Objectives The purpose of this randomized study was to compare sirolimus-eluting stenting with coronary artery bypass grafting (CABG) for patients with unprotected left main (ULM) coronary artery ...disease. Background CABG is considered the standard of care for treatment of ULM. Improvements in percutaneous coronary intervention (PCI) with use of drug-eluting stents might lead to similar results. The effectiveness of drug-eluting stenting versus surgery has not been established in a randomized trial. Methods In this prospective, multicenter, randomized trial, 201 patients with ULM disease were randomly assigned to undergo sirolimus-eluting stenting (n = 100) or CABG using predominantly arterial grafts (n = 101). The primary clinical end point was noninferiority in freedom from major adverse cardiac events, such as cardiac death, myocardial infarction, and the need for target vessel revascularization within 12 months. Results The combined primary end point was reached in 13.9% of patients after surgery, as opposed to 19.0% after PCI (p = 0.19 for noninferiority). The combined rates for death and myocardial infarction were comparable (surgery, 7.9% vs. stenting, 5.0%; noninferiority p < 0.001), but stenting was inferior to surgery for repeat revascularization (5.9% vs. 14.0%; noninferiority p = 0.35). Perioperative complications including 2 strokes were higher after surgery (4% vs. 30%; p < 0.001). Freedom from angina was similar between groups (p = 0.33). Conclusions In patients with ULM stenosis, PCI with sirolimus-eluting stents is inferior to CABG at 12-month follow-up with respect to freedom from major adverse cardiac events, which is mainly influenced by repeated revascularization, whereas for hard end points, PCI results are favorable. A longer follow-up is warranted. (Percutaneous Coronary Intervention PCI With Drug-Eluting Stents DES Versus Coronary Artery Bypass Graft CABG for Patients With Significant Left Main Stenosis; NCT00176397 )
Objectives The goal of this study was to evaluate the safety and performance of the NeoChord DS1000 system (NeoChord, Inc., Minneapolis, Minnesota). Background There is an increasing interest in ...transcatheter mitral valve (MV) treatment. The NeoChord DS 1000 system enables off-pump beating heart transapical MV repair with implantation of artificial neo-chordae. Methods Patients with severe mitral regurgitation (MR) due to isolated posterior prolapse were included in this TACT (Transapical Artificial Chordae Tendinae) trial. All patients were scheduled for off-pump transapical implantation of neo-chordae. Results Thirty patients at 7 centers were enrolled. Major adverse events included 1 death due to post-cardiotomy syndrome and concomitant sepsis and 1 minor stroke with the patient fully recovered at the 30-day follow-up visit. Additional patients experienced procedural major adverse events related to a reoperation or conversion to standard of care. Acute procedural success (placement of at least 1 neo-chord and reduction of MR from 3+ or 4+ to ≤2+) was achieved in 26 patients (86.7%). In 4 patients neo-chordae were not placed for technical and/or patient-specific reasons. These patients underwent intraoperative (3 patients) or post-operative (1 patient) standard MV repair. At 30 days, 17 patients maintained an MR grade ≤2+. Four patients who developed recurrent MR were successfully treated with open MV repair during 30-day follow-up. Results improved with experience: durable reduction in MR to ≤2+ at 30 days was achieved in 5 (33.3%) of the first 15 patients and 12 (85.7%) of the last 14 patients. Conclusions Off-pump transapical implantation of artificial chordae to correct MR is technically safe and feasible; however, it yields further potential for improvement of efficacy and durability. (Safety and Performance Study of the NeoChord Device TACT; NCT01777815 )
Objective Spinal cord injury remains an invincible complication affecting up to 1 of 5 patients after thoracoabdominal aortic aneurysm repair. A staged surgical approach has been suggested to ...eliminate paraplegia by induction of arteriogenesis within the paraspinal collateral network; however, its clinical implementation was deferred because it required 2 major procedures. Methods First-in-man experience with minimally invasive, selective segmental artery endovascular coil embolization before Crawford type II and III thoracoabdominal aortic aneurysm repair for arteriogenic preconditioning of the collateral network is reported. A 45-year-old man received bilateral elective minimally invasive, selective segmental artery endovascular coil embolization of 2 unilateral lumbar segmental arteries 4 weeks before open surgical repair. A 67-year-old woman who was planned for total endovascular treatment received minimally invasive, selective segmental artery endovascular coil embolization at the fourth lumbar level and coil embolization of the inferior mesenteric artery 8 weeks before endovascular repair. Results Minimally invasive, selective segmental artery endovascular coil embolization was technically successful and did not result in any neurologic impairment. Both patients were discharged after 72 hours of clinical surveillance. Patient 1 returned for definite open single-stage thoracoabdominal aortic aneurysm repair after 4 weeks and left the hospital without any neurologic impairment on day 35 postoperatively. Patient 2 returned for total endovascular repair 8 weeks after she underwent minimally invasive, selective segmental artery endovascular coil embolization; she recovered well and was discharged without spinal cord injury 8 days after extensive single-stage endovascular thoracoabdominal aortic aneurysm repair. Both patients are alive with no neurologic injury at 1-year follow-up. Conclusions Minimally invasive, selective segmental artery endovascular coil embolization for arteriogenic preconditioning of the paraspinal arterial collateral network is clinically feasible and may eventually eliminate ischemic spinal cord injury to enable safe open or endovascular repair of extensive thoracoabdominal aortic aneurysms and prevent paraplegia altogether in the near future.
Objective Adult postcardiotomy cardiogenic shock potentially requiring mechanical circulatory support occurs in 0.5% to 1.5% of cases. Risk factors influencing early or long-term outcome after ...extracorporeal membrane oxygenation implantation are not well described. Methods Between May 1996 and May 2008, 517 adult patients received extracorporeal membrane oxygenation support for postcardiotomy cardiogenic shock. Procedures were isolated coronary artery bypass grafting (37.4%), isolated valve surgery (14.3%), coronary artery bypass grafting plus valve surgery (16.8%), thoracic organ transplantion (6.5%), and other combinations (25.0%). Fifty-four preoperative and 42 procedural risk factors concerning in-hospital mortality were evaluated by logistic regression analyses. Results Mean age was 63.5 years, 71.5% were male, ejection fraction was 45.9% ± 17.6%, logistic EuroSCORE was 21.6% ± 20.7%. Extracorporeal membrane oxygenation was established through thoracic (60.8%) or extrathoracic (39.2%) cannulation. Extracorporeal membrane oxygenation support was 3.28 ± 2.85 days. Intra-aortic balloon pumps were implanted in 74.1%. Weaning from extracorporeal membrane oxygenation was successful for 63.3%, and 24.8% were discharged. Cerebrovascular events occurred in 17.4%, gastrointestinal complications in 18.8%, and renal replacement therapy in 65.0%. Risk factors for hospital mortality were age older than 70 years (odds ratio, 1.6), diabetes (odds ratio, 2.5), preoperative renal insufficiency (odds ratio, 2.1), obesity (odds ratio, 1.8), logistic EuroSCORE greater than 20% (odds ratio, 1.8), operative lactate greater than 4 mmol/L (odds ratio, 2.2). Isolated coronary artery bypass grafting (odds ratio, 0.44) was protective. Cumulative survivals were 17.6% after 6 months, 16.5% after 1 year, and 13.7% after 5 years. Conclusions Extracorporeal membrane oxygenation support is an acceptable option for patients with postcardiotomy cardiogenic shock who otherwise would die and is justified by good long-term outcome of hospital survivors. Because of high morbidity and mortality, extracorporeal membrane oxygenation must be decided by individual risk profile.
To the Editor: IL-33 is a member of the IL-1 family of cytokines that is constitutively expressed in healthy skin and was found to be increased in the skin of patients with atopic dermatitis (AD). ...Because it can be released after tissue damage or physical stress including scratching of the skin,1 it has been classified as an alarmin concerned with alerting the immune system.2 It enhances TH2 responses by inducing IL-5 and IL-13 as well as TH1 responses via upregulation of IFN-γ. Because existing FLG within the stratum corneum is not expected to be affected by 24-hour stimulation, evaluation was restricted to keratinocytes with detectable nuclear counterstaining.
Surgical risk of preoperative malperfusion in acute type A aortic dissection Girdauskas, Evaldas, MD; Kuntze, Thomas, MD; Borger, Michael A., MD, PhD ...
Journal of thoracic and cardiovascular surgery/The Journal of thoracic and cardiovascular surgery/The journal of thoracic and cardiovascular surgery,
12/2009, Letnik:
138, Številka:
6
Journal Article
Recenzirano
Odprti dostop
Objective Patients who have type A dissection with preoperative malperfusion syndromes are believed to be at extremely high surgical risk. Our aim was to evaluate perioperative and long-term results ...of patients with preoperative malperfusion. Methods A total of 276 patients (174 men; mean age 59.5 ± 13.4 years) underwent surgery for acute type A dissection between October 1994 and January 2008. Preoperative malperfusion syndromes were diagnosed in 93 (33.7%) patients (group I) and involved coronary circulation in 41 (15%) patients, central nervous system in 39 (14%) patients, limb ischemia in 32 (11.6%) patients, and mesenteric circulation in 8 (3%) patients. Postoperative results were compared between patients with preoperative malperfusion and those without this complication (group II, n = 183). Results In-hospital mortality was 29.0% in group I versus 13.6% in group II ( P = .002). The postoperative intensive care unit stay was longer (11.4 ± 9.7 vs 7.7 ± 6.9 days; P = .04) in the malperfusion group. A total of 6 (75%) patients with mesenteric malperfusion died. Long-term follow-up (range, 1–122 months postoperatively) was available in 100% of survivors. One-year and 5-year overall survivals were 49.8% ± 11.8% and 41.8% ± 12.6% in group I versus 70.4% ± 7.6% and 56% ± 10.4% in group II ( P = .005). Cox regression analysis identified preoperative malperfusion as a significant risk factor for long-term mortality after surgery for type A dissection (hazard ratio, 1.7; 95% confidence intervals, 1.2–3.1). Conclusions Preoperative malperfusion is a significant risk factor influencing perioperative and long-term survival after surgery for acute type A dissection. Percutaneous interventional procedures and delayed surgery should be considered in patients with clinically apparent mesenteric malperfusion because of the dismal prognosis of immediate surgical therapy.
Objective Aortic surgical procedures requiring hypothermic circulatory arrest are associated with altered hemostasis and increased bleeding. In a randomized clinical trial, we evaluated effects of ...thromboelastometrically guided algorithm on transfusion requirements. Methods Fifty-six consecutive patients (25 with acute type A dissection) undergoing aortic surgery with hypothermic circulatory arrest were enrolled in a randomized trial during a 6-month period. Patients were randomly allocated to treatment group (n = 27) with thromboelastometrically guided transfusion algorithm or control group (n = 29) with routine transfusion practices (clinical judgment–guided transfusion followed by transfusion according to coagulation test results). Primary end point was cumulative allogeneic blood units (red blood cells, fresh-frozen plasma, and platelets) transfused. Results Transfusion of allogeneic blood was significantly reduced in the thromboelastometry group: median 9.0 units (interquartile range, 2.0–30.0 units) versus. 16.0 units (9.0–23.0 units, P = .02). Most significant decrease was in the use of fresh-frozen plasma (3.0 units, 0–12.0 units, vs 8.0 units, 4.0–18.0 units, P = .005). Postoperative blood loss (890 mL/d, 600–1250 mL/d vs 950 mL/d, 650–1400 mL/d, p = 0.5) and rate of surgical re-exploration (19% vs 24%, P = .7) were similar between groups. Thromboelastometrically guided algorithm significantly decreased need for massive perioperative transfusion (odds ratio, 0.45; 95% confidence interval, 0.2–0.9; P = .03) in multivariable logistic regression analysis. Conclusions Thromboelastometrically guided transfusion is associated with a decreased use of allogeneic blood units and reduced incidence of massive transfusion in patients undergoing aortic surgery with circulatory arrest.
Objectives The purpose of this randomized study was to compare sirolimus-eluting stenting (SES) with minimally invasive direct coronary artery bypass (MIDCAB) surgery for patients with isolated ...proximal left anterior descending (LAD) coronary artery disease. Background Bare-metal stenting is inferior to MIDCAB surgery in patients with isolated proximal LAD lesions due to a higher reintervention rate with similar results for mortality and reinfarction. SES are effective in restenosis reduction. Methods A total of 130 patients with significant proximal LAD coronary artery disease were randomized to either SES (n = 65) or MIDCAB surgery (n = 65). The primary clinical end point was noninferiority in freedom from major adverse cardiac events (MACE), such as cardiac death, myocardial infarction, and the need for target vessel revascularization within 12 months. Results Follow-up was completed for all patients. MACE occurred in 7.7% of patients after stenting, as compared with 7.7% after surgery (p = 0.03 for noninferiority). The individual components of the combined end point revealed mixed results. Although noninferiority was revealed for the difference in death and myocardial infarction (1.5% vs. 7.7%, noninferiority p < 0.001), noninferiority was not established for the difference in target vessel revascularization (6.2% vs. 0%, noninferiority p = 0.21). Clinical symptoms improved significantly in both treatment groups in comparison with baseline, and the percentage of patients free from angina after 12 months was 81% versus 74% (p = 0.49). Conclusions In isolated proximal LAD disease, SES is noninferior to MIDCAB surgery at 12-month follow-up with respect to MACE at a similar relief in clinical symptoms. (MIDCAB Versus DES in Proximal LAD Lesions; NCT00299429 )
The Trifecta valve (St. Jude Medical, St. Paul, MN) is a stented bovine pericardial bioprosthesis for aortic valve replacement (AVR). Implantation experience and midterm follow-up of this valve have ...not yet been reported from a large single-center cohort.
We retrospectively analyzed data from 918 patients (73.2 ± 6.5 years; logistic European System for Cardiac Operative Risk Evaluation EuroSCORE, 13.2 ± 14.3) who underwent AVR. Analyses addressed implantation safety, short- and long-term survival, and hemodynamic valve performance.
Concomitant procedures were performed in 54.9% of the patients. Low cardiac output syndrome, postoperative bleeding requiring transfusion or reoperation, and acute renal failure requiring temporary hemodialysis occurred at rates of 4.3%, 7.0%, and 11.7%, respectively. At discharge, 44 patients (4.8%) were identified with moderate prosthesis-patient mismatch (PPM) and none was identified with severe PPM. Mean follow-up was 2.7 ± 1.6 years (maximum, 7.4 years). Survival at 30 days was 88.7% and 92.0% for all patients and patients with isolated AVR, respectively; 5-year overall survival for these groups was 73.4% and 82.2%, respectively. Myocardial infarction (odds ratio OR, 78; 95% confidence interval CI, 20.8-294) and inotropic medication (OR, 6.8; 95% CI, 3.2-14.5) were the strongest independent predictors for long-term mortality. Five-year freedom from structural valve deterioration (SVD) was 97.9% ± 1.5%. Left ventricular ejection fraction (LVEF) after implantation was similar to baseline and was stable over time (range, 58.9%-62.3%). The mean gradient improved substantially (39.3 mm Hg at baseline versus 9.4 mm Hg at 6 months).
This large single-center cohort shows the easy and safe implantation, adequate hemodynamic performance, and satisfactory durability of the Trifecta valve at midterm follow-up.
Objective To determine the influence of silent and symptomatic cerebral embolism on outcome of urgent/emergent surgery after acute infective endocarditis (AIE). Methods From a total of 1571 patients ...with AIE admitted to our institution between May 1995 and March 2012 about one-quarter (375 patients; mean age, 61.8 ± 13.6 years) presented with cerebral embolism confirmed by cranial computed tomography. Isolated aortic valve endocarditis was present in 165 patients (44%), 132 patients (36%) had isolated AIE of the mitral valve, and 64 (17%) patients had left-sided double valve endocarditis. Results Although the majority of patients presented with neurologic symptoms, 1 out of 3 patients experienced a so-called silent asymptomatic cerebral embolism or transient ischemic attack (n = 135). The rate of silent embolism was equivalent in patients with isolated aortic valve versus isolated mitral valve endocarditis (37% vs 34%; P = .54). Comparing patients with silent embolism versus symptomatic embolism, 18 patients with silent embolism versus 12 patients with symptomatic embolism developed postoperative hemiparesis ( P = .69). Three versus 4 had severe postoperative intracerebral bleeding ( P = .71). Median follow-up of survivors with cerebral embolism was 4.1 years (935 cumulative patient-years). Hospital mortality was 21.4% versus 19.6% ( P = .68), with a long-term survival of 45% ± 5% versus 47% ± 4% at 5 years ( P = .83) and 40% ± 6% versus 32% ± 5% at 10 years ( P = .86). Independent risk factors of mortality were age at surgery ( P < .01), chronic obstructive pulmonary disease ( P = .01), preoperative requirement of catecholamines ( P = .02), dialysis ( P < .01), and duration of cardiopulmonary bypass ( P < .01). Conclusions Survival after surgery for AIE is significantly impaired once cerebral embolism has occurred; however, it does not differ in patients with symptomatic versus silent cerebral embolism. Routine computed tomography scans are therefore mandatory due to the high incidence of asymptomatic cerebrovascular embolism—which appears to be equally as dangerous as symptomatic embolism.
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