Clinical, Functional, and Quality of Life Outcomes after Computer Assisted Vacuum Thrombectomy for Pulmonary Embolism: Interim Analysis of the STRIKE-PE Study.

PURPOSE: To report 90-day results from the first interim analysis of the STRIKE-PE study, which is evaluating safety, effectiveness, and functional and quality of life (QoL) outcomes of Computer Assisted Vacuum Thrombectomy (CAVT) with the Indigo Aspiration System for the treatment of acute pulmonary embolism (PE). METHODS: STRIKE-PE is a prospective, international, multicenter study that will enroll 600 adult patients with acute PE of ≤14 days and a right ventricle/left ventricle (RV/LV) ratio of ≥0.9 who receive first-line endovascular treatment with CAVT. Primary endpoints are change in RV/LV ratio and incidence of composite major adverse events (MAEs) within 48 hours. Secondary endpoints include functional and QoL assessments. RESULTS: The first 150 consecutive patients were treated with Lightning 12 CAVT. Mean age was 61.3 years, 54.7% were men, 94.7% presented with intermediate-risk PE, and 5.3% presented with high-risk PE. Median thrombectomy and procedure times were 33.5 minutes and 70 minutes, respectively, resulting in a mean reduction in systolic pulmonary artery pressure of 16.3% (P < .001). Mean RV/LV ratio decreased from 1.39 before thrombectomy to 1.01 at 48 hours, a 25.7% reduction (P < .001). Four patients (2.7%) experienced a composite MAE within 48 hours. At 90-day follow-up, patients exhibited statistically significant improvements in the Borg dyspnea scale and QoL measures, and the NYHA class distribution returned to that reported before the index PE. CONCLUSION: These interim results demonstrate a rapid reduction in RV/LV ratio, achieved with a fast thrombectomy time while maintaining safety. This is accompanied by improvements in 90-day functional and QoL outcomes.

Paclitaxel-Coated Balloon vs Uncoated Balloon for Coronary In-Stent Restenosis: The AGENT IDE Randomized Clinical Trial.

Importance: Drug-coated balloons offer a potentially beneficial treatment strategy for the management of coronary in-stent restenosis. However, none have been previously evaluated or approved for use in coronary circulation in the United States. Objective: To evaluate whether a paclitaxel-coated balloon is superior to an uncoated balloon in patients with in-stent restenosis undergoing percutaneous coronary intervention. Design, Setting, and Participants: AGENT IDE, a multicenter randomized clinical trial, enrolled 600 patients with in-stent restenosis (lesion length <26 mm and reference vessel diameter >2.0 mm to ≤4.0 mm) at 40 centers across the United States between May 2021 and August 2022. One-year clinical follow-up was completed on October 2, 2023. Interventions: Participants were randomized in a 2:1 allocation to undergo treatment with a paclitaxel-coated (n = 406) or an uncoated (n = 194) balloon. Main Outcomes and Measures: The primary end point of 1-year target lesion failure-defined as the composite of ischemia-driven target lesion revascularization, target vessel-related myocardial infarction, or cardiac death-was tested for superiority. Results: Among 600 randomized patients (mean age, 68 years; 157 females [26.2%]; 42 Black [7%], 35 Hispanic [6%] individuals), 574 (95.7%) completed 1-year follow-up. The primary end point at 1 year occurred in 17.9% in the paclitaxel-coated balloon group vs 28.6% in the uncoated balloon group, meeting the criteria for superiority (hazard ratio [HR], 0.59 [95% CI, 0.42-0.84]; 2-sided P = .003). Target lesion revascularization (13.0% vs 24.7%; HR, 0.50 [95% CI, 0.34-0.74]; P = .001) and target vessel-related myocardial infarction (5.8% vs 11.1%; HR, 0.51 [95% CI, 0.28-0.92]; P = .02) occurred less frequently among patients treated with paclitaxel-coated balloon. The rate of cardiac death was 2.9% vs 1.6% (HR, 1.75 [95% CI, 0.49-6.28]; P = .38) in the coated vs uncoated balloon groups, respectively. Conclusions and Relevance: Among patients undergoing coronary angioplasty for in-stent restenosis, a paclitaxel-coated balloon was superior to an uncoated balloon with respect to the composite end point of target lesion failure. Paclitaxel-coated balloons are an effective treatment option for patients with coronary in-stent restenosis. Trial Registration: ClinicalTrials.gov Identifier: NCT04647253.

Long term recovery of right ventricular function after treatment of intermediate and high risk pulmonary emboli.

INTRODUCTION: Pulmonary embolism (PE) is a common and significant source of mortality and morbidity worldwide. A subset of patients with PE, particularly those who have intermediate and high risk events, are at increased risk for long-term right ventricular (RV) dysfunction; however, the impact of novel advanced therapies used for acute PE, including catheter-directed intervention, on long-term RV function remains uncertain. We sought to determine whether use of advanced therapies (catheter-directed intervention or systemic thrombolysis) is associated with improved long-term RV function. MATERIALS AND METHODS: Retrospective, single-center cohort study of adult (≥18 year old) patients admitted and discharged alive with a diagnosis of acute PE, who fell under the category of intermediate or high risk, with available follow-up echocardiograms at least 6 months after the index, seen at a single quaternary referral center in Los Angeles, CA between 2012 and 2021. RESULTS: There were 113 patients in this study (58 (51.3 %) treated with anticoagulation alone, 12 (10.6 %) treated with systemic thrombolysis, and 43 (38.1 %) treated with catheter-directed intervention), with approximately equal gender and racial distribution. Patients treated with advanced therapies were significantly more likely to have moderate-severe RV dysfunction (100 % for those treated with thrombolysis, 88.3 % for those treated with catheter-directed intervention, vs 55.2 % for those treated with anticoagulation alone; p < 0.001). At a follow-up of about 1.5 years, patients treated with advanced therapy (systemic thrombolysis or catheter-directed intervention) were more likely to have normalization of RV function (93-100 % vs 81 % for anticoagulation alone, p = 0.04). The subgroup of patients with intermediate-risk PE was significantly more likely to have normalization of RV function (95.6 % vs 80.4 % for anticoagulation alone, p = 0.03). Use of advanced therapy was not associated with substantial short-term adverse events among patients who survived to hospital discharge. CONCLUSION: Patients with intermediate and high risk PE were more likely to have recovery in RV function long-term if treated with catheter-directed intervention or systemic thrombolysis, as compared to anticoagulation alone, without substantial safety issues, despite having worse RV function at baseline. Further data is needed to verify this observation.

Sustained Mechanical Aspiration Thrombectomy for High Thrombus Burden Coronary Vessel Occlusion: The Multicenter CHEETAH Study.

BACKGROUND: Poor myocardial reperfusion due to distal embolization and microvascular obstruction after percutaneous coronary intervention is associated with increased risk of morbidity and mortality. Prior trials have not shown a clear benefit of routine manual aspiration thrombectomy. Sustained mechanical aspiration may mitigate this risk and improve outcomes. The objective of this study is to evaluate sustained mechanical aspiration thrombectomy before percutaneous coronary intervention in high thrombus burden acute coronary syndrome patients. METHODS: This prospective study evaluated the Indigo CAT RX Aspiration System (Penumbra Inc, Alameda CA) for sustained mechanical aspiration thrombectomy before percutaneous coronary intervention at 25 hospitals across the USA. Adults presenting within 12 hours of symptom onset with high thrombus burden and target lesion(s) located in a native coronary artery were eligible. The primary end point was a composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York Heart Association class IV heart failure within 30 days. Secondary end points included Thrombolysis in Myocardial Infarction thrombus grade, Thrombolysis in Myocardial Infarction flow, myocardial blush grade, stroke, and device-related serious adverse events. RESULTS: From August 2019 through December 2020, a total of 400 patients were enrolled (mean age 60.4 years, 76.25% male). The primary composite end point rate was 3.60% (14/389 [95% CI, 2.0-6.0%]). Rate of stroke within 30 days was 0.77%. Final rates of Thrombolysis in Myocardial Infarction thrombus grade 0, Thrombolysis in Myocardial Infarction flow 3, and myocardial blush grade 3 were 99.50%, 97.50%, and 99.75%, respectively. No device-related serious adverse events occurred. CONCLUSIONS: Sustained mechanical aspiration before percutaneous coronary intervention in high thrombus burden acute coronary syndrome patients was safe and was associated with high rates of thrombus removal, flow restoration, and normal myocardial perfusion on final angiography.

Continuous mechanical aspiration thrombectomy performs equally well in main versus branch pulmonary emboli: A subgroup analysis of the EXTRACT-PE trial.

INTRODUCTION: The EXTRACT-PE trial evaluated the safety and performance of the Indigo Aspiration System (Penumbra Inc.) with an 8F continuous mechanical aspiration thrombectomy system for the treatment of pulmonary embolism (PE). This subgroup analysis evaluates performance outcomes of patients with main pulmonary artery (PA) emboli versus discrete unilateral or bilateral PA emboli without main PA involvement. METHODS: The EXTRACT-PE trial was a prospective, single-arm, multicenter trial that enrolled 119 patients with acute submassive PE. Emboli location was collected at the time of enrollment, CT obstruction was measured and assessed by a Core Lab, and patients were grouped on whether emboli involved the main PA (with or without branch vessels) or not (branch vessels alone). Procedural device time, changes in the right ventricle to left ventricle (RV/LV) ratio, and systolic PA pressure from pre-and posttreatment were compared between the two groups. RESULTS: Out of the 119 patients enrolled, 118 had core lab-assessed clot locations. Forty-five (38.1%) had emboli that involved the main PA and 73 (61.9%) had only branch emboli. No significant difference was observed between these groups for 30-day mortality, procedural device time, changes in RV/LV ratio, reduction in CT Obstruction Index, or for systolic PA pressure from pre-and posttreatment. The mean absolute reduction in clot burden was significant in both groups. CONCLUSION: Continuous mechanical aspiration thrombectomy with the 8F Indigo Aspiration System was effective at improving clinical outcomes for submassive PE patients regardless of emboli location, and clot burden was significantly reduced in both groups.

Initial experience with a continuous mechanical aspiration system for thrombus removal before percutaneous coronary intervention.

OBJECTIVES: Here we investigate the safety and efficacy of a continuous mechanical aspiration system when used before percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS). BACKGROUND: Historically, trials of routine manual aspiration thrombectomy in ACS patients have reported mixed results. This may be due to the technical limitations of manual aspiration, which suffers from decreasing vacuum power as aspiration is performed. METHODS: This is a retrospective case series of all patients treated with continuous mechanical aspiration (Indigo CAT RX Aspiration System; Penumbra Inc.) before PCI between August 2017 and July 2020 at five centers in the United States. Data regarding angiographic assessments, procedure, and safety were examined. RESULTS: Seventy-two patients (mean age 60 ± 12.5 years, 34.7% female) with ST Elevation Myocardial Infarction (STEMI) (80.6%) or Non-ST Elevation Myocardial Infarction (NSTEMI) (19.4%) were included. Target vessels were the right coronary (43.1%), left anterior descending (33.3%), and left circumflex (23.6%). Preprocedure, 94.4% had a high thrombus burden (thrombolysis in myocardial infarction [TIMI] thrombus grade ≥ 3). Median aspiration time was 35 s and median access-to-reperfusion time was 10 min. After CAT RX alone, 86.1% had complete perfusion (TIMI flow grade 3). After the procedure, 94.4% had TIMI thrombus grade <3% and 97.2% had TIMI flow grade 3. There were no cases of ischemic stroke. Cardiovascular mortality at 30 days was 1.4%. CONCLUSIONS: In our initial experience, aspirating thrombus from ACS patients using the Indigo CAT RX Aspiration System before PCI was safe and effective for reducing thrombus burden and restoring flow.

Renal Artery Variations in Patients With Mild-to-Moderate Hypertension From the RADIANCE-HTN SOLO Trial.

PURPOSE: To assess the variability of renal artery (RA) anatomy and presence of RA-pathology in patients with mild-to-moderate hypertension enrolled in the RADIANCE-HTN SOLO trial. BACKGROUND: RADIANCE-HTN SOLO was a multicenter, international, blinded, randomized, sham-controlled trial evaluating ultrasound-based endovascular renal denervation (RDN) in patients with mild-to-moderate hypertension while off antihypertensive medications. METHODS: Eligible subjects had pre-randomization renal CT- or MR- angiography (CTA, MRA) to confirm anatomic suitability and to define RA ablation sites. All images were sent for independent review for evaluation of RA anatomy and other vascular pathology. RESULTS: A total of 324 patients underwent RA imaging (282 CTA and 42 MRA). Of those, 178 had simple anatomy with a single left and single right RA with mean diameters of 5.4 ± 0.9 and 5.1 ± 0.8 mm and mean lengths of 40.0 ± 12.9 and 52.0 ± 13.1 mm, respectively. Twenty-seven patients (8.3%) had unilateral or bilateral dual RAs with mean diameters of 4.0 ± 0.9 mm on the left and 3.9 ± 0.9 mm on the right. Forty percent (129/324) of patients had at least 1 accessory RA, with mean accessory diameters of 2.4 ± 0.8 mm on the left and 2.3 ± 0.8 mm on the right. Twenty-eight patients (8.6%) had at least 1 short (<25 mm) main RA. Incidental findings included: 9 patients (2.8%) with atherosclerotic RA stenosis ≥30%, 9 patients (2.8%) with fibromuscular dysplasia of RA and 2 patients (0.6%) with kidney and adrenal gland tumors. CONCLUSIONS: Pre-procedure CTA or MRA imaging is a valuable aid in assessing RA anatomy prior to RDN because of variable RA anatomy. CTA or MRA may detect RA lesions, and renal or adrenal tumors which may need additional workup prior to consideration of RDN. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT02649426.

Rationale and design of a randomized study comparing the agent drug coated balloon to plain old balloon angioplasty in patients with In-stent restenosis.

BACKGROUND: Drug-coated balloon (DCB) technology was developed as an alternative treatment for obstructive coronary artery disease (CAD) and in-stent restenosis (ISR). Management of coronary ISR is clinically challenging and frequently encountered in practice. The Agent DCB uses an inactive excipient to effectively deliver a targeted, therapeutic dose of paclitaxel to the vessel wall. STUDY DESIGN: AGENT IDE is a prospective, multicenter, randomized controlled trial to evaluate superiority of the Agent DCB to balloon angioplasty in treating patients with ISR. A total of 480 patients with ISR of a previously treated lesion length <26 mm and reference vessel diameter >2.0 mm to ≤4.0 mm will be initially randomized. Subjects presenting with recent myocardial infarction (MI), complex lesions, or thrombus in the target vessel will be excluded. An adaptive group sequential design with one formal interim analysis for sample size re-estimation will be conducted, and the sample size may be increased to a maximum of 600 subjects. The primary endpoint is the rate of 12-month target lesion failure (TLF; composite of any ischemia-driven revascularization of the target lesion (TLR), target vessel related MI, or cardiac death) and will be tested for superiority in the test arm against the control. Functional status and general health-related quality of life will be measured by changes in the EQ-5D scores. Subjects will be followed for 5 years following the index procedure. CONCLUSION: This study will prospectively evaluate the safety and efficacy of Agent DCB in patients treated for coronary ISR.

Indigo Aspiration System for Treatment of Pulmonary Embolism: Results of the EXTRACT-PE Trial.

OBJECTIVES: This study sought to prospectively evaluate the safety and efficacy of the Indigo aspiration system in submassive acute pulmonary embolism (PE). BACKGROUND: PE treatment with thrombolytics has bleeding risks. Aspiration thrombectomy can remove thrombus without thrombolytics, but data are lacking. METHODS: This study was a prospective, single-arm, multicenter study that enrolled patients with symptomatic acute PE ≤14 days, systolic blood pressure ≥90 mm Hg, and right ventricular-to-left ventricular (RV/LV) ratio >0.9. The primary efficacy endpoint was change in RV/LV ratio from baseline to 48 h post-procedure on core lab-adjudicated computed tomography angiography. The primary safety endpoint was a composite of 48-h major adverse events: device-related death, major bleeding, and device-related serious adverse events (clinical deterioration, pulmonary vascular, or cardiac injury). All sites received Institutional Review Board approval. RESULTS: A total of 119 patients (mean age 59.8 ± 15.0 years) were enrolled at 22 U.S. sites between November 2017 and March 2019. Median device insertion to removal time was 37.0 (interquartile range: 23.5 to 60.0) min. Two (1.7%) patients received intraprocedural thrombolytics. Mean RV/LV ratio reduction from baseline to 48 h post-procedure was 0.43 (95% confidence interval: 0.38 to 0.47; p < 0.0001). Two (1.7%) patients experienced 3 major adverse events. Rates of cardiac injury, pulmonary vascular injury, clinical deterioration, major bleeding, and device-related death at 48 h were 0%, 1.7%, 1.7%, 1.7%, and 0.8%, respectively. CONCLUSIONS: In this prospective, multicenter study the Indigo aspiration system was associated with a significant reduction in the RV/LV ratio and a low major adverse event rate in submassive PE patients. Intraprocedural thrombolytic drugs were avoided in 98.3% of patients. (Evaluating the Safety and Efficacy of the Indigo aspiration system in Acute Pulmonary Embolism [EXTRACT-PE]; NCT03218566).

Optical coherence tomography guided carotid artery stent procedure: technique and potential applications.

OBJECTIVES: To (1) present a guide on how to perform optical coherence tomography (OCT) in carotid artery stenting (CAS), to (2) highlight several instructive cases illustrating OCT-guidance as an interventional strategy, and to (3) present the largest case-series of OCT-guided CAS performed in North America, demonstrating its feasibility as an imaging modality in this setting. BACKGROUND: OCT is an intravascular imaging method that captures images with an axial resolution 10 times higher than intravascular ultrasound. OCT has proven to be a useful modality in coronary angiography and may have similar applications in evaluating carotid atherosclerotic disease. METHODS: We compared our experience in CAS utilizing OCT (40 patients) versus that of CAS without OCT guidance (52 patients). RESULTS: No strokes or deaths occurred in either group postprocedurally or at 12 months. Fluoroscopy time was reduced in the OCT arm (14 ± 1 vs. 16 ± 1 min). Postprocedural creatinine levels were identical (1 ± 0 mg/dl, P = 0.96). Procedure time (96 ± 8 vs. 80 ± 3 min, P = 0.06) and contrast use (94 ± 4 vs. 83 ± 4 ml, P = 0.05) was slightly elevated in the OCT arm. CONCLUSIONS: We established a standardized protocol to consistently obtain OCT images that helped guide interventional decision-making during CAS. OCT imaging in the carotids requires a higher contrast load and prolongs procedure time. However, it can be performed without significant increases in fluoroscopy time or negatively affecting renal function. There were no negative safety signals in this pilot study.

Spontaneous Coronary Artery Dissection: Insights From Histology and Optical Coherence Tomography.

Spontaneous coronary artery dissection (SCAD) is a well-known but infrequent cause of acute coronary syndrome (ACS), and often goes unrecognized. Although management of SCAD is, at times, controversial, when a patient presents with ACS, percutaneous coronary intervention (PCI) is frequently necessary. We present a patient with ST-segment elevation myocardial infarction (STEMI) with SCAD that illustrates two important points: use of intracoronary optical coherence tomography to guide PCI, and histologic assessment to provide a unique insight into the etiology of SCAD. Following the case, we briefly review the important aspects of the pathophysiology, epidemiology, diagnosis, and interventional management of SCAD.

Lower Extremity Revascularization Using Optical Coherence Tomography-Guided Directional Atherectomy: Final Results of the EValuatIon of the PantheriS OptIcal COherence Tomography ImagiNg Atherectomy System for Use in the Peripheral Vasculature (VISION) Study.

PURPOSE: To evaluate the safety and efficacy of a novel optical coherence tomography (OCT)-guided atherectomy catheter in treating patients with symptomatic femoropopliteal disease. METHODS: The VISION trial ( ClinicalTrials.gov identifier NCT01937351) was a single-arm, multicenter, global investigational device exemption study enrolling 158 subjects (mean age 67.2±10.5 years; 87 men) across 20 participating sites. In this cohort, 198 lesions were treated with an average length of 53±40 mm using the Pantheris catheter alone or Pantheris + adjunctive therapy. The primary safety endpoint was the composite of major adverse events (MAEs) through 6 months (objective performance goal 43.2%). Technical success (primary efficacy outcome) was defined as the percent of target lesions with a residual diameter stenosis ≤50% after treatment with the Pantheris device alone (objective performance goal 87.0%). Procedural success was defined as reduction in stenosis to ≤30% after Pantheris ± adjunctive therapy. Tissue specimens retrieved from each treated lesion were histologically analyzed to evaluate the accuracy and precision of OCT image guidance. RESULTS: The primary efficacy outcome was achieved in 192 (97.0%) of the 198 lesions treated with the Pantheris catheter. Across all lesions, mean diameter stenosis was reduced from 78.7%±15.1% at baseline to 30.3%±11.8% after Pantheris alone (p<0.001) and to 22.4%±9.9% after Pantheris ± adjunctive therapy (p<0.001). Of the 198 target lesions, 104 (52.5%) were treated with the Pantheris alone, 84 (42.4%) were treated with Pantheris + adjunctive angioplasty, and 10 (5.1%) with Pantheris + angioplasty + stenting. The composite MAE outcome through 6 months occurred in 25 (16.6%) of 151 subjects. There were no clinically significant perforations, 1 (0.5%) catheter-related dissection, 4 (2%) embolic events, and a 6.4% clinically driven target lesion revascularization rate at 6 months. The 40-lesion chronic total occlusion (CTO) subset (mean lesion length 82±38 mm) achieved a similar significant reduction in stenosis to 35.5%±13.6% after Pantheris alone (p<0.001). Histological analysis of atherectomy specimens confirmed <1% adventitia in 82.1% of the samples, highlighting the precision of OCT guidance. Characterization of the OCT-guided lesions revealed evidence of an underestimation of disease burden when using fluoroscopy. CONCLUSION: OCT-guided atherectomy for femoropopliteal disease is safe and effective. Additionally, the precision afforded by OCT guidance leads to greater removal of plaque during atherectomy while sparing the adventitia.

Clot Extraction With the FlowTriever Device in Acute Massive Pulmonary Embolism.

Clinical guidelines support the use of systemic thrombolytic therapy for acute massive pulmonary embolism (PE). When anticoagulation and thrombolysis fail or are contraindicated, options become limited. We report an acute PE case in which treatment options were limited, and a novel device, the FlowTriever (Inari Medical, Irvine, California), was successfully used. This is the first case report of the use of this device that we are aware of.

Diagnostic imaging capabilities of the Ocelot -Optical Coherence Tomography System, ex-vivo evaluation and clinical relevance.

BACKGROUND: Optical coherence tomography (OCT) is a high-resolution sub-surface imaging modality using near-infrared light to provide accurate and high contrast intra-vascular images. This enables accurate assessment of diseased arteries before and after intravascular intervention. This study was designed to corroborate diagnostic imaging equivalence between the Ocelot and the Dragonfly OCT systems with regards to the intravascular features that are most important in clinical management of patients with atherosclerotic vascular disease. These intravascular features were then corroborated in vivo during treatment of peripheral arterial disease (PAD) pathology using the Ocelot catheter. METHODS: In order to compare the diagnostic information obtained by Ocelot (Avinger Inc., Redwood City, CA) and Dragonfly (St. Jude Medical, Minneapolis, MN) OCT systems, we utilized ex-vivo preparations of arterial segments. Ocelot and Dragonfly catheters were inserted into identical cadaveric femoral peripheral arteries for image acquisition and interpretation. Three independent physician interpreters assessed the images to establish accuracy and sensitivity of the diagnostic information. Histologic evaluation of the corresponding arterial segments provided the gold standard for image interpretation. In vivo clinical images were obtained during therapeutic interventions that included crossing of peripheral chronic total occlusions (CTOs) using the Ocelot catheter. RESULTS: Strong concordance was demonstrated when matching image characteristics between both OCT systems and histology. The Dragonfly and Ocelot system's vessel features were interpreted with high sensitivity (91.1-100%) and specificity (86.7-100%). Inter-observer concordance was documented with excellent correlation across all vessel features. The clinical benefit that the Ocelot OCT system provided was demonstrated by comparable procedural images acquired at the point of therapy. CONCLUSIONS: The study demonstrates equivalence of image acquisition and consistent physician interpretation of images acquired by the Ocelot and the Dragonfly OCT systems in-spite of distinct image processing algorithms and catheter configurations. This represents a dramatic shift away from both fluoroscopic imaging and diagnostic-only OCT imaging during peripheral arterial intervention towards therapeutic devices that incorporate real time diagnostic OCT imaging. In the clinical practice, these diagnostic capabilities have translated to best-in-class safety and efficacy for CTO crossing using the Ocelot catheter.

Takotsubo Cardiomyopathy: Clinical Characteristics and Outcomes.

Takotsubo cardiomyopathy (TC) is a reversible characteristic of left ventricular (LV) ballooning on cardiac imaging without significant coronary artery disease that is precipitated by stress. We performed a retrospective analysis of consecutive patient records to analyze outcomes of patients with TC. Of 100 patients with TC (90% women, mean age 67.7 y, SD = 15.96), 44 patients presented to the emergency room with chest pain, biomarker elevation, and electrocardiographic changes (ST segment elevation in 47%; primary TC) and 56 patients subsequently developed TC after an alternative initial diagnosis (ST segment elevation 27%; secondary TC; P = 0.04). Inciting events differed in those with primary versus secondary TC, with 48% of primary TC patients describing emotional stress; most secondary TC (75%) manifested after a surgical procedure or infection. Average length of hospital stay for primary TC was 6.68 days (SD = 5.32, range 1-28 d) and 18.22 (SD = 20.76, range 3-129 d) for secondary TC (P < .0001). Time to resolution of LV function was equal in both groups. With regard to mortality, eight of nine deaths occurred in secondary TC patients, and all nine deaths were attributable to comorbid medical conditions. Primary TC is frequently related to emotional stress, and carries a benign prognosis. Secondary TC is associated with an acute medical condition and results in a higher death rate.

Complete percutaneous approach for arterial access in transfemoral transcatheter aortic valve replacement: a comparison with surgical cut-down and closure.

OBJECTIVES: This study sought to investigate the immediate safety and feasibility of complete percutaneous access/closure of arteriotomy for device deployment compared to the surgical approach for transfemoral transcatheter aortic valve replacement (TAVR). BACKGROUND: The percutaneous approach for arterial access for device deployment in transfemoral TAVR is a potential alternative to the surgical approach. METHODS: In 274 patients who underwent transfemoral TAVR using Edward Sapien heart valve, 140 had a complete percutaneous approach using a "pre-closure" technique whereas 134 had surgical cut-down/repair for arterial access/closure of device deployment. Immediate vascular access/closure success, associated complications and clinical outcomes were compared. RESULTS: While overall acute success of access/closure and in-hospital access-related events were similar, significant isolated stenosis/dissection at the access site developed more frequently in the percutaneous group (7.1% vs. 0.7%, P = 0.007). Contrary, wound infections requiring prolonged antibiotics use or surgical debridement occurred more frequently in the surgical group (0.7% vs. 6.7%, P = 0.007). Although the rate of major vascular complications was not different, the surgical group developed more frequent minor bleeding (27.1% vs. 38.8%, P = 0.04) and underwent transfusion of packed red blood cells of ≤3 units (25.7% vs. 43.3%, P = 0.002). Median hospital stay was shorter in the percutaneous group (3 days vs. 4 days, P = 0.002). CONCLUSIONS: The percutaneous approach is a feasible access/closure method with a potential of lowering access site infection and bleeding, and shortening hospital stay, while maintaining similar rates of major vascular complications compared to the surgical approach.

A randomized, controlled pilot study of autologous CD34+ cell therapy for critical limb ischemia.

BACKGROUND: Critical limb ischemia portends a risk of major amputation of 25% to 35% within 1 year of diagnosis. Preclinical studies provide evidence that intramuscular injection of autologous CD34+ cells improves limb perfusion and reduces amputation risk. In this randomized, double-blind, placebo-controlled pilot study, we evaluated the safety and efficacy of intramuscular injections of autologous CD34+ cells in subjects with moderate or high-risk critical limb ischemia, who were poor or noncandidates for surgical or percutaneous revascularization (ACT34-CLI). METHODS AND RESULTS: Twenty-eight critical limb ischemia subjects were randomized and treated: 7 to 1 × 10(5) (low-dose) and 9 to 1 × 10(6) (high-dose) autologous CD34+ cells/kg; and 12 to placebo (control). Intramuscular injections were distributed into 8 sites within the ischemic lower extremity. At 6 months postinjection, 67% of control subjects experienced a major or minor amputation versus 43% of low-dose and 22% of high-dose cell-treated subjects (P=0.137). This trend continued at 12 months, with 75% of control subjects experiencing any amputation versus 43% of low-dose and 22% of high-dose cell-treated subjects (P=0.058). Amputation incidence was lower in the combined cell-treated groups compared with control group (6 months: P=0.125; 12 months: P=0.054), with the low-dose and high-dose groups individually showing trends toward improved amputation-free survival at 6 months and 12 months. No adverse safety signal was associated with cell administration. CONCLUSIONS: This study provides evidence that intramuscular administration of autologous CD34+ cells was safe in this patient population. Favorable trends toward reduced amputation rates in cell-treated versus control subjects were observed. These findings warrant further exploration in later-phase clinical trials. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00616980.