Worldwide CTEPH Registry: Long-Term Outcomes With Pulmonary Endarterectomy, Balloon Pulmonary Angioplasty, and Medical Therapy.

BACKGROUND: The European Chronic Thromboembolic Pulmonary Hypertension registry (CTEPH), conducted between 2007 and 2012, reported the major impact of pulmonary endarterectomy (PEA) on the long-term survival of patients with CTEPH. Since then, 2 additional treatments for inoperable CTEPH have become available: balloon pulmonary angioplasty (BPA), and an approved oral drug therapy with the guanylate cyclase stimulator riociguat. The current registry aimed to evaluate the effect of these new therapeutic approaches in a worldwide context. METHODS: Participation in this international global registry included 34 centers in 20 countries. Between February 2015 and September 2016, 1009 newly diagnosed, consecutive patients were included and followed until September 2019. RESULTS: Overall, 605 patients (60%) underwent PEA and 185 (18%) underwent BPA; 76% of the 219 remaining patients not receiving mechanical intervention (ie, neither PEA nor BPA) were treated with pulmonary hypertension drugs. Oof patients undergoing PEA and BPA, 38% and 78% also received drugs for pulmonary hypertension, respectively. Median age at diagnosis was higher in the BPA and No PEA/BPA groups than in the PEA group: 66 and 69, respectively, versus 60 years. Pulmonary vascular resistance (PVR) was similar in all groups, with an average of 643 dynes/(s·cm-5). During an observation period (>3 years; ≤5.6 years), death was reported in 7%, 11%, and 27% of patients treated by PEA and BPA, and those receiving no mechanical intervention (P<0.001). In Kaplan-Meier analysis, 3-year survival was 94%, 92%, and 71% in the 3 groups, respectively. PEA 3-year survival improved by 5% from that observed between 2007 and 2012. There was no survival difference in patients receiving vitamin K antagonists and non-vitamin K oral anticoagulants (P=0.756). In Cox regression, reduced mortality was associated with: PEA and BPA in the global cohort; history of venous thromboembolism and lower PVR in the PEA group; lower right atrial pressure in the BPA group; and use of pulmonary hypertension drugs, oxygen therapy, and lower right atrial pressure, as well as functional class in the group receiving no mechanical intervention. CONCLUSIONS: This second international CTEPH registry reveals important improvement in patient survival since the introduction of BPA and an approved drug for pulmonary hypertension. The type of anticoagulation regimen did not influence survival. REGISTRATION: URL https://clinicaltrials.gov; Unique identifier: NCT02656238.

Status and Future Directions for Balloon Pulmonary Angioplasty in Chronic Thromboembolic Pulmonary Disease With and Without Pulmonary Hypertension: A Scientific Statement From the American Heart Association.

Balloon pulmonary angioplasty continues to gain traction as a treatment option for patients with chronic thromboembolic pulmonary disease with and without pulmonary hypertension. Recent European Society of Cardiology guidelines on pulmonary hypertension now give balloon pulmonary angioplasty a Class 1 recommendation for inoperable and residual chronic thromboembolic pulmonary hypertension. Not surprisingly, chronic thromboembolic pulmonary hypertension centers are rapidly initiating balloon pulmonary angioplasty programs. However, we need a comprehensive, expert consensus document outlining critical concepts, including identifying necessary personnel and expertise, criteria for patient selection, and a standardized approach to preprocedural planning and establishing criteria for evaluating procedural efficacy and safety. Given this lack of standards, the balloon pulmonary angioplasty skill set is learned through peer-to-peer contact and training. This document is a state-of-the-art, comprehensive statement from key thought leaders to address this gap in the current clinical practice of balloon pulmonary angioplasty. We summarize the current status of the procedure and provide a consensus opinion on the role of balloon pulmonary angioplasty in the overall care of patients with chronic thromboembolic pulmonary disease with and without pulmonary hypertension. We also identify knowledge gaps, provide guidance for new centers interested in initiating balloon pulmonary angioplasty programs, and highlight future directions and research needs for this emerging therapy.

2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.

AIM: The "2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease" provides recommendations to guide clinicians in the treatment of patients with lower extremity peripheral artery disease across its multiple clinical presentation subsets (ie, asymptomatic, chronic symptomatic, chronic limb-threatening ischemia, and acute limb ischemia). METHODS: A comprehensive literature search was conducted from October 2020 to June 2022, encompassing studies, reviews, and other evidence conducted on human subjects that was published in English from PubMed, EMBASE, the Cochrane Library, CINHL Complete, and other selected databases relevant to this guideline. Additional relevant studies, published through May 2023 during the peer review process, were also considered by the writing committee and added to the evidence tables where appropriate. STRUCTURE: Recommendations from the "2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease" have been updated with new evidence to guide clinicians. In addition, new recommendations addressing comprehensive care for patients with peripheral artery disease have been developed.

Future of Endovascular and Surgical Treatments of Atherosclerotic Intracranial Stenosis.

Intracranial atherosclerotic disease and resultant intracranial stenosis is a global leading cause of stroke, and poses an ongoing treatment challenge. Among patients with intracranial stenosis, those with hemodynamic compromise are at high risk for recurrent stroke despite medical therapy and risk factor modification. Revascularization of the hypoperfused territory is the most plausible treatment strategy for these high-risk patients, yet surgical and endovascular therapies have not yet shown to be sufficiently safe and effective in randomized controlled trials. Advances in diagnostic and therapeutic technologies have led to a resurgence of interest in surgical and endovascular treatment strategies, with a growing body of evidence to support their further evaluation in the treatment of select patient populations. This review outlines the current and emerging endovascular and surgical treatments and highlights promising future management strategies.

Midterm outcomes of rotational atherectomy-assisted endovascular treatment of severe peripheral arterial disease.

OBJECTIVE: We evaluated the midterm results of atherectomy-assisted angioplasty for the treatment of femoropopliteal lesions and the identification of possible subgroups of patients with superior outcomes. METHODS: We conducted a single-center, physician-initiated, nonindustry-sponsored retrospective analysis of patients with Rutherford category ranging from II to V and de novo occlusive or stenotic lesions of the superficial femoral (SFA) and/or popliteal arteries treated with atherectomy-assisted angioplasty (Jetstream rotational atherectomy + drug-eluting ballooning). In cases of subintimal recanalization or patients without an SFA stamp, with previous ipsilateral bypass surgery, systemic coagulopathy, end-stage renal disease requiring hemodialysis, life expectancy of <12 months, and intolerance to aspirin, clopidogrel, and/or heparin were excluded. RESULTS: In a total of 103 enrolled patients, the median SFA and/or popliteal lesion length was 80 mm (interquartile range, 61.2 mm) with 73 lesions being occlusive (70.9%) and 84 (81.5%) classified as Fanelli calcification score 3 and 4. Technical success was met in 96.1% of cases (n = 99) at a median operative time of 108 minutes. Adjunctive stenting was needed in 10 patients (9.8%). At a median follow-up of 18.0 ± 10.8 months, Rutherford class clinical improvement was present in 77 patients (74.8%), and 7 patients (6.79%) presented target lesion occlusion needing reintervention in 6 cases (5.82%). The primary patency rates were 97% at 12 months and 83% at 24 months with secondary patency rates of 99% at 12 months and 91% at 24 months of follow-up. There were no significant differences when treating differently located lesions, diabetic vs nondiabetic patients, or comparing experienced vs nonexperienced operators. CONCLUSIONS: The use of rotational atherectomy and drug-eluting balloons for the treatment of severe femoropopliteal disease showed relatively low need for bailout stenting and good midterm primary patency rates. The influence of lesion location, diabetes mellitus, or operator experience did not show statistically different results in terms of patency. Longer term outcomes and comparative analysis are needed to consolidate further clinical evidence.

Comparison of endovascular therapies for chronic limb-threatening ischemia and claudication.

OBJECTIVE: Analysis of regional data from the Vascular Quality Initiative (VQI) suggested improved survival for patients undergoing stent placement compared with balloon angioplasty and atherectomy. Using national data from the VQI linked to Medicare claims data through the Vascular Implant Surveillance and Interventional Outcomes Network program, this study aimed to compare the rates of mortality, reintervention, and amputation after endovascular interventions (atherectomy, stenting, and balloon angioplasty) for two separate cohorts: patients with chronic limb-threatening ischemia (CLTI) and patients with claudication. METHODS: This was a secondary data analysis of Society for Vascular Surgery National VQI data linked to Medicare claims, between October 2016 and December 2019. Patients aged ≥65 years with symptoms of claudication or CLTI and a diagnosis of occlusive disease were included. Urgent or emergent interventions or those with concurrent procedures (endarterectomy, bypass, or bilateral intervention) were excluded. Interventions were grouped into (1) balloon angioplasty only; (2) stent (with or without balloon angioplasty); or (3) atherectomy (alone, with or without stent, with or without balloon angioplasty). Propensity score-matched cohorts were constructed to conduct pairwise intervention comparisons of mortality, reintervention, and amputation rates. Multivariable logistic regression was used to derive propensity scores for each patient. Kaplan-Meier estimates and Cox proportional hazards ratios (HRs) (95% confidence interval [CI]) analyses were performed. RESULTS: A total of 9785 (2665 claudication, 7120 CLTI) eligible patients were identified. After propensity score matching for the CLTI group, 2826, 3608, and 2796 pairs of cases were used to compare balloon angioplasty vs atherectomy, balloon angioplasty vs stent, and stent vs atherectomy, respectively. No statistically significant difference in mortality was observed among all interventions. However, atherectomy was associated with a significant increase in reintervention rate compared with balloon angioplasty (HR, 1.22; 95% CI, 1.06-1.39; P = .01) and compared with stenting (HR, 1.27; 95% CI, 1.10-1.46; P < .01) within the first year after the index procedure. Of note, both atherectomy (HR, 0.82; 95% CI, 0.68-0.98; P < .05) and stenting (HR, 0.76; 95% CI, 0.64-0.90; P < .01) showed lower rates of major amputation when compared with balloon angioplasty within 1 year after the index procedure. In the claudication group, there were no significant differences observed among interventions for peripheral arterial disease for mortality, reintervention, or amputation rates. CONCLUSIONS: Further studies are needed to identify appropriate indications for atherectomy, because there may be a subset of patients with CLTI who benefit from this therapy with respect to amputation rates. Until then, caution should be exercised when using atherectomy because it is also associated with higher reintervention rates.

Outcomes of endovascular intervention for atherosclerotic lesions confined to the popliteal artery.

OBJECTIVE: Most surgeons employ an endovascular-first approach to the treatment of peripheral arterial disease (PAD), but controversy remains regarding the ideal interventions for the management of isolated popliteal artery disease (IPAD). Indeed, there are a paucity of data that compare outcomes of popliteal stents vs other peripheral vascular interventions (PVIs). The goal of this study was to evaluate outcomes of PVIs in IPAD. METHODS: The Vascular Study Group of New England database was queried for all IPAD PVIs performed for atherosclerotic occlusive disease from 2010 to 2021. Those with at least 1 year of follow-up data available were included for analysis. The primary endpoint was 1-year freedom from a composite target lesion (TL) treatment failure that included restenosis >50% on duplex, reintervention, or ipsilateral major amputation. RESULTS: We included 689 procedures performed on 634 patients. Of these, 250 (36.3%) were treated with plain balloons (POBA), 215 (31.2%) had stents, 170 (24.7%) had special balloons (drug-coated, cutting, or lithotripsy), and 54 (7.8%) atherectomies were performed. Stent placement was associated with lower freedom from TL treatment failure (72.6%) than special balloon (81.2%; P = .048) and atherectomy (88.9%; P = .012), but not POBA (76.8%; P = .293). On multivariable logistic regression, stents (odds ratio, 0.637; P = .021) and preoperative P2Y12 inhibitor therapy (odds ratio, 0.683; P = .048) were both associated with lower freedom from intervention failure. CONCLUSIONS: Popliteal stent placement is associated with a higher rate of TL treatment failure at 1 year when compared with other PVIs including special balloon angioplasty and atherectomy, but not POBA, and should therefore be avoided in favor of special balloons or atherectomy whenever feasible.

Pedal medial arterial calcification influences the outcomes of isolated infra-malleolar interventions for chronic limb-threatening ischemia.

OBJECTIVE: Inframalleolar disease is present in most diabetic patients presenting with tissue loss. Inframalleolar (pedal) artery disease and pedal medial arterial calcification (pMAC) are associated with major amputation in patients with chronic limb-threatening ischemia (CLTI). This study aimed to examine the impact of pMAC on the outcomes after isolated inframalleolar (pedal artery) interventions. METHODS: A database of lower extremity endovascular intervention for patients with tissue loss between 2007 and 2022 was retrospectively queried. Patients with CLTI were selected, and those undergoing isolated inframalleolar intervention on the dorsalis pedis and medial and lateral tarsal arteries and who had foot x-rays were identified. X-rays were assessed blindly for pMAC and scored on a scale of 0 to 5. Patients with concomitant superficial femoral artery and tibial interventions were excluded. Intention to treat analysis by the patient was performed. Amputation-free survival (survival without major amputation) was evaluated. RESULTS: A total of 223 patients (51% female; 87% Hispanic; average age, 66 years; 323 vessels) underwent isolated infra-malleolar intervention for tissue loss. All patients had diabetes, 96% had hypertension, 79% had hyperlipidemia, and 63% had chronic renal insufficiency (55% of these were on hemodialysis). Most of the patients had Wound, Ischemia, and foot Infection (WIfI) stage 3 disease and had various stages of pMAC: severe (score = 5) in 48%, moderate (score = 2-4) in 31%, and mild (score = 0-1) in 21% of the patients. Technical success was 94%, with a median of one vessel treated per patient. All failures were in severe pMAC. Overall, major adverse cardiovascular events was 0.9% at 90 days after the procedure. Following the intervention, most patients underwent a planned forefoot amputation (single digit, multiple digits, ray amputation, or trans-metatarsal amputation). WIfI ischemic grade was improved by 51%. Wound healing at 3 months was 69%. Those not healing underwent below-knee amputations. The overall 5-year amputation-free survival rate was 35% ± 9%. The severity of pMAC was associated with decreased AFS. CONCLUSIONS: Increasing severity of pMAC influences the technical and long-term outcomes of infra-malleolar intervention in diabetes. Severe pMAC is associated with amputation and should be considered as a variable in the shared decision-making of diabetic patients with CLTI.

Surveillance and risk factors for early restenosis following transcarotid artery revascularization.

OBJECTIVE: Restenosis after transcarotid artery revascularization (TCAR) is a known complication. When identified in the early postoperative period, it may be related to technique. We evaluated our TCAR experience to identify potentially modifiable factors impacting restenosis. METHODS: This is a single-institution, retrospective review of patients undergoing TCAR from November 2017 to July 2022. Restenosis was defined as >50% stenosis on duplex ultrasound (DUS) examination or computed tomographic angiography (CTA). Continuous variables were compared using Kruskal-Wallis's test. Categorical variables were compared using the Fisher's exact test. RESULTS: Of 61 interventions, 11 (18%) developed restenosis within the median follow-up of 345 days (interquartile range, 103-623 days). Among these patients, 82% (9/11) had >50% stenosis, and 18% (2/11) had >80% stenosis. Both patients with high-grade restenosis were symptomatic and underwent revascularization. Diagnosis of post-TCAR restenosis was via DUS examination in 45% (5/11), CTA in 18% (2/11), or both CTA/DUS examination in 36% (4/11). Restenosis occurred within 1 month in 54% (6/11) and 6 months in 72% (8/11) of patients. However, three of the six patients with restenosis within 1 month had discordant findings on CTA vs DUS imaging. Patient comorbidities, degree of preoperative stenosis, medical management, balloon size, stent size, lesion characteristics, and predilatation angioplasty did not differ. Patients with restenosis were younger (P = .02), had prior ipsilateral endarterectomy (odds ratio [OR], 6.5; P = .02), had history of neck radiation (OR, 18.3; P = .01), and lower rate of postdilatation angioplasty (OR, 0.11; P = .04), without an increased risk of neurological events. CONCLUSIONS: Although post-TCAR restenosis occurred in 18% of patients, only 3% of patients had critical restenosis and required reintervention. Patient factors associated with restenosis were younger age, prior endarterectomy, and history of neck radiation. Although early restenosis may be mitigated by improved technique, the only technical factor associated with restenosis was less use of postdilatation angioplasty. Balancing neurological risk, this factor may have increased application in appropriate patients. Diagnosis of restenosis was inconsistent between imaging modalities; current surveillance paradigms and diagnostic thresholds may warrant reconsideration.

Needle-free, Novel Fossa Ovalis Puncture with Percutaneous Transluminal Coronary Angioplasty Guidewire and Microcatheter in Pigs and a Human with an Extremely Tortuous Inferior Vena Cava.

Background: Transseptal puncture (TSP) performed with the Brockenbrough (BRK) needle is technically demanding and carries potential risks. The back end of the percutaneous transluminal coronary angioplasty (PTCA) guidewire is blunt and flexible, with good support, it can puncture the right ventricle-free wall, which is thicker than the atrial-septum. The guidewire is thin and easy to manipulate. This study evaluated the performance of TSP with a PTCA guidewire and microcatheter without a needle. Methods: The back end of a PTCA guidewire was advanced into the Tiger (TIG) catheter, within the SL1 sheath, to puncture the fossa ovalis (FO) under fluoroscopy. Subsequently, the microcatheter was inserted into the left atrium (LA) above the guidewire, and the front end of the guidewire was exchanged in the LA. After the puncture site was confirmed by contrast, the TIG catheter and a 0.032 inch wire were advanced into the LA. Finally, the sheath, with the dilator, was advanced over the wire into the LA. The safety margin of this method was tested in a pig model. Results: The puncture was successful in all seven pigs tested with a puncture-to-sheath entry time of < 20 minutes and no procedure-related complications. The method was successfully used to perform a difficult TSP in a patient with an extremely tortuous inferior vena cava, in whom puncture with a BRK needle had repeatedly failed. Conclusions: Cardiologists may use the PTCA guidewire and microcatheter as an alternative to the needle while performing TSP in special conditions, such as an extremely tortuous inferior vena cava.

Effects of right ventricular remodeling in chronic thromboembolic pulmonary hypertension on the outcomes of balloon pulmonary angioplasty: a 2D-speckle tracking echocardiography study.

BACKGROUND: Balloon pulmonary angioplasty (BPA) improves the prognosis of chronic thromboembolic pulmonary hypertension (CTEPH). Right ventricle (RV) is an important predictor of prognosis in CTEPH patients. 2D-speckle tracking echocardiography (2D-STE) can evaluate RV function. This study aimed to evaluate the effectiveness of BPA in CTEPH patients and to assess the value of 2D-STE in predicting outcomes of BPA. METHODS: A total of 76 patients with CTEPH underwent 354 BPA sessions from January 2017 to October 2022. Responders were defined as those with mean pulmonary artery pressure (mPAP) ≤ 30 mmHg or those showing ≥ 30% decrease in pulmonary vascular resistance (PVR) after the last BPA session, compared to baseline. Logistic regression analysis was performed to identify predictors of BPA efficacy. RESULTS: BPA resulted in a significant decrease in mPAP (from 50.8 ± 10.4 mmHg to 35.5 ± 11.9 mmHg, p < 0.001), PVR (from 888.7 ± 363.5 dyn·s·cm-5 to 545.5 ± 383.8 dyn·s·cm-5, p < 0.001), and eccentricity index (from 1.3 to 1.1, p < 0.001), and a significant increase in RV free wall longitudinal strain (RVFWLS: from 15.7% to 21.0%, p < 0.001). Significant improvement was also observed in the 6-min walking distance (from 385.5 m to 454.5 m, p < 0.001). After adjusting for confounders, multivariate analysis showed that RVFWLS was the only independent predictor of BPA efficacy. The optimal RVFWLS cutoff value for predicting BPA responders was 12%. CONCLUSIONS: BPA was found to reduce pulmonary artery pressure, reverse RV remodeling, and improve exercise capacity. RVFWLS obtained by 2D-STE was an independent predictor of BPA outcomes. Our study may provide a meaningful reference for interventional therapy of CTEPH.

Balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension due to septic emboli.

We present the case of a 28-year-old woman with a history of tricuspid valve endocarditis leading to chronic thromboembolic pulmonary hypertension (CTEPH) with multiple pulmonary artery chronic total occlusions (CTOs) due to septic emboli. Following a multidisciplinary care discussion, the patient was brought forward for balloon pulmonary angioplasty (BPA) with successful revascularization of all chronically occluded territories. This case highlights advances in pulmonary artery CTO interventions and demonstrates the feasibility of BPA for CTEPH patients with a history of septic emboli.

The "Cuttering (Cutting-Dottering Balloon) Technique" for treatment of flow-limiting coronary intramural hematoma.

BACKGROUND: Coronary artery dissections are caused by a tear in the vessel endothelium, resulting in blood extravasation into the subintimal space, with subsequent intramural hematoma (IMH). One potential technique to deal with this complication is the use of cutting balloons, however, a significant number of cases experienced distal propagation of the hematoma. We describe a novel technique that enhances the possibility of creating intimal tears between the false and true lumen, aiding in hematoma drainage and restoring distal coronary flow. METHODS: We conducted a retrospective analysis of seven consecutive patients who underwent percutaneous coronary intervention complicated by flow-limiting intramural hematomas. All patients were treated using the "Cuttering Technique," based on the operators' preference. Procedural success was defined as achieving a distal thrombolysis in myocardial infarction 3 (TIMI 3) flow. RESULTS: In five out of seven patients treated with "Cuttering Technique" we observed a complete restoration of TIMI 3 flow into the dissected segment. CONCLUSIONS: Our cases show the effectiveness of the "Cuttering Technique" as a viable approach for managing IMHs. This technique enhances the possibility of creating intimal tears between the false and true lumens, aiding in hematoma drainage and restoring distal coronary flow.

Pericardial tamponade in coronary interventions: Morbidity and mortality.

BACKGROUND: Cardiac tamponade or pericardial tamponade (PT) can be a complication following invasive cardiac procedures. METHODS: Patients who underwent various procedures in the cardiac catheterization lab (viz. coronary interventions) were identified using the International Classification of Diseases, Ninth and Tenth Edition, Clinical Modification (International classification of diseases [ICD]-9-Clinical modification [CM] and ICD-10-CM, respectively) from the Nationwide Inpatient Sample (NIS) database. Patient demographics, presence of comorbidities, PT-related events, and in-hospital death were also abstracted from the NIS database. RESULTS: The frequency of PT-related events in the patients undergoing CI from 2010 to 2017 ranged from 3.3% to 8.4%. Combined in-hospital mortality/morbidity of PT-related events were higher with increasing age (odds ratio [OR] [95% CI]: chronic total occlusion (CTO) = 1.19 [1.10-1.29]; acute coronary syndrome (ACS) = 1.21 [1.11-1.33], both p < 0.0001) and female sex (OR [95%CI]: CTO = 1.70 [1.45-2.00]; ACS = 1.72 [1.44-2.06], both p < 0.0001). In-hospital mortality related to PT-related events was found to be 8.5% for coronary procedures. In-hospital mortality was highest amongst the patients undergoing percutaneous transluminal coronary angioplasty (PTCA) for ACS (ACS vs. non-CTO PTCA vs. CTO PTCA: 15.7% vs. 10.4% and 14.4%, p < 0.0001 and ACS vs. non-CTO PTCA vs. CTO PTCA: 12.1% vs. 8.1% and 5.6%, p = 0.0001, respectively). CONCLUSIONS: In the real-world setting, PT-related events in CI were found to be 3.3%-8.4%, with in-hospital mortality of 8.5%. The patients undergoing PTCA for ACS were found to have highest mortality. Older patients undergoing CTO PTCA independently predicted higher mortality.

Impact of multiple ballooning on coronary lesions as assessed by optical coherence tomography and intravascular ultrasound.

BACKGROUND: Optimal lesion preparation for coronary lesions has been reappraised in the interventional community, given the increasing use of drug-coated balloons for de novo lesions; however, whether multiple ballooning could achieve more favorable angiographic results compared with single ballooning remains unknown. We aimed to investigate the incremental effect of multiple ballooning on de novo coronary lesions over single ballooning as assessed by optical coherence tomography (OCT) and intravascular ultrasound (IVUS) among patients undergoing percutaneous coronary intervention (PCI). METHODS: Patients with chronic coronary syndrome (CCS) undergoing PCI were enrolled. Ballooning before stent implantation was repeatedly performed for three times using the same semi-compliant balloon. OCT and IVUS were performed after each balloon dilatation. Primary outcome measure was the difference in the mean lumen area between post-1st ballooning (1B) and post-3rd ballooning (3B) as assessed by OCT. RESULTS: A total of 32 lesions in 30 patients undergoing PCI between May 2021 and August 2022 were analyzed. Major plaque types of the lesions were fibrous (68.8%) and lipid (28.1%). Mean lumen area by OCT was significantly increased from 1B to 3B (5.9 ± 2.9 mm2 vs. 6.0 ± 2.9 mm2, difference: 0.2 ± 0.4 mm2, p = 0.040). There were significant increases from 1B to 3B in minimum lumen area by OCT (3.1 ± 1.5 mm2 vs. 3.6 ± 1.7 mm2, difference: 0.5 ± 0.6 mm2, p < 0.001) and mean dissection angle by OCT (65.6 ± 24.9° vs. 95.2 ± 34.0°, difference: 29.6 ± 25.5°, p < 0.001). Additionally, mean plaque area by IVUS was significantly decreased (8.0 ± 4.2 mm2 vs. 7.8 ± 4.1 mm2, difference: -0.2 ± 0.2 mm2, p < 0.001). CONCLUSIONS: Among CCS patients with mainly non-calcified lesions, multiple ballooning significantly increased the lumen area and dissection angle compared with single ballooning.

A multicenter prospective observational study appraising the effectiveness of the Supera stent after subintimal recanalization of femoro-popliteal artery occlusion: The SUPERSUB II study.

BACKGROUND: Complex femoropopliteal artery disease represents a challenge. The Supera stent holds the promise of improving the results of endovascular therapy for complex femoropopliteal disease. AIMS: We aimed at appraising the early and long-term effectiveness of the Supera stent after successful subintimal angioplasty (SuperSUB strategy) for complex femoropopliteal lesions. METHODS: We conducted a multicenter, prospective, single-arm observational study including consecutive patients at participating centers in whom Supera was implanted after successful subintimal angioplasty for complex femoropopliteal lesions. RESULTS: A total of 92 patients were included Femoropopliteal arteries were the most common target, and lesion length was 261 ± 102 mm. Most procedures were technically demanding, with antegrade femoral access in 35 (38%) and retrograde distal access in 55 (60%). Supera stent length was 281 ± 111 mm, with 4, 5, and 6 mm devices being most commonly used: 32 (35%), 35 (38%), and 23 (25%), respectively. Technical success was achieved in 100% of subjects, as was clinical success (per subject), whereas procedural success (per subject) was obtained in 98%. At 24 months, freedom from clinically driven target lesion revascularization was 93%, whereas primary patency was 87%. When compared with a similar historical cohort, Supera stent use appeared to be associated with a reduction in resources. CONCLUSION: Use of Supera stent after successful subintimal recanalization of complex lower limb arterial lesions yields favorable procedural results, which are maintained over follow-up, and are associated also with a favorable resource use profile.

Paclitaxel-coated versus sirolimus-coated balloon angioplasty for coronary artery disease: A systematic review and meta-analysis.

BACKGROUND: Although use of sirolimus-based analogs has shown superiority over paclitaxel in drug-eluting stents, the relative efficacy of these two agents released from drug-coated balloons (DCB) is unclear. The present meta-analysis is aimed to compare outcomes after percutaneous coronary intervention (PCI) with paclitaxel-coated balloons (PCB) versus sirolimus-coated balloons (SCB) for either in-stent restenosis or native de novo lesions. METHODS: The study outcomes were 1) target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or target lesion revascularization, and 2) follow-up angiographic parameters including late lumen loss (LLL), diameter stenosis, and minimal lumen diameter (MLD). Pooled odds ratios (OR) and weighted mean differences (WMD) with 95% confidence intervals (CI) were calculated by using random-effects models. RESULTS: A search of PubMed, EMBASE, and Cochrane Library from their inception to January 2024 identified five randomized clinical trials and three observational studies with a total of 1861 patients (889 in PCB and 972 in SCB groups). During 9-12 months of follow-up, there was no significant difference in TLF (OR 1.01, 95% CI 0.75-1.35) between the two groups. On follow-up angiography at 6-9 months, MLD (WMD 0.10, 95% CI 0.02-0.17) was larger in PCB but there was no statistically significant difference in LLL (WMD -0.11, 95% CI -0.23-0.02) and diameter stenosis (WMD -3.33, 95% CI -8.11-1.45). CONCLUSIONS: Among patients undergoing DCB-only PCI, the risk of TLF was similar during 9-12 months of follow-up after PCB and SCB treatment. However, the MLD was larger favoring PCB over SCB on follow-up angiography.

Optical Coherence Tomography Predictors of SIde Branch REstenosis after unprotected Left Main bifurcation angioplasty using double kissing crush technique (OP-SIBRE LM Study).

BACKGROUND: Among the two stent strategies, contemporary evidence favors double kissing crush technique (DKC) for complex unprotected distal left main bifurcation (UdLMB) lesions. However one of the major challenges to these lesions is side branch (SB) restenosis. AIMS: Our aim was to identify optical coherence tomographic (OCT) characteristics that may predict SB restenosis (SBR) after UdLMB angioplasty using DKC technique. METHODS: This was a single-center, retrospective study that included 60 patients with complex UdLMB disease, who underwent OCT-guided angioplasty using DKC technique. Angiographic follow-up was performed in all patients at 1 year to identify patients with SBR. Patients with SBR group were compared with patients without SBR (NSBR group) for OCT parameters during index procedure. RESULTS: Twelve (20%) patients developed SBR at 1-year follow-up. The SBR group had longer SB lesion (18.8 ± 3.2 vs. 15.3 ± 3.7 mm, p = 0.004) and neo-metallic carinal length (2.1 vs. 0.1 mm, p < 0.001) when compared to the NSBR group. Longer neo-metallic carinal length was associated with the absence of the dumbbell sign, presence of hanging stent struts across the SB ostium on OCT of final MB pullback. On multivariate regression analysis, SB distal reference diameter (DRD) and SB stent expansion were identified as independent predictors of SBR with SB-DRD of ≤2.8 mm (area under curve-0.73, sensitivity-83.3%, and specificity-62.5%) and SB stent expansion of ≤89% (area under curve-0.88, sensitivity-83.3%, and specificity- 81.2%) as the best cut off values to predict SBR. CONCLUSIONS: SB DRD and SB stent expansion are the OCT predictors of future SBR after UdLMB angioplasty using DKC technique.

Outcomes of Noncompliant Balloons in the Treatment of Lower Extremity Chronic Limb Threatening Ischemia: A Prospective Study.

PURPOSE: This is a prospective study to investigate the clinical outcomes of using noncompliant balloons in lower limb angioplasty for chronic limb threatening ischemia (CLTI). MATERIALS AND METHODS: This is a prospective single-center cohort study performed at a local tertiary hospital in Singapore. Consecutive patients who underwent lower limb angioplasty for CLTI using a noncompliant balloon catheter were enrolled if they were aged 40 years and above, presented with CLTI Rutherford grade 4 to 6, and had TASC C or D lesions in the lower limb vessels that were at least 100mm in length. Patient demographics, Rutherford grading, lesion characteristics, complications, and follow-up data were collected and analyzed. The primary outcomes were 30-day freedom from major adverse events, amputation-free survival (AFS) at 12 months, and freedom from clinically driven target lesion revascularization (cdTLR) at 12 months. Secondary outcomes included clinical success and target lesion primary patency (TLPP) at 12 months. Amputation-free survival, freedom from cdTLR, and TLPP were calculated by Kaplan-Meier analysis. RESULTS: From May 2020 to December 2021, 50 patients (50 limbs) were enrolled. 43 (86%) patients had diabetes mellitus, while 12 patients (24%) had end-stage renal failure. 85 lesions were treated, including 59 (69.4%) below-the-knee (BTK) lesions. All the lesions were TASC C (n=45, 52.9%) or TASC D (n=40, 47.1%) lesions. Mean lesion length was 231.4±116.2mm. Technical success rate was 96.5%. No patients were lost to follow-up. Median follow-up duration was 282 days (IQR: 31-390 days). One patient died on day 26 due to an acute myocardial infarction. Two patients had groin hematomas postprocedure, both of which were treated conservatively. AFS, freedom from cdTLR, and TLPP at 12 months postprocedure was 70.0% (95% confidence interval [CI]: 58.4%-83.9%), 90.1% (95% CI: 83.4%-97.4%), and 61.1% (95% CI: 50.7%-73.6%), respectively. CONCLUSION: Early results have shown that the use of a high-pressure, noncompliant balloon is effective in lower limb angioplasty for CLTI in a highly challenging group of patients with a high prevalence of long BTK disease. Good vessel patency and limb salvage rates can be achieved, with a low complication rate. We await more long-term outcomes on vessel patency. CLINICAL IMPACT: There are many devices in the market for use in lower limb angioplasty. However, many of them come with an increased financial cost, procedural time and procedural difficulty. We report our prospective results with the exclusive use of a high pressure, non-compliant balloon, in a challening group of patients with a high prevalence of diabetes and end stage renal failure, achieving amputation free surival at 6 and 12 months post-procedure of 84.0% and 70.0% respectively. The use of non-compliant balloon is technically easy and does not add additional steps compared to a standard POBA procedure, thus limiting costs. We believe this article can be a push factor for clinicians to consider the use of these high pressure, non-compliant balloons in their patient care.

The Untold Story: Early and Mid-Term Results of Subintimal Angioplasty in Superficial Femoral Artery Versus Popliteal Artery Chronic Total Occlusion.

OBJECTIVES: This study aims to compare the immediate and mid-term outcomes of subintimal angioplasty (SIA) of chronic total occlusions (CTOs) of superficial femoral artery (SFA) versus popliteal artery (PA) and to identify possible predictors of loss of limb-based patency (LBP). METHODS: This is a retrospective analysis of chronic lower-limb ischemia (CLI) patients (Rutherford classes 3-6) presenting with CTO of SFA or PA treated by SIA and selective stenting in the period 2018 to 2021. Immediate outcomes were compared between the SFA and PA groups, including technical success, perioperative complications, and 30-day major amputation and mortality rates. Mid-term outcomes for technically successful procedures included limb-based patency (LBP), wound healing rate, amputation-free survival (AFS), and major adverse limb events (MALEs). RESULTS: A total of 450 CLI patients underwent SIA of CTO at the SFA (n=260, 57.8%) and the PA (n=190, 42.2%). The indication for revascularization was chronic limb-threatening ischemia in 80.8% of SFA group and 84.2% of PA group. Technical success rate was higher in the PA group compared to the SFA group (96.3% vs 91.2%; p=0.03). The 30-day amputation rates were comparable between the SFA and PA groups (7.7% vs 6.8%, p=0.7, respectively). No perioperative mortality or systemic major complications occurred in the present study. Kaplan-Meier estimate of the 1-year rates were significantly better for SFA group regarding LBP (82% for SFA group vs 43% for PA group, p=0.006), AFS (88% vs 64%, p=0.02), and wound healing (79% vs 58%, p=0.027), respectively. The number of runoff vessels was the only factor associated with loss of LBP (hazard ratio [HR], 0.055; 95% confidence interval [CI]: 0.001-3.020, p=0.039). CONCLUSIONS: Subintimal angioplasty is an effective and safe endovascular treatment option of CTO at SFA and PA with satisfactory immediate outcomes. The mid-term outcomes, however, are better for SFA lesions in terms of improved LBP, AFS, and wound healing rates. CLINICAL IMPACT: Subintimal angioplasty is a valuable tool in the armamentarium of endovascular surgeons, as re-entry devices aren't always widely accessible. This study aims to assess the technical outcomes of peripheral vascular interventions for infrainguinal chronic total occlusions and identify possible predictors for successful subintimal angioplasty .Subintimal angioplasty is an effective treatment option for infrainguinal CTO with difference in result of immediate outcomes in popliteal lesions and SFA lesions.