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Published: 14 July 2021
by MDPI
Journal of Clinical Medicine, Volume 10; doi:10.3390/jcm10143102

Abstract:
The aim of this study was to compare patients with transcatheter aortic valve replacement (TAVR) receiving new generation prostheses SAPIEN 3 (S3, Edwards Lifesc.) and Evolut R (ER, Medtronic Inc.) in terms of periprocedural and long-term outcome. Our retrospective, single-center analysis included 359 consecutive patients with severe aortic stenosis who underwent TAVR with S3 or ER from 2014–2016 (mean age 82 ± 7 years, 47% male, mean EuroSCORE II 8.0 ± 8%, mean follow-up 3.8 years). Device Success was equal (S3 93.0% vs. ER 92.4%, p = 0.812). We report a 30-day mortality of 2.8% in the S3 group, and 2.1% in the ER group (p = 0.674). There was no difference in stroke, conversion to open surgery, vascular and bleeding complications or myocardial infarction. While prosthesis mean gradients were higher with S3 (12.0 mmHg vs. 8.2 mmHg, p< 0.001), there was a trend to less paravalvular regurgitation (PVR moderate or severe: 1% vs. 3.6%, p = 0.088). All-cause mortality up to 5 years did not show a difference (mean survival S3 3.5 ± 0.24 years, ER 3.3 ± 0.29 years, p = 0.895). Independent predictors of long-term mortality were impaired LVEF, chronic kidney injury, peripheral artery disease, malignant tumor and periprocedural stroke. New generation TAVR valves offer an excellent implant and outcome success rate. Long-term survival was independent of prostheses choice and mainly attributed to comorbidities and complications.
Published: 14 July 2021
by MDPI
Medicina, Volume 57; doi:10.3390/medicina57070711

Abstract:
Transcatheter aortic valve implantation (TAVI) has become the leading technique for aortic valve replacement in symptomatic patients with severe aortic stenosis with conventional surgical aortic valve replacement (SAVR) now limited to patients younger than 65–75 years due to a combination of unsuitable anatomies (calcified raphae in bicuspid valves, coexistent aneurysm of the ascending aorta) and concerns on the absence of long-term data on TAVI durability. This incredible rise is linked to technological evolutions combined with increased operator experience, which led to procedural refinements and, accordingly, to better outcomes. The article describes the main and newest technical improvements, allowing an extension of the indications (valve-in-valve procedures, intravascular lithotripsy for severely calcified iliac vessels), and a reduction of complications (stroke, pacemaker implantation, aortic regurgitation).
, M. Angelillis, C. Fiorina, C. Tamburino, F. Bedogni, G. Bruschi, M. Montorfano, A. Poli, F. De Felice, B. Reimers, et al.
International Journal of Cardiology, Volume 335, pp 85-92; doi:10.1016/j.ijcard.2021.03.071

Abstract:
Background Concomitant mitral regurgitation (MR) impaired prognosis in patients undergoing transcatheter aortic valve implantation (TAVI). It has been suggested that the use of first generation self-expandable valve in patients with significant MR is associated with worse outcome as compared with balloon expandable valve. However, the impact of newer generation transcatheter devices on MR has not been investigated so far. We aim to assess the prognostic impact of MR in patients undergoing TAVI with the first-generation vs. the latest generation of self-expandable valves. Methods We analyzed 2964 consecutive patients who underwent TAVI. Patients were classified into 4 groups according to the degree of baseline MR and the generation of self expandable valve implanted. Results Of 1234 patients with moderate or severe MR, 817 were treated with first generation and 417 patients with second generation valves. Whereas, of 1730 patients with no or mild MR, 1130 were treated with first generation and 600 patients with second generation valves. Although, concomitant moderate-severe MR was found to be an independent predictor of mortality after TAVI, the use of newer generation self expandable valves was associated with higher survival rate at 1 year irrespective of the degree of preprocedural MR. At multivariable analysis the use of newer generation valve was associated with MR improvement throughout 1 year follow-up. Conclusion Baseline moderate-severe MR is associated with an increase in mortality after TAVI. However, the degree of preprocedural MR doesn't impact survival when a second generation self expandable valve is used.
Taishi Okuno, Nicolas Brugger, , Dik Heg, George C.M. Siontis, Mirjam G. Winkel, Jonas Lanz, , , , et al.
Journal of Cardiovascular Computed Tomography, Volume 15, pp 356-365; doi:10.1016/j.jcct.2020.10.003

Abstract:
Background Mitral annular calcification (MAC) has been associated with mitral valve (MV) disease and cardiovascular events in patients undergoing transcatheter aortic valve implantation (TAVI). We aimed to investigate the incidence and impact of mitral calcium volume (MCV) quantified by multidetector computed tomography (MDCT) on MV function and clinical outcomes after TAVI. Methods Consecutive patients with exploitable echocardiography and MDCT performed during TAVI screening were enrolled in this retrospective analysis. Mitral calcium was assessed visually and measured using a semi-automatic tool developed for the aortic valve in an off-label fashion. Results MCV >0 mm3 was found in 65% of the 875 included patients. Patients with calcification were older (82 ± 6 versus 81 ± 7; P = 0.002) and had high prevalence of renal dysfunction (69% versus 61%; P = 0.017) and mitral stenosis (25% versus 4%, P < 0.001). MCV correlated well with visual MAC severity (r = 0.94; P < 0.001), but showed a greater predictive value for mitral stenosis (AUC = 0.804 vs. 0.780, P = 0.012) , while it was not a predictor of mitral regurgitation (AUC = 0.514). Correlations were found between MCV and echocardiographic parameters including MV area, mean transmitral gradient, and pressure half-time (P < 0.001 for all). MCV did not impact on cardiovascular mortality or new permanent pacemaker implantation after TAVI. Conclusions Calcification of the mitral apparatus is common in TAVI candidates and results in mitral stenosis in 25% of the patients. Increasing MCV predicts mitral stenosis, but had no impact on clinical outcomes following TAVI. Clinical trial registration NCT01368250.
Shigeru Saito, Kentaro Hayashida, Morimasa Takayama, Tsuyoshi Goto, Leo Ihlberg, Yoshiki Sawa
Circulation Journal, Volume 85, pp 991-1000; doi:10.1253/circj.cj-20-0064

Abstract:
Background:The REPRISE Japan study, a prospective multicenter single-arm trial, was undertaken to confirm the safety and effectiveness of transcatheter aortic valve replacement (TAVR) with the LOTUS valve in Japanese subjects with severe symptomatic calcific aortic stenosis at extreme or high surgical risk. Methods and Results:REPRISE Japan enrolled 40 subjects in the transfemoral (TF) cohort (mean age 84 years; mean [±SD] Society of Thoracic Surgeons [STS] score 6.4±2.9%); 10 additional subjects were treated with a transaortic (TAo) approach (mean age 84 years; mean STS score 6.3±3.3%). A subanalysis was also performed on subjects treated with the 21-mm LOTUS valve (n=15; mean age 84 years; mean STS score 5.3±2.1%). The primary safety endpoint (a composite of all-cause mortality, stroke, life-threatening or major bleeding events, acute kidney injury [Stage 2/3], and major vascular complications at 30 days) occurred in 15% of TF subjects. The primary effectiveness endpoint (a composite of all-cause mortality, disabling stroke, and moderate or greater paravalvular leak [PVL; core laboratory assessed] at 6 months) occurred in 5.3% of TF subjects. Across the TF, TAo, and 21-mm LOTUS valve cohorts, no subjects exhibited moderate or greater PVL at 6 months. The 30-day rate of pacemaker implantation was 22.5% in the TF cohort (TAo: 20%; 21 mm: 13.3%). Conclusions:Data from REPRISE Japan confirm the safety and efficacy of the LOTUS Valve when used in Japanese clinical practice.
Masashi Ota, Masaki Izumo, Yasuhide Mochizuki, Haruka Nishikawa, Yukio Sato, Mika Watanabe, Toshiki Kaihara, Kazuaki Okuyama, Ryo Kamijima, Yasuhiro Tanabe, et al.
Circulation Journal, Volume 85, pp 1068-1075; doi:10.1253/circj.cj-20-1173

Abstract:
Background:Although diastolic flow reversal (DFR) in the descending aorta, assessed via transesophageal echocardiography (TEE), is a simple and easy indicator for evaluating aortic regurgitation, the association between DFR pattern and clinical outcomes following transcatheter aortic valve implantation (TAVI) is unclear. The purpose of this study was to evaluate the effect of DFR patterns on clinical outcomes following TAVI. Methods and Results:Two-hundred and eleven patients (mean age, 83.6±5.7 years; 69% female) who underwent TAVI were retrospectively assessed via intraprocedural TEE. DFR was evaluated using pulsed-wave Doppler in the descending aorta before and after TAVI. The primary endpoint was major adverse cardio-cerebrovascular events (MACCEs). Although only 7 patients (3.3%) had moderate or severe paravalvular leak, as assessed by color Doppler echocardiography, holo-DFR (HDFR) was observed in 33 patients (16.0%) after TAVI. MACCEs occurred in 40 patients during the median follow up of 282 days (interquartile range: 160–478 days). The estimated cumulative MACCE-free survival at 1 year was significantly lower in patients with HDFR than in those without HDFR. A Cox proportional hazards analysis revealed that HDFR after TAVI was independently associated with MACCEs. Conclusions:HDFR was associated with an increased risk of MACCEs after TAVI. DFR evaluated by intraprocedural echocardiography could serve as a simple and easy method for predicting clinical outcomes.
Yuji Xie, Lingyun Fang, He Li, Mingxing Xie
European Heart Journal; doi:10.1093/eurheartj/ehab402

Abstract:
A 65-year-old man with a history of mechanical mitral valve replacement was admitted to our hospital for severe haemolytic anaemia and dyspnoea. Admission transthoracic echocardiography demonstrated severe aortic regurgitation and two mitral paravalvular leaks (PVLs), accompanied with dilated cardiac chambers and mild ventricular systolic dysfunction. Due to high risk of operation, the patient underwent transapical transcatheter aortic valve implantation (TAVI) and mitral PVL closure.
Laura J. Davidson, Charles J. Davidson
JAMA: The Journal of the American Medical Association, Volume 325, pp 2480-2494; doi:10.1001/jama.2021.2133

Abstract:
Importance More than 40 million people are living with either mitral or aortic valve disease worldwide, and more than 180 000 heart valve replacement surgeries are performed each year in the US. Transcatheter valve repair has emerged as an important therapeutic option for patients who are candidates for heart valve replacement. Observations All transcatheter valve therapies involve a multidisciplinary team of interventional cardiologists, cardiothoracic surgeons, radiologists, echocardiographers, nurses, and social workers, termed theheart team, to determine the optimal approach for managing each patient. Transcatheter aortic valve implantation (TAVI) is an aortic valve replacement procedure that is performed percutaneously and is currently approved for patients with severe, symptomatic aortic stenosis in all surgical risk categories. The TAVI procedure can be performed using a balloon-expandable or self-expanding valve. In a low-risk cohort of patients (PARTNER [Placement of Aortic Transcatheter Valves] 3 trial), the rates of death from any cause, stroke, or rehospitalization were 8.5% for patients receiving TAVI and 15.1% for patients undergoing surgical aortic valve replacement. Decision-making regarding therapy choice should be based on individual anatomy (including the number of leaflets, annular size, and peripheral arterial anatomy), comorbidities (including concomitant coronary artery disease and aortopathies), and patient preference guide. A mitral transcatheter edge-to-edge repair device is approved by the US Food and Drug Administration for high-risk patients with degenerative and functional mitral regurgitation that has excellent safety and efficacy in these populations. In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial, the annualized rate of all hospitalizations for heart failure was 35.8% among patients who underwent transcatheter edge-to-edge repair and received medical therapy compared with 67.9% among patients in the medical therapy alone group. Transcatheter tricuspid valve repair and replacement trials are ongoing and show promise for the treatment of patients with tricuspid regurgitation, which previously had limited therapeutic options. Multimodality imaging, which includes transthoracic echocardiography, transesophageal echocardiography, computed tomography, and intracardiac echocardiography, is important for preprocedural planning, device selection, and optimal outcomes. Conclusions and Relevance Approximately 78 000 TAVI procedures and 10 000 transcatheter mitral valve repairs take place yearly in the US to treat patients with severe, symptomatic aortic stenosis and mitral regurgitation, respectively. Transcatheter valve therapies have expanded therapeutic options for patients, including for those who previously had no viable surgical options.
Clinical Research in Cardiology pp 1-9; doi:10.1007/s00392-021-01882-3

Abstract:
Background Transcatheter aortic valve implantation (TAVI) has become standard treatment for elderly patients with symptomatic severe aortic valve stenosis. The ACURATE neo AS study evaluates 30-day and 1-year clinical and hemodynamic outcomes in patients treated with the ACURATE neo2 valve. Methods The primary endpoint of this single-arm multicenter study is 30-day all-cause mortality. Other key endpoints include device performance, echocardiographic measures assessed by an independent core laboratory, and VARC-2 clinical efficacy and safety endpoints through 12 months. Results The study enrolled 120 patients (mean age 82.1 ± 4.0 years; 67.5% female, mean baseline STS score 4.8 ± 3.8%). The VARC-2 composite safety endpoint at 30 days occurred in 13.3% of patients. All-cause mortality was 3.3% at 30 days and 11.9% at 1 year. The 30-day stroke rate was 2.5% (disabling stroke 1.7%); there were no new strokes between 30 days and 12 months. The rate of permanent pacemaker implantation was 15.0% (18/120) at 30 days and 17.8% (21/120) at 1 year. No patients required re-intervention for valve-related dysfunction and there were no cases of valve thrombosis or endocarditis. Patients demonstrated significant improvement in mean aortic valve gradient (baseline 38.9 ± 13.1 mmHg, 1 year 7.8 ± 3.5 mmHg; P < 0.001 in a paired analysis). In the overall population, paravalvular leak was evaluated at 1 year as none/trace in 60.5%, mild in 37.0%, and moderate in 2.5%; no patients had severe PVL. Conclusions One-year outcomes from the ACURATE neo AS study support the safety and performance of TAVI with the ACURATE neo2 valve. Graphic Abstract
Mathias Wolfrum, , Jarkko Piuhola, Heidi Lehtola, José Antonio Baz, Andrés Iñiguez, Lokien X. van Nunen, Pim A. L. Tonino, Matti Niemelä,
Catheterization and Cardiovascular Interventions; doi:10.1002/ccd.29833

Abstract:
Objectives We aimed to determine the safety and efficacy of the Allegra transcatheter heart valve (THV) for the treatment of severe aortic valve stenosis in a large patient population treated under real-world conditions. Background The Allegra is a novel self-expanding THV with supra-annular bovine leaflets. The valve is available in three different sizes (23, 27, and 31 mm), all are delivered through an 18F sheath. Methods Consecutive patients undergoing TAVR with the Allegra THV were enrolled in a multicenter-registry. Data were collected throughout initial hospital-stay and at 30-day follow-up. Clinical endpoints were defined according to the updated definitions of the Valve-Academic-Research-Consortium. Results This registry included 255 patients (mean age 83 ± 6 years, 48% women) from four European centers. Median European System for Cardiac Operative Risk Evaluation II score (EuroSCORE II) was 3.3% (IQR 1.9–5.8%). Acute device success was 95.7%. The remaining 11 patients had either moderate paravalvular regurgitation immediately after the procedure (7 patients) or the device could not be optimal positioned requiring implantation of a second THV (4 patients). Major vascular complications and major/life-threatening bleedings occurred in 10 (3.9%) and 12 (4.7%) patients, respectively. At 30 day follow-up, mean effective orifice area was 2.2 ± 0.5 cm2, mean gradient was 6.9 ± 3.8 mmHg, 7 (3.3%) patients had more than mild paravalvular leakage, 3 patients (1.2%) had died, 6 patients (2.4%) had a stroke and 30 (12.8%) patients had required implantation of a new permanent pacemaker. Conclusions Transfemoral implantation of the Allegra THV resulted in favorable clinical and echocardiographic outcomes during hospitalization and short-term follow up.
Luciana de Cerjat Bernardes P. da Cunha, Enio Eduardo Guerios, , Luiz A. Carvalho, Pedro Lemos, Rogério Sarmento-Leite, Alexandre A. Abizaid, José Antonio Mangione, Adriano Dourado Oliveira, Alexandre Siciliano, et al.
Arquivos Brasileiros de Cardiologia, Volume 116, pp 1059-1069; doi:10.36660/abc.20190772

Abstract:
Mitral regurgitation (MR) is prevalent in patients undergoing transcatheter aortic valve implantation (TAVI). There are some controversies about the prognostic impact of MR in survival of TAVI patients. To examine the relationship between TAVI and MR in a patient population from the Brazilian TAVI Registry. Seven hundred and ninety-five patients from the Brazilian TAVI Registry were divided at baseline, discharge, and follow-up according to their MR grade as follows: absent/mild (AMMR) or moderate/severe (MSMR). They were subsequently regrouped according to their immediate and late changes in MR severity after TAVI as follows: no change, improved, or worsened MR. Predictors and prognostic impact on baseline as well as changes in MR severity were analyzed. Statistical significance was set at p < 0.05. Baseline MSMR was present in 19.3% of patients and was a predictor of increased late mortality. Immediately after TAVI, 47.4 % of cases improved to AMMR, predicted by a higher Society of Thoracic Surgeons score and a higher grade of baseline aortic regurgitation. Upon follow-up, 9.2% of cases of AMMR worsened to MSMR, whereas 36.8% of cases of MSMR improved to AMMR. Lower baseline left ventricular ejection fraction (LVEF) and improvement in LVEF at follow-up were predictors of MR improvement. Progressive worsening of MR upon follow-up was an independent predictor of higher late mortality after TAVI (p = 0.005). Baseline MSMR predicts late mortality after TAVI. Lower LVEF and improved LVEF at follow-up predict MR improvement after TAVI. Progressive worsening of MR severity at follow-up is an independent predictor of late mortality, which is a rare finding in the literature.
Benoy Shah, Syed Haider, John Rawlins, Alison Calver, Simon Corbett, Dhrubo Rakhit, Sunil Ohri, Nick Curzen
Acute coronary syndromes & Interventional cardiology, Volume 107; doi:10.1136/heartjnl-2021-bcs.39

Abstract:
Introduction Valve-in-valve transcatheter aortic valve implantation (V-in-V TAVI) has become an increasingly popular alternative to re-do surgery for patients with failing aortic bioprosthetic valves. The Trifecta aortic valve replacement (AVR), designed for supra-annular insertion, consists of a titanium stent with externally mounted leaflets fashioned from bovine pericardium. Several studies have reported premature structural degeneration of the Trifecta valve. There are currently few data regarding the feasibility & efficacy of V-in-V TAVI within Trifecta bioprostheses. Methods This represents a retrospective review of prospectively collected data at our centre for TAVI procedures performed between January 1st 2015 and December 31st 2020 inclusive. In cases of V-in-V TAVI to treat a failing Trifecta valve, we collected demographic, procedural, echocardiographic and short-term follow-up data from electronic records systems for both this NHS Trust and primary care. Results Over a 6-year period, we performed 549 TAVI procedures, of which 51 (9.3%) were V-in-V cases. Of these 51, 15 (29%) were for patients with failing Trifecta valves (9 female, mean age 80.9 ± 5.6yrs;. predominant stenosis in 5 & transvalvular regurgitation in 10). Figures 1 & 2 demonstrate examples of prosthesis stenosis & prosthesis regurgitation treated by V-in-V TAVI. The median time from original AVR to V-in-V TAVI procedure was 59 months (IQR 36.5, range 16–93 months). All procedures were performed via the transfemoral route and 13/15 under conscious sedation. A balloon-expandable TAVI valve was used in 14 patients & a self-expanding valve in 1 patient. Post-procedural echocardiography revealed a mean aortic peak velocity 2.9 ± 0.4m/s & mean aortic gradient 19 ± 5mmHg. Paravalvular aortic regurgitation was absent in 7 cases, trivial in 6 & mild in 2 patients. In-hospital and 30-day mortality were 0%. There were three deaths during follow-up (36, 14 & 3 months post procedure), all of which were non-cardiac in nature. Conclusion V-in-V TAVI is a safe and feasible alternative to re-do surgical AVR for patients with a failing Trifecta aortic bioprosthesis. Unlike other bioprosthetic valves, the Trifecta valve cannot be fractured to enable a larger V-in-V TAVI valve to be implanted. Thus, longer term follow-up of such patients will allow a full understanding of the long-term haemodynamic and clinical outcomes in this patient cohort. Conflict of Interest Nil
Philippe Généreux, Nicolo Piazza, Maria C. Alu, Tamim Nazif, Rebecca T. Hahn, Philippe Pibarot, Jeroen J. Bax, Jonathon A. Leipsic, Philipp Blanke, Eugene H. Blackstone, et al.
Journal of the American College of Cardiology, Volume 77, pp 2717-2746; doi:10.1016/j.jacc.2021.02.038

Abstract:
The Valve Academic Research Consortium (VARC), founded in 2010, was intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. Rapid evolution of the field, including the emergence of new complications, expanding clinical indications, and novel therapy strategies have mandated further refinement and expansion of these definitions to ensure clinical relevance. This document provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research. Several years after the publication of the VARC-2 manuscript, an in-person meeting was held involving over 50 independent clinical experts representing several professional societies, academic research organizations, the US Food and Drug Administration (FDA), and industry representatives to (i) evaluate utilization of VARC endpoint definitions in clinical research, (ii) discuss the scope of this focused update, and (iii) review and revise specific clinical endpoint definitions. A writing committee of independent experts was convened and subsequently met to further address outstanding issues. There were ongoing discussions with FDA and many experts to develop a new classification schema for bioprosthetic valve dysfunction and failure. Overall, this multi-disciplinary process has resulted in important recommendations for data reporting, clinical research methods, and updated endpoint definitions. New definitions or modifications of existing definitions are being proposed for repeat hospitalizations, access site-related complications, bleeding events, conduction disturbances, cardiac structural complications, and bioprosthetic valve dysfunction and failure (including valve leaflet thickening and thrombosis). A more granular 5-class grading scheme for paravalvular regurgitation (PVR) is being proposed to help refine the assessment of PVR. Finally, more specific recommendations on quality-of-life assessments have been included, which have been targeted to specific clinical study designs. Acknowledging the dynamic and evolving nature of less-invasive aortic valve therapies, further refinements of clinical research processes are required. The adoption of these updated and newly proposed VARC-3 endpoints and definitions will ensure homogenous event reporting, accurate adjudication, and appropriate comparisons of clinical research studies involving devices and new therapeutic strategies.
, Nikhil Joshi, Mark Turner, Stephen Dorman
Published: 1 June 2021
JACC: Case Reports, Volume 3, pp 859-863; doi:10.1016/j.jaccas.2021.03.020

Abstract:
We present the case of a 76-year-old man with recently treated infective endocarditis and severe residual native pure aortic regurgitation that was causing recurrent pulmonary edema. In view of his prohibitive surgical risk, he underwent transcatheter aortic valve implant with an excellent clinical outcome. (Level of Difficulty: Intermediate.)
Uri Landes, Guy Witberg, Janarthanan Sathananthan, Won-Keun Kim, Pablo Codner, Nicola Buzzatti, Matteo Montorfano, Rebecca Godfrey, David Hildick-Smith, Chiara Fraccaro, et al.
JAMA Cardiology; doi:10.1001/jamacardio.2021.1145

Abstract:
Importance Transcatheter aortic valve replacement (TAVR) failure is often managed by an urgent implantation of a supplementary valve during the procedure (2-valve TAVR [2V-TAVR]). Little is known about the factors associated with or sequelae of 2V-TAVR. Objective To examine the incidence, causes, and outcomes of 2V-TAVR. Design, Setting, and Participants A retrospective cohort study was performed using data from an international registry of 21 298 TAVR procedures performed from January 1, 2014, through February 28, 2019. Among the 21 298 patients undergoing TAVR, 223 patients (1.0%) undergoing 2V-TAVR were identified. Patient-level data were available for all the patients undergoing 2V-TAVR and for 12 052 patients (56.6%) undergoing 1V-TAVR. After excluding patients with missing 30-day follow-up or data inconsistencies, 213 2V-TAVR and 10 010 1V-TAVR patients were studied. The 2V-TAVR patients were compared against control TAVR patients undergoing a 1-valve TAVR (1V-TAVR) using 1:4 17 propensity score matching. Final analysis included 1065 (213:852) patients. Exposures Urgent implantation of a supplementary valve during TAVR. Main Outcomes and Measures Mortality at 30 days and 1 year. Results The 213 patients undergoing 2V-TAVR had similar age (mean [SD], 81.3 [0.5] years) and sex (110 [51.6%] female) as the 10 010 patients undergoing 1V-TAVR (mean [SD] age, 81.2 [0.5] years; 110 [51.6%] female). The 2V-TAVR incidence decreased from 2.9% in 2014 to 1.0% in 2018 and was similar between repositionable and nonrepositionable valves. Bicuspid aortic valve (odds ratio [OR], 2.20; 95% CI, 1.17-4.15;P = .02), aortic regurgitation of moderate or greater severity (OR, 2.02; 95% CI, 1.49-2.73;P< .001), atrial fibrillation (OR, 1.43; 95% CI, 1.07-1.93;P = .02), alternative access (OR, 2.59; 95% CI, 1.72-3.89;P< .001), early-generation valve (OR, 2.32; 95% CI, 1.69-3.19;P< .001), and self-expandable valve (OR, 1.69; 95% CI, 1.17-2.43;P = .004) were associated with higher 2V-TAVR risk. In 165 patients (80%), the supplementary valve was implanted because of residual aortic regurgitation after primary valve malposition (94 [46.4%] too high and 71 [34.2%] too low). In the matched 2V-TAVR vs 1V-TAVR cohorts, the rate of device success was 147 (70.4%) vs 783 (92.2%) (P< .001), the rate of coronary obstruction was 5 (2.3%) vs 3 (0.4%) (P = .10), stroke rate was 9 (4.6%) vs 13 (1.6%) (P = .09), major bleeding rates were 25 (11.8%) vs 46 (5.5%) (P = .03) and annular rupture rate was 7 (3.3%) vs 3 (0.4%) (P = .03). The hazard ratios for mortality were 2.58 (95% CI, 1.04-6.45;P = .04) at 30 days, 1.45 (95% CI, 0.84-2.51;P = .18) at 1 year, and 1.20 (95% CI, 0.77-1.88;P = .42) at 2 years. Nontransfemoral access and certain periprocedural complications were independently associated with higher risk of death 1 year after 2V-TAVR. Conclusions and Relevance In this cohort study, valve malposition was the most common indication for 2V-TAVR. Incidence decreased over time and was low overall, although patients with a bicuspid or regurgitant aortic valve, nontransfemoral access, and early-generation or self-expandable valve were at higher risk. These findings suggest that compared with 1V-TAVR, 2V-TAVR is associated with high burden of complications and mortality at 30 days but not at 1 year.
Sarah Moharem-Elgamal, , Sundar Veerappan, Nathan Manghat, Radwa Bedair, Stephen Dorman, Massimo Caputo, Mark Hamilton,
International Journal of Cardiology Congenital Heart Disease, Volume 3; doi:10.1016/j.ijcchd.2021.100116

Abstract:
This study sought to evaluate the feasibility and effectiveness of TAVI for treatment of aortic stenosis in the ACHD population. Review of 802 patients that underwent TAVI from January 2008 to November 2019. 13 ACHD patients with different underlying congenital anatomy were identified (isolated bicuspid aortic valve was excluded and not defined as ACHD). The main endpoints were: paravalvular aortic regurgitation> grade 2 post-procedure, and all-cause 30-day mortality. Periprocedural and post-procedural complications were defined according to the UK TAVI registry. Median age was 66.7 years (range 29–84 years). Eleven patients had severe aortic stenosis (AS), 1 had both severe AS and severe aortic regurgitation (AR) and 1 had severe AR. Median hospital stay was 9 days (range 6–28 days). One patient required a pacemaker post-TAVI. No mortality or paravalvular AR > grade 2 at 30-days. Twelve patients had a reduction in NYHA class on their first post TAVI follow-up. TAVI is viable option as an alternative to surgery for ACHD patients. Further experience with the use of TAVI in the ACHD patients is required to assess long-term outcomes in this unique group of patients.
, Akihiro Isotani, Shinichi Shirai, Kenji Ando
European Heart Journal - Case Reports, Volume 5; doi:10.1093/ehjcr/ytab150

Abstract:
Background Dobutamine stress echocardiography (DSE) in classical low-flow, low-gradient (LFLG) aortic stenosis (AS) is recommended in recent guidelines to differentiate true-severe AS from pseudo-severe AS. However, DSE for patients with concomitant significant mitral regurgitation (MR) is often inaccurate or inconclusive. Case summary A 73-year-old man with a history of coronary artery bypass grafting was referred to our institution with congestive heart failure. Transthoracic echocardiogram showed severe functional MR and LFLG AS. The results of DSE to determine the severity of AS were inconclusive owing to the absence of flow reserve, usually defined as stroke volume increase of ≥20%. In addition, calcium score by computed tomography scan was also inconclusive. Our heart team decided to reassess the severity of AS after percutaneous edge-to-edge mitral valve repair (PMVR), considering the patient’s high surgical risk. Percutaneous edge-to-edge mitral valve repair was uneventful, resulting in marked reduction of MR from severe to trivial. Dobutamine stress echocardiography after PMVR revealed true-severe AS with the presence of flow reserve. Transcatheter aortic valve implantation (TAVI) was performed, and the patient ambulatorily discharged. Discussion The coexistence of significant AS may lead to overestimation of the severity of MR, and reportedly, concomitant MR improves in the majority of patients after TAVI, especially MR of functional aetiology. However, the coexistence of significant MR often leads to inconclusive DSE results because dobutamine stress may worsen MR and fail to increase the stroke volume. In our case, DSE after PMVR was useful to diagnose the true-severe AS for the patient with LFLG AS and severe functional MR.
, Allan Davies, Alessia Gambaro, Francesca Musella, Ana Luisa Costa, Vasileios Panoulas, Edward Nicol, Alison Duncan, Simon Davies, Saeed Mirsadraee
Quantitative Imaging in Medicine and Surgery, Volume 11, pp 1970-1982; doi:10.21037/qims-20-1122

Abstract:
Complication rates of paravalvular aortic regurgitation (PVR) and permanent pacemaker insertion remain high in patients undergoing trans-catheter aortic valve insertion for severe aortic stenosis. The spatial distribution of calcium between individual aortic valve leaflets, and its potential role in these complications is gaining interest. We aimed to assess the accuracy of individual aortic valve leaflet calcium quantification, and to determine its effect on the frequency of these complications. This was a retrospective study of 251 patients who underwent trans-catheter aortic valve insertion using the Evolut RTM valve. The off-line Terarecon software platform was used for Agatston scoring the short axis views. There was a correlation between the sum of the individual leaflet and the total aortic valve calcium score. There was a univariate association between an increase [per 100 Agatston unit (AU)] in both right coronary leaflet (RCL) and left coronary leaflet (LCL) calcium with the risk of PVR. There was an association between an increase in LCL calcium score (per 100 AU) and need for post-implantation balloon aortic valvuloplasty (BAV). There was no association between individual leaflet calcification on the risk of permanent pacemaker insertion. This study supports the idea that a quantifiable and reproducible method of individual valve leaflet calcification score may serve as an independent risk factor for paravalvular regurgitation, beyond visual assessment of asymmetry. However, the same may not be true of spatial calcium distribution and permanent pacemaker implantation (PPI).
Małgorzata Ryś, Tomasz Hryniewiecki, Adam Witkowski, Ilona Michałowska, Karina Zatorska, Patrycjusz Stokłosa, Małgorzata Nieznańska, Piotr Szymański
Kardiologia Polska; doi:10.33963/kp.15987

Abstract:
Presence of mitral annular calcification (MAC) affects prognosis in patients undergoing transcatheter aortic valve implantation (TAVI). MAC frequently coexists with calcifications of mitro-aortic continuity (CMAC). We aimed at qualitative and semi-quantitative analysis of calcifications of the mitral complex - MAC and CMAC in multi-slice computed tomography, in order to assess their impact on the occurrence and dynamics of mitral regurgitation (MR) following TAVI. The study group consisted of 94 patients (mean [SD] age was 79.9 [8.02] years; 67.1% female). Agatston scale - Calcium Score was used for quantitative analysis. MAC and CMAC were also assessed semi-quantitatively as either non-severe or severe. MR following TAVI was defined as unchanged, improved or worsened by at least one degree. Patients with MAC (59,6%) had higher mean aortic gradients (P = 0.02) and smaller left ventricular diastolic diameter (P = 0.002). Patients with CMAC (48.9%) had higher Calcium Score aortic valve (P = 0.006). After TAVI MR improved in 17 (18.1%) patients and worsened in 7 (7.5%) patients. In multivariable logistic regression analysis MR worsening was associated with higher CMAC [OR 1.092 (95% CI) 1.006 -1.185, P = 0.03], as well as bicuspid aortic valve [OR 6.348 (95% CI) 1.048-38.436, P = 0.04]. CMAC was associated with MR worsening following TAVI. This is of relevance in procedural planning in patients with severe AS and coexisting MR in whom arguments for and against surgical repair of concomitant mitral insufficiency are considered.
, Dee Dee Wang, Amit Pursnani, Michael Salinger, Hyde M. Russell, Mackram Eleid, Tarun Chakravarty, Marvin H. Ng, Susheel K. Kodali, Christopher U. Meduri, et al.
JACC: Cardiovascular Interventions, Volume 14, pp 846-858; doi:10.1016/j.jcin.2021.01.051

Abstract:
The authors report 1-year outcomes of high-risk patients with failed surgical annuloplasty rings undergoing transseptal mitral valve–in–ring (MViR) with the SAPIEN 3 aortic transcatheter heart valve (THV). The MITRAL (Mitral Implantation of Transcatheter Valves) trial is the first prospective study evaluating transseptal MViR with the SAPIEN 3 aortic THV in high-risk patients with failed surgical annuloplasty rings. Prospective enrollment of high-risk patients with symptomatic moderate to severe or severe mitral regurgitation (MR) or severe mitral stenosis and failed annuloplasty rings at 13 U.S. sites. The primary safety endpoint was technical success. The primary THV performance endpoint was absence of MR grade ≥2+ or mean mitral valve gradient ≥10 mm Hg (30 days and 1 year). Secondary endpoints included procedural success and all-cause mortality (30 days and 1 year). Thirty patients were enrolled between January 2016 and October 2017 (median age 71.5 years [interquartile range: 67.0 to 76.8 years], 36.7% women, median Society of Thoracic Surgeons score 7.6% [interquartile range: 5.1% to 11.8%], 76.7% in New York Heart Association functional class III or IV). Technical success was 66.7% (driven primarily by need for a second valve in 6 patients). There was no intraprocedural mortality or conversion to surgery. The primary performance endpoint was achieved in 85.7% of survivors at 30 days (24 of 28) and 89.5% of patients alive at 1 year with echocardiographic data available (17 of 19). All-cause mortality at 30 days was 6.7% and at 1 year was 23.3%. Among survivors at 1-year follow-up, 84.2% were in New York Heart Association functional class I or II, the median mean mitral valve gradient was 6.0 mm Hg (interquartile range: 4.7 to 7.3 mm Hg), and all had ≤1+ MR. Transseptal MViR was associated with a 30-day mortality rate lower than predicted by the Society of Thoracic Surgeons score. At 1 year, transseptal MViR was associated with symptom improvement and stable THV performance.
, Amit Pursnani, Akhil Narang, Michael Salinger, Dee Dee Wang, Mackram Eleid, Susheel K. Kodali, Isaac George, Lowell Satler, Ron Waksman, et al.
JACC: Cardiovascular Interventions, Volume 14, pp 859-872; doi:10.1016/j.jcin.2021.02.027

Abstract:
The aim of this study was to assess 1-year clinical outcomes among high-risk patients with failed surgical mitral bioprostheses who underwent transseptal mitral valve-in-valve (MViV) with the SAPIEN 3 aortic transcatheter heart valve (THV) in the MITRAL (Mitral Implantation of Transcatheter Valves) trial. The MITRAL trial is the first prospective study evaluating transseptal MViV with the SAPIEN 3 aortic THV in high-risk patients with failed surgical mitral bioprostheses. High-risk patients with symptomatic moderate to severe or severe mitral regurgitation (MR) or severe mitral stenosis due to failed surgical mitral bioprostheses were prospectively enrolled. The primary safety endpoint was technical success. The primary THV performance endpoint was absence of MR grade ≥2+ or mean mitral valve gradient ≥10 mm Hg (30 days and 1 year). Secondary endpoints included procedural success and all-cause mortality (30 days and 1 year). Thirty patients were enrolled between July 2016 and October 2017 (median age 77.5 years [interquartile range (IQR): 70.3 to 82.8 years], 63.3% women, median Society of Thoracic Surgeons score 9.4% [IQR: 5.8% to 12.0%], 80% in New York Heart Association functional class III or IV). The technical success rate was 100%. The primary performance endpoint in survivors was achieved in 96.6% (28 of 29) at 30 days and 82.8% (24 of 29) at 1 year. Thirty-day all-cause mortality was 3.3% and was unchanged at 1 year. The only death was due to airway obstruction after swallowing several pills simultaneously 29 days post-MViV. At 1-year follow-up, 89.3% of patients were in New York Heart Association functional class I or II, the median mean mitral valve gradient was 6.6 mm Hg (interquartile range: 5.5 to 8.9 mm Hg), and all patients had MR grade ≤1+. Transseptal MViV in high-risk patients was associated with 100% technical success, low procedural complication rates, and very low mortality at 1 year. The vast majority of patients experienced significant symptom alleviation, and THV performance remained stable at 1 year.
, Dee Dee Wang, Mackram F. Eleid, Amit Pursnani, Michael Salinger, Hyde M. Russell, Susheel K. Kodali, Isaac George, Vinayak N. Bapat, George D. Dangas, et al.
JACC: Cardiovascular Interventions, Volume 14, pp 830-845; doi:10.1016/j.jcin.2021.01.052

Abstract:
The aim of this study was to evaluate 1-year outcomes of valve–in–mitral annular calcification (ViMAC) in the MITRAL (Mitral Implantation of Transcatheter Valves) trial. The MITRAL trial is the first prospective study evaluating the feasibility of ViMAC using balloon-expandable aortic transcatheter heart valves. A multicenter prospective study was conducted, enrolling high-risk surgical patients with severe mitral annular calcification and symptomatic severe mitral valve dysfunction at 13 U.S. sites. Between February 2015 and December 2017, 31 patients were enrolled (median age 74.5 years [interquartile range (IQR): 71.3 to 81.0 years], 71% women, median Society of Thoracic Surgeons score 6.3% [IQR: 5.0% to 8.8%], 87.1% in New York Heart Association functional class III or IV). Access was transatrial (48.4%), transseptal (48.4%), or transapical (3.2%). Technical success was 74.2%. Left ventricular outflow tract obstruction (LVOTO) with hemodynamic compromise occurred in 3 patients (transatrial, n = 1; transseptal, n = 1; transapical, n = 1). After LVOTO occurred in the first 2 patients, pre-emptive alcohol septal ablation was implemented to decrease risk in high-risk patients. No intraprocedural deaths or conversions to open heart surgery occurred during the index procedures. All-cause mortality at 30 days was 16.7% (transatrial, 21.4%; transseptal, 6.7%; transapical, 100% [n = 1]; p = 0.33) and at 1 year was 34.5% (transatrial, 38.5%; transseptal, 26.7%; p = 0.69). At 1-year follow-up, 83.3% of patients were in New York Heart Association functional class I or II, the median mean mitral valve gradient was 6.1 mm Hg (IQR: 5.6 to 7.1 mm Hg), and all patients had ≤1+ mitral regurgitation. At 1 year, ViMAC was associated with symptom improvement and stable transcatheter heart valve performance. Pre-emptive alcohol septal ablation may prevent transcatheter mitral valve replacement–induced LVOTO in patients at risk. Thirty-day mortality of patients treated via transseptal access was lower than predicted by the Society of Thoracic Surgeons score. Further studies are needed to evaluate safety and efficacy of ViMAC.
, José‐Antonio Baz, José Moreu, Alberto Berenguer, Ariana Gonzálvez‐García, Guillermo Galeote Md, Ubaldo Hernández, Tomás Cantón, Santiago Jiménez‐Valero, , et al.
Catheterization and Cardiovascular Interventions; doi:10.1002/ccd.29742

Abstract:
Objectives The objective was to evaluate the results of valve‐in‐valve procedures performed with the Allegra device. Background Transcatheter aortic valve implantation to treat degenerated biological aortic valves (valve‐in‐valve) is an established procedure in most catheterization laboratories, but the results are poorer than procedures done in native aortic stenosis. The Allegra device (Biosensors, Morges, Switzerland) has an excellent design to treat these patients. Methods All patients with severely degenerated biological aortic valve treated with the Allegra device in centers from Spain until December 2020 were included (n = 29). Hemodynamic results and 30‐day clinical outcomes were evaluated. The predominant hemodynamic failure was stenosis in 15, regurgitation in 11, and a combination of both in 3 cases. Time from aortic valve replacement to valve‐in‐valve procedure was 8.4 ± 3.9 years (range 3.3–22.1). Results After the procedure, maximum and mean trans‐valvular gradients were 17.4 ± 12.3 and 8.4 ± 6.1 mmHg, respectively. Device success was obtained in 28 patients (96.6%). In one patient with a degenerated 19 mm prosthetic valve, mean gradient after the procedure was 22 mmHg. No patients had a para‐valvular leak grade >1. There were no deaths during the hospitalization or at 30 days and one patient suffered a stroke. Conclusions The Allegra trans‐catheter aortic valve offers optimal hemodynamic results in patients with severely degenerated biological aortic valve.
, Shintaro Nakano, Chiho Tokunaga, Toshihisa Asakura, Atsushi Iguchi, Hiroyuki Nakajima, Akihiro Yoshitake
Published: 19 April 2021
Heart and Vessels pp 1-8; doi:10.1007/s00380-021-01842-x

Abstract:
This study aimed to evaluate the early and mid-term outcomes of transcatheter aortic valve implantation (TAVI) and to assess valve durability. A total of 146 consecutive patients who underwent TAVI for severe aortic stenosis between October 2013 and August 2018 were retrospectively reviewed. All patients (mean age, 84 ± 6 years; age range 53–98 years; 42 males [28.7%]) had multiple comorbidities, with a mean logistic EuroSCORE of 30.9 ± 17.4%. Eighteen patients (12.3%) were aged 90 years or over. Five in-hospital deaths (3.4%) occurred, and 36 patients (24.7%) experienced major TAVI-related complications. With the transfemoral approach, 10 patients had major vascular complications, which mostly occurred with first-generation devices (n = 9) but less commonly with new-generation low-profile devices (P = 0.0078). During a follow-up period of 580 ± 450 (11–1738) days, 29 late deaths occurred. The survival rate was 86.0%, 78.0%, and 61.7% at 1, 2, and 3 years, respectively. Multivariate Cox hazard regression analysis revealed that more-than-moderate tricuspid regurgitation was the only independent risk factor for late deaths due to any cause (hazard ratio, 3.145; 95% confidence interval, 1.129–8.762; P = 0.0283). No statistically significant differences between post-TAVI before discharge from the hospital and at 4 years after TAVI were observed with respect to aortic valve area (1.76 ± 0.49 cm2 vs. 1.64 ± 0.38 cm2; P = 0.1871) and mean pressure gradient (10.0 ± 4.6 mmHg vs. 7.9 ± 3.3 mmHg; P = 0.5032). TAVI was a feasible method with acceptable early and mid-term outcomes and valve durability for at least 4 years in poor-risk patients. Further close follow-up is essential to evaluate late outcomes and valve durability.
VARC-3 WRITING COMMITTEE, Philippe Généreux, Nicolo Piazza, Maria C Alu, , , , Jeroen J Bax, Jonathon A Leipsic, Philipp Blanke, et al.
European Heart Journal, Volume 42, pp 1825-1857; doi:10.1093/eurheartj/ehaa799

Abstract:
Aims The Valve Academic Research Consortium (VARC), founded in 2010, was intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. Rapid evolution of the field, including the emergence of new complications, expanding clinical indications, and novel therapy strategies have mandated further refinement and expansion of these definitions to ensure clinical relevance. This document provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research. Methods and results Several years after the publication of the VARC-2 manuscript, an in-person meeting was held involving over 50 independent clinical experts representing several professional societies, academic research organizations, the US Food and Drug Administration (FDA), and industry representatives to (i) evaluate utilization of VARC endpoint definitions in clinical research, (ii) discuss the scope of this focused update, and (iii) review and revise specific clinical endpoint definitions. A writing committee of independent experts was convened and subsequently met to further address outstanding issues. There were ongoing discussions with FDA and many experts to develop a new classification schema for bioprosthetic valve dysfunction and failure. Overall, this multi-disciplinary process has resulted in important recommendations for data reporting, clinical research methods, and updated endpoint definitions. New definitions or modifications of existing definitions are being proposed for repeat hospitalizations, access site-related complications, bleeding events, conduction disturbances, cardiac structural complications, and bioprosthetic valve dysfunction and failure (including valve leaflet thickening and thrombosis). A more granular 5-class grading scheme for paravalvular regurgitation (PVR) is being proposed to help refine the assessment of PVR. Finally, more specific recommendations on quality-of-life assessments have been included, which have been targeted to specific clinical study designs. Conclusions Acknowledging the dynamic and evolving nature of less-invasive aortic valve therapies, further refinements of clinical research processes are required. The adoption of these updated and newly proposed VARC-3 endpoints and definitions will ensure homogenous event reporting, accurate adjudication, and appropriate comparisons of clinical research studies involving devices and new therapeutic strategies.
Journal of Cardiovascular Development and Disease, Volume 8; doi:10.3390/jcdd8040044

Abstract:
Background: Whereas transcatheter aortic valve implantation (TAVI) has become the gold standard for aortic valve stenosis treatment in high-risk patients, it has recently been extended to include intermediate risk patients. However, the mortality rate at 5 years is still elevated. The aim of the present study was to develop a novel machine learning (ML) approach able to identify the best predictors of 5-year mortality after TAVI among several clinical and echocardiographic variables, which may improve the long-term prognosis. Methods: We retrospectively enrolled 471 patients undergoing TAVI. More than 80 pre-TAVI variables were collected and analyzed through different feature selection processes, which allowed for the identification of several variables with the highest predictive value of mortality. Different ML models were compared. Results: Multilayer perceptron resulted in the best performance in predicting mortality at 5 years after TAVI, with an area under the curve, positive predictive value, and sensitivity of 0.79, 0.73, and 0.71, respectively. Conclusions: We presented an ML approach for the assessment of risk factors for long-term mortality after TAVI to improve clinical prognosis. Fourteen potential predictors were identified with the organic mitral regurgitation (myxomatous or calcific degeneration of the leaflets and/or annulus) which showed the highest impact on 5 years mortality.
Sahoor A Khan,
Published: 16 April 2021
by BMJ
Heart; doi:10.1136/heartjnl-2021-319179

Abstract:
Approximately 2% of people between the ages of 70 and 83 suffer from moderate or greater aortic regurgitation (AR) in the United States. Left untreated, this disease is progressive and fatal; however, up to 8% of patients with AR, who meet the criteria for surgical intervention, do not receive treatment. As such, there is a pressing need to address the lack of treatment options for the thousands of patients with AR who meet a class I indication for aortic valve replacement but who still do not receive surgery. The advent of transcatheter aortic valve implantation (TAVI) has significantly altered the paradigm of treatment for valvular heart disease and is now a well-established therapeutic option for patients with severe aortic stenosis. While transcatheter devices dedicated for the treatment of AR are under investigation, they are not commercially available at this time. Nevertheless, there is a growing body of data that demonstrate acceptable safety and efficacy for the off-label use of current TAVI devices for the treatment of severe AR. Given the dearth of treatment options for inoperable patients with severe AR, available TAVI devices should be considered for this patient population.
Giuliano Costa, Paola D'Errigo Rs, Stefano Rosato Rs, Roberto Valvo, , Corrado Tamburino Md, Francesco Cerza Rs, Fulvia Seccareccia Rs, , for the OBSERVANT Research Group
Catheterization and Cardiovascular Interventions; doi:10.1002/ccd.29701

Abstract:
Objectives To compare clinical outcomes of balloon‐expandable (BE) and self‐expanding (SE) transcatheter aortic valves (TAVs) up to 5 years. Background To date, no robust, comparative data of BE and SE TAVs at long‐term are available. Methods We considered a total of 1,440 patients enrolled in the multicenter OBSERVANT study and undergoing transfemoral transcatheter aortic valve implantation (TF‐TAVI) with either supra‐annular SE (n = 830, 57.6%) and intra‐annular BE (n = 610, 42.4%) valves. Clinical outcomes of the two groups were compared after adjustment using inverse probability of treatment weighting (IPTW) and confirmed by sensitivity analysis with propensity score matching. Results Patients receiving SE valve showed a higher all‐cause mortality at 5 years (Kaplan–Meier estimates 52.3% vs. 47.7%; Hazard ratio [HR] 1.18, 95% confidence interval [CI] 1.01–1.38, p = .04). Landmark analyses showed that there was a not statistically significant reversal of risk excess against the BE group starting from 3 years after TAVI (3–5 years HR 0.97, 95% CI 0.76–1.25, p = .86). Post‐procedural, moderate/severe paravalvular regurgitation (PVR)(HR 1.46, 95% CI 1.14–1.87; p < .01) and acute kidney injury (AKI)(HR 3.89, 95% CI 2.47–6.38; p < .01) showed to be independent predictors of 5‐year all‐cause mortality in multivariable analysis. Conclusions Considering the intrinsic limitations of the OBSERVANT study, we found that patients undergoing TF‐TAVI with a supra‐annular SE valve had a higher all‐cause mortality compared to those receiving an intra‐annular BE valve at 5 years. A late catch up phenomenon of patients receiving the BE valve was observed beyond 3 years. Post‐procedural moderate/severe PVR seems to play a crucial role in determining this finding. Comparative studies of new generation devices with longer follow‐up are needed to evaluate the benefit of each specific TAV type.
Giuliano Costa, Paola D'Errigo, Stefano Rosato, Roberto Valvo, Fausto Biancari, Corrado Tamburino, Francesco Cerza, Stefano Domenico Cicala, Fulvia Seccareccia, Marco Barbanti, et al.
Published: 13 April 2021
The publisher has not yet granted permission to display this abstract.
, Erez Kachel, Yigal Kassif, Muin Faqeeh, Preisman Sergey, Leonid Sternik, Liza Grosman-Rimon, Wadi Kinany, Offer Amir, Eylon Ram, et al.
Journal of Cardiothoracic Surgery, Volume 16, pp 1-6; doi:10.1186/s13019-021-01445-7

Abstract:
Background While left ventricular assisted devices (LVAD) have revolutionized the treatment of advanced heart failure, they are associated with a wide range of complications, including bleeding and infection which are the most common complications reported in the literature. Our case series report four unusual complications not related to gastrointestinal bleeding and infections and their management. Case presentation A 61 year old female after LVAD implantation with late onset of severe symptomatic aortic regurgitation treated by transfemoral transcatheter valve implantation (TAVI) with good long term results. A 75 year old male patient with acute pump failure secondary to cable damage, who underwent urgent pump replacement. A 49 year old female patient with a history of myoma who developed massive uterine bleeding which was treated with emergent open hysterectomy after failed gonadotropin-releasing hormone therapy replacement. A 57 year old male patient with device display failure 1 month after LVAD implantation without the ability to monitor speed, power consumption and blood flow. Conclusions LVAD patients can be presented with a great variety of complications. Physicians should be aware of their manifestations and the management options.
Serkan Aslan, Ali Riza Demir, Fatih Uzun, Omer Celik, Ali Kemal Kalkan, Mehmet Erturk
Turk Kardiyoloji Dernegi Arsivi-Archives of the Turkish Society of Cardiology, Volume 49, pp 180-190; doi:10.5543/tkda.2021.32582

Abstract:
The study aimed to evaluate the influence of different degrees of multidetector computed tomography (MDCT)-based perimeter oversizing on incidence and severity of paravalvular aortic regurgitation (PAR) and conduction disturbances (CD) for the Portico device. We retrospectively analyzed 63 patients who underwent transcatheter aortic implantation (TAVI) in our center from March 2017 to June 2019. Patients were divided into two groups (group I, below %13.9; group II, above 13.9%) based on the degree of oversizing. Oversizing was calculated as (Device nominal perimeter / MDCT-derived annular perimeter - 1) * 100. Procedural and clinical data were evaluated by VARC-2 definitions. Mild or greater PAR was present in 76.4% of patients in group I and 34.4% of patients in group II (P = 0.009). The rate of CD tended to be lower in the patient's group I (P = 0.034). A cutoff value of 13.9% was identified as having the best predictive value for mild or greater PAR. On multivariate analysis, a lower percentage of oversizing (odds ratio 6.38; %95 confidence interval 2.00 - 20.33; P = 0.002) emerged as the most powerful independent predictor of PAR, whereas the implantation depth and severe oversizing were independent predictors of CD (P = 0.003 and P = 0.029, respectively). We demonstrated that the optimal acceptable perimeter-based oversizing range appears to be between 10 - 15%. Perimeter-based oversizing by MDCT inversely correlated with PAR after TAVI for Portico device, and its preoperative evaluation could help in predicting PAR and CD.
Lulu Liu, Miao Chen, Bo Chen,
Published: 2 April 2021
Journal of Cardiac Surgery, Volume 36, pp 2565-2568; doi:10.1111/jocs.15549

Abstract:
We report a successful transcatheter aortic valve implantation in an high‐risk elderly patient with pure aortic regurgitation and type III endoleak after thoracic endovascular aortic repair.
, Geza Fontos, Sai Satish, Gergely Szabo, Tunde Pinter, Zsolt Piroth, Marton Vertesaljai, Matyas Pal, Adrienn Mandzak, Zalan Gulyas, et al.
International Journal of Cardiology, Volume 329, pp 153-161; doi:10.1016/j.ijcard.2020.12.058

Abstract:
Background Although post-TAVI PAR is commonly seen, its exact evaluation, grading and the true impact on patients' survival are still debated. This single center study aimed to evaluate the effect of post transcatheter aortic valve implantation (TAVI) paravalvular aortic regurgitation (PAR) on patients' survival. The outcome was evaluated by the three most commonly used techniques just after TAVI in the interventional arena. Methods 201 high risk patients with severe symptomatic aortic stenosis underwent TAVI with the self-expandable system. The severity of post-TAVI PAR was prospectively evaluated by aortography and transesophageal echocardiography (TEE) using a four-class scheme and hemodynamic evaluation by calculation of the regurgitation index (RI). Median follow up time was 763 days. Results Post-TAVI PAR results of the three different modalities were concordant with each other (all p < 0.001). Patients with grade 0-I PAR by aortography had better long term outcomes compared to those who had grade II-III PAR (unadjusted HR 1.77 [95% CI, 1.04–3.01], p = 0.03). Although in multivariate analysis neither aortography nor TEE were shown to be significant predictors of survival, hemodynamic assessment using the exact RI result was a significant predictor of survival and its effect was found to be linear (adjusted HR 0.72 [95% CI, 0.52–0.98] for 10% point increase in RI, p = 0.03595). Conclusions Among the three modalities that are frequently used to evaluate the outcome, post-TAVI RI showed the highest added predictive value for survival.
Sugat Ratna Tuladhar, Shane Mulderrig, Mila Della Barbera, Luca Vedovelli, , Chiara Tessari, Stefan Jockenhoevel, Dario Gregori, Gaetano Thiene, Sotiris Korossis, et al.
Materials Science and Engineering: C, Volume 123; doi:10.1016/j.msec.2021.111936

Abstract:
Glutaraldehyde-treated, surgical bioprosthetic heart valves undergo structural degeneration within 10–15 years of implantation. Analogous preliminary results were disclosed for percutaneous heart valves (PHVs) realized with similarly-treated tissues. To improve long-term performance, decellularised scaffolds can be proposed as alternative fabricating biomaterials. The aim of this study was to evaluate whether bovine and porcine decellularised pericardia could be utilised to manufacture bioengineered percutaneous heart valves (bioPHVs) with adequate hydrodynamic performance and leaflet resistance to crimping damage. BioPHVs were fabricated by mounting acellular pericardia onto commercial stents. Independently from the pericardial species used for valve fabrication, bioPHVs satisfied the minimum hydrodynamic performance criteria set by ISO 5840-3 standards and were able to withstand a large spectrum of cardiac output conditions, also during extreme backpressure, without severe regurgitation, especially in the case of the porcine group. No macroscopic or microscopic leaflet damage was detected following bioPHV crimping. Bovine and porcine decellularized pericardia are both suitable alternatives to glutaraldehyde-treated tissues. Between the two types of pericardial species tested, the porcine tissue scaffold might be preferable to fabricate advanced PHV replacements for long-term performance. Current percutaneous heart valve replacements are formulated with glutaraldehyde-treated animal tissues, prone to structural degeneration. In order to improve long-term performance, bovine and porcine decellularised pericardia were utilised to manufacture bioengineered replacements, which demonstrated adequate hydrodynamic behaviour and resistance to crimping without leaflet architectural alteration.
, Luísa M. Branco, António Fiarresga, Duarte Cacela, Lídia Sousa, Ruben Ramos, Rui C. Ferreira
Revista Portuguesa de Cardiologia, Volume 40, pp 261-269; doi:10.1016/j.repc.2020.07.016

Abstract:
Paravalvular leak (PVL) is a common serious complication associated with prosthetic valve implantation. The aim of this study was to report our single-center experience in a retrospective review and to analyze possible predictors of success. We performed 33 percutaneous PVL closures in 26 patients (54% female, mean age 65±13 years). All mitral prostheses were studied previously with 3D transesophageal echocardiography (TEE), and aortic prostheses with 2D/3D TEE. 3D TEE and fluoroscopy were used for the assessment, planning, and guidance of the interventions. Twelve patients also underwent computed tomography angiography for better characterization of anatomic details. Eighteen patients (69.2%) were admitted due to heart failure (New York Heart Association [NYHA] III or IV, seven (26.9%) because of heart failure and hemolysis, and one (3.8%) due to hemolysis only. Regarding the leaks, 46.2% were in aortic and 53.8% in mitral prostheses, 88.5% in mechanical and 7.7% in biological prostheses, and 3.8% in transcatheter aortic valve implants. All the aortic patients had severe aortic regurgitation. Furthermore, all mitral patients but one had moderate to severe or severe mitral regurgitation. Closure was successful in 17 patients (65.4%), partially successful in four (15.4%) and unsuccessful in five (19.2%). After the procedure, 69% were in NYHA I-II. Hemolysis worsened in three patients despite successful closure; all required further valvular surgery and two died. Regarding angiographic and echocardiographic procedural success, we analyzed age, gender, type of prosthesis (mechanical or biological), location (aortic or mitral), clinical data, maximum leak diameter, anatomic regurgitant orifice, leak location (anterior, posterior, inferior and lateral for mitral leaks and left, right and non-coronary sinus for aortic leaks), and number of devices (plugs) used for closure. No parameters presented a significant relationship with success excepting previous hemolysis. There was a relationship between clinical improvement and reduction of PVL (p=0.0001). In follow-up, cardiac-related events (new hospital admissions, cardiac valvular surgery, need for transfusion) were more frequent in patients with partially successful or unsuccessful closure (p=0.012). There was a relationship between cardiac-related events and death (p=0.029). Percutaneous PVL closure has emerged as an alternative treatment for PVL. Predictors of procedural success are difficult to establish. Survival is related to reduction of regurgitation and improvement in NYHA functional class. Os leaks perivalvulares são uma complicação potencialmente grave após cirurgia protésica, com uma taxa de mortalidade ainda importante, sobretudo em doentes submetidos a reoperações sucessivas. Avaliar retrospetivamente a nossa experiência e resultados e encontrar possíveis fatores preditores de sucesso. Revimos 33 procedimentos consecutivos de encerramento de leak perivalvular efetuados em 26 doentes (dts) (54% dos dts eram de sexo feminino, idade média 65 ± 13 anos). Todos os casos de leaks em posição mitral foram previamente estudados com ecocardiograma transesofágico 3 D (ETE), os leaks em posição aórtica foram avaliados por ETE 2D e nalguns casos 3D. Utilizaram-se a ecocardiografia transesofágica (2D/3D) e a fluoroscopia para a avaliação, planeamento, orientação e libertação dos dispositivos de encerramento; 12 dts efetuaram previamente angioTAC para melhor caracterização e definição anatómica do leak. Clinicamente 18 dts tinham queixas de insuficiência cardíaca (New York Heart Association [NYHA] III/IV (69,2%), 7 dts tinham insuficiência cardíaca e hemólise (26,9%) e um doente apenas emólise (3,8%); 46,2% dos leaks eram aórticos e 53,8% mitrais, a maioria, 88,5%, em próteses mecânicas, 7,7% em próteses biológicas e 3,8% (um dt) em prótese percutânea aórtica (VAP). Todos os dts de leak aórtico tinham insuficiência cardíaca por regurgitação grave, os dts com leak mitral tinham insuficiência cardíaca, alguns, hemólise e um tinha apenas hemólise. O grau de regurgitação mitral era moderado a grave ou grave, com excepção do doente só com hemólise. O encerramento foi considerado de sucesso em 17 dts (65,4%), sucesso parcial em 4 (15,4%) e insucesso em 5 (19,2%). Após o procedimento, 69% melhoraram, com melhoria das queixas de ICC (NYHA I-II), 3 dts tiveram um agravamento da hemólise apesar do encerramento ser considerado de sucesso, tendo necessitado de cirurgia, complicada em dois casos (morte). Na tentativa de encontrar fatores preditores de sucesso de encerramento do leak, analisámos dados clínicos (idade, sexo, tipo e localização da prótese, manifestações clinicas), dados ecocardiográficos (diâmetro máximo do leak, área do orifício anatómico, localização do leak, classificando-o em anterior, posterior, inferior e lateral para as próteses mitrais e para as próteses aórticas de acordo com o seio coronário adjacente em esquerdo, direito e não coronário) e ainda o número de dispositivos de encerramento utilizados (plugs). Nenhum dos parâmetros avaliados teve correlação com o sucesso do encerramento, com excepção para a hemólise. Verificou-se relação entre melhoria clínica e redução do leak (p = 0,0001). Os dts com sucesso parcial/insucesso tiveram mais eventos cardíacos (p = 0,012), a ocorrência...
F Noriega, A Viana-Tejedor, T Luque, A Travieso, D Corrochano, A Mcinerney, C Ferrera, G Tirado-Conte, P Jimenez-Quevedo, I Nunez-Gil, et al.
European Heart Journal: Acute Cardiovascular Care, Volume 10; doi:10.1093/ehjacc/zuab020.157

Abstract:
Funding Acknowledgements Type of funding sources: None. Background. Delirium is frequent in patients admitted to critical care units. Its incidence after transcatheter aortic valve implantation (TAVI) is up to 30%. Clinical and demographic factors have been related to delirium, but echocardiographic parameters have not been evaluated. Purpose. The aim of this study was to assess clinical and echocardiographic predictors of delirium in patients admitted to an acute cardiac care unit (ACCU) after transfemoral TAVI. Methods. 501 patients admitted to ACCU after TAVI were included. Delirium was evaluated by Confusion Assessment Method. Clinical cardiovascular and geriatric conditions were assessed, as well as echocardiographic parameters. Results. The incidence of delirium was 22% (110 patients). Delirium was associated with age (83.8 ± 4.6 vs 82.6 ± 6.1 years, p = 0.026), dyslipidaemia (50.0% vs 61.4%, p = 0.032), prior peripheral arterial disease (11.9% vs 5.4%, p = 0.017) and cognitive impairment (10.0% vs 1.8%, p < 0.001). There was no relationship to gender, other cardiovascular risk factors or geriatric conditions. Table shows echocardiographic parameters at baseline and after TAVI, with no statistical association with delirium. Conclusion. Delirium is a common complication after TAVI in ACCU. Age, the absence of dyslipidaemia, or the presence of cognitive impairment or prior peripheral arterial disease are clinical predictors of delirium. There are not echocardiographic predictors of delirium. Echocardiographic parametersWithout delirium(n = 391)With delirium(n = 110)p valueBaseline echocardiographic parametersLeft ventricular ejection fraction (%)57.7 ± 13.457.5 ± 14.10.912Mitral regurgitation (moderate to severe)106 (27.1)34 (30.9)0.433Pulmonary hypertension168 (43.0)53 (49.1)0.258Aortic regurgitation (moderate to severe)74 (18.9)21 (19.1)0.969Peak aortic gradient (mmHg)78.7 ± 25.278.5 ± 23.30.935Mean aortic gradient (mmHg)47.1 ± 16.146.7 ± 14.80.838Aortic valvular area (cm2)0.6 ± 0.20.6 ± 0.20.589Aortic annulus diameter (mm)22.5 ± 2.722.4 ± 2.50.615After TAVI echocardiographic parametersAortic regurgitation (moderate to severe)36 (9.3)11 (10.0)0.813Peak aortic gradient (mmHg)17.6 ± 9.617.7 ± 8.30.916Mean aortic gradient (mmHg)8.9 ± 5.49.3 ± 4.90.481Aortic valvular area (cm2)2.0 ± 0.62.2 ± 0.60.478Values are mean ± standard deviation, or n (%).
, Yehia Saleh, Lawrenshey Charles, Rohan Prasad, Zulfiqar Qutrio Baloch, Mohanad A. Hasan, George S. Abela
Cardiovascular Revascularization Medicine, Volume 25, pp 57-62; doi:10.1016/j.carrev.2020.10.002

Abstract:
Transcatheter aortic valve replacement (TAVR) is now indicated in patients with symptomatic aortic stenosis and low, moderate, and high surgical risk. There are multiple types of valves available in TAVR. SAPIEN 3, and Evolut R are two of the most commonly used valves. We conducted a systematic review and meta-analysis of all studies that compared SAPIEN 3 vs Evolut R in patients undergoing TAVR. The primary endpoint of this meta-analysis was 30-day mortality. Secondary outcomes included major of life-threatening bleeding, risk of stroke, need of permanent pacemaker implantation, and risk of moderate to severe paravalvular regurgitation (PVR). We included a total of 9 studies. One study was a randomized clinical trial, five were prospective observational studies and three were retrospective. 30-day mortality rate was similar between SAPIEN 3 and Evolut R (odds ratio (OR) 1.19; 95% confidence interval (CI) 0.72 to 1.93; p=0.47). The risk of major or life-threatening bleeding (OR of 0.83, 95% CI 0.50 to 1.39; p=0.48), and the risk of stroke (OR of 0.82, 95% CI 0.38 to 1.78; p=0.62) were also similar between the two types of valves. Compared to SAPIEN 3, Evolut R was associated with statistically significant risk of permanent pacemaker implantation (OR of 1.40, 95% CI 1.15 to 1.70; p=0.0007), and moderate to severe PVR (OR of 2.56, 95% CI 1.14 to 5.74; p=0.02). At 30 day follow up, both Evolut R and SAPIEN 3 shared similar risks of 30-day mortality, major or life-threatening bleeding, and stroke; however greater odds of pacemaker placement implantation and moderate to severe PVR were associated with Evolut R.
, Omar A. Oliva, Mattia Squillace, Michele Bellamoli, Enrico Poletti, Antonio Popolo Rubbio, Luca Testa, Francesco Bedogni, Federico De Marco
Published: 1 April 2021
JACC: Case Reports, Volume 3, pp 678-681; doi:10.1016/j.jaccas.2021.02.022

Abstract:
Redo transcatheter aortic valve replacement (TAVR) may pose the risk of coronary flow obstruction. We report 2 cases of severe TAVR regurgitation due to different physiopathological mechanisms in which TAVR-in-TAVR could be at high risk for sinus sequestration. Both cases were successfully treated by in-series implantation of a second transcatheter heart valve, thus avoiding sinus sequestration. (Level of Difficulty: Intermediate.)
, Luísa M. Branco, António Fiarresga, Duarte Cacela, Lídia Sousa, Ruben Ramos, Rui C. Ferreira
Revista Portuguesa de Cardiologia (English Edition), Volume 40, pp 261-269; doi:10.1016/j.repce.2020.07.012

Abstract:
Paravalvular leak (PVL) is a common serious complication associated with prosthetic valve implantation. The aim of this study was to report our single-center experience in a retrospective review and to analyze possible predictors of success. We performed 33 percutaneous PVL closures in 26 patients (54% female, mean age 65±13 years). All mitral prostheses were studied previously with 3D transesophageal echocardiography (TEE), and aortic prostheses with 2D/3D TEE. 3D TEE and fluoroscopy were used for the assessment, planning, and guidance of the interventions. Twelve patients also underwent computed tomography angiography for better characterization of anatomic details. Eighteen patients (69.2%) were admitted due to heart failure (New York Heart Association [NYHA] III or IV, seven (26.9%) because of heart failure and hemolysis, and one (3.8%) due to hemolysis only. Regarding the leaks, 46.2% were in aortic and 53.8% in mitral prostheses, 88.5% in mechanical and 7.7% in biological prostheses, and 3.8% in transcatheter aortic valve implants. All the aortic patients had severe aortic regurgitation. Furthermore, all mitral patients but one had moderate to severe or severe mitral regurgitation. Closure was successful in 17 patients (65.4%), partially successful in four (15.4%) and unsuccessful in five (19.2%). After the procedure, 69% were in NYHA I-II. Hemolysis worsened in three patients despite successful closure; all required further valvular surgery and two died. Regarding angiographic and echocardiographic procedural success, we analyzed age, gender, type of prosthesis (mechanical or biological), location (aortic or mitral), clinical data, maximum leak diameter, anatomic regurgitant orifice, leak location (anterior, posterior, inferior and lateral for mitral leaks and left, right and non-coronary sinus for aortic leaks), and number of devices (plugs) used for closure. No parameters presented a significant relationship with success excepting previous hemolysis. There was a relationship between clinical improvement and reduction of PVL (p=0.0001). In follow-up, cardiac-related events (new hospital admissions, cardiac valvular surgery, need for transfusion) were more frequent in patients with partially successful or unsuccessful closure (p=0.012). There was a relationship between cardiac-related events and death (p=0.029). Percutaneous PVL closure has emerged as an alternative treatment for PVL. Predictors of procedural success are difficult to establish. Survival is related to reduction of regurgitation and improvement in NYHA functional class. Os leaks perivalvulares são uma complicação potencialmente grave após cirurgia protésica, com uma taxa de mortalidade ainda importante, sobretudo em doentes submetidos a reoperações sucessivas. Avaliar retrospetivamente a nossa experiência e resultados e encontrar possíveis fatores preditores de sucesso. Revimos 33 procedimentos consecutivos de encerramento de leak perivalvular efetuados em 26 doentes (dts) (54% dos dts eram de sexo feminino, idade média 65 ± 13 anos). Todos os casos de leaks em posição mitral foram previamente estudados com ecocardiograma transesofágico 3 D (ETE), os leaks em posição aórtica foram avaliados por ETE 2D e nalguns casos 3D. Utilizaram-se a ecocardiografia transesofágica (2D/3D) e a fluoroscopia para a avaliação, planeamento, orientação e libertação dos dispositivos de encerramento; 12 dts efetuaram previamente angioTAC para melhor caracterização e definição anatómica do leak. Clinicamente 18 dts tinham queixas de insuficiência cardíaca (New York Heart Association [NYHA] III/IV (69,2%), 7 dts tinham insuficiência cardíaca e hemólise (26,9%) e um doente apenas emólise (3,8%); 46,2% dos leaks eram aórticos e 53,8% mitrais, a maioria, 88,5%, em próteses mecânicas, 7,7% em próteses biológicas e 3,8% (um dt) em prótese percutânea aórtica (VAP). Todos os dts de leak aórtico tinham insuficiência cardíaca por regurgitação grave, os dts com leak mitral tinham insuficiência cardíaca, alguns, hemólise e um tinha apenas hemólise. O grau de regurgitação mitral era moderado a grave ou grave, com excepção do doente só com hemólise. O encerramento foi considerado de sucesso em 17 dts (65,4%), sucesso parcial em 4 (15,4%) e insucesso em 5 (19,2%). Após o procedimento, 69% melhoraram, com melhoria das queixas de ICC (NYHA I-II), 3 dts tiveram um agravamento da hemólise apesar do encerramento ser considerado de sucesso, tendo necessitado de cirurgia, complicada em dois casos (morte). Na tentativa de encontrar fatores preditores de sucesso de encerramento do leak, analisámos dados clínicos (idade, sexo, tipo e localização da prótese, manifestações clinicas), dados ecocardiográficos (diâmetro máximo do leak, área do orifício anatómico, localização do leak, classificando-o em anterior, posterior, inferior e lateral para as próteses mitrais e para as próteses aórticas de acordo com o seio coronário adjacente em esquerdo, direito e não coronário) e ainda o número de dispositivos de encerramento utilizados (plugs). Nenhum dos parâmetros avaliados teve correlação com o sucesso do encerramento, com excepção para a hemólise. Verificou-se relação entre melhoria clínica e redução do leak (p = 0,0001). Os dts com sucesso parcial/insucesso tiveram mais eventos cardíacos (p = 0,012), a ocorrência...
European Heart Journal - Case Reports, Volume 5; doi:10.1093/ehjcr/ytab112

Abstract:
Background Pulmonary hypertension (PH) is most commonly caused by left-sided heart disease and may negatively affect the long-term prognosis and quality of life of patients with chronic heart failure (CHF). CardioMEMS (Micro-Electro-Mechanical-System) allows physicians to monitor pulmonary artery (PA) pressures remotely and optimize heart failure treatment based on haemodynamic parameters, which provides further insight into the effect of valvular interventions. Case summary We present a case of a 61-year-old male patient with an ischaemic cardiomyopathy, poor LV function, moderate to severe mitral regurgitation, and severe aortic valve regurgitation in refractory heart failure. Right heart catheterization and CardioMEMS monitoring revealed severe pulmonary hypertension with mean PA pressures of 55 mmHg and a mean pulmonary capillary wedge pressure of 21 mmHg despite up titration of heart failure medication and sildenafil. Pulmonary and systemic causes of pulmonary hypertension were excluded. After heart team consensus, the patient underwent transcatheter aortic valve implantation (TAVI) which resulted in normalization of PA pressures and a significant improvement of functional performance. Discussion To the best of our knowledge, this is the first case report describing the direct effects of TAVI on continuous PA pressures in a patient with poor LV function and severe aortic regurgitation. Elective TAVI appeared to be safe and very effective in reverting severe pulmonary hypertension. Most strikingly, drug interventions could not affect the elevated pulmonary pressures, but TAVI corrected the aortic valve insufficiency with normalization of left-sided pulmonary hypertension.
Paul Tl Chiam, Choon Pin Lim, Yean Teng Lim, Cumaraswamy Sivathasan
Annals of the Academy of Medicine, Singapore, Volume 50, pp 274-276; doi:10.47102/annals-acadmedsg.2020442

, Cesar Veiga, Generosa Fdez-Manin, Victor Alfonso Jimenez, Pablo Juan-Salvadores, Laura Busto, Jose Antonio Baz, Andrés Iñiguez
Computer Methods in Biomechanics and Biomedical Engineering pp 1-9; doi:10.1080/10255842.2021.1906233

Abstract:
Trans-catheter aortic valve implantation (TAVI) is an increasingly adopted technique which provides a minimal invasive solution for patients who suffer from severe aortic stenosis. Some complications of the procedure could be annular rupture or paravalvular leakage, both related with adverse outcome. In TAVI with balloon expandable devices, a mismatch between those two factors leads to a conflict situation, where improving one worsens the other. The presented research proposes a methodology that uses numerical simulation to obtain certain TAVI outcomes related with aortic regurgitation due to paravalvular leakage, such as perivalvular area, aortic eccentricity or annular pressure. The application of the methodology for two patients shows the possibility of predicting those quantities. The highest stress values are distributed along the contact area. Results also show that a great deformation on the aortic annulus does not necessarily imply a higher stress; pressure can either be converted into root reshape or into root stretching. Validation of the results was done using scientific publications, clinical guidelines and clinical reports. Numerical simulation provides a suitable tool that could possibly contribute to optimize the planification procedure adjusting the mismatch between size and pressure.
Q Sun, B Wang, C J Zhu, F J Mou, Z Y Yin, P P Wang, X N Chen, R J Chen, Y Liu, F Li, et al.
Published: 24 March 2021
The publisher has not yet granted permission to display this abstract.
Jacopo Andrea Oreglia, Federico De Marco, Francesco Soriano, Stefano Nava
Aortic Valve Transcatheter Intervention pp 179-188; doi:10.1002/9781119720621.ch19

Abstract:
Mechanical circulatory support (MCS) may be used in selected cases of transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS). In clinical practice, MCS may be used preemptively in patients presenting with exceedingly high periprocedural risk, or emergently for patients with procedural complications of TAVI. Although TAVI results have significantly improved in terms of safety and efficacy, periprocedural life‐threatening complications such as severe aortic regurgitation, acute coronary occlusion, annular or ventricular perforation or aortic dissection still occur, may lead to sudden circulatory failure requiring emergency hemodynamic support and are associated with increased mortality. This chapter presents the hemodynamic effects, contraindications, and technical considerations of intra‐aortic balloon pump, Impella, extracorporeal membrane oxygenation, and TandemHeart. Prophylactic use of MCS may be useful in patients who present with exceedingly high perioperative risk.
Published: 19 March 2021
Global Heart, Volume 16; doi:10.5334/gh.959

Abstract:
The aim of the present analysis is to compare the quantitative angiographic aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) among three balloon-expandable valves. Quantitative videodensitometric aortography is an objective, accurate, and reproducible tool for adjudication of AR following TAVI. This is a retrospective corelab analysis, independent from industry, of aortograms from patients treated with TAVI using the balloon-expandable Myval transcatheter heart valve (THV) (Meril Life Sciences Pvt. Ltd., India), Sapien 3, and XT THVs (Edwards Lifesciences, Irvine, CA, USA). The study comprised of 108 analyzable aortograms from consecutive patients in a multicenter European registry who underwent Myval THV implantation. The results of quantitative assessment of AR in the Sapien 3 THV (n = 397) and Sapien XT THV (n = 239) were retrieved from a published pooled database. The Myval THV had the lowest proportion of patients with moderate or severe angiographic quantitative AR (2.8%) compared to the Sapien 3 THV (8.3%; p = 0.049) and Sapien XT THV (10.9%; p = 0.012). Furthermore, the Myval THV had the lowest mean angiographic quantitative AR (6.3 ± 6.3%), followed by Sapien 3 THV (7.6 ± 7.1%) and Sapien XT THV (8.8 ± 7.5%), and it was significantly lower than that of the Sapien XT THV (p = 0.006), but not significantly different from Sapien 3 THV (p = 0.246). The Myval THV, in comparison with other BEV’s analyzed in our database, showed a lower occurrence of moderate or severe AR after TAVI. These results should be confirmed in prospective cohorts of randomized patients with head-to-head THV comparisons.
Felice Gragnano, Carmen Spaccarotella, Andreina Carbone, Augusto Esposito, Paolo Calabrò, Giampaolo Niccoli
Aortic Valve Transcatheter Intervention pp 147-159; doi:10.1002/9781119720621.ch16

Abstract:
Significant mitral regurgitation (MR) is commonly observed in patients with severe aortic stenosis (AS) in a complex multivalvular disease scenario. Recent data suggest a coexistence of the two conditions in nearly 25–30% of patients undergoing transcatheter aortic valve implantation (TAVI), a proportion which is likely to increase in the next future. Observational studies and a post‐hoc analysis of large trials showed that significant MR could exert a negative impact on short‐ and long‐term clinical outcomes after TAVI. The first step in the assessment MR in patients with AS is the identification of the MR etiology, distinguishing a primary and secondary MR with the transthoracic and/or transesophageal echocardiography. TAVI patients with severe residual MR, who remain symptomatic despite optimal medical therapy, are those who need a more intense treatment with a multivalvular intervention, with TAVI and Mitraclip devices.
Masaki Miyasaka, Norio Tada, Masataka Taguri, Shigeaki Kato, , Masaki Hata, , Toru Naganuma, Masahiro Yamawaki, Futoshi Yamanaka, et al.
Published: 18 March 2021
by BMJ
Open Heart, Volume 8; doi:10.1136/openhrt-2020-001531

Abstract:
Background The balloon-expandable SAPIEN 3 (S3) is superior to the older-generation balloon-expandable SAPIEN XT (XT) in a lower incidence of paravalvular aortic regurgitation, lower complication rates and better survival in transcatheter aortic valve implantation (TAVI). However, prosthesis–patient mismatch (PPM) more frequently occurs in S3 than XT. Further, little information is available on PPM after TAVI using S3 in Asians. This study aims to determine the incidence and predictors of PPM in S3 by focusing on the difference between S3 and XT using data from a Japanese multicentre registry. Methods From the Optimised transCathEter vAlvular iNtervention-TAVI (OCEAN-TAVI) registry, 2134 patients undergoing TAVI using S3 or XT were included. PPM was defined as moderate if ≧0.65 but ≦0.85 cm2/m2 or severe if 2/m2 at the indexed effective orifice area by postprocedural echocardiography. Results The incidence of moderate and severe PPM in S3 was 13.3% and 1.3%, respectively. The 20 mm transcatheter heart valve (THV) was more frequently used in S3 than XT (7.4% vs 2.4%, p Conclusions The incidence of PPM after TAVI using S3 was 14.6% overall in this Asian population. PPM was more frequently observed in S3 than XT. A considerable number of patients were treated by the 20 mm S3 in an Asian cohort. The 20 mm THV was identified as a strong predictor for PPM.
, Michaela M. Hell, Martin Geyer, Felix Kreidel, Jaqueline G. Da Rocha E Silva, Meike Seidl, Tobias F. Ruf, Angela Kornberger, Andres Beiras-Fernandez, Thomas Münzel, et al.
Frontiers in Cardiovascular Medicine, Volume 8; doi:10.3389/fcvm.2021.623146

Abstract:
Objectives: We investigated performance and outcome of the latest-generation balloon-expandable SAPIEN 3 Ultra prosthesis (S3U) compared to the established SAPIEN 3 prosthesis (S3) in a real-world cohort, with focus on paravalvular regurgitation (PVR). Background: PVR is an adverse prognostic indicator of short- and long-term survival after transcatheter aortic valve replacement (TAVR). The S3U has been designed to improve sealing. Methods: We enrolled 343 consecutive patients presenting with severe native aortic valve stenosis eligible for a balloon-expandable prosthesis. The established S3 was implanted in the first 200 patients, the following 143 patients received the novel S3U after introduction in our institution. Primary endpoint was PVR after TAVR. Furthermore, we investigated procedural parameters and in-hospital and 30-day outcome. Results: PVR was significantly lower in the S3U cohort compared to the S3 cohort. They differed in their rate of mild PVR (11.2 vs. 48.0%, p < 0.001), whereas at least moderate PVR was similarly low in both cohorts (0.7 vs. 0.5%, p = 0.811). A significant reduction of post-dilatation rate, fluoroscopy time, and amount of contrast was observed in patients treated with the novel S3U (p < 0.001). The rate of adverse events in the in-hospital course and at 30 days were similarly low. At 30 days more patients receiving S3U improved in NYHA class (improvement ≥2 grades 34.6 vs. 19.9%, p = 0.003). Conclusion: The current study provides evidence that the novel S3U strongly minimizes PVR, thereby demonstrating the efficacy of improved sealing. Further studies will have to address if the observed reduction of PVR with S3U has prognostic significance.
Basile Marie, Charles Henri David, Guillaume Guimbretière, Yohann Foucher, Antoine Buschiazzo, Vincent Letocart, Thibaut Manigold, Julien Plessis, Philippe Jaafar, Hélène Morin, et al.
European Journal of Cardio-Thoracic Surgery; doi:10.1093/ejcts/ezab109

Abstract:
OBJECTIVES The carotid approach for transcatheter aortic valve replacement (TAVR) has been shown to be feasible and safe. The goal of this study was to compare the 30-day outcomes of trans-carotid (TC) and transfemoral (TF) TAVR. METHODS This retrospective study enrolled 500 consecutive patients treated by TC-TAVR (n = 100) or TF-TAVR (n = 400) with percutaneous closure between January 2018 and January 2020 at the Nantes University Hospital. The primary end-point was the occurrence of cardiovascular death and cerebrovascular events at 30 days. RESULTS The mean age was 79.9 ± 8.1 in the TC group and 81.3 ± 6.9 (P = 0.069) in the TF group. The TC group had more men (69% vs 50.5%; P = 0.001) and more patients with peripheral vascular disease (86% vs 14.8%; P < 0.0001). Cardiac characteristics were similar between the groups, and the EuroSCORE II was 3.8 ± 2.6% vs 4.6 ± 6.0%, respectively (P = 0.443). The 30-day mortality was 2% in the TC group versus 1% in the TF group (P = 0.345). TC-TAVR was not associated with an increased risk of stroke (2% vs 2.5%; P = 0.999) or major vascular complications (2% vs 4%; P = 0.548). More permanent pacemakers were implanted in the TF group (14.9% vs 5.6%; P = 0.015), and no moderate or severe aortic regurgitation was observed in the TC group (0 vs 3.3%; P = 0.08). TC-TAVR was not associated with an increased risk of mortality or stroke at 30 days (odds ratio 1.32; 95% confidence interval 0.42–4.21; P = 0.63) in the multivariable analysis. CONCLUSIONS No statistically significant differences between TC-TAVR and TF-TAVR were observed; therefore, TC-TAVR should be the first alternative in patients with anatomical contraindications to the femoral route.
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