A Machine Learning Model for the Accurate Prediction of 1-Year Survival in TAVI Patients: A Retrospective Observational Cohort Study.

BACKGROUND: predicting the 1-year survival of patients undergoing transcatheter aortic valve implantation (TAVI) is indispensable for managing safe early discharge strategies and resource optimization. METHODS: Routinely acquired data (134 variables) were used from 629 patients, who underwent transfemoral TAVI from 2012 up to 2018. Support vector machines, neuronal networks, random forests, nearest neighbour and Bayes models were used with new, previously unseen patients to predict 1-year mortality in TAVI patients. A genetic variable selection algorithm identified a set of predictor variables with high predictive power. RESULTS: Univariate analyses revealed 19 variables (clinical, laboratory, echocardiographic, computed tomographic and ECG) that significantly influence 1-year survival. Before applying the reject option, the model performances in terms of negative predictive value (NPV) and positive predictive value (PPV) were similar between all models. After applying the reject option, the random forest model identified a subcohort showing a negative predictive value of 96% (positive predictive value = 92%, accuracy = 96%). CONCLUSIONS: Our model can predict the 1-year survival with very high negative and sufficiently high positive predictive value, with very high accuracy. The "reject option" allows a high performance and harmonic integration of machine learning in the clinical decision process.

Comparison between Surgical Access and Percutaneous Closure Device in 787 Patients Undergoing Transcatheter Aortic Valve Replacement.

BACKGROUND: The vascular access in transcatheter aortic valve replacement (TAVR) was initially dominated by a surgical approach. Meanwhile, percutaneous closure systems became a well-established alternative. The aim of this study was to compare the clinical outcome between the two approaches. METHODS: In this retrospective study, we observed 787 patients undergoing a TAVR-Procedure between 2013 and 2019. Of those, 338 patients were treated with surgical access and 449 with the Perclose ProGlide™-System (Abbott, Chicago, IL, USA). According to the Bleeding Academic Research Consortium (BARC) and Valve Academic Research Consortium (VARC) criteria, the primary combined endpoints were defined. RESULTS: Overall hospital mortality was 2.8% with no significant difference between surgical (3.8%) and percutaneous (2.2%) access (p = 0.182). Major vascular complications or bleeding defined as the primary combined endpoint was not significantly different in either group (Surgical group 5.3%, ProGlide group 5.1%, p = 0.899). In the ProGlide group, women with pre-existing peripheral artery disease (PAD) were significantly more often affected by a vascular complication (p = 0.001 for female sex and p = 0.03 for PAD). CONCLUSIONS: We were able to show that the use of both accesses is safe. However, the surgical access route should also be considered in case of peripheral artery disease.

Balloon Transcatheter Aortic Valve Replacement After Aortic Valve Repair With HAART 300 Device.

The HAART 300 (BioStable Science and Engineering, Austin, TX) is a rigid, elliptical device introduced to facilitate aortic valve repair providing annular stabilization in the setting of aortic regurgitation. Percutaneous strategies have been described for patients with dysfunctional biological prostheses or recurrence insufficiency after mitral ring annuloplasty. This report shows the feasibility of aortic valve-in-ring transcatheter aortic valve replacement (TAVR). The sufficient ring stability to support the implanted TAVR-prosthesis and the fact that the elliptical shape of the HAART-ring did not result in a problem concerning paravalvular leakage were important for the success of this procedure.

Two approaches-one phenomenon-thrombocytopenia after surgical and transcatheter aortic valve replacement.

BACKGROPUND AND AIM: Postoperative thrombocytopenia after surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR) and aggravating causes were the aim of this retrospective study. METHODS: Data of all patients treated with SAVR (n = 1068) and TAVR (n = 816) due to severe aortic valve stenosis was collected at our center from 2010 to 2017. Preprocedural and postprocedural values were collected from electronic patient records. RESULTS: There was a significant drop in platelets in both groups, the TAVR group showed overall superior platelet preservation compared to the AVR group (P < .001). In the SAVR subgroup analysis, a significant difference in platelet preservation was observed between the valve types (P < .001), particularly with the Freedom SOLO valve. In the TAVR subgroup analysis, the valve type did not influence platelet count (PLT) reduction (P = .13). In the SAVR subgroup analyses, PLT was found to be worsened with cardiopulmonary bypass (CPB) duration. CONCLUSION: Thrombocytopenia frequently occurs after implantation of a biological heart valve prosthesis, with a higher frequency observed in patients after cardiac surgery rather than TAVR. Although some surgical bioprosthetic models are more susceptible to this phenomenon, CPB duration seems to be a major determinant for the development of postoperative thrombocytopenia.

Functionality and Outcome in Older Patients with Severe Aortic Stenosis (FOOPAS): an interdisciplinary study concept for a prospective trial.

BACKGROUND: Frailty is a geriatric syndrome that can influence mortality and functional recovery after treatment of severe aortic stenosis (AS). The integration of standardized geriatric assessment (GA) in clinical practice is limited by a lack of consensus on how to measure it. OBJECTIVES: This study aims to compare the incremental predictive value of different frailty scales to predict the outcomes following surgical aortic valve replacement, transcatheter aortic valve implantation, and conservative treatment of severe AS. METHODS: A prospective cohort of 300 older adults with severe AS will be assembled after standard clinical examinations and a comprehensive GA, including 18 different tests and values. Primary outcome parameters are overall mortality, cardiovascular mortality, quality of life, and functionality. Secondary parameters are overall complications, cardiovascular complications, and costs. RESULTS: Expected results will contribute to the growing body of evidence on frailty based on parameters that influence clinical and functional outcome in elderly patients independent of the method of treatment. The pre-procedural assessment is expected to be valuable in discriminating new post-procedural complications from simple exacerbations of pre-existing conditions. Therefore, a new frailty test which is simple and feasible for application in a clinical routine by most medical professionals, may help in identifying patients for whom further GA should be considered. Finally, such a frailty score could support heart teams to find the right treatment for patients suffering from AS. CONCLUSION: Comparison of different frailty scales has not only the goal of finding a predictive value of mortality but also to bring in a meaningful improvement for each individual patient and to avoid disability or fatal outcomes.

Sutureless versus Transfemoral Transcatheter Aortic Valve Implant: A Propensity Score Matching Study.

BACKGROUND AND AIM OF THE STUDY: Transcatheter aortic valve implantation (TAVI), especially via the transfemoral (TF) route, is increasingly performed in patients considered in the 'gray zone' between TAVI and surgery. However, the best treatment option in this patient population remains to be established. METHODS: Since 2010, a total of 923 patients underwent either TAVI (n = 538) or sutureless aortic valve replacement (AVR) (n = 385) at the authors' institutions. Among these patients, 79 treated with TF-TAVI were compared with 79 propensity score-matched patients who had undergone elective isolated AVR with the sutureless Perceval bioprosthesis. RESULTS: In-hospital mortality did not differ significantly between patients who underwent sutureless AVR or TF-TAVI (none versus three; 3.8%; p = 0.123). Similarly, postoperative complications were comparable between groups. Atrioventricular block requiring postoperative pacemaker implantation occurred in seven patients (9.2%) of the sutureless group and in eight patients (11.1%) of the TF-TAVI group (p = 0.455). The use of blood products varied between groups in terms of red blood cell transfusions (1.7 ± 2 versus 0.3 ± 0.9 units for the sutureless group versus TF-TAVI group; p <0.001). Paravalvular leakage at discharge was present in three patients (3.8%) in the sutureless group and in 26 patients (32.9%) in the TF-TAVI group (p <0.001). The mean follow up was longer for sutureless AVR (36 ± 21 versus 27 ± 20 months; p = 0.003). Survival rates were 97.5% and 84.8% in the sutureless and TF-TAVI groups, respectively (p = 0.001). CONCLUSIONS: Both, TF-TAVI and sutureless AVR are well-standardized, safe and effective procedures. TF-TAVI seems to be a valuable alternative to surgical AVR for frail patients, reducing the need for perioperative blood transfusion. In contrast, in patients with a favorable long-term survival outcome, minimally invasive AVR remains the procedure of choice as it is associated with better long-term results.

Transapical transcatheter valve-in-ring implantation following mitral annuloplasty.

Despite advances in surgical techniques for mitral valve repair, more than 20% of patients require reoperation within 10 years due to recurrence of severe mitral regurgitation. However, reoperations on the mitral valve are often associated with increased morbidity and mortality. We report a transapical mitral valve-in-ring implantation in a patient who had undergone mitral valve repair for ischemic mitral regurgitation using a complete semi-rigid Memo 3D mitral ring (LivaNova Group, Milan, Italy).

Transcatheter aortic valve-in-valve implantation and sutureless aortic valve replacement: two strategies for one goal in redo patients.

BACKGROUND: The most appropriate approach for high-risk patients with degenerated bioprostheses remains a matter of debate. The aim of the study was to evaluate the clinical and hemodynamic outcome of redo patients undergoing transcatheter aortic valve-in-valve implantation (VinV-TAVI) and sutureless aortic valve replacement (AVR), with assessment of patient-prosthesis mismatch (PPM) in the perioperative and follow-up period. METHODS: From 2010, 343 patients underwent TAVI and 220 patients underwent sutureless AVR at our institution. Among these, 14 patients had prior bioprosthetic AVR and indication for reintervention because of valve degeneration. Patients from the TAVI group (N.=6) underwent VinV-TAVI, and patients from the sutureless group (N.=8) underwent redo AVR. RESULTS: Mean age was 78.8±3 years in the sutureless group and 80.2±2.3 in the VinV-TAVI group. Logistic EuroSCORE was 36.4±24.1% and 33.8±13.8% in the sutureless and VinV-TAVI group, respectively. There was no in-hospital death. No patient was lost to follow-up (21±13 months, range 6 to 42). Quality of life measured with the EQ-5D questionnaire improved by 65% in the sutureless group and by 67% in the VinV-TAVI group. At follow-up echocardiographic evaluation, no paravalvular leak or intraprosthetic regurgitation was observed in either group. The mean iEOA was 0.96±0.08 vs. 0.71±0.15 cm2/m2 in the sutureless vs. VinV-TAVI group. CONCLUSIONS: In patients undergoing redo aortic valve surgery for degenerated bioprostheses, both VinV-TAVI and sutureless AVR are effective in terms of clinical outcome. As regards echocardiographic evaluation, no leak was observed in either group and no cases of severe PPM were recorded in the sutureless group.

Clinical Outcome and Cost Analysis of Sutureless Versus Transcatheter Aortic Valve Implantation With Propensity Score Matching Analysis.

Surgical sutureless and interventional transcatheter aortic valve prostheses are nowadays extensively adopted in high-risk elderly patients. An explorative analysis was carried out to compare the clinical outcome and costs associated to these approaches. Since 2010, a total of 626 patients were distributed between transcatheter aortic valve implantation (TAVI; n = 364) and sutureless (n = 262) groups. Patients of both groups were not comparable for clinical and surgical characteristics, but many patients were in a "gray zone"; therefore, a retrospective propensity score analysis was possible and performed. For the matched pair samples, postoperative, follow-up clinical data, and costs data were obtained. In-hospital death occurred in 5 patients in sutureless group and 3 patients in TAVI group (p = 0.36). Blood transfusions were higher in sutureless group (2.1 ± 2.3 vs 0.4 ± 1.0 U). TAVI group had a shorter intensive care unit and hospital stay (2.2 ± 2.7 vs 3.2 ± 3.5 days, p = 0.037; 12 ± 6 vs 14 ± 6 days, p = 0.017). No differences in postoperative neurologic (p = 0.361), renal (p = 0.106), or respiratory (p = 0.391) complications were observed between groups. At follow-up (24.5 ± 13.8 months), 1 patient in sutureless group and 7 patients in TAVI group died (p = 0.032). Paravalvular leakage occurred more frequently in patients in TAVI group (35 [34%] vs 7 [6.9%]; p <0.001) with an impact on follow-up survival rate. The costs associated to the 2 procedures are similar when the cost of the device was excluded (p = 0.217). When included, the sutureless approach resulted a cost saving (€22,451 vs €33,877, p <0.001). In conclusion, the patients in the "gray zone" record a satisfying clinical outcome after sutureless surgery and TAVI. Patients in the sutureless group endure more hospital complications, but TAVI entails a higher follow-up mortality. On the costs aspects, TAVI technologies are more expensive, and it reflects on higher overall hospital costs.

Sutureless replacement versus transcatheter valve implantation in aortic valve stenosis: a propensity-matched analysis of 2 strategies in high-risk patients.

OBJECTIVE: This propensity-matched study compared clinical and echocardiographic outcomes between patients undergoing transcatheter aortic valve implantation (TAVI) and sutureless aortic valve replacement. METHODS: From January 2010 to March 2012, 122 patients (age 79.4 ± 5.3 years, logistic euroSCORE 12% ± 8.4%) underwent minimally invasive sutureless aortic valve replacement, and 122 (age 84.6 ± 6.2 years, logistic euroSCORE 20.9% ± 2.5%) underwent TAVI. After propensity matching, 37 matched pairs were available for analysis. RESULTS: Preoperative characteristics and risk scores of matched groups were comparable. In-hospital mortalities were 0% in the sutureless group and 8.1% (n = 3) in the TAVI group (P = .24). Permanent pacemaker implantation was required in 4 patients in the sutureless group and 1 patient in the TAVI group (10.8% vs 2.7%; P = .18). A neurologic event was recorded in 2 patients of each group. Predischarge echocardiographic data showed higher paravalvular leak rate in the TAVI group (13.5% vs 0%; P = .027). At mean follow-up of 18.9 ± 10.1 months, overall cumulative survival was 91.9% and significantly differed between groups (sutureless 97.3% vs TAVI 86.5%; P = .015). In the TAVI group, a significant difference in mortality was observed between patients with (n = 20) and without (n = 17) paravalvular leak (25% vs 0%; P = .036). CONCLUSIONS: Combining the advantage of standard diseased valve removal with shorter procedural times, minimally invasive sutureless aortic valve replacement may be the first-line treatment for high-risk patients considered in the "gray zone" between TAVI and conventional surgery.