Gender analysis of the pivotal results of the Medtronic Talent Thoracic Stent Graft System (VALOR) trial

PurposeThis study evaluated the differences between male and female patients undergoing thoracic endovascular aneurysm repair (TEVAR) in a pivotal Food and Drug Administration (FDA)-approved trial.MethodsThe Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms (VALOR) study was a prospective, nonrandomized, multicenter, pivotal trial conducted in the United States. Patients were enrolled between December 2003 and June 2005. Follow-up was conducted at 30 and 365 days.ResultsVALOR enrolled 115 men (58.9%; 69.3 ± 11.7 years old), and 80 women (41.1%; 71.6 ± 10.1 years old). Iliac conduits were used more often in women, who had smaller diameter external iliac arteries, than in men (38.8% vs 8.8%, P < .001). Women required more blood transfusions and had a longer hospital length of stay. At 30 days, more major adverse events occurred in women than in men (52.5% vs 33.0%, P = .008), with more vascular access-related and respiratory complications. No gender-based differences were seen in all-cause mortality or in aneurysm-related death. The composite end point of 365-day “successful aneurysm treatment,” defined as no aneurysm growth >5 mm at the 365-day follow-up visit compared with the 30-day follow-up visit and absence of any type I endoleak requiring a secondary procedure, favored women over men (98.2% vs 82.4%, P = .004).ConclusionsTEVAR with the Talent device provided similar rates of 365-day mortality and morbidity for men and women. Although female patients had higher rates of periprocedural complications, they also more often had successful aneurysm treatment at the 1-year follow-up

Endovascular stent grafting versus open surgical repair of descending thoracic aortic aneurysms in low-risk patients: A multicenter comparative trial

ObjectiveResults are presented from the first completed multicenter trial directed at gaining approval from the US Food and Drug Administration of endovascular versus open surgical repair of descending thoracic aortic aneurysms.MethodsBetween September 1999 and May 2001, 140 patients with descending thoracic aneurysms were enrolled at 17 sites and evaluated for a Gore TAG Thoracic Endograft. An open surgical control cohort of 94 patients was identified by enrolling historical and concurrent subjects. Patients were assessed before treatment, at treatment, and at hospital discharge and returned for follow-up visits at 1 month, 6 months, and annually thereafter.ResultsOne hundred thirty-seven of 140 patients had successful implantation of the endograft. Perioperative mortality in the endograft versus open surgical control cohort was 2.1% (n = 3) versus 11.7% (n = 11, P < .001). Thirty-day analysis revealed a statistically significant lower incidence of the following complications in the endovascular cohort versus the surgical cohort: spinal cord ischemia (3% vs 14%), respiratory failure (4% vs 20%), and renal insufficiency (1% vs 13%). The endovascular group had a higher incidence of peripheral vascular complications (14% vs 4%). The mean lengths of intensive care unit stay (2.6 ± 14.6 vs 5.2 ± 7.2 days) and hospital stay (7.4 ± 17.7 vs 14.4 ± 12.8 days) were significantly shorter in the endovascular cohort. At 1 and 2 years’ follow-up, the incidence of endoleaks was 6% and 9%, respectively. Through 2 years of follow-up, there were 3 reinterventions in the endograft cohort and none in the open surgical control cohort. Kaplan–Meier analysis revealed no difference in overall mortality at 2 years.ConclusionsIn this multicenter study early outcomes with descending aortic endovascular stent grafting were very encouraging when compared with those of a well-matched surgical cohort. However, at 2 years’ follow-up, there is an incidence of endoleaks and reinterventions associated with endovascular versus open surgical repair. Continued vigilant surveillance of patients treated with an endograft is important

Effect of volume reduction on lung transplant timing and selection for chronic obstructive pulmonary disease

AbstractBackground: End-stage chronic obstructive pulmonary disease has traditionally been treated with lung transplantation. For 2 years, our lung transplantation program has placed patients with appropriate criteria for lung transplantation and volume reduction into a prospective management algorithm. These patients are offered the lung volume reduction option as a “bridge” to “extend” the eventual time to transplantation. We examine the results of this pilot program. Methods: From October 11, 1993, to April 17, 1997, 31 patients were evaluated for lung transplantation who also had physiologic criteria for volume reduction (forced expiratory volume in 1 second ≤ 25%; residual volume > 200%; significant ventilation/perfusion heterogeneity). All patients completed 6 weeks of pulmonary rehabilitation and then had baseline pulmonary function and 6-minute walk tests. These patients were then offered volume reduction as a “bridge” and were simultaneously listed for transplantation. Postoperatively, these 31 patients were then divided into two groups: Those with satisfactory results at 4 to 6 months after volume reduction and those with unsatisfactory results. Volume reduction was performed through a video thoracic approach in 87% of the patients and bilateral median sternotomy in the remaining 13%. The condition of the patients was monitored after the operation with repeated pulmonary function tests and 6-minute walk tests at 3-month intervals. Results: Twenty-four of 31 patients (77.4%) had primary success (at 4 to 6 months) results after lung volume reduction and 7 patients (22.6%) had primary failure, including 1 patient who died in the perioperative period (3.2%). Four patients (16.7%) from the primary success cohort had significant deterioration in their pulmonary function during intermediate-term follow-up and were then reconsidered for lung transplantation. Two of them have subsequently undergone transplantation with good postoperative pulmonary function results. Interestingly, three patients had α1-antitrypsin deficiency; two had a poor outcome of lung volume reduction and primary failure. Conclusions: Lung volume reduction in these patients is safe. Seventy-seven percent of otherwise suitable candidates for lung transplantation achieved initial good results from volume reduction and were deactivated from the list (placed on status 7). Most patients entering our prospective management algorithm have either significantly delayed or completely avoided lung transplantation after volume reduction. Lung volume reduction has substantially affected the practice, timing, and selection of patients for lung transplantation. Our waiting list now has a reduced percentage of patients with a diagnosis of chronic obstructive pulmonary disease compared with 3 years ago. Our experience suggests that lung volume reduction may be limited as a “bridge” in α1-antitrypsin deficiency. (J Thorac Cardiovasc Surg 1998;115:9-18

Valve-sparing and valve-replacing techniques for aortic root replacement in patients with Marfan syndrome: Analysis of early outcome

ObjectiveA prospective, international registry study was initiated to provide contemporary comparative data on short-term clinical outcomes after aortic valve-sparing and aortic valve-replacing root operations in patients with Marfan syndrome. The purpose of this initial report is to describe the study design and to compare early outcomes in the first 151 enrolled patients.MethodsWe assessed 30-day outcomes in 151 patients who met strict Ghent diagnostic criteria for Marfan syndrome and underwent aortic root replacement with either valve-replacing (n = 46) or valve-sparing techniques (n = 105) at one of 18 participating centers. In the valve replacement group, a mechanical composite valve graft was used in 39 (85%) patients and a bioprosthetic valve in 7 (15%). In the valve-sparing group, David V procedures were performed in 57 (54%) patients, David I in 38 (36%), David IV in 8 (8%), Florida sleeve in 1 (1%), and Yacoub remodeling in 1 (1%).ResultsNo in-hospital or 30-day deaths occurred. Despite longer crossclamp and cardiopulmonary bypass times in the valve-sparing group, there were no significant between-group differences in postoperative complications. Thirty-day valve-related complications occurred in 2 (4%) patients undergoing valve replacement and in 3 (3%) undergoing valve-sparing procedures (P = .6).ConclusionsThe analysis of early outcomes revealed that valve-sparing techniques were the most common approach to root replacement in patients with Marfan syndrome in these centers. The complexity of valve-sparing root replacement did not translate into any demonstrable adverse early outcomes. Subsequent analysis will compare the 3-year durability of these two surgical approaches

PREDICTORS OF SUBSEQUENT INTERVENTION AFTER INITIAL TREATMENT FOR ACUTE AORTIC DISSECTION

none15siopenLettinga, Mark; Patel, Himanshu; Peterson, Mark; Ehrlich, Marek; Myrmel, Truls; Conklin, Lori; Mussa, Firas; Bavaria, Joseph; Gleason, Thomas; Di Eusanio, Marco; Montgomery, Daniel; Eagle, Kim; Isselbacher, Eric; Nienaber, Christoph; Trimarchi, SantiLettinga, Mark; Patel, Himanshu; Peterson, Mark; Ehrlich, Marek; Myrmel, Truls; Conklin, Lori; Mussa, Firas; Bavaria, Joseph; Gleason, Thomas; Di Eusanio, Marco; Montgomery, Daniel; Eagle, Kim; Isselbacher, Eric; Nienaber, Christoph; Trimarchi, Sant

The future of aortic surgery in Europe†

At least every ten years, each specialty should reflect upon its past, its present and its future, in order to be able to reconfirm the direction in which it is headed, to adopt suggestions from inside and outside and, consequently, to improve. As such, the aim of this manuscript is to provide the interested reader with an overview of how aortic surgery and (perhaps more accurately) aortic medicine has evolved in Europe, and its present standing; also to provide a glimpse into the future, trying to disseminate the thoughts of a group of people actively involved in the development of aortic medicine in Europe, namely the Vascular Domain of the European Association of Cardio-Thoracic Surgery (EACTS

Evaluation of flow after transcatheter aortic valve replacement in patients with low-flow aortic stenosis : a secondary analysis of the PARTNER randomized clinical trial

Importance: Low-flow (LF) severe aortic stenosis (AS) is an independent predictor of mortality in patients undergoing aortic valve replacement (AVR). Little is known about improvement in flow after AVR and its effects on survival. Objective: To determine whether higher flow (left-ventricular stroke volume index [LVSVI]) after transcatheter AVR (TAVR) would indicate better clinical outcomes in this at-risk population. Design, Setting, and Participants: A substudy analysis of data from the Placement of Aortic Transcatheter Valves (PARTNER) randomized clinical trial and continued-access registry was conducted. A total of 984 participants with evaluable echocardiograms and baseline LF AS (LVSVI =35 mL/m2) were included. The trial was conducted at 26 sites in the United States and Canada. Patients were stratified after TAVR into tertiles by discharge LVSVI status (severe low flow [SLF], moderate low flow [MLF], and normal flow [(NF]). The present study was conducted from May 11, 2007, to January 9, 2012, with data analysis performed from April 25, 2014, to January 21, 2016. Main Outcomes and Measures: The primary end point was all-cause mortality at 1 year. Results: Baseline characteristics of 984 patients with LF AS included mean (SD) age, 84 (7) years; 582 (59.1%) men; mean Society of Thoracic Surgeons (STS) score, 11.4% (4.0%); and mean LVSVI, 27.6 (5.0) mL/m2. The discharge LVSVI values by group were SLF, 23.1 (3.5) mL/m2; MLF, 31.7 (2.2) mL/m2; and NF, 43.1 (7.0). All-cause mortality at 1 year was SLF, 26.5%; MLF, 20.1%; and NF, 19.6% (P¿=¿.045). Mean LVSVI normalized by 6 months in the MLF (35.9 [9.3] mL/m2) and NF (38.8 [11.1] mL/m2) groups, but remained low in the SLF group at 6 months and 1 year (31.4 [8.4] and 33.0 [8.3] mL/m2], respectively) (P¿<¿.001 for all groups). Reported as multivariate hazard ratio, mortality at 1 year was higher in the SLF group compared with the other groups (1.61; 95% CI, 1.17-2.23; P¿=¿.004). In addition to SLF, sex (1.59; 95% CI, 1.18-2.13; P¿=¿.002), presence of atrial fibrillation (1.41; 95% CI, 1.06-1.87; P¿=¿.02), STS score (1.03; 95% CI, 1.01-1.06; P¿=¿.02), presence of moderate or severe mitral regurgitation at discharge (1.65; 95% CI, 1.21-2.26; P¿=¿.001), pre-TAVR mean transvalvular gradient (0.98; 95% CI, 0.97-0.99; P¿=¿.004), and effective orifice area index (1.87; 95% CI, 1.09-3.19; P¿=¿.02) were independent predictors of 1-year mortality.CONCLUSIONS AND RELEVANCE: Severe LF at discharge is associated with an increased risk of mortality following TAVR in patients with severe AS and preexisting LF. The identification of remedial causes of persistent LF after TAVR may represent an opportunity to improve the outcome of these patients

A multicenter clinical trial of endovascular stent graft repair of acute catastrophes of the descending thoracic aorta

OBJECTIVE: Thoracic endovascular aortic repair (TEVAR) is applicable to a spectrum of thoracic aortic pathology with half of the procedures performed world-wide for indications other than degenerative aneurysm of the descending thoracic aorta (DTA). This multicenter, prospective study queried perioperative and one-year results of TEVAR using the commercially available GORE TAG device, in the treatment of acute complicated Type B dissection (cTBD), traumatic aortic tear (TT), and ruptured degenerative aneurysm (RDA) of the DTA. METHODS: This prospective, non-randomized, literature controlled study included 59 patients; cTBD, n = 19; RDA, n = 20; TT, n = 20. The primary end-point was the composite of death and total paraplegia in subjects at <or= 30 days post-treatment compared with a cohort from current literature. Secondary end-points included adverse events related to device, procedural and systemic complications, and one-year survival. RESULTS: All 59 patients had successful endoprosthesis deployment. Fifteen of 19 (79%) patients in the cTBD group had either rupture or malperfusion syndromes at presentation. Combined 30-day mortality/paraplegia rate was 13.6% (8/59), with seven (11.9%) deaths (cTBD [3], RDA [3] and TT [1]) and 1 (TT, 1.7%) case of paraplegia. The primary end-point for the TEVAR cohort was significantly lower (P = .008) when compared with a composite literature control of 800 patients (combined 30-day mortality/paraplegia of 29.6%). Thirty-day complications of any nature occurred in 48 (81%) patients; 11 (18.6%) were device related, and 43 (73%) experienced one or more systemic adverse events. Six (10%) patients required additional TEVAR implantations and 3 (5%) patients (one in each pathology group) required conversion to open surgery. Seventeen (29%) patients had endoleaks of any kind or degree through 30 days; cTBD (7), TT (2), RDA (8). Nine patients (15.3%) had perioperative strokes with two resultant deaths. During mean follow-up time of 409 +/- 309 days, an additional 12 patients died, one patient required open conversion (cTBD), and two patients had major device related events. Actuarial survival at one year was 66% (range, 52%-77%) for the entire cohort; (cTBD) 79% (range, 53%-92%), (TT) 79% (range, 53%-92%) and (RDA) 37% (range, 16%-59%). On regression analysis, age at treatment (1.05 [range, 1.01-1.09]; P = .008) and chronic obstructive pulmonary disease (COPD) (4.3 [range, 1.3-14.4]; P = .02) were predictive of death at one year. CONCLUSION: This study confirmed treatment advantages for TEVAR for thoracic aortic catastrophes when compared with literature-based results of open repair. One-year treatment results indicate a low incidence of graft-related complications. TEVAR is the preferred initial treatment for the DTA catastrophes studied herein