was used to create two comparable cohorts. The primary outcome was a composite of all-cause mortality, vascular complications, bleeding events, and need for blood transfusion. Outcomes were assessed during early (within 7 days of ablation) and extended follow-up (within 8-30 days of ablation). RESULTS: After PSM, 28 872 patients were included (14 436 in each cohort). The primary composite outcome occurred less frequently in the VCD cohort during early (1.97% vs. 2.60%, odds ratio (OR) 0.76, 95% confidence interval (CI) 0.65-0.88; p < .001) and extended follow-up (1.15% vs. 1.43%, OR 0.80, 95% CI 0.65-0.98; p = .032). This was driven by a lower rate of vascular complications during early follow-up in the VCD cohort (0.83% vs. 1.26%, OR 0.66, 95% CI 0.52-0.83; p < .001), and fewer bleeding events during early (0.90% vs. 1.23%, OR 0.73, 95% CI 0.58-0.92; p = .007) and extended follow-up (0.36% vs. 0.59%, OR 0.61, 95% CI 0.43-0.86; p = .005). CONCLUSION: Following AF ablation, femoral venous hemostasis with a VCD was associated with reduced complications compared with hemostasis without a VCD.

9.
World Neurosurg ; 188: e305-e311, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38796148

ABSTRACT

OBJECTIVE: Puncture-site complications in interventional radiology sometimes cause severe conditions. Vascular closure devices play an important role in preventing puncture-site complications. Vascular closure devices are divided into 2 types, the directly suturing or clipping type (active approximators) and adherent sealant types (passive approximators). However, which types of vascular closure device are the safest and most effective for achieving hemostasis remains unclear. We analyzed the efficacy of each type of vascular closure device and risk factors for puncture-site complications. METHODS: This study investigated 327 consecutive cases of neuroendovascular surgery using a transfemoral procedure during a 2-year study period. Passive approximators (Angioseal [St Jude Medical, Saint Paul, MN] and Exoseal [Cordis Corporation, Miami, FL]) were mainly used in the first half and active approximators (Perclose [Abbot Vascular, Santa Clara, CA]) in the second. We compared groups and estimated risk factors for puncture-site complications. RESULTS: All procedures were successful. Comparing groups with and without puncture-site complications, use of passive approximators and ≥3 antithrombotic medications tended to be more frequent and distance from skin to femoral artery and body mass index tended to be lower in the group with complications without significance. The cutoff for femoral artery depth calculated from a receiver operating characteristic curve was 16.43 mm. Multivariate analysis revealed ≥3 antithrombotic medications (P = 0.002, OR 15.29, 95% CI 2.76-85.76) and passive approximator use in patients with femoral artery depth <16.43 mm (P < 0.001, OR 17.08, 95% CI 2.95-57.80) were significantly higher in the group with puncture-site complications. CONCLUSIONS: Passive approximator use in patients with shallow femoral artery depth increases puncture-site complications in neuroendovascular treatment.


Subject(s)
Endovascular Procedures , Femoral Artery , Punctures , Vascular Closure Devices , Humans , Femoral Artery/surgery , Male , Female , Middle Aged , Aged , Punctures/adverse effects , Endovascular Procedures/adverse effects , Endovascular Procedures/methods , Adult , Risk Factors , Retrospective Studies , Aged, 80 and over
10.
Article in English | MEDLINE | ID: mdl-38795098

ABSTRACT

BACKGROUND: Differences in the efficacy and safety between the preclose and postclose suture-mediated vascular closure systems for femoral vein access have not been adequately studied. OBJECTIVES: This study aimed to evaluate the efficacy and safety of these 2 suturing techniques in femoral vein access. METHODS: Patients subjected to elective catheter ablation via the femoral vein using a sheath of 8- to 13-F inner diameter (n = 282) were randomized to the preclose or postclose groups for the single-suture technique using ProGlide/ProStyle (Abbott Vascular). Duplex ultrasound was performed on days 1 and 90 after the procedure to evaluate vascular complications. The primary efficacy endpoint was rebleeding requiring recompression, and the primary safety endpoint was any major complication occurring within 90 days. The secondary efficacy endpoints included time to hemostasis and time to ambulation, and the secondary safety endpoint was any minor complication occurring within 90 days. RESULTS: The preclose group demonstrated a significantly lower rebleeding rate (5 of 141 [3.5%] vs 15 of 141 [10.6%]; P = 0.03) and shorter time to hemostasis (254.0 ± 120.4 seconds vs 299.8 ± 208.2 seconds; P = 0.02) compared with the postclose group. Five patients in each group were lost to follow-up at 90 days. Incidence of major complications were similar in both groups (1 of 136 [0.7%]; P = 1.00), whereas minor complications were observed in 18 of 136 (13.2%) and 21 of 136 (15.4%) patients in the preclose and postclose groups, respectively, without a significant difference (P = 0.73). CONCLUSIONS: In femoral vein access using the single-suture technique with ProGlide/ProStyle, the preclose technique presented a higher hemostasis rate than the postclose technique, without compromising safety.

12.
Gastrointest Endosc ; 2024 May 09.
Article in English | MEDLINE | ID: mdl-38734256

ABSTRACT

BACKGROUND AND AIM: After endoscopic full-thickness resection (EFTR), defects require a reliable and sustained closure. We present a novel, through-the-scope "bow-tie" (TTS-BT) closing device enabling direct defect closure without scope withdrawal. This preclinical study aimed to evaluate the feasibility and safety of this device for large defect closure after EFTR in a porcine model. METHODS: Exposed EFTR was performed for virtual lesions > 2 cm in the stomach of twelve pigs. Subsequently, TTS-BT closing devices were used for defect closure. Conventional metal clips were used to close any remaining defects. Gastroscopy was performed for 8 weeks to examine the wound sites and the pigs were subsequently sacrificed. After sacrificing the pigs, the wound healing was histologically verified by hematoxylin-eosin (HE) staining. The primary outcome was a successful closure rate, while the secondary outcomes were complete healing rate, closure time, and incidence of adverse events. RESULTS: The median long and short diameters of perforations were 4.0 (3.0-6.0) cm and 3.0 (2.0-4.0) cm, respectively. Defect closure using novel TTS-BT closure devices and conventional metal clips was successfully performed in all pigs. Complete healing was achieved in the defects of 12 pigs. The median closure time was 13 (9-38) minutes. No serious adverse events occurred during the 8-week follow-up. CONCLUSIONS: The novel TTS-BT closure device is feasible and safe for closing large gastric perforations and could be a promising tool for clinical practice.

13.
Medicina (Kaunas) ; 60(5)2024 Apr 26.
Article in English | MEDLINE | ID: mdl-38792900

ABSTRACT

Percutaneous closure of the patent foramen ovale (PFO) is generally regarded as a safe and effective procedure, indicated in patients with a prior PFO-associated stroke. While it is highly safe, rarely, it could be accompanied by a migration of the device, mainly caused by the interplay of a specific PFO morphology and inappropriate device sizing. Herein, we outline a seldom-observed complication of an unintentional detachment of the PFO closure device during implantation, leading to its migration into the abdominal aorta, and a unique management approach. Due to the inability to recapture the occluder with a snare, which is considered to be a mainstay of endovascular retrieval methods, two coronary guidewires were maneuvered through the mesh of the occluder and then captured with a snare proximally to the occluder. This innovative dual-wire-snare system was carefully pulled to the common femoral artery, a position deemed suitable for surgical extraction via arteriotomy, which was achieved successfully.


Subject(s)
Foramen Ovale, Patent , Septal Occluder Device , Humans , Foramen Ovale, Patent/surgery , Foramen Ovale, Patent/complications , Septal Occluder Device/adverse effects , Female , Embolism/etiology , Middle Aged
14.
Vascular ; : 17085381241256191, 2024 May 24.
Article in English | MEDLINE | ID: mdl-38785381

ABSTRACT

BACKGROUND: Majority of EVAR procedures are performed with percutaneous arterial access, unless there is severe steno-occlusive disease in the common femoral arteries (CFA). We present our experience of using MANTA closure device with a retrospective evaluation of its safety and efficacy, in the elective setting, and in the emergent setting for ruptured aortic aneurysm. DESIGN AND METHODS: Between Feb 2021 and May 2023 a total of 75 EVAR procedures were closed with a Manta device. Data was collected prospectively and analysed retrospectively. In 75 patients, 128 CFAs were closed with a Manta closure device including 4 emergent ruptured aneurysms. RESULTS: 67 male and 8 female patients with a median age of 77 years had percutaneous EVAR using Manta as a closure device. 128 CFAs were closed with Manta closure device. 3% (4/128) had deployment failures, with three requiring surgical cut down and closure. In one patient, a second Manta device deployment achieved satisfactory haemostasis. Three deployments were complicated by pseudoaneurysms of the CFA, all requiring no further interventions/treatment. No death related to severe haemorrhage from device failure. The pre- and post-procedure CFA puncture site AP diameter was recorded in a total of 106 cases with appropriate follow-up. 66% of these (70/106) had no reduction in CFA diameter post Manta closure. 34% (36/106) had some reduction of vessel AP size CFA post EVAR. No adverse features or further treatment was required due to reduction of vessel diameter in these cases (ongoing yearly surveillance). CONCLUSIONS: Manta closure device is safe and easy to deploy with an overall success rate of 97%. There is a short learning curve. Ultrasound assessment and precise puncture at the healthy section of femoral artery are the key to achieve successful haemostasis with Manta closure device. Our findings suggest there is an association of non-clinically significant mild reduction in CFA vessel AP diameter post Manta closure device, which does not require further intervention.

15.
JTCVS Open ; 18: 80-86, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38690437

ABSTRACT

Objective: Open decannulation from femoral venoarterial extracorporeal membrane oxygenation (VA-ECMO) carries high risk of morbidity, including groin wound infection. This study evaluated the impact of percutaneous decannulation on rates of groin wound infection in patients decannulated from femoral VA-ECMO. Methods: Between January 1, 2022, and April 30, 2023, 47 consecutive patients received percutaneous femoral VA-ECMO and survived to decannulation. A percutaneous suture-mediated closure device was used for decannulation in patients with relatively smaller arterial cannulas. Patients with larger arterial cannulas or unsuccessful percutaneous closures underwent surgical cutdown and repair of the femoral artery. The primary outcome was arterial site wound infection following decannulation. Results: Among the 47 patients who survived to decannulation from VA-ECMO, 21 underwent percutaneous decannulation and 27 underwent surgical cutdown. One patient underwent 2 VA-ECMO runs, one with percutaneous decannulation and one with surgical cutdown. Percutaneous decannulation was attempted in 22 patients, with 21 of 22 (95.5%) success rate. Decannulation procedure length was significantly shorter in the percutaneous group (79 minutes vs 148 minutes, P = .0001). The percutaneous group had significantly reduced rates of groin wound complications (0% vs 40.7%, P = .001) and groin wound infections (0% vs 22.2%, P = .03) when compared with the surgical cutdown group. Three patients (14.3%) in the percutaneous group experienced vascular complications, including pseudoaneurysm at the distal perfusion catheter site and nonocclusive thrombus of the common femoral artery. Conclusions: Percutaneous decannulation may reduce decannulation procedure length and rate of groin wound infection in patients who survive to decannulation from VA-ECMO.

16.
Europace ; 26(5)2024 May 02.
Article in English | MEDLINE | ID: mdl-38647070

ABSTRACT

AIMS: Simplified ablation technologies for pulmonary vein isolation (PVI) are increasingly performed worldwide. One of the most common complications following PVI are vascular access-related complications. Lately, venous closure systems (VCSs) were introduced into clinical practice, aiming to reduce the time of bed rest, to increase the patients' comfort, and to reduce vascular access-related complications. The aim of the present study is to compare the safety and efficacy of using a VCS to achieve haemostasis following single-shot PVI to the actual standard of care [figure-of-eight suture and manual compression (MC)]. METHODS AND RESULTS: This is a prospective, multicentre, randomized, controlled, open-label trial performed at three German centres. Patients were randomized 1:1 to undergo haemostasis either by means of VCS (VCS group) or of a figure-of-eight suture and MC (F8 group). The primary efficacy endpoint was the time to ambulation, while the primary safety endpoint was the incidence of major periprocedural adverse events until hospital discharge. A total of 125 patients were randomized. The baseline characteristics were similar between the groups. The VCS group showed a shorter time to ambulation [109.0 (82.0, 160.0) vs. 269.0 (243.8, 340.5) min; P < 0.001], shorter time to haemostasis [1 (1, 2) vs. 5 (2, 10) min; P < 0.001], and shorter time to discharge eligibility [270 (270, 270) vs. 340 (300, 458) min; P < 0.001]. No major vascular access-related complication was reported in either group. A trend towards a lower incidence of minor vascular access-related complications on the day of procedure was observed in the VCS group [7 (11.1%) vs. 15 (24.2%); P = 0.063] as compared to the control group. CONCLUSION: Following AF ablation, the use of a VCS results in a significantly shorter time to ambulation, time to haemostasis, and time to discharge eligibility. No major vascular access-related complications were identified. The use of MC and a figure-of-eight suture showed a trend towards a higher incidence of minor vascular access-related complications.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Pulmonary Veins , Suture Techniques , Humans , Atrial Fibrillation/surgery , Female , Male , Middle Aged , Catheter Ablation/adverse effects , Catheter Ablation/methods , Prospective Studies , Pulmonary Veins/surgery , Suture Techniques/adverse effects , Aged , Treatment Outcome , Germany , Time Factors , Vascular Closure Devices , Early Ambulation , Hemostatic Techniques/instrumentation
17.
Catheter Cardiovasc Interv ; 103(7): 1125-1137, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38639140

ABSTRACT

BACKGROUND: Despite the use of two crossed Perclose ProGlide™ (Abbott Vascular Devices) is the most widespread technique to close the main arterial access in transfemoral transcatheter aortic valve implantation (TF-TAVI), the safest and most effective strategy still remains much debated. AIMS: The aim of the present study was to evaluate the performance of a single Perclose ProGlide suture-mediated closure device to obtain femoral hemostasis after sheathless implantation of self-expanding transcatheter heart valves through their 14 F-equivalent fix delivery systems. METHODS: This prospective observational study included 439 patients undergoing TF-TAVI at the "Montevergine" Clinic of Mercogliano, Italy. All patients underwent hemostasis of the large-bore access using a single Perclose ProGlide with preclose technique, after sheathless implantation of self-expanding transcatheter heart valves through 14 F-equivalent fix delivery systems. A multidetector computed tomography analysis of size, tortuosity, atherosclerotic, and calcification burdens of the ilio-femoral access route was made by a dedicated corelab. Vascular complications (VCs), percutaneous closure device (PCD) failure, and bleedings were adjudicated by a clinical events committee. RESULTS: A total of 81 different VCs were observed in 60 patients (13.7%); among these, 41 (5% of patients) were categorized as major. PCD failure occurred in 14 patients (3.2%). At the logistic regression analysis, no predictors of PCD failure have been identified. CONCLUSION: This registry suggests that the use of a single suture-mediated closure device could be considered a safe and efficient technique to achieve access site hemostasis in patients undergoing TF-TAVI through 14 F-equivalent fix delivery systems.


Subject(s)
Catheterization, Peripheral , Femoral Artery , Hemostatic Techniques , Punctures , Suture Techniques , Transcatheter Aortic Valve Replacement , Vascular Closure Devices , Humans , Femoral Artery/diagnostic imaging , Male , Female , Transcatheter Aortic Valve Replacement/instrumentation , Transcatheter Aortic Valve Replacement/adverse effects , Prospective Studies , Aged, 80 and over , Treatment Outcome , Catheterization, Peripheral/adverse effects , Aged , Hemostatic Techniques/instrumentation , Hemostatic Techniques/adverse effects , Suture Techniques/adverse effects , Suture Techniques/instrumentation , Risk Factors , Time Factors , Aortic Valve/surgery , Aortic Valve/diagnostic imaging , Aortic Valve/physiopathology , Italy , Equipment Design , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/physiopathology , Hemorrhage/etiology , Hemorrhage/prevention & control
18.
Cureus ; 16(3): e57150, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38681362

ABSTRACT

PURPOSE: Transcatheter closure is the first-line treatment option for hemodynamically significant secundum atrial septal defects (ASDs). This study examines our center's experience with this procedure over the last 15 years. MATERIALS AND METHODS: Pediatric patients aged 0-18 years with secundum ASDs who were planned for transcatheter closure in our clinic between January 2007 and January 2023 were retrospectively evaluated. RESULTS: Transcatheter secundum ASD closure was planned for a total of 334 patients during the study period: 191 girls (57.2%) and 143 boys (42.8%). Their mean age was 8.08±3.9 years, and their mean weight was 30±15.6 kg. Defect diameter measured transesophageally ranged from 5 to 35 mm, with a mean of 12.56±4.02 mm. Transesophageal echocardiographic examination revealed a single secundum ASD in 319 patients (95.5%) and multiple secundum ASDs in 15 patients (4.5%). In 11 patients (3.3%), the procedure was terminated before initiating transcatheter ASD closure because of insufficient vena cava rims or a very large or multi-fenestrated defect. The 323 patients (96.7%) who underwent transcatheter ASD closure had a mean pulmonary artery pressure of 15.1±4.0 mmHg and a mean Qp/Qs ratio of 1.97±0.56. The procedure failed in four patients (1.3%) because of device embolization (n=2) or the inability to properly position the device (n=2). Major complications other than device embolization observed during or after transcatheter closure included anesthetic-induced respiratory depression (n=1) and total atelectasis of the lung (n=1). No new major complications were detected during the patients' long-term follow-up. CONCLUSION: With appropriate patient and device selection, transcatheter closure is a safe and effective treatment for secundum ASD and should be the first treatment of choice.

19.
Heart Rhythm ; 2024 Apr 10.
Article in English | MEDLINE | ID: mdl-38608918

ABSTRACT

BACKGROUND: Venous vascular access complications are usually nonfatal but are the most common complications after transvenous catheter intervention. Vascular closure devices (VCDs) have recently become available for venous closure. OBJECTIVE: This study aimed to evaluate the feasibility and efficacy of real-time ultrasound-guided venous closure with suture-mediated VCDs in patients who underwent catheter ablation. METHODS: This single-center observational study enrolled 226 consecutive patients who underwent elective catheter ablation with femoral venipuncture. For hemostasis, vessel closure by VCD was performed with real-time ultrasound guidance after 2022 (n = 123) and without ultrasound guidance in 2021 (n = 103). The occurrence of venous access site-related complications (major, minor, or other) was compared. RESULTS: The rate of device failure was significantly lower in patients with ultrasound guidance than in those without (1.6% vs 6.3%; P = .048). The occurrence of all venous access site-related complications was significantly lower in patients with ultrasound guidance than in those without (4.9% vs 18.4%; P = .001). Time to ambulation was shorter in patients with ultrasound guidance than in those without (2.0 ± 0.1 hours vs 2.2 ± 0.6 hours; P < .001). CONCLUSION: Real-time ultrasound guidance can reduce device failure, access site-related complications, and time to ambulation in performing venous closure with a VCD.

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