Itzhak Kronzon

Review of surgical prosthetic paravalvular leaks: diagnosis and catheter-based closure

Paravalvular leak (PVL) is an uncommon yet serious complication associated with surgical prosthetic valve implantation. Paravalvular leak can have significant clinical consequence such as congestive heart failure, haemolytic anaemia, and infective endocarditis. Recently, transcatheter therapy has been applied to the treatment of this disorder with reasonable procedural and clinical success. This review discusses the current state of PVLs, the utilization of multi-modality imaging in their diagnosis and treatment, and the available therapeutic options. Further aim of this review is to examine transcatheter therapy of PVLs including the principles, outcomes, and procedural-related complications.

Mitral Annular Plane Systolic Excursion as a Surrogate for Left Ventricular Ejection Fraction

BACKGROUNDnAssessing left ventricular function is a common indication for echocardiography. It generally requires expert echocardiographer estimation and is somewhat subjective and prone to reader discordance. Mitral annular plane systolic excursion (MAPSE) has been suggested as a surrogate measurement for left ventricular function. The aim of this study was to examine the accuracy of MAPSE for predicting left ventricular ejection fraction (EF) on the basis of a large cohort of consecutive echocardiograms.nnnMETHODSnThe study design was a retrospective analysis of 600 two-dimensional echocardiographic studies performed in a single laboratory. MAPSE measurement was performed by an untrained observer and compared with the EF as determined by an expert echocardiographer. The first 300 studies served as a calibration cohort to establish an algorithm for predicting EF on the basis of MAPSE measurement. The following 300 studies served as a verification cohort to test the accuracy of the established algorithm.nnnRESULTSnUsing the first 300 studies, an algorithm was developed to predict EF. Cutoff values for normal EF (≥11 mm for women and ≥13 mm for men) and severely reduced EF (<6 mm for men and women) were identified. For the intermediate-range MAPSE values, a gender-specific regression equation was calculated to generate a predicted EF. Using this algorithm, predicted EFs were determined for the 300 patients in the verification cohort. By comparing the predicted EF and the expert-reported EF, positive and negative predictive values, sensitivity (73%-92%), specificity (81%-100%), and accuracy (82%-86%) of MAPSE for predicting EF were calculated.nnnCONCLUSIONSnMAPSE measurement by an untrained observer was found to be a highly accurate predictor of EF.

CT angiography-fluoroscopy fusion imaging for percutaneous transapical access.

OBJECTIVESnThe aim of this proof-of-principle study is to validate the accuracy of fusion imaging for percutaneous transapical access (TA).nnnBACKGROUNDnStructural heart disease interventions, including TA, are commonly obtained under fluoroscopic guidance, which lacks important spatial information. Computed tomographic angiography (CTA)-fluoroscopy fusion imaging can provide the 3-dimensional information necessary for improved accuracy in planning and guidance of these interventions.nnnMETHODSnTwenty consecutive patients scheduled for percutaneous left ventricular puncture and device closure using CTA-fluoroscopy fusion guidance were prospectively recruited. The HeartNavigator software (Philips Healthcare, Best, the Netherlands) was used to landmark the left ventricular epicardium for TA (planned puncture site [PPS]). The PPS landmark was compared with the position of the TA closure device on post-procedure CTA (actual puncture site). The distance between the PPS and actual puncture site was calculated from 2 fixed reference points (left main ostium and mitral prosthesis center) in 3 planes (x, y, and z). The distance from the left anterior descending artery at the same z-plane was also assessed. TA-related complications associated with fusion imaging were recorded.nnnRESULTSnThe median (interquartile range [IQR]) TA distance difference between the PPS and actual puncture site from the referenced left main ostium and mitral prosthesis center was 5.00 mm (IQR: 1.98 to 12.64 mm) and 3.27 mm (IQR: 1.88 to 11.24 mm) in the x-plane, 4.48 mm (IQR: 1.98 to 13.08 mm) and 4.00 mm (IQR: 1.62 to 11.86 mm) in the y-plane, and 5.57 mm (IQR: 3.89 to 13.62 mm) and 4.96 mm (IQR: 1.92 to 11.76 mm) in the z-plane. The mean TA distance to the left anterior descending artery was 15.5 ± 7.8 mm and 22.7 ± 13.7 mm in the x- and y-planes. No TA-related complications were identified, including evidence of coronary artery laceration.nnnCONCLUSIONSnWith the use of CTA-fluoroscopy fusion imaging to guide TA, the actual puncture site can be approximated near the PPS. Moreover, fusion imaging can help maintain an adequate access distance from the left anterior descending artery, thereby, potentially reducing TA-related complications.

Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis: An Expert Statement

The VARC (Valve Academic Research Consortium) for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials. No such standardization exists for circumferentially sutured surgical valve paravalvular leak (PVL) closure. This document seeks to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices. The PVL Academic Research Consortium met to review evidence and make recommendations for assessment of disease severity, data collection, and updated endpoint definitions. A 5-class grading scheme to evaluate PVL was developed in concordance withxa0VARC recommendations. Unresolved issues in the field are outlined. The current PVL Academic Research Consortiumxa0provides recommendations for assessment of diseasexa0severity, data collection, and endpoint definitions. Future research in the field is warranted.

Interventional Echocardiography in Structural Heart Disease

Over the past decade, catheter based treatments of an increasing variety of cardiac diseases have expanded dramatically. These advancements became available through new developments and improvements in available devices, as well as increasing expertise of operators. However, arguably it is the innovation and progress in imaging techniques, and in particular in echocardiography, that allowed for such a surge in available percutaneous procedures. In this paper, current echocardiographic techniques, imaging protocols and recommendations will be reviewed and clinical examples will be shown to illustrate the use and importance of echocardiographic imaging in catheter based procedures for structural heart disease.

Clinical trial principles and endpoint definitions for paravalvular leaks in surgical prosthesis

The VARC (Valve Academic Research Consortium) for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials. No such standardization exists for circumferentially sutured surgical valve paravalvular leak (PVL) closure. This document seeks to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices. The PVL Academic Research Consortium met to review evidence and make recommendations for assessment of disease severity, data collection, and updated endpoint definitions. A 5-class grading scheme to evaluate PVL was developed in concordance with VARC recommendations. Unresolved issues in the field are outlined. The current PVL Academic Research Consortium provides recommendations for assessment of diseasexa0severity, data collection, and endpoint definitions. Future research in the field is warranted.

A Constrained Heart A Case of Sudden Onset Unrelenting Chest Pain

Information about a real patient is presented in stages (boldface type) to expert clinicians (Dr Kronzon, Dr Machnicki, and Dr Ruiz), who respond to the information, sharing their reasoning with the reader (regular type). A discussion by the authors follows. nnA 43-year-old athletic black male was awoken from sleep with severe left-sided, nonradiating chest pain. He has no past medical history and denied any recent injury, infection, or drug use. He described the chest pain as nonreproducible on palpation but sharp that increased in severity when laying on his left side. Because of his symptoms the patient went to the local emergency department. On arrival, his temperature was 98.3°F, pulse 79 bpm, blood pressure 170/100 mm Hg, and respiratory rate of 24 breaths per minute with oxygen saturation of 98% on room air. Physical examination revealed a jugular venous pressure of 8 cm H 2 O, clear lungs on auscultation, regular rate with normal S1 and S2 sounds without murmurs, rubs, or gallops. There was no lateral displacement of the point of maximum impulse. The abdomen was nondistended with normal bowel sounds and was free of bruits. The extremities were warm, with 2+ palpable pulses with no arterial pulse delay. Cardiac enzymes were drawn and an initial ECG ( Figure 1) showed normal sinus rhythm with >5-mm ST-segment elevations in the lateral and inferior lead segments. nnnnFigure 1. nResting 12-lead ECG on presentation demonstrating marked ST elevations in leads I, II, aVL, aVF, and V4–V6 with down slopping ST depressions in aVR and V1–V3. There are no pathological q waves.nnnnDr Ruiz: When a patient presents with chest pain, the 12-lead ECG is 1 of the principal tools used in diagnosis. This test can be performed quickly and helps narrow the differential, especially when the application of timely treatment aimed at coronary …

PERCUTANEOUS TRANSAPICAL CLOSURE OF POST–OPERATIVE PERIMEMBRANOUS VENTRICULAR SEPTAL DEFECTS IN THE COMPLEX PATIENT

Percutaneous closure of perimembranous ventricular septal defects (pmVSDs) using transcatheter techniques has been well described, utilizing retrograde transaortic and/or antegrade venous approaches. However, tortuous or malaligned tracts in relation to access can make the procedure a challenge. In

PERCUTANEOUS MELODY VALVE–IN–VALVE IMPLANTATION WITH SIMULTANEOUS PARAVALVULAR LEAK CLOSURE: COMPLETE TRANSCATHETER REPAIR OF A FAILING MITRAL BIOPROSTHESIS

Structural deterioration and paravalvular leak (PVL) are complications associated with surgically–implanted prosthetic valves. Until recently, the only available treatment has been surgery. Percutaneous PVL closure has demonstrated reasonable technical success and clinical outcomes. In addition,