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Transcatheter aortic valve implantation (TAVI) or replacement (TAVR) was recently approved by the FDA for intermediate risk patients with severe aortic stenosis (AS). This technique was already worldwide adopted for inoperable and high-risk patients. Improved device technology, imaging analysis and operator expertise has reduced the initial worrisome higher complications rate associated with TAVR, making it comparable to surgical aortic valve replacement (SAVR). However, many answers need to be addressed before adoption in lower risk patients. This paper highlights the pros and cons of TAVI based mostly on randomized clinical trials involving the two device platforms approved in the United States. We focused our analysis on metrics that will play a key role in expanding TAVR indication in healthier individuals. We review the significance and gave a perspective on paravalvular leak (PVL), valve performance, valve durability, leaflet thrombosis, stroke and pacemaker requirement., Competing Interests: Conflicts of Interest: Dr. George is a consultant for Edwards Lifesciences and Medtronic. The other authors have no conflicts of interest to declare.

A growing number of nonagenarians is recorded as life expectancy increases. Unfortunately, this extreme-aged group is plagued by increased prevalence of aortic stenosis amidst a higher occurrence of comorbidities that pose dilemmas to cardiologists and cardiac surgeons when having to choose a conservative or interventional treatment modality, and a surgical or transcatheter aortic valve implantation (TAVI) approach. TAVI is an expensive procedure, which also confers a higher mortality and morbidity risk in nonagenarians, compared to younger patients. Considering the physiologic rather the chronologic age alone, and adopting a shared-decision making approach (participatory medicine), it may be more realistic to determine a patient's candidacy for this non-surgical therapeutic modality. Thus, it comes down to the patient selection process by having the heart team review each nonagenarian case individually and getting the patient and the family involved, always aiming to prolong and improve patient's quality of life (QoL), but also taking into consideration patient preferences and values, sharing and respecting goals, realistic expectations, and end-of-life views and ideas. One should keep in mind that there is always the possibility that TAVI may be clinically futile for patients who have a multitude of comorbidities and extreme frailty, for whom a transition to palliative care might be prudent. Selecting nonagenarian patients with low comorbidity index and with no extreme frailty, adopting a minimalistic approach and paying attention to vascular access hemostasis may provide the elements that may lead to a successful, desirable and hopefully cost-effective outcome., Competing Interests: Conflicts of Interest: The authors have no conflicts of interest to declare.

Objective: We sought to compare the new transcatheter aortic valve replacement (TAVR) device ACURATE neo (ACT) with the already established CoreValve (MCV) and SAPIEN XT (SXT) for the treatment of severe aortic stenosis (AS)., Background: Very few data on TAVR devices are available beyond MCV and SAPIEN and there is no previous study comparing ACT with MCV and SXT., Methods: We prospectively evaluated consecutive patients who underwent transfemoral TAVR for the treatment of severe AS. Clinical outcomes were reported following Valve Academic Research Consortium 2 (VARC-2) criteria., Results: A total of 162 patients (ACT n = 49, MCV n = 56, SXT n = 57), were included. MCV group had higher valve embolization/migration rates (ACT none; MCV 9%; SXT 2%; P = 0.034) causing lower device success rates (ACT 98%; MCV 86%; SXT 95%; P = 0.043). At 30 days, there was no significant difference in all-cause mortality (P = 0.22), cardiovascular mortality (P = 0.20), periprocedural myocardial infarction (P = 0.40), stroke (P = 0.64), major vascular complications (P = 0.48), life-threatening bleeding (P = 0.29), acute kidney injury stage 2/3 (P = 0.69), or VARC-2 composite early safety endpoints (P = 0.21). MCV group had higher rates of new permanent pacemaker implantation (ACT 6%; MCV 25%; SXT 11%; P = 0.013). Follow-up echocardiography showed no significant difference in aortic valve mean pressure gradient (P = 0.73) or moderate/severe aortic regurgitation (P = 0.19) between groups., Conclusions: In a "real world" registry, ACT compared favorably against the well-studied SXT and MCV devices in both safety and efficacy. MCV implantation was associated with lower device success rates and higher rates of new permanent pacemaker implantation. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

Transcatheter aortic valve implantation (TAVI) is a rapidly evolving therapeutic modality currently available for patients with severe aortic stenosis (AS) that are unsuitable for surgery because of technical/anatomical issues or high-estimated surgical risk. Transfemoral approach is the preferred TAVI delivery route when possible. Alternative non-transfemoral access options include transaortic, trans-subclavian and transapical access. Other approaches are also feasible (transcarotid, transcaval, and antegrade aortic) but are restricted to operators and hospitals with experience. The peculiarities of each of the vascular approaches designed for TAVI delivery make it necessary to carefully assess patient's atherosclerotic load and location, arterial size and tortuosity, and presence of mural thrombus. Several clinical trials are currently ongoing and in the near future the indications for these approaches will likely be better defined and extended to a broader spectrum of TAVI candidates., Competing Interests: Conflicts of Interest: The authors have no conflicts of interest to declare.

Background: In patients treated with transcatheter aortic valve implantation (TAVI), age is recognized as one of the most important risk factors. The aim of our study was to evaluate whether early and mid-term results of TAVI were worse in patients over 85 year old compared with the younger population., Methods: From September 2010 to November 2015, 162 consecutive patients (mean age 78.4 ± 7.1 years, 47.5% females) underwent TAVI in our Institution. Patients were divided into two groups: 1) elderly (≥ 85 year old) and 2) younger patients (< 85 year old). Primary clinical study endpoints were the fol-lowing: death, myocardial infarction, stroke, major and minor access site, and bleeding complications. The secondary endpoints included: pacemaker implantation rate, paravalvular leakage, acute kidney injury, and duration of hospitalization., Results: Twenty-six patients were 85 or older (mean 87.5 ± 2.1). In the remaining 136 (84%), the average age was 76.7 ± 6.4. Baseline clinical profiles were similar in both groups, though history of pre-vious cardiac surgery (p = 0.0047) and chronic obstructive pulmonary disease (p = 0.0099) were more common in the younger group, and glomerular filtration rate was lower in the older group (p = 0.045). Major, life threatening and minor bleeding complications, as well as vascular access site complications did not differ between the two groups. Rates of myocardial infarction and stroke were comparably low in both groups. Similar results were also found in the incidence of secondary endpoints. In-hospital mortality and 1-year mortality did not differ between groups., Conclusions: TAVI in patients aged 85 and older is still a relatively safe procedure and age itself should not be a discriminatory factor in TAVI qualification. (Cardiol J 2017; 24, 4: 358-363).

Transaortic approach represents an alternative variant of transcatheter aortic valve implantation (TAVI) which combines benefits of antegrade transapical approach and high safety profile characteristic of transfemoral approach. This method has substantial advantages over subclavian and transapical approaches in cases of pronounced myocardial hypertrophy, left ventricular dysfunction, thinning of left ventricular wall. We describe here a hybrid intervention with simultaneous coronary artery bypass grafting and TAVI in a patient from high surgical risk group with multivessel coronary artery involvement and critical aortic stenosis. The intervention was a successful alternative to open heart surgery with cardiopulmonary bypass.

Degenerative aortic stenosis (AS) is the most common valvular disease in the western world with a prevalence expected to double within the next 50 years. International guidelines advocate the use of cardiovascular magnetic resonance (CMR) as an investigative tool, both to guide diagnosis and to direct optimal treatment. CMR is the reference standard for quantifying both left and right ventricular volumes and mass, which is essential to assess the impact of AS upon global cardiac function. Given the ability to image any structure in any plane, CMR offers many other diagnostic strengths including full visualisation of valvular morphology, direct planimetry of orifice area, the quantification of stenotic jets and in particular, accurate quantification of valvular regurgitation. In addition, CMR permits reliable and accurate measurements of the aortic root and arch which can be fundamental to appropriate patient management. There is a growing evidence base to indicate tissue characterisation using CMR provides prognostic information, both in asymptomatic AS patients and those undergoing intervention. Furthermore, a number of current clinical trials will likely raise the importance of CMR in routine patient management. This article will focus on the incremental value of CMR in the assessment of severe AS and the insights it offers following valve replacement.

Objective: The impact of paravalvular aortic regurgitation (PAR) on hemodynamic performance after transcatheter aortic valve implantation (TAVI) remains disputable. Common parameters such as the diastolic blood pressure or the blood pressure amplitude do not provide reproducible results. The aim of our study was to evaluate the impact of PAR on hemodynamics and outcome using the relative amplitude index (RAI). Methods: PAR was prospectively evaluated by echocardiography before discharge in 110 patients. The RAI was calculated according to the formula: RAI = [(Post-TAVI BP amplitude)/(Post-TAVI SBP) − (Pre-TAVI BP amplitude)/(Pre-TAVI SBP)] × 100%, where BP is blood pressure and SBP is systolic blood pressure. Correlations of increased RAI with perioperative outcome were investigated and factors influencing mortality were isolated. Results: The incidence of moderate and severe PAR after TAVI was 9% and 1%, respectively. Diastolic pressure or post-TAVI amplitude did not correlate to perioperative outcome. RAI increased from 2 when PAR was <2+ to 7 when PAR was ≥2+ (P = .006). A cut-off value of RAI ≥14 was associated with increased perioperative mortality (29 vs 5%; P = .013) and acute renal injury requiring dialysis (71 vs 18%; P = .001). RAI ≥14 was also associated with higher follow-up mortality at 1 year (57 vs 16%; P = .007). RAI ≥14 (odds ratio [OR], 3.390; 95% confidence interval [CI], 1.6-7.194; P = .00146), PAR ≥2+ (OR, 4.717; 95% CI, 1.828-12.195; P = .00135), and perioperative renal replacement therapy (OR, 12.820; 95% CI, 5.181-31.250; P = .00031) were found to be independent predictors of mortality at 1 year. Conclusions: The RAI is a useful tool to predict perioperative and 1-year outcome in patients with PAR after TAVI. [Copyright &y& Elsevier]

Objectives: The primary analysis estimated the cost-effectiveness of transfemoral transcatheter aortic valve implantation (Edwards SAPIEN heart valve; Edwards Lifesciences LLC, Irvine, Calif) compared with standard management in inoperable patients with severe, symptomatic aortic stenosis. The secondary analysis estimated the cost-effectiveness of transcatheter aortic valve implantation (transfemoral or transapical approaches) (SAPIEN heart valve) compared with surgical aortic valve replacement in operable patients with severe, symptomatic aortic stenosis. Methods: A combined decision tree and Markov model was developed to compare costs, life-years, and quality-adjusted life-years over a 20-year time horizon from the Canadian health-care payer perspective. The Placement of Aortic Transcatheter Valves trial provided rates of postoperative complications and mortality. Costs were derived from the Ontario Case Costing Initiative. Comprehensive sensitivity analyses were used to explore the impact of uncertainty on the cost-effective estimates. Results: In the primary analysis, comparing transfemoral transcatheter aortic valve implantation and standard management resulted in incremental cost-effectiveness ratios of $36,458/life-year and $51,324/quality-adjusted life-year. In the secondary analysis, transcatheter aortic valve implantation (transfemoral or transapical) and surgical aortic valve replacement were compared, resulting in an incremental cost-effectiveness ratio of $870,143/life-year and transcatheter aortic valve implantation being dominated by surgical aortic valve replacement when comparing quality-adjusted life-years. Deterministic sensitivity analysis for the primary analysis identified the procedural costs and 1-year mortality rates of both transfemoral transcatheter aortic valve implantation and standard management to be the most sensitive parameters in the model, whereas results from the secondary analysis were largely unchanged. Removal of long-term complications in both analyses led to more favorable incremental cost-effectiveness ratios for transcatheter aortic valve implantation. Conclusions: This economic evaluation suggested that transfemoral transcatheter aortic valve implantation was a cost-effective option compared with standard management for inoperable patients with severe, symptomatic aortic stenosis, but it might not be a cost-effective treatment compared with surgical aortic valve replacement for operable patients. [Copyright &y& Elsevier]

The author discusses the partnership, innovation, and transparency investments to provide a healthier future for patients. He states that investment in research and development are critical factors for innovation of benefits for patients. He says that surgeon and the industry will work on minimally invasive surgeries for treatment of cardiac diseases. He adds that this will meet the patient needs, save healthcare costs, and provide better outcomes.

Calcific aortic stenosis is the most frequent manifestation of valvular heart disease. The preferred treatment for patients of all age groups is surgical aortic valve replacement. Recently, transcatheter aortic valve implantation (TAVI) has become the standard of care for patients that are deemed to be at high risk for open heart surgery. The most common access route for TAVI is the retrograde transfemoral (TF) approach, followed by the antegrade transapical (TA) approach. Both access routes have distinct indications. While the TF route is least invasive and the access of choice at most centers, the apical route is used complementary in patients with poor femoral access. In addition, the TA approach holds various benefits such as a short distance from the operator to the annulus facilitating exact positioning of the valve and the possibility to accommodate larger sheaths. Furthermore, the TA approach not only provides direct access to the aortic valve but also the mitral valve allowing for a wide range of interventions. Various apical closure devices are currently being developed under the premise of increasing overall safety of the TA-TAVI approach by further standardizing the procedure, alleviating left ventricular access and minimizing the risk of complications, such as apical bleeding. The aim of this article is to give an overview of current devices for apical closure. The ideal apical closure device should be easy to put in place, leave a minimum of foreign material, provide complete hemostasis and have a minimal risk of displacement. So far the range of commercially available devices in Europe is very limited with only one CE-certified device on the market and one device that is expected to receive CE-certification soon. Off-the-shelf closure devices could help flatten the initial operator learning curve and facilitate a safe apical access, ultimately leading to an entirely percutaneous TA-TAVI approach.

Transfemoral transcatheter aortic valve implantation (TAVI) is nowadays a routine therapy for elderly patients with severe aortic stenosis (AS) and high perioperative risk. With growing experience, further development of the devices, and the expansion to "intermediate-risk" patients, there is increasing interest in performing this procedure under conscious sedation (TAVI-S) rather than the previously favoured approach of general anesthesia (TAVI-GA). The proposed benefits of TAVI-S include; reduced procedure time, shorter intensive care unit (ICU) length of stay, reduced need for intraprocedural vasopressor support, and the potential to perform the procedure without the direct presence of an anesthetist for cost-saving reasons. To date, no randomized trial data exists. We reviewed 13 non-randomized studies/registries reporting data from 6,718 patients undergoing TAVI (3,227 performed under sedation). Patient selection, study methods, and endpoints have differed considerably between published studies. Reported rates of in-hospital and longer-term mortality are similar for both groups. Up to 17% of patients undergoing TAVI-S require conversion to general anesthesia during the procedure, primarily due to vascular complications, and urgent intubation is frequently associated with hemodynamic instability. Procedure related factors, including hypotension, may compound preexisting age-specific renal impairment and enhance the risk of acute kidney injury. Hypotonia of the hypopharyngeal muscles in elderly patients, intraprocedural hypercarbia, and certain anesthetic drugs, may increase the aspiration risk in sedated patients. General anesthesia and conscious sedation have both been used successfully to treat patients with severe AS undergoing TAVI with similar reported short and long-term mortality outcomes. The authors believe that the significant incidence of complications and unplanned conversion to general anesthesia during TAVI-S mandates the start-to-finish presence of an experienced cardiac anesthetist in order to optimize patient outcomes. Good quality randomized data is needed to determine the optimal anesthetic regimen for patients undergoing TAVI.

Objective: To assess midterm (3 years) clinical outcomes of transcatheter aortic valve implantation (TAVI) in Belgium using the Edwards SAPIEN valve or the Medtronic CoreValve transcatheter heart valve (THV)., Background: Medium and long term follow-up data of both THVs are still relatively scarce, although of great clinical relevance for a relatively new but rapidly expanding treatment modality. Therefore, reporting mid- and long term clinical outcome data, coming from large "real world" national registries, remains contributive., Methods: Between December 2007 and March 2012, 861 "real world" patients who were not candidates for surgical aortic valve replacement as decided by the local heart teams, underwent TAVI at 23 sites. Eleven sites exclusively used SAPIEN THV (n = 460), while 12 exclusively used CoreValve THV (n = 401). Differences in clinical outcomes by valve system were assessed, according to access route and baseline EuroSCORE risk profile (<10%: low, 10-20%: intermediate and >20%: high risk)., Results: Overall cumulative survival at 3 years was 51% for SAPIEN vs. 60% for CoreValve (P = 0.021). In transfemorally treated patients, SAPIEN and CoreValve had similar survival at 3 years for each of the baseline EuroSCORE cohorts (low risk: 72% vs. 76%, P = 0.45; intermediate risk: 62% vs. 59%, P = 0.94; high risk: 48% vs. 53%, P = 0.65)., Conclusion: Cumulative midterm 3 year survival after transfemoral TAVI in "real world" patients refused for surgery with similar baseline EuroSCORE risk profile is not different between SAPIEN or CoreValve., (© 2015 Wiley Periodicals, Inc.)

Even though experience and techniques have constantly improved over the last years, peri- and postprocedural complications in high risk TAVI-collectives remain a major issue affecting outcome and survival. Acute kidney injury (AKI) is a frequent complication after transcatheter aortic valve implantation (TAVI) and effects outcome and survival. However, the definition of AKI in published studies dealing with the phenomenon of AKI after TAVI varies widely and lacks standardization. This Review aims to present an overview over the current literature concerning AKI after TAVI with regard to the definition of AKI, the impact of AKI on mortality and potential risk factors for renal impairment after TAVI.

Transcatheter aortic valve implantation (TAVI) has gained widespread acceptance as a treatment option for patients at high risk for conventional aortic valve replacement. The most commonly used access site for TAVI is the common femoral artery. Yet, in a significant number of patients the transfemoral access is not suitable due to peripheral vascular disease of the lower extremity. In these cases the transaxillary approach can serve as an alternative implantation route. By considering the anatomical requirements and providing an adequate endovascular "safety-net" during the procedure the transaxillary TAVI approach results in excellent procedural and clinical outcome. However, whether the transaxillary access for TAVI is superior to other non-transfemoral approaches (e.g., transapical or direct aortic) needs to be studied in the future in a prospective randomized trial.

Background: Transcatheter aortic-valve implantation (TAVI) is an established alternative therapy in patients with severe aortic stenosis and a high surgical risk. Despite a rapid growth in its use, very few data exist about the efficacy of cardiac rehabilitation (CR) in these patients. We assessed the hypothesis that patients after TAVI benefit from CR, compared to patients after surgical aortic-valve replacement (sAVR)., Methods: From September 2009 to August 2011, 442 consecutive patients after TAVI (n = 76) or sAVR (n = 366) were referred to a 3-week CR. Data regarding patient characteristics as well as changes of functional (6-min walk test. 6-MWT), bicycle exercise test), and emotional status (Hospital Anxiety and Depression Scale) were retrospectively evaluated and compared between groups after propensity score adjustment., Results: Patients after TAVI were significantly older (p < 0.001), more female (p < 0.001), and had more often coronary artery disease (p = 0.027), renal failure (p = 0.012) and a pacemaker (p = 0.032). During CR, distance in 6-MWT (both groups p ≤ 0.001) and exercise capacity (sAVR p ≤ 0.001, TAVI p ≤ 0.05) significantly increased in both groups. Only patients after sAVR demonstrated a significant reduction in anxiety and depression (p ≤ 0.001). After propensity scores adjustment, changes were not significantly different between sAVR and TAVI, with the exception of 6-MWT (p = 0.004)., Conclusions: Patients after TAVI benefit from cardiac rehabilitation despite their older age and comorbidities. CR is a helpful tool to maintain independency for daily life activities and participation in socio-cultural life., (© The European Society of Cardiology 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.)

Transcatheter aortic valve implantation (TAVI) is an established treatment option for symptomatic patients with severe aortic valvular disease who are not suitable for conventional surgical aortic valve replacement. Despite improving experience and techniques, ischaemic and bleeding complications after TAVI remain prevalent and impair survival in this generally old and comorbid-rich population. Due to changing aetiology of complications over time, antiplatelet and anticoagulant therapy after TAVI should be carefully balanced. Empirically, a dual antiplatelet strategy is generally used after TAVI for patients without an indication for oral anticoagulation (OAC; e. g. atrial fibrillation, mechanical mitral valve prosthesis), including aspirin and a thienopyridine. For patients on OAC, a combination of OAC and aspirin or thienopyridine is generally used. This review shows that current registries are unfit to directly compare antithrombotic regimens. Small exploring studies suggest that additional clopidogrel after TAVI only affects bleeding and not ischemic complications. However, these studies are lack in quality in terms of Cochrane criteria. Currently, three randomised controlled trials are recruiting to gather more knowledge about the effects of clopidogrel after TAVI.

Sutureless aortic valve implantation has emerged as an innovative alternative for treatment of aortic stenosis. By avoiding the placement of sutures, this approach aims to improve surgical outcomes by facilitating less traumatic minimally invasive approaches and reducing cross-clamp and cardiopulmonary bypass duration. However, the absence of sutures may have detrimental effects after sutureless interventions, including paravalvular leakages, valve dislocation, and stent-infolding. Transcatheter aortic valve-in-valve implantation (A-ViV) is emerging as a valuable procedure in patients with dysfunctioning biological aortic valves who are deemed inoperable with conventional surgery. Here we present the first-in-man case of trans-femoral implant of a balloon expandable aortic valve in a leaking sutureless self-expandable valve.

Transcatheter valve implantation is progressively becoming the first line option for high risk patients in the management of severe aortic valve stenosis. Surgery is likely to remain the gold standard treatment option for intermediate risk patients since it ensures ablation of the underlying pathology and the calcified aortic valvular tissue, which potentially can act as a nidus of chronic embolization and provoke neurocognitive dysfunction in this subset of active patients. The surgical approach is continually evolving, with sutureless technology having the potential to facilitate ministernotomy and minithoracotomy approaches. Furthermore, Nitinol stented models can be introduced through thoracoscopic trocars, enabling the evolution of totally endoscopic aortic valve replacement (TEAVR). We present herein the development of TEAVR, starting from the cadaver experience in our lab. We transitioned through a clinical minithoracotomy video-assisted experience until we finally could initiate a program of human sutureless TEAVR. The limitations of this approach, which is still in refinement, and possible innovative solutions in order to build up a quick and reproducible procedure are discussed.

Background: Transcatheter aortic valve implantation (TAVI) has been developed recently for patients with high morbidities and who are believed to be not tolerate standard surgical aortic valve replacement. Nevertheless, the TAVI is associated with complications such as potential obstruction of coronary ostia, mitral valve insufficiency, and stent migration although it seems promising. Impairment of the coronary blood flow after TAVI is catastrophic and it was believed to be associated with the close position of the coronary orifice and the aortic leaflets and valve stent. However, few data was available as to the anatomic relationship between valve stent and aortic root anatomic structures including the coronary arterial ostia, aortic leaflets., Methods: The aortic roots were observed in 40 hearts specimens. The width of aortic leaflet, height of aortic sinus annulus to the sinutubular junction (STJ), distance between aortic sinus annulus to its corresponding coronary ostia, and coronary arterial ostia to its corresponding STJ level were measured. Moreover, the relationships of valve stent, aortic leaflets and coronary ostia before/post stent implantation and after the open of aorta were evaluated respectively., Results: Approximate three quarters of the coronary ostia were located below the STJ level. The mean distances from left, right and posterior aortic sinus annulus to the related STJ level was comparable, which was 18.5±2.7, 18.9±2.6, 18.7±2.6 mm, respectively. Meanwhile, the height of left and right aortic sinus annulus to its corresponding coronary ostia was 16.6±2.8 and 17.2±3.1 mm for left and right side respectively., Conclusions: Most of the coronary ostia were located below the STJ level and could be covered by the leaflets. This highlights the need of modified stents to prevent occlusion of coronary flow after TAVI.

Background: Significant paravalvular leakage after transcatheter aortic valve implantation (TAVI) correlates with increased morbidity and mortality, but adverse consequences of trivial paravalvular leakage have stimulated few investigations. Using a unique method distinctly different from other diagnostic approaches, we previously reported elevated backflow velocities of short duration (transients) in mechanical valve closure. In this study, similar transients were found in a transcatheter valve paravalvular leakage avatar., Methods: Paravalvular leakage rate (zero to 58 mL/second) and aortic valve incompetence (volumetric back flow/forward flow; zero to 32%) were made adjustable using a mock transcatheter aortic valve device and tested in quasi-steady and pulsatile flow test systems. Projected dynamic valve area (PDVA) from the back illuminated mock transcatheter aortic valve device was measured and regional backflow velocities were derived by dividing volumetric flow rate by the PDVA over the open and closing valve phase and the total closed valve area derived from backflow leakage., Results: Aortic incompetence from 1-32% generated negative backflow transients from 8 to 267 meters/second, a range not dissimilar to that measured in mechanical valves with zero paravalvular leakage. Optimal paravalvular leakage was identified; not too small generating high backflow transients, not too large considering volume overload and cardiac energy loss caused by defective valve behavior and fluid motion., Conclusions: Thrombogenic potential of transcatheter aortic valves with trivial aortic incompetence and high magnitude regional backflow velocity transients was comparable to mechanical valves. This may have relevance to stroke rate, asymptomatic microembolic episodes and indications for anticoagulation therapy after transcatheter valve insertion.

Background: Transcatheter aortic valve implantation (TAVI) has emerged as an acceptable treatment modality for patients with severe aortic stenosis who are deemed inoperable by conventional surgical aortic valve replacement (AVR). However, the role of TAVI in patients who are potential surgical candidates remains controversial., Methods: A systematic review was conducted using five electronic databases, identifying all relevant studies with comparative data on TAVI versus AVR. The primary endpoint was all-cause mortality. A number of periprocedural outcomes were also assessed according to the Valve Academic Research Consortium endpoint definitions., Results: Fourteen studies were quantitatively assessed and included for meta-analysis, including two randomized controlled trials and eleven observational studies. Results indicated no significant differences between TAVI and AVR in terms of all-cause and cardiovascular related mortality, stroke, myocardial infarction or acute renal failure. A subgroup analysis of randomized controlled trials identified a higher combined incidence of stroke or transient ischemic attacks in the TAVI group compared to the AVR group. TAVI was also found to be associated with a significantly higher incidence of vascular complications, permanent pacemaker requirement and moderate or severe aortic regurgitation. However, patients who underwent AVR were more likely to experience major bleeding. Both treatment modalities appeared to effectively reduce the transvalvular mean pressure gradient., Conclusions: The available data on TAVI versus AVR for patients at a higher surgical risk showed that major adverse outcomes such as mortality and stroke appeared to be similar between the two treatment modalities. Evidence on the outcomes of TAVI compared with AVR in the current literature is limited by inconsistent patient selection criteria, heterogeneous definitions of clinical endpoints and relatively short follow-up periods. The indications for TAVI should therefore be limited to inoperable surgical candidates until long-term data become available.

Background: Transcatheter aortic valve implantation (TAVI) represents a significant development in the treatment of high risk patients with aortic stenosis. As one of the first centers to perform transapical TAVI (taTAVI), we herein review our five-year experience with this technique., Methods: All patients undergoing taTAVI with an Edwards Sapien valve at the Leipzig Heart Center between 2006 and 2011 (n=439) were analysed. Data was drawn from a prospective database and retrospectively analysed. The learning curve was reviewed by means of descriptive statistics as well as cumulative sum failure analysis (CUSUM). All results are presented in compliance with Valve Academic Research Consortium (VARC) criteria., Results: The mean patient age was 81.5±6.4 years and 64.0% were female. The mean logistic EuroSCORE and STS risk of mortality were 29.7%±15.7% and 11.4%±7.6%, respectively. Procedural success was 90.2%. Stroke occurred in 2.1% of patients intra-operatively and a further 2.1% suffered stroke during their hospital stay. Mean transvalvular gradient was 9.0±3.9 mmHg and effective valve orifice area 1.3±0.6 cm(2). Moderate or greater aortic insufficiency was present in 5.7% of patients and remained stable during follow up. Overall survival was 90% at 30 days, 73% at 1 year, 68% at 2 years, 58% at 3 years, 53% at 4 years, and 44% at 5 years. CUSUM analysis revealed a definitive learning curve regarding the occurrence of major complications, with a progressive improvement after the initial 150 cases., Conclusion: TaTAVI has become a routine approach for high risk patients with symptomatic severe aortic stenosis. Although taTAVI is a safe procedure with reproducible results, future research should focus on methods of reducing known complications and the associated learning curve for this procedure.

Background: Transcatheter aortic valve implantation (TAVI) through a transapical approach (TAAVI) for severe aortic stenosis becomes the procedure of choice in cases where patients have peripheral artery disease and unfeasible access due to excessive atherosclerotic disease of the iliofemoral vessels and aorta. The present systematic review aimed to assess the safety, success rate, clinical outcomes, hemodynamic outcomes, and survival benefits of TAAVI., Methods: Electronic searches were performed in 6 databases from January 2000 to February 2012. The primary end points included feasibility and safety. Other end points included echocardiographic findings, functional class improvement, and survival., Results: After applying the inclusion and exclusion criteria, 48 out of 154 shortlisted potentially relevant articles were selected for assessment. Of these, 26 studies from 24 centers including total number of 2,807 patients were included for appraisal and data extraction. The current evidence on TAAVI for aortic stenosis is limited to observational studies. Successful TAAVI implantation occurred in >90% of patients. On average, the procedure took between 64 to 154 minutes to complete. The incidence of major adverse events included 30-day mortality (4.7-20.8%); cerebrovascular accident (0-16.3%); major tachyarrhythmia (0-48.8%); bradyarrhythmia requiring permanent pacemaker insertion (0-18.7%); cardiac tamponade (0-11%); major bleeding (1-17%); myocardial infarction (0-6%); aortic dissection/rupture (0-5%); moderate to severe paravalvular leak (0.7-24%); cardiopulmonary bypass support (0-15%); conversion to surgery (0-9.5%); and valve-in-valve implantation (0.6-8%). Mean aortic valve area improved from 0.4-0.7 cm(2) before TAAVI to 1.4-2.1 cm(2) after TAAVI. The peak pressure gradient across the aortic valve decreased from >70 mmHg to <20 mmHg after TAAVI. One-year survival ranged from 49.3% to 82% and the 3-year survival was 58% in 2 series., Conclusions: TAAVI appears to be feasible with a reasonable safety and efficacy portfolio. Randomised controlled trials are required to compare transapical vs. transfemoral TAVI when both techniques are equally feasible.