Intravascular Lithotripsy for Treatment of Severely Calcified Common Femoral Artery Disease: Results From the Disrupt PAD III Observational Study.

BACKGROUND: Surgical endarterectomy is currently considered the front-line therapy for the treatment of calcified lesions in the common femoral artery (CFA). Endovascular interventions have evolved, and their use is increasing in frequency. Intravascular lithotripsy (IVL) has shown promising safety and effectiveness in calcified CFA lesions in a small pilot study, but "real-world" evidence from a larger cohort is lacking. METHODS: The Disrupt PAD III Observational Study (NCT02923193) was a prospective, multicenter registry designed to assess the acute safety and effectiveness of IVL treatment for calcified peripheral arterial disease. Any concomitant treatment with other calcium-modifying technologies as well as definitive treatment strategies was at the discretion of the operators. Patients with CFA lesions were evaluated for acute angiographic safety and effectiveness outcomes following IVL treatment as determined by an independent angiographic core lab. RESULTS: Common femoral artery treatment was indicated in 177 patients (n=163 could be analyzed based on core-laboratory data) enrolled at 23 sites. Characteristics for 164 treated lesions included moderate-severe calcification 95.1%, diameter stenosis 74.8±17.7%, and lesion length 53.6±53.1 mm. Concomitant calcium-modifying therapy was used in 32.3% of lesions. Final therapy included drug-coated balloons in 68.9% and stenting in 16.5% of lesions. Post-IVL and final residual stenoses were 29.2±16.5%and 23.6±11.5%, respectively. No vascular complications (flow-limiting dissections, perforations, embolization, slow or no reflow, or abrupt closure) were present at the end of the procedure by core-laboratory assessment, with 1 (0.8%) flow-limiting dissection initially occurring immediately following IVL treatment. CONCLUSION: This study represents the largest real-world experience of IVL treatment in heavily calcified CFA lesions. Intravascular lithotripsy treatment showed significant stenosis reduction and favorable periprocedural safety in this challenging patient population. CLINICAL IMPACT: In this study we show that calcified common femoral artery disease can be safely and effectively treated with shockwave balloon angioplasty with high procedural success and low complication rates and in clinical practice can now be offered as an alternative to surgical treatment in those patients reluctant to or high risk for vascular surgery. This opens another option for clinicians to treat calcified common femoral artery disease without the risk of dissection, perforation or distal embolization that are associated with atherectomy. This study shows that shockwave lithoplasty offers an innovative plaque modification technology to tackle calcified disease in the common femoral artery.

Percutaneous intervention of a giant native coronary artery aneurysm using self-expanding stents.

In the absence of standardized management guidelines, coronary artery aneurysms (CAAs) present therapeutic challenges. Percutaneous coronary intervention (PCI) is rarely explored, especially in giant aneurysms with persistent angina, where surgery might be presumed as a preferred option. We describe the technical aspects and feasibility of PCI using Gore Viabahn expanded polytetrafluoroethylene (ePTFE)-covered nitinol self-expanding stents in a 66-year-old woman with a complex medical history and an enlarging, symptomatic right coronary artery aneurysm. The case was complicated by endoleak after the first stent, but intravascular ultrasound guidance enabled the precise deployment of additional stents, resulting in the successful exclusion of the aneurysm. This case demonstrates steps to successful CAA PCI with Gore Viabahn ePTFE-covered nitinol self-expanding stents and emphasizes that in unsuitable surgical candidates, PCI might be a potential alternative for symptomatic CAAs.

Feasibility and Safety of High-Risk Percutaneous Coronary Intervention Without Mechanical Circulatory Support.

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PROMISE I: Early feasibility study of the LimFlow System for percutaneous deep vein arterialization in no-option chronic limb-threatening ischemia: 12-month results.

OBJECTIVE: We report the 6- and 12-month outcomes of the PROMISE I early feasibility study after treatment of no-option chronic limb-threatening ischemia (CLTI) with percutaneous deep vein arterialization (pDVA) using the LimFlow System. METHODS: Thirty-two patients with no-option CLTI, previously offered major amputation, were enrolled in this single-arm early feasibility study of the LimFlow pDVA System. No-option CLTI was defined as being ineligible for surgical or endovascular arterial revascularization. Patients were assessed for clinical status, pain, wound healing, and duplex ultrasound at 30 days, 6 months, and 12 months post-treatment. Primary endpoint analysis was amputation-free survival (AFS) at 30 days and 6 and 12 months. AFS was defined as freedom from above-ankle amputation of the index limb and freedom from all-cause mortality. Secondary endpoints evaluated included technical success of the procedure, and wound healing at 6 and 12 months. RESULTS: Of 32 enrolled patients, 31 (97%) were successfully treated with the LimFlow System at the time of the procedure, and two (6.3%) were lost to follow-up. The 30-day, 6-month, and 12-month AFS rates were 91%, 74%, and 70% respectively. The wound healing status of fully healed or healing was 67% at 6 months, and 75% at 12 months. Reintervention was performed in 16 patients (52%) with 14 (88%) of the maintenance reinterventions occurring within the first 3 months. The majority of reinterventions (n = 12; 75%), involved the arterial inflow tract proximal to the stented LimFlow circuit, and no in-stent stenoses were determined to have been the cause of reintervention. CONCLUSIONS: The LimFlow pDVA System was utilized in treating patients with no-option CLTI. A high technical success rate was observed, with a significant percentage of patients surviving free of major amputation at 12 months. These results suggest early safety and provide an initial assessment of the efficacy of the LimFlow pDVA System that supports the expansion of carefully executed studies to determine whether this is a viable option that can be used in this critically disadvantaged and growing patient population.

Cangrelor vs. glycoprotein IIb/IIIa inhibitors during percutaneous coronary intervention.

BACKGROUND: To date, there are no real-world studies comparing cangrelor to glycoprotein IIb/IIIa inhibitors (GPI) during percutaneous coronary intervention (PCI). Thus, we performed this study to evaluate the safety and effectiveness of cangrelor compared to GPI during PCI. METHODS: We identified patients who underwent PCI at our institution who received either cangrelor or GPI during PCI. Patients already on GPI or cangrelor prior to PCI or who received both cangrelor and GPI were excluded. Baseline demographics and clinical outcomes were extracted. Major bleeding is defined as a composite of major hematoma >4 cm, hematocrit drop >15, and gastrointestinal bleeding. RESULTS: A total of 2072 patients received adjunctive antiplatelet therapy during PCI (cangrelor [n=478]; GPI [n=1594]). Patients' mean age was 61±12 years. Most (66%) presented with acute coronary syndrome. Patients who received cangrelor were older and had a higher percentage of acute coronary syndrome and lower baseline hematocrit in comparison with patients who received GPI. Procedural success was achieved in 94% of patients, with no difference between groups. Major bleeding events (1.7% vs. 5.1%, P=.001), any vascular complication rates, and hospital length of stay were significantly lower in the cangrelor group. In-hospital ischemic events did not differ between groups. On regression analysis, patients on cangrelor were noted to have significantly lower major bleeding events (OR 0.23; 95% CI, 0.09-0.59). CONCLUSIONS: Balancing ischemic and bleeding risks with adjunctive antiplatelet drugs is of prime importance during PCI. Our real-world analysis shows that cangrelor is safe and effective when compared to GPI during PCI.

One-Year Outcomes After Treatment of Ostial In-Stent Restenosis in Left Circumflex Versus Left Anterior Descending or Right Coronary Artery.

The prognosis of left circumflex (LC) versus non-LC in-stent restenosis (ISR) ostial lesions following treatment has not been assessed. We aimed to assess this prognosis. Anecdotally, treatment of ostial LC ISR has been associated with high recurrence rates. We performed a retrospective analysis of patients from our institution who underwent coronary intervention of an ostial ISR lesion between 2003 and 2018. The primary endpoint was target lesion revascularization (TLR) and major adverse cardiovascular events (MACE). Overall, 563 patients underwent ostial ISR lesion intervention, 144 for an ostial LC ISR lesion. Compared to patients with ostial ISR in non-LC lesions, patients with ostial LC ISR were older, had higher rates of diabetes mellitus and previous coronary bypass surgery. At 1-year follow-up, TLR-MACE rates were 26.6% in the LC group versus 18.4% in the non-LC group (p = 0.036). The TLR rate was also higher in the LC group compared to the non-LC group (p = 0.0498). Univariate and multivariate analyses demonstrated a higher TLR-MACE rate for LC versus non-LC ostial ISR lesions. In conclusion, our study shows increased event rates after treatment of LC versus non-LC ISR lesions. Further studies should be done to assess the optimal treatment approach for ostial LC ISR.

Adverse events and modes of failure related to the FilterWire EZ Embolic Protection System: Lessons learned from an analytic review of the FDA MAUDE database.

OBJECTIVES: To assess the commonly reported complications and failure modes for FilterWire EZ Embolic Protection Devices (EPD) by analyzing the postmarketing surveillance data from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. BACKGROUND: EPDs prevent distal embolization of atheroembolic materials during percutaneous interventions resulting in reduced microvascular obstruction and improved microcirculation while maintaining tissue perfusion. The FilterWire EZ EPD (Boston Scientific, Natick, MA) is approved for use in interventions of de novo saphenous vein grafts (SVG) and carotid artery stenosis. Robust data on the commonly reported complications and failure modes associated with the FilterWire EZ device are limited. METHODS: The MAUDE database was queried from September 1, 2008, through September 30, 2018, for FilterWire EZ system, yielding 474 reports. After exclusion of duplicate and incomplete reports, 464 device reports were included in the final analysis. RESULTS: Device-related adverse events were most commonly reported for carotid (n = 281) and SVG (n = 101) interventions. The most commonly reported major complications were: ischemic stroke (n = 57), vessel perforation or dissection (n = 12), death (n = 8), and myocardial infarction (n = 5). Minor complications included: hypotension (n = 68), bradycardia (n = 41), and vasospasm (n = 27). The most commonly reported failure modes were: detachment and/or damage of the device components (n = 118), device entrapment (n = 90), and stent-related issues (n = 46). CONCLUSIONS: Analysis of the MAUDE dataset is helpful in identifying the commonly reported adverse events and failure modes of FilterWire EZ devices. This platform serves as an important tool for both physicians and manufacturers to optimize device performance and clinical outcomes.

Adverse Events and Modes of Failure Related to Impella RP: Insights from the Manufacturer and User Facility Device Experience (MAUDE) Database.

BACKGROUND/PURPOSE: Right ventricular (RV) mechanical circulatory support remains an important adjunctive therapy for RV failure refractory to medical therapy. Impella RP (Abiomed, Danvers, MA) is approved for providing temporary RV support for patients with acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery. Robust data on the most commonly reported complications and failure modes for the Impella RP are lacking. We analyzed the post-marketing surveillance data from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database to assess these endpoints. MATERIALS/METHODS: The MAUDE database was queried for the time period January 1, 2009, through December 31, 2018, for Impella devices by Searching for the following event types: "injury", "malfunction", "death", and "other". The search yielded 436 device reports. Impella RP medical device reports were screened, and 35 reports were included for the final analysis. RESULTS: In cases of reported complications, Impella RP was placed most commonly for right ventricular failure (RVF) developing in postcardiotomy patients (20%). The most commonly reported complications included bleeding (42.9%) and vascular complications (22.8%). The modes of failure included damage or fracture of the device elements (34.2%); thrombus, or clot in the system (17.1%); and device detachment (8.6%). CONCLUSIONS: Findings from the MAUDE database highlight the failure modes of the Impella RP device that should be addressed in order to improve the device performance and obtain improved clinical outcomes when utilized for RVF.

Relation of Sex and Race to Outcomes in Patients Undergoing Percutaneous Intervention With Drug-Eluting Stents.

Cardiovascular disease is the leading cause of death in men and women, black and white. However, there exists limited outcomes data for women and blacks after percutaneous coronary intervention (PCI). The aim of this study was to evaluate the 1-year major cardiovascular events in patients who underwent PCI based on gender and race. We retrospectively analyzed data that were prospectively collected over 13 years at a large tertiary hospital in the United States. There were 12,050 patients who underwent PCI for both stable disease and acute coronary syndrome from 2003 to 2016. Of those, 1,952 were black men, 6,013 white men, 1,619 black women, and 2,466 white women. Major cardiovascular events at 1 year were assessed, and proportional Cox hazard model analyses were performed to assess outcome adjusted for confounding factors (i.e., age, body mass index, presentation with acute myocardial infarction, diabetes, smoking, history of coronary artery disease, family history of coronary artery disease, hyperlipidemia, hypertension, previous cardiovascular intervention, and chronic kidney disease). At 1 year, white men had significantly lower major cardiovascular events driven by lower rate of death compared with the other groups. Adjusted for confounders, major cardiovascular events were 1.3 to 1.5 times more likely to occur in black men and women and white women than in white men. There was a significant race by gender interaction (p <0.001).

Comparison of treatment strategies for femoro-popliteal disease: A network meta-analysis.

OBJECTIVES: We sought to compare treatment strategies in a Bayesian network meta-analysis of randomized controlled trials. BACKGROUND: Peripheral artery disease (PAD) is a prevalent morbidity that is treated with various strategies. METHODS: We performed a MEDLINE search for randomized studies comparing at least 2 treatment strategies, including bypass surgery, percutaneous transluminal angioplasty (PTA) balloons, stents, covered stents, drug-eluting stents (DES), and drug-coated balloons (DCB), in patients with native femoro-popliteal disease. Mixed treatment comparison model generation was performed to directly and indirectly compare the strategies in terms of restenosis and target lesion revascularization (TLR) presented as odds ratios (OR, [95% credible intervals]). RESULTS: Twenty-nine studies with 4,820 patients were included in the present study. PTA was the largest group with 1,900 patients, followed by DCB (n = 1,343), bare metal stents (n = 941), covered stents (n = 304), DES (n = 236), and bypass (n = 92). Mean age was 68 ± 9 years, 64% were male, 37% diabetic, and 55% smokers. Mean lesion length was 77 ± 44 mm, and 39% were total occlusions. Bayesian hierarchical random-effects model demonstrated all treatments were significantly better than, or had a trend toward superiority over, PTA, with DCB ranking well in both restenosis (OR = 0.29, [0.17-0.47]) and TLR (OR = 0.31, [0.20-0.46]). Nonetheless, none of the therapies showed superiority in terms of survival or amputations. CONCLUSION: Treatment of femoro-popliteal disease has significantly evolved in recent years, with higher rates of patency and freedom from TLR. However, the utility of these treatment strategies in terms of reduction of amputations and overall survival remains in question.

Vascular access in critical limb ischemia.

Currently, percutaneous endovascular intervention is considered a first line of therapy for treating patients with critical limb ischemia. As the result of remarkable development of techniques and technologies, percutaneous endovascular intervention has led to rates of limb salvage comparable to those achieved with bypass surgery, with fewer complications, even in the presence of lower rates of long-term patency. Currently, interventionalists have a multiplicity of access routes including smaller arteries, with both antegrade and retrograde approaches. Therefore, the choice of the optimal access site has become an integral part of the success of the percutaneous intervention. By understanding the technical aspects, as well as the advantages and limitations of each approach, the interventionalists can improve clinical outcomes in patients with severe peripheral arterial disease. This article reviews the access routes in critical limb ischemia, their advantages and disadvantages, and the clinical outcomes of each.

Innovative use of self-expanded polytetrafluoroethylene endoprosthesis for percutaneous endovascular interventions.

VIABAHN® endoprosthesis (Gore & Associates, Flagstaff, AZ), a nitinol self-expanding polytetrafluoroethylene (PTFE) lined stent, has demonstrated utility for percutaneous treatment of chronic occlusive disease involving the superficial femoral artery. In a case series communication we aimed to describe the feasibility of a PTFE-lined stent for percutaneous treatment of conditions other than chronic occlusive disease. We report the successful use of PTFE-endoprosthesis to percutaneously treat several vascular conditions, including arterio-venous fistula closure, reconstruction of a distal limb of an aorto-femoral endoprosthesis aneurysm, femoral artery perforation repair, and an exclusion of large saphenous vein graft aorto-coronary bypass aneurysm. This case series illustrates the feasibility of the "off-label" use of self-expanded PTFE endoprosthesis to percutaneously treat several conditions, which would otherwise require "open" surgical reconstructions.

Clinical outcomes and treatment after drug-eluting stent failure: the absence of traditional risk factors for in-stent restenosis.

BACKGROUND: The optimal percutaneous treatment of drug-eluting stent (DES) in-stent restenosis (ISR) and the correlates for recurrent DES ISR remain unclear. METHODS AND RESULTS: From 2003 to 2008, 563 patients presenting with recurrent symptoms of ischemia and angiographic ISR after DES implantation were included. Of these, 327 were treated with re-DES (58.1%), 132 underwent vascular brachytherapy (23.4%), and 104 were treated with conventional balloon angioplasty (18.5%). Variables associated with target lesion revascularization at 1 year were explored by individual proportional hazard models. This population presents a high prevalence of comorbidities, including diabetes (43.7%), previous myocardial infarction (MI) (45.8%), coronary bypass graft surgery (39.2%), chronic renal failure (18.8%), and heart failure (17.3%). Baseline clinical characteristics were balanced among the 3 groups; however, patients undergoing vascular brachytherapy presented with more complex lesions and a higher prevalence of prior stent/vascular brachytherapy failure than did the rest of the population. The overall incidence of recurrent DES failure at 1-year follow-up was 12.2%, which was similar among the 3 groups (P=0.41). The rate of the composite end point (death, Q-wave-MI and target lesion revascularization) at 1-year follow-up was 14.1% for re-DES, 17.5% for vascular brachytherapy, and 18.0% for conventional balloon angioplasty (P=0.57). After univariable analysis tested the traditional known covariates related to ISR, none of them were associated with repeat target lesion revascularization. CONCLUSIONS: Recurrence of ISR after DES treatment failure is neither infrequent nor benign, and optimal therapy remains unclear and challenging. Given the absence of traditional risk factors for ISR in this population, further research is required to elucidate both the correlates involved in DES ISR and the optimal treatment for this condition.

Diagnóstico diferencial da dor torácica: ênfase em causas não coronarianas / Diferential diagnosis of chest pain: enphasis on non coronary causes

Revisa-se a abordagem do paciente com dor torácica e discutem-se seus principais diagnósticos diferencias. Serão abordadas, especialmente, as dores de origem musculoesquelética, gastrointestinal, psicogênica e pulmonar, além das de origem cardíaca e isquêmica.

Reviews the current approach to the patient with chest pain complain, discussing the main diferential diagnosis. Although the studies show that most these pains are of noncardiac orgin, anciliary exams made have as their objectivies discard coronary diseases and other fatal patologies. Since the non ischemic causes are more prevalent in the medical practice we will discuss in this article the musculoskeletal, gastrointestinal orgin, psicogenic, pulmonary orgin pains, other than ischemic pain.

Abordagem conservadora de lesão renal em vítima de trauma toracoabdominal contuso / Conservative manegement of renal injury in blunt abdominal trauma

No trauma contuso de abdômen, a prioridade do cirurgião é investigar a presença ou a ausência de lesão visceral valendo-se do exame clínico e de métodos de imagem apropriados. O objetivo deste relato de caso é descrever vítima de trauma abdominal contuso, admitida no setor de politraumatizados do HPSJXXIII, em que houve necessidade de tratamento conservador de lesão renal grau IV-V.

Lunt abdominal trauma the priority of the surgeon must be search either trhe presence or the absence of visceral injuries essentialy after clinical exam and appropriate diagnostic imaging. The objective of this case report is to describe a patient victim of blunt abdominal, trauma admitted to HJPSXXIIIÆs trauma section, which had the need of conservative management after a level IV kidney injury.

A further word of caution before using the internal mammary artery for coronary revascularization in patients with severe peripheral vascular disease!

OBJECTIVES: To characterize the clinical and angiographic characteristics of patients with collateralization from the internal mammary artery to the iliac artery. BACKGROUND: The use of the internal mammary arteries for coronary revascularization has become the standard of care in coronary artery bypass grafting (CABG). However, in patients with aortoiliac disease, the internal mammary arteries may become a major collateral route to the lower extremities. METHODS: A case series of 15 patients admitted for diagnostic coronary angiography were retrospectively identified, who were observed to have collateral flow from one or both internal mammary artery(ies) to an occluded or stenotic iliac artery. RESULTS: The mean age was 63.2 +/- 11.2 years; eight were men (53.3%). Coronary angiography was done as a perioperative evaluation for peripheral vascular surgery in three patients (20%) and was done because of cardiac symptoms or a positive thallium scan in 12 (80%). The finding that the mammary artery collateralized the iliac artery led to major treatment changes in all patients, seven (46.6%) who required CABG. In five patients (33%), use of one or both internal mammary artery(ies) for coronary grafts was avoided. CABG was deferred in one patient, whereas in another, percutaneous intervention in both iliac arteries preceded CABG using both mammary arteries. There was no incidence of postoperative acute lower extremity ischemia. CONCLUSIONS: Selective angiographic visualization of the internal mammary artery is an essential part of the preoperative evaluation in patients with severe peripheral vascular disease undergoing CABG.