Transcatheter Valve Implantation Research Articles

VD01 A CASE OF “VERY” SIMULTANEOUS TRANSAPICAL TRANSCATHETER AORTIC AND MITRAL VALVE IMPLANTATION

Abstract The ever widening diffusion of biological prostheses and the achievement of higher mean age have focused attention on new possible scenario: off-label use of transcatheter valve implantation (TAVI) via a valve-in-valve procedure as an alternative strategy to standard surgery redo valve replacement. We report the first simultaneous Transapical Transcatheter Aortic and Mitral Valve Implantation performed after contemporary wires positioning in aortic and mitral size. After apical puncture, soft and subsequent stiff guidewires were inserted trans-apically through the 2 prosthesis. The first wire was advanced through the aortic prosthesis and placed in femoral artery. The second one was inserted through the mitral prosthesis and placed in right superior pulmonary vein. The aortic prosthesis was introduced through a trans-apically placed sheath, positioned, and then deployed into the degenerated aortic bioprosthesis under fluoroscopic guidance. The same procedure was used for mitral prosthesis using the previous positioned wire.

TCT-686 Mixed aortic valve disease: Impact on outcome after transcatheter aortic valve implantation

The introduction of transcatheter valve implantation (TAVI) into clinical practice has provided new treatment options for patients with severe aortic valve stenosis. Mixed aortic valve disease with concomitant aortic regurgitation is common amongst these patients. We sought to investigate in

Concurrent transcatheter transfemoral tricuspid valve-in-valve and aortic valve implantation using a 3D printed model for pre-OT planning.

Re-operation of a tricuspid bioprosthesis carries high morbidity and mortality, especially when carried out with other concomitant valvular heart surgery. Concurrent transcatheter valve implantation has evolved as an alternative option. Here we report on a 77-year-old lady who suffered from symptomatic severe recurrent stenosis of a tricuspid bioprosthesis (Sorin Pericarbon More, 27) and moderate to severe aortic stenosis (AS) who was declined for redo open heart surgery as it was deemed very high risk. We used a 3D customised printed right heart model for pre-OT rehearsal. Percutaneous V-in-V TVR using a 26 mm Edwards SAPIEN 3 was performed under general anaesthesia via the right femoral vein and showed a satisfactory result in one single attempt. We also evaluated the necessity of aortic valve intervention in detail before and after V-in-V TVR. After confirmation of severe AS, a 26 mm Medtronic CoreValve Evolut R was deployed in the non-calcified rheumatic aortic valve without any predilatation or post-dilatation via the right femoral artery. No significant gradient or leakage was seen. This case shows the feasibility and safety of concurrent transfemoral V-in-V TVR and TAVI. Rehearsal using a 3D printed model helped to increase the accuracy and success rate of the procedure. The transcatheter approach allows detailed haemodynamic assessment after each valvular intervention in the case of multiple valve interventions.

Effect of SAPIEN 3 Transcatheter Valve Implantation on Health Status in Patients With Severe Aortic Stenosis at Intermediate Surgical Risk: Results From the PARTNER S3i Trial

ObjectivesThe aim of this study was to evaluate whether transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve (S3-TAVR) results in improved quality of life (QoL) compared with previous-generation TAVR devices or surgical aortic valve replacement (SAVR). BackgroundIn patients with severe aortic stenosis at intermediate surgical risk, TAVR using the SAPIEN XT valve (XT-TAVR) results in similar QoL compared with SAVR. Compared with SAPIEN XT, the SAPIEN 3 valve offers a lower delivery profile and modifications to reduce paravalvular regurgitation. MethodsBetween February and December 2014, 1,078 patients at intermediate surgical risk with severe aortic stenosis were treated with S3-TAVR in the PARTNER S3i (Placement of Aortic Transcatheter Valve) trial. QoL was assessed at baseline, 1 month, and 1 year using the Kansas City Cardiomyopathy Questionnaire, Medical Outcomes Study Short Form-36, and EQ-5D. QoL outcomes of S3-TAVR patients were compared with those in the SAVR and XT-TAVR arms of the PARTNER 2A trial using propensity score stratification to adjust for differences between the treatment groups. ResultsOver 1 year, S3-TAVR was associated with substantial improvements in QoL compared with baseline. At 1 month, S3-TAVR was associated with better QoL than either SAVR or XT-TAVR (adjusted differences in Kansas City Cardiomyopathy Questionnaire overall summary score 15.6 and 3.7 points, respectively; p < 0.001). At 1 year, the differences in QoL between S3-TAVR and both SAVR and XT-TAVR were reduced but remained statistically significant (adjusted differences 2.0 and 2.2 points, respectively; p < 0.05). Similar results were seen for generic QoL outcomes. ConclusionsAmong patients at intermediate surgical risk with severe aortic stenosis, S3-TAVR resulted in improved QoL at both 1 month and 1 year compared with both XT-TAVR and SAVR.

Recent advances in transcatheter management of pulmonary regurgitation after surgical repair of tetralogy of Fallot.

Surgical repair of tetralogy of Fallot (ToF) in childhood is associated with generally good outcomes, and almost all children can be expected to survive until adulthood. However, significant pulmonary regurgitation leading to progressive right ventricular dilatation is common in teenagers or young adults because of the nature of the surgical intervention. In patients whose repair included placement of a right ventricle to pulmonary artery conduit, it has been possible to place a stented valve within the conduit to treat this. Pulmonary regurgitation after repair of ToF via a transannular patch technique has historically involved repeat surgery as the dimensions of the right ventricular outflow tract have been too large for commercially available valves. This review summarises the novel transcatheter valves available for management of pulmonary regurgitation after surgical repair of ToF in patients in whom the dimensions of the right ventricular outflow tract have previously been considered too large for transcatheter valve implantation.

Innovative interventional catheterization techniques for congenital heart disease.

Since 1929, when the first cardiac catheterization was safely performed in a human by Dr. Werner Forssmann (on himself), there has been a rapid progression of cardiac catheterization techniques and technologies. Today, these advances allow us to treat a wide variety of patients with congenital heart disease using minimally invasive techniques; from fetus to infants to adults, and from simple to complex congenital cardiac lesions. In this article, we will explore some of the exciting advances in cardiac catheterization for the treatment of congenital heart disease, including transcatheter valve implantation, hybrid procedures, biodegradable technologies, and magnetic resonance imaging (MRI)-guided catheterization. Additionally, we will discuss innovations in imaging in the catheterization laboratory, including 3D rotational angiography (3DRA), fusion imaging, and 3D printing, which help to make innovative interventional approaches possible.

Pitfalls and Safeguards in the Open Implantation of Mitral Transcatheter Valves in Patients with Increased Risk of Annulus Rupture

Pitfalls and Safeguards in the Open Implantation of Mitral Transcatheter Valves in Patients with Increased Risk of Annulus Rupture

Transcatheter Double Valve Replacement of an Aortic and Mitral Valve in the Native Annulus

The role of percutaneous technology for aortic valve replacement therapy has been well established in the literature. However, transcatheter therapies for mitral valve disease are still in a very early phase. Successful transcatheter valve implantation in mitral valves with calcified annulae via different access sites has been reported. Most of the procedures that have been done are not well described or illustrated. We describe here the technique for performing a double transcatheter valve replacement in the native calcified aortic and mitral annulus utilizing a percutaneous transfemoral approach.

Reduced inflammatory response by transcatheter, as compared to surgical aortic valve replacement

Objectives. The inflammatory response to on-pump cardiac surgery is well known. Systemic inflammatory response syndrome after transcatheter valve implantation (TAVI) has been reported. The objective of this study was to study the inflammatory response during TAVI, and compare with the response during surgical aortic valve replacement. Methods. Eighteen patients undergoing transcatheter implantation, either by a transfemoral (n = 9) or transaortal (n = 9) approach were compared with eighteen patients admitted for surgical replacement. Blood samples per- and postoperatively were analysed for C3bc, terminal complement complex, myeloperoxidase, macrophage inflammatory protein-1β, monocyte chemo-attractant peptide-1, eotaxin, IL-6 and troponin-T. All markers were measured at defined time points and the areas under the curve were compared. Results. Activation of complement, granulocytes, monocytes and eosinophils were significantly lower in the transcatheter group as compared to the surgical group (<0.01). There was no difference in generation of troponin T and IL-6. A small difference in complement activation was observed between the transfemoral and transaortal placement of TAVI. There was no significant difference in clinical outcomes between the TAVI and surgical groups. Discussion. Activation and release of inflammatory markers was significantly less during with TAVI as compared to SAVR, particularly for markers associated with extracorporeal circulation. TAVI and SAVR generated the same degree of IL-6 and troponin T, indicating that the burden on the myocardial tissue was the same.Clinical Trials: Gov ID: NCT03074838 Unique protocol ID: 2012/7919

Transcatheter Mitral Valve Implantation in Open Heart Surgery: An Off-Label Technique

Extensive mitral annulus calcifications are considered a contraindication for valve surgery. We describe the case of a 76-year-old female with severe mitral and aortic stenosis associated with extensive calcifications of the heart. The patient underwent an open mitroaortic valve replacement using transcatheter aortic valve implantation with an Edwards SAPIEN XT valve (Edwards Lifesciences Corp., Irvine, CA, USA) in the mitral position. The aortic valve was replaced using a stentless valve prosthesis (LivaNova SOLO; LivaNova PLC, London, UK). Postoperative echocardiography showed that the prosthetic valve was in the correct position and there were no paravalvular leaks. A bailout open transcatheter valve implantation can be considered a safe and effective option in selected cases with an extensively calcified mitral valve.

Abstract 23085: 30-Day Outcomes of Transseptal Transcatheter Mitral Valve Replacement for Failed Surgical Bioprostheses (Mitral Valve-in-Valve): The MITRAL Trial (Mitral Implantation of TRAnscatheter vaLves)

Introduction: Transcatheter mitral valve replacement (TMVR) using aortic transcatheter heart valves (THV) is developing as an alternative to surgery for patients with severely degenerated mitral valve (MV) bioprostheses. Retrospective self-reported registries have collected outcomes on these TMVR procedures in the STS/ACC Transcatheter Valve Therapy Registry and in the Valve-in-Valve International Database. Most reported TMVR procedures for failed surgical bioprostheses have been performed using a transapical access approach. A prospective comprehensive evaluation of mitral Valve-in-Valve (VIV) outcomes, including transseptal access has not previously been conducted. Objectives: To evaluate in-hospital and 30-day clinical outcomes of transseptal mitral VIV with SAPIEN 3 THV in patients with very high surgical risk. Methods: Prospective enrollment of very high surgical risk patients with symptomatic severely degenerated MV surgical bioprostheses in 30 patients at 15 sites in the U.S. Candidates were assessed by a case review committee prior to approval. Baseline qualifying echocardiograms and cardiac CT studies were analyzed by independent core labs. Echocardiograms, cardiac CT studies and neurology evaluations were also performed after mitral VIV procedures. Clinical events were adjudicated by a clinical events committee and safety was monitored by a data safety monitoring board. Results: 26 patients have been enrolled between July 2016 and June 2017. Mean age was 83 years, 62% female, mean STS score was 10% and 62% were in New York Heart Association class III or IV. Transseptal access was used in all procedures. Technical success was achieved in all patients and there was no in-hospital mortality. There was no 30-day cardiovascular mortality and 4% (1 patient) 30-day all-cause mortality (1 patient died of asphyxia on day 29 after choking on pills at home), which was lower than the 30-day mortality in the TVT registry (9%). Detailed procedural, in-hospital and 30-day outcomes will be presented on the complete cohort of 30 patients. Conclusions: In patients without surgical alternatives, transseptal mitral ViV procedures in failed surgical bioprostheses are associated with high technical and procedural success and low 30-day mortality.

Transcatheter valve implantation to inferior vena cava to control carcinoid symptoms

Severe carcinoid syndrome and carcinoid heart disease in neuroendocrine tumours can have a significant impact on a patient’s quality of life and are a major cause of morbidity and mortality....

TCT-279 Baseline and dobutamine stress hemodynamic physiology of the stenotic aortic valve before and after transcatheter valve implantation

TCT-279 Baseline and dobutamine stress hemodynamic physiology of the stenotic aortic valve before and after transcatheter valve implantation

TCT-227 Prognostic impact of obesity on transcatheter valve implantation for severe aortic valve stenosis

TCT-227 Prognostic impact of obesity on transcatheter valve implantation for severe aortic valve stenosis

Early Outcomes of Percutaneous Transvenous Transseptal Transcatheter Valve Implantation in Failed Bioprosthetic Mitral Valves, Ring Annuloplasty, and Severe Mitral Annular Calcification

ObjectivesThe aim of this study was to examine 1-year outcomes of transseptal balloon-expandable transcatheter heart valve implantation in failed mitral bioprosthesis, ring annuloplasty, and mitral annular calcification (MAC). BackgroundImmediate outcomes following transseptal mitral valve implantation in failed bioprostheses are favorable, but data on subsequent outcomes are lacking. MethodsPercutaneous transseptal implantation of balloon-expandable transcatheter heart valves was performed in 87 patients with degenerated mitral bioprostheses (valve in valve [VIV]) (n = 60), previous ring annuloplasty (valve in ring) (n = 15), and severe MAC (valve in MAC) (n = 12). ResultsThe mean Society of Thoracic Surgeons risk score was 13 ± 8%, and the mean age was 75 ± 11 years. Acute procedural success was achieved in 78 of 87 patients (90%) in the overall group and 58 of 60 (97%) in the VIV group, with a success rate of 20 of 27 (74%) in the valve in ring/valve in MAC group. Thirty-day survival free of death and cardiovascular surgery was 95% (95% confidence interval [CI]: 92% to 97%) in the VIV subgroup and 78% (95% CI: 70% to 86%) in the valve in ring/valve in MAC group (p = 0.008). One-year survival free of death and cardiovascular surgery was 86% (95% CI: 81% to 91%) in the VIV group compared with 68% (95% CI: 58% to 78%) (p = 0.008). At 1 year, 36 of 40 patients (90%) had New York Heart Association functional class I or II symptoms, no patients had more than mild residual mitral prosthetic or periprosthetic regurgitation, and the mean transvalvular gradient was 7 ± 3 mm Hg. ConclusionsOne-year outcomes following successful transseptal balloon-expandable transcatheter heart valve implantation in high-risk patients with degenerated mitral bioprostheses are excellent, characterized by durable symptom relief and prosthesis function. Although mitral valve in ring and valve in MAC have higher operative morbidity and mortality, 1-year outcomes after an initially successful procedure are favorable in carefully selected patients.

Transcatheter Aortic Valve Replacement: Outcomes, Indications, Complications, and Innovations.

Transcatheter aortic valve replacement (TAVR) has become the standard of care for the treatment of severe aortic stenosis in individuals who are at prohibitive surgical risk and presents a viable alternative to surgery in selected patients who are at high operative risk. To date, outcomes from the PARTNER (Placement of AoRtic TraNscathetER Valve) and Medtronic CoreValve® US Pivotal trials continue to show the benefits of TAVR in these high-risk subgroups out to 5 and 3years, respectively (as reported by Mack et al. Lancet. 85:2477-2484 2015; Kapadia et al. Lancet. 385:2485-2491 2015; Deeb et al. J Am Coll Cardiol. 67:2565-2574 2016). Furthermore, the recent release of the PARTNER-2 and SURTAVI trial results among other international data suggest that clinical outcomes for intermediate risk patients may be promising for TAVR compared to surgical aortic valve replacement (SAVR) (as reported by Leon et al. N Engl J Med. 374:1609-1620 2016; Reardon et al. N Engl J Med. 376:1321-1331 2017). However, several questions persist regarding TAVR-specific complications as well as long-term durability. Paravalvular regurgitation, permanent pacemaker implantation, stroke, vascular access injury, and renal failure in post-TAVR patients remain adversaries in the quest to perfect this groundbreaking, game-changing technology (as reported by Khatri et al. Ann Intern Med. 158:35-46 2013). In this review, we provide an up-to-date synopsis of results from landmark clinical trials that cumulatively attest to the comparability of TAVR to best medical therapy and SAVR in extreme-risk, high-risk, and intermediate-risk patient populations. We continue with a review of studies that seek to compare transcatheter vs. surgical valve implantation in lower-risk subgroups. We also introduce ongoing efforts to optimize the peri-procedural management of TAVR and conclude with a presentation of management strategies and new generation valve platforms that seek to address some of the current limitations of transcatheter valve implantation.

Conduction Disturbances After Transcatheter Aortic Valve Replacement: Current Status and Future Perspectives.

Transcatheter aortic valve replacement (TAVR) has become a well-accepted option for treating patients with aortic stenosis at intermediate to high or prohibitive surgical risk. TAVR-related conduction disturbances, mainly new-onset left bundle-branch block and advanced atrioventricular block requiring permanent pacemaker implantation, remain the most common complication of this procedure. Furthermore, improvements in TAVR technology, akin to the increasing experience of operators/centers, have translated to a major reduction in periprocedural complications, yet the incidence of conduction disturbances has remained relatively high, with perhaps an increasing trend over time. Several factors have been associated with a heightened risk of conduction disturbances and permanent pacemaker implantation after TAVR, with prior right bundle-branch block and transcatheter valve type and implantation depth being the most commonly reported. New-onset left bundle-branch block and the need for permanent pacemaker implantation may have a significant detrimental association with patients' prognosis. Consequently, strategies intended to reduce the risk and to improve the management of such complications are of paramount importance, particularly in an era when TAVR expansion toward treating lower-risk patients is considered inevitable. In this article, we review the available evidence on the incidence, predictive factors, and clinical association of conduction disturbances after TAVR and propose a strategy for the management of these complications.

Comparison of hemodynamic and clinical outcomes of transcatheter and sutureless aortic bioprostheses: how to make the right choice in intermediate risk patients

Current surgical treatment options for aortic valve stenosis (AS), as alternatives to that of conventional operation with a midline sternotomy, include sutureless valve replacement (SUAVR) and transcatheter valve implantation (TAVI). Patients with high surgical risk, or those who are judged to be inoperable, are typically good candidates for the TAVI procedure. The best treatment option in patients with an intermediate risk profile, however, the so called "grey zone", is still currently under debate. Sutureless aortic valve replacement has been recently presented as a valid alternative for patients with low- to intermediate-risk. Data available on prostheses' hemodynamic performance and patients' clinical outcomes play a crucial role in the process of device selection. Compared to TAVI, SUAVR provides lower rate of significant postoperative paravalvular leak (PVL), which has shown to be a predictor for mortality. On the contrary, transcatheter valves seem to perform better in terms of transvalvular mean and peak gradients. Therefore, SUAVR and TAVI are both reliable options in patients with severe aortic valve stenosis, as an alternative to conventional surgery, and the choice of the best device should be tailored to patient's anatomical and surgical characteristics.

Transcatheter Valve Implantation in Mitral Annular Calcification During Open Surgery: Extended Collar Technique

We describe an improvised technique during open surgery of inserting a transcatheter heart valve in the mitral position under very challenging circumstances. This is the first described use of the "extended collar" technique, which allowed implantation of a transcatheter heart valve in severe mitral valve annular calcification, into which a surgical valve could not safely be implanted. We believe that this technique is reproducible and may be helpful to other surgeons when faced with similar difficult circumstances.

Transseptal transcatheter mitral valve-in-valve: A step by step guide from preprocedural planning to postprocedural care.

Transcatheter mitral valve replacement has been successfully performed with the use of aortic transcatheter heart valves in hundreds of patients worldwide with severe dysfunction of a degenerated mitral bioprosthesis and high surgical risk for repeat operation. The delivery approach in the vast majority of the mitral valve-in-valve procedures has been transapical. Although the transseptal approach may be more technically challenging, it is less invasive and may be preferred by patients. Data from case series and a large international registry suggest that patients treated with transseptal mitral valve-in-valve have faster recovery, more improvement in left ventricular ejection fraction and possibly lower mortality compared with patients treated with transapical approach. A prospective clinical trial, the MITRAL trial (Mitral Implantation of TRAnscatheter vaLves) is evaluating the safety and feasibility of transvenous transseptal mitral valve-in-valve. The experience from this trial has allowed us to improve our procedural approach. In anticipation of a wider adoption of the transseptal approach for mitral valve-in-valve, we describe our current method step-by-step from planning the procedure through postprocedural management. This is an evolving technique that has changed with experience and the transition to newer generation transcatheter heart valve devices. We discuss the use of cardiac computed tomography for planning the procedure including transseptal puncture and valve size selection, provide procedural and technical tips, and discuss postprocedural care.