Transcatheter mitral valve implantation versus conventional redo surgery for degenerated mitral valve prostheses and rings in a multicenter registry.

OBJECTIVES: Degeneration of mitral prostheses/rings may be treated by redo surgery, and, recently, by transcatheter valve-in-valve/ring implantation. This multicenter registry presents results of transcatheter valve-in-valve and repeat surgery for prostheses/rings degeneration. METHODS: Data provided by 10 German heart centers underwent propensity score-matched retrospective analysis. The primary endpoint was 30-day/midterm mortality. Perioperative outcome was assessed according to the Mitral Valve Academic Research Consortium criteria. Further, the influence of moderate or greater tricuspid regurgitation (TR) on 30-day/midterm mortality was analyzed. RESULTS: Between 2014 and 2019, 273 patients (79 transcatheter mitral valve-in-valve [TM-ViV] and 194 redo mitral valve replacement [Re-MVR]) underwent repeat procedure for mitral prosthesis/ring degeneration. Propensity score matching distinguished 79 patient pairs. European System for Cardiac Operative Risk Evaluation (EuroSCORE) II-predicted risk was 15.7 ± 13.7% in the TM-ViV group and 15.0% ± 12.7% in the Re-MVR group (P = .5336). TM-ViV patients were older (74.73 vs 72.2 years; P = .0030) and had higher incidence of atrial fibrillation (54 vs 40 patients; P = .0233). Severe TR incidence was similar (17.95% in TM-ViV vs 14.10%; P = .1741). Sixty-eight TM-ViV patients previously underwent mitral valve replacement, whereas 41 Re-MVR patients underwent valve repair (P < .0001). Stenosis was the leading degeneration mechanism in 42 TM-ViV versus 22 Re-MVR patients (P < .0005). The 30-day/midterm mortality did not differ between groups. Moderate or greater TR was a predictor of total (odds ratio [OR], 4.36; P = .0011), 30-day (OR, 3.76; P = .0180), and midterm mortality (OR, 4.30; P = .0378), irrespective of group. CONCLUSIONS: In both groups, observed mortality was less than predicted. Redo surgery enabled treatment of concomitant conditions, such as atrial fibrillation or TR. TR was shown to be a predictor of total, 30-day, and midterm mortality in both groups.

Cardiac surgery score (CASUS) improves outcome prediction in patients treated with extracorporal life support (ECLS).

INTRODUCTION: The often-unexpected necessity of extracorporeal life support (ECLS) implies that information on patients and end-organ functions at time of implantation is scarce. However, there is a need for early prognostic indicators and a score predicting the outcome. Therefore, we evaluated established laboratory parameters and widely used intensive care scores - cardiac surgery score (CASUS) and sequential organ failure assessment (SOFA) after ECLS implantation. METHODS: In this retrospective analysis, 90 consecutive adult patients with veno-arterial ECLS were included. Baseline demographic data, laboratory markers, CASUS and SOFA were acquired 12 h after ECLS implantation. RESULTS: A total of 61 patients (67.8%) could be weaned from ECLS and 48 patients (53.3%) were discharged from hospital. Four patients were switched to a left ventricular assist device. The outcome did not depend on indication for ECLS. Furthermore, multivariable regression analysis identified lactate (OR=1.08; 95%CI: 1.01-1.26; p=0.03) and urine output (OR=0.99; 95%CI: 0.986-0.998; p=0.01) as independent predictors of in-hospital mortality. Evaluating intensive care scores, CASUS (AUROC=0.68; 95%CI: 0.57-0.77; p=0.002) had a higher prognostic relevance in comparison with SOFA (AUROC=0.58; 95%CI: 0.47-0.69; p=0.187). CONCLUSIONS: Our data indicate that lactate and urine output are early independent predictors for in-hospital mortality of ECLS patients. The CASUS proved to be a satisfactory evaluation tool with good prognostic abilities in these special patients.

Predictors for quality of life of patients with a portable out-of-centre-implanted extracorporeal membrane oxygenation device.

Objectives: Despite progress in the treatment of cardiopulmonary organ failure, the mortality rate for patients with acute respiratory distress syndrome (ARDS) and cardiogenic shock remains high. Extracorporeal membrane oxygenation (ECMO) is a promising treatment option, but long-term outcomes and health-related quality of life (HRQOL) are unknown. Methods: Detailed information related to pre- and post-device data and outcomes from a consecutive sample of 71 patients treated with ECMO was analysed. Long-term survivors were given a detailed follow-up examination after a median time of 31 months that included multiple scoring systems for HRQOL assessment. Results: Seventy-one patients received a portable out-of-centre-implanted ECMO system. The survival rate at hospital discharge was 48%. Median HRQOL scores were 80% on the Karnofsky index (normal ≥80%), 80% on the Euroqol-5D (normal ≥75%) and 73.1% on the quality-of-life index (normal ≥70%). Mental scores were 96.7% on the Mini-Mental State Examination (normal ≥90.0%), 77.8% on the DemTect (normal ≥72.0%), 87.0% on the test for early detection of dementia with depression demarcation (TFDD; normal ≥74.0%) and confirmed good mental state and HRQOL for patients at follow-up. Univariate analysis for in-hospital mortality indicated that ventilation time before device implantation, higher Acute Physiology and Chronic Health Evaluation (APACHE) II score, higher lactate level at the time of ECMO implantation and female gender were associated with adverse outcomes. Conclusions: In our cohort of patients, survivors of out-of-hospital ECMO implantation demonstrated good mental and quality-of-life conditions with well-recovered cardiopulmonary function during long-term follow-up. The indicators for adverse outcomes, pre-implantation lactate levels, pre-ventilation time and APACHE II score, should be considered before implantation of an ECMO device. Clinical trial: This study is registered at DRKS (Deutsches Register Klinischer Studien) under the code DRKS00009735 and was submitted to the WHO.

Direct aortic access for transcatheter aortic valve replacement with a fully repositionable and retrievable nonmetallic valve system.

OBJECTIVE: The standard procedure of transcatheter aortic valve implantation involves transfemoral access. Nevertheless, the use of this access route is limited by the vessel diameter, calcification, and tortuosity, making a subgroup of patients ineligible for peripheral access. We report the first use of direct aortic transcatheter aortic valve implantation with the Direct Flow Medical valve (Direct Flow Medical, Inc, Santa Rosa, Calif) in 15 patients at the Halle-Wittenberg University. METHODS: Between January 2014 and May 2015, 55 patients with severe aortic valve disease underwent transcatheter aortic valve implantation with the Direct Flow Medical valve at the Halle-Wittenberg University. Subgroups of 15 patients were treated using direct aortic access because of small vessel diameter, excessive calcification, or extreme tortuosity of the iliofemoral vessels. RESULTS: The mean patient age was 79.1 ± 6.72 years, and 10 patients (66%) were male. The mean logistic European System for Cardiac Operative Risk Evaluation was 23.4% ± 16.9%, and the mean Society of Thoracic Surgeons score was 7.8% ± 6.8%. Access related to redo-sternotomy during transcatheter aortic valve implantation was required in 4 patients (27%). Valve retrieval was performed in 2 patients (13%). There was no conversion to surgical aortic valve replacement and no incidence of major stroke. The postimplant mean gradient was 9.3 ± 2.5 mm Hg. No patient had moderate or severe paravalvular leakage. All patients survived the first 30 days. CONCLUSIONS: Direct aortic access seems to be a feasible and safe endovascular alternative for implantation of the Direct Flow Medical valve. This access provides direct and accurate control of the entire implantation procedure.

Cervical Necrotizing Fasciitis--The Value of the Laboratory Risk Indicator for Necrotizing Fasciitis Score as an Indicative Parameter.

PURPOSE: Cervical necrotizing fasciitis (CNF) is uncommon, difficult to diagnose, and rapidly progressive. The objective of the present study was to determine the predictive value of the laboratory risk indicator for necrotizing fasciitis (LRINEC) score for CNF. MATERIALS AND METHODS: The LRINEC score for 16 consecutive cases of CNF and 595 cases of severe non-necrotizing neck infections was determined over a 6.5-year period in a single-center retrospective cohort study and case report. CNF was confirmed by histologic examination and operative report documentation. RESULTS: Using a cutoff score of 6, the LRINEC score had a sensitivity of 0.94 (95% confidence interval [CI] 0.92 to 0.96) and specificity of 0.94 (95% CI 0.70 to 1.00). The positive predictive value was 0.29 (95% CI 0.17 to 0.44), and the negative predictive value was 0.99 (95% CI 0.99 to 1.00). CONCLUSIONS: The LRINEC score can detect early cases of CNF. Patients with a LRINEC score of ≥6 must be carefully evaluated for the presence of CNF.

Evaluation of hemodynamic and regional tissue perfusion effects of minimized extracorporeal circulation (MECC).

Minimized extracorporeal circulation (MECC, Maquet, Cardiopulmonary AG, Hirrlingen, Germany) is an established procedure to perform coronary revascularization. Studies showed positive effects of MECC compared to conventional cardiopulmonary bypass (CCPB) procedures in terms of transfusion requirements, less inflammation reactions, and neurological impairments. Recent retrospective studies showed higher mean arterial pressure (MAP) and a lower frequency of vasoactive drug use. We addressed this issue in this study. The hypothesis was to find a higher MAP during coronary bypass grafting surgery in patients treated with MECC systems. We performed a prospective, controlled, randomized trial with 40 patients either assigned to MECC (n = 18) or CCPB (n = 22) undergoing coronary bypass grafting. Primary endpoints were the perioperative course of mean arterial pressure, and the consumption of norepinephrine. Secondary endpoints were the regional cerebral and renal oxygen saturation (rSO2) as an indicator of area perfusion and the course of hematocrit. Clinical and demographic characteristics did not significantly differ between both groups. Thirty-day mortality was 0%. At four of five time points during extracorporeal circulation (ECC) MAP values were significantly higher in the MECC group compared to CCPB patients (after starting the ECC 60 +/- 11 mmHg vs. 49 +/- 10 mmHg, p = .002). MECC patients received significantly less norepinephrine (MECC 22.5 +/- 35 microg vs. CCPB 60.5 +/- 75 microg, p = .045). The rSO2 measured at right and left forehead and the renal area was similar for both groups during ECC and significantly higher at CCPB group 1 and 4 hours after termination of CPB. Minimized extracorporeal circulation provides a higher mean arterial pressure during ECC and we found a lower consumption of vasoactive drugs in the MECC group. There was a decrease in regional tissue saturation at 1 and 4 hours post bypass in the MECC group possibly due to increased systemic inflammation and extravascular fluid shift in the CCPB group.

Minimal extracorporeal circulation and off-pump compared to conventional cardiopulmonary bypass in coronary surgery.

OBJECTIVES: Although minimal extracorporeal circulation (MECC) and off-pump surgery are equal or better alternatives to conventional cardiopulmonary bypass (CCPB) regarding perioperative morbidity, use of blood and blood products and completeness of revascularization, CCPB is still being used in the majority of coronary artery bypass grafting (CABG) operations. METHODS AND RESULTS: We investigated 1472 CABG operations in our center. A total of 1143 CABG operations were performed using CCPB, 220 using MECC and 109 were performed as off-pump coronary artery bypass (OPCAB). All patients were recorded prospectively. Perioperative follow-up was focused on the occurrence of arrhythmia, neurocognitive disorders and the need of blood and blood products. Operative mortality rates were comparable in all three groups. The mean number of distal anastomoses was 3.2+/-0.6 in the MECC group, 3.4+/-0.7 in the CCPB group and 1.9+/-0.8 in the OPCAB group (P=0.01). Arrhythmia occurred in 25% of the MECC group and in 35.6% of the CCPB group (P=0.05). Arrhythmia occurred in 21.7% of the OPCAB group. Seven patients (3%) of the MECC group suffered neurocognitive disorders perioperatively compared to 74 (7%) patients of the CCPB group (P=0.05) and three patients of the OPCAB group (3%). The median number of blood transfusions per patient was 0.8 in the MECC group, 1.8 in the CCPB group and 0.8 in the OPCAB group (P<0.0001). CONCLUSIONS: Perioperative morbidity of MECC and OPCAB is comparable to or even less in comparison to CCPB. MECC allows CABG surgery in cardiac arrest so that completeness of revascularization is being warranted and longer patency rates can be guaranteed. Furthermore, the use of blood and blood products is significantly less in MECC surgery so that MECC should be considered first choice in CABG surgery over CCPB and OPCAB.