Objective Under Food and Drug Administration investigational device exemption, the Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT) has been testing the safety of less aggressive ...anticoagulation than recommended by the American College of Cardiology/American Heart Association guidelines after implantation of an approved bileaflet mechanical valve. Methods In this first limb of the PROACT, patients with elevated risk factors for thromboembolism were randomized at 33 US centers to receive lower dose warfarin (test international normalized ratio INR, 1.5-2.0) or continue standard warfarin (control INR, 2.0-3.0), 3 months after mechanical aortic valve replacement. The INR was adjusted by home monitoring; all patients received 81 mg aspirin daily. Adverse events were independently adjudicated. Results A total of 375 aortic valve replacement patients were randomized into control (n = 190) and test (n = 185) groups from September 2006 to December 2009. The mean age ± standard deviation was 55.2 ± 12.5 years; 79% were men; and 93% were in sinus rhythm preoperatively. Calcific degeneration was present in 67%; active endocarditis was excluded. Concomitant procedures included coronary artery bypass grafting (27%), aortic aneurysm repair (14%), and other (25%). The follow-up duration averaged 3.82 years (755.7 patient-years pt-yrs for control; 675.2 pt-yrs for test). The mean INR was 2.50 ± 0.63 for the control and 1.89 ± 0.49 for the test groups ( P < .0001). The test group experienced significantly lower major (1.48% vs 3.26%/pt-yr; P = .047) and minor (1.32% vs 3.41%/pt-yr; P = .021) bleeding rates. The incidence of stroke, transient ischemic attack, total neurologic events, and all-cause mortality were similar between the 2 groups. Conclusions INR can be safely maintained between 1.5 and 2.0 after aortic valve replacement with this approved bileaflet mechanical prosthesis. With low-dose aspirin, this resulted in a significantly lower risk of bleeding, without a significant increase in thromboembolism.
Objective Spinal cord ischemia (SCI) is a devastating but potentially preventable complication of thoracic endovascular aortic repair (TEVAR). The purpose of this analysis was to determine what ...factors predict SCI after TEVAR. Methods All TEVAR procedures at a single institution were reviewed for patient characteristics, prior aortic repair history, aortic centerline of flow analysis, and procedural characteristics. SCI was defined as any lower extremity neurologic deficit that was not attributable to an intracranial process or peripheral neuropathy. Forty-three patient and procedural variables were evaluated individually for association with SCI. Those with the strongest relationships to SCI ( P < .1) were included in a multivariable logistic regression model, and a stepwise variable elimination algorithm was bootstrapped to derive a best subset of predictors from this model. Results From 2002 to 2013, 741 patients underwent TEVAR for various indications, and 68 (9.2%) developed SCI (permanent: n = 38; 5.1%). Because of the lack of adequate imaging for centerline analysis, 586 patients (any SCI, n = 43; 7.4%) were subsequently analyzed. Patients experiencing SCI after TEVAR were older (SCI, 72 ± 11 years; no SCI, 65 ± 15 years; P < .0001) and had significantly higher rates of multiple cardiovascular risk factors. The stepwise selection procedure identified five variables as the most important predictors of SCI: age (odds ratio OR multiplies by 1.3 per 10 years; 95% confidence interval CI, 0.9-1.8, P = .06), aortic coverage length (OR multiplies by 1.3 per 5 cm; CI, 1.1-1.6; P = .002), chronic obstructive pulmonary disease (OR, 1.9; CI, 0.9-4.1; P = .1), chronic renal insufficiency (creatinine concentration ≥ 1.6 mg/dL; OR, 1.9; CI, 0.8-4.2; P = .1), and hypertension (defined as chart history or medication; OR, 6.4; CI, 2.6-18; P < .0001). A logistic regression model with just these five covariates had excellent discrimination (area under the receiver operating characteristic curve = .83) and calibration ( χ2 = 9.8; P = .28). Conclusions This analysis generated a simple model that reliably predicts SCI after TEVAR. This clinical tool can assist decision-making about when to proceed with TEVAR, guide discussions about intervention risk, and help determine when maneuvers to mitigate SCI risk should be implemented.
Background The Food and Drug Administration has approved devices for endovascular management of thoracic endovascular aortic aneurysm repair (TEVAR); however, limited data exist describing the ...outcomes of TEVAR for aneurysms attributable to chronic type B aortic dissection (cTBAD). This study was undertaken to determine the results of endovascular treatment of cTBAD with aneurysmal degeneration. Methods A retrospective analysis of all patients treated for cTBAD with aneurysmal degeneration at the University of Florida from 2004 to 2011 was performed. Computed tomograms with centerline reconstruction were analyzed to determine change in aortic diameter, relative proportions of aortic treatment lengths, and false lumen perfusion status. Reintervention and mortality were estimated using life-tables. Cox regression analysis was completed to predict mortality. Results Eighty patients underwent TEVAR for aneurysm due to cTBAD (mean age ± standard deviation, 60 ± 13 years male, 87.5%; n = 70; median follow-up, 26 range, 1-74 months). Median time from diagnosis of TBAD to TEVAR was 16 (range, 1-72) months. Prior aortic root/arch replacement had been performed in 29% (n = 23) at a median interval of 28.5 (range, 0.5-312) months. Mean preoperative aneurysm diameter was 62.0 ± 9.9 mm. In 75% (n = 60) of cases, coverage was proximal to zone 3, and 24% (n = 19) underwent carotid-subclavian bypass or other arch debranching procedure. Spinal drains were used in 78% (pre-op 71%, n = 57; post-op 6%, n = 5). Length of stay was 6.5 ± 4.7 days with a composite morbidity of 26% and in-hospital mortality of 2.5% (n = 2). Overall neurologic event rate was 17% (spinal cord ischemia 10% n = 8, with a permanent deficit observed in 6.2% n = 5; stroke 7.5%). Aneurysm diameter reduced or stabilized in 65%. The false lumen thrombosed completely within the thoracic aorta in 52%, and reintervention within the treated aortic segment was required in 16% (n = 13).One- and 3-year freedom from reintervention (with 95% confidence interval CI) was 80% (range, 68%-88%) and 70% (range, 57%-80%), respectively. Survival at 1 and 5 years was 89% (range, 80%-94%) and 70% (range, 55%-81%) and was not significantly different among patients requiring reintervention or experiencing favorable aortic remodeling. Multivariable analysis identified coronary artery disease (hazard ratio HR, 6.4; 95% CI, 2.3-17.7; P < .005), prior infrarenal aortic surgery (HR, 8.6; 95% CI, 2.3-31.7; P = .001), and congestive heart failure (HR, 11.9; 95% CI, 1.9-73.8; P = .008) as independent risk factors for mortality. Hyperlipidemia was found to be protective (HR, 0.2; 95% CI, 0.05-0.6; P = .004). No significant difference in predictors of mortality were found between patients who underwent reintervention vs those who did not ( P = .2). Conclusions TEVAR for cTBAD with aneurysmal degeneration can be performed safely but spinal cord ischemia rates may be higher than previously reported. Liberal use of procedural adjuncts to reduce this complication, such as spinal drainage, is recommended. Reintervention is common, but long-term survival does not appear to be impacted by remediation.
Background In patients with Marfan syndrome, the complications of aortic degeneration, including dissection, aneurysm, and rupture represent the main cause of mortality. Although contemporary ...management of ascending aortic disease requires open surgical reconstruction, endovascular repair is now available for management of descending thoracic and abdominal aortic pathology (ie, thoracic endovascular aortic repair TEVAR, endovascular aneurysm repair EVAR). The short- and long-term benefit of endovascular repair in Marfan patients remains largely unproven. We examine our outcomes after EVAR in this patient population. Methods All patients with a diagnosis of Marfan syndrome who were treated with TEVAR/EVAR were evaluated in a retrospective review. Perioperative, procedure-specific and patient covariate data were aggregated. Primary endpoints were overall mortality and procedural success as divided into three categories: (1) successful therapy, (2) primary failure, or (3) secondary failure. Results Between 2000 and June 2010, 16 patients were identified as having undergone 19 TEVAR/EVAR procedures. These included three emergent operations (two for acute dissection/malperfusion and one for anastomotic disruption early after open repair). All 16 patients had previously undergone at least one (range, 1-5) open operation of the ascending aorta or arch at a time interval from 33 years to 1 week prior to the index endovascular repair. During a median follow-up of 9.3 months (range, 0-46 months), there were four deaths (25%). Six patients (38%) had successful endovascular interventions. Despite early success, there was one death in this group at 1 month postintervention. Seven patients (44%) experienced primary treatment failure with five undergoing open conversion and one undergoing left subclavian coil embolization (the seventh was lost to follow-up and presented 4 months later in cardiac arrest and expired without repair). There were three deaths in the primary treatment failure group. Two patients experienced secondary treatment failure. One underwent the index TEVAR for acute dissection with malperfusion and required a subsequent TEVAR for more distal aortic pathology. He is stable without disease progression. The other patient underwent open conversion after a second EVAR with four-vessel “chimney” stent grafts and is stable with his entire native aorta having been replaced. Conclusions Aortic disease associated with Marfan syndrome is a complex clinical problem and many patients require remedial procedures. Endovascular therapy can provide a useful adjunct or bridge to open surgical treatment in selected patients. However, failure of endovascular therapy is common, and its use should be judicious with close follow-up to avoid delay if open surgical repair is required.
Objectives This study sought to examine the relationships between right ventricular (RV) function, body composition, and prognosis in patients with advanced heart failure (HF). Background Previous ...studies investigating HF-related cachexia have not examined the impact of RV function on body composition. We hypothesized that RV dysfunction is linked to weight loss, abnormal body composition, and worsened prognosis in advanced HF. Methods Subjects with advanced HF (n = 408) underwent prospective assessment of body composition (skinfold thickness, dual-energy X-ray absorptiometry), comprehensive echocardiography, and blood testing. Subjects were followed up for adverse events (defined as death, transplantation, or circulatory assist device). Results Subjects with RV dysfunction (51%) had lower body mass index, lower fat mass index, and were more likely to display cachexia (19%). The extent of RV dysfunction correlated with greater antecedent weight loss and a lower fat/lean body mass ratio. Over a median follow-up of 541 days, there were 150 events (37%). Risk of event was greater in subjects with RV dysfunction (hazard ratio: 3.09 95% confidence interval (CI): 2.18 to 4.45) and cachexia (hazard ratio: 2.90 95% CI: 2.00 to 4.12) in univariate and multivariate analyses. Increased body mass index was associated with a lower event rate (HR per kg/m2 : 0.92 95% CI: 0.88 to 0.96), and this protection was mediated by a higher fat mass (0.91 95% CI: 0.87 to 0.96) but not a fat-free mass index (0.97 95% CI: 0.92 to 1.03). Conclusions RV dysfunction and cardiac cachexia often coexist, have additive adverse impact, and might be mechanistically interrelated. Wasting of fat but not of lean mass was predictive of adverse outcome, suggesting that fat loss is either a surrogate of enhanced catabolism or adipose tissue is cardioprotective in the context of HF.
Background We sought to evaluate the hospital and midterm results of different surgical revascularization techniques in pediatric patients within the European Congenital Heart Surgeons Association. ...Methods From 1973 to 2011, 80 patients from 13 European Congenital Heart Surgeons Association centers underwent 65 pediatric coronary artery bypass grafting (PCABG) and 27 other coronary artery procedures (OCAP; 12 patients had combined PCABG and other coronary artery procedures). Excluded were patients with Kawasaki disease. Median age at the time of coronary procedure was 2.3 years (range, 2 days to 16.9 years); 33 patients (41.2%) were younger then 12 months. An emergency procedure was necessary in 34 patients (42.5%). Results Twelve patients (15%) died in the hospital; age at surgery ( p = 0.02) and the need for an emergent procedure ( p = 0.0004) were related to hospital mortality. Median follow-up time was 7.6 years (range, 0.9 to 23 years). There were 3 late cardiac deaths, all after a median time of 4 years (range, 9 months to 8.8 years) after PCABG. Fourteen patients (20.5%) presented with symptoms, including congestive heart failure (n = 10) and angina (n = 4), that were significantly associated with a low ejection fraction ( p < 0.001) and the presence of moderate or severe mitral valve regurgitation ( p = 0.0003). Six patients underwent a reintervention for impaired myocardial perfusion; all of them had a stenotic or atretic PCABG ( p = 0.001), and the majority were symptomatic (5 of 6 patients; 83.3%; p = 0.001). Conclusions Both PCABG and other coronary artery procedures are suitable surgical options in pediatric patients with impaired myocardial perfusion, which increases operative and midterm survival. Such population of patients needs to be followed for life to prevent and treat any possible cause of further myocardial ischemia.
AbstractBackgroundThe clinical effectiveness of primary prevention implantable cardioverter defibrillator (ICD) therapy is under debate. It is urgently needed to better identify patients who benefit ...from prophylactic ICD therapy. The EUropean Comparative Effectiveness Research to Assess the Use of Primary Prophylac Tic Implantable Cardioverter Defibrillators (EU-CERT-ICD) completed in 2019 will assess this issue. SummaryThe EU-CERT-ICD is a prospective investigator-initiated non-randomized, controlled, multicenter observational cohort study done in 44 centers across 15 European countries. A total of 2327 patients with heart failure due to ischemic heart disease or dilated cardiomyopathy indicated for primary prophylactic ICD implantation were recruited between 2014 and 2018 (>1500 patients at first ICD implantation, >750 patients non-randomized non-ICD control group). The primary endpoint was all-cause mortality, and first appropriate shock was co-primary endpoint. At baseline, all patients underwent 12‑lead ECG and Holter-ECG analysis using multiple advanced methods for risk stratification as well as documentation of clinical characteristics and laboratory values. The EU-CERT-ICD data will provide much needed information on the survival benefit of preventive ICD therapy and expand on previous prospective risk stratification studies which showed very good applicability of clinical parameters and advanced risk stratifiers in order to define patient subgroups with above or below average ICD benefit. ConclusionThe EU-CERT-ICD study will provide new and current data about effectiveness of primary prophylactic ICD implantation. The study also aims for improved risk stratification and patient selection using clinical risk markers in general, and advanced ECG risk markers in particular.
Background Risk factors for spinal cord ischemia (SCI) after thoracic endovascular aneurysm repair (TEVAR) remain unclear. Aortic coverage was examined as a risk factor for SCI using quantitative ...three-dimensional computed tomography angiography (CTA) analysis. Methods The medical records, radiographic imaging studies, and a prospectively maintained database of all TEVAR procedures performed during a 7-year period were retrospectively reviewed. Preoperative anatomic dimensions and postoperative graft path lengths were measured from CTAs using curved planar and orthogonal multiplanar reformations along centerline paths. SCI was defined as transient or permanent lower extremity neurologic deficit without associated intracerebral hemispheric events. Results Of 326 TEVAR cases, 241 patients (74%) had satisfactory imaging. Thirty-three (10%) had SCI. These patients were older (72.7 ± 10.6 vs 64.7 ± 15.8 years, p = 0.005) and had longer intraoperative procedure times (137 ± 65 vs 113 ± 68 minutes, p = 0.05). Despite similar total lengths of native thoracic aorta (295.0 ± 36.3 vs 283.1 ± 39.8 mm, p = 0.17), patients with permanent SCI had a greater absolute (260.5 ± 40.9 vs 195.8 ± 81.6 mm, p = 0.002) and proportionate (88.8% ± 12.1% vs 67.6% ± 24.0%, p = 0.001) length of aortic coverage. The average length of uncovered aorta proximal to the celiac artery in patients with SCI was 17.3 ± 21.8 mm vs 63.1 ± 62.9 mm in patients without SCI ( p = 0.0006). Neither the patency of the hypogastric arteries nor left subclavian artery was associated with SCI. Conclusions The extent and distal location (relative to the celiac artery) of aortic coverage were associated with an increased risk of SCI. Prophylactic measures for spinal cord protection should be considered in patients whose thoracic aortas require extensive coverage.
Objective The RIFLE criteria are new international consensus definitions for acute kidney injury introduced to facilitate research across disciplines. We identified risk factors for acute kidney ...injury, renal replacement therapy, and mortality using the RIFLE criteria (RIFLE = r isk, i njury, f ailure, l oss, e nd stage) in patients undergoing deep hypothermic circulatory arrest for aortic arch reconstruction. Methods A single-center retrospective cohort study of 267 patients undergoing aortic arch surgery with deep hypothermic circulatory arrest was conducted between July 2001 and October 2005. Known predictors (age, chronic kidney disease, surgery status, redo, diabetes, hypertension, blood transfusion, bypass, and deep hypothermic circulatory arrest time) were used in multivariate logistic regression models for acute kidney injury, renal replacement therapy, and mortality. Results Mean age was 64 years (range 23–89 years) with 166 men (62%). Seventy-five (28%) had RIFLE scores of I or F, and 22 (8%) required dialysis. Risk factors for acute kidney injury were hypertension (odds ratio OR = 2.17; 95% confidence intervals CI, 1.14–4.15), chronic kidney disease (OR = 9.04; 95% CI, 1.97–41.59), packed red blood cells greater than 5 units (OR = 2.37; 95% CI, 1.20-4.69), and admission creatinine/Modification of Diet in Renal Disease predicted creatinine ratio greater than 1 (OR = 3.54; 95% CI, 1.95–6.45). Risk factors for mortality were age (per 10 years) (OR = 2.35; 95% CI, 1.35–4.06), AKI (RIFLE class R, I, or F) (OR = 4.60; 95% CI, 1.34–15.77), and cerebrovascular accident (OR = 19.1; 95% CI, 4.96–73.58). Mortality increased with each RIFLE stratification (RIFLE class 0 = 3%, R = 9%, I = 12%, and F = 38%). Conclusions Acute kidney injury as defined according to the RIFLE classification is a risk factor for mortality and will be useful in future studies of renal dysfunction in thoracic aortic surgery.
Objective Despite improved short-term outcomes, concerns remain regarding durability of thoracic endovascular aortic repair (TEVAR). The purpose of this analysis was to evaluate the ...pathology-specific incidence of secondary aortic interventions (SAI) after TEVAR and their impact on survival. Methods Retrospective review was performed of all TEVAR procedures and SAI at one institution from 2004-2011. Kaplan-Meier analysis was used to estimate survival. Results Of 585 patients, 72 (12%) required SAI at a median of 5.6 months (interquartile range, 1.4-14.2) with 22 (3.7%) requiring multiple SAI. SAI incidence differed significantly by pathology ( P = .002) acute dissection (21.3%), postsurgical (20.0%), chronic dissection (16.7%), degenerative aneurysm (10.8%), traumatic transection (8.1%), penetrating ulcer (1.5%), and other etiologies (14.8%). Most common indications after dissection were persistent false lumen flow and proximal/distal extension of disease. For degenerative aneurysms, SAI was performed primarily to treat type I/III endoleaks. SAI patients had a greater mean number of comorbidities ( P < .0005), stents placed ( P = .0002), and postoperative complications after the index TEVAR ( P < .0005) compared with those without SAI. Freedom from SAI at 1 and 5 years (95% confidence interval) was estimated to be 86% (82%-90%) and 68% (57%-76%), respectively. There were no differences in survival (95% confidence interval) between patients requiring SAI and those who did not SAI 1-year, 88% (77%-93%); 5-year, 51% (37%-63%); and no SAI 1-year, 82% (79%-85%); 5-year, 67% (62%-71%) (log-rank, P = .2). Conclusions SAI after TEVAR is not uncommon, particularly in patients with dissection, but does not affect long-term survival. Aortic pathology is the most important variable impacting survival and dictated need, timing, and mode of SAI. The varying incidence of SAI by indication underscores the need for diligent surveillance protocols that should be pathology-specific.
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