Lorenzo Bagozzi

Transapical off-pump mitral valve repair with Neochord implantation: Early clinical results

BACKGROUND This prospective study aims to assess early clinical outcomes in patients undergoing Transapical Off-Pump Mitral Valve Intervention with Neochord Implantation (TOP-MINI). METHODS AND RESULTS Forty-nine patients with severe symptomatic degenerative mitral regurgitation (MR) were treated. Median age was 72 years (IQR 58-78) and median Euroscore-I was 3.26% (IQR 0.88-8.15). Forty-four patients (89.8%) presented with posterior leaflet prolapse (LP), 4 (8.2%) with anterior LP and 1 (2%) with combined disease. Acute procedure success (defined as successful placement of at least 3 neochords with reduction of residual MR to less than 2+) was achieved in all patients. In-hospital mortality was 2%. At 30 days major adverse events included one AMI (2%) successfully treated percutaneously and one sepsis (2%), no stroke or bleeding events occurred. At 3 months overall survival was 98%. MR was absent in 16 patients (33.4%), was grade 1+ in 15 (31.2%), and was grade 2+ in 12 (25%). Five patients (10.4%) developed recurrent severe MR due to anterior native chordae rupture. Four of them were successfully re-operated. At 3 months follow-up freedom from reoperation was 91.7 ± 4%. CONCLUSIONS Early results with Neochord procedure indicate that TOP-MINI is feasible and safe. Efficacy is maintained up to 3 months follow-up with significant clinical benefit for the patients.

Prosthetic valve thrombosis: When prevention is better than treatment

We have recently read with great interest the study reported by Özkan et al, included in the 2015 second issue of your Journal. In this work, they accurately demonstrate how an ultraslow (25 hours) infusion of low-dose (25 mg) plasminogen activator represents a safer thrombolytic treatment in patients with prosthetic valve thrombosis (PVT), showing moderately low nonfatal complications and mortality. Prosthetic valve thrombosis is a rare but life-threatening process originating from the formation of a fibrous cloth, which can evolve to a definitive obstructing thrombus. The literature usually identified an obstructive and nonobstructive PVT type according with Doppler echocardiographic measurements. The obstructive form is the less frequent, including approximately 0.3% to 1.3% of patient-year and often requiring prosthesis replacement. On the contrary, the nonobstructive PVT represents a more common type, with a reported incidence as high as 10% in some transesophageal echocardiography (TEE) studies. As previously showed from the same group, TEE provides a useful guide to assess imaging of the thrombus, including the size, mobility, and location. In this way, it can help clinicians in treatment decisions, allowing to differentiate thrombi from pannus formation or strands. We have already shown that multidetector computed tomography can be used for the accurate imaging of thrombi on prosthetic aortic valves. Nevertheless, these techniques usually simply confirm an advanced PVT form, typically when critical symptoms have already appeared. Mortality and fatal complications, although reduced in recent years, can occur as a consequence of the subsequent treatment, which include reoperation or recently developed thrombolytic protocols (as previously described). Therefore, an early detection of thrombotic formations appears decisive for patients prognosis. For this purpose, we focused in an in vitro and in vivo ultrasound phonocardiographic analysis of the closing sound produced by several mechanical heart valves (MHVs), to assess an early detection of thrombotic apposition and consequent MHV dysfunction. Examining different simulated MHV thrombotic formations in a Sheffield pulse duplicator, we acquired closing sound in a specific frequency range related to power spectra, analyzing them with an artificial neural network (ANN). This allowed to classify the presence of thrombotic formations of different weight and shape, with an improvement in the efficiency related to the extension of the analysis to the ultrasound region. Several studies have dealt with this topic in the recent years. An in vivo study based on a hand-held device (Thrombocheck) evaluated MHV closing sound on the time domain (furthermore deriving a frequency domain analysis), being able to recognize a large number of MHV failure, later confirmed on cinefluoroscopy. Some other in vitro studies tested commercially available MHV closure sounds at different hemodynamic conditions, demonstrating that each particular valve has a typical “fingerprint” in spectral signal of frequencies produced by the closure of the valve at different conditions. This concept brought to the application of ANNs to analyze power spectra of different types of valve. In addition, this method showed to be able to distinguish functional and dysfunctional prosthesis, differentiating obstructive from nonobstructive forms and identifying precocious apposition of minimal cloths.

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.

Learning curve analysis of transapical NeoChord mitral valve repair

OBJECTIVES Transapical off-pump mitral valve intervention with neochordae implantation is a novel, minimally invasive procedure for treatment of degenerative mitral valve regurgitation. The aim of this study was to apply control charts (CUSUM curves) to monitor the performance of NeoChord repair during the initial phase of its adoption. METHODS The first 112 consecutive patients who underwent NeoChord repair at our institution between November 2013 and March 2016 were included in the analysis. Mitral Valve Academic Research Consortium criteria for 1-year patient success was utilized to determine failed procedures. Control charts had predetermined acceptable and unacceptable failure rates of 5% and 15%, respectively. RESULTS The actual incidence of 1-year-patient failure was 11% (12 of 112 cases), with a cluster of failures within the first 20 cases. The CUSUM analysis demonstrated an initial learning curve; however, the upper boundary (alarm line) was never crossed. The reassurance line was first crossed after 40 procedures and performance remained stable after 49 procedures. CONCLUSIONS NeoChord repair is a safe procedure, and the results are maintained through the 1-year follow-up. A relative high number of implants were required to overcome the learning curve at our institution due to the concurrent development of patient selection criteria and the technical refinement of the procedure. Future studies are needed to assess the evolution of the learning curve after the wide adoption of the procedure across European and North American centres.

Low INTERMACS Profiles: Temporary ECMO or TAH Support

According to the INTERMACS registry, “low profiles” define the highest severity in the spectrum of advanced heart failure.

Endomyocardial biopsy under echocardiographic monitoring

Endomyocardial biopsy is a common procedure for monitoring cardiac allograft rejection; several techniques have been described so far, throughout different access sites and under echocardiographic or X-ray control. We describe the routine technique adopted at our centre based on echo-guided puncture of jugular vein and echocardiographic assessment of endomyocardial sampling with direct visualization of the bioptome tip. We also report the most common complications of the procedure, especially concerning the risk of iatrogenic tricuspid regurgitation, and same examples of histopathological findings drawn from our own iconographic collection.

ONE YEAR CLINICAL RESULTS OF THE ECHO GUIDED TRANSAPICAL MITRAL VALVE REPAIR WITH NEOCHORD IMPLANTATION

Transapical Off-Pump mitral valve repair with Neochord implantation (TOP-MINI) is an innovative minimally invasive procedure to treat degenerative mitral regurgitation (MR) due to prolapse or flail. Clinical and echocardiographic outcomes of consecutive patients through 1 year follow-up (FU) were

Orthotopic heart transplantation: the bicaval technique

Heart transplantation still remains the gold standard therapy for end-stage heart failure, although several other approaches have emerged, such as biventricular pacing, left ventricular assist devices (LVADs) and total artificial heart. Moreover, the increasing use of LVADs as a bridge to transplant is posing the technical challenge of LVAD removal during the procedure. We in this paper describe the bicaval technique, which currently represents the routine approach for orthotopic heart transplantation.