Intravascular lithotripsy compared to rotational atherectomy for the treatment of calcified distal left main coronary artery disease: A single center experience.

BACKGROUND: The safety and efficacy of intravascular lithotripsy (IVL) for the treatment of calcified distal left main (LM) disease remains unclear, especially compared to rotational atherectomy (RA). METHODS: We retrospectively analyzed the baseline clinical, angiographic, intravascular ultrasound (IVUS) characteristics and procedural outcomes of 107 patients who underwent distal LM percutaneous coronary intervention (PCI) with IVL (with or without adjunct atherectomy) versus RA alone for plaque modification before stenting at a single center between 2020 and 2022. RESULTS: A total of 50 patients underwent calcium modification with IVL with or without adjunct atherectomy and 57 with RA only. The mean age was 73 years and with a high prevalence of diabetes (58.9%), chronic kidney disease (42.1%), prior revascularization (coronary artery bypass graft surgery [36.4%] or prior PCI [32.7%]). Acute coronary syndrome was the primary indication for PCI in over 50% of the patients in both groups. Medina 1-1-1 LM bifurcation disease was identified in 64% and 60% of the IVL and RA groups (p = 0.64) respectively. Final minimum stent area in distal LM (>8.2 mm2 ), ostial LAD (>6.3 mm2 ) and ostial LCX (>5.0 mm2 ) were achieved in 96%, 85% and 89% of cases treated with IVL respectively and 93%, 93% and 100% of cases treated with RA respectively (LM p = 1.00; LAD p = 0.62; LCX; p = 1.00 for difference between the two groups). Procedural success (technical success without in-hospital major adverse events) was achieved in 98% of the IVL group and 86% of the RA-only group (p = 0.04). There were eight procedural complications (flow-limiting dissection, perforation, or slow/no-reflow) in the RA group compared to four in the IVL group (NS), and one patient in the RA required salvaged mechanical support compared to none in the IVL group. CONCLUSION: Plaque modification with coronary IVL appears to be efficacious and safe for the treatment of severely calcified distal LM lesions compared to RA only. Larger randomized studies are needed to confirm these findings.

Impact of Active and Historical Cancers on the Management and Outcomes of Acute Myocardial Infarction Complicating Cardiogenic Shock.

BACKGROUND: There are limited data on the outcomes of acute myocardial infarction-cardiogenic shock (AMI-CS) in patients with concomitant cancer. METHODS: A retrospective cohort of adult AMI-CS admissions was identified from the National Inpatient Sample (2000-2017) and stratified by active cancer, historical cancer, and no cancer. Outcomes of interest included in-hospital mortality, use of coronary angiography, use of percutaneous coronary intervention, do-not-resuscitate status, palliative care use, hospitalization costs, and hospital length of stay. RESULTS: Of the 557,974 AMI-CS admissions during this 18-year period, active and historical cancers were noted in 14,826 (2.6%) and 27,073 (4.8%), respectively. From 2000 to 2017, there was a decline in active cancers (adjusted odds ratio, 0.70 [95% CI, 0.63-0.79]; P < .001) and an increase in historical cancer (adjusted odds ratio, 2.06 [95% CI, 1.89-2.25]; P < .001). Compared with patients with no cancer, patients with active and historical cancer received less-frequent coronary angiography (57%, 67%, and 70%, respectively) and percutaneous coronary intervention (40%, 47%, and 49%%, respectively) and had higher do-not-resuscitate status (13%, 15%, 7%%, respectively) and palliative care use (12%, 10%, 6%%, respectively) (P < .001). Compared with those without cancer, higher in-hospital mortality was found in admissions with active cancer (45.9% vs 37.0%; adjusted odds ratio, 1.29 [95% CI, 1.24-1.34]; P < .001) but not historical cancer (40.1% vs 37.0%; adjusted odds ratio, 1.01 [95% CI, 0.98-1.04]; P = .39). AMI-CS admissions with cancer had a shorter hospitalization duration and lower costs (all P < .001). CONCLUSION: Concomitant cancer was associated with less use of guideline-directed procedures. Active, but not historical, cancer was associated with higher mortality in patients with AMI-CS.

Temporal Trends, Predictors and Outcomes of Inpatient Palliative Care Use in Cardiac Arrest Complicating Acute Myocardial Infarction.

BACKGROUND: Utilization of inpatient palliative care services (PCS) has been infrequently studied in patients with cardiac arrest complicating acute myocardial infarction (AMI-CA). METHODS: Adult AMI-CA admissions were identified from the National Inpatient Sample (2000-2017). Outcomes of interest included temporal trends and predictors of PCS use and in-hospital mortality, length of stay, hospitalization costs and discharge disposition in AMI-CA admissions with and without PCS use. Multivariable logistic regression and propensity matching were used to adjust for confounding. RESULTS: Among 584,263 AMI-CA admissions, 26,919 (4.6%) received inpatient PCS. From 2000 to 2017 PCS use increased from <1% to 11.5%. AMI-CA admissions that received PCS were on average older, had greater comorbidity, higher rates of cardiogenic shock, acute organ failure, lower rates of coronary angiography (48.6% vs 63.3%), percutaneous coronary intervention (37.4% vs 46.9%), and coronary artery bypass grafting (all p < 0.001). Older age, greater comorbidity burden and acute non-cardiac organ failure were predictive of PCS use. In-hospital mortality was significantly higher in the PCS cohort (multivariable logistic regression: 84.6% vs 42.9%, adjusted odds ratio 3.62 [95% CI 3.48-3.76]; propensity-matched analysis: 84.7% vs. 66.2%, p < 0.001). The PCS cohort received a do- not-resuscitate status more often (47.6% vs. 3.7%), had shorter hospital stays (4 vs 5 days), and were discharged more frequently to skilled nursing facilities (73.6% vs. 20.4%); all p < 0.001. These results were consistent in the propensity-matched analysis. CONCLUSIONS: Despite an increase in PCS use in AMI-CA, it remains significantly underutilized highlighting the role for further integrating of these specialists in AMI-CA care.

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.

Impact of body mass index on outcome and health status after chronic total occlusion percutaneous coronary intervention: Insights from the OPEN-CTO study.

BACKGROUND: The effect of body mass index (BMI) on the procedural outcomes and health status (HS) change after chronic total occlusion (CTO) percutaneous coronary intervention (PCI) is largely unknown. METHODS: Thousand consecutive patients enrolled in a 12-center prospective CTO PCI study (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion Hybrid Procedures [OPEN-CTO]) were categorized into three groups by baseline BMI (obese ≥30, overweight 25-30, and normal 18.5-25), after excluding seven patients with BMI <18.5. Baseline and follow-up HS at 1 year were quantified using the Seattle Angina Questionnaire, Rose Dyspnea Score, and Personal Health Questionnaire-8 (PHQ-8). Hierarchical, multivariable logistic, and repeated measures linear regression models were used to assess procedural success, major adverse cardiovascular and cerebrovascular events (MACCE), and HS outcomes, as appropriate. RESULTS: The obese and overweight were 47.6% and 37.4%, respectively. While procedure time and contrast dose were similar among the groups, total radiation dose (mGy) was higher with increased BMI (3,019 ± 2,027, 2,267 ± 1,714, 1,642 ± 1,223, p < .01). Procedural success rates, as well as MACCE rates, were similar among the three groups (obese 83.1%, overweight 79.8%, normal 81.9%, p = .47 and 5.1, 8.4, and 8.7%, p = .11). These rates remained similar after adjustment for baseline characteristics. The HS improvement from baseline to 12 months after adjustment was similar in obese and overweight patients compared to normal weight patients. CONCLUSIONS: CTO PCI in obese and overweight patients can be performed with similar success and complication rates. Obese and overweight patients derive similar HS benefit from CTO PCI compared to normal weight patients.

Outcomes of Chronic Total Occlusion Percutaneous Coronary Intervention in Patients With Renal Dysfunction.

Although contemporary chronic total occlusion (CTO) percutaneous coronary intervention (PCI) is performed with high success rates, 10% to 13% of patients presenting with CTOs have chronic kidney disease (CKD), and the comparative safety, efficacy, and health status benefit of CTO PCI in these patients, has not been well defined. We examined the association of baseline renal function with periprocedural major adverse cardiovascular and cerebral events and health status outcomes in 957 consecutive patients (mean age 65.3 ± 10.3 years, 19.4% women, 90.3% white, 23.6 CKD [estimated glomerular filtration rate {eGFR} < 60]) in the OPEN-CTO (Outcomes, Patients Health Status, and Efficiency in Chronic Total Occlusions Registry) study. Hierarchical multivariable regression models were used to examine the independent association of baseline eGFR with technical success, periprocedural complications and change in health status, using Seattle Angina Questionnaire (SAQ) over 1 year. Crude rates of acute kidney injury were higher (13.5% vs 4.4%, p <0.001) and technical success lower (81.8% vs 88.4%, p = 0.01) in patients with CKD. There were no significant differences in other periprocedural complications. After adjustment for confounding factors, there was no significant association of baseline eGFR with technical success or periprocedural major adverse cardiovascular and cerebral events (death, myocardial infarction, emergent bypass surgery, stroke, perforation), whereas patients with lower eGFR had higher rates of acute kidney injury. The difference in SAQ summary score, between patients on the 10th and 90th percentile for baseline eGFR distribution was not clinically significant (1 month: -0.91; 1 year: -3.06 points). In conclusion, CTO PCI success, complication rates, and the health status improvement after CTO PCI are similar in patients across a range of baseline eGFRs.

Initial report of safety and procedure duration of robotic-assisted chronic total occlusion coronary intervention.

BACKGROUND: No previous reports have examined the impact of robotic-assisted (RA) chronic total occlusion (CTO) PCI on procedural duration or safety compared to totally manual CTO PCI. METHODS: Among 95 patients who underwent successful PCI of a single CTO lesion at two centers, 49 (52%) were performed RA and were performed 46 (48%) totally manually. Cockpit time was the time the primary operator entered to robotic cockpit until the procedure was complete. "Theoretical" cockpit time in the control group was time the primary operator would have entered the cockpit after lesion crossing until the procedure was complete. Major adverse events (MAEs) were the composite of death, myocardial infarction, clinical perforation, significant vessel dissection, arrhythmia, acute thrombosis, and stroke. RESULTS: The lesion characteristics, procedural time, and contrast dose were similar. All procedures except for one (2%) selected for robotic completion after lesion crossing were completed successfully. The frequency of MAE was similar between groups and there were no in-hospital deaths. The cockpit time was 8 min longer in RA CTO PCI than the theoretical cockpit time in totally manual CTO PCI (40.6 ± 12.7 vs. 32.1 ± 17.8, p < .01). CONCLUSION: RA CTO PCI was not associated with excess adverse events compared with totally manual CTO PCI and resulted in an average 41 min cockpit time equaling to 48% of procedure time without radiation exposure or requirement for the primary operator to wear a lead apron. Understanding the relationship between cockpit time and reductions in radiation exposure and lead apron-related orthopedic complications for operators requires future study.

Late-term safety and effectiveness of everolimus-eluting stents in chronic total coronary occlusion revascularization: Final 4-year results from the evaluation of the XIENCE coronary stent, Performance, and Technique in Chronic Total Occlusions (EXPERT CTO) multicenter trial.

BACKGROUND: Limited study has detailed the late-term safety and efficacy of chronic total coronary occlusion (CTO) revascularization among multiple centers applying modern techniques and with newer-generation drug-eluting stents. METHODS: Among 20 centers, 222 patients enrolled in the XIENCE coronary stent, performance, and technique (EXPERT) CTO trial underwent CTO percutaneous coronary intervention (PCI) with everolimus-eluting stents (EES). Through planned 4-year follow-up, the primary composite endpoint of major adverse cardiac events (MACE; death, myocardial infarction [MI] and target lesion revascularization) and rates of individual component endpoints and stent thrombosis were determined. RESULTS: Demographic, lesion, and procedural characteristics included prior bypass surgery, 9.9%; diabetes, 40.1%; lesion length, 36.1 ± 18.5 mm; and stent length, 51.7 ± 27.2 mm. By 4 years, MACE rates were 31.6 and 22.4% by the pre-specified ARC and per-protocol definitions, respectively. Clinically-indicated target lesion revascularization at 4 years was 11.3%. In landmark analyses of events beyond the first year of revascularization, the annualized rates of target vessel-related MI and clinically-indicated target lesion revascularization were 0.53 and 1.3%, respectively. Through 4 years, the cumulative definite/probable stent thrombosis rate was 1.7% with no events occurring beyond the initial year of index revascularization. CONCLUSIONS: In a multicenter registration trial representing contemporary technique and EES, these results demonstrate sustained long-term safety and effectiveness of EES in CTO percutaneous revascularization and can be used to inform shared decision making with patients being considered for CTO PCI relative to late safety and vessel patency.

Patient Characteristics Associated With Antianginal Medication Escalation and De-Escalation Following Chronic Total Occlusion Percutaneous Coronary Intervention.

Background Prior research has shown that providers may infrequently adjust antianginal medications (AAMs) following chronic total occlusion (CTO) percutaneous coronary intervention (PCI). Patient characteristics associated with AAM titration and the variation in postprocedure AAM management after CTO PCI across hospitals have not been reported. We sought to determine the frequency and potential correlates of AAM escalation and de-escalation after CTO PCI. Methods and Results Using the 12-center OPEN CTO registry (Outcomes, Patient Health Status, and Efficiency iN Chronic Total Occlusion Hybrid Procedures), we assessed AAM use at baseline and 6 months after CTO PCI. Escalation was defined as any addition of a new class of AAM or dose increase, whereas de-escalation was defined as a reduction in the number of AAMs or dose reduction. Angina was assessed 6 months after the index CTO PCI attempt using the Seattle Angina Questionnaire Angina Frequency domain. Potential correlates of AAM escalation (vs no change) or de-escalation (vs no change) were evaluated using multivariable modified Poisson regression models. Adjusted variation across sites was evaluated using median rate ratios. AAMs were escalated in 158 (17.5%), de-escalated in 351 (39.0%), and were unchanged at 6-month follow-up in 392 (43.5%). Patient characteristics associated with escalation included lung disease, ongoing angina, and periprocedural major adverse cardiac and cerebral events (periprocedural myocardial infarction, stroke, death, emergent cardiac surgery, or clinically significant perforation), whereas de-escalation was more frequent among patients taking more AAMs, those treated with complete revascularization, and after treatment of non-CTO lesions at the time of the index procedure. There was minimal variation in either escalation (median rate ratio, 1.11; P=0.36) or de-escalation (median rate ratio, 1.10; P=0.20) compared to no change of AAMs across sites. Conclusions Escalation or de-escalation of AAMs was less common than continuation following CTO PCI, with little variation across sites. Further research is needed to identify patients who may benefit from AAM titration after CTO PCI and develop strategies to adjust these medications in follow-up. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT02026466.

De-escalation of antianginal medications after successful chronic total occlusion percutaneous coronary intervention: Frequency and relationship with health status.

BACKGROUND: Successful chronic total occlusion (CTO) percutaneous coronary intervention (PCI) can markedly reduce angina symptom burden, but many patients often remain on multiple antianginal medications (AAMs) after the procedure. It is unclear when, or if, AAMs can be de-escalated to prevent adverse effects or limit polypharmacy. We examined the association of de-escalation of AAMs after CTO PCI with long-term health status. METHODS: In a 12-center registry of consecutive CTO PCI patients, health status was assessed at 6 months after successful CTO PCI with the Seattle Angina Questionnaire and the Rose Dyspnea Scale. Among patients with technical CTO PCI success, we examined the association of AAM de-escalation with 6-month health status using multivariable models adjusting for revascularization completeness and predicted risk of post-PCI angina (using a validated risk model). We also examined predictors and variability of AAMs de-escalation. RESULTS: Of 669 patients with technical success of CTO PCI, AAMs were de-escalated in 276 (35.9%) patients at 1 month. Patients with AAM de-escalation reported similar angina and dyspnea rates at 6 months compared with those whose AAMs were reduced (any angina: 22.5% vs 20%, P = .43; any dyspnea: 51.8% vs 50.1%, P = .40). In a multivariable model adjusting for complete revascularization and predicted risk of post-PCI angina, de-escalation of AAMs at 1 month was not associated with an increased risk of angina, dyspnea, or worse health status at 6 months. CONCLUSIONS: Among patients with successful CTO PCI, de-escalation of AAMs occurred in about one-third of patients at 1 month and was not associated with worse long-term health status.

Randomized Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusions: The CrossBoss First Trial.

OBJECTIVES: The authors performed a multicenter, randomized-controlled, clinical trial comparing upfront use of the CrossBoss catheter versus antegrade wire escalation for antegrade crossing of coronary chronic total occlusions. BACKGROUND: There is equipoise about the optimal initial strategy for crossing coronary chronic total occlusions. METHODS: The primary endpoints were the time required to cross the chronic total occlusion or abort the procedure and the frequency of procedural major adverse cardiovascular events. The secondary endpoints were technical and procedural success, total procedure time, fluoroscopy time required to cross and total fluoroscopy time, total air kerma radiation dose, total contrast volume, and equipment use. RESULTS: Between 2015 and 2017, 246 patients were randomized to the CrossBoss catheter (n = 122) or wire escalation (n = 124) at 11 U.S. centers. The baseline clinical and angiographic characteristics of the study groups were similar. Technical and procedural success were 87.8% and 84.1%, respectively, and were similar in the 2 groups. Crossing time was similar: 56 min (interquartile range: 33 to 93 min) in the CrossBoss group and 66 min (interquartile range: 36 to 105 min) in the wire escalation group (p = 0.323), as was as the incidence of procedural major adverse cardiovascular events (3.28% vs. 4.03%; p = 1.000). There were no significant differences in the secondary study endpoints. CONCLUSIONS: As compared with wire escalation, upfront use of the CrossBoss catheter for antegrade crossing of coronary chronic total occlusions was associated with similar crossing time, similar success and complication rates, and similar equipment use and cost.

Safety and Effectiveness of Everolimus-Eluting Stents in Chronic Total Coronary Occlusion Revascularization: Results From the EXPERT CTO Multicenter Trial (Evaluation of the XIENCE Coronary Stent, Performance, and Technique in Chronic Total Occlusions).

OBJECTIVES: This study sought to evaluate procedural and clinical outcomes among patients undergoing chronic total occlusion (CTO) percutaneous coronary intervention (PCI) using contemporary methods and everolimus-eluting stents (EES). BACKGROUND: Limited studies have detailed the procedural and late-term safety and efficacy of CTO revascularization among multiple centers applying modern techniques and with newer-generation drug-eluting stents. METHODS: Among 20 centers, 250 consecutive patients were enrolled for attempted CTO PCI. Procedural and in-hospital clinical outcomes were examined in addition to the 1-year primary endpoint of death, myocardial infarction, and target lesion revascularization (major adverse cardiac events [MACE]). RESULTS: Demographic, lesion, and procedural characteristics included prior bypass surgery: 9.9%; diabetes: 40.1%; lesion length: 36.1 ± 18.5 mm; and stent length: 51.7 ± 27.2 mm. Procedural success, defined as guidewire recanalization with no in-hospital MACE, was 96.4%. Success with antegrade-only methods was 97.9% and 86.2% by retrograde/combined methods, respectively. Compared with a pre-specified performance goal derived from 6 prior CTO drug-eluting stent trials (1-year MACE: 24.4%), treatment with EES was associated with significantly lower composite adverse events for both intent-to-treat (18.5%, 1-sided upper confidence interval: 23.4%, p = 0.025) and per-protocol populations (8.2%, 1-sided upper confidence interval: 12.3%, p < 0.0001). Target lesion revascularization at 1 year was 6.3%. Dual antiplatelet therapy adherence was 53.9% at 1 year, yet subacute definite stent thrombosis occurred in only 2 patients (0.9%), and late probable stent thrombosis occurred in 1 patient (0.5%). CONCLUSIONS: In a multicenter registration trial representing contemporary technique and EES, favorable procedural success and late-term clinical outcomes support CTO PCI in a patient population with high lesion complexity. (EXPERT CTO: Evaluation of the XIENCE PRIME LL and XIENCE Nano Everolimus Eluting Coronary Stent Coronary Stents, Performance, and Technique in Chronic Total Occlusions; NCT01435031).