Augusto D’Onofrio

Sutureless aortic valve replacement as an alternative treatment for patients belonging to the “gray zone” between transcatheter aortic valve implantation and conventional surgery: A propensity-matched, multicenter analysis

OBJECTIVE The aim of this propensity-matched, multicenter study was to compare early clinical and echocardiographic outcomes of patients undergoing transapical aortic valve implantation (TA-TAVI) versus patients undergoing sutureless aortic valve replacement (SU-AVR) for severe symptomatic aortic valve stenosis. METHODS We reviewed 468 TA-TAVIs performed in 20 centers from April 2008 to May 2011, and 51 SU-AVRs performed in 3 centers from March to September 2011. Based on a propensity score analysis, 2 groups with 38 matched pairs were created. Variables used in the propensity analysis were age, sex, body surface area, New York Heart Association class, logistic EuroSCORE, peripheral vascular disease, chronic obstructive pulmonary disease, aortic valve area, mitral regurgitation, and left ventricular ejection fraction. RESULTS Preoperative characteristics of the 2 groups were comparable. Hospital mortality was 5.3% and 0% in the TA-TAVI and SU-AVR groups, respectively (P = .49). We did not observe stroke or acute myocardial infarction in the 2 groups. Permanent pacemaker implantation was needed in 2 patients of each group (5.3%, P = 1.0). Dialysis was required in 2 patients (5.3%) in the SU-AVR group and in 1 patient (2.7%) in the TA-TAVI group (P = 1.0). Predischarge echocardiographic data showed that the incidence of paravalvular leak (at least mild) was greater in the TA-TAVI group (44.7% vs 15.8%, P = .001), but there were no differences in terms of mean transprosthetic gradient (10.3 ± 5 mm Hg vs 11 ± 3.7 mm Hg, P = .59). CONCLUSIONS This preliminary experience showed that, in patients at high risk for conventional surgery, SU-AVR is as safe and effective as TA-TAVI and that it is associated with a lower rate of postprocedural paravalvular leak.

Clinical and hemodynamic outcomes of ''all-comers'' undergoing transapical aortic valve implantation: Results from the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA)

OBJECTIVE The aim of this study was to assess clinical and hemodynamic outcomes of transapical aortic valve implantation (TA-TAVI) in patients enrolled in the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA). METHODS From April 2008 until November 2010, 504 patients from 20 Italian centers were enrolled in the I-TA registry. Mean logistic EuroSCORE and Society of Thoracic Surgeons score were 24% ± 16% and 11% ± 4%, respectively. Mean follow-up was 9.2 ± 6.5 months (range, 1-26 months). Outcomes were analyzed according to intraoperative complications, procedural volume (high-volume centers, >20 cases; low-volume centers, < 20 cases) and learning curve (first 50% cases vs second 50% cases of each center). RESULTS All-cause overall mortality was 8.3% (42 patients). Device success was 99% (500/504 patients). Intraoperative severe complications occurred in 24 (4.8%) patients. Overall 2-year survival was 71.5% ± 6.2%. At discharge, peak and mean gradients were 16.4 ± 11.2 and 8.7 ± 4.1 mm Hg, respectively, and effective orifice area was 1.67 cm(2). These values remained stable at 3, 6, and 12 months after surgery. Independent risk factors for mortality after TA-TAVI were as follows: New York Heart Association class III and IV (odds ratio [OR], 4.43; 95% confidence intervals [CI], 1.28-15.40; P = .02); logistic EuroSCORE greater than 20 (OR, 1.83; 95% CI, 1.02-3.29; P = .04); creatinine concentration greater than 200 μmol/L (OR, 2.56; 95% CI, 1.07-6.15; P = .03), and intraoperative complications (OR, 5.80; 95% CI, 2.68-12.55; P < .001). There were no significant differences in outcomes between high- and low-volume centers and between the first and the second 50% of cases. CONCLUSIONS TA-TAVI represents a safe and effective alternative treatment for patients who are inoperable or at high risk for surgery. The occurrence of an intraoperative complication significantly affects survival. Procedural volume and learning curve have no impact on patient survival.

Intermediate Clinical and Hemodynamic Outcomes After Transcatheter Aortic Valve Implantation

BACKGROUND Concerns still exist regarding long-term results and freedom from valve-related adverse events in transcatheter aortic valve implantation (TAVI). The aim of this single-center retrospective study was to assess intermediate-term (up to 5-year) clinical and hemodynamic outcomes in patients undergoing TAVI. METHODS From 2007 through 2013, 338 consecutive patients underwent TAVI at our institution. Preoperative variables were defined according to the European System for Cardiac Operative Risk Evaluation (EuroSCORE) definitions, and outcomes were reported according to the Valve Academic Research Consortium (VARC)-2 definitions. Multivariate logistic regression analysis was performed to identify independent predictors of mortality at follow-up. RESULTS transfemoral (TF) and transapical (TA) TAVI were performed in 233 (69%) and 105 (31%) patients, respectively. All-cause 30-day mortality was 4.4%, with no differences between TA and TF procedures. Thirty-day cardiovascular death, stroke, and myocardial infarction were not different between groups. The acute kidney injury (AKI) rate was higher in the TA group (30.5% versus 11.2%; p < 0.001). Access-related complications were more frequent in the TF group (36.1% versus 11.4%; p < 0.001). Mean follow-up was 22.3 ± 17.8 months (range, 1-74 months). Overall survival rates at 1, 3, and 5 years were 85.5% ± 2.1%, 69.9% ± 3.2%, and 61% ± 4.3%, respectively. Independent predictors of all-cause mortality at follow-up were previous myocardial infarction (odds ratio [OR], 2.7), any grade of paravalvular leak (PVL) (OR, 2.5), and AKI (OR, 3.1). Mean gradient and effective orifice area at follow-up were 10.7 ± 12.0 mm Hg and 1.1 ± 0.9 cm(2)/m(2), respectively. CONCLUSIONS Our data show that TAVI has good early and intermediate-term clinical and hemodynamic outcomes in high-risk or inoperable patients with severe symptomatic aortic valve stenosis. PVL of any grade has a significant impact on survival.

Aortic valve calcium scoring is a predictor of paravalvular aortic regurgitation after transcatheter aortic valve implantation

Degenerative aortic stenosis is the most common native valve disorder in the ageing population of industrialized nations. Surgical aortic valve replacement has excellent clinical outcomes but there is an increasing number of patients with severe aortic stenosis who are not considered surgical candidates because of significant co-morbidity. Transcatheter aortic valve implantation (TAVI) has been established as a clinically accepted minimally invasive therapeutic option for selected high-risk patients with symptomatic aortic valve stenosis (1-4). The Edwards SAPIENTM prosthes i s (Edwards Lifescience, Irvine, USA) which can be deployed via both transfemoral and transapical routes, and the CoreValve Revalving System® (CoreValve Inc., Irvine, California) which is inserted only via a transfemoral approach, represent the currently used transcatheter aortic valves. The technical feasibility has been shown for both approaches (5,6) and when successful, transcatheter aortic valve replacement results in marked hemodynamic and clinical improvements (7,8). However, despite a clear benefit of survival and improvement in symptoms (1,2), TAVI is also associated with post-implantation paravavular aortic regurgitation (PAR) in up to 60% of patients (3). In contrast with surgery, TAVI does not involve excision of the diseased native valve. The metal stent of the implanted device leads to compression of native valve cusps and associated calcification against the aortic annulus and aortic wall. The precise mechanism behind this phenomenon remains unclear. PAR may be related to the specific anatomy of the annulus and aortic root, as well as to the amount and distribution of leaflet and annular calcification (9). Although efforts have been made to reduce this incidence significantly (10,11), PAR still necessitates additional interventions in a considerable number of patients and its presence is known to confer a higher mortality rate amongst patients undergoing TAVI procedures (12). This has led to guarded acceptance of TAVI in patients others than those in high-risk or inoperable patient populations. Therefore, careful patient selection is of fundamental importance to avoid intraoperative complications. Excessive calcification of the aortic valve cusps may result in haemodynamically relevant PAR (10), further sustaining pressure overload, which is poorly tolerated by these patients. As a result, several imaging methods have been routinely used for procedure planning and proper device selection (9,13-20). The size of the aortic annulus is commonly assessed by transoesophageal echocardiography (TEE) (9), and multidetector row computed tomography (MDCT) (14,15). MDCT has increased its role because it not only enables the evaluation of the distances from the annulus to the coronary ostia, but also allows accurate detection, localization and quantification of aortic valve calcification and calcification of the entire aorta (14-22). It has been demonstrated that the amount of aortic valve calcium is associated with unfavorable prognosis (23). Recent studies using MDCT have focused on the role of aortic valve calcium (AVC) and its relation to post TAVI AR (17-22). We are providing a video presentation entitled “Aortic valve calcium scoring is a predictor of paravalvular aortic regurgitation after transcatheter aortic valve implantation” (Video 1). Aortic valve calcium scoring is a predictor of paravalvular aortic regurgitation after transcatheter aortic valve implantation

One-Stage Off-Pump Transapical Mitral Valve Repair and Aortic Valve Replacement

Transcatheter aortic valve implantation (TAVI) is routinely performed in high-risk patients presenting with severe symptomatic aortic valve stenosis. The use of TAVI in patients with symptomatic pure aortic regurgitation (AR) is less common1 because of the limited number of devices specifically designed for this pathology. Nowadays, the only device specifically approved for use in pure aortic insufficiency is the Jena Valve (Jena Valve Technology, Munich, Germany), currently available only for the transapical approach.2 Transcatheter mitral valve repair has been also proposed with the use of different technologies. Recently, transapical off-pump mitral valve repair with neochord implantation (TOP-MINI) using the NeoChord DS 1000 device (NeoChord, Eden Praire, MN) has been shown to be feasible and safe for repairing degenerative mitral valve disease.3–5 Unlike TAVI and other percutaneous devices, transapical off-pump mitral valve intervention with Neochord implantation is approved not just for high-surgical-risk candidates. Two-stage treatment of aortic valve stenosis and mitral regurgitation (MR) using transcatheter techniques has already been described. Here, we present the first-in-humans 1-stage transapical off-pump concomitant aortic valve implantation and mitral valve repair in a patient experiencing pure AR and degenerative MR. A 78-year-old man with severe AR and MR in New York Heart Association functional class III despite optimal medical therapy was referred to our institution. He presented systemic arterial hypertension and moderate 2-vessel coronary artery disease. Preoperative transesophageal echocardiography confirmed the presence of severe AR and severe MR with severe calcifications of the posterior mitral annulus and annular portion of the posterior mitral leaflet (Figure 1 and Movies I–III in the online-only Data Supplement). His left ventricular ejection fraction was 67%, with initial signs of ventricular dilatation (left ventricle end-diastolic volume, 86 mL/m2). Figure 1. Preoperative transesophageal echocardiography (TEE). A , Two-dimensional TEE color Doppler showing severe aortic regurgitation (AR) and …

Transaortic balloon-expandable aortic valve implantation

undergoing multiple redo mitral valve surgery. A right thoracotomy requires minimal retraction and dissection of the heart and provides good exposure of the mitral valve. Cardiopulmonary bypass on ventricular fibrillation can decrease the manipulation of the aorta without aortic cannulation and cross-clamps. The disadvantage of this approach is the increased risk of cerebral vascular insufficiency. Femoral arterial cannulation can cause stroke if the aorta has atherosclerotic changes. When the femoral artery is unavailable, arterial cannulation can be achieved using the right subclavian artery. Because air embolism is also a cause of stroke, vent placement across the aortic root and carbon dioxide flooding of the thoracic cavity are recommended to remove air from the heart. The repeat leak incidence after surgical treatment of mitral PVL has been reported to be 22%. For PVL repair without repeat replacement, the leak size and location should be defined accurately by preoperative transesophageal echocardiography. In the present cases, we decided that their PVLs could be treated using this technique because of the small leak size and number. If the size is large or multiple leaks are present, repeat MVR

An unexpected finding: stuck leaflet after transapical mitral valve-in-valve implantation.

Transapical mitral valve-in-valve (ViV) implantation was performed in an inoperable patient with a dysfunctional 29-mm Hancock II bioprosthesis (Medtronic, Minneapolis, Minnesota). The true internal diameter of the 29-mm Hancock II valve is 24 mm [(1)][1], thus a 26-mm Sapien-XT (Edwards

Abnormal heart rate variability and atrial fibrillation after aortic surgery.

Introduction Complete denervation of transplanted heart exerts protective effect against postoperative atrial fibrillation; various degrees of autonomic denervation appear also after transection of ascending aorta during surgery for aortic aneurysm. Objective This study aimed to evaluate if the level of cardiac denervation obtained by resection of ascending aorta could exert any effect on postoperative atrial fibrillation incidence. Methods We retrospectively analysed the clinical records of 67 patients submitted to graft replacement of ascending aorta (group A) and 132 with aortic valve replacement (group B); all episodes of postoperative atrial fibrillation occurred during the 1-month follow-up have been reported. Heart Rate Variability parameters were obtained from a 24-h Holter recording; clinical, echocardiographic and treatment data were also evaluated. Results Overall, 45% of patients (group A 43%, group B 46%) presented at least one episode of postoperative atrial fibrillation. Older age (but not gender, abnormal glucose tolerance, ejection fraction, left atrial diameter) was correlated with incidence of postoperative atrial fibrillation. Only among a subgroup of patients with aortic transection and signs of greater autonomic derangement (heart rate variability parameters below the median and mean heart rate over the 75th percentile), possibly indicating more profound autonomic denervation, a lower incidence of postoperative atrial fibrillation was observed (22% vs. 54%). Conclusion Transection of ascending aorta for repair of an aortic aneurysm did not confer any significant protective effect from postoperative atrial fibrillation in comparison to patients with intact ascending aorta. It could be speculated that a limited and heterogeneous cardiac denervation was produced by the intervention, creating an eletrophysiological substrate for the high incidence of postoperative atrial fibrillation observed.

Transoesophageal echo-guided mitral valve repair using the Harpoon system

Transapical off-pump echo-guided mitral valve repair with implantation of artificial ePTFE chordae with the Harpoon device has been proposed to treat patients presenting with severe mitral regurgitation due to posterior leaflet prolapse. The device is inserted in the left ventricle and steered to the surface of the diseased portion of the leaflet. The Harpoon device is actuated, and the leaflet is perforated by a needle that consequently releases an ePTFE chord that is fixed on the atrial surface by a double-helix coiled knot. The chord is then tensioned and fixed on the epicardial surface of the ventricle under echocardiography guidance.

Early and Mid-Term Results of Rapid-Deployment Valves: The Intuity Italian Registry (INTU-ITA)

BACKGROUND Rapid deployment bioprostheses (RDBs) have been recently introduced into clinical practice for the treatment of severe aortic valve stenosis. The aim of this retrospective multicenter study was to assess early and mid-term clinical and hemodynamic outcomes of patients undergoing RDB implantation. METHODS Data from a national registry that included patients who underwent isolated or combined aortic valve replacement with RDB in Italy were analyzed. Definitions of the European System for Cardiac Operative Risk Evaluation were used for preoperative variables and updated definitions from the Valve Academic Research Consortium were used for postoperative outcomes assessment. Univariable and multivariable analyses were performed to identify independent predictors of mortality. Follow-up was performed with clinical and echocardiographic examinations at each study site and, if this was not possible, through telephonic interviews. The Kaplan-Meier method was used for survival analysis. RESULTS A total of 902 patients (December 2012 through November 2017) from 20 national centers were included in the registry. Device success was 95.9%, and 30-day all-cause mortality was 2.8%. Postoperative pacemaker implantation was needed in 63 patients (6.9%). At discharge, peak and mean transaortic gradients were 19 ± 7 mm Hg and 11 ± 4 mm Hg, respectively. Mild and moderate aortic regurgitation were found in 71 patients (8.2%) and in 10 patients (1.2%), respectively. Median follow-up time was 357 days (interquartile range: 103 to 638 days). Survival at 4 years was 86% ± 1%. Preoperative conduction disturbances and history of previous myocardial infarction were independently associated with mortality. CONCLUSIONS Aortic RDBs provide good early and mid-term clinical and hemodynamic outcomes. These devices may be considered as a reasonable alternative to conventional bioprostheses, especially in minimally invasive and combined operations.