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BACKGROUND: Chronic total occlusions (CTO) are frequent among patients with coronary artery disease. Revascularization with percutaneous coronary intervention (PCI) is safe and feasible in experienced hands. However, randomized data are needed to demonstrate symptomatic as well as prognostic effect of CTO-PCI compared to optimal medical therapy alone. METHODS: This trial aims to evaluate the effect of CTO PCI in patients with a CTO lesion and target vessel diameter ≥ 2.5 mm, and myocardial ischemia in the relevant territory. First, all patients are subjected to optimal medical therapy (OMT) for at least for 3 months and non-CTO lesions are managed according to guidelines. Subsequently, prior to randomization myocardial ischemia and quality of life (Seattle Questionnaire (SAQ)) is assessed. Patients are divided into two cohorts based on their SAQ score and randomized to either OMT alone or OMT and CTO-PCI. Cohort A is defined as Low- or asymptomatic patients with a quality-of-life score > 60 and/or CCS class < 2, and more than 10 % ischemia in the left ventricle (LV). Cohort B is symptomatic patients with a quality-of-life score < 60 or CCS class angina > 1 and at least ischemia in 5% of the LV. The primary end-point in cohort A is a composite of major adverse cardiac and cerebral events, hospitalization for heart failure and malignant ventricular arrhythmias. The primary endpoint in cohort B is difference in quality of life 6 months after randomization. IMPLICATIONS: This trial is designed to investigate if CTO-PCI improves QoL and MACCE. Both positive and negative outcome of the trial will affect future guidelines and recommendations on how to treat patients with CTO.
Subject(s)
Coronary Artery Disease , Coronary Occlusion , Percutaneous Coronary Intervention , Humans , Coronary Occlusion/surgery , Coronary Artery Disease/etiology , Quality of Life , Percutaneous Coronary Intervention/adverse effects , Angina Pectoris/etiology , Chronic Disease , Treatment OutcomeABSTRACT
INTRODUCTION: Antegrade dissection and re-entry (ADR) is an integral part of the hybrid algorithm, which has allowed for improved outcomes in chronic total occlusion (CTO) coronary intervention (PCI). METHODS: A new ADR method, Subintimal Antegrade FEnestration and Re-entry (SAFER), is described. The results of a first-in-man series are presented. RESULTS: SAFER was performed on seven consecutive patients with angiographic and clinical success in all patients. CONCLUSIONS: This first-in-man study has shown that the SAFER technique is feasible and effective with the possibility of improving the antegrade PCI CTO success rate.
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AIM: Chronic total occlusions (CTO) in patients with history of coronary artery bypass graft (CABG) show more advanced and complex atherosclerotic pathology. Aim of our study is to compare outcomes in patients undergoing CTO percutaneous coronary intervention (PCI) with previous CABG versus those without in the REgistry of Crossboss and Hybrid procedures in FrAnce the NetheRlands, BelGium and UnitEd Kingdom (RECHARGE). METHODS & RESULTS: The RECHARGE cohort (1,252 patients) was divided in two groups according to the presence of previous CABG (217) or not. We also focused, in the post-CABG group, on a comparison between CTO in previously grafted vessels versus non-grafted vessels. The CTO complexity scores were higher and the success rate (71.9% vs. 88.7%, p < .001) was lower in the CABG group, this difference was driven by higher failure rates in high-complexity-score CTO. The rate of in-hospital complications was similar. In the post-CABG group, the procedural success of CTO located in previously grafted vessels versus those in vessels not previously grafted, was comparably suboptimal (73.1% vs. 68%, p = .47). CONCLUSION: Patients undergoing CTO PCI with prior CABG have a higher prevalence of comorbidities and more complex lesion characteristics. In the post-CABG population the success rate was significantly lower, particularly in high CTO complexity scores, though complication rates were comparable. In the post-CABG population, the CTO success rate was independent of the presence of a previous graft on the CTO vessel.
Subject(s)
Coronary Occlusion , Percutaneous Coronary Intervention , Belgium/epidemiology , Chronic Disease , Coronary Angiography , Coronary Artery Bypass/adverse effects , Coronary Occlusion/diagnostic imaging , Coronary Occlusion/surgery , Humans , Netherlands , Percutaneous Coronary Intervention/adverse effects , Registries , Risk Factors , Treatment Outcome , United Kingdom/epidemiologyABSTRACT
BACKGROUND: The Cobra PzF coronary stent is cobalt chromium with flat thin struts, nano-coated with Polyzene-F that enhance rapid reendothelialization and reduce the risk of stent thrombosis and restenosis. It is designed to overcome shortfalls of BMS and DES in patients requiring short DAPT duration. AIMS: To report procedural and 1-year clinical outcomes following Cobra PzF stent implantation in routine practice PCI. METHODS: e-Cobra registry is a multicenter prospective study to evaluate Cobra PzF stent in routine practice in patients deemed appropriate for short DAPT after PCI. The primary endpoint was MACE rate at 12 months (Cardiac death, MI, TLR). The secondary endpoint was definite stent thrombosis at 12 months. RESULTS: Among 940 patients (72% men, 72.8 ± 13.4 years) with multiple co-morbidities, 47% had acute coronary syndromes, and 62% were defined as high bleeding risk. A total of 1,229 lesions were treated with 1,314 stents. 36% of patients had lesion type B2 or C classification. Angiographic success was achieved in all cases. One-year follow-up was available for 97% of patients. The primary endpoint occurred in 9.0% of patients, including cardiac death 3.7%, MI 4.8%, and TLR 4.3%. Definite stent thrombosis occurred in six out of 915 (0.7%). CONCLUSION: The Cobra PzF stent was safe and effective in routine practice patients and seems feasible in situations when short DAPT or Mono Antiplatelet Therapy (MAPT) is needed. One-year follow-up was associated with satisfactory clinical outcomes and validate previously reported data.
Subject(s)
Percutaneous Coronary Intervention , Stents , Aged , Aged, 80 and over , Coated Materials, Biocompatible , Coronary Angiography , Coronary Restenosis/etiology , Female , Humans , Male , Middle Aged , Percutaneous Coronary Intervention/adverse effects , Prospective Studies , Prosthesis Design , Stents/adverse effects , Thrombosis/etiology , Treatment OutcomeABSTRACT
OBJECTIVES: This study sought to create a contemporary scoring tool to predict technical outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) from patients treated by hybrid operators with differing experience levels. BACKGROUND: Current scoring systems need regular updating to cope with the positive evolutions regarding materials, techniques, and outcomes, while at the same time being applicable for a broad range of operators. METHODS: Clinical and angiographic characteristics from 880 CTO-PCIs included in the REgistry of CrossBoss and Hybrid procedures in FrAnce, the NetheRlands, BelGium and UnitEd Kingdom (RECHARGE) were analyzed by using a derivation and validation set (2:1 ratio). Variables significantly associated with technical failure in the multivariable analysis were incorporated in the score. Subsequently, the discriminatory capacity was assessed and the validation set was used to compare with the J-CTO score and PROGRESS scores. RESULTS: Technical success in the derivation and validation sets was 83% and 85%, respectively. Multivariate analysis identified six parameters associated with technical failure: blunt stump (beta coefficient (b) = 1.014); calcification (b = 0.908); tortuosity ≥45° (b = 0.964); lesion length 20 mm (b = 0.556); diseased distal landing zone (b = 0.794), and previous bypass graft on CTO vessel (b = 0.833). Score variables remained significant after bootstrapping. The RECHARGE score showed better discriminatory capacity in both sets (area-under-the-curve (AUC) = 0.783 and 0.711), compared to the J-CTO (AUC = 0.676) and PROGRESS (AUC = 0.608) scores. CONCLUSIONS: The RECHARGE score is a novel, easy-to-use tool for assessing the risk for technical failure in hybrid CTO-PCI and has the potential to perform well for a broad community of operators. © 2017 Wiley Periodicals, Inc.
Subject(s)
Coronary Occlusion/surgery , Decision Support Techniques , Percutaneous Coronary Intervention , Aged , Chronic Disease , Clinical Competence , Coronary Angiography , Coronary Occlusion/diagnostic imaging , Coronary Occlusion/physiopathology , Europe , Female , Humans , Male , Middle Aged , Percutaneous Coronary Intervention/adverse effects , Predictive Value of Tests , Reproducibility of Results , Risk Assessment , Risk Factors , Treatment OutcomeABSTRACT
OBJECTIVES: The French Ebiomatrix registry aimed to confirm the results of the Leaders trial in an all-comer population in France. BACKGROUND: The Leaders trial showed the Biolimus-eluting-sent (BES) to be equivalent to the Cypher stent in terms of safety and efficacy at 1 year and superior regarding stent thrombosis after 1 year. METHODS: BES recipients were enrolled in 42 French centers with up to 24-month clinical follow up. RESULTS: 2365 patients were included. Mean age: 65.7 ±11.2 years, 76.1% males, 31.8% had diabetes, 36.5% ACS (28.7% non-ST-elevation MI and 7.8% with ST-elevation MI). 1.7 ± 1.0 stents/patient were implanted and procedural success was 99.5%. 12-month follow-up was completed in 94.3% patients and 24 months in 91.4%. MACCE rates at 12 and 24 months were 5.8% and 9% (all cause-death 1.5% and 2.2%; stent thrombosis definite/probable 0.4% and 0.6%), respectively. MACCE were not significantly higher in diabetic patients compared with non-diabetics but cardiac death was higher (1.6% vs. 0.6%, P = 0.01 at 1 year and 1.9% vs. 0.6, P = 0.005 at 2 years) as was stent thrombosis (0.9% vs. 0.2%, P = 0.009 and 1.2 vs. 0.3% P = 0.008). Compared with non-ACS patients, MACCE was significantly higher in the ACS subgroup (7.5% vs. 4.8%, P = 0.001 at 1 year and 10.3% vs.8.1%, P = 0.07 at 2 years). CONCLUSION: In this large real-world registry, the BES with biodegradable polymer showed excellent acute and mid-term outcomes with a 5.8% and 9% rate of MACCE at one and 2 years and a very low rate of stent thrombosis between 1 and 2 years (0.2%), thus demonstrating the replicability of the LEADERS trial in a registry population. © 2017 The Authors Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc.
Subject(s)
Coronary Artery Disease/surgery , Drug-Eluting Stents , Percutaneous Coronary Intervention/methods , Postoperative Complications/epidemiology , Registries , Absorbable Implants , Aged , Coronary Artery Disease/diagnosis , Female , Follow-Up Studies , France/epidemiology , Humans , Incidence , Male , Prospective Studies , Prosthesis Design , Risk Factors , Survival Rate/trends , Time Factors , Treatment OutcomeABSTRACT
OBJECTIVES: We sought to demonstrate the safety and efficacy of rapid left ventricular (LV) pacing through the guidewire during balloon aortic valvuloplasty (BAV) and Transaortic valve implantation (TAVI). BACKGROUND: Right ventricular temporary pacing during TAVI and BAV is time-consuming and associated with vascular and pericardial complications. METHODS: Rapid left ventricular pacing was provided via the back-up 0.035â³ guidewire. The cathode of an external pacemaker was placed on the tip of the 0.035â³ wire and the anode on a needle inserted into the groin. Insulation was ensured by the balloon or TAVI catheter. RESULTS: 38 BAV and 87 TAVI procedures were performed in 113 consecutive patients in three centers with one for one pacing (160-200 bpm) in all patients. A significant reduction in blood pressure was achieved with a mean systolic pressure of 44 mm Hg during stimulation. Mean procedural time was 49.7 ± 31 min for BAV and 68.7 ± 30.9 for TAVI. A temporary venous pacemaker was required in 12 patients; only 12% of TAVI patients had a femoral central venous catheter. Femoral venous puncture was not performed in BAV patients. No venous vascular complications were observed. One case of successfully treated tamponade (0.8%) occurred 8 hr post procedure. In-hospital mortality rates were 4.6% and 2.6% in the TAVI and BAV groups, respectively. CONCLUSIONS: Use of the LV guidewire for rapid pacing during BAV and TAVI was shown to be simple, reproducible, and prevented complications associated with RV temporary leads thus potentially simplifying TAVI and enhancing its safety. © 2016 Wiley Periodicals, Inc.
Subject(s)
Balloon Valvuloplasty/methods , Cardiac Catheterization/methods , Heart Ventricles/physiopathology , Pacemaker, Artificial , Postoperative Complications/prevention & control , Transcatheter Aortic Valve Replacement/methods , Aged, 80 and over , Aortic Valve Stenosis , Echocardiography , Electrocardiography , Female , Follow-Up Studies , Heart Ventricles/diagnostic imaging , Humans , Intraoperative Period , Male , Postoperative Complications/epidemiology , Prospective StudiesABSTRACT
OBJECTIVES: This observational study assessed the 9-month clinical outcomes in an « all comers ¼ population with a focus on patients with atrial fibrillation (AF) after thin strut bare metal stenting. BACKGROUND: Drug eluting stent (DES) implantation is the treatment of choice for coronary artery disease (CAD) leaving only marginal indications for the use of bare metal stents (BMS). However, selected treatment populations with DES contraindications such as patients who cannot sustain 6-12 months of dual antiplatelet therapy (DAPT) remain candidates for BMS implantations. METHODS: Thin strut bare metal stenting in a priori defined subgroups were investigated in a non-randomized, international, multicenter «all comers¼ observational study. Primary endpoint was the 9-month TLR rate whereas secondary endpoints included the 9-month MACE and procedural success rates. RESULTS: A total of 783 patients of whom 98 patients had AF underwent BMS implantation. Patient age was 70.4 ± 12.8 years. Cardiovascular risk factors in the overall population were male gender (78.2%, 612/783), diabetes (25.2%, 197/783), hypertension (64.1%, 502/783), cardiogenic shock (4.9%, 38/783) and end stage renal disease (4.9%, 38/783). In-hospital MACE was 4.1% (30/783) in the overall population. The 9-month TLR rate was 4.5% (29/645) in the non-AF group and 3.3% (3/90) in the AF group (P = 0.613). At 9 months, the MACE rate in the AF-group and non-AF group was not significantly different either (10.7%, 69/645 vs. 6.7%, 6/90; P = 0.237). Accumulated stroke rates were 0.3% (2/645) in the non-AF subgroup at baseline and 1.1% (1/90) in the AF subgroup (P = 0.264). CONCLUSION: Bare metal stenting in AF patients delivered acceptably low TLR and MACE rates while having the benefit of a significantly shorter DAPT duration in a DES dominated clinical practice. © 2015 Wiley Periodicals, Inc.
Subject(s)
Atrial Fibrillation/etiology , Coronary Artery Disease/therapy , Metals , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/instrumentation , Stents , Aged , Aged, 80 and over , Anticoagulants/administration & dosage , Asia , Atrial Fibrillation/diagnosis , Atrial Fibrillation/mortality , Atrial Fibrillation/therapy , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/mortality , Drug Therapy, Combination , Europe , Female , Hemorrhage/chemically induced , Humans , Male , Middle Aged , Myocardial Infarction/etiology , Percutaneous Coronary Intervention/mortality , Platelet Aggregation Inhibitors/administration & dosage , Prosthesis Design , Risk Factors , Stroke/etiology , Time Factors , Treatment OutcomeABSTRACT
BACKGROUND: The safety and efficacy of carotid artery stenting (CAS) can be affected by certain technical and anatomical factors. However, it is not known whether the use of a dual-layer micromesh stent (DLMS) with a low-crossing profile could reduce the risks associated with complex vascular anatomies during CAS. METHODS: This study involved 1965 asymptomatic or symptomatic carotid artery stenosis patients who received the Roadsaver DLMS during CAS, as part of a prospective, multicenter observational ROADSAVER study, conducted from January 2018 to February 2021. The primary outcome was the 30-day rate of major adverse events (MAE; i.e. any death or stroke) after CAS. Procedural details and outcomes were compared between patients with complex anatomical features and those without. RESULTS: One or more complex anatomical characteristics were identified in 1639 (83.4%) patents. Patients with complex anatomies were older and had a higher prevalence of arterial hypertension, cardiovascular disease, and prior stroke. Between patients with or without complex anatomical features, no significant differences were found either in procedural techniques, or in 30-day MAE (age-adjusted odds ratio (95% CI) for complexities vs. no complexities: 0.76 (0.35, 1.66); p=0.4905) and any stroke (age-adjusted odds ratio (95% CI) for complexities vs. no complexities: 0.89 (0.37, 2.17); p=0.8032) incidence. Furthermore, neither the presence of specific types of anatomic complexity nor their number (per patient) markedly influenced the 30-day MAE and any stroke incidence. CONCLUSIONS: In this real-world cohort of patients undergoing CAS with the Roadsaver DLMS, no significant difference in the occurrence of 30-day MAE and any stroke was observed between patients with or without high-risk anatomical features.
Subject(s)
Carotid Stenosis , Endovascular Procedures , Prosthesis Design , Stents , Stroke , Humans , Aged , Carotid Stenosis/complications , Carotid Stenosis/diagnostic imaging , Carotid Stenosis/therapy , Carotid Stenosis/surgery , Carotid Stenosis/mortality , Male , Female , Prospective Studies , Treatment Outcome , Risk Factors , Endovascular Procedures/instrumentation , Endovascular Procedures/adverse effects , Time Factors , Middle Aged , Risk Assessment , Stroke/etiology , Stroke/prevention & control , Aged, 80 and overABSTRACT
Background: Adenosine administration for fractional flow reserve (FFR) measurement may induce heart pauses. Aims: To assess the accuracy and tolerability of direct wire pacing (DWP) during measurement of FFR. Methods: Adults with at least one intermediate coronary artery stenosis (40%-80%) were consecutively enrolled between June 2021 and February 2022 in this randomized, noninferiority, crossover trial (NCT04970082) carried out in France. DWP was applied (DWP) or not (standard method) through the pressure guidewire used for FFR measurement during adenosine-induced maximal hyperaemia. Subjects were randomly assigned to the allocation sequence (DWP first or standard first). A 2-minute washout period was observed between the two FFR measurements performed for each stenosis. The primary endpoint was the reproducibility of FFR measurements between methods. Results: A total of 150 focal lesions, presented by 94 subjects, were randomized (ratio: 1:1). The FFR values obtained with each method were nearly identical (R = 0.98, p = 0.005). The mean FFR difference of 0.00054 (95% confidence interval: 0.004 to 0.003) showed the noninferiority of FFR measurement with DWP vs. that with the standard method. Higher levels of chest discomfort were reported with DWP than with the standard method (0.61 ± 0.84 vs. 1.05 ± 0.89, p < 0.001), and a correlation was observed between the electrical sensations reported with DWP and chest discomfort (p < 0.001). Pauses (n = 20/148 lesions) were observed with the standard method, but did not correlate with chest discomfort (p = 0.21). No pauses were observed with DWP. Conclusions: DWP during FFR measurement resulted in accurate and reproducible FFR values, and eliminated the pauses induced by adenosine.
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Data regarding rotational atherectomy percutaneous coronary intervention (RA PCI) angioplasty in the left main (LM) coronary artery are scarce, and mostly outdated. We aimed to describe clinical outcomes of RA PCI in LM. Patients requiring RA in 8 European countries and 19 centers were prospectively and consecutively included in the European registry of Cardiac Care of Calcified and Complex patients registry. In-hospital data collection and 1-year follow-up were performed for each patient. Between October 2016 and July 2018, 966 patients with complete data were included. Among them, 241 presented with an LM lesion, and 171 required an LM lesion preparation by RA. The latter, allocated to the LM-RA group, were compared with the 725 patients in the non-LM-RA group. Clinical success of the RA procedure was comparable in both groups, but in-hospital major adverse cardiac events were higher in the RA-LM group (7.6% vs 3.2%, adjusted p = 0.04), mainly driven by a higher in-hospital mortality rate (5.3 vs 0.3%, adjusted p = 0.005). At 1-year follow-up, mortality and major adverse cardiac event rates were comparable in both groups (12.9% vs 8.0%, adjusted p value: 0.821, and 15.8% vs 10.9%, adjusted p value: 0.329, respectively), but the rate of target vessel revascularization remained higher in the RA-LM group (5.3% vs 3.2%, adjusted p = 0.021). In conclusion, RA PCI is an efficient option for calcified LM lesions, providing acceptable outcomes regarding this population with high risk at 1 year, and yields comparable outcomes with RA PCI performed on non-LM lesions.
Subject(s)
Atherectomy, Coronary , Coronary Artery Disease , Percutaneous Coronary Intervention , Vascular Calcification , Humans , Atherectomy, Coronary/methods , Percutaneous Coronary Intervention/methods , Treatment Outcome , Coronary Angiography/methods , Vascular Calcification/surgeryABSTRACT
BACKGROUND: Radial access is currently the first line of access in interventional cardiology. Nevertheless, this technique carries a 1%-10% risk of radial artery occlusion (RAO) based on series. METHODS: We conducted a large-scale echo-Doppler evaluation of radial patency including prospectively all patients who underwent coronary angiography and/or angioplasty with radial catheterization at our center in 2018. RESULTS: A total of 1106 patients were enrolled in the cohort. Average patient age was 70 years, 24.5% were females and 75.5% were males, and 28.3% were diabetics. Five Fr and 6 Fr devices were used in 527 procedures and 565 procedures, respectively. Our study highlighted a very low RAO rate (0.99%). These results are mainly due to the high attention given to patent hemostasis, which was achieved in 1091 patients (98.6%). According to the literature, female gender is a multivariate predictive factor of RAO (P<.01). Furthermore, we confirm the protective nature of heparin (P=.04) with an average heparin dose of 69.73 IU/kg. CONCLUSIONS: Our study focused on a large population with 1106 patients who underwent radial catheterization shows that a very low rate of RAO (0.99%) can be achieved. These results are correlated with a high attention to patent hemostasis and a close collaboration between the medical and paramedical staff.
Subject(s)
Arterial Occlusive Diseases , Catheterization, Peripheral , Aged , Cardiac Catheterization/adverse effects , Catheterization, Peripheral/adverse effects , Female , Hemostasis , Humans , Male , Radial Artery , Vascular PatencyABSTRACT
During stent positioning after predilating with a non-compliant balloon, we observed major motion of our device in the left main coronary artery. Under those conditions, accurate stent placement was uncertain. To remedy this situation, we decided to perform a rapid direct wire pacing with a good final angiographic result.
Subject(s)
Stents , HumansABSTRACT
Data regarding the potential influence of gender on outcomes of rotational atherectomy (RA) percutaneous coronary intervention (PCI) are scarce and conflicting. Using the Euro4C registry, an international prospective multicentric registry of RA PCI, we evaluated the influence of gender on clinical outcomes of RA PCI. Between October 2016 and July 2018, 966 patients were included. In them, 267 (27.6%) were females. Female patients were older than males (77.7 years old ± 9.8 vs 73.3 ± 9.5 years old respectively, p < 0.001) had a poorer renal function (43,1% of females had a GFR < 60 ml/min:1.73m² vs 30.4% of males, p < 0.001) and were more frequently admitted for an acute coronary syndrome (32.2% vs 22.3% pâ¯=â¯0.002). During RA procedure, women were less likely to be treated by radial approach (65.0% vs 74.4%, pâ¯=â¯0.004). In-hospital major adverse cardiac event rate-defined as cardiovascular death, myocardial infarction, stroke/transient ischemic attack, target lesion revascularization, and coronary artery bypass grafting surgery-was higher in the female group (7.1% vs 3.7%, pâ¯=â¯0.043). However, coronary perforation, dissection, slow/low flow and tamponade did not significantly differ in gender, neither did cardiovascular medications at discharge. At 1 year follow-up, rate of major adverse cardiac event was 18.4% in the female group vs 11.2% in the male group (adjusted Hazard Ratio 1.82 [1.24 to 2.67], pâ¯=â¯0.002). No significant bleeding differences were observed in gender, neither in hospital, nor during follow-up. In conclusion women had worse clinical outcomes following RA PCI during hospitalization and at 1 year follow-up than did men.
Subject(s)
Acute Coronary Syndrome/epidemiology , Atherectomy, Coronary/methods , Coronary Artery Disease/surgery , Vascular Calcification/surgery , Age Distribution , Aged , Aged, 80 and over , Cardiac Tamponade/epidemiology , Cardiovascular Diseases/mortality , Coronary Artery Bypass/statistics & numerical data , Coronary Artery Disease/epidemiology , Europe/epidemiology , Female , Humans , Male , Middle Aged , Myocardial Infarction/epidemiology , Percutaneous Coronary Intervention/methods , Postoperative Complications/epidemiology , Radial Artery , Registries , Renal Insufficiency/epidemiology , Sex Factors , Stroke/epidemiology , Treatment Outcome , Vascular Calcification/epidemiology , Vascular System Injuries/epidemiologyABSTRACT
BACKGROUND: Vascular and bleeding complications related to secondary femoral access site are frequent in patients undergoing transcatheter aortic valve replacement (TAVR), and their occurrence is associated to poorer outcomes. We aimed to evaluate the clinical impact of vascular closure devices (VCDs) for secondary femoral access hemostasis in TAVR procedures. METHODS: This was a multicenter study including 4031 patients who underwent TAVR (mean age, 81 ± 8 years; mean Society of Thoracic Surgeons [STS] score, 4.9 [interquartile range, 3.3-7.6]), and had a secondary femoral access. The 30-day clinical outcomes were analyzed according to femoral access-site hemostasis (manual compression vs VCD), and according to the type of VCD (Perclose [Abbott Cardiovascular] vs Angio-Seal [Terumo Interventional Systems]) using a propensity-matched, multivariable, logistic regression model. RESULTS: Manual compression was used in 941 patients (23.3%) and VCDs were used in 3090 patients (76.7%; Perclose in 1549 patients [38.4%] and Angio-Seal in 1541 patients [38.2%]) for secondary femoral access hemostasis. Vascular complications related to secondary access site occurred in 162 patients (4%), and were more frequent in patients who underwent manual compression (7.2%) compared with VCD hemostasis (3%; adjusted P<.001). In the VCD group, the use of Angio-Seal (vs Perclose) was associated with a higher rate of vascular complications (3.7% vs 2.4%, respectively; adjusted P=.02), femoral artery pseudoaneurysm (1.3% vs 0.4%, respectively; adjusted P<.01), invasive treatment requirement for treating vascular complications (surgery: 0.8% vs 0.3%, respectively [adjusted P=.03]; and thrombin injection: 0.9% vs 0%, respectively [adjusted P<.001]). CONCLUSION: VCDs represented a safer and more effective alternative compared with manual compression for secondary femoral access-site hemostasis in patients undergoing TAVR procedures, and the Perclose VCD was associated with the lowest risk of vascular complications. Future randomized studies are warranted.
Subject(s)
Transcatheter Aortic Valve Replacement , Vascular Closure Devices , Aged , Aged, 80 and over , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Femoral Artery/surgery , Hemostasis , Hemostatic Techniques , Humans , Treatment OutcomeABSTRACT
OBJECTIVES: To determine the occurrence of vascular complications (VCs) following transfemoral transcatheter aortic valve replacement (TAVR) with new-generation devices according to the use of a crossover technique (COT). BACKGROUND: The use of a COT (with/without balloon) has been associated with a reduction of VCs in TAVR patients. However, scarce data support its use with second-generation devices. Also, its potential benefit in obese patients (at high-risk of VCs) has not been elucidated. METHODS: A multicenter study including 2214 patients who underwent full percutaneous transfemoral TAVR (COT, 1522 patients; no COT, 692 patients). Thirty-day events were evaluated according to the use of a COT using a multivariate logistic regression model. A subanalysis was performed in obese patients. RESULTS: Primary access major VCs (3.5% COT vs 3.9% no COT; P=.19), major/life-threatening bleeding (3.4% COT vs 2.0% no COT; P=.33), and mortality rates (2.4% COT vs 2.6% no COT; P=.23) were similar between groups. However, minor VCs (11.7% COT vs 5.9% no COT; P<.001) and postprocedural acute renal failure (8.9% COT vs 3.9% no COT; P<.001) were higher in patients undergoing the COT. In the overall cohort, percutaneous closure device failure was more frequent in obese patients (4.0% in the obese group vs 1.9% in the non-obese group; P<.01), but these differences were no longer significant in those undergoing a COT (3.4% in the obese group vs 2.0% in the non-obese group; P=.12). Indeed, in the subset of obese patients, the COT tended to be associated with fewer VCs (3.4% COT vs 5.9% no COT; P=.09). CONCLUSIONS: The use of a COT was not associated with a reduction of major VCs or improved outcomes. However, some patient subsets, such as those with higher body mass index, may benefit from the use of a COT. These findings would suggest the application of a tailored strategy, following a risk-benefit assessment in each TAVR candidate.
Subject(s)
Aortic Valve Stenosis , Transcatheter Aortic Valve Replacement , Aortic Valve Stenosis/diagnosis , Aortic Valve Stenosis/surgery , Femoral Artery/surgery , Hemostasis , Humans , Risk Factors , Transcatheter Aortic Valve Replacement/adverse effects , Treatment OutcomeABSTRACT
The COVID-19 pandemic has modified practice for patients with symptomatic aortic stenosis and could result in higher mortality rates due to treatment delays. In this clinical case series, 3 patients underwent ambulatory transcatheter aortic valve replacement (TAVR) thanks to patient and entourage willingness, careful patient selection (including a history of permanent pacemaker placement), and a minimalist procedural approach. No complications occurred during the 30-day follow-up. Performing ambulatory TAVR could reduce the clinical consequences of wait times, minimize exposure to coronavirus contamination, and reduce the use of hospital resources that might be needed for COVID-19 patients. Thanks to a scrupulous minimalist TAVR protocol, ambulatory outpatient management of aortic stenosis was possible in the context of the COVID-19 pandemic.
La pandémie de COVID-19 a modifié la prise en charge des patients présentant une sténose aortique symptomatique, et les retards dans les traitements pourraient entraîner une hausse des taux de mortalité. Dans le cadre de cette série de cas cliniques, trois patients ont subi un remplacement valvulaire aortique par cathéter (RVAC) ambulatoire, rendu possible grâce à la volonté des patients et de leur entourage, aux choix consciencieux des candidats (par exemple, les receveurs d'un stimulateur cardiaque implantable) et à une approche comportant des interventions minimales. On n'a observé aucune complication durant les 30 jours du suivi. Le RVAC ambulatoire pourrait atténuer les répercussions cliniques associées au temps d'attente, réduire le risque d'exposition au coronavirus et diminuer l'utilisation des ressources hospitalières, qui pourraient être consacrées aux patients atteints de la COVID-19. Un protocole méticuleux et minimaliste de RVAC a permis la prise en charge ambulatoire de la sténose aortique durant la pandémie de COVID-19.
ABSTRACT
BACKGROUND: The treatment of chronic total occlusion of coronary arteries by percutaneous coronary intervention (CTO PCI) is one of the most representative technical advances in ischemic cardiomyopathy of last decade. However, how the complex histopathological remodeling and the new techniques affect healing processes after stent implantation remains unknown. OBJECTIVE: The objective of the PERFE-CTO study is to analyze stent coverage, malapposition and other mechanical abnormalities 3â¯months after CTO recanalization using intravascular imaging. METHODS: In a French prospective interventional multicenter study, stent strut coverage, acquired malapposition and neointimal hyperplasia (NIH) proliferation will be systematically assessed with 3â¯months angiogram control and intracoronary optical frequency domain imaging (OFDI) after successful CTO PCI of >20â¯mm in length. The impact of routine systematical intracoronary imaging after these complex procedures will also be evaluated by measuring the rate of significant mechanical abnormalities (strut malapposition, edge dissection, thrombus) that was undetected by fluoroscopy alone and by complementary PCI when needed. Secondarily, these data will be compared according to clinical characteristics, antiplatelet therapy use or desobstruction technique (antegrade vs. retrograde, true lumen vs. subintima). Each patient will undergo a one-year clinical follow-up. A total of 150 analyzed CTO lesions is expected. CONCLUSION: The PERFE-CTO study will provide essential understanding of the early history after CTO recanalization and the identification of inadequate evolution (stent thrombosis, restenosis or late delayed stent endothelization and cardiovascular outcomes) using intravascular imaging to improve long-term CTO results.
Subject(s)
Coronary Occlusion/therapy , Coronary Vessels/diagnostic imaging , Endothelium, Vascular/diagnostic imaging , Percutaneous Coronary Intervention/instrumentation , Re-Epithelialization , Stents , Tomography, Optical Coherence , Chronic Disease , Coronary Occlusion/diagnostic imaging , France , Humans , Neointima , Percutaneous Coronary Intervention/adverse effects , Predictive Value of Tests , Prospective Studies , Research Design , Time Factors , Treatment OutcomeABSTRACT
BACKGROUND: High bleeding risk (HBR) patients undergoing percutaneous coronary intervention have been widely excluded from randomized device registration trials. The LF study (LEADERS FREE) reported superior outcomes of HBR patients receiving 30-day dual antiplatelet therapy after percutaneous coronary intervention with a polymer-free drug-coated stent (DCS). LFII was designed to assess the reproducibility and generalizability of the benefits of DCS observed in LF to inform the US Food and Drug Administration in a device registration decision. METHODS: LFII was a single-arm study using HBR inclusion/exclusion criteria and 30-day dual antiplatelet therapy after percutaneous coronary intervention with DCS, identical to LF. The 365-day rates of the primary effectiveness (clinically indicated target lesion revascularization) and safety (composite cardiac death and myocardial infarction) end points were reported using a propensity-stratified analysis compared with the LF bare metal stent arm patients as controls. RESULTS: A total of 1203 LFII patients were enrolled with an average 1.7 HBR criteria per patient, including 60.7% >75 years of age, 34.1% on anticoagulants, and 14.7% with renal failure. Propensity-adjusted 365-day clinically indicated target lesion revascularization was significantly lower with DCS (7.2% versus 9.2%; hazard ratio, 0.72 [95% CI, 0.52-0.98]; P=0.0338 for superiority), as was the primary safety (cardiac death and myocardial infarction) composite (9.3% versus 12.4%; hazard ratio, 0.72 [95% CI, 0.55-0.94]; P=0.0150 for superiority). Stent thrombosis rates were 2.0% DCS and 2.2% bare metal stent. Major bleeding at 1 year occurred in 7.2% DCS patients and 7.2% bare metal stent. CONCLUSIONS: LFII reproduces the results of the DCS arm of LF in an independent, predominantly North American cohort of HBR patients.
Subject(s)
Acute Coronary Syndrome/therapy , Coronary Artery Disease/therapy , Coronary Thrombosis/prevention & control , Drug-Eluting Stents , Percutaneous Coronary Intervention/instrumentation , Platelet Aggregation Inhibitors/administration & dosage , ST Elevation Myocardial Infarction/therapy , Acute Coronary Syndrome/diagnostic imaging , Acute Coronary Syndrome/mortality , Aged , Aged, 80 and over , Canada , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/mortality , Coronary Thrombosis/diagnostic imaging , Coronary Thrombosis/mortality , Drug Administration Schedule , Dual Anti-Platelet Therapy , Europe , Female , Hemorrhage/chemically induced , Humans , Male , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/mortality , Platelet Aggregation Inhibitors/adverse effects , Prosthesis Design , Recurrence , Risk Assessment , Risk Factors , ST Elevation Myocardial Infarction/diagnostic imaging , ST Elevation Myocardial Infarction/mortality , Time Factors , Treatment Outcome , United StatesABSTRACT
BACKGROUND: Transfemoral approach has been commonly used as secondary access in transcatheter aortic valve replacement (TAVR). Scarce data exist on the use and potential clinical benefits of the transradial approach as secondary access during TAVR procedures. The objective of the study is to determine the occurrence of vascular complications (VC) and clinical outcomes according to secondary access (transfemoral versus transradial) in patients undergoing TAVR. METHODS: This was a multicenter study including 4949 patients who underwent TAVR (mean age, 81±8 years, mean Society of Thoracic Surgeons score, 4.9 [3.3-7.5]). Transfemoral and transradial approaches were used as secondary access in 4016 (81.1%) and 933 (18.9%) patients, respectively. The 30-day clinical events (vascular and bleeding complications, stroke, acute kidney injury, and mortality) were evaluated and defined according to Valve Academic Research Consortium-2 criteria. Clinical outcomes were analyzed according to the secondary access (transfemoral versus transradial) in the overall population and in a propensity score-matched population involving 2978 transfemoral and 928 transradial patients. RESULTS: Related-access VC occurred in 834 (16.9%) patients (major VC, 5.7%) and were related to the secondary access in 172 (3.5%) patients (major VC, 1.3%). The rate of VC related to the secondary access was higher in the transfemoral group (VC, 4.1% versus 0.9%, P<0.001; major VC, 1.6% versus 0%, P<0.001). In the propensity score-matched population, VC related to the secondary access remained higher in the transfemoral group (4.7% versus 0.9%, P<0.001; major VC, 1.8% versus 0%, P<0.001), which also exhibited a higher rate of major/life-threatening bleeding events (1.0% versus 0%, P<0.001). Significant differences between secondary access groups were observed regarding the rates of 30-day stroke (transfemoral: 3.1%, transradial: 1.6%; P=0.043), acute kidney injury (transfemoral: 9.9%, transradial: 5.7%; P<0.001), and mortality (transfemoral: 4.0%, transradial: 2.4%, P=0.047). CONCLUSIONS: The use of transradial approach as secondary access in TAVR procedures was associated with a significant reduction in vascular and bleeding complications and improved 30-day outcomes. Future randomized studies are warranted.