ABSTRACT
PURPOSE: To report the results of a study evaluating JetStream atherectomy for the treatment of in-stent restenosis (ISR). MATERIALS AND METHODS: The JetStream XC atherectomy device, a rotational cutter with aspiration capacity, was evaluated in a prospective, multicenter study (JET-ISR) of 60 patients (mean age 70.2±10.8 years; 40 men) with femoropopliteal ISR (ClinicalTrials.gov identifier NCT02730234). Lesion length was 19.9±13.5 cm; 33 (55%) were chronic total occlusions and 26 (45%) were TransAtlantic Inter-Society Consensus class D. No drug-bearing device was allowed, and stenting was performed only for bailout. Lesion characteristics and stent integrity were evaluated by an independent core laboratory. The primary endpoint was target lesion revascularization (TLR) at 6 months with bailout stenting considered as TLR. Secondary endpoints included TLR (without bailout stenting) and clinical patency (no restenosis or TLR) at 1 year. The Kaplan-Meier method was employed to evaluate time-to-event endpoints; estimates are given with 95% confidence interval (CI). RESULTS: Bailout stenting was required in 6 of 60 limbs (10%). There were no stent fractures or deformities after atherectomy + adjunctive angioplasty reported by the core laboratory. Kaplan-Meier estimates of freedom from TLR at 6 months and 1 year were 79.3% (95% CI 68.9% to 89.8%) and 60.7% (95% CI 47.8% to 73.6%), respectively. When bailout stenting at the index procedure was not considered a TLR event, freedom from TLR estimates at 6 months and 1 year were 89.3% (95% CI 81.2% to 97.4%) and 66.8% (95% CI 54.3% to 74.2%), respectively. Clinical patency rates at 6 months and 1 year were 77.5% (31/40) and 51.7% (15/29), respectively. CONCLUSION: JetStream atherectomy using the XC device and no drug-eluting devices is feasible, with good clinical patency and 1-year freedom from TLR.
Subject(s)
Peripheral Arterial Disease , Aged , Aged, 80 and over , Angioplasty, Balloon/adverse effects , Atherectomy/adverse effects , Coronary Restenosis , Female , Femoral Artery/diagnostic imaging , Femoral Artery/surgery , Humans , Male , Middle Aged , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/therapy , Popliteal Artery/diagnostic imaging , Popliteal Artery/surgery , Prospective Studies , Retrospective Studies , Treatment Outcome , Vascular PatencyABSTRACT
PURPOSE: To validate 3 angiographic scoring systems for peripheral artery calcification using intravascular ultrasound (IVUS) as the gold standard. METHODS: The study employed preprocedure angiography and IVUS data from 47 patients (median age 72 years; 34 men) in the 55-patient JetStream G3 Calcium Study ( ClinicalTrials.gov identifier NCT01273623) to validate the 3 angiographic scoring systems [Peripheral Academic Research Consortium (PARC), Peripheral Arterial Calcium Scoring System (PACSS), and the DEFINITIVE Ca++ trial]. Preprocedure angiograms were analyzed using conventional quantitative vessel analysis software in 2 orthogonal views. Calcium length was evaluated by markers placed beside the artery during the procedure; calcium deposit(s) were assessed as being on one or both sides of the vessel wall. The 3 calcium scoring systems used these 2 basic angiographic elements to evaluate calcium severity. Based on these criteria, calcium severity varied from none to focal, mild, moderate, or severe in PARC; grade 0 to 4 in PACSS; and none, moderate, or severe in the DEFINITIVE Ca++ system. Calcium location on IVUS was classified as superficial, deep, or mixed. Lesion length was the segment between the most normal looking proximal and distal reference sites. Superficial, deep, and calcium length were based on motorized IVUS pullback. RESULTS: IVUS detected calcium in 44/47 (93.6%) lesions, and angiography detected calcium in 26/47 (55.3%) lesions (p<0.001). The sensitivity, specificity, positive predictive value, and negative predictive value of angiography relative to IVUS were 59%, 100%, 100%, and 14%, respectively. With increasing severity of angiographic calcium, there was a stepwise increase in the prevalence of IVUS superficial calcium and the maximum arc and length of superficial calcium. Using PARC criteria, with increasing severity of calcification, IVUS maximum calcium arc increased from 120° for none to 305° for severe (p<0.001); the length of calcium increased from 7 to 68 mm (p<0.001). Though a similar trend was seen in IVUS superficial calcium, it was not observed in IVUS deep calcium. Similar observations were seen when using the PACSS and DEFINITIVE Ca++ scoring systems. CONCLUSION: IVUS confirmed that the PARC, PACSS, and DEFINITIVE Ca++ calcium scoring systems can be used to classify the degree of calcium in peripheral artery disease, especially superficial calcium.
Subject(s)
Angiography/methods , Peripheral Arterial Disease/diagnostic imaging , Ultrasonography, Interventional , Vascular Calcification/diagnostic imaging , Aged , Female , Humans , Male , Predictive Value of Tests , Prospective Studies , Radiographic Image Interpretation, Computer-Assisted , Reproducibility of Results , Severity of Illness IndexABSTRACT
Left atrial masses are rare but clinically significant findings, which can present as diverse pathological entities, including primary tumors, thrombi, and metastases. Their diverse pathological entities contribute to a wide range of clinical manifestations, often presenting with nonspecific symptoms that pose challenges for early diagnosis. Within the realm of medicine, unique presentations emphasize the intricate interplay between the size, location, and functional impact of pathological processes. They serve as reminders to healthcare providers to approach each patient as an individual, recognizing that even seemingly minor abnormalities can have significant consequences. To illustrate this, we present two distinct cases of patients with left atrial masses, showcasing the importance of clinical suspicion and a wide knowledge base in identifying and managing these conditions effectively.
ABSTRACT
We present an unusual case of a geriatric patient with right-sided cardiac displacement and rotation (Pseudo-Dextrocardia) secondary to radiation-induced pulmonary fibrosis (RIPF) after radiation for carcinoma of the right breast. This patient with heart failure with reduced ejection fraction (HFrEF) underwent cardiac resynchronization therapy with a defibrillator (CRT-D) for primary prevention of sudden cardiac death. Cannulization of the coronary sinus ostium was difficult, likely due to the significant cardiac displacement. However, after multiple attempts, it was eventually successful. The clinical manifestations, evaluation, and technical and procedural issues in this patient with an unusual anatomic variant are summarized.
ABSTRACT
A 40-year-old woman presented with recurrent pericarditis and pericardial effusion while receiving treatment with all-trans retinoic acid and arsenic trioxide for recently diagnosed acute promyelocytic leukemia. She was successfully treated with the interleukin-1 inhibitor rilonacept after experiencing multiple recurrences with triple therapy with aspirin, colchicine, and steroids. (Level of Difficulty: Advanced.).
ABSTRACT
AIMS: Endovascular treatment of calcified femoral-popliteal disease is challenging. We sought to evaluate the mechanism of lumen gain when using the JETSTREAM Atherectomy System to treat calcified peripheral artery lesions. METHODS AND RESULTS: The JETSTREAM Calcium Study was a prospective, single-arm, multicentre study to evaluate the JETSTREAM Atherectomy System for severely calcified femoral-popliteal artery lesions, i.e., patients with claudication and lesions with superficial calcium >90° and >5 mm in length as determined by intravascular ultrasound (IVUS). The 2.1 mm catheter was used in this study without distal protection. Fifty-five patients underwent angiographic screening: 26 (45%) met IVUS inclusion criteria. Angiographic calcium was moderate in eight cases and severe in 14, with no available data for four cases. Visual diameter stenosis was 86±9% pre-treatment, 37±13% post atherectomy, and 10±6% post adjunctive treatment (adjunctive PTA+stenting in eight and adjunct PTA alone in 16). IVUS showed lumen area increased from 6.6±3.7 mm2 to 10.0±3.6 mm2 (p=0.001): calcium reduction was responsible for 86±23% of the lumen increase. Although the superficial calcium arc did not change (151±70° to 146±71°, p=0.83), the arc of reverberation increased (23±20° to 65±40°, p=0.006), indicating device-related modification of calcium. Adjunctive balloon angioplasty was performed in 62% of the lesions, and stent implantation in 31%. In 11 cases with adjunctive balloon dilation, the MLA increased from 7.1 (6.4, 7.8) mm2 post atherectomy to 11.9 (10.3, 13.5) mm2 post balloon (p<0.001) without flow-limiting dissection. No major adverse events occurred up to 30 days post procedure in either the study group or the patients who were excluded from the analysis. CONCLUSIONS: The JETSTREAM Atherectomy System increased lumen dimensions in moderately or severely calcified femoral-popliteal lesions by removing superficial calcium without major complications.
Subject(s)
Atherectomy/methods , Femoral Artery/diagnostic imaging , Peripheral Arterial Disease/therapy , Popliteal Artery/diagnostic imaging , Ultrasonography, Interventional , Vascular Calcification/therapy , Aged , Aged, 80 and over , Angioplasty, Balloon/instrumentation , Atherectomy/instrumentation , Constriction, Pathologic , Equipment Design , Female , Humans , Male , Middle Aged , Peripheral Arterial Disease/diagnostic imaging , Predictive Value of Tests , Prospective Studies , Radiography , Severity of Illness Index , Stents , Treatment Outcome , Vascular Access Devices , Vascular Calcification/diagnostic imagingABSTRACT
Optical coherent reflectometry, a forward-looking, fiberoptic-guided device was used in 72 patients to direct radiofrequency energy across the central intraluminal portion of 75 chronic total occlusions in peripheral arteries (iliac, femoral, and popliteal) that failed attempts with conventional guidewires. The system was successful in crossing 76% of the chronic total occlusions with no clinical perforations or distal embolizations, and complications consisted of a single dissection greater than or equal to grade C.
Subject(s)
Arterial Occlusive Diseases/surgery , Catheter Ablation , Aged , Chronic Disease , Female , Fiber Optic Technology , Humans , Male , Prospective StudiesABSTRACT
Although randomized clinical trials have demonstrated efficacy of coronary irradiation versus placebo for the treatment of in-stent restenosis (ISR), durable long-term benefit in community practice is less well defined. From January 1, 2001, through June 30, 2002, consecutive percutaneous coronary intervention (n = 3,869) were analyzed at our center with a total of 330 patients undergoing coronary irradiation for ISR (53, Ir192; 12, P32; 265 Novoste Sr90). Novoste Sr90 was successfully performed in 265 of 270 (98%) of patients attempted by 10 operators. The mean patient age was 63 years (range 35 90) with 55% male (145/265) and 45% female (120/265). ISR anatomic subsets included multi-lesion (45/265; 17%), multi-vessel (27/265; 10.0%) and saphenous vein graft (16/265; 6.0%) interventions. At a mean follow-up of 10.5 2.8 (SD) months, fifty-three (20%) of the Novoste Sr90 treated patients had returned for symptoms requiring repeat angiography. Of these, 23 patients had repeat percutaneous coronary intervention (PCI) including 2 target site revascularizations (TSR), twelve non-TSR (distinct from the radiated segment of the target vessel), and 9 non-target vessel revascularizations (TVR). Coronary artery bypass surgery was performed in 11 total patients, 4 due to TSR, and 7 due to non-TVR. Clinical TSR was 2.3% (6/265) and TVR was 6.8% (18/265). In conclusion, the Novoste SR90 Beta-Cath System for the treatment of ISR is associated with a high procedural success rate and low TSR and TVR. Revascularization in follow-up is predominantly due to progressive disease outside the radiated segment and aggressive secondary prevention, especially prolonged anti-platelet therapy, appear critical to long-term procedural success.
Subject(s)
Beta Particles/therapeutic use , Community Health Services , Coronary Restenosis/radiotherapy , Stents , Strontium Radioisotopes/therapeutic use , Adult , Aged , Aged, 80 and over , Angioplasty, Balloon, Coronary , Coronary Disease/complications , Coronary Disease/diagnostic imaging , Coronary Disease/therapy , Coronary Restenosis/diagnostic imaging , Coronary Restenosis/etiology , Female , Follow-Up Studies , Humans , Male , Middle Aged , Ohio , Radiography , Stents/adverse effects , Treatment OutcomeABSTRACT
Endovascular therapy for disease of the superficial femoral artery (SFA) and the popliteal artery remains controversial. Percutaneous treatment of this arterial segment presents a particular technical challenge, as the extent of disease varies from short, focal, and stenotic to long, diffuse, and occluded lesions. Over the last 2 decades, multiple therapies have been evaluated, including simple balloon angioplasty, directional atherectomy, stenting (both balloon-expandable and self-expanding), and more recently, intra-arterial radiation, laser, and cryotherapy. Regardless of which modality is used, however, endovascular therapy as a revascularization strategy has the potential to improve symptoms and quality of life and, in selected patients, to avoid limb amputation. While percutaneous endovascular treatment has been historically associated with high procedural success and favorable short and intermediate-term patency rates, long-term clinical results have proven disappointing. Conventional balloon angioplasty is limited by elastic recoil, dissection, and restenosis. Balloon-expandable stents (particularly in the distal SFA) are associated with late stent deformation and mechanical compression, with resultant late clinical failure. Newer self-expanding stents have shown improved initial results but have been limited by late mechanical fatigue and associated restenosis. With the development of several newer endovascular techniques in recent years, the possibilities for treating this condition have increased dramatically. Currently, no long-term comparative data exist regarding the role of these alternative technologies. This article summarizes and compares important data about new endovascular options for intervention therapy in SFA and popliteal disease. In addition, based on this analysis, we propose a contemporary treatment strategy, integrating older and newer technologies into a real-world algorithm.