Commissural alignment and the ACURATE neo2 transcatheter aortic valve: Impact on valve performance.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is increasingly being used to treat severe aortic stenosis in younger patients. Accordingly, lifetime management regarding future reintervention and coronary access is a concern. AIMS: To assess the impact of commissural alignment on ACURATE neo2 transcatheter aortic valve (TAV) performance. METHODS: COMALIGN-neo2 was an observational, retrospective study enrolling consecutive TAVR patients treated with the ACURATE neo2 (October 2021 to October 2022). The degree of commissural (mis)-alignment (CMA) with the native aortic valve commissures was determined and transvalvular gradient, effective orifice area, patient-prosthesis mismatch (PPM), and aortic regurgitation (AR) were assessed. RESULTS: Among 825 patients, the mean age was 80.7 years and 42% were female. Commissural alignment was achieved in 60% of cases; mild (26%), moderate (9%), and severe misalignment (5%) were found less often. Severe PPM occurred more frequently in patients with severe CMA (14.7%) compared to aligned valves (p = 0.034). By multivariate analysis, severe CMA (odds ratio [OR]: 3.12, 95% confidence interval [CI] [1.09-8.90]; p = 0.033) and lack of postdilatation (OR: 3.85, [1.33-11.1]; p = 0.012) were associated with severe PPM. Higher rates of ≥mild AR (51.4%) were found in TAVs implanted with severe CMA compared to aligned (34.3%), mildly (38.1%) or moderately (36.0%) misaligned TAVs (p = 0.030). Multivariate analysis identified severe CMA (OR: 2.05, [1.05-4.02]; p = 0.037) to be an independent predictor of ≥mild AR. CONCLUSIONS: COMALIGN-neo2 is the largest study to date assessing the impact of commissural alignment on acute TAV performance. Severe CMA with the ACURATE neo2 platform was associated with worse valve hemodynamics and increased risk for mild AR.

Outcomes of transfemoral TAVR using two new-generation devices in patients with horizontal aorta.

BACKGROUND: Challenging anatomies and comorbidities have impact on success in transcatheter aortic valve replacement (TAVR). There is controversy whether the extent of the aortic angle (AA) has an impact on procedural outcomes. Matched comparative outcome data of new generation transcatheter heart valves (THVs) in horizontal aorta (HA) are scarce. METHODS: A total of 1582 patients with severe native aortic stenosis (AS) treated with the SAPIEN3 Ultra (Ultra; n = 526) or ACURATE Neo2 (Neo2; n = 1056) THVs from January 2017 to January 2023 were analyzed. Patients with non-horizontal aortas (AA < 51.7°, n = 841) were excluded. The population was matched by 1-to-1 nearest-neighbor matching (Ultra, n = 246; Neo2, n = 246). Clinical and procedural outcome were evaluated according to VARC-3 recommendations. RESULTS: Technical success (93.1% vs. 94.7%, p = 0.572) was high after Ultra and Neo2. Device success (80.5% vs. 89.8%, p = 0.05) was inferior with Ultra. Neo2 reveals superior hemodynamic properties with lower rate of severe prosthesis patient mismatch (12.0% vs. 3.7%, p = 0.001) and elevated gradients ( ≥ $\ge $ 20 mmHg: 11.9% vs. 1.7%, p < 0.001). Ultra showed a lower rate of relevant paravalvular regurgitation ( > $\gt $ mild paravalvular regurgitation or Valve-in-Valve due to paravalvular regurgitation: 0.0% vs. 3.7%, p = 0.004). The rate of procedural bailout maneuvers (0.8% vs. 0.4%, p = 1.000) and thirty-day all-cause mortality (1.3% vs. 2.2%, p = 0.496) was similar. CONCLUSION: Transfemoral TAVR in patients with severe aortic stenosis and HA, using the balloon expandable Sapien3 Ultra and self-expanding ACURATE Neo2 prosthesis, is feasible and safe. Therefore, valve selection between these platforms should be made irrespective of the aortic angle by a team experienced with both valves based on their specific advantages. Large, randomized trials in this sub-group of patients would be necessary to compare long term outcomes.

Percutaneous trans-axilla transcatheter aortic valve replacement.

The left axillary artery is an attractive alternative access route for transcatheter aortic valve replacement (TAVR) and may provide better outcomes compared to other alternatives. Nevertheless, there remain concerns about vascular complications, lack of compressibility, and thorax-related complications. Between March 2019 and March 2021, 13 patients underwent transaxillary TAVR for severe aortic stenosis at the University Hospital Bonn. The puncture was performed with a puncture at the distal segment of the axillary artery through the axilla, with additional femoral access for applying a safety wire inside the axillary artery. Device success was defined according to the VARC 2 criteria. The study participants were advanced in age (77 ± 9 years old), and 54% were female, with an intermediate risk for surgery (STS risk score 4.7 ± 2.0%). The average diameter of the distal segment of the axillary artery was 5.8 ± 1.0 mm (i.e., the puncture site) and 7.6 ± 0.9 mm for the proximal axillary artery. Device success was achieved in all patients. 30-day major adverse cardiac and cerebrovascular events were 0%. With complete percutaneous management, stent-graft implantation was performed at the puncture site in 38.5% of patients. Minor bleeding was successfully managed with manual compression. Moreover, no thorax-related complications, hematomas, or nerve injuries were observed. Percutaneous trans-axilla TAVR was found to be feasible and safe. This modified approach may mitigate the risk of bleeding and serious complications in the thorax and be less invasive than surgical alternatives.

Mannitol Is Associated with Less Postoperative Delirium after Aortic Valve Surgery in Patients Treated with Bretschneider Cardioplegia.

BACKGROUND: Heart surgery with extracorporeal circulation (ECC) often leads to postoperative delirium (POD). This is associated with increased morbidity resulting in longer hospital stay and associated costs. The purpose of our study was to analyze the effect of intraoperative mannitol application on POD in patients undergoing elective aortic valve replacement (AVR). MATERIALS AND METHOD: s In our retrospective single-center study, 259 patients underwent elective AVR, using Bretschneider cardioplegic solution for cardiac arrest, between 2014 and 2017. Patients were divided in mannitol (n = 188) and nonmannitol (n = 71) groups. POD was assessed using the confusion assessment method for the intensive care unit (ICU). Statistical significance was assumed at p < 0.05. RESULTS: Baseline patient characteristics did not differ between the groups. Incidence of POD was significantly higher in the nonmannitol group (33.8 vs. 13.8%; p = 0.001). These patients required longer ventilation time (24.1 vs. 17.1 hours; p = 0.021), higher reintubation rate (11.3 vs. 2.7%; p = 0.009), ICU readmission (12.7 vs. 4.8%; p = 0.026), prolonged ICU (112 vs. 70 hours; p = 0.040), and hospital stay (17.8 vs. 12.6 days; p < 0.001), leading to higher expenses (19,349 € vs. 16,606 €, p < 0.001). A 30-day mortality was not affected, but nonmannitol group showed higher Simplified Acute Physiology Score II score (32.2 vs. 28.7; p < 0.001). Mannitol substitution was independently associated with lower incidence of POD (odds ratio: 0.40; 95% confidence interval: 0.18-0.89; p = 0.02). CONCLUSION: Treatment with mannitol during ECC was associated with decreased incidence of POD. This was accompanied by shorter ventilation time, ICU and hospital stay, and lower treatment expenses.

Atrial fibrillation recurrence and spontaneous conversion to sinus rhythm after cardiac surgery: Insights from 426 patients with continuous rhythm monitoring.

INTRODUCTION: Cardiac surgery may influence occurrence and persistence of atrial fibrillation (AF). In patients with a history of cardiac surgery and postoperative pacemaker or implantable cardioverter defibrillator implantation we attempted to quantify AF characteristics and investigate factors that influence AF recurrence. METHODS: In 426 patients (319 male; age: 73 SD: 9 years) with a history of cardiac surgery (364 CABG; 69 mitral valve; 57 aortic valve and 59 combination procedures) the heart rhythm history (mean: 351 days SD: 54 days) was reconstructed and investigated for AF recurrence patterns. RESULTS: AF developed and subsequently recurred in 75% of patients (n = 320). The mean AF burden in these patients was 0.21 (21% of the total observed time spent in AF) and 4085 episodes of AF were observed and analyzed. AF episodes spontaneously terminated within 24 h (n = 2509), 48 h (n = 700), 72 h (n = 279), and 1 week (n = 31). The probability of spontaneous conversion to sinus rhythm (SR) decreased with time spent in AF and plateaued after approximately 7 days. Patient age, LVEF and presence of coronary artery disease significantly influenced the probability of spontaneous conversion to SR. Type of cardiac surgery also significantly influenced AF episode characteristics. CONCLUSION: AF episodes are common in patients with a history of cardiac surgery. Spontaneous conversion to SR diminishes with increasing time spent in AF and is influenced by AF characteristics and several patient-related factors. Continuous monitoring can provide detailed information about AF recurrence that may immensely improve our understanding and influence the clinical management of AF.

Fluid Therapy With Gelatin May Have Deleterious Effects on Kidney Function: An Observational Trial.

OBJECTIVE: To explore the effects of fluid therapy with the synthetic colloids hydroxyethyl starch (HES) and gelatin (GEL) on the incidence of acute kidney injury (AKI) and need for renal replacement therapy (RRT) in patients undergoing cardiac surgery. DESIGN: Secondary analysis of a prospective observational study in cardiac surgical patients. DESIGN: University hospital. PARTICIPANTS: The study included 584 elective patients (excluding patients on preoperative dialysis). MEASUREMENTS AND MAIN RESULTS: Anamnestic and surgical core data, hemodynamics, and hemodynamic treatments were recorded intraoperatively and postoperatively. Postoperative kidney dysfunction was graded according to the Acute Kidney Injury Network criteria from perioperative changes in plasma creatinine and urine flow. Statistical analyses were performed descriptively, by logistic and probit regression, omitting inotropic and vasoactive medications as established renal risk factors. The incidence of AKI and new renal replacement therapy was 28.6% and 7.5%, respectively. Patients with AKI were older, had a higher additive Euroscore, lower preoperative glomerular filtration rates and hemoglobin level, and presented with a longer duration of cardiopulmonary bypass and surgery and higher postoperative drainage loss. HES (1 [0-2] units of 500 mL) and GEL (3 [2-5] units of 500 mL) were used in 317 and 563 patients, respectively. Crystalloids were used in all patients (4,560 [4,080-5,042] mL). Patients presenting with AKI or new RRT were treated with significantly higher amounts of GEL. The use of HES and crystalloids did not differ between these groups. Probit regression showed significant dose-response relationships between the amount of infused gelatin and the probability of AKI and new RRT. Probit regression showed significant (p = 0.0001 and 0.0003, respectively) dose-response relationships between the total units of gelatin polysuccinate infused and the probability of AKI and new RRT (Fig 1). Logistic regression revealed a statistically significant odds ratio (OR) of 1.9741 (95% CI: 1.3104-2.9740; p = 0.0011) for an association between the number of gelatin units infused and AKI (grade 1-3) but no direct association between the number of gelatin units administered and new RRT. No association between a decrease in kidney function and the application of HES was observed. CONCLUSIONS: Taking into account the limitations of the small sample size and a low event rate, the nonconsideration of established renal risk factors such as inotropes and vasopressors, and potentially unmeasured confounders, these findings suggested that gelatin solutions may have deleterious effects on renal function in cardiac surgical patients. The adverse clinical effects of HES on kidney function observed in other studies may have been blunted by the restrictive use of this synthetic colloid.

Gender-Dependent Clinical Outcome and Other Predictors of In-Hospital Mortality Following Out-Of-Center Extracorporeal Membrane Oxygenation and Extracorporeal Life Support: A Single Center Experience.

BACKGROUND: Out-of-center extracorporeal membrane oxygenation (ECMO) and extracorporeal life support (ECLS) implantation for the treatment of acute cardiorespiratory failure with subsequent transport to a tertiary care center has been introduced successfully into the medical practice. However, due to the very specific and resource intensive nature of this therapeutic concept, it seems important to generate algorithms for adequate patient selection. The aim of our study was to analyze the impact of patients' gender on early clinical outcome in this specific therapeutic scenario. METHODS: Ninety-seven consecutive patients treated by out-of-center ECMO/ECLS implantation and subsequent transport and treatment in our tertiary care cardiovascular center within the Hallesche Extracorporeal Life Support Program (HELP) retrospectively were analyzed, regarding the impact of patients' gender on early clinical outcome. RESULTS: Mechanical circulatory support successfully was weaned in two-thirds of the male patients. This result was achieved in only one-third of the female patients (59.4% in male vs. 33.3% in female, P = .0267). Overall survival significantly was higher in the male group (62.5% in male versus 30.3% in female, P = .0052). In uni- and multivariate logistic regression analysis, female gender was an independent predictor of in-hospital mortality (uni: OR:3.833, CI:1.597-9.745, P = .0034; multi: OR:3.477, CI:1.146-11.494, P = .0322). Worse outcome also was associated with following independent predictors, age, SOFA score, lactate and ventilation time pre-ECMO/ECLS implantation. CONCLUSION: The current study demonstrates a worse early survival for women, following emergent out-of- center ECMO/ECLS implantation and subsequent transport and treatment in our tertiary care cardiovascular center. Gender should be included in patient selection algorithms while basic research approaches are needed to better understand the mechanisms underlying these gender- specific outcome disparities.

Data Science Meets the Clinician: Challenges and Future Directions.

In the last three decades a profound transformation of the medical profession has taken place. The modern clinician is required to consume vast amounts of information from clinical studies, critically reviewing evidence that may or may not lead to changes in clinical practice. The present article presents some challenges that this era of information poses to clinicians and patients.

The effects of systemic oxygenation on cerebral oxygen saturation and its relationship to mixed venous oxygen saturation: A prospective observational study comparison of the INVOS and ForeSight Elite cerebral oximeters.

PURPOSE: The present study aimed to test the hypothesis that cerebral oxygen saturation (ScO2) measurements with the INVOS-5100-C and the ForeSight-Elite cerebral oximeters vary in their correlation with mixed venous oxygen saturation (SvO2) upon changes in systemic oxygenation in extubated cardiac surgical patients. Additionally, we aimed to elucidate whether the ScO2 measurements of both devices can be used interchangeably to detect reduced SvO2. METHODS: Forty-eight spontaneously breathing patients extubated after cardiac surgery were included in this prospective observational study. The patients were exposed to both high (10 oxygen L·min-1 via face mask) and low (room air) inspiratory oxygen concentrations. Bi-hemispherical ScO2 was determined with the INVOS and ForeSight Elite cerebral oximeters. The SvO2 was measured with a pulmonary artery catheter. RESULTS: Significant changes in oxygen delivery, ScO2 (by both cerebral oximeters), and SvO2 were observed upon variation of oxygenation. The minimum mean (standard deviation) ScO2 (ScO2min) using the INVOS and ForeSight did not differ significantly during high oxygen delivery [63.1 (8.6) % vs 65.8 (4.7) %, respectively; P = 0.07], but during low oxygen delivery, the INVOS value was significantly lower than that of the ForeSight oximeter [56.7 (8.9) % vs 61.3 (4.4) %, respectively; P = 0.003]. Both devices differed in the correlation between ScO2min and SvO2 for the combined oxygenation data (0.59, INVOS vs 0.28, ForeSight; correlation difference, 0.31; Bonferroni-adjusted 95% confidence interval [CI], 0.08 to 0.54; P = 0.008). The receiver-operating curve analysis revealed an area under the curve of 0.83 (95% CI, 0.74 to 0.9; P = 0.005) for detecting an SvO2 below 50% by ScO2min with the INVOS and 0.51 (95% CI, 0.41 to 0.62; P = 0.92), respectively, with the ForeSight. CONCLUSIONS: These findings suggest that the cerebral oximeters tested react differently to variations in systemic oxygenation and in their relationship with SvO2 and thus give different information on cardiopulmonary function. These findings raise doubt about whether these devices should be used interchangeably.

Does Undersizing of Transcatheter Aortic Valve Bioprostheses during Valve-in-Valve Implantation Avoid Coronary Obstruction? An In Vitro Study.

Background The transcatheter aortic valve-in-valve implantation (TAViVI) is an evolving treatment strategy for degenerated surgical aortic valve bioprostheses (SAVBs) in patients with high operative risk. Although hemodynamics is excellent, there is some concern regarding coronary obstruction, especially in SAVB with externally mounted leaflet tissue, such as the Trifecta (St. Jude Medical Inc., St. Paul, Minnesota, United States). We investigated coronary flow and hydrodynamics before and after TAViVI in a SAVB with externally mounted leaflet tissue (St. Jude Medical, Trifecta) with an undersized transcatheter aortic valve bioprosthesis (Edwards Sapien XT; Edwards Lifesciences LLC, Irvine, California, United States) in an in vitro study. Materials and Methods An aortic root model was constructed incorporating geometric dimensions known as risk factors for coronary obstruction. Investigating the validity of this model, we primarily performed recommended TAViVI with the Sapien XT (size 26 mm) in a Trifecta (size 25 mm) in a mock circulation. Thereafter, hydrodynamic performance and coronary flow (left/right coronary diastolic flow [lCF/rCF]) after TAViVI with an undersized Sapien XT (size 23 mm) in a Trifecta (size 25 mm) were investigated at two different coronary ostia heights (COHs, 8 and 10 mm). Results Validation of the model led to significant coronary obstruction (p < 0.001). Undersized TAViVI showed no significant reduction with respect to coronary flow (lCF: COH 8 mm, 0.90-0.87 mL/stroke; COH 10 mm, 0.89-0.82 mL/stroke and rCF: COH 8 mm, 0.64-0.60 mL/stroke; COH 10 mm, 0.62-0.58 mL/stroke). Mean transvalvular gradients (4-5 mm Hg, p < 0.001) increased significantly after TAViVI. Conclusions In our in vitro model, undersized TAViVI with the balloon-expandable Sapien XT into a modern generation SAVB (Trifecta) successfully avoided coronary flow obstruction.

Preoperative plasma growth-differentiation factor-15 for prediction of acute kidney injury in patients undergoing cardiac surgery.

BACKGROUND: Growth-differentiation factor-15 (GDF-15) is an emerging humoral marker for risk stratification in cardiovascular disease. Cardiac-surgery-associated acute kidney injury (CSA-AKI), an important complication in patients undergoing cardiac surgery, is associated with poor prognosis. The present secondary analysis of an observational cohort study aimed to determine the role of GDF-15 in predicting CSA-AKI compared with the Cleveland-Clinic Acute Renal Failure (CC-ARF) score and a logistic regression model including variables associated with renal dysfunction. METHODS: Preoperative plasma GDF-15 was determined in 1176 consecutive patients undergoing elective cardiac surgery. Patients with chronic kidney disease stage 5 were excluded. AKI was defined according to Kidney-Disease-Improving-Global-Outcomes (KDIGO) - creatinine criteria. The following variables were screened for association with development of postoperative AKI: age, gender, additive Euroscore, serum creatinine, duration of cardiopulmonary bypass, duration of surgery, type of surgery, total circulatory arrest, preoperative hemoglobin, preoperative oxygen-supplemented cerebral oxygen saturation, diabetes mellitus, hemofiltration during ECC, plasma GDF-15, high sensitivity troponin T (hsTNT), and N-terminal prohormone of B-type natriuretic peptide (NTproBNP). RESULTS: There were 258 patients (21.9 %) with AKI (AKI stage 1 (AKI-1), n = 175 (14.9 %); AKI-2, n = 6 (0.5 %); AKI-3, n = 77 (6.5 %)). The incidence of AKI-1 and AKI-3 increased significantly from the lowest to the highest tertiles of GDF-15. In logistic regression, preoperative GDF-15, additive Euroscore, age, plasma creatinine, diabetes mellitus, and duration of cardiopulmonary bypass were independently associated with AKI. Inclusion of GDF-15 in a logistic regression model comprising these variables significantly increased the area under the curve (AUC 0.738 without and 0.750 with GDF-15 included) and the net reclassification ability to predict AKI. Comparably, in receiver operating characteristic analysis the predictive capacity of the CC-ARF score (AUC 0.628) was improved by adding GDF-15 (AUC 0.684) but this score also had lower predictability than the logistic regression model. In random forest analyses the predictive capacity of GDF-15 was especially pronounced in patients with normal plasma creatinine. CONCLUSION: This suggests that preoperative plasma GDF-15 independently predicts postoperative AKI in patients undergoing elective cardiac surgery and is particularly helpful for risk stratification in patients with normal creatinine. TRIAL REGISTRATION: NCT01166360 on July 20, 2010.

Age-related reoperation rate after the Ross procedure: a report from the German Ross Registry.

BACKGROUND AND AIM OF THE STUDY: An increasing number of young adult patients are choosing bioprostheses for aortic valve replacement (AVR). In this context, the Ross operation deserves renewed consideration as an alternative biological substitute. After both the Ross procedure and bioprosthetic AVR, reoperation rates remain a concern and may be related to age at surgery. Herein are reported details of freedom from reoperation after the Ross procedure for different age groups. METHODS: The reoperation rates of 1,925 patients (1,444 males, 481 females; mean age 41.2 ± 15.3 years) from the German Ross registry with a mean follow up of 7.4 ± 4.7 years (range: 0.00-18.51 years; total 12,866.6 patient-years) were allocated to three age groups: group I < 40 years; group II 40-60 years; and group III > 60 years. RESULTS: At 10 years (respectively 15 years) of follow up, freedom from reoperation was 86% (76%) in group I, 93% (85%) in group II, and 89% (83%) in group III. CONCLUSION: There is some evidence that, at least during the first 10 and 15 years after AVR, the Ross procedure provides a significantly lower reoperation rate in young adult and middle-aged patients aged < 60 years. This information may be of interest to the patients' or physicians' decision-making for aortic valve surgery.

Postoperative intubation time is associated with acute kidney injury in cardiac surgical patients.

INTRODUCTION: Acute kidney injury (AKI) is a frequent complication after cardiac surgery and is associated with a poor prognosis. Mechanical ventilation is an important risk factor for developing AKI in critically ill patients. Ventilation with high tidal volumes has been associated with postoperative organ dysfunction in cardiac surgical patients. No data are available about the effects of the duration of postoperative respiratory support in the immediate postoperative period on the incidence of AKI in patients after cardiac surgery. METHOD: We performed a secondary analysis of 584 elective cardiac surgical patients enrolled in an observational trial on the association between preoperative cerebral oxygen saturation and postoperative organ dysfunction and analyzed the incidence of AKI in patients with different times to extubation. The latter variable was graded in 4 h intervals (if below 16 h) or equal to or greater than 16 h. AKI was staged according to the AKI Network criteria. RESULTS: Overall, 165 (28.3%) patients developed AKI (any stage), 43 (7.4%) patients needed renal replacement therapy. Patients developing AKI had a significantly (P <0.001) lower renal perfusion pressure (RPP) in the first 8 hours after surgery (57.4 mmHg (95% CI: 56.0 to 59.0 mmHg)) than patients with a postoperatively preserved renal function (60.5 mmHg ((95% CI: 59.9 to 61.4 mmHg). The rate of AKI increased from 17.0% in patients extubated within 4 h postoperatively to 62.3% in patients ventilated for more than 16 h (P <0.001). Multivariate logistic regression analysis of variables significantly associated with AKI in the univariate analysis revealed that the time to the first extubation (OR: 1.024/hour, 95% CI: 1.011 to 1.044/hour; P <0.001) and RPP (OR: 0.963/mmHg; 95% CI: 0.934 to 0.992; P <0.001) were independently associated with AKI. CONCLUSION: Without taking into account potentially unmeasured confounders, these findings are suggestive that the duration of postoperative positive pressure ventilation is an important and previously unrecognized risk factor for AKI in cardiac surgical patients, independent from low RPP as an established AKI trigger, and that even a moderate delay of extubation increases AKI risk. If replicated independently, these findings may have relevant implications for clinical care and for further studies aiming at the prevention of cardiac surgery associated AKI.

Atrial fibrillation burden estimates derived from intermittent rhythm monitoring are unreliable estimates of the true atrial fibrillation burden.

BACKGROUND: Estimates of atrial fibrillation (AF) burden (AFB) derived from intermittent rhythm monitoring (IRM) are increasingly being used as an outcome measure after therapeutic interventions; however, their accuracy has never been validated. The aim of this study was to compare IRM-derived AFB estimates to the true AFB as measured by implantable continuous monitoring (CM) devices. METHODS: Rhythm histories from 647 patients (mean AFB: 12 ± 22%; 687 patient·years) with CM devices were analyzed. IRM of various frequencies and durations were simulated and the obtained IRM-derived AF burdens were compared to the true AFB measured by CM. RESULTS: The relative error of the IRM burden estimates was dependent on the IRM length (P < 0.001), frequency of IRM (P < 0.001), the true AFB (P < 0.001), and its temporal aggregation (AF density, P < 0.001). In paroxysmal AF patients, the relative error even with aggressive IRM strategies was >80% of the true AFB. The relative error decreased with higher true AF burdens, lower AF densities, and higher IRM frequency or duration (P < 0.001). However, even in patients with high AF burdens and/or low AF densities, IRM estimates of AFB significantly deviated from the true AFB (relative error >20%, P < 0.001) and resulted in a substantial measurement error. CONCLUSION: IRM-derived AFB estimates are unreliable estimators of the true AFB. Particularly for paroxysmal AF patients, IRM-derived AFB estimates should not be used to evaluate outcomes after AF interventions.

Clinical outcomes and lessons learned with aortic valve repair in 508 patients.

BACKGROUND AND AIM OF THE STUDY: Aortic valve repair is an attractive alternative to valve replacement. Herein is presented the authors' single-center experience and lessons learned from 508 patients undergoing AVR, in three different groups. METHODS: Between 1993 and 2010, a total of 508 patients (148 females, 360 males; mean age 54 ± 17 years) underwent aortic valve repair. Operations included valve-sparing surgery (n = 253), isolated leaflet intervention (n = 158), and sinotubular junction (STJ) remodeling (n = 97). Aortic valve repair was defined as any primary or concomitant procedure performed at the level of the aortic valve or root for the restoration of function and/or anatomy of the valve. The mean follow up was 6.9 ± 3.8 years (range: 0-18 years; median: 6.3 years; total: 3,477 patient-years). The completeness of clinical follow up was 95%. RESULTS: The 30-day mortality with and without dissection was 4.4% (8/180) and 1.8% (6/328), respectively. Late survival without dissection, although statistically inferior, followed closely the expected general population. In total, 53 patients required a cardiac, valve-related reoperation. Among the valve-sparing group, no significant difference in freedom from reoperation at 10 years was observed between the David and Yacoub types (n = 147 (89%) versus n = 113 (79%); p = 0.373, respectively). Among patients who underwent isolated leaflet interventions, the number required to restore valve function (repair score) significantly affected the durability and incidence of reoperations (hazard ratio 1.47; 95% CI 1.1-2.0; p = 0.01), with the risk for failure being higher early after the operation. Patients with functional aortic insufficiency (AI) requiring only STJ remodeling resulted in the most durable outcome (freedom from reoperation 97.5% at 10 years). At the latest echocardiographic follow up (448 patients; total: 2,755 pt-yr; mean: 6.4 ± 3.7 years; completeness 88%), 97% of patients had AI of grade ≤ 2. CONCLUSION: Aortic valve repair is an attractive alternative to conventional replacement in many patients and pathologies. In particular, pathologies requiring multiple leaflet interventions and repair techniques may lead to suboptimal results. Leaflet quality and leaflet-adjusted root stabilization/reconstruction are key elements for durable results.

[Catheter-based and surgical treatment for aortic valve diseases]. / Katheterbasierte und operative Therapie bei Aortenvitien.

The pathophysiology of aortic valve diseases is of predominantly degenerative nature, characterized by calcific aortic valve stenosis, which is associated with a reduction in prognosis. The prevalence of aortic valve insufficiency also increases with advancing age. Timely causal treatment is crucial in the management of aortic valve diseases. Following the indication for intervention, the heart team plays a central role in evaluating the results and making therapeutic decisions that consider the patient's preferences. In the assessment of treatment options, considerations regarding the long-term perspective are particularly crucial, especially in younger patients. The most common therapeutic approach for aortic valve diseases is the introduction of a new valve prosthesis. In the majority of cases, this is now achieved through catheter-based implantation of a bioprosthetic heart valve, known as transcatheter aortic valve implantation (TAVI). Open surgical aortic valve replacement (AVR) is favored in younger patients with low surgical risk or in the case that TAVI is not feasible. In AVR, both biological and the longest-lasting mechanical prosthesis types are used. Surgical repair techniques are primarily applied in cases of aortic valve regurgitation. Notably, TAVI, as well as surgical procedures for the treatment of aortic valve diseases, have undergone significant advancements in recent years, including expanded indications for TAVI and, on the surgical side, in particular the development of minimally invasive surgical techniques.

ACURATE neo2 Versus SAPIEN 3 Ultra Transcatheter Heart Valve in Severe Aortic Valve Calcification: A Propensity-Matched Analysis.

BACKGROUND: Comparative data on transcatheter self-expanding ACURATE neo2 (NEO2) and balloon-expandable SAPIEN 3 Ultra prostheses in technically challenging anatomy of severe aortic valve calcified aortic annuli are scarce. METHODS: A total of 1987 patients with severe native aortic stenosis treated with the self-expanding NEO2 (n=1457) or balloon-expandable SAPIEN 3 Ultra (n=530) from January 2017 to April 2023 were evaluated. The primary end point was procedural outcome according to the Valve Academic Research Consortium 3 definitions. Propensity matching defined 219 pairs with severe calcification (calcium density cutoff, 758 AU/cm2) of the native aortic valve. RESULTS: Technical success (90.4% versus 91.8%; risk difference, 1.4% [95% CI, -4.4 to -7.2]; P=0.737) and device success at 30 days (80.8% versus 75.8%; risk difference, -5.0% [95% CI, -13.2 to 3.1]; P=0.246) were comparable between NEO2 and SAPIEN 3 Ultra. The rate of severe prosthesis-patient mismatch (1.1% versus 10.1%; risk difference, 10.0% [95% CI, 4.0-13.9]; P<0.001) and mean transvalvular gradient ≥20 mm Hg (2.8% versus 14.3%; risk difference, 11.5% [95% CI, 5.8-17.1]; P<0.001) was lower with NEO2. The rate of more-than-mild paravalvular leakage or valve-in-valve due to paravalvular leakage was significantly higher (6.2% versus 0.0%; risk difference, 6.2% [95% CI, -10.1 to -2.7]; P=0.002), and there was a tendency for a higher rate of device embolization or migration (1.8% versus 0.0%; risk difference, -1.8% [95% CI, -4.1 to 0.4]; P=0.123) with NEO2. Multivarate regression revealed no independent impact of transcatheter heart valve selection on device success (odds ratio, 0.93 [95% CI, 0.48-1.77]; P=0.817). CONCLUSIONS: In patients with severely calcified annuli, supraannular implantation of NEO2 showed hemodynamic advantages. Nevertheless, NEO2 was associated with a higher incidence of relevant paravalvular leakage and a numerically higher rate of device embolization than SAPIEN 3 Ultra in this particular patient group.

Comparison of two self-expanding transcatheter heart valves for degenerated surgical bioprostheses: the AVENGER multicentre registry.

BACKGROUND: There is a lack of comparative data on transcatheter aortic valve implantation (TAVI) in degenerated surgical prostheses (valve-in-valve [ViV]). AIMS: We sought to compare outcomes of using two self-expanding transcatheter heart valve (THV) systems for ViV. METHODS: In this retrospective multicentre registry, we included consecutive patients undergoing transfemoral ViV using either the ACURATE neo/neo2 (ACURATE group) or the Evolut R/PRO/PRO+ (EVOLUT group). The primary outcome measure was technical success according to Valve Academic Research Consortium (VARC)-3. Secondary outcomes were 30-day all-cause mortality, device success (VARC-3), coronary obstruction (CO) requiring intervention, rates of severe prosthesis-patient mismatch (PPM), and aortic regurgitation (AR) ≥moderate. Comparisons were made after 1:1 propensity score matching. RESULTS: The study cohort comprised 835 patients from 20 centres (ACURATE n=251; EVOLUT n=584). In the matched cohort (n=468), technical success (ACURATE 92.7% vs EVOLUT 88.9%; p=0.20) and device success (69.7% vs 73.9%; p=0.36) as well as 30-day mortality (2.8% vs 1.6%; p=0.392) were similar between the two groups. The mean gradients and rates of severe PPM, AR ≥moderate, or CO did not differ between the groups. Technical and device success were higher for the ACURATE platform among patients with a true inner diameter (ID) >19 mm, whereas a true ID ≤19 mm was associated with higher device success - but not technical success - among Evolut recipients. CONCLUSIONS: ViV TAVI using either ACURATE or Evolut THVs showed similar procedural outcomes. However, a true ID >19 mm was associated with higher device success among ACURATE recipients, whereas in patients with a true ID ≤19 mm, device success was higher when using Evolut.

A comprehensive evaluation of rhythm monitoring strategies for the detection of atrial fibrillation recurrence: insights from 647 continuously monitored patients and implications for monitoring after therapeutic interventions.

BACKGROUND: Intermittent rhythm monitoring (IRM) to detect atrial fibrillation (AF) recurrence is employed to evaluate the success of therapeutic interventions. In a large population of patients with continuous monitoring (CM), we investigated the sensitivity of various frequencies and durations of IRM strategies on the detection of AF recurrence, the dynamics behind AF recurrence detection, and we describe measures to evaluate temporal AF recurrence. METHODS AND RESULTS: Rhythm histories of 647 patients (mean AF burden, 0.12±0.22; median, 0.014; 687 patient-years) with implantable CM devices were reconstructed and analyzed. With the use of computationally intensive simulation, the sensitivity of IRM of various frequencies and durations on the identification of AF recurrence was evaluated. Prolonged-duration IRM was superior to shorter IRM (P<0.0001). However, even with aggressive IRM strategies, AF recurrence was not detected in a great proportion of patients. The temporal AF burden aggregation (AF density) was directly related to IRM sensitivity (P<0.0001). Even at similar AF burdens, patients with high-density AF required higher-frequency or prolonged-duration IRM to achieve the same sensitivity as in low-density AF (P<0.0001). Patients with high-density, low-burden AF benefit the most from CM for detection of AF recurrence. CONCLUSIONS: IRM follow-up is significantly inferior to CM. IRM strategies will not identify AF recurrence in a great proportion of patients at risk. Temporal AF characteristics play a significant role in AF recurrence detection with the use of IRM. For the scientific, evidence-based evaluation of AF treatments, CM should be strongly recommended. Prospective studies are required to evaluate whether CM to guide clinical management can also improve patient outcomes. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00806689.

Coronary Reaccess After Modified Chimney Stenting in a Self-Expanding Transcatheter Valve-in-Valve.

We demonstrate a modified technique of heterotopic chimney stenting for coronary obstruction during valve-in-valve transcatheter aortic valve replacement With successful end-on cannulation via the stent ostium. Our technique was reproducible on the bench with successful reaccess and without any interaction between the deployed coronary stent and the prosthetic leaflets.