Kinetic Elephant Trunk Technique: Early Results in Chronic Symptomatic Aortic Dissection Management.

BACKGROUND: The aim was to expand our understanding of the dynamic evolution of the aorta throughout the dissection time course. We investigated how the disease process can be modulated to equalize lumen pressure, enhance perfusion, and stabilize the aorta along its entire length using the kinetic elephant trunk (kET) technique. METHODS: We performed the kET on 9 patients with chronic symptomatic aortic dissection (CSAD) as a primary or secondary intervention, regardless of the chronicity of the dissection. Endovascular scissoring of the intraluminal septum is performed in the infradiaphragmatic dissected aorta to equalize pressure between true and false lumens and allow all branched vessels to be supplied from one lumen. The Streamliner Multilayer Flow Modulator (SMFM), an uncovered cobalt-alloy aortic device, is deployed from the aortic sinus, covering the supra-aortic branches, distally into the distal aorta (primary intervention). In the case of a previous ascending aorta Dacron graft, the SMFM is deployed (secondary intervention) at the level of the Dacron graft so that it is overlapped with the graft and landed in the distal aorta. RESULTS: In the initial study period, all-cause and aortic-related survival were 100%, respectively; all great vessels and visceral branches were patent; and freedom of stroke, end-organ ischemia, paraplegia, and renal failure were 100%. CONCLUSIONS: The kET is a treatment process for managing CSAD. Its simplicity, consistency, and reproducibility in high-risk patients with low morbidity and mortality add to the armamentarium of the cardiovascular specialist. Further assessment of the medium- and long-term outcomes is needed to fully establish the benefits of kET.

A clinical review of early outcomes from contemporary flow modulation versus open, fenestrated and branch technologies in the management of thoracoabdominal aortic aneurysm.

Traditional therapeutic options for complex thoracoabdominal aneurysm include open repair, hybrid repair or endovascular repair (involving fenestrated or branched endografts). The Streamliner Multilayer Flow Modulator has been available for treatment of thoracoabdominal aneurysms since 2010. Its design permits blood flow to perfuse through the mesh in a modus that preserves collateral branch patency, while modulating turbulent to laminar flow within the device. The flow then stagnates over time within the surrounding aneurysm sac. Significant complications, including paraplegia, renal failure and cerebrovascular accident, are much lower with Streamliner Multilayer Flow Modulator treatment. Application of the Streamliner Multilayer Flow Modulator to complex aortic pathologies presents a novel solution to an, as of yet, unmet clinical need, and has resulted in promising clinical outcomes when compared to existing solutions. The Streamliner Multilayer Flow Modulator offers potential for treatment of thoracoabdominal aortic pathologies in patients and is not just confined to those with complexity that dictates no other management options. While current literature illustrates that there is a decreased risk of mortality and associated complications when this new disruptive technology is utilised, there is still a need for prospective, long-term clinical trials, as well as comparative trials to accurately assess outcomes of Streamliner Multilayer Flow Modulator treatment that are both precise and reproducible. This article is a review of current clinical literature regarding contemporary flow modulating technology compared with open, branched and fenestrated managements, presenting early outcomes.

Endovascular management of chronic symptomatic aortic dissection with the Streamliner Multilayer Flow Modulator: Twelve-month outcomes from the global registry.

OBJECTIVE: Reported are initial 12-month outcomes of patients with chronic symptomatic aortic dissection managed by the Streamliner Multilayer Flow Modulator (SMFM; Cardiatis, Isnes, Belgium). Primary end points were freedom from rupture- and aortic-related death, and reduction in false lumen index. Secondary end points were patency of great vessels and visceral branches, and freedom of stroke, paraplegia, and renal failure. METHODS: Out of 876 SMFM implanted globally, we have knowledge of 542. To date, 312 patients are maintained in the global registry, of which 38 patients were identified as having an aortic dissection (12.2%). Indications included 35 Stanford type B dissections, two Stanford type A and B dissections, and one mycotic Stanford type B dissection. RESULTS: There were no reported ruptures or aortic-related deaths. All cause survival was 85.3% Twelve-month freedom from neurologic events was 100%, and there were no incidences of end-organ ischemia, paraplegia or renal insult. Morphologic analysis exhibited dissection remodeling by a reduction in longitudinal length of the dissected aorta, and false lumen volume. A statistically significant reduction in false lumen index (P = .016) at 12 months, and a borderline significant increase in true lumen volume (P = .053) confirmed dissection remodeling. CONCLUSIONS: The SMFM is an option in management of complex pan-aortic dissection. Results highlight SMFM implantation leads to dissection stabilization with no further aneurysm progression, and no retrograde type A dissection. Thoracic endovascular aneurysm repair by SMFM ensued in freedom from aortic rupture, neurologic stroke, paraplegia and renal failure. Further analysis of the global registry data will inform long-term outcomes.

Systematic Review and Patient-Level Meta-analysis of the Streamliner Multilayer Flow Modulator in the Management of Complex Thoracoabdominal Aortic Pathology.

PURPOSE: To examine the safety and short-term efficacy of the Streamliner Multilayer Flow Modulator (SMFM) in the management of patients with complex thoracoabdominal aortic pathology who are unfit for alternative interventions. METHODS: Biomedical databases were systematically searched for articles published between 2008 and 2015 on the SMFM. A patient-level meta-analysis was used to evaluate aneurysm-related survival. Secondary outcomes were all-cause survival, stroke, spinal cord ischemia, renal impairment, and branch vessel patency. Other considerations were the impact of compliance with the instructions for use (IFU) on clinical outcome. Mean values and Kaplan-Meier estimates are presented with the 95% confidence interval (CI). RESULTS: Fifteen articles (3 multicenter cohort studies, 3 observational cohort studies, and 9 case reports) were included, presenting 171 patients (mean age 68.8±12.3 years; 139 men). The mean aneurysm diameter was 6.7±1.6 cm (95% CI 6.4 to 6.9 cm). Technical success reported in 15 studies was 77.2%. Aneurysm-related survival at 1 year was 78.7% (95% CI 71.7% to 84.4%). One-year all-cause survival was 53.7% (95% CI 46.0% to 61.3%). There were no reported cases of spinal cord ischemia, renal insult, or stroke. CONCLUSION: The SMFM can be safely utilized in some patients with complex thoracoabdominal pathologies provided operators adhere to the IFU. The SMFM is a novel technology with no long-term published data on its sustained effectiveness and a lack of comparative studies. Randomized clinical trials, registries, and continued assessment are essential before this flow-modulating technology can be widely disseminated.

Evaluation of functionality and biological response of the multilayer flow modulator in porcine animal models.

BACKGROUND: This study outlines the use of non-aneurysmal porcine animal models to study device functionality and biological response of the Multilayer Flow Modulator (MFM) (Cardiatis, Isnes, Belgium), with an emphasis on preclinical device functionality and biological response characteristics in an otherwise healthy aorta. METHODS: Twelve animals were implanted with the study device in the abdominal aorta, in 6 animals for 1 month and 6 animals for 6 months. Upon completion of the study period, each animal underwent a necropsy to examine how the implanted device had affected the artery and surrounding tissue. Neointima and stenosis formation were recorded via morphometry, and endothelialization via histopathological analysis. RESULTS: The MFM devices were delivered to their respective implantation sites without difficulty. Six of the implanted stents were oversized with percentages ranging from 2.6% to 18.8%. Statistical analysis was carried out and showed no significance between the regular sized stent group and oversized stent group for neointimal area (P=0.17), neointimal thickness (P=0.17), and percentage area stenosis (P=0.65). Histopathological findings showed in most areas flattened endothelium like cells lined the luminal surface of the neointima. Scanning electron microscopy also showed the devices were well tolerated, inciting only a minimal neointimal covering and little fibrin or platelet deposition. Neointimal thickness of 239.7±55.6 µm and 318.3±130.4 µm, and percentage area stenosis of 9.6±2.6% and 12.6±5% were recorded at 1 and 6 months respectively. No statistical differences were found between these results. CONCLUSION: The MFM devices were delivered to their respective implantation sites without difficulty and incited little neointimal and stenosis formation in the aorta, affirming its functionality and biocompatibility.

Will our training programs meet the challenges of increasingly complex endovascular aortic surgery?

It has been more than 2 decades since endovascular therapies appeared for the treatment of vascular disease. With each new enhancement in a therapeutic approach has come the demand for training to assure competence in the clinical setting. In the early days when the technology was relatively simple, training within the specific specialty through established training programs (eg, residencies, fellowships) was effective. However, today's endovascular treatment of complex aortic disease, as well as other vascular pathologies, is presenting demands that the current system cannot meet. New technologies will demand multispecialty collaboration, so current training programs must be altered if we are to meet the demands in education for future aortic interventions. This personal perspective reviews the evolution of endovascular therapy and the impact of product development's changing landscape on training. A new training paradigm must concentrate on centers of excellence with maximum flexibility to meet the needs and demands of our young trainees. It is vital that this approach be global, disease-focused, and linked to developments in epigenomics.

Institutional differences in endovascular aneurysm repair and aneurysm morphology.

BACKGROUND: Variability exists between institutions in the application of endovascular aneurysm repair (EVAR). This study compares patient-specific variables from a high-volume North American institution with one from the UK. METHODS: One hundred consecutive patients from each institution were studied. All were treated for an intact, infrarenal aortic aneurysm. Patient characteristics and aneurysm-related variables, measured from computed tomography according to Society for Vascular Surgery (USA) reporting standards, were examined. RESULTS: The median (range) age of the American patients was 74 (55-97) years and that of the British patients, 73 (49-89) years. There were 78 men in the American group and 79 men in the British group. All American patients were treated by EVAR compared to 11 % of the British group. Mean (SD) aneurysm diameter for the former was 55 (9) mm and for the latter 64 (11) mm (P < 0.001). While there was no difference in mean diameter of the infrarenal aortic neck (P = 0.918), the aneurysms of British patients (22 %) were more likely to be angulated >60° than those of the American patients (11 %) (P = 0.039). Furthermore, the mean (SD) length of infrarenal aortic neck was shorter in the British patients [21 (11) mm] compared to the American group [25 (12) mm] (P = 0.003). The mean diameter of the common iliac arteries was larger in the British patients than in the American group (P < 0.001). Mean external iliac artery diameter was no different between the groups (P = 0.507). CONCLUSIONS: This group of British patients have a more advanced pattern of aneurysm morphology than American patients of similar age. This difference may, in part, explain variability in the application of EVAR.

Hybrid repair of thoracic aortic lesions for zone 0 and 1 in high-risk patients.

PURPOSE: Some patients with aortic arch or descending thoracic aorta pathologies are not suited for open repair because of comorbidities that may increase their risk of procedural complications or death. Endovascular approaches may also be difficult when there are inadequate proximal landing zones in the aortic arch. We report our experience using rerouting techniques with bypass, stenting of the branches, or a combination of both to create a landing area in zones 0 and 1 of the aortic arch. METHODS: Since November 2002, thoracic aortic endoluminal grafts were placed in 38 patients in whom the endograft was deployed in zone 0 (n = 27) or zone 1 (n = 11). A retrospective review is included. RESULTS: There were 11 women and 27 men with a mean age of 65.4 years (range 38-88). Aortic pathology included 12 Stanford type A dissections, 10 aortic arch aneurysms, 8 Stanford type B dissections, 3 descending thoracic aortic aneurysms, 2 aortobronchial fistulas, 1 innominate artery aneurysm and 2 aortic arch pseudoaneurysms. In zone 0, 21 had thoracic debranching with an ascending bypass, three patients had a remote-inflow and three patients had a chimney-stent with carotid-carotid bypass. In zone 1, five patients had a carotid-carotid bypass, one patient had an aortic to left common carotid artery (LCCA) bypass and five patients had chimney-stent on the LCCA. Fifty-eight percent of the patients were symptomatic and 26% emergent. Three patients required hemodialysis postoperatively (7.9%), 18 patients (47.4%) required prolonged mechanical ventilation for respiratory insufficiency. Paraplegia occurred in one patient (2.7%), and five patients suffered a cerebrovascular accident (13.1%). There were four early type I and two type II endoleaks. Overall 30-day mortality was 23.7%. CONCLUSIONS: The hybrid approach for repair of the aortic arch pathologies is feasible in patients unfit for open repair. We present the results of performing different techniques to treat the aortic arch with hybrid repair with antegrade or retrograde inflow, stenting of the branches or a combination of both. Long-term results are unknown, and larger series results and comparative studies are needed to determine safety and efficacy.

Mejores resultados en ruptura de aneurismas de aorta abdominal manejados con reparación endovascular: Algoritmo sugerido / Improved outcome of ruptured abdominal aortic aneurysms managed with endovascular repair: A suggested algorithm

Antecedentes: El propósito de este estudio es comparar la morbilidad y la mortalidad tanto de la reparación abierta (RA) como endovascular de la ruptura del aneurisma aórtico abdominal(rAAAs); y de presentar un algoritmo para el tratamiento y evaluaciones de la tomografía computarizada (CT) para determinar el uso de un balón oclusivo supra-celíaco. Métodos: Una revisión gráfica retrospectiva se realizó de los rAAAs tratados ya sea con reaparicióna cielo abierto (RA), ya sea con reparación aórtica endovascular (EVAR) entre junio de 1998 y junio de 2009. Se informaron las co-morbilidades, los datos peri-procedimientos y tanto la morbosidad como la mortalidad. Las TC se revisaron desde el uso inicial del balón oclusivo (Marzo de 2001) a fin de evaluar el hematoma retroperitoneal. Se desarrolló un algoritmo para determinarcuándo el balón oclusivo se debería implementar. El test exacto de Fisher, el t-test, y el test log rank fueron los que se utilizaron para el análisis estadístico.Resultados: Entre junio de 1998 y junio de 2009, 105 pacientes, 75 (71.4%) hombres, edad promedio de 74 años (rango 47-93) presentaron un rAAA y a 69 (65.2%) se les realizó la reparación a cielo abierto. 87 pacientes (82.9%) fueron sintomáticos y 25 (23.8%) tenían un AAA conocido. El tiempo medio transcurrido entre el diagnóstico y el tratamiento fue de 5 a 6 horas, 4.5 horas para la RA y de 8 horas para EVAR. El test rank log mostró una mejoría en la supervivencia con EVARa pesar del tiempo promedio más prolongado desde el diagnóstico al tratamiento. (p=0.02). Se administraron casi tres veces más concentrados de hematíes en el cohorte de reparación a cielo abierto (RA), 6.3 unidades y en EVAR 2.2 unidades. Se utilizaron vasopresores perioperatorios en el 57.1% de los casos, dos veces más en la RA, 69.6%, que con EVAR 33.3%. Se utilizó el balón oclusivo aórtico en el 27,6% de los casos, dos veces más frecuente en RA que en EVAR (41,7% verus 20,3%)...

Antecedentes: O propósito deste estudo é comparar a morbilidade e a mortalidade tanto da reparação aberta (RA) quanto endovascular, utilizadas no tratamento da ruptura do aneurisma aórtico abdominal (rAAAs); e de apresentar um algorítmo para o tratamento e avaliações da tomografiacomputarizada (CT) para assim determinar o uso de um balão para oclusão supra-celíaca. Métodos: Realizou-se uma revisão gráfica retrospectiva das rAAAs tratadas, seja com reparação a céu aberto (RA), ou com reparação aórtica endovascualar (EVAR) entre os meses de junho de1998 e junho de 2009. Informaram-se as comorbilidades, os dados periprocedimentos , além da morbidade e mortalidade. As TC foram revisadas desde o uso inicial do balão oclusivo (março de 2001) com o objetivo de avaliar o hematoma retroperitoneal. Desenvolveu-se um algorítmo para determinar quando o balão oclusivo deveria ser implementado. Para esta análise estatística, utilizaram-se o teste exato de Fisher, o t-test, e o test log Rank. Resultados: Entre junho de 1998 ejunho de 2009, 105 pacientes, 75 (71.4%) homens, com média de idade de 74 anos (média 47-93) apresentaram uma rAAA e em 69 (65.2%) realizou-se uma reparação a céu aberto. 87 pacientes (82.9%) foram sintomáticos e 25 (23.8%) tinham um AAA conhecido. O tempo médio transcorrido entre o diagnóstico e o tratamento foi de 5 a 6 horas, 4.5 horas para a RA e de 8 horas para aEVAR. O test rank log mostrou uma melhoria na sobrevivência com a EVAR, apesar do tempo médio mais prolongado do diagnóstico ao tratamento. (p=0.02). Administraram-se quase três vezes mais concentrados de hematies no grupo de reparação a céu aberto (RA), 6.3 unidades e no grupo EVAR, 2.2 unidades. Utilizaram-se vasopressores perioperatórios em 57.1% dos casos: 33.3% com EVAR e 69.6% com a RA, ou seja, duas vezes a mais. Utilizou-se o balão oclusivo aórtico em 27.6 % dos casos, duas vezes mais frequente nos casos da RA do que nos de EVAR (41.7 % versus 20.3%)...

Background: The purpose of this study is to compare morbidity and mortality of open and endovascular repair of ruptured abdominal aortic aneurysms (rAAAs); and present a treatment algorithm and assessment of computer tomography (CT) to determine usage of a supra-celiac occlusive balloon.Methods: Restrospective chart review was done of rAAAs treated with open (OR) or endovascular aortic repair (EVAR) between June 1998 and June 2009. Comorbidities, periprocedural data, and postoperative morbidity and mortality were recorded. CTs were reviewed from the initial use of the occlusive balloon (March 2001) to assess the retroperitoneal hematoma. An algorithm was developed determining when the occlusive balloon should be implemented. Fisher’s exact test, and log rank test were used for statistical analysis. Results: Between June 1998 and June 2009, 105 patients, 75 (71.4%) males, mean age of 74.0 years (range 47-93), presented with a rAAA and 69 (65.2%) received open repair. Eighty-seven patients(82.9%) were symptomatic and 25 (23.8%) had a known AAA. Mean time elapsed between diagnosis to treatment was 5.6 hours, 4.5 hours for OR and 8.0 hours for EVAR. Log rank test showsimproved survivability with the EVAR despite higher mean time from diagnosis to intervention (p=0.02). Nearly three times as much packed red blood cells were given in open repair cohort, O,6.3 units and EVAR, 2.2 units. Perioperative vasopressors were used in 57.1% of total cases, more than 2 times as often for O, 69.6%, and EVAR, 33.3%. Aortic occlusive balloon was used in 27.6% of cases, twice as often in EVAR (41.7% versus 20.3%)...

Report on endograft management of traumatic thoracic aortic transections at 30 days and 1 year from a multidisciplinary subcommittee of the Society for Vascular Surgery Outcomes Committee.

OBJECTIVES: The Society for Vascular Surgery Outcomes Committee, including ad hoc members from Society of Thoracic Surgeons, American Association of Thoracic Surgery, and Society for Interventional Radiology, collected outcomes of patients with traumatic thoracic aortic transections treated with endovascular grafts. Results through 1 year of follow-up are reported. METHODS: Data from five physician-sponsored investigational device exemption clinical trials from 2000 to 2008 were entered using standardized forms and definitions. Adverse events were reported early (≤30 days) and late (>30 days) by body system. Major adverse events included one or more of the following: death, stroke, myocardial infarction, renal failure, respiratory failure, paralysis, or bowel ischemia. RESULTS: There were 60 symptomatic patients (68.3% men; mean age, 46 years) with traumatic aortic transections, of which 97% were due to a motor vehicle accident and 3% were related to other blunt trauma. The average total injury severity score was 39, most with involvement of the chest and abdomen. The average surgical time was 125 minutes. The mean hospital length of stay was 17 days. Associated procedures for the management of nonaortic injuries occurred in 51.7%. All-cause mortality was 9.1% at 30 days and 14.4% at 1 year. One or more major adverse events occurred in 23.3% of the patients, major adverse events occurred early in 20.0% and late in 3.6%. Death accounted for 41.7% of the early and all of the late major adverse events. Early adverse events included 16.7% pulmonary, 13.3% neurologic, and 11.7% vascular complications. Late adverse events included one patient (1.8%) with pulmonary failure and one patient (1.8%) who died of an unknown cause. CONCLUSIONS: One-year results of endograft placement for the management of patients with traumatic aortic injury are acceptable. Most cases treated were due to motor vehicle accident and associated with multiple coexisting injuries. Approximately three-quarters of the deaths occurred ≤30 days, indicating the acute severity of the condition. Although the relatively low rates of adverse and major adverse events are consistent with what is anticipated in an otherwise healthy population, future device and procedural developments may facilitate improved outcomes in the future.

Report on the results of thoracic endovascular aortic repair for acute, complicated, type B aortic dissection at 30 days and 1 year from a multidisciplinary subcommittee of the Society for Vascular Surgery Outcomes Committee.

OBJECTIVE: This study analyzed 1-year outcome after thoracic endovascular aortic repair (TEVAR) in patients with complicated type B aortic dissection (cTBAoD) who had rupture or malperfusion and symptom onset ≤14 days (acute), 15 to 30 days (subacute), and 31 to 90 days (chronic) until required intervention. The main focus of this report is primarily on the acute cohort. METHODS: Clinical data were systematically collected from five physician-sponsored investigational device exemption (IDE) clinical trials between 2000 and 2008 using standardized definitions and forms. Adverse events were reported early (≤30 days) and late (>30 days) by body system. Major adverse events included death, stroke, myocardial infarction, renal failure, respiratory failure, paralysis, and bowel ischemia. RESULTS: There were 99 cTBAoD patients: 85 were acute, 11 were subacute, and 3 were chronic. Among the acute patients, 31.8% had rupture and 71.8% had malperfusion, including 55.7% lower extremity, 36.1% renal, 19.7% visceral, 8.2% other, and 3.3% spinal cord (patients may have more than one source). Rupture and malperfusion were both reported for three acute patients. Additional findings for the acute cohort included pain (76.5%), hypertension (43.5%), and bleeding (8.2%); comorbidities included hypertension (83.5%), current/past smoking history (69.8%), and diabetes (12.9%). The main focus of this analysis was the acute cohort (n = 85). Age averaged 59 years (72.9% male). Early adverse events included pulmonary (36.5%), vascular (28.2%), renal (25.9%), and neurologic (23.5%). Early major adverse events occurred in 37.6% of patients, including death (10.6%), stroke (9.4%), renal failure (9.4%), and paralysis (9.4%); late adverse events included vascular (15.8%), cardiac (10.5%), gastrointestinal (6.6%), and hemorrhage (5.3%). The point-estimate mortality rate was 10.8 (95% confidence interval [CI], 4.1-17.5) at 30 days and 29.4 (95% CI, 18.4-40.4) at 1 year, when 34 patients remained at risk. CONCLUSIONS: Emergency TEVAR for patients with cTBAoD (malperfusion or rupture) provided acceptable mortality and morbidity results out to 1 year. Manufacturers can use this 30-day mortality point-estimate of 10.8 (95% CI, 4.1-17.5) for the acute cohort to establish a performance goal for use in single-arm commercial IDE trials if the Food and Drug Administration and other regulatory bodies concur.

Endovascular management of malperfusion in acute type B aortic dissections.

PURPOSE: To examine the feasibility, efficacy, and midterm results of endovascular stent-graft management of acute type B aortic dissection complicated by renal, visceral, or lower limb malperfusion. METHODS: A retrospective review was conducted to identify all patients with acute type B dissection treated endovascularly at a single center between 1998 and 2009. Of the 85 patients identified, 23 (27%) consecutive patients (20 men; mean age 60.9 ± 11.6 years) presented with clinical and imaging evidence of end-organ malperfusion: 7 (30%) renal, 6 (26%) lower limb, 4 (17%) renal and lower limb, 3 (13%) visceral, and single cases of renal/visceral, renal/lower limb/spinal cord, and renal/visceral/spinal cord/lower limb. RESULTS: All patients had stent-graft coverage of the proximal entry tear; 5 (22%) patients required additional branch vessel stenting, and 2 (9%) had femorofemoral bypass graft. Successful correction of malperfusion was achieved in 21 (91%) patients. In 1 patient, ischemia in the lower limb was resolved but not in the left kidney; the other patient had an ischemic but viable lower limb and did not require any additional intervention. Thirty-day mortality was 9% (2/23 patients). The incidences of postoperative stroke and paraplegia were 17% (4/23) and 9% (2/23), respectively. The 21 survivors were followed for 17.2 ± 15 months; during this period, 1 patient died, 1 was lost to follow-up, and 5 patients underwent additional open or endovascular procedures. CONCLUSION: Endovascular coverage of the proximal entry tear in acute type B dissections complicated by end-organ malperfusion resulted in correction of malperfusion in the majority of patients. It is a reasonable first line of treatment, but its superiority must be assessed in comparison with other techniques, such as fenestration.

Endovascular management of recurrent adult coarctation of the aorta.

Traditional open surgical repair has proven to be an effective treatment for the management of primary and recurrent coarctation of the thoracic aorta. Potential complications at short-term and long-term follow-up have included recurrent coarctation, hypertension, premature coronary artery disease, cerebrovascular disease, and anastomotic pseudoaneurysm. Endovascular repair of recurrent coarctation of the thoracic aorta offers a less invasive treatment approach in potential high-risk surgical patients.

Transhepatic approach to closure of patent foramen ovale: report of 2 cases in adults.

Patent foramen ovale is increasingly diagnosed in patients who are undergoing clinical study for cryptogenic stroke or migraine. In addition, patent foramen ovale is often suspected as a cause of paradoxical embolism in patients who present with arterial thromboembolism. The femoral venous approach to closure has been the mainstay. When the femoral approach is not feasible, septal occluder devices have been deployed via a transjugular approach.Herein, we describe 2 cases of patent foramen ovale in which the transhepatic approach was used for closure. To our knowledge, this is the 1st report of a transhepatic approach to patent foramen ovale closure in an adult patient. Moreover, no previous case of patent foramen ovale closure has been reported in a patient with interrupted inferior vena cava.

Inherent problems with randomized clinical trials with observational/no treatment arms.

Randomized clinical trials (RCTs) offering an observation/no treatment (OBS/NoRx) arm as control and which are focused on the management of a condition with potentially life-threatening consequences, however small the risk, often experience a significant rate of crossover to treatment by those randomized to the OBS/NoRx arm. Results of these trials when analyzed on intent-to-treat basis often fail to resolve the issue at which they were directed. The authors have observed this in trials of abdominal aortic aneurysms with this design and use these to exemplify the dilemmas RCTs of such design create, with crossovers ranging from 27% to over 60% (EVAR II, UKSAT, ADAM, PIVOTAL). Results of these trials are frequently used as level I medical evidence and their potential impact on clinical decision making and reimbursement can be quite significant and long-lasting. Recommendations regarding trial end points and suggestions to mitigate the high crossover effect are offered. It may be that some clinical conditions dealing with potentially life-threatening problems should not be studied in randomized prospective clinical trials containing an OBS/NoRx arm.

Thoracic endografting is a viable option for the octogenarian.

BACKGROUND: The objective of our study is to determine the feasibility of thoracic aortic endografting in octogenarians. METHODS: Between 2000 and 2006 a total of 504 consecutive patients from two high-volume institutions underwent thoracic endoluminal graft repair for various thoracic aortic pathologies. The following devices were used: Gore TAG (W.L. Gore, Flagstaff, AZ); Talent (Medtronic, Minneapolis, MN); and Zenith (Cook, Inc, Bloomington, IN). One hundred one (101 of 504; 20%) patients were octogenarians; 60 males (1.5:1, M:F) with a mean age of 83.7 years. Indications for intervention included the following: atherosclerotic aneurysms, 75 (75 of 101, 74%); acute and chronic dissections, 11(11 of 101, 11%); penetrating aortic ulcers, 9 (9 of 101, 9%); contained ruptures, 5 (5 of 101, 5%); and 1 transection (1 of 101, 1%). Mean length of follow-up was 3.4 +/- 2.1 years. RESULTS: No intraoperative deaths were noted. Thirty-day mortality was 10% (10 of 101 patients) with an overall late mortality of 26.7% (27 of 101 patients). Mean hospital stay was 6.3 days. A total of 12 neurologic events were noticed: 2 paraplegia (2 of 101, 2%); 4 paraparesis (4 of 101, 4%), 3 with full recovery; and 6 (6 of 101, 6%) cerebrovascular accidents with full recovery in half. A total of 15 endoleaks (15 of 101, 15%) were seen and, in 11, interventions were required. CONCLUSIONS: Our data suggest that technical success is high and age-specific outcomes in this group of patients are favorable. Further studies are warranted.

Is endovascular repair the new gold standard for primary adult coarctation?

OBJECTIVE: Primary adult aortic coarctation (PAAC) is an unusual cause of hypertension. The standard of care includes surgical repair, which can be associated with considerable morbidity and operative risk. Although balloon angioplasty has been successfully used in paediatric and adolescent patients with coarctation, little information exists regarding the endovascular repair of PAAC. This study examines the procedural safety and efficacy of endovascular repair of PAAC along with midterm outcomes. METHODS: Between January 2000 and July 2008, 16 patients underwent endovascular repair of PAAC. All patients were hypertensive with 13 patients (81.3%) receiving medical therapy. Symptoms included chest pain (n=11, 69%), progressive fatigue (n=5, 31%), exercise intolerance (n=4, 25%) and shortness of breath (n=3, 19%). Associated cardiac concerns included depressed ejection fraction (n=6, 38%), pulmonary hypertension (n=5, 31%), ascending aortic dilatation (n=5, 31%) and bicuspid aortic valve (n=4, 25%). Endovascular repair was achieved using a percutaneous femoral approach. Balloon angioplasty of the coarctation was performed prior to treatment using a balloon-expandable uncovered stent. Aortic diameters were assessed using intravascular ultrasound. Pre- and post-procedure pressure gradients were measured and success was determined as a residual pressure gradient across the treated aorta of less than 20 mmHg. RESULTS: The male:female (M:F) ratio was 9:7 with a mean age of 39.7 years. Procedural success was 100%. Mean pre-procedural aortic diameter was 8.4mm (3-14 mm) and mean post-procedural aortic diameter was 16.3mm (10-20mm) (p=0.04). The mean pre-procedural pressure gradient was 48.3 mmHg (25-100 mmHg) and the mean post-procedural pressure gradient was 0.5 mmHg (0-15 mmHg) (p=0.05). Twelve patients received one stent, two patients received two stents, one patient received three stents and one other patient received a thoracic stent graft. The rate of paraplegia was 0% with no blood transfusions, strokes or deaths. Follow-up ranged from 12 to 72 months (mean=22.8 months). One patient required re-intervention with an additional stent 14 months following the initial procedure and all the patients remain symptom-free. CONCLUSION: Endovascular repair of PAAC is safe and effective and compares favourably with open surgical repair. Midterm follow-up suggests that the treatment is durable and may be an alternative to surgical repair. Although this is the largest endovascular treatment series for PAAC reported to date, additional study and follow-up are needed.

Transplantation of cardiac progenitor cell sheet onto infarcted heart promotes cardiogenesis and improves function.

AIMS: Cell-based therapy for myocardial infarction (MI) holds great promise; however, the ideal cell type and delivery system have not been established. Obstacles in the field are the massive cell death after direct injection and the small percentage of surviving cells differentiating into cardiomyocytes. To overcome these challenges we designed a novel study to deliver cardiac progenitor cells as a cell sheet. METHODS AND RESULTS: Cell sheets composed of rat or human cardiac progenitor cells (cardiospheres), and cardiac stromal cells were transplanted onto the infarcted myocardium after coronary artery ligation in rats. Three weeks later, transplanted cells survived, proliferated, and differentiated into cardiomyocytes (14.6 +/- 4.7%). Cell sheet transplantation suppressed cardiac wall thinning and increased capillary density (194 +/- 20 vs. 97 +/- 24 per mm(2), P < 0.05) compared with the untreated MI. Cell migration from the sheet was observed along the necrotic trails within the infarcted area. The migrated cells were located in the vicinity of stromal-derived factor (SDF-1) released from the injured myocardium, and about 20% of these cells expressed CXCR4, suggesting that the SDF-1/CXCR4 axis plays, at least, a role in cell migration. Transplantation of cell sheets resulted in a preservation of cardiac contractile function after MI, as was shown by a greater ejection fraction and lower left ventricular end diastolic pressure compared with untreated MI. CONCLUSION: The scaffold-free cardiosphere-derived cell sheet approach seeks to efficiently deliver cells and increase cell survival. These transplanted cells effectively rescue myocardium function after infarction by promoting not only neovascularization but also inducing a significant level of cardiomyogenesis.