Five-year results from a prospective, single-arm European trial on decellularized allografts for aortic valve replacement-the ARISE Study and ARISE Registry Data.

OBJECTIVES: Decellularized aortic homografts (DAH) were introduced as a new option for aortic valve replacement for young patients. METHODS: A prospective, EU-funded, single-arm, multicentre study in 8 centres evaluating non-cryopreserved DAH for aortic valve replacement. RESULTS: A total of 144 patients (99 male) were prospectively enrolled in the ARISE Trial between October 2015 and October 2018 with a median age of 30.4 years [interquartile range (IQR) 15.9-55.1]; 45% had undergone previous cardiac operations, with 19% having 2 or more previous procedures. The mean implanted DAH diameter was 22.6 mm (standard deviation 2.4). The median operation duration was 312 min (IQR 234-417), the median cardiopulmonary bypass time was 154 min (IQR 118-212) and the median cross-clamp time 121 min (IQR 93-150). No postoperative bypass grafting or renal replacement therapy were required. Two early deaths occurred, 1 due to a LCA thrombus on day 3 and 1 due ventricular arrhythmia 5 h postoperation. There were 3 late deaths, 1 death due to endocarditis 4 months postoperatively and 2 unrelated deaths after 5 and 7 years due to cancer and Morbus Wegener resulting in a total mortality of 3.47%. After a median follow-up of 5.9 years [IQR 5.1-6.4, mean 5.5 years. (standard deviation 1.3) max. 7.6 years], the primary efficacy end-points peak gradient with median 11.0 mmHg (IQR 7.8-17.6) and regurgitation of median 0.5 (IQR 0-0.5) of grade 0-3 were excellent. At 5 years, freedom from death/reoperation/endocarditis/bleeding/thromboembolism were 97.9%/93.5%/96.4%/99.2%/99.3%, respectively. CONCLUSIONS: The 5-year results of the prospective multicentre ARISE trial continue to show DAH to be safe for aortic valve replacement with excellent haemodynamics.

Automated titanium fastener vs. hand-tied knots for prosthesis fixation in infective endocarditis.

Objectives: To date, there is no evidence regarding the safety of automated titanium fastener compared with hand-tied knots for prosthesis fixation in infective endocarditis. Methods: Between January 2016 and December 2022, a total of 220 patients requiring surgery for infective endocarditis were included in this retrospective analysis. The primary study endpoint was re-endocarditis during follow-up. The secondary study endpoints included stroke onset, all-cause mortality, and a composite outcome of either re-endocarditis, stroke, or all-cause mortality during follow-up. Results: Suture-securing with an automated titanium fastener was performed in 114 (51.8%) patients, whereas the conventional technique of hand knot-tying was used in 106 (48.2%) patients. The risk of re-endocarditis was significantly lower in the automated titanium fastener group, as shown in a multivariable proportional competing risk regression model (adjusted sub-hazard ratio 0.33, 95% confidence interval 0.11-0.99, p = 0.048). The multivariable Cox proportional hazards regression analysis showed that the automated titanium fastener group was not associated with an increased risk of stroke-onset or attaining the composite outcome, respectively, (adjusted hazard ratio 0.54, 95% confidence interval 0.27-1.08, p = 0.082), (adjusted hazard ratio 0.65, 95% confidence interval 0.42-1.02, p = 0.061). Also, this group was not associated with an increased risk of all-cause mortality, as demonstrated in the multivariable Poisson regression analysis (adjusted incidence-rate ratio 1.42, 95% confidence interval 0.83-2.42, p = 0.202). Conclusions: The use of automated titanium fastener device seems to be safe for infective endocarditis. Analyses of larger cohorts are required.

Matched comparison of decellularized homografts and bovine jugular vein conduits for pulmonary valve replacement in congenital heart disease.

For decades, bovine jugular vein conduits (BJV) and classic cryopreserved homografts have been the two most widely used options for pulmonary valve replacement (PVR) in congenital heart disease. More recently, decellularized pulmonary homografts (DPH) have provided an alternative avenue for PVR. Matched comparison of patients who received DPH for PVR with patients who received bovine jugular vein conduits (BJV) considering patient age group, type of heart defect, and previous procedures. 319 DPH patients were matched to 319 BJV patients; the mean age of BJV patients was 15.3 (SD 9.5) years versus 19.1 (12.4) years in DPH patients (p = 0.001). The mean conduit diameter was 24.5 (3.5) mm for DPH and 20.3 (2.5) mm for BJV (p < 0.001). There was no difference in survival rates between the two groups after 10 years (97.0 vs. 98.1%, p = 0.45). The rate of freedom from endocarditis was significantly lower for BJV patients (87.1 vs. 96.5%, p = 0.006). Freedom from explantation was significantly lower for BJV at 10 years (81.7 vs. 95.5%, p = 0.001) as well as freedom from any significant degeneration at 10 years (39.6 vs. 65.4%, p < 0.001). 140 Patients, matched for age, heart defect type, prior procedures, and conduit sizes of 20-22 mm (± 2 mm), were compared separately; mean age BJV 8.7 (4.9) and DPH 9.5 (7.3) years (p = n.s.). DPH showed 20% higher freedom from explantation and degeneration in this subgroup (p = 0.232). Decellularized pulmonary homografts exhibit superior 10-year results to bovine jugular vein conduits in PVR.

Long-term outcome of bicuspid aortic valve disease.

AIMS: Bicuspid aortic valve (BAV) is a common congenital condition that is frequently associated with aortic stenosis (AS) and aortic regurgitation (AR), as well as aortic aneurysms, but specific outcome data are scarce. The present study sought to assess outcomes in a large cohort of consecutive patients with BAV. METHODS AND RESULTS: A total of 581 consecutive patients (median age 29 years, 157 female) with BAV were included in the study and followed prospectively in a heart valve clinic follow-up programme. The overall survival rate after 10 years was 94.5%. During follow-up, 158 patients developed an indication for surgery. Event-free survival rates were 97%, 94%, 87%, and 73% at 1, 2, 5, and 10 years, respectively. In the multivariable analysis, event rates were independently predicted by AS [subdistribution hazard ratio (SHR) 2.3 per degree of severity], AR (SHR 1.5 per degree of severity), baseline aortic dilatation ≥ 40 mm (SHR 1.9), and age (SHR 1.3) (P < 0.001). CONCLUSION: BAV disease is associated with a high rate of cardiac events, but state-of-the-art care results in good survival with low rates of infective endocarditis, aortic dissection, and sudden death. Incremental degrees of AS and regurgitation, the presence of aortic dilatation, and age are predictive of cardiac events.

HeartMate 3 Snoopy: Noninvasive cardiovascular diagnosis of patients with fully magnetically levitated blood pumps during echocardiographic speed ramp tests and Valsalva maneuvers.

PURPOSE: The HeartMate 3 (HM3) left ventricular assist device (LVAD) has demonstrated excellent clinical outcomes; however, pump speed optimization is challenging with the available HM3 monitoring. Therefore, this study reports on clinical HM3 parameters collected with a noninvasive HM3 monitoring system (HM3 Snoopy) during echocardiographic speed ramp tests and Valsalva maneuvers. METHODS: In this prospective, single-center study, the HM3 data communication between the controller and pump was recorded with a novel data acquisition system. Twelve pump parameters sampled every second (1 Hz) and clinical assessments (echocardiography, electrocardiogram (ECG), and blood pressure measurement) during speed ramp tests were analyzed using Pearson's correlation (r, median [IQR]). The cause for the occurrence of pulsatility index (PI)-events during ramp speed tests and valsalva maneuvers was investigated. RESULTS: In 24 patients (age: 58.9 ± 8.8 years, body mass index: 28.1 ± 5.1 kg/m2, female: 20.8%), 35 speed ramp tests were performed with speed changes in the range of ±1000 rpm from a baseline speed of 5443 ± 244 rpm. Eight HM3 pump parameters from estimated flow, motor current, and LVAD speed together with blood pressure showed positive collinearities (r = 0.9 [0.1]). Negative collinearities were observed for pump flow pulsatility, pulsatility index, rotor noise, and left ventricular diameters (r = -0.8 [0.1]), whereas rotor displacement and heartrate showed absence of collinearities (r = -0.1 [0.08]). CONCLUSIONS: In this study, the HM3 Snoopy was successfully used to acquire more parameters from the HM3 at a higher sampling rate. Analysis of HM3 per-second data provide additional clinical diagnostic information on heart-pump interactions and cause of PI-events.

Left Atrial Decompression With the HeartMate3 in Heart Failure With Preserved Ejection Fraction: Virtual Fitting and Hemodynamic Analysis.

Effective treatment of heart failure with preserved ejection fraction (HFpEF) remains an unmet medical need. Although left atrial decompression using mechanical circulatory support devices was previously suggested, the heterogeneous HFpEF population and the lack of tailored devices have prevented the translation into clinical practice. This study aimed to evaluate the feasibility of left atrial decompression in HFpEF patients with a HeartMate 3 (HM3, Abbott Inc, Chicago, USA) in silico and in vitro . Anatomic compatibility of the HM3 pump was assessed by virtual device implantation into the left atrium through the left atrial appendage (LAA) and left atrial posterior wall (LAPW) of 10 HFpEF patients. Further, the efficacy of left atrial decompression was investigated experimentally in a hybrid mock loop, replicating the hemodynamics of an HFpEF phenotype at rest and exercise conditions. Virtual implantation without substantial intersection with surrounding tissues was accomplished through the LAA in 90% and 100% through the LAPW. Hemodynamic analysis in resting conditions demonstrated normalization of left atrial pressures without backflow at a pump speed of around 5400 rpm, whereas a range of 6400-7400 rpm was required during exercise. Therefore, left atrial decompression with the HM3 may be feasible in terms of anatomic compatibility and hemodynamic efficacy.

Femoral vessel complications after transfemoral TAVR-A contemporary sonography-based assessment of 480 patients with third-generation transcatheter valves.

BACKGROUND: Postinterventional sonographic assessment of the femoral artery after transfemoral transcatheter aortic valve replacement (TF-TAVR) has the potential to identify several pathologies. We investigated the incidence and risk factors of femoral vessel complications in a modern TAVR collective using postinterventional sonography. METHODS: Between September 2017 and March 2022, 480 patients underwent TF-TAVR with postinterventional femoral sonography at a single center. Clinical outcomes and adverse events were analyzed after the Valve Academic Research Consortium 3 (VARC-3) criteria. RESULTS: In this cohort (51.2% male; age 80 ± 7.5 years, median EuroSCORE II 3.7) 74.8% (n = 359) were implanted with a self-expandable and 25.2% (n = 121) with a balloon-expandable valve. The main access (valve-delivery) was located right in 91.4% (n = 438), and the primary closure system was Proglide in 95% (n = 456). Vascular complications (VC) were observed in 29.16% (n = 140) of patients; 23.3% (n = 112) presented with minor- and 5.8% (n = 28) with major VC. Postinterventional femoral artery stenosis on the main access was observed in 9.8% (n = 47). Multivariable logistic regression analysis revealed female sex (p = .03, odds ratio [OR] 2.32, 95% confidence interval [CI] 1.09-4.89) and the number of used endovascular closure devices (p = .014, OR 0.11, 95%CI 0.02-0.64) as predictive factors for femoral artery stenosis. CONCLUSIONS: The incidence of postinterventional femoral artery stenosis following TF-TAVR was higher than expected with a number of used closure devices and female sex being independent risk factors. Considering the continuous advance of TAVR in low-risk patients with preserved physical activity, emphasis should be directed at the correct diagnosis and follow-up of these complications.

An Atraumatic Mock Loop for Realistic Hemocompatibility Assessment of Blood Pumps.

OBJECTIVE: Conventional mock circulatory loops (MCLs) cannot replicate realistic hemodynamic conditions without inducing blood trauma. This constrains in-vitro hemocompatibility examinations of blood pumps to static test loops that do not mimic clinical scenarios. This study aimed at developing an atraumatic MCL based on a hardware-in-the-loop concept (H-MCL) for realistic hemocompatibility assessment. METHODS: The H-MCL was designed for 450 ± 50 ml of blood with the polycarbonate reservoirs, the silicone/polyvinyl-chloride tubing, and the blood pump under investigation as the sole blood-contacting components. To account for inherent coupling effects a decoupling pressure control was derived by feedback linearization, whereas the level control was addressed by an optimization task to overcome periodic loss of controllability. The HeartMate 3 was showcased to evaluate the H-MCL's accuracy at typical hemodynamic conditions. To verify the atraumatic properties of the H-MCL, hemolysis (bovine blood, n = 6) was evaluated using the H-MCL in both inactive (static) and active (minor pulsatility) mode, and compared to results achieved in conventional loops. RESULTS: Typical hemodynamic scenarios were replicated with marginal coupling effects and root mean square error (RMSE) below 1.74 ± 1.37 mmHg while the fluid level remained within ±4% of its target value. The normalized indices of hemolysis (NIH) for the inactive H-MCL showed no significant differences to conventional loops ( ∆NIH = -1.6 mg/100 L). Further, no significant difference was evident between the active and inactive mode in the H-MCL ( ∆NIH = +0.3 mg/100 L). CONCLUSION AND SIGNIFICANCE: Collectively, these findings indicated the H-MCL's potential for in-vitro hemocompatibility assessment of blood pumps within realistic hemodynamic conditions, eliminating inherent setup-related risks for blood trauma.

Aortic Valve Replacement in Adult Patients with Decellularized Homografts: A Single-Center Experience.

BACKGROUND: decellularized aortic homografts (DAH) represent a promising alternative for aortic valve replacement in young adults due to their low immunogenicity and thrombogenicity. Herein, we report our midterm, single-center experience in adult patients with non-frozen DAH from corlife. METHODS: safety, durability, and hemodynamic performance were evaluated according to current guidelines in all consecutive patients who had received a DAH at our center since 03/2016. RESULTS: seventy-three (mean age 47 ± 11 years, 68.4% (n = 50) male) patients were enrolled. The mean diameter of the implanted DAH was 24 ± 2 mm. Mean follow-up was 36 ± 27 months, with a maximum follow-up of 85 months and cumulative follow-up of 215 years. No cases of stenosis were observed, in four (5.5%) cases moderate aortic regurgitation occurred, but no reintervention was required. No cases of early mortality, non-structural dysfunction, reoperation, valve endocarditis, or thrombosis were observed. Freedom from bleeding and thromboembolic events was 100%; freedom from re-intervention was 100%; survival was 98.6% (n = 72). CONCLUSIONS: early and mid-term results showed low mortality and 100% freedom from reoperation, thromboembolic events, and bleeding at our center. However, in order for this novel approach to be established as a valid alternative to aortic valve replacement in young patients, long-term data are required.

Ross procedure with personalized external aortic root support.

The Ross-Personalized External Aortic Root Support procedure is a surgical aortic valve replacement technique in which the autologous pulmonary valve is transposed in the aortic position to replace the malfunctioning aortic valve and a homograft is implanted in the pulmonary position. To prevent autograft dilatation, a Personalized External Aortic Root Support prosthesis is included in the proximal autograft anastomosis and wrapped around the ascending aorta. The aorta is transected transversely, the aortic valve is resected, and the coronary arteries are mobilized and cut out of the sinuses, leaving a rim. The pulmonary autograft is harvested by transecting the pulmonary artery and part of the right ventricular outflow tract. The autograft is approximated to the aortic root and inverted inside the ventricle. The proximal anastomosis is performed including the prosthesis between the aortic root and the autograft. The coronary buttons are threaded through appropriately positioned and sized holes in the prosthesis and reimplanted into the autograft. The ascending aorta is appropriately adapted and anastomosed with the distal autograft. When the patient is off cardiopulmonary bypass, the prosthesis can be closed longitudinally and is anchored to the distal aortic adventitia.

Anatomical Compliance of Cavopulmonary Assist Device Designs: A Virtual Fitting Study in Fontan Patients.

Several device designs for cavopulmonary mechanical circulatory support (MCS) are under investigation, however, challenged by the Fontan population's heterogeneity in size, cardiovascular and thoracic anatomy. This study aimed to preclinically assess the anatomical compliance of proposed device designs in silico. Representative double- and single-outlet cavopulmonary assist device (CPAD) designs were virtually implanted into CT imaging data of 10 patients previously palliated with total cavopulmonary connection (TCPC) for functionally univentricular hearts. Anatomical device compatibility was characterized concerning pump proximity to cardiovascular, respiratory and thoracic structures, as well as pump in- and outflow graft configuration. In 10 Fontan patients with a median age of 10.4 years (interquartile range [IQR] 5.0-15.3 years) and a median body surface area of 1.09 m2 (IQR 0.76-1.28 m2), implantation of a double-outlet CPAD was feasible in 1 patient (10%). In all other, adverse device intersection with the trachea and (neo-)aorta, or posterior pulmonary artery outflow graft kinking were observed. A single-outlet design permitted enhanced device mobilization adapting to individual anatomical conditions, resulting in device fit in nine of 10 patients (90%). Despite vast anatomical variations among single ventricle patients, a single-outlet device design may provide intracorporeal cavopulmonary MCS to a broad spectrum of failing Fontan patients.

Durability of bioprosthetic aortic valve replacement in patients under the age of 60 years - 1-year follow-up from the prospective INDURE registry.

OBJECTIVES: We report 1-year safety and clinical outcomes in patients <60 years undergoing bioprosthetic surgical aortic valve intervention. METHODS: The INSPIRIS RESILIA Durability Registry is a prospective, multicentre registry to assess clinical outcomes of patients <60 years. Patients with planned SAVR with or without concomitant replacement of the ascending aorta and/or coronary bypass surgery were included. Time-related valve safety, haemodynamic performance and quality of life (QoL) at 1 year were assessed. RESULTS: A total of 421 patients were documented with a mean age of 53.5 years, 76.5% being male and 27.2% in NYHA class III/IV. Outcomes within 30 days included cardiovascular-related mortality (0.7%), time-related valve safety (VARC-2; 5.8%), thromboembolic events (1.7%), valve-related life-threatening bleeding (VARC-2; 4.3%) and permanent pacemaker implantation (3.8%). QoL was significantly increased at 6 months and sustained at 1 year. Freedom from all-cause mortality at 1 year was 98.3% (95% confidence interval 97.1; 99.6) and 81.8% were NYHA I versus 21.9% at baseline. No patient developed structural valve deterioration stage 3 (VARC-3). The mean aortic pressure gradient was 12.6 mmHg at 1 year and the effective orifice area was 1.9 cm2. CONCLUSIONS: The 1-year data from the INSPIRIS RESILIA valve demonstrate good safety and excellent haemodynamic performance as well as an early QoL improvement. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov: NCT03666741.

Increased Drop in Activity of Alkaline Phosphatase in Plasma from Patients with Endocarditis.

(1) Infective endocarditis is a severe inflammatory disease associated with substantial mortality and morbidity. Alkaline phosphatase (AP) levels have been shown to change significantly during sepsis. Additionally, we previously found that a higher initial AP drop after cardiac surgery is associated with unfavorable outcomes. Therefore, the course of AP after surgery for endocarditis is of special interest. (2) A total of 314 patients with active isolated left-sided infective endocarditis at the Department of Cardiac Surgery (Medical University of Vienna, Vienna, Austria) between 2009 and 2018 were enrolled in this retrospective analysis. Blood samples were analyzed at different time points (baseline, postoperative days 1-7, postoperative days 14 and 30). Patients were categorized according to relative alkaline phosphatase drop (≥30% vs. <30%). (3) A higher rate of postoperative renal replacement therapy with or without prior renal replacement therapy (7.4 vs. 21.8%; p = 0.001 and 6.7 vs. 15.6%; p = 0.015, respectively) and extracorporeal membrane oxygenation (2.2 vs. 19.0%; p = 0.000) was observed after a higher initial alkaline phosphatase drop. Short-term (30-day mortality 3.0 vs. 10.6%; p = 0.010) and long-term mortality (p = 0.008) were significantly impaired after a higher initial alkaline phosphatase drop. (4) The higher initial alkaline phosphatase drop was accompanied by impaired short- and long-term outcomes after cardiac surgery for endocarditis. Future risk assessment scores for cardiac surgery should consider alkaline phosphatase.

Aortic root geometry following composite valve graft implantation: Implications for future valve-in-valve procedures.

OBJECTIVES: Biological composite valve grafts (CVGs) are being performed more frequently, which increases the need for interventions treating bioprosthetic valve failure. The feasibility of valve-in-valve procedures in this population is uncertain. This study aimed to assess changes in aortic root geometry and coronary height following CVG implantation to better understand future interventions. METHODS: We retrospectively identified 64 patients following bioprosthetic CVG replacement with pre- and postoperative computed tomography angiography. Root assessment was conducted as in preprocedural transcatheter aortic valve evaluation using a virtual valve simulation. RESULTS: In 64 patients (age, 67.6 ± 9.3 years; 76.6% men) the preoperative coronary height was 14.3 ± 6.8 mm for the left coronary artery (LCA) and 17.9 ± 5.9 mm for the right coronary artery (RCA), which significantly decreased after CVG implantation, with 8.7 ± 4.4 mm for the LCA and 11.3 ± 4.4 mm for the RCA (P < .001). The virtual valve-to-coronary distances measured 4.0 ± 1.3 mm (LCA) and 4.6 ± 1.4 mm (RCA). Overall, 59.4% (n = 38) of patients with bio-CVGs would have been at risk for coronary obstruction, 29.7% (n = 19) for LCA, 10.9% (n = 7) for RCA, and 18.8% (n = 12) for combined LCA and RCA. CONCLUSIONS: Coronary height significantly decreased following CVG implantation. The majority of patients after bio-CVG were at a potential risk for coronary obstruction in future valve-in-valve procedures. Further studies are needed to identify the best possible technique for coronary reimplantation and other measures to diminish the risk for future coronary obstruction in this population.

Human Factors Evaluation of HeartMate 3 Left Ventricular Assist Device Peripherals: An Eye Tracking Supported Simulation Study.

BACKGROUND: Despite recent design improvements, human factors issues continue to challenge left ventricular assist device (LVAD) therapy. The aim of this study was to evaluate user experience of former non-HeartMate 3 (HM3) LVAD patients post heart transplantation (HTX) and laypersons (LP) with HM3 LVAD peripherals in simulated everyday and emergency scenarios. METHODS: This single center cohort study included untrained HTX and LP. Seven scenarios, including battery exchanges (without alarm, advisory alarm, dim light, consolidated bag), change of power supply, driveline dis-/reconnection and controller exchange were simulated. Subjects' gaze behavior was recorded using eye tracking technology. Success rate, pump-off-time, duration to success (DTS), percental fixation duration per areas of interest and post-scenario-survey results were defined as outcome measures. RESULTS: Thirty subjects completed 210 scenarios, initially solving 82.4% (HTX vs. LP, p = 1.00). Changing power supply revealed highest complexity (DTS = 251 ± 93s, p = 0.76): 26.7% succeeded at first attempt (p = 0.68), 56.7% at second attempt, with significantly more LP failing (p = 0.04), resulting in 10 hazards from driveline disconnections (pump-off-time 2-118s, p = 0.25). Comparison on initial success showed differences in fixation durations for seven areas of interest (p < 0.037). Decreasing DTS during battery exchanges (p < 0.001) indicate high learnability. Exchanging batteries within the bag took longer (median DTS = 75.0 (IQR = 45.0)s, p = 0.09), especially in elderly subjects (r = 0.61, p < 0.001). Subjects with less initial success were more afraid of making mistakes (p = 0.048). CONCLUSION: This eye tracking based human factors study provided insights into user experiences in handling HM3 peripherals. It highlights unintuitive and hazardous characteristics, providing guidance for future user-centered design of LVAD wearables.

Cyclic pressure induced decellularization of porcine descending aortas.

The demand for decellularized xenogeneic tissues used in reconstructive heart surgery has increased over the last decades. Complete decellularization of longer and tubular aortic sections suitable for clinical application has not been achieved so far. The present study aims at analyzing the effect of pressure application on decellularization efficacy of porcine aortas using a device specifically designed for this purpose. Fresh porcine descending aortas of 8 cm length were decellularized using detergents. To increase decellularization efficacy, detergent treatment was combined with pressure application and different treatment schemes. Quantification of penetration depth as well as histological staining, scanning electron microscopy, and tensile strength tests were used to evaluate tissue structure. In general, application of pressure to aortic tissue does neither increase the decellularization success nor the penetration depth of detergents. However, it is of importance from which side of the aorta the pressure is applied. Application of intermittent pressure from the adventitial side does significantly increase the decellularization degree at the intimal side (compared to the reference group), but had no influence on the penetration depth of SDC/SDS at both sides. Although the present setup does not significantly improve the decellularization success of aortas, it is interesting that the application of pressure from the adventitial side leads to improved decellularization of the intimal side. As no adverse effects on tissue structure nor on mechanical properties were observed, optimization of the present protocol may potentially lead to complete decellularization of larger aortic segments.

Exercise Performance and Quality of Life of Left Ventricular Assist Device Patients After Long-Term Outpatient Cardiac Rehabilitation.

PURPOSE: Exercise performance and quality of life (QoL) of left ventricular assist device (LVAD) patients improve after early cardiac rehabilitation (CR). The purpose of this study was to examine the efficacy of multiprofessional long term phase 3 outpatient CR, and whether cardiopulmonary exercise testing (CPX) and 6-min walk testing (6MWT) post-LVAD implantation predict hospital readmission. METHODS: This retrospective observational cohort study included 29 LVAD patients (58.6 ± 7.7 yr, female: 13.8%, body mass index: 29.4 ± 3.3 kg/m 2 ). Functional performance tests (CPX, 6MWT, sit-to-stand test), QoL, and psychological surveys (Kansas City Cardiomyopathy Questionnaire, hospital anxiety and depression scale, and Control Convictions about Disease and Health [KKG]) were performed at baseline and at the end of CR. RESULTS: The CR was initiated at a median (IQR) of 159 (130-260) d after LVAD implantation for a duration of 340 (180-363) d with 46.8 ± 23.2 trainings. The 6MWT (408.4 ± 113.3 vs 455.4 ± 115.5 m, P = .003) and sit-to-stand test (16.7 ± 6.9 vs 19.0 ± 5.3 repetitions, P = .033) improved, but relative peak oxygen uptake (V˙ o2peak : 9.4 [8.2-14.4] vs 9.3 [7.8-13.4] mL/min/kg, P = .57) did not change. Using receiver operating characteristic curve analysis, baseline V˙ o2peak values were associated with readmission 1-yr after CR onset (C-statistic = 0.88) with a cutoff value of V˙ o2peak < 9.15 mL/min/kg (100% sensitivity, 78% specificity, P < .001). The Kansas City Cardiomyopathy Questionnaire self-efficacy and knowledge (+6.3 points), QoL (+5.0 points), and social limitation (+7.1 points) demonstrated clinically important changes. In addition, the hospital anxiety and depression scale showed a significant reduction in anxiety (4.6 ± 3.2 vs 2.6 ± 2.4, P = .03). CONCLUSIONS: Long-term CR is safe and LVAD outpatients showed improvement of QoL, anxiety, and submaximal exercise performance. In addition, V˙ o2peak and 6MWT have prognostic value for readmission.

Feasibility of an Animal Model for Cavopulmonary Support With a Double-Outflow Pump.

Both single- and double-outflow cavopulmonary assist devices (CPADs) were recently proposed for the Fontan population, whereas single-outflow configurations were evaluated in large animal trials and double-outflow concepts are lacking an equivalent in vivo assessment. The aim of this study was to test the hemodynamic properties of a double-outflow CPAD device in an acute sheep model. The two inflow cannulae of a CPAD were anastomosed to the caval veins. Outflow graft connection was performed via end-to-side anastomosis to the right (RPA) and main pulmonary artery (MPA). Speed ramp protocols were conducted, and hemodynamic effects were monitored in terms of caval flows, cardiac output (CO), central venous pressure (CVP), pulmonary artery pressure (PAP), and left atrial pressure (LAP). Six experiments were conducted (53.35 ± 5.1 kg). In three experiments, the animal model was established, the CPAD was examined, and restoration of biventricular equivalency in terms of venous return was achieved. Venous pressures (CVP) declined linearly with increasing pump speed (r > 0.879), whereas caval flow (r > 0.973), CO (r > 0.993), PAP (r > 0.973), and LAP (r > 0.408) increased. Despite the considerable complexity of the sheep model caused by the sheep pulmonary arterial anatomy that requires substantial graft bending, the CPAD was evaluated in three acute experiments and showed the potential to completely substitute a subpulmonary ventricle.

Relationship of Fibroblast Growth Factor 23 With Hospitalization for Heart Failure and Cardiovascular Outcomes in Patients Undergoing Cardiac Surgery.

Background Fibroblast growth factor 23 (FGF-23) is crucial in regulating phosphate and vitamin D metabolism and is moreover associated with an increased cardiovascular risk. The specific objective of this study was to investigate the influence of FGF-23 on cardiovascular outcomes, including hospitalization for heart failure (HHF), postoperative atrial fibrillation, and cardiovascular death, in an unselected patient population after cardiac surgery. Methods and Results Patients undergoing elective coronary artery bypass graft and/or cardiac valve surgery were prospectively enrolled. FGF-23 blood plasma concentrations were assessed before surgery. A composite of cardiovascular death/HHF was chosen as primary end point. A total of 451 patients (median age 70 years; 28.8% female) were included in the present analysis and followed over a median of 3.9 years. Individuals with higher FGF-23 quartiles showed elevated incidence rates of the composite of cardiovascular death/HHF (quartile 1, 7.1%; quartile 2, 8.6%; quartile 3, 15.1%; and quartile 4, 34.3%). After multivariable adjustment, FGF-23 modeled as a continuous variable (adjusted hazard ratio for a 1-unit increase in standardized log-transformed biomarker, 1.82 [95% CI, 1.34-2.46]) as well as using predefined risk groups and quartiles remained independently associated with the risk of cardiovascular death/HHF and the secondary outcomes, including postoperative atrial fibrillation. Reclassification analysis indicated that the addition of FGF-23 to N-terminal pro-B-type natriuretic peptide provides a significant improvement in risk discrimination (net reclassification improvement at the event rate, 0.58 [95% CI, 0.34-0.81]; P<0.001; integrated discrimination increment, 0.03 [95% CI, 0.01-0.05]; P<0.001). Conclusions FGF-23 is an independent predictor of cardiovascular death/HHF and postoperative atrial fibrillation in individuals undergoing cardiac surgery. Considering an individualized risk assessment, routine preoperative FGF-23 evaluation may improve detection of high-risk patients.