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• W2605106309 abstract "AS NEW INFORMATION continues to emerge from clinical trials and registries, transcatheter valve technology is moving forward at a breakneck pace. Information that was once considered current is now less certain while investigators continue to set new standards and guidelines for reporting observations and outcomes. Since the Edwards SAPIEN valve (Edwards Lifesciences, Inc., Irvine, CA) gained approval by the Food and Drug Administration for the management of inoperable candidates with aortic stenosis in November 2011, for high-risk operable candidates in October 2012, and for intermediate-risk patients in August 2016, we have witnessed a surge in the adoption of this groundbreaking technology. Transcatheter aortic valve replacement (TAVR) has since become a viable option for properly selected patients with severe aortic stenosis who are unsuitable, high-, or intermediate-risk surgical candidates. The PARTNER (Placement of AoRTic TraNscathetER Valves) trial paved the way to widespread implementation of this new therapy after demonstrating that TAVR was at least non-inferior to surgical aortic valve replacement in this very-high-risk pool.1Leon M.B. Smith C.R. Mack M. et al.PARTNER Trial InvestigatorsTranscatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery.N Engl J Med. 2010; 363: 1597-1607Crossref PubMed Scopus (5420) Google Scholar Since the publication of this landmark study and its follow-up,2Kodali S.K. Williams M.R. Smith C.R. et al.Two-year outcomes after transcatheter or surgical aortic-valve replacement.N Engl J Med. 2012; 366: 1686-1695Crossref PubMed Scopus (1900) Google Scholar TAVR procedures have increased at a rapid pace worldwide. According to the most recent Annual Report of the Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) Transcatheter Valve Registry, 54,782 TAVR procedures were performed in the United States from 2012 through 2015, with an annual increase from 4,627 in 2012 to 24,808 in 2015.3Grover F.L. Vemulapalli S. Carroll J.D. et al.for the STS/ACC TVT Registry2016 Annual Report of the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.J Am Coll Cardiol. 2017; 69: 1215-1230Crossref PubMed Scopus (370) Google Scholar The SOURCE 3 Registry (SAPIEN Aortic Bioprosthesis European Outcome), a European multicenter registry of the thirdgeneration SAPIEN 3 valve, reported on 1,947 patients from 80 centers in 10 countries who underwent TAVR with this new-generation prosthesis between July 2014 and October 2015.4Wendler O. Schymik G. Treede H. et al.SOURCE 3 Registry: Design and 30-day results of the European Postapproval Registry of the latest generation of the SAPIEN 3 transcatheter heart valve.Circulation. 2017; 135: 1123-1132Crossref PubMed Scopus (149) Google Scholar Thirty-day all-cause mortality was 2.2%, and moderate paravalvular leak (PVL) was seen in only 3.1% of reported cases (a reduction from 6.3% and 5.5% in the SOURCE XT Registry for 30-day all-cause mortality and PVL, respectively). These results compared favorably with PARTNER registry patients who received the SAPIEN 3 and PARTNER 2A outcomes.5Kodali S. Thourani V.H. White J. et al.Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-risk patients with aortic stenosis.Eur Heart J. 2016; 37: 2252-2262Crossref PubMed Scopus (275) Google Scholar, 6Leon M.B. Smith C.R. Mack M.J. et al.PARTNER 2 InvestigatorsTranscatheter or surgical aortic-valve replacement in intermediate-risk patients.N Engl J Med. 2016; 374: 1609-1620Crossref PubMed Scopus (3203) Google Scholar So, it is evident that as new outcome data emerge and technology evolves, we can expect these numbers to continue to improve. In the current issue of the Journal, Duke investigators conducted a single-center retrospective observational study of 196 patients to determine the impact of moderate or greater PVL measured with transesophageal echocardiography (TEE) at the time of TAVR on survival, and to compare grading of severity between transthoracic echocardiography (TTE) and TEE.7Teeter E, Bottiger B, Dakik CG, et al. Assessment of paravalvular leak after transcatheter aortic valve replacement: Transesophageal compared with transthoracic echocardiography. J Cardiothorac Vasc Anesth (in press).Google Scholar The modest agreement that they found between TTE and TEE raised important questions regarding study timing, potential for interobserver variability, and lack of standardization of grading methods among published studies. The lack of an association between both significant and non-significant PVL and 30-day mortality in their study population differed from many of the recent reports from larger-scale trials in which the general consensus has been that moderate or greater PVL is a harbinger for adverse consequences. Despite a constantly evolving technology, PVL post-TAVR remains a common problem, compounded by the variability in reporting of this phenomenon. As the old saying goes, timing is everything, and earlier reports may not reflect our current state of affairs. As an example, a recent meta-analysis of 12,926 patients from 45 studies examined incidence, predictors, and outcomes of aortic regurgitation (AR) following TAVR.8Athappan G. Patvardhan E. Tuzcu M. et al.Incidence, predictors, and outcomes of aortic regurgitation after transcatheter aortic valve replacement.J Am Coll Cardiol. 2013; 61: 1585-1595Crossref PubMed Scopus (615) Google Scholar The pooled estimate for moderate or severe AR was 11.7% (95% confidence interval: 9.6-14.1). This number seems rather high compared to an earlier meta-analysis of 3,519 patients from 16 studies that estimated the incidence of moderate or severe AR post-TAVR at 7.4%9Généreux P. Head S.J. Van Mieghem N.M. et al.Clinical outcomes after transcatheter aortic valve replacement using valve academic research consortium definitions: A weighted meta-analysis of 3,519 patients from 16 studies.J Am Coll Cardiol. 2012; 59: 2317-2326Crossref PubMed Scopus (455) Google Scholar; then, there are data from the PARTNER trial in which moderate or severe PVL at 1 and 2 years was 7.0% and 6.9% respectively.2Kodali S.K. Williams M.R. Smith C.R. et al.Two-year outcomes after transcatheter or surgical aortic-valve replacement.N Engl J Med. 2012; 366: 1686-1695Crossref PubMed Scopus (1900) Google Scholar A number of factors may account for these discrepancies, including later introduction of the CoreValve (Medtronic, Inc., Minneapolis, MN), more precise peri-procedural planning, and better operator experience. In the analysis by Athappan et al,8Athappan G. Patvardhan E. Tuzcu M. et al.Incidence, predictors, and outcomes of aortic regurgitation after transcatheter aortic valve replacement.J Am Coll Cardiol. 2013; 61: 1585-1595Crossref PubMed Scopus (615) Google Scholar patients with moderate or severe AR had increased mortality at both 30 days and 1 year. Predictors of post-TAVR AR came from 25 studies and included depth of implantation (with both extremes of high or low positioning being associated with greater chances of PVL), valve undersizing, and Agatson calcium score (higher scores being associated with risk of PVL). These investigators also suggested that mild AR might be associated with increased long-term mortality, which has been an inconsistent finding among other studies (mild AR as an adverse prognosticator also was demonstrated in the 2-year outcomes from the PARTNER trial).4Wendler O. Schymik G. Treede H. et al.SOURCE 3 Registry: Design and 30-day results of the European Postapproval Registry of the latest generation of the SAPIEN 3 transcatheter heart valve.Circulation. 2017; 135: 1123-1132Crossref PubMed Scopus (149) Google Scholar They noted the lack of core laboratory assessment of AR and a lack of published standards for AR post-TAVR might have contributed to the quality of reported data. Echocardiographic studies performed in different laboratories also might have affected findings concerning mild degrees of AR. The general belief, however, is that more-than-mild grades of AR are associated with increased early and late mortality.2Kodali S.K. Williams M.R. Smith C.R. et al.Two-year outcomes after transcatheter or surgical aortic-valve replacement.N Engl J Med. 2012; 366: 1686-1695Crossref PubMed Scopus (1900) Google Scholar, 10Abdel-Wahab M. Zahn R. Horack M. et al.Aortic regurgitation after transcatheter aortic valve implantation: Incidence and early outcome. Results from the German Transcatheter Aortic Valve Interventions Registry.Heart. 2011; 97: 899-906Crossref PubMed Scopus (440) Google Scholar, 11Tamburino C. Capodanno D. Ramondo A. et al.Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis.Circulation. 2011; 123: 299-308Crossref PubMed Scopus (985) Google Scholar Data from the STS/ACC registry3Grover F.L. Vemulapalli S. Carroll J.D. et al.for the STS/ACC TVT Registry2016 Annual Report of the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.J Am Coll Cardiol. 2017; 69: 1215-1230Crossref PubMed Scopus (370) Google Scholar showed that moderate/severe AR was 6.9% at discharge or 30 days, with improvement noted over the 4-year period of observation (10.8% incidence in 2012 v 6.2% in 2015, p < 0.0001). Variability in reporting of PVL1Leon M.B. Smith C.R. Mack M. et al.PARTNER Trial InvestigatorsTranscatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery.N Engl J Med. 2010; 363: 1597-1607Crossref PubMed Scopus (5420) Google Scholar, 11Tamburino C. Capodanno D. Ramondo A. et al.Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis.Circulation. 2011; 123: 299-308Crossref PubMed Scopus (985) Google Scholar, 12Smith C.R. Leon M.B. Mack M.J. et al.Transcatheter versus surgical aortic-valve replacement in high-risk patients.N Engl J Med. 2011; 364: 2187-2198Crossref PubMed Scopus (4766) Google Scholar, 13Rodes-Cabau J. Webb J.G. Cheung A. et al.Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: Acute and late outcomes of the multicenter Canadian experience.J Am Coll Cardiol. 2010; 55: 1080-1090Crossref PubMed Scopus (869) Google Scholar is multifactorial and includes level of experience with the procedure, type, size, and generation of prosthesis, selected imaging modalities, and lack of standardized guidelines for reporting. The natural course of PVL following TAVR is also poorly understood, and patient mortality may have other natural causes found in an aging and frail population. At 5 years, only 51 of 179 patients in the TAVR group were still alive from PARTNER 1B,14Kapadia S.R. Leon M.B. Makkar R.R. et al.5-year outcomes of transcatheter valve replacement compared with standard treatment for patients with inoperable aortic stenosis (PARTNER 1): A randomized controlled trial.Lancet. 2015; 385: 2485-2491Abstract Full Text Full Text PDF PubMed Scopus (618) Google Scholar although quality-of-life metrics were favorable. The question then becomes whether significant PVL is causative or coincidental in some of the reporting. In some instances, PVL has been shown to improve over time, which might represent annular remodeling15Webb J.G. Altwegg L. Boone R.H. et al.Transcatheter valve implantation: Impact on clinical and valve-related outcomes.Circulation. 2009; 119: 3009-3016Crossref PubMed Scopus (526) Google Scholar, 16Ewe S.H. Delgado V. Ng A.C. et al.Outcomes after transcatheter aortic valve implantation: Transfemoral versus transapical approach.Ann Thorac Surg. 2011; 92: 1244-1251Abstract Full Text Full Text PDF PubMed Scopus (71) Google Scholar or continued expansion of the CoreValve Nitinol frame in the early days post-implantation.17Popma J.J. Adams D.H. Reardon M.J. et al.CoreValve United States Clinical I: Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery.J Am Coll Cardiol. 2014; 63: 1972-1981Crossref PubMed Scopus (789) Google Scholar Short-term worsening of PVL has not been reported. So why does PVL develop and what can be done to prevent it? Factors implicated in the development of PVL include asymmetric distribution of calcium, commissural calcification, and extensive aortic calcification causing under-expansion of the valve stent18Ewe S.H. Ng A.C. Schuijf J.D. et al.Location and severity of aortic valve calcium and implications for aortic regurgitation after transcatheter aortic valve implantation.Am J Cardiol. 2011; 108: 1470-1477Abstract Full Text Full Text PDF PubMed Scopus (174) Google Scholar; eccentricity of the aortic annulus19Wong D.T. Bertaso A.G. Liew G.Y. et al.Relationship of aortic annular eccentricity and paravalvular regurgitation post transcatheter aortic valve implantation with CoreValve.J Invasive Cardiol. 2013; 25: 190-195PubMed Google Scholar; improper sizing20Buzzatti N. Maisano F. Latib A. et al.Computed tomography-based evaluation of aortic annulus, prosthesis size and impact on early residual aortic regurgitation after transcatheter aortic valve implantation.Eur J Cardiothorac Surg. 2013; 43: 43-51Crossref PubMed Scopus (54) Google Scholar; and malposition of the prosthesis. These observations apply to both the SAPIEN valve and CoreValve.21Généreux P. Head S.J. Hahn R. et al.Paravalvular leak after transcatheter aortic valve replacement: The new Achilles’ heel? A comprehensive review of the literature.J Am Coll Cardiol. 2013; 61: 1125-1136Crossref PubMed Scopus (323) Google Scholar Quantification of aortic root calcium using the Agatston score, which is obtained using multi-slice contrast-enhanced computed tomography, also has been correlated to higher degrees of PVL.22Haensig M. Lehmkuhl L. Rastan A.J. et al.Aortic valve calcium scoring is a predictor of significant paravalvular aortic insufficiency in transapical-aortic valve implantation.Eur J Cardiothorac Surg. 2012; 41: 1234-1240Crossref PubMed Scopus (112) Google Scholar Technical factors, improved valve design, and pre-procedural evaluation are therefore finite entities that can improve on PVL risk. Better understanding of aortic annular geometry has been instrumental in ensuring proper sizing of a prosthesis. The aortic annulus is not circular but rather oval (while the prosthesis annulus is round); hence, proper sizing is important in both the selection and size of the prosthesis.23Piazza N. De Jaegere P. Schultz C. et al.Anatomy of the aortic valvular complex and its implications for transcatheter implantation of the aortic valve.Circ Cardiovasc Interv. 2008; 1: 74-81Crossref PubMed Scopus (464) Google Scholar, 24Sinning J.M. Vasa-Nicotera M. Chin D. et al.Evaluation and management of paravalvular aortic regurgitation after transcatheter aortic valve replacement.J Am Coll Cardiol. 2013; 62: 11-20Crossref PubMed Scopus (151) Google Scholar In the early TAVR experience, 2-dimensional echocardiography was used to estimate aortic annular size. This method has been shown to actually underestimate true annular dimensions because the maximum diameter is not transected by the ultrasound beam.25Detaint D. Lepage L. Himbert D. et al.Determinants of significant paravalvular regurgitation after transcatheter aortic valve: Implantation impact of device and annulus discongruence.J Am Coll Cardiol Intv. 2009; 2: 821-827Crossref Scopus (332) Google Scholar, 26Tzikas A. Schultz C.J. Piazza N. et al.Assessment of the aortic annulus by multi-slice computed tomography, contrast aortography, and trans-thoracic echocardiography in patients referred for transcatheter aortic valve implantation.Catheter Cardiovasc Interv. 2011; 77: 868-875Crossref PubMed Scopus (70) Google Scholar TEE measurements also tend to be larger than those obtained by TTE but still underestimate true diameter.27Moss R.R. Ivens E. Pasupati et al.Role of echocardiography in percutaneous valve implantation.JACC Cardiovasc Imaging. 2008; 1: 15-24Crossref PubMed Scopus (232) Google Scholar, 28Jayasuriya C. Moss R.R. Munt B. Transcatheter aortic valve implantation in aortic stenosis: The role of echocardiography.J Am Soc Echocardiogr. 2011; 24: 15-27Abstract Full Text Full Text PDF PubMed Scopus (44) Google Scholar Multi-detector computed tomography has subsequently become the new gold standard for assessment of the aortic annulus and root and has shown good predictability, with noted reductions in the incidence of PVL.29Wilson A.B. Webb J.G. Labounty T.M. et al.3-dimensional aortic annular assessment by multidetector computed tomography predicts moderate or severe paravalvular regurgitation after transcatheter aortic valve replacement: A multicenter retrospective analysis.J Am Coll Cardiol. 2012; 59: 1287-1294Crossref PubMed Scopus (346) Google Scholar Because the surgical aortic annulus within the aortic root cannot be visualized on multi-slice computed tomography, a non-circular “virtual aortic annulus” has been described, which includes anchoring points at the nadir attachments of the 3-valve cusps.23Piazza N. De Jaegere P. Schultz C. et al.Anatomy of the aortic valvular complex and its implications for transcatheter implantation of the aortic valve.Circ Cardiovasc Interv. 2008; 1: 74-81Crossref PubMed Scopus (464) Google Scholar, 24Sinning J.M. Vasa-Nicotera M. Chin D. et al.Evaluation and management of paravalvular aortic regurgitation after transcatheter aortic valve replacement.J Am Coll Cardiol. 2013; 62: 11-20Crossref PubMed Scopus (151) Google Scholar A multi-center retrospective analysis using multi-detector computed tomography assessment of aortic annular diameter, circumference, and area showed that oversizing the prosthesis by ≥10% of the annulus area decreased the risk of moderate or severe PVL.29Wilson A.B. Webb J.G. Labounty T.M. et al.3-dimensional aortic annular assessment by multidetector computed tomography predicts moderate or severe paravalvular regurgitation after transcatheter aortic valve replacement: A multicenter retrospective analysis.J Am Coll Cardiol. 2012; 59: 1287-1294Crossref PubMed Scopus (346) Google Scholar This oversizing serves to anchor the stent frame to the aortic annular region. This factor alone likely has contributed to the differences in earlier and later estimates of PVL. The role of 3D TEE in predicting PVL from preoperative annular sizing is still poorly defined; however, this modality appears promising.30Hahn R.T. Khalique O. Williams M.R. et al.Predicting paravalvular regurgitation following transcatheter valve replacement: Utility of a novel method for three-dimensional echocardiographic measurements of the aortic annulus.J AM Soc Echocardiogr. 2013; 26: 1044-1052Abstract Full Text Full Text PDF Scopus (57) Google Scholar One study showed that 3D TEE was superior to 2D TEE for baseline annular measurements.31Jilaihawa H. Doctor N. Kashif M. et al.Aortic annular sizing for transcatheter aortic valve replacement using cross-sectional 3-dimensional transesophageal echocardiography.J Am Coll Cardiol. 2013; 61: 908-916Crossref PubMed Scopus (136) Google Scholar CT imaging had a high degree of discrimination while mean cross-sectional diameter by 3D TEE had an intermediate value. (Cross-sectional 3D TEE measurements were smaller compared to cross-sectional CT.) As expected, 2D TEE measurements had a low discriminatory value. So, how much is too much, and how reliable are our estimations? Quantitative and qualitative assessments of PVL have not been uniform across TAVR studies, making our understanding of this problem and its precise impact on both short-term and long-term outcomes a challenge. The heterogeneity among studies is due to a number of factors, not limited to but including the imaging modality used to assess PVL severity (ie, TTE v TEE v fluoroscopy/angiography), type of prosthesis, timing of studies, grading methods, and reliance on central core laboratory analysis. The PARTNER trial was unique in its use of a central core laboratory to assess PVL. American Society of Echocardiography guidelines for the assessment of native valves were used, as prosthetic valve guidelines were not yet available in the early arm of the study.32Zoghbi W.A. Enriquez-Sarano M. Foster E. et al.Recommendations for evaluation of the severity of native valvular regurgitation with two-dimensional and Doppler echocardiography.J Am Soc Echocardiogr. 2003; 16: 777-802Abstract Full Text Full Text PDF PubMed Scopus (3381) Google Scholar Even with the use of core laboratories, however, disparities were noted in the incidence of moderate and severe PVL in the PARTNER 1 and 2 trials, indicating intra-core laboratory inconsistencies, possibly related to different methodologies and failure to use a multi-parametric assessment (as opposed to circumferential extent as the primary grading parameter) to grade PVL. When a consortium of core echocardiography laboratory directors reviewed 87 patients from the Partner 2B cohort, the core laboratory tended to overestimate PVL severity.33Hahn R.T. Pibarot P. Weissman N.J. et al.Assessment of paravalvular aortic regurgitation after transcatheter aortic valve replacement. Intra-core laboratory variability.J Am Soc Echocardiogr. 2015; 28: 415-422Abstract Full Text Full Text PDF PubMed Scopus (51) Google Scholar In the Duke study, echocardiographic quantification of PVL was broken down into 2 broad categories: significant (moderate or greater) and nonsignificant (no, trivial, or mild) based on Valve Academic Research Consortium (VARC) 2 guidelines. Furthermore, study interpretation was by CT anesthesiologists for TEE and a core laboratory for post-procedural TTE. VARC 2 echocardiographic recommendations24Sinning J.M. Vasa-Nicotera M. Chin D. et al.Evaluation and management of paravalvular aortic regurgitation after transcatheter aortic valve replacement.J Am Coll Cardiol. 2013; 62: 11-20Crossref PubMed Scopus (151) Google Scholar include both quantitative (regurgitant volume, regurgitant fraction, effective regurgitant orifice area) and semi-quantitative parameters (descending aorta diastolic flow reversal and circumferential extent of PVL). In the short-axis assessment of the circumferential degree of PVL, <10% is mild, 10-29% moderate and ≥30% severe. Importantly, though, VARC 2 criteria have been adapted; they serve as guidelines, and further validation will be needed as clinical experience continues to grow.34Kappetein A.P. Head S.J. Genereux P. et al.Updated standardized endpoint definitions for transcatheter aortic valve implantation. The Valve Academic Research Consortium-2 Consensus Document.J Am Coll Cardiol. 2012; 60: 1438-1454Crossref PubMed Scopus (1417) Google Scholar In their systematic review of PVL after TAVR, Généreux et al sought to better quantify PVL and its progression and clinical consequences.21Généreux P. Head S.J. Hahn R. et al.Paravalvular leak after transcatheter aortic valve replacement: The new Achilles’ heel? A comprehensive review of the literature.J Am Coll Cardiol. 2013; 61: 1125-1136Crossref PubMed Scopus (323) Google Scholar Problems with quantification included the dynamic environment of the hybrid suite with acute hemodynamic derangements that can affect Doppler measurements and color flow, acoustic shadowing from a prosthesis in the aortic position often compounded by mitral annular and root calcification resulting in colorflow attenuation, multiple jets, and the eccentric nature of PVL and the shape of the regurgitant orifice (crescentic or circumferential). These elements can make quantification using jet dimensions, vena contracta, and pressure half-time difficult, as these semi-quantitative parameters are better suited to central jets. Accurate quantification of PVL with echocardiography therefore remains an ongoing challenge. All procedures in the Duke study were performed under general anesthesia, which raises another important issue: the effect of general anesthesia on the quantitation of AR. This observation is reminiscent of the varying degrees of mitral regurgitation seen in the operating room under anesthesia when compared to preoperative studies.35Grewal K.S. Malkowski M.J. Piracha A.R. et al.Effect of general anesthesia on the severity of mitral regurgitation by transesophageal echocardiography.Am J Cardiol. 2000; 85: 199-203Abstract Full Text Full Text PDF PubMed Scopus (108) Google Scholar The aortic regurgitation index (ARI), developed by a group of German investigators,36Sinning J.M. Hammerstingl C. Vasa-Nicotera M. et al.Aortic regurgitation index defines severity of periprosthetic regurgitation and predicts outcome in patients after transcatheter aortic valve implantation.J Am Coll Cardiol. 2012; 59: 1134-1141Crossref PubMed Scopus (325) Google Scholar is the ratio of the gradient between diastolic blood pressure and left ventricular end-diastolic pressure to systolic blood pressure ([DBP-LVEDP]/SBP) × 100. Among a group of 146 patients receiving the CoreValve, this group found that patients with ARI <25% had significantly increased mortality at 1 year compared to ARI ≥25% (46.0% v 16.7%, p < 0.001) and that this index was a predictor of 1-year mortality independent of degree of PVL. Of note, increased left ventricular diastolic dysfunction or an increase in aortic stiffness may result in a low diastolic transvalvular gradient, with a falsely positive ARI.37Pibarot P. Hahn R.T. Weissman N.J. et al.Assessment of paravalvular regurgitation following TAVR. A proposal of unifying grading scheme.J Am Coll Cardiol Img. 2015; 8: 340-360Crossref Scopus (203) Google Scholar Further large-scale validation of this formula is needed; however, it may be a good complementary adjunct to conventional imaging modalities. The current grading method for PVL post-TAVR clearly has its limitations. Grading schemes in general have not been universally standardized, making comparison of studies difficult. Conventional grading on a 1-to-4+ scale has not been validated adequately with, for example, unclear distinctions between trivial, trace, and mild degrees of AR. A multi-pronged approach that utilizes hemodynamic measurements along with echocardiography should allow for more precise quantification of PVL immediately post-TAVR and aid in determining when further interventions are needed. Pibarot et al have advocated for a more expanded 5-point approach to grading of PVL after TAVR because of difficulty in distinguishing between the “gray zones” that can overlap with different methodologies.37Pibarot P. Hahn R.T. Weissman N.J. et al.Assessment of paravalvular regurgitation following TAVR. A proposal of unifying grading scheme.J Am Coll Cardiol Img. 2015; 8: 340-360Crossref Scopus (203) Google Scholar With changing trends in procedural anesthetic management, there has been a significant shift from general anesthesia to monitored anesthesia care. Consequently, early procedural evaluation of PVL was predominantly with TEE, while TTE is gradually becoming the more common procedural modality. This latter point may allow for better head-to-head comparisons between intraoperative and post-procedural assessment with TTE. Data from the SOURCE 3 Registry reported that 59.9% of transfemoral procedures were performed with conscious sedation.4Wendler O. Schymik G. Treede H. et al.SOURCE 3 Registry: Design and 30-day results of the European Postapproval Registry of the latest generation of the SAPIEN 3 transcatheter heart valve.Circulation. 2017; 135: 1123-1132Crossref PubMed Scopus (149) Google Scholar The STS/ACC Registry reported that 97.6% of patients underwent TAVR under general anesthesia in 2012 compared to 82.6% in 2015.3Grover F.L. Vemulapalli S. Carroll J.D. et al.for the STS/ACC TVT Registry2016 Annual Report of the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.J Am Coll Cardiol. 2017; 69: 1215-1230Crossref PubMed Scopus (370) Google Scholar The discordance between TEE and TTE in the Duke investigation is difficult to interpret for 3 important reasons: the dynamic hemodynamic environment in the hybrid suite (compounded with general anesthesia), non-blinding of study interpretation with multiple readers and operators, and the implantation of both CoreValve (n = 151) and Edwards SAPIEN (n = 66) prostheses. Only 1 recent study appeared to address the TTE versus TEE question. A comparison of AR assessment post-TAVR with TTE to peri-procedural TEE by Goncalves et al suggested that patient hemodynamics might result in underestimation of PVL with TEE and that post-procedural TTE might be an acceptable alternative to TEE.38Goncalves A. Nyman C. Singh A. et al.Transthoracic echocardiography to assess aortic regurgitation after TAVR: A comparison with periprocedural transesophageal echocardiography.Cardiology. 2017; 137: 1-8Crossref PubMed Scopus (8) Google Scholar A strength of their study was that all images were independently reviewed by 2 experienced observers with no access to clinical data. They used the VARC-2 recommendations and based severity of PVL on the Unifying Grading Scheme Proposal.37Pibarot P. Hahn R.T. Weissman N.J. et al.Assessment of paravalvular regurgitation following TAVR. A proposal of unifying grading scheme.J Am Coll Cardiol Img. 2015; 8: 340-360Crossref Scopus (203) Google Scholar They found that mild-to-moderate AR was seen with a greater frequency following TTE compared to TEE (44% v 22%, p < 0.01) from a group of 163 patients. The investigators also found that in 46 patients in whom AR was detected by TTE but not at TEE/TAVR, that blood pressure was significantly higher at the time of TTE. Conversely, when patients had no AR or AR by both modalities, there were no differences in blood pressure, suggesting that different hemodynamics might have accounted for the discrepancies. Their median follow-up was 185 days (IQR 39-424), and no mortality was attributed by TEE or TTE to the presence of AR. All patients in this study received the Edwards SAPIEN valve, primarily by a transfemoral route. The median timespan between TTE and TEE examinations was 4 days (IQR 2-10 days). They noted only a fair kappa agreement for diagnosing AR between TTE and TEE (κ = 0.25), and a weaker correlation when grading its severity (κ = 0.11); while the Duke investigators found a modest agreement (κ = 0.47) between TTE and TEE. In the latter study, whether “significant” PVL was detected by TEE or TTE, survival difference was the same; however, with only 22 patients (11.2%) experiencing moderate or greater post-deployment PVL by TEE and 8 later on by TTE (4.1%), their study lacked sufficient power to adequately draw conclusions relative to larger studies. Greater use of the CoreValve might have contributed to the later reduction in significant PVL due to post-deployment conformational changes. When TEE and TTE failed to agree, 38% of patients showed higher grades of PVL with TEE versus TTE. This goes against the notion that PVL can be underestimated under anesthesia; hence, other factors may be in play. Conversely, a true reduction in PVL actually might have occurred. So where do we go from here? New and improved transcatheter valves are addressing the PVL issue, and if results from the SOURCE 3 Registry are any indication of an ongoing trend toward eliminating this problem (at the expense of a greater need for permanent pacemaker implant), we may finally gain a fuller understanding of the impact of moderate or greater PVL on outcomes. If and when this technology finds its place in a healthier patient population, we may ultimately get answers to the question of whether PVL actually serves as a surrogate marker for adverse outcomes, or is the primary culprit. The Duke investigators have made it clear that larger-scale studies permitting direct comparisons between TTE and TEE as imaging modalities for TAVR are needed, although the ongoing shift away from general anesthesia and the introduction of 3D echocardiographic imaging into routine practice may once again redirect our thinking in this rapidly changing field." @default.
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• W2605106309 date "2017-08-01" @default.
• W2605106309 modified "2023-10-16" @default.
• W2605106309 title "Are Transthoracic and Transesophageal Echocardiography Equal “PARTNERS” in the Assessment of Paravalvular Leak After TAVR?" @default.
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