Clinical Evaluation of the Eurosets Trilly Oxygenator During Cardiopulmonary Bypass in a Pediatric Population.

The equipment selected for cardiopulmonary bypass (CPB) in pediatric cardiac surgery critically influences the safety, efficiency, efficacy and pathophysiological impact in perioperative use and the post-operative outcome. In this report, we present a single-center retrospective analysis of the clinical efficacy, efficiency and safety of the Trilly oxygenator (Eurosets Srl, Medolla, MO, Italy), which has an integrated arterial filter. It has a blood flow capacity of 500 to 3500ml/min, an AAMI index of 4.000ml / min, and a static fill prime (oxygenating module + heat exchanger) of 130 ml. We used this device on 42 pediatric patients who underwent repair of various congenital heart defects with cardiopulmonary bypass. Pre- and intraoperative patient data were collected for the evaluation of gas transfer and metabolic parameters in relation to blood flow, temperature and hematologic profiles. The mean age of the patients was 8.07 ± 2.9 years. Eight patients had cyanotic heart disease, 7 had chromosomal abnormalities and 9 had previously undergone cardiac surgery. The STAT Mortality Category Score was distributed as follows: Cat. 1 (37.5%), Cat. 2 (35%), Cat. 3 (5%), Cat. 4 (22.5%), Cat. 5 (0%). The mean bodyweight was 29.03 ± 8.25 kg and the blood flow rate was 2664.88 ± 508.43 ml / min. The mean cardiopulmonary bypass time was 95±51.4 min and the cross-clamp time was 37±34.6 min. The mean gas transfer values were as follows: partial pressure of oxygen, post oxygenator, 224.7±28 mmHg; partial pressure of carbon dioxide, post oxygenator, 42±4 mmHg; oxygen delivery 356.9± 88.8 ml/min/m2; carbon dioxide transfer, 52.81± 1.98 mmHg, mixed venous saturation 77.78 %; and mean hematocrit value 29.0±4 %. The Trilly oxygenator was effective in terms of oxygen uptake, carbon dioxide removal, and heat exchange in a pediatric population undergoing cardiopulmonary bypass. This retrospective analysis showed that the Trilly is both safe and effective in clinical practice without iatrogenic problems.

Cardiac surgery in adults with high-surgical complexity CHD: results of a network collaborative programme.

BACKGROUND: Adults with CHD often exhibit complex cardiac abnormalities, whose management requires specific clinical and surgical expertise. To enable easier access of these patients to highly specialised care, we implemented a collaborative programme that incorporates medical and surgical specialists belonging to both paediatric and adult cardiovascular institutions. OBJECTIVES: The objective of this study was to review the experience gained and to analyse the surgical outcome of major cardiac surgery. METHODS: We retrospectively reviewed all consecutive patients admitted for major cardiac surgery using our network between January, 2010 and December, 2013. Analysis of surgical outcome was performed in patients selected for major cardiac surgery with cardiopulmonary bypass. Early and late outcomes were evaluated. RESULTS: Out of a total of 433 inward patients, 86 were selected for surgery. The median age was 25.5 years, -64 patients (74.4%) had previously undergone heart surgery, and -55 patients (64%) had been subjected to at least one sternotomy. Abnormalities of the left ventricular and right ventricular outflow tract were the most frequent (37.2% and 30.2%, respectively), and despite high-surgical complexity only one death occurred (in-hospital mortality 1.1%). On a median follow-up time of 4 years no deaths and no heart-failure events have occurred; one patient underwent further cardiac surgery programmed at the time of discharge. CONCLUSIONS: Low mortality and morbidity rates can be obtained in high-surgical complexity adults with CHD populations when paediatric and adult cardiac specialists operate in the same multidisciplinary environment.

Short-length ligamentum arteriosum as a cause of congenital narrowing of the left main stem bronchus.

An entity that has received little attention as cause or recurrent respiratory disorder is the narrowing of the left main stem bronchus. When not associated with congenital heart disorders, this condition has been ascribed to primary localized malacia of the bronchial cartilages or to the anterior displacement of the descending aorta in front to the adjacent vertebral bodies. Four girls were evaluated for recurrent/chronic respiratory symptoms. A pulsatile extrinsic compression on the posterior bronchial wall of the left main stem bronchus was detected, pressed between the descending aorta, posteriorly, and the left pulmonary artery, anteriorly. The two arteries were closely linked together by a short-length ligamentum that was resected, allowing the mobilization of the aorta with posterior aortopexy, stabilizing the space created between the pulmonary artery and the descending aorta. The reduced compression on the left main bronchus resulted in the enlargement of its caliber and in a marked improvement of the respiratory symptoms. Pediatr Pulmonol. 2016;51:1356-1361. © 2016 Wiley Periodicals, Inc.

Emergency percutaneous, bicaval double-lumen, ECMO cannulation in neonates and infants: insights from three consecutive cases.

BACKGROUND: Veno-venous extracorporeal membrane oxygenation (ECMO) is probably the preferable configuration to assist children with respiratory failure who do not respond to maximized conventional therapies. The single-vessel, double-lumen approach through the internal jugular vein is extremely advantageous, especially in infants, where femoral access presents limitations related to the small dimensions of the veins. In case of emergencies, ECMO might need to be started at the bedside, without the availability of fluoroscopic guidance. To our knowledge, a completely percutaneous approach has not been reported before in children younger than 1 year and weighing less than 5 kg. METHODS: We describe 3 cases of emergency bedside, percutaneous, bicaval double-lumen cannulation under real-time transthoracic ultrasound control in 2 neonates and 1 infant. RESULTS: In our experience, this approach proved to be safe, effective and time saving, while minimizing bleeding from the cannula insertion site. Cannulation times, from decision making to the beginning of ECMO flow, were 30, 28, 25 minutes respectively, from patient 1 to 3. We do not report any cannula-related injury to vessels and heart structures. CONCLUSIONS: Our preliminary data suggest that, with the described precautions, percutaneous, echo-guided, bicaval double-lumen cannulation in neonates and infants could be effective and free from major complications. Further evaluation should be warranted in the neonatal population.

Successful experience in bridging patients to heart transplantation with the MicroMed DeBakey ventricular assist device.

BACKGROUND: Pulsatile left ventricular assist devices are used with increasing frequency to bridge patients with end-stage heart failure to heart transplantation (HTx). Implantation of pulsatile devices is a cumbersome surgical procedure that is associated with major complications, such as bleeding, thromboembolism, and infection. Recently, a continuous axial flow left ventricular assist device (DeBakey ventricular assist device) has been introduced with the goal of reducing the incidence of major complications. METHODS: We reviewed our experience with 11 patients who received a DeBakey ventricular assist device axial flow pump for bridge to HTx from April 2000 through November 2001. RESULTS: Two patients (18.2%) died of multiple-organ failure while on left ventricular assist device support. Bleeding requiring thoracotomy occurred in 2 patients (18.2%). One patient had a minor neurologic event, and one patient developed left ventricular assist device thrombosis, which was successfully treated without pump exchange. Renal failure developed in 1 patient and hepatic dysfunction in 2 patients. There were no instances of right heart failure. No device, pocket, or drive-line infections occurred. Nine patients (9 of 11, 81.8%) had HTx within 51 +/- 49 days (range, 11 to 141 days) after left ventricular assist device implant. One patient died 29 days after HTx because of acute rejection. CONCLUSIONS: The continuous axial flow DeBakey ventricular assist device had reliable features, including a high rate of bridge to HTx. This device had low complication and system failure rates. We consider the DeBakey ventricular assist device a favorable alternative to pulsatile heart assist devices as a bridge to HTx.

Aortic complications after bicuspid aortic valve replacement: long-term results.

BACKGROUND: Bicuspid aortic valve (BAV) is a risk factor for aortic dissection and aneurysm. We studied patients with BAV and tricuspid aortic valve (TAV) to evaluate long-term changes in the ascending aorta after aortic valve replacement (AVR). PATIENTS AND METHODS: One hundred consecutive patients were allocated into two groups according to the presence of BAV (group A, 50 patients) or TAV (group B, 50 patients). Mean age was 51 +/- 12 years in group A, and 50 +/- years 12 in group B. No patients had hypertension or Marfan's syndrome. Until July 2001, mean follow-up was 234 +/- 47 months in group A and 241 +/- 43 months in group B. RESULTS: Five patients (10%, CL 5.7 to 13.9) in group A suffered late acute aortic dissection. Acute aortic dissection (5 vs 0, p = 0.0001) and sudden death (7 vs 0, p = 0.0001) occurred more frequently in patients with BAV. All survivors were assessed by echocardiogram. The mean diameter of the ascending aorta was 48.4 mm in group A and 36.8 mm in group B. Three patients in group A were operated on because of ascending aorta aneurysm more than 6 cm in diameter. CONCLUSIONS: As a result of our experience, we recommend a policy of prophylactic replacement of even a seemingly normal and definitely a mildly enlarged ascending aorta in cases of BAV at the moment of AVR, and consideration of a similar approach for any other cardiac surgical procedure in patients with BAV.

Surgical treatment of acute myocardial infarction.

BACKGROUND: The role of surgical revascularization in the treatment of acute myocardial infarction (AMI) has changed considerably over the last 30 years along with improvement in intraoperative management and techniques of myocardial protection. The aim of this work was to analyze the long-term results of our experience of emergency myocardial surgical revascularization for AMI. METHODS: Between January 1986 and October 2003, 237 patients (85.3% males; mean age 59.6 +/- 9.6 years) underwent emergency coronary artery bypass graft for severe AMI. At admission 82 patients (34.6%) were in cardiogenic shock, while 124 patients (52.3%) presented major preoperative complications (acute pulmonary edema, mechanical ventilation, intra-aortic counterpulsation, cardiac arrest). Preoperative intra-aortic counterpulsation was performed in 125 patients (52.7%). The mean time interval between symptom onset and surgery was 9.4 hours. Three-vessel disease was detected in 107 patients (45%), with main left stenosis in 12.9%. RESULTS: There were overall 50 hospital deaths (21.1%). Amongst patients with major preoperative complications, mortality was 36.2% (45 cases out of 124); mortality for cardiogenic shock was 40.2% (33 patients out of 82). Survival of the first 140 patients undergoing operation and then discharged was 97.8% at 1 year and 79.6% at 5 years. The survival rate of the first 60 patients in cardiogenic shock operated on and then discharged is 98.8% at 1 year and 81.2% at 5 years. The ejection fraction in 102 echocardiographically controlled patients was 37.2 +/- 8.5% preoperatively and 44.0 +/- 10.1% at pre-discharge (p = 0.0001). CONCLUSIONS: Surgical revascularization for AMI, especially if complicated by cardiogenic shock, is a valid therapeutic option that carries a high periprocedural risk but that is balanced by a satisfactory late survival. A more precise patient's risk assessment at admission, improvement of surgical and myocardial protection techniques, extensive use of intra-aortic counterpulsation, and new circulatory support when needed, can improve outcomes and late survival.

Pulmonary valve implantation with the new Shelhigh Injectable Stented Pulmonic Valve.

BACKGROUND: Pulmonary regurgitation (PR) occurs frequently after tetralogy of Fallot (TOF) repair, impairing long-term prognosis and necessitating reinterventions. Myocardial damage, invasiveness, and the risks of pulmonary valve replacement (PVR) therefore need to be minimized. The new Shelhigh Injectable Stented Pulmonic Valve (Shelhigh Inc, Union, NJ) allows implantation without cardiopulmonary bypass (CPB) under direct control. METHODS: Twelve symptomatic patients (age, 21.3 +/- 12.5; range, 5.8 to 53.5 years) with severe PR and progressive right ventricular (RV) dilatation with dysfunction received the Shelhigh valve in sizes 21 (n = 1), 25 (n = 4), 27 (n = 3), 29 (n = 2), and 31 mm (n = 2). RESULTS: Valve insertion was successful and hemodynamic performance excellent in all: peak systolic gradient, 14.5 +/- 4.6 (range, 10 to 20) mm Hg; mean gradient, 6.3 +/- 1.6 (range, 4 to 8) mm Hg. Four patients underwent concomitant procedures on CPB: one reduction plasty of a dilated main pulmonary artery, two tricuspid valve repairs, and one VSD closure. Early recovery was uneventful. There were no reoperations. During a mean follow-up of 5.4 +/- 4.3 months (range, 0.3 to 10.6 months) echocardiography showed good results, with low gradients and recovered RV function in all. All presented in New York Heart Association functional class 1 at the latest follow-up. CONCLUSIONS: The Shelhigh valve allows easy PVR without CPB up to large valve sizes, with less invasiveness compared with a conventional approach. Further follow-up is needed to assess its durability and long-term performance.

Bridge to transplantation with the MicroMed DeBakey ventricular assist device axial pump: a single centre report.

OBJECTIVE: Left ventricular assist devices (VADs) are an accepted therapy to bridge patients with end-stage heart failure to heart transplantation. The DeBakey VAD, a continuous axial flow pump weighing 93 g, has been introduced into clinical practice as a bridge to transplant. METHODS: Starting from April 2000,17 patients (12 males, five females, mean age 44.3 +/- 12.8 years; 11 dilated idiopathic cardiomyopathy, five ischaemic cardiomyopathy, one pulsatile device failure) with end-stage heart failure were implanted with a DeBakey VAD as a bridge to transplantation at our institution. Before implant, all patients suffered from severe heart failure (New York Heart Association functional class IV) despite optimal medical therapy and were put on the waiting list for heart transplantation. Mean cardiac index was 1.59 +/- 0.51 l/min/m2. RESULTS: Fourteen patients were successfully transplanted after 99 +/- 117 days of assistance (range 11-443 days). Two patients died during assistance of multiorgan failure, one patient is still on VAD. No patient needed additional right ventricular mechanical support. Left ventricular/left VAD thrombosis occurred in one patient who was successfully treated conservatively. No clinical elevation of plasma free haemoglobin was detected. Neither device, driveline, abdominal pocket infection nor device failure occurred. CONCLUSIONS: In our experience with the continuous axial flow DeBakey VAD, a high success rate was obtained associated with a low risk of complications. All the patients tolerated continuous blood flow for extended periods that makes this device a valuable alternative to pulsatile VADs as a bridge to transplantation.

Left ventricular assist devices as bridge to heart transplantation: The Niguarda Experience.

BACKGROUND: Congestive heart failure is the leading cause of death in Western countries. Heart transplantation currently is the only accepted therapy for patients with end-stage heart failure, but the supply of donor hearts is inadequate, and different mechanical circulatory support systems have been investigated as bridges to heart transplant. METHODS: Since April 1992, 53 patients (47 men, 6 women, aged 12 to 61 years) received left ventricle mechanical circulatory support as bridge to heart transplant. The two principal devices used were: the Novacor LVAS in 31 patients and the DeBakey VAD in 11 patients. RESULTS: All patients survived the operation. Mean duration of LVAD support was 2.8 +/- 5.6 months. Thirty-seven patients (71.1%) underwent heart transplantation. Twelve major bleeding episodes occurred in nine patients (16.9%). Globally, major and minor neurologic events occurred in 13 patients (24.5%). Ten patients (19.9%) assisted with the Novacor Wearable LVAS device were discharged at home while waiting for heart transplant (HTx). The mean follow-up of the 34 discharged transplanted patients was 45.3 +/- 37 months. Actuarial survival of transplanted patients while on LVAD was 91.0 +/- 4.9% and 83.4 +/- 8.5% at 1 and 5 years, respectively. No differences in post-transplant long-term survival and rejection and allograft vasculopathy occurred between patients transplanted with or without LVAD implanted. CONCLUSIONS: LVAD therapy proved to be effective in bridging patients with end-stage heart failure to HTx. While on LVAD support, patients assisted with implantable wearable devices could be discharged at home, ameliorating their quality of life. The excellent survival rate after HTx is concomitant with a low incidence of rejection and cardiac allograft vasculopathy.