Network Meta-Analysis Comparing the Short- and Long-Term Outcomes of Alternative Access for Transcatheter Aortic Valve Replacement

BackgroundSeveral studies have pair-wise compared access sites for transcatheter aortic valve replacement (TAVR) but pooled estimate of overall comparative efficacy and safety outcomes are not well known. We sought to compare short- and long-term outcomes following various alternative access routes for TAVR.MethodsThirty-four studies with a pooled sample size of 32,756 patients were selected by searching PubMed and Cochrane library databases from inception through 11th June 2021 for patients undergoing TAVR via 1 of 6 different access sites: Transfemoral (TF), Transaortic (TAO), Transapical (TA), Transcarotid (TC), Transaxillary/Subclavian (TSA), and Transcaval (TCV). Data were extracted to conduct a frequentist network meta-analysis with a random-effects model using TF access as a reference group.ResultsCompared with TF, both TAO [RR 1.91, 95% CI (1.46–2.50)] and TA access [RR 2.12, 95% CI (1.84–2.46)] were associated with an increased risk of 30-day mortality. No significant difference was observed for stroke, myocardial infarction, major bleeding, conversion to open surgery, and major adverse cardiovascular or cerebrovascular events at 30 days between different accesses. Major vascular complications were lower in TA [RR 0.43, (95% CI, 0.28–0.67)] and TC [RR 0.51, 95% CI (0.35–0.73)] access compared to TF. The 1-year mortality was higher in TAO [RR of 1.35, (95% CI, 1.01–1.81)] and TA [RR 1.44, (95% CI, 1.14–1.81)] groups.ConclusionNon-thoracic alternative access site utilization for TAVR implantation (TC, TSA and TCV) is associated with outcomes similar to conventional TF access. Thoracic TAVR access (TAO and TA) translates into increased short and long-term mortality.     

Successful transfemoral aortic valve replacement in a bicuspid aortic stenotic valve: Requirements for a safe implant

Although transcatheter aortic valve replacement (TAVR) has been accepted as an attractive alternative for high‐risk patients with severe symptomatic aortic stenosis (AS), patients with congenital bicuspid AS has been typically disqualified for this indication due to an implied risk of device dislocation, distortion, or device malfunctioning. Nonetheless, bicuspid AS is not uncommon and frequently missed by transthoracic echocardiography. We reported an interesting case of a high‐risk patient with severe symptomatic bicuspid AS who underwent successful TAVR and discussed the anatomic requirements for a safe implant in patients with bicuspid AS considered candidates for TAVR. © 2013 Wiley Periodicals, Inc.     

Simultaneous thoracic aortic endovascular graft and transfemoral transcatheter aortic valve replacement in a patient with a descending aortic thrombus

Severe descending thoracic and abdominal aortic pathology can deter consideration of transfemoral (TF) access for transcatheter aortic valve replacement (TAVR) in adults with severe symptomatic aortic stenosis (AS) and may lead to utilization of alternative access sites. We report a case of an 88-year-old frail woman with severe symptomatic AS referred for TAVR with demonstration of a large thrombus in the descending thoracic aorta immediately distal to the left subclavian artery. Given concerns of thrombus embolization with femoral advancement of the transcatheter valve, coverage with a thoracic aortic endograft was planned immediately prior to the TAVR.     

The use of MitraClip to prevent posttranscatheter aortic valve replacement left ventricular “suicide”

Patients with concomitant severe aortic stenosis (AS) and left ventricular outflow tract (LVOT) obstruction undergoing transcatheter aortic valve replacement (TAVR) are at risk for hemodynamic collapse due to a sudden decrease in afterload causing worsening LVOT obstruction. We present a case of an 88-year-old female with symptomatic, severe AS, and LVOT obstruction with systolic anterior motion (SAM) of the mitral leaflet in whom alcohol septal ablation was contraindicated secondary to a chronic total occlusion of the right coronary artery that filled retrograde via septal collaterals. MitraClip at the time of TAVR was successfully performed to treat SAM with subsequent stabilization of LVOT gradients despite treatment of the patient's AS. This novel approach may represent a feasible option to prevent hemodynamic complications after TAVR in patients with significant LVOT obstruction secondary to SAM and AS.     

Salvaging lowermost deployment of an acurate device during transcatheter aortic valve replacement with balloon and lasso pull techniques

Transcatheter aortic valve replacement (TAVR), also known as transcatheter aortic valve implantation (TAVI), is being used with increasing frequency in patients with severe aortic stenosis at high or prohibitive surgical risk. A number of devices are becoming available for TAVR, and competence in using them is mandatory to maximize the safety and efficacy of TAVR, while individualizing device selection in keeping with patient features. The ACURATE TF is a novel promising device for transfemoral TAVR. However, its peculiar features may require additional maneuvers in case of complications. We hereby report the case of a patient undergoing transfemoral TAVR with the ACURATE TF device, in whom lowermost deployment was complicated by massive aortic regurgitation. With two separate remedial actions, the balloon pull and lasso techniques, we were able to pull back the device and significantly reduce post‐TAVR aortic regurgitation. Awareness of this complication and the possible use of these two techniques may increase the safety and efficacy of TAVR with this and other new devices. © 2015 Wiley Periodicals, Inc.     

Role of Multimodality Imaging in Transcatheter Aortic Valve Replacement

The treatment of aortic stenosis (AS) has reached an exciting stage with the introduction of transcatheter aortic valve replacement (TAVR). It is the treatment of choice in patients with severe AS who are considered very high risk for surgical valve replacement. Multimodality imaging (MMI) plays a crucial role in TAVR patient selection, intra‐procedure guidance, and follow‐up. With the ever‐increasing scope for TAVR, a better understanding of MMI is essential to improve outcomes and prevent complications.     

Health-Related Quality of Life After Transcatheter or Surgical Aortic Valve Replacement in High-Risk Patients with Severe Aortic Stenosis: an Updated Review of Literature

Recent trials have highlighted the comparable mortality benefits and durability of the results for patients with severe aortic stenosis (AS) and high surgical risk managed with either transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (AVR). Various national guidelines and international regulatory bodies have approved TAVR, thereby leading to potential wide usage and dissemination of this technique worldwide. Quality-of-life outcomes, in spite of being an important measure of success and acceptability of the procedure, have not been publicized as extensively. For high risk patients with severe AS, implementation of TAVR has resulted in comparable survival, but different and novel adverse events compared with AVR. We present an updated review focusing on the quality-of-life outcomes and issues with this new and important procedural approach.     

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)

     

Postextrasystolic Potentiation in Low‐Gradient,Severe Aortic Stenosis: A Poor Man's Stress Echo?

An elderly man with dyspnea and syncope was found to have severe aortic stenosis (AS) by the continuity equation, despite a transaortic gradient that was only moderately elevated, in the setting of severe left ventricular dysfunction. The transaortic gradient increased during postextrasystolic beats, suggesting that his that his AS was truly severe; this was confirmed by dobutamine echocardiography. He underwent transcatheter aortic‐valve replacement (TAVR), with subsequent improvement in left ventricular systolic function. The diagnostic and prognostic significance of postextrasystolic potentiation, with associated increase in aortic stenosis gradient, deserves renewed attention in the TAVR era.     

Transcatheter Aortic Valve Replacement for Severe Aortic Stenosis in Women: Clinical Characteristics and Outcomes

Aortic stenosis (AS), 1 of the most common valve diseases in developed countries, carries a poor prognosis if left untreated. Transcatheter aortic valve replacement (TAVR) has become the standard of care for high-risk and inoperable patients with severe aortic stenosis (AS). Women represent a significant proportion of patients with severe AS and demonstrate specific clinical, anatomic, and pathophysiological features that are evident both before and after valve replacement. In this review, we discuss these features as well as the outcomes of women undergoing TAVR for AS.     

Low-Risk Transcatheter Versus Surgical Aortic Valve Replacement – An Updated Meta-Analysis of Randomized Controlled Trials

ObjectivesTo perform a meta-analysis including all available randomized controlled trials (RCTs) to date comparing transcatheter aortic valve replacement (TAVR) to surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis (AS) and low surgical risk.BackgroundCurrent guidelines recommend SAVR for patients with severe symptomatic AS and low surgical risk. A few RCTs have evaluated TAVR in low surgical risk patients but equipoise exists related to TAVR valve durability, paravalvular leak (PVL) and role of TAVR in younger, low surgical risk patients.MethodsFive databases were analyzed from January-2000 to March-2019 for RCTs comparing SAVR to TAVR in low-risk severe AS patients.ResultsFour RCTs on low-risk TAVR patients with 2887 patients were included. Mean follow-up was ~24.1 ± 24 months. Early mortality was lower with TAVR compared to SAVR (RR: 0.44, 95% CI: 0.20–0.95, P = 0.038) whereas long-term mortality was similar (RR: 0.67, 95% CI: 0.39–1.14, P = 0.141). Both early and long-term stroke rates were similar. TAVR was associated with lower risk of atrial fibrillation, major bleeding, acute kidney injury (AKI) and rehospitalization, but higher rates of permanent pacemaker implantation (PPM) and moderate or severe PVL. There was no difference in major vascular complications, myocardial infarction, endocarditis, aortic valve gradients and valve area at follow-up.ConclusionsIn low-risk patients with severe AS, TAVR has a lower early mortality compared to SAVR with no difference in long-term mortality. Although complication rates varied between TAVR and SAVR, our study findings suggest that transfemoral-TAVR is an appropriate treatment option for severe symptomatic AS in patients with low surgical risk.     

Transaortic transcatheter aortic valve implantation using edwards sapien valve

Objectives: To evaluate feasibility and outcome of Transoartic Transcatheter Sapien valve implantation. Background: Transcatheter Aortic valve implantation (TAVI) using the Edwards SAPIEN device (Edwards LifeScience, Irvine, CA) is usually performed via the transfemoral (TF) or transapical (TA) routes. Some patients are not suitable for these approaches. We report our experience with the novel transaortic (TAo) approach via a partial upper sternotomy and discuss the advantages and future applications. Methods: Between January 2008 to March 2011 193 patients with severe aortic stenosis underwent TAVI with the Edwards SAPIEN bioprosthesis at the St. Thomas' Hospital, London. 108 patients were unable to undergo a TF‐TAVI and of those 17 were accepted for a TAo‐TAVI on the basis of anatomy, risk, LV function, and significant respiratory disease. Results: The TAo‐TAVI group (n = 17) had more prevalent respiratory disease than the TA‐TAVI group (47.0% vs. 18.7%, P = 0.011). Otherwise the groups were similar in demographics and history. Despite this the 30 day mortalities were not significantly different between the groups (TAo‐TAVI 4.3% at 30 days versus TA‐TAVI 7.7%, P = 0.670). There were no significant differences in procedural complications. Conclusions: The TA‐TAVI approach may not be desirable in patients with severe chest deformity, poor lung function or poor left ventricular function. TAo‐TAVI via a partial sternotomy is safe and feasible in these patients. © 2011 Wiley Periodicals, Inc.     

Combined surgical and catheter‐based treatment of extensive thoracic aortic aneurysm and aortic valve stenosis

An extensive thoracic aortic aneurysm (TAA) is a potentially life‐threatening condition and remains a technical challenge to surgeons. Over the past decade, repair of aortic arch aneurysms has been accomplished using both hybrid (open and endovascular) and totally endovascular techniques. Thoracic endovascular aneurysm repair (TEVAR) has changed and extended management options in thoracic aorta disease, including in those patients deemed unfit or unsuitable for open surgery. Accordingly, transcatheter aortic valve replacement (TAVR) is increasingly used to treat patients with symptomatic severe aortic valve stenosis (AS) who are considered at high risk for surgical aortic valve replacement. In this report, we describe the combined surgical and catheter‐based treatment of an extensive TAA and AS. To our knowledge, this is the first report of hybrid TAA repair combined with TAVR. © 2014 Wiley Periodicals, Inc.     

Percutaneous Coronary Intervention of Complex Calcific Coronary Lesions Utilizing Orbital Atherectomy Prior to Transcatheter Aortic Valve Replacement

BackgroundCoronary artery disease (CAD), often with severe calcification, is present in up to 75% of patients with severe aortic stenosis (AS) referred for transcatheter aortic valve replacement (TAVR). Management of CAD in such patients is challenging. Orbital atherectomy (OA) is an effective treatment of severely calcified coronary lesions prior to stent implantation. However, there is limited data on the use of OA for percutaneous coronary intervention (PCI) to treat calcific CAD patients prior to TAVR (OA PCI + TAVR).MethodsRetrospective analysis of patients with moderate/severe calcific CAD and moderate/severe AS who underwent staged OA PCI + TAVR at one high-volume institution. Data were analyzed to assess the 1-year major adverse cardiac events after index OA PCI [MACE: death, target lesion revascularization (TLR), and myocardial infarction (MI)].ResultsThere were 18 patients (mean age of 82) treated with staged OA PCI + TAVR, and of those, 10 (56%) were male, 7 (39%) Caucasian, and 11 (61%) Hispanic/Latino. The average left ventricular ejection fraction was 49% and congestive heart failure was present in 12 patients (67%). There were no angiographic complications (0%), stent thrombosis (0%), or stroke events (0%). The 30-day and 1-year MACE rates were 5.6% (0% death, 0% TLR, 5.6% MI) and 17% (0% death, 11% TLR, and 17% MI [all non-Q-wave MI]), respectively.ConclusionsIn this single-center observational cohort series, patients with heavily calcified coronary lesions treated with OA prior to TAVR had low rates of MACE at 30 days and 1 year. The results demonstrate the feasibility and safety of OA for the treatment of complex calcific coronary lesions prior to TAVR. An up-to-date literature review of atherectomy before, during, or after TAVR in patients with concomitant severe AS and calcific CAD is also provided.Table of contents summaryThere is limited data on the use of orbital atherectomy (OA) for percutaneous coronary intervention (PCI) to treat calcific coronary artery disease (CAD) patients prior to transcatheter aortic valve replacement (TAVR). Our primary aim was to evaluate the feasibility, safety, and 1-year outcome of OA PCI pre-TAVR in patients with complex CAD and severe aortic stenosis (AS). We also aimed to provide a brief up-to-date literature review of atherectomy before, during, or after TAVR in patients with concomitant severe AS and calcific CAD. This retrospective cohort study found that OA is feasible and safe for the treatment of severely calcified coronary lesions before TAVR, resulting in acceptable 30-day and 1-year outcomes.     

Long-term outlook for transcatheter aortic valve replacement

Transcatheter aortic valve replacement (TAVR) revolutionized the treatment of severe symptomatic aortic stenosis (AS). TAVR is increasingly offered for lower-risk patients. The role and place of TAVR in the future treatment of AS is not clear yet. In this review, we discuss the long-term outlook for TAVR, its challenges and its relationship to conventional surgical aortic valve replacement.     

Is it really “paradoxical” or just the ventricle?

• Patients with paradoxical low flow low gradient (PLFLG) aortic stenosis (AS) have favorable mid‐term outcomes after transcatheter aortic valve replacement (TAVR). These outcomes were comparable to those patients with high gradient AS (HGAS).
• Clinicians should avoid delaying referral of patients with PLFLG AS for valve replacement for either surgical aortic valve replacement (SAVR) or TAVR.
• Further studies are need to understand the increased early mortality after TAVR in PLFLG AS compared to HGAS, and to determine whether improvements of TAVR procedural techniques can result in better outcomes.

     

A Review of Alternative Access for Transcatheter Aortic Valve Replacement

With the advent of transcatheter aortic valve replacement (TAVR), appropriately selected intermediate-, high-, and extreme-risk patients with severe aortic stenosis (AS) are now offered a less invasive option compared to conventional surgery. In contemporary practice, TAVR is performed predominantly via a transfemoral arterial approach, whereby a transcatheter heart valve (THV) is delivered in a retrograde fashion through the iliofemoral arterial system and thoraco-abdominal aorta, into the native aortic valve annulus. While the majority of patients possess suitable anatomy for transfemoral arterial access, there is a subset of patients with extensive peripheral vascular disease that precludes this traditional approach to TAVR. Fortunately, innovation in the field of structural heart disease has led to the refinement of alternative access options for THV delivery. Selection of the most appropriate route of therapy mandates a careful consideration of multiple factors, including patient anatomy, technical feasibility, and equipment specifications. Furthermore, understanding the risks conferred by each access site for valve delivery—notably stroke, vascular injury, and major bleeding—is of paramount importance when selecting the approach that will best optimize the outcome for an individual. In this review, we provide a comprehensive summary of alternative approaches to transfemoral arterial TAVR as well as the available outcome data supporting each of these various techniques.     

Valvuloplasty balloon entrapment in a self‐expanding aortic valve stent frame after inadvertent wire passage through the outflow struts

Transcatheter aortic valve replacement (TAVR) is a leading‐edge therapy option for patients with severe aortic stenosis (AS) and high surgical risk. However, this minimally invasive procedure is associated with specific complications that may be life‐threatening. Valvuloplasty balloon entrapment during postdilatation in transcatheter self‐expanding aortic valve stent frames has not yet been a focus of interest in this context. Although it is a rare event, it may critically influence outcome, and different management strategies can be considered. Hereafter, we present the case of a 67‐year‐old male who underwent transfemoral TAVR and subsequent postdilatation. The valvuloplasty balloon was entrapped in the self‐expanding aortic valve stent frame after inadvertent wire passage through the outflow struts. Since surgical risk was high, we preferred a percutaneous approach and extracted the entrapped balloon with high traction force under rapid pacing after valve stabilization with another balloon, which was placed in the annular position.     

Transcatheter aortic valve replacement in patients with severe aortic stenosis and heart failure

Severe aortic stenosis (AS) and heart failure (HF) represent an important and high-risk group of patients who are often referred for transcatheter aortic valve replacement (TAVR) due to high risk for surgical intervention. Thus far, randomized controlled trials have shown comparable outcomes between TAVR and surgical aortic valve replacement in patients with severe AS and heart failure with reduced ejection fraction. In the current review, we will discuss (1) the pathophysiology of HF in patients with severe AS, (2) role of imaging modalities in management, (3) role of biomarkers of HF on prognosis, (4) impact of other valvular heart diseases, (5) evidence from the contemporary trials on the role of TAVR in patients with severe AS and HF, and (6) future directions and research.     

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.