Comparison of costs associated with transcatheter mitral valve repair: PASCAL vs MitraClip in a real-world setting

Abstract Aims We aimed to conduct a clinical process cost analysis to evaluate all upcoming costs of mitral valve transcatheter edge-to-edge repair (M-TEER) treatment using the MitraClip and the PASCAL repair system. Methods First, we prospectively enrolled 107 M-TEER patients treated with either the PASCAL or MitraClip system and compared all upcoming costs during the M-TEER procedure and the associated in-hospital stay. Second, we retrospectively analysed 716 M-TEER procedures with regard to the occurrence of complications and their associated costs. All materials used in the catheterization laboratory for the procedures were evaluated. The cost analysis considered various expenses, such as general in-hospital costs, device costs, catheter laboratory and material costs. Results In the prospective study, 51 patients were treated using the PASCAL system, and 56 were treated using the MitraClip system. The two groups had comparable baseline characteristics and comorbidities. The total in-hospital costs were 25 414 (Interquartile range (IQR) 24 631, 27 697) € in the PASCAL group and 25 633 (IQR 24 752, 28 256) € in the MitraClip group (p = 0.515). The major cost driver was initial material expenditure, mostly triggered by device costs, which were similar to the PASCAL and MitraClip systems. Overall intensive care unit and general ward costs did not differ between the PASCAL and MitraClip groups. In the retrospective analysis, M-TEER-related complications were rare but were associated with higher costs, mainly due to prolonged hospitalisation. Conclusion The major cost driver of M-TEER was the material expenditure, which was mostly triggered by high device costs. The costs of treating patients were similar for the PASCAL and MitraClip systems. M-TEER-related complications are associated with higher costs, mainly due to prolonged hospitalisation. This analysis provides valuable insights into reducing expenses by modifying the process of M-TEER

G-EYE advanced colonoscopy for improved polyp detection rates - a randomized tandem pilot study with different endoscopists

Background and aims The most commonly missed polyps in colonoscopy are those located behind haustral folds. The G-EYE system is a standard colonoscope consisting of re-processable balloon at its distal tip. The G-EYE balloon improves the detection of polyps by straightening the haustral folds. In our back-to-back tandem study, we aimed to determine whether and to what extent the G-EYE system could reduce adenoma miss rates in screening colonoscopy. Methods Patients referred to colonoscopy were randomized into 2 groups. Group A underwent a standard colonoscopy (SC) followed by balloon colonoscopy (BC), and Group B underwent BC followed by SC. In this randomized tandem study, the investigator's level of training and the endoscopists themselves were changed after each withdrawal. Each endoscopist was blinded to the results of the first withdrawal. Results Fifty-eight patients were enrolled and randomized into 2 groups with similar baseline characteristics. Nine patients were excluded from the study. Twenty-five patients underwent SC followed by BC while 24 underwent BC followed by SC. The adenoma miss rate for SC was 41 %, with an additional detection rate of 69 % for BC (ratio 1.69). The overall miss rate for polyps was 60 % for SC, with an additional detection rate of 150 % for BC (ratio 2.5). Experienced investigators who used BC were able to identify an additional 7 polyps while inexperienced investigators. Conclusions Although our results could not clearly confirm that BC improves adenoma detection, the investigator's experience appears to be a major determinant of the adenoma detection rate

Outcome and Midterm Survival after Heart Transplantation Is Independent from Donor Length of Stay in the Intensive Care Unit

Prolonged treatment of organ donors in the intensive care unit (ICU) may be associated with complications influencing the outcome after heart transplantation (HTx). We therefore aim to explore the potential impact of the donor length of stay (LOS) in the ICU on outcomes in our cohort. We included all patients undergoing HTx in our center between September 2010 and April 2022 (n = 241). Recipients were divided around the median into three groups regarding their donor LOS in the ICU: 0 to 3 days (≤50th percentile, n = 92), 4 to 7 days (50th–75th percentile, n = 80), and ≥8 days (≥75th percentile, n = 69). Donor LOS in the ICU ranged between 0 and 155 days (median 4, IQR 3–8 days). No association between the LOS in the ICU and survival after HTx was observed (AUC for overall survival 0.514). Neither the Kaplan–Meier survival analysis up to 5 years after HTx (Log-Rank p = 0.789) nor group comparisons showed significant differences. Baseline recipient characteristics were comparable between the groups, while the donor baselines differed in some parameters, such as less cardiopulmonary resuscitation prior to HTx in those with a prolonged LOS. However, regarding the recipients’ peri- and postoperative parameters, the groups did not differ in all of the assessed parameters. Thus, in this retrospective analysis, although the donors differed in baseline parameters, the donor LOS in the ICU was not associated with altered recipient survival or outcome after HTx

Early Postoperative Neurologic Events Are Associated With Worse Outcome and Fatal Midterm Survival After Adult Heart Transplantation

Background Neurologic events during primary stay in heart transplant (HTx) recipients may be associated with reduced outcome and survival, which we aim to explore with the current study. Methods and Results We screened and included all patients undergoing HTx in our center between September 2010 and December 2022 (n=268) and checked for the occurrence of neurologic events within their index stay. Neurologic events were defined as ischemic stroke, hemorrhage, hypoxic ischemic injury, or acute symptomatic neurologic dysfunction without central nervous system injury. The cohort was then divided into recipients with (n=33) and without (n=235) neurologic events after HTx. Using a multivariable Cox regression model, the association of neurologic events after HTx and survival was assessed. Recipients with neurologic events displayed a longer intensive care unit stay (30 versus 16 days; P=0.009), longer mechanical ventilation (192 versus 48 hours; P<0.001), and higher need for blood transfusion, and need for hemodialysis after HTx was substantially higher (81% versus 55%; P=0.01). Resternotomy (36% versus 26%; P=0.05) and mechanical life support (extracorporeal life support) after HTx (46% versus 24%; P=0.02) were also significantly higher in patients with neurologic events. Covariable‐adjusted multivariable Cox regression analysis revealed a significant independent association of neurologic events and increased 30‐day (hazard ratio [HR], 2.5 [95% CI, 1.0–6.0]; P=0.049), 1‐year (HR, 2.2 [95% CI, 1.1–4.3]; P=0.019), and overall (HR, 2.5 [95% CI, 1.5–4.2]; P<0.001) mortality after HTx and reduced Kaplan‐Meier survival up to 5 years after HTx (P<0.001). Conclusions Neurologic events after HTx were strongly and independently associated with worse postoperative outcome and reduced survival up to 5 years after HTx

Donor Noradrenaline Support Is Not Associated with Decreased Survival in Heart Transplant Recipients

Objective: Although the application of higher doses of norepinephrine (NE) in potential organ donors is a frequent reason for heart decline, its associations with outcomes after heart transplantation (HTx) are discussed controversially. Therefore, we aimed to explore donor NE support&rsquo;s potential impact on outcomes in our single-center heart transplant cohort. Methods: All patients who had undergone HTx in our center between September 2010 and April 2022 (n = 241) were screened for eligibility. From those, all patients with complete data on donor NE support (n = 238) were included. Recipients were divided into three groups according to their donor NE support: without support (n = 26), with low support of 0.01&ndash;0.2 &micro;g/kg/min (n = 132), and with high support of &gt; 0.2 &micro;g/kg/min (n = 80). Receiver operating characteristics (ROC) and Kaplan Meier analysis was used to investigate the association of donor NE support and mortality after heart transplantation. Recipient and donor variables, including peri- and postoperative characteristics, were reviewed and compared. Results: NE support in donors ranged between 0 and 2.94 &micro;g/kg/min (median 0.13 &micro;g/kg/min, IQR 0.05&ndash;0.26 &micro;g/kg/min). No association between donor NE support and mortality after HTx was observed (AUC for overall survival 0.494). Neither Kaplan-Meier analysis in survival up to 5 years after transplantation (Log Rank p = 0.284) nor group comparisons showed significant differences between the groups. With few exceptions, baseline characteristics in recipients and donors were comparable between the groups. Regarding peri- and postoperative parameters, increasing donor NE support was associated with a longer duration of mechanical ventilation (68 h and 95 h vs. 47 h), longer postoperative IMC/ICU stay (14 vs. 15 vs. 19 days), and a higher need for mechanical life support post-HTx (26% and 39% vs. 12%). Conclusion: In this retrospective analysis, NE support in donors prior to heart transplantation was unrelated to differing survival after heart transplantation. However, higher doses of donor NE were associated with prolonged ventilation, longer duration on IMC/ICU, and a higher need for extracorporeal life support in recipients post-HTx