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Objectives “Clopidogrel resistance,” also defined as heightened platelet reactivity (HPR) while on clopidogrel therapy, may lead to a sub-optimal antiplatelet effect and a potential thrombotic event. There is limited literature addressing the prevalence of HPR in a large cohort of patients receiving either coronary or endovascular interventions. Methods In a large integrated healthcare system, patients with a P2Y12 reaction units (PRU) test were identified. HPR was defined as a PRU ≥ 200 during clopidogrel therapy. Vascular and coronary interventions were identified utilizing CPT codes, HPR prevalence was calculated, and Fischer’s exact test was used to determine significance. Results From an initial cohort of 2,405,957 patients (October 2014 to January 2020), we identified 3301 patients with PRU tests administered. Of these, 1789 tests had a PRU ≥ 200 (HPR overall prevalence, 54%). We then identified 1195 patients who underwent either an endovascular or coronary procedure and had a PRU measurement. This corresponded to 935 coronary and 260 endovascular interventions. In the coronary cohort, the HPR prevalence was 54% (503/935). In the vascular cohort, the HPR prevalence was 53% (137/260); there was no difference between cohorts in HPR prevalence ( p = 0.78). Conclusion “Clopidogrel resistance” or HPR was found to be present in nearly half of patients with cardiovascular disease undergoing intervention. Our data suggest HPR is more common in the cardiovascular patient population than previously appreciated. Evaluating patients for HPR is both inexpensive ($25) and rapid (< 10 min). Future randomized studies are warranted to determine whether HPR has a clinically detectable effect on revascularization outcomes. more...

Aortic stenosis is the most common valvulopathy requiring replacement by means of the surgical or transcatheter approach. Transcatheter aortic valve replacement (TAVR) has quickly become a viable and often preferred treatment strategy compared to surgical aortic valve replacement. However, transcatheter heart valve system deployment not infrequently injures the specialized electrical system of the heart, leading to new conduction disorders including high-grade atrioventricular block and complete heart block (CHB) necessitating permanent pacemaker implantation (PPI), which may lead to deleterious effects on cardiac function and patient outcomes. Additional conduction disturbances (e.g., new-onset persistent left bundle branch block, PR/QRS prolongation, and transient CHB) currently lack clearly defined management algorithms leading to variable strategies among institutions. This article outlines the current understanding of the pathophysiology, patient and procedural risk factors, means for further risk stratification and monitoring of patients without a clear indication for PPI, our institutional approach, and future directions in the management and evaluation of post-TAVR conduction disturbances. more...

There is an increasing need for alternative access in patients with prohibitive surgical risk who have unsuitable anatomy for transfemoral transcatheter aortic valve replacement (TAVR). Data on differences in periprocedural outcomes via alternative access sites are scarce. We performed a retrospective analysis of patients who underwent Transaxillary (TAX) or Transapical (TAP) TAVR at our center from 2012 to 2019. All data was summarized and displayed as mean ± SD for continuous variables and number of patients in each group. A propensity score was created for each patient in the dataset to determine the probability of axillary vs apical access. We adjusted for propensity score using multivariate logistic regression. A total of 102 patients underwent TAVR via alternative access: 28 patients (27%) via TAX and 74 patients (73%) via transapical (TAP) access. The average time to extubation in the TAX group was 5.3 ± 3.5 hours vs 9.1 ± 8.8 hours in the TAP patients (P = 0.03). None of the TAX patients required reintubation compared to 23% of TAP TAVR (P = 0.003). The average hospital length of stay for TAX was 2.4 ± 2.0 days compared to 6.9 ± 3.3 days (P0.0001) for TAP. TAX TAVR patients had significantly lower re-intubation rates, shorter time to extubation and in-hospital length of stay, but higher pacemaker implantation rates. TAX TAVR had improved periprocedural outcomes compared to TAP TAVR and remains the preferred TAVR alternative access. more...

Recent trials have shown impressive results in low-risk patients undergoing Transcatheter Aortic Valve Replacement (TAVR) with low procedural complication rates, short hospital length of stay, zero mortality, and zero disabling stroke at 30 days and have led to a Food and Drug Administration indication for TAVR in these patients. The long-term data on subclinical leaflet thrombosis, valve durability, effects of pacemaker implantation, right ventricular pacing, and progressive paravalvular leak is unclear. We describe clinical and procedural considerations for patient selection and introduce future potential procedural challenges. Finally, we discuss the importance of considering life expectancy and durability prior to TAVR in this low risk relatively young cohort and emphasize the importance of a heart team approach. more...

The VARC (Valve Academic Research Consortium) for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials. No such standardization exists for circumferentially sutured surgical valve paravalvular leak (PVL) closure. This document seeks to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices. The PVL Academic Research Consortium met to review evidence and make recommendations for assessment of disease severity, data collection, and updated endpoint definitions. A 5-class grading scheme to evaluate PVL was developed in concordance with VARC recommendations. Unresolved issues in the field are outlined. The current PVL Academic Research Consortium provides recommendations for assessment of disease severity, data collection, and endpoint definitions. Future research in the field is warranted. more...

Paravalvular leaks (PVLs) are a well-recognized complication of prosthetic valves that are detected up to 18% of all implanted surgical valves. Perioperative morbidity is thought to be lower in percutaneous compared to surgical PVL repair. However, a direct comparison of PVL closure techniques has never been performed. Our study is the first to demonstrate that elective PVL closure with monitored anesthesia care can be achieved with high success and low complications rates resulting in short hospital stays.This is a retrospective cohort of patients admitted electively for catheter-based treatment of symptomatic prosthetic paravalvular regurgitation from Jan 2013 to April 2018. Both mitral and aortic PVLs were included. Patients' demographics, risk factors, procedural outcomes, In-hospital and thirty-day mortality were all reported. We followed the Valve Academic Research Consortium (VARC) criteria to define device and procedural technical success. In-hospital and 30- day outcomes were assessed by retrospective chart review.A total of 54 PVLs in thirty-seven patients were repaired (65% aortic35% mitral). The mean-age in the mitral cohort was lower than the aortic cohort (61 vs 72years, P0.0001) but the two groups shared similar clinical risk factors (P0.05). Average hospital stay was 1-2days (1.5days overall cohort) which was significantly lower in the aortic compared to the mitral cohort (P=0.009). All procedures were guided by TEE under conscious sedation with monitored anesthesia care. Procedural technical success defined as any significant residual shunt was 81% in the overall cohort and 88% in the aortic group. No procedural deaths were reported. Short-term mortality during the first 30days was 5.4% (two patients).Elective catheter-based repair of symptomatic prosthetic paravalvular regurgitation appears to be safe and effective. The use of conscious sedation with monitored anesthesia care resulted in short hospital stay. more...

Background Transcaval access may enable fully percutaneous transcatheter aortic valve replacement (TAVR) without the hazards and discomfort of transthoracic (transapical or transaortic) access. Objectives The authors performed a prospective, independently adjudicated, multicenter, single-arm trial of transcaval access for TAVR in patients who were ineligible for femoral artery access and had high or prohibitive risk of complications from transthoracic access. Methods A total of 100 patients underwent attempted percutaneous transcaval access to the abdominal aorta by electrifying a caval guidewire and advancing it into a pre-positioned aortic snare. After exchanging for a rigid guidewire, conventional TAVR was performed through transcaval introducer sheaths. Transcaval access ports were closed with nitinol cardiac occluders. A core laboratory analyzed pre-discharge and 30-day abdominal computed tomograms. The Society of Thoracic Surgeons predicted risk of mortality was 9.6 ± 6.3%. Results Transcaval access was successful in 99 of 100 patients. Device success (access and closure with a nitinol cardiac occluder without death or emergency surgical rescue) occurred 98 of 99 patients; 1 subject had closure with a covered stent. Inpatient survival was 96%, and 30-day survival was 92%. Second Valve Academic Research Consortium (VARC-2) life-threatening bleeding and modified VARC-2 major vascular complications possibly related to transcaval access were 7% and 13%, respectively. Median length of stay was 4 days (range 2 to 6 days). There were no vascular complications after discharge. Conclusions Transcaval access enabled TAVR in patients who were not good candidates for transthoracic access. Bleeding and vascular complications, using permeable nitinol cardiac occluders to close the access ports, were common but acceptable in this high-risk cohort. Transcaval access should be investigated in patients who are eligible for transthoracic access. Purpose-built closure devices are in development that may simplify the procedure and reduce bleeding. (Transcaval Access for Transcatheter Aortic Valve Replacement in People With No Good Options for Aortic Access; NCT02280824) more...

Transcatheter aortic valve replacement (TAVR) is an effective, nonsurgical treatment option for patients with severe aortic stenosis. The optimal treatment strategy for treating concomitant coronary artery disease (CAD) has not been tested prospectively in a randomized clinical trial. Nevertheless, it is standard practice in the United States to perform coronary angiography and percutaneous coronary intervention for significant CAD at least 1 month before TAVR. All existing clinical trials were designed using this strategy. Therefore, it is wrong to extrapolate current American College of Cardiology/American Heart Association Appropriate Use Criteria against invasive procedures in asymptomatic patients to the TAVR population when evaluating the quality of care by cardiologists or hospitals. In this statement from the Interventional Section Leadership Council of the ACC, it is recommended that percutaneous coronary intervention should be considered in all patients with significant proximal coronary stenosis in major coronary arteries before TAVR, even though the indication is not covered in current guidelines. more...

Background As a foundation for quality improvement, assessing clinical outcomes across hospitals requires appropriate risk adjustment to account for differences in patient case mix, including presentation after cardiac arrest. Objectives The aim of this study was to develop and validate a parsimonious patient-level clinical risk model of in-hospital mortality for contemporary patients with acute myocardial infarction. Methods Patient characteristics at the time of presentation in the ACTION (Acute Coronary Treatment and Intervention Outcomes Network) Registry–GWTG (Get With the Guidelines) database from January 2012 through December 2013 were used to develop a multivariate hierarchical logistic regression model predicting in-hospital mortality. The population (243,440 patients from 655 hospitals) was divided into a 60% sample for model derivation, with the remaining 40% used for model validation. A simplified risk score was created to enable prospective risk stratification in clinical care. Results The in-hospital mortality rate was 4.6%. Age, heart rate, systolic blood pressure, presentation after cardiac arrest, presentation in cardiogenic shock, presentation in heart failure, presentation with ST-segment elevation myocardial infarction, creatinine clearance, and troponin ratio were all independently associated with in-hospital mortality. The C statistic was 0.88, with good calibration. The model performed well in subgroups based on age; sex; race; transfer status; and the presence of diabetes mellitus, renal dysfunction, cardiac arrest, cardiogenic shock, and ST-segment elevation myocardial infarction. Observed mortality rates varied substantially across risk groups, ranging from 0.4% in the lowest risk group (score 59). Conclusions This parsimonious risk model for in-hospital mortality is a valid instrument for risk adjustment and risk stratification in contemporary patients with acute myocardial infarction. more...

Balloon aortic valvuloplasty (BAV) is commonly used in patients with severe decompensated aortic stenosis (AS) and provides symptomatic improvement without any benefit in overall survival [(1)][1]. Outcomes following BAV are often short-lived due to development of valvular restenosis [(2)][2], which more...

Compared with recent advances in treatment of serious cardiovascular diseases, such as myocardial infarction and stroke, the treatment and outcome of acute pulmonary embolism (PE) have remained relatively unchanged over the last few decades. This has prompted several experts to call for the formation of multidisciplinary PE response teams with a more proactive approach to the treatment of PE. In the current document, we discuss the formation of such teams and describe the available treatment options beyond anticoagulation, with a focus on the interventional approach. Acknowledging the paucity of data to support widespread adoption of such techniques, we call for the collection of outcomes data in multicenter registries and support for randomized trials to evaluate interventional treatments in patients with high-risk PE. more...

Patients who are comatose after cardiac arrest continue to be a challenge, with high mortality. Although there is an American College of Cardiology Foundation/American Heart Association Class I recommendation for performing immediate angiography and percutaneous coronary intervention (when indicated) in patients with ST-segment elevation myocardial infarction, no guidelines exist for patients without ST-segment elevation. Early introduction of mild therapeutic hypothermia is an established treatment goal. However, there are no established guidelines for risk stratification of patients for cardiac catheterization and possible percutaneous coronary intervention, particularly in patients who have unfavorable clinical features in whom procedures may be futile and affect public reporting of mortality. An algorithm is presented to improve the risk stratification of these severely ill patients with an emphasis on consultation and evaluation of patients prior to activation of the cardiac catheterization laboratory. more...

Background Major bleeding is a frequent complication for patients with acute myocardial infarction (AMI) and is associated with significant morbidity and mortality. Objective To develop a contemporary model for inhospital major bleeding that can both support clinical decision-making and serve as a foundation for assessing hospital quality. Methods An inhospital major bleeding model was developed using the Acute Coronary Treatment and Intervention Outcomes Network Registry–Get With the Guidelines (ACTION Registry–GWTG) database. Patients hospitalized with AMI between January 1, 2012 and December 31, 2013 across 657 hospitals were used to create a derivation cohort (n=144,800) and a validation cohort (n=96,684). Multivariable hierarchal logistic regression was used to identify significant predictors of major bleeding. A simplified risk score was created to enable prospective risk stratification for clinical care. Results The rate of major bleeding in the overall population was 7.53%. There were 8 significant, independent factors associated with major bleeding: presentation after cardiac arrest (OR 2.99 [2.77-3.22]); presentation in cardiogenic shock (OR 2.22 [2.05-2.40]); STEMI (OR 1.72 [1.65-1.80]); presentation in heart failure (OR 1.55 [1.47-1.63]); baseline hemoglobin less than 12 g/dL (1.55 [1.48-1.63]); heart rate (per 10 beat per minute increase) (OR 1.13 [1.12-1.14]); weight (per 10 kilogram decrease) (OR 1.12 [1.11-1.14]); creatinine clearance (per 5-mL decrease) (OR 1.07 [1.07-1.08]). The model discriminated well in the derivation (C-statistic = 0.74) and validation (C-statistic = 0.74) cohorts. In the validation cohort, a risk score for major bleeding corresponded well with observed bleeding: very low risk (2.2%), low risk (5.1%), moderate risk (10.1%), high risk (16.3%), and very high risk (25.2%). Conclusion The new ACTION Registry–GWTG inhospital major bleeding risk model and risk score offer a robust, parsimonious, and contemporary risk-adjustment method to support clinical decision-making and enable hospital quality assessment. Strategies to mitigate risk should be developed and tested as a means to lower costs and improve outcomes in an era of alternative payment models. more...

Valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) is a safe and effective therapy for failed surgical bioprosthetic aortic valves in patients who are at high risk for surgery. Both balloon-expanding valves (BEVs) (Medtronic, Minneapolis, Minnesota) and self-expanding valves (SEVs) ( more...

A 52-year-old male patient, with a medical history of surgically repaired double outlet right ventricle presented with severe aortic stenosis (AS) and hepatitis C with cirrhosis, presented with New York Heart Association Class IV heart failure. During evaluation for a liver transplant, he was deemed a poor surgical candidate due to his aortic valve disease and cirrhosis with model for end-stage liver disease score of 14. Transthoracic echocardiogram showed severe AS with a mean gradient of 62 mm Hg and calculated aortic valve area of 0.74 cm(2) with a normal ejection fraction of 65%. The patient underwent transfemoral implantation of a 23-mm Edwards Sapien commercial heart valve with significant mean gradient reduction across the aortic valve from 62 to 13 mm Hg. The patient was observed in the coronary care unit and discharged home 2 days postprocedure with his clinical symptoms greatly improved. more...

Studies have suggested that operator proficiency has a substantial effect on complication rates and procedural outcomes. Endovascular simulators have been used for training and have been proposed as an alternative to the conventional assessment of skills. The present study sought to validate simulation as an objective method for proficiency evaluation in carotid artery stenting. Interventional cardiologists classified as novice, intermediate, or experienced practitioners performed 3 simulated, interactive carotid stenting cases on an AngioMentor endovascular simulator. An automated algorithm scored the participants according to the technical performance, medical management, and angiographic results. A total of 33 interventional cardiologists (8 novices, 15 intermediates, and 10 experts) completed 82 simulated procedures. The composite scores for the case simulations varied significantly by operator experience, with better scores for the more experienced groups (p 0.0001). The metrics that discriminated between operator experience groups included fluoroscopy time, crossing the carotid lesion with devices other than a 0.014-in. wire before filter deployment, and incomplete coverage of the lesion by the stent. In conclusion, the results of the present study validate that a simulator with an automated scoring system is able to discriminate between levels of operator proficiency for carotid artery stenting. Simulator-based performance assessment could have a role in initial and ongoing proficiency evaluations and credentialing of interventional operators of high-risk endovascular procedures. more...

Purpose In this international multispecialty document, quality benchmarks for processes of care and clinical outcomes are defined. It is intended that these benchmarks be used in a quality assurance program to assess and improve processes and outcomes in acute stroke revascularization. Materials and Methods Members of the writing group were appointed by the American Society of Neuroradiology, Canadian Interventional Radiology Association, Cardiovascular and Interventional Radiological Society of Europe, Society of Cardiac Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, European Society of Minimally Invasive Neurological Therapy, and Society of Vascular and Interventional Neurology. The writing group reviewed the relevant literature from 1986 through February 2012 to create an evidence table summarizing processes and outcomes of care. Performance metrics and thresholds were then created by consensus. The guideline was approved by the sponsoring societies. It is intended that this guideline be fully updated in 3 years. Results In this international multispecialty document, quality benchmarks for processes of care and clinical outcomes are defined. These include process measures of time to imaging, arterial puncture, and revascularization and measures of clinical outcome up to 90 days. Conclusions Quality improvement guidelines are provided for endovascular acute ischemic stroke revascularization procedures. © 2013 Wiley Periodicals, Inc. more...

Patients with coronary artery disease (CAD) are destined to lifelong antiplatelet therapy in form of aspirin (acetylsalicylic acid) alone, or in combination with other P2Y2 inhibitors. Proton pump inhibitors (PPIs) are the preferred agents for the treatment and prophylaxis of gastrointestinal injury associated with nonsteroidal anti-inflammatory drug or acetylsalicylic acid or both,1 but recent data has raised questions about their association with negative cardiovascular events. We report 2 cases of patients with known CAD presented with chest pain mimicking angina pectoris that successfully resolved on discontinuation of the PPIs. One male and one female patient with known history of CAD receiving PPIs were referred to us with symptoms of refractory angina that was unresponsive to conventional optimized medical therapy. The angina was reported to be related to exertion in both the patients. Neither patient had a diagnosis of Prinzmetal angina or peptic ulcer disease; however, both patients reported a history of gastroesophageal reflux disease. Both patients were on dual antiplatelet therapy. No ischemic changes on the electrocardiogram were noted for either patient. Patient 1 had an exercise stress test that was negative for any inducible ischemia whereas patient 2 had no obstructive lesion seen on coronary angiography. Both patients reported to be symptom free after discontinuation of PPIs at 8 months of follow-up. It is our opinion that a relationship between PPIs and angina-like chest pain is plausible, as these 2 cases demonstrate the causative role of PPIs in precipitation of their symptoms. We postulate that this association should be considered in differential diagnosis of chest pain. In light of above findings we suggest that this is hypothesis generating and we are exploring the role of PPIs in patients with history of CAD and refractory angina-like symptoms despite complete revascularization. more...

Background: Current “best” medical therapy with anti-platelet and/or anti-thrombotic agents for symptomatic atherosclerotic intracranial (IC) disease is associated with high recurrence. IC catheter-based therapy (CBT) using balloon angioplasty with or without stent placement is an option for patients who have failed medical therapy. We sought to examine the outcomes of CBT for patients with symptomatic IC arterial disease managed by experienced interventional cardiologists. Methods: We retrospectively studied 89 consecutive symptomatic patients with 99 significant (≥70% diameter) IC arterial stenoses who underwent CBT. CBT was performed by experienced interventional cardiologists with the consultative support of a neurovascular team. The primary endpoint was stroke and vascular death. Results: Procedure success was achieved in 96/99 (97%) lesions and percent diameter stenosis was reduced from 91% ± 7.5% preprocedure to 19% ± 15% postprocedure (P < 0.001). The rate of in-hospital periprocedural stroke and all death was 3%. The primary endpoint of stroke and vascular death rate at 1 year was 5.7% (5/88) and at 2 years was 13.5% (11/81). The 2-year all-cause mortality was 11.3% (10/88). Conclusions: For patients with symptomatic IC arterial stenosis who have failed medical therapy or are considered very high risk for stroke, CBT performed by experienced interventional cardiologists is safe and offers both high procedural success rates and excellent clinical outcomes at 1 year. CBT is an attractive option for this high-risk patient population considering the expected 12–15% rate of recurrent stroke at 1 year. © 2012 Wiley Periodicals, Inc. more...

The objective of this paper is to describe outcomes of endovascular therapy in patients with symptomatic common femoral artery (CFA) lesions. Symptomatic atherosclerotic disease of the common femoral artery is an uncommon clinical entity, and there is no consensus regarding the suitability of catheter-based therapy. We reviewed the records of 26 consecutive patients treated with catheter-based therapy for symptomatic CFA lesions between 1994 and 2009. Angiographic success and procedure success were obtained in all vessels and in all patients. At 1 year, 100% (16/16) of the claudication patients and 70% (7/10) of the critical limb ischemia (CLI) patients maintained clinical success. The ankle— brachial index (ABI) significantly improved from a baseline of 0.47 ± 0.18 to 0.77 ± 0.18 ( p < 0.001) after the procedure. At their most recent clinic visit (31 months ± 14 months), clinical success was maintained in 100% of the claudication patients and in 70% (7/10) of the CLI patients. During the follow-up period, femoral vascular access for an unrelated procedure was obtained through the CFA stent. In conclusion, patients with symptomatic CFA atherosclerotic disease obtained excellent clinical outcomes with angioplasty with stenting. We found that angioplasty with stenting of the CFA did not preclude future CFA vascular access. Our data suggest that catheter-based therapies should be considered as an option to open surgery in selected patients with symptomatic CFA disease. more...

High on-treatment platelet reactivity (HPR) is relatively common with clopidogrel (42.7%) and less so with prasugrel (9.8%) or ticagrelor (1.5%). HPR to all 3 drugs has not been reported in the same patient. 72 year old white male with type 1 diabetes mellitus and severe diffuse vascular disease more...

Aortic valve (AV) homograft is the preferred treatment for aortic prosthetic valve bacterial endocarditis (PVBE). However, many patients present with rapid deterioration due to heart failure (HF) and are poor surgical candidates. Valve-in-Valve (ViV) TAVR is a widely used treatment for failing more...

Paravalvular leaks (PVLs) are a well-recognized complication of prosthetic heart valves that are detected in up to 18% of all implanted surgical valves. Perioperative morbidity is thought to be overall low in percutaneous PVL repair. However, a direct comparison of the timing of the PVL closure to more...

Objectives The aim of this study was to demonstrate the safety and long-term durability of catheter-based therapy for symptomatic vertebral artery stenosis (VAS). Background Symptomatic VAS carries with it a 5-year 30% to 35% risk of stroke. The 2-year mortality approaches 30% for medically managed strokes involving the posterior circulation. Surgical bypass is rarely performed, due to high morbidity and mortality. Endovascular revascularization with primary stenting offers an attractive treatment option for these patients. Methods One-hundred five consecutive symptomatic patients (112 arteries, 71% male) underwent stent placement for extracranial (91%) and intracranial (9%) VAS from 1995 to 2006. Fifty-seven patients (54%) had bilateral VAS, 71 patients (68%) had concomitant carotid disease, and 43 patients (41%) had a prior stroke. Results Procedural and clinical success was achieved in 105 (100%) and 95 (90.5%) patients, respectively. One-year follow-up was obtained in 87 (82.9%) patients, of which 69 patients (79.3%) remained symptom-free. At 1 year, 6 patients (5.7%) had died and 5 patients (5%) had a posterior circulation stroke. Target vessel revascularization occurred in 7.4% at 1 year. At a median follow-up of 29.1 months (interquartile range 12.8 to 50.9 months), 13.1% underwent target vessel revascularization, 71.4% were alive, and 70.5% remained symptom-free. Conclusions In experienced hands, stenting for symptomatic VAS can be accomplished with a very high success rate (100%), with few periprocedural complications, and is associated with durable symptom resolution in the majority (approximately 80%) of patients. We conclude that endovascular stenting of vertebral artery atherosclerotic disease is safe and effective compared with surgical controls and should be considered first-line therapy for this disease. more...

Percutaneous intervention for peripheral artery disease has evolved from balloon angioplasty for simple focal lesions to multimodality techniques that enable treatment of severe arterial insufficiency. This technological expansion comes without a standard approach or algorithm, which makes the decision-making process more subjective than objective. Nevertheless, clinical tools are available that can have a favorable effect on patient care, and these promote usage. So, when are standard endovascular techniques (such as balloon and stents) good enough, and when are the latest advances (eg, atherectomy, drug-eluting stents) more appropriate? This section will address these questions for acute limb ischemia (ALI) and chronic critical limb ischemia (CLI). It will also delineate the problem of restenosis, particularly of the superficial femoral artery (SFA), and describe treatment alternatives. The discussion will review the role of drug-eluting stents, atherectomy devices, reentry catheters, and brachytherapy, as well as their potential complications and appropriate remedies. Treatment algorithms for aortoiliac and infrainguinal disease are provided in Figures 1 through 3⇓⇓. Figure 1. Treatment algorithm for acute lower-limb ischemia. *Short infusion of thrombolytic therapy proximal to occlusion can be used to facilitate wire traversal. Figure 2. Simplified treatment algorithm for symptomatic aortoiliac disease in patients deemed candidates for revascularization. In patients with multilevel disease, the aortoiliac segment should be addressed first. TASC indicates TransAtlantic Inter-Society Consensus; AI, aortoiliac; PTA, percutaneous transluminal angioplasty; PE, physical examination; ABI, ankle-brachial index; and U/S, ultrasound. Figure 3. Simplified treatment algorithm for symptomatic infrainguinal peripheral arterial disease, assuming concomitant aortoiliac disease has been treated and the patient is an acceptable candidate for revascularization. *Alternative therapies to PTA include cryotherapy, atherectomy (directional, rotational, ablative), and cutting balloon. †Alternative stent options include stent (graft, balloon expanding, and self expanding) and drug-eluting stent. PTA indicates percutaneous transluminal angioplasty; TASC, TransAtlantic Inter-Society Consensus; PE, physical examination; … more...

Background: Carotid artery stent (CAS) placement is an alternative to carotid endarterectomy (CEA) for stroke prevention. Clinical adoption of CAS depends on its safety and efficacy compared to CEA. There are conflicting reports in the literature regarding the safety of CAS in the elderly. To address these safety concerns, we report our single-center 13-year CAS experience in very elderly (≥80 years of age) patients. Methods: Between 1994 and 2007, 816 CAS procedures were performed at the Ochsner Clinic Foundation. Very elderly patients, those ≥80 years of age, accounted for 126 (15%) of all CAS procedures. Independent neurologic examination was performed before and after the CAS procedure. Results: The average patient age was 82.9 ± 2.9 years. Almost one-half (44%) were women and 40% were symptomatic from their carotid stenoses. One-third of the elderly patients met anatomic criteria for high surgical risk as their indication for CAS. The procedural success rate was 100% with embolic protection devices used in 50%. The 30-day major adverse coronary or cerebral events (MACCE) rate was 2.7% (n = 3) with all events occurring in the symptomatic patient group [death = 0.9% (n = 1), myocardial infarction = 0%, major (disabling) stroke = 0.9% (n = 1), and minor stroke = 0.9% (n = 1)]. Conclusion: Elderly patients, ≥80 years of age, may undergo successful CAS with a very low adverse event rate as determined by an independent neurological examination. We believe that careful case selection and experienced operators were keys to our success. more...

Objectives: We report outcomes in patients undergoing catheter-based intervention for symptomatic subclavian and innominate artery (S/IA) atherosclerosis. Background: Symptomatic S/IA obstructive lesions have traditionally been treated with open surgical revascularization. Catheter-based endovascular therapies reduce the morbidity and mortality associated with surgery in many vascular beds. Methods: Between December 1993 and May 2006, 170 patients underwent primary stent placement in 177 S/IA arteries. Indications for revascularization included arm ischemia (57%), subclavian steal syndrome (37%), coronary-subclavian steal syndrome (21%), and planned coronary bypass surgery with the involved internal mammary artery (8%). Results: Technical success was achieved in 98.3% (174/177) arteries, including 99.4% for stenotic lesions (155/156) and 90.5% for occlusions (19/21). There were no procedure-related deaths and one stroke (0.6%, 1/170). Follow-up was obtained in 151 (89%) patients at 35.2 ± 30.8 months, with a target vessel revascularization rate of 14.6% (23/157). At last follow-up, 82% (124/151) of all treated patients remained asymptomatic with a primary patency of 83% and a secondary patency of 96%. Conclusions: Catheter-based revascularization with stents for symptomatic S/IA lesions is safe and effective with excellent patency rates and sustained symptom resolution in the majority (>80%) of patients over 3 years of follow-up. Percutaneous primary stent therapy is the preferred method of revascularization in patients with suitable anatomy. more...

Objective: To assess the impact of stent revascularization on the renal function of diabetic and nondiabetic patients with renal insufficiency. Background: Renal artery revascularization has been shown to stabilize or improve renal function in patients with significant renal artery stenosis and impaired renal function. However, some studies have suggested negligible or no benefit of renal function in diabetic patients with the same condition. Methods: We retrospectively compared data from 50 consecutive patients undergoing renal artery stent placement with renal insufficiency (serum creatinine ≥1.5–4.0 mg/dl) and global ischemia (bilateral or solitary [single] kidney renal artery stenosis) There were 17 diabetic (DM) and 33 nondiabetic (NDM) patients. The endpoints included the follow-up measurements of renal function, blood pressure, and number of antihypertensive medications. Results: After stent placement, at a mean follow-up of 42 ± 18 months (range: 6–62 months), 79% NDM (N = 26), and 76% DM patients (N = 13) (P = NS) had improvement in the slope of the reciprocal of creatinine (1/SCr), indicating a beneficial effect in renal function in many patients. Conclusion: Renal artery stent placement appears to be equally beneficial in preserving renal function in DM and NDM patients with ischemic nephropathy and global renal ischemia. © 2006 Wiley-Liss, Inc. more...

ObjectivesThe purpose of this study was to determine the safety and effectiveness of the SAPIEN XT versus SAPIEN systems (Edwards Lifesciences, Irvine, California) in patients with symptomatic, severe aortic stenosis (AS) who were not candidates for surgery.BackgroundTranscatheter aortic valve replacement (TAVR) has become the standard of care for inoperable patients with severe, symptomatic AS. In the PARTNER (Placement of Aortic Transcatheter Valves) IB trial, a reduction in all-cause mortality was observed in patients undergoing TAVR with the balloon-expandable SAPIEN transcatheter heart valve compared with standard therapy, but the SAPIEN valve was associated with adverse periprocedural complications, including vascular complications, major bleeding, and paravalvular regurgitation. The newer, low-profile SAPIEN XT system was developed to reduce these adverse events.MethodsA total of 560 patients were enrolled at 28 sites in the United States from April 2011 to February 2012. Patients were randomized to receive the SAPIEN or SAPIEN XT systems. The primary endpoint was a nonhierarchical composite of all-cause mortality, major stroke, and rehospitalization at 1 year in the intention-to-treat population, assessed by noninferiority testing. Pre-specified secondary endpoints included cardiovascular death, New York Heart Association functional class, myocardial infarction, stroke, acute kidney injury, vascular complications, bleeding, 6-min walk distance, and valve performance (by echocardiography).ResultsBoth overall and major vascular complications were higher at 30 days in patients undergoing TAVR with SAPIEN compared with SAPIEN XT (overall: 22.1% vs. 15.5%; p = 0.04; major: 15.2% vs. 9.5%; p = 0.04). Bleeding requiring blood transfusions was also more frequent with SAPIEN compared with SAPIEN XT (10.6% vs. 5.3%; p = 0.02). At 1-year follow-up, the nonhierarchical composite of all-cause mortality, major stroke, or rehospitalization was similar (37.7% SAPIEN vs. 37.2% SAPIEN XT; noninferiority p value more...

We performed percutaneous transluminal intervention in 20 consecutive patients (21 limbs) with common femoral artery (CFA) lesions causing symptomatic limb ischemia. In 12 limbs, concurrent additional percutaneous intervention proximal or distal to the target CFA lesion was performed. Angiographic success was obtained in 100%, with procedural success (angiographic success without a major in-hospital complications) in 90% and clinical success (procedural success and in-hospital improvement by at least one Fontaine functional class) in 81% of the limbs. The in-hospital Fontaine class improved by at least one functional class in 17 of 19 patients (89%), and the overall in-hospital event-free survival was 90% (18 of 20 patients). At follow-up (11.4 ± 6 months), the overall event-free survival was 90% (18 of 20 patients) and 17 of 19 patients (89%) continue to show improvement by at least one functional (Fontaine) class. Percutaneous intervention of the CFA can be performed with a rate of high technical success and a low complication rate. It provides excellent clinical results at mid-term follow-up and appears to be a reasonable alternative to surgical therapy in patients at high risk for surgery. Catheter Cardiovasc Interv 2004;62:230–233. © 2004 Wiley-Liss, Inc. more...

Hypertrophic cardiomyopathy is a complex genetic condition with a heterogeneous clinical course. Some patients remain asymptomatic throughout life while others develop one or more of the adverse clinical consequences including symptoms of congestive heart failure with exertional dyspnea and functional disability (usually with preserved left ventricular systolic function), atrial fibrillation, or sudden cardiac death. Because of this heterogenicity in the clinical presentations, management of patients with hypertrophic cardiomyopathy includes a wide range of pharmacologic therapies as well as invasive approaches. In recent years, nonsurgical catheter-based treatment of hypertrophic cardiomyopathy has been increasingly used in the management of a subset of these patients. The authors present a case of percutaneous transluminal septal myocardial ablation in a patient with hypertrophic cardiomyopathy who was symptomatic despite maximal medical treatment. more...

Percutaneous coronary interventions are performed with a high success rate, though failures still occur. Inability to deliver stents to the target lesion is the most common cause for failures. We present two cases using Rotaglide applied on the stents to enable delivery, showing that Rotaglide is effective in improving stent delivery. more...

Paravalvular leaks (PVL) are a well-recognized complication of prosthetic valve replacement. Most are asymptomatic and benign, but some may cause symptoms due to a large regurgitant volume or hemolysis. Surgical repair of paravalvular leak carries significant morbidity and mortality. The more...

Transcatheter aortic valve implantation (TAVI) has broadened treatment options for high-risk patients with severe aortic stenosis. The 1-year mortality after TAVI has been described to be 24-30%. Improved pre-procedural testing is needed to better determine those most likely to benefit from TAVI. more...

A 64-year-old male with Budd–Chiari syndrome (BCS) due to inferior vena cava (IVC) occlusion after liver transplant presented with massive ascites and lower extremity edema. He was found to have chronic total occlusion of the supra-hepatic IVC with thrombosis in the infra-hepatic IVC, hepatic, renal, and iliac veins. Attempts to recanalize the occlusion by multiple operators failed. He was not a surgical candidate. The patient underwent venography of the IVC, and placement of a McNamara catheter for catheter-directed thrombolysis on the first day. The second day, he underwent right internal jugular access with contrast injections to mark the superior aspect of the occlusion via a Multipurpose catheter. An adult transseptal needle (Bard Electrophysiology Division C. R. Bard, Inc., Lowell, MA, USA) was used to create a tract through a 6French Raabe Sheath and traverse the occlusion. A 10-mm Snare (Cook, Bloomington, IN, USA) cranially retracted the guidewire. Intravascular ultrasound was performed to further delineate the diameter of the IVC at the lesion before dilation with a 6.0mm×40mm PTA balloon and a 10mm×29mm Palmaz Stent (Cordis Corporation, Bridgewater, NJ, USA) deployment. The patient lost 24.6kg in 2 weeks with resolution of ascites and pedal edema. Learning objective: This case provides a unique approach to percutaneous intervention of inferior vena cava chronic total occlusion in the setting of Budd–Chiari syndrome post-liver transplant. There was use of an inferior and superior marker followed by use of transseptal needle to transverse the occlusion followed by balloon dilation and stent placement. While the disease and intervention have been described, the use of dual cranial/caudal markers and use of transseptal needle is unique to this particular case.> more...

The management of extracranial carotid artery disease is primarily concerned with the prevention of acute stroke. In order to understand the current risks of carotid angiography performed by interventional cardiologists, we undertook a retrospective study to determine the neurologic complications in patients who underwent selective cerebral angiography. All patients undergoing studies that were limited to diagnostic aortic arch angiography and selective four-vessel cerebral angiography in the cardiac catheterization laboratories during the past 6 years were included in this study. Hospital records were reviewed to determine any in-hospital cerebrovascular complications following carotid angiography, ranging from transient ischemic attack to major disabling stroke or death. A total of 189 consecutive patients underwent 191 diagnostic studies limited to aortic arch and four-vessel cerebral angiography in the cardiac catheterization laboratories between 1 January 1995 and 31 December 2000. Only one (0.52%) neurological complication, a minor stroke, occurred in our study population. There were no transient ischemic attacks, major strokes, or death. We have shown that experienced interventional cardiologists can perform diagnostic aortic arch and selective carotid and vertebral angiography in a cardiac catheterization laboratory with a very low complication rate. Because the risks of angiography add to those of revascularization of the carotid artery, the most highly skilled angiographer, regardless of primary specialty, should perform these studies. more...

The results of the VeGAS 2 trial further extend knowledge of the AngioJet device and demonstrate benefits in success, safety, and greater convenience to the patient and physician due to a single, combined procedure for thrombus removal and definitive intervention in this high-risk patient group. AngioJet should be regarded as the therapy of choice for treatment of thrombotic SVGs or native coronary arteries. more...

Despite advances in mechanical and pharmacologic therapy, thrombus-containing lesions are at high risk for adverse events and remain a challenging subset for percutaneous coronary revascularization. Recently, rheolytic thrombectomy with the AngioJet device has been shown to safely remove intracoronary thrombus, but the overall cost-effectiveness of this technique is unknown.We determined in-hospital and 1-year follow-up costs for 349 patients with overt intracoronary thrombus who were randomly assigned to treatment with intracoronary urokinase (6- to 30-hour infusion followed by definitive revascularization; n = 169) or immediate thrombectomy with the AngioJet device (n = 180) as part of the Vein Graft AngioJet Study (VeGAS) 2 trial. Catheterization laboratory costs were based on measured resource utilization and 1998 unit costs, whereas all other costs were estimated from hospital charges and cost center-specific cost-to-charge ratios.Compared with urokinase, rheolytic thrombectomy reduced the incidence of periprocedural myocardial infarction (12.8% vs 30.3%, P.001) and major hemorrhagic complications (2.8% vs 11.2%, P.001) and shortened length of stay by nearly 1 day (4.2 vs 4.9 days; P =.02). As a result, AngioJet treatment reduced procedural costs, hospital room/nursing costs, and ancillary costs with resulting hospital cost savings of approximately $3500 per patient during the initial hospitalization ($15,311 vs $18,841, P.001). These cost savings were maintained at 1 year of follow-up ($24,389 vs $29,109, P.001).Compared with standard treatment with intracoronary urokinase, rheolytic thrombectomy both improves clinical outcomes and reduces overall medical care costs for patients with extensive intracoronary thrombus. more...

Rotational atherectomy is used to debulk calcified or complex coronary stenoses. Whether aggressive burr sizing with minimal balloon dilation (1 atm) to limit deep wall arterial injury improves results is unknown. Patients being considered for elective rotational atherectomy were randomized to either an "aggressive" strategy (n = 249) (maximum burr/artery0.70 alone, or with adjunctive balloon inflationor = 1 atm), or a "routine" strategy (n = 248) (maximum burr/arteryor =0.70 and routine balloon inflationor =4 atm). Patient age was 62 +/- 11 years. Fifty-nine percent routine and 60% aggressive strategy patients had class III to IV angina. Fifteen percent routine and 16% aggressive strategy patients had a restenotic lesion treated; lesion length was 13.6 versus 13.7 mm. Reference vessel diameter was 2.64 mm. Maximum burr size (1.8 vs 2.1 mm), burr/artery ratio (0.71 vs 0.82), and number of burrs used (1.9 vs 2.7) were greater for the aggressive strategy, p0.0001. Final minimum lumen diameter and residual stenosis were 1.97 mm and 26% for the routine strategy versus 1.95 mm and 27% for the aggressive strategy. Clinical success was 93.5% for the routine strategy and 93.9% for the aggressive strategy. Creatine kinase-myocardial band (CK-MB) was5 times normal in 7% of the routine versus 11% of the aggressive group. CK-MB elevation was associated with a decrease in rpm of5,000 from baseline for a cumulative time5 seconds, p = 0.002. At 6 months, 22% of the routine patients versus 31% of the aggressive strategy patients had target lesion revascularization. Angiographic follow-up (77%) showed minimum lumen diameter to be 1.26 mm in the routine group versus 1.16 mm in the aggressive group, and the loss index 0.54 versus 0.62. Dichotomous restenosis was 52% for the routine strategy versus 58% for the aggressive strategy. Multivariable analysis indicated that left anterior descending location (odds ratio 1.67, p = 0.02) and operator-reported excessive speed decrease5,000 rpm (odds ratio 1.74, p = 0.01) were significantly associated with restenosis. Thus, the aggressive rotational atherectomy strategy offers no advantage over more routine burr sizing plus routine angioplasty. Operator technique reflected by an rpm decrease of5,000 from baseline is associated with CK-MB elevation and restenosis. more...

Summary Background Percutaneous transmyocardial laser revascularisation (PTMR) is a proposed catheter-based therapy for refractory angina pectoris when bypass surgery or angioplasty is not possible. We undertook a randomised trial to assess the safety and efficacy of this technique. Methods 221 patients with reversible ischaemia of Canadian Cardiovascular Society angina class III (61%) or IV (39%) and incomplete response to other therapies were recruited from 13 centres. Patients were randomly assigned PTMR with a holmium:YAG laser plus continued medical treatment (n=110) or continued medical treatment only (n=111). The primary endpoint was the exercise tolerance at 12 months. Analyses were by intention to treat. Findings 11 patients died and 19 withdrew; 92 PTMR-group and 99 medical-treatment-group patients completed the study. Exercise tolerance at 12 months had increased by a median of 89·0 s (IQR -15 to 183) with PTMR compared with 12·5 s (−67 to 125) with medical treatment only (p=0·008). On masked assessment, angina class was II or lower in 34·1% of PTMR patients compared with 13·0% of those medically treated. All indices of the Seattle angina questionnaire improved more with PTMR than with medical care only. By 12 months there had been eight deaths in the PTMR group and three in the medical treatment group, with similar survival in the two groups. Interpretation PTMR was associated with increased exercise tolerance time, low morbidity, lower angina scores assessed by masked reviewers, and improved quality of life. Although there is controversy about the mechanism of action, and the contribution of the placebo effect cannot be quantified, this unmasked study suggests that this palliative procedure provides some clinical benefits in the defined population of patients. more...

Purpose: To present the results of a multicenter registry established to collect data on carotid stent procedures in patients with restenosis following carotid endarterectomy. Methods: The procedural details, outcomes, and late follow-up results were collected from 14 centers in the United States. Thirty-day and late stroke and death rates were analyzed. Results: Three hundred and thirty-eight patients (201 men; 71 ± 8 years) underwent carotid stenting in 358 arteries. The average duration from carotid endarterectomy was 5.5 ± 7.3 years. Sixty-one percent of the patients were asymptomatic. The overall 30-day stroke and death rate was 3.7%. The minor stroke rate was 1.7% (6/358), and the major nonfatal stroke rate was 0.8% (3/358). The fatal stroke rate was 0.3% (1/358), and the nonstroke-related death rate was 0.9% (3/338). There was 1 (0.3%) fatal and 1 (0.3%) nonfatal stroke during the follow-up period. The overall 3-year rate of freedom from all fatal and nonfatal strokes was 96% ± 1% (±SE). Conclusions: Carotid artery stenting can be performed in patients with restenosis following carotid endarterectomy with 30-day complication rates comparable to those of most published studies on repeat carotid endarterectomy. Results of late follow-up suggest that this technique is durable and efficacious. more...

Purpose: To report a case of paradoxical emboli to multiple visceral vessels treated with both mechanical (AngioJet device) and pharmacological (urokinase) thrombolysis. Methods and Results: A 72-year-old man presented with a 48-hour history of symptomatic right renal ischemia, which was treated with heparinization. Five days later, an abrupt creatinine elevation prompted arteriography, which demonstrated thromboembolism of the superior mesenteric artery (SMA) and both renal arteries. The AngioJet aspiration device was employed to successfully remove the clot from the SMA; urokinase infusion restored flow to the left kidney. At the 16-month follow-up evaluation, the patient was normotensive without medication and had a stable creatinine (1.4 mg/dL). Conclusions: Because of its speed and minimal morbidity, the AngioJet device may be an attractive alternative to surgical embolectomy or pharmacological thrombolysis in highly selected cases of acute visceral artery thromboembolism. more...