Racial disparities in chronic total occlusion percutaneous coronary interventions: insights from the PROGRESS-CTO registry.

OBJECTIVES: There is limited data on race and outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). The authors sought to evaluate CTO PCI techniques and outcomes in different racial groups. METHODS: We examined the baseline characteristics and procedural outcomes of 11 806 CTO PCIs performed at 44 US and non-US centers between 2012 and March 2023. In-hospital major adverse cardiac events (MACE) included death, myocardial infarction, repeat target-vessel revascularization, pericardiocentesis, cardiac surgery, and stroke prior to discharge. RESULTS: The most common racial group was White (84.5%), followed by Black (5.7%), "Other" (3.9%), Hispanic (2.9%), Asian (2.4%), and Native American (0.7%). There were significant differences in the baseline characteristics between different racial groups. When compared with non-White patients, the retrograde approach and antegrade dissection re-entry were more likely to be the successful crossing strategies in White patients without any significant differences in technical success (86.4% vs 86.4%; P = .93), procedural success (84.8% vs 85.0%; P = .79), and in-hospital MACE (2.0% vs 1.5%; P = .15) between the 2 groups. The technical success rate was significantly higher in the "Other" racial group (91.0% vs 86.4% in White, 86.9% in Asian, 84.5% in Black, 84.5% in Hispanic, and 83.3% in Native American; P = .03) without any significant differences in procedural success or in-hospital MACE rates between the groups. CONCLUSIONS: Despite differences in baseline characteristics and procedural techniques, the procedural success and in-hospital MACE of CTO PCI were not significantly different between most racial groups.

The Retrograde Approach to Chronic Total Occlusion Percutaneous Coronary Interventions: Technical Analysis and Procedural Outcomes.

BACKGROUND: Retrograde chronic total occlusion (CTO) percutaneous coronary intervention (PCI) is associated with lower success and higher complication rates when compared with the antegrade approach. OBJECTIVES: This study sought to assess contemporary techniques and outcomes of retrograde CTO PCI. METHODS: We examined the baseline characteristics, procedural techniques and outcomes of 4,058 retrograde CTO PCIs performed at 44 centers between 2012 and 2023. Major adverse cardiac events (MACE) included any of the following in-hospital events: death, myocardial infarction, repeat target vessel revascularization, pericardiocentesis, cardiac surgery, and stroke. RESULTS: The average J-CTO (Multicenter CTO Registry in Japan) score was 3.1 ± 1.1. Retrograde crossing was successful in 60.5% and lesion crossing in 81.6% of cases. The collaterals pathways successfully used were septals in 62.0%, saphenous vein grafts in 17.4%, and epicardials in 19.1%. The technical and procedural success rates were 78.7% and 76.6%, respectively. When retrograde crossing failed, technical success was achieved in 50.3% of cases using the antegrade approach. In-hospital MACE was 3.5%. The clinical coronary perforation rate was 5.8%. The incidence of in-hospital MACE with retrograde true lumen crossing, just marker antegrade crossing, conventional reverse controlled antegrade and retrograde tracking (CART), contemporary reverse CART, extended reverse CART, guide-extension reverse CART, and CART was 2.1%, 0.8%, 5.5%, 3.0%, 2.1%, 3.2%, and 4.1%, respectively; P = 0.01). CONCLUSIONS: Retrograde CTO PCI is utilized in highly complex cases and yields moderate success rates with 5.8% perforation and 3.5% periprocedural MACE rates. Among retrograde crossing strategies, retrograde true lumen puncture was the safest. There is need for improvement of the efficacy and safety of retrograde CTO PCI.

Modulating pro-adhesive nature of metallic surfaces through a polypeptide coupling via diazonium chemistry.

The design of biomaterials able to facilitate cell adhesion is critical in the field of tissue engineering. Precise control of surface chemistry at the material/tissue interface plays a major role in enhancing the interactions between a biomaterial and living cells. Bio-integration is particularly important in case of various electrotherapies, since a close contact between tissue and electrode's surface facilitates treatment. A promising approach towards surface biofunctionalization involves the electrografting of diazonium salts followed by the modification of organic layer with pro-adhesive polypeptides. This study focuses on the modification of platinum electrodes with a 4-nitrobenzenediazonium layer, which is then converted to the aminobenzene moiety. The electrodes are further biofunctionalized with polypeptides (polylysine and polylysine/laminin) to enhance cell adhesion. This study also explores the differences between physical and chemical coupling of selected polypeptides to modulate pro-adhesive nature of Pt electrodes with respect to human neuroblastoma SH-SY5Y cells and U87 astrocytes. Our results demonstrate the significant enhancement in cell adhesion for biofunctionalized electrodes, with more amplified adhesion noted for covalently coupled polypeptides. The implications of this research are crucial for the development of more effective and functional biomaterials, particularly biomedical electrodes, which have the potential to advance the field of bioelectronics and improve patients' outcomes.

Surface grafting of poly-L-lysine via diazonium chemistry to enhance cell adhesion to biomedical electrodes.

The ability to study and regulate cell behavior at a biomaterial interface requires a strict control over its surface chemistry. Significance of studying cell adhesion in vitro and in vivo has become increasingly important, particularly in the field of tissue engineering and regenerative medicine. A promising surface modification route assumes using organic layers prepared by the method of electrografting of diazonium salts and their further functionalization with biologically active molecules as cell adhesion promoters. This work reports the modification of platinum electrodes with selected diazonium salts and poly-L-lysine to increase the number of sites available for cell adhesion. As-modified electrodes were characterized in terms of their chemical and morphological properties, as well as wettability. In order to monitor the process of cell attachment, biofunctionalized electrodes were used as substrates for culturing human neuroblastoma SH-SY5Y cells. The experiments revealed that cell adhesion is favored on the surface of diazonium-modified and poly-L-lysine coated electrodes, indicating proposed modification route as a valuable strategy enhancing the integration between bioelectronic devices and neural cells.

Angiographic Features and Clinical Outcomes of Balloon Uncrossable Lesions during Chronic Total Occlusion Percutaneous Coronary Intervention.

Background: Balloon uncrossable lesions are defined as lesions that cannot be crossed with a balloon after successful guidewire crossing. Methods: We analyzed the association between balloon uncrossable lesions and procedural outcomes of 8671 chronic total occlusions (CTOs) percutaneous coronary interventions (PCIs) performed between 2012 and 2022 at 41 centers. Results: The prevalence of balloon uncrossable lesions was 9.2%. The mean patient age was 64.2 ± 10 years and 80% were men. Patients with balloon uncrossable lesions were older (67.3 ± 9 vs. 63.9 ± 10, p < 0.001) and more likely to have prior coronary artery bypass graft surgery (40% vs. 25%, p < 0.001) and diabetes mellitus (50% vs. 42%, p < 0.001) compared with patients who had balloon crossable lesions. In-stent restenosis (23% vs. 16%. p < 0.001), moderate/severe calcification (68% vs. 40%, p < 0.001), and moderate/severe proximal vessel tortuosity (36% vs. 25%, p < 0.001) were more common in balloon uncrossable lesions. Procedure time (132 (90, 197) vs. 109 (71, 160) min, p < 0.001) was longer and the air kerma radiation dose (2.55 (1.41, 4.23) vs. 1.97 (1.10, 3.40) min, p < 0.001) was higher in balloon uncrossable lesions, while these lesions displayed lower technical (91% vs. 99%, p < 0.001) and procedural (88% vs. 96%, p < 0.001) success rates and higher major adverse cardiac event (MACE) rates (3.14% vs. 1.49%, p < 0.001). Several techniques were required for balloon uncrossable lesions. Conclusion: In a contemporary, multicenter registry, 9.2% of the successfully crossed CTOs were initially balloon uncrossable. Balloon uncrossable lesions exhibited lower technical and procedural success rates and a higher risk of complications compared with balloon crossable lesions.

Development of a Sustainable Tungsten and Iron Bimetal-Immobilized SBA-15 Composite for Enhanced Wet Catalytic Oxidation of Dye Capacity.

In this study, wet catalytic decomposition of Orange (II) dye was carried out with tungsten and iron bimetal-incorporated mesoporous SBA-15 (W-Fe@SBA-15) under visible light. The synthesized hybrid composite material was characterized by physicochemical methods, powder X-ray diffraction (PXRD) spectroscopy, scanning electron microscopy combined with energy-dispersive X-ray (SEM-EDX) spectroscopy studies, Fourier transform infrared (FT-IR) spectroscopy, transmission electron microscopy (TEM), atomic force microscopy (AFM), thermogravimetric analysis (TGA), and surface property studies to understand the nature of the dye degradation process and for catalytic studies. The maximum degradation of Orange (II) dye measured by a UV-visible spectrophotometer was 99% at a contaminant volume of 2.7 × 10-4 mol/L and a catalyst quantity of 2 g/L in 140 min reaction time. Using gas chromatography-mass spectrometry (GC-MS), the final products were chemically identified. The mechanistic steps of the process were carried out through a series of experiments. The recyclability of the catalyst added a novel feature for such a heterogeneous catalysis that can reduce secondary pollutants in water with no leaching effect observed.

Development of phimosis as an adverse drug reaction to capecitabine with irinotecan.

We present a case of a 32-year-old male who developed capecitabine-induced phimosis which resolved spontaneously without the need for circumcision within a few days of discontinuation of chemotherapy. The patient was on capecitabine with irinotecan chemotherapy for peritoneal metastasis from adenocarcinoma of the lower esophagus. A detailed literature review showed a few case reports with penile and scrotal erythema, ulceration, and swelling along with hand-foot syndrome, but none reported the occurrence of phimosis with spontaneous resolution.

Preprocedural coronary computed tomography angiography in chronic total occlusion percutaneous coronary intervention: Insights from the PROGRESS-CTO registry.

BACKGROUND: Preprocedural coronary computed tomography angiography (CCTA) can be useful in procedural planning for chronic total occlusion (CTO) percutaneous coronary intervention (PCI). METHODS: We examined the clinical, angiographic and procedural characteristics and outcomes of cases with vs. without preprocedural CCTA in PROGRESS-CTO (NCT02061436). Multivariable logistic regression was used to adjust for confounding factors. RESULTS: Of 7034 CTO PCI cases, preprocedural CCTA was used in 375 (5.3%) with increasing frequency over time. Patients with preprocedural CCTA had a higher prevalence of prior coronary artery bypass graft surgery (39% vs. 27%, p < 0.001) and angiographically unfavorable characteristics including higher prevalence of proximal cap ambiguity (52% vs. 33%, p < 0.001) and moderate/severe calcification (59% vs. 41%, p < 0.001) compared with those without CCTA. CCTA helped resolve proximal cap ambiguity in 27%, identified significant calcium not seen on diagnostic angiography in 18%, changed estimated CTO length by >5 mm in 10%, and was performed as part of initial coronary artery disease work up in 19%. CCTA cases had higher J-CTO (2.6 ± 1.2 vs. 2.3 ± 1.3, p < 0.001) and PROGRESS-CTO (1.3 ± 1.0 vs. 1.2 ± 1.0 p = 0.027) scores. After adjusting for potential confounders, cases with preprocedural CCTA had similar technical success (odds ratio [OR]: 1.18, 95% confidence interval [CI], 0.83-1.67) and incidence of major adverse cardiovascular events (OR: 1.47, 95% CI, 0.72-3.00). CONCLUSION: Preprocedural CCTA was used in ~5% of CTO PCI cases. While CCTA may help with procedural planning, especially in complex cases, technical success and MACE were similar with or without CCTA.

Prevalence and outcomes of balloon undilatable chronic total occlusions: Insights from the PROGRESS-CTO.

BACKGROUND: The prevalence, treatment, and outcomes of balloon undilatable lesions encountered in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) have received limited study. METHODS: We examined the clinical characteristics and procedural outcomes of balloon undilatable lesions in the Prospective Global Registry for the Study of CTO Intervention (PROGRESS-CTO, NCT02061436). RESULTS: Of 6535 CTO PCIs performed between 2012 and 2022, 558 (8.5%) lesions were balloon undilatable. In this subset, patients were older (mean age 67 ± 10 vs. 64 ± 10, p < 0.001) and had higher prevalence of comorbidities: diabetes mellitus (54% vs. 40%, p < 0.001), prior PCI (71% vs. 59%, p < 0.001), prior myocardial infarction (52% vs. 45%, p = 0.003), and prior coronary artery bypass graft surgery (44% vs. 25%, p < 0.001). The CTO lesion length was estimated to be 34 ± 23 mm, mean J-CTO score was 2.9 ± 1.1 and mean PROGRESS-CTO score was 1.4 ± 1.0. A cutting balloon was used in 27%, a scoring balloon in 15%, laser in 14%, rotational atherectomy in 28%, orbital atherectomy in 10%, intravascular lithotripsy in 1% and other modalities/approaches in 5%. Balloon undilatable lesions had lower technical success (90.9% vs. 93.8%, p = 0.007) and higher incidence of major adverse cardiovascular events (MACE) (composite of in-hospital death, acute myocardial infarction, stroke, re-PCI, emergency CABG, and pericardiocentesis) (5.0% versus 1.3%, p < 0.001). CONCLUSION: Approximately 1 in 12 CTO (8.5%) lesions are balloon undilatable. Treatment of balloon undilatable lesions is associated with lower technical success and higher in-hospital MACE.

Outcomes of chronic total occlusion percutaneous coronary intervention in patients with reduced left ventricular ejection fraction.

BACKGROUND: The relationship between left ventricular ejection fraction (LVEF) and the success and safety of coronary chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study. METHODS: We examined the clinical characteristics and outcomes of CTO PCI in the Prospective Global Registry for the Study of CTO Intervention (PROGRESS-CTO) after stratifying patients by LVEF (≤35%, 36%-49%, and ≥50%). RESULTS: A total of 7827 CTO PCI procedures with LVEF data were included. Mean age was 64 ± 10 years, 81% were men, 43% had diabetes mellitus, 61% had prior PCI, 45% had prior myocardial infarction, and 29% had prior coronary artery bypass graft surgery. Technical success was similar in the three LVEF strata: 85%, 86%, and 87%, p = 0.391 for LVEF ≤35%, 36%-49%, and ≥50%, respectively. In-hospital mortality was higher in lower LVEF patients (1.1%, 0.4%, and 0.3%, respectively, p = 0.001). In-hospital major adverse cardiovascular events (MACE) were numerically higher in lower EF patients (2.7%, 2.1%, and 1.9%, p = 0.271). At a median follow-up of 2 months (interquartile range: 19-350 days), patients with lower LVEF continued to have higher mortality (4.9%, 3.2%, and 1.4%, p < 0.001) while the MACE rates were similar (9.3%, 9.6%, and 7.4%, p = 0.172). CONCLUSION: CTO PCI can be performed with high technical success in patients with reduced LVEF but is associated with higher in-hospital and post-discharge mortality.

Distal Radial Access in Chronic Total Occlusion Percutaneous Coronary Intervention: Insights From the PROGRESS-CTO Registry.

BACKGROUND: The outcomes of distal radial access (dRA) in chronic total occlusion percutaneous coronary intervention (CTO-PCI) have received limited study. METHODS: We compared the clinical, angiographic, and procedural characteristics of 120 CTO-PCIs performed via dRA access with 2625 CTO-PCIs performed via proximal radial access (pRA) in a large, multicenter registry. RESULTS: The dRA group had lower mean PROGRESS-CTO score than the pRA group (1.0 ± 1 vs 1.2 ± 1, respectively; P=.05), while J-CTO score (2.4 ± 1.2 vs 2.3 ± 1.3; P=.43) and PROGRESS-CTO Complications score (2.8 ± 1.8 vs 2.6 ± 1.9; P=.16) were similar in the dRA vs pRA groups, respectively. Technical success was similar in the 2 groups (90% dRA vs 86% pRA; P=.14). Concomitant use of femoral access did not alter procedural success. The incidence of major periprocedural adverse cardiac events was similar in the 2 groups (0.8% dRA vs 2.4% pRA; P=.26), whereas the incidence of tamponade requiring pericardiocentesis was lower with dRA (0% dRA vs 4.69% pRA; P<.001), as was air kerma radiation dose (median, 1.7 Gy; interquartile range [IQR], 0.97-2.63 Gy in the dRA group vs median, 2.27 Gy; IQR, 1.2-3.9 Gy in the pRA group; P<.001). CONCLUSIONS: Use of dRA in CTO-PCI is associated with similar procedural success and risk of complications as compared with pRA.

Impact of Successful Chronic Total Occlusion Percutaneous Coronary Interventions on Subsequent Clinical Outcomes.

BACKGROUND: The impact of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) on angina and subsequent incidence of major adverse cardiovascular event (MACE) rate remains controversial. METHODS: We compared patient- reported angina change and the incidence of MACE (defined as death, myocardial infarction [MI], target-vessel revascularization) between successful vs failed CTO-PCI in 1612 patients participating in a large, multicenter registry. RESULTS: CTO-PCI was successful in 1387 patients (86%). Compared with failed CTO-PCI, successful CTO-PCI patients were less likely to have history of heart failure (33% vs 41%; P=.02), prior MI (49% vs 62%; P<.01), or prior coronary revascularization (63% vs 71% [P=.03] for PCI and 30% vs 40% [P<.01] for coronary artery bypass graft surgery). Patients in the successful CTO-PCI group had lower J-CTO scores (2.4 ± 1.3 vs 3.1 ± 1.1; P<.01) and lower PROGRESS-CTO Complications scores (1.1 ± 1.0 vs 1.6 ± 1.0; P<.01). After a mean follow-up of 181 ± 153 days, patients with successful PCI were more likely to have angina improvement (83% vs 38%; P<.01) and had lower incidence of 1-year MACE (8% vs 15%; P<.01), death (3% vs 7%; P<.01), and MI (2% vs 4%; P=.02). On multivariable analysis, however, CTO-PCI success was not independently associated with MACE. CONCLUSION: Compared with failed CTO-PCI, successful CTO-PCI is associated with better angina improvement and lower incidence of MACE (on univariable analysis) during follow-up.

Retrograde Chronic Total Occlusion Percutaneous Coronary Intervention via Saphenous Vein Graft.

OBJECTIVES: The aim of this study was to examine the use of saphenous vein grafts (SVGs) for retrograde crossing during chronic total occlusion (CTO) percutaneous coronary intervention (PCI). BACKGROUND: The use of SVGs for retrograde crossing during CTO PCI has received limited study. METHODS: A total of 1,615 retrograde CTO PCIs performed between 2012 and 2019 at 25 centers were examined. Clinical, angiographic, and technical characteristics and procedural outcomes were compared among retrograde cases via SVGs (SVG group) versus other collateral vessels (non-SVG group). RESULTS: Retrograde CTO PCI via SVGs was performed in 189 cases (12%). Patients in the SVG group were older (mean age 70 ± 9 years vs. 64 ± 10 years; p < 0.01) and had higher rates of prior myocardial infarction (62% vs. 51%; p < 0.01) and prior PCI (81% vs. 70%; p < 0.01). They were more likely to have moderate or severe calcification (81% vs. 65%; p < 0.01) and moderate or severe tortuosity (53% vs. 44%; p = 0.02) and had similar J-CTO (Multicenter CTO Registry in Japan) scores (3.2 ± 1.0 vs. 3.1 ± 1.1; p = 0.13) but higher PROGRESS-CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) scores (4.7 ± 1.7 vs. 3.1 ± 1.1; p < 0.01). Technical (85% vs. 78%; p = 0.04) and procedural (81% vs. 74%; p = 0.04) success rates were higher in the SVG group, with no difference in in-hospital major adverse events (6.4% vs. 4.4%; p = 0.22). Contrast volume was lower in the SVG group (225 ml [173 to 325 ml] vs. 292 ml [202 to 400 ml]; p < 0.01). CONCLUSIONS: Use of SVGs for retrograde crossing is associated with higher rates of technical and procedural success and similar rates of in-hospital major adverse cardiac events compared with retrograde CTO PCI via other collateral vessels.

Outcomes of subintimal plaque modification in chronic total occlusion percutaneous coronary intervention.

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.

Impact of concomitant treatment of non-chronic total occlusion lesions at the time of chronic total occlusion intervention.

BACKGROUND: During chronic total occlusion (CTO) percutaneous coronary intervention (PCI), sometimes non-CTO lesions are also treated. METHODS: We compared the clinical and procedural characteristics and outcomes of CTO PCIs with and without concomitant treatment of a non-CTO lesion in a contemporary multicenter CTO registry. RESULTS: Of the 3598 CTO PCIs performed at 21 centers between 2012 and 2018, 814 (23%) also included PCI of at least one non-CTO lesion. Patients in whom non-CTO lesions were treated were older (65 ±â€¯10 vs. 64 ±â€¯10 years, p = 0.03), more likely to present with an acute coronary syndrome (32% vs. 23%, p < 0.01), and less likely to undergo PCI of a right coronary artery (RCA) CTO (46% vs. 58%, p < 0.01). The most common non-CTO lesion location was the left anterior descending artery (31%), followed by the circumflex (29%) and the RCA (25%).Combined non-CTO and CTO-PCI procedures had similar technical (88% vs. 87%, p = 0.33) and procedural (85% vs. 85%, p = 0.74) success and major in-hospital complication rates (3.4% vs. 2.7%, p = 0.23), but had longer procedure duration (131 [88, 201] vs. 117 [75, 179] minutes, p < 0.01), higher patient air kerma radiation dose (3.0 [1.9, 4.8] vs. 2.8 [1.5, 4.6] Gray, p < 0.01) and larger contrast volume (300 [220, 380] vs. 250 [180, 350] ml, p < 0.01). CONCLUSIONS: Combined CTO PCI with PCI of non-CTO lesions is associated with similar success and major in-hospital complication rates compared with cases in which only CTOs were treated, but requires longer procedure duration and higher radiation dose and contrast volume.

Usefulness of Atherectomy in Chronic Total Occlusion Interventions (from the PROGRESS-CTO Registry).

There is limited data on the use of atherectomy during chronic total occlusion (CTO) percutaneous coronary intervention (PCI). We compared the clinical and procedural characteristics and outcomes of CTO PCIs performed with or without atherectomy in a contemporary multicenter CTO PCI registry. Between 2012 and 2018, 3,607 CTO PCIs were performed at 21 participating centers. Atherectomy was used in 117 (3.2%) cases: rotational atherectomy in 105 cases, orbital atherectomy in 8, and both in 4 cases. Patients in whom atherectomy was used, were older (68 ± 8 vs 64 ± 10 years, p <0.0001) and had higher Japan-chronic total occlusion score (3.0 ± 1.2 vs 2.4 ± 1.3, p <0.0001). CTO PCI cases in which atherectomy was used had similar technical (91% vs 87%, p = 0.240) and procedural (90% vs 85%, p = 0.159) success and in-hospital major adverse cardiac event (4% vs 3%, p = 0.382) rates. However, atherectomy cases were associated with higher rates of donor vessel injury (4% vs 1%, p = 0.031), tamponade requiring pericardiocentesis (2.6% vs 0.4%, p = 0.012) and more often required use of a left ventricular assist device (9% vs 5%, p = 0.031). Atherectomy cases were associated with longer procedural duration (196 [141, 247] vs 119 [76, 180] minutes, p <0.0001), and higher patient air kerma radiation dose (3.6 [2.5, 5.6] vs 2.8 [1.6, 4.7] Gray, p = 0.001). In conclusion, atherectomy is currently performed in approximately 3% of CTO PCI cases and is associated with similar technical and procedural success and overall major adverse cardiac event rates, but higher risk for donor vessel injury and tamponade.

Procedural Outcomes of Percutaneous Coronary Interventions for Chronic Total Occlusions Via the Radial Approach: Insights From an International Chronic Total Occlusion Registry.

OBJECTIVES: This study examined the frequency and outcomes of radial access for chronic total occlusion (CTO) percutaneous coronary intervention (PCI). BACKGROUND: Radial access improves the safety of PCI, but its role in CTO PCI remains controversial. METHODS: We compared the clinical, angiographic, and procedural characteristics of 3,790 CTO interventions performed between 2012 and 2018 via radial-only access (RA) (n = 747) radial-femoral access (RFA) (n = 844) and femoral-only access (n = 2,199) access at 23 centers in the United States, Europe, and Russia. RESULTS: Patients' mean age was 65 ± 10 years, and 85% were men. Transradial access (RA and RFA) was used in 42% of CTO interventions and significantly increased over time from 11% in 2012 to 67% in 2018 (p < 0.001). RA patients were younger (age 62 ± 10 years vs. 64 ± 10 years and 65 ± 10 years; p < 0.001), less likely to have undergone prior coronary artery bypass graft surgery (18% vs. 39% and 35%; p < 0.001), and less likely to have undergone prior PCI (60% vs. 63% and 66%; p = 0.005) compared with those who underwent RFA and femoral-only access PCI. RA CTO PCI lesions had lower J-CTO (Multicenter CTO Registry in Japan) (2.1 ± 1.4 vs. 2.6 ± 1.3 and 2.5 ± 1.3; p < 0.001) and PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) complication (2.3 ± 1.9 vs. 3.2 ± 2.0 and 3.2 ± 1.9; p < 0.001) scores. The mean sheath size was significantly smaller in the RA group (6.6 ± 0.7 vs. 7.0 ± 0.6 and 7.3 ± 0.8; p < 0.0001), although it increased with lesion complexity. Antegrade dissection re-entry (20% vs. 33% and 32%; p < 0.001) was less commonly used with RA, whereas use of retrograde techniques was highest with RFA (47%). The overall rates of technical success (89% vs. 88% vs. 86%; p = 0.061), procedural success (86% vs. 85% vs. 85%; p = 0.528), and in-hospital major complication (2.47% vs. 3.40% vs. 2.18%; p = 0.830) were similar in all 3 groups, whereas major bleeding was lower in the RA group (0.55% vs. 1.94% and 0.88%; p = 0.013). CONCLUSIONS: Transradial access is increasingly being used for CTO PCI and is associated with similar technical and procedural success and lower major bleeding rates compared with femoral-only access interventions. (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention [PROGRESS CTO]; NCT02061436).

Efficacy and Safety Results of the Afatinib Expanded Access Program.

INTRODUCTION: Afatinib is an oral, irreversible ErbB family blocker approved for first-line treatment of metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). The expanded access program (EAP) allowed early access to afatinib and provided additional data on its safety, tolerability, and efficacy. METHODS: The afatinib EAP was an open-label, multicenter, single-arm program in the United States that treated and followed patients with locally advanced or metastatic NSCLC harboring EGFR mutations. Afatinib 40 mg was administered orally once daily until discontinuation due to disease progression, adverse events (AEs), or transition to commercially available drug. RESULTS: Three hundred twenty-two patients received ≥1 dose of afatinib. Most patients had received prior therapies. Drug-related AEs occurred in 89.4% of patients, including 7.8% with serious AEs. The most common afatinib-related AEs (all grades) were diarrhea (77.0%) and rash (36.0%). Dose reductions occurred in 31.1% of patients. Discontinuation rates due to diarrhea (1.6%) or rash/acne (0.3%) were low. Efficacy data were collected and analyzed when available, with 17.1% and 69.9% of patients achieving objective response and disease control, respectively, in this highly pretreated population. CONCLUSIONS: No additional or unexpected safety concerns were revealed, and afatinib demonstrated antitumor activity in a heavily pretreated NSCLC patient population in a routine clinical setting. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01649284. FUNDING: Boehringer Ingelheim Pharmaceuticals, Inc.

Intensity modulated radiation therapy with simultaneous integrated boost based dose escalation on neoadjuvant chemoradiation therapy for locally advanced distal esophageal adenocarcinoma.

AIM: To evaluate impact of radiation therapy dose escalation through intensity modulated radiation therapy with simultaneous integrated boost (IMRT-SIB). METHODS: We retrospectively reviewed the patients who underwent four-dimensional-based IMRT-SIB-based neoadjuvant chemoradiation protocol. During the concurrent chemoradiation therapy, radiation therapy was through IMRT-SIB delivered in 28 consecutive daily fractions with total radiation doses of 56 Gy to tumor and 5040 Gy dose-painted to clinical tumor volume, with a regimen at the discretion of the treating medical oncologist. This was followed by surgical tumor resection. We analyzed pathological completion response (pCR) rates its relationship with overall survival and event-free survival. RESULTS: Seventeen patients underwent dose escalation with the IMRT-SIB protocol between 2007 and 2014 and their records were available for analysis. Among the IMRT-SIB-treated patients, the toxicity appeared mild, the most common side effects were grade 1-3 esophagitis (46%) and pneumonitis (11.7%). There were no cardiac events. The Ro resection rate was 94% (n = 16), the pCR rate was 47% (n = 8), and the postoperative morbidity was zero. There was one mediastinal failure found, one patient had local failure at the anastomosis site, and the majority of failures were distant in the lung or bone. The 3-year disease-free survival and overall survival rates were 41% (n = 7) and 53% (n = 9), respectively. CONCLUSION: The dose escalation through IMRT-SIB in the chemoradiation regimen seems responsible for down-staging the distal esophageal with well-tolerated complications.

Early safety and efficacy of percutaneous left atrial appendage suture ligation: results from the U.S. transcatheter LAA ligation consortium.

BACKGROUND: Transcatheter left atrial appendage (LAA) ligation may represent an alternative to oral anticoagulation for stroke prevention in atrial fibrillation. OBJECTIVES: This study sought to assess the early safety and efficacy of transcatheter ligation of the LAA for stroke prevention in atrial fibrillation. METHODS: This was a retrospective, multicenter study of consecutive patients undergoing LAA ligation with the Lariat device at 8 U.S. sites. The primary endpoint was procedural success, defined as device success (suture deployment and <5 mm leak by post-procedure transesophageal echocardiography), and no major complication at discharge (death, myocardial infarction, stroke, Bleeding Academic Research Consortium bleeding type 3 or greater, or cardiac surgery). Post-discharge management was per operator discretion. RESULTS: A total of 154 patients were enrolled. Median CHADS2 score (congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke, transient ischemic attack, or thromboembolism [doubled]) was 3 (interquartile range: 2 to 4). Device success was 94%, and procedural success was 86%. A major complication occurred in 15 patients (9.7%). There were 14 major bleeds (9.1%), driven by the need for transfusion (4.5%). Significant pericardial effusion occurred in 16 patients (10.4%). Follow-up was available in 134 patients at a median of 112 days (interquartile range: 50 to 270 days): Death, myocardial infarction, or stroke occurred in 4 patients (2.9%). Among 63 patients with acute closure and transesophageal echocardiography follow-up, there were 3 thrombi (4.8%) and 13 (20%) with residual leak. CONCLUSIONS: In this initial multicenter experience of LAA ligation with the Lariat device, the rate of acute closure was high, but procedural success was limited by bleeding. A prospective randomized trial is required to adequately define clinical efficacy, optimal post-procedure medical therapy, and the effect of operator experience on procedural safety.