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Incidence, Predictors, and Implications of Access Site Complications With Transfemoral Transcatheter Aortic Valve Implantation
Our study objective was to assess the incidence, predictors, and implications of access site complications related to transfemoral transcatheter aortic valve implantation (TAVI). We pooled the prospective TAVI databases of 5 experienced centers in Europe enrolling only transfemoral cases for this analysis. Access site complications were defined according to the Valve Academic Research Consortium end-point definitions. The global transfemoral TAVI database contained 986 patients. Percutaneous access and closure was performed in 803 patients (81%) and a surgical strategy in 183 (19%). Incidences of major vascular complications, life-threatening/disabling bleeding, and major bleeding were 14.2%, 11%, and 17.8% respectively. In the patient cohort with a completely percutaneous access strategy, major vascular complications and life-threatening/disabling bleedings were related to closure device failure in 64% and 29%, respectively. Female gender (odds ratio 1.63, 95% confidence interval 1.12 to 2.36) and use of >19Fr system (2.87, 1.68 to 4.91) were independent predictors for major vascular complications. Female gender (odds ratio 2.04, 95% confidence interval 1.31 to 3.17), use of >19Fr system (1.86, 1.02 to 3.38), peripheral arterial disease (2.14, 1.27 to 3.61), learning effect (0.45, 0.27 to 0.73), and percutaneous access strategy (2.39, 1.16 to 4.89) were independently associated with life-threatening/disabling bleedings. In conclusion, transfemoral TAVI is associated with a >10% incidence of major vascular-related complications. A considerable number of these events is related to arteriotomy closure failure. Arterial sheath size and female gender are important determinants of major vascular complications and life-threatening/disabling bleeding.
Journal Article
Davidson's principles and practice of medicine / editors Christopher Haslett and 3 others ; illustrated by Robert Britton
\"An internationally famous and best-selling medical textbook, Davidson is renowned for providing a rational and easily understood basis for the practice of medicine. As a concise yet up-to-date and comprehensive text on clinical medicine, it has met the requirements of several generations of medical students preparing for their final examinations.\" \"The evolution of this classic textbook continues in this Eighteenth Edition, with colour utilised to enhance the presentation of the content, while the text has been restructured and updated throughout in keeping with the expanding knowledge base of disease pathogenesis and clinical practice.\"--Jacket.
Book
Adverse impact of bleeding and transfusion on the outcome post-transcatheter aortic valve implantation: Insights from the Pooled-RotterdAm-Milano-Toulouse In Collaboration Plus (PRAGMATIC Plus) initiative
Little is known about the impact of bleeding and red blood cells transfusion (RBC) on the outcome post transcatheter aortic valve implantation (TAVI).
Between November 2005 and August 2011, 943 consecutive patients underwent TAVI. Bleeding was assessed according to the Valve Academic Research Consortium definitions. Patients receiving RBC were compared to those not requiring transfusion.
Life-threatening and major bleedings occurred respectively in 13.9% and 20.9% of the patients, significantly more frequently in the RBC cohort. Vascular complications occurred in 23.2% of the patients. Major and minor vascular complications were more frequent in the RBC group: 19.3 vs 5.2%, P < .001; 15.3 vs 9%, P = .003, respectively. Thirty-day all-cause mortality was 7.2%. Of the overall cohort, 38.9% required RBC transfusion; those receiving at least 4 U of RBC had higher 30-day all-cause mortality than those receiving 1 to 4 U of RBC and those not requiring transfusion: 14.4%, vs 6.3% vs 6.3%, respectively, P = .008. By multivariate analysis, transfusion of RBC was associated with an increased 30-day and 1-year mortality. Major stroke and all stages of acute kidney injury were significantly more frequent in the RBC cohort.
Bleeding is frequent after TAVI, mainly driven by vascular complications. RBC transfusion was associated with increased mortality at 1 year and increased risk of major stroke and acute kidney injury. Specific scores are needed to identify the patients at higher risk for TAVI-related bleeding and RBC transfusion.
Journal Article
Socio-Economic Inequalities and Heart Failure Morbidity and Mortality: A Systematic Review and Data Synthesis
Abstract
Socio-economic status (SES) has been associated with incident and prevalent heart failure (HF), as well as its morbidity and mortality. However, the precise nature of the relationship between SES and HF remains unclear due to inconsistent data. This study aims to provide a comprehensive assessment and data synthesis of the relationship between SES and HF morbidity and mortality. We performed a systematic search and data synthesis using six databases following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Guidelines. The included studies comprised observational studies that reported on HF incidence and prevalence, HF hospitalizations, worsening HF (WHF) and all-cause mortality, as well as treatment options (medical, device and advanced HF therapies). SES was measured on both individual and area levels, encompassing single (e.g., income, education, employment, social risk score, living conditions and housing characteristics) and composite indicators. Among the 4124 studies screened, 79 were included, with an additional 5 identified through cross-referencing. In the majority of studies, a low SES was associated with an increased HF incidence (72%) and prevalence (75%). For mortality, we demonstrated that low SES was associated with increased mortality in 45% of the studies, with 18% of the studies showing mixed results (depending on the indicator, gender or follow-up) and 38% showing non-significant results. Similar patterns were observed for the association between SES, WHF, medical therapy prescriptions and the utilization of devices and advanced HF therapies. There was no clear pattern in the used SES indicators and HF outcomes. This systematic review, using contemporary data, shows that while socio-economic disparity may influence HF incidence, management and subsequent adverse events, these associations are not uniformly predictive. Our review highlights that the impact of SES varies depending on the specific indicators used, reflecting the complexity of its influence on health disparities. Assessment and recognition of SES as an important risk factor can assist clinicians in early detection and customizing HF treatment, while also aiding policymakers in optimizing resource allocation.
Journal Article
Transforming echocardiography with artificial intelligence
The system performs automated view classification, image quality assessment, segmentation, and quantification of 68 guideline-recommended parameters, including left and right ventricular volumes and function, atrial size, Doppler indices (e.g., E/e’), and global longitudinal strain [1, 2–3]. An automated audit trail is incorporated, allowing careful post-analysis follow-up for any necessary future evaluations of system performance. At Erasmus MC, although a large proportion of referrals are complex, the overall demand for echocardiography is rising, particularly in structured follow-up programmes for cardio-oncology, valve disease, and genetic screening.
Journal Article
A scoping review on advancements in noninvasive wearable technology for heart failure management
Wearables offer a promising solution for enhancing remote monitoring (RM) of heart failure (HF) patients by tracking key physiological parameters. Despite their potential, their clinical integration faces challenges due to the lack of rigorous evaluations. This review aims to summarize the current evidence and assess the readiness of wearables for clinical practice using the Medical Device Readiness Level (MDRL). A systematic search identified 99 studies from 3112 found articles, with only eight being randomized controlled trials. Accelerometery was the most used measurement technique. Consumer-grade wearables, repurposed for HF monitoring, dominated the studies with most of them in the feasibility testing stage (MDRL 6). Only two of the described wearables were specifically designed for HF RM, and received FDA approval. Consequently, the actual impact of wearables on HF management remains uncertain due to limited robust evidence, posing a significant barrier to their integration into HF care.
Journal Article
Effect of Body Mass Index on Short- and Long-Term Outcomes After Transcatheter Aortic Valve Implantation
Better outcomes have been reported after percutaneous cardiac intervention in obese patients (“obesity paradox”). However, limited information is available on the effect of the body mass index on the outcomes after transcatheter aortic valve implantation (TAVI). We, therefore, sought to determine the effect of the body mass index on the short- and long-term outcomes in patients who underwent TAVI. The population consisted of 940 patients, of whom 25 (2.7%) were underweight, 384 had a (40.9%) normal weight, 372 (39.6%) were overweight, and 159 (16.9%) were obese. Overall, the obese patients were younger (79.7 ± 6.4 years vs 81.7 ± 7.3 and 80.8 ± 7.0 years, p = 0.008) and had a greater prevalence of preserved left ventricular and renal function. On univariate analysis, obese patients had a greater incidence of minor stroke (1.3% vs 0 and 0.3%, p = 0.03), minor vascular complications (15.7% vs 9.1% and 11.6%, p = 0.028) and acute kidney injury stage I (23.3% vs 10.7% and 16.1%, p <0.001). After adjustment, body mass index, as a continuous variable, was associated with a lower risk of mortality at 30 days (odds ratio 0.93, 95% confidence interval 0.86 to 0.98, p = 0.023) and no effect on survival after discharge (hazard ratio 1.01, 95% confidence interval 0.96 to 1.07, p = 0.73). In conclusion, obesity was associated with a greater incidence of minor, but no major, perioperative complications after TAVI. After adjustment, obesity was associated with a lower risk of 30-day mortality and had no adverse effect on mortality after discharge, underscoring the “obesity paradox” in patients undergoing TAVI.
Journal Article
Impact of preoperative chronic kidney disease on short- and long-term outcomes after transcatheter aortic valve implantation: A Pooled-RotterdAm-Milano-Toulouse In Collaboration Plus (PRAGMATIC-Plus) initiative substudy
Only limited and conflicting data on the impact of preoperative chronic kidney disease (CKD) on outcomes after transcatheter aortic valve implantation (TAVI) are available.
We retrospectively analyzed pooled data from the prospective TAVI databases of 4 centers (942 patients). Valve Academic Research Consortium end point definitions were used. The outcomes were compared among patients with normal estimated glomerular filtration rate (≥90 mL/min), mild (60-89 mL/min), moderate (30-59 mL/min), and severe (<30 mL/min) CKD and those on chronic hemodialysis (HD). The primary end point was 1-year survival.
A total of 109 patients had a normal estimated glomerular filtration rate (11.6%); 329 (34.9%) had mild, 399 (42.5%) moderate, 72 (7.5%) severe CKD, and 33 (3.5%) were on HD. Baseline and procedural characteristics were similar among all groups except for Logistic EuroSCORE. Major stroke, life-threatening bleeding, all-cause 30-day mortality (HD 15.2%, severe CKD 8.3%, moderate CKD 8.3%, mild CKD 6.7%, normal 1.8%, P = .007) and 1-year survival (HD 54.8%, severe CKD 67.2%, moderate CKD 80.0%, mild CKD 85.2%, normal eGFR 91.4%, HD vs severe CKD P = .23, severe CKD vs moderate CKD P = .002, moderate CKD vs mild CKD P = .04, moderate CKD vs normal eGFR P = .03, by log-rank test) differed significantly across groups. Through multivariable analysis, HD and severe CKD were independently associated with an increased risk of 1-year mortality (hazard ratios 5.07 [95% CI 1.79-14.35, P = .002] and 4.03 [95% CI 1.52-10.69, P = .005], respectively).
Patients with CKD who undergo TAVI have a higher-risk profile and worse 30-day and 1-year outcomes. Chronic hemodialysis and severe preprocedural CKD are independently associated with an increased risk of 1-year mortality after TAVI.
Journal Article
Delivering hospital care at home in a Dutch Tertiary University Hospital: protocol for a prospective feasibility cohort study evaluating a Virtual Ward for early discharge of inpatients
IntroductionVirtual Wards (VWs) facilitate hospital-level monitoring, diagnostics and treatment within patients’ homes, while the hospital team retains responsibility for care. International research indicates that VWs decrease hospital length of stay without increasing readmissions; however, the feasibility and key operational determinants within Dutch care remain uncertain. This protocol outlines the VW for Early Discharge in Patients Receiving Inpatient Care (VIP Care) study.Methods and analysisThe VIP Care study is a single-centre prospective feasibility cohort study conducted at Erasmus University Medical Center (Erasmus MC), Rotterdam, the Netherlands. The study encompasses seven predefined subcohorts with n=51 eligible patients per subcohort: (1) bacterial, fungal or parasitic infections; (2) viral respiratory infections; (3) dehydration; (4) decompensated heart failure; (5) high-dose corticosteroid treatment; (6) post-transsphenoidal pituitary surgery follow-up and (7) severe inflammatory skin disease with or without bacterial or viral superinfection. Adults who require hospital-level monitoring and/or therapy may qualify for early discharge to the VW.The VW integrates scheduled, patient-performed measurements using (European Conformity) CE-marked devices with structured symptom assessment submitted via a patient application, and data review in an electronic health record-integrated clinician cockpit. Submissions are evaluated by VW tele-nurses using prespecified Early Warning Score based thresholds and an escalation protocol. Patients receive a daily physician telephone review. Diagnostics and treatments are administered at home to hospital standards through established home-care services.The primary outcome (feasibility) is adherence to transfer, defined as the proportion of eligible inpatients who provide written informed consent and are subsequently successfully transferred to the VW. The prespecified feasibility threshold is 30%. Secondary outcomes include reach (eligibility, invitation and consent rates among admitted patients), operational performance during the VW episode (alert frequency and handling, contact volumes and actions), length of stay on the ward and in the VW, emergency department reassessments and 30-day readmissions. Qualitative interviews will be conducted to identify implementation determinants.Ethics and disseminationThe study received approval from the Erasmus MC Medical Ethics Committee (MEC-2024–0060; amendment MEC-2024–0060 A0001). Incremental risk is considered minimal. Written informed consent is obtained. Findings will be disseminated through peer-reviewed publications, conference presentations and an accessible lay summary.Trial registration numberClinicalTrials.gov NCT06936891; CCMO NL85516.078.24. Recruitment began in May 2025 and is ongoing.
Journal Article