Direct transapical aortic valve implantation: a modified transcatheter approach avoiding balloon predilatation

Transcatheter aortic valve implantation (T-AVI) is an accepted alternative treatment option for patients with aortic stenosis seen inoperable or high risk for aortic valve (AV) replacement. However, a significant risk of stroke and cerebrovascular complications raises concern. Cerebral embolizations during T-AVI are frequent and recent data demonstrates that balloon aortic valvuloplasty during transcatheter procedures causes nearly as many high-intensity transient signals and microembolic signals as the deployment of the transcatheter heart valve itself. Omitting predilatation, therefore, may reduce the incidence of microembolizations and a possible stroke. We have developed a novel technique of 'Direct Transapical Aortic Valve Implantation', which enables surgeons to avoid predilatation of the native AV. So far, a total of six consecutive patients were treated using the Edwards SAPIEN XT? transcatheter heart valve (Edwards Lifesciences, Irvine, CA, USA). Compared with conventional transapical implantations using the same device, procedure time was shorter, less contrast used and duration of fluoroscopy reduced. Procedural success was achieved in all patients, and all were discharged home without greater than or equal to moderate paravalvular leakage observed. Direct transapical implantation is technically safe and effective, with shorter radiation/procedure times. It is the next logical step in the direction of a full percutaneous transapical approach and potentially can result in reduced microembolizations.     

TAVI for pure aortic valve insufficiency in a patient with a left ventricular assist device

We report transcatheter aortic valve implantation (TAVI) for pure aortic valve insufficiency in a patient with an otherwise normal aortic valve and a long-term left ventricular assist device (LVAD). An oversized 29-mm Edwards SAPIEN valve (Edwards Lifesciences, Irvine, CA) was implanted in the 21-mm native aortic valve annulus. Despite the complete absence of aortic calcifications, the prosthesis remained stably anchored inside the annulus. The reported experience demonstrates that TAVI is feasible even in patients with pure aortic valve regurgitation and can be a reasonable option in patients with aortic regurgitation after LVAD implantation.     

Transapical valve implantation after David operation and stenting of the descending aorta

This case report illustrates our experience with transapical minimally invasive aortic valve implantation in a patient with an extended aneurysm of the thoracoabdominal aorta, who had previously undergone a replacement of the ascending aorta with concomitant aortic valve reconstruction (David procedure). Endovascular stent grafting of the descending aorta was also performed. The implantation of a 23-mm SAPIEN valve (Edwards Lifesciences, Irvine, CA) did not interfere with the existing 26-mm aortic Hemashield prosthesis (Boston Scientific, Natick, MA) or the previously implanted endograft in the descending aortic position. No paravalvular leakage with aortic valve regurgitation, prosthesis instability, or coronary malperfusion was seen after valve implementation.     

Association of transaortic approach and transoesophageal echocardiography as the primary imaging technique for improved results in transcatheter valve implantation

OBJECTIVES The transaortic access has been proposed to perform transcatheter aortic valve implantation in patients with no other available access. We hypothesize that its coupling with transoesophageal echocardiographic guidance may further reduce procedure-related morbidity. METHODS Transoesophageal echocardiography was adopted as the primary imaging modality to produce high-resolution images and to guide the deployment of the transcatheter valve. This imaging modality allows continuous visualization not only of the prosthesis and of the delivery system, but also of the surrounding anatomical landmarks (aortic annulus, sinotubular junction and anterior mitral leaflet). RESULTS We report an initial series of eight patients, who were treated by a transaortic delivery of the transcatheter valve (SAPIEN Valve, Edwards Lifesciences Inc., Irvine, CA, USA) through an upper mini-sternotomy and guided by transoesophageal echocardiography. The procedure was uneventful in all patients; there were no cases of access site morbidity, periprocedural stroke or renal failure. CONCLUSIONS The association of the transaortic route and the transoesophageal echo guidance has the potential to improve the results of transcatheter valve implantation, and deserves further investigation.     

A case of SAPIEN XT valve fallen into left ventricle during valve-in-valve transcatheter aortic valve implantation

Late transcatheter heart valve embolization is a rare but life-threatening complication of transcatheter aortic valve implantation. Surgical intervention is performed for most cases, but some cases were treated by valve-in-valve transcatheter aortic valve implantation. We describe a patient in whom a 29-mm Edwards SAPIEN XT valve migrated into the left ventricular outflow tract 41 days after the initial implantation. We tried to perform valve-in-valve transcatheter aortic valve implantation using a transfemoral approach. As soon as the second transcatheter heart valve touched the first implanted valve, it fell into the left ventricle. Immediate surgical intervention was required. The first valve was removed, and surgical aortic valve replacement was successfully performed. In conclusion, we should choose surgical aortic valve replacement for late transcatheter heart valve embolization. Even if we need to treat by catheter intervention, transapical approach may be better.     

Trans-catheter valve-in-valve implantation: in vitro hydrodynamic performance of the SAPIEN + cloth trans-catheter heart valve in the Carpentier-Edwards Perimount valves

Objective: Since 1990, over 1.2 million bioprosthetic valves were implanted for aortic stenosis. Given the risk of structural valve deterioration, the need to redo AVR will likely rise. Recently, SAPIEN valve-in-valve (ViV) has been advocated. We evaluated the in vitro hydrodynamic performance of the Edwards SAPIEN + cloth trans-catheter heart valve (THV) implanted within the Carpentier-Edwards Perimount (CEP) valve. Methods: Both 23- and 26-mm Edwards SAPIEN + cloth THVs (Model 9000MIS) were deployed within 23- or 25-mm (1) CEP aortic bioprosthesis (Models 2700 and 2800), (2) CEP Magna (Model 3000), and (3) CEP plus pericardial mitral (Model 6900P), respectively. Tests included: (1) mean pressure gradient; (2) pulsatile effective orifice area (EOA); (3) regurgitant volume; (d) migration during accelerated wear testing (AWT; 20 million cycles @ 200 mmHg); and (5) valve dislodgement pressure. Values tested per ISO 5840:2005 valve standards; mean ± SD. Results: Post-deployment pressure gradient across the combined valves ranges from 2.8 ± 0.3 to 8.7 ± 0.5 mmHg. The post-deployment EOA of the valves ranged from 1.7 ± 0.1 to 2.0 ± 0.0 cm². Pulsatile flow regurgitant volume ranged from 2.1 ± 0.7 to 7.6 ± 1.2 ml. Migration during the AWT ranged from 0.01 ± 0.27 to 1.61 ± 0.92 mm. Pressure increase during the tests to quantify migration ranged from >400 to >800 mmHg. Conclusions: Compared with the rigorous ISO 5840:2500 valve standards, the Edwards SAPIEN + cloth THV implanted ViV within the CEP valve demonstrated excellent hydrodynamic performance.     

经导管心脏瓣膜研究进展

经导管主动脉瓣置换术已成为治疗严重主动脉瓣狭窄的主要方式,目前市售瓣膜主要包括球囊可膨胀瓣膜和自膨胀瓣膜。新一代球囊可膨胀瓣膜由SAPIEN XT和SAPIEN 3瓣膜组成,最新自膨胀瓣膜为可重新定位的Evolut Pro系统。本文对经导管心脏瓣膜研究进展进行综述。     

Transcatheter aortic valve implantation: first trans-iliac experience in Japan

Conventional aortic valve replacement (AVR) is the gold standard surgical treatment for symptomatic aortic valve stenosis. However, some patients are not referred for open surgical procedure because of their high risk due to complicated co-morbidities. We describe the first case in Japan of successful transcatheter aortic valve implantation (TAVI). An 81-year-old woman with severe interstitial pneumonia was referred for significant aortic valve stenosis. Conventional AVR might have been risky, so TAVI was planned after informed consent was obtained. Under general anesthesia was established, a 23-mm Edwards SAPIEN transcatheter heart valve was implanted through the common iliac artery. Postoperative echocardiographic assessment showed satisfactory hemodynamic function with a stable valve position, and she was discharged on day 7 without complications. At the 6-month follow-up, there had been no untoward events, and there was marked improvement in her functional status. TAVI for symptomatic aortic valve stenosis is a less invasive, alternative approach for high-risk patients.     

Stent and leaflet stresses in 26-mm,third-generation,balloon-expandable transcatheter aortic valve

Objectives

Transcatheter aortic valve replacement has proven successful in treating intermediate-risk, high-risk, and inoperable patients with severe aortic stenosis. Third-generation, balloon-expandable transcatheter aortic valves were developed with an outer sealing skirt to reduce paravalvular leakage. As transcatheter aortic valve replacement use expands, long-term durability questions remain. Valve design influences durability, where regions of increased leaflet stress are vulnerable to early degeneration. However, third-generation transcatheter aortic valve stresses are unknown. Our goals were to determine the stent and leaflet stresses of third-generation, balloon-expandable transcatheter aortic valves.

Transfemoral aortic valve replacement with the SAPIEN XT valve: step-by-step

Transcatheter aortic valve replacement (TAVR) has become an attractive alternative for patients with severe aortic stenosis at high surgical risk. We describe a step-by-step approach to performing TAVR with the SAPIEN XT valve.     

Management of aortic valve dysfunction after transapical approach using the technique "valve after valve"

We report a case of a 77-year-old patient with severe aortic stenosis who underwent transapical aortic valve implantation with a 23-mm Edwards Sapien valve (Edwards Lifesciences Inc, Irvine CA). This procedure was complicated with the occurrence of an acute regurgitation due to entrapment of one of the leaflets that was successfully managed by valve after valve technique.     

Transapical minimally invasive aortic valve implantation; the initial 50 patients

OBJECTIVE: To evaluate the feasibility of minimally invasive transapical beating heart aortic valve implantation (TAP-AVI) for high-risk patients with aortic stenosis. METHODS: TAP-AVI was performed via a small anterolateral minithoracotomy in 50 patients from February 2006 to March 2007. A balloon expandable transcatheter xenograft (Edwards SAPIEN THV, Edwards Lifesciences, Irvine, CA, USA) was used. Mean age was 82.4+/-5 years and 39 (78%) were female. Implantation was performed in a hybrid operative theatre using fluoroscopic and echocardiographic visualization. Average EuroSCORE predicted risk for mortality was 27.6+/-12%. Seven (14%) patients were re-operations with patent bypass grafts. RESULTS: TAP-AVI (13 patients 23 mm and 37 patients 26 mm) was successfully performed on the beating heart under temporary rapid ventricular pacing in 47 (94%) patients, and implantation was performed completely off-pump in 34 (68%) patients. Three patients required early conversion; two of them were successfully discharged. There was no prosthesis migration or embolization observed. Echocardiography revealed good hemodynamic function in all and minor incompetence in 23 patients, mostly paravalvular, without any signs of hemolysis. Mortality was due to the overall health condition and non-valve related in all patients. Actuarial survival at 1 month, 6 months and 1 year was 92+/-3.8%, 73.9+/-6.2% and 71.4+/-6.5%, respectively. CONCLUSIONS: Transapical minimally invasive aortic valve implantation is feasible using an off-pump technique. Good results have been achieved in the initial 50 patients, especially when considering the overall high-risk profile of these patients.     

Transcatheter aortic valve implantation with balloonexpandable valve: early experience from China

Objective

The aim of the current study was to evaluate the early experience of the application of transcatheter aortic valve implantation with the balloon-expandable system in China. The transcatheter aortic valve implantation technology has been widely used for patients with inoperable severe aortic stenosis in the developed world. The application of transcatheter aortic valve implantation is still in the early stages of testing in China, particularly for the balloon-expandable valve procedure.

Methods

This was a retrospective study. All patients undergoing transcatheter aortic valve implantation with balloon-expandable system in our hospital between 2011 and 2014 were included. Edwards SAPIEN XT Transcatheter Heart Valve was used. The improvement of valve and heart function was evaluated as well as 30-day mortality and major complications according to the VARC-2 definition.

Results

A total of 10 transcatheter aortic valve implantation procedures with the balloon-expandable system were performed in our hospital, of which 9 were transfemoral and 1 was transapical. The median age was 76 years, and the median STS score and Logistic EuroSCORE (%) were 8.9 and 16.2. The implantation was successfully conducted in all patients, only 2 patients had mild paravalvular leak. There was no second valve implantation. Moreover, no 30-day mortality or complications was reported. Following the transcatheter aortic valve implantation procedure, the heart and valve functions had improved significantly. During the follow-up period of 3-34 months, one patient died of lung cancer 13 months after the operation.

Conclusion

This early experience has provided preliminary evidence for the safety and efficacy of transcatheter aortic valve implantation procedure with the balloon-expandable system in the developing world with an increasing aging population.     

Transapical approach for sutureless stent-fixed aortic valve implantation: experimental results.

OBJECTIVE: Percutaneous aortic valve implantation has been performed in patients with severe aortic stenosis judged as nonsurgical candidates. We evaluated a facilitated transapical antegrade approach for potential use in surgical high-risk patients. METHODS: A pericardial xenograft fixed within a 23-mm stent (Cribier-Edwards aortic prosthesis, Edwards Inc., Irvine, CA, USA) was implanted using a transapical approach in fifteen 35-45 kg pigs. A limited or a full sternotomy was used to transapically introduce a crimped valve through a 24-F sheath. Deployments were performed on the beating heart either with ventricular unloading using femoro-femoral cardiopulmonary bypass (CPB) or rapid ventricular pacing (RVP), all under fluoroscopic and echocardiographic visualization. RESULTS: All valves were successfully deployed at the target site with acceptable visualization of the noncalcified annulus. Valve migration occurred in six procedures (three distal and three retrograde) secondary to inadequate reduction of ventricular output, unfavorable annular anatomy, excessive crimping of the valve, and dislodgement by the delivery balloon. Exact positioning of the valve into the target area was confirmed by autopsy at the end of the procedures. Paravalvular leak was noted in five implants. CONCLUSIONS: The transapical approach provides a safe, accurate, and effective route for facilitated antegrade delivery of a stent-fixed valve. Advanced stent design will lead to better stability of the implant and may minimize the risk of paravalvular leakage in future. Identifying the appropriate population for human feasibility trials remains a challenge.     

Transcatheter valve-in-valve implantation Edwards Sapien XT in a direct flow valve after early degeneration

In recent years, the use of bioprosthetic valve (BPV) has increased significantly with both surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI) due to reasons such as the advantage of not using anticoagulants. Nevertheless, major disadvantage of all BPV is the risk of early structural valve deterioration, leading to valve dysfunction, and requires reoperation, which significantly increases the risk of mortality or major morbidity especially after SAVR. There are a limited number of TAV-in-TAV case reports due to TAVI BPV degeneration. In our knowledge, this is the second report of TAV-in-TAV implantation wherein a previously implanted transfemoral 25-mm nonmetallic Direct Flow SVD valve treated with ViV TAVI via Edwards Sapien XT.     

Commissural detachment and Valsalva sinus dilatation after implantation of Prima Plus stentless valve with full root technique

The stentless aortic bioprosthesis has been used because of its excellent hemodynamics and few valve-related complications. We report a case of redo aortic root replacement for severe aortic regurgitation and dilatation of the Valsalva sinus 7 years after the implantation of a Prima Plus aortic root bioprosthesis (Edwards LifeScience, Irvine, CA, USA) using a full root technique. Intraoperative findings showed the complete detachment of the commissure between the left and non-coronary cusps, and Valsalva sinus dilatation of the porcine aortic root bioprosthesis. Redo aortic root replacement with a 23-mm porcine bioprosthesis and 28-mm straight graft was performed. There were no findings of intimal tear, suture dehiscence, degeneration, and perforation of the bioprosthesis. Such complications associated with the Edwards Prima Plus aortic root bioprosthesis were rarely reported. Commissural detachment of a porcine stentless aortic bioprosthesis can occur; thus, careful follow-up involving echocardiography and computed tomography is necessary.     

Effect of Balloon‐Expandable Transcatheter Aortic Valve Replacement Positioning: A Patient‐Specific Numerical Model

Transcatheter aortic valve replacement (TAVR) has emerged as a life‐saving and effective alternative to surgical valve replacement in high‐risk, elderly patients with severe calcific aortic stenosis. Despite its early promise, certain limitations and adverse events, such as suboptimal placement and valve migration, have been reported. In the present study, it was aimed to evaluate the effect of various TAVR deployment locations on the procedural outcome by assessing the risk for valve migration. The deployment of a balloon‐expandable Edwards SAPIEN valve was simulated via finite element analysis in a patient‐specific calcified aortic root, which was reconstructed from CT scans of a retrospective case of valve migration. The deployment location was parametrized in three configurations and the anchorage was quantitatively assessed based on the contact between the stent and the native valve during the deployment and recoil phases. The proximal deployment led to lower contact area between the native leaflets and the stent which poses higher risk for valve migration. The distal and midway positions resulted in comparable outcomes, with the former providing a slightly better anchorage. The approach presented might be used as a predictive tool for procedural planning in order to prevent prosthesis migration and achieve better clinical outcomes.     

Serial Doppler echocardiographic evaluation of small-sized sorin bicarbon prostheses

OBJECTIVE: The Sorin Bicarbon prosthesis (Sorin Biomedica, Saluggia, Italy) is a bileaflet valve with curved-profile leaflets, a rolling hinge mechanism, and a pyrolytic carbon-coated titanium alloy housing and sewing ring. Although the Sorin Bicarbon prosthesis has been implanted in greater than 80,000 patients, and reference values on the hemodynamic performance of valve prostheses are needed to avoid patient-prosthesis mismatch, few Doppler echocardiographic data are available on the prosthesis in the aortic position. The aim of this study is to provide a detailed echocardiographic evaluation of the hemodynamic performance and regression of left ventricular hypertrophy after aortic valve replacement with the Sorin Bicarbon prosthesis. METHODS: The study included 182 patients who received a 21-mm (n = 61) or 23-mm (n = 121) Sorin Bicarbon prosthesis for pure or prevalent aortic stenosis who underwent serial echocardiograms at 3, 6, and 12 months after aortic valve replacement. RESULTS: Mean and peak gradients significantly decreased (P <.001) during follow-up to values of 12 +/- 3 and 22 +/- 6 mm Hg for the 21-mm prosthesis and values of 11 +/- 4 and 19 +/- 6 mm Hg for the 23-mm prosthesis at 1 year. Left ventricular mass index showed a 17% decrease to 120 +/- 27 g/m(2) in recipients of the 21-mm prosthesis (P <.001) and a 21% decrease to 123 +/- 29 g/m(2) in recipients of the 23-mm prosthesis (P <.001). A larger prosthesis size was the only predictor of a higher left ventricular mass index regression. Among recipients of the 21-mm prosthesis, body surface area of greater than 1.85 m(2) was associated with a lower regression of left ventricular mass index. The effective orifice area index was 1.00 +/- 0.11 and 1.08 +/- 0.14 cm(2)/m(2) in recipients of the 21-mm and 23-mm prostheses, respectively. CONCLUSIONS: Size 21 mm and 23 mm Sorin Bicarbon prostheses show low transprosthetic gradients, with significant reduction of left ventricular mass index during the first postoperative year. The reported effective orifice areas might be useful for aortic valve replacement in patients with a small aortic annulus to avoid patient-prosthesis mismatch.     

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.     

Transapical implantation of a self-expanding aortic valve bioprosthesis — animal feasibility study

Background: Severe peripheral arterial disease may pose a limitation to the applicability of trans-arterial aortic valve implantation in patients who are otherwise candidates. For this reason, transapical aortic valve implantation has been proposed as a possible alternative. Objective: To evaluate the acute safety and performance of a specially designed delivery system, the CoreValve Tranzap™ delivery catheter, for the transapical implantation of a self-expandable aortic valve prosthesis in a porcine animal model. Methods: Thirteen pigs were implanted with a self-expandable aortic valve bioprosthesis using a 21F catheter delivery system through a transapical approach. The delivery system was evaluated for: (1) the ability to access the implantation site; (2) the ability to precisely position the delivery catheter; (3) control of the delivery of the prosthesis; (4) safe retrieval of the delivery catheter; and (5) the ability to close the apical access site of the heart. Results: Successful implantation was achieved in 100% of the cases. The following points were achieved in all animals: (1) passage of the delivery catheter through an incision in the left ventricular apex; (2) positioning of the delivery catheter on the implantation site; (3) controlled deployment of the aortic valve prosthesis; (4) the safe retrieval of the delivery catheter system; and (5) the adequate closure of the apex of the heart. Conclusion: This study demonstrates the acute safety and feasibility of the CoreValve Tranzap™ delivery system for the transapical implantation of the CoreValve self-expanding aortic valve bioprosthesis in a porcine animal model.