ZEBRA study: The Z stitch Early Bed Rest Assessment study.

Background: Safe and effective management of venous vascular access is a key component of electrophysiology (EP) procedures. Recently, the Z-stitch method has been developed for effective venous hemostasis. However, the standard postprocedure protocol often includes prolonged bed rest, which may affect patient satisfaction. The ZEBRA (Z stitch Early Bed Rest Assessment) study aims to systematically investigate and quantify patient satisfaction metrics and safety parameters associated with the early mobilization after Z-stitch placement. Objective: This study primarily investigates whether early mobilization following Z-stitch placement in venous vascular access management during EP procedures enhances patient satisfaction without compromising safety. Methods: In this prospective, multicenter, randomized clinical trial, approximately 200 patients undergoing various EP procedures at Oregon Health and Science University and Veterans Affairs Portland Health Care System will be randomly assigned to either a 1- or 4-hour bed rest regimen post-Z stitch. Patient satisfaction will be assessed through survey, alongside monitoring for hematomas, bleeding complications, and other safety endpoints. The study includes stratification based on heparin administration and sheath size to ensure robust and nuanced data analysis. Results: We anticipate that early mobilization will lead to higher patient satisfaction scores. We also expect to closely monitor and report the incidence of hematomas, pain medication use, healthcare costs, patient outcomes at 30 days, time to ambulation, and hospital readmissions or emergency visits related to groin complications. Conclusion: The ZEBRA study is poised to fill a critical knowledge gap in postprocedure care in EP labs. By rigorously evaluating the impact of early mobilization on patient satisfaction and safety, this study could significantly influence future guidelines and improve patient experiences in EP procedures.

Biventricular Assist Devices as a Bridge to Heart Transplantation Under the New Donor Heart Allocation System in the United States.

Biventricular assist devices (BiVADs) for pre-heart transplant care is rare. The outcomes of pretransplant BiVAD support after the 2018 heart transplant allocation policy change are entirely unknown at this time. The United Network of Organ Sharing database was retrospectively queried from October 2018 to June 2022 to identify patients supported to transplant with BiVADs. They were compared to patients listed as Status 2 for heart transplantation with an isolated VAD (uni-VAD). The primary outcome of interest was 1 year survival. Secondary outcomes included length of stay, posttransplant stroke, dialysis, and pacemaker implantation. The frequency of BiVAD use for heart transplantation has remained unchanged after the 2018 allocation policy change, making up approximately 2% of transplant recipients annually. Patients supported with BiVADs appeared to be similar to patients supported with uni-VADs. One year survival was similar between the groups (88.57% vs. 87.90%). Length of stay was longer and there was a trend toward higher frequencies of posttransplant dialysis use. Patients supported to transplant with BiVADs appear to have posttransplant outcomes comparable to patients commonly listed as Status 2 with an isolated VAD. Compared to past analyses, there is a suggestion of improved survival with the 2018 allocation policy change.

Eyeball Test for the Assessment of Frailty in Elderly Patients With Cardiovascular Disease: A Prospective Study.

Frailty has been associated with poor outcomes in patients with cardiovascular diseases (CVDs). We aimed to assess the accuracy of the Eyeball test for frailty assessment in elderly patients with CVD. This is a prospective study including stable patients ≥75 years old who were followed-up in a cardiology clinic. Frailty assessment was performed separately through the Eyeball test and the Fried test in a blinded way. Cardiologists were asked to rate the frailty status of participants based on their routine clinical assessment and grade frailty on a Fried-type scale (1 to 5, with frailty defined as a score ≥3). Each patient then underwent formal frailty assessment using the Fried test. Included were 300 consecutive patients with a mean age of 81 ± 6 years. Frailty was diagnosed in 109 (36%) and 125 patients (41%) according to the Fried and Eyeball tests, respectively. The Eyeball test demonstrated 86% sensitivity and 82% specificity for the diagnosis of frailty. A receiver operating characteristics curve analysis demonstrated an area under the curve of 0.82 for the diagnosis of frailty. The Eyeball test demonstrated a very high negative predictive value of 90% and a modest positive predictive value of 73% for frailty assessment. Similar results were observed after subgroup analysis according to age and gender. In conclusion, the Eyeball test is an accurate method to rule out frailty in elderly patients with CVD. However, when frailty is suspected based on the Eyeball test, a formal tool such as the Fried test should be used to confirm the diagnosis.

Five-Year Outcomes of Patients With Mitral Structural Valve Deterioration Treated With Transcatheter Valve in Valve Implantation - A Single Center Prospective Registry.

The Valve-in-Valve (ViV) technique is an emerging alternative for the treatment of bioprosthetic structural valve deterioration (SVD) in the mitral position. We report on intermediate-term outcomes of patients with symptomatic SVD in the mitral position who were treated by transcatheter mitral valve-in-valve (TM-ViV) implantation during the years 2010-2019 in our center. Three main outcomes were examined during the follow-up period: NYHA functional class, TM-ViV hemodynamic data per echocardiography, and mortality. Our cohort consisted of 49 patients (mean age 77.4 ± 10.5 years, 65.3% female). The indications for TM-ViV were mainly for regurgitant pathology (77.6%). All 49 patients were treated with a balloon-expandable device. The procedure was performed via transapical access in 17 cases (34.7%) and transfemoral vein/trans-atrial septal puncture in 32 cases (65.3%). Mean follow-up was 4.4 ± 2.0 years. 98% and 91% of patients were in NYHA I/II at 1 and 5 years, respectively. Mitral regurgitation was ≥moderate in 86.3% of patients prior to the procedure and this decreased to 0% (p < 0.001) following the procedure and was maintained over 2 years follow-up. The mean trans-mitral valve gradients decreased from pre-procedural values of 10.1 ± 5.1 mmHg to 7.0 ± 2.4 mmHg at 1 month following the procedure (p = 0.03). Mortality at 1 year was 16% (95%, CI 5-26) and 35% (95%, CI 18-49) at 5 years. ViV in the mitral position offers an effective and durable treatment option for patients with SVD at high surgical risk.

Tricuspid Structural Valve Deterioration Treated with a Transcatheter Valve-in-Valve Implantation: A Single-Center Prospective Registry.

The valve-in-valve (ViV) technique is an emerging alternative for the treatment of bioprosthetic structural valve deterioration (SVD) in the tricuspid position. We report on the outcomes of patients treated by a transcatheter tricuspid valve-in-valve (TT-ViV) implantation for symptomatic SVD in the tricuspid position during the years 2010-2019 at our center. Three main outcomes were examined during the follow-up period: TT-ViV hemodynamic data per echocardiography, mortality and NYHA functional class. Our cohort consisted of 12 patients with a mean age 65.4 ± 11.9 years, 83.3% male. The mean time from initial valve intervention to TT-ViV was 17.4 ± 8.7 years. The indications for TT-ViV were varied (41.7% for predominant regurgitation, 33.3% for predominant stenosis and 25.0% with a mixed pathology). All patients were treated with a balloon-expandable device. The mean follow-up was 3.4 ± 1.3 years. Tricuspid regurgitation was ≥ moderate in 57.2% of patients prior to the procedure and this decreased to 0% following the procedure. The mean transtricuspid valve gradients mildly decreased from the mean pre-procedural values of 9.0 mmHg to 7.0 mmHg at one month following the procedure (p = 0.36). Mortality at one year was 8.0% (95% CI 0-23). At the baseline, 4 patients (33.3%) were in NYHA functional class III/IV; this was reduced to 2 patients (18.2%) at the one year follow-up and both were in NYHA III. The TT-ViV procedure offered a safe, feasible and less invasive treatment option for patients with SVD in our detailed cohort.

5 Year Outcomes of Patients With Aortic Structural Valve Deterioration Treated With Transcatheter Valve in Valve - A Single Center Prospective Registry.

The Valve-in-Valve (ViV) technique is an established alternative for the treatment of structural bioprosthetic valve deterioration (SVD). Data describing the intermediate term follow up of patients treated with this approach is scarce. We report on our intermediate-term outcomes of patients with SVD in the Aortic position treated with ViV. Included were patients with symptomatic SVD in the aortic position valve who were treated by Valve in valve transcatheter aortic valve implantation (ViV-TAVI) during the years 2010-2019 in our center. Three main outcomes were examined during the follow up period: NYHA functional class, ViV-TAVI hemodynamic per echocardiography, and mortality. Our cohort consisted of 85 patients (mean age 78.8 ± 8.9 years). The indications for aortic ViV were: SVD isolated aortic stenosis in 37.6%, SVD isolated aortic regurgitation in 42.2% and combined valve pathology in 20.0%. Self-expandable and balloon-expandable devices were used in 73 (85.9%) and 12 (14.1%), respectively. Average follow up was 3.7 ± 2.4 years. 95 and 91% of patients were in NYHA functional class I/II at 1 and 5 year follow up respectively. At one year, the mean trans-aortic valve pressure was 15 ± 9 mmHg and rates of ≥ moderate aortic regurgitation were 3.7%. Mortality at one year was 8.6% (95% CI 2.3-14.4) and 31% (95% CI 16.5-42.5) at 5 years. ViV in the aortic position offers an effective and durable treatment option for patient with SVD, with low rates of all-cause mortality, excellent hemodynamic and improved functional capacity at intermediate follow up.