Retrograde chronic total occlusion percutaneous coronary intervention via ipsilateral collaterals.

BACKGROUND: There is limited data on retrograde chronic total occlusion (CTO) percutaneous coronary intervention (PCI) via ipsilateral epicardial collaterals (IEC). AIMS: To compare the clinical and angiographic characteristics, and outcomes of retrograde CTO PCI via IEC versus other collaterals in a large multicenter registry. METHODS: Observational cohort study from the Prospective Global registry for the study of Chronic Total Occlusion Intervention (PROGRESS-CTO). RESULTS: Of 4466 retrograde cases performed between 2012 and 2023, crossing through IEC was attempted in 191 (4.3%) cases with 50% wiring success. The most common target vessel in the IEC group was the left circumflex (50%), in comparison to other retrograde cases, where the right coronary artery was most common (70%). The Japanese CTO score was similar between the two groups (3.13 ± 1.23 vs. 3.06 ± 1.06, p = 0.456); however, the IEC group had a higher Prospective Global Registry for the Study of Chronic Total Occlusion Intervention (PROGRESS-CTO) score (1.95 ± 1.02 vs. 1.27 ± 0.92, p < 0.0001). The most used IEC guidewire was the SUOH 03 (39%), and the most frequently used microcatheter was the Caravel (43%). Dual injection was less common in IEC cases (66% vs. 89%, p < 0.0001). Technical (76% vs. 79%, p = 0.317) and procedural success rates (74% vs. 79%, p = 0.281) were not different between the two groups. However, IEC cases had a higher procedural complications rate (25.8% vs. 16.4%, p = 0.0008), including perforations (17.3% vs. 9.0%, p = 0.0001), pericardiocentesis (3.1% vs. 1.2%, p = 0.018), and dissection/thrombus of the donor vessel (3.7% vs. 1.2%, p = 0.002). CONCLUSION: The use of IEC for retrograde CTO PCI was associated with similar technical and procedural success rates when compared with other retrograde cases, but higher incidence of periprocedural complications.

Trends In Percutaneous Device Use For The Treatment Of Venous Thromboembolism Over Time In The PINC AI Healthcare Database And The National Inpatient Sample.

The number of different methodologies of reperfusion therapy to treat venous thromboembolism (VTE) has increased substantially. Nevertheless, investigation of data representativeness and device-level usage in administrative databases has been limited. Using the National Inpatient Sample (NIS) and the PINC AI Healthcare Database (PHD), all hospital encounters with a diagnosis code of VTE were identified between 1/1/2016 and 12/31/2020. Patient demographics and trends in treatment modalities were evaluated over time. An algorithm was developed to identify specific devices used for VTE treatment in the PHD cohort. 145,870 VTE patients treated with reperfusion therapy were identified in the NIS (Pulmonary embolism (PE): 88,725; isolated DVT (iDVT): 57,145) and 39,311 in the PHD (PE: 25,383; iDVT: 13,928). Patient demographics were qualitatively similar in the NIS and PHD. Over time, there was a significant increase in the use of mechanical thrombectomy (MT) in the PE and iDVT populations (p<0.05 in both databases) with catheter directed thrombolysis (CDT) use plateauing in PE (p=0.83 and p=0.14 in NIS and PHD respectively) and significantly decreasing for the iDVT population (p<0.05 in both databases). In the PHD cohort, specific reperfusion devices were identified in 14,105 patients (PE: 9,098; iDVT: 5,007). In conclusion, the use of MT for the treatment of VTE has increased over time, while rates of CDT therapy have remained stagnant or decreased. Further research is needed to understand the uptake of these treatment modalities as well as the unique abilities of the PHD to study specific device therapy in the VTE population.

A cross-sectional study of outcomes for patients undergoing mechanical thrombectomy for pulmonary embolism during 2018-2022: Insights from the PINC AI Healthcare Database.

Background and Aims: Mechanical thrombectomy (MT) treatments for pulmonary embolism (PE) have yet to be compared directly. We aimed to determine if patient outcomes varied following treatment of PE with different MT devices. Methods: All PE encounters with an index treatment of MT between January 2018 and March 2022 were analyzed for in-hospital mortality, discharge to home, and 30-day readmission outcomes in the PINC AI™ Healthcare Database. MT devices used in each encounter were extracted from hospital charge description free-text fields using keyword text and fuzzy matching. Unadjusted and adjusted logistic regression was used to model outcomes by device. Results: A total of 5893 encounters were identified using MT as the sole index PE treatment and 1812 using MT with another treatment. Of these, 41% had insufficient information to identify the devices used (unspecified MT), 33% used the FlowTriever System (large-bore volume-controlled aspiration MT), 23% the Indigo System (continuous aspiration MT), and 3% some other MT. Large-bore volume-controlled aspiration MT was used with other treatments 13% of the time compared with 23% and 39% for unspecified MT and continuous aspiration MT, respectively. Adjusted logistic regression modeling revealed the odds of in-hospital mortality were significantly higher for patients treated with unspecified MT ([OR] = 1.42, 95% confidence interval [CI]: [1.10-1.83], p = 0.008) or continuous aspiration MT (OR = 1.63, 95% CI: [1.21-2.19], p = 0.001) compared with large-bore volume-controlled aspiration MT. Discharge to home was significantly lower in these same groups (OR = 0.84, 95% CI: [0.73-0.96], p = 0.01, and OR = 0.63, 95% CI: [0.53-0.74], p < 0.001, respectively), but readmission risks at 30 days were comparable (OR = 1.08, 95% CI: [0.84-1.38], p = 0.56, and OR = 1.20, 95% CI: [0.89-1.62], p = 0.24, respectively). Conclusion: PE outcomes and treatment patterns differ significantly based on the type of MT utilized. Clinical studies directly comparing MT treatments are needed to further understand optimal treatment of PE.

Update on chronic total occlusion percutaneous coronary intervention.

Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) continues to evolve. This review summarizes recent publications categorized by outcomes, techniques, complications, and ongoing studies in this rapidly growing area.

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.

Long-Term Outcomes in Patients With Chronic Total Occlusion.

Although a chronic total occlusion (CTO) in the setting of an acute coronary syndrome is associated with greater risk, the prognosis of patients with a CTO and stable coronary artery disease (CAD) remains unknown. This study aimed to investigate adverse event rates in patients with stable CAD with and without a CTO. In 3,597 patients with stable CAD (>50% coronary luminal stenosis) who underwent cardiac catheterization, all-cause mortality, cardiovascular mortality, and the composite major adverse cardiac event (MACE) rates for cardiovascular death, myocardial infarction, and heart failure hospitalization were evaluated. Cox proportional hazards and Fine and Gray subdistribution hazard models were used to compare event-free survival in patient subsets after adjustment for covariates. Event rates were higher in patients with CTOs than in those without CTOs after adjusting for demographic and clinical characteristics (cardiovascular death hazard ratio [HR] 1.29, 95% confidence interval [CI] 1.05 to 1.57, p = 0.012). Patients with CTO revascularization had lower event rates than those of patients without CTO revascularization (cardiovascular death HR 0.43, CI 0.26 to 0.70, p = 0.001). Those with nonrevascularized CTOs were at particularly great risk when compared with those without CTO (cardiovascular death HR 1.52, CI 1.25 to 1.84, p <0.001). Moreover, those with revascularized CTOs had similar event rates to those of patients with CAD without CTOs. Patients with CTO have higher rates of adverse cardiovascular events than those of patients with significant CAD without CTO. This risk is greatest in patients with nonrevascularized CTO.

International survey of chronic total occlusion percutaneous coronary intervention operators.

BACKGROUND: Contemporary chronic total occlusion (CTO) percutaneous coronary intervention (PCI) practice has received limited study. AIM: To examine the contemporary CTO PCI practice. METHODS: We performed an online, anonymous, international survey of CTO PCI operators. RESULTS: Five hundred forty-five CTO PCI operators and 190 interventional cardiology fellows with an interest in CTO PCI participated in this survey. Almost half were from the United States (41%), most (93%) were men, and the median h/week spent in the hospital was 58. Median annual case numbers were 205 (150-328) for PCIs and 20 (5-50) for CTO PCIs. Almost one-fifth (17%) entered CTO cases into registries, such as PROGRESS-CTO (55%) and EuroCTO (20%). More than one-third worked at academic institutions (39%), 31% trained dedicated CTO fellows, and 22% proctored CTO PCI. One-third (34%) had dedicated CTO PCI days. Most (51%) never discharged CTO patients the same day, while 17% discharged CTO patients the same day >50% of the time. After successful guidewire crossing, 38% used intravascular imaging >90% of the time. Most used CTO scores including J-CTO (81%), PROGRESS-CTO (35%), and PROGRESS-CTO complications scores (30%). Coronary artery perforation was encountered within the last month by 19%. On a scale of 0-10, the median comfort levels in treating coronary artery perforation were: covered stents 8.8 (7.0-10), coil embolization 5.0 (2.1-8.5), and fat embolization 3.7 (0.6-7.3). Most (51%) participants had a complication cart/kit and 25% conducted regular complication drills with catheterization laboratory staff. CONCLUSION: Contemporary CTO PCI practices vary widely. Further research on barriers to following the guiding principles of CTO PCI may improve patient outcomes.

Technical aspects of entrapped coronary guidewire retrieval using rotational atherectomy device: A case series.

BACKGROUND: This article highlights four unique cases where rotational atherectomy (RA Rotapro, Boston Scientific) was used to cut and retrieve an entrapped coronary guidewire with parts extending into the aorta We discuss the technique and step by step approach to the retrieval procedure. CASE SUMMARY: Three of four cases described a guide wire entrapment in the right coronary artery (RCA), and one in the left anterior descending artery via retrograde route. In all cases the guide wire was intact within the intracoronary segment. In Case 1, the guide wire (Runthrough; Terumo) was entrapped in an acute marginal branch during chronic total occlusion (CTO) percutaneous coronary intervention. In Case 2, a whisper wire (Abbott) was entrapped during re-wiring of the right posterolateral branch through stent struts, the traction on the wire caused severe malformation of distal and proximal stents requiring second staged procedure to complete revascularization of the RCA CTO. In Case 3, a Runthrough wire was entrapped between two layers of stents and fractured at the proximal point with filaments extending into descending aorta. And in Case 4, a Pilot 200 (Abbott) wire was entrapped retrograde in the subintimal space via saphenous vein graft connection by tying a knot at the distal tip of the wire. In all four cases RA was used to successfully cut and remove the entrapped guide wires. DISCUSSION: Rotablation technique appears to be a safe and effective strategy for the management of entrapped coronary guidewire when conventional strategies fail.

Lesion complexity and procedural outcomes associated with ostial chronic total occlusions: Insights from the PROGRESS-CTO Registry.

OBJECTIVES: Ostial CTOs can be challenging to revascularize. We aim to describe the outcomes of ostial chronic total occlusion (CTO) percutaneous coronary intervention (PCI). METHODS: We examined the clinical and angiographic characteristics and procedural outcomes of 8788 CTO PCIs performed at 35 US and non-US centers between 2012 and 2022. In-hospital major adverse cardiac events (MACE) included death, myocardial infarction, urgent repeat target-vessel revascularization, tamponade requiring pericardiocentesis or surgery, and stroke. RESULTS: Ostial CTOs constituted 12% of all CTOs. Patients with ostial CTOs had higher J-CTO score (2.9 ± 1.2 vs 2.3 ± 1.3; P less than .01). Ostial CTO PCI had lower technical (82% vs. 86%; P less than .01) and procedural (81% vs. 85%; P less than .01) success rates compared with non-ostial CTO PCI. Ostial location was not independently associated with technical success (OR 1.03, CI 95% 0.83-1.29 P =.73). Ostial CTO PCI had a trend towards higher incidence of MACE (2.6% vs. 1.8%; P =.06), driven by higher incidence of in-hospital death (0.9% vs 0.3% P less than.01) and stroke (0.5% vs 0.1% P less than .01). Ostial lesions required more often use of the retrograde approach (30% vs 9%; P less than .01). Ostial CTO PCI required longer procedure time (149 [103,204] vs 110 [72,160] min; P less than .01) and higher air kerma radiation dose (2.3 [1.3, 3.6] vs 2.0 [1.1, 3.5] Gray; P less than .01). CONCLUSIONS: Ostial CTOs are associated with higher lesion complexity and lower technical and procedural success rates. CTO PCI of ostial lesions is associated with frequent need for retrograde crossing, higher incidence of death and stroke, longer procedure time and higher radiation dose.

Impact of target vessel on the procedural techniques and outcomes of chronic total occlusion percutaneous coronary intervention.

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.

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.

High Sensitivity Troponin Level and Benefits of Chronic Total Occlusion Revascularization.

Background The survival benefit of revascularization of chronic total occlusion (CTO) of the coronary arteries remains a subject of controversy. We measured high sensitivity troponin-I (hsTn-I) levels as an estimate of myocardial ischemia in patients with stable coronary artery disease, with the hypothesis that (1) patients with CTO have higher levels of hsTn-I than patients without CTO, (2) hsTn-I levels will predict adverse cardiovascular events in patients with CTO, and (3) patients with elevated hsTn-I levels will have a survival benefit from CTO revascularization. Methods and Results In 428 patients with stable coronary artery disease and CTO undergoing coronary angiography, adverse event rates were investigated. Cox proportional hazards models and Fine and Gray subdistribution hazard models were performed to determine the association between hsTn-I level and incident event rates in patients with CTO. HsTn-I levels were higher in patients with compared with those without CTO (median 6.7 versus 5.6 ng/L, P=0.002). An elevated hsTn-I level was associated with higher adverse event rates (adjusted all-cause mortality hazard ratio, 1.19 [95% CI, 1.08-1.32]; P=0.030) for every doubling of hsTn-I level. CTO revascularization was performed in 28.3% of patients. In patients with a high (>median) hsTn-I level, CTO revascularization was associated with substantially lower all-cause mortality (adjusted hazard ratio, 0.26 [95% CI, 0.08-0.88]; P=0.030) compared with those who did not undergo revascularization. In patients with a low (

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.

Trends and Outcomes of Antegrade Dissection and Re-Entry in Chronic Total Occlusion Percutaneous Coronary Intervention.

BACKGROUND: The contemporary frequency and outcomes of antegrade dissection and re-entry (ADR) for chronic total occlusion (CTO) percutaneous coronary intervention (PCI) have received limited study. OBJECTIVES: The aim of this study was to determine the frequency and outcomes of ADR use in a large multicenter CTO PCI registry. METHODS: The characteristics and outcomes of ADR were examined among 12,568 patients who underwent 12,841 CTO PCIs at 46 U.S. and non-U.S. centers between 2012 and 2023. RESULTS: ADR was used in 2,385 of the procedures (18.6%). ADR use declined from 37.9% in 2012 to 14.5% in 2022 (P < 0.001). Patients in whom ADR was used had a high prevalence of comorbidities. Compared with cases that did not use ADR, ADR cases had more complex angiographic characteristics, higher mean J-CTO (Multicenter CTO Registry in Japan) score (2.94 ± 1.11 vs 2.23 ± 1.26; P < 0.001), lower technical success (77.0% vs 89.3%; P < 0.001), and higher in-hospital major adverse cardiac events (3.7% vs 1.6%; P < 0.001). The use of the CrossBoss declined from 71% in 2012 to 1.4% in 2022 and was associated with higher technical success (87%) compared with wire-based techniques (73%). The Stingray device displayed higher technical success (86%) compared with subintimal tracking and re-entry (STAR) (74%) and limited antegrade subintimal tracking (78%); however, its use has been decreasing, with STAR becoming the most used re-entry technique in 2022 (44% STAR vs 38% Stingray). CONCLUSIONS: The use of ADR has been decreasing. ADR was used in more complex lesions and was associated with lower technical success and higher major adverse cardiac events compared with non-ADR cases. There has been a decrease in Stingray use and an increase in the use of STAR for re-entry.

Outcomes in High-Risk Pulmonary Embolism Patients Undergoing FlowTriever Mechanical Thrombectomy or Other Contemporary Therapies: Results From the FLAME Study.

BACKGROUND: Hemodynamically unstable high-risk, or massive, pulmonary embolism (PE) has a reported in-hospital mortality of over 25%. Systemic thrombolysis is the guideline-recommended treatment despite limited evidence. The FLAME study (FlowTriever for Acute Massive PE) was designed to generate evidence for interventional treatments in high-risk PE. METHODS: The FLAME study was a prospective, multicenter, nonrandomized, parallel group, observational study of high-risk PE. Eligible patients were treated with FlowTriever mechanical thrombectomy (FlowTriever Arm) or with other contemporary therapies (Context Arm). The primary end point was an in-hospital composite of all-cause mortality, bailout to an alternate thrombus removal strategy, clinical deterioration, and major bleeding. This was compared in the FlowTriever Arm to a prespecified performance goal derived from a contemporary systematic review and meta-analysis. RESULTS: A total of 53 patients were enrolled in the FlowTriever Arm and 61 in the Context Arm. Context Arm patients were primarily treated with systemic thrombolysis (68.9%) or anticoagulation alone (23.0%). The primary end point was reached in 9/53 (17.0%) FlowTriever Arm patients, significantly lower than the 32.0% performance goal (P<0.01). The primary end point was reached in 39/61 (63.9%) Context Arm patients. In-hospital mortality occurred in 1/53 (1.9%) patients in the FlowTriever Arm and in 18/61 (29.5%) patients in the Context Arm. CONCLUSIONS: Among patients selected for mechanical thrombectomy with the FlowTriever System, a significantly lower associated rate of in-hospital adverse clinical outcomes was observed compared with a prespecified performance goal, primarily driven by low all-cause mortality of 1.9%. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04795167.

Randomized controlled trial of mechanical thrombectomy vs catheter-directed thrombolysis for acute hemodynamically stable pulmonary embolism: Rationale and design of the PEERLESS study.

BACKGROUND: The identification of hemodynamically stable pulmonary embolism (PE) patients who may benefit from advanced treatment beyond anticoagulation is unclear. However, when intervention is deemed necessary by the PE patient's care team, data to select the most advantageous interventional treatment option are lacking. Limiting factors include major bleeding risks with systemic and locally delivered thrombolytics and the overall lack of randomized controlled trial (RCT) data for interventional treatment strategies. Considering the expansion of the pulmonary embolism response team (PERT) model, corresponding rise in interventional treatment, and number of thrombolytic and nonthrombolytic catheter-directed devices coming to market, robust evidence is needed to identify the safest and most effective interventional option for patients. METHODS: The PEERLESS study (ClinicalTrials.gov identifier: NCT05111613) is a currently enrolling multinational RCT comparing large-bore mechanical thrombectomy (MT) with the FlowTriever System (Inari Medical, Irvine, CA) vs catheter-directed thrombolysis (CDT). A total of 550 hemodynamically stable PE patients with right ventricular (RV) dysfunction and additional clinical risk factors will undergo 1:1 randomization. Up to 150 additional patients with absolute thrombolytic contraindications may be enrolled into a nonrandomized MT cohort for separate analysis. The primary end point will be assessed at hospital discharge or 7 days post procedure, whichever is sooner, and is a composite of the following clinical outcomes constructed as a hierarchal win ratio: (1) all-cause mortality, (2) intracranial hemorrhage, (3) major bleeding, (4) clinical deterioration and/or escalation to bailout, and (5) intensive care unit admission and length of stay. The first 4 components of the win ratio will be adjudicated by a Clinical Events Committee, and all components will be assessed individually as secondary end points. Other key secondary end points include all-cause mortality and readmission within 30 days of procedure and device- and drug-related serious adverse events through the 30-day visit. IMPLICATIONS: PEERLESS is the first RCT to compare 2 different interventional treatment strategies for hemodynamically stable PE and results will inform strategy selection after the physician or PERT determines advanced therapy is warranted.

Frequency and outcomes of ad hoc chronic total occlusion percutaneous coronary intervention: insights from the progress-cto registry.

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.

Use of the Carlino Technique in Chronic Total Occlusion Percutaneous Coronary Intervention.

We examined the outcomes of the Carlino technique in chronic total occlusion (CTO) percutaneous coronary interventions (PCIs). We analyzed the baseline clinical and angiographic characteristics and outcomes of 128 CTO PCIs that included the Carlino technique at 22 US and no-US centers between 2016 and 2023. The Carlino technique was used in 128 (2.8%) of 4,508 cases that used anterograde dissection and reentry (78.9%) or the retrograde approach (21.1%) during the study period, and it increased steadily over time (from 0.0% in 2016 to 8.3% in 2023). The mean patient age was 65.6 ± 9.7 years, and 88.7% of the patients were men with high prevalence of hypertension (89.1%) and dyslipidemia (80.2%). The Carlino technique was more commonly used in cases with moderate to severe calcification (77.2% vs 55.5%, p <0.001) with higher J-CTO (3.3 ± 0.9 vs 3.0 ± 1.1, p = 0.007), Prospective Global Registry for the Study of Chronic Total Occlusion Intervention (PROGRESS-CTO) (1.7 ± 1.0 vs 1.4 ± 1.0, p = 0.001), PROGRESS-CTO Mortality (2.6 ± 0.9 vs 2.0 ± 0.9, p = 0.013) and PROGRESS-CTO Perforation (3.7 ± 1.1 vs 3.5 ± 1.0, p = 0.029) scores. Carlino cases had longer procedure and fluoroscopy time, and higher contrast volume and radiation dose. Carlino cases had lower technical (65.6% vs 78.5%, p <0.001) and procedural (63.3% vs 76.3%, p <0.001) success, similar major adverse cardiac events (6.2% vs 3.2%, p = 0.101) and higher incidence of pericardiocentesis (3.9% vs 1.3%, p = 0.042), perforation (18.0% vs 8.9%, p = 0.001) and contrast-induced acute kidney injury (2.3% vs 0.4%, p = 0.012). The Carlino technique was associated with higher procedural success when used for retrograde crossing (81.5% vs 58.4%, p = 0.047). The Carlino technique is increasingly being used in CTO PCI especially for higher complexity lesions.