Report on outcomes of valve-in-valve transcatheter aortic valve implantation and redo surgical aortic valve replacement in the Netherlands.

OBJECTIVE: We sought to investigate real-world outcomes of patients with degenerated biological aortic valve prostheses who had undergone valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) or reoperative surgical aortic valve replacement (redo-SAVR) in the Netherlands. METHODS: Patients who had undergone ViV-TAVI or redo-SAVR for a degenerated biological aortic valve prosthesis in the Netherlands between January 2014 and December 2018 were eligible for this retrospective study. Patients with a prior homograft, active endocarditis or mechanical aortic valve prosthesis were excluded. Patients were matched using the propensity score. The primary endpoint was a composite of 30-day all-cause mortality and in-hospital postoperative stroke. Secondary endpoints were all-cause mortality at different time points, in-hospital postoperative stroke, pacemaker implantation and redo procedures within one year. Baseline characteristics and outcome data were collected from the Netherlands Heart Registration. RESULTS: From 16 cardiac centres, 653 patients were included in the study (374 ViV-TAVI and 279 redo-SAVR). European System for Cardiac Operative Risk Evaluation I (EuroSCORE I) was higher in ViV-TAVI patients (19.4, interquartile range (IQR) 13.3-27.9 vs 13.8, IQR 8.3-21.9, p < 0.01). After propensity score matching, 165 patients were matched with acceptable covariate balance. In the matched cohorts, the primary endpoint was not significantly different for ViV-TAVI and redo-SAVR patients (odds ratio 1.30, 95% confidence interval 0.57-3.02). Procedural, 30-day and 1­year all-cause mortality rates, incidence of in-hospital postoperative stroke, pacemaker implantation and redo procedures within one year were also similar between cohorts. CONCLUSION: Patients with degenerated aortic bioprostheses treated with ViV-TAVI or redo-SAVR have similar mortality and morbidity.

Can sterilization of disposable face masks be an alternative for imported face masks? A nationwide field study including 19 sterilization departments and 471 imported brand types during COVID-19 shortages.

BACKGROUND: Face masks, also referred to as half masks, are essential to protect healthcare professionals working in close contact with patients with COVID-19-related symptoms. Because of the Corona material shortages, healthcare institutions sought an approach to reuse face masks or to purchase new, imported masks. The filter quality of these masks remained unclear. Therefore, the aim of this study was to assess the quality of sterilized and imported FFP2/KN95 face masks. METHODS: A 48-minute steam sterilization process of single-use FFP2/KN95 face masks with a 15 minute holding time at 121°C was developed, validated and implemented in the Central Sterilization Departments (CSSD) of 19 different hospitals. Masks sterilized by steam and H2O2 plasma as well as new, imported masks were tested for particle filtration efficiency (PFE) and pressure drop in a custom-made test setup. RESULTS: The results of 84 masks tested on the PFE dry particle test setup showed differences of 2.3±2% (mean±SD). Test data showed that the mean PFE values of 444 sterilized FFP2 face masks from the 19 CSSDs were 90±11% (mean±SD), and those of 474 new, imported KN95/FFP2 face masks were 83±16% (mean±SD). Differences in PFE of masks received from different sterilization departments were found. CONCLUSION: Face masks can be reprocessed with 121 °C steam or H2O2 plasma sterilization with a minimal reduction in PFE. PFE comparison between filter material of sterilized masks and new, imported masks indicates that the filter material of most reprocessed masks of high quality brands can outperform new, imported face masks of unknown brands. Although the PFE of tested face masks from different sterilization departments remained efficient, using different types of sterilization equipment, can result in different PFE outcomes.

Is there an adequate alternative to commercially manufactured face masks? A comparison of various materials and forms.

BACKGROUND: There is a worldwide shortage of medical-grade face masks. Donning masks can play an important role in curbing the spread of SARS-CoV-2. AIM: To conclude whether there is an effective mask for the population to wear in public that could easily be made during a medical face mask shortage using readily available materials. METHODS: We determined the effectiveness of readily available materials and models for making a face mask. The outcomes were compared with N95/FFP2/KN95 masks that entered the Netherlands in April-May 2020. Masks were tested to determine whether they filtered a minimum of 35% of 0.3-µm particles, are hydrophobic, seal on the face, are breathable, and can be washed. FINDINGS: Fourteen of the 25 (combinations of) materials filtered at least 35% of 0.3-µm particles. Four of the materials proved hydrophobic, all commercially manufactured filters. Two models sealed the face. Twenty-two of the 25 materials were breathable at <0.7 mbar. None of the hydrophobic materials stayed intact after washing. CONCLUSIONS: It would be possible to reduce the reproduction rate of SARS-CoV-2 from 2.4 to below one if 39% of the population would wear a mask made from ePM1 85% commercially manufactured filter fabric and in a duckbill form. This mask performs better than 80% of the imported N95/FFP2/KN95 masks and provides a better fit than a surgical mask. Two layers of quilt fabric with a household paper towel as filter is also a viable choice for protecting the user and the environment.

Stentless bioprostheses have ideal haemodynamics, even in the small aortic root.

OBJECTIVE: To determine normal Doppler and 2D gradients and flow characteristics of the Freestyle stentless aortic bioprosthesis related to valve size. BACKGROUND: The Freestyle stentless aortic bioprosthesis is one of the newer aortic xenografts. Only limited data are available of the echocardiographic flow characteristics during a mid-term follow-up period of this valve. Therefore valve performance related to valve size was measured during a follow-up period of two years. METHODS: 175 consecutive patients with a Freestyle aortic bioprosthesis underwent an echocardiographic and Doppler examination according to a common protocol. Investigations were done within 4 weeks after operation, after 3 to 6 months, and after 1 and 2 years. RESULTS: With a valve size from 19 to 27 mm mean gradients decreased from 8.0 +/- 5.1 mmHg at discharge to 5.8 +/- 3.8 mmHg after 3-6 months (p < 0.001). Thereafter gradients remained stable. The performance index, the ratio of the measured effective orifice area in the patient divided by the effective orifice area measured in vitro increased from 69 +/- 20% at discharge to 79 +/- 29% after one, two and three years. Performance index was especially very high in the smaller sized valves with a performance index of 85 +/- 17% for the 21 mm valve. During follow-up mean gradients remained below 10 mmHg even in the 21 mm valve. CONCLUSION: Stentless xenografts have ideal haemodynamics, even in the small aortic root.

Echocardiographic parameters of the freestyle stentless bioprosthesis in aortic position: the European experience.

The objective of this study was to determine normal Doppler and 2-dimensional characteristics of the Freestyle stentless aortic bioprosthesis. The Freestyle aortic bioprosthesis is a new type of aortic xenograft, and experience is limited. We therefore determined the normal range of echocardiographic and Doppler examinations of this valve. Three hundred thirty-nine consecutive patients with a Freestyle aortic bioprosthesis underwent an echocardiographic and Doppler examination according to a common protocol. Investigations were done within 4 weeks after operation, after 3 to 6 months, and after 1, 2, and 3 years. With a valve size from 19 to 27 mm, mean gradients decreased from 7.9 +/- 5.1 mm Hg at discharge to 5.5 +/- 3. 8 mm Hg after 3 to 6 months (P <.001). Thereafter, gradients remained stable. Effective orifice area 1 year after implantation was 1.59 +/- 0.58 cm(2) for the 21-mm valves, 1.92 +/- 0.74 cm(2) for the 23-mm valves, 2.03 +/- 0.64 cm(2) for the 25-mm valves, and 2.52 +/- 0.72 cm(2) for the 27-mm valves (P <.001). The performance index, the ratio of the measured effective orifice area in the patient divided by the effective orifice area measured in vitro, increased from 67% +/- 20% at discharge to 82% +/- 29% after 1, 2, and 3 years. Performance index was especially very high in the smaller-sized valves. After implantation with the subcoronary technique or root-inclusion technique, small cavities could be seen between the native aortic root and the Freestyle valve. Doppler values were evaluated for the Freestyle stentless porcine bioprostheses in the aortic root. Gradients appear to be close to those measured in native valves over a time period of 3 years.

Efficacy and safety of a blood conservation program including low-dose aprotinin in routine myocardial revascularization.

OBJECTIVES: We attempted to analyze the efficacy and safety of an extensive blood saving program applied in a large cohort of patients. MEASURES: Blood saving included reinfusion of intraoperative predonated blood, aprotinin (2 million KIU) in the prime solution, reinfusion of any residual volume, postoperative acceptance of normovolemic anemia (hematocrit > or = 25%) and autotransfusion of shed blood. SETTING, EXPERIMENTAL DESIGN AND PATIENTS: In our general hospital with a heart surgery service (1150 cases/year), we studied the records of 527 non-selected consecutive patients, who were prospectively treated with this program being applied in primary myocardial revascularization between. RESULTS: We avoided the use of donor blood in 86.9% of the patients requiring a mean of 0.2+/-0.01 unit of donor blood per patient. No repeat thoracotomy for bleeding was needed in any patient. Univariate analysis revealed that female gender, a low level of hematocrit, high age, a small stature, weight, body surface area, and red cell volume prebypass significantly (p<0.001) were correlated to treatment with donor blood. Multiple regression showed that a small red cell volume and a low prebypass hematocrit were the most (p<0.0001) significant predictors for the use of donor blood. Observing a low incidence of morbidity (myocardial infarction, gastrointestinal, neurological thromboembolic, renal and wound complications), the safety of this program seems to be emphasized. CONCLUSIONS: Extensive blood saving including low-dose aprotinin reduced effectively and safely the need for donor blood in a large cohort of patients.

The Monostrut prosthetic valve. Predictors for valve-related events during an eight years' experience.

All postoperative complications, including transient ischaemic attacks (TIA) and cerebrovascular accidents (CVA) of 259 patients, in whom a total of 301 Monostrut tilting-disc valves were implanted between January 1985 and December 1991 were evaluated retrospectively. The follow-up was maximally 8 years, with a mean of 3.5 years, and totaled 914 patient-years. In this study we found no mechanical deterioration of the Monostrut valve and demonstrated the elimination of valve thrombosis in patients receiving adequate anticoagulation. The actuarial probability of being free of thrombo-embolism was 94.7% +/- 1.7% and free of anticoagulant related hemorrhage 95.4% +/- 1.5% at 8-years. In comparison with earlier reports by others, our findings show a lower ratio of thromboembolic and hemorrhagic events. We demonstrated a correlation (p < 0.05) between thrombo-embolic and hemorrhagic complications. In addition, a lower incidence of CVA's (0.22 per 100 patient-years), but a higher incidence of TIA's (0.66 per 100 patient-years) in comparison with the general Dutch population was found. At eight years follow-up, all patients were in Class I or II of the New York Heart Association Classification. Although the overall valve related event-free survival at eight years was only 47.9%, 93.5% of the patient were satisfied with their operative result. Predictive factors for late mortality were the occurrence of paravalvular leakage (p < 0.01), the age of the patient at the time of operation (p < 0.01) and the number of diseases coronary arteries (p < 0.01).(ABSTRACT TRUNCATED AT 250 WORDS)