Ashish Pershad

Early safety and efficacy of percutaneous left atrial appendage suture ligation: results from the U.S. transcatheter LAA ligation consortium

BACKGROUND Transcatheter left atrial appendage (LAA) ligation may represent an alternative to oral anticoagulation for stroke prevention in atrial fibrillation. OBJECTIVES This study sought to assess the early safety and efficacy of transcatheter ligation of the LAA for stroke prevention in atrial fibrillation. METHODS This was a retrospective, multicenter study of consecutive patients undergoing LAA ligation with the Lariat device at 8 U.S. sites. The primary endpoint was procedural success, defined as device success (suture deployment and <5 mm leak by post-procedure transesophageal echocardiography), and no major complication at discharge (death, myocardial infarction, stroke, Bleeding Academic Research Consortium bleeding type 3 or greater, or cardiac surgery). Post-discharge management was per operator discretion. RESULTS A total of 154 patients were enrolled. Median CHADS2 score (congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke, transient ischemic attack, or thromboembolism [doubled]) was 3 (interquartile range: 2 to 4). Device success was 94%, and procedural success was 86%. A major complication occurred in 15 patients (9.7%). There were 14 major bleeds (9.1%), driven by the need for transfusion (4.5%). Significant pericardial effusion occurred in 16 patients (10.4%). Follow-up was available in 134 patients at a median of 112 days (interquartile range: 50 to 270 days): Death, myocardial infarction, or stroke occurred in 4 patients (2.9%). Among 63 patients with acute closure and transesophageal echocardiography follow-up, there were 3 thrombi (4.8%) and 13 (20%) with residual leak. CONCLUSIONS In this initial multicenter experience of LAA ligation with the Lariat device, the rate of acute closure was high, but procedural success was limited by bleeding. A prospective randomized trial is required to adequately define clinical efficacy, optimal post-procedure medical therapy, and the effect of operator experience on procedural safety.

Wire-Interwoven Nitinol Stent Outcome in the Superficial Femoral and Proximal Popliteal Arteries Twelve-Month Results of the SUPERB Trial

Background—Stent-based therapy in the superficial femoral and popliteal arteries in patients with peripheral artery disease is compromised by restenosis and risk of stent fracture or distortion. A novel self-expanding nitinol stent was developed that incorporates an interwoven-wire design (Supera stent, IDEV Technologies, Inc, Webster, TX) to confer greater radial strength, flexibility, and fracture resistance. Methods and Results—This prospective, multicenter, investigational device exemption, single-arm trial enrolled 264 patients with symptomatic peripheral artery disease undergoing percutaneous treatment of de novo or restenotic lesions of the superficial femoral or proximal popliteal (femoropopliteal) artery. Freedom from death, target lesion revascularization, or any amputation of the index limb at 30 days (+7 days) postprocedure was achieved in 99.2% (258/260) of patients (P<0.001). Primary patency at 12 months (360±30 days) was achieved in 78.9% (180/228) of the population (P<0.001). Primary patency by Kaplan–Meier analysis at 12 months (360 days) was 86.3%. No stent fracture was observed by independent core laboratory analysis in the 243 stents (228 patients) evaluated at 12 months. Clinical assessment at 12 months demonstrated improvement by at least 1 Rutherford–Becker category in 88.7% of patients. Conclusions—The SUPERB Trial, an investigational device exemption study using an interwoven nitinol wire stent in the femoropopliteal artery, achieved the efficacy and safety performance goals predesignated by the Food and Drug Administration. On the basis of the high primary patency rate, absence of stent fracture, and significant improvements in functional and quality-of-life measures, the Supera stent provides safe and effective treatment of femoropopliteal lesions in symptomatic patients with peripheral artery disease. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00933270.

Early results with the LARIAT device for left atrial appendage exclusion in patients with atrial fibrillation at high risk for stroke and anticoagulation

To evaluate early outcomes of left atrial appendage (LAA) closure via a percutaneous LAA ligation approach with the SentreHeart LARIAT™ snare device.

Validation and incremental value of the hybrid algorithm for CTO PCI.

To evaluate the outcomes and benefits of using the hybrid algorithm for chronic total occlusion (CTO) percutaneous coronary intervention (PCI).

Renal artery aneurysm: Successful exclusion with a stent graft

Renal artery aneurysms are uncommon. They are either incidentally discovered or identified during workup for secondary hypertension. An association with rupture at sizes greater than 1.5 cm exists. In this case report, the exclusion of a renal aneurysm with a covered stent is described. In spite of compromise of a side‐branch vessel, there were no deleterious effects on renal function at 6‐month follow‐up. Catheter Cardiovasc Interv 2004;61:314–316.

The Outcomes, Patient Health Status, and Efficiency IN Chronic Total Occlusion Hybrid Procedures registry: rationale and design

Background Patients with chronic total occlusions of a coronary artery represent a complex, yet common, clinical conundrum among patients with ischemic heart disease. Chronic total occlusion angioplasty is increasingly being used as a treatment for these complex lesions. There is a compelling need to better quantify the safety, efficacy, benefits, and costs of the procedure. Methods To address these gaps in knowledge, we designed the Outcomes, Patient Health Status, and Efficiency IN Chronic Total Occlusion Hybrid Procedures (OPEN CTO) study, an investigator-initiated multicenter, single-arm registry including 12 centers with a planned enrollment of 1000 patients. To ensure the accuracy of our observations, we used a unique auditing process through the National Cardiovascular Disease Registries’ Cath/PCI Registry, angiographic core lab analysis, clinical events adjudication, and a systematic collection of patient-reported outcomes and costs. Results Between 21 January 2014 and 22 July 2015, 1000 patients were enrolled in OPEN CTO. A total of 28 patients either refused (N=26) or were missed by the screening process (N=2). In the National Cardiovascular Disease Registry Cath/PCI registry audit, there were 1096 chronic total occlusion-percutaneous coronary intervention procedures that were performed by participating operators during the time they enrolled in OPEN CTO. Overall, 987 of those patients could be definitively matched to an OPEN CTO enrolled patient (enrolled group). The remaining 109 were considered to be not enrolled in OPEN CTO (not enrolled group). Compared with the enrolled group, the patients in the nonenrolled group were less frequently of White race and more frequently of Hispanic origin. Procedural outcomes including National Cardiovascular Disease Registry-defined technical success, procedural success, and major adverse coronary events rates were similar. Conclusion OPEN CTO is the most comprehensive and rigorously collected dataset to date that will provide unique insights into the success, safety, benefits, and the costs of chronic total occlusion-percutaneous coronary intervention using a reproducible technical approach to patients with these complex lesions.

SUPERB final 3-year outcomes using interwoven nitinol biomimetic supera stent

Long‐term outcomes of an interwoven nitinol stent design represent the best in class for treatment of lower limb arterial obstructive disease

Optical coherence tomography findings after chronic total occlusion interventions: Insights from the “AngiographiC evaluation of the everolimus-eluting stent in chronic Total occlusions” (ACE-CTO) study (NCT01012869)

BACKGROUND There is limited information on optical coherence tomography (OCT) findings after percutaneous coronary intervention (PCI) of chronic total occlusions (CTOs). OCT allows high resolution imaging that can enhance understanding of the vascular response after stenting of chronically occluded vessels. METHODS The Angiographic Evaluation of the Everolimus-Eluting Stent in Chronic Total Occlusions (ACE-CTO) study collected angiographic and clinical outcomes from 100 patients undergoing CTO PCI with the everolimus-eluting stent (EES). OCT was performed 8-months post stenting in 62 patients. Every third frame was analyzed throughout the course of the stented arterial segment. Lumen contours were semi-automatically traced and stent struts were manually delineated, with automatic measurement of the strut to lumen distance. Struts on the luminal side of the lumen contour were classified as malapposed if the distance to the lumen contour exceeded 0.108mm. RESULTS A total of 44,450 struts in 6047 frames were analyzed, of which 4113 9.3%, 95% confidence intervals [CI] 9.0% to 9.5%) were malapposed and 1230 (2.8%, 95% CI 2.6% to 2.9%) were uncovered. Fifty-five of 62 patients (88.7%, 95% CI 78.5% to 98.4%) had at least one malapposed stent strut and 50 patients (80.7%, 95% CI 69.2% to 88.6%) had at least one uncovered stent strut. Mean strut-intimal thickness of the apposed and malapposed struts was 0.126±0.140mm and -0.491±0.440mm, respectively. CONCLUSION High rates of stent strut malapposition and incomplete stent strut coverage were observed after CTO PCI using EES, highlighting unique challenges associated with stent implantation in CTOs.

Postinfarct VSD management using 3D computer printing assisted percutaneous closure

Postinfarct VSD (PIVSD) carries a grim prognosis. The mainstay of management has been surgical repair. The advent of septal occluder devices has offered an attractive alternative to surgical repair. Most PIVSD have serpiginous tracts with necrotic tissue, which makes assessing the defect challenging. 3D computer printing has become useful in preprocedure planning of complex surgical procedures in multiple subspecialties.

Comparison of 30-Day Outcomes of Transfemoral Versus Transapical Approach for Transcatheter Aortic Valve Replacement: A Single-Center US Experience.

BACKGROUND The optimal access route for transcatheter aortic valve replacement (TAVR) remains debatable. We compared early safety outcomes at 30 days between the transfemoral (TF) and transapical (TA) approaches in a single, high-volume center in the United States. METHODS Data were collected retrospectively on consecutive patients who underwent TAVR by the TF or TA approach. The primary endpoints included the following: all-cause mortality; stroke; major and life threatening bleeding; renal failure; valve-related dysfunction requiring an intervention; and moderate to severe paravalvular leak and major vascular complications at 30 days. The secondary endpoints included need for a pacemaker and hospital length of stay. RESULTS A total of 123 well-matched patients underwent TAVR (TF 66 [54%] and TA 57 [46%]). All-cause mortality at 30 days was identical in both groups (TF 4.5% vs TA 5.3%, p = 0.999). The rates of myocardial infarction (TF 1.6% vs TA 1.5%, p = 0.999) and stroke (TF 3.0% vs TA 5.3%, p = 0.662) were similar. Major bleeding, acute renal failure, valve-related dysfunction, paravalvular leak, and mean hospital length of stay were also similar in both groups. Unplanned vascular complications, fluoroscopy time, and contrast utilization were significantly lower in the TA group. CONCLUSIONS The TA approach has similar early safety outcomes when compared with the TF approach. The TA approach is more procedurally efficient when compared with the TF approach.