Telemedical management in patients waiting for transcatheter aortic valve implantation: the ResKriVer-TAVI study design

AimsThe majority of patients with severe aortic stenosis (AS) planned for transcatheter aortic valve implantation (TAVI) are elective outpatients. During the COVID-19 pandemic, the time between the heart team’s decision and TAVI increased due to limited healthcare resources. We therefore implemented telemedical approaches to identify AS patients at risk for clinical deterioration during the waiting time. The purpose of the prospective, randomized, controlled ResKriVer-TAVI study (DRKS00027842) is to investigate whether a digital concept of telemedical interventional management (TIM) in AS patients waiting for TAVI improves the clinical outcomes. In the present article, we report the study protocol of the ResKriVer-TAVI trial.MethodsResKriVer-TAVI will enroll AS patients planned for elective TAVI. Randomization to the TIM group or standard care will be made on the day of the heart team’s decision. TIM will include a daily assessment of weight, blood pressure, a 2-channel electrocardiogram, peripheral capillary oxygen saturation, and a self-rated health status until admission for TAVI. TIM will allow optimization of medical therapy or an earlier admission for TAVI if needed. Standard care will not include any additional support for patients with AS. All patients of the TIM group will receive a rule-based TIM including standard operating procedures when a patient is crossing prespecified values of a vital sign.ResultsThe primary endpoint consists of days lost due to cardiovascular hospitalization and death of any cause within 180 days after the heart team’s decision. Major secondary endpoints include all-cause mortality within 365 days, the number of telemedical interventions, and adherence to TIM. Follow-up visits will be conducted at admission for TAVI as well as 6 and 12 months after the heart team’s decision.ConclusionsResKriVer-TAVI will be the first randomized, controlled trial investigating a telemedical approach before TAVI in patients with AS. We hypothesize that primary and secondary endpoints of AS patients with TIM will be superior to standard care. The study will serve to establish TIM in the clinical routine and to increase the resilience of TAVI centers in situations with limited healthcare resources

Retrospektive Analyse von Faktoren, die die Aplasiedauer nach intensiver Chemotherapie bei Patienten mit Akuter Myeloischer Leukämie (AML) beeinflussen

Die Akute Myeloische Leukämie (AML) ist eine klonale Neoplasie der hämatopoetischen Stammzellen, die das Knochenmark, das Blut und andere Organe infiltriert (Döhner and Bloomfield, 2015; Herold, 2015). Patienten mit malignen hämatologischen Erkrankungen haben ein erhöhtes Risiko an einer invasiven Pilzinfektion zu erkranken, dies gilt insbesondere für Patienten mit prolongierter und starker Neutropenie, die bei Patienten nach intensiver Chemotherapie regelhaft auftritt (Rodríguez-Veiga et al., 2019). Von einer schweren Neutropenie spricht man, wenn der Wert der Neutrophilen Granulozyten im Blut 500 Zellen/ μL unterschreitet (Herold, 2015, p.66). Aus diesem Grund gibt es eine starke Empfehlung zur Anwendung einer antimykotischen Prophylaxe bei diesen Patienten (Mellinghoff et al., 2018). Hierfür kommen verschiedene Azol- Antimykotika zum Einsatz. Nach Umstellen des Standards der antimykotischen Prophylaxe bei AML- Patienten nach intensiver Chemotherapie auf Posaconazol, welches auf Grund mehrerer Studien zur Erstlinienanwendung empfohlen wurde, schien die Rate an prolongierter Neutropenie und Thrombozytopenie zuzunehmen (Mellinghoff et al., 2018). Ziel dieser retrospektiven Studie war es Hinweise zu ermitteln, ob dieser Zusammenhang zufällig ist oder ob die Gabe von Posaconazol tatsächlich durch Arzneimittelwechselwirkungen mit den eingesetzten Zytostatika zu einer verlängerten Aplasiedauer führen könnte. Hier untersuchten wir den Einfluss der antimykotischen Medikation und anderer Faktoren auf die Dauer der Aplasie an Patienten mit AML in der Klinik für Hämatologie und Onkologie der Universitätsmedizin Greifswald. Es konnten 83 erwachsene Patienten mit einem medianen Alter von 54 Jahren in die Studie eingeschlossen und 218 Therapiezyklen ausgewertet werden. Es zeigten sich signifikante Assoziationen zwischen der Dauer der Aplasie der Neutrophilen und der Medikation mit Voriconazol oder Posaconazol im Vergleich zu Fluconazol oder keiner antimykotischen Prophylaxe. Insbesondere in den zweiten und dritten Chemotherapie- Zyklen zeigte sich ein erhöhtes Risiko einer prolongierten Aplasie für Neutrophile bei der Anwendung mit Posaconazol oder Voriconazol. Für die Thrombozyten- Regeneration zeigten sich Assoziationen, die zwar nicht signifikant waren, allerdings den gleichen Trend anzeigen. Es erscheint uns möglich, dass hier auf Grund des Interaktionspotenzials von Posaconazol und Voriconazol ein erhöhtes Risiko einer prolongierten Aplasie besteht.Acute myeloid leukemia (AML) is a clonal neoplasm of hematopoietic stem cells that infiltrates the bone marrow, blood, and other organs (Döhner and Bloomfield, 2015; Herold, 2015). Patients with hematologic malignancies are at increased risk of invasive fungal infection, especially those with prolonged and severe neutropenia, which is a regular side effect in patients after intensive chemotherapy (Rodríguez-Veiga et al., 2019). Severe neutropenia is when the value of neutrophil granulocytes in the blood falls below 500 cells/ µL (Herold, 2015, p.66). For this reason, there is a strong recommendation to use antifungal prophylaxis in these patients (Mellinghoff et al., 2018). Various azole antifungal drugs are used for this purpose. After switching the standard of antifungal prophylaxis in AML- patients after intensive chemotherapy to posaconazole, the rate of prolonged neutropenia and thrombocytopenia seemed to increase (Mellinghoff et al., 2018). The aim of this retrospective study was to determine evidence of whether this association was coincidental or whether posaconazole administration could actually lead to prolonged aplasia due to drug interactions with the cytostatic drugs used in chemotherapy. Here, we investigated the influence of antifungal medication and other factors on the duration of aplasia in patients with AML at the Department of Hematology and Oncology, Greifswald University Medicine, Germany. Eighty-three adult patients with a median age of 54 years were included in the study and 218 cycles of therapy were evaluated. Significant associations were found between the duration of neutrophil aplasia and medication with voriconazole or posaconazole compared to fluconazole or no antifungal prophylaxis. In particular, the second and third chemotherapy cycles showed an increased risk of prolonged aplasia for neutrophils when after administration of posaconazole or voriconazole. For thrombocyte regeneration, associations were shown that, although not significant, indicated the same trend. It seems possible to us that there is an increased risk of prolonged aplasia here due to the interaction potential of posaconazole and voriconazole with the chemotherapeutic drugs themselves

Right heart and left atrial strain to differentiate cardiac amyloidosis and Fabry disease

Abstract Echocardiographic differentiation of cardiac amyloidosis (CA) and Fabry disease (FD) is often challenging using standard echocardiographic parameters. We retrospectively analyzed the diagnostic accuracy of right heart and left atrial strain parameters to discriminate CA from FD using receiver operating characteristic curve analyses and logistic regression models. A total of 47 FD and 88 CA patients with left ventricular wall thickening were analyzed. The comparison of both cardiomyopathies revealed significantly reduced global and free wall longitudinal right ventricular strain (RVS; global RVS: CA − 13 ± 4%, n = 67, vs. FD − 18 ± 4%, n = 39, p < 0.001) as well as right atrial strain (RAS; reservoir RAS: CA 12 ± 8%, n = 70, vs. FD 26 ± 9%, n = 40, p < 0.001) and left atrial strain (LAS) in CA patients. Individually, global RVS as well as phasic LAS and RAS showed the highest diagnostic accuracy to distinguish CA and FD. The best diagnostic accuracy was achieved by combining the age, basal RV diameter, global RVS, and reservoir and conduit RAS (area under the curve 0.96 [95% CI 0.90–1.00]). Differential echocardiographic diagnostic work-up of patients with suspected CA or FD can be improved by integrating structural and functional parameters of the right heart and the left atrium. Trial registration: DRKS00027403