Abstract Background In patients with severe aortic stenosis at increased risk for surgery, self-expanding transcatheter aortic valve replacement (TAVR) is associated with improved 2-year survival ...compared with surgery. Objectives This study sought to determine whether this clinical benefit was sustained over time. Methods Patients with severe aortic stenosis deemed at increased risk for surgery by a multidisciplinary heart team were randomized 1:1 to TAVR or open surgical valve replacement (SAVR). Three-year clinical and echocardiographic outcomes were obtained in those patients with an attempted procedure. Results A total of 797 patients underwent randomization at 45 U.S. centers; 750 patients underwent an attempted procedure. Three-year all-cause mortality or stroke was significantly lower in TAVR patients (37.3% vs. 46.7% in SAVR; p = 0.006). Adverse clinical outcome components were also reduced in TAVR patients compared with SAVR patients, including all-cause mortality (32.9% vs. 39.1%, respectively; p = 0.068), all stroke (12.6% vs. 19.0%, respectively; p = 0.034), and major adverse cardiovascular or cerebrovascular events (40.2% vs. 47.9%, respectively; p = 0.025). At 3 years aortic valve hemodynamics were better with TAVR patients (mean aortic valve gradient 7.62 ± 3.57 mm Hg vs. 11.40 ± 6.81 mm Hg in SAVR; p < 0.001), although moderate or severe residual aortic regurgitation was higher in TAVR patients (6.8% vs. 0.0% in SAVR; p < 0.001). There was no clinical evidence of valve thrombosis in either group. Conclusions Patients with severe aortic stenosis at increased risk for surgery had improved 3-year clinical outcomes after TAVR compared with surgery. Aortic valve hemodynamics were more favorable in TAVR patients without differences in structural valve deterioration. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902 )
Abstract Background The U.S. pivotal trial for the self-expanding valve found that among patients with severe aortic stenosis at increased risk for surgery, the 1-year survival rate was 4.9 ...percentage points higher in patients treated with a self-expanding transcatheter aortic valve bioprosthesis than in those treated with a surgical bioprosthesis. Objectives Longer-term clinical outcomes were examined to confirm if this mortality benefit is sustained. Methods Patients with severe aortic stenosis who were at increased surgical risk were recruited. Eligible patients were randomly assigned in a 1:1 ratio to transcatheter aortic valve replacement with the self-expanding transcatheter valve (transcatheter aortic valve replacement TAVR group) or to aortic valve replacement with a surgical bioprosthesis (surgical group). The 2-year clinical and echocardiographic outcomes were evaluated in these patients. Results A total of 797 patients underwent randomization at 45 centers in the United States. The rate of 2-year all-cause mortality was significantly lower in the TAVR group (22.2%) than in the surgical group (28.6%; log-rank test p < 0.05) in the as-treated cohort, with an absolute reduction in risk of 6.5 percentage points. Similar results were found in the intention-to-treat cohort (log-rank test p < 0.05). The rate of 2-year death or major stroke was significantly lower in the TAVR group (24.2%) than in the surgical group (32.5%; log-rank test p = 0.01). Conclusions In patients with severe aortic stenosis who are at increased surgical risk, the higher rate of survival with a self-expanding TAVR compared with surgery was sustained at 2 years. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902 )
Objectives Recent national trends in off-pump versus on-pump coronary artery bypass grafting have not been reported. Methods We analyzed data from the Society of Thoracic Surgeons Adult Cardiac ...Surgery Database regarding isolated primary coronary artery bypass grafting operations (N = 2,137,841; 1997-2012). The off-pump percentages were calculated in aggregate, by center, and by surgeon. On the basis of the 2007/2008 yearly off-pump volume, the analysis subgroups were “high” (center n > 200, surgeon n > 100), “intermediate” (center n = 50-200, surgeon n = 20-100), and “low” (center n = 1-49, surgeon n = 1-19). Results The use of off-pump procedures peaked in 2002 (23%) and again in 2008 (21%), followed by a progressive decline in off-pump frequency to 17% by 2012. After 2008, off-pump rates declined among both high-volume and intermediate-volume centers and surgeons; little change was observed for low-volume centers or surgeons (off-pump rates = 10% since 2008). By the end of the study period, 84% of centers performed fewer than 50 off-pump cases per year, 34% of surgeons performed no off-pump operations, and 86% of surgeons performed fewer than 20 off-pump cases per year. Except for a higher (7.8%) conversion rate in 2003, the rate for conversions fluctuated approximately 6%. Conclusions Enthusiasm for off-pump coronary artery bypass grafting has been tempered. The percentage of coronary artery bypass grafting operations performed off-pump has steadily declined over the last 5 years, and currently this technique is used in fewer than 1 in 5 patients who undergo surgical coronary revascularization. A minority of surgeons and centers continue to perform off-pump coronary artery bypass grafting in most of their patients.
Short- and long-term mortality in women who undergo coronary artery bypass grafting (CABG) has been evaluated in multiple studies with conflicting results. The investigators conducted a meta-analysis ...of all existing studies to evaluate the impact of female gender on mortality in patients who undergo isolated CABG. A comprehensive search of studies published through May 31, 2012 identified 20 studies comparing men and women who underwent isolated CABG. All-cause mortality was evaluated at short-term (postoperative period and/or at 30 days), midterm (1-year), and long-term (5-year) follow-up. Odds ratios (ORs) and 95% confidence interval (CIs) were calculated using a random-effects model. A total of 966,492 patients (688,709 men 71%, 277,783 women 29%) were included in this meta-analysis. Women were more likely to be older; had significantly greater co-morbidities, including hypertension, diabetes mellitus, hyperlipidemia, unstable angina, congestive heart failure, and peripheral vascular disease; and were more likely to undergo urgent CABG (51% vs 44%, p <0.01). Short-term mortality (OR 1.77, 95% CI 1.67 to 1.88) was significantly higher in women. At midterm and long-term follow-up, mortality remained high in women compared with men. Women remained at increased risk for short-term mortality in 2 subgroup analyses including prospective studies (n = 41,500, OR 1.83, 95% CI 1.59 to 2.12) and propensity score–matched studies (n = 11,522, OR 1.36, 95% CI 1.04 to 1.78). In conclusion, women who underwent isolated CABG experienced higher mortality at short-term, midterm, and long-term follow-up compared with men. Mortality remained independently associated with female gender despite propensity score–matched analysis of outcomes.
Outcomes of 3309 thoracoabdominal aortic aneurysm repairs Coselli, Joseph S., MD; LeMaire, Scott A., MD; Preventza, Ourania, MD ...
The Journal of thoracic and cardiovascular surgery,
05/2016, Letnik:
151, Številka:
5
Journal Article
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Abstract Objective Since the pioneering era of E. Stanley Crawford, our multimodal strategy for thoracoabdominal aortic aneurysm repair has evolved. We describe our approximately 3-decade ...single-practice experience regarding 3309 thoracoabdominal aortic aneurysm repairs and identify predictors of early death and other adverse postoperative outcomes. Methods We analyzed retrospective (1986-2006) and prospective data (2006-2014) obtained from patients (2043 male; median age, 67 59-73 years) who underwent 914 Crawford extent I, 1066 extent II, 660 extent III, and 669 extent IV thoracoabdominal aortic aneurysm repairs, of which 723 (21.8%) were urgent or emergency. Repairs were performed to treat degenerative aneurysm (64.2%) or aortic dissection (35.8%). The outcomes examined included operative death (ie, 30-day or in-hospital death) and permanent stroke, paraplegia, paraparesis, and renal failure necessitating dialysis, as well as adverse event, a composite of these outcomes. Results There were 249 operative deaths (7.5%). Permanent paraplegia and paraparesis occurred after 97 (2.9%) and 81 (2.4%) repairs, respectively. Of 189 patients (5.7%) with permanent renal failure, 107 died in the hospital. Permanent stroke was relatively uncommon (n = 74; 2.2%). The rate of the composite adverse event (n = 478; 14.4%) was highest after extent II repair (n = 203; 19.0%) and lowest after extent IV repair (n = 67; 10.2%; P < .0001). Estimated postoperative survival was 83.5% ± 0.7% at 1 year, 63.6% ± 0.9% at 5 years, 36.8% ± 1.0% at 10 years, and 18.3% ± 0.9% at 15 years. Conclusions Repairing thoracoabdominal aortic aneurysms poses substantial risks, particularly when the entire thoracoabdominal aorta (extent II) is replaced. Nonetheless, our data suggest that thoracoabdominal aortic aneurysm repair, when performed at an experienced center, can produce respectable outcomes.
Objective We compared the short-term outcomes between patients who had undergone classic repair for type I aortic dissection and those who had undergone concomitant antegrade stenting in the ...descending thoracic aorta. Methods From January 2005 to December 2012, 112 patients were treated for acute type I aortic dissection. Eighty-seven patients (group A) underwent traditional operations on the ascending and proximal arch (n = 79, 90.8%), total arch (n = 7, 8.1%), or ascending aorta (n = 1, 1.2%). Twenty-five patients (group B) underwent ascending and proximal arch repair and antegrade stent grafting in the descending thoracic aorta. Various concomitant procedures were performed in both groups. The circulatory arrest times were similar between the 2 groups. Results The 30-day mortality was 13.8% (n = 12) in group A and 12% (n = 3) in group B. Nine patients in group A (10.3%) and 3 in group B (12%) experienced a postoperative stroke. In group A, 1 patients (1.5%) developed transient spinal cord ischemia, and in group B, 2 patients had transient paraparesis (8.0%). Preoperatively, 24 group A patients and 19 group B patients had malperfusion; this condition resolved postoperatively in 13 group A patients (54.2%) and 16 group B patients (84.2%; P < .037). Eight group A patients (10.8%) and 1 group B patient (4.5%) underwent additional postoperative procedures on the thoracoabdominal aorta a median of 776.5 days (range, 168.5-1102.0) and 54 days postoperatively, respectively. Conclusions Antegrade endovascular grafting of the descending thoracic aorta during repair of acute type I aortic dissection is technically safe, does not increase the circulatory arrest time, and could help patients with preoperative malperfusion. Long-term follow-up data are needed.
Objectives We examined the early and midterm outcomes of homograft use in reoperative aortic root and proximal aortic surgery for endocarditis and estimated the associated risk of postoperative ...reinfection. Methods From January 2001 to January 2014, 355 consecutive patients underwent reoperation of the proximal thoracic aorta. Thirty-nine patients (10.9%; mean age, 55.4 ± 13.3 years) presented with active endocarditis; 30 (76.9%) had prosthetic aortic root infection with or without concomitant ascending and arch graft infection, and 9 (23.1%) had proximal ascending aortic graft infection with or without aortic valve involvement. Sixteen patients (41.0%) had genetically triggered thoracic aortic disease. Twelve patients (30.8%) had more than 1 prior sternotomy (mean, 2.4 ± 0.6). Results Valved homografts were used to replace the aortic root in 29 patients (74.4%); nonvalved homografts were used to replace the ascending aorta in 10 patients (25.6%). Twenty-five patients (64.1%) required concomitant proximal arch replacement with a homograft, and 2 patients (5.1%) required a total arch homograft. Median cardiopulmonary bypass, cardiac ischemia, and circulatory arrest times were 186 (137-253) minutes, 113 (59-151) minutes, and 28 (16-81) minutes. Operative mortality was 10.3% (n = 4). The rate of permanent stroke was 2.6% (n = 1); 3 additional patients had transient neurologic events. One patient (1/35, 2.9%) returned with aortic valve stenosis 10 years after the homograft operation. During the follow-up period (median, 2.5 years; range, 1 month to 12.3 years), no reinfection was reported, and survival was 65.7%. Conclusions This is one of the largest North American single-center series of homograft use in reoperations on the proximal thoracic aorta to treat active endocarditis. In this high-risk population, homograft tissue can be used with acceptable early and midterm survival and a low risk of reinfection. When necessary, homograft tissue may be extended into the distal ascending and transverse aortic arch, with excellent results. These patients require long-term surveillance for both infection and implant durability.
Objectives This study sought to evaluate the safety and efficacy of the CoreValve transcatheter heart valve (THV) for the treatment of severe aortic stenosis in patients at extreme risk for surgery. ...Background Untreated severe aortic stenosis is a progressive disease with a poor prognosis. Transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis is a potentially effective therapy. Methods We performed a prospective, multicenter, nonrandomized investigation evaluating the safety and efficacy of self-expanding TAVR in patients with symptomatic severe aortic stenosis with prohibitive risks for surgery. The primary endpoint was a composite of all-cause mortality or major stroke at 12 months, which was compared with a pre-specified objective performance goal (OPG). Results A total of 41 sites in the United States recruited 506 patients, of whom 489 underwent attempted treatment with the CoreValve THV. The rate of all-cause mortality or major stroke at 12 months was 26.0% (upper 2-sided 95% confidence bound: 29.9%) versus 43.0% with the OPG (p < 0.0001). Individual 30-day and 12-month events included all-cause mortality (8.4% and 24.3%, respectively) and major stroke (2.3% and 4.3%, respectively). Procedural events at 30 days included life-threatening/disabling bleeding (12.7%), major vascular complications (8.2%), and need for permanent pacemaker placement (21.6%). The frequency of moderate or severe paravalvular aortic regurgitation was lower 12 months after self-expanding TAVR (4.2%) than at discharge (10.7%; p = 0.004 for paired analysis). Conclusions TAVR with a self-expanding bioprosthesis was safe and effective in patients with symptomatic severe aortic stenosis at prohibitive risk for surgical valve replacement. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902 )
Molecular mechanisms of thoracic aortic dissection Wu, Darrell, MD; Shen, Ying H., MD, PhD; Russell, Ludivine, MS ...
The Journal of surgical research,
10/2013, Letnik:
184, Številka:
2
Journal Article
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Abstract Thoracic aortic dissection (TAD) is a highly lethal vascular disease. In many patients with TAD, the aorta progressively dilates and ultimately ruptures. Dissection formation, progression, ...and rupture cannot be reliably prevented pharmacologically because the molecular mechanisms of aortic wall degeneration are poorly understood. The key histopathologic feature of TAD is medial degeneration, a process characterized by smooth muscle cell depletion and extracellular matrix degradation. These structural changes have a profound impact on the functional properties of the aortic wall and can result from excessive protease-mediated destruction of the extracellular matrix, altered signaling pathways, and altered gene expression. Review of the literature reveals differences in the processes that lead to ascending versus descending and sporadic versus hereditary TAD. These differences add to the complexity of this disease. Although tremendous progress has been made in diagnosing and treating TAD, a better understanding of the molecular, cellular, and genetic mechanisms that cause this disease is necessary to developing more effective preventative and therapeutic treatment strategies.
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