Comparison of the surgical and transcatheter aortic valve replacement in high-risk patients

Introduction: Transcatheter aortic valve implantation (TAVI) has evolved as an alternative method for surgical valve replacement in high-risk patients. Initially the transfemoral (TF) approach was used, later the transapical (TA) approach was adopted as an option for selected patients. The aim of our study was to compare the safety and anatomical and functional success of TAVI procedures with surgical aortic valve replacement (SAVR).Material and methods: The study included 45 consecutive high-risk patients with symptomatic severe aortic stenosis indicated for aortic valve intervention who met the entry criteria (age >75 years; logistic Euroscore >15%). The patients were allocated to one of three groups according the type of procedure: SAVR (n=15), TAVI TA (n=15) and TAVI TF (n=15). The groups did not differ in their preoperative characteristics except for myocardial infarction, which was more common in the TAVI groups. The Edwards Sapien valve was implanted in the TAVI patients and Edwards Perimount bioprosthesis was used in the SAVR patients. The TA approach was used in patients who were not eligible for the TF approach.Results: All procedures were technically successful. The prostheses used in the SAVR group were smaller in size than those implanted in the TA and TF groups (SAVR, 22.2(21.7;22.8); TA, 24.0(23.6;24.3); TF, 25.0(24.6;25.3)). The TA group patients were exposed to radiation for a shorter period and received a larger amount of contrast medium (TA, 9.7(9.0;10.5)min and 278.3(238.5;318.1)ml; TF, (15.0(13.7;16.4)min, 200.7(179.2;222.1)ml) in TF group). There were no statistically significant differences in the duration of procedures, stay in the intensive care unit and in the hospital, and intra- and post-operative complications among the groups. Early mortality (30 days) was 2.2%. One patient died of clostridium sepsis on day 12 (early mortality, 2.2%). Another patient died due to the multi-organ failure on the 58th day of hospital stay. Five other patients died during one-year follow-up (one-year survival rate, 86.3%). The functional class highly improved in all the patients, of whom 80% were with NYHA classes I or II.Conclusion: Our results show that TAVI is a safe method for treatment of aortic stenosis in high-risk patients and its early results are comparable with surgical aortic valve replacement. The TF and TA approaches are equally efficient, with similar outcomes and complication rates. Provided these results are confirmed at long-term follow-up, it can be assumed that the indication criteria for TAVI approaches will expand.     

“Valve‐in‐valve” for the treatment of paravalvular leaks following transcatheter aortic valve implantation

Transcatheter aortic valve implantation (TAVI) is commonly associated with some degree of aortic regurgitation (AR) secondary to the presence of paravalvular leaks. We present the case of an 86‐year‐old woman diagnosed with severe aortic stenosis who underwent TAVI with a 23‐mm Edwards‐SAPIEN valve. The procedure complicated with a severe paravalvular leak following TAVI that was unresponsive to balloon postdilation. This complication was successfully managed with the implantation of a second valve of the same diameter within the first one (“valve‐in‐valve”) resulting in trivial residual AR and the absence of significant transvalvular gradient at the end of the procedure. © 2009 Wiley‐Liss, Inc.     

Transcatheter aortic valve implantation with either CoreValve or SAPIEN XT devices in patients with a single coronary artery

Transcatheter aortic valve implantation (TAVI) is associated with a risk of coronary obstruction. This complication is potentially lethal when the origin of the coronary arteries is anomalous. We describe two cases of TAVI with the SAPIEN XT (Edwards Lifesciences) and CoreValve devices (Medtronic) in patients with a single coronary artery. The tools and techniques used to anticipate the risk of acute coronary occlusion are discussed.     

Do Outcomes from Transcatheter Aortic Valve Implantation Vary According to Access Route and Valve Type? The UK TAVI Registry

Objectives

To determine whether outcomes from transcatheter aortic valve implantation (TAVI) vary according to access route and valve type in a real‐world population.

Background

Registry and uncontrolled trial data have found that patients undergoing nonfemoral TAVI have higher early and late mortality. It is not clear whether worse outcomes relate directly to access route. There have been no direct comparisons of outcomes according to valve type.

Methods

Data were collected prospectively on 1,620 patients undergoing TAVI in the UK and compared in 4 groups: SAPIEN transfemoral (TF); SAPIEN transapical (TA); CoreValve TF, CoreValve subclavian. Univariable and multivariable regression analysis was performed to identify independent predictors of mortality.

Results

Mortality in patients undergoing SAPIEN TAVI via a TA approach was higher than with TF at 30 days (11.2% vs. 4.4%, P < 0.01), 1 year (28.7% vs. 18.1%, P = 0.01), and 2 years (56.0% vs. 43.5%, P = 0.01). Logistic EuroSCORE was higher in TA patients (22.5 ± 12.9% vs. 17.7 ± 11.1%, P < 0.0001). After multivariable analysis TA access was associated with increased mortality at 30 days (OR 2.56, 95% CI 1.46–4.48, P < 0.01) and 2 years (OR 1.75, 1.08–2.74, P = 0.02). There was no significant difference in mortality at any time‐point between patients treated with SAPIEN (n = 812) and CoreValve (n = 808) prostheses. CoreValve‐treated patients had a higher rate of permanent pacemaker implantation (23.1% vs. 7.2%, P < 0.0001), and grade ≥2 aortic regurgitation on postprocedure echocardiography (13.0% vs. 7.3%, P < 0.01).

Conclusions

Patients undergoing TA TAVI experienced increased early and late mortality compared to a TF approach. Survival was not influenced by valve type. (J Interven Cardiol 2014;27:86–95)

     

Acute coronary occlusion following TAVI

Transcatheter aortic valve implantation (TAVI) has nowadays replaced open heart surgery as an alternative therapeutic tool in selected patients. Thirty‐five percent of patients with severe degenerative aortic valve stenosis (AS) remain untreated because of the existing comorbidities that increase their perioperative risk. TAVI is a relatively new technique that has “come to stay” in the everyday clinical practice considering, that is the only alternative to surgery and appears to have excellent long term results. Herein, we describe a vascular complication immediately after the implantation of the Edwards SAPIEN (Edwards Lifesciences, Irvine, CA) prosthesis, followed by ad hoc percutaneous coronary intervention. © 2010 Wiley‐Liss, Inc.     

Concomitant transatrial valve‐in‐valve in pulmonal and tricuspid position

Transcatheter valve implantation in the pulmonary valve has been established as a valuable treatment option for patients with conduit failure in the right ventricular outflow tract, most often with the use of the Melody valve. Transcatheter valve‐in‐valve (VIV) implantation in the tricuspid position is restricted to single case reports, most often with the implantation of the Edwards SAPIEN valve. A 67 years old male with carcionoid syndrome and previously implanted bioprosthesis in the pulmonary and tricuspid valve now presented with worsening symptoms due to degeneration of both bioprostheses. The risk of new open surgery was deemed to high. We report of the first transatrial double VIV implantation using the balloon expandable Edwards SAPIEN XT in pulmonary and tricuspid position. © 2015 Wiley Periodicals, Inc.     

Transfemorally or transapically deployed Sapien Edwards bioprosthesis is always deformed

Objective: To study the impact of femoral compared to apical access on the Sapien‐Edwards (SE) prosthesis deployment and geometry in patients treated with transcatheter aortic valve implantation (TAVI) for aortic stenosis. Background: SE prosthesis deformation exists after its deployment through transfemoral (TF ‐ TAVI) approach. However, no study comparing the deformation between TF ‐ TAVI and transapical (TA ‐ TAVI) approaches has yet been published. Methods: Forty consecutive patients received TAVI with the SE prosthesis (TF ‐ TAVI n = 25; TA ‐ TAVI n = 15). A fluoroscopic analysis of the prosthesis was then performed. The stent frame geometry was assessed during deployment in the profile view, and after implantation in the profile and frontal views. Results: Expansion kinetics revealed a triphasic stent deployment with both approaches; the aortic extremity being the first to open. After implantation, on the profile view, the stent shape was never rectangular (therefore never cylindrical) in both groups. It had a biconic shape in most of the patients (76% vs. 93.3% for TF ‐ TAVI and TA ‐ TAVI patients, respectively, P = 0.224) with a wider aortic extremity relative to the ventricular one. The frontal view analysis showed that circular deployment of the stent was never achieved. A greater leaflet to stent mismatch was noted in TA ‐ TAVI patients, however, the difference was not statistically significant (12% vs. 33.3%, P = 0.126). Conclusion: Fluoroscopically assessed, the geometry of SE prosthesis was never cylindrical after deployment, whatever the access for implantation was. Longitudinal deformation was greater after TF ‐ TAVI whereas leaflet to stent mismatch tended to be more pronounced after TA ‐ TAVI. (J Interven Cardiol 2012;25:53–61)     

The predictive value and evolution of N-terminal pro-B-type natriuretic peptide levels following transcutaneous aortic valve implantation

Aims: We sought to define the predictive value and evolution of N‐terminal pro‐B‐type natriuretic peptide (NT‐proBNP) levels following transcutaneous aortic valve implantation (TAVI). Methods and Results: We investigated 91 consecutive patients who underwent TAVI (59 transfemoral [TF], 32 transapical [TA]) in our institution. The balloon‐expandable valve was implanted in 75 and the self‐expanding in 16 patients. The baseline (within 48 hours prior to procedure), early (24–74 hours), and late (3–12 months) postprocedural NT‐proBNP levels were determined. The mortality status of all patients was ascertained as of September 2010. The 30‐day and 1.3(mean)‐year mortality was 3% and 12% (2%, 9% in the TF and 6%, 19% in the TA group). Increased baseline (χ²= 5.9, P = 0.016) and early (χ²= 4.9, P = 0.028) NT‐proBNP levels were predictive of mortality. All decrements of the NT‐proBNP levels in the TF patients were significant (baseline 4,984 ± 8,106 vs. early 3,912 ± 6,551 pg/mL, P = 0.016; late 633 ± 606 pg/mL, P = 0.003). In contrast, there was a trend for the early levels to increase in the TA patients (6,423 ± 8,897 vs. 8,100 ± 10,178 pg/mL, P = 0.090), and a significant decline in the late levels as compared to baseline (1,704 ± 3,417 pg/mL, P = 0.005). Conclusion: NT‐proBNP levels are predictive of mortality following TAVI. There is a differential early evolution of their levels between the TF and TA patients and a significant decline later in both groups. (J Interven Cardiol 2011;24:462–469)     

First‐in‐man transcatheter aortic valve implantation of a 20‐mm edwards SAPIEN XT valve: One step forward for the treatment of patients with severe aortic stenosis and small aortic annulus

We present the case of an 85‐year‐old woman diagnosed with severe aortic stenosis, porcelain aorta, and a small aortic annulus (17.3 mm), who underwent successful transfemoral transcatheter aortic valve implantation (TAVI) with a 20‐mm Edwards SAPIEN XT valve using the NovaFlex+ delivery system. At 1‐month follow‐up the patient was in NYHA functional class I, and Doppler echocardiography showed a mean residual gradient of 15 mm Hg and trivial paravalvular aortic regurgitation. This case, which shows for the first time the feasibility of TAVI with a 20‐mm valve, opens a new avenue for the challenging treatment of patients with aortic stenosis and a small aortic annulus. © 2011 Wiley Periodicals, Inc.     

Transcatheter aortic valve implantation: Current status and future perspectives

Although surgical aortic valve replacement is the standard therapy for severe aortic stenosis(AS),about one third of patients are considered inoperable due to unacceptable surgical risk.Under medical treatment alone these patients have a very poor prognosis with a mortality rate of 50%at 2 years.Transcatheter aortic valve implantation(TAVI)has been used in these patients,and has shown robust results in the only randomized clinical trial of severe AS treatment performed so far.In this review,we will focus on the two commercially available systems:Edwards SAPIEN valve and CoreValve Revalving system.Both systems have demonstrated success rates of over 90%with 30-d mortality rates below 10%in the most recent transfemoral TAVI studies.Moreover,long-term studies have shown that the valves have good haemodynamic performance.Some studies are currently exploring the non-inferiority of TAVI procedures vs conventional surgery in high-risk patients,and long-term clinical results of the percutaneous valves.In this article we review the current status of TAVI including selection of patients,a comparison of available prostheses,results and complications of the procedure,clinical outcomes,and future perspectives.     

Acute and late outcomes of Transcatheter Aortic Valve Implantation (TAVI) for the treatment of severe symptomatic aortic stenosis in patients at high- and low-surgical risk

Background: This prospective study examines the impact of EuroSCORE and transfemoral (TF) or transapical (TA) delivery approach on mortality at 30 days and 1 year in patients with severe aortic stenosis implanted with either the Edwards SAPIEN Transcatheter Heart Valve (THV) or Medtronic CoreValve. Methods and Results: TAVI was successfully performed in 293 (97.7%) of 300 patients (TF: 174, TA: 126, mean EuroSCORE 24.0). The mortality at 30 days and after 1 year was 6.0% and 17.3%. Mortality depends significantly on the logistic EuroSCORE with a 30‐day odds ratio (OR) of 1.92 (95% CI 1.41 to 2.62, P < 0.001) and after 1 year of 1.67 (95% CI 1.34 to 2.08, P < 0.001). Mortality in patients with a logistic EuroSCORE <15 (n = 113) or ≥15 (n = 187) at 30 days was 0.9% versus 9.1% and after 1 year 7.1% versus 23.5% demonstrating significantly less mortality (P < 0.001) in patients with lower logistic EuroSCOREs. In this specific setup of our center there was no significant difference (P = 0.553) in mortality regarding the technical approach for TA (4.0% and 15.9%) and for TF (7.5% and 18.4%). Severe cardiac complications occurred in 20 patients (6.7%) with a 30‐day mortality of 45.0%. Conclusion: The mortality in patients undergoing TAVI correlates significantly with the logistic EuroSCORE. Patients with a logistic EuroSCORE <15 can be implanted, with a low 30‐day mortality and good long‐term outcome over 1 year. (J Interven Cardiol 2012;25:364–374)     

Transcatheter aortic valve implantation for high risk patients With severe aortic stenosis using the Edwards Sapien balloon‐expandable bioprosthesis: A single centre study with immediate and medium‐term outcomes

Background : Transcatheter aortic valve implantation (TCAVI) is an emerging alternative therapy to open‐heart surgery in high‐risk patients with symptomatic aortic stenosis. Methods : Between January 2007 and May 2009, 46 patients underwent TCAVI with the 23 mm or 26 mm Edwards Sapien bioprosthesis via either the transapical (TA‐AVI) or transfemoral (TF‐AVI) approach. All patients had an estimated operative mortality risk of >15%. Results : A total of 46 patients (30 TA‐AVI, 16 TF‐AVI) with a mean aortic valve area (AVA) of 0.63 ± 0.2 cm² and mean gradient of 54 ± 16 mm Hg were treated. Predicted operative mortality was 25.3% by logistic Euroscore and 8.7% by Society of Thoracic Surgeons risk score. Procedural success was 93% in the TA‐AVI group and 88% in the TF‐AVI group. There was one intraprocedural death in the TA‐AVI group. Overall 30‐day mortality was 6.5% (2‐TA‐AVI, 1‐TF‐AVI). Four patients (9.5%) died from noncardiac causes after 30 days. Successful TCAVI was associated with a significant increase in AVA from 0.6 ± 0.1 cm² to 1.6 ± 0.6 cm² in the TA‐AVI group and 0.6 ± 0.1 cm² to 1.4 ± 0.2 cm² in the TF‐AVI group at a mean follow up of 7.4 ± 4.4 and 8.3 ± 5.0 months, respectively. At discharge, there was significant improvement in AVA (P < 0.0001), transaortic mean gradient (P < 0.0001), and mitral regurgitation (P = 0.01). At medium term follow up, the valve area was maintained and there was significant improvement in NYHA class in both groups (P < 0.0001). Conclusion : At medium term follow‐up, both transcatheter approaches demonstrated good valve durability with no cardiac‐related mortality post hospital discharge. © 2009 Wiley‐Liss, Inc.     

Complications and Mortality in Patients Undergoing Transcatheter Aortic Valve Replacement With Edwards SAPIEN & SAPIEN XT Valves: A Meta‐Analysis of World‐Wide Studies and Registries Comparing the Transapical and Transfemoral Accesses

Introduction

Both transfemoral (TF) and transapical (TA) routes are utilized for Transcatheter Aortic Valve Replacement (TAVR) using Edwards SAPIEN & SAPIEN XT valves. We intended to perform a meta‐analysis comparing the complication rates between these two approaches in studies published before and after the standardized Valve Academic Research Consortium (VARC) definitions.

Methods

We performed a comprehensive electronic database search for studies published until January 2014 comparing TF and TA approaches using the Edwards SAPIEN/SAPIEN XT aortic valve. Studies were analyzed based on the following endpoints: 1‐year mortality, 30‐day mortality, stroke, new pacemaker implantation, bleeding, and acute kidney injury.

Results

Seventeen studies were included in the meta‐analysis. Patients undergoing TA TAVR had a significantly higher logistic EuroSCORE (24.6 ± 12.9 vs. 21.3 ± 12.0; P < 0.001). The cumulative risks for 30‐day mortality (RR 0.61; 95%CI 0.46–0.81; P = 0.001), 1‐year mortality (RR 0.68; 95%CI 0.55–0.84; P < 0.001), and acute kidney injury (RR 0.53; 95%CI 0.38–0.73; P < 0.001) were significantly lower for patients undergoing TF as compared to TA approach. Both approaches had a similar incidence of 30‐day stroke, pacemaker implantation, and major or life‐threatening bleeding. Studies utilizing the VARC definitions and those pre‐dating VARC yielded similar results.

Conclusion

This meta‐analysis demonstrates a decreased 30‐day and 1‐year mortality in TF TAVR as compared to TA TAVR. Post‐procedure acute kidney injury and the need for renal replacement therapy are also significantly lower in the TF group. These differences hold true even after utilizing the standardized Valve Academic Research Consortium criteria. (J Interven Cardiol 2015;28:266–278)

     

Early Experience of Transaortic TAVI—The Future of Surgical TAVI?

BackgroundTrans-catheter aortic valve implantation (TAVI) is now a well recognised procedure for the high risk surgical patient with native or bioprosthetic aortic valve stenosis. Transfemoral and transapical implantation techniques are well described. With increasing referral of more marginal transapical patients, we describe our experience of a transaortic TAVI approach which we believe reduces the postoperative wound pain, respiratory complications, operative risk and hospital stay.MethodsPatients referred for surgical TAVI underwent trans-catheter aortic valve implantation via an upper sternotomy and direct cannulation of the ascending aorta.ResultsThirteen patients with a mean age of 81 years underwent transaortic Edwards SAPIEN valve implantation. There was no in hospital mortality in our series. One patient required insertion of a permanent pacemaker for complete heart block. There were no aortic cannulation complications.ConclusionThe transaortic TAVI approach provides good exposure of the distal ascending aorta, a familiar cannulation site for cardiac surgeons. Our initial experience demonstrates the approach to be a safe technique with the potential for faster and less complicated recovery in patients undergoing surgical TAVI procedures. With further experience and greater acceptance, the transaortic approach may ultimately become the procedure of choice for patients unsuitable for a transfemoral approach.     

Risk for permanent pacemaker after transcatheter aortic valve implantation: a comprehensive analysis of the literature

Risk for Permanent Pacemaker After Transcatheter Aortic Valve Implantation. Background: Permanent pacemaker (PM) requirement is a known complication after transcatheter aortic valve implantation (TAVI). There are, however, no systematic data concerning this complication. Objective: To determine the incidence and potential predictors of permanent PM requirement after TAVI based on published literature. Methods: We conducted a MEDLINE search to identify potentially relevant literature dealing with PM requirement after TAVI. Data were collected on paper extraction forms by 2 independent investigators. Results: There were 32 relevant published studies comprising data of 5,258 patients without an implanted PM before TAVI. An Edwards‐Sapiens® prosthesis (ESP) was implanted in 2,887 patients, whereas 2,371 patients received a CoreValve® prosthesis (CVP). The crude incidence of PM implantation after TAVI was 15%. Six hundred and fourteen of 2,371 (25.8%) CVP patients and 189 of the 2,887 (6.5%) ESP patients had to receive a permanent PM (odds ratio [OR] 4.91, 95% confidence interval [CI] 4.12–5.86, P < 0.001). Presence of right bundle branch block (RBBB) before TAVI was a significant predictor for development of complete atrioventricular (AV) block and subsequent PM need (OR 1.358, 95% CI 1.001–1.841, P = 0.02). More than 90% of all AV‐block requiring PM implantation occurred immediately or within 7 days after TAVI. Conclusion: Patients undergoing TAVI with implantation of CVP are at significantly higher risk for development of AV block and subsequent need for permanent PM, particularly if RBBB preexists. Since AV block occurs in >90% within the first week after the procedure, careful monitoring should be performed for at least 7 days after TAVI.     

Transcatheter aortic valve implantation

Aortic stenosis is the most important valvular heart disease affecting the elderly population. Surgical aortic valve replacement is the mainstay of treatment, although a substantial number of patients are considered high risk for surgery. Many of these patients do not undergo surgery and have poor outcomes from medically treated symptomatic, severe aortic stenosis. Transcatheter aortic valve implantation (TAVI) provides a promising treatment option for some of these patients. Several devices are under investigation. The Edwards Sapien valve (Edwards Lifesciences, Irvine, CA) and the CoreValve (Medtronic, Minneapolis, MN) have the largest human experience to date. Initial data suggest that these devices have an acceptable safety profile and provide excellent hemodynamic relief of aortic stenosis. The Edwards Sapien valve is currently under investigation in the United States in the PARTNER (Placement of Aortic Transcatheter Valve) trial in high-risk surgical or inoperable patients; TAVI is available for clinical use in both Canada and Europe. TAVI is not used in low- or intermediate-risk surgical patients; however, future studies may prove its applicability in these subsets. The major complications of TAVI include access site-related problems and device malpositioning/migration. There are several new-generation prosthetic valves and delivery systems designed to be low profile and repositionable. Technical advances and refinement of the implantation methods may make TAVI even safer and ultimately a better treatment option, not only for patients with high surgical risk but also for those with moderate or low risk.     

Valve prosthesis distortion after cardiac compression in a patient who underwent transcatheter aortic valve implantation (TAVI)

Transcatheter aortic valve implantation (TAVI) has been developed as an alternative to conventional aortic valve replacement for the treatment of symptomatic severe aortic stenosis in high‐risk patients. Nevertheless, TAVI has been associated with serious complications such as stroke, vascular injury, renal failure, and arrhythmia. Herein we describe a case of distortion of the Edward‐Sapien prosthesis (Edwards Lifesciences, USA), which was mounted on a balloon‐expandable stent, after chest compression for cardiac resuscitation in a patient who underwent TAVI for severe aortic stenosis. © 2012 Wiley Periodicals, Inc.     

Severe intraprosthetic regurgitation and valve embolization after transcatheter aortic valve implantation

Transcatheter aortic valve implantation is a novel therapeutic approach for high‐risk patients with severe symptomatic aortic stenosis. The success rate of this new procedure is high; however, procedural complications can occur and may result in devastating outcomes. Here, we report a case of transfemoral catheter aortic valve implantation using the Edwards SAPIEN valve complicated by severe intravalvular leak due to immobile cusp associated with shock. We treated with a second valve that embolized and deployed in the descending aorta. A third valve was then deployed within the first with elimination of aortic regurgitation and immediate hemodynamic improvement. © 2012 Wiley Periodicals, Inc.     

Transcatheter tricuspid valve replacement With the Edwards SAPIEN valve

We describe a case of percutaneous tricuspid valve implantation in a 20‐year‐old man with previous tricuspid valve replacement in the setting of pulmonary atresia with intact ventricular septum. He developed symptomatic endocarditis‐induced tricuspid regurgitation of the tricuspid bioprosthesis. Tricuspid valvar competence was restored with implantation of a 26‐mm Edwards SAPIEN valve. © 2011 Wiley‐Liss, Inc.     

Fungal endocarditis after transfemoral aortic valve implantation

Transcatheter aortic valve implantation (TAVI) was introduced in 2006 as an alternative for surgical aortic valve replacement (SAVR) as treatment for patients with aortic stenosis. Endocarditis after TAVI has been anecdotally reported, but concerns aroused because SAVR is often needed to explant the endocarditic valve in a high risk patient previously deemed not to be a surgical candidate. We report a case of a patient who underwent TAVI because he was too high risk to undergo SAVR. Several months later, he developed an intermittent self‐limiting fever of unknown origin which eventually was diagnosed as endocarditis. The valve was surgically removed, and pathology showed an infection caused by Histoplasma capsulatum. The patient recovered fully and remains in good condition.© 2011 Wiley Periodicals, Inc.