Transapical TAVI: Survival, Hemodynamics, Devices and Machine Learning. Lessons Learned After 10-Year Experience.

Aim of this single-center, retrospective study was to assess early and long-term clinical and hemodynamic results of transapical aortic valve implantation (TA-TAVI), and to identify predictors of survival at follow-up. All patients undergoing TA-TAVI for severe aortic valve stenosis at our institution were reviewed. A hybrid approach based on machine-learning techniques was employed to identify survival predictors, using a bagging-decision-tree algorithm and a Random-Forest algorithm, respectively. Two-hundred-thirty-four consecutive patients underwent TA-TAVI (March 2009-May 2019). All cause 30-day mortality was 5.1%. Device success was 95.7%. Median follow-up time was 35.2 months. Kaplan-Meier overall survival rates at 2, 5, and 8 years were 75%, 44%, and 15%, respectively. Structural-valve-deterioration occurred in 25 patients (11.3%) overall. The strongest predictors of survival at follow-up were age, body-mass-index, and ejection fraction. TA-TAVI provided valid early and long-term outcomes. These data support its choice as an optimal alternative access whenever the transfemoral route is not feasible.

Propensity-Weighted Comparison of Conventional Stented and Rapid-Deployment Aortic Bioprostheses.

Aim of this study was to compare early clinical and hemodynamic outcomes of Intuity and ME bioprostheses. A propensity score weighting approach was performed. Preoperative variables were defined according to EuroSCORE criteria and postoperative complications according to VARC-2 definitions. We evaluated 375 patients who underwent SAVR with the 2 study devices. Intuity and ME were implanted in 252 (67.2%) and in 123 (32.8%) patients, respectively. There were no differences in terms of postoperative complications, including mortality (1% in each group; OR 0.46[0.05;4.21]). The incidence of pace-maker implantation was 6% and 5% in Intuity and ME groups, respectively (OR 0.53[0.27;1.07]). Intuity showed significantly lower gradients (Median mean gradients: 9mmHg vs 14mmHg, P<0.001), larger effective orifice area index (1.13cm2/m2 vs 1cm2/m2, P=0.007) and lower incidence of patient-prosthesis mismatch (7.1% vs 22.8%, P=0.006). The RD Intuity provides similar early clinical outcomes but shows significantly better hemodynamic performance compared to the ME valve.

Standard versus rapid-deployment aortic valve replacement and concomitant myocardial revascularization: 5-year bi-centre clinical outcomes.

OBJECTIVES: Clinical outcomes of 2 generations of pericardial bioprostheses in concomitant aortic valve and coronary artery bypass graft surgery were analysed. METHODS: Patients were recruited from 2 European centres and divided into 2 groups based on the type of aortic bioprosthesis used: Edwards Intuity Elite™ rapid-deployment (RD) bioprostheses or standard Edwards Magna Ease (ME). A propensity score weighting approach was used for data analysis. RESULTS: A total of 285 patients were included: 144 (50.5%) in the RD group and 141 (49.5%) in the ME group. Thirty-day mortality was 2.8% (RD) and 5% (ME) (P = 0.09). Significantly shorter times of aortic cross-clamp and cardiopulmonary bypass were observed in the RD cohort [94 vs 120 min (P < 0.001); 128 vs 160 min (P < 0.001)]. The RD group was associated with a lower median transvalvular gradient at discharge and follow-up (both P < 0.001). However, 5-year survival was not different, being 93% in RD patients and 91% in the ME group [hazard ratio 0.89 (95% confidence interval: 0.38-2.09), P = 0.784]. The 5-year cumulative incidence of combined events (including percutaneous coronary interventions, endocarditis, thromboembolic events, rehospitalizations and bleeding) favoured the ME group [16.1% (RD) vs 7.3% (ME)] [hazard ratio 2.38 (95% confidence interval:1.03-5.52), P = 0.043]. However, this turned similar when the Cox model analysis was adjusted for revascularization variables (P = 0.067). CONCLUSIONS: RD and ME pericardial bioprostheses used in concomitant aortic valve replacement and coronary artery revascularization provide equivalent clinical and haemodynamic 5-year outcomes, despite constant lower transvalvular gradients and shorter surgical operating times observed with RD technology.

Carpentier-Edwards Magna Ease bioprosthesis: a multicentre clinical experience and 12-year durability.

OBJECTIVES: The goal of this multicentre retrospective study was to compare long-term clinical and haemodynamic outcomes of the Carpentier-Edwards Magna Ease (CEME) bioprosthesis by patient age. METHODS: We included consecutive patients who underwent isolated and combined surgical aortic valve replacement (AVR) with CEME valve between January 2008 and March 2020 at 4 cardiac surgery centres in Italy. Survival distribution was evaluated at follow-up according to age and surgery type (combined or isolated AVR), together with freedom from structural valve deterioration (SVD), reoperation and combined events, i.e. SVD, reoperation, endocarditis and thromboembolic events. RESULTS: A total of 1027 isolated and 1121 combined AVR were included; 776 patients were younger than 65 years whereas 1372 were 65 years or older. The 30-day Valve-Academic-Research-Consortium mortality was 2% (<65 years) and 6% (≥ 65 years) (P < 0.001), whereas it was 3% for isolated AVR and 7% for combined AVR (P < 0.001). The 12-year survival was 81% for those younger than 65 years vs 45% for those equal to or older than 65 years (P < 0.001), whereas they were 61% vs 49% for isolated and combined AVR (P = 0.10). The 12-year freedom from combined events, excluding death, was 79% for those younger than 65 years vs 87% for those equal to or older than (P = 0.51), whereas they were 83% for isolated and 86% for combined AVR (P = 0.10). The 12-year freedom from SVD was 93% and 93% in patients younger than 65 and those equal to or older than 65 years (P = 0.63), and the results were comparable even in cases with isolated and combined AVR (92% vs 94%, P = 0.21). A multivariable Cox analysis including gender, presence of patient-prosthesis mismatch, isolated AVR and age showed that only the age was an independent risk factor for the incidence of SVD (P = 0.029). CONCLUSIONS: Outcomes from this large multicentre analysis demonstrated that a CEME bioprosthesis provides good clinical results and long-term durability even in patients younger than 65 years. Furthermore, the hazard for SVD has been shown to be lower for older age. CLINICAL TRIAL REGISTRATION NUMBER: 105n/AO/21.

Fulminant myocarditis parvovirus B19 related in a young woman.

We present the case of a 18-year-old female with fulminant lymphocytic myocarditis caused by Parvovirus B19 (PVB19), successfully treated using temporary LVAD. In the literature there is no consensus on the surgical strategy. While some surgeons prefer to use a single device supporting only the LV, others prefer to start immediately with a biventricular supporting. At pre-procedural ultrasound evaluation, her anatomical features were not suitable for a percutaneous device such as the Impella. Thus, a temporary paracorporeal continuous flow LVAD was inserted. The heart recovery allowed LVAD removal 9 days after the implant.

Conduction disorders after aortic valve replacement with rapid-deployment bioprostheses: early occurrence and one-year evolution.

BACKGROUND: Rapid-deployment bioprostheses represent one of the newest aortic valve substitutes introduced into clinical practice. The aim of this retrospective single-center study was to evaluate the occurrence of conduction disorders (CDs) after rapid-deployment aortic valve implantation at discharge and at 1-year follow-up, and to identify risk factors for CDs and permanent pacemaker implantation (PPI). METHODS: All patients who reached 1-year follow-up after isolated or combined aortic valve replacement (AVR) with rapid-deployment bioprostheses (Intuity Elite, Edwards Lifesciences, Irvine, CA) at our institution were included in this study. Standard 12-lead electrocardiograms (ECGs) were recorded before the procedure (within 24 hours), after the procedure as soon as the patient was moved to the intensive care unit (ICU), every day during in-hospital stay and at 1-year follow-up. The primary endpoint was the incidence of postoperative CDs at discharge and at 1-year follow up. Patients were divided in two groups: those who developed the primary endpoint (Group CD) and those who didn't (Group Non-CD). RESULTS: A total of 98 consecutive patients were included in the study. At discharge, the primary endpoint occurred in 40 patients (40.8%). In particular, new CDs and PPI occurred in 33 (33.7%) and in 7 (7.1%) patients, respectively. Valve size was the only independent predictor of primary endpoint at discharge. At 1-year, 30 patients (31.3%) presented with CDs or pacemaker-induced rhythm. In particular, in 25 patients of Group CD (64.1%), 1-year follow-up ECG revealed the persistence of the same CD as at discharge or pacemaker-induced rhythm, while 14 patients (35.9%) showed recovery of their CD. Age and prosthesis size were identified as independent predictors of CDs/pacemaker-induced rhythm at 1-year follow-up. CONCLUSIONS: According to our data, nearly 40% of patients develop a new CD after rapid-deployment aortic valve implantation. Of these, one third recover after one year. Bioprosthesis size and age were identified as independent risk factors for occurrence of CD after surgery.

Reversing Inoperability in Eisenmenger Syndrome: The "Drug-and-Banding" Approach.

Eisenmenger syndrome (ES) has been considered a cause of inoperability in patients with congenital heart disease (CHD). Even if long-standing vasodilators are efficient to reduce pulmonary vascular resistance (PVR), the best approach to grant stable repair of these patients is still unknown. We describe the case of a 28-year-old man with a diagnosis of untreated large ventricular septal defect and established ES. After few years of vasodilator therapy, the patient underwent pulmonary banding with significant reduction of his PVR. His CHD was then repaired, with clinical and functional improvement at 2-year follow-up.

Evaluation of Conduction Disorders After Aortic Valve Replacement With Rapid Deployment Bioprostheses.

OBJECTIVE: The aim of this retrospective, single-center study was to evaluate the occurrence of conduction disorders after rapid deployment aortic bioprosthesis implantation. METHODS: Electrocardiograms of patients undergoing INTUITY (Edwards Lifesciences, Irvine, CA USA) bioprosthesis implantation were collected at admission, during postoperative course, and at discharge. Primary end point was the occurrence of new-onset conduction disorders, defined as complete left bundle branch block, complete right bundle branch block, permanent pacemaker implantation, and worsening of pre-existing rhythm abnormalities. Secondary end points were the assessment of preoperative and postoperative QRS duration and the identification of transitory conduction disorders. RESULTS: Forty-four patients (July 2015-December 2016) were included in the analysis. Preoperatively, patients with normal conduction and with already existing disorders were 25 (56.8%) and 19 (43.2%), respectively. Primary end point occurred in 14 patients (31.8%). Two patients (4.5%) received pacemaker implantation. In patients with normal preoperative conduction, new abnormalities were found in eight cases (32%): all left bundle branch blocks with one pacemaker implantation. Worsening of pre-existing conduction disorders was found in six patients (31.6%) with one pacemaker implantation. QRS duration increased in 20 patients (45.4%), and average increase was 37 milliseconds. Overall, we observed a significant increase of QRS (96 ± 21 milliseconds vs. 111 ± 28 milliseconds, P < 0.001). Three patients experienced a new-onset temporary left bundle branch block. CONCLUSIONS: New-onset conduction disorders or worsening of pre-existing rhythm abnormalities occur in one third of patients after rapid deployment aortic bioprosthesis implantation. Although the incidence of postoperative pacemaker implantation before discharge is low, strict follow-up is mandatory to identify a potential need for pacemaker implantation in a timely manner.