Jason H. Rogers

Overview of New Technologies for Lower Extremity Revascularization

Lower extremity peripheral arterial occlusive disease poses a unique challenge to traditional angioplasty-based endovascular therapies. The diffuse nature of lower extremity atherosclerotic disease, the presence of chronic total occlusions, poor distal runoff, and the presence of critical limb ischemia all have contributed to the disappointing results of balloon angioplasty for complex infrainguinal arterial disease. These challenges have spawned the development of a host of new technologies in an attempt to improve the safety and effectiveness of percutaneous revascularization for lower extremity peripheral arterial occlusive disease. This review summarizes the recent advances in available technologies, including novel angioplasty balloons; nitinol stents, stent grafts, and drug-eluting stents; excisional, laser, and rotational atherectomy devices; devices for crossing total occlusions; true-lumen reentry devices; thrombectomy catheters; and embolic protection devices.

Clinical Presentation, Management, and Outcomes of Angiographically Documented Early, Late, and Very Late Stent Thrombosis

OBJECTIVES The aim of this study was to describe differences in treatment and in-hospital mortality of early, late, and very late stent thrombosis (ST). BACKGROUND Early, late, and very late ST may differ in clinical presentation, management, and in-hospital outcomes. METHODS We analyzed definite (angiographically documented) ST cases identified from February 2009 to June 2010 in the CathPCI Registry. We stratified events by timing of presentation: early (≤1 month), late (1 to 12 months), or very late (≥12 months) following stent implantation. Multivariable logistic regression modeling was performed to compare in-hospital mortality for each type of ST after adjusting for baseline comorbidities. RESULTS During the study period, 7,315 ST events were identified in 7,079 of 401,662 patients (1.8%) presenting with acute coronary syndromes. This ST cohort consisted of 1,391 patients with early ST (19.6%), 1,370 with late ST (19.4%), and 4,318 with very late ST (61.0%). Subjects with early ST had a higher prevalence of black race and diabetes, whereas subjects with very late ST had a higher prevalence of white race and a lower prevalence of prior myocardial infarction or diabetes. In-hospital mortality was significantly higher in early ST (7.9%) compared with late (3.8%) and very late ST (3.6%, p<0.001). This lower mortality for late and very late ST persisted after multivariable adjustment (odds ratio: 0.53 [95% confidence interval (CI): 0.36 to 0.79] and 0.58 [95% CI: 0.43 to 0.79], respectively). CONCLUSIONS Significant differences exist in the presentation and outcomes of early, late, and very late ST. Among patients with acute coronary syndromes who are undergoing percutaneous coronary intervention for angiographically documented ST, early ST is associated with the highest in-hospital mortality.

Percutaneous Septal Sinus Shortening A Novel Procedure for the Treatment of Functional Mitral Regurgitation

Background— The septal-to-lateral (SL) mitral annular diameter is increased in functional mitral regurgitation (MR). We describe a novel percutaneous technique (the percutaneous septal sinus shortening system) that ameliorates functional MR in an ovine model. Methods and Results— Sheep underwent rapid right ventricular pacing to obtain moderate to severe functional MR with SL enlargement. The percutaneous septal sinus shortening system was placed via standard interventional techniques consisting of a bridge (suture) element between interatrial septal wall and great cardiac vein anchors. Through progressive tensioning of the bridge element, direct SL shortening was achieved. Sheep underwent short-term (n=19) and long-term (n=4) evaluation after device implantation. In short-term studies, SL diameter decreased an average of 24% (32.5±3.5 to 24.6±2.4 mm; P<0.001), and MR grade significantly improved (2.1±0.6 to 0.4±0.4; P<0.001). Despite continued rapid pacing, chronic device implantation resulted in durable SL shortening (30.4±1.9 mm before implantation to 25.3±0.8 mm at 30 days; P=0.01) and MR reduction (1.8±0.5 before implantation to 0.2±0.1 at 30 days; P=0.01). Increased cardiac output, decreased wedge pressure, and decreased brain natriuretic peptide levels were observed in animals undergoing long-term device implantation. Conclusions— The percutaneous septal sinus shortening system is effective in ameliorating functional MR in an ovine tachycardia model. The procedure, which uses standard catheter techniques, can be deployed largely under fluoroscopic guidance. The unique bridge element appears durable and allows direct and precise SL shortening to a diameter optimal for MR reduction.

Coronary Artery Disease in Patients With Psoriasis Referred for Coronary Angiography

Patients with psoriasis may have an increased risk of cardiovascular disease and myocardial infarction. The aim of this study was to investigate whether psoriasis is associated with an increased prevalence of coronary artery disease (CAD) independent of established cardiovascular risk factors in patients undergoing coronary angiography. A retrospective cohort analysis was performed by linking records of all patients undergoing coronary angiography from 2004 through 2009 with dermatology medical records. From an overall cohort of 9,473 patients, we identified 204 patients (2.2%) with psoriasis before coronary angiography. Patients with psoriasis had higher body mass index (31.3 ± 8.1 vs 29.3 ± 7.1 kg/m(2), p <0.001) but the prevalence of other risk factors was similar. Median duration of psoriasis before cardiac catheterization was 8 years (interquartile range 2 to 24). Patients with psoriasis were more likely to have CAD (84.3% vs 75.7%, p = 0.005) at coronary angiography. After adjusting for established cardiovascular risk factors, psoriasis was independently associated with presence of angiographically confirmed CAD (adjusted odds ratio 1.8, 95% confidence interval 1.2 to 2.8, p = 0.006). In patients with psoriasis, duration of psoriasis >8 years was also independently associated with angiographically confirmed CAD after adjusting for established cardiovascular risk factors (adjusted odds ratio 3.5, 95% confidence interval 1.3 to 9.6, p = 0.02). In conclusion, patients with psoriasis and especially those with psoriasis for >8 years have a higher prevalence of CAD than patients without psoriasis undergoing coronary angiography.

Percutaneous edge-to-edge MitraClip therapy in the management of mitral regurgitation

MitraClip therapy consists of percutaneous edge-to-edge coaptation of the mitral leaflets that is analogous to the surgical Alfieri technique. The safety profile of the MitraClip device is favourable, and survival outcomes in high-surgical-risk patients are superior to historical controls. However, questions remain regarding long-term efficacy and durability. In the U.S.A., the MitraClip device has been studied in a safety and feasibility trial, a randomized pivotal trial against surgical mitral valve repair, and a non-randomized high-risk registry. In addition, the MitraClip now has over 2 years of CE-mark approval and a rapidly expanding clinical experience in Europe, primarily in patients at high risk for surgery. A dedicated multidisciplinary team is necessary, as well as thoughtful patient selection, familiarity with the technical aspects of the procedure including transesophageal ultrasound imaging and post-procedure monitoring. Currently available clinical data are herein reviewed, with emphasis on the current role of MitraClip therapy in relation to existing surgical techniques. Since the MitraClip procedure is still relatively new, continued investigation is required to further define patient populations that will benefit most.

Zotarolimus-Eluting Peripheral Stents for the Treatment of Erectile Dysfunction in Subjects With Suboptimal Response to Phosphodiesterase-5 Inhibitors

OBJECTIVES This study sought to evaluate the safety and feasibility of zotarolimus-eluting stent implantation in focal atherosclerotic lesions of the internal pudendal arteries among men with erectile dysfunction (ED) and a suboptimal response to phosphodiesterase-5 inhibitors. BACKGROUND ED, a common condition, is often mediated by atherosclerosis. Current treatment options are limited. METHODS Male subjects with atherosclerotic ED and a suboptimal response to phosphodiesterase-5 inhibitors were enrolled in this prospective, multicenter, single-armed safety and feasibility trial. A novel combination of clinical, duplex ultrasound, and invasive angiographic factors were used to determine eligibility for stent therapy. The primary safety endpoint was any major adverse event 30 days after the procedure. The primary feasibility end point was improvement in the International Index of Erectile Function (Erectile Dysfunction Domain) score ≥ 4 points in ≥ 50% of subjects at 3 months. We report 6-month follow-up results, including duplex ultrasound and angiography. RESULTS Forty-five lesions were treated with stents in 30 subjects. Procedural success was 100% with no major adverse events through follow-up. The primary feasibility endpoint at 6 months was achieved by 59.3% of intention-to-treat subjects (95% confidence interval: 38.8% to 77.6%) and 69.6% of per-protocol subjects (95% confidence interval: 47.1% to 86.8%). Duplex ultrasound peak systolic velocity of the cavernosal arteries increased from baseline by 14.4 ± 10.7 cm/s at 30 days and 22.5 ± 23.7 cm/s at 6 months. Angiographic binary restenosis (≥ 50% lumen diameter stenosis) was reported in 11 (34.4%) of 32 lesions. CONCLUSIONS Among patients with ED and limited response with pharmacologic therapy, percutaneous stent revascularization of the internal pudendal artery is feasible and is associated with clinically meaningful improvement in both subjective and objective measures of erectile function.

Internal pudendal artery stenoses and erectile dysfunction: Correlation with angiographic coronary artery disease

Objectives: To describe the angiographic characteristics of pelvic arterial disease in patients with erectile dysfunction (ED) nonresponsive to phosphodiesterase‐5 inhibitors (PDE5i) and suspected coronary artery disease (CAD). Background: ED and CAD share common risk factors which can result in endothelial dysfunction, atherosclerosis and flow‐limiting stenoses in the coronary and internal pudendal arteries. Methods: Ten patients undergoing cardiac catheterization with ED and a history of unsatisfactory response to a PDE5i were studied. ED severity was quantified using the International Index of ED scoring system. We performed angiography and quantitative vessel analysis of the coronary arteries, bilateral common and internal iliac arteries, and internal pudendal arteries (IPAs). Results: In this pilot observational study, we found a high correlation between the presence of angiographic CAD and IPA disease. The reference IPA diameters at the point of maximal stenosis were 2.7 ± 0.4 mm (right IPA) and 2.7 ± 0.5 mm (left IPA). In the nine patients with IPA disease, the average stenosis severity was 55 ± 31% (right) and 66% ± 25% (left), and average lesion length was 12.4 ± 5.2 mm (right) and 10.0 ± 3.5 mm (left). Four patients had unilateral IPA total occlusions, three of whom had moderate contralateral disease. The majority of IPA stenoses occurred in the mid to distal IPA and appears amenable to percutaneous revascularization. Conclusions: This represents the first angiographic report of CAD correlated with IPA disease in patients with ED. Further investigation is required to determine whether the development of macrovascular disease in the IPA causes ED and whether endovascular treatment is safe and effective in this population.

Percutaneous Mitral Valve Repair in the Initial EVEREST Cohort Evidence of Reverse Left Ventricular Remodeling

Background— Percutaneous repair of mitral regurgitation (MR) permits examination of the effect of MR reduction without surgery and cardiopulmonary bypass on left ventricular (LV) dimensions and function. The goal of this analysis was to determine the extent of reverse remodeling at 12 months after successful percutaneous reduction of MR with the MitraClip device. Methods and Results— Of 64 patients with 3 and 4+ MR who achieved acute procedural success after treatment with the MitraClip device, 49 patients had moderate or less MR at 12-month follow-up. Their baseline and 12-month echocardiograms were compared between the group with and without LV dysfunction. In patients with persistent MR reduction and pre-existing LV dysfunction, there was a reduction in LV wall stress, reduced LV end-diastolic volume, LV end-systolic volume and increase in LV ejection fraction in contrast to those with normal baseline LV function, who showed reduction in LV end-diastolic volume, LV wall stress, no change in LV end-systolic volume, and a fall in LV ejection fraction. Conclusions— Patients with pre-existing LV dysfunction demonstrate reverse remodeling and improved LV ejection fraction after percutaneous mitral valve repair. Clinical Trial Registration— URL: . Unique identifiers: [NCT00209339][1], [NCT00209274][2]. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00209339&atom=%2Fcirccvim%2F6%2F4%2F522.atom [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00209274&atom=%2Fcirccvim%2F6%2F4%2F522.atomBackground—Percutaneous repair of mitral regurgitation (MR) permits examination of the effect of MR reduction without surgery and cardiopulmonary bypass on left ventricular (LV) dimensions and function. The goal of this analysis was to determine the extent of reverse remodeling at 12 months after successful percutaneous reduction of MR with the MitraClip device. Methods and Results—Of 64 patients with 3 and 4+ MR who achieved acute procedural success after treatment with the MitraClip device, 49 patients had moderate or less MR at 12-month follow-up. Their baseline and 12-month echocardiograms were compared between the group with and without LV dysfunction. In patients with persistent MR reduction and pre-existing LV dysfunction, there was a reduction in LV wall stress, reduced LV end-diastolic volume, LV end-systolic volume and increase in LV ejection fraction in contrast to those with normal baseline LV function, who showed reduction in LV end-diastolic volume, LV wall stress, no change in LV end-systolic volume, and a fall in LV ejection fraction. Conclusions—Patients with pre-existing LV dysfunction demonstrate reverse remodeling and improved LV ejection fraction after percutaneous mitral valve repair. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifiers: NCT00209339, NCT00209274.

Safety and feasibility of acute percutaneous septal sinus shortening: first-in-human experience.

Multiple percutaneous therapies for the treatment of functional and ischemic mitral regurgitation (FMR/IMR) are under development. We previously reported a novel percutaneous technique, the percutaneous septal sinus shortening [PS3] System™, which was effective in ameliorating FMR in an animal model. We herein report results from the first‐in‐human safety and feasibility pilot study involving the PS3 System.

Acute effect of percutaneous MitraClip therapy in patients with haemodynamic decompensation

To evaluate the haemodynamic effect of acute procedural success (APS) after MitraClip therapy in patients with haemodynamic decompensation.