Transcatheter heart valve explant with infective endocarditis-associated prosthesis failure and outcomes: the EXPLANT-TAVR international registry.

BACKGROUND AND AIMS: Surgical explantation of transcatheter heart valves (THVs) is rapidly increasing, but there are limited data on patients with THV-associated infective endocarditis (IE). This study aims to assess the outcomes of patients undergoing THV explant for IE. METHODS: All patients who underwent THV explant between 2011 and 2022 from 44 sites in the EXPLANT-TAVR registry were identified. Patients with IE as the reason for THV explant were compared to those with other mechanisms of bioprosthetic valve dysfunction (BVD). RESULTS: A total of 372 patients from the EXPLANT-TAVR registry were included. Among them, 184 (49.5%) patients underwent THV explant due to IE and 188 (50.5%) patients due to BVD. At the index transcatheter aortic valve replacement, patients undergoing THV explant for IE were older (74.3 ± 8.6 vs. 71 ± 10.6 years) and had a lower Society of Thoracic Surgeons risk score [2.6% (1.8-5.0) vs. 3.3% (2.1-5.6), P = .029] compared to patients with BVD. Compared to BVD, IE patients had longer intensive care unit and hospital stays (P < .05) and higher stroke rates at 30 days (8.6% vs. 2.9%, P = .032) and 1 year (16.2% vs. 5.2%, P = .010). Adjusted in-hospital, 30-day, and 1-year mortality was 12.1%, 16.1%, and 33.8%, respectively, for the entire cohort, with no significant differences between groups. Although mortality was numerically higher in IE patients 3 years postsurgery (29.6% for BVD vs. 43.9% for IE), Kaplan-Meier analysis showed no significant differences between groups (P = .16). CONCLUSIONS: In the EXPLANT-TAVR registry, patients undergoing THV explant for IE had higher 30-day and 1-year stroke rates and longer intensive care unit and hospital stays. Moreover, patients undergoing THV explant for IE had a higher 3-year mortality rate, which did not reach statistical significance given the relatively small sample size of this unique cohort and the reduced number of events.

Current Prostheses for Transcatheter Heart Valve Replacement: A Technical and Clinical Review.

Transcatheter aortic valve replacement (TAVR) has become a cornerstone in today's treatment of aortic stenosis. Modern transcatheter prostheses are continuously evolving and each one features different design traits. In this review, the authors provide insight in the technical differences of current prostheses and TAVR related clinical decision pathways, preferably useful for the beginners but also for advanced operators. Additionally, procedural considerations and comparative outcomes of the prostheses are discussed. In doing so, the authors aim to facilitate the choice of the ideal transcatheter valve procedure for each individual.

Observed versus predicted mortality after isolated tricuspid valve surgery.

BACKGROUND: Aim of this study is to analyse the performances of Clinical Risk Score (CRS) and European System for Cardiac Operative Risk Evaluation (EuroSCORE)-II in isolated tricuspid surgery. METHODS: Three hundred and eighty-three patients (54 ± 16 year; 54% female) were enrolled. Receiver operating characteristic analysis was performed to evaluate the relationship between the true positive fraction of test results and the false-positive fraction for a procedure. RESULTS: Considering the 30-day mortality the area under the curve was 0.6 (95% confidence interval [CI] 0.50-0.72) for EuroSCORE II and 0.7 (95% CI 0.56-0.84) for CRS-score. The ratio of expected/observed mortality showed underestimation when considering EuroSCORE-II (min. 0.46-max. 0.6). At multivariate analysis, the CRS score (p = .005) was predictor of late cardiac death. CONCLUSION: We suggest using both scores to obtain a range of expected mortality. CRS to speculate on late survival.

Off-Pump Tricuspid Annuloplasty through a Direct Transatrial Approach: Early Results.

Severe tricuspid regurgitation constitutes a growing disease burden. Conventional surgery for tricuspid valve disease has an increased risk while several interventional procedures are currently under clinical investigation, yet do not offer comprehensive solutions. We investigated a novel surgical approach for off-pump beating-heart tricuspid annuloplasty in circulating blood through a single port in the right atrium. Early feasibility results in preclinical porcine in vivo studies encourage further development of this approach, combining the proven concept of surgical annuloplasty with the benefits of minimally invasive off-pump procedures in a hybrid setting.

Extra-anatomic aortic bypass with aortic-, mitral-, and tricuspid surgery in a 53-year old: A single-stage approach for complex coarctation associated with triple valve pathology.

Coarctation is rare in patients over 50 years of age; however, if present, it can be associated with complex intracardiac pathologies and represent a formidable surgical challenge. Herein, we report a single-stage approach for surgical repair of coarctation associated with aortic, mitral, and tricuspid valve pathology using an ascending-to-descending aortic bypass with posterior pericardial access.

A rare case of quadruple valve surgery with bioprosthetic pulmonary valve replacement in an octogenarian for degenerative valvular disease: Technical aspects.

Quadruple valve surgery represents a complex and rare surgical procedure, requiring a systematic and standardized approach. In this intervention, pulmonary valve replacement (PVR) in patients without pre-existing congenital heart disease represents a challenge and no large data have been reported yet. We hereby report a case of bioprosthetic PVR in an octogenarian within a quadruple valve procedure, illustrating our preferred technique of PVR with bioprosthetic implantation and right ventricular outflow tract reconstruction.

Dipeptidyl Peptidase-4 Inhibitor-Associated Pancreatic Carcinoma: A Review of the FAERS Database.

BACKGROUND: To date, there is limited literature regarding the association between dipeptidyl peptidase-4 (DPP-4) inhibitors and pancreatic carcinoma. OBJECTIVE: To describe the comparative incidence of DPP-4 inhibitors and pancreatic carcinoma as reportedly available in the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database. The goal was to provide health care practitioners a general understanding of the drug-disease occurrence. METHODS: This is a case/noncase study utilizing Empirica Signal software to query FAERS from November 1968 to December 31, 2013. The software was used to calculate a disproportionality statistic--namely, the empirical Bayesian geometric mean (EBGM)--for reports of DPP-4 inhibitors-associated pancreatic carcinoma. The FDA considers an EBGM significant if the fifth percentile of the distribution is at least 2, defined as an EB05 ≥ 2. With use of a disproportionality analysis, DPP-4 inhibitors were compared with all agents listed in FAERS. RESULTS: A total of 156 patients experienced pancreatic carcinoma while receiving DPP-4 inhibitor therapy. An EB05 of 10.3 was determined for sitagliptin, 7.1 for saxagliptin, 4.9 for linagliptin, and 1.4 for alogliptin, compared with all other agents included in FAERS. Although an EB05 > 2 was achieved in 2 other antihyperglycemic agents, the findings were not consistent within their medication classes. CONCLUSION: There appears to be a statistical association between DPP-4 inhibitor use and pancreatic carcinoma. Causality cannot be inferred from the data provided. Additional clinical studies are needed to further explore this statistical association.

SGLT-2 Inhibitors: A Novel Mechanism in Targeting Glycemic Control in Type 2 Diabetes Mellitus.

OBJECTIVE: To review the chemistry, pharmacology, pharmacodynamics, pharmacokinetics, clinical efficacy, tolerability, dosing, drug interactions, and administration of canagliflozin, dapagliflozin, and empagliflozin, and comparing the benefit and risk aspects of using these agents in the older adult diabetes patient population. DATA SOURCES, STUDY SELECTION, DATA EXTRACTION, AND DATA SYNTHESIS: A search of PubMed using the terms "SGLT-2 inhibitors," "canagliflozin," "dapagliflozin," "empagliflozin," "efficacy," and "tolerability" was performed to find relevant primary literature on each of the sodium/glucose cotransporter 2 (SGLT-2) inhibitors currently approved for use in type 2 diabetes. Phase III trials for all agents were included. All English-language articles from 2010 to 2015 appearing in these searches were reviewed for relevance to this paper. In addition, related articles suggested in the PubMed search were also reviewed. The SGLT-2 inhibitors have shown a reduction in hemoglobin A1c values and fasting plasma glucose levels with a low incidence of hypoglycemia. The incidence of mycotic infections is increased in patients taking an SGLT-2 inhibitor. CONCLUSION: SGLT-2 inhibitors may be a viable treatment option for patients not controlled on other oral agents. The risk of hypoglycemia is small. However, the clinical efficacy and tolerability of these agents has not been fully elucidated in older and frail patients.

Evaluation of a Novel Automated Suturing Technology for Mitral Chordal Implantation: 1-Year Results.

PURPOSE: A new automated expanded polytetrafluoroethylene (ePTFE) suture placement device and a new customized titanium fastener deployment device were clinically evaluated in open and less-invasive mitral valve repair (MVr). DESCRIPTION: Twelve patients were monitored for 1 year after undergoing MVr using the study devices. The study end points included surgical outcomes, operative times, valve repair durability, adverse events, and mortality. EVALUATION: Three patients received 1 ePTFE chord using the study technology, and 9 patients received 2 chords. Mitral regurgitation at 30 days was absent in 8 patients, trace in 2, and mild in 2. At the 1-year follow-up, mitral regurgitation was absent in 7 patients, trace in 2, mild in 2, and moderate in 1. There were no replacement chord failures, reoperations, or death. CONCLUSIONS: The initial outcomes of new automated ePTFE suture placement and titanium fastener deployment devices encourage further clinical evaluations.

Cerebral Protection Strategies in Aortic Arch Surgery-Past Developments, Current Evidence, and Future Innovation.

Surgery of the aortic arch remains a complex procedure, with neurological events such as stroke remaining its most dreaded complications. Changes in surgical technique and the continuous innovation in neuroprotective strategies have led to a significant decrease in cerebral and spinal events. Different modes of cerebral perfusion, varying grades of hypothermia, and a number of pharmacological strategies all aim to reduce hypoxic and ischemic cerebral injury, yet there is no evidence indicating the clear superiority of one method over another. While surgical results continue to improve, novel hybrid and interventional techniques are just entering the stage and the question of optimal neuroprotection remains up to date. Within this perspective statement, we want to shed light on the current evidence and controversies of cerebral protection in aortic arch surgery, as well as what is on the horizon in this fast-evolving field. We further present our institutional approach as a large tertiary aortic reference center.

Decellularized aortic homografts versus mechanical composite grafts for aortic root replacement.

OBJECTIVES: Mechanical composite valve grafts (MCVGs) are the first-line therapy for aortic root replacement in young adults. Decellularized aortic homografts (DAH) present a promising novel alternative due to their lower thrombogenicity. We aimed to compare both treatment options regarding survival and valve-related adverse events. METHODS: This study was designed as a single-centre retrospective cohort study including patients who underwent root replacement with MCVG or DAH between 2000 and 2022. Urgent or emergent procedures were excluded. RESULTS: The study cohort included 289 patients (MCVG n = 216, DAH n = 73) with a mean age of 48.5 ± 12 years (MCVG 49 ± 12 years vs DAH 47 ± 11 years; P = 0.23) and a median EuroScore II of 1.7% (1.2, 2.6). The 30-day mortality was 1% (n = 3). Cumulative survival at 3 years was 99% for DAH and 94% for MCVG, respectively (P = 0.15). Mean follow-up was 98.9 ± 72.7 months. Bleeding events (n = 14, 6.5%) and thromboembolism (n = 14, 6.5%) were only observed in the MCVG group (P = 0.19 and 0.09, respectively). Four cases (5%) of moderate structural valve deterioration occurred, all in the DAH group (P ≤ 0.001). The cumulative incidence of a composite end point of valve-related adverse events was significantly higher in the MCVG group (P = 0.0295). CONCLUSIONS: Aortic root replacement with MCVGs and decellularized aortic homografts showed low mortality in an elective setting. Patients in the homograft cohort demonstrated significantly higher freedom from valve-related adverse events. DAH present a promising treatment option for young patients requiring root replacement; however, data on long-term durability are needed.

No difference in early functional outcome between the direct anterior approach and posterior approach in patients following total hip arthroplasty.

BACKGROUND: Objective and subjective outcomes in the direct anterior approach (DAA) and posterior approach (PA) in total hip arthroplasty (THA) were assessed in this study, using the Oxford Hip Score (OHS) as primary outcome. Pain, 3 objective performance-based tests, surgical time, blood loss and length of stay were assessed as secondary outcomes. METHODS: Patients with primary end-stage osteoarthritis were prospectively enrolled by shared decision making for the DAA (32 patients) or PA (26 patients). Baseline data were collected preoperatively and outcomes postoperatively at 2-, 6-, 9- and 12-month follow-up. RESULTS: There is no significant difference (p < 0.05) between the DAA and PA on primary outcome (OHS). There was a main effect of time which indicated an increase of OHS over time independent of group (p < 0.01). CONCLUSIONS: In the current study, no significant differences in postoperative functional outcome were found between DAA and PA in all follow-up moments.

First-in-Man Study of a Novel, Balloon-Adjustable Mitral Annuloplasty Ring.

Objectives: Mitral valve repair is the current standard approach for mitral valve regurgitation. However, patients suffering from functional mitral regurgitation have a significant risk of recurrent regurgitation. Adjustable mitral rings may provide a solution for this adverse event. Methods: A single-center, first-in-man clinical study was performed on patients suffering from mitral valve regurgitation. Patients were implanted with the study ring and followed for six months. A balloon catheter can be inserted into the study ring frame at any time after implantation and inflated independently in the areas P1, P2, or P3, which reduces the anterior-posterior diameter. Results: Five patients (75.4 ± 6.1 years; EuroSCORE II 2.1 ± 0.9%; three female) were successfully implanted. Mechanisms of mitral regurgitation were prolapse of the P2-segment in three patients and annular dilation in two patients. Surgical implantation according to the protocol was feasible and is described herein. Median cardiopulmonary bypass time and cross clamp time were 105 (118; 195) and 94 (90; 151) min, respectively. The median intensive care unit stay was 2 (2; 3) days. No perioperative, 30-day, or 6-month mortality was observed, and the repair was stable without residual or recurrent regurgitation ≥ grade 2. All patients reached the primary endpoint without device-related morbidity. Conclusions: Successful implantation was completed in five patients without device-related adverse events. Ring implantation was safe and feasible for all patients. The opportunity of post-implant adjustment to improve leaflet coaptation is a promising new therapeutic strategy that is assessed in a phase II study.

Femoral vessel complications after transfemoral TAVR-A contemporary sonography-based assessment of 480 patients with third-generation transcatheter valves.

BACKGROUND: Postinterventional sonographic assessment of the femoral artery after transfemoral transcatheter aortic valve replacement (TF-TAVR) has the potential to identify several pathologies. We investigated the incidence and risk factors of femoral vessel complications in a modern TAVR collective using postinterventional sonography. METHODS: Between September 2017 and March 2022, 480 patients underwent TF-TAVR with postinterventional femoral sonography at a single center. Clinical outcomes and adverse events were analyzed after the Valve Academic Research Consortium 3 (VARC-3) criteria. RESULTS: In this cohort (51.2% male; age 80 ± 7.5 years, median EuroSCORE II 3.7) 74.8% (n = 359) were implanted with a self-expandable and 25.2% (n = 121) with a balloon-expandable valve. The main access (valve-delivery) was located right in 91.4% (n = 438), and the primary closure system was Proglide in 95% (n = 456). Vascular complications (VC) were observed in 29.16% (n = 140) of patients; 23.3% (n = 112) presented with minor- and 5.8% (n = 28) with major VC. Postinterventional femoral artery stenosis on the main access was observed in 9.8% (n = 47). Multivariable logistic regression analysis revealed female sex (p = .03, odds ratio [OR] 2.32, 95% confidence interval [CI] 1.09-4.89) and the number of used endovascular closure devices (p = .014, OR 0.11, 95%CI 0.02-0.64) as predictive factors for femoral artery stenosis. CONCLUSIONS: The incidence of postinterventional femoral artery stenosis following TF-TAVR was higher than expected with a number of used closure devices and female sex being independent risk factors. Considering the continuous advance of TAVR in low-risk patients with preserved physical activity, emphasis should be directed at the correct diagnosis and follow-up of these complications.

Mechanical versus Biological Valve Prostheses for Infective Endocarditis Presenting with Stroke.

Objectives: This study aimed to compare the clinical outcomes of mechanical and biological valve prostheses in patients with infective endocarditis presenting with stroke. Methods: Ninety-five adults with infective endocarditis complicated by stroke at baseline who underwent aortic and/or mitral valve replacement were analyzed retrospectively. The primary outcome was a composite outcome of all-cause mortality, ischemic stroke, hemorrhagic stroke, and re-endocarditis. Secondary outcomes included the individual components of the composite outcome and modified Rankin scale deterioration during follow-up. Results: Among the study cohort, 34 patients (35.8%) received mechanical valve prostheses and 61 (64.2%) received biological valve prostheses. Implantation of a mechanical valve prosthesis seems to be associated with a decreased risk of attaining the composite outcome (adjusted HR 0.46, 95% CI 0.22-0.96, and p = 0.037). Analyses of the individual components of the composite outcome showed that implantation of a mechanical valve prosthesis might not be associated with an increased risk of ischemic stroke, hemorrhagic stroke, and all-cause mortality during the follow-up period. Further, the risk of re-endocarditis was significantly lower in recipients of a mechanical valve prosthesis (adjusted HR 0.15, 95% CI 0.06-0.77, p = 0.026). Notably, a trend toward decreased risk of modified Rankin scale deterioration throughout the follow-up period was observed in this group (adjusted odds ratio 0.22, 95% CI 0.05-1.02, p = 0.053). Conclusions: Implantation of mechanical valve prostheses in patients presenting with infective endocarditis complicated by stroke seems to be beneficial in terms of a reduced risk of experiencing a composite outcome. Analyses of larger cohorts are required to validate our findings.

Automated titanium fastener for surgical aortic valve replacement-preventive role for infective endocarditis?

OBJECTIVES: Evidence on long-term clinical outcomes considering suture-securing techniques used for surgical aortic valve replacement is still uncertain. METHODS: A total of 1405 patients who underwent surgical aortic valve replacement between January 2016 and December 2022 were included and grouped according to the suture-securing technique used (automated titanium fastener versus hand-tied knots). The occurrence of infective endocarditis during follow-up was set as the primary study end-point. As secondary study end-points, stroke, all-cause mortality and a composite outcome of either infective endocarditis, stroke, or all-cause mortality were assessed. RESULTS: The automated titanium fastener was used in 829 (59%) patients, whereas the hand-knot tying technique was used in 576 (41%) patients. The multivariable proportional competing risk regression analysis showed a significantly lower risk of infective endocarditis during follow-up in the automated titanium fastener group (adjusted sub-hazard ratio 0.44, 95% confidence interval 0.20-0.94, P = 0.035). The automated titanium fastener group was not associated with an increased risk of mortality or attaining the composite outcome, respectively (adjusted hazard ratio 0.81, 95% confidence interval 0.60-1.09, P = 0.169; adjusted hazard ratio 0.82, 95% confidence interval 0.63-1.07, P = 0.152). This group was not associated with an increased risk of stroke (adjusted sub-hazard ratio 0.82, 95% confidence interval 0.47-1.45, P = 0.504). Also, a significantly lower rate of early-onset infective endocarditis was observed in the automated titanium fastener group, (0.4% vs 1.4%, P = 0.032). CONCLUSIONS: Suture-securing with an automated titanium fastener device appears to be superior compared to the hand-knot tying technique in terms of lower risk of infective endocarditis.

Automated titanium fastener vs. hand-tied knots for prosthesis fixation in infective endocarditis.

Objectives: To date, there is no evidence regarding the safety of automated titanium fastener compared with hand-tied knots for prosthesis fixation in infective endocarditis. Methods: Between January 2016 and December 2022, a total of 220 patients requiring surgery for infective endocarditis were included in this retrospective analysis. The primary study endpoint was re-endocarditis during follow-up. The secondary study endpoints included stroke onset, all-cause mortality, and a composite outcome of either re-endocarditis, stroke, or all-cause mortality during follow-up. Results: Suture-securing with an automated titanium fastener was performed in 114 (51.8%) patients, whereas the conventional technique of hand knot-tying was used in 106 (48.2%) patients. The risk of re-endocarditis was significantly lower in the automated titanium fastener group, as shown in a multivariable proportional competing risk regression model (adjusted sub-hazard ratio 0.33, 95% confidence interval 0.11-0.99, p = 0.048). The multivariable Cox proportional hazards regression analysis showed that the automated titanium fastener group was not associated with an increased risk of stroke-onset or attaining the composite outcome, respectively, (adjusted hazard ratio 0.54, 95% confidence interval 0.27-1.08, p = 0.082), (adjusted hazard ratio 0.65, 95% confidence interval 0.42-1.02, p = 0.061). Also, this group was not associated with an increased risk of all-cause mortality, as demonstrated in the multivariable Poisson regression analysis (adjusted incidence-rate ratio 1.42, 95% confidence interval 0.83-2.42, p = 0.202). Conclusions: The use of automated titanium fastener device seems to be safe for infective endocarditis. Analyses of larger cohorts are required.

Low degree of formal education and musical experience predict degree of music-induced stress reduction in relatives and friends of patients: a single-center, randomized controlled trial.

OBJECTIVE: To determine the factors that may predict music-induced relaxation in friends and family of patients in the emergency department. BACKGROUND: It remains unclear to date which demographic and experiential factors predict the effectiveness of music-induced relaxation. Furthermore, in-hospital stressors for friends and family of patients rather than patients themselves are underresearched and deserve in-depth investigation to improve this group's experience in health care environments. METHODS: A total of 169 relatives and friends of patients in the emergency department-waiting area completed a series of questionnaires, including the Spielberger State-Trait Anxiety Inventory (STAI), the Music Experience Questionnaire (MEQ), and a demographic survey. They were then randomly assigned to either Case Group (1 hour in the waiting area with classical music in the background) or Control Group (1 hour with no music) before completing a second, identical copy of the STAI to measure change from baseline. Data were analyzed for associations between music intervention, change in STAI scores, MEQ scores, and demographic characteristics. RESULTS: Participants who underwent the music intervention experienced a 9.8% decrease in overall mean State Anxiety, whereas those in the Control Group experienced no change over time (P = 0.001). Higher education significantly inversely correlated with the effectiveness of music intervention: participants with no formal education beyond high school showed a greater overall mean decrease in State Anxiety than those with a college education or beyond in response to classical music (P = 0.006). Furthermore, MEQ scores indicated that the Social Uplift scale (a measure of one's tendency to be uplifted in a group-oriented manner by music) was highly predictive of the effectiveness of music intervention. CONCLUSIONS: Music is an effective and inexpensive means of reducing anxiety in friends and family of patients, who are underresearched in medicine. Moreover, low educational attainment and tendency to respond positively to music in a group setting can predict the effectiveness of music-induced relaxation.