Kavous Hakim-Meibodi

Clinical and haemodynamic outcomes in 658 patients receiving the Perceval sutureless aortic valve: early results from a prospective European multicentre study (the Cavalier Trial)†.

OBJECTIVES The aim of the Cavalier trial was to evaluate the safety and performance of the Perceval sutureless aortic valve in patients undergoing aortic valve replacement (AVR). We report the 30-day clinical and haemodynamic outcomes from the largest study cohort with a sutureless valve. METHODS From February 2010 to September 2013, 658 consecutive patients (mean age 77.8 years; 64.4% females; mean logistic EuroSCORE 10.2%) underwent AVR in 25 European Centres. Isolated AVRs were performed in 451 (68.5%) patients with a less invasive approach in 219 (33.3%) cases. Of the total, 40.0% were octogenarians. Congenital bicuspid aortic valve was considered an exclusion criterion. RESULTS Implantation was successful in 628 patients (95.4%). In isolated AVR through sternotomy, the mean cross-clamp time and the cardiopulmonary bypass (CPB) time were 32.6 and 53.7 min, and with the less invasive approach 38.8 and 64.5 min, respectively. The 30-day overall and valve-related mortality rates were 3.7 and 0.5%, respectively. Valve explants, stroke and endocarditis occurred in 0.6, 2.1 and in 0.1% of cases, respectively. Preoperative mean and peak pressure gradients decreased from 44.8 and 73.24 mmHg to 10.24 and 19.27 mmHg at discharge, respectively. The mean effective orifice area improved from 0.72 to 1.46 cm(2). CONCLUSIONS The current 30-day results show that the Perceval valve is safe (favourable haemodynamic effect and low complication rate), and can be implanted with a fast and reproducible technique after a short learning period. Short cross-clamp and CPB times were achieved in both isolated and combined procedures. The Perceval valve represents a promising alternative to biological AVR, especially with a less invasive approach and in older patients.

Mechanical circulatory support devices as destination therapy-current evidence.

Advanced heart failure is an increasing problem worldwide. Nowadays, mechanical circulatory support devices (MSCD) are an established therapeutic option for terminal heart failure after exhaustion of medical and conventional surgical treatment, and are becoming a realistic alternative to heart transplantation (HTX). There are a number of different treatment options for these patients, such as bridge to transplantation (BTT), bridge to candidacy (BTC), bridge to recovery (BTR) and the destination therapy (DT) option. The latter option has become more frequent throughout the last years, due to a donor organ shortage and an increasing number of older patients with terminal heart failure who are not eligible for HTX. These factors have led to a rapidly increasing number of LVAD implantations as well as centers which perform these procedures. This has also been due to improved LVAD survival rates and quality of life following the introduction of smaller, intrapericardial and more durable continuous flow left ventricular devices. The most common complications for these patients are device-related problems, such as coagulation disorders, gastrointestinal bleeding, device related infection, pump thrombosis or cerebrovascular accidents. However, some questions still remain unanswered or under debate, such as the exact time-point for LVAD implantation. In addition, aspects such as better biocompatibility for LVADs remain a major challenge. This review will concentrate on DT for terminal heart failure and provide an overview of the current evidence for LVAD implantation in this patient group, with particular emphasis on indication and time-point of implantation, choice of LVADs, and long term outcomes and quality of life.

Excessive negative venous line pressures and increased arterial air bubble counts during miniaturized cardiopulmonary bypass: an experimental study comparing miniaturized with conventional perfusion systems

OBJECTIVES Miniaturized cardiopulmonary bypass (MCPB) is increasingly used in cardiac surgery, because it can lower clinically significant complications such as systemic inflammatory response, haemolysis and high transfusion requirements. A limitation of MCPB is the risk of excessive negative pressure in the venous line during volume depletion, probably leading to gaseous microembolism. METHODS In an experimental study with 24 pigs, we compared conventional open cardiopulmonary bypass (CCPB group, n = 11) with MCPB (n = 13). The same pump and identical tubing materials were used in both groups. Primary endpoints were pressure values in the venous line and the right atrium as well as the amount of air bubbles >500 µm. Secondary endpoints were biochemical parameters of systemic inflammatory response, ischaemia, haemodilution and haemolysis. RESULTS Nearly 20% of venous pressure values were below -150 mmHg and approximately 10% of the right atrial pressure values were below -100 mmHg in the MCPB group, during the experiment. No such low values were observed in the CCPB group. In addition, the number of large arterial air bubbles was higher in the MCPB group compared with the CCPB group (mean ± standard deviation [SD]: 13 444 ± 5709 vs 0.9 ± 0.6, respectively; P < 0.001). Bubble volume was also significantly larger during MCPB compared with CCPB (mean ± SD: 1522 ± 654 vs 4.1 ± 2.5 µl, respectively; P < 0.001). Blood levels of interleukin-6, free haemoglobin and creatine kinase were significantly higher in the CCPB group compared with the MCPB group. CONCLUSIONS Despite the benefits of MCPB regarding systemic inflammatory response and haemolysis, this technique is associated with excessive negative venous line pressures and a significant increase in the number and volume of arterial air bubbles compared with CCPB. Mini-perfusion systems and the management of MCPB require further refinements to avoid such adverse effects.

Clinical outcome in cardiac transplant recipients receiving tacrolimus retard.

Tacrolimus (TAC) retard is a new oral formulation of TAC that is given once instead of twice daily. We investigated the efficacy and safety of TAC retard in heart transplant recipients during a 36-month follow-up period. We included 11 patients receiving TAC retard (once-daily [OD] group) and 11 age- and sex-matched patients receiving TAC (twice-daily [TD] group). The primary endpoint was a composite of death, graft loss, and drug discontinuation (treatment failure). Secondary endpoints were biopsy-proven rejection, malignancy, infection, and safety parameters determined on the basis of laboratory evaluations. In the OD and TD groups, the primary endpoint was reached by 18.2% and 45.54% of patients, respectively (P = .277). In detail, 3-year survivals were 90.0% and 70.0% (P = .291) and freedom from drug discontinuation 90.9% and 77.9% (P = .533), respectively. Freedom from biopsy-proven rejection, malignancy, and infection were similar between the groups. Moreover, biochemical parameters of kidney and liver function, hematologic parameters, and C-reactive protein levels were similar. Despite a remarkably higher prescribed dose, blood trough levels of TAC were below the lower target value in several patients of the OD group at the end of the follow-up period, but in none of the patients in the TD group. In conclusion, this small 3-year follow-up study suggests efficacy and safety in patients receiving TAC retard similar to those in patients receiving TAC. Nevertheless, the required dose of TAC retard for achieving acceptable blood trough levels should be investigated in more detail.

Anaortic off-pump versus clampless off-pump using the PAS-Port device versus conventional coronary artery bypass grafting: mid-term results from a matched propensity score analysis of 5422 unselected patients

OBJECTIVES Meta‐analyses from observational and randomized studies have demonstrated benefits of off‐pump surgery for hard and surrogate endpoints. In some of them, increased re‐revascularization was noted in the off‐pump groups, which could impact their long‐term survival. Therefore, we analyzed the course of all patients undergoing isolated coronary surgery regarding the major cardiac and cerebrovascular event (MACCE) criteria. METHODS A prospective register was taken from a high‐volume off‐pump center recording all anaortic off‐pump (ANA), clampless off‐pump (PAS‐Port) and conventional (CONV) coronary artery bypass operations between July 2009 and June 2015. Propensity Score Matching was performed based on 28 preoperative risk variables. RESULTS We identified 935 triplets (N = 2805). Compared with CONV, in‐hospital mortality of both the ANA group (OR for ANA [95% CI] 0.25 [0.06; 0.83], P = 0.021), and the PAS‐Port group was lower (OR for PAS‐Port [95% CI] 0.50 [0.17; 1.32], P = 0.17). In the mid‐term follow‐up there were no significant differences between the groups regarding mortality (HR for ANA [95%‐CI] 0.83 [0.55‐1.26], P = 0.38; HR for PAS‐Port [95%‐CI] 1.06 [0.70‐1.59], P = 0.79), incidence of stroke (HR for ANA 0.81 [0.43‐1.53], P = 0.52; HR for PAS‐Port 0.78 [0.41‐1.50], P = 0.46), myocardial infarction (HR for ANA 0.53 [0.22‐1.31], P = 0.17; HR for PAS‐Port 0.78 [0.37‐1.66], P = 0.52) or re‐revascularization rate (HR for ANA 0.99 [0.67‐1.44], P = 0.94; HR for PAS‐Port 0.95 [0.65‐1.38], P = 0.77). CONCLUSIONS Both off‐pump clampless techniques were associated with lower in‐hospital mortality compared with conventional CABG. The mid‐term course showed no difference with regard to the MACCE criteria between anaortic off‐pump, clampless off‐pump using PAS‐Port and conventional CABG.

The Thoratec system implanted as a modified total artificial heart: the Bad Oeynhausen technique.

The CardioWest™ total artificial heart (SynCardia Systems, Tuscon, AZ, USA) is the only FDA-approved total artificial heart determined as a bridge to human heart transplantation for patients dying of biventricular heart failure. Implantation provides immediate hemodynamic restoration and clinical stabilization, leading to end-organ recovery and thus eventually allowing cardiac transplantation. Occasionally, implantation of a total artificial heart is not feasible for anatomical reasons. For this patient group, we have developed an alternative technique using the paracorporeal Thoratec biventricular support system (Thoratec, Pleasanton, CA, USA) as a modified total artificial heart. A detailed description of the implantation technique is presented.

Management of end-stage heart failure patients with or without ventricular assist device: an observational comparison of clinical and economic outcomes

OBJECTIVES Heart transplantation (HT) and ventricular assist devices (VAD) for the management of end-stage heart failure have not been directly compared. We compare the outcomes and use of resources with these 2 strategies in 2 European countries with different allocation systems. METHODS We studied 83 patients managed by VAD as the first option in Bad Oeynhausen, Germany (Group I) and 141 managed with either HT or medical therapy, as the first option, in Paris, France (Group II). The primary end-point was 2-year survival. Kaplan-Meier analyses were performed after the application of propensity score weights to mitigate the effects of non-random group assignment. The secondary end-points were resource utilization and costs. Subgroup analyses were performed for patients undergoing HT and patients treated with inotropes at the enrolment time. RESULTS The Group I patients were more severely ill and haemodynamically compromised, and 28% subsequently underwent HT vs 55% primary HT in Group II, P < 0.001. The adjusted probability of survival was 44% in Group I vs 70% in Group II, P <0.0001. The mean cumulated 2-year costs were €281 361 ± 156 223 in Group I and €47 638 ± 35 061 in Group II, P < 0.0001. Among patients who underwent HT, the adjusted probability of survival in Group I (n = 23) versus Group II (n = 78) was 76% versus 68%, respectively (0.09), though it differed in the inotrope-treated subgroups (77% in Group I vs 67% in Group II, P = 0.04). CONCLUSIONS HT should remain the first option for end-stage heart failure patients, associated with improved outcomes and better cost-effectiveness profile. VAD devices represent an option when transplant is not possible or when patient presentation is not optimal.

Preclinical determination of the best functional position for transcatheter heart valves implanted in rapid deployment bioprostheses

AIMS The aim of this study was to determine the best functional position of a transcatheter heart valve (THV) implanted as a valve-in-valve (ViV) procedure in small rapid deployment valves (RDV) in an in vitro model. METHODS AND RESULTS A 21 mm Perceval, Enable or INTUITY RDV was mounted into a pulse duplicator and a 23 mm balloon-expandable or a self-expanding THV was deployed (valve-in-valve) in two different positions. Under physiological hydrodynamic conditions, the performance of the THV was characterised by mean transvalvular pressure gradient (MPG), effective orifice area (EOA) and regurgitation volume (RV). Leaflet kinematics were assessed with high-speed video recordings, and X-ray images were acquired. All THV/RDV combinations met ISO requirements regarding hydrodynamic performance. In most cases, the higher position of the THV performed better than the lower one in terms of a lower MPG and increased EOA. Leaflet motion of the implanted THV was impaired in the lower position. In contrast, regurgitation volumes were relatively small and similar, regardless of the THV position. CONCLUSIONS ViV implantation of a THV in a small RDV yielded satisfactory hydrodynamic results. In most cases, a high implantation position achieved lower MPG, higher EOA and a reduced risk of impaired THV leaflet function. Fluoroscopy images of the best functional ViV positions are presented as a blueprint for patient procedures.

Successful repeated thrombolysis in a patient with HeartWare thrombosis - the importance of Doppler flow pattern.

Here we present a patient after implantation of a left ventricular assist device (HeartWare) for destination therapy complicated by recurrent thrombosis of the device. At 14 months after implantation, the patient presented with a pump thrombosis after an INR incompliance period. A surgical pump exchange was performed and the patient recovered uneventfully. Five months later a pump thrombosis occurred again, and the patient refused surgery. Systemic thrombolysis was carried out this time. Three and 6 months later the same clinical picture was presented again, and repeat thrombolysis was performed successfully. The patient was discharged and has remained stable since, without any symptoms of thrombosis of the device.

Isolated Latent Tricuspid Regurgitation Caused by Blunt Trauma

Isolated tricuspid regurgitation with rupture of the chordae tendinae caused by blunt trauma is uncommon. We present a 20-year-old man who was asymptomatic for four months after a traffic accident, but then developed severe tricuspid regurgitation, caused by rupture of the chordae tendinae. We performed minimally invasive tricuspid valve repair with chordal reconstruction and annuloplasty. We discuss the optimal treatment of traumatic valve insufficiency in a young patient and review the literature.