Impact of Calcium Eccentricity on the Safety and Effectiveness of Coronary Intravascular Lithotripsy: Pooled Analysis From the Disrupt CAD Studies.

BACKGROUND: Coronary intravascular lithotripsy (IVL) safely facilitates successful stent implantation in severely calcified lesions. This analysis sought to determine the relative impact of lesion calcium eccentricity on the safety and effectiveness of IVL using high-resolution optical coherence tomography imaging. METHODS: Individual patient-level data (n=262) were pooled from 4 distinct international prospective studies (Disrupt CAD I, II, III, and IV) and analyzed by an independent optical coherence tomography core laboratory. IVL performance in eccentric versus concentric calcification was analyzed by dividing calcified lesions into quartiles (≤180° [most eccentric], 181°-270°, 271°-359°, and 360° [concentric]) by maximum continuous calcium arc. RESULTS: In the 230 patients with clear imaging field on optical coherence tomography, there were no differences in preprocedure minimum lumen area, diameter stenosis, or maximum calcium thickness. The calcium length and volume index increased progressively with increasing mean and maximum continuous calcium arc (ie, concentricity). Conversely, the minimum calcium thickness decreased progressively with increasing concentricity. Post-procedure, the number of calcium fractures, fracture depth, and fracture width increased with increasing concentricity, with a 4-fold increase in the number of fractures in lesions with 360° of calcium arc compared with ≤180°. This increase in IVL-induced calcium fracture with increasing calcium burden and concentricity facilitated stent expansion and luminal gain such that there were no significant differences across quartiles. CONCLUSIONS: IVL induced calcium fractures proportional to the magnitude of coronary artery calcium, including in eccentric calcium, leading to consistent improvements in stent expansion and luminal gain in both eccentric and concentric calcified coronary lesions.

Intravascular Imaging During Percutaneous Coronary Intervention: JACC State-of-the-Art Review.

Coronary angiography has historically served as the gold standard for diagnosis of coronary artery disease and guidance of percutaneous coronary intervention (PCI). Adjunctive use of contemporary intravascular imaging (IVI) technologies has emerged as a complement to conventional angiography-to further characterize plaque morphology and optimize the performance of PCI. IVI has utility for preintervention lesion and vessel assessment, periprocedural guidance of lesion preparation and stent deployment, and postintervention assessment of optimal endpoints and exclusion of complications. The role of IVI in reducing major adverse cardiac events in complex lesion subsets is emerging, and further studies evaluating broader use are underway or in development. This paper provides an overview of currently available IVI technologies, reviews data supporting their utilization for PCI guidance and optimization across a variety of lesion subsets, proposes best practices, and advocates for broader use of these technologies as a part of contemporary practice.

Intravascular Lithotripsy for Treatment of Calcified Coronary Artery Disease.

Intravascular lithotripsy (IVL) uses acoustic shock waves in a balloon-based delivery system to modify severely calcified atherosclerotic coronary vascular lesions in preparation for stent implantation. IVL results in circumferential and longitudinal calcium fracture, which improves transmural vessel compliance and facilitates subsequent stent expansion without requiring high-pressure balloon dilation. Clinical trials have demonstrated IVL to be safe (low rates of major adverse cardiac events in hospital and to 1 year; low rates of severe angiographic complications), effective (high rates of procedural success), and easy to use (little or no learning curve) when applied in the treatment of severely calcified coronary arteries.

Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions: Patient-Level Pooled Analysis of the Disrupt CAD Studies.

OBJECTIVES: The aim of this pooled analysis was to assess the cumulative safety and effectiveness of coronary intravascular lithotripsy (IVL). BACKGROUND: The clinical outcomes of IVL to optimize target lesion preparation in severely calcified de novo coronary stenoses have been examined in 4 prospective studies (Disrupt CAD I [NCT02650128], Disrupt CAD II [NCT03328949], Disrupt CAD III [NCT03595176], and Disrupt CAD IV [NCT04151628]). METHODS: Patient data were pooled from the Disrupt CAD studies, which shared uniform study criteria, endpoint definitions and adjudication, and procedural follow-up. The primary safety endpoint was freedom from major adverse cardiovascular events (composite of cardiac death, all myocardial infarction, or target vessel revascularization) at 30 days. The primary effectiveness endpoint was procedural success, defined as stent delivery with a residual stenosis ≤30% by quantitative coronary angiography without in-hospital major adverse cardiovascular events. Secondary outcomes included serious angiographic complications, target lesion failure, cardiac death, and stent thrombosis at 30 days. RESULTS: Between December 2015 and April 2020, 628 patients were enrolled at 72 sites from 12 countries. Presence of severe calcification was confirmed in 97.0% of target lesions with an average calcified segment length of 41.5 ± 20.0 mm. The primary safety and effectiveness endpoints were achieved in 92.7% and 92.4% of patients, respectively. At 30 days, the rates of target lesion failure, cardiac death, and stent thrombosis were 7.2%, 0.5%, and 0.8%. Rates of post-IVL and final serious angiographic complications were 2.1% and 0.3%, with no IVL-associated perforations, abrupt closure, or episodes of no reflow. CONCLUSIONS: In the largest cohort of patients treated with coronary IVL assessed to date, coronary IVL safely facilitated successful stent implantation in severely calcified coronary lesions with a high rate of procedural success.

Clinical and health status outcomes among patients treated with single as compared to multivessel angioplasty during chronic total occlusion percutaneous coronary interventions: a report from the OPEN CTO registry.

BACKGROUND: Patients with coronary chronic total occlusions (CTO) often have multivessel coronary artery disease. We utilized the OPEN CTO study to evaluate patients who underwent single-vessel versus multivessel percutaneous coronary intervention (PCI) during CTO PCI. METHODS: Patients were considered to have undergone single-vessel CTO PCI if they underwent target-vessel only CTO PCI. Patients who underwent multivessel PCI during their index CTO PCI procedure were considered to have undergone multivessel PCI. The additional lesions treated in the multivessel group could be either a separate CTO lesion in a separate epicardial vessel or PCI attempt of any non-CTO stenosis during the same index procedure. Multivariate regression models were used to evaluate predictors of technical success, in-hospital major adverse cardiac and cerebrovascular events (MACCE), and health status measures. RESULTS: Eighty hundred twenty-one patients underwent single-vessel CTO PCI and 179 (17.9%) underwent multivessel PCI during their CTO PCI procedure. Baseline comorbidities, index CTO lesion complexity, and successful crossing strategies used were similar between the two groups. Total procedural time (142.6 versus 115.9 minutes, P < 0.01) and contrast administered (293.8 versus 255.0 ml, P < 0.01) were increased in the multivessel CTO PCI group. Single-vessel versus multivessel PCI during these cases did not affect the likelihood of achieving technical success [odds ratio (OR) 1.05, 95% confidence interval (CI) 0.63-1.75] nor the risk for MACCE (OR 1.23, 95% CI 0.72-2.11). Quality of life (QOL) metrics were similar between the two groups at baseline and 30-day follow-up. CONCLUSION: There were no significant differences in technical success, in-hospital MACCE rates, or QOL metrics at 30-day follow-up for patients who underwent single-vessel versus multivessel PCI during CTO PCI.

Outcomes of retrograde chronic total occlusion percutaneous coronary intervention: A report from the OPEN-CTO registry.

OBJECTIVES: We sought to assess in-hospital and long-term outcomes of retrograde compared with antegrade-only percutaneous coronary intervention for chronic total occlusion (CTO PCI). BACKGROUND: Procedural and clinical outcomes following retrograde compared with antegrade-only CTO PCI remain unknown. METHODS: Using the core-lab adjudicated OPEN-CTO registry, we compared the outcomes of retrograde to antegrade-only CTO PCI. Primary endpoints included were in-hospital major adverse cardiac and cerebrovascular events (MACCE) (all-cause death, stroke, myocardial infarction [MI], emergency cardiac surgery, or clinically significant perforation) and MACCE at 1-year (all-cause death, MI, stroke, target lesion revascularization, or target vessel reocclusion). RESULTS: Among 885 single CTO procedures from the OPEN-CTO registry, 454 were retrograde and 431 were antegrade-only. Lesion complexity was higher (J-CTO score: 2.7 vs. 1.9; p < .001) and technical success lower (82.4 vs. 94.2%; p < .001) in retrograde compared with antegrade-only procedures. All-cause death was higher in the retrograde group in-hospital (2 vs. 0%; p = .003), but not at 1-year (4.9 vs. 3.3%; p = .29). Compared with antegrade-only procedures, in-hospital MACCE rates (composite of all-cause death, stroke, MI, emergency cardiac surgery, and clinically significant perforation) were higher in the retrograde group (10.8 vs. 3.3%; p < .001) and at 1-year (19.5 vs. 13.9%; p = .03). In sensitivity analyses landmarked at discharge, there was no difference in MACCE rates at 1 year following retrograde versus antegrade-only CTO PCI. Improvements in Seattle Angina Questionnaire Quality of Life scores at 1-year were similar between the retrograde and antegrade-only groups (29.9 vs 30.4; p = .58). CONCLUSIONS: In the OPEN-CTO registry, retrograde CTO procedures were associated with higher rates of in-hospital MACCE compared with antegrade-only; however, post-discharge outcomes, including quality of life improvements, were similar between technical modalities.

Prehospital use of a modified HEART Pathway and point-of-care troponin to predict cardiovascular events.

CLINICAL TRIAL REGISTRATION: clinicaltrials.gov (NCT02709135).

Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Artery Disease.

BACKGROUND: Coronary calcification hinders stent delivery and expansion and is associated with adverse outcomes. Intravascular lithotripsy (IVL) delivers acoustic pressure waves to modify calcium, enhancing vessel compliance and optimizing stent deployment. OBJECTIVES: The purpose of this study was to assess the safety and effectiveness of IVL in severely calcified de novo coronary lesions. METHODS: Disrupt CAD III (NCT03595176) was a prospective, single-arm multicenter study designed for regulatory approval of coronary IVL. The primary safety endpoint was freedom from major adverse cardiovascular events (cardiac death, myocardial infarction, or target vessel revascularization) at 30 days. The primary effectiveness endpoint was procedural success. Both endpoints were compared with a pre-specified performance goal (PG). The mechanism of calcium modification was assessed in an optical coherence tomography (OCT) substudy. RESULTS: Patients (n = 431) were enrolled at 47 sites in 4 countries. The primary safety endpoint of the 30-day freedom from major adverse cardiovascular events was 92.2%; the lower bound of the 95% confidence interval was 89.9%, which exceeded the PG of 84.4% (p < 0.0001). The primary effectiveness endpoint of procedural success was 92.4%; the lower bound of the 95% confidence interval was 90.2%, which exceeded the PG of 83.4% (p < 0.0001). Mean calcified segment length was 47.9 ± 18.8 mm, calcium angle was 292.5 ± 76.5°, and calcium thickness was 0.96 ± 0.25 mm at the site of maximum calcification. OCT demonstrated multiplane and longitudinal calcium fractures after IVL in 67.4% of lesions. Minimum stent area was 6.5 ± 2.1 mm2 and was similar regardless of demonstrable fractures on OCT. CONCLUSIONS: Coronary IVL safely and effectively facilitated stent implantation in severely calcified lesions.

Management of Percutaneous Coronary Intervention Complications: Algorithms From the 2018 and 2019 Seattle Percutaneous Coronary Intervention Complications Conference.

Complications of percutaneous coronary intervention (PCI) may have significant impact on patient survival and healthcare costs. PCI procedural complexity and patient risk are increasing, and operators must be prepared to recognize and treat complications, such as perforations, dissections, hemodynamic collapse, no-reflow, and entrapped equipment. Unfortunately, few resources exist to train operators in PCI complication management. Uncertainty regarding complication management could contribute to the undertreatment of patients with high-complexity coronary disease. We, therefore, coordinated the Learning From Complications: How to Be a Better Interventionalist courses to disseminate the collective experience of high-volume PCI operators with extensive experience in chronic total occlusion and high-risk PCI. From these conferences in 2018 and 2019, we developed algorithms that emphasize early recognition, effective treatment, and team-based care of PCI complications. We think that an algorithmic approach will result in a logical and systematic response to life-threatening complications. This construct may be useful for operators who plan to perform complex PCI procedures.

Point-of-Care Troponin Testing during Ambulance Transport to Detect Acute Myocardial Infarction.

Objective: Use of point-of-care (POC) troponin (cTn) testing in the Emergency Department (ED) is well established. However, data examining POC cTn measurement in the prehospital setting, during ambulance transport, are limited. The objective of this study was to prospectively test the performance of POC cTn measurement by paramedics to detect myocardial infarction (MI) among patients transported to the ED for acute chest pain. Methods: A prospective cohort study of adults with non-traumatic chest pain was conducted in three Emergency Medical Services agencies (December 2016 to January 2018). Patients with ST-elevation MI on ECG were excluded. During ambulance transport paramedics initiated intravenous access, collected blood, and used a POC device (i-STAT; Abbott Laboratories) to measure cTn. Following ED arrival, participants received standard evaluations including clinical blood draws for cTn measurement in the hospital central lab (AccuTnI +3 assay; Beckman Coulter, or cTnI-Ultra assay; Siemens). Blood collected during ambulance transport was also analyzed for cTn in the central lab. Index visit MI was adjudicated by 3 experts using central lab cTn measures from the patient's clinical blood draws. Test characteristics (sensitivity, specificity, and predictive values) for detection of MI were calculated for POC and central lab cTn measurement of prehospital blood and compared with McNemar's test. Results: During the study period prehospital POC cTn results were obtained on 421 patients, of which 5.0% (21/421) had results >99th percentile upper reference limit. MI was adjudicated in 16.2% (68/421) during the index visit. The specificity and positive predictive value of the POC cTn measurement were 99.2% (95% CI 97.5-99.8%) and 85.7% (95% CI 63.7-97.0%) for MI. However, the sensitivity and NPV of prehospital POC cTn were 26.5% (95% CI 16.5-38.6%) and 87.5% (95% CI 83.9-90.6%). Compared to POC cTn, the central lab cTn measurement of prehospital blood resulted in a higher sensitivity of 67.9% (95% CI 53.7-80.1%, p < 0.0001), but lower specificity of 92.4% (95% CI 88.4-95.4%, p = 0.0001). Conclusions: Prehospital POC i-STAT cTn measurement in patients transported with acute chest pain was highly specific for MI but had low sensitivity. This suggests that prehospital i-STAT POC cTn could be useful to rule-in MI, but should not be used to exclude MI.