Balloon-expandable Bioprosthesis Research Articles

Coronary angiography and intervention after transcatheter aortic valve implantation (TAVI): the nationwide SWEDEHEART registry

Abstract Background Coronary access after transcatheter aortic valve implantation (TAVI) can be challenging and complicate percutaneous coronary intervention (PCI). Therefore, pre-existing severe coronary stenosis is usually treated either before or during the TAVI procedure. However, due to the progressive nature of coronary artery disease (CAD), some patients require urgent or elective coronary angiography and intervention after their TAVI procedure. Purpose To assess the indication, the incidence, and feasibility of coronary angiography and intervention after TAVI. Methods All patients undergoing TAVI between 2008 and 2021 from the Swedish Transcatheter Cardiac Intervention Registry (SWENTRY) were included. SWENTRY was further linked to the Swedish Coronar Angiography and Angioplasty Registry (SCAAR) and the National Cause of Death Registry. Results Among 8819 patients undergoing TAVI, 697 angiograms were performed in 515 patients (5.8%) after TAVI (43.1 % after balloon-expandable bioprosthesis, 49.5 % after self-expandable bioprosthesis) at a median follow up of 841 days (interquartile range: 346 to 1457 days). PCI was performed in 347 patients (49.8%) with a success rate of 92.5% with no significant differences between patients implanted with balloon-expandable and self-expandable bioprostheses (93.0% vs.91.5%; p=0.62). The most common indications for PCI after TAVI were non-ST elevation acute coronary syndrome (NSTE-ACS) (45.8%), chronic coronary syndrome (30.3%), ST elevation myocardial infarction (6.9%) and congestive heart failure (3.5%). The cumulative incidence of angiograms with or without PCI at 30 days, 1 year, 2 years and 5 years were 6.9, 37.2, 60.2 and 90.2 percent of the total number of angiograms respectively (Figure). Conclusion Coronary angiogram and interventions after TAVI are rare, with an incidence declining over time after TAVI. The main indication for coronary angiogram and PCI was NSTE-ACS. PCIs were successfully performed after TAVI, with no apparent differences between balloon-expandable and self-expandable bioprostheses.

C49 NO CONTRAST TAVI

Abstract Background Chronic renal failure is a common comorbidity in patients undergoing TAVI. Large amounts of contrast media are generally needed to safely perform TAVI with potential deleterious effects on renal function and long term life quality. Objectives Every step of the procedure can be safely replaced by no contrast techniques: ultrasound guided vascular puncture and final check, alignement of 3 guides in Valsalva sinuses to check coplanarity or cusp overlap, coupling of hemodynamics and transthoracic echocardiography to check the results and need of postdilatation, measure of gradient across the arterial puncture to rule out iatrogenic stenosis. Matherials and Methods 3 patients with severe renal failure (GFR < 30 ml/min/ 1.73 m2) and 1 patient with moderate renal failure and previous double renal transplantation underwent TAVI with protocol without contrast in our center in the last year. All cases were performed with local anesthesia and conscious sedation. 3 cases were performed with balloon expandable bioprosthesis and 1 with self expandable bioprosthesis. Results We were able to perform TAVI procedure without contrast in all 4 patients in which the technique was attempted without complications. Hemodynamics was excellent in all cases with no residual gradient or significant leaks. No vascular complication occured. Procedural time was generally 20% longer than average procedure but X rays dose exposure was reduced because less cine acquisitions were needed. Conclusions TAVI with no use of contrast media is feasible and safe by extensive use of vascular ultrasound, hemodynamics, transthoracic echocardiography and multiple guides to depict coronary sinuses and assure correct prothesis implantation.

New Percutaneous Approaches for the Treatment of Heavily Calcified Mitral Valve Stenosis.

Important breakthroughs have considerably improved the outcomes of the percutaneous treatment of valvular heart diseases during the last decades. However, calcium deposition and progressive calcification of the left-sided heart valves present a challenge with prognostic implications that have not been addressed until recently. In the case of native mitral stenosis with no surgical options, a compelling need for tackling heavily calcified valves has led to the development of novel debulking techniques and to the use of aortic balloon-expandable bioprosthesis in the mitral position. In this section of the special issue "Mitral Valve Disease: State of the Art", we will review standard approaches and indications for the treatment of native mitral stenosis; summarize these two innovative solutions and their evidence, describing both procedures in a "step-by-step" fashion; and briefly comment on future directions in this field.

Long-term Follow up after Transfemoral Transcatheter Aortic Valve Implantation in Lower Risk Patients Using the Balloon-Expandable Bioprosthesis: Gender-Dependent Outcomes.

Long-term data on gender-related outcomes after transfemoral transcatheter aortic valve implantation (TF-TAVI) using newer generations heart valves in lower-risk patients are sparse. We aimed to evaluate gender-dependent long-term outcomes after TF-TAVI in lower-risk patients using the third-generation balloon expandable bioprosthesis. Data of 103 patients undergoing TF-TAVI using the third-generation balloon expandable bioprosthesis were analyzed. We conducted up to six years follow up and performed comparison on gender basis: men (45 patients; 82 ± 4.7 years; STS Score 3.7 ± 1.6%) vs. women (58 patients; 83.2 ± 4.5 years; STS Score 3.6 ± 1.8%). The mean follow-up time was 30 months. Cardiovascular risk factors at baseline were similar, without significant differences between men and women. The 30-day mortality was 4.4% in men vs. 3.4% in women (P = 0.745). The 30-day stroke was 4.4% in men vs. 1.7% in women (P = 0.582). The major vascular injury rate and the pacemaker rate was 2.3% vs. 10.7% (P = 0.134) and 19.5% vs. 18.9% (P = 1) in men vs. women, respectively. There was a significant difference of mean long-term survival: men, 42.1 months [95%CI: 33.154-51.101] vs. women, 57.3 months [95%CI: 50.618-64.159], P = 0.015. Although considerably more prone to procedural complications, women had a significantly long-term survival benefit after TF-TAVI in lower-risk patients despite similar baseline characteristics.

Long-Term Outcomes After Transfemoral-Transcatheter Aortic Valve Implantation in Very Old Patients Using the Balloon-Expandable Bioprosthesis.

Transcatheter aortic valve implantation (TAVI) can be safely performed in old patients. Increasing longevity raises often the question whether TAVI can be still useful for patients beyond a certain age limit. Data on long-term outcomes of elderly patients after TAVI are sparse. We sought to assess the impact of very advanced age on long-term outcomes after transfemoral (TF)-TAVI. Data of 103 patients undergoing TF-TAVI with the balloon-expandable bioprosthesis between May/2014 and May/2019 were analyzed. We divided the cohort into two age groups: ≥85 years (group1: n = 37; 87.5 ± 2.6 years; STS-Score 3.9 ± 1.4) versus < 85 years (group2: n = 66; 80 ± 3.1 years; STS-Score 3.4 ± 1.8). We conducted up to 6 years clinical follow-up. Overall mortality at 30 days was 3.8% without significant differences between the two age groups. Incidence of major vascular injury (8.6 vs. 6.3%, p = .695) and stroke (2.8 vs. 3%, p = 1) was not significantly different between group 1 and 2, respectively. More than mild paravalvular leakage was found in 1 patient (group 1). The mean long-term survival probability was 51.3 months [95% CI: 42.234–60.430] in group 1 versus 49.5 months [95% CI: 42.155–56.972] in group2 (p = .921). Long-term outcomes of very old patients after TF-TAVI show a similar treatment benefit compared to the younger patients.

Unplanned Percutaneous Coronary Revascularization After TAVR: A Multicenter InternationalRegistry.

This study sought to evaluate the incidence and causes of percutaneous coronary intervention (PCI) at different time periods following transcatheter aortic valve replacement (TAVR). Coronary artery disease (CAD) and aortic stenosis frequently coexist, but the optimal management of CAD following TAVR remains incompletely elucidated. Patients undergoing unplanned PCI after TAVR were retrospectively included in an international multicenter registry. Between July 2008 and March 2019, a total of 133 patients (0.9%; from a total cohort of 15,325) underwent unplanned PCI after TAVR (36.1% after balloon-expandable bioprosthesis, 63.9% after self-expandable bioprosthesis). The median time to PCI was 191 days (interquartile range: 59 to 480 days). The daily incidence of PCI was highest during the first week after TAVR and then declined over time. Overall, the majority of patients underwent PCI due to an acute coronary syndrome, and specifically 32.3% had non-ST-segment elevation myocardial infarction, 15.4% had unstable angina, 9.8% had ST-segment elevation myocardial infarction, and 2.2% had cardiac arrest. However, chronic coronary syndromes are the main indication beyond 2 years. PCI success was reported in almost all cases (96.6%), with no significant differences between patients treated with balloon-expandable and self-expandable bioprostheses (100% vs. 94.9%; p=0.150). Unplanned PCI after TAVR is rare, with an incidence declining over time after TAVR. The main indicationto PCI is acute coronary syndrome in the first 2 years after TAVR, and thereafter chronic coronary syndromesbecome prevalent. Unplanned PCIs are frequently successfully performed after TAVR, with no apparentdifferences between balloon-expandable and self-expandable bioprostheses. (Revascularization After Transcatheter Aortic Valve Implantation [REVIVAL]; NCT03283501).

234 The role of preprocedural assessment of aortic valve calcium volume for the optimization of percutaneous aortic bioprosthesis implantation (TAVI)

Abstract Aims Paravalvular leaks (PVL) and conduction disorders requiring permanent pacemaker implantation (PPI) in patients with severe Aortic Valvular Stenosis (SA) undergoing percutaneous aortic valve prosthesis (TAVI) still have a significant and unacceptable incidence for patients at medium and low surgical risk, who represent, with increasing scientific evidence, the prevalent population. The appearance of these complications seems to be related to clinical, anatomical and procedural factors, which influence the decision-making process of the type and size of bioprosthesis to be implanted. Particular attention has been paid to the role of the volume of calcium present at the native aortic valve (VCA) as a predictor of these complications, in order to optimize the percutaneous procedure. The VCA can be quantified using algorithms derived from Multilayer Computed Computed Axial Tomography (MSCT), an examination that has become a pivotal element in the evaluation of the patient's eligibility for TAVI.The aim of our study was to document the pre-procedural added value of VCA in terms of possible containment of adverse events and how much it may affect the choice of the type of bioprosthesis to be implanted. Methods and results 111 patients underwent TAVIs at the Interventional Cardiology Unit of the AOU S. Giovanni di Dio and Ruggi D'Aragona, between 2017 and 2020, subsequently divided into 2 groups: group A (self-expandable bioprosthesis, Medtronic Evolut R or Evolut Pro) and group B (balloon expandable bioprosthesis, Edward Sapien 3).The clinical, electrocardiographic, echocardiographic and anatomical parameters of the enrolled patients were analyzed, and the VCA in the preprocedural phase was quantified for each of them, using an algorithm extracted from the MSCT reading software, OsiriX (OsiriX-MD v.2.8.2 64-bit). A univariate logistic regression analysis was performed for the risk of developing the composite event of significant PVL and IPP.In Group B, no significant variables were found, while in Group A, the VCA (OR: 1.001; 95% CI, 1.000-1.002; p &amp;lt; 0.043) and incomplete left branch block (OR: 5.781; 95% CI, 0.013-32.988; p &amp;lt; 0.048) were significant. Subsequently, these two variables were tested in a multivariate regression model according to which only the VCA emerged as an independent predictor for the composite event (OR: 1.001; 95% CI, 1.000-1.002; p &amp;lt; 0.039). Conclusion VCA is significantly associated with the risk of moderate to severe PVL and rhythm disturbances requiring PPI, in the group of patients in whom a self-expandable bioprosthesis was implanted, unlike patients who received a balloon-expandable bioprosthesis where this association is not significant.

Undersizing but overfilling eliminates the gray zones of sizing for transcatheter aortic valve replacement with the balloon-expandable bioprosthesis.

Current recommendations for valve size selection are based on multidimensional annular measurements, yet the overlap between two different transcatheter heart valve (THV) sizes remains. We sought to evaluate whether undersizing but overfilling eliminates the gray zones of valve sizing. Data of 246 consecutive patients undergoing transcatheter aortic valve replacement (TAVR) with the balloon-expandable bioprosthesis with either conventional sizing and nominal filling (group 1 (NF-TAVR), n=154) or undersizing but overfilling under a Less Is More (LIM)-Principle (group 2 (LIM-TAVR), n=92) were compared. Paravalvular leakage (PVL) was graded angiographically and quantitatively using invasive hemodynamics. Annulus rupture (AR) occurred only in group 1 (n=3). Due to AR adequate evaluation of PVL was possible in 152 patients of group 1. More than mild PVL was found in 13 (8.6%) patients of group 1 and 1 (1.1%) patient of group 2 (p=0.019). Postdilatation was performed in 31 (20.1%) patients of group 1 and 6 patients (6.5%) of group 2 (p=0.003). For patients with borderline annulus size in group 1 (n=35, 22.7%) valve size selection was left to the physiciańs choice resulting in selection of the larger prosthesis in 10 (28.6%). In group 2 all patients with borderline annulus (n=36, 39.1%) received the smaller prosthesis (LIM-TAVR). The postprocedural mean transvalvular pressure gradient was significantly higher in the NF-TAVR-group (11.7±4 vs. 10.1±3.6mmHg, p=0.005). LIM-TAVR eliminates the gray zones of sizing and associated PVL, can improve THV-performance, reduce incidence of annular rupture and simplify the procedure especially in borderline cases.

MDCT planning of trans catheter aortic valve implantation (TAVI): determination of optimal c-arm angulation.

A fluoroscopic view perpendicular to the aortic valve annulus is required during transcatheter aortic valve implantation (TAVI) for obtaining an optimal deployment of the bioprosthesis. By predicting c-arm angulation, pre-procedural MDCT could decrease the number of aortograms, shorten the time of the procedure and reduce the amount of intra-arterial contrast agent. The aim of our study was to assess the accuracy of MDCT in predicting c-arm angulation at the cath. lab. In this single center study, we investigated MDCT prediction of c-arm angulation in patients having undergone a TAVI procedure using SAPIEN 3® (Edwards Lifesciences, USA). Prior to the procedure, an experienced radiologist had reported the angulation using dedicated software (CTreport). After the procedure, a blinded experienced radiologist retrospectively measured the angles using the same method (CTstudy). Interobserver variability was drawn from the comparison between CTreport and CTstudy. Then, the mean angular difference between the predicted MDCT angles (CTstudy) was compared to the working view recorded at the cath. lab. Seventy-nine patients (M/F = 0.65; mean age: 85.2years ± 5.3) were included. Interobserver variability was 5.9 ± 6.1°. The mean absolute difference between MDCT and fluoroscopy was 8.8 ± 7.1°. The present study showed that MDCT could predict the coplanar fluoroscopic angles prior to TAVI using a balloon-expandable bioprosthesis Sapien 3® placed via a transfemoral approach with a mean angular difference of 8.8 ± 7.1°. Reproducibility was considered good as the mean difference between two independent measures was 5.9 ± 6.1°.

Effect of oral anticoagulation on clinical outcomes and haemodynamic variables after successful transcatheter aortic valve implantation

The effect of oral anticoagulation on clinical and haemodynamic outcomes following successful transcatheter aortic valve implantation is unclear. To evaluate the effect of oral anticoagulation within the first year after transcatheter aortic valve implantation. All patients undergoing transcatheter aortic valve implantation in two French tertiary centres from 2010 to 2016 were included prospectively. The composite outcome of death, stroke, readmission for heart failure or major/life-threatening bleeding according to Valve Academic Research Consortium 2 criteria within 1year was evaluated. Valvular haemodynamic deterioration was defined as mean transprosthetic gradient ≥20mmHg or an increase of ≥10mmHg during echocardiographic follow-up. Of the 1139 patients included, 400 (35.1%) were discharged on oral anticoagulation. The primary endpoint was more frequent in the group with versus without oral anticoagulation (29.4% vs. 17.3% 21.5%; hazard ratio 1.83, 95% confidence interval 1.42-2.35). Composite endpoint risk factors were chronic pulmonary and kidney diseases, previous atrial fibrillation, left ventricular ejection fraction ≤30% at discharge and no femoral vascular approach, but not oral anticoagulation prescription at discharge. Conversely, 58patients were identified with valvular haemodynamic deterioration, including 11 (19%) in the group with oral anticoagulation and 47 (81%) in the group without oral anticoagulation. Valvular haemodynamic deterioration risk factors were absence of oral anticoagulation exposure, increased body mass index, use of a balloon-expandable bioprosthesis and use of a bioprosthesis with diameter ≤23mm. Antithrombotic treatment crossover (i.e. oral anticoagulation interruption or introduction during follow-up) occurred in 9.6% of patients, and was a risk factor for death (adjusted hazard ratio 3.39, 95% confidence interval 1.63-7.07). Baseline characteristics, rather than oral anticoagulation prescription at discharge, were associated with adverse outcomes following successful transcatheter aortic valve implantation. Conversely, oral anticoagulation was associated with reduced valvular haemodynamic deterioration.

Conduction disturbances following surgical aortic valve replacement with a rapid-deployment bioprosthesis

BackgroundThe implantation of rapid-deployment aortic valves may interfere with the conduction system of the heart. This study evaluates the occurrence and predictive factors of conduction anomalies in patients undergoing surgical aortic valve replacement (SAVR) with a rapid-deployment balloon-expandable bioprosthesis in a single-center, real-world experience. MethodsBetween May 2010 and April 2019, 700 consecutive patients were included in a prospective, ongoing database with a longitudinal follow-up preoperatively, at discharge, and at 3 months, 1 year, 3 years, and 5 years postoperatively. Thirty-seven patients (5.3%) had a permanent pacemaker at baseline and were excluded from further analysis, leaving 663 patients for analysis. Assessment of conduction anomalies was performed by electrocardiography (ECG) monitoring and repeated 12-lead ECG during the hospital stay and at postoperative follow-ups. ResultsPreoperatively, 126 patients (19.0%) presented with different conduction disturbances. New permanent pacemaker implantation (PPI) occurred in 61 patients during the first 14 days (cumulative incidence, 9.4%). The indication for PPI was complete atrioventricular block in 47 cases (77%). Preoperative conduction anomalies, such as right bundle branch block, as well as operative characteristics (concomitant procedures) were found to be independent predictors for new PPI. One-year survival was 98% in patients with new early PPI and 96% in those without new early PPI (P = .60). ConclusionsThe PPI rate was in the range of previous reports for rapid-deployment prostheses. PPI did not have a significant influence on short- to intermediate-term survival. Case selection with exclusion of patients presenting with baseline conduction disturbances may decrease the rate of new PPIs after SAVR with rapid-deployment balloon-expandable bioprostheses.

Safety and efficacy of a self-expanding versus a balloon-expandable bioprosthesis for transcatheter aortic valve replacement in patients with symptomatic severe aortic stenosis: a randomised non-inferiority trial

Transcatheter aortic valve replacement (TAVR) is the preferred treatment option for older patients with symptomatic severe aortic stenosis. Differences in the properties of available TAVR systems can affect clinical outcomes. Among patients undergoing TAVR, we compared the self-expanding ACURATE neo TAVR system with the balloon-expandable SAPIEN 3 TAVR system with regard to early safety and efficacy. In this randomised non-inferiority trial, patients (aged ≥75 years) undergoing transfemoral TAVR for treatment of symptomatic severe aortic stenosis, and who were deemed to be at increased surgical risk, were recruited at 20 tertiary heart valve centres in Germany, the Netherlands, Switzerland, and the UK. Participants were randomly assigned (1:1) to receive treatment with the ACURATE neo or the SAPIEN 3 with a computer-based randomly permuted block scheme, stratified by study centre and Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) category. The primary composite safety and efficacy endpoint comprised all-cause death, any stroke, life-threatening or disabling bleeding, major vascular complications, coronary artery obstruction requiring intervention, acute kidney injury (stage 2 or 3), rehospitalisation for valve-related symptoms or congestive heart failure, valve-related dysfunction requiring repeat procedure, moderate or severe prosthetic valve regurgitation, or prosthetic valve stenosis within 30 days of the procedure. Endpoint assessors were masked to treatment allocation. Non-inferiority of ACURATE neo compared with SAPIEN 3 was assessed in the intention-to-treat population on the basis of a risk-difference margin of 7·7% for the primary composite endpoint, with a one-sided α of 0·05. This trial is registered with ClinicalTrials.gov (number NCT03011346) and is ongoing but not recruiting. Between Feb 8, 2017, and Feb 2, 2019, up to 5132 patients were screened and 739 (mean age 82·8 years [SD 4·1]; median STS-PROM score 3·5% [IQR 2·6-5·0]) were enrolled. 30-day follow-up was available for 367 (99%) of 372 patients allocated to the ACURATE neo group, and 364 (99%) of 367 allocated to the SAPIEN 3 group. Within 30 days, the primary endpoint occurred in 87 (24%) patients in the ACURATE neo and in 60 (16%) in the SAPIEN 3 group; thus, non-inferiority of the ACURATE neo was not met (absolute risk difference 7·1% [upper 95% confidence limit 12·0%], p=0·42). Secondary analysis of the primary endpoint suggested superiority of the SAPIEN 3 device over the ACURATE neo device (95% CI for risk difference -1·3 to -12·9, p=0·0156). The ACURATE neo and SAPIEN 3 groups did not differ in incidence of all-cause death (nine patients [2%] vs three [1%]) and stroke (seven [2%] vs 11 [3%]); whereas acute kidney injury (11 [3%] vs three [1%]) and moderate or severe prosthetic aortic regurgitation (34 [9%] vs ten [3%]) were more common in the ACURATE neo group. TAVR with the self-expanding ACURATE neo did not meet non-inferiority compared to the balloon-expandable SAPIEN 3 device in terms of early safety and clinical efficacy outcomes. An early composite safety and efficacy endpoint was useful in discriminating the performance of different TAVR systems. Boston Scientific (USA).

Transcatheter Transseptal Mitral Valve-in-Valve Replacement: An Early Australian Case Series and Literature Review

Transcatheter mitral valve implantation for degenerated bioprostheses has recently emerged as an alternative to redo mitral valve surgery, particularly in patients at high risk for reoperative cardiac surgery. We sought to examine our early experience of transcatheter transseptal mitral valve-in-valve procedures. Prospectively collected data was retrospectively reviewed in patients undergoing transcatheter transseptal mitral valve-in-valve implantation using the Edwards Sapien 3 balloon expandable bioprosthesis (Edwards Lifesciences, Irvine, CA, USA). Seven (7) patients underwent the procedure between December 2017 and November 2018. Three (3) patients were young Indigenous Australians (age range 33-41years) who were not suitable for mechanical prostheses; four patients were elderly (age range 82-92 years) and considered high risk for reoperative surgery. The median (maximum, minimum) EuroSCORE II of the group was 7.32 (4.81, 19.89). Procedural success was obtained in six of the seven patients; these six patients had no significant complications and had a median hospital stay of 3 days. In one patient, the device displaced towards the left ventricle on inflation, resulting in left ventricular outflow tract obstruction and haemodynamic instability. Urgent redo mitral valve surgery and explantation of the transcatheter prosthesis was undertaken, however, this patient died postoperatively of multi-organ failure. Of the successfully deployed valves, the median (maximum, minimum) gradient across the new mitral prosthesis was 5.5 mmHg (4, 7) and only one patient had mild mitral regurgitation, all others had no or trivial regurgitation. At 30 days, these six patients are well and all are in New York Heart Association (NYHA) Class I. Our early experience with transcatheter transseptal mitral valve-in-valve implantation demonstrates this procedure to be feasible in our institution with acceptable early results. Further follow-up is necessary to determine the longevity of valves implanted in this manner, especially in the younger population.

Intermediate-term outcome of 500 consecutive rapid-deployment surgical aortic valve procedures†.

OBJECTIVESThe Edwards INTUITY Valve System is a balloon-expandable bioprosthesis, inspired from the Edwards Magna valve and transcatheter technology, with a subvalvular stent frame to enable rapid deployment. We report a single-centre experience of aortic valve replacement with this novel bioprosthesis.METHODSFive hundred consecutive patients, of whom 45.6% were female with a mean age of 73.5 [standard deviation (SD) 7.9 years], with severe aortic stenosis who received a rapid deployment aortic valve between May 2010 and July 2017 were included in a prospective and ongoing database. The median follow-up time was 12 months, and the total accumulated follow-up time was 818 patient years. Preoperative characteristics, operative parameters, survival, valve-related adverse events and valve haemodynamics were assessed.RESULTSThirty-day mortality was 0.8% (4/500), and overall survival at 1, 3 and 5 years was 94%, 89% and 81%, respectively. A minimally invasive surgical approach was chosen in 236 patients (47%), of which 122 (24%) were operated on through an anterior right thoracotomy. Cross-clamp and cardiopulmonary bypass times for isolated aortic valve replacement were 53 (SD 17) and 89 (SD 29) min for full sternotomy as well as 75 (SD 23) and 110 (SD 31) min for minimally invasive surgery approaches (P < 0.001). Mean gradients at discharge, 1, 3 and 5 years were 13 (SD 5), 11 (SD 4), 12 (SD 5) and 11 (SD 3) mmHg, respectively. New pacemaker implantation was necessary in 8.6% of patients. A single case (0.2%) of structural degeneration was registered after 6 years. Valve explantation for non-structural dysfunction or endocarditis occurred in 9 patients (1.8%).CONCLUSIONSThis rapid deployment aortic valve has shown excellent results concerning haemodynamic performance, durability and safety. Implantation requires specific training, and the rate of pacemaker implantation remains a matter of concern. This novel valve also facilitates minimally invasive approaches and may be beneficial in complex combined procedures.

Endovascular resection of the native aortic valve before transcatheter aortic valve implantation: state of the art and review.

Transcatheter aortic valve implantation was introduced into clinical practice in 2002 as a rescue approach in patients presenting with symptomatic severe aortic stenosis but not eligible for conventional aortic valve replacement. This technique allows implantation of a balloon expandable bioprosthesis without resection of the native aortic valve. Several complications are described as a consequence of the residual highly calcified valve being squeezed against the aortic wall by the stent of the implant. This can result in deformation of the metal stent and paravalvular leakage, risk of occlusion of the coronary ostia, or central and peripheral embolization of valvular debris. To avoid these complications, many authors suggest the possibility to resect and remove the native aortic valve before transcatheter aortic valve implantation. In this field, different authors have described possible techniques and different sources of energy to resect the calcified valve. In this article, we review the development of these experimental techniques and discuss future prospects in this field.

Sudden Onset Massive Paravalvular Aortic Regurgitation Induced by Balloon Rupture during Transcatheter Aortic Valve Implantation: A Case Report

A 78-year-old woman with severe aortic stenosis underwent transcatheter aortic valve implantation (TAVI) with a balloon expandable bioprosthesis: a 23-mm Sapien XT valve (Edwards Life Sciences, Inc., CA, USA). A set of the valve and a balloon (NovaFlex, Edwards Transfemoral Balloon Catheter, Edwards Life Sciences, Inc., CA, USA) was successfully delivered to an optimal position using a 16-French expandable introducer hydrophilic sheath. Inflation of the balloon was commenced, and expansion was initially smooth. However, it ruptured immediately before completion of expansion, resulting in a rapid deterioration in hemodynamics. Even though no migration of the stent valve was observed, transesophageal echocardiography and aortography revealed massive paravalvular aortic regurgitation (AR), suggesting that AR was attributable to insufficient expansion. After post -dilatation of the stent valve using a 23- mm balloon (Edwards Transfemoral Balloon Catheter, Edwards Life Sciences, Inc., CA, USA), the patient’s condition began to improve, and further aortography indicated an improvement in paravalvular AR. This case represented that balloon rupture could led to sudden onset massive paravalvular AR. Interventional cardiologists should recognize it as a significant complication in patients undergoing TAVI using a balloon-expandable bioprosthesis, with the possibility of severe cardiogenic shock.

Valve-in-Valve in the Tricuspid Position for a Stenosed Bioprosthesis

The strategy of transcatheter valve-in-valve implantation into failing mitral and aortic bioprosthetic valves is a documented approach. It allows one to avoid performing a high-risk repeat cardiac surgery in elderly patients with multiple comorbidities. Tricuspid valve-in-valve implantation has been documented only a few times in the literature. We report the case of a 65-year-old woman with a failing bioprosthetic tricuspid valve who had undergone 3 prior open heart operations. We attempted a transatrial transcatheter approach and successfully deployed a 29-mm Edwards Sapien balloon-expandable bioprosthesis into a severely stenotic tricuspid bioprosthesis. This case demonstrates the technical feasibility and safety of this approach.

Left Ventricular Embolization of an Aortic Balloon-Expandable Bioprosthesis: Balloon Capture and Reimpaction as an Alternative to Emergent Conversion to Open-Heart Surgery

An 83-year-old man with severe symptomatic aortic stenosis, deemed to be high risk for conventional surgery (Logistic EuroSCORE 26.63%, Society of Thoracic Surgeons Score 7.2%) was referred to our institution for a transcatheter aortic valve implantation. A transapical approach was chosen, because

Complete Crush of a Balloon-expandable Bioprosthesis After Prolonged Cardiopulmonary Resuscitation

We report on a case of an 88-year-old woman with severe aortic stenosis. Concomitant morbidities consisted of severe atherosclerosis, a large thoracoabdominal aortic aneurysm, atrial fibrillation, malignancy of the rectum with termino-terminal descendorectostomy, chronic renal insufficiency, and adipositas (body mass index, 31.1). Due to the high surgical risk (EuroSCORE II, 12.3%), the patient was considered to be a good candidate for transcatheter aortic valve implantation (TAVI). In an interdisciplinary approach the patient underwent transapical TAVI (Edwards Sapien XT, 26 mm) due to anatomic reasons (horizontal aorta) in addition to a large thoracoabdominal aneurysm that was mostly covered by thrombus formation (Figure A, B). Due to the relevant comorbidities, we decided to embed the TAVI as part of a staged procedure treatment strategy. The procedure went exceptionally well with a wire position that was kept at all times out of the thoracic aneurysm and was followed by a benign postinterventional course. As a sign of …

Direct Transatrial Transcatheter SAPIEN Valve Implantation Through Right Minithoracotomy in a Degenerated Mitral Bioprosthetic Valve

Transcatheter valve implantation into failing surgical mitral bioprosthetic valves have been reported. This strategy avoids performing high-risk repeat cardiac surgery in elderly patients with multiple comorbidities. All these patients have been treated by a transapical approach. We report a case of failing bioprosthetic mitral valve in an 82-year-old woman successfully treated with a 29-mm Edwards SAPIEN balloon expandable bioprosthesis (Edwards Lifesciences, Irvine, CA) with direct left atrial approach through a right anterior thoracotomy. Our experience demonstrates the technical feasibility and safety of this approach. Therefore, mitral valve-in-surgical valve implantation may be a viable treatment alternative in carefully selected patients.