Severe Paravalvular Leak Research Articles

Initial experience with repositionable J-Valve for severe aortic regurgitation: a single-center experience.

This study aimed to evaluate the clinical outcomes of treating high-risk patients presenting with severe aortic regurgitation (AR) or aortic stenosis (AS) using transcatheter aortic valve replacement (TAVR). This retrospective study included 290 consecutive patients with symptomatic severe aortic regurgitation or aortic stenosis. All patients who underwent TAVR with J-Valve (Med Tech College LLC, Fort Wayne, IN, USA) at our institution between March 2014 and July 2019. Preoperative demographic data, clinical and echocardiographic parameters, procedural parameters, postoperative clinical outcomes, and echocardiographic parameters were recorded retrospectively. The study included a total of 290 participants. 161 patients had severe aortic regurgitation and 129 patients had severe aortic stenosis. The baseline characteristics of the two groups were similar. The device success rate was high for both aortic regurgitation and aortic stenosis groups (95.0% vs. 93.0%, P=0.47). All-cause mortality of both groups was similar at 30 days (1.9% vs. 3.9%, P=0.48). Patients treated for aortic regurgitation had a higher incidence of pacemaker implantation compared to the aortic stenosis group (8.3% vs. 0.8%, P<0.01) at 30 days postoperation. There was no significant difference between the groups in moderate or severe paravalvular leakage (1.9% vs. 0, P=0.13). The use of larger prostheses was more common in the aortic regurgitation group compared to the aortic stenosis group (66.5% vs. 13.2%, P<0.01). Mean pressure gradient was lower in the aortic stenosis group (8.5±2.9 vs. 12.9±6.6, P<0.01), but structural valve deterioration was more common in the aortic stenosis group (9.7% vs. 0, P<0.01) at 30 days postop. In this study, we found that the prognosis of patients with aortic regurgitation is comparable to that of patients with aortic stenosis after TAVR with J-valve. For patients with severe aortic regurgitation or aortic stenosis, TAVR is an effective therapeutic option. Pacemaker rate in the aortic regurgitation group was higher, but structural valve deterioration was more common in aortic stenosis patients.

Transcatheter aortic valve implantation (balloon-expandable versus self-expandable valves) - what echocardiographic parameters should we evaluted?

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Transcatheter aortic valve implantation (TAVI) is currently the recommended treatment for aortic stenosis (AS) in high or intermediate-risk or inoperable patients. Balloon-expandable valve (BEV) and self-expanding valve (SEV) are the two major types of transcatheter heart valves (TTHV). Despite major diferences, both designs are recomended, however, there are only limited data available for the comparison of newer generation BEV and SEV. Purpose Compare echocardiographic and clinical parameters, during 1 year of follow-up of a balloon-expandable (BS) versus self-expanding (SE) transcatheter aortic valve implantantation, with emphasis on the composite endpoits proposed by uptade Valve Academic Researc Consortium (VARC-2). Methods Retrospective, comparative study in patients with symptomatic severe AS with a high operative risk, who implanted BEV or SEV between January 2016 and December 2019. All patients underwent echocardiographic study before an after the procedure (on the day , 6 months and 1 year of follow up), clinical data were collected. The following ecocardiographic parameters were evaluated: transvalvular and prosthetic aortic gradientes and paravalvular leak (PVL). Results We studied 106 patients (81 ± 8 years, 60% female) with severe AS (mean gradient of 49 ± 12 mmHg), who were threated with BE or SE transcatheter aortic valve. Comparative analysis between BEV vs SEV, showed: there were no statistically significant in mean transprosthetic gradients (9.5 ± 4.8 vs 10 ±6.2; p = 0.49). There were no statistically significant differences between BE and SE valves in the cumulative incidence of death from any cause (21% vs. 28%; p = 0.49), death from cardiovascular causes (3.3% vs. 0%; p= 0.26), all strokes (1.6% vs. 1.6%; p = 0.85), pacemaker implatation (18% vs. 15% p = 0.79); major bleeding (3.3% vs 6.5%; p = 0.18) and renal injury (1.6% vs. 2.1%: p = 0.67). There were statistically significant differences between BE and SE valves in the cumulative incidence of moderate or severe PVL (5% vs. 23.9%; p = 0.009) and repeat hospitalization (11.6% vs. 28%;p = 0.04). Device sucess was achieved in 97 % for BEV vs 91% for SEV (p = 0,39). The early safety at 30 days was observed in 5% for BVE vs. 4.3% for SVE (p = 0.87). The clinical efficacy after 30 days was achieved in 1,6% for BVE vs. 4.3% for SVE (p = 0.03), with higher incidence of moderate or severe PVL. The composite endpoint valve safety occured in 3,3 % for BVE vs 26% for SVE (p &amp;lt; 0,001), with moderate or severe PVL in 23%. Conclusion(s): In patients with symptomatic severe aortic stenosis who implanted BEV or SEV transcatheter aortic valve there was a significant improvement in the hemodynamic status. The present study suggests that use of SEV was associated with a higher risk of PVL and repeat hospitalization, with a endpoint clinical efficacy after 30 days (4,3%) and time-related valve safety (26%).

Transcatheter aortic valve replacement in the developing world: Lessons learnt and its implications for practice

BackrgroundTranscatheter aortic valve replacement (TAVR) has become an accepted modality of treatment in intermediate and high surgical risk patients of symptomatic severe calcific aortic stenosis (AS). We herein report Indian data of 84 intermediate and high-risk patients who underwent TAVR at two Armed Forces cardiac centres. MethodsMost of the patients underwent TAVR in cardiac catheterization lab by percutaneous transfemoral approach, under conscious sedation. Patients were followed up and echocardiographic parameters were assessed after six months of procedure. ResultsTotal of 84 intermediate and high-risk patients underwent TAVR between Jan 2017 and June 2021. Mean age of population was 71.5 ± 8.4 years; 28.5% of patients had bicuspid aortic valve and Mean STS score was 6.34 ± 2.08. Majority (92.8%) patients underwent the procedure under conscious sedation. Self-expanding valves were used in 72.6% and balloon expandable in 27.4% of patients. Predilatation was done in 64% patients while 13% cases underwent post dilatation. Procedural mortality was 2.3%. Rate of permanent pacemaker implantation was 4.9%. Ischemic stroke occurred in 1.1% of patents. There was no case of severe paravalvular leak. Emergency surgical aortic valve replacement was done in 2.4% patients. Procedural success in this study was 97.6%. All-cause mortality was 9.5% at 6 months. ConclusionsTAVR is an effective treatment modality in intermediate and high-risk Indian patients with severe aortic stenosis. Patients with bicuspid or previous bio prosthetic aortic valves also have a good outcome post TAVR.

Self-expanding transcatheter aortic valve replacement in patients with extremely horizontal aortas.

To evaluate the feasibility of self-expanding transcatheter aortic valve replacement (TAVR) in patients with aortic stenosis and extremely horizontal aortas (aortic angulation ≥70°). As TAVR using a self-expanding prosthesis is an off-label treatment for patients with extremely horizontal aortas, these patients are often excluded from randomized controlled trials involving self-expanding TAVR. This study enrolled 27 consecutive patients with extremely horizontal aortas who underwent self-expanding TAVR for severe aortic stenosis. The patients' average age was 76.4 years, with a median Society of Thoracic Surgeons score of 4.53%. The device success and 30-day mortality rates were 66.7% and 7.4%, respectively. The sinotubular junction (STJ) was significantly smaller in the device success group (p = 0.001). The receiver operating characteristic curve analysis found that the area under the curve was 0.907 (95% confidence interval: 0.790-1.000, p = 0.001), validating the association between STJ diameter and device success. An optimal cutoff of 33.6 mm was determined using the Youden index, with a sensitivity and specificity of 88.9% and 77.8%, respectively. The device success rate was significantly higher (93.3% vs. 33.3%, p = 0.003) in patients with STJ diameters ≤33.6 mm (n = 15). In the subgroup analyses, severe valve calcification (n = 9) was associated with a higher incidence of moderate or severe paravalvular leakage (44.0% vs. 0%, p = 0.008), while a higher rate of second valve implantation (60.0% vs. 9.1%, p = 0.030) was found in patients with less than moderate valve calcification (n = 5). Self-expanding TAVR could be suitable for patients with extremely horizontal aortas after careful preoperative evaluation.

30-Day and 1-Year Outcomes With HYDRA Self-Expanding TranscatheterAortic Valve: The Hydra CE Study.

This study sought to evaluate the 30-day and 1-year safety and performance of the Hydra transcatheter aortic valve (THV) (in the treatment of symptomatic severe aortic stenosis in patients at high or extreme surgical risk. The Hydra THV is a novel repositionable self-expanding system with supra-annular bovine pericardial leaflets. The Hydra CE study was a premarket, prospective, multicenter, single-arm study conducted across 18 study centers in Europe and Asia-Pacific countries. The primary endpoint was all-cause mortality at 30days. All endpoints were adjudicated by an independent clinical events committee. A total of 157 patients (79.2 ± 7.1 years of age, 58.6% female; Society of Thoracic Surgeons score 4.7 ± 3.4%) were enrolled. Successful implantation was achieved in 94.3% cases. At 30days, there were 11 (7.0%) deaths, including 9 (5.7%) cardiovascular deaths, of which 5 (3.2%) were device related. At 1 year, there were 23 (14.6%) deaths, including 13 (8.3%) cardiovascular deaths. At 30days, there were significant improvement of effective orifice area (from 0.7 ± 0.2cm2 to 1.9 ± 0.6cm2) and mean aortic valve gradient (from 49.5 ± 18.5mmHg to 8.1 ± 3.7mmHg), which were sustained up to 1 year. Moderate or severe paravalvular leak was observed in 6.3% of patients at 30days and 6.9% of patients at 1 year. The rate of new permanent pacemaker implantation was 11.7% at 30days and 12.4% at 1 year. The Hydra CE study demonstrated that transcatheter aortic valve replacement with Hydra THV offered favorable efficacy at 1 year, providing large effective orifice area and low transvalvular gradient as well as acceptable complication rates with regard to new permanent pacemaker and paravalvular leak. (A Clinical Evaluation of the HYDRA Self Expanding Transcatheter Aortic Valve; NCT02434263).

Transfermoral transcatheter aortic valve implantation using self-expanding Allegra bioprosthesis: One-year single-center outcomes.

BackgroundThe NAUTILUS study aimed to evaluate the safety and performance of the Allegra bioprosthesis in high-risk recipients undergoing transcatheter aortic valve implantation and previously reported 30-day outcomes. In the current investigation 1-year results of the trial are presented.MethodsTwenty-seven recipients with severe, symptomatic aortic valve stenosis at high surgical risk, who underwent treatment using the next-generation self-expanding Allegra via transfemoral approach were prospectively enrolled. Clinical endpoints assessed were: mortality, stroke, permanent pacemaker implantation, New York Heart Association class and re-hospitalizations. Prosthetic valve performance evaluation comprised of: mean gradient, effective orifice area and paravalvular leak.ResultsPatients were elderly (82.8 ± 4.2 years) and predominantly female (n = 19, 70.4%). All of them were deemed to be at high surgical risk with a mean logistic EuroSCORE of 12.5 ± 6.7. The bioprosthesis was successfully implanted in 92.6% of the cases (n = 25). At 1-year, all-cause mortality was 12.0% (n = 3) and stroke was 4.0% (n = 1). Three (12%) of patients developed complete atrioventricular block and received permanent pacemakers. 84% of patients were in New York Heart Association class II or lower. Need for subsequent hospitalization arose in 48% patients. The echocardiographic assessment confirmed an acceptable hemodynamic profile of the Allegra with low mean transprosthetic gradient (9.5 ± 3.4 mmHg), absence of severe paravalvular leak and a 20%-presence of moderate paravalvular leak.ConclusionsThe current follow-up observation study shows that the Allegra was associated with a satisfactory safety profile and hemodynamic performance at 1-year after implantation.

Efficacy and Safety of Emergent Transcatheter Aortic Valve Implantation in Patients with Acute Decompensated Aortic Stenosis: Systematic Review and Meta-Analysis.

Introduction The aim of this systematic review and meta-analysis was to investigate the efficacy and safety of emergent transcatheter aortic valve implantation (TAVI) in patients with decompensated aortic stenosis (AS) by comparing the clinical outcomes with the patients who had received the elective TAVI. Methods By searching PubMed, EMBASE, and Cochrane databases, we obtained the studies comparing the clinical outcomes of emergent TAVI and elective TAVI. Finally, 14 studies were included. Results A total of 14 eligible articles with 73,484 patients were included in this meta-analysis. Emergent TAVI was associated with a higher mortality during hospitalization (HR 2.09, 95% CI [1.39 to 3.14]), 30 days (HR 2.29, 95% CI [1.69 to 3.10]), and 1 year (HR 1.96, 95% CI [1.55 to 2.49]). Consistently, the incidence of acute kidney injury (AKI) (RR 2.48, 95% CI [1.85 to 3.32]), dialysis (RR 2.37, 95% CI [1.95 to 2.88]), bleeding (RR 1.62, 95% CI [1.27 to 2.08]), major bleeding (RR 1.05, 95% CI [1.00 to 1.10]), and 30-day rehospitalization (RR 1.30, 95% CI [1.07, 1.58]) were more common in patients receiving emergent TAVI. No statistical differences were found in the occurrence rate of vascular complications (RR 1.11, 95% CI [0.90, 1.36]), major vascular complications (RR 1.14, 95% CI [0.52, 2.52]), permanent pacemaker (PPM) placement (RR 1.05, 95% CI [0.99, 1.11]), cerebrovascular events (RR 1.11, 95% CI [0.98, 1.25]), moderate to severe paravalvular leakage (PVL) (RR 1.23, 95% [CI 0.94 to 1.61]), and device success (RR 0.99, 95% CI [0.97, 1.01]). Conclusion Emergent TAVI is associated with some postoperative complications and increased mortality compared with elective TAVI. Emergent TAVI should be implemented cautiously and individually.

First experiences with anew balloon-expandable Myval transcatheter aortic valve: apreliminary study.

BackgroundIn the present article, we present our first experiences with a new type of balloon-expandable Myval valve (Meril Life Sciences, Gujarat, India).Materials and methodsA total of 25 consecutive patients who underwent transcatheter aortic valve implantation (TAVI) from June 2020 to November 2020 were included in the study.ResultsThe mean age of the study population was 83 (75–87) years; 17 (68%) were female, and 20 (80%) had hypertension. The Society of Thoracic Surgeons (STS) score of the group was 5.4% ± 3.5%. TAVI was performed via the transfemoral route on all patients. In 19 (76%) cases, we started the procedure without predilation. In two (10.5%) cases performed without predilation, the prosthesis did not pass the native valve. We had to implant the valve from the descending aorta in one (4%) patient. We used Prostar XL (Abbott Vascular, Santa Clara, CA, USA) for six (24%) patients and ProGlide (Abbott Vascular) for 19 (76%) patients for vascular closure. Two (8%) in-hospital deaths occurred in our study but there were no deaths in the 30-day and 90-day follow-up. Vascular complications were observed in one (4%) patient. None of the patients in our study had severe paravalvular leak (PVL), while two (8%) patients had moderate PVL. A permanent pacemaker (PPM) was required in two (8%) patients for the indication of complete atrioventricular block. The mean hospital stay for the whole group was 4 (3–7) days.ConclusionBased on our experiences, the new balloon-expandable valve Myval is easy to use, efficient, and has only a few negligible drawbacks such as the need for predilation of the sheath. While shaft flexibility may have advantages in some situations including in very tortuous arteries, it may cause some difficulties in alignment of the valves.Video onlineThe online version of this article contains a video. The article and the video are available online (10.1007/s00059-021-05069-4). The video can be found in the article back matter as “Electronic Supplementary Material”.

Subsequent open-cardiac surgery after transcatheter aortic valve implantation-indications and outcomes

Abstract Background Transcatheter aortic valve implantation (TAVI) has been historically done in high-risk patients or patients who are deemed unfit for open-heart surgery. Despite high procedural success rates subsequent open surgery remains an issue, immediately after TAVI implantation or during follow-up as bailout strategy. Purpose Aim of this study was to report on indications and clinical outcomes of patients who underwent open-cardiac surgery following TAVI. Methods Between 01/2011 and 12/2020 our centre performed 3131 TAVI procedures. Twenty-seven patients (including patients in whom TAVI was performed in other centres) underwent subsequent open-heart surgery via cardiopulmonary bypass after previous TAVI. Demographic, intraprocedural data and indications for surgery were evaluated. The VARC-2 criteria were applied to report on clinical outcomes. Results Twenty-seven patients (aged 79 [IQR 76–84]; 59.3% male) were operated on for endocarditis (n=11; 40.7%), 3 patients for annular rupture, severe paravalvular leak and severe stenosis, respectively as well as 1 patient each for severe tricuspidal valve regurgitation, valve thrombosis, malpositioning, valve migration, ostial right coronary artery obstruction, left ventricular rupture and type A aortic dissection. The interval between the index TAVI procedure to open surgery was 3 months (IQR 0–26 months). Eight patients underwent emergency subsequent surgery on the same day immediately after TAVI. The surgical data including the procedures are shown in Figure 1. Four patients died intraoperatively due to uncontrolled bleeding. Immediate procedural and procedural mortality was 25.9% and 40.7%, respectively and all-cause mortality was 51.9% (11/12 died for cardiovascular reasons). Figure 2 shows the Kaplan-Meier estimator for survival. Intraoperative, immediate, procedural and all-cause mortality in patients operated on immediately after TAVI was 25.0%, 25.0%, 37.5%, and 50% respectively. No disabling stroke was observed while a non-disabling stroke occurred in 1 patient. New permanent pacemaker implantation was needed in 3 patients (11.1%). One patient required an additional, second operation to remove a left ventricular thrombus as bailout procedure. One patient suffered from a persisting endocarditis and was discharged on permanent antibiotic intake. Conclusions Subsequent open-heart surgery after TAVI is rare, but may urgently become necessary due to TAVI related complications or progressing other cardiac pathologies. Despite a substantial early attrition rate clinical outcome is acceptable and a relevant number of patients can be discharged after surgery for immediate life-threatening TAVI complications. The option of subsequent surgical conversion remains an indispensable tool in the setting of a modern heart team-based approach. These results substantiate recommendations regarding both, having a cardiac surgical service on site and performing TAVI as an interdisciplinary team. Funding Acknowledgement Type of funding sources: None. Surgical detailsKaplan-Meier estimator for survival

Recurrence of left ventricular pseudoaneurysm after multiple mitral valve replacements.

Left ventricular pseudoaneurysm (LVPA) formation is a potentially lethal complication of myocardial infarction (MI) and mitral valve (MV) replacement that requires prompt diagnosis and treatment. A female patient who had been complaining of exertional dyspnea underwent a two-dimensional transthoracic echocardiogram (TTE) which revealed a functioning mechanical MV with severe paravalvular leak, severe tricuspid regurgitation (TR) and severely elevated pulmonary artery systolic pressure. Moreover, echo-lucent space at the postero-lateral portion of the left ventricle near the MV was seen, suggestive of a large LVPA. Transesophageal echocardiography (TEE) and computed tomography (CT) angiography confirmed these findings. Afterwards, the patient had a surgical repair for the LVPA along with mitral and tricuspid valve (TV) replacement. Three months later, the patient presented with symptoms of congestive heart failure. The LVPA had recurred at the same location of the previous pseudoaneurysm and given the high risk for reoperating on the patient, close monitoring and medical management were deemed as a better option.

Outcomes After Transcatheter Aortic Valve Replacement in Bicuspid Versus Tricuspid Anatomy: A Systematic Review and Meta-Analysis.

The aim of this study was to compare the feasibility, safety, and clinical outcomes of transcatheter aortic valve replacement (TAVR) in bicuspid aortic valve (BAV) versus tricuspid aortic valve (TAV) stenosis. At present, limited observational data exist supporting TAVR in the context of bicuspid anatomy. Primary endpoints were 1-year survival and device success. Secondary endpoints included moderate to severe paravalvular leak (PVL) and a composite endpoint of periprocedural complications; incidence rates of individual procedural endpoints were also explored individually. In the main analysis, 17 studies and 181,433 patients undergoing TAVR were included, of whom 6,669 (0.27%) had BAV. A secondary analysis of 7,071 matched subjects with similar baseline characteristics was also performed. Device success and 1-year survival rates were similar between subjects with BAV and those with TAV (97% vs 94% [P=0.55] and 91.3% vs 90.8% [P=0.22], respectively). In patients with BAV, a trend toward a higher risk for periprocedural complications was observed in our main analysis (risk ratio [RR]: 1.12; 95% CI: 0.99-1.27; P=0.07) but not in the matched population secondary analysis (RR: 1.00; 95%CI: 0.81-1.24; P=0.99). The risk for moderate to severe PVL was higher in subjects with BAV (RR: 1.42; 95%CI: 1.29-1.58; P< 0.0001) as well as the incidence of cerebral ischemic events (2.4% vs 1.6%; P=0.015) and of annular rupture (0.3% vs 0.02%; P=0.014) in matched subjects. TAVR is a feasible option among selected patients with BAV anatomy, but the higher rates of moderate to severe PVL, annular rupture, and cerebral ischemic events observed in the BAV group warrant caution and further evidence.

Association Between Transcatheter Aortic Valve Replacement for Bicuspid vs Tricuspid Aortic Stenosis and Mortality or Stroke Among Patients at Low Surgical Risk

There are limited data on outcomes of transcatheter aortic valve replacement (TAVR) for bicuspid aortic stenosis in patients at low surgical risk. To compare the outcomes of TAVR with a balloon-expandable valve for bicuspid vs tricuspid aortic stenosis in patients who are at low surgical risk. Registry-based cohort study of patients undergoing TAVR at 684 US centers. Participants were enrolled in the Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapies Registry from June 2015 to October 2020. Among 159 661 patients (7058 bicuspid, 152 603 tricuspid), 37 660 patients (3243 bicuspid and 34 417 tricuspid) who were at low surgical risk (defined as STS risk score <3%) were included in the analysis. TAVR for bicuspid vs tricuspid aortic stenosis. Coprimary outcomes were 30-day and 1-year mortality and stroke. Secondary outcomes included procedural complications and valve hemodynamics. Among 159 661 patients (7058 bicuspid; 152 603 tricuspid), 3168 propensity-matched pairs of patients with bicuspid and tricuspid aortic stenosis at low surgical risk were analyzed (mean age, 69 years; 69.8% men; mean [SD] STS-predicted risk of mortality, 1.7% [0.6%] for bicuspid and 1.7% [0.7%] for tricuspid). There was no significant difference between the bicuspid and tricuspid groups' rates of death at 30 days (0.9% vs 0.8%; hazard ratio [HR], 1.18 [95% CI, 0.68-2.03]; P = .55) and at 1 year (4.6% vs 6.6%; HR, 0.75 [95% CI, 0.55-1.02]; P = .06) or stroke at 30 days (1.4% vs 1.2%; HR, 1.14 [95% CI, 0.73-1.78]; P = .55) and at 1 year (2.0% vs 2.1%; HR 1.03 [95% CI, 0.69-1.53]; P = .89).There were no significant differences between the bicuspid and tricuspid groups in procedural complications, valve hemodynamics (aortic valve gradient: 13.2 mm Hg vs 13.5 mm Hg; absolute risk difference [RD], 0.3 mm Hg [95% CI, -0.9 to 0.3 mm Hg]), and moderate or severe paravalvular leak (3.4% vs 2.1%; absolute RD, 1.3% [95% CI, -0.6% to 3.2%]). In this preliminary, registry-based study of propensity-matched patients at low surgical risk who had undergone TAVR for aortic stenosis, patients treated for bicuspid vs tricuspid aortic stenosis had no significant difference in mortality or stroke at 30 days or 1 year. Because of the potential for selection bias and absence of a control group treated surgically for bicuspid aortic stenosis, randomized trials are needed to adequately assess the efficacy and safety of transcatheter aortic valve replacement for bicuspid aortic stenosis in patients at low surgical risk.

Clinical results and 30-day outcomes of self-expanding transcatheter aortic valves: comparative case-matched analysis of CoreValve® versus ACURATE neo™.

Transcatheter aortic valve replacement (TAVR) is associated with excellent results in patients with severe aortic stenosis. In highly calcified aortic anuli with increased risk of annulus rupture and in favor of the supra-annular design, self-expandable prostheses are frequently used. In this regard, we aimed to perform a comparative analysis of clinical and 30-day outcomes after TAVR using the self-expanding CoreValve® Evolut R or ACURATE neo™ prosthesis. Out of 343 consecutive patients treated with either CoreValve® Evolut R or ACURATE neo™ from January 2014 to December 2017, 76 patients were assigned each per group after 1:1 propensity score matching in regard of preoperative characteristics. Pre- and periprocedural outcomes were retrospectively collected and assessed. Outcomes at 30 days are reported according to the established Valve Academic Research Consortium (VARC-2) criteria. Device success and 30-day survival accounted for 93.4% (n = 71), respectively 97.4% (n = 74) in both groups (p = 1.00). No statistically significant differences regarding clinical parameters were observed. The combined safety endpoint at 30 days was comparable (84.2% (n = 64) CoreValve® vs 85.5% (n = 65) ACURATE neo™; p = 0.848). Except a trend toward higher stroke (p = 0.08) and pacemaker (p = 0.07) rate in the CoreValve® group, major vascular complications, incidence of life-threatening or disabling bleeding, and incidence of postoperative acute kidney injury were comparable. Postoperative hemodynamic parameters showed no significant differences between the implanted valves. Both self-expandable prostheses showed good postoperative hemodynamic performance with a low incidence of severe paravalvular leakage, all- cause mortality, and comparable clinical outcomes.

Influence of deep implantation on conduction disturbances after transcatheter aortic valve implantation

HintergrundReizleitungsstörungen sind häufige Komplikationen der Transkatheter-Aortenklappenimplantation (TAVI). Ein Einflussfaktor ist die bisher nicht standardisiert bestimmte Implantationstiefe.FragestellungGibt es Unterschiede zwischen den anatomischen Regionen bei tiefer Implantation hinsichtlich neuer Reizleitungsstörungen und Überleben?Material und MethodenRetrospektive Kohortenanalyse, 420 Patienten mit transfemoraler TAVI mit Klappenprothesen der neuen Generation, davon 352 Patienten ohne vorbestehenden Schrittmacher für Analysen zur neuen Schrittmacherimplantation. Auswertung der fluoroskopisch gemessenen Implantationstiefen an der non- (NCC) und der links-koronaren Tasche (LCC) sowie der aus Patientenakten ersichtlichen Verläufe. Die tiefe Implantation definierte sich als tiefes Quartil der Implantationstiefe der jeweiligen Prothese. Das Überleben ergab sich aus einem 2‑jährigen Follow-up.Ergebnisse und DiskussionDie tiefe Implantation war nur am NCC mit erhöhter Schrittmacherimplantationsrate assoziiert (p = 0,013), am LCC mit dem häufigeren Auftreten eines permanenten Linksschenkelblocks (p = 0,014). Neue oder vorbestehende Schrittmacherimplantationen hatten keinen Einfluss auf das 2‑jährige Überleben. Eine tiefe Implantation war nicht mit einer schlechteren Überlebensprognose assoziiert. Die Implantationstiefe könnte bezüglich der Bedeutung für neue Schrittmacherimplantationen standardisiert am NCC gemessen werden. In der Eingriffsplanung könnte eine Abschätzung der Implantationstiefe am NCC oder LCC relevant für den Verlauf nach TAVI sein. Die Schrittmacherimplantation kann wie auch die tiefe Implantation am LCC oder NCC, bei Abwesenheit von mittel- bis hochgradigen paravalvulären Leckagen, als prognostisch sicher gewertet werden.

Effect of Diastolic Flow Reversal Patterns on Clinical Outcomes Following Transcatheter Aortic Valve Implantation - An Intraprocedural Echocardiography Study.

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. 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.

Clinical outcomes of isolated redo mitral valve replacement in patients with mitral prosthetic heart valve dysfunction

Objectives: Redo mitral valve replacement (redo-MVR) represents a clinical challenge due to a higher rates of peri-operative morbidity and mortality. Patients and Methods: This retrospective study enrolled a total of 103 patients who underwent isolated redo-MVR due to prosthetic valve dysfunction. Patients who had an isolated bypass, low echocardiographic quality, history of repeated re-replacements (more than twice), paravalvular leak repair without preoperative and intraoperative transesophageal echocardiography examination, isolated congenital surgery or isolated open-heart surgical intervention (of any type) without a valve procedure at their first or later operations were excluded. The primary endpoint of the study was in-hospital death. Secondary endpoint included individual morbidity. Results: A total of 103 patients (mean age: 50.7 13.4 years; male: 58) who underwent isolated redo-MVR were enrolled in this study. The most common complaint of the patients at admission was obstruction or heart failure-related symptoms (80.6%) and the primary indication for redo-MVR was prosthetic valve thrombosis in 58 patients (56.3%). In-hospital mortality was 12.6% (13 patients). The post-operative complications included major bleeding (n=11) post-operative infection (sepsis, mediastinitis, pneumonia, wound infection, n=15), low cardiac output syndrome (n=10), acute kidney injury (n=17), pericardial effusion with tamponade (n=10), pleural effusion requiring hospitalization and drainage (n=18), ischemic stroke (n=4), fatal ventricular arrhythmia (n=1), peripheral embolism (n=1), moderate to severe paravalvular leak (n=5). There was not any catastrophic heart laceration. Conclusion: In-hospital mortality and complications of the isolated redo-MVR in our center are acceptable. With a well-defined protocol and appropriate patient selection, mortality in emergencies cases may be reduced.

Incidence of valvular regurgitation and leaflet perforation by using automated titanium fasteners (CORKNOT\xae) in heart valve repair or replacement: less usual than reported

BackgroundCORKNOT® facilitates a reduction in cardiopulmonary bypass (CPB) time, aortic cross clamp (ACC) time and operative time, but reported to be associated with other complications. We aim to quantify the incidence of valvular complications related to CORKNOT® and determine the feasibility of its use between different valvular surgeries.MethodsPatients who underwent heart valve repair or replacement surgery via the use of automated titanium suture fasteners (CORKNOT®) in a tertiary care hospital were included in the study. This single-centre retrospective study was conducted on 132 patients between January 2016 and June 2018.ResultsIn our study, the overall mean operative time was 320.0 ± 97.0 min, mean CPB time was 171.4 ± 76.0 min and the calculated mean ACC time was 105.9 ± 54.0 min. Fifty-eight patients (43.9%) underwent minimally invasive valve replacement or repair surgery and 66 patients (50.0%) underwent concomitant procedures. A total of 157 valves were operated on, with 112 (84.8%) single valve surgeries, 15 (11.4%) double valve surgeries and 5 (3.8%) triple valve surgeries. After reviewed by the cardiologist blinded towards the study, we report trivial and/or mild paravalvular leak (PVL) in immediate post-operative echocardiography was found in 1 (1.01%) patients. There were no reported cases of valvular thrombosis, leaflet perforation, device dislodgement or embolization, moderate and/or severe PVL during hospitalization and follow-up echocardiography within 1 year. Single mitral valve and aortic surgeries had comparable incidences of post surgical complications.ConclusionWe conclude the feasibility of CORKNOT® utilisation in mitral and aortic valve surgeries. Additionally, incidence of CORKNOT® related complications in heart valve repair or replacement surgery is less usual in our setting than previously reported. These results motivate the use of CORKNOT® as a valid alternative with complete commitment.

Clinical consequences of consecutive self-expanding transcatheter heart valve iterations.

ObjectiveTo compare early clinical outcomes after transcatheter aortic valve implantation (TAVI) with three consecutive generations of self-expanding valves (SEVs).MethodsClinical endpoints of consecutive patients who underwent TAVI with CoreValve, Evolut R or Evolut PRO were included in a prospective database.ResultsTAVI was performed with CoreValve (n = 116), Evolut R (n = 160) or Evolut PRO (n = 92). Evolut R and Evolut PRO showed a tendency towards lower permanent pacemaker implantation (PPI) rates compared to CoreValve (CoreValve 27% vs Evolut R 16% vs Evolut PRO 18%, p = 0.091). By multivariable regression analysis CoreValve had a significantly higher risk for PPI (odds ratio (OR) 2.79, 95% confidence interval (CI) 1.31–5.94, p = 0.008) compared to Evolut R, while Evolut R and PRO were similar. Severe paravalvular leakage (PVL) occurred only with CoreValve, but no significant difference was observed in moderate PVL (10% vs 8% vs 6%, p = 0.49). CoreValve had a tendency towards a higher risk for more-than-mild PVL as compared with the Evolut platform (R + PRO) (OR 2.46, 95% CI 0.98–6.16, p = 0.055). No significant differences in all-cause mortality (7% vs 4% vs 1%, p = 0.10), stroke (6% vs 3% vs 2%, p = 0.21) or major vascular complications (10% vs 12% vs 4%, p = 0.14) were observed.ConclusionsTAVI with self-expanding valves was safe, and device iterations may result in a lower need for PPI. More-than-mild PVL seemed to occur less often with repositionable technology.Supplementary InformationThe online version of this article (10.1007/s12471-021-01568-5) contains supplementary material, which is available to authorized users.

Impact of Anesthesia Strategy and Valve Type on Clinical Outcomes After Transcatheter Aortic Valve Replacement

BackgroundThe randomized SOLVE-TAVI (compariSon of secOnd-generation seLf-expandable vs. balloon-expandable Valves and gEneral vs. local anesthesia in Transcatheter Aortic Valve Implantation) trial compared newer-generation self-expanding valves (SEV) and balloon-expandable valves (BEV) as well as local anesthesia with conscious sedation (CS) and general anesthesia (GA) in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). Both strategies showed similar outcomes at 30 days. ObjectivesThe purpose of this study was to compare clinical outcomes during 1-year follow-up in the randomized SOLVE-TAVI trial. MethodsUsing a 2 × 2 factorial design 447 intermediate- to high-risk patients with severe, symptomatic aortic stenosis were randomly assigned to transfemoral TAVR using either the SEV (Evolut R, Medtronic Inc., Minneapolis, Minnesota) or the BEV (Sapien 3, Edwards Lifesciences, Irvine, California) as well as CS or GA at 7 sites. ResultsIn the valve-comparison strategy, rates of the combined endpoint of all-cause mortality, stroke, moderate or severe paravalvular leakage, and permanent pacemaker implantation were similar between the BEV and SEV group (n = 84, 38.3% vs. n = 87, 40.4%; hazard ratio: 0.94; 95% confidence interval: 0.70 to 1.26; p = 0.66) at 1 year. Regarding the anesthesia comparison, the combined endpoint of all-cause mortality, stroke, myocardial infarction, and acute kidney injury occurred with similar rates in the GA and CS groups (n = 61, 25.7% vs. n = 54, 23.8%; hazard ratio: 1.09; 95% confidence interval: 0.76 to 1.57; p = 0.63). ConclusionsIn intermediate- to high-risk patients undergoing transfemoral TAVR, newer-generation SEV and BEV as well as CS and GA showed similar clinical outcomes at 1 year using a combined clinical endpoint. (SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI [SOLVE-TAVI]; NCT02737150)

Long‑term outcomes of transcatheter self-expanding aortic valve implantations in inoperable and high surgical-risk patients with severe aortic stenosis: a single-center single-valve registry.

Transcatheter aortic valve implantation (TAVI) is being increasingly used in patients with longer life expectancy. Data on long‑term outcomes are still limited. The aim of the study was to assess the clinical outcomes of patients treated with TAVI and identify baseline and procedure‑related factors influencing long‑term survival. Symptomatic patients with critical aortic stenosis who were inoperable or had high surgical risk were qualified for TAVI. Between August 2012 and December 2017, 248 consecutive patients treated with self ‑expanding Medtronic valve implantation at American Heart of Poland in Bielsko‑Biała were prospectively enrolled. Patients were followed for 30 days after the procedure and subsequently annually. All events were classified according to the Valve Academic Research Consortium‑2 (VARC‑2) criteria and assessed. Survival was compared between the subgroups defined by the EuroSCORE II (European System for Cardiac Operative Risk Evaluation II) and with matched representatives from the general population. The median (interquartile range) follow‑up was 3.4 (2.5-4.6) years, and the longest follow‑up lasted 7.8 years. A total of 92 patients (37.1%) died during the follow‑up. The Kaplan-Meier estimates for cumulative mortality at 1, 3, 5, and 7 years were: 11.3%, 26.8%, 42.1%, and 60.6%. Patients with EuroSCORE II greater than 6% experienced worse survival compared with those with EuroSCORE II 6% or less (P = 0.008). Patients with EuroSCORE II 6% or less had similar survival to the general population. Male sex, baseline eGFR of less than 50 ml/min/1.73 m2, chronic obstructive pulmonary disease, moderate / severe paravalvular leak, absence of postdilatation, major vascular complication, and stroke at 30 days were independently associated with long‑term mortality. TAVI with a self‑expanding Medtronic valve implantation according to a consistent protocol was associated with favorable outcomes. Patients with lower EuroSCORE II scores had the same prognosis as the actuarial survival of the general population.