A randomized controlled trial of levosimendan to reduce mortality in high-risk cardiac surgery patients (CHEETAH): Rationale and design.

OBJECTIVE: Patients undergoing cardiac surgery are at risk of perioperative low cardiac output syndrome due to postoperative myocardial dysfunction. Myocardial dysfunction in patients undergoing cardiac surgery is a potential indication for the use of levosimendan, a calcium sensitizer with 3 beneficial cardiovascular effects (inotropic, vasodilatory, and anti-inflammatory), which appears effective in improving clinically relevant outcomes. DESIGN: Double-blind, placebo-controlled, multicenter randomized trial. SETTING: Tertiary care hospitals. INTERVENTIONS: Cardiac surgery patients (n = 1,000) with postoperative myocardial dysfunction (defined as patients with intraaortic balloon pump and/or high-dose standard inotropic support) will be randomized to receive a continuous infusion of either levosimendan (0.05-0.2 µg/[kg min]) or placebo for 24-48 hours. MEASUREMENTS AND MAIN RESULTS: The primary end point will be 30-day mortality. Secondary end points will be mortality at 1 year, time on mechanical ventilation, acute kidney injury, decision to stop the study drug due to adverse events or to start open-label levosimendan, and length of intensive care unit and hospital stay. We will test the hypothesis that levosimendan reduces 30-day mortality in cardiac surgery patients with postoperative myocardial dysfunction. CONCLUSIONS: This trial is planned to determine whether levosimendan could improve survival in patients with postoperative low cardiac output syndrome. The results of this double-blind, placebo-controlled randomized trial may provide important insights into the management of low cardiac output in cardiac surgery.

Neurocognitive deficit and quality of life after mitral valve repair.

BACKGROUND AND AIM OF THE STUDY: Postoperative cognitive dysfunction (POCD) is a relevant complication after cardiac surgery that affects patient outcome. The study aims was to prospectively evaluate neurocognitive functions, quality of life (QoL) and psychological distress following minimally invasive mitral valve (MV) repair. METHODS: A total of 98 consecutive patients (64 males, 34 females; mean age 53.7 +/- 10.3 years; mean logistic EuroSCORE 3.23 +/- 2.90) who underwent MV repair through a Hearthport Port-Access system was enrolled in the study. Neurocognitive evaluations were performed using the Mini-Mental State Examination, Trail-Making Test (TMT-A and -B) and digit span shortly before surgery, at hospital discharge, and at three months postoperatively. Measures of QoL (Medical Outcomes, Study Short Form, SF-36) and psychological distress (Hospital Anxiety and Depression Scale, HADS) were also undertaken. RESULTS: The large degree of POCD referred to in other studies was not observed; rather, a clear sign of improvement was observed when considering TMT-B (p <0.001) and digit span forward (p < 0.05) tests at the three-month follow up. These results also agreed with the QoL and mood state indices, which showed improvements (p < 0.05) in all SF-36 and HADS scores. No significant relationship was found between neurocognitive impairment and the cross-clamp and cardiopulmonary bypass times. CONCLUSION: The study results highlighted the low risk of neurocognitive deficits after MV repair. A substantial improvement in the patients' neurocognitive assessment and QoL, from the preoperative condition to the three-month follow up after surgery, was observed. However, the small number of patients demonstrating a clear cognitive decline made it difficult to identify causative factors for POCD.

Clinical and hemodynamic outcomes after aortic valve replacement with stented and stentless pericardial xenografts: a propensity-matched analysis.

BACKGROUND AND AIM OF THE STUDY: Pericardial aortic xenografts have demonstrated excellent durability, and also freedom from tissue failure and from endocarditis. The aim of this single-center propensity-matched study was to compare the clinical and hemodynamic results of aortic valve replacement (AVR) with that for stented and stentless pericardial bioprostheses. METHODS: A total of 111 consecutive AVRs with the Perimount Magna stented valve, performed between December 2002 and December 2007, and 150 consecutive AVRs with the Pericarbon Freedom stentless bioprosthesis, performed between July 1999 and December 2007, was reviewed. Based on a propensity-score analysis, 81 matched pairs were created. The mean age of the 162 patients was 74 +/- 7 years. In total, 31 (38%) and 39 (48%) associated procedures were performed in the stented and stentless groups, respectively (p = 0.20). The mean follow up for stented-valve patients was 20 +/- 9 months (range: 6-35 months), and for stentless-valve patients was 36 +/- 21 months (range: 6-83 months) (p < 0.05). RESULTS: The operative mortality was 4.9% (n = 4) and 6.2% (n = 5) (p = 0.77) in the stented- and stentless-valve groups, respectively. The cumulative actuarial freedom from structural valve deterioration, non-structural dysfunction, reoperation, prosthetic valve endocarditis, hemorrhage and thromboembolic events after 24 months were 98.4 +/- 1.5% and 96.4 +/- 2.6% (p = 0.12) for the stented- and stentless-valve groups, respectively; the actuarial survival rates after 24 months were 82.6 +/- 5.2% and 83.8 +/- 4.3% (p = 0.82), respectively, while freedom from valve-related death was 98.4 +/- 1.5% and 97.2 +/- 1.9% (p = 0.56), respectively. No statistically significant differences were identified between the peak and mean transaortic gradients. CONCLUSION: Both, the stented and stentless pericardial aortic xenografts provided good clinical and hemodynamic results. However, the study results failed to demonstrate any difference regarding early outcomes between the two groups.

Endovascular treatment of aberrant right subclavian (lusorian) artery to oesophagus fistula: a case report.

The creation of a fistula between the subclavian artery and the oesophagus is extremely rare. All the reported cases of subclavian oesophagus-arterial fistulae have been described either in aberrant subclavian arteries or as caused by foreign bodies in the oesophagus. In this article, a case of fistulous communication between an aberrant right subclavian and the oesophagus managed with the positioning of endovascular prosthesis is presented.

Long-term results of aortic valve replacement with Edwards Prima Plus stentless bioprosthesis: eleven years' follow up.

BACKGROUND AND AIM OF THE STUDY: The Edwards Lifesciences Prima Plus stentless valve (ELSV) is a bioprosthesis manufactured from a porcine aortic root. The study aim was to evaluate late clinical outcomes after aortic valve replacement (AVR) with ELSV implanted as a miniroot in patients with aortic valve disease. METHODS: Between 1993 and 2004, 318 patients (232 males, 86 females; mean age 69 +/- 9 years; range: 37-83 years) underwent AVR with the ELSV. Preoperatively, 102 patients (32%), 162 (51%) and 54 (17%) were in NYHA classes I/II, III and IV, respectively. Aortic stenosis, aortic regurgitation and combined lesions were present in 124 patients (39%), 114 (36%) and 41 (13%), respectively. Twenty patients (6%) were referred for an acute aortic dissection, 20 (6%) for an aortic root aneurysm, and 139 (44%) had an associated aneurysmal dilatation of the ascending aorta. The ascending aorta was replaced in 159 patients (50%); aortic arch replacement was required in 10 (3%). Coronary artery bypass graft was performed in 86 patients (27%). The follow up was based on clinical data. RESULTS: Operative mortality was 5% (n = 17). There were 49 late deaths (5.2%/pt-yr). Valve-related mortality occurred in 10 patients (1%/pt-yr). Actuarial survival at five and 10 years was 78% and 33%, respectively. Actuarial freedom from valve reoperation and structural valve deterioration at 10 years were 100% and 64%. Actuarial freedom from embolic events and endocarditis at 10 years were 84% and 81%, respectively. CONCLUSION: The ELSV, when implanted as a miniroot, provided good early and long-term results in terms of survival and freedom from major complications.

Can the left subclavian artery revascularization during aortic arch surgery be managed using the in situ left internal mammary artery?

The management of the left subclavian artery (LSA) revascularization during aortic arch surgery is controversial and often challenging, especially during an emergency life-saving procedure. We report on a case of a 64-year old man, admitted to our institution with a Type A acute aortic dissection who underwent a frozen elephant trunk procedure with debranching of the supra-aortic vessels completed with an LSA revascularization using the in situ left internal mammary artery.

Redo After Failure of Aortic Homografts With a Rapid Deployment Valve.

Homograft implantation in the aortic position was a common approach for full root aortic surgical procedures in the early 2000s. Reintervention after degeneration of such homografts remains a challenge. We report two cases of successful implantation of the Edwards Intuity Elite rapid deployment valve into patients with degeneration of existing aortic homograft implants leading to severe aortic regurgitation.

Hemodynamic effects of inhaled nitric oxide and phosphodiesterase inhibitor (dipyridamole) on secondary pulmonary hypertension following heart valve surgery in adults.

BACKGROUND: Inhaled nitric oxide (iNO) is proposed in the management of pulmonary hypertension (PH) in patients undergoing cardiac surgery. Secondary PH related to a long-standing heart valve disease however may be refractory to iNO. Aim of this prospective study was to determine whether the combination of iNO plus dipyridamole (DP), a cyclic guanosine monophosphate-specific phosphodiesterase inhibitor (PDE5), may enhance and/or prolong the response to iNO in adult patients with secondary valve-related PH undergoing cardiac surgery, and attenuate rebound events related to its discontinuation. METHODS: Responses in 27 patients, 11 male, mean age 72+/-11 years, with PH due to mitral and/or aortic valve disease, were studied in the Intensive Care Unit after cardiac surgery, during sedation and stable hemodynamic conditions. The effect of isolated iNO administration (40 ppm), iNO combined with DP (0.2 mg/kg i.v.), and DP alone (1 mg/kg/24 h) on pulmonary vascular resistance, mean pulmonary artery pressure, cardiac index, mixed venous O2Sat%, and mean arterial pressure were determined. RESULTS: All patients showed at least a 10% decrease in pulmonary vascular resistance vs. baseline after administration of iNO [responders]. Inhaled NO and the combination of iNO/DP produced a reduction of pulmonary vascular resistance and mean pulmonary artery pressure (p<0.05). Cardiac index improved with a significant difference between iNO and the association iNO/DP versus baseline (p<0.05). This significant hemodynamic improvement versus baseline was maintained during isolated DP administration (p<0.05), but not during isolated iNO discontinuation. Mixed venous oxygen saturation showed an overall improvement of 17% (p<0.05). CONCLUSIONS: Inhaled NO and DP infusion might represent a valuable association in the management of PH secondary to a heart valve disease in patients undergoing cardiac surgery. Their beneficial hemodynamic effects might be particularly valuable in the management of patients with associated right ventricular dysfunction.

Survival after stentless and stented xenograft aortic valve replacement: a concurrent, controlled trial.

BACKGROUND: To define the impact of stentless versus stented valve design on survival late after xenograft aortic valve replacement, a retrospective analysis of all consecutive patients operated on between January 1992 and April 2000 was undertaken. METHODS: Two hundred ninety-two patients had stented (group 1) and 376 stentless (group 2) xenograft aortic valve replacements. Age was older in group 1 (75 +/- 4 vs 70 +/- 7 years, p = 0.01), whereas male gender and aortic stenosis were equally prevalent. Advanced New York Heart Association class III-IV (85% vs 78%, p = 0.03) and associated procedures (53% vs 41%, p = 0.01) were more common in group 1. Aortic cross-clamp (80 +/- 28 vs 96 +/- 23 minutes, p = 0.01) and bypass (91 +/- 56 vs 129 +/- 34 minutes, p = 0.01) times were shorter in group 1. Logistic regression and Cox proportional hazard methods were used to define the role of demographic and operative variables on hospital and late survival, freedom from valve-related mortality, and reintervention. RESULTS: Early mortality was higher in group 1 (6.2% vs 2.6%, p = 0.02). Smaller aortic anulus (p = 0.008), aortic cross-clamp (p = 0.03), and coronary disease requiring bypass (p = 0.03) were associated with hospital mortality. During follow-up (37 +/- 30 vs 43 +/- 35 months, p = NS), 66 late deaths were recorded (12% vs 9%, p = NS). At 8 years, survival (70 +/- 5% vs 81 +/- 3%, p = 0.01), freedom from cardiac- (85 +/- 1% vs 92 +/- 3%, p = 0.02), and valve-related death (79 +/- 5% vs 95 +/- 2%, p = 0.004) were higher in group 2. Freedom from structural deterioration was similar (92 +/- 5% vs 93 +/- 3%, p = NS), but freedom from reoperation was lower in group 2 (99 +/- 1% vs 90 +/- 4%, p = 0.009). Multivariate analysis showed female gender (p = 0.02), age (p = 0.03), and smaller valve size (p = 0.05) to be associated with late mortality; age (p = 0.06) and diagnosis of aortic stenosis (p = 0.008) with cardiac mortality; longer intensive care unit stay (p = 0.001) and stented xenografts (p = 0.05) with valve-related mortality; and younger age (p = 0.01) and stentless xenograft (p = 0.05) with reoperation. CONCLUSIONS: Use of stentless xenografts correlates with better survival and freedom from cardiac- and valve-related mortality than stented valves. However, bias favoring stented valves in older and sicker patients exists. Selective survival advantage of stentless xenograft is confined to valve-related mortality. Stentless valves are more likely to be replaced for dysfunction.

Survival after stentless and stented xenograft aortic valve replacement: a concurrent, case-match trial.

BACKGROUND: In order to compare the long-term outcome of stented vs stentless aortic xenografts, a non-randomized, concurrent case-match trial was conducted on all consecutive patients operated between January 1992 and April 2000. METHODS: Two hundred and ninety-two patients had stented (group 1) and 376 stentless (group 2) xenograft aortic valve replacement (AVR). Group 1 patients were older (75.0 +/- 4.1 vs 70.4 +/- 6.7 years, p = 0.01), while male gender and aortic stenosis were equally prevalent. NYHA functional class III-IV (85 vs 78%, p = 0.03) and associated procedures (53 vs 41%, p = 0.01) were more common in group 1. The aortic cross-clamping (79.7 +/- 27.8 vs 96.1 +/- 23.3, p = 0.001) and bypass (91.4 +/- 57.5 vs 128.5 +/- 34.0, p = 0.002) times were shorter in group 1. A case-match analysis identified 113 identical patient pairs, on the basis of age, gender, diagnosis, NYHA class, associated cardiac disease, and valve size. RESULTS: The early mortality was higher in group 1 (5.3 vs 2.7%, p = 0.3), though not significantly. During follow-up (37 +/- 30 vs 43 +/- 35 months, p = 0.6), 26 late deaths were recorded (10.3 vs 13.6%, p = 0.4). The 8-year survival was comparable (76 +/- 7 vs 75 +/- 5%, p = 0.2), but freedom from cardiac (77 +/- 7 vs 90 +/- 4%, p = 0.02) and from valve-related death (78 +/- 7 vs 91 +/- 4%, p = 0.02) was higher in group 2. Freedom from structural deterioration (99 +/- 1 vs 98 +/- 2%, p = 0.7) and from reoperation (99 +/- 1 vs 95 +/- 3%, p = 0.2) at 8 years was similar. The late functional status was equally satisfactory (NYHA class I-II 92.7 vs 94.7%, p = 0.06). CONCLUSIONS: The survival free from cardiac and valve-related mortality when stentless xenografts for AVR are used is superior to that achieved with stented grafts. Stentless AVR has the potential of conferring selective survival advantages late after operation.

Suitability of stentless bioprostheses for combined replacement of the aortic valve and ascending aorta.

BACKGROUND: The Edwards Prima stentless valve (EPSV) is a bioprosthesis made of the porcine aortic root which, owing to its versatility, may be implanted with different techniques depending on the underlying disease. The aim of this study was to demonstrate the usefulness of the EPSV implanted as a miniroot in patients with disease of the aortic valve and ascending aorta. METHODS: Between January 1998 and July 2002, 91 patients (mean age 67 +/- 7 years) underwent combined replacement of the aortic valve and ascending aorta with an EPSV for aortic stenosis (n = 12), incompetence (n = 45) or mixed disease (n = 26); all had aneurysmal dilation of the ascending aorta and 8 had an acute aortic dissection. The EPSV was implanted using the miniroot (or inclusion) technique and by extending the aorta with a tubular graft; aortic arch replacement was required in 5 patients. Hospital survivors underwent clinical and echocardiographic follow-up at 6 and 12 months and yearly thereafter. RESULTS: The hospital mortality was 11% (10 patients). Causes of death included stroke (n = 3), septic shock (n = 3), myocardial infarction (n = 2), and low output syndrome (n = 2). The mean follow-up of the 81 discharged patients was 16 +/- 13 months and was 100% complete; there were 6 late deaths due to non-cardiac causes. All patients presented with clinical improvement (95% are in NYHA functional class I) with low transvalvular gradients and significant regression of left ventricular hypertrophy at two-dimensional echocardiography. CONCLUSIONS: The EPSV used as a miniroot has proved to be a valid option in patients requiring simultaneous replacement of the aortic valve and ascending aorta. Due to the limited information available on the long-term fate of the porcine aortic valve and root, the use of this device as a miniroot should presently be limited to elderly patients.

Amplatzer septal occluder migration into the pulmonary trunk: surgical removal through a totally thoracoscopic approach.

The Amplatzer Septal Occluder for transcatheter closure of interatrial communications is a standard procedure and a widely accepted alternative to surgery in most patients with atrial septal defect (ASD). Device dislocation or embolization has been reported as one of the commonest complications of ASD percutaneous closure. In this case, if a transcatheter removal is not possible, it requires a surgical therapy, usually through a median sternotomy. We report on a case of a 30-year-old woman, who underwent percutaneous closure of an ostium secundum ASD. After a late embolization of the Amplatzer Septal Occluder into the pulmonary trunk 10 months later, the implant was successfully obtained via a surgical removal through a video-guided minimally invasive port-access approach. This case shows that, in experienced hands, the port-access technique for surgical procedures on the pulmonary trunk is feasible, and therefore, it might be a good alternative option to the traditional surgery, mainly in young patients.

RIFLE criteria for cardiac surgery-associated acute kidney injury: risk factors and outcomes.

The aims of this study were to identify risk factors and evaluate the association with clinical outcomes of postoperative cardiac surgery-associated acute kidney injury (CSA-AKI). Data from 2488 consecutive adult patients were analyzed. Patients were classified as having CSA-AKI based on the risk, injury, failure, loss of kidney function, and end-stage kidney disease (RIFLE) criteria using peak postoperative creatinine in the postoperative intensive care unit (ICU). Multiple stepwise logistic regression analysis was used to identify independent risk factors for CSA-AKI. CSA-AKI occurred in 584 patients (23.5%). CSA-AKI patients had significantly longer aortic cross-clamp and cardiopulmonary bypass times. Furthermore, CSA-AKI patients had higher hospital mortality (5.5% vs 1.5%, P<.001) and significantly longer ICU and hospital stays. Independent risk factors for CSA-AKI were age, peripheral vascular disease, hypertension, left ventricular ejection fraction, cardiopulmonary bypass time, and surgery on the thoracic aorta. In conclusion, patients who develop CSA-AKI have a higher preoperative risk profile, more complex surgery, and worse clinical outcomes.

Aortic valve replacement with the Sorin Pericarbon Freedom stentless prosthesis: 7 years' experience in 130 patients.

OBJECTIVES: Aortic stentless pericardial valves were introduced into clinical practice to combine properties of both stentless and pericardial prostheses. The aim of this single-center retrospective study was to assess midterm clinical and hemodynamic results of aortic valve replacement with the Sorin Pericarbon Freedom stentless bioprosthesis. METHODS: From July 1999 through November 2005, 130 consecutive patients (73 [56.1%] male patients) underwent aortic valve replacement with the Sorin Pericarbon Freedom bioprosthesis at our institution. Mean age was 76 +/- 5 years (range, 42-86 years), and associated procedures were performed in 50 (38.4%) patients; of these, 41 were coronary artery bypass grafts. Surgical intervention under urgent/emergency conditions and reoperations were performed in 18 (13.8%) and 7 (5.3%) patients, respectively. Mean crossclamp and cardiopulmonary bypass times were 82 +/- 24 and 125 +/- 40 minutes, respectively. All patients underwent clinical and echocardiographic follow-up (100% complete), and the total cumulative follow-up was 324 patient/years (mean, 2.5 +/- 1.8; range, 6 months-7 years). RESULTS: Overall hospital mortality was 8.4%. Overall patient survival was 63% +/- 6% and 50% +/- 10% at 5 and 7 years, respectively. Late deaths occurred in 23 patients, and 6 of them were valve related (1.8% patient/years). Freedom from valve-related death and reoperation was 91% +/- 4% and 94% +/- 4%, respectively, at 7 years. No structural valve deterioration was observed. Endocarditis, thromboembolism, and hemorrhagic complications occurred in 2 (0.6% patient/years), 1 (0.3% patient/years), and 1 (0.3% patient/years) patients, respectively. Mean transprosthetic gradients for valve sizes 23, 25, and 27 were 12.1 +/- 3.8, 10.8 +/- 3.8, and 9 +/- 3.1 mm Hg, respectively. CONCLUSIONS: The Sorin Pericarbon Freedom stentless bioprosthesis provides good early and midterm results in terms of hemodynamic performance, survival, and freedom from valve-related complications.

Repair of ascending aorta pseudoaneurysm without circulatory arrest in redo patient.

A pseudoaneurysm of the ascending aorta is an unusual and potentially fatal complication after aortic surgical operations. TEE and CT scan are the investigations of choice. Surgical treatment is mandatory. We describe the successful management of a pseudoaneurysm of the ascending aorta, with aorto-sternal-cutaneous fistula requiring right axillary and femoral artery cannulation with Remote Access Perfusion(R) aortic cannula (Estech(R), California, USA). Behaving like this we avoid hypotermic circulatory arrest, provide safe reentry and prevent an impending rupture.