Pre-surgery optimization of patients' expectations to improve outcome in heart surgery: Study protocol of the randomized controlled multi-center PSY-HEART-II trial.

The PSY-HEART-I trial indicated that a brief expectation-focused intervention prior to heart surgery improves disability and quality of life 6 months after coronary artery bypass graft surgery (CABG). However, to investigate the clinical utility of such an intervention, a large multi-center trial is needed to generalize the results and their implications for the health care system. The PSY-HEART-II study aims to examine whether a preoperative psychological intervention targeting patients' expectations (EXPECT) can improve outcomes 6 months after CABG (with or without heart valve replacement). EXPECT will be compared to Standard of Care (SOC) and an intervention providing emotional support without targeting expectations (SUPPORT). In a 3-arm multi-center randomized, controlled, prospective trial (RCT), N = 567 patients scheduled for CABG surgery will be randomized to either SOC alone or SOC and EXPECT or SOC and SUPPORT. Patients will be randomized with a fixed unbalanced ratio of 3:3:1 (EXPECT: SUPPORT: SOC) to compare EXPECT to SOC and EXPECT to SUPPORT. Both psychological interventions consist of 2 in-person sessions (à 50 minute), 2 phone consultations (à 20 minute) during the week prior to surgery, and 1 booster phone consultation post-surgery 6 weeks later. Assessment will occur at baseline approx. 3-10 days before surgery, preoperatively the day before surgery, 4-6 days later, and 6 months after surgery. The study's primary end point will be patients' illness-related disability 6 months after surgery. Secondary outcomes will be patients' expectations, subjective illness beliefs, quality of life, length of hospital stay and blood sample parameters (eg, inflammatory parameters such as IL-6, IL-8, CRP). This large multi-center trial has the potential to corroborate and generalize the promising results of the PSY-HEART-I trial for routine care of cardiac surgery patients, and to stimulate revisions of treatment guidelines in heart surgery.

Less loop diuretic use in patients on sacubitril/valsartan undergoing remote pulmonary artery pressure monitoring.

AIMS: Control of pulmonary pressures monitored remotely reduced heart failure hospitalizations mainly by lowering filling pressures through the use of loop diuretics. Sacubitril/valsartan improves heart failure outcomes and increases the kidney sensitivity for diuretics. We explored whether sacubitril/valsartan is associated with less utilization of loop diuretics in patients guided with haemodynamic monitoring in the CardioMEMS European Monitoring Study for Heart Failure (MEMS-HF). METHODS AND RESULTS: The MEMS-HF population (n = 239) was separated by the use of sacubitril/valsartan (n = 68) or no use of it (n = 164). Utilization of diuretics and their doses was prespecified in the protocol and was monitored in both groups. Multivariable regression, ANCOVA, and a generalized linear model were used to fit baseline covariates with furosemide equivalents and changes for 12 months. MEMS-HF participants (n = 239) were grouped in sacubitril/valsartan users [n = 68, 64 ± 11 years, left ventricular ejection fraction (LVEF) 25 ± 9%, cardiac index (CI) 1.89 ± 0.4 L/min/m2 ] vs. non-users (n = 164, 70 ± 10 years, LVEF 36 ± 16%, CI 2.11 ± 0.58 L/min/m2 , P = 0.0002, P < 0.0001, and P = 0.0015, respectively). In contrast, mean pulmonary artery pressure (PAP) values were comparable between groups (29 ± 11 vs. 31 ± 11 mmHg, P = 0.127). Utilization of loop diuretics was lower in patients taking sacubitril/valsartan compared with those without (P = 0.01). Significant predictor of loop diuretic use was a history of renal failure (P = 0.005) but not age (P = 0.091). After subjects were stratified by sacubitril/valsartan or other diuretic use, PAP was nominally, but not significantly lower in sacubitril/valsartan-treated patients (baseline: P = 0.52; 6 months: P = 0.07; 12 months: P = 0.53), while there was no difference in outcome or PAP changes. This difference was observed despite lower CI (P = 0.0015). Comparable changes were not observed for other non-loop diuretics (P = 0.21). CONCLUSIONS: In patients whose treatment was guided by remote PAP monitoring, concomitant use of sacubitril/valsartan was associated with reduced utilization of loop diuretics, which could potentially be relevant for outcomes.

Pulmonary artery pressure-guided therapy in ambulatory patients with symptomatic heart failure: the CardioMEMS European Monitoring Study for Heart Failure (MEMS-HF).

AIMS: Heart failure (HF) leads to repeat hospitalisations and reduces the duration and quality of life. Pulmonary artery pressure (PAP)-guided HF management using the CardioMEMS™ HF system was shown to be safe and reduce HF hospitalisation (HFH) rates in New York Heart Association (NYHA) class III patients. However, these findings have not been replicated in health systems outside the United States. Therefore, the CardioMEMS European Monitoring Study for Heart Failure (MEMS-HF) evaluated the safety, feasibility, and performance of this device in Germany, The Netherlands, and Ireland. METHODS AND RESULTS: A total of 234 NYHA class III patients (68 ± 11 years, 22% female, ≥1 HFH in the preceding year) from 31 centres were implanted with a CardioMEMS sensor and underwent PAP-guided HF management. One-year rates of freedom from device- or system-related complications and from sensor failure (co-primary outcomes) were 98.3% [95% confidence interval (CI) 95.8-100.0] and 99.6% (95% CI 97.6-100.0), respectively. Survival rate was 86.2%. For the 12 months post- vs. pre-implant, HFHs decreased by 62% (0.60 vs. 1.55 events/patient-year; hazard ratio 0.38, 95% CI 0.31-0.48; P < 0.0001). After 12 months, mean PAP decreased by 5.1 ± 7.4 mmHg, Kansas City Cardiomyopathy Questionnaire (KCCQ) overall/clinical summary scores increased from 47.0 ± 24.0/51.2 ± 24.8 to 60.5 ± 24.3/62.4 ± 24.1 (P < 0.0001), and the 9-item Patient Health Questionnaire sum score improved from 8.7 ± 5.9 to 6.3 ± 5.1 (P < 0.0001). CONCLUSION: Haemodynamic-guided HF management proved feasible and safe in the health systems of Germany, The Netherlands, and Ireland. Physician-directed treatment modifications based on remotely obtained PAP values were associated with fewer HFH, sustainable PAP decreases, marked KCCQ improvements, and remission of depressive symptoms.

Cold atmospheric plasma: a new tool for the treatment of superficial driveline infections.

Percutaneous driveline infections (DI) are leading factors for morbidity and mortality in ventricular assist device (VAD) patients. In recent years, cold atmospheric plasma (CAP) has been safely and effectively used in clinical settings to treat topical infections. We describe the first use of CAP to treat a superficial DI. CAP was applied with the kinPen® MED plasma jet device (neoplas tools GmbH, Greifswald, Germany), in the treatment of a DI in a 66-year-old VAD patient in Klinikum Karlsburg, Germany. The patient received a daily application of CAP of 1 min for 12 days. One CAP application was administered each week for 4 weeks in our outpatient clinic after patient discharge. Laboratory tests were conducted and photographs of the driveline exit site were taken. After CAP treatment, the local infection was completely regressed without any signs of exudation or recurrence of the infection. There were no adverse side effects observed, and the HVAD logfile data did not show any abnormalities during treatment. Here, we demonstrate a successful resolution of a VAD DI with the kinPen plasma jet device. We believe that CAP has the potential to be a simple and effective tool in the treatment of superficial DIs.

New insights into bicuspid aortic valve disease: the elongated anterior mitral leaflet.

OBJECTIVES: The bicuspid aortic valve (BAV) is associated with various cardiovascular malformations, most predominantly with dilatation of the aortic root and ascending aorta. After sporadic observations of various BAV-associated mitral valve pathologies, we sought to systematically examine the mitral valve morphology in patients with a BAV. METHODS: Forty-four operated patients with a BAV (type I L/R) and 40 operated patients with a tricuspid aortic valve (TAV) as well as 20 healthy subjects (Normal) were examined by means of transthoracic echocardiography. In all patients, the primary operative indication was aortic valve pathology (stenosis/regurgitation), and no patients with degenerative mitral valve pathology were included. RESULTS: In patients with a BAV, the anterior mitral leaflet (AML) was significantly elongated in comparison with patients with a TAV and Normal subjects (33.2 ± 6.6 vs 27.7 ± 3.2 vs 27.0 ± 1.9 mm; P < 0.001). Regression analysis revealed that patients with a BAV had significantly elongated AML (P < 0.001) even after correcting for the mitral annulus (MA) diameter and somatometric characteristics (weight, height, body surface area, age). Furthermore, patients with a BAV and concomitant aortic valve insufficiency had significantly elongated AML in comparison with the other groups (35.2 ± 7.6 vs 28.4 ± 3.7 mm; P < 0.001). This difference persisted even after correcting for MA diameter and somatometric differences (P < 0.001). AML heights >32 mm in patients undergoing aortic root/valve procedures were highly predictive of the presence of a BAV [specificity: 90%, positive predictive value: 82%, area under curve: 0.80 (95% CI: 0.71-0.88)]. CONCLUSIONS: We provide evidence that the cardiovascular alterations observed in the BAV are not limited to the aortic valve or ascending aorta but also involve the AML, and seem to be more pronounced in patients with a BAV with concomitant, clinically significant aortic regurgitation.

Influence of crank length and crank width on maximal hand cycling power and cadence.

The effect of different crank lengths and crank widths on maximal hand cycling power, cadence and handle speed were determined. Crank lengths and crank widths were adapted to anthropometric data of the participants as the ratio to forward reach (FR) and shoulder breadth (SB), respectively. 25 able-bodied subjects performed maximal inertial load hand cycle ergometry using crank lengths of 19, 22.5 and 26% of FR and 72, 85 and 98% of SB. Maximum power ranged from 754 (246) W for the crank geometry short wide (crank length x crank width) to 873 (293) W for the combination long middle. Every crank length differed significantly (P < 0.05) from each other, whereas no significant effect of crank width to maximum power output was revealed. Optimal cadence decreased significantly (P < 0.001) with increasing crank length from 124.8 (0.9) rpm for the short to 107.5 (1.6) rpm for the long cranks, whereas optimal handle speed increased significantly (P < 0.001) with increasing crank length from 1.81 (0.01) m/s for the short to 2.13 (0.03) m/s for the long cranks. Crank width did neither influence optimal cadence nor optimal handle speed significantly. From the results of this study, for maximum hand cycling power, a crank length to FR ratio of 26% for a crank width to SB ratio of 85% is recommended.

Differences in the recovery of platelet counts after biological aortic valve replacement.

Observations among Karlsburg patients in 2006 revealed that the majority of very low platelet levels inducing postoperative heparin-induced-thrombocytopenia (HIT)-diagnostics with at the end negative results appeared related to aortic valve replacement (AVR) with stentless bioprostheses. We compared the postoperative courses of platelet counts in patients having had AVR with stentless prostheses (Sorin Biomedica Freedom Solo [SOLO]) or stented prostheses (Carpentier Edwards Perimount [PM]). Between February 2005 and April 2007, 209 patients received AVR with SOLO, in 137 patients a PM-prosthesis was implanted. The mean platelet levels were compared from the first up to the fifth postoperative day. A higher occurrence of platelet levels below 100 Gpt/l between the second and the fifth postoperative day was found in the SOLO-group (71.9%) compared with the other biological substitute PM (36.6%). Differences in platelet counts between SOLO- and PM-subgroups were measured for day 2 (P=0.03), day 3 (P=0.0004) day 4 (P=0.0007), day 5 (P=0.0002) and at discharge (P<0.0001). Following intervention with conventional biological AVR, differences in the postoperative recovery of platelet counts can be detected, depending on the prosthesis used. The causes for and the clinical implications of this phenomenon are not yet assessed.