-
Trials Jun 2024Endovascular therapy has become established as a first-line therapy in most arterial regions. However, open vascular surgery (endarterectomy) remains the treatment of...
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.
Topics: Humans; Angioplasty, Balloon; Atherectomy; Coated Materials, Biocompatible; Endarterectomy; Equivalence Trials as Topic; Femoral Artery; Limb Salvage; Multicenter Studies as Topic; Peripheral Arterial Disease; Prospective Studies; Quality of Life; Randomized Controlled Trials as Topic; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency
PubMed: 38851710
DOI: 10.1186/s13063-024-08219-1 -
European Heart Journal. Case Reports Jun 2024Iatrogenic aortic valve injury during cardiovascular catheterization interventions is extremely rare. Severe aortic regurgitation that ensues can be catastrophic and the...
BACKGROUND
Iatrogenic aortic valve injury during cardiovascular catheterization interventions is extremely rare. Severe aortic regurgitation that ensues can be catastrophic and the management is typically with surgical valve replacement or repair. Percutaneous management of native pure aortic regurgitation is difficult due to anatomical challenges and the limitations of current transcatheter heart valve technology to anchor in the absence of leaflet or annular calcification.
CASE SUMMARY
An 82-year-old female underwent rotational atherectomy (RA) for a severely calcified stenosis of the left anterior descending artery. The patient was discharged well following placement of two drug eluting stents. She represented to hospital 7 days later with acute pulmonary oedema. Bedside transthoracic echocardiography demonstrated new, severe AR with preserved left ventricular size and function. Review of the prior percutaneous coronary intervention revealed significant trauma to the aortic valve during RA, with contrast seen refluxing into the LV during diastole, evolving throughout the procedure. Given the patient was not an operative candidate, an oversized transcatheter aortic valve was successfully implanted. In the post-operative setting, the patient suffered a stroke. Extensive hypoattenuated leaflet thickening (HALT) and thrombus was seen on dedicated 4D CT imaging. She made full neurological recovery and valve function returned to normal following a period of anticoagulation.
CONCLUSION
Although iatrogenic aortic valve laceration is rare, this case highlights several important learning points including the importance of good guide catheter support during RA; the feasibility of Transcatheter Aortic Valve Replacement for pure native AR; and the detection and management of HALT.
PubMed: 38845809
DOI: 10.1093/ehjcr/ytae226 -
The American Journal of Cardiology Jun 2024Use of peripheral vascular intervention (PVI) for intermittent claudication (IC) continues to expand, but there is uncertainty whether baseline demographics, procedural...
Co-Morbidity Differences Associated With Long-Term Amputation and Repeat Revascularization Rates After Femoropopliteal Artery Intervention for Intermittent Claudication by Gender, Race, and Ethnicity.
Use of peripheral vascular intervention (PVI) for intermittent claudication (IC) continues to expand, but there is uncertainty whether baseline demographics, procedural techniques and outcomes differ by gender, race, and ethnicity. This study aimed to examine amputation and revascularization rates up to 4 years after femoropopliteal (FP) PVI for IC by gender, race, and ethnicity. Patients who underwent FP PVI for IC between 2016 and 2020 from the PINC AI Healthcare Database were analyzed. The primary outcome was any index limb amputation, assessed by Kaplan-Meier estimate. Secondary outcomes included index limb major amputation, repeat revascularization, and index limb repeat revascularization. Unadjusted and adjusted hazard ratios (HRs) were estimated using Cox proportional hazard regression models. This study included 19,324 patients with IC who underwent FP PVI, with 41.2% women, 15.6% Black patients, and 4.7% Hispanic patients. Women were less likely than men to be treated with atherectomy (45.1% vs 47.8%, p = 0.0003); Black patients were more likely than White patients to receive atherectomy (50.7% vs 44.9%, p <0.001), and Hispanic patients were less likely than non-Hispanic patients to receive atherectomy (41% vs 47%, p = 0.0004). Unadjusted rates of any amputation were similar in men and women (6.4% for each group, log-rank p = 0.842), higher in Black patients than in White patients (7.8% vs 6.1%, log-rank p = 0.007), and higher in Hispanic patients than in non-Hispanic patients (8.8% vs 6.3%, log-rank p = 0.031). After adjustment for baseline characteristics, Black race was associated with higher rates of repeat revascularization (adjusted HR 1.13, 95% confidence interval 1.04 to 1.22) and any FP revascularization (adjusted HR 1.10, 95% confidence interval 1.01 to 1.20). No statistical difference in amputation rate was observed among comparison groups. Women and men with IC had similar crude and adjusted amputation and revascularization outcomes after FP PVI. Black patients had higher repeat revascularization and any FP revascularization rates than did White patients. Black and Hispanic patients had higher crude amputation rates, but these differences were attenuated by adjustment for baseline characteristics. Black patients were more likely to receive atherectomy and had higher rates of any repeat revascularization and specifically FP revascularization. Further study is necessary to determine whether these patterns are related to disease-specific issues or practice-pattern differences among different populations.
PubMed: 38834142
DOI: 10.1016/j.amjcard.2024.05.021 -
Clinical Research in Cardiology :... Jun 2024Severely calcified coronary bifurcations complicate percutaneous coronary interventions (PCI) and often necessitate dedicated lesion preparation. We compared the...
BACKGROUND
Severely calcified coronary bifurcations complicate percutaneous coronary interventions (PCI) and often necessitate dedicated lesion preparation. We compared the outcomes of single- versus two-stent techniques for treating heavily calcified true bifurcation lesions following rotational atherectomy (RA).
METHODS
Among patients receiving RA for severely calcified true bifurcations at a single center, 59 were treated with a single stent, and another 59 received two stents. We analyzed in-hospital adverse outcomes and 1-year rates of the bifurcation-oriented composite endpoint (BOCE), defined as cardiac death, target bifurcation myocardial infarction (TB-MI), or target bifurcation revascularization (TBR).
RESULTS
The single-stent arm was associated with more in-hospital adverse outcomes (adj. OR, 6.13; 95% CI, 1.34-28.0; p = 0.019), driven by higher peri-procedural MI rates (18.6% vs. 5.1%, p = 0.043) and more side branch compromise (13.6% vs. 0%, p = 0.006). After 1 year, both techniques had comparable 1-year BOCE (adj. HR, 0.38; 95% CI, 0.12-1.23; p = 0.106). We observed a significant interaction between the treatment technique and the presence of LM bifurcation (p interaction = 0.012), favoring single-stent technique in patients with non-LM bifurcations (HR 0.14, 95% CI 0.03-0.68; p = 0.015). Notably, the single-stent technique had lower rates of TBR (2% vs. 15%, p log-rank = 0.026) after 1 year.
CONCLUSION
Patients with severely calcified true bifurcation lesions, treated with RA followed by a single stent implantation, had more in-hospital adverse outcomes compared to those treated with two stents. However, the superior outcomes of the two-stent technique did not translate into improved long-term results. In fact, the two-stent technique was even associated with higher rates of revascularization after 1 year.
PubMed: 38832996
DOI: 10.1007/s00392-024-02461-y -
European Heart Journal. Case Reports May 2024Coronary guidewire entrapment is not an uncommon complication of percutaneous coronary intervention, especially in the setting of complex coronary anatomy. Core wire...
BACKGROUND
Coronary guidewire entrapment is not an uncommon complication of percutaneous coronary intervention, especially in the setting of complex coronary anatomy. Core wire fracture with uncoiling of spring wire represents a catastrophic complication, posing great technical difficulty in percutaneous retrieval.
CASE SUMMARY
The patient was a 50-year-old Asian male with ischaemic cardiomyopathy and severe left ventricular impairment. Coronary angiography showed severe left main and triple-vessel disease. Coronary artery bypass graft was declined due to high surgical risk. Percutaneous coronary intervention was performed under mechanical circulatory support. However, it was complicated with guidewire entrapment and unravelling with deformity of the newly implanted stent in the left anterior descending artery. The complication was successfully bailed out by rotational atherectomy and the novel intravascular ultrasound (IVUS) and enhanced stent visualization (ESV) system guided 'Twist-wire' technique. Complete wire fragments retrieval was achieved with excellent final angiographic and IVUS results immediately after procedure and at 4-month follow-up angiography.
DISCUSSION
This case represents a rare phenomenon of branch point protrusion of stent causing guidewire-stent edge entanglement. A novel 'Twist-wire' technique with IVUS and ESV guidance was highlighted to allow successful retrieval of fluoroscopically invisible uncoiled wire filaments.
PubMed: 38817316
DOI: 10.1093/ehjcr/ytae258 -
Annals of Vascular Surgery May 2024Intravascular ultrasound (IVUS) facilitates detailed visualization of endoluminal anatomy not adequately appreciated on conventional angiography. However, it is unclear...
BACKGROUND
Intravascular ultrasound (IVUS) facilitates detailed visualization of endoluminal anatomy not adequately appreciated on conventional angiography. However, it is unclear if IVUS use improves clinical outcomes of peripheral vascular interventions (PVIs) for peripheral arterial disease. This study aimed to evaluate the impact of IVUS on 1-year outcomes of PVI in the vascular quality initiative (VQI).
METHODS
The VQI-PVI modules were reviewed (2016-2020). All patients with available 1-year follow-up after lower extremity PVI were included and grouped as IVUS-PVI or non-IVUS PVI based on use of IVUS. Propensity matching (1:1) was performed using demographics and comorbidities. One-year major amputation and patency rates were compared. A generalized estimating equation model was used to identify predictors of 1-year outcomes. Subgroup analysis based on Trans-Atlantic Intersociety Consensus (TASC) classification, treatment length and treatment modalities were performed using same modeling approaches.
RESULTS
There were 56,633 procedures (non-IVUS PVI = 55,302 vs. IVUS-PVI = 1,331) in 44,042 patients. Propensity matching yielded a total cohort of 1,854 patients matched (1:1), with no baseline differences. Lower extremity revascularization for claudication was performed in 60.4%, while one-third (33.9%) had chronic limb threatening ischemia (CLTI). IVUS was more commonly used for lesions >15 cm in length (46.6% vs. 43.3%) and for aortoiliac disease (31.8% vs. 27.2%). Rates of atherectomy and stenting were significantly higher with IVUS-PVI (21.1% vs. 16.8%), while balloon angioplasty was less common (13.5% vs. 24.4%). One-year patency was better with IVUS-PVI (97.7% vs. 95.2%, P = 0.004). On subgroup analysis, IVUS (odds ratio [OR] 2.20, 95% confidence interval [CI] 1.29-3.75) was associated with improved patency in CLTI patients, TASC C or D lesions, and treatment length >15 cm. Adjunctive IVUS use during PVI did not significantly impact 1-year amputation (OR 1.7, 95% CI 0.78-3.91). On multivariable regression, adjunctive use of IVUS (OR 2.46 95% CI 1.43-4.25) and aortoiliac interventions (OR 2.91, 95% CI 1.09-7.75) were independent predictors of patency. Treatment modalities such as atherectomy, stenting or balloon angioplasty did not significantly impact patency at 1-year.
CONCLUSIONS
IVUS during lower extremity PVI is associated with improved 1-year patency, when compared to angiography alone. Certain subgroups, such as CLTI patients, lesions>15 cm, and TASC C or D lesions might benefit from adjunctive use of IVUS.
PubMed: 38810722
DOI: 10.1016/j.avsg.2024.03.008 -
Catheterization and Cardiovascular... May 2024A 66-year-old man with multiple comorbidities including severe peripheral artery disease and heart failure with reduced ejection fraction presented with complex coronary...
A 66-year-old man with multiple comorbidities including severe peripheral artery disease and heart failure with reduced ejection fraction presented with complex coronary artery disease with an elevated Society of Thoracic Surgeons Predicted Risk of Mortality for coronary artery bypass grafting and a Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery score of 18. With a multidisciplinary heart team approach, the patient successfully underwent percutaneous axillary venoarterial extracorporeal membrane oxygenation (VA-ECMO) supported high-risk percutaneous coronary intervention of a heavily calcified left main bifurcation lesion. Given the patient's peripheral artery disease, alternative arterial access for ECMO cannulation was performed percutaneously via the right axillary artery. Additionally, adequate coronary calcium modification was critical to successful stenting of a heavily calcified left main bifurcation. This case highlights a novel approach to obtaining alternative arterial access for ECMO cannulation and emphasizes the importance of calcium modification to achieve excellent stent results.
PubMed: 38796712
DOI: 10.1002/ccd.31113 -
Cardiovascular Revascularization... May 2024The optimal treatment for coronary calcified nodules (CNs) is still unclear. The aim of this study was to compare the modification of these lesions by coronary...
BACKGROUND
The optimal treatment for coronary calcified nodules (CNs) is still unclear. The aim of this study was to compare the modification of these lesions by coronary intravascular lithotripsy (IVL) and rotational atherectomy (RA) using optical coherence tomography (OCT).
METHODS
ROTA.shock was a 1:1 randomized, prospective, double-arm multi-center non-inferiority trial that compared the use of IVL and RA with percutaneous coronary intervention (PCI) in severely calcified lesions. In 19 of the patients out of this study CNs were detected by OCT in the target lesion and were treated by either IVL or RA.
RESULTS
The mean angle of CNs was significantly larger in final OCT scans than before RA (92 ± 17° vs. 68 ± 7°; p = 0.01) and IVL (89 ± 18° vs. 60 ± 10°; p = 0.03). The CNs were thinner upon final scans than in initial native scans (RA: 17.8 ± 7.8 mm vs. 38.6 ± 13.1 mm; p = 0.02; IVL: 16.5 ± 9.0 mm vs. 37.2 ± 14.3 mm; p = 0.02). Nodule volume did not differ significantly between native and final OCT scans (RA: 0.66 ± 0.12 mm vs. 0.61 ± 0.33 mm; p = 0.68; IVL: 0.64 ± 0.19 mm vs. 0.68 ± 0.22 mm; p = 0.74). Final stent eccentricity was high with 0.62 ± 0.10 after RA and 0.61 ± 0.09 after IVL.
CONCLUSION
RA or IVL are unable to reduce the volume of the calcified plaque. CN modulation seems to be mainly induced by the stent implantation and not by RA or IVL.
PubMed: 38796321
DOI: 10.1016/j.carrev.2024.05.030 -
The American Journal of Cardiology Jul 2024We develop and evaluate an artificial intelligence (AI)-based algorithm that uses pre-rotation atherectomy (RA) intravascular ultrasound (IVUS) images to automatically...
Development and Validation of Artificial Intelligence-Based Algorithms for Predicting the Segments Debulked by Rotational Atherectomy Using Intravascular Ultrasound Images.
We develop and evaluate an artificial intelligence (AI)-based algorithm that uses pre-rotation atherectomy (RA) intravascular ultrasound (IVUS) images to automatically predict regions debulked by RA. A total of 2106 IVUS cross-sections from 60 patients with de novo severely calcified coronary lesions who underwent IVUS-guided RA were consecutively collected. The 2 identical IVUS images of pre- and post-RA were merged, and the orientations of the debulked segments identified in the merged images were marked on the outer circle of each IVUS image. The AI model was developed based on ResNet (deep residual learning for image recognition). The architecture connected 36 fully connected layers, each corresponding to 1 of the 36 orientations segmented every 10°, to a single feature extractor. In each cross-sectional analysis, our AI model achieved an average sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 81%, 72%, 46%, 90%, and 75%, respectively. In conclusion, the AI-based algorithm can use information from pre-RA IVUS images to accurately predict regions debulked by RA and will assist interventional cardiologists in determining the treatment strategies for severely calcified coronary lesions.
Topics: Humans; Ultrasonography, Interventional; Atherectomy, Coronary; Male; Artificial Intelligence; Female; Algorithms; Aged; Coronary Artery Disease; Vascular Calcification; Predictive Value of Tests; Middle Aged; Coronary Vessels; Retrospective Studies
PubMed: 38782227
DOI: 10.1016/j.amjcard.2024.05.027 -
EuroIntervention : Journal of EuroPCR... May 2024
Topics: Humans; Atherectomy, Coronary; Plaque, Atherosclerotic; Vascular Calcification; Coronary Artery Disease; Treatment Outcome
PubMed: 38776145
DOI: 10.4244/EIJ-E-24-00014