Predictors of permanent pacemaker implantation for transcatheter self-expandable aortic valve implant in the cusp overlap era.

BACKGROUND: Predictors of permanent pacemaker implantation (PPMI) after self-expanding transcatheter aortic valve implant (TAVI) were described. Is unknown if PPMI predictors remain in the era of high implants using the cusp overlap (COP). METHODS: Single-center, prospective, consecutive case series of patients undergoing self-expanding TAVI with the COP approach. The status of PPMI and other clinical events were ascertained at 30 days. RESULTS: A total of 261 patients were included (84% with Evolut, n = 219). Implant depth >4 mm was infrequent (13.8%). TAVI depth (OR 1.259; p = 0.005), first or second-degree auriculo-ventricular block (OR 3.406; p = 0.033), right-bundle (OR 15.477; p < 0.0001), and incomplete left-bundle branch block (OR 7.964; p = 0.036) were found to be independent predictors of PPMI. The risk of PPMI with deep implant and no electrical disturbances was 3%, and 0% with high implant and no prior electrical disturbances. Those who received PPMI had no statistically significant increased risk of death, myocardial infarction, stroke, bleeding events, or vascular complications at 30 days, but longer hospital stay (mean difference 1.43 days more, p = 0.003). CONCLUSIONS: Implant depth and prior conduction abnormalities remain the main predictors of PPMI using self-expanding TAVI in the COP era. Patients with high implants and no prior conduction abnormalities may be candidates for early discharge after uneventful self-expanding TAVI, while the rest may need inpatient monitoring regardless of achieving a high implant. The need for PPMI was associated with longer hospital stays.

Impact of Cusp-Overlap View for TAVR with Self-Expandable Valves on 30-Day Conduction Disturbances.

METHODS AND RESULTS: We retrospectively compared 257 consecutive patients undergoing TAVR with self-expandable valves using either CON (n = 101) or COVL (n = 156) in four intermediate/low volume centers. There were no significant differences in baseline characteristics between the groups. The 30-day incidence of new-onset LBBB (12.9% vs. 5.8%; p=0.05) and PPMI rate (17.8% vs. 6.4%; p=0.004) was significantly lower when using the COVL implantation view. There was no difference between the CON and COVL groups in 30-day incidence of death (4.9% vs. 2.6%), any stroke (0% vs. 0.6%), and the need for surgical aortic valve replacement (0% for both groups). CONCLUSION: Using the COVL view for implantation, we achieved a significant reduction of the LBBB and PPMI rate after TAVR in comparison with the traditional CON view, without compromising the TAVR outcomes when using self-expandable prostheses.

Intravascular ultrasound for cardiac allograft vasculopathy detection.

Cardiac allograft vasculopathy (CAV) after heart transplantation is a fibro-proliferative process affecting coronary arteries of the graft in up to 46.8% of the cases during the first 10 years post-transplantation. It is one of the main causes of graft loss and death. Due to graft denervation, CAV causing ischemia is usually clinically silent until the disease is far advanced. In this study, we compared coronary angiography with intravascular ultrasound (IVUS) for CAV detection. OUTCOMES: A total of 114 patients with HTx who underwent coronary angiography and IVUS between March 2018 and March 2019 were included. Mean follow-up was 87 ± 61 month. Lesions documented by coronary angiography were found in only 27 (24%) of the 114 patients. IVUS revealed ISHLT CAV 0 in 87 patients (76.3%); ISHLT CAV1 in 15 (13,1%) and ISHLT CAV2 and CAV3 in 6 patients (5.2%) each. Among 328 IVUS images, maximum intimal thickness (MIT) >0.5 mm was obtained in 60 vessels (52%) with 24 patients having three-vessel and 19 two-vessel involvement. CONCLUSION: As an adjunct to conventional coronary angiography to detect angiographically silent CAV in heart transplant patients, IVUS is a reliable and safe technique with a low complication rate. Large multicenter studies are necessary to confirm these findings and the potential long-term clinical impact of early detection in clinically and angiographically silent phase.

Transradial Versus Transfemoral Carotid Artery Stenting: A 16-Year Single-Center Experience.

AIMS: Limited data exist on radial access in carotid artery stenting (CAS). This single-center study was performed to compare the outcome and complication rates of transradial (TR) and transfemoral (TF) CAS. METHODS AND RESULTS: The clinical and angiographic data of 775 consecutive patients with high risk for carotid endarterectomy, treated between 1999 and 2016 by CAS with cerebral protection, were evaluated. Patients were divided into 2 groups according to vascular access: TR (n = 101; 13%) and TF (n = 674). Primary combined end-point: in-hospital major adverse cardiac and cerebral events. Secondary end-points: angiographic outcome of the procedure and crossover rate to another puncture site. Angiographic success was achieved in all 775 patients, the crossover rate was 4.9% in the TR and 0% in the TF group (P < 0.05). TR was performed at the right side in 97% of cases. The incidence of in-hospital major adverse cardiac and cerebral events was 2% in the TR and 3.6% in the TF group (P = ns). CONCLUSIONS: The TR approach for CAS is safe and efficacious, with acceptable cross-over rate. In both groups, vascular complications rarely occurred.

Endovascular Repair of an Aortic Arch Aneurysm with Triple Chimney Stent Grafts: A Case Report.

The treatment of an aortic arch aneurysm in high-risk individuals poses a significant challenge. We present a surgical patient with a patent left internal mammary artery (LIMA) graft and a large aortic arch aneurysm who underwent aortic stent-graft implantation and complete endovascular branching to preserve the LIMA inflow, with successful exclusion of the aneurysm. A moderate flow, proximal type I endoleak was observed after deployment that disappeared at 2-year follow-up.

Transcatheter aortic valve implantation without balloon predilation: a single-center pilot experience.

AIM: To assess the results of transcatheter aortic valve implantation (TAVI) using the Medtronic CoreValve prosthesis (Medtronic, Minneapolis, MN), without balloon predilation, in high-risk patients with degenerated severe aortic stenosis. METHODS AND RESULTS: Fifty-one consecutive patients who underwent direct TAVI, 98% through a transfemoral approach. Patients were 79 ± 8 years of age, 74% in New York Heart Association classes III or IV and at high risk for surgical valve replacement (mean logistic EuroScore 20 ± 15). Mean aortic valve area was 0.7 ± 0.2 cm(2). Procedural success rate was 94.2%. In-hospital, there were 2 deaths, 1 minor stroke with minimal sequelae, and 14 (28%) pacemaker implantation. At 30 days, there was one additional stroke and no new deaths. The mean postprocedural transprosthetic gradient was 15 ± 5 mm Hg; periprosthetic severe regurgitation was absent and moderate in one case. After a median follow-up of 7 months, there were five additional deaths (two cardiac), while 84% of survivors were in New York Heart Association classes I or II. CONCLUSIONS: These results suggest that direct CoreValve implantation in patients with severe aortic stenosis is feasible and may lead to hemodynamic and clinical improvement in patients who are poor candidates for aortic valve surgery, pending confirmation in larger series with longer follow-up.

Usage patterns and 1-year outcomes with the TAXUS Liberté stent: results of the TAXUS OLYMPIA registry.

OBJECTIVES: The TAXUS OLYMPIA registry is a prospective, global, post-approval program designed to collect clinical outcome data through 1 year from patients receiving the TAXUS Liberté paclitaxel-eluting stent in routine interventional cardiology practice. BACKGROUND: The thin-strut TAXUS Liberté stent has been studied in ongoing clinical trials with specific inclusion/exclusion criteria. METHODS: Between September 2005 and April 2007, a total of 21,954 patients from 365 sites in 57 countries eligible to receive a TAXUS Liberté stent were enrolled in the TAXUS OLYMPIA registry. Baseline characteristics and procedure patterns were collected and clinical follow-up is available for 1 year. The primary endpoint was the composite cardiac event (cardiac death, MI, and reintervention of the target vessel) rate related to the TAXUS Liberté stent at 1 year. All cardiac events were monitored and all endpoints were independently adjudicated. RESULTS: Complex patients and lesions were prevalent, including: 27% medically-treated diabetes, 58% ACC/AHA type B2/C lesions, 32% multiple stenting, 13% long lesions (>28 mm), and 10% small vessels (<2.5 mm). At 1 year, the composite cardiac event rate was 4.4%, including 1.4% cardiac death, 1.0% MI, and 3.2% TVR. Stent thrombosis (ST, angiographically confirmed) occurred in 0.8% of patients, with 0.4% ST occurring >30 days postprocedure. The composite cardiac event rate related to the TAXUS Liberté stent was 3.8% at 1 year. CONCLUSIONS: Low 1-year cardiac event rates were reported with TAXUS Liberté in a broad spectrum of patients, thereby confirming the technical and clinical performance of this stent in a "real-world" setting.

[Aortic valvular replacement by catheterism. Current state]. / Reemplazo valvular aórtico por cateterismo. Estado actual.

Severe aortic stenosis is a common disease whose prevalence is steadily growing with population ageing. Surgical aortic valve replacement (SAVR) has been the only effective alternative until the introduction of transcatheter aortic valve replacement (TAVR or TAVI). This procedure was initially used for non-surgical candidate patients where two randomized clinical trials and several registries showed superiority over conservative medical treatment. Furthermore, two additional clinical trials including high surgical risk patients proved the non-inferiority of TAVR versus surgical replacement. Similar findings regarding effectiveness were observed in other clinical trials including intermediate and low risk patients. Technical and procedural improvements, including learning curve and the current minimally invasive strategy have decreased periprocedural and mid-term complications such as those related with vascular access, stroke, the need for permanent pacemaker implantation and paravalvular leak. All things considered, durability is a pending question to establish which would be the role of TAVR in current and future practice.

La estenosis aórtica grave es una enfermedad común cuya prevalencia crece con el envejecimiento de la población. El reemplazo valvular aórtico quirúrgico (SAVR) ha sido la única alternativa efectiva hasta la aparición del reemplazo valvular aórtico por cateterismo (TAVR o TAVI). Este procedimiento se usó inicialmente para pacientes inoperables en quienes dos ensayos clínicos aleatorios y varios registros mostraron su superioridad sobre el tratamiento médico conservador. Dos ensayos clínicos adicionales en pacientes que, a pesar de ser considerados operables, tenían alto riesgo quirúrgico, demostraron la no inferioridad de TAVR versus reemplazo quirúrgico. Investigaciones posteriores probaron también su efectividad en pacientes de riesgo intermedio y bajo. Algunas complicaciones, como las relacionadas al acceso vascular, el accidente cerebro vascular, la necesidad de marcapasos definitivo y la regurgitación periprotésica, han ido disminuyendo con la mejoría de la tecnología, la curva de aprendizaje y la estrategia mínimamente invasiva actual. Queda pendiente determinar la durabilidad para establecer cuál será el papel de TAVR en la práctica clínica.

Reemplazo valvular aórtico por cateterismo. Estado actual / Aortic valvular replacement by catheterism. Current state

Resumen La estenosis aórtica grave es una enfermedad común cuya prevalencia crece con el envejecimiento de la población. El reemplazo valvular aórtico quirúrgico (SAVR) ha sido la única alternativa efectiva hasta la aparición del reemplazo valvular aórtico por cateterismo (TAVR o TAVI). Este procedimiento se usó inicialmente para pacientes inoperables en quienes dos ensayos clínicos aleatorios y varios registros mostraron su superioridad sobre el tratamiento médico conservador. Dos ensayos clínicos adicionales en pacientes que, a pesar de ser considerados operables, tenían alto riesgo quirúrgico, demostraron la no inferioridad de TAVR versus reemplazo quirúrgico. Investigaciones posteriores probaron también su efectividad en pacientes de riesgo intermedio y bajo. Algunas complicaciones, como las relacionadas al acceso vascular, el accidente cerebro vascular, la necesidad de marcapasos definitivo y la regurgitación periprotésica, han ido disminuyendo con la mejoría de la tecnología, la curva de aprendizaje y la estrategia mínimamente invasiva actual. Queda pendiente determinar la durabilidad para establecer cuál será el papel de TAVR en la práctica clínica.

Abstract Severe aortic stenosis is a common disease whose prevalence is steadily growing with population ageing. Surgical aortic valve replacement (SAVR) has been the only effective alternative until the introduction of transcatheter aortic valve replacement (TAVR or TAVI). This procedure was initially used for non-surgical candidate patients where two randomized clinical trials and several registries showed superiority over conservative medical treatment. Furthermore, two additional clinical trials including high surgical risk patients proved the non-inferiority of TAVR versus surgical replacement. Similar findings regarding effectiveness were observed in other clinical trials including intermediate and low risk patients. Technical and procedural improvements, including learning curve and the current minimally invasive strategy have decreased periprocedural and mid-term complications such as those related with vascular access, stroke, the need for permanent pacemaker implantation and paravalvular leak. All things considered, durability is a pending question to establish which would be the role of TAVR in current and future practice.

Hybrid strategy for unstable patients with severe carotid and cardiac disease requiring surgery.

BACKGROUND: Concurrent severe carotid and cardiac disease is a challenging situation where staged surgery is probably the most common strategy. However, in patients with an unstable clinical presentation, the best approach is still a matter of debate. The aim of the study was to report in-hospital and midterm outcome in patients who received carotid artery stenting and synchronous cardiac surgery. METHODS: From June 1998 to July 2012, 54 consecutive patients who were treated at a high-volume university medical center with this hybrid approach were included in the study. All of the patients received carotid angioplasty while being administered aspirin and regular unfractionated heparin. Then, all of the patients were immediately transferred to the operating room for coronary and/or cardiac valve surgery. All of the patients were administered aspirin and clopidogrel once bleeding was ruled out, after surgery. RESULTS: There were 5 in-hospital surgical related deaths, and no patient suffered a stroke or required carotid urgent re-intervention. At follow-up (55 ± 28 months; range 1-144 months), there were no new neurological deficits, while one additional death occurred. CONCLUSIONS: In this series, synchronous carotid stenting and cardiac surgery were feasible with an acceptable complication rate in a high-surgical-risk population, which could not undergo staged procedures.

Tratamiento endovascular de aneurismas de aorta con estrategia minimalista / Endovascular Treatment of Aortic Aneurysms with Minimalistic Approach

RESUMEN Introducción: Los aneurismas de aorta siguen siendo una patología frecuente, en especial aquellos localizados en la aorta abdominal. Desde 1990, gracias al avance en los dispositivos y las técnicas endovasculares, la cirugía convencional ha dejado de ser la única opción de tratamiento. Presentamos nuestros resultados en el manejo del aneurisma de aorta con técnica endovascular mínimamente invasiva. Objetivos: Analizar los resultados a 30 días del implante de endoprótesis en la aorta torácica y abdominal con una estrategia mínimamente invasiva. Material y métodos: Entre marzo de 2012 y abril de 2019 se realizaron 395 implantes consecutivos de endoprótesis de aorta; en 264 (67%) de los cuales se utilizó una técnica mínimamente invasiva (MIN-A). De este grupo 240 procedimientos (90,9%) fueron llevados a cabo para reparar la aorta abdominal (EVAR) y 24 (9,1%) la aorta torácica (TEVAR). Resultados: De 264 pacientes se logró éxito técnico (ET) del implante en el 99,6% y éxito clínico (EC) en el 97,7%. La mortalidad a 30 días fue del 1,1% dado por neumonía, insuficiencia cardíaca y EPOC. Ningún paciente presentó IAM, ACV o necesitó de conversión a reparación quirúrgica de urgencia. El tiempo promedio del procedimiento fue de 62 minutos (SD ± 17). Algunos pacientes requirieron conversión a cierre quirúrgico del acceso [20 (7%) durante los primeros 100 casos, y 7 (3%) en los últimos 164 pacientes p = 0,05)]. El sangrado mayor que requirió transfusión fue del 1,1%. El tiempo promedio para la deambulación fue de 18 horas (SD ± 10), que luego de los primeros 100 pacientes disminuyó en forma significativa a 13 horas (SD ± 2,9 p = 0,05). La estadía hospitalaria en promedio fue de 1,4 días (SD ± 1,14) con 5 casos externados el mismo día del procedimiento. Conclusiones: Los procedimientos de reparación endovascular de aneurismas de la aorta con una estrategia miniinvasiva fueron factibles y seguros, ya que permitieron convertir estos procedimientos en abordajes percutáneos, con bajas tasas de complicaciones asociadas al acceso, menor tiempo quirúrgico, rápida deambulación y menor estadía hospitalaria, sin modificar la seguridad global del procedimiento. La curva de aprendizaje permitió bajar la tasa de conversiones a cirugía, así como los tiempos de deambulación.

ABSTRACT Background: Aortic aneurysms, particularly of the abdominal aorta, are still common. Since 1990, conventional surgery is no longer the only treatment option due to advances in endovascular devices and techniques. We present our results in the management of aortic aneurysms with a minimally invasive endovascular technique. Objectives: The aim of this study was to analyze the 30-day outcomes of endograft implantation in the thoracic aorta and abdominal aorta using a minimally invasive approach. Methods: Between March 2012 and April 2019, 395 consecutive endografts were implanted in the aorta, and 264 (67%) were performed using a minimally invasive approach (MIN-A). Among this group, 240 (90.9%) corresponded to abdominal endo-vascular aortic repair (EVAR) and 24 (9.1%) to thoracic endovascular aortic repair (TEVAR). Results: Technical success (TS) of the implant was achieved in 99.6% of the 264 patients and clinical success (CS) in 97.7%. Thirty-day mortality was 1.1% due to pneumonia, heart failure and chronic obstructive pulmonary disease. There were no cases of myocardial infarction, stroke or need for conversion to urgent surgical repair. Mean duration of the procedure was 62 minutes (SD ± 17). Some patients required conversion to surgical closure of the access site [20 (7%) during the first 100 cases and 7 (3%) in the final 164 patients, p = 0.05]. Three (1.1%) patients presented major bleeding requiring transfusion. Mean time to ambulation was 18 hours (SD ± 10) that significantly decreased to 13 hours after the first 100 patients (SD ± 2.9; p= 0.05). Mean length of hospital stay was 1.4 days (SD ± 1.14) with 5 patients discharged on the same day of the procedure. Conclusions: Endovascular aortic aneurysm repair using a minimally invasive strategy was feasible and safe, turning this procedure into a percutaneous approach, with low access site-related complications, shorter operative time, rapid ambulation and shorter length of hospital stay, without modifying overall safety of the procedure. The learning curve resulted in reduced rate of conversion to surgery and earlier ambulation.

Carotid artery stenting protected with an emboli containment system.

BACKGROUND AND PURPOSE: Fear of distal embolization and stroke has aroused concern regarding carotid stenting. Devices to protect the cerebral circulation may make carotid stenting safer. METHODS: A multidisciplinary study group tested a balloon occlusion-aspiration emboli entrapment device in conjunction with carotid stenting. The device consists of an elastomeric balloon on a steerable wire with a detachable adapter that inflates and deflates the distal temporary occlusion balloon. An aspiration catheter is used to remove trapped emboli after stenting and before occlusion balloon deflation. RESULTS: Seventy-five patients with severe internal carotid artery stenosis were treated with stents deployed with this cerebrovasculature protection system. All 75 patients (100%) had grossly visible particulate material aspirated, and all were treated successfully without major or minor stroke or death at 30 days. Preintervention stenosis was 81+/-10%, and residual stenosis was 5+/-7%. Nine patients (12%) had angiographic evidence of thrombus before intervention, but no patient had thrombus or vessel cutoff after the procedure. Four patients (5%) developed transient neurological symptoms during protection balloon occlusion, but symptoms resolved with balloon deflation. The 22 to 667 particles aspirated per patient ranged from 3.6 to 5262 microm in maximum diameter (mean, 203+/-256 microm). These particles included fibrous plaque debris, lipid or cholesterol vacuoles, and calcific plaque fragments. CONCLUSIONS: Protected carotid stenting was performed successfully and safely in this study early in the experience with cerebrovascular protection devices. Particulate emboli are frequent with stenting, and cerebral protection will likely be necessary to minimize stroke. Randomized trials comparing protected carotid stenting with endarterectomy are warranted.

Clinical outcome after saphenous vein stenting with Taxus Liberté stent: results from the OLYMPIA Registry (TAXUS Liberté Postapproval Global Program).

We evaluated the incidence of clinical events after implantation of the TAXUS Liberté paclitaxel-eluting stent in saphenous vein graft (SVG) lesions in an unselected patient population. The OLYMPIA (TAXUS Liberté Post-Approval Global Registry) program gathered data on 21 954 patients receiving at least 1 TAXUS Liberté stent, including 345 patients with SVG lesions. All cardiac events were monitored with independent adjudication of end points. Patients enrolled at procedure started with no mandated inclusion/exclusion criteria. In SVG-OLYMPIA (n = 345), baseline comorbidities/complex disease were more frequent than the rest of the OLYMPIA (n = 21 560). SVG-OLYMPIA had similar cardiac death, target vessel revascularization, and definitive stent thrombosis rates than the rest of OLYMPIA. Despite higher baseline risk, the SVG-OLYMPIA had similar 12-month clinical outcome than the rest of the OLYMPIA registry, confirming the safety and efficacy of the TAXUS Liberté stent in this high-risk group.

Improvement in executive function after unilateral carotid artery stenting for severe asymptomatic stenosis.

OBJECT: Executive functions are crucial for organizing and integrating cognitive processes. While some studies have assessed the effect of carotid artery stenting (CAS) on cognitive functioning, results have been conflicting. The object of this study was to assess the effect of CAS on cognitive status, with special interest on executive functions, among patients with severe asymptomatic internal carotid artery (ICA) stenosis. METHODS: The authors prospectively assessed the neuropsychological status of 20 patients with unilateral asymptomatic extracranial ICA stenosis of 60% or more by using a comprehensive assessment battery focused on executive functions before and after CAS. Individual raw scores on neuropsychological tests were converted into z scores by normalizing for age, sex, and years of education. The authors compared baseline and 3-month postoperative neuropsychological scores by using Wilcoxon signed-rank tests. RESULTS: The mean preoperative cognitive performance was within normal ranges on all variables. All patients underwent a successful CAS procedure. Executive function scores improved after CAS, relative to baseline performance as follows: set shifting (Trail-Making Test Part B: -0.75 ± 1.43 vs -1.2 ± 1.48, p = 0.003) and processing speed (digit symbol coding: -0.66 ± 0.85 vs -0.97 ± 0.82, p = 0.035; and symbol search: -0.24 ± 1.32 vs -0.56 ± 0.77, p = 0.049). The benefit of CAS for working memory was marginally significant (digit span backward: -0.41 ± 0.61 vs -0.58 ± 0.76, p = 0.052). Both verbal (immediate Rey Auditory Verbal Learning Test: 0.35 ± 1.04 vs -0.22 ± 0.82, p = 0.011) and visual (delayed Rey-Osterrieth Complex Figure: 0.27 ± 1.26 vs -0.22 ± 1.01, p = 0.024) memory improved after CAS. CONCLUSIONS: The authors found a beneficial effect on executive function and memory 3 months after CAS among their prospective cohort of consecutive patients with unilateral and asymptomatic ICA stenosis of 60% or more.

Angioplasty for treatment of isolated below-the-knee arterial stenosis in patients with critical limb ischemia.

OBJECTIVE: To report our experience in patients with critical limb ischemia (CLI) due to isolated below-the-knee (BTK) arterial lesions. METHODS: Between 1992 and 2009, we performed 2747 peripheral angioplasties, while 2.8% (78 of 2747) were only BTK and were included in the present study. RESULTS: Mean age was 70.2 ± 11 years, 58.4% had diabetic, 85.7% were smokers, and 20.8% had chronic renal failure. Baseline Rutherford class: 50 patients with class IV and 27 with class V to VI. Angiographic and clinical success were 97.4% and 90.91%, respectively. At 30 days, there were no deaths, 2 patients had acute vessel closure and 2 major amputation. At long-term follow-up (22.4 ± 9.6 months), there were 7 unrelated deaths (10%), 5 amputations (7.1%), 3 reinterventions (4.2%), while 16 patients remained symptomatic. Overall amputation and amputation plus claudication-free survival were 90% and 70%, respectively. CONCLUSION: Endovascular treatment of BTK lesions represents a safe and effective treatment option to patients with CLI.