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1.
Trials ; 25(1): 370, 2024 Jun 08.
Article in English | MEDLINE | ID: mdl-38851710

ABSTRACT

BACKGROUND: Endovascular therapy has become established as a first-line therapy in most arterial regions. However, open vascular surgery (endarterectomy) remains the treatment of choice for common femoral artery (CFA) lesions. The aim of this study is to investigate the acute and mid-term results of directional atherectomy plus drug-coated balloon (DCB) in comparison to endarterectomy in treatment of de novo arteriosclerotic CFA lesions. METHODS: This prospective, randomized, multicenter non-inferiority study will enroll 306 participants with symptomatic (Rutherford category 1 to 5) de novo stenosis of the CFA including the bifurcation. Patients eligible for both treatment groups could be included in this 1:1 randomized trial. Primary efficacy endpoint is patency of the target lesion at 12 months defined as restenosis < 50% without the need of clinically driven target lesion revascularization (cdTLR). Primary safety endpoint is a combined endpoint including death, myocardial infarction, major or minor amputation of the target limb, and peri-procedural complications at 30 days. Secondary endpoints include primary patency of the target lesion at 6 and 24 months, secondary patency, cdTLR 6, 12, and 24 months, change in ankle-brachial index, and Rutherford-Becker class at 6, 12, and 24 months. Limb salvage, change in quality of life measured by Walking Impairment Questionnaire, and major adverse events including death, myocardial infarction, and minor or major amputation of the target limb will be determined at 6, 12, 24, and 36 months. DISCUSSION: Endovascular treatment of CFA lesions is still a matter of debate. Few studies compared modern endovascular therapy methods against the so-called gold standard surgical endarterectomy so far. Based on recent positive results, this study aims to confirm non-inferiority of a "leaving nothing behind" endovascular approach combining directional atherectomy and DCB compared to surgical therapy. TRIAL REGISTRATION: ClinicalTrials.gov NCT02517827.


Subject(s)
Endarterectomy , Femoral Artery , Peripheral Arterial Disease , Vascular Patency , Humans , Femoral Artery/surgery , Prospective Studies , Treatment Outcome , Peripheral Arterial Disease/therapy , Peripheral Arterial Disease/surgery , Peripheral Arterial Disease/physiopathology , Time Factors , Endarterectomy/adverse effects , Endarterectomy/methods , Atherectomy/adverse effects , Atherectomy/methods , Multicenter Studies as Topic , Equivalence Trials as Topic , Angioplasty, Balloon/adverse effects , Angioplasty, Balloon/methods , Angioplasty, Balloon/instrumentation , Coated Materials, Biocompatible , Limb Salvage , Quality of Life , Vascular Access Devices , Randomized Controlled Trials as Topic
2.
J Egypt Natl Canc Inst ; 36(1): 15, 2024 May 13.
Article in English | MEDLINE | ID: mdl-38736004

ABSTRACT

BACKGROUND: Giant sacrococcygeal teratomas (SCTs) are at risk of perinatal morbidity and mortality due to their high vascularity. Pre-operative embolization of the feeding arteries, prior to complete surgical resection, may assist in minimizing the intraoperative blood loss by occluding these feeding arteries. CASE PRESENTATION: We present a case of a highly vascular giant SCT in a neonate, which was successfully embolized through an endovascular approach prior to surgery. The femoral artery approach was chosen, with access established using a Micropuncture introducer as a sheath. Embolization was performed using a combination of microcoils, Gelfoam slurry, and polyvinyl alcohol particles. The patient developed femoral artery spasm post-procedure, which resolved with the application of a glyceryl trinitrate patch. CONCLUSIONS: Performing pre-operative endovascular embolization on a giant sacrococcygeal teratoma presents particular challenges, primarily due to the difficulty in assessing small vessels and the potential complications associated with this procedure. Nevertheless, this technique proves exceptionally valuable in helping the surgeon minimize blood loss during surgery, thereby reducing the risks of morbidity and mortality. Comprehensive planning for the embolization procedure is essential, encompassing the identification of potential vascular access points and alternatives, along with careful selection of the appropriate catheter.


Subject(s)
Embolization, Therapeutic , Sacrococcygeal Region , Teratoma , Humans , Teratoma/therapy , Teratoma/pathology , Embolization, Therapeutic/methods , Infant, Newborn , Female , Endovascular Procedures/methods , Preoperative Care , Treatment Outcome , Femoral Artery/surgery , Femoral Artery/diagnostic imaging
3.
Medicine (Baltimore) ; 103(19): e37889, 2024 May 10.
Article in English | MEDLINE | ID: mdl-38728483

ABSTRACT

RATIONALE: Anesthesia management of patients with dilated cardiomyopathy (DCM) has always been a challenge for anesthesiologists. Eighty percent of patients with DCM have heart failure as the first symptom, which may be accompanied by arrhythmias, thromboembolism, etc. Thrombosis is a significant contributing factor to adverse cardiovascular and cerebrovascular events, and its risk is severely underestimated in the anesthetic management of DCM. PATIENT CONCERNS: We present a case of a 54-year-old hypersensitive female patient with dilated cardiomyopathy and purpura who underwent an interventional thrombectomy under general anesthesia following a lower limb thromboembolism. DIAGNOSIS: Patient underwent an interventional thrombectomy under general anesthesia, with in situ thrombosis occurring during the surgery. INTERVENTIONS: After maintaining stable hemodynamics, proceed with the intervention to retrieve the embolus. OUTCOME: Patients in the advanced DCM developed acute thrombosis twice during embolization. LESSONS: This case discusses the causes of intraoperative thrombosis and summarizes and reflects on the anesthesia management of this case, which has always been one of the difficult points for anesthesiologists to master. In the anesthesia management of DCM patients, it is also necessary to maintain hemodynamic stability, enhance perioperative coagulation management, use anticoagulants rationally, and avoid the occurrence of thrombotic events.


Subject(s)
Anesthesia, General , Cardiomyopathy, Dilated , Femoral Artery , Thrombectomy , Humans , Female , Middle Aged , Cardiomyopathy, Dilated/complications , Cardiomyopathy, Dilated/surgery , Thrombectomy/methods , Femoral Artery/surgery , Anesthesia, General/methods , Thromboembolism/etiology
4.
Medicina (Kaunas) ; 60(5)2024 May 08.
Article in English | MEDLINE | ID: mdl-38792960

ABSTRACT

Background and Objectives: Lower extremity arterial disease is one of the most prevalent manifestations of atherosclerosis. The results from numerous studies regarding the best revascularization method of an occluded superficial femoral artery have been conflicting. The aim of this study was to compare the patency of transvenous endovascular with open femoropopliteal bypass, both with vein and prosthetic grafts. To our knowledge, a direct patency comparison between transvenous endovascular and open femoropopliteal bypass has not been published. This could help elucidate which method is preferable and in which cases. Materials and Methods: Patients with complex TASC-C and D SFA lesions were offered endovascular transvenous or open bypass. A total of 384 consecutive patients with PAD requiring surgical treatment were evaluated for inclusion in this study. Three-year follow-up data were collected for 52 endovascular procedures, 80 prosthetic grafts, and 44 venous bypass surgeries. Bypass patency was investigated by Duplex US every 6 months. Kaplan-Meier plots were used to analyze primary, primary-assisted, and secondary patency for endovascular transvenous, autovenous, and prosthetic bypasses. Results: Primary, primary-assisted, and secondary patency in venous group at 3 years was 70.5%, 77.3%, and 77.3%, respectively. In the endovascular transvenous group, primary, primary-assisted, and secondary patency at 3 years was 46.2%, 69.2%, and 76.9%, respectively. The lowest patency rates at 3 years were noted in the prosthetic graft group with 22.5% primary, 26.6% primary-assisted, and 28.2% secondary patency. Conclusions: The saphenous vein is the best graft to perform in above-the-knee femoropopliteal bypass. Transvenous endovascular bypass is a viable option with comparable primary-assisted and secondary patency. Primary patency is substantially lower for endovascular transvenous compared to venous bypass. Patients treated with endovascular transvenous bypass will require a significant number of secondary procedures to provide optimal patency. Prosthetic grafts should only be used if no other option for bypass is available.


Subject(s)
Endovascular Procedures , Femoral Artery , Popliteal Artery , Vascular Patency , Humans , Femoral Artery/surgery , Male , Female , Popliteal Artery/surgery , Aged , Endovascular Procedures/methods , Middle Aged , Treatment Outcome , Peripheral Arterial Disease/surgery , Aged, 80 and over , Blood Vessel Prosthesis Implantation/methods
6.
J Pharmacol Toxicol Methods ; 127: 107517, 2024.
Article in English | MEDLINE | ID: mdl-38797367

ABSTRACT

INTRODUCTION: Rat telemetry is the assay of choice to assess the potential effects of novel drug candidates on cardiovascular parameters during early drug discovery. Telemetry device implantation can be combined with venous catheter and access button implantation when intravenous administration of the drug substance is required. METHODS: Rats (Sprague Dawley or Han Wistar) were implanted with telemetry devices for arterial blood pressure measurement using either direct aortic catheterisation (n = 131) or aortic catheterisation via the femoral artery (n = 17). Bipolar leads for ECG recording were also implanted in some of the animals (n = 102). Femoral vein catheters and access buttons were implanted as a separate surgery after the initial telemetry implantation (n = 43). RESULTS: 128 animals (86%) were implanted successfully with telemetry devices without any notable surgical or post-surgical problems. When considering the 2 different catheterisation methods separately, the success rate of the direct aortic approach was 88% compared to 76% with the aortic placement via the femoral artery. Lameness was the most common post-surgical problem. Blood loss during surgery and ischaemic patches on the tail were also observed at a low incidence with the direct aortic approach. Catheter pull-out occurred in some rats before the first signal check reducing the overall success rate for blood pressure measurement using the direct aortic approach to 85%. A 95% success rate was observed for catheter and access button implantation. DISCUSSION: A high success rate is possible when implanting telemetry devices in rats with and without venous catheters and access buttons. We have attempted to provide solutions to problems and describe refinements to the procedure which may further improve surgical outcomes.


Subject(s)
Rats, Sprague-Dawley , Rats, Wistar , Telemetry , Animals , Telemetry/methods , Telemetry/instrumentation , Rats , Male , Femoral Artery/surgery , Blood Pressure/drug effects , Electrocardiography/methods , Drug Evaluation, Preclinical/methods
7.
Jt Dis Relat Surg ; 35(2): 433-438, 2024 Mar 21.
Article in English | MEDLINE | ID: mdl-38727125

ABSTRACT

Amputation secondary to vascular complications of recurrent dislocations after total hip arthroplasty (THA) is an extremely rare. We describe an unusual case of above-knee amputation resulting from vascular complications after recurrent dislocations of a THA. A 63-year-old male patient with walking pain and limp has a history of acetabular fracture and central dislocation of the femoral head. He was diagnosed as post-traumatic arthritis and subluxation of the femoral head and suffered from four similar dislocations in 210 days after the THA. The patient received conservative treatment after every hip dislocation. However, four months after the fourth reduction, the emergent femoral artery and popliteal artery exploration and catheter thrombectomy were performed at another hospital. An ipsilateral above-knee amputation was done after sepsis and failure of the revascularization procedure. Clinicians should be cognizant that above-knee amputation resulting from vascular complications after recurrent dislocations of a THA may occur. The lack of adherence to critical treatment may have led to the severe outcome of amputation. In conclusion, patient education and compliance are essential for both the treatment of hip dislocations and arterial occlusion. More active and effective measures should be used to prevent such catastrophic events.


Subject(s)
Amputation, Surgical , Arthroplasty, Replacement, Hip , Hip Dislocation , Recurrence , Humans , Male , Middle Aged , Arthroplasty, Replacement, Hip/adverse effects , Hip Dislocation/surgery , Hip Dislocation/etiology , Femoral Artery/surgery
8.
Acta Orthop Belg ; 90(1): 131-134, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38669662

ABSTRACT

Compartment syndrome of the thigh and a pseudoaneurysm of the arteria profunda femoris are rare entities that usually occur independently. Untreated, both can lead to life-threatening complications making prompt diagnosis and management mandatory. The diagnosis of an acute compartment syndrome can be suspected clinically, and subsequently needs to be confirmed by intra-compartmental pressure measurement. Treatment should be done by urgent fasciotomy within 6 hours. A pseudoaneurysm can also be suspected clinically. Various imaging modalities exist to confirm the diagnosis, with duplex ultrasound being the diagnostic test of choice. Treatment is depending on the importance of clinical symptoms and on the size of the pseudoaneurysm. We present the first case in which an acute compartment syndrome of the thigh was complicated by a pseudoaneurysm of the arteria profunda femoris. The pseudoaneurysm was subsequently complicated by hemorrhage and infection.


Subject(s)
Aneurysm, False , Compartment Syndromes , Femoral Artery , Thigh , Humans , Aneurysm, False/complications , Aneurysm, False/diagnostic imaging , Aneurysm, False/surgery , Compartment Syndromes/etiology , Compartment Syndromes/surgery , Compartment Syndromes/diagnosis , Femoral Artery/diagnostic imaging , Femoral Artery/surgery , Male , Acute Disease , Fasciotomy/methods , Female , Middle Aged
9.
Innovations (Phila) ; 19(2): 192-195, 2024.
Article in English | MEDLINE | ID: mdl-38606852

ABSTRACT

OBJECTIVE: Femoral artery cannulation is the most commonly used approach for cardiopulmonary bypass (CPB) in robotic cardiac procedures. However, without adding a distal perfusion cannula, leg ischemia can occur in up to 11.5% of patients. There is a well-described 2 to 4 mm size arterial branch that originates from the medial side of the external iliac artery or inferior epigastric artery, immediately above the inguinal ligament, and connects to the obturator artery. Therefore, it was historically named the corona mortis, which means "crown of death" in Latin. When peripheral cannulation is performed above this branch in the external iliac artery, we consider it a corona "vitae" because of its role as a limb-saving collateral. We report herein our standard technique of peripheral cannulation without the need of a distal perfusion cannula and preventing limb ischemia. METHODS: We included all patients who underwent robotic cardiac surgery with peripheral cannulation over a 16-month period at our institution. We cannulated just above the level of the inguinal ligament through a 2 to 3 cm transverse skin incision. The incidence of limb ischemia and vascular complications was recorded and analyzed. RESULTS: During the study period, 133 patients underwent robotic cardiac procedures with peripheral "external iliac" CPB. The size of the cannula was 21F or larger in 73% and 23F in 54% of the patients. No leg ischemia or femoral artery complications requiring additional intervention occurred. CONCLUSIONS: External iliac cannulation can be successfully performed in robot-assisted cardiac surgery using relatively large cannulas without the need of a distal limb perfusion catheter, with good results. In our view, given the importance of the corona mortis ("crown of death" in Latin) in perfusing the limb during CPB, we propose a new name for this artery in robotic cardiac surgery, namely, the corona vitae ("crown of life" in Latin).


Subject(s)
Iliac Artery , Robotic Surgical Procedures , Humans , Iliac Artery/surgery , Robotic Surgical Procedures/methods , Male , Female , Aged , Cardiac Surgical Procedures/methods , Cardiopulmonary Bypass/methods , Middle Aged , Ischemia/prevention & control , Catheterization, Peripheral/methods , Femoral Artery/surgery , Catheterization/methods
10.
J Comp Eff Res ; 13(6): e240025, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38606556

ABSTRACT

Aim: Use long-term follow-up data from the IMPERIAL study to determine whether drug-eluting polymer-based nitinol stent treatment can delay the time to repeat intervention for femoropopliteal artery disease and how such a delay may result in cost savings in a value-based episode of care. Patients & methods: The IMPERIAL randomized controlled trial was an international study of a paclitaxel-eluting polymer-coated stent (Eluvia, Boston Scientific, MA, USA) versus a polymer-free paclitaxel-coated stent (Zilver PTX, Cook Corporation, IN, USA) for treating lesions of the femoropopliteal arterial segment. Study patients (n = 465) had symptomatic lower limb ischemia. Safety and efficacy assessments were performed through 5 years. Mean time to first reintervention was calculated in post-hoc analysis for patients who underwent a clinically driven target lesion revascularization (CD-TLR) through 3 or 5 years following the index procedure. To simulate potential cost savings associated with differential CD-TLR burden over time, a cost-avoidance analysis using input parameters from IMPERIAL and US 100% Medicare standard analytical files was developed. Results: Among patients with a first CD-TLR through 3 years of follow-up, mean time to reintervention was 5.5 months longer (difference 166 days, 95% CI: 51, 282 days; p = 0.0058) for patients treated with Eluvia (n = 56) than for those treated with Zilver PTX (n = 30). Through the 5-year study follow-up period, CD-TLR rates were 29.3% (68/232) for Eluvia and 34.2% (39/114) for Zilver PTX (p = 0.3540) and mean time to first reintervention exceeded 2 years for patients treated with Eluvia at 737 days versus 645 days for the Zilver PTX group (difference 92 days, 95% CI: -85, 269 days; p = 0.3099). Simulated savings considering reinterventions occurring over 1 and 5 years following initial use of Eluvia over Zilver PTX were US $1,395,635 and US $1,531,795, respectively, when IMPERIAL CD-TLR rates were extrapolated to 1000 patients. Conclusion: IMPERIAL data suggest initial treatment with Eluvia extends the time patients spend without undergoing reintervention. This extension may be associated with cost savings in relevant time frames.


Subject(s)
Drug-Eluting Stents , Femoral Artery , Paclitaxel , Peripheral Arterial Disease , Popliteal Artery , Humans , Drug-Eluting Stents/economics , Popliteal Artery/surgery , Peripheral Arterial Disease/economics , Peripheral Arterial Disease/therapy , Femoral Artery/surgery , Male , Female , Aged , Paclitaxel/therapeutic use , Paclitaxel/economics , Paclitaxel/administration & dosage , Time Factors , Middle Aged , Polymers/therapeutic use , Alloys/economics , Cost-Benefit Analysis , Cost Savings
11.
Head Neck ; 46(7): E71-E74, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38606699

ABSTRACT

BACKGROUND: The concept of reserve flow perfusion for free flap reconstruction has been demonstrated in various applications in the literature. As it relates to the anterolateral thigh (ALT) free flap, the reserve flow principle has been primarily described to either augment or "supercharge" a large ALT to optimize skin perforator supply or lengthen the vascular pedicle. METHODS: We report a case of a 77-year old male with chronic renal failure who had extensive atherosclerosis of the proximal descending lateral circumflex femoral artery (LCFA) where arterial anastomosis was unable to be performed. RESULTS: We were able to circumvent this limitation by establishing reserve flow perfusion solely through the distal end of the descending LCFA. We describe our technique within the context of current literature on the topic of reverse flow perfusion in free flap reconstruction. CONCLUSION: This report uniquely describes applying the distally based, reverse arterial flow principle in an ALT flap to circumvent an atherosclerotic proximal pedicle.


Subject(s)
Anastomosis, Surgical , Atherosclerosis , Femoral Artery , Free Tissue Flaps , Thigh , Humans , Male , Aged , Free Tissue Flaps/blood supply , Thigh/surgery , Thigh/blood supply , Femoral Artery/surgery , Anastomosis, Surgical/methods , Atherosclerosis/surgery , Plastic Surgery Procedures/methods , Kidney Failure, Chronic/surgery
13.
Int J Cardiol ; 404: 131977, 2024 Jun 01.
Article in English | MEDLINE | ID: mdl-38508322

ABSTRACT

PURPOSE: To evaluate the best endovascular treatment for de novo femoropopliteal lesions at long-term follow-up through network meta-analysis of randomized controlled trials. METHODS: Medical databases were searched on September 17, 2023. 17 trials and 7 treatments were selected. Outcomes were primary patency, target lesion revascularization (TLR), major amputation and all-cause mortality at 3 and/or 5 years. RESULTS: Regarding 3-year primary patency, drug-eluting stents (DES) was the best and better than balloon angioplasty (BA; odds ratio [OR], 4.96; 95% confidence interval [CI], 2.68-9.18), bare metal stents (BMS; OR, 2.81; 95% CI, 1.45-5.46), cryoplasty (OR, 6.75; 95% CI, 2.76-16.50), covered stents (CS; OR, 3.25; 95% CI, 1.19-8.87) and drug-coated balloons (DCB; OR, 2.04; 95% CI, 1.14-3.63). Regarding 5-year primary patency, DES was the best and better than BMS (OR, 2.34; 95% CI, 1.10-4.99). Regarding 3-year TLR, DES was the best and better than BA (OR, 0.24; 95% CI, 0.13-0.44). Regarding 5-year TLR, DES was the best and better than BA (OR, 0.20; 95% CI, 0.09-0.42) and balloon angioplasty with brachytherapy (OR, 0.21; 95% CI, 0.06-0.74). Regarding 3- and 5-year major amputation, DCB was the best. Regarding 3-year mortality, DES was the best and better than CS (OR, 0.09; 95% CI, 0.01-0.67). CONCLUSIONS: DES was the best treatment regarding 3-year primary patency, TLR and mortality, and DCB was the best regarding major amputation. DES was the best treatment regarding 5-year TLR, and DCB was the best regarding primary patency and major amputation. DES and DCB should be given priority in treating femoropopliteal lesions.


Subject(s)
Angioplasty, Balloon , Drug-Eluting Stents , Peripheral Arterial Disease , Humans , Femoral Artery/diagnostic imaging , Femoral Artery/surgery , Popliteal Artery/diagnostic imaging , Popliteal Artery/surgery , Network Meta-Analysis , Treatment Outcome , Vascular Patency , Randomized Controlled Trials as Topic , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/surgery , Coated Materials, Biocompatible
14.
Stroke ; 55(4): 840-848, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38527149

ABSTRACT

BACKGROUND: Transfemoral access is predominantly used for mechanical thrombectomy in patients with stroke with a large vessel occlusion. Following the interventional cardiology guidelines, routine transradial access has been proposed as an alternative, although its safety and efficacy remain controversial. We aim to explore the noninferiority of radial access in terms of final recanalization. METHODS: The study was an investigator-initiated, single-center, evaluator-blinded, noninferiority randomized clinical trial. Patients with stroke undergoing mechanical thrombectomy, with a patent femoral artery and a radial artery diameter ≥2.5 mm, were randomly assigned (1:1) to either transradial (60 patients) or transfemoral access (60 patients). The primary binary outcome was the successful recanalization (expanded Treatment in Cerebral Ischemia score, 2b-3) assigned by blinded evaluators. We established a noninferiority margin of -13.2%, considering an acceptable reduction of 15% in the expected recanalization rates. RESULTS: From September 2021 to July 2023, 120 patients were randomly assigned and 116 (58 transradial access and 58 transfemoral access) with confirmed intracranial occlusion on the initial angiogram were included in the intention-to-treat analysis. Successful recanalization was achieved in 51 (87.9%) patients assigned to transfemoral access and in 56/58 (96.6%) patients assigned to transradial (adjusted 1 side risk difference [RD], -5.0% [95% CI, -6.61% to +13.1%]) showing noninferiority of transradial access. Median time from angiosuite arrival to first pass (femoral, 30 [interquartile range, 25-37] minutes versus radial: 41 [interquartile range, 33-62] minutes; P<0.001) and from angiosuite arrival to recanalization (femoral: 42 (IQR, 28-74) versus radial: 59.5 (IQR, 44-81) minutes; P<0.050) were longer in the transradial access group. Both groups presented 1 severe access complication and there was no difference in the rate of access conversion: transradial 7 (12.1%) versus transfemoral 5 (8.6%) (P=0.751). CONCLUSIONS: Among patients who underwent mechanical thrombectomy, transradial access was noninferior to transfemoral access in terms of final recanalization. Procedural delays may favor transfemoral access as the default first-line approach. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05225636.


Subject(s)
Stroke , Thrombectomy , Humans , Brain Ischemia/surgery , Brain Ischemia/complications , Femoral Artery/surgery , Stroke/surgery , Stroke/complications , Thrombectomy/adverse effects , Thrombectomy/methods , Treatment Outcome
15.
Catheter Cardiovasc Interv ; 103(5): 771-781, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38451155

ABSTRACT

BACKGROUND: ProGlide is a percutaneous suture-mediated closure device used in arterial and venous closure following percutaneous intervention. Risk of vascular complications from use, particularly related to failure in hemostasis, or acute vessel closure, remains significant and often related to improper suture deployment. We describe a technique of ultrasound-guided ProGlide deployment in transfemoral transcatheter aortic valve implantation (TF-TAVI). AIMS: The aim of this study is to assess vascular outcomes for ultrasound-guided deployment of ProGlide vascular closure devices in patients undergoing TF-TAVI. METHODS: We collected relevant clinical data of patients undergoing TAVI in a large volume centre. PRIMARY OUTCOME: main access Valve Academic Research Consortium 3 (VARC-3) major vascular complication. SECONDARY OUTCOME: any major/minor VARC-3 vascular complication, its type (bleed or ischemia), and treatment required (medical, percutaneous, or surgical). We performed inverse weighting propensity score analysis to compare the population undergoing ultrasound-guided versus conventional ProGlide deployment for main TAVI access. Ultrasound technique for ProGlide insertion was performed as described below. RESULTS: Five hundred and seventeen patients undergoing TF-TAVI were included. PRIMARY OUTCOME: In 126 (ultrasound-guided) and 391 (conventional ProGlide insertion), 0% versus 1.8% (p < 0.001) had a major VARC-3 vascular complication, respectively. SECONDARY OUTCOME: 0.8% (one minor VARC-3 bleed) vs 4.1% (13 bleeds and three occlusions) had any VARC-3 vascular complication (major and minor) (p < 0.001). Surgical treatment of vascular complication was required in 0.8% versus 1.3% (p = NS). CONCLUSIONS: Ultrasound-guided deployment of ProGlide for vascular closure reduced the risk of major vascular complications in a large population undergoing TAVI.


Subject(s)
Aortic Valve Stenosis , Transcatheter Aortic Valve Replacement , Vascular Closure Devices , Humans , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/complications , Cohort Studies , Femoral Artery/diagnostic imaging , Femoral Artery/surgery , Treatment Outcome , Hemorrhage/etiology , Risk Reduction Behavior , Ultrasonography, Interventional/adverse effects , Aortic Valve/diagnostic imaging , Aortic Valve/surgery
16.
Int Heart J ; 65(2): 230-236, 2024 Mar 30.
Article in English | MEDLINE | ID: mdl-38479851

ABSTRACT

This study aimed to compare lower limb events associated with preplanned and finally selected treatment strategies-the validity and usefulness of the physician-chosen strategy were verified.We examined the data of 1003 patients in the registry of multicenter endovascular treatment for superficial femoral and popliteal artery disease study and prospectively enrolled patients who underwent endovascular treatment (EVT) of the femoropopliteal (FP) artery between February 2017 and June 2018 from 67 Japanese institutes. The outcome measures were major adverse limb events (MALE) and target vessel revascularization.The EVT strategies were classified into balloon angioplasty-alone (37.3%), primary stenting (26.7%), and provisional stenting (36.0%) groups. In the initial strategy analysis for the balloon angioplasty-alone, primary stenting, and provisional stenting groups, two-year rates of freedom from MALE (95% confidence interval) were 0.680 (0.620-0.732), 0.754 (0.688-0.808), and 0.798 (0.746-0.840), respectively. Additionally, the rate of MALE was significantly higher among patients in the balloon angioplasty-alone group than among those in the primary or provisional stenting groups in the initial strategy analysis (P = 0.007). Changes in treatment strategy were more frequent in the primary stenting group than in the other groups. Furthermore, the rate of MALE did not significantly differ among the three groups in the final strategy analysis (P = 0.56).Limb outcomes for the final applied strategy did not differ among the three strategies. Additionally, the physician's selection bias was mostly appropriate in the EVT of the FP artery.


Subject(s)
Angioplasty, Balloon , Peripheral Arterial Disease , Humans , Femoral Artery/surgery , Peripheral Arterial Disease/surgery , Peripheral Arterial Disease/etiology , Popliteal Artery/surgery , Popliteal Artery/pathology , Stents , Treatment Outcome , Vascular Patency , Multicenter Studies as Topic
17.
JACC Cardiovasc Interv ; 17(5): 608-618, 2024 Mar 11.
Article in English | MEDLINE | ID: mdl-38479962

ABSTRACT

BACKGROUND: Whether intraluminal drug-coated balloon (DCB) angioplasty is superior to subintimal DCB angioplasty regarding femoropopliteal (FP) chronic total occlusion (CTO) outcomes has not been systematically determined. OBJECTIVES: The aim of this study was to compare the 1-year clinical outcomes of intraluminal and subintimal DCB angioplasty for the treatment of patients with symptomatic FP CTO. METHODS: This subanalysis of POPCORN (Prospective Multi-Center Registry of Drug-Coated Balloon for Femoropopliteal Disease) evaluated 469 lesions in 469 symptomatic patients with lower extremity artery disease who presented with FP CTO and underwent DCB treatment. Wire passage (intraluminal vs subintimal) was evaluated using intravascular ultrasound. The outcome measure, 1-year freedom from restenosis, was compared between subintimal and intraluminal DCB angioplasty groups after propensity score matching analysis. The Institutional Review Boards of participating centers approved this study. Informed consent was obtained from the participants or their families. RESULTS: During the median follow-up period of 14.2 months, restenosis occurred in 140 patients. After propensity score matching, the subintimal group had a significantly lower 1-year rate of freedom from restenosis than the intraluminal group (77.0% vs 84.2%, respectively; P = 0.024). Interaction analysis revealed a more marked increased risk for restenosis in the subintimal DCB angioplasty group in patients with severe calcification, low-dose DCB use, or smoking. CONCLUSIONS: The present study revealed that intraluminal DCB angioplasty was superior to subintimal DCB angioplasty for FP CTO treatment, with a significantly better 1-year rate of freedom from restenosis.


Subject(s)
Angioplasty, Balloon , Peripheral Arterial Disease , Humans , Femoral Artery/diagnostic imaging , Femoral Artery/surgery , Popliteal Artery/diagnostic imaging , Popliteal Artery/surgery , Prospective Studies , Treatment Outcome , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/therapy , Peripheral Arterial Disease/etiology , Angioplasty, Balloon/adverse effects , Coated Materials, Biocompatible , Vascular Patency
18.
Khirurgiia (Mosk) ; (3): 21-28, 2024.
Article in Russian | MEDLINE | ID: mdl-38477240

ABSTRACT

OBJECTIVE: To compare the short-term and long-term outcomes of hybrid interventions after various infrainguinal reconstructions (restoration of blood flow through superficial femoral artery and pulsatile blood flow through deep femoral artery) in patients with iliac-femoral arterial disease. MATERIAL AND METHODS: A retrospective analysis included patients after hybrid iliac-femoral interventions between 2014 and 2018. These interventions included stenting of iliac arteries and various open infrainguinal reconstructions. The first group (n=41) consisted of patients who underwent reconstruction of superficial femoral artery, the second group (n=88) - restoration of pulsatile blood flow in deep femoral artery. We analyzed the Rutherford score, perioperative complications, primary patency rates and limb salvage rates after 12 months in both groups. RESULTS: Significant improvement (Rutherford score +3) was achieved in 28 (70%) and 14 (15.9%) patients, respectively (p<0.05). There were no significant between-group differences in the number of postoperative complications. Surgery time was longer in the first group (median 160 and 130 min, respectively, p<0.05). However, intraoperative blood loss was similar. Primary patency rates after 12 months were 82.4% and 95.1%, respectively (p=0.054). Limb salvage rates after 12 months were 94.7% and 100%, respectively (p<0.05). CONCLUSION: This study highlights the potential advantages of restoring pulsatile blood flow through the deep femoral artery in hybrid interventions. Higher primary patency and limb salvage rates in the second group indicate better long-term outcomes after restoration of blood flow through the deep femoral artery. Further prospective studies are needed to confirm these results and determine the underlying mechanisms of differences.


Subject(s)
Arterial Occlusive Diseases , Femoral Artery , Humans , Retrospective Studies , Vascular Patency , Femoral Artery/surgery , Iliac Artery/surgery , Limb Salvage , Stents , Treatment Outcome , Arterial Occlusive Diseases/surgery , Risk Factors
19.
Int Angiol ; 43(2): 262-270, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38454886

ABSTRACT

BACKGROUND: To estimate the impact of anesthetic conduct, alone and in combination with the type of femoral access, on early results after endovascular aneurysm repair (EVAR). METHODS: A retrospective multicenter analysis on patients undergoing elective standard EVAR at four academic centers was performed. Patients undergoing the procedure through either local or general anesthesia were compared. Comparative subanalyses of the two groups were performed for the type of femoral access to evaluate further impact on outcomes. RESULTS: Five hundred twenty-four patients underwent elective standard EVAR, of which 207 (39.5%) under general anesthesia and 317 (60.5%) under local anesthesia. Patients who underwent general anesthesia had higher 30-day mortality rates (3.4% vs. 0.3%, P=0.005), as well as slightly worse 30-day major systemic complication rates (8.2% vs. 5.4%, P=0.195). There were no differences in terms of reinterventions (2.1% vs. 2.5%, P=0.768) and aneurysm-related mortality (0% vs. 0.4%, P=0.422) at one year. Total intervention times were significantly longer in the general anesthesia group (126 vs. 89 minutes, P=0.001), as well as the total length of hospital stay (7.6 vs. 5.3 days, P=0.007). At subanalyses, the combination of local anesthesia with bilateral percutaneous femoral access further improved 30-day outcomes and determined an additional reduction in total intervention times and ICU stays. CONCLUSIONS: EVAR performed under local anesthesia has a significantly better impact on early results when compared to general anesthesia. Combining percutaneous bilateral femoral access to local anesthesia reduced procedural times, ICU stays and consequently improved early results.


Subject(s)
Anesthesia, General , Anesthesia, Local , Aortic Aneurysm, Abdominal , Endovascular Procedures , Femoral Artery , Length of Stay , Humans , Anesthesia, Local/adverse effects , Endovascular Procedures/adverse effects , Endovascular Procedures/mortality , Female , Male , Retrospective Studies , Aged , Treatment Outcome , Femoral Artery/surgery , Anesthesia, General/mortality , Anesthesia, General/adverse effects , Aged, 80 and over , Aortic Aneurysm, Abdominal/surgery , Aortic Aneurysm, Abdominal/mortality , Postoperative Complications , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/mortality , Time Factors , Risk Factors , Middle Aged , Endovascular Aneurysm Repair
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