Martin Czerny

Randomized comparison of strategies for type B aortic dissection: the INvestigation of STEnt Grafts in Aortic Dissection (INSTEAD) trial.

Background— Thoracic endovascular aortic repair (TEVAR) represents a novel concept for type B aortic dissection. Although life-saving in acute emergencies, outcomes and survival of TEVAR in stable dissection are unknown. Methods and Results— One hundred forty patients in stable clinical condition at least 2 weeks after index dissection were randomly subjected to elective stent-graft placement in addition to optimal medical therapy (n=72) or to optimal medical therapy alone (n=68) with surveillance (arterial pressure according to World Health Organization guidelines ≤120/80 mm Hg). The primary end point was all-cause death at 2 years, whereas aorta-related death, progression (with need for conversion or additional endovascular or open surgery), and aortic remodeling were secondary end points. There was no difference in all-cause deaths, with a 2-year cumulative survival rate of 95.6±2.5% with optimal medical therapy versus 88.9±3.7% with TEVAR (P=0.15); the trial, however, turned out to be underpowered. Moreover, the aorta-related death rate was not different (P=0.44), and the risk for the combined end point of aorta-related death (rupture) and progression (including conversion or additional endovascular or open surgery) was similar (P=0.65). Three neurological adverse events occurred in the TEVAR group (1 paraplegia, 1 stroke, and 1 transient paraparesis), versus 1 case of paraparesis with medical treatment. Finally, aortic remodeling (with true-lumen recovery and thoracic false-lumen thrombosis) occurred in 91.3% of patients with TEVAR versus 19.4% of those who received medical treatment (P<0.001), which suggests ongoing aortic remodeling. Conclusions— In the first randomized study on elective stent-graft placement in survivors of uncomplicated type B aortic dissection, TEVAR failed to improve 2-year survival and adverse event rates despite favorable aortic remodeling. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00525356.

Endovascular Repair of Type B Aortic Dissection Long-term Results of the Randomized Investigation of Stent Grafts in Aortic Dissection Trial

Background—Thoracic endovascular aortic repair (TEVAR) represents a therapeutic concept for type B aortic dissection. Long-term outcomes and morphology after TEVAR for uncomplicated dissection are unknown. Methods and Results—A total of 140 patients with stable type B aortic dissection previously randomized to optimal medical treatment and TEVAR (n=72) versus optimal medical treatment alone (n=68) were analyzed retrospectively for aorta-specific, all-cause outcomes, and disease progression using landmark statistical analysis of years 2 to 5 after index procedure. Cox regression was used to compare outcomes between groups; all analyses are based on intention to treat. The risk of all-cause mortality (11.1% versus 19.3%; P=0.13), aorta-specific mortality (6.9% versus 19.3%; P=0.04), and progression (27.0% versus 46.1%; P=0.04) after 5 years was lower with TEVAR than with optimal medical treatment alone. Landmark analysis suggested a benefit of TEVAR for all end points between 2 and 5 years; for example, for all-cause mortality (0% versus 16.9%; P=0.0003), aorta-specific mortality (0% versus 16.9%; P=0.0005), and for progression (4.1% versus 28.1%; P=0.004); Landmarking at 1 year and 1 month revealed consistent findings. Both improved survival and less progression of disease at 5 years after elective TEVAR were associated with stent graft induced false lumen thrombosis in 90.6% of cases (P<0.0001). Conclusions—In this study of survivors of type B aortic dissection, TEVAR in addition to optimal medical treatment is associated with improved 5-year aorta-specific survival and delayed disease progression. In stable type B dissection with suitable anatomy, preemptive TEVAR should be considered to improve late outcome. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT01415804.

Natural History of Very Severe Aortic Stenosis

Background— We sought to assess the outcome of asymptomatic patients with very severe aortic stenosis. Methods and Results— We prospectively followed 116 consecutive asymptomatic patients (57 women; age, 67±16 years) with very severe isolated aortic stenosis defined by a peak aortic jet velocity (AV-Vel) ≥5.0 m/s (average AV-Vel, 5.37±0.35 m/s; valve area, 0.63±0.12 cm2). During a median follow-up of 41 months (interquartile range, 26 to 63 months), 96 events occurred (indication for aortic valve replacement, 90; cardiac deaths, 6). Event-free survival was 64%, 36%, 25%, 12%, and 3% at 1, 2, 3, 4, and 6 years, respectively. AV-Vel but not aortic valve area was shown to independently affect event-free survival. Patients with an AV-Vel ≥5.5 m/s had an event-free survival of 44%, 25%, 11%, and 4% at 1, 2, 3, and 4 years, respectively, compared with 76%, 43%, 33%, and 17% for patients with an AV-Vel between 5.0 and 5.5 m/s (P<0.0001). Six cardiac deaths occurred in previously asymptomatic patients (sudden death, 1; congestive heart failure, 4; myocardial infarction, 1). Patients with an initial AV-Vel ≥5.5 m/s had a higher likelihood (52%) of severe symptom onset (New York Heart Association or Canadian Cardiovascular Society class >II) than those with an AV-Vel between 5.0 and 5.5 m/s (27%; P=0.03). Conclusions— Despite being asymptomatic, patients with very severe aortic stenosis have a poor prognosis with a high event rate and a risk of rapid functional deterioration. Early elective valve replacement surgery should therefore be considered in these patients.

Retrograde ascending aortic dissection during or after thoracic aortic stent graft placement: insight from the European registry on endovascular aortic repair complications

Background— Single-center reports have identified retrograde ascending aortic dissection (rAAD) as a potentially lethal complication of thoracic endovascular aortic repair (TEVAR). Methods and Results— Between 1995 and 2008, 28 centers participating in the European Registry on Endovascular Aortic Repair Complications reported a total of 63 rAAD cases (incidence, 1.33%; 95% CI, 0.75 to 2.40). Eighty-one percent of patients underwent TEVAR for acute (n=26, 54%) or chronic type B dissection (n=13, 27%). Stent grafts with proximal bare springs were used in majority of patients (83%). Only 7 (15%) patients had intraoperative rAAD, with the remaining occurring during the index hospitalization (n=10, 21%) and during follow-up (n=31, 64%). Presenting symptoms included acute chest pain (n=16, 33%), syncope (n=12, 25%), and sudden death (n=9, 19%) whereas one fourth of patients were asymptomatic (n=12, 25%). Most patients underwent emergency (n=25) or elective (n=5) surgical repair. Outcome was fatal in 20 of 48 patients (42%). Causes of rAAD included the stent graft itself (60%), manipulation of guide wires/sheaths (15%), and progression of underlying aortic disease (15%). Conclusions— The incidence of rAAD was low (1.33%) in the present analysis with high mortality (42%). Patients undergoing TEVAR for type B dissection appeared to be most prone for the occurrence of rAAD. This complication occurred not only during the index hospitalization but after discharge up to 1050 days after TEVAR. Importantly, the majority of rAAD cases were associated with the use of proximal bare spring stent grafts with direct evidence of stent graft–induced injury at surgery or necropsy in half of the patients.

Inflammatory response and myocardial injury following coronary artery bypass grafting with or without cardiopulmonary bypass.

OBJECTIVE In coronary artery bypass grafting (CABG) without cardiopulmonary bypass (CPB) the inflammatory response is suggested to be minimized. Coronary anastomoses are performed during temporary coronary occlusion. Inflammatory response and myocardial ischaemia need to be studied in a randomized study comparing CABG in multivessel disease with versus without CPB. METHODS Following randomization 30 consecutive patients received CABG either with (n=16) or without CPB (n=14). Primary study endpoints were parameters of the inflammatory response (interleukin (IL)-6, interleukin-10, ICAM-1, P-selectin) and of myocardial injury (myoglobin, creatine kinase-MB (CK-MB), troponin I) (intraoperatively, 4, 8, 16, 24 and 48 h after surgery). The secondary endpoint was clinical outcome. RESULTS The incidence of major (death: CABG with CPB n=1, not significant (n.s.)) and minor adverse events (wound infection: with CPB n=2, without CPB n=1, n.s. ; atrial fibrillation: with CPB n=3, without CPB n=2, n.s.) was comparable between both groups. The release of IL-6 was comparable during 8 h of observation (n.s.). Immediately postoperatively IL-10 levels were higher in the operated group with CPB (211.7+/-181.9 ng/ml) than in operated patients without CPB (104.6+/-40.3 ng/ml, P=0.0017). Thereafter no differences were found between both groups. A similar pattern of release was observed in serial measures of ICAM-1 and P-selectin, with no difference between both study groups (n.s.). Eight hours postoperatively the cumulative release of myoglobin was lower in operated patients without CPB (1829.7+/-1374. 5 microg/l) than in operated patients with CPB (4469.8+/-4525.7 microg/l, P=0.0152). Troponin I release was 300.7+/-470.5 microg/l (48 h postoperatively) in patients without CPB and 552.9+/-527.8 microg/l (P=0.0213). CK-MB mass release was 323.5+/-221.2 microg/l (24 h postoperatively) in operated patients without CPB and 1030. 4+/-1410.3 microg/l in operated patients with CPB (P=0.0003). CONCLUSIONS This prospective randomized study suggests that in low-risk patients the impact of surgical access on inflammatory response may mimic the influence of long cross-clamp and perfusion times on inflammatory response. Our findings indicate that multiregional warm ischaemia, caused by snaring of the diseased coronary artery, causes considerably less myocardial injury than global cold ischaemia induced by cardioplegic cardiac arrest.

Thoracic Endovascular Aortic Repair (TEVAR) for the treatment of aortic diseases: a position statement from the European Association for Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Interventions (EAPCI)

Thoracic endovascular aortic repair (TEVAR) is an emerging treatment modality, which has been rapidly embraced by clinicians treating thoracic aortic disease.1–4 Fundamentally, it is a far less invasive approach than open surgery and its availability and relative ease of application has changed and extended management options in thoracic aortic disease, including in those patients deemed unfit or unsuitable for open surgery. In the operating room, this requires considerable perceptual, cognitive and psychomotor demands on the operators. The dramatic expansion of TEVAR activity has necessarily prompted a requirement to systematically consider the indications, appropriateness, limitations and delivery of this treatment, which has been adopted by many specialties including cardiologists, cardiovascular surgeons, radiologists and vascular surgeons.5 Our task has been to generate a multidisciplinary position statement that supports and advises all clinicians utilizing this technological advance. This document focuses on the main diagnoses—thoracic aortic aneurysm (TAA), thoracic aortic dissection (TAD) of the descending aorta (type B according to the Stanford classification) and thoracic aortic injury (TAI)—indications and applicability of TEVAR and includes information regarding its limitations and complications. It acts as a position statement for both societies that reflects current understanding of thoracic aortic endovascular therapy. ### Evaluation of symptoms and patient status Symptoms in patients with TAA and chronic dissection are rare and non-specific.6,7 New onset of hoarseness or dysphagia may suggest a developing aneurysm in the distal aortic arch and proximal descending aorta. Most asymptomatic cases are discovered incidentally, while symptomatic patients have usually developed complications. Even in patients with acute aortic syndromes, chest pain, back pain and signs of malperfusion are often misinterpreted due to lack of awareness. In cases of clinical suspicion, a computed tomography (CT)-angiography is the diagnostic modality of first choice. ### Multidisciplinary consultation Patient selection should be performed on an individual basis according to anatomy, pathology, comorbidity and …

The vacuum-assisted closure system for the treatment of deep sternal wound infections after cardiac surgery.

BACKGROUND The VAC system (vacuum-assisted wound closure) is a noninvasive active therapy to promote healing in difficult wounds that fail to respond to established treatment modalities. The system is based on the application of negative pressure by controlled suction to the wound surface. The method was introduced into clinical practice in 1996. Since then, numerous studies proved the effectiveness of the VAC System on microcirculation and the promotion of granulation tissue proliferation. METHODS Eleven patients (5 men, 6 women) with a median age of 64.4 years (range 50 to 78 years) with sternal wound infection after cardiac surgery (coronary artery bypass grafting = 5, aortic valve replacement = 5, ascending aortic replacement = 1) were fitted with the VAC system by the time of initial surgical debridement. RESULTS Complete healing was achieved in all patients. The VAC system was removed after a mean of 9.3 days (range 4 to 15 days), when systemic signs of infection resolved and quantitative cultures were negative. In 6 patients (54.5%), the VAC system was used as a bridge to reconstructive surgery with a pectoralis muscle flap, and in the remaining 5 patients (45.5%), primary wound closure could be achieved. Intensive care unit stay ranged from 1 to 4 days (median 1 day). Duration of hospital stay varied from 13 to 45 days (median 30 days). In-hospital mortality was 0%, and 30-day survival was 100%. CONCLUSIONS The VAC system can be considered as an effective and safe adjunct to conventional and established treatment modalities for the therapy of sternal wound infections after cardiac surgery.

Complete revascularization in coronary artery bypass grafting with and without cardiopulmonary bypass.

BACKGROUND The feasibility of complete revascularization on the beating heart without cardiopulmonary bypass (CPB) as compared with the standard operation with CPB in elective low-risk patients with multivessel disease has not been clearly demonstrated in a prospective trial. METHODS Eighty selected low-risk patients were enrolled. In preoperative study with coronary angiography, the decision was made whether complete revascularization without CPB could be performed. Patients were randomly assigned to receive CABG either with (n = 40) or without CPB (n = 40). Randomization criteria were age, sex, and left ventricular ejection fraction. Completeness of revascularization as well as short- and mid-term clinical outcome in a 13.4 +/- 6.5 month follow-up period were monitored. RESULTS Twenty-six of 40 (65%) patients undergoing CABG without CPB underwent complete revascularization. In 5 of these patients (12.5%) suitable vessels were discarded for technical reasons and 9 patients (22.5%) were switched to CABG with CPB owing to the deeply intramyocardial course of target vessels (n = 5) or to hemodynamic instability (n = 4). In the group of patients operated on with CPB, 34 of 40 patients (85%) received complete revascularization. In 6 patients (15%) suitable vessels were discarded for technical reasons. Mean number of bypass grafts was 3.1 +/- 0.8 with CPB and 2.6 +/- 0.5 without CPB (p = 0.043). Clinical outcome and hospital stay were comparable in both groups. No patient died during the study period. No myocardial infarction was observed. Three patients undergoing CABG without CPB underwent successful PTCA 3 months after surgery. CONCLUSIONS CABG without the use of CPB is effective for complete revascularization in the majority of selected low-risk patients. Nevertheless, it has to be stated that the rate of incomplete revascularization in this early series of CABG without CPB is higher, and compromises the basic principle of complete revascularization.

Multimodality Imaging of Diseases of the Thoracic Aorta in Adults: From the American Society of Echocardiography and the European Association of Cardiovascular Imaging Endorsed by the Society of Cardiovascular Computed Tomography and Society for Cardiovascular Magnetic Resonance

Steven A. Goldstein, MD, Co-Chair, Arturo Evangelista, MD, FESC, Co-Chair, Suhny Abbara, MD, Andrew Arai, MD, Federico M. Asch, MD, FASE, Luigi P. Badano, MD, PhD, FESC, Michael A. Bolen, MD, Heidi M. Connolly, MD, Hug Cu ellar-Cal abria, MD, Martin Czerny, MD, Richard B. Devereux, MD, Raimund A. Erbel, MD, FASE, FESC, Rossella Fattori, MD, Eric M. Isselbacher, MD, Joseph M. Lindsay, MD, Marti McCulloch, MBA, RDCS, FASE, Hector I. Michelena, MD, FASE, Christoph A. Nienaber, MD, FESC, Jae K. Oh, MD, FASE, Mauro Pepi, MD, FESC, Allen J. Taylor, MD, Jonathan W. Weinsaft, MD, Jose Luis Zamorano, MD, FESC, FASE, Contributing Editors: Harry Dietz, MD, Kim Eagle, MD, John Elefteriades, MD, Guillaume Jondeau, MD, PhD, FESC, Herv e Rousseau, MD, PhD, and Marc Schepens, MD, Washington, District of Columbia; Barcelona and Madrid, Spain; Dallas and Houston, Texas; Bethesda and Baltimore, Maryland; Padua, Pesaro, and Milan, Italy; Cleveland, Ohio; Rochester, Minnesota; Zurich, Switzerland; New York, New York; Essen and Rostock, Germany; Boston, Massachusetts; Ann Arbor, Michigan; New Haven, Connecticut; Paris and Toulouse, France; and Brugge, Belgium

Evidence, lack of evidence, controversy, and debate in the provision and performance of the surgery of acute type A aortic dissection

Acute type A aortic dissection is a lethal condition requiring emergency surgery. It has diverse presentations, and the diagnosis can be missed or delayed. Once diagnosed, decisions with regard to initial management, transfer, appropriateness of surgery, timing of operation, and intervention for malperfusion complications are necessary. The goals of surgery are to save life by prevention of pericardial tamponade or intra-pericardial aortic rupture, to resect the primary entry tear, to correct or prevent any malperfusion and aortic valve regurgitation, and if possible to prevent late dissection-related complications in the proximal and downstream aorta. No randomized trials of treatment or techniques have ever been performed, and novel therapies-particularly with regard to extent of surgery-are being devised and implemented, but their role needs to be defined. Overall, except in highly specialized centers, surgical outcomes might be static, and there is abundant room for improvement. By highlighting difficulties and controversies in diagnosis, patient selection, and surgical therapy, our over-arching goal should be to enfranchise more patients for treatment and improve surgical outcomes.