Transcatheter Aortic Valve Intervention Research Articles

Evolving Indications for Transcatheter Aortic Valve Interventions.

The purpose of this review was to summarize recent progress in the field of transcatheter aortic valve replacement (TAVR), discuss expansion of indications, and identify areas of future clinical applications. Favorable clinical outcomes as well as continued refinement of transcatheter heart valve technology have prompted the continuous expansion of indications for TAVR. The results of randomized clinical trials comparing the safety and efficacy of TAVR relative to conventional surgical aortic valve replacement (SAVR) in lower- than high-risk patients have recently been published, and trials among lower-risk categories are ongoing. Furthermore, evidence of the feasibility and safety of TAVR in patients with other pathological conditions is accumulating. Large pivotal randomized studies support the extension of TAVR to intermediate-risk patients. Moreover, TAVR is emerging as a valuable treatment option for other categories including patients with bicuspid aortic valve, those with pure native aortic regurgitation deemed inoperable, and those with degenerated surgical bioprosthetic valves.

A systematic review of reported cases of combined transcatheter aortic and mitral valve interventions.

To summarize the published data of combined transcatheter aortic and mitral valve intervention (CTAMVI). CTAMVI, a combination of either transcatheter aortic valve replacement (TAVR) or transcatheter aortic valve-in-valve (TAViV) and transcatheter mitral valve replacement (TMVR), transcatheter mitral valve-in-valve/valve-in-ring (TMViV/ViR), or percutaneous mitral valve repair (PMVR) is an attractive alternative in high-surgical risk patients with combined aortic and mitral valve disease. However, its procedural details and clinical outcomes have not been well described. We performed a systematic review of all the published articles from PUBMED and EMBASE. A total of 37 studies with 60 patients were included. The indication for CTAMVI was high or inoperable surgical risk and symptomatic severe aortic stenosis (92%) or severe aortic regurgitation (8%) combined with moderate to severe/severe mitral stenosis (30%) or moderate/severe mitral regurgitation (65%) or both (5%). In majority of the cases, aortic valve intervention was performed prior to the mitral valve. Mortality rate were 25% for TAVR + TMVR (range 42 days to 10 months), 17% for TAVR + TMViV/ViR (range 13 days to 6 months), 0% for TAViV + TMViV/ViR (range 6-365 days), and 15% for TAVR/ViV + PMVR (range 17 days to 419 days). Significant (more than moderate) paravalvular regurgitation post-procedure was rare. CTAMVI appears to confer reasonable clinical outcome. Further large study is warranted to clarify the optimal strategy, procedural details and clinical outcomes in the future.

Five-year follow-up after transcatheter aortic valve implantation for symptomatic aortic stenosis

ObjectivesTranscatheter aortic valve implantation (TAVI) has been implemented into the care of elderly patients suffering from severe symptomatic aortic stenosis. However, data on long-term follow-up are sparse and predictors of...

Poor Performance of Surgery Risk Models for Balloon Aortic Valvuloplasty

Background: Balloon aortic valvuloplasty (BAV) still has a limited role as a palliative or bridging procedure of inoperable severe symptomatic aortic stenosis patients in the current era of surgical and transcatheter aortic valve interventions. Risk stratification for this high risk procedure has not been previously investigated. We assessed the prognostic utility of contemporary surgical risk scores for BAV. Methods: All patients undergoing BAV at Auckland City Hospital from 2005-2016 were included and EuroSCORE II and STS scores were retrospectively calculated, and their performance in predicting mortality outcomes assessed. Results: Across 65 patients undergoing 79 BAV procedures, with mean age 83.9+/-8.6 years and 34 (52.3%) being male, the mean logistic EuroSCORE was 22.8%, EuroSCORE II 9.0% and STS Score 7.8%. There were 2 deaths (3.1%) at 30 days, and 21 (32.3%) at 1 year. Areas under the curve (95% confidence interval) for EuroSCORE, EuroSCORE II and STS Score at predicting 1-year mortality were 0.546 (0.397-0.694), 0.510 (0.351-0.669) and 0.582 (0.444-0.721). The only independent predictor of mortality during follow-up was left ventricular ejection fraction<40% with hazards ratio (95% confidence interval) of 3.10 (1.42-6.73). Conclusion: Conventional surgical risk scores were unable to predict mortality after BAV. Future risk models development specifically from BAV-only cohorts is recommended to improve accurate risk stratification in this cohort of patients.

TCT-750 Bivalirudin versus Heparin Anticoagulation in Transcatheter Aortic Valve Interventions. A Systematic review and a Meta-analysis

Bivalirudin may be an effective anticoagulation alternative to heparin in transcatheter aortic valve interventions. There is no clear superiority of one agent and there is a scarcity of data directly comparing heparin and bivalirudin for these procedures. We aimed to compare the safety and efficacy

Three-Year Follow-up of Transcatheter Aortic Valve Intervention Cases From a Single Private Hospital

Three-Year Follow-up of Transcatheter Aortic Valve Intervention Cases From a Single Private Hospital

PROVINCIAL SYSTEM OF CARE OPTIMIZES ACCESS AND OUTCOMES IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE IMPLANTATION

The British Columbia (BC) Transcatheter Heart Valve (THV) Program is a centrally coordinated, evaluated, and funded system of care led by Cardiac Services BC (CSBC) in close collaboration with provincial cardiac sites. The BC THV Program aims to ensure equitable access to transcatheter aortic valve implantation (TAVI) and other THV procedures, support excellent outcomes, and facilitate the planning of health services. We describe a prospective observational cohort of 583 patients who underwent TAVI in BC between March 2012 and June 2014. High surgical risk patients with aortic stenosis for TAVI are referred to four hospitals. Referral volumes and wait times are monitored by CSBC. Heart Teams at each site manage processes of care from referral to follow-up, and risk-stratify patients according to planned TAVI procedure. Lower volume and more complex TAVI procedures, including non-transfemoral access and valve-in-valve implantation are concentrated at a single site. In-hospital and thirty-day outcomes are reported according to VARC-2 definitions. There were 1,158 referrals for eligibility assessment received. The median wait time from acceptance to procedure was 37 days (IQR 16,70); there were 16 deaths on the wait list and 42 deaths under assessment. The median age was 83 (IQR 78,87) and median STS score was 6% (IQR 4,8). Transfemoral (TF) access was performed in 499 (85.6%) cases. Transcatheter valve-in-valve procedure in patients with failed bioprosthetic valves was performed in 43 (7.4%). A balloon-expandable valve was inserted in 386 (66.2%) and a self-expanding valve in 189 (32.4%). All cause in-hospital mortality was 3.1% (TF: 2.6%; Non-TF: 6.0%) and disabling stroke occurred in 1.7% (TF: 1.4%; Non-TF: 3.6%). Major vascular complications occurred in 2.2% of patients (TF: 2.2%; Non-TF: 2.4%). Median length of stay was 3 (IQR 3,6) days (TF: 3 IQR3,5; Non-TF: 7 IQR5,11), with 93% of patients (TF: 94.2%; Non-TF: 84.1%) discharged directly home. Mortality outcomes achieved in the BC TF TAVI program, were superior to the reports of national registries, including US Transcatheter Valve Therapies (TVT), German Aortic Valve Registry (GARY), French Transcatheter Aortic Valve Intervention (FRANCE 2), and UK TAVI Registry. Length of stay was among the lowest reported in a health service region, with most patients discharged home. This experience demonstrates the potential benefits of a provincial system of care for TAVI. On-going evaluation is needed to ensure quality of services, optimal resource utilization, and health services planning as transcatheter treatment options become increasingly available.

Comparison of transcatheter aortic valve and surgical bioprosthetic valve durability: A fatigue simulation study

Transcatheter aortic valve (TAV) intervention is now the standard-of-care treatment for inoperable patients and a viable alternative treatment option for high-risk patients with symptomatic aortic stenosis. While the procedure is associated with lower operative risk and shorter recovery times than traditional surgical aortic valve (SAV) replacement, TAV intervention is still not considered for lower-risk patients due in part to concerns about device durability. It is well known that bioprosthetic SAVs have limited durability, and TAVs are generally assumed to have even worse durability, yet there is little long-term data to confirm this suspicion. In this study, TAV and SAV leaflet fatigue due to cyclic loading was investigated through finite element analysis by implementing a computational soft tissue fatigue damage model to describe the behavior of the pericardial leaflets. Under identical loading conditions and with identical leaflet tissue properties, the TAV leaflets sustained higher stresses, strains, and fatigue damage compared to the SAV leaflets. The simulation results suggest that the durability of TAVs may be significantly reduced compared to SAVs to about 7.8 years. The developed computational framework may be useful in optimizing TAV design parameters to improve leaflet durability, and assessing the effects of underexpanded, elliptical, or non-uniformly expanded stent deployment on TAV durability.

Invited Commentary

Imagination is more important than knowledge. For knowledge is limited, whereas imagination embraces the entire world.–Albert Einstein, 1929 While Einstein wanted to describe imagination as the driving force behind the search for knowledge, the widespread use of a transcatheter aortic valve replacement (TAVR) is an example for the replacement of knowledge by imagination. It is quite astonishing that a novel technique like TAVR with at first a non-inferiority status [1Smith C.R. Leon M.B. Mack M.J. et al.Transcatheter versus Surgical Aortic-Valve Replacement in High-Risk Patients.N Engl J Med. 2011; 364: 2187-2198Crossref PubMed Scopus (4768) Google Scholar] over the established methods, shown in only 1 prospective randomized trial (by the way, sponsored by the same company selling the novel devices) with a very limited number of participants, could gain such relevance in patient treatment as well as in the scientific discussion. The superiority [2Adams D.H. Popma J.J. Reardon M.J. et al.Transcatheter aortic-valve replacement with a self-expanding prosthesis.N Engl J Med. 2014; 370: 1790-1798Crossref PubMed Scopus (2023) Google Scholar] of TAVR over conventional AVR could only later be shown in an, again, company-sponsored trial. The paper of Ribeiro and colleagues [3Ribeiro H. Dahou A. Urena M. et al.Myocardial injury after transaortic versus transapical transcatheter aortic valve replacement.Ann Thorac Surg. 2015; 99: 2001-2009Abstract Full Text Full Text PDF PubMed Scopus (38) Google Scholar] deals with 2 different TAVR techniques (transaortic versus transapical approach) regarding myocardial injury and ventricular function after the procedure. A clear message can be read between the lines, although very cautiously phrased: transaortic (TAO) TAVR is superior to transapical (TA) TAVR because TAO TAVR leads to less myocardial injury and to a better left ventricular recovery. Interestingly, this does not lead to better clinical outcomes after 30 days or 12 months in the TAO TAVR group, as one would expect knowing the influence of high cardiac biomarkers on long-term outcomes after valve surgery [4Paparella D. Guida P. Caparrotti S. et al.Myocardial damage influences short- and mid-term survival after valve surgery: a prospective multicenter study.J Thorac Cardiovasc Surg. 2014; 148: 2373-2379Abstract Full Text Full Text PDF PubMed Scopus (21) Google Scholar]. One important detail to be found in Supplemental Table 3 is not mentioned by the authors. Moderate or severe aortic valve regurgitation occurs nearly 4 times more often (nearly significantly more often) in the TAO TAVR group. Although there are data available on how high-degree aortic regurgitation worsens long-term survival [5Abdel-Wahab M. Zahn R. Horack M. et al.Aortic regurgitation after transcatheter aortic valve implantation: incidence and early outcome. Results from the German transcatheter aortic valve interventions registry.Heart. 2011; 97: 899-906Crossref PubMed Scopus (440) Google Scholar], the clinical outcomes of the 2 patient groups in this study are similar. Is it possible that higher biomarkers in the TA TAVR group and more aortic regurgitation in the TAO TAVR group balance each other? Clearly, the hypotheses of Ribeiro and colleagues [3Ribeiro H. Dahou A. Urena M. et al.Myocardial injury after transaortic versus transapical transcatheter aortic valve replacement.Ann Thorac Surg. 2015; 99: 2001-2009Abstract Full Text Full Text PDF PubMed Scopus (38) Google Scholar] have to be proven “by future studies with larger sample size … to determine whether or not differences in myocardial injury … translate into significant differences in mortality…”, as the authors state themselves. Ribeiro and colleagues are to be congratulated on an excellent study inspired by their imagination, but they still have to contribute to the “limited knowledge.” Einstein again: “It’s important to go on asking questions.” Myocardial Injury After Transaortic Versus Transapical Transcatheter Aortic Valve ReplacementThe Annals of Thoracic SurgeryVol. 99Issue 6PreviewThe release of cardiac biomarkers of myocardial injury after transcatheter aortic valve replacement (TAVR) is common, but no data exist on patients undergoing TAVR through a transaortic approach. We aimed to evaluate the incidence and prognostic significance of the increase in cardiac biomarkers in nontransfemoral TAVR candidates, comparing transaortic and transapical approaches. Full-Text PDF

The impact of transcatheter aortic valve implantation on quality of life: results from the German transcatheter aortic valve interventions registry.

Transcatheter aortic valve implantation (TAVI) has proven a survival benefit in patients with severe symptomatic aortic stenosis (AS). Recently published data from the German TAVI registry reported a 1-year mortality rate of 19.9%. However, there are limited data for the effect of TAVI on quality of life (QoL), especially in real life settings. The German TAVI registry was launched to evaluate safety, effectiveness and QoL of TAVI in daily clinical routine. We analyzed health-related QoL, using the EQ-5D questionnaire. Quality-of-life data were eligible for 460 patients who survived 12months after TAVI (82.5±6.0years; 32.2% men). At baseline, QoL (EQ-5D-index: 0.63±0.26) was markedly depressed, but significantly improved 30days and 12months (0.67±0.24; 0.70±0.24; p<0.0001) after TAVI procedure. In addition, the visual analogue health scale, recording the patient's self-rated health, significantly (p<0.0001) increased from 42.0±15.9% at baseline to 57.0±17.2% (30days) and 57.7±19.6% (12months). A lower EQ-5D-index at baseline, a percutaneous transfemoral/transaxillar TAVI procedure, and indications other than frailty for TAVI were determinants for an improved QoL 1year after TAVI. Among patients with AS, TAVI resulted in meaningful improvements in QoL. This benefit was present shortly after TAVI and maintained for at least 1year. Different gains in QoL regarding patient-subgroups and determinants for improved QoL could give further impetus for patient selection.

A Review of the Key Clinical Trials of 2014.

IntroductionOver the last year, multiple, potentially practice-changing, cardiology trials or studies have been published or presented at international meetings including the American College of Cardiology, European Association for Percutaneous Cardiovascular Interventions, European Society of Cardiology, Transcatheter Cardiovascular Therapeutics, Heart Failure Congress, Heart Rhythm Society, Heart Failure Society of America, American Society of Hypertension and the American Heart Association.MethodsClinical trial results presented at major cardiology conferences during 2014 were reviewed by the authors. Search terms included heart failure (HF), acute coronary syndrome, stable coronary disease, interventional cardiology, atrial fibrillation, electrophysiology and coronary prevention. Selection criteria were trials of broad relevance to the cardiology community, those with potential to change current practice and those with potential to guide further phase III research.ResultsIn this paper, the authors describe and place in clinical context, new HF, data including neprilysin inhibitors, intravenous ferric carboxymaltose, potassium-absorbing compounds, quadripolar leads for cardiac resynchronization therapy and intraventricular device intervention. New trial data are also described for acute coronary syndromes (clopidogrel, prasugrel, ticagrelor), stable coronary artery disease (ivabradine), percutaneous coronary intervention (the role of thrombectomy or treatment of non-culprit lesions during primary intervention, pressure wire studies and outcomes of new stent designs), transcatheter aortic valve intervention data, atrial fibrillation (anticoagulation and direct current cardioversion), electrophysiology (leadless pacemaker devices, use of quinidine in Brugada syndrome) and coronary prevention (landmark Ezetimibe outcome data, PCSK9 clinical trials, childhood prevalence of hypertension, renal denervation for resistant hypertension and the role of cardiac computerized tomography in cardiovascular screening).ConclusionThis paper summarizes key clinical trials during 2014 and should be of practical interest to clinicians and cardiology researchers.Electronic supplementary materialThe online version of this article (doi:10.1007/s40119-015-0036-0) contains supplementary material, which is available to authorized users.

Comparison of Outcomes of Patients With Left Ventricular Ejection Fractions ≤30% Versus ≥30% Having Transcatheter Aortic Valve Implantation (from the German Transcatheter Aortic Valve Interventions Registry)

Transcatheter aortic valve implantation (TAVI) is rapidly evolving in Germany. Especially severe reduced left ventricular ejection fraction (LVEF) is known as a prominent risk factor for adverse outcome in open heart surgery. Thus, the data of the prospective multicenter German Transcatheter Aortic Valve Interventions Registry were analyzed for outcomes in patients with severe depressed LVEF. Data of 1,432 patients were consecutively collected after transcatheter aortic valve implantation. Patients were divided into 2 groups (A: LVEF ≤30%, n= 169, age 79.9 ± 6.7years, logES 34.2 ± 17.8%; B: LVEF >30%, n= 1,263, age 82.0 ± 6.1years, logES 18.9 ± 12.0%), and procedural success rates, New York Heart Association classification, and quality of life were compared at 30days and 1 year, respectively. Technical success was achieved in 95.9% (A) and 97.6% (B). Survival and the New York Heart Association classification at 30days demonstrated an excellent outcome in both groups. There was a significant improvement according to the self-assessment in health condition (0 to 100 scale) with a much larger gain in group A (28 vs 19patients, p<0.0001). Nevertheless, low cardiac output syndrome (12.3% vs 5.9%, p <0.01) and resuscitation (10.4% vs 5.6%, p <0.05) were more frequently seen in group A, contributing to a higher mortality at 30days (14.3% vs 7.2%) and 1 year (33.7% vs 18.1%, p <0.001). Inconclusion, this real-world registry demonstrated a comparably high success rate for patients with severe reduced LVEF and an early improvement in functional status as demonstrated by substantial benefit, despite a doubled postprocedural mortality.

068-I * CLINICAL AND HAEMODYNAMIC OUTCOMES IN 804 PATIENTS RECEIVING THE FREEDOM SOLO STENTLESS AORTIC VALVE: RESULTS FROM AN INTERNATIONAL PROSPECTIVE MULTICENTRE STUDY

OBJECTIVES: The Freedom SOLO™ valve (Sorin Group, Italy) is a stentless aortic bioprosthesis designed for simplified implantation. The present multicentre study is the largest prospective evaluation of this prosthesis. Herein, we report on outcomes at 3-year follow-up. METHODS: From March 2009 to February 2013, a total of 804 consecutive patients (mean age 74.9 ± 6.3 years; 45.1% females) underwent aortic valve replacement with the Freedom SOLO™ valve at 33 centres. Concomitant procedures (70.2% coronary artery bypass grafting) were performed in 376 patients. The cumulative follow-up included 1100 patient-years (mean 16.5 ± 10.8 months; range: 0–40.5 months). RESULTS: Sixty-four patients died (14 early, 50 late); 12 deaths (1 early, 11 late) were valve-related. Operative mortality (30 days) was 1.7%. At 3 years, overall survival was 82.6% [95% confidence interval (CI) 75.5–87.8%] and freedom from valve-related death was 95.5% (95% CI 89.2–98.2%). Linearized late event rates were 0.82%/patient-years for non-structural valve dysfunction, 0.55%/patient-years for structural valve deterioration, 1.55%/patient-years for endocarditis, 3.64%/patient-years for thromboembolism and 3.18%/patient-years for bleeding. In total, there were 22 reinterventions [19 valve explants, 2 refixations, 1 transcatheter aortic valve intervention (TAVI)] for endocarditis (11), non-structural dysfunction (9) and structural valve deterioration (2). Freedom from reintervention was 95.2% (95% CI 91.2–97.4%) at 3 years. There were no instances of valve thrombosis or haemolysis. At 1, 2 and 3 years, 97.0, 95.5 and 91.4% of patients were in NYHA class I or II. Between discharge and 3 years after surgery, mean transvalvular gradients exhibited a non-significant increase (6.5 ± 4.3 vs 8.7 ± 6.5 mmHg), whereas effective orifice area index remained stable (0.9 ± 0.2 vs 0.8 ± 0.3 cm 2 /m 2 ). At 3 years, no patient presented with more than mild aortic regurgitation. Left ventricular mass index decreased significantly between discharge and 1 year after surgery (139.4 ± 40.9 vs 122.4 ± 35.3 g/m 2 , P< 0.001) and remained unchanged thereafter. Left ventricular size and function did not change over time. CONCLUSIONS: The Freedom SOLO™ valve is a unique stentless pericardial bioprosthesis whose design favours haemodynamic performance and thus facilitates left ventricular reverse remodelling. In terms of survival, morbidity and functional status, it is associated with beneficial outcomes up to 3 years after surgery. Ongoing follow-up will assess the valve at the long-term course.

Aortic Valve Replacement after Previous Coronary Artery Bypass Grafting with Patent Internal Mammary Artery

With the aging population, more patients who have undergone previous coronary artery bypass grafting (CABG) are surviving long enough to require subsequent aortic valve replacement (AVR). Conventional redo AVR after prior CABG involves resternotomy, dissection and clamping of the patent bypass graft vessel. Favorable results have been reported for AVR following previous CABG; however, the problems of this procedure includes that injury to the patent bypass grafts can result in catastrophic complications. Increasing patient age and comorbidities may increase operative mortality, less invasive percutaneous aortic valve intervention has advanced. However, because there are no sufficient data comparing transcatheter aortic valve intervention with surgical AVR, currently, the surgical approach should still be consider as the standard of treatment for AVR following previous CABG. We report a patient in whom successful conventional AVR was underwent after previous CABG with patent left internal mammary artery.

Different impact of sex on baseline characteristics and major periprocedural outcomes of transcatheter and surgical aortic valve interventions: Results of the multicenter Italian OBSERVANT Registry

Despite the widespread use of transcatheter aortic valve implantation (TAVI), the role of sex on outcome after TAVI or surgical aortic valve replacement (AVR) has been poorly investigated. We investigated the impact of sex on outcome after TAVI or AVR. There were 2108 patients undergoing TAVI or AVR who were enrolled in the Italian Observational Multicenter Registry (OBSERVANT). Thirty-day mortality, major periprocedural morbidity, and transprosthetic gradients were stratified by sex according to interventions. Female AVR patients showed a worse risk profile compared with male AVR patients, given the higher mean age, prevalence of frailty score of 2 or higher, New York Heart Association class of 3 or higher, lower body weight, and preoperative hemoglobin level (P ≤ .02). Similarly, female TAVI patients had a different risk profile than male TAVI patients, given a higher age and a lower body weight and preoperative hemoglobin level (P≤.005), but with a similar New York Heart Association class, frailty score, EuroSCORE (P=NS), a better left ventricular ejection fraction and a lower prevalence of left ventricular ejection fraction less than 30%, porcelain aorta, renal dysfunction, chronic obstructive pulmonary disease, arteriopathy, and previous cardiovascular surgery or percutaneous coronary intervention (P ≤ .01). Women showed a smaller aortic annulus than men in both populations (P<.001). Female sex was an independent predictor in the AVR population for risk-adjusted 30-day mortality (odds ratio [OR], 2.34; P=.043) and transfusions (OR, 1.47; P=.003), but not for risk-adjusted acute myocardial infarction, stroke, vascular complications, permanent atrioventricular block (P=NS). Female sex was an independent predictor in the TAVI population for risk-adjusted major vascular complications (OR, 2.92; P=.018) and transfusions (OR, 1.93; P=.003), but proved protective against moderate to severe postprocedural aortic insufficiency (P=.018). Female sex is a risk factor for mortality after aortic valve replacement, for major vascularcomplications after TAVI, and for transfusions after both approaches.

Incidence and predictors of permanent pacemaker implantation following transcatheter aortic valve implantation: Analysis from the german transcatheter aortic valve interventions registry

To determine predictors of permanent pacemaker (PPM) implantation up to 30 days after transcatheter aortic valve implantation (TAVI) in a prospective multicenter registry. Conduction disorders requiring PPM implantation are one of the most common complications seen after TAVI. Knowledge about possible predictors may help to decrease the rate of PPM implantations. In total, 1347 consecutive patients who underwent TAVI in 22 centers were prospectively enrolled in the German transcatheter aortic valve interventions registry. Both Medtronic CoreValve™ and Edwards Sapien™ valves were implanted. Patients with preprocedurally implanted PPM or implantable cardioverter defibrillator were excluded from the analysis (n = 199). Regression analysis of baseline and procedure characteristics of the remaining 1,147 patients was performed. Procedural success was achieved in 97.4% of the cases. The rate for PPM after TAVI was 33.7%. The absence of prior valve surgery, the use of Medtronic CoreValve™ prosthesis and the presence of a porcelain aorta were identified as independent predictors for PPM after TAVI. Mortality at 30 days did not differ between patients with or without PPM necessity (6.0% vs. 8.1%, respectively; HR 0.72; CI (0.45-1.16); P = 0.17). PPM is a common postprocedure requirement after TAVI. The absence of prior valve surgery, the implantation of Medtronic CoreValve™ prosthesis, and the presence of a porcelain aorta were independently associated with PPM after TAVI.

Predictors of One-Year Mortality After Transcatheter Aortic Valve Implantation for Severe Symptomatic Aortic Stenosis

Transcatheter aortic valve implantation (TAVI) is already an accepted option to treat elderly patients with severe symptomatic aortic stenosis who are inoperable or at high surgical risk. However, short- and long-term mortality after TAVI remains an important issue, raising the need to further improve the technology of TAVI as well as to identify patients who will not benefit from TAVI. A total of 1,391 patients treated with TAVI at 27 hospitals were included in the German Transcatheter Aortic Valve Interventions - Registry. One-year follow-up data were available for 1,318 patients (94.8%), with a mean follow-up period of 12.9 ± 4.5 months. One-year mortality was 19.9%. Survivors and nonsurvivors showed multiple differences in patient characteristics, indications for interventions, preintervention and interventional characteristics, and postintervention events. A higher logistic European System for Cardiac Operative Risk Evaluation score was associated with higher 1-year mortality (p <0.0001). Cox proportional-hazards analysis revealed the following independent predictors of mortality: among preintervention findings: previous mitral insufficiency ≥II° (p= 0.0005), low-gradient aortic stenosis (p= 0.0008), previous decompensation (p= 0.0061), previous myocardial infarction (p= 0.0138), renal failure (p= 0.0180), previous New York Heart Association class IV (p= 0.0254), and female gender (p= 0.0346); among procedural factors: intraprocedural conversion to surgery (p= 0.0009), peri-intervention stroke (p= 0.0003), and residual aortic insufficiency ≥II° (p= 0.0022); and among postprocedural events: postintervention myocardial infarction (p= 0.0009) and postintervention pulmonary embolism (p= 0.0025). In conclusion, 1-year mortality after TAVI was 19.9% in this series. Patient characteristics and procedural as well as postintervention factors associated with mortality were identified, which may allow better patient selection and better care for these critically ill patients.

Complications during transcatheter aortic valve intervention requiring the use of extracorporal circulation: A single center experience

Objective: Even though Transcatheter aortic valve implantation (TAVI) is a promising treatment option for high-risk patients considered inoperable for surgical aortic valve replacement, use of the heart-lung-machine (HLM) is still necessary in some cases in order to control severe complications. We intended to evaluate incidence and outcome for TAVI patients requiring extra-corporal circulatory support during intervention in our institution.

Maintaining a minimally invasive approach—vascular closure after trans-catheter aortic valve intervention

Trans-catheter aortic valve implantation (TAVI) is now recognised as an effective way to treat patients with symptomatic aortic stenosis when open surgical repair is not feasible or considered too high risk. Retrograde trans-femoral TAVI (TF-TAVI) requires large bore vascular access (18-24F), and successful management of the access site is key to maintaining the minimally invasive nature of the procedure. This editorial reviews the current techniques available to facilitate percutaneous vascular closure and the common complications associated with vascular access.

The impact of transcatheter aortic valve implantation on quality of life. Results from the German transcatheter aortic valve interventions registry

The impact of transcatheter aortic valve implantation on quality of life. Results from the German transcatheter aortic valve interventions registry