Transcatheter or Surgical Treatment of Aortic-Valve Stenosis.

BACKGROUND: Among low-risk patients with severe, symptomatic aortic stenosis who are eligible for both transcatheter aortic-valve implantation (TAVI) and surgical aortic-valve replacement (SAVR), data are lacking on the appropriate treatment strategy in routine clinical practice. METHODS: In this randomized noninferiority trial conducted at 38 sites in Germany, we assigned patients with severe aortic stenosis who were at low or intermediate surgical risk to undergo either TAVI or SAVR. Percutaneous- and surgical-valve prostheses were selected according to operator discretion. The primary outcome was a composite of death from any cause or fatal or nonfatal stroke at 1 year. RESULTS: A total of 1414 patients underwent randomization (701 to the TAVI group and 713 to the SAVR group). The mean (±SD) age of the patients was 74±4 years; 57% were men, and the median Society of Thoracic Surgeons risk score was 1.8% (low surgical risk). The Kaplan-Meier estimate of the primary outcome at 1 year was 5.4% in the TAVI group and 10.0% in the SAVR group (hazard ratio for death or stroke, 0.53; 95% confidence interval [CI], 0.35 to 0.79; P<0.001 for noninferiority). The incidence of death from any cause was 2.6% in the TAVI group and 6.2% in the SAVR group (hazard ratio, 0.43; 95% CI, 0.24 to 0.73); the incidence of stroke was 2.9% and 4.7%, respectively (hazard ratio, 0.61; 95% CI, 0.35 to 1.06). Procedural complications occurred in 1.5% and 1.0% of patients in the TAVI and SAVR groups, respectively. CONCLUSIONS: Among patients with severe aortic stenosis at low or intermediate surgical risk, TAVI was noninferior to SAVR with respect to death from any cause or stroke at 1 year. (Funded by the German Center for Cardiovascular Research and the German Heart Foundation; DEDICATE-DZHK6 ClinicalTrials.gov number, NCT03112980.).

A parametric study on pulse duplicator design and valve hemodynamics.

BACKGROUND: In vitro assessment is mandatory for artificial heart valve development. This study aims to investigate the effects of pulse duplicator features on valve responsiveness, conduct a sensitivity analysis across valve prosthesis types, and contribute on the development of versatile pulse duplicator systems able to perform reliable prosthetic aortic valve assessment under physiologic hemodynamic conditions. METHODS: A reference pulse duplicator was established based on literature. Further optimization process led to new designs that underwent a parametric study, also involving different aortic valve prostheses. These designs were evaluated on criteria such as mean pressure differential and pulse pressure (assessed from high-fidelity pressure measurements), valve opening and closing behavior, flow, and regurgitation. Finally, the resulting optimized setup was tested under five different hemodynamic settings simulating a range of physiologic and pathologic conditions. RESULTS: The results show that both, pulse duplicator design and valve type significantly influence aortic and ventricular pressure, flow, and valve kinematic response. The optimal design comprised key features such as a compliance chamber and restrictor for diastolic pressure maintenance and narrow pulse pressure. Additionally, an atrial reservoir was included to prevent atrial-aortic interference, and a bioprosthetic valve was used in mitral position to avoid delayed valve closing effects. CONCLUSION: This study showed that individual pulse duplicator features can have a significant effect on valve's responsiveness. The optimized versatile pulse duplicator replicated physiologic and pathologic aortic valve hemodynamic conditions, serving as a reliable characterization tool for assessing and optimizing aortic valve performance.

Subcostal bilateral internal thoracic artery harvesting with the da Vinci SP System: an experimental feasibility study.

We evaluated the feasibility of harvesting bilateral internal thoracic arteries with the da Vinci SP through a single left sided subcostal incision. Complete bilateral mobilization with sufficiently long conduits for multivessel grafting was possible in two human cadavers and two live porcine. Creating the subcostal access and docking the SP system took between 14 to 21 min and total harvest time ranged from 65 to 125 minutes in all models. No major bleeding was observed in the live porcine and hemostasis managed with the available instrumentation. One porcine deceased during surgery due to ventricular fibrillation followed by cardiac arrest. The robotic harvesting was technically easily reproduced by the surgeons and required no additional rib-spreading. Further studies will be required to assess if this subcostal approach with the da Vinci SP system yields true clinical benefits in patients.

Permanent Pacemaker Implantation and Long-Term Outcomes of Patients Undergoing Concomitant Mitral and Tricuspid Valve Surgery.

BACKGROUND: Tricuspid valve annuloplasty (TA) during mitral valve repair (MVr) is associated with increased risk of permanent pacemaker (PPM) implantation, but the magnitude of risk and long-term clinical consequences have not been firmly established. OBJECTIVES: This study assesses the incidence rates of PPM implantation after isolated MVr and following MVr with TA as well as the associated long-term clinical consequences of PPM implantation. METHODS: State-mandated hospital discharge databases of New York and California were queried for patients undergoing MVr (isolated or with concomitant TA) between 2004 and 2019. Patients were stratified by whether or not they received a PPM within 90 days of index surgery. After weighting by propensity score, survival, heart failure hospitalizations (HFHs), endocarditis, stroke, and reoperation were compared between patients with or without PPM. RESULTS: A total of 32,736 patients underwent isolated MVr (n = 28,003) or MVr + TA (n = 4,733). Annual MVr + TA volumes increased throughout the study period (P < 0.001, trend), and PPM rates decreased (P < 0.001, trend). The incidence of PPM implantation <90 days after surgery was 7.7% for MVr and 14.0% for MVr + TA. In 90-day conditional landmark-weighted analyses, PPMs were associated with reduced long-term survival among MVr (HR: 1.96; 95% CI: 1.75-2.19; P < 0.001) and MVr + TA recipients (HR: 1.65; 95% CI: 1.28-2.14; P < 0.001). In both surgical groups, PPMs were also associated with an increased risk of HFH (HR: 1.56; 95% CI: 1.27-1.90; P < 0.001) and endocarditis (HR: 1.95; 95% CI: 1.52-2.51; P < 0.001), but not with stroke or reoperation. CONCLUSIONS: Compared to isolated MVr, adding TA to MVr was associated with a higher risk of 90-day PPM implantation. In both surgical groups, PPM implantation was associated with an increase in mortality, HFH, and endocarditis.

Temporary extracorporeal life support: single-centre experience with a new concept.

OBJECTIVES: The combination of veno-arterial extracorporeal membrane oxygenation with a micro-axial flow pump (ECMELLA) is increasingly used for cardiogenic shock (CS) therapy. We report our experience with a novel single-artery access ECMELLA setup with either femoral (2.0) or jugular venous cannulation (2.1), respectively. METHODS: Data from 67 consecutive CS patients treated with ECMELLA 2.0 (n = 56) and 2.1 (n = 11) from December 2020 and December 2022 in a tertiary cardiac center were retrospectively analyzed. RESULTS: The mean age was 60.7 ± 11 years, 56 patients (84%) were male. CS aetiology was acute on chronic heart failure (n = 35, 52%), myocardial infarction (n = 13, 19.5%), postcardiotomy syndrome (n = 16, 24%) and myocarditis (n = 3, 4.5%). Preoperatively 31 patients (46%) were resuscitated, 53 (79%) were on a ventilator and 60 (90%) were on inotropic support. The median vasoactive inotropic score was 32, and the mean arterial lactate was 8.1 mmol/l. In 39 patients (58%), veno-arterial extracorporeal membrane oxygenation was explanted after a median ECMELLA support of 4 days. Myocardial recovery was achieved in 18 patients (27%), transition to a durable left ventricular assist device in 16 (24%). Thirty-three patients (n = 33; 49%) died on support (25 on ECMELLA and 8 on Impella after de-escalation), 9 (13%) of whom were palliated. Axillary access site bleeding occurred in 9 patients (13.5%), upper limb ischaemia requiring surgical revision in 3 (4.5%). Axillary site infection occurred in 6 cases (9%), and perioperative stroke in 10 (15%; 6 hemorrhagic, 4 thromboembolic). CONCLUSIONS: ECMELLA 2.0/2.1 is a feasible and effective therapy for severe CS. The single-artery cannulation technique is associated with a relatively low rate of access-related complications.

Acute Kidney Injury After Heart Transplantation: Risk Factors and Clinical Outcomes.

OBJECTIVE: Acute kidney injury (AKI) requiring renal-replacement therapy (RRT) after heart transplantation (OHT) is common and impairs outcomes. This study aimed to identify independent donor and recipient risk factors associated with RRT after OHT. DESIGN: A retrospective data analysis. SETTING: Data were collected from clinical routines in a maximum-care university hospital. PARTICIPANTS: Patients who underwent OHT. INTERVENTIONS: The authors retrospectively analyzed data from 264 patients who underwent OHT between 2012 and 2021; 189 patients were eligible and included in the final analysis. MEASUREMENTS AND MAIN RESULTS: The mean age was 48.0 ± 12.3 years, and 71.4% of patients were male. Ninety (47.6%) patients were on long-term mechanical circulatory support (lt-MCS). Posttransplant AKI with RRT occurred in 123 (65.1%) patients. In a multivariate analysis, preoperative body mass index >25 kg/m² (odds ratio [OR] 4.74, p < 0.001), elevated preoperative creatinine levels (OR for each mg/dL increase 3.44, p = 0.004), administration of red blood cell units during transplantation procedure (OR 2.31, p = 0.041) and ischemia time (OR for each hour increase 1.77, p = 0.004) were associated with a higher incidence of RRT. The use of renin-angiotensin-aldosterone system blockers before transplantation was associated with a reduced risk of RRT (OR 0.36, p = 0.013). The risk of mortality was 6.9-fold higher in patients who required RRT (hazard ratio 6.9, 95% CI: 2.1-22.6 p = 0.001). Previous lt-MCS, as well as donor parameters, were not associated with RRT after OHT. CONCLUSIONS: The implementation of guideline-directed medical therapy, weight reduction, minimizing ischemia time (ie, organ perfusion systems, workflow optimization), and comprehensive patient blood management potentially influences renal function and outcomes after OHT.

Single arterial access technique for simultaneous dual mechanical circulatory support in cardiogenic shock.

Temporary mechanical circulatory support is a treatment of choice for patients in severe cardiogenic shock. Combining veno-arterial extracorporeal life support (ECLS) with devices that enable left ventricular unloading emerges as a promising strategy to diminish detrimental effect of elevated left ventricular afterload and to improve survival. However, the need to establish multiple arterial access sites remains a major drawback of this approach due to a significant rate of vascular complications. We describe herein a case of a single arterial access for ECLS and intra-aortic balloon pump using axillary artery that may provide a simple, modular and flexible approach for escalation or de-escalation of mechanical circulatory support.

Treatment of cardiac implantable electronic device endocarditis in pacemaker-dependent patients utilizing a percutaneous aspiration system.

With the increasing use of cardiac implantable electronic devices, the number of patients with cardiac implantable electronic device-related endocarditis is also rising. The treatment of this type of endocarditis is a challenging clinical task, in particular if device removal is required in patients who are pacemaker dependent. This video tutorial describes a treatment strategy for cardiac implantable electronic device-related endocarditis involving the tricuspid valve in pacemaker-dependent patients. The proposed treatment strategy consists of implanting an epicardial pacemaker via a minimally invasive subxiphoid approach, percutaneous aspiration of tricuspid valve vegetations and complete transvenous explantation of the infected cardiac implantable electronic device system using advanced lead extraction tools.

Analysis of factors affecting outcome in acute type A aortic dissection complicated by preoperative cardiopulmonary resuscitation.

OBJECTIVES: Cardiopulmonary resuscitation (CPR) aggravates the pre-existing dismal prognosis of patients suffering from acute type A aortic dissection (ATAAD). We aimed to identify factors affecting survival and outcome in ATAAD patients requiring CPR at presentation at 2 European aortic centres. METHODS: Data on 112 surgical candidates and undergoing preoperative CPR were retrospectively evaluated. Patients were divided into 2 groups according to 30-day mortality. A multivariable model identified predictors for 30-day mortality. RESULTS: Preoperative death occurred in 23 patients (20.5%). In the remaining 89 surgical patients (79.5%) circulatory arrest time (41 ± 20 min in 30-day non-survivors vs 30 ± 13 min in 30-day survivor, P = 0.003) as well as cardiopulmonary bypass time (320 ± 132 min in 30-day non-survivors vs 252 ± 140 min in 30-day survivor, P = 0.020) time was significantly longer in patients with worse outcome. Thirty-day mortality of the total cohort was 61.6% (n = 69) with cardiac failure in 48% and aortic rupture or haemorrhagic shock (28%) as predominant reasons of death. Age [odds ratio (OR) 1.04, 95% confidence interval (CI) 1.01-1.09, P = 0.034], preoperative coronary (OR 3.42, 95% CI 1.34-9.26, p = 0.012) and spinal malperfusion (OR 12.49, 95% CI 1.83-225.02, P = 0.028) emerged as independent predictors for 30-day mortality while CPR due to tamponade was associated with improved early survival (OR 0.29, 95% CI 0.091-0.81, P = 0.023). CONCLUSIONS: Assessment of underlying cause for CPR is mandatory. Pericardial tamponade, rapidly resolved with pericardial drainage, is a predictor for improved survival, while age and presence of coronary and spinal malperfusion are associated with dismal outcome in this high-risk patient group.

Mechanical Circulatory Support Strategies in Takotsubo Syndrome with Cardiogenic Shock: A Systematic Review.

BACKGROUND: Takotsubo syndrome is, by definition, a reversible form of acute heart failure. If cardiac output is severely reduced, Takotsubo syndrome can cause cardiogenic shock, and mechanical circulatory support can serve as a bridge to recovery. To date, there are no recommendations on when to use mechanical circulatory support and on which device is particularly effective in this context. Our aim was to determine the best treatment strategy. METHODS: A systematic literature research and analysis of individual patient data was performed in MEDLINE/PubMed according to PRISMA guidelines. Our research considered original works published until 31 July 2023. RESULTS: A total of 93 publications that met the inclusion criteria were identified, providing individual data from 124 patients. Of these, 62 (50%) were treated with veno-arterial extracorporeal life support (va-ECLS), and 44 (35.5%) received a microaxial left ventricular assist device (Impella). Eighteen patients received an Impella CP and twenty-one an Impella 2.5. An intra-aortic balloon pump (IABP) without other devices was used in only 13 patients (10.5%), while other devices (BiVAD or Tandem Heart) were used in 5 patients (4%). The median initial left ventricular ejection fraction was 20%, with no difference between the four device groups except for the IABP group, which was less affected by cardiac output failure (p = 0.015). The overall survival was 86.3%. Compared to the other groups, the time to cardiac recovery was shorter with Impella (p < 0.001). CONCLUSIONS: Though the Impella treatment is new, our analysis may show a significant benefit of Impella compared to other MCS strategies for cardiogenic shock in Takotsubo syndrome.

Patterns in acute aortic dissection and a connection to meteorological conditions in Germany.

Acute type A aortic dissection (ATAAD) is a dramatic emergency exhibiting a mortality of 50% within the first 48 hours if not operated. This study found an absolute value of cosine-like seasonal variation pattern for Germany with significantly fewer ATAAD events (Wilcoxon test) for the warm months of June, July, and August from 2005 to 2015. Many studies suspect a connection between ATAAD events and weather conditions. Using ERA5 reanalysis data and an objective weather type classification in a contingency table approach showed that for Germany, significantly more ATAAD events occurred during lower temperatures (by about 4.8 K), lower water vapor pressure (by about 2.6 hPa), and prevailing wind patterns from the northeast. In addition, we used data from a classification scheme for human-biometeorological weather conditions which was not used before in ATAAD studies. For the German region of Berlin and Brandenburg, for 2006 to 2019, the proportion of days with ATAAD events during weather conditions favoring hypertension (cold air advection, in the center of a cyclone, conditions with cold stress or thermal comfort) was significantly increased by 13% (Chi-squared test for difference of proportions). In contrast, the proportion was decreased by 19% for conditions associated with a higher risk for patients with hypotension and therefore a lower risk for patients with hypertension (warm air advection ahead of warm fronts, conditions with no thermal stress or heat stress, in the center of a cyclone with thermal stress). As many studies have shown that hypertension is a risk factor for ATAAD, our findings support the hypothesized relation between ATAAD and hypertension-favoring weather conditions.

Transcatheter management of pure native aortic valve regurgitation in patients with left ventricular assist device.

OBJECTIVES: Aortic valve regurgitation (AR) frequently complicates the clinical course after left ventricular assist device (LVAD) implantation. Transcatheter aortic valve implantation (TAVI) has emerged as an alternative to surgical aortic valve replacement (SAVR) in this cohort with a mostly high surgical risk profile. The unique challenges in LVAD patients, such as presence of non-calcified aortic valves and annular dilatation, raise concerns about device migration and paravalvular leakage (PVL) leading to missing device success. This study evaluates procedural outcomes and survival rates in LVAD patients who underwent TAVI, emphasizing strategies to enhance device success. METHODS: Between January 2017 and April 2023, 27 LVAD patients with clinically significant AR underwent elective or urgent TAVI at our centre. Primary end-points were procedural success rates, without the need for a second transcatheter heart valve (THV) and postprocedural AR/PVL. Secondary outcomes included survival rates and adverse events. RESULTS: Among the cohort, 14.8% received AR-dedicated TAVI devices, with none requiring a second THV. There was no intraprocedural AR, and 1 patient (25%) had AR > 'trace' at discharge. Additionally, 25.9% underwent device landing zone (DLZ) pre-stenting with a standard TAVI device, all without needing a second THV. There was no intraprocedural AR, and none to trace AR at discharge. Among the 59.3% receiving standard TAVI devices, 37.5% required a second THV. In this subgroup, intraprocedural AR > 'trace' occurred in 12.5%, decreasing to 6.25% at discharge. In-hospital mortality was 3.7%, and median follow-up survival was 388 days (interquartile range 208-1167 days). CONCLUSIONS: TAVI yields promising procedural outcomes and early survival rates in LVAD patients with AR. Tailored TAVI devices and pre-stenting techniques enhance procedural success. Continued research into these strategies is essential to optimize outcomes in this complex patient cohort.

A simulation-based phantom model for generating synthetic mitral valve image data-application to MRI acquisition planning.

PURPOSE: Numerical phantom methods are widely used in the development of medical imaging methods. They enable quantitative evaluation and direct comparison with controlled and known ground truth information. Cardiac magnetic resonance has the potential for a comprehensive evaluation of the mitral valve (MV). The goal of this work is the development of a numerical simulation framework that supports the investigation of MRI imaging strategies for the mitral valve. METHODS: We present a pipeline for synthetic image generation based on the combination of individual anatomical 3D models with a position-based dynamics simulation of the mitral valve closure. The corresponding images are generated using modality-specific intensity models and spatiotemporal sampling concepts. We test the applicability in the context of MRI imaging strategies for the assessment of the mitral valve. Synthetic images are generated with different strategies regarding image orientation (SAX and rLAX) and spatial sampling density. RESULTS: The suitability of the imaging strategy is evaluated by comparing MV segmentations against ground truth annotations. The generated synthetic images were compared to ones acquired with similar parameters, and the result is promising. The quantitative analysis of annotation results suggests that the rLAX sampling strategy is preferable for MV assessment, reaching accuracy values that are comparable to or even outperform literature values. CONCLUSION: The proposed approach provides a valuable tool for the evaluation and optimization of cardiac valve image acquisition. Its application to the use case identifies the radial image sampling strategy as the most suitable for MV assessment through MRI.

Driveline infections in left ventricular assist devices-Incidence, epidemiology, and staging proposal.

BACKGROUND: Driveline infections (DLI) are a serious complication in patients with left ventricular assist devices (LVAD). Apart from the differentiation between superficial and deep DLI, there is no consensus on the classification of the severity of DLI. Little is known about risk factors and typical bacteria causing DLI in centrifugal-flow LVADs. METHODS: In this single-center study with 245 patients, DLI were classified by their local appearance using a modification of a score suggested by the Sharp Memorial group. The driveline exit site was inspected routinely every 6 months. RESULTS: Severe DLI were detected in 34 patients (15%) after 6 months and in 24 patients (22%) after 24 months. The proportion of patients with DLI increased significantly during the follow-up (p = 0.0096). The most common bacteria in local smears were Corynebacterium, coagulase-negative Staphylococcus, and Staphylococcus aureus. Fifty-nine patients were hospitalized more than once for DLI. In these patients, S. aureus was the most common bacterium. It was also the most common bacterium in blood cultures. Higher BMI, no partnership, and a HeartMate 3 device were identified as risk factors for DLI in a multivariable cause-specific Cox regression. CONCLUSION: This study is a standardized analysis of DLI in a large cohort with centrifugal-flow LVADs.