Hypoattenuated Leaflet Thickening After Implantation of the ACURATE neo or the ACURATE neo2 Transcatheter Heart Valve.

Subclinical leaflet thrombosis, identified as hypoattenuated leaflet thickening (HALT) on cardiac computed tomography scan, has been observed after transcatheter aortic valve replacement (TAVR). However, data on HALT after the implant of the supra-annular ACURATE neo/neo2 prosthesis are limited. This study aimed to determine the prevalence and risk factors for the development of HALT after TAVR with the ACURATE neo/neo2. A total of 50 patients who received the ACURATE neo/neo2 prosthesis were prospectively enrolled. Patients underwent a contrast-enhanced multidetector row cardiac computed tomography scan at before, after, and 6 months after TAVR. At the 6-month follow-up, HALT was detected in 16% (8 of 50 patients). These patients had a lower implant depth of the transcatheter heart valve (8 ± 2 mm vs 5 ± 2 mm, p = 0.001), less calcified native valve leaflets, a better expansion of the frame at the level of the left ventricular outflow tract, and were less often hypertensive. Thrombosis of the sinus of Valsalva occurred in 18% (9/50). There was no difference in the anticoagulation regimen between patients with and without thrombotic findings. In conclusion, HALT was present in 16% of patients at 6 months follow-up, patients presenting with HALT had a lower implant depth of the transcatheter heart valve, and HALT was detected in patients on oral anticoagulation therapy.

Continued non-vitamin K antagonist oral anticoagulants versus vitamin K antagonists during transcatheter aortic valve implantation.

BACKGROUND: One-third of patients undergoing transcatheter aortic valve implantation (TAVI) have an indication for long-term oral anticoagulation (OAC). AIMS: We aimed to investigate whether continued non-vitamin K antagonist oral anticoagulant (NOAC) therapy compared with continued vitamin K antagonist (VKA) therapy during TAVI is equally safe and effective.  Methods: Consecutive patients on OAC with either NOAC or VKA undergoing transfemoral TAVI at five European centres were enrolled. The primary outcome measure was a composite of major/life-threatening bleeding, stroke, and all-cause mortality at 30 days. RESULTS: In total, 584 patients underwent TAVI under continued OAC with 294 (50.3%) patients receiving VKA and 290 (49.7%) patients receiving NOAC. At 30 days, the composite primary outcome had occurred in 51 (17.3%) versus 36 (12.4%) patients with continued VKA and with continued NOAC, respectively (odds ratio [OR] 0.68, 95% confidence interval [CI]: 0.43-1.07; p=0.092). Rates of major/life-threatening bleeding (OR 0.87, 95% CI: 0.52-1.47; p=0.606) and stroke (OR 1.02, 95% CI: 0.29-3.59; p=0.974) were not different between groups. In a multivariate Cox regression analysis, continued NOAC, compared with continued VKA, was associated with a lower risk for all-cause 1-year mortality (hazard ratio [HR] 0.61, 95% CI: 0.37-0.98; p=0.043). The analysis of the propensity score-matched cohort revealed similar results. CONCLUSIONS: Continued NOAC compared with continued VKA during TAVI led to comparable outcomes with regard to the composite outcome measure indicating that continued OAC with both drugs is feasible. These hypothesis-generating results need to be confirmed by a dedicated randomised controlled trial.

[The "Mickey Mouse Heart"]. / Das «Mickey-Mouse-Herz¼.

The "Mickey Mouse Heart" Abstract. The "Mickey Mouse Heart" describes patients with a combination of HFpEF, massive biatrial dilatation and dilatation of the mitral- and tricuspid annulus, atrial fibrillation and severe mitral- and tricuspid regurgitation. Most frequently elderly patients with HFpEF are affected by this syndrome. The underlying molecular mechanisms or risk factors for the typical biatrial dilatation are unknown. The guideline-directed heart failure therapy as well as the evaluation of early rhythm control for atrial fibrillation and the treatment of mitral- and tricuspid regurgitation are recommended.

Aortic valve repair: An exciting journey / Reparación valvular aórtica: una experiencia emocionante

Abstract Aortic valve repair has become an attractive alternative to aortic valve replacement in most of the patients with aortic insufficiency. To improve reproducibility and durability "geometric anatomy" of the valve has been developed to guide the repair. Expert centers were able to publish remarkable short- and long-term results for aortic valve sparing procedures. Therefore, data comparing composite valve grafting and aortic valve sparing procedures revealed similar early mortality. Also, late mortality, thromboembolism, stroke and bleeding risks were significantly lower in patients undergoing aortic valve repair and late durability was equivalent1. However, the complexity of the procedures makes aortic valve repair difficult to be adopted into daily surgical practice. Accordingly, starting your own aortic valve repair program requires conviction, training, facilities, quality control and a well structured heart valve team to let your program succeed.

Resumen La reparación valvular aórtica se ha convertido en una alternativa atractiva al reemplazo, en la mayoría de pacientes con insuficiencia aórtica. Para mejorar la reproducibilidad y la durabilidad, se ha desarrollado una "anatomía geométrica" de la válvula para guiar la reparación. Los centros expertos han publicado resultados notables a corto y largo plazo en preservación valvular aórtica. Además, los estudios que compararon el cambio valvular por tubo valvulado con los procedimientos de preservación valvular, mostraron una mortalidad temprana similar, con riesgos de mortalidad tardía, como tromboembolia pulmonar, accidente cerebrovascular y hemorragia, significativamente menores en los pacientes sometidos a reparación valvular aórtica, con una durabilidad tardía equivalente1. Sin embargo, la complejidad de los procedimientos dificulta la adopción de la reparación valvular aórtica en la práctica diaria. En consecuencia, comenzar un programa de reparación valvular aórtica requiere convicción, capacitación, instalaciones, control de calidad y un equipo bien estructurado para que sea exitoso.

Five-Year Outcomes With Biodegradable-Polymer Sirolimus-Eluting Stents Versus Durable-Polymer Everolimus-Eluting Stents in Patients With Acute Coronary Syndrome: A Subgroup Analysis of the BIOSCIENCE Trial.

BACKGROUND: Thin-strut biodegradable polymer sirolimus-eluting stents (BP-SES) have been shown to reduce target lesion failure (TLF) at one-year follow-up compared with durable polymer everolimus-eluting stents (DP-EES) among patients with acute coronary syndrome (ACS). The long-term clinical benefits of thin-strut BP-SES over DP-EES in ACS patients after complete degradation of the polymer coating remain uncertain. METHODS: We performed a post-hoc subgroup analysis of ACS patients included into the BIOSCIENCE randomized trial (NCT01443104). The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target-vessel myocardial infarction or clinically indicated target lesion revascularization, at 5 years. RESULTS: Among 2119 patients enrolled between March 2012 and May 2013, 1131 (53%) presented with ACS. The 5-year cumulative incidence of TLF was significantly lower in patients with ACS compared to chronic coronary syndrome [16.5% vs. 22.9%; rate ratio (RR), 0.69; 95% confidence interval (CI), 0.57-0.85; p < 0.001]. At 5 years, TLF occurred similarly in ACS patients treated with BP-SES and DP-EES (16.9% vs. 16.0%; RR, 1.04; 95% CI, 0.78-1.41; p = 0.78). The individual components of the primary endpoint did not differ between ACS patients treated with BP-SES or DP-EES at 5 years. Overall, there was no interaction between clinical presentation and treatment effect. CONCLUSIONS: In a subgroup analysis of the BIOSCIENCE trial, we found no difference in long-term outcomes between ACS patients treated with BP-SES or DP-EES at 5 years.

Case Report: Sapien 3 Transcatheter Heart Valve Embolization: Cause, Management, and Redo.

The transcatheter heart valve (THV) embolization is a rare but challenging complication in transcatheter aortic valve implantation (TAVI). We report the case of an 81-year-old man with Sapien 3 embolization caused by interrupted rapid pacing. In this setting, we describe the embolized THV management and the technique of the second Sapien 3 implantation.

Safety and Efficacy of Transcatheter Aortic Valve Replacement With Continuation of Vitamin K Antagonists or Direct Oral Anticoagulants.

OBJECTIVES: This study investigated whether transcatheter aortic valve replacement (TAVR) with peri-procedural continuation of oral anticoagulation is equally safe and efficacious as TAVR with peri-procedural interruption of anticoagulation. BACKGROUND: A significant proportion of patients undergoing TAVR have an indication for long-term oral anticoagulation. The optimal peri-procedural management of such patients is unknown. METHODS: Consecutive patients on oral anticoagulation who underwent transfemoral TAVR at 5 European centers were enrolled. Oral anticoagulation was either stopped 2 to 4 days before TAVR or continued throughout the procedure. Primary safety outcome was major bleeding. Secondary efficacy endpoints included vascular complications, stroke, and mortality. RESULTS: Of 4,459 patients, 584 patients were treated with continuation of anticoagulation and 733 with interruption of anticoagulation. At 30 days, major or life-threatening bleedings occurred in 66 (11.3%) versus 105 (14.3%; odds ratio [OR]: 0.86; 95% confidence interval [CI]: 0.61 to 1.21; p = 0.39) and major vascular complications in 64 (11.0%) versus 90 (12.3%; OR: 0.89; CI: 0.62 to 1.27; p = 0.52) of patients with continuation and with interruption of anticoagulation, respectively. Transfusion of packed red blood cells was less often required in patients with continuation of anticoagulation (80 [13.7%] vs. 130 [17.7%]; OR: 0.59; 95% CI: 0.42 to 0.81; p = 0.001). Kaplan-Meier estimates of survival at 12 months were 85.3% in patients with continuation of anticoagulation and 84.0% in patients with interruption of anticoagulation (hazard ratio: 0.90; 95% CI: 0.73 to 1.12; p = 0.36). CONCLUSIONS: Continuation of oral anticoagulation throughout TAVR did not increase bleeding or vascular complication rates. Moreover, packed red blood cell transfusions were less often required in patients with continuation of oral anticoagulation.

Predictors of paravalvular leak following implantation of the ACURATE neo transcatheter heart valve: the PREDICT PVL study.

OBJECTIVES: Report predictors and the natural course of paravalvular leak (PVL) following implantation of the ACURATE neo transcatheter heart valve (THV). BACKGROUND: Understanding the mechanisms of PVL may help to improve patient selection, patient outcomes and the design of next-generation THVs. METHODS: A total of 30 patients (mean age 81±5 years, 47% women) undergoing transcatheter aortic valve replacement with the ACURATE neo were enrolled in the PREDICT PVL study. The effective regurgitant orifice area (EROA, in mm2) of PVL was assessed by transthoracic and transoesophageal echocardiography before discharge and at 6 months follow-up. RESULTS: PVL was none/trace in 10 (33%), mild in 18 (60%) and moderate in 2 (7%) patients and occurred in distinct locations with largest EROAs in the area of the left coronary cusp and its adjacent commissures. Independent predictors for EROA were implantation depth (r coefficient -1.9 mm2 per mm implantation depth, p=0.01), leaflet calcification (6.2 mm2 per calcification grade, p=0.03) and THV size L (7.6 mm2 more than size S or M, p=0.01). At 6 months follow-up, EROA decreased by 29% from 13.7±9.7 mm2 to 9.5±7.9 mm2 (p<0.01). Patients with smaller EROAs were more likely to be in New York Heart Association class 1 than patients with larger EROAs (p<0.01). CONCLUSIONS: PVL occurred predominantly in the region of the left coronary cusp and decreased by 29% during 6 months of follow-up. Our results underscore the importance of adequate patient selection and optimal implantation depth.

Increasing Mortality From Premature Coronary Artery Disease in Women in the Rural United States.

Background Previous reports have described a leveling off of mortality from premature coronary artery disease (CAD). In recent years, the prevalence of cardiovascular risk factors has increased in rural communities and young adults. Methods and Results We extracted CAD mortality rates from the Centers for Disease Control and Prevention Wide-Ranging Online Data for Epidemiologic Research (CDC WONDER) database from 1999 to 2017, focusing on mortality from premature CAD (defined as <65 years of age in women) and urban-rural differences. Variations in mortality rates over time, assessed with Joinpoint regression modeling, are expressed as estimated annual percentage change (95% CI) and stratified by urbanization, sex, age, and race. Age-adjusted mortality rates decreased for women and men. Stratification by urbanization revealed that premature CAD mortality is stagnating among women in rural areas. However, this stagnation conceals a statistically significant increase in CAD mortality rates since 2009 in women aged 55 to 64 years (estimated annual percentage change: +1.4%; 95% CI, +0.3% to +2.5%) and since 1999 in women aged 45 to 54 years (estimated annual percentage change: +0.6%; 95% CI, +0.2% to 1.0%). Since 1999, mortality has been stagnating in the youngest group (aged 35-44 years; estimated annual percentage change: +0.2%; 95% CI, -0.4% to +0.8%). Stratification by race indicated an increase in mortality rates among white rural women. Premature CAD mortality remains consistently higher in the rural versus urban United States, regardless of sex, race, and age group. Conclusions Premature CAD mortality rates have declined over time. However, stratification by sex and urbanization reveals disparities that would otherwise remain concealed: CAD mortality rates have increased among women from rural areas since at least 2009.

Simplifying transfemoral ACURATE neo implantation using the TrueFlow nonocclusive balloon catheter.

OBJECTIVES: This study aimed to investigate the safety and efficacy of ACURATE neo transcatheter aortic valve replacement (TAVR) facilitated by predilatation with the nonocclusive TrueFlow balloon catheter. BACKGROUND: Now that TAVR is moving forward, physicians have attempted to simplify and streamline the procedure and the so-called minimalist approach has become more popular. METHODS: We enrolled 142 patients (mean age: 82 ± 5 years, 61% female) in a prospective registry. Patients at low risk for intraprocedural third-degree atrioventricular block (AVB) underwent TAVR with the TrueFlow balloon without rapid pacing and without insertion of a provisional pacemaker (n = 121). The remaining 21 patients were predilated with rapid pacing using a provisional pacemaker and a standard balloon. RESULTS: Predilatation with the TrueFlow balloon was successful in all 121 patients. Postdilatation was less frequently required after predilatation with the TrueFlow (25% vs. 57%, p = .003). Moreover, median procedural duration with the TrueFlow was significantly shorter (42 [interquartile range, IQR: 34-53] vs. 55 [IQR: 46-61] min, p = .004). In-hospital outcomes were similar. At 30 days, there was no mortality, two (1%) patients had suffered a stroke and only four (3%) had required implantation of a new pacemaker. CONCLUSION: Among patients with a low risk for intraprocedural third-degree AVB, the TrueFlow nonocclusive balloon catheter facilitates implantation of the ACURATE neo without the necessity of rapid pacing and a provisional pacemaker.

Relevance of New Conduction Disorders After Implantation of the ACURATE Neo Transcatheter Heart Valve in the Aortic Valve Position.

The ACURATE neo transcatheter heart valve has been associated with very low rates of new conduction disorders (CDs). We assessed the clinical relevance of new CDs in patients undergoing transcatheter aortic valve replacement (TAVR) with this valve. Data of consecutive patients without a pre-existing left bundle branch block (LBBB) or a permanent pacemaker (PPM) undergoing TAVR with the ACURATE neo were analyzed from the prospective SwissTAVI registry. Patients with new CDs were compared with patients with an unchanged electrocardiogram (ECG). ACURATE neo was implanted in 203 patients (mean age 82 ± 6 years, 63% women), CDs occurred in 28 patients (22 [11%] developed a LBBB, 6 [3%] required a PPM). New CDs resulted in a longer median duration of hospitalization (7 vs 5 days, interquartile range 4 to 13 vs 3 to 8 days, p = 0.04). At 1-year follow-up, left ventricular ejection fraction was significantly lower in patients with new CDs comparedwith patients with an unchanged ECG (54% ± 13% vs 61% ± 9%, p <0.01). Kaplan-Meier estimates of survival at 1-year were 89% in patients with new CDs and 95% in patients with an unchanged ECG (hazard ratio 2.0, 95% confidence interval 0.7 to 6.2, p = 0.22). After TAVR with the self-expanding ACURATE neo valve, the rate of new CDs, including complete LBBB was low and very few patients required a new PPM. However, new CDs prolonged initial hospitalization and increased the risk for left ventricular-dysfunction at 1-year follow-up. Patients without new CDs had excellent outcomes with a very high survival rate at 1-year follow-up.

Valve-in-Valve Implantation Using the ACURATE Neo in Degenerated Aortic Bioprostheses: An International Multicenter Analysis.

OBJECTIVES: This study reports an international experience using the transfemoral ACURATE neo transcatheter heart valve (Boston Scientific, Marlborough, Massachusetts) for the treatment of degenerated surgical aortic bioprostheses. BACKGROUND: Transcatheter valve-in-valve procedures have emerged as an alternative to redo surgery. Supra-annular prostheses might be particularly useful in this indication. METHODS: This is an international multicenter analysis including 85 patients from 14 centers in Europe and Canada undergoing an ACURATE neo valve-in-valve procedure from March 2015 to February 2019. RESULTS: Internal diameter of the degenerated bioprosthesis was 20.3 ± 2.1 mm. Prosthesis size S was used in 70 (82%) procedures. The median depth of implantation was 3 mm and the upper crown of the ACURATE neo was positioned above the stent posts of the degenerated bioprosthesis in 54 (64%) and inside in 31 (36%). Mean transvalvular gradient before discharge was significantly lower if the upper crown was above the degenerated bioprosthesis (13.7 ± 5.9 mm Hg vs. 19.5 ± 10.0 mm Hg; p = 0.001). However, a high position of the ACURATE neo resulted in embolization in 1 patient, conversion to open-heart surgery in 1, and need for reintervention due to transcatheter heart valve failure within the first 18 months of follow-up in 4. CONCLUSIONS: This early experience shows that a high implantation of the ACURATE neo with the upper crown above the stent posts of the degenerated bioprosthesis resulted in lower mean transvalvular gradients but a higher rate of malpositioning and early valve degeneration.

Insights From a Multidisciplinary Introduction of the MANTA Vascular Closure Device.

OBJECTIVES: The aim of this paper is to report insights from the first 100 consecutive cardiovascular procedures with MANTA closure. BACKGROUND: The collagen-based MANTA vascular closure device (Teleflex, Wayne, Pennsylvania) has recently been approved for the closure of large-bore femoral access. METHODS: Procedural and access site-related complications were analyzed according to Valve Academic Research Consortium-2 criteria. Duration of bleeding after device closure was recorded. RESULTS: Patients underwent transcatheter aortic valve replacement (n = 75), endovascular aortic replacement (n = 21), or Impella left ventricular support (n = 4). In these 100 patients, a total of 122 MANTA devices were used (22 patients had bilateral large-bore access). None of the patients received protamine. Immediate hemostasis was achieved in 70 patients and hemostasis within 5 min in 87 patients. There were 7 patients with major and 4 patients with minor MANTA-associated vascular complications: femoral artery occlusion in 2, ongoing bleeding in 5, and pseudoaneurysm formation in 4 patients. One patient was treated with covered stent implantation, 7 required surgical revision, and 4 received thrombin injection. Complications occurred significantly more often in patients with peripheral artery disease and a minimal artery diameter <6 mm. Careful review of these complications suggests 3 distinct failure mechanisms. In vessels with narrow femoral artery diameters, elevation of the toggle may lead to occlusion of the artery, incomplete apposition of the plug may lead to perivascular (potentially retroperitoneal) bleeding, or pseudoaneurysm formation may occur. CONCLUSIONS: In this paper, MANTA-associated complications are addressed, 3 distinct failure mechanisms are suggested, and strategies to avoid these complications and improve procedural outcomes are discussed.

Transfemoral implantation of the ACURATE neo prosthesis using a low-profile expandable introducer system: A multicenter registry.

BACKGROUND: The ACURATE neo prosthesis is commonly implanted using introducer sheaths with inner diameters of up to 20 French. The use of only the expandable mesh component of the transGlide introducer system (Meshonly) would substantially decrease the inner diameter to 13 French. We sought to assess the feasibility and safety of using Meshonly for femoral access of the ACURATE neo device and to compare outcomes with patients in whom standard sheaths were used. METHODS AND RESULTS: We retrospectively analyzed a total of 551 patients with severe aortic stenosis from 4 high volume centers in Germany and Switzerland undergoing transfemoral TAVI between February 2016 and February 2018 with implantation of the ACURATE neo device. The median age was 81.7 [78.3-85.2], 67.0% were female, the STS score was 4.2% [2.8-6.5]. The use of the Meshonly was feasible in all attempted cases (n = 272); in all other patients, a standard sheath was used. Major vascular complications at the main access-site (VARC-2) were less frequent in the Meshonly group than in the standard sheath group (1.5% vs. 7.9%; p < 0.001). In the multivariable analysis, the use of Meshonly was independently associated with less major vascular complications (odds ratio 0.10 [95% CI 0.02-0.48]; p = 0.004). CONCLUSIONS: Transfemoral implantation of the ACURATE neo device using the Meshonly was associated with a lower rate of major access-related complications when compared to the standard of care.