Jon C. George

Stem cell therapy in acute myocardial infarction: a review of clinical trials.

Stem cells (SCs) possess the ability to differentiate into cells of various tissues. Although the differentiation of SCs into functional cardiomyocytes has been difficult to demonstrate in humans, clinical trials using SCs in the setting of acute myocardial infarction (AMI) have demonstrated variable results. Interpretation of these trials has been difficult because of multiple variables, which include differences in trial design, cell type, timing of cell delivery, and outcome measurements. Herein, a summary of all clinical trials in subgroups of direct injection, indirect mobilization, and combination approaches of SC therapy in AMI is provided with significant findings in each group.

Randomized Controlled Study of Excimer Laser Atherectomy for Treatment of Femoropopliteal In-Stent Restenosis: Initial Results From the EXCITE ISR Trial (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis)

OBJECTIVES The purpose of this study was to evaluate the safety and efficacy of excimer laser atherectomy (ELA) with adjunctive percutaneous transluminal angioplasty (PTA) versus PTA alone for treating patients with chronic peripheral artery disease with femoropopliteal bare nitinol in-stent restenosis (ISR). BACKGROUND Femoropopliteal stenting has shown superiority to PTA for lifestyle-limiting claudication and critical limb ischemia, although treating post-stenting artery reobstruction, or ISR, remains challenging. METHODS The multicenter, prospective, randomized, controlled EXCITE ISR (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis) trial was conducted across 40 U.S. centers. Patients with Rutherford Class 1 to 4 and lesions of target lesion length ≥4 cm, vessel diameter 5 to 7 mm were enrolled and randomly divided into ELA + PTA and PTA groups by a 2:1 ratio. The primary efficacy endpoint was target lesion revascularization (TLR) at 6-month follow up. The primary safety endpoint was major adverse event (death, amputation, or TLR) at 30 days post-procedure. RESULTS Study enrollment was stopped at 250 patients due to early efficacy demonstrated at a prospectively-specified interim analysis. A total of 169 ELA + PTA subjects (62.7% male; mean age 68.5 ± 9.8 years) and 81 PTA patients (61.7% male; mean age 67.8 ± 10.3 years) were enrolled. Mean lesion length was 19.6 ± 12.0 cm versus 19.3 ± 11.9 cm, and 30.5% versus 36.8% of patients exhibited total occlusion. ELA + PTA subjects demonstrated superior procedural success (93.5% vs. 82.7%; p = 0.01) with significantly fewer procedural complications. ELA + PTA and PTA subject 6-month freedom from TLR was 73.5% versus 51.8% (p < 0.005), and 30-day major adverse event rates were 5.8% versus 20.5% (p < 0.001), respectively. ELA + PTA was associated with a 52% reduction in TLR (hazard ratio: 0.48; 95% confidence interval: 0.31 to 0.74). CONCLUSIONS The EXCITE ISR trial is the first large, prospective, randomized study to demonstrate superiority of ELA + PTA versus PTA alone for treating femoropopliteal ISR. (Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis [EXCITE ISR]; NCT01330628).

Timing of Staged Percutaneous Coronary Intervention in Multivessel Coronary Artery Disease

Based on the guidelines for the management of patients with ST-segment elevation myocardial infarction (STEMI), revascularization should not be performed in a noninfarct artery at the time of primary percutaneous coronary intervention. However, the timing of a staged intervention of the nonculprit

Final results of the Chronic Total Occlusion Crossing With the Ocelot System II (CONNECT II) study.

Purpose: To evaluate the safety and effectiveness of the optical coherence tomography–guided Ocelot catheter to cross femoropopliteal chronic total occlusions (CTOs). Methods: The CONNECT II study was a prospective, multicenter, non-randomized single-arm study of the safety and effectiveness of the Ocelot catheter in CTO crossing. Key inclusion criteria were a 99% to 100% stenosed femoropopliteal segment, lesion length between 1 and 30 cm, and resistance to guidewire crossing. The main exclusion criterion was a severely calcified target vessel. The primary safety endpoint was 30-day major adverse events (MAE), while the primary effectiveness endpoint was successful CTO crossing (i.e., guidewire placement in the distal true lumen) with the Ocelot catheter. Endpoint analysis was based on pre-specified objective performance criteria. Between February and June 2012, 100 patients (55 men; mean age 69 years) were enrolled. Most of the CTOs (94%) were in the superficial femoral artery (SFA); mean lesion length was 16.6±9.3 cm. Results: Through 30 days, 2 patients experienced MAE (significant perforations) related to the Ocelot catheter. The Ocelot catheter successfully crossed 97% of target CTOs either alone (72%), in conjunction with an assist device (18%), or in conjunction with a re-entry device (7%). Both primary safety and effectiveness endpoints were met. Conclusion: The Ocelot catheter with optical coherence tomography guidance offers physicians a reliable option for crossing femoral and popliteal chronic total occlusions with low MAE rates.

Percutaneous mitral valve repair: lessons from the EVEREST II (Endovascular Valve Edge-to-Edge REpair Study) and beyond.

The 24-month results of the EVEREST II (Endovascular Valve Edge-to-Edge REpair Study), presented at the American College of Cardiology 2011 Scientific Sessions/i2 Summit and recently published ([1][1]), investigating the safety and efficacy of the MitraClip (Abbott Vascular, Santa Clara, California

Renal Artery Stenting: Lessons From ASTRAL (Angioplasty and Stenting for Renal Artery Lesions)

The investigators of the recently published ASTRAL (Angioplasty and Stenting for Renal Artery Lesions) trial concluded that there was “substantial risk without worthwhile clinical benefit from revascularization in patients with atherosclerotic renovascular disease” ([1][1]). We believe that the

Stent fractures after superficial femoral artery stenting: risk factors and impact on patency.

Purpose: To determine the risk factors and clinical impact of stent fractures after superficial femoral artery (SFA) stenting. Methods: From May 2009 to June 2012, 171 consecutive patients (mean age 74.5±7.8, years; 106 men) who presented with SFA stenosis or occlusion in 205 limbs underwent stent implantation in the SFA at a single center. Stent fractures were determined by radiography and classified into types I through V. Loss of patency was assessed by duplex ultrasonography (>2.4 peak systolic velocity ratio) or angiography (percent diameter stenosis >50%). Results: The 12- and 24-month primary patency rates were 49.8% and 43.4%, respectively. Stent fractures occurred in 12.5% and 26.8% per limb (6.6% and 19.4% per stent) at 12 and 24 months, respectively. Primary patency was numerically worse in the stent fracture group but not statistically different from the group without fractures at 2 years. Primary patency for different classes of stent fracture were 30.8% (type I), 50.0% (type II), and 31.3% (type III–V). Hyperlipidemia (p=0.001), TransAtlantic Inter-Society Consensus II classification (p=0.007), chronic total occlusion (CTO; p<0.001), proximal lesion location (p=0.008), lesion calcification (p=0.025), total stent length (p=0.005), stent diameter (p=0.001), and number of stents (p=0.001) were statistically significant predictors of stent fracture. Multivariate analysis showed that CTO (hazard ratio 0.173, 95% confidence interval 0.042 to 0.716, p=0.015) was an independent predictor of stent fracture. Conclusion: Stent fractures occur more frequently in patients with CTOs after treatment of longer stented lesions. Although multivariate analysis showed that CTO was the only independent predictor regardless of stent length or number, the stent fracture rate was numerically higher in the severe calcification and proximal SFA lesion subgroups. Stent fracture did not appear to affect long-term patency rates, but this is yet to be confirmed with further follow-up.

SUPERA interwoven nitinol Stent Outcomes in Above-Knee IntErventions (SAKE) study.

PURPOSE To report experience with the novel interwoven-wire self-expanding nitinol SUPERA stent (IDEV Technologies, Inc/Abbott Laboratories, Inc, Webster, Texas) for the treatment of severely diseased superficial femoral and popliteal arteries. MATERIALS AND METHODS Consecutive patients with severely diseased superficial femoral and popliteal arteries who received SUPERA stents (n = 80 patients [98 limbs]; mean age, 70.8 y; 80% male) were retrospectively identified. Patients were followed for an average of 14.3 months after intervention. RESULTS Total occlusions were present in 39% of the lesions, 21% had tissue loss, and 61% demonstrated calcification on fluoroscopy. Patients were prescribed dual antiplatelet therapy (aspirin and clopidogrel) for at least 30 days unless contraindicated, followed by aspirin alone indefinitely. The mean (± SD) lesion length was 143 mm (± 98). Based on need for clinical intervention, primary patency was 96.9% at 6 months and 85.8% at 12 months (Kaplan-Meier estimates). Assisted primary patency and secondary patency rates at 12 months were 96.8% and 100%, respectively. Ankle-brachial index increased from 0.60 at baseline to 0.83 at last follow-up (P < .001). No stent fractures were found by fluoroscopy inspection in 19 limbs (16 patients) that required reintervention. CONCLUSIONS Based on experience with multiple operators at a single clinical center, the interwoven nitinol stent design provides a viable option for high-grade obstructive disease in the femoropopliteal artery.

Crossing chronic total occlusions with the Ocelot system: the initial European experience.

AIMS The aim of the study was to determine the safety, efficacy and feasibility of a new chronic total occlusion (CTO) device using optical coherence tomography (OCT) technology, the Ocelot catheter (Avinger, Inc., Redwood City, CA, USA), for crossing of SFA CTOs following guidewire failure. METHODS AND RESULTS Prospective, multicentre, market preference testing. Thirty-three patients with confirmed CTO (99-100% stenosis by visual estimate) of their superficial femoral artery (SFA) were treated between September 28, 2011, and December 9, 2011, at three European centres. Ocelot crossed 94% (31/33) of CTOs, allowing guidewire placement in the distal true lumen. All (100%) lesions were treated without any major adverse safety events. Procedural time and contrast dose were significantly reduced (p<0.0001) when compared with a similar, non-OCT-guided CTO crossing device (Wildcat catheter; Avinger, Inc.). Overall physician feedback on the catheter performance was positive with an 87% average rating of excellent or good across seven categories. Performance ratings of Ocelots OCT imaging guidance were consistently positive with an 86% average rating of excellent or good across five OCT categories. CONCLUSIONS The Ocelot catheter combines advanced CTO crossing technology with real-time OCT guidance. When compared with a similar non-OCT-guided catheter, crossing efficacy and safety profile improved. Total procedure time and contrast volumes were significantly reduced. The Ocelot is a safe, efficient and effective tool for crossing CTOs.

ACC Interventional Scientific Council: News and ViewsRenal Artery Stenting: Lessons From ASTRAL (Angioplasty and Stenting for Renal Artery Lesions)

The investigators of the recently published ASTRAL (Angioplasty and Stenting for Renal Artery Lesions) trial concluded that there was “substantial risk without worthwhile clinical benefit from revascularization in patients with atherosclerotic renovascular disease” ([1][1]). We believe that the