Direct Access Valve Replacement (DAVR) — are we entering a new era in cardiac surgery?

Objective: This study validates the off-pump antegrade trans-ventricular route for ultrasound-guided direct access aortic valve replacement. Direct access aortic valve replacement using a transthoracic and valved stent-based approach offers numerous advantages over the remote access percutaneous approach and may one day provide an alternative treatment modality for aortic valve disease. Methods: Valved stents were implanted off-pump in 17 pigs (72.10 ± 8.4 kg) via the direct access transapical approach using a left-sided mini-thoracotomy and continuous ultrasonic and fluoroscopic guidance. Acute valved stent function was studied with intravascular and two-dimensional intracardiac ultrasound. The invasive valve gradient was assessed with pull-back pressure catheter. All valved stents were tested in vitro before insertion. Macroscopic analysis was performed at necropsy. Results: In 11 of the 17 pigs, valved stents were delivered to the target site over the native aortic valve leaflets without interference of coronary blood flow and with good acute valve function. Three valved stents were deployed supra-annularly, two of those occluded the right coronary orifice and one the left coronary orifice, leading to fatal outcomes. Three valved stents dislodged into the left ventricle, one because of size-mismatch and two because of failure to unfold correctly. In 11 properly sized and deployed valved stents, two showed a moderate and one a severe paravalvular leak. Conclusions: Seventeen pigs underwent direct access valve replacement of the aortic valve with deployment of a valved stent into the native aorta. Eleven valves observed for an average 5-h period showed satisfactory, postimplantation valve functio

Transmyocardial laser revascularisation in acutely ischaemic myocardium

Objective: Although recent experience suggests that transmyocardial laser revascularisation (TMLR) relieves angina, its mechanism of action remains undefined. We examined its functional effects and analysed its morphological features in an animal model of acute ischaemia. Methods: A total of 15 pigs were randomised to ligation of left marginal arteries (infarction group, n=5), to TMLR of the left lateral wall using a holmium:yttrium-aluminium garnet (Ho:YAG) laser (laser group, n=5), and to both (laser-infarction group, n=5). All the animals were sacrificed 1 month after the procedure. Haemodynamics and echocardiography with segmental wall motion score were carried out at both time intervals (scale 0-3: 0, normal; 1, hypokinesia; 2, akinesia; 3, dyskinesia). Histology of the involved area was analysed. Results: Laser group showed no change of the segmental wall motion score of the involved area 30 min after the laser channels were made (score: 0±0). Infarction and laser-infarction groups both showed a persistent and definitive increase of the segmental wall motion score (at 30 min: 1.6±0.3 and 2±0, respectively; at 1 month: 1.8±0.2 and 1.8±0.4, respectively). These increases were all statistically significant in comparison with baseline values (P<0.5), however comparison between infarction and laser-infarction groups showed no significant difference. On macroscopic examination of the endocardial surface, no channel was opened. On histology, there were signs of neovascularisation around the channels in the laser group, whereas in the laser-infarction group the channels were embedded in the infarction scar. Conclusions: In this acute pig model, TMLR did not provide improvement of contractility of the ischaemic myocardium. To the degree that the present study pertains to the clinical setting, the results suggest that mechanisms other than blood flow through the channels should be considered, such as a laser-induced triggering of neovascularisation or neural destructio

Double-crowned valved stents for off-pump mitral valve replacement

Objective: An animal model has been designed to assess the feasibility of off-pump mitral valve replacement using valved stents. Methods: Glutaraldehyde-preserved homograft was sutured inside a prosthetic tube (Dacron). Then, two self-expandable nitinol Z-stents were sutured on the external surface of the prosthesis in such a way to create two self-expanding crowns for fixation. In adult pigs and under general anesthesia, the left atrium was exposed through a left thoracotomy and atrio-ventricular roadmapping was performed with intravascular ultrasound (IVUS) and fluoroscopy. The double-crowned valved stents were loaded into a delivery sheath. The sheath was then introduced into the left atrium and the valved stents was deployed in mitral position in such a way that the part in between the two stents was at the level of the mitral annulus. Intracardiac Unltrasound (ICUS) was used to assess the valve function. Hemodynamic parameters were gathered as well. Animal survived for no more than 3h after the valve deployment and gross anatomy examination of the left heart was carried out. Results: The mean height of the valved stents was 29.4±0.2mm, with an internal diameter of 20.4±1.0mm, and an external diameter of 25.5±0.8mm. The procedure was successfully carried out in eight animals. In vivo evaluation showed a native mitral annulus diameter of 24.9±0.6mm, and a mean mitral valve area of 421.4±17.5mm2. ICUS showed a mild mitral regurgitation in three out of eight animals. Mean pressure gradient across the valved stents was 2.6±3.1mmHg. Mean pressure gradient across the left ventricular outflow tract (LVOT) was 6.6±5.2mmHg. The mean survival time was 97.5±56.3min (survival time range was 40-180min). One animal died due to the occlusion of the LVOT because of valved stents displacement. Postmortem evaluation confirmed correct positioning of the valved stent in the mitral position in seven out of eight animals. No atrial or ventricular lesions due to the valved stents were found. Conclusions: Off-pump implantation of a self-expandable valved stent in the mitral position is technically feasible. Further studies will assess if this procedure is also feasible in human

Self-expandable valved stent of large size: off-bypass implantation in pulmonary position

Objective: To evaluate the feasibility of the off-bypass implantation of a self-expandable valved stent of large size in pulmonary position. Materials and methods: A glutaraldehyde preserved valved bovine jugular xenograft with internal diameter=22 mm, mounted in two rings of nitinol ‘Z' stent, expandable from 7 to 24 mm of internal diameter, was acutely evaluated in 6 adult pigs, mean body weight 55.6 kg (range 47-67 kg). Through a stent-graft delivery system (24 French) the self expandable valved stent was implanted off-bypass in pulmonary valve position by trans-ventricular approach through median sternotomy. Results: The mean diameter of the main pulmonary artery measured was 21.7±1.6 mm. The mean length of the self expandable valved stent was 23.1±0.7 mm, the mean internal diameter 21.6±0.7 mm and the mean external diameter 26.3±0.7 mm. The mean peak pressure gradient recorded across the valve was 6.33±2.8 mmHg (range 4.5-9.6 mmHg) at Doppler echocardiography, and 4.5±3.1 mmHg (range 0-7 mmHg) at invasive measurement, with a pulmonary blood flow of 3.03±0.05 l/min. Intra-vascular ultrasound showed complete opening and closure of the valve (mean area reduction from 315.08±54.13 to 0 mm2). Conclusions: (a) Off-bypass implantation of self-expandable valved stent is feasible in pulmonary position; (b) off-bypass surgical approach allows for valved stent implantation of adult size with adequate hemodynamic functioning; and (c) intra-vascular ultrasound makes implantation and evaluation easy and reproducibl

Surgeons produce innovative ideas which are frequently lost in the labyrinth of patents

Thoracic and cardiovascular surgery are innovative specialties that regularly recruit the latest technological developments into their armoury of devices and equipment. The introduction of new technology is dependant on patents; an important but single component of intellectual property. Patents enable the attribution of rights to concepts, ideas and inventions and this facilitates ownership, subsequent licensing and overall management of innovation and its outcome. It is not just thoracic and cardiovascular surgery, but the healthcare world in general that experiences ongoing technological evolution; so to remain contemporary, it is important that those in positions of responsibility are familiar with the relevant processes. This requires basic medico-legal knowledge and may be entwined with significant financial responsibility. Penetrating clinical, academic and industrial environments, informed awareness of patents also contributes to important leadership skills, encouraging the incorporation of innovation into the professional milieu. We aim to present through this manuscript an overview of these issues in order to promote awareness of patents within thoracic and cardiovascular surgery using a descriptive and practical approach

Double-crowned valved stents for off-pump mitral valve replacement

OBJECTIVE: An animal model has been designed to assess the feasibility of off-pump mitral valve replacement using valved stents. METHODS: Glutaraldehyde-preserved homograft was sutured inside a prosthetic tube (Dacron). Then, two self-expandable nitinol Z-stents were sutured on the external surface of the prosthesis in such a way to create two self-expanding crowns for fixation. In adult pigs and under general anesthesia, the left atrium was exposed through a left thoracotomy and atrio-ventricular roadmapping was performed with intravascular ultrasound (IVUS) and fluoroscopy. The double-crowned valved stents were loaded into a delivery sheath. The sheath was then introduced into the left atrium and the valved stents was deployed in mitral position in such a way that the part in between the two stents was at the level of the mitral annulus. Intracardiac Unltrasound (ICUS) was used to assess the valve function. Hemodynamic parameters were gathered as well. Animal survived for no more than 3h after the valve deployment and gross anatomy examination of the left heart was carried out. RESULTS: The mean height of the valved stents was 29.4+/-0.2 mm, with an internal diameter of 20.4+/-1.0mm, and an external diameter of 25.5+/-0.8 mm. The procedure was successfully carried out in eight animals. In vivo evaluation showed a native mitral annulus diameter of 24.9+/-0.6 mm, and a mean mitral valve area of 421.4+/-17.5 mm2. ICUS showed a mild mitral regurgitation in three out of eight animals. Mean pressure gradient across the valved stents was 2.6+/-3.1 mmHg. Mean pressure gradient across the left ventricular outflow tract (LVOT) was 6.6+/-5.2 mmHg. The mean survival time was 97.5+/-56.3 min (survival time range was 40-180 min). One animal died due to the occlusion of the LVOT because of valved stents displacement. Postmortem evaluation confirmed correct positioning of the valved stent in the mitral position in seven out of eight animals. No atrial or ventricular lesions due to the valved stents were found. CONCLUSIONS: Off-pump implantation of a self-expandable valved stent in the mitral position is technically feasible. Further studies will assess if this procedure is also feasible in humans

Self-expandable valved stent of large size: off-bypass implantation in pulmonary position

OBJECTIVE: To evaluate the feasibility of the off-bypass implantation of a self-expandable valved stent of large size in pulmonary position. MATERIALS AND METHODS: A glutaraldehyde preserved valved bovine jugular xenograft with internal diameter = 22 mm, mounted in two rings of nitinol 'Z' stent, expandable from 7 to 24 mm of internal diameter, was acutely evaluated in 6 adult pigs, mean body weight 55.6 kg (range 47-67 kg). Through a stent-graft delivery system (24 French) the self expandable valved stent was implanted off-bypass in pulmonary valve position by trans-ventricular approach through median sternotomy. RESULTS: The mean diameter of the main pulmonary artery measured was 21.7 +/- 1.6 mm. The mean length of the self expandable valved stent was 23.1 +/- 0.7 mm, the mean internal diameter 21.6 +/- 0.7 mm and the mean external diameter 26.3 +/- 0.7 mm. The mean peak pressure gradient recorded across the valve was 6.33 +/- 2.8 mmHg (range 4.5-9.6 mmHg) at Doppler echocardiography, and 4.5 +/- 3.1 mmHg (range 0-7 mmHg) at invasive measurement, with a pulmonary blood flow of 3.03 +/- 0.05 l/min. Intra-vascular ultrasound showed complete opening and closure of the valve (mean area reduction from 315.08 +/- 54.13 to 0 mm2). CONCLUSIONS: (a) Off-bypass implantation of self-expandable valved stent is feasible in pulmonary position; (b) off-bypass surgical approach allows for valved stent implantation of adult size with adequate hemodynamic functioning; and (c) intra-vascular ultrasound makes implantation and evaluation easy and reproducible

Are there accurate predictors of long-term vital and functional outcomes in cardiac surgical patients requiring prolonged intensive care?

BACKGROUND AND OBJECTIVE: The decision to maintain intensive treatment in cardiac surgical patients with poor initial outcome is mostly based on individual experience. The risk scoring systems used in cardiac surgery have no prognostic value for individuals. This study aims to assess (a) factors possibly related to poor survival and functional outcomes in cardiac surgery patients requiring prolonged (&gt; or = 5 days) intensive care unit (ICU) treatment, (b) conditions in which treatment withdrawal might be justified, and (c) the patient's perception of the benefits and drawbacks of long intensive treatments. METHODS: The computerized data prospectively recorded for every patient in the intensive care unit over a 3-year period were reviewed and analyzed (n=1859). Survival and quality of life (QOL) outcomes were determined in all patients having required &gt; or =5 consecutive days of intensive treatment (n=194/10.4%). Long-term survivors were interviewed at yearly intervals in a standardized manner and quality of life was assessed using the dependency score of Karnofsky. No interventions or treatments were given, withhold, or withdrawn as part of this study. RESULTS: In-hospital, 1-, and 3-year cumulative survival rates reached 91.3%, 85.6%, and 75.1%, respectively. Quality of life assessed 1 year postoperatively by the score of Karnofsky was good in 119/165 patients, fair in 32 and poor in 14. Multivariate logistic regression analysis of 19 potential predictors of poor outcome identified dialysis as the sole factor significantly (p=0.027) - albeit moderately - reducing long-term survival, and sustained neurological deficit as an inconstant predictor of poor functional outcome (p=0.028). One year postoperatively 0.63% of patients still reminded of severe suffering in the intensive station and 20% of discomfort. Only 7.7% of patients would definitely refuse redo surgery. CONCLUSIONS: This study of cardiac surgical patients requiring &gt; or =5 days of intensive treatment did not identify factors unequivocally justifying early treatment limitation in individuals. It found that 1-year mortality and disability rates can be maintained at a low level in this subset of patients, and that severe suffering in the ICU is infrequent

Augmented venous return for minimally invasive open heart surgery with selective caval cannulation

OBJECTIVE: Minimally invasive open heart surgery involves limited intrathoracic cannulation sites necessitating cardiopulmonary bypass to be initiated via peripheral access using percutaneous cannulae with the tip placed into the right atrial cavity. However, surgery involving the opening of the right heart obliges the surgeon to maintain the end of the cannulae into the vena cavae. The impeded venous return due to the smaller diameter may be alleviated by inserting a centrifugal pump in the venous line. METHODS: Right anterior mini-thoracotomy and exposure of the femoral site were performed before the patient was heparinized. Cannulation of the femoral artery, the inferior vena cava via the femoral vein and the superior vena cava through the mini-thoracotomy was performed and cardiopulmonary bypass was initiated. Venous drainage was augmented with the centrifugal pump. Cardiac arrest was provoked and both vena cavae were snared before performing the intracardiac procedure. RESULTS: Twenty consecutive patients were operated on using this technique (15 males/five females; age: 44.8 +/- 14.3 years; bodyweight: 73.5 +/- 15.1 kg; body surface area: 1.8 +/- 0.2 m2; theoretical blood flow rate: 4.4 +/- 0.5 l/min). The cannula sizes were 21.9 +/- 2.2 Fr for the femoral artery, 26.5 +/- 1.7 Fr for the inferior vena cava and 23.8 +/- 2.5 Fr for the superior vena cava. Venous drainage through the single inferior vena cava cannula was 2.1 +/- 0.6 l/min (48.8 +/- 13.3% of the theoretical flow). Adding the superior vena cava cannula increased the venous flow to 3.1 +/- 0.4 l/min (70.7 +/- 9.6% of the theoretical value, P &lt; 0.005). The use of the centrifugal pump increased the flow to 4.1 +/- 0.6 l/min (93.4 +/- 8.9% of the theoretical flow, P &lt; 0.001) with a mean inlet negative pressure of -69 +/- 10.2 mmHg. The mean bypass time was 64.0 +/- 24.6 min for a mean operative time of 226.3 +/- 61.0 min. Minimum venous saturation was 69.4 +/- 8.5%. CONCLUSIONS: Despite the smaller diameter of the vena cavae compared to the right atrium, and a smaller internal diameter of percutaneous cardiopulmonary bypass cannulae compared to classic ones; the centrifugal pump improves the venous drainage significantly so that minimally invasive open heart procedures can be performed under optimal and safe perfusion conditions

Hemodynamics optimization during off-pump coronary artery bypass: the 'no compression' technique

OBJECTIVE: Heart manipulation during OPCAB may cause hemodynamical instability in particular for access to the posterior and lateral walls. The 'no compression' technique involves enucleation of the heart without any compression on the cavities, and stabilization of the target area with a suction device. The impact of this technique on hemodynamics is assessed. METHODS: In order to analyze a homogeneous group, 26 consecutive patients with triple grafts, one to each side of the heart in the same sequential order (posterior, lateral and anterior wall successively) were selected. Heart rate (HR), mean pulmonary arterial pressure (PAP, mmHg), pulmonary capillary wedge pressure (PCWP, mmHg), mean arterial pressure (MAP, mmHg), cardiac output index (COI, l/min per m(2)), and central venous saturation (SvO(2),%) were monitored. A coronary shunt was used for all the anastomoses. RESULTS: HR was stable with baseline value of 60+/-10 and the highest value for the anterior wall, 63.6+/-8 (P=0.23). PAP and PCWP exhibited their highest increase, when compared with baseline, for the lateral wall, 23.9+/-4.7 vs. 20.7+/-6.2 (P=0.06), and 17.2+/-4.7 vs. 14.9+/-5.6 (P=0.16), respectively. MAP, COI and SvO(2), exhibited their largest drop, when compared with baseline, for the lateral wall too, 73.1+/-9.1 vs. 77.1+/-7.5 (P=0.12), 1.99+/-0.47 vs. 2.26+/-0.55 (P=0.09), and 70.5+/-8.4 vs. 74.8+/-9.3 (P=0.12), respectively. CONCLUSIONS: None of the hemodynamical parameter differed significantly from baseline value for all three territories. While hemodynamics was perfectly maintained during the posterior and anterior walls revascularization, exposure of the lateral wall led to marginal changes only