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BACKGROUND: Atrial fibrillation (AF) is common in patients undergoing transcatheter aortic valve replacement (TAVR) and is associated with increased risk of bleeding and stroke. While left atrial appendage occlusion (LAAO) is approved as an alternative to anticoagulants for stroke prevention in patients with AF, placement of these devices in patients with severe aortic stenosis, or when performed at the same time as TAVR, has not been extensively studied. METHODS: WATCH-TAVR (WATCHMAN for Patients with AF Undergoing TAVR) was a multicenter, randomized trial evaluating the safety and effectiveness of concomitant TAVR and LAAO with WATCHMAN in AF patients. Patients were randomized 1:1 to TAVR + LAAO or TAVR + medical therapy. WATCHMAN patients received anticoagulation for 45 days followed by dual antiplatelet therapy until 6 months. Anticoagulation was per treating physician preference for patients randomized to TAVR + medical therapy. The primary noninferiority end point was all-cause mortality, stroke, and major bleeding at 2 years between the 2 strategies. RESULTS: The study enrolled 349 patients (177 TAVR + LAAO and 172 TAVR + medical therapy) between December 2017 and November 2020 at 34 US centers. The mean age of patients was 81 years, and the mean scores for CHA2DS2-VASc and HAS-BLED (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly, Drugs/alcohol concomitantly) were 4.9 and 3.0, respectively. At baseline, 85.4% of patients were taking anticoagulants and 71.3% patients were on antiplatelet therapy. The cohorts were well-balanced for baseline characteristics. The incremental LAAO procedure time was 38 minutes, and the median contrast volume used for combined procedures was 119 mL versus 70 mL with TAVR alone. At the 24-month follow-up, 82.5% compared with 50.8% of patients were on any antiplatelet therapy, and 13.9% compared with 66.7% of patients were on any anticoagulation therapy in TAVR + LAAO compared with TAVR + medical therapy group, respectively. For the composite primary end point, TAVR + LAAO was noninferior to TAVR + medical therapy (22.7 versus 27.3 events per 100 patient-years for TAVR + LAAO and TAVR + medical therapy, respectively; hazard ratio, 0.86 [95% CI, 0.60-1.22]; Pnoninferiority<0.001). CONCLUSIONS: Concomitant WATCHMAN LAAO and TAVR is noninferior to TAVR with medical therapy in severe aortic stenosis patients with AF. The increased complexity and risks of the combined procedure should be considered when concomitant LAAO is viewed as an alternative to medical therapy for patients with AF undergoing TAVR. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03173534.
Subject(s)
Aortic Valve Stenosis , Atrial Appendage , Atrial Fibrillation , Stroke , Transcatheter Aortic Valve Replacement , Humans , Aged , Aged, 80 and over , Atrial Fibrillation/complications , Atrial Fibrillation/drug therapy , Transcatheter Aortic Valve Replacement/adverse effects , Platelet Aggregation Inhibitors/adverse effects , Atrial Appendage/surgery , Stroke/epidemiology , Stroke/etiology , Stroke/prevention & control , Hemorrhage/chemically induced , Anticoagulants/adverse effects , Aortic Valve Stenosis/complications , Aortic Valve Stenosis/surgery , Treatment OutcomeABSTRACT
BACKGROUND: The impact of occlusion length on the procedural techniques and outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study. METHODS: We examined the clinical and angiographic characteristics and procedural outcomes of 10,335 CTO PCIs at 42 US and non-US centers between 2012 and 2022. The cohort was divided into two groups based on lesion length (≥20 mm vs. <20 mm). RESULTS: Long lesions were present in 7208 (70%) patients. Comorbidities were more common in patients with long CTOs. Compared with short lesions, long lesions had higher J-CTO score (2.8 ± 1.1 vs. 1.3 ± 1; p < 0.001) and retrograde wiring was more often the initial (15.5% vs. 4.0%; p < 0.001) and successful (22.8% vs. 8.2%; p < 0.001) crossing strategy. Long lesions were more likely to require longer procedure (123 vs. 91 min; p < 0.001) and fluoroscopy (47.1 vs. 32.2 min; p < 0.001) time, larger contrast volume (218 vs. 200 mL; p < 0.001) and higher air kerma radiation dose (2.4 vs. 1.7 Gy; p < 0.001). After adjusting for potential confounders, long lesions were associated with lower technical success (odds ratio [OR]: 0.91 per 10 mm increase; 95% confidence interval [CI]: 0.88, 0.94) and higher major adverse cardiovascular events (MACE) (OR: 1.08 per 10 mm increase; 95% CI: 1.02, 1.15). CONCLUSIONS: CTO PCI of long occlusions is independently associated with lower rates of technical success and higher rates of in-hospital MACE.
Subject(s)
Coronary Occlusion , Percutaneous Coronary Intervention , Humans , Percutaneous Coronary Intervention/adverse effects , Treatment Outcome , Risk Factors , Coronary Occlusion/etiology , Coronary Angiography/methods , Registries , Chronic DiseaseABSTRACT
BACKGROUND: Donor vessel injury is a potentially life-threatening complication of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). AIMS: Our goal was to examine the incidence, mechanisms, treatment, and outcomes of patients with donor vessel injury in a large multicenter CTO PCI registry. METHODS: We analyzed the baseline clinical and angiographic characteristics, and procedural outcomes of 12,349 CTO PCIs performed between 2012 and 2022 at 44 centers. RESULTS: The incidence of donor vessel injury was 0.35% (n = 43). The baseline clinical characteristics of patients with and without donor vessel injury were similar. Cases complicated by donor vessel injury were more complex with higher Japanese CTO score (2.9 ± 1.1 vs. 2.4 ± 1.3; p = 0.004) and lower procedural success rate (69.8% vs. 85.2%; p = 0.004). The retrograde approach was used more commonly in donor vessel injury cases (68.9% vs. 30.9%; p < 0.001). Most (53.5%) donor vessel injuries were guide catheter-induced, whereas 20.9% were due to donor vessel thrombosis. Of the 43 patients with donor vessel injury, 36 (83.7%) were treated with stenting and seven (16.3%) received a left ventricular assist device. The incidence of major adverse cardiovascular events (MACEs) was significantly higher in cases with donor vessel injury (23.3% vs. 2.0%; p < 0.001). Of the 43 patients with donor vessel injury, five patients (11.6%) experienced acute myocardial infarction and four patients (9.3%) died. CONCLUSIONS: Donor vessel injury, occurred in 0.35% of CTO PCIs performed by experienced operators, was mainly due to guide catheter-induced dissection or thrombosis and was associated with lower procedural success and higher MACE.
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OBJECTIVES: The EVOLVE 48 study evaluated the safety and effectiveness of the SYNERGY 48 mm stent for the treatment of long lesions. BACKGROUND: Clinical evidence supporting the use of very long stents during percutaneous coronary intervention (PCI) is limited. The bioabsorbable polymer SYNERGY stent has shown good long-term data in a broad population of patients undergoing PCI. METHODS: Patients with lesion length >34- ≤44 mm and reference vessel diameter (RVD) ≥2.5- ≤ 4.0 mm were enrolled in this prospective, multicenter, single-arm study. The primary endpoint was 12-month target lesion failure (TLF; composite of target lesion revascularization [TLR], target-vessel myocardial infarction [TV-MI], or cardiac death) compared to a prespecified performance goal (PG). RESULTS: A total of 100 patients with mean lesion length of 35.34 ± 7.15 mm (26 patients with lesion length > 40 mm) and mean RVD 2.72 ± 0.44 mm were enrolled. Moderate to severe calcification was present in 30% of the patients and 89% had pre-TIMI flow grade 3. The rates of technical and clinical procedural success were 100%. One-year TLF was observed in 4.1% patients compared to a prespecified PG of 19.5% (95% upper confidence bound = 9.1%; p < 0.0001). Cardiac death and TLR were each observed in one patient, and TV-MI in two patients treated with SYNERGY 48 mm stent. Between the 1-2-year timeframe, TV-MI occurred in one additional patient. None of the patients experienced a definite or probable stent thrombosis through 2 years. CONCLUSIONS: PCI of long coronary lesions with the 48 mm SYNERGY stent demonstrated good procedural and clinical outcomes through 2 years, supporting its clinical safety and efficacy.
Subject(s)
Cardiovascular Agents , Drug-Eluting Stents , Percutaneous Coronary Intervention , Absorbable Implants , Cardiovascular Agents/adverse effects , Everolimus/adverse effects , Humans , Percutaneous Coronary Intervention/adverse effects , Polymers , Prospective Studies , Prosthesis Design , Sirolimus , Stents , Treatment OutcomeABSTRACT
OBJECTIVES: Few case reports have demonstrated promising results of drug-coated balloons (DCBs) as an emerging management for carotid artery in-stent restenosis (CAISR). Herein, we report 6 cases of CAISR which were treated with a DCB with or without new stent deployment. BACKGROUND: Carotid artery in-stent restenosis is a high-risk condition with an estimated incidence rate that varies widely from 6% to 40%. Several strategies are available now for the management of the CAISR including conventional balloon angioplasty, plaque modification balloon angioplasty, and new stent placement. METHODS: A retrospective review of consecutive patients with a diagnosis of severe CAISR at Baylor Scott & White The Heart Hospital Plano from 2011 to 2021 was performed. This study was approved by the Baylor Scott & White Research Institute institutional review board. RESULTS: Six patients underwent DCB angioplasty with or without stent placement under an embolic protection device. Resolution of CAISR was achieved in all cases with 0% to 10% residual stenosis in all cases. Following the procedure, 1 patient had a brief episode of syncope with balloon inflation with immediate recovery on deflation of the balloon. There were otherwise no significant neurological or cardiac events prior to discharge. All patients were asymptomatic at their follow-up visit with no neurological or cardiac events reported at 12, 24, and 36 months following the procedure. CONCLUSION: While CAISR treatment remains a challenging condition, our study shows that the use of DCB with or without stent placement is a feasible and promising treatment option when compared with other conventional treatment options. CLINICAL IMPACT: Carotid artery in-stent restenosis treatment remains a challenging condition. Our study shows that the use of drug coated balloon with or without stent placement is a feasible and promising treatment option when compared with current conventional treatment options.
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BACKGROUND: When crossing into the distal true lumen fails during chronic total occlusion (CTO) percutaneous coronary intervention (PCI), subintimal plaque modification (SPM) is often performed to restore antegrade flow and facilitate subsequent lesion recanalization. METHODS: Between January 2012 and May 4, 2019, 4,659 CTO PCIs were included in the PROGRESS-CTO registry, of which 935 (20%) had a prior unsuccessful attempt. Of those 935 patients, 119 (13%) had prior SPM. We analyzed the outcomes of the 58 SPM procedures for which data were available, as well as the outcomes of the 60 subsequent CTO PCI attempts. RESULTS: Mean patient age was 67 ± 9 years and 86% were men. Patients had high prevalence of cardiovascular risk factors such as dyslipidemia (91%), hypertension (93%) diabetes (48%), prior PCI (61%), and prior coronary artery bypass graft surgery (47%). The target CTO lesions often had proximal cap ambiguity (54%), moderate/severe calcification (73%), moderate/severe tortuosity (63%), and high J-CTO score (mean 3.2 ± 1.1). The technical and procedural success of subsequent CTO PCI were high (83% for both) with an acceptable rate of in-hospital major adverse cardiovascular events (3.3%). Technical and procedural success were higher for repeat attempts that were performed ≥60 days after the index CTO PCI (94% vs. 69%, p = .015). Median (interquartile range) subsequent procedure time was 147 (100, 215) min, contrast volume was 185 (150, 260) ml, and air kerma radiation dose was 2.5 (1.4, 4.2) Gray. CONCLUSION: Repeat CTO PCI attempts after SPM are associated with high likelihood for successful revascularization with acceptable risks.
Subject(s)
Coronary Artery Disease/therapy , Coronary Occlusion/therapy , Percutaneous Coronary Intervention , Plaque, Atherosclerotic , Aged , Chronic Disease , Coronary Artery Disease/diagnostic imaging , Coronary Occlusion/diagnostic imaging , Female , Humans , Male , Middle Aged , Percutaneous Coronary Intervention/adverse effects , Registries , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Treatment OutcomeABSTRACT
Proximal radial artery (PRA) access for cardiac catheterization is safe but can jeopardize subsequent use of the artery because of occlusion. Distal radial artery (DRA) access in the anatomical snuffbox preserves the RA but safety and potential detrimental effects on hand function are unknown. We aimed to assess hand function and complications after DRA and PRA. In this single-center trial, 300 patients were randomly allocated 1:1 to cardiac catheterization through DRA or PRA. The primary end point of change in hand function from baseline to 1 year was a composite of the Quick Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, hand grip test, and thumb-forefinger pinch test. The secondary end points included access feasibility and complications. Of 216 patients with 1-year completed follow-up, 112 were randomly allocated to DRA and 104 to PRA, with balanced demographics and procedural characteristics. Both groups had similar access site bleeding rates (DRA 0% vs PRA 1.4%, p = 0.25). Radial artery occlusion occurred in 1 PRA patient versus 2 in DRA. There was no significant difference in change of hand function, median (interquartile range) hand grip (DRA 0.7 [-3 to 4.5] vs PRA 1.3 [-2 to 4.3] kg, p = 0.57), pinch grip (DRA -0.1 [-1.1 to 1] vs PRA -0.3 [-1 to 0.7] kg, p = 0.66), and Quick DASH (DRA 0 [-6.6 to 2.3] vs PRA 0 [-4.6 to 2.9] points, p = 0.58). The composite of hand function was comparable between PRA and DRA. In conclusion, DRA is a safe strategy for cardiac catheterization, with a low complication rate. Compared with PRA, there is no increased risk of hand dysfunction or radial artery occlusion at 1 year.
Subject(s)
Cardiac Catheterization , Radial Artery , Humans , Male , Female , Cardiac Catheterization/methods , Middle Aged , Aged , Hand Strength/physiology , Follow-Up Studies , Time FactorsABSTRACT
Background: In March 2022, a COVID-19 outbreak disrupted the global supply of iodine contrast media (ICM). Healthcare systems implemented contrast-saving strategies to maintain their remaining ICM supplies. This study sought to determine the impact of contrast shortage on the incidence of contrast-associated acute kidney injury (CA-AKI). Methods: This was a retrospective study of 265 patients undergoing 278 percutaneous coronary interventions (PCI) during 4-month periods prior to (9/1/2021 to 12/31/2021) and during (5/1/2022 to 8/31/2022) contrast shortage at a single center. The primary endpoint was the incidence of CA-AKI between study periods. Results: A total of 148 and 130 PCIs were performed before and during contrast shortage, respectively. The incidence of CA-AKI significantly decreased from 11.5% to 4.6% during contrast shortage (P = 0.04). During the shortage, average contrast volume per PCI was significantly lower (123 ± 62 mL vs 88 ± 46 mL, P < 0.001), while coronary imaging was significantly higher (34.3% vs 50%, P = 0.009) compared to preshortage. All-cause mortality at discharge was comparable between study periods (2.8% vs 3.3%, respectively; P = 0.90). Conclusion: The scarcity of ICM for PCI procedures in this single-center experience was associated with a significant increase in the utilization of intravascular imaging and a significant reduction in CA-AKI.
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Plaque modification microcatheters (PM) (Tornus [Asahi] and Turnpike Gold [Teleflex]) are devices that are mainly used to modify the cap or lesion and maintain good support in chronic total occlusion (CTO) percutaneous coronary artery intervention (PCI). We evaluated the frequency of use and outcomes of plaque modification microcatheters in an international multicenter registry. Plaque modification microcatheters were utilized in 242 cases (1.6%: Tornus in 51% and Turnpike Gold in 49%) with decreasing frequency over time (P-for-trend: 0.007 and 0.035, respectively). Technical and procedural success and the incidence of major cardiac adverse events were similar with Tornus and Turnpike Gold use. PM are infrequently utilized in CTO-PCI and are associated with high success and acceptable complication rates.
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Pulmonary vein stenosis (PVS) is a condition that has seen a decrease in incidence in recent years. Whereas balloon angioplasty and stenting are both acceptable treatment options for PVS, they are limited by the high rate of restenosis. This research paper presents 4 cases of severe symptomatic PVS that were successfully treated with the use of drug-coated balloons, resulting in positive outcomes. (Level of Difficulty: Advanced.).
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Background Proximal radial artery (pRA) access for cardiac catheterization is safe but can jeopardize subsequent use of the artery because of occlusion. Distal radial artery (dRA) access in the anatomical snuffbox preserves the radial artery, but safety and potential detrimental effects on hand function are unknown. Methods and Results In the DIPRA (Distal Versus Proximal Radial Artery Access for Cardiac Catheterization and Intervention) study, a single-center trial, 300 patients were randomized 1:1 to cardiac catheterization through dRA or pRA. The primary end point of change in hand function from baseline to 30 days was a composite of the QuickDASH (Quick Disabilities of the Arm, Shoulder and Hand) questionnaire, hand-grip test, and thumb forefinger pinch test. Secondary end points included access feasibility and complications; 254 of 300 patients completed follow-up at 30 days; of these, 128 were randomized to dRA and 126 to pRA with balanced demographic and procedural characteristics. Both groups had similar rates of access site bleeding (dRA 0% versus pRA 1.4%; P=0.25). Six patients with dRA failed access compared with 2 patients with pRA. Radial artery occlusion occurred in 2 pRA versus none in dRA. There were no significant differences in change in hand function, median hand-grip (dRA 0 [-3.2, 3.3] versus pRA 0.7 [-2.3, 3.3] kg; P=0.21), pinch-grip (dRA -0.3 [-1.2, 0.5] versus pRA 0 [-0.9, 0.9] kg; P=0.09), and QuickDASH (dRA 0 [-4.6, 2.3] versus pRA 0 [-4.6, 2.3] points, P=0.96). There was no significant difference in the composite of hand function between pRA and dRA. Conclusions dRA is a safe strategy for cardiac catheterization with a low complication rate. Compared with pRA, there is no increased risk of hand dysfunction at 30 days. Registration URL: https://www.ClinicalTrials.gov. Unique identifier: NCT04318990.
Subject(s)
Arterial Occlusive Diseases , Percutaneous Coronary Intervention , Humans , Radial Artery , Wrist , Cardiac Catheterization/adverse effects , Coronary Angiography/methods , Percutaneous Coronary Intervention/adverse effects , Treatment OutcomeABSTRACT
Background: The Society of Thoracic Surgeons (STS) score has been used to risk stratify patients undergoing transcatheter aortic valve replacement (TAVR). The Transcatheter Valve Therapy (TVT) score was developed to predict in-hospital mortality in high/prohibitive-risk patients. Its performance in low and intermediate-risk patients is unknown. We sought to compare TVT and STS scores' ability to predict clinical outcomes in all-surgical-risk patients undergoing TAVR. Methods: Consecutive patients undergoing TAVR from 2012-2020 within a large health care system were retrospectively reviewed and stratified by STS risk score. Predictive abilities of TVT and STS scores were compared using observed-to-expected mortality ratios (O:E) and area under the receiver operating characteristics curves (AUCs) for 30-day and 1-year mortality. Results: We assessed a total of 3270 patients (mean age 79 ± 9 years, 45% female), including 191 (5.8%) low-risk, 1093 (33.4%) intermediate-risk, 1584 (48.4%) high-risk, and 402 (5.8%) inoperable. Mean TVT and STS scores were 3.5% ± 2.0% and 6.1% ± 4.3%, respectively. Observed 30-day and 1-year mortality were 2.8% (92/3270; O:E TVT 0.8 ± 0.16 vs STS 0.46 ± 0.09), and 13.2% (432/3270), respectively. In the all-comers population, both TVT and STS risk scores showed poor prediction of 30-day (AUC: TVT 0.68 [0.62-0.74] vs STS 0.64 [0.58-0.70]), and 1-year (AUC: TVT 0.65 [0.62-0.58] vs STS 0.65 [0.62-0.58]) mortality. After stratifying by surgical risk, discrimination of the TVT and STS scores remained poor in all categories at 30 days and 1 year. Conclusions: An updated TAVR risk score with improved predictive ability across all-surgical-risk categories should be developed based on a larger national registry.
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BACKGROUND: Procedural success and clinical outcomes after transcatheter aortic valve replacement (TAVR) have improved, but residual aortic regurgitation (AR) and new permanent pacemaker implantation (PPI) rates remain variable because of a lack of uniform periprocedural management and implantation. OBJECTIVES: The Optimize PRO study evaluates valve performance and procedural outcomes using an "optimized" TAVR care pathway and the cusp overlap technique (COT) in patients receiving the Evolut PRO/PRO+ (Medtronic) self-expanding valves. METHODS: Optimize PRO, a nonrandomized, prospective, postmarket study conducted in the United States, Canada, Europe, Middle East, and Australia, is enrolling patients with severe symptomatic aortic stenosis and no pre-existing pacemaker. Sites follow a standardized TAVR care pathway, including early discharge and a conduction disturbance management algorithm, and transfemoral deployment using the COT. RESULTS: A total of 400 attempted implants from the United States and Canada comprised the main cohort of this second interim analysis. The mean age was 78.7 ± 6.6 years, and the mean Society of Thoracic Surgeons predictive risk of mortality was 3.0 ± 2.4. The median length of stay was 1 day. There were no instances of moderate or severe AR at discharge. At 30 days, all-cause mortality or stroke was 3.8%, all-cause mortality was 0.8%, disabling stroke was 0.7%, hospital readmission was 10.1%, and cardiovascular rehospitalization was 6.1%. The new PPI rate was 9.8%, 5.8% with 4-step COT compliance. In the multivariable model, right bundle branch block and the depth of the implant increased the risk of PPI, whereas using the 4-step COT lowered 30-day PPI. CONCLUSIONS: The use of the TAVR care pathway and COT resulted in favorable clinical outcomes with no moderate or severe AR and low PPI rates at 30 days while facilitating early discharge and reproducible outcomes across various sites and operators. (Optimize PRO; NCT04091048).
Subject(s)
Aortic Valve Insufficiency , Aortic Valve Stenosis , Heart Valve Prosthesis , Stroke , Transcatheter Aortic Valve Replacement , Humans , United States , Aged , Aged, 80 and over , Transcatheter Aortic Valve Replacement/adverse effects , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/complications , Critical Pathways , Prospective Studies , Risk Factors , Treatment Outcome , Aortic Valve Insufficiency/etiology , Heart Valve Prosthesis/adverse effectsABSTRACT
BACKGROUND: Although discouraged, ad hoc chronic total occlusion (CTO) percutaneous coronary intervention (PCI) is occasionally performed. METHODS: We examined the clinical, angiographic characteristics, and procedural outcomes of patients who underwent ad hoc CTO PCI in the Prospective Global Registry for the Study of CTO Intervention (PROGRESS-CTO, NCT02061436). RESULTS: Of the 10,998 patients included in the registry, 899 (8.2%) underwent ad hoc CTO PCI. The incidence of ad hoc CTO PCI decreased from 18% in 2016 to 3% in 2022. Ad hoc CTO PCI patients had a lower prevalence of comorbidities and less complex angiographic characteristics demonstrated by lower J-CTO score (1.9±1.2 vs 2.4±1.3, P < .001). In these patients, PROGRESS-CTO major adverse cardiovascular events (MACE) (1.9±1.4 vs 2.5±1.7), mortality (1.2±1.0 vs 1.6±1.1), and perforation (1.5±1.2±2.2 vs 1.5) scores were lower (P < .001). Technical success was similar between the groups (86%). MACE were lower in the ad hoc CTO PCI group (.8% vs 2.0%, P=.009). Ad hoc CTO PCI was not associated with MACE after adjusting for potential confounders, odds ratio: .69 (95% confidence interval, .30-1.57). In patients with higher J-CTO scores, planned CTO PCI was associated with higher technical success (P < .001). CONCLUSION: Approximately 8% of CTO PCI procedures are performed ad hoc, usually in less complex lesions and patients with lower complication risk. While ad hoc CTO PCI might be appropriate for carefully selected cases, a staged approach is recommended for most CTO PCI.
Subject(s)
Coronary Occlusion , Percutaneous Coronary Intervention , Humans , Treatment Outcome , Percutaneous Coronary Intervention/methods , Prospective Studies , Coronary Angiography/methods , Registries , Coronary Occlusion/diagnosis , Coronary Occlusion/epidemiology , Coronary Occlusion/surgery , Chronic Disease , Risk FactorsABSTRACT
The impact of a previous failure on procedural techniques and outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study. We examined the clinical and angiographic characteristics and procedural outcomes of 9,393 patients who underwent 9,560 CTO PCIs at 42 United States and non-United States centers between 2012 and 2022. A total of 1,904 CTO lesions (20%) had a previous failed PCI attempt. Patients who underwent reattempt CTO PCI were more likely to have a family history of coronary artery disease (37% vs 31%, p <0.001) and dyslipidemia (87.9% vs 84.3%, p <0.001) but were less likely to have heart failure (25.1% vs 29.5%; p <0.001) and cerebrovascular disease (8.7% vs 10.4%, p = 0.04). Patients with previous failure had a higher Japanese CTO (3.33 ± 1.16 vs 2.12 ± 1.19, p <0.001) score and required longer procedure (120 vs 111 minutes, p <0.001) and fluoroscopy (46.9 vs 40.4 minutes, p <0.001) times and higher air kerma radiation dose (2.3 vs 2.1 gray, p = 0.013). Technical success rates (84.3% vs 86.5%, p = 0.011) were lower in patients with a previous failure compared with patients who underwent first-attempt CTO PCI with no significant difference in in-hospital major adverse cardiac events. After adjusting for potential confounders, a previous failure was not associated with technical failure. Operators performing >30 CTO PCIs annually were more likely to achieve technical success in patients with previous failure. In conclusion, a previous failed CTO PCI attempt was associated with higher lesion complexity, longer procedure time, and lower technical success; however, the association with lower technical success did not remain significant in multivariable analysis.
Subject(s)
Coronary Occlusion , Percutaneous Coronary Intervention , Humans , Treatment Outcome , Risk Factors , Percutaneous Coronary Intervention/methods , Coronary Occlusion/diagnosis , Coronary Occlusion/surgery , Coronary Occlusion/etiology , Coronary Angiography/methods , Chronic Disease , RegistriesABSTRACT
BACKGROUND: There is limited information on the impact of the target vessel on the procedural techniques and outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). METHODS: We analyzed the baseline clinical and angiographic characteristics and procedural outcomes of 11,580 CTO PCIs performed between 2012 and 2022 at 44 centers. RESULTS: The most common CTO target vessel was the right coronary artery (RCA) (53.1%) followed by the left anterior descending artery (LAD) (26.0%) and the left circumflex artery (LCX) (19.8%). RCA CTOs were longer and more complex, with a higher Japanese CTO score compared with LAD or LCX CTOs. Technical success was higher among LAD (88.8%) lesions when compared with RCA (85.7%) or LCX (85.8%) lesions (P less than .001). The incidence of major adverse cardiovascular events (MACE) was overall 1.9% (n = 220) and was similar among target vessels (P=.916). There was a tendency toward more frequent utilization of the retrograde approach for more proximal occlusions in all 3 target vessels. When compared with all other RCA lesions combined, distal RCA lesions had higher technical success (87.7% vs 85.3%; P=.048). Technical success was similar between various locations of LAD CTOs (P=.704). First/second/third obtuse marginal branch had lower technical success when compared with all other LCX lesion locations (82.7% vs 86.8%; P=.014). There was no association between MACE and CTO location in all 3 target vessels. CONCLUSIONS: LAD CTO PCIs had higher technical and procedural success rates among target vessels. The incidence of MACE was similar among target vessels and among various locations within the target vessel.
Subject(s)
Percutaneous Coronary Intervention , Vascular Diseases , Humans , Percutaneous Coronary Intervention/adverse effects , Coronary Vessels/diagnostic imaging , Coronary Vessels/surgery , AngiographyABSTRACT
Chronic total occlusion (CTO) percutaneous coronary interventions (PCIs) can be lengthy procedures. We sought to investigate the effect of procedural time on CTO PCI outcomes. We examined the procedural time required for the various steps of CTO PCI in 6,442 CTO PCIs at 40 US and non-US centers between 2012 and 2022. The mean and median procedure times were 129 ± 76 and 112 minutes, respectively, with no significant change over time. The median times from access to wire insertion, guidewire manipulation time, and post crossing were 20, 32, and 53 minutes, respectively. Lesions crossed in <30 minutes were less complex, as reflected by lower Japanese CTO score (1.89 ± 1.19, p <0.001) than lesions that were not successfully crossed (2.88 ± 1.22) and lesions that were crossed in ≥30 minutes (2.85 ± 1.13). The likelihood of successful crossing if crossing was not achieved after 30, 90, and 180 minutes were a 76.7%, 60.7%, and 42.7%, respectively. The parameters independently associated with ≥30 minutes guidewire manipulation time in patients with a primary antegrade approach included left anterior descending target vessel, proximal cap ambiguity, blunt/no stump, occlusion length, previous failed attempt, medium/severe calcification, and medium/severe tortuosity. The mean duration of CTO PCI is approximately 2 hours (â¼20% of time for access to wire insertion, â¼30% wire manipulation time, and â¼50% postwiring time). Guidewire crossing time was shorter in less complex lesions and in cases without complications.
Subject(s)
Calcinosis , Coronary Occlusion , Percutaneous Coronary Intervention , Humans , Percutaneous Coronary Intervention/methods , Treatment Outcome , Coronary Occlusion/diagnosis , Coronary Occlusion/surgery , Time Factors , Chronic Disease , Coronary Angiography/methods , RegistriesABSTRACT
BACKGROUND: Death is a rare but devastating complication of chronic total occlusion (CTO) percutaneous coronary intervention. METHODS: We examined the clinical characteristics and procedural outcomes of patients who died periprocedurally in the Prospective Global Registry for the Study of CTO Interventions (PROGRESS-CTO). RESULTS: Of the 12 928 patients who underwent CTO percutaneous coronary intervention between 2012 and 2022, 52 (0.4%) died during the index hospitalization. Patients who died were more likely to have a history of heart failure (43% versus 28%; P=0.023). The J-CTO ([Multicenter CTO Registry of Japan]; 2.8±1.1 versus 2.4±1.3; P=0.019), PROGRESS-CTO mortality (2.6±0.9 versus 1.6±1.1; P<0.001), and PROGRESS-CTO pericardiocentesis (2.9±1.1 versus 1.9±1.3; P<0.001) scores were higher in patients who died. In these patients, the use of left ventricular assist devices was also higher (41% versus 3.5%; P<0.001), and retrograde crossing was more often the first crossing strategy (33% versus 13%; P<0.001). The cause of death was cardiac in 43 patients (83%) and noncardiac in 9 patients (17%). Complications leading to cardiac death were: tamponade in 30 patients (58%), acute myocardial infarction in 9 (17.3%), and cardiac arrest/shock in 4 (7.7%). Noncardiac causes of death were: stroke in 3 (5.8%), renal failure in 2 (3.8%), respiratory distress in 2 (3.8%), and hemorrhagic shock in 2 (3.8%). CONCLUSIONS: Approximately 0.4% of patients who underwent CTO percutaneous coronary intervention died during the index hospitalization. The main cause of death was tamponade in 58%. PROGRESS-CTO complication scores might help in risk stratification and procedural planning in patients undergoing CTO percutaneous coronary intervention. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique Identifier: NCT02061436.
Subject(s)
Coronary Occlusion , Percutaneous Coronary Intervention , Humans , Coronary Occlusion/diagnostic imaging , Coronary Occlusion/therapy , Coronary Occlusion/etiology , Prospective Studies , Treatment Outcome , Percutaneous Coronary Intervention/adverse effects , Registries , Chronic Disease , Risk Factors , Coronary AngiographyABSTRACT
BACKGROUND: Aortic coarctation in the adult is usually associated with chronic systemic hypertension, which leads to the sequelae of congestive heart failure, vascular dysfunction and decreased lifespan. Open and endovascular treatment modalities both provide excellent procedural outcomes with minimal mortality and morbidity, but a structured algorithm for workup and periprocedural decision making is not well established. We outline our heart team decision making approach along with our institution's experience treating this condition. METHODS: We retrospectively reviewed twenty-four consecutive adult patients treated for aortic coarctation since 2010 at a single center. Outcomes of interest included mortality, treatment approach, device used and post-procedure hypertension status. We describe our protocol for work-up and intervention decision making. We explain our rationale for recommending treatment and the approach, open or endovascular, using existing literature and our experience. RESULTS: Procedural success rate was 100%, and there were no 30-day, one-year or five-year mortalities, whether the approach was open or endovascular. At last contact, 32% of patients were normotensive and no longer taking blood pressure medications. Several patients presented with complex problems as a result of commonly described complications of prior open or endovascular repair, and we describe our approach to the management of these difficult cases. CONCLUSIONS: Even at a high-volume heart and vascular hospital, aortic coarctation is an uncommon presentation in adult patients. Our experience suggests that excellent outcomes are obtained by discussing each patient among a multidisciplinary heart team and developing a work-up and treatment protocol to guide selection of interventional modality.
ABSTRACT
BACKGROUND: Radial artery (RA) catheterization is the access of choice over femoral artery access for most interventional vascular procedures given its safety and faster patient recovery. There has been growing interest in distal radial artery (dRA) access as an alternative to the conventional proximal radial artery (pRA) access. Preserving the RA is important which serves as a potential conduit for future coronary artery bypass surgery, dialysis conduit or preserve the artery for future cardiovascular procedures. The dRA runs in close proximity to the radial nerve, which raises the concern of potential detrimental effects on hand function. STUDY DESIGN: The Distal versus Proximal Radial Artery Access for cardiac catheterization and intervention (DIPRA) trial is a prospective, randomized, parallel-controlled, open-label, single center study evaluating the outcomes of hand function and effectiveness of dRA compared to pRA access in patients undergoing cardiac catheterization. The eligible subjects will be randomized to dRA and pRA access in a (1:1) fashion. The primary end point is an evaluation of hand function at one and twelve months follow-up. Secondary end points include rates of access site hematoma, access site bleeding, other vascular access complications, arterial access success rate, and RA occlusion at one and twelve months follow up. CONCLUSION: Effects of dRA on hand function remains unknown and it's use questionable in the presence of a widely accepted pRA. DIPRA trial is designed to determine the safety and effectiveness of dRA for diagnostic and interventional cardiovascular procedures compared to the standard of care pRA.