Fabio De Robertis

Early outcomes of bilateral sequential single lung transplantation after ex-vivo lung evaluation and reconditioning

BACKGROUND Ex vivo lung perfusion (EVLP) is a novel approach for extended evaluation and/or reconditioning of donor lungs not meeting standard International Society for Heart and Lung Transplantation criteria for transplantation. METHODS We retrospectively evaluated 13 consecutive EVLP runs between January 2009 and December 2010. Lungs rejected for routine transplantation were implanted to the EVLP circuit and reperfused using acellular supplemented Steen Solution (Vitrolife, Göteborg, Sweden) up to a target flow rate of 40% of the donors calculated flow at a cardiac index of 3.0 liters/min/m(2); target left atrial pressure < 5 mm Hg; and pulmonary artery pressure < 15 mm Hg. Mechanical ventilation was introduced after rewarming to 32°C: tidal volume, 6 to 8 ml/kg; respiratory rate, 7 to 8 breaths/min; duration of inspiration/expiration (I/E) ratio, 1:2; and positive end-expiratory pressure, 5 to 10 cm H(2)O. Hemodynamic and respiratory data monitoring with hourly clinical assessment were performed. Donor data, conversion rate to transplantation, and recipient outcome were analyzed. RESULTS Donor data (n = 13) were: age, 44.23 ± 8.33 years; female/male, 8:5; cause of death: intracranial hemorrhage, 11 (85%), stroke, 1 (7.5%), hypoxic brain injury, 1 (7.5%); smoking history, 9 (69%), 17.44 ± 8.92 pack-years; mechanical ventilation, 102.6 ± 91.92 hours; chest x-ray imaging: abnormal, 12 (92.5%); normal, 1 (7.5%). EVLP: mean 141 ± 28.83 minutes. Arterial partial pressure of oxygen/fraction of inspired oxygen 100% before termination of the circuit vs pre-retrieval value: 57.32 ± 9.1 vs 42.36 ± 14.13 kPa (p < 0.05). Six (46%) pairs of donor lungs were transplanted. Median follow-up was 297.5 days (range, 100-390 days), with 100% survival at 3 months. CONCLUSIONS EVLP may facilitate assessment and/or reconditioning of borderline lungs, with a conversion rate of 46 % and good short-term survival.

The left axillary artery — a new approach for transcatheter aortic valve implantation

OBJECTIVE Transcatheter aortic valve implantation (TAVI) is an alternative treatment for aortic stenosis in selected cases, but requires appropriate vascular access. We report our initial clinical experience with a novel endovascular approach for TAVI. METHODS Between 1 April 2007 and 31 August 2008, 48 patients underwent TAVI at our institution. Of these, eight patients (17%) were deemed to be best served through direct surgical exposure of the left axillary artery rather than a trans-femoral or TA approach. RESULTS Procedural success was achieved in seven of eight cases. In one patient the axillary artery was too small to accept the 18 French sheath. In the remaining seven, the device was implanted without major complication and with only trivial paravalvular aortic regurgitation. The in-hospital mortality was 0%. The 30-day mortality was 12.5% (one patient). There was one localised dissection at the origin of the vertebral artery. There was one late pericardial effusion and a permanent pacemaker was implanted in five patients. CONCLUSIONS TAVI can be performed through a left axillary artery approach. This is a technically simple procedure and, in this small initial clinical experience, was performed with encouraging results. It is a realistic option in patients in whom neither the trans-femoral or trans-apical approaches are optimal.

The influence of bilateral internal mammary arteries on short- and long-term outcomes: A propensity score matching in accordance with current recommendations

OBJECTIVES We undertook a single-center, 12 years outcomes analysis of the influence of bilateral internal mammary arteries (BIMA) over single internal mammary artery (SIMA) on short-term outcomes and long-term outcomes by means of propensity score matching technique in accordance to current recommendations. METHODS A propensity score was generated for each patient from a multivariable logistic regression model based on 20 pretreatment covariates. The study population consisted of 4195 patients undergoing coronary artery bypass graft procedure using SIMA (n = 3445; 78.3%) or BIMA (n = 750; 21.7%). A total of 750 matching sets were derived. RESULTS The BIMA group was associated with an increased rate of superficial sternal wound infection (5.6% vs 1.7%; P = .0001) but the incidence of deep sternal wound infection was comparable between the 2 groups, at 2.1% and 1.5% in BIMA and SIMA groups, respectively (P = .43). With regard to other postoperative complications the 2 groups were comparable. Operative mortality rate did not significantly differ between the 2 groups, at 0.7% and 1.2% in the BIMA and SIMA groups, respectively (P = .28). After a mean follow-up time of 4.8 ± 3.2 years, BIMA use was associated with a significantly lower risk for late mortality (hazard ratio, 0.61; 95% confidence interval 0.38-0.97; P = .03) and need for repeat revascularization (hazard ratio, 0.75; 95% confidence interval, 0.53-0.96; P = .03). CONCLUSIONS When compared with SIMA grafting, BIMA use did not increase operative morbidity and mortality and was associated with a better long-term survival.

De Novo Aortic Regurgitation After Continuous-Flow Left Ventricular Assist Device Implantation

BACKGROUND Significant aortic regurgitation (AR) after continuous-flow left ventricular assist device (cf-LVAD) placement affects device performance and patient outcomes. This study examined the development of AR and long-term results after implantation of cf-LVADs. METHODS The study included all patients with no or less than mild AR who underwent HeartMate II (58 [62%]; Thoratec Corp, Pleasanton, CA) or HeartWare (35 [38%]; HeartWare International, Framingham, MA) implantation at our institute from July 2006 to July 2012. Serial echocardiograms were obtained preoperatively, at 1, 3 and 6 months postoperatively, and then at a minimum of 4-month intervals in patients with longer-term support. Kaplan-Meier estimates for freedom from moderate or greater AR were generated. Logistic regression analysis was used to define independent predictors of AR after cf-LVAD implantation. RESULTS Median duration of LVAD support was 527 days (25(th), 75(th): 289, 907; range, 60 to 2,433 days). Mild AR developed in 48 patients (51.6%) over a median duration of 126 days, with progression to moderate AR in 13 (14%) over 493 days and to severe AR in 2 (2.1%) over 1,231 days. The incidence of mild or greater AR was 43.1% in HeartMate II vs 65.7% in HeartWare recipients (p = 0.035). Overall freedom from moderate or greater AR was 94.7% ± 2.6% at 1 year, 86.9% ± 4.5% at 2 years, 82.8% ± 5.9% at 3 years, and 31% ± 16.9% at 4 years. Independent predictors of AR were duration of support (odds ratio, 1.002; 95% confidence interval, 1.000 to 1.004; p = 0.017) and a persistently closed aortic valve (odds ratio, 0.193; 95% confidence interval, 0.097 to 0.382; p < 0.001). CONCLUSIONS AR is associated with longer cf-LVAD support duration and persistent aortic valve closure. Incidence of moderate or greater AR after cf-LVAD implantation increases significantly after 3 years. The clinical implications of these data may warrant consideration of prophylactic aortic valve replacement at the time of cf-LVAD implantation, particularly with expected longer duration of support and in patients with preexisting AR that is more than mild.

Does grafting of the left anterior descending artery with the in situ right internal thoracic artery have an impact on late outcomes in the context of bilateral internal thoracic artery usage

BACKGROUND Despite their well-established advantages, bilateral internal thoracic arteries (BITA) are still largely underused. This is partly because of the technical complexities associated with the use of the right internal thoracic artery (RITA) to guarantee the universally accepted gold standard left internal thoracic artery (LITA) to left anterior descending artery (LAD) graft. The use of the in situ RITA for LAD grafting is a less technically demanding strategy. The impact of this strategy on early and late outcomes is investigated in the context of BITA usage. METHODS Among 1667 patients undergoing first-time isolated coronary artery bypass grafting using BITA, in situ RITA for LAD grafting was used in 546 patients compared with in situ LITA to LAD in 1121 patients. Propensity score matching was carried out to investigate the impact of in situ RITA to LAD on early and late outcomes including mortality and need for repeat revascularization. RESULTS A total of 546 propensity matched pairs were available for comparison. In the propensity matched cohort, the mean follow-up time was 7.8±3.8 years. RITA to LAD did not increase the risk for late death (hazard ratio [HR], 0.78; 95% confidence interval [CI], 0.48-1.26), the need for repeat revascularization (HR, 0.83; 95% CI, 0.70-2.42), and the composite of death or repeat revascularization (HR, 0.81; 95% CI, 0.64-1.14). CONCLUSIONS Using in situ BITA with retrosternal in situ RITA for LAD grafting is a technically less demanding, safe, and effective strategy that can increase usage of BITA by avoiding a composite graft configuration or technically challenging retrocaval routing of in situ RITA through the transverse sinus.

Long-term results after lung transplantation using organs from circulatory death donors: a propensity score-matched analysis †

OBJECTIVES Due to organ shortage in lung transplantation (LTx), donation after circulatory death (DCD) has been implemented in several countries, contributing to an increasing number of organs transplanted. We sought to assess long-term outcomes after LTx with organs procured following circulatory death in comparison with those obtained from donors after brain death (DBD). METHODS Between January 2007 and November 2013, 302 LTxs were performed in our institution, whereby 60 (19.9%) organs were retrieved from DCD donors. We performed propensity score matching (DCD:DBD = 1:2) based on preoperative donor and recipient factors that were significantly different in univariate analysis. RESULTS After propensity matching, there were no statistically significant differences between the groups in terms of demographics and preoperative donor and recipient characteristics. There were no significant differences regarding intraoperative variables and total ischaemic time. Patients from the DCD group had significantly higher incidence of primary graft dysfunction grade 3 at the end of the procedure (P = 0.014), and significantly lower pO2/FiO2 ratio during the first 24 h after the procedure (P = 0.018). There was a trend towards higher incidence of the need for postoperative extracorporeal life support in the DCD group. Other postoperative characteristics were comparable. While the overall cumulative survival was not significantly different, the DCD group had significantly poorer results in terms of bronchiolitis obliterans syndrome (BOS)-free survival in the long-term follow-up. CONCLUSIONS Long-term results after LTx with organs procured following DCD are in general comparable with those obtained after DBD LTx. However, patients transplanted using organs from DCD donors have a predisposition for development of BOS in the longer follow-up.

Risk factors predictive of one-year mortality after lung transplantation

OBJECTIVES Lung transplantation (LTx) is a life-saving therapy for patients with end-stage lung disease. However, there remains a significant postoperative complication rate and mortality in this extreme patient group. The aim of the present study was to identify donor, recipient and perioperative risk factors for one-year mortality after LTx. METHODS A total of 252 LTxs were performed in our institution between 2007 and 2013. Donor and recipient demographics and clinical characteristics of 1-year survivors and non-survivors were collected and compared retrospectively. Multivariate logistic regression analysis was performed on univariate predictors for 1-year mortality with an entry criterion of P < 0.05. RESULTS Multivariate analysis revealed female-to-male transplantation (95% CI: 0.088-0.767; P = 0.015), lower pO2/FiO2-ratio at 72 h postoperatively (95% CI: 0.988-0.999; P = 0.024), need for postoperative extracorporeal membrane oxygenation (ECMO) support (95% CI: 0.035-0.658; P = 0.012) and on-pump technique (95% CI: 0.007-0.944; P = 0.045) as the only independent predictors for 1-year mortality. Mainly unplanned intraoperative conversion to cardiopulmonary bypass contributed to poorer survival in patients who underwent LTx using cardiopulmonary bypass (P < 0.001). CONCLUSIONS Our results show that the unplanned use of CPB (conversion from off- to on-pump) might adversely affect outcome after LTx. Also, the negative impact of female-to-male transplantation should not be underestimated during recipient selection. Furthermore, poor early postoperative oxygenation, particularly with the need for extracorporeal oxygenation, might be a very strong negative prognostic factor after LTx.

Outcomes after implantation of 139 full-support continuous-flow left ventricular assist devices as a bridge to transplantation

OBJECTIVES Left ventricular assist devices (LVADs) are a routine treatment for patients with advanced heart failure as a bridge to transplantation. The aim of this study was to present our institutional experience and mid-term outcomes after implantation of 139 continuous-flow (cf) LVADs as a bridge to transplantation. METHODS One hundred and thirty-nine consecutive LVAD implantations were performed in our institution between July 2007 and August 2013. The mean age of the population was 44.0 ± 13.7 years and 24 (17%) of the patients were female. A substantial number of the patients were on preoperative mechanical support: 35 (25%) with an intra-aortic balloon pump, 9 (6.5%) with an extracorporeal membrane oxygenator and 25 (18%) with previous LVAD, for LVAD exchange. RESULTS The mean support duration was 514 ± 481 days, whereas the longest support duration was 2493 days (>6 years). The overall cumulative survival rate following cfLVAD implantation was 89% at 30 days, 76% at 1 year and 66% at 2 years (Fig. 1). There was a statistically significant difference in survival in favour of first LVAD implantation compared with VAD exchange: 91 vs 80% at 30 days, 79 vs 57% at 1 year and 70 vs 43% at 2 years (log-rank P = 0.010). Postoperatively, patients had a significant improvement in end-organ function 1 month after LVAD implantation. In addition, comparison of two different devices [HeartMate II (HM II) and HeartWare] using propensity score matching showed no significant differences in survival and most postoperative adverse events. However, patients supported with HM II required significantly more units of fresh frozen plasma (P = 0.020) with a trend towards a higher use of red blood cells (P = 0.094), and were also more likely to develop percutaneous site infections (P = 0.022). CONCLUSIONS HM II and HeartWare cfLVADs have excellent early postoperative outcomes and good mid-term survival, despite a considerable number of patients needing VAD exchange.

Influence of Donor Smoking on Midterm Outcomes After Lung Transplantation

BACKGROUND Lung transplantation (LTx) is significantly limited by donor organ shortage. Donor smoking history of more than 20 pack-years is considered an extended donor criterion. In this study, we retrospectively evaluated impact of donor smoking history and extent of smoking on midterm outcome after LTx. METHODS In all, 237 LTx were performed in our institution between 2007 and 2012. Patients were divided into three groups, receiving lungs from 53% nonsmoking donors, 29% smoking donors with fewer than 20 pack-years, and 18% heavy smokers with more than 20 pack-years. RESULTS Preoperative donor and recipient characteristics among the groups were comparable. However, donors from the heavy smokers group were significantly older (p < 0.001). The overall presence of abnormal histology (inflammation or metaplasia) in donor main bronchi samples increased with the extent of smoking but did not reach statistical significance (p = 0.211). Although metaplasia was found in significantly more donors from the heavy smokers group (p = 0.037), this did not translate into inferior outcomes for the recipients. There were no statistically significant differences in PaO2/FiO2 ratio after LTx, duration of mechanical ventilation (p = 0.136), intensive care unit stay (p = 0.133), and total postoperative hospital stay (p = 0.322). One-year and three-year survival were comparable across all three groups (log rank p = 0.151). Prevalence of bronchiolitis obliterans syndrome (p = 0.616), as well as bronchiolitis obliterans syndrome free survival (p = 0.898) after LTx were also comparable. CONCLUSIONS In our experience, history and extent of donor smoking do not significantly affect early and midterm outcomes after LTx. Although this finding does not obviate the need for longer-term observation, donor lungs from even heavy smokers may not per se contraindicate LTx and may provide a valuable avenue for expanding donor organ availability.

Outcomes and Predictors of Early Mortality After Continuous-Flow Left Ventricular Assist Device Implantation as a Bridge to Transplantation

Left ventricular assist devices (LVADs) are fast becoming standard of care for patients with advanced heart failure. However, despite continuous improvement in VAD technology, there remains a significant early postoperative morbidity and mortality in this extreme patient group. The aim of the current study was to explore the short-term outcomes and predictors for 90 day mortality in the patients after implantation of continuous-flow LVAD. Perioperative clinical, echocardiographic, hemodynamic, and laboratory data of 90 day survivors and nonsurvivors were collected and compared retrospectively. Multivariate logistic regression analysis was performed on univariate predictors for 90 day mortality with an entry criterion of p < 0.1. Between July 2006 and May 2012, 117 patients underwent implantation of a continuous-flow LVAD as a bridge to transplantation: 71 (60.7%) HeartMate II (Thoratec Corp, Pleasanton, CA) and 46 (39.3%) HVAD (HeartWare International, Framingham, MA). All-cause 90 day mortality was 17.1%. Multivariate analysis revealed higher preoperative central venous pressure (odds ratio [OR], 1.18; 95% confidence interval [CI], 1.014–1.378; p = 0.033) and higher age (OR, 1.14; 95% CI, 1.01–1.38; p = 0.045) as the only independent predictors for 90 day mortality. Optimization of preoperative volume status, preload, and right heart function as well as age-based selection of candidates for LVAD support are the critical factors influencing early outcome after continuous-flow LVAD implantation.