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Treatment of calcific aortic stenosis with the percutaneous heartvalve: Mid-term follow-up from the initial feasibility studies: The French experience
Abstract
The aim of this work was to study the feasibility, safety, efficacy, and durability of percutaneous heart valve (PHV) implantation in the aortic position.
We developed a PHV (equine pericardium valve in a balloon-expandable, stainless-steel stent) to treat patients with inoperable aortic stenosis (AS).
Thirty-six patients (aortic valve area < or =0.7 cm2, New York Heart Association [NYHA] functional class IV, and severe comorbidities), formally declined for surgery, were recruited on a compassionate basis. The PHV was implanted by retrograde or antegrade trans-septal approach. Clinical and echocardiographic outcomes were assessed serially.
Twenty-seven patients were implanted successfully (23 antegrade, 4 retrograde) in the subcoronary position with improvement in valve area (0.60 +/- 0.11 cm2 to 1.70 +/- 0.10 cm2, p < 0.0001) and transvalvular gradient (37 +/- 13 mm Hg to 9 +/- 2 mm Hg, p < 0.0001). Paravalvular aortic regurgitation was grade 0 to 1 (n = 10), grade 2 (n = 12), and grade 3 (n = 5). One week post-procedure, improvement in left ventricular function (45 +/- 18% to 53 +/- 14%, p = 0.02) was most pronounced in patients with ejection fraction <50% (35 +/- 10% to 50 +/- 16%, p < 0.0001). Thirty-day major adverse events after successful implantation were 26% (pericardial tamponade, stroke, arrhythmia, urosepsis, and one death unexplained at autopsy). Eleven patients are currently alive with follow-up of 9 months (n = 2), 10 months (n = 3), 11 months (n = 1), 12 months (n = 2), 23 months (n = 1), and 26 months (n = 2). All patients experienced amelioration of symptoms (>90% NYHA functional class I to II). Percutaneous heart valve function remained unchanged during follow-up, and no deaths were device-related.
Percutaneous heart valve implantation is feasible in inoperable patients with end-stage AS leading to hemodynamic and clinical improvement. Continued advances and improved patient selection should decrease adverse events in the near future.
... In 2004, Cribier reported implantation in six high risk inoperable patients using the antegrade atrial trans-septal approach (13). In the next series Cribier used both antegrade and retrograde approaches (14). These implantations were undertaken under mild sedation and in local anesthesia and without extracorporeal circulation. ...
... Initially, Cribier used the percutaneous femoral venous route, transseptal atrial puncture, balloon dilatation of the atrial septum, right atrium to left atrium access, mitral valve, left ventricle, and finally antegrade through the aortic valve where the 260-cm-long guidewire was advanced and snared from the femoral artery and externalized via the arterial sheath (12)(13)(14). The procedure was very complex and demanding and required extensive experience with cardiac catheterization and therefore complications were common. ...
... They were against it because TAVI was not about cardiac surgery but interventional cardiology and they did not recommend Edwards to engage in such a radical shift in business strategy. When Alain Cribier had performed the FIM and small series of implantation with the PVT valve (12)(13)(14), Edwards' CEO realized that his company was far behind with their own inhouse TAVI development, and PVT was several years ahead of them. The Edwards' CEO acknowledged that PVT could undoubtedly sell their company for a considerable sum to one of Edwards' competitors which would outperform them and leave Edwards as a minor company in the heart valve market. ...
This story is about the invention of transcatheter aortic valve implantation (TAVI), and the people who transformed it from a concept and primitive device to a breakthrough lifesaving treatment for hundreds of thousands of patients with aortic valve stenosis. It is an inspirational example of a new disruptive technology that began with an idea most dismissed. The story describes the ups and downs from idea, design, construction, animal testing, proof-of-concept, scientific publication hurdles, a patent, license agreement, cooperation with several companies, fighting in patent courts in Europe and USA and finally how multinational companies financially bypassed the inventor. It is also a story about the struggles and battles the inventor experienced when injected into a world of lawyers and patent fights. I hope my personal story and journey can provide an inspiration and word of caution for new inventors.
... Two registries published in 2004 and 2006 described the early outcomes of TAVR, with most procedures performed via an antegrade transseptal approach [9,10]. Despite this procedure offering a novel therapy for patients who were at high surgical risk for TAVR, the transseptal approach carried high procedural complexity, a need for atrial septal crossing and a risk of injury to the anterior mitral valve leaflet with subsequent mitral regurgitation. ...
... The frequency of use of alternative accesses in TAVR has changed over the past decade, with an overall trend of decreased use of transapical access and increased utilization Two registries published in 2004 and 2006 described the early outcomes of TAVR, with most procedures performed via an antegrade transseptal approach [9,10]. Despite this procedure offering a novel therapy for patients who were at high surgical risk for TAVR, the transseptal approach carried high procedural complexity, a need for atrial septal crossing and a risk of injury to the anterior mitral valve leaflet with subsequent mitral regurgitation. ...
Transcatheter aortic valve replacement (TAVR) has emerged as an alternative treatment option for patients with severe aortic stenosis regardless of surgical risk, particularly in those with a high and prohibitive risk. Since the advent of TAVR, transfemoral access has been the standard of care. However, given comorbidities and anatomical limitations, a proportion of patients are not good candidates for a transfemoral approach. Alternative access, including transapical, transaortic, transaxillary, transsubclavian, transcarotid, and transcaval, can be considered. Each alternative access has advantages and disadvantages, so the vascular route should be tailored to the patient’s characteristics. However, there is no standardized algorithm when choosing the optimal alternative vascular access. In this review, we analyzed the evolution and current evidence for the most common alternative access for TAVR and proposed an algorithm for choosing the optimal vascular access in this patient population.
... The first clinical trials which successfully elucidated the feasibility and safety of TAVR were the Registry of Endovascular Critical Aortic Stenosis Treatment (RECAST) and the Initial Registry of EndoVascular Implantation of Valves in Europe (I-REVIVE) [5,6]. ...
... A Heart Team consisting of an interventional cardiologist, cardiac surgeon, clinical A schematic for management of AS adopted from the 2020 AHA guidelines (image obtained from Ref. [16]). 6 cardiologist, and anesthetist are responsible for actively performing the preprocedural screening and work-up. However, because these patients are generally elder with many comorbidities, physicians from even other specialties often participate in pre-procedural optimization. ...
In just over a decade, there have been paradigm shifts globally in the catheter-based therapies available for the management of patients with severe aortic stenosis. The use of transcatheter aortic valve replacement (TAVR) has been a crucial turning point in the field of cardiology as it granted an option for a minimally invasive method to replace a valve for patients who may or may not be suitable for cardiac surgery. In this chapter, we discuss the current practices and considerations as well as the ongoing evolution of catheter-based approaches for TAVR. The predominant focus of the chapter will be on aortic valve device modifications, prototypes of valves, device delivery systems, and the various techniques. However, discussions on indications/contraindications, proper work-up, preparation, equipment and personnel , complications, and post-procedural management & surveillance will also be reviewed.
... The implantations were performed using mild sedation, without rapid right ventricular pacing or extracorporeal circulation. These early trials demonstrated above 75% procedural success with lasting hemodynamic performance at follow-up [78]. The main limitation observed was the incidence of 25% moderate-to severe paravalvular regurgitation, which occurred due to the availability of only a single size 23 mm valve prosthesis from Percutaneous Valve Technology (PVT, co-founded by Cribier) [78]. ...
... These early trials demonstrated above 75% procedural success with lasting hemodynamic performance at follow-up [78]. The main limitation observed was the incidence of 25% moderate-to severe paravalvular regurgitation, which occurred due to the availability of only a single size 23 mm valve prosthesis from Percutaneous Valve Technology (PVT, co-founded by Cribier) [78]. ...
Aortic valve stenosis (AVS) is the most frequent valvular heart disease in industrialized countries, presenting with very high mortality if left untreated. While drug treatment can sometimes alleviate symptoms, it fails to stop progression or cure the underlying disease. Until the first decade of this millennium, surgical aortic valve replacement (SAVR) remained the only available therapy option with a positive impact on mortality and morbidity. Even though several studies reported highly positive effects of SAVR regarding the improved quality of life and better physical performance, SAVR remained an intervention that, due to its remarkable complexity and the need for heart-lung machine and cardioplegia, was limited by the patients’ comorbid profile. While unsatisfying hemodynamic results after transcatheter aortic balloon valvuloplasty in high-risk surgical patients limited its adoption as an alternative treatment, it provided the impetus for further interventional approaches to the therapy of AVS. This review considers the invention and development of transcatheter aortic valve implantation (TAVI), which established itself as a catheter-based, minimally invasive procedure over the past decade, and has become an equivalent treatment method for high-risk surgical patients. For that matter, early TAVI concepts, their amendments, and the associated pioneers are recognized for paving the way to a revolutionary diversification in AVS treatment.
... The mean follow-up period, calculated from nine papers, was 35.66 [27.50-43.81] months. ...
... The noAVR approach is mainly oriented toward the management of cardiovascular risk factors, which include controlling hypertension and volume status. Valvuloplasty may indeed accompany medication but it has lower survival rates when compared to noAVR because of increased risk of restenosis occurring after the procedure, which may lead to deterioration of the valve already 1 year after surgery.35,36 Indeed, despite the fact that valvuloplasty reduces the transvalvular pressure gradient and improves symptoms, it does not fully resolve the stenosis, because the postvalvuloplasty AVA usually does not exceed 1.0 cm 2 .31,37 ...
Background and aim
Classical and paradoxical low‐flow, low‐gradient (LFLG) aortic stenosis (AS) are the most challenging subtypes of AS. The current therapeutic options are aortic valve replacement (AVR) and conservative management: AVR promotes long‐term survival but is invasive, while conservative management yields a poor prognosis but is noninvasive since it uses no aortic valve replacement (noAVR). The present meta‐analysis investigated the rate of survival of patients with LFLG AS undergoing either AVR or noAVR interventions.
Methods
The meta‐analysis compared the outcomes of AVR with those of noAVR in terms of patient survival. In both groups, a meta‐regression was conducted to investigate the impact on patient survival of the left ventricular ejection fraction (LVEF), either preserved (paradoxical LFLG AS) or reduced (classical LFLG AS).
Results
The relative risk of survival between the AVR and noAVR groups was 1.99 [1.40, 2.82] (p = .0001), suggesting that survival tends to be better in AVR patients than in noAVR patients. The meta‐regression revealed that a reduced LVEF may be related to a higher survival in AVR patients when compared to a preserved LVEF (p = .04). Finally, the analysis indicated that LVEF seems not to be prognostic of survival in noAVR patients (p = .18).
Conclusions
Patients with LFLG AS have better survival if they undergo AVR. In AVR patients, reduced LVEF rather than preserved LVEF is related to better survival, whereas there seems to be no difference in prognostic value between reduced and preserved LVEF in noAVR patients.
... T he transcatheter aortic valve implantation (TAVI) procedure is an established therapy for patients with severe aortic stenosis with high or intermediate surgical risk. 1,2 TAVI has been shown to reduce all-cause mortality, cardiac symptoms, and re-hospitalization compared with medical therapy. 3 However, high-grade atrioventricular conduction disturbances (ie, second-degree atrioventricular block Mobitz type 2 or complete atrioventricular block) requiring permanent pacemaker implantation remain a common problem after TAVI and are observed in 10% to 20% of patients. ...
... Using that strategy, only persistent HAVB can be found. (2) The percentage of pacing recorded in the pacemaker over the entire follow-up period was extracted. Of note, specific algorithms (eg, AAI-DDD) were used to prevent unnecessary right ventricular pacing and the lower rate limit was programmed to 40 bpm. ...
Background
Left bundle branch block ( LBBB ) is common after transcatheter aortic valve implantation ( TAVI ) and is an indicator of subsequent high‐grade atrioventricular block ( HAVB ). No standardized protocol is available to identify LBBB patients at risk for HAVB . The aim of the current study was to evaluate the safety and efficacy of an electrophysiology study tailored strategy in patients with LBBB after TAVI .
Methods and Results
We prospectively analyzed consecutive patients with LBBB after TAVI . An electrophysiology study was performed to measure the HV ‐interval the day following TAVI . In patients with normal His‐ventricular ( HV )‐interval ≤55 ms, a loop recorder was implanted ( ILR ‐group), whereas pacemaker implantation was performed in patients with prolonged HV ‐interval >55 ms ( PM ‐group). The primary end point was occurrence of HAVB during a follow‐up of 12 months. Secondary end points were symptoms, hospitalizations, adverse events because of device implantation or electrophysiology study, and death. Of 373 patients screened after TAVI , 56 patients (82±6 years, 41% male) with LBBB were included. HAVB occurred in 4 of 41 patients (10%) in the ILR ‐group and in 8 of 15 patients (53%) in the PM ‐group ( P <0.001). We did not identify other predictors for HAVB than the HV interval. The negative predictive value for the cut‐off of HV 55 ms to detect HAVB was 90%. No HAVB ‐related syncope occurred in the 2 groups.
Conclusions
An electrophysiology study tailored strategy to LBBB after TAVI with a cut‐off of HV >55 ms is a feasible and safe approach to stratify patients with regard to developing HAVB during a follow‐up of 12 months.
... Surgical valve replacement is the standard treatment procedure for patients with severe symptomatic aortic stenosis. However, percutaneous aortic valve replacement has become popular in recent years, especially for elderly patients and those with comorbidities who are at high risk for surgery (2) . Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure employed for the treatment of aortic valve disease in patients who are considered high-risk or ineligible for traditional openheart surgery (1) . ...
... TAVI is performed by inserting a bioprosthetic valve through a catheter, which is then implanted within the diseased aortic valve. Increasing numbers of ssAS patients have been treated using this less-invasive technology worldwide since the first TAVI in 2002 [8][9][10]. ...
Objective:
Aortic stenosis (AS) is a heart valve disease characterized by left ventricular outflow fixed obstruction. It can be managed by surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI). However, real-world evidence for TAVI or SAVR outcomes is lacking in Taiwan. This study aimed to compare the clinical outcomes of TAVI and SAVR for treating of AS in Taiwan.
Materials and methods:
The National Health Insurance Research Database is a nationally representative cohort that contains detailed registry and claims data from all 23 million residents of Taiwan. This retrospective cohort study used this database to compare patients who underwent SAVR (bioprosthetic valves) or TAVI from 2017 to 2019. Survival outcomes and length of hospital stay (LOS) and intensive care unit (ICU) stay between TAVI and SAVR in the matched cohort. A Cox proportional hazards model was performed to identify the effect of treatment type on survival rates while controlling variables including age, gender, and comorbidities.
Results:
We identified 475 and 1605 patients who underwent TAVI and SAVR with a bioprosthetic valve, respectively. Patients who underwent TAVI were older (82.19 vs. 68.75 y/o) and more likely to be female (55.79% vs. 42.31%) compared with patients who underwent SAVR. Propensity score matching (PSM) on age, gender, and Elixhauser Comorbidity Index (ECI) score revealed that 375 patients who underwent TAVI were matched with patients who underwent SAVR. A significant difference was found in survival rates between TAVI and SAVR. The 1-year mortality rate was 11.44% with TAVI and 17.55% with SAVR. Both the mean total LOS (19.86 vs. 28.24 days) and mean ICU stay (6.47 vs. 11.12 days) for patients who underwent TAVI were shorter than those who underwent SAVR.
Conclusion:
Patients who had undergone TAVI had better survival outcomes and shorter LOS compared with patients who had undergone SAVR in Taiwan.
... The patient's clinical improvement and hemodynamic findings at 30 days are consistent with the reported literature. 18,19 TAVI has emerged as an alternative technique to treat aortic stenosis patients with high surgical risk. Careful preprocedural planning is required for a successful TAVI procedure. ...
Surgical aortic valve replacement has remained the gold standard therapy for symptomatic severe aortic stenosis patients for decades. However, in past decade transcatheter aortic valve implantation has been an alternative to surgical aortic valve replacement in patients with symptomatic severe aortic stenosis who are not suitable for open heart surgery. We report first case of transcatheter aortic valve implantation in Nepal in an 80-year-old female with symptomatic severe AS who was successfully treated and had good functional and hemodynamic results at one-months follow-up.
... Since the first pioneering procedure by Cribier et al. in 2002, TAVI has become an acceptable standard of care in patients with symptomatic severe AS who are not eligible for surgery. After several first-in-man trials, Edwards Sapien Valve and CoreValve received the CE mark in 2007 as the first TAVI prostheses on the European market [33][34][35]. The Placement of AoRTic TraNscathetER Valve (PARTNER) 1 trial demonstrated the superiority of TAVI with the Edwards Sapien valve system (Edwards Lifesciences, Irvine, CA, USA) over optimal medical treatment. ...
There is a worldwide expansion in percutaneous therapy for valvular heart disease. Rapidly evolving technology and the general increase in life expectancy will support the evolution of new treatment options dedicated to structural heart interventions. Tran-scatheter aortic valve implantation for severe aortic valve stenosis and percutaneous mitral valve repair with the MitraClip system for severe mitral regurgitation have been demonstrated as a feasible, innovative alternative for surgical treatment. Despite the inequality in clinical experience, both procedures have encouraging results and now are a part of everyday clinical practice. More importantly, rapid development is expected in the next decades. However, the global coronavirus disease 2019 (COVID-19) pandemic imposed redistribution of healthcare resources. Hospitals were obliged to modify their workflow and limit TAVI and MitraClip procedures to urgent or in highly symptomatic patients. Despite this encumbrance improvement in technology and experience supported by robust evidence from current studies might extend indications for both procedures. The future holds promise for this treatment modality to become the preferred procedure for all patients despite age or risk and reserving surgical treatment for a minority. Thus, we present state-of-the-art and current evidence for both methods assumed to change the paradigm of treatment of valvular heart failure in the future.
... An important element to consider is that up to 2011, even with propensity-matching, most of the studies were tested on retrospective observational data and no suitable randomized comparative studies had been published [29][30][31][32][33][34]. ...
Aortic stenosis is a disease that is increasing in prevalence and manifests as decreased cardiac output, which if left untreated can result in heart failure and ultimately death. It is primarily a disease of the elderly who often have multiple comorbidities. The advent of transcatheter aortic valve therapies have changed the way we treat these conditions. However, long-term results of these therapies remain uncertain. Recently there has been an increasing number of studies examining the role of both surgical aortic valve replacement and transcatheter aortic valve replacement. We therefore performed a systematic review using Ovid MEDLINE, Ovid Embase, and the Cochrane Library. Two investigators searched papers published between January 1, 2007 and to date using the following terms: “aortic valve stenosis,” “aortic valve operation” and “transcatheter aortic valve therapy”. Both strategies in aortic stenosis treatment highlighted specific indications alongside the pitfalls such as structural valve degeneration and valve thrombosis which have a bearing on clinical outcomes. We propose some recommendations to help clinicians in the decision-making process as technological improvements make both surgical and transcatheter therapies viable options for patients with aortic stenosis. Finally we assess the role of finite element analysis in patient selection for aortic valve replacement.
THVT and AVR-S are both useful tools in the armamentarium against aortic stenosis. The decision between the two treatment strategies should be best guided by a strong robust evidence
... SAVR is the treatment of choice in symptomatic patients with severe AS [3]. However, TAVR has lately become a less invasive although valuable alternative to manage symptomatic patients at intermediate or high risk of surgical procedure [4,5]. It has already been proven that TAVR is non-inferior to surgery when performed in experienced centers, with respect to the risk of death or stroke within five years of follow-up [6,7]. ...
Background:
Intervention-induced platelet hypercoagulability may pose a risk of serious adverse events for patients.
Aims:
The aim of this study was to assess whether surgical (SAVR) and transcatheter aortic valve replacement (TAVR) differ in periprocedural platelet activity.
Methods:
The total number of 24 patients with a mean age (SD) of 71 (13) years who underwent SAVR (n=12) or TAVR (n=12) were recruited for the study. The following parameters were evaluated at four time-points: (i) platelet indices: total platelet count (PLT), platelet distribution width (PDW) and mean platelet volume (MPV), (ii) MPV/PLT ratio, (iii) platelet level of lipid peroxidation: malondialdehyde (MDA) content and MDA/PLT ratio. Eventually, percentage variations of PLT, PDW and MPV in relation to the baseline values were determined.
Results:
MPV/PLT ratio increased significantly after procedures in both groups (P = 0.01 in TAVI and P = 0.01 in SAVR). MDA concentrations were significantly higher when assessed directly post-procedure (P = 0.04) as well as 24h later (P = 0.01) in the SAVR and TAVI groups. The indirect parameter of platelet activity indexed for platelet counts (MDA/PLT) was comparable between both groups before and 48 hours after procedures, but was significantly higher in SAVR patients, particularly after 24h after interventions (P = 0.04; medians TAVR vs. SAVR, respectively).
Conclusion:
Standard surgical aortic valve replacement is associated with a more pronounced platelet reaction to intervention-induced injury, as compared to the transcatheter-based procedure. The importance of these laboratory findings requires further investigation focused on early and late clinical outcomes.
... Transeptal TAVR proved reproducible and feasible in approximately 85% of cases, where it was conducted for compassionate use, but the takeover of Percutaneous Valve Technologies by Edwards Lifesciences in 2004 began the transition of TAVR into both a mainstream clinical and commercial reality (7). The early Cribier-Edwards 23-mm valve was redesigned and accompanied by delivery catheters for implantation of the valve from the retrograde transfemoral and antegrade transapical routes, opening the door for widespread adoption of the procedure. ...
The management of aortic stenosis has been revolutionized by transcatheter aortic valve replacement (TAVR). Initially only undertaken in patients at prohibitive or high surgical risk, as the evidence base and indications have expanded, TAVR is now approved and undertaken in patients at all risk levels. Evolution of valve technology, delivery systems and pathways for patient work-up have been rapid, with associated reductions in the complication profile, particularly vascular complications. Challenges remain as TAVR continues to advance, however, specifically achieving further reduction in paravalvular regurgitation, the requirement for permanent pacemaker implantation, and balancing the risks of thrombosis and bleeding. In this review, we outline the historical advances leading to contemporary TAVR practice, and discuss the future trajectory.
... Different rates of AR have been reported after TAVR with the reported frequency of moderate to severe regurgitation up to 24% in early generation prostheses. The number of patients with moderate or severe AR after TAVR in our study (20%) was in line with previous reports using either by the CoreValve system or the Edwards SAPIEN XT valve [2][3][4][5][6][7] . Newer generation of TAVR prostheses have been developed with incrementally lower grades of moderate or severe AR 26 . ...
Postprocedural aortic regurgitation (AR) has negative impact on patient outcome after transcatheter aortic valve replacement (TAVR). Standard assessment of AR severity by echocardiography is hampered after TAVR. Measurement of pressure half-time (PHT) by echocardiography is not limited in these patients but it may be affected by concomitant left ventricular hypertrophy (LVH). This study sought to evaluate distinct cut-off values of PHT differentiating between patients without and with more than mild LVH for grading of AR after TAVR with cardiac magnetic resonance (CMR) as the reference method for comparison. 71 patients (age 81 ± 6 years) with severe aortic stenosis undergoing TAVR were included into the study. Transthoracic echocardiography (TTE) and CMR were performed after TAVR. Left ventricular mass index was calculated by TTE. PHT was measured by continuous-wave Doppler echocardiography of aortic regurgitation jet. In 18 patients (25%) PHT could not be obtained due to no or very faint Doppler signal. Aortic regurgitant volume and regurgitant fraction were calculated by CMR by flow analysis of the ascending aorta. In 14 of 53 patients (26%) AR after TAVR was moderate or severe as categorized by CMR analysis. More than mild LVH was present in 27 of 53 patients (51%). PHT correlated inversely less to regurgitant fraction by CMR analysis in patients with LVH (r = −0.293; p = 0.138) than in patients without LVH (r = −0.455; p = 0.020). In patients without relevant LVH accuracy of PHT to predict moderate or severe paravalvular regurgitation AUC was 0.813 using a cut-off value of 347 ms and AUC was 0.729 in patients with more than mild LVH using a cut-off value of 420 ms. Analysis of PHT by TTE with distinct cut-off values for patients without and with more than mild LVH allows detection of moderate or severe AR after TAVR as defined by CMR. In none of the patients in which PHT could not be measured AR was categorized as more than trace by CMR analysis.
... Over the past 5 years, the development of minimally invasive transcatheter valve implantation has been explored. [2][3][4][5][6][7][8][9][10][11][12][13] Transarterial and transapical transcatheter aortic valve implantation (AVI) has been explored by cardiologists and cardiac surgeons worldwide. Many reports have shown favorable early clinical and echocardiographic outcomes with transarterial or transapical AVI. ...
We performed the first human case of successful transapical transcatheter aortic valve implantation on a beating heart in October 2005, and therefore we have the longest follow-up on transapical aortic valve implantation in humans. We now report clinical and echocardiographic outcomes of transapical aortic valve implantation in 71 patients.
Between October 2005 and February 2009, 71 patients (44 female) underwent transcatheter transapical aortic valve implantation with either 23- or 26-mm Edwards Lifesciences transcatheter bioprostheses. All patients with symptomatic aortic stenosis were declined for conventional aortic valve replacement owing to unacceptable operative risks and were not candidates for transfemoral aortic valve implantation because of poor arterial access. Clinical and echocardiographic follow-ups were performed before discharge, at 1 and 6 months, and then yearly. The mean follow-up was 12.9 +/- 11.5 months with a total of 917.3 months of follow-up.
Mean age was 80.0 +/- 8.1 years and predicted operative mortality was 34.5% +/- 20.4% by logistic EuroSCORE and 12.1% +/- 7.7% by The Society of Thoracic Surgeons Risk Calculator. Valves were successfully implanted in all patients. Twelve patients died within 30 days (30-day mortality: 16.9% in all patients, 33% in the first 15 patients, and 12.5% in the remainder), and 10 patients died subsequently. Overall survival at 24 and 36 months was 66.3% +/- 6.4% and 58.0% +/- 9.5%, respectively. Among 59 patients who survived at least 30 days, 24- and 36-month survivals were 79.8% +/- 6.4% and 69.8% +/- 10.9%, respectively. Late valve-related complications were rare. New York Heart Association functional class improved significantly from preoperative 3.3 +/- 0.8 to 1.8 +/- 0.8 at 24 months. The aortic valve area and mean gradient remained stable at 24 months (1.6 +/- 0.3 cm(2) and 10.3 +/- 5.9 mm Hg, respectively).
Our outcome suggests that transapical transcatheter aortic valve implantation provides sustained clinical and hemodynamic benefits for up to 36 months in selected high-risk patients with symptomatic severe aortic stenosis.
... Transcatheter aortic valve implantation has revolutionized the treatment of patients with severe symptomatic aortic stenosis (AS) who are at prohibitive or high surgical risk [1][2][3][4][5]. TAVI is a good alternative to SAVR in high and intermediate surgical risk patients [6,7]. ...
This retrospective study was aimed to compare the safety and efficacy of the Direct Flow Medical (DFM) valve with the more established Sapien 3 (S3) valve in transfemoral TAVI in high-risk aortic stenosis (AS) patients. Between February 2014 and August 2016, 99 and 68 patients had the S3 and DFM valves at our center, respectively. The device success rate was statistically similar among the S3 and DFM groups (p = 0.15). The overall post-procedural complication rate was similar between the two groups (p = 0.4). The procedural time was significantly shorter in the S3 group (p < 0.001) and the post-procedure peak pressure gradient (p < 0.001) was significantly higher in the DFM group. However, the frequency of valvular or paravalvular leaks was similar between both valve groups. We found no significant differences in terms of safety between the DFM and S3 valves. This study confirms the safety and efficacy of the DFM valve in high-risk AS patients.
... This was done via a trans-septal anterograde approach. Since then the technique has improved, with a progression to the much simpler retrograde approach, with the first publication in 2006 byCribier et al. showing marked improvements in valve area and reductions in transvalvular gradients using this technique.20 The rapid evolution of technology means that the majority of patients can undergo this procedure via the femoral artery, as the current sheath sizes for the smallest valves are now reduced to 14 French, compared to the 24 French sheaths used in the early versions of the valves. ...
Transcatheter aortic valve implantation (TAVI) is a recent development in the treatment of severe aortic stenosis, whereby a new valve is inserted without the need for open heart surgery. It has been associated with a high stroke risk in early studies and the risk is thought to be primarily embolic. I used Transcranial Doppler (TCD) to assess the effects of embolization on the brain. Initially a pilot study was performed with TCD to establish a suitable protocol, prior to moving to a full study of TCD. This showed embolization was present in all TAVI procedures at each stage, but most frequent during valve deployment. The same TCD protocol along with MRI scans was used in a multi-centre study called DEFLECT-1, looking at a novel embolic deflection device named the TriGuard device. This showed cerebral infarct volume, but not embolic number, was reduced using the device compared with historical controls. I also used the data collected from TCD in a study showing that balloon aortic valvuloplasty (BAV) was an unnecessary part of the TAVI procedure when using balloon-expandable valves. Highly calcified valve tissue is displaced during the TAVI procedure, a likely embolic source. I assessed aortic valve calcification from CT scans and showed that the degree of calcification correlated with the number of emboli released during valve deployment. Finally I looked at the effects of TAVI on cognitive function. The rationale for a new battery of cognitive tests using a fully computerised system of cognitive testing (CANTAB Eclipse) is given. This battery of tests was then used to assess cognitive function pre-TAVI and post-TAVI at various time intervals. I showed that there was improvement in certain domains and overall there was no evidence of declining cognition in any domain.
... these leads (20)(21)(22)(23)(24). Although temporary pacing leads with a distal screw for active myocardial fixation have been used to attempt to reduce dislodgment and loss of pace capture, these leads have exhibited dislodgment rates of up to 6%. ...
Objectives:
This multicenter retrospective study of the initial U.S. experience evaluated the safety and efficacy of temporary cardiac pacing with the Tempo® Temporary Pacing Lead.
Background:
Despite increasing use of temporary cardiac pacing with the rapid growth of structural heart procedures, temporary pacing leads have not significantly improved. The Tempo lead is a new temporary pacing lead with a soft tip intended to minimize the risk of perforation and a novel active fixation mechanism designed to enhance lead stability.
Methods:
Data from 269 consecutive structural heart procedures were collected. Outcomes included device safety (absence of clinically significant cardiac perforation, new pericardial effusion, or sustained ventricular arrhythmia) and efficacy (clinically acceptable pacing thresholds with successful pace capture throughout the index procedure). Postprocedure practices and sustained lead performance were also analyzed.
Results:
The Tempo lead was successfully positioned in the right ventricle and achieved pacing in 264 of 269 patients (98.1%). Two patients (0.8%) experienced loss of pace capture. Procedural mean pace capture threshold (PCT) was 0.7 ± 0.8 mA. There were no clinically significant perforations, pericardial effusions, or sustained device-related arrhythmias. The Tempo lead was left in place postprocedure in 189 patients (71.6%) for mean duration of 43.3 ± 0.7 hr (range 2.5-221.3 hr) with final PCT of 0.84 ± 1.04 mA (n = 80). Of these patients, 84.1% mobilized out of bed with no lead dislodgment.
Conclusion:
The Tempo lead is safe and effective for temporary cardiac pacing for structural heart procedures, provides stable peri and postprocedural pacing and allows mobilization of patients who require temporary pacing leads.
... Embolizations of THVs have been observed since the early transcatheter aortic valve implantation (TAVI) experiences. [1][2][3] The consequences of THV migration and embolization vary considerably. 4 Some may go unnoticed by the patient (e.g. ...
Resumo Fundamento O implante percutâneo de bioprótese valvar aórtica (TAVI) consolidou-se como opção terapêutica da estenose aórtica de grau importante. Dados sobre as características evolutivas dos procedimentos e dos resultados obtidos com a técnica ao longo da última década, em escala nacional, são desconhecidos. Objetivos Analisar a tendência temporal referente ao perfil demográfico, características dos procedimentos e desfechos hospitalares de pacientes submetidos a TAVI na Rede D’Or São Luiz. Métodos Registro observacional envolvendo 29 instituições nacionais. Comparou-se características dos procedimentos realizados de 2012 a 2017 (Grupo 1) e de 2018 a 2023 (Grupo 2). Foram considerados significantes os resultados com valor de p < 0,05. Resultados Foram analisados 661 casos, 95 pertencentes ao Grupo 1 e 566 ao Grupo 2. A média de idade foi 81,1 anos. Observou-se no Grupo 1 maior prevalência de pacientes em classe funcional III ou IV e escore de risco > 8%. Foi mais frequente o emprego de anestesia geral, monitorização ecocardiográfica transesofágica e via de acesso por dissecção. Maior taxa de sucesso do procedimento (95,4% versus 89,5%; p = 0,018) foi aferida em implantes efetivados a partir de 2018, assim como menor mortalidade (3,9% versus 11,6%; p = 0,004) e necessidade de marcapasso definitivo (8,5% versus 17,9%; p = 0,008). Conclusões A análise temporal de 10 anos do Registro TAVIDOR demonstra uma queda na complexidade clínica dos pacientes. Além disso, o avanço para técnicas de implante minimalistas, somadas à evolução tecnológica dos dispositivos, podem ter contribuído para desfechos favoráveis dentre aqueles cujo implante ocorreu no último quinquênio.
Background: Transcatheter aortic valve implantation (TAVI) has established itself as the preferential strategy to approach severe aortic stenosis. Information on procedural improvements and nationwide results obtained with the technique throughout the past decade are unknown.
Objectives: To assess the temporal variation of the demographic profile, procedural characteristics, and in-hospital outcomes of patients undergoing TAVI procedures at the Rede D’Or São Luiz.
Methods: Observational registry comprising 29 national institutions, comparing the characteristics of the TAVI
procedures performed from 2012 to 2017 (Group 1) to those performed from 2018 to 2023 (Group 2). The statistical significance level adopted was p < 0.05.
Results: This study assessed 661 patients, 95 in Group 1 and 566 in Group 2, with a mean age of 81.1 years. Group 1 patients had a higher prevalence of New York Heart Association functional class III or IV and STS risk score > 8%. In addition, they more often underwent general anesthesia, transesophageal echocardiographic monitoring, and access through femoral dissection. Group 2 patients had a higher success rate of the TAVI procedure (95.4% versus 89.5%; p = 0.018), lower mortality (3.9% versus 11.6%; p = 0.004), and less often needed permanent pacemaker implantation (8.5% versus 17.9%; p = 0.008).
Conclusions: The 10-year temporal trends analysis of the TAVIDOR Registry shows a reduction in patients’ clinical complexity over time. Furthermore, the advance to minimalistic implantation techniques, added to the technological evolution of the devices, may have contributed to the favorable outcomes observed among those whose implantation occurred in the last 5 years studied.
Aims
Aortic root motion is suspected to contribute to proximal aortic dissection. While motion of the aorta in four dimensions can be traced with real-time imaging, displacement and rotation in quantitative terms remain unknown. The hypothesis was to show feasibility of quantification of three-dimensional aortic root motion from dynamic CT imaging.
Methods and results
Dynamic CT images of 40 patients for coronary assessment were acquired using a dynamic protocol. Scans were ECG-triggered and segmented in 10 time-stepped phases (0–90%) per cardiac cycle. With identification of the sinotubular junction (STJ), a patient-specific co-ordinate system was created with the z-axis (out-of-plane) parallel to longitudinal direction. The left and right coronary ostia were traced at each time-step to quantify downward motion in reference to the STJ plane, motion within the STJ plane (in-plane), and the degree of rotation. Enrolled individuals had an age of 65 ± 12, and 14 were male (35%). The out-of-plane motion was recorded with the largest displacement of 10.26 ± 2.20 and 8.67 ± 1.69 mm referenced by left and right coronary ostia, respectively. The mean downward movement of aortic root was 9.13 ± 1.86 mm. The largest in-plane motion was recorded at 9.17 ± 2.33 mm and 6.51 ± 1.75 mm referenced by left and right coronary ostia, respectively. The largest STJ in-plane motion was 7.37 ± 1.96 mm, and rotation of the aortic root was 11.8 ± 4.60°.
Conclusion
In vivo spatial and temporal displacement of the aortic root can be identified and quantified from multiphase ECG-gated contrast-enhanced CT images. Knowledge of normal 4D motion of the aortic root may help understand its biomechanical impact in patients with aortopathy and pre- and post-surgical or transcatheter aortic valve replacement.
Cardiac tamponade is one of the most severely life-threatening emergencies encountered, mainly because of its significant impact on the pumping capacity of the heart by compressing the cardiac chambers due to the rapid accumulation of blood, fluid, pus, or clots in the pericardial sac. These accumulations may be collected following traumas, malignancies, uremia, and many other medical conditions as well as surgical procedures. Numerous errors and medicolegal aspects have been identified in diagnosing and treating cardiac tamponade associated with cardiac-related procedures such as valve replacement surgeries, cardiac pacemaker implantation, pericardiocentesis, and other non-cardiac related procedures such as peri-hiatal surgeries. Patients taking anticoagulants or anticancer medications are especially susceptible to developing cardiac tamponade when undergoing surgical procedures, raising the question of preoperative screening to avoid errors. Misdiagnosis, treatment delay or failure to deliver the utmost quality of treatment, lack of complication screening and follow-ups for those at risk, surgeons rushing to complete cases, burnout, and other human factors are predispositions to the development of cardiac tamponade. Fortunately, most of these errors occurring within healthcare settings are avoidable and must be prevented for eliminating any risks to reduce the incidence and mortality of cardiac tamponade cases resulting from iatrogenic etiology. It is an intricate condition where precision and caution are crucial.
Résumé
Le TAVI (Transcatheter Aortic Valve Implantation) est une innovation française, initiée en 2002 par l’équipe de cardiologie du CHU de Rouen et dont on célèbre cette année le 20e anniversaire. Cette technique consiste à implanter une prothèse valvulaire au sein de la valve aortique calcifiée du rétrécissement valvulaire dégénératif de l’adulte (RAC) en utilisant des techniques usuelles de cathétérisme cardiaque. Le RAC est la maladie valvulaire acquise la plus fréquente de l’adulte, touchant principalement les sujets âgés. Sa prévalence augmente avec l’âge, concernant environ 7 % de la population au-dessus de 75 ans, ce qui est considérable. De très nombreux patients ne peuvent pas bénéficier du seul traitement possible, le remplacement valvulaire chirurgical (RVA), en raison de leur grand âge ou de comorbidités. Ces patients sont voués à une mort certaine à court terme, 80 % dans les trois ans après l’apparition des premiers symptômes. Ceci a motivé notre intérêt pour le développement de techniques alternatives interventionnelles moins invasives que le RVA, d’abord la dilatation percutanée aortique au ballonnet avec un premier cas mondial à Rouen en 1985, puis le TAVI afin de pallier les limitations de cette première approche. Le développement de cette procédure, a été une fascinante odyssée de 20 ans dont les principales étapes sont rappelées dans cet article.
Cette technique, dont la seule évocation soulevait les pires critiques, a connu un succès considérable et une expansion mondiale qui défie l’imagination. Ceci a résulté de la combinaison d’avancées technologiques continuelles depuis le premier cas et d’une évaluation scientifique des plus rigoureuses par d’innombrables registres contrôlés, mais également par plusieurs études randomisées successives contre le RVA chez des patients à risque chirurgical dégressif. La non-infériorité ou la supériorité du TAVI par rapport au RVA sur l’amélioration des patients et la mortalité à moyen et long terme ont ainsi pu être constamment démontrés, ce qui a créé un nouveau paradigme pour l’approche thérapeutique du RAC.
A l’heure actuelle, le TAVI peut être proposé en première intention à tout patient âgé de plus de 65 ans aux USA et de plus de 75 ans en Europe, quel que soit le risque chirurgical, le RVA restant indiqué pour les patients non candidats au TAVI. Plus de 1,5 million de patients ont été traités par TAVI dans le monde et une croissance de 4 à 10 % est prévue annuellement. Depuis 2019, le nombre de TAVI dépasse celui du RVA dans plusieurs pays dont les USA.
Les effets collatéraux de cette technologie de rupture sur les pratiques médicales et sur le développement de nombreuses techniques interventionnelles pour d’autres maladies valvulaires ou structurelles myocardiques sont notables. A cet égard, l’histoire du TAVI pourrait constituer une grande source d’inspiration pour tous les jeunes médecins et chercheurs qui se vouent à l’amélioration des techniques médicales.
Transcatheter aortic valve replacement (TAVR) is an established therapy for the treatment of severe aortic stenosis. The evolution of technology and procedural approaches has facilitated the development of streamlined clinical pathways to optimize patient care and improve outcomes. The revision of historical practices and the adoption of contemporary best practices throughout patients' journey from referral to discharge create opportunities to drive quality improvement. Nursing expertise and leadership are essential to recalibrate preprocedure, periprocedure, and postprocedure practice to transform the way we care for TAVR, achieve excellent outcomes, and promote high-performing health services for the treatment of valvular heart disease.
Transcatheter aortic valve implantation (TAVI) is a breakthrough technology to replace the aortic valve in patients with severe aortic stenosis using simple cardiac catheterization instead of thoracic surgery. Initiated 20 years ago by my colleagues and me, TAVI has been performed in >1.5 million patients globally and has profoundly altered the landscape of cardiovascular medicine.
Currently, there are two different balloon‐expandable transcatheter heart valve systems available (Edwards Sapien 3 and Meril's MyVal valve systems). Both have a unique mechanism of balloon‐expansion, an efficient paravalvular sealing skirt and are non‐repositionable. The rates of paravalvular leakage and conduction abnormalities/pacemaker implantation are low. Successive improvements have been introduced to these valves and the Edwards Sapien platform has been extensively studied in randomized clinical trials in high, intermediate, and low surgical risk patients. In this chapter, transfemoral transcatheter aortic valve replacement with both valve systems will be discussed.
Background. – Since the first-in-man implantation of a transcatheter aortic stented valve in April 2002 in Rouen, the procedure has expanded worldwide. In our centre, all transfemoral procedures have been performed using local anaesthesia without transoesophageal echocardiographic monitoring.
Aim. – To report our experience of transfemoral arterial transcatheter aortic valve implantation (TAVI) over the last 2 decades, following the evolution of devices, practices and indications.
Methods. – Between 2002 and 2021, 2097 consecutive patients had a TAVI procedure in our centre. Among them, 1780 underwent transfemoral arterial aortic valve implantation, and were subdivided into three groups according to the time period: before 2009; 2009–2014; and 2014–2021.
Results. – Median age was 85 years, and remained unchanged over time. The mean logistic EuroSCORE gradually decreased over time (28% before 2009 vs 15% for 2009–2014 vs 11% since 2014; P < 0.001). Predilatation was performed almost systematically before 2009 (93%), but was rarely performed in the last period (14%; P < 0.001). Thirty-day all-cause mortality decreased over time, and was only 1.4% in 2021. Length of stay decreased considerably, with a median duration of only 2 days after the procedure, and > 70% of patients were discharged home within 72 hours. Similarly, procedural duration, X-ray time and contrast volume decreased over time.
Conclusion. – Transfemoral aortic valve implantation, performed as a minimalist “stent-like‿ procedure using only local anaesthesia, is feasible in the vast majority of patients, with excellent outcomes.
Introduction. The development of paraprosthetic regurgitation after transcatheter aortic valve implantation (TAVI) in patients with critical aortic stenosis is an actual problem, which predictors are not well understood. One of the main reasons is calcification of the aortic valve, which does not allow the aortic valve prosthesis to fully expand.
Objective – to identify a possible relationship between the severity of aortic valve calcification and the degree of paraprosthetic regurgitation after TAVI.
Materials and methods. The study included 23 patients with critical symptomatic aortic stenosis and high risk factors for EuroScore II and STS. The single center study is a retrospective analysis of aortic valve calcification measured by preoperative multislice computed tomography. Calcification (calcium index) of the aortic valve was quantified according to the Agatson method. Paraprosthetic regurgitation was evaluated by transthoracic echocardiography according to the ACC/AHA recommendations. The observation period was 12 months. Results. There female patients predominated in the study group (n=15, 65 %). The mean value of the calcium index (CI) of the aortic valve was 5179.7±2334.1 Agatson units. Intraoperatively, half of the patients (n=12, 52 %) after implantation of aortic valve prosthesis had paraprosthetic regurgitation of more than II degree, which required postdilation. The calcium index in this group of patients was significantly higher (6088.3±2274.4, p=0.049). After implantation of an aortal valve prosthesis, paraprosthetic regurgitation of I–II degrees was observed in 16 patients (70 %) with a CI of 5902.1±2191.9, in 7 patients (30 %) with a CI of 3528.7±1537.2 paraprosthetic regurgitation was absent (p=0.021). In the postoperative period (12 months), no lethal outcomes were detected in the study group. Paraprosthetic regurgitation of I–II degrees was detected in 14 patients with a CI of 5676.6±2275, paraprosthetic regurgitation was absent in 9 patients with a CI of 4406.9±2338.3 (p=0.21).
Conclusion. Patients with severe calcification of the aortic valve have an increased risk of developing significant paraprosthetic regurgitation and the use of more aggressive intervention techniques.
Background/Objective
While postoperative stroke is a known complication of Transcatheter Aortic Valve Implantation (TAVI), predictors of early stroke occurrence have not been specifically reviewed. The objective of this study was to estimate the predictors and incidence of stroke during the first 30 days post-TAVI.
Methods
A cohort of 506 consecutive patients having undergone TAVI between January 2017 and June 2019 was extracted from a prospective database. Preoperative, intraoperative and postoperative characteristics were analyzed by univariate analysis followed by logistic regression to find predictors of the occurrence of stroke or death within the first 30 days after the procedure.
Results
Incidence of stroke within 30 days post-TAVI was 4.9%, [CI 95% 3.3–7.2], i.e., 25 strokes. Four out of the 25 patients (16%) with a stroke died within 30 days post-TAVI. After logistic regression analysis, the predictors of early stroke related to TAVI were: CHA2Ds2VASc score ≥ 5 (odds ratio [OR] 2.62; 95% CI: 1.06–6.49; p = .037), supra-aortic access vs. femoral access (OR: 9.00, 95%CI: 2.95–27.44; p = .001) and introduction post-TAVI of a single vs. two or three antithrombotic agents (OR: 5.13; CI 95%: 1.99 to 13.19; p = .001). Over the 30-day period, bleeding occurred in 28 patients (5.5%), in 25 of whom, it was associated with femoral or iliac artery access injury. Anti-thrombotic regimen was not associated with bleeding; two patients out of 48 (4.1%) bled with a single anti-thrombotic regimen vs. 26 patients out of 458 (5.6%) with a dual or triple anti-thrombotic regimen (p = 0.94). The overall 30-day mortality rate was 3.9%, [95% CI 2.5–6.0]. Patients with a single post-TAVI antithrombotic agent (OR: 44.07 [CI 95% 13.45–144.39]; p < .0001) and patients with previous coronary artery bypass surgery or coronary artery stenting (OR: 6.16, [CI 95% 1.99–21.29]; p = .002) were at significantly higher risk of death within the 30-day period.
Conclusion
In this large-scale single-center retrospective study, a single post-TAVI antithrombotic regimen independently predicted occurrence of early stroke or death. Dual or triple antithrombotic regimen was not associated with a higher risk of bleeding and should be considered as an option in patients undergoing TAVI.
A little is known about long-term hemodynamic performance of the transcatheter heart valves (THVs). The aim of the present study was to assess hemodynamic outcome, structural valve deterioration (SVD) and bioprosthetic valve failure (BVF) in patients treated with transcatheter aortic valve replacement (TAVR) five or more years ago. All consecutive patients treated at Bologna and Florence University Hospitals with TAVR between January 2008 and December 2013 were analyzed in a retrospective registry with regards to demographic, procedural and outcome data as well as follow-up data on mortality and echocardiographic characteristics. Standardized definitions were used to define outcomes and durability of the THVs. 400 patients were included in the study, mostly treated with transfemoral TAVR (71.8%), using first generation balloon-expandable (37%) or self-expanding (63%) devices. The 1-year mortality was 21.8% (87 patients) and 5-year mortality was 53.8% (215 patients). Median follow-up was 45.5 months (14.0–68.9) totaling 1516.7 patient/years, with the longest follow-up being 10.25 years. At least one follow-up echocardiogram was available for 320 patients (80%), SVD occurred in 19 of these patients (5.94%): moderate in 17 patients (5.31%) and severe in two patients (0.63%). The hemodynamic presentation was stenosis in most of the cases (12 patients). Late BVF was registered in 10 patients (3.13%) and this was mainly driven by transcatheter paravalvular leak closure (six patients) with subsequent good long-term outcome. Our results confirm that TAVR appears to be a long-lasting treatment strategy with low rates of structural valve degeneration and valve failure.
Decision-making for the management of valvular disease (VHD) is rapidly evolving with advances in surgical and interventional techniques. The main causes of VHD has moved from rheumatic to degenerative, more particularly in industrial countries. In this chapter will be briefly discuss the aetiologies, presentation, and natural history of VHD in adults. The medical and surgical options available to date and the threshold for intervention will be then described. The role of a multidisciplinary Heart Valve Team working together with a geriatrician has become crucial to determine the optimal therapeutic option for VHD in older adults. Surgical valve replacement has been for decades the only possible option for the three leading VHDs in developed countries: aortic stenosis (AS), aortic regurgitation (AR) and mitral regurgitation (MR). Mitral stenosis (MS) has almost disappeared in Western countries while its prevalence remains high in the developing world.
Antegrade transseptal approach was utilized in the first human case of transcatheter aortic valve replacement (TAVR) and in the early phase of TAVR. Various challenges with the antegrade transseptal approach including procedural complexity, need for atrial septal crossing, and potential for injury to the mitral valve apparatus led it to being supplanted by other approaches. These challenges have now largely been mitigated as structural interventionalists routinely perform left atrial procedures. We report a case of antegrade transseptal TAVR using a large bore sheath placed in the mid left ventricle across the mitral orifice to protect the mitral valve apparatus and facilitate valve deployment. An 84‐year‐old man with heart failure symptoms was seen for severe aortic stenosis. The severity of peripheral arterial disease precluded femoral, axillary, carotid, or transcaval routes. After transseptal puncture and creation of an arteriovenous rail, a long 26‐Fr sheath was advanced from the right femoral vein transseptally over the arteriovenous rail, past the mitral valve inflow to the mid left ventricular cavity. The sheath provided a stable platform with stable intraprocedure hemodynamics. Balloon valvuloplasty was performed in an antegrade manner, after which a 29‐mm SAPIEN S3 prosthesis was advanced into the aortic valve position and deployed under rapid pacing. We observed no injury to the mitral leaflets or subvalvular apparatus after the procedure. The antegrade transseptal approach should be revisited as an option for patients at high surgical risk with no other suitable access site. The use of a large bore sheath facilitates this approach.
Background: The purpose of this meta-analysis was to evaluate the relationship between elevated cardiac troponin pre- transcatheter aortic valve replacement (TAVR) and long-term all-cause mortality.
Methods: Prospective studies with the endpoint of all-cause mortality were included. We primarily used the fixed-effect model weighted by inverse variance. Meta-regression and subgroup analyses were conducted to explore the potential sources of heterogeneity by specified study characteristics.
Results: Seven prospective studies comprising of 3049 subjects were included in our meta-analysis. Pre-procedural elevated cardiac troponin was associated with increased risk of long-term mortality post TAVR [hazard ratio (HR) 2.25, 95% CI 1.83 to 2.78, p = 0.000, I² = 30.3%, p for heterogeneity 0.197]. In addition, Subgroup analyses has shown that the group with an younger age (<82y) seemed to have a higher risk of all-cause mortality than the group with older age (≥82y) [HR 4.08 (2.41 to 6.89) VS 2.01 (1.60 to 2.53), P = 0.016 for subgroup difference].
Conclusions: Pre-procedural elevated cardiac troponin was associated with increased long-term all-cause mortality in patients undergoing TAVR.
Importance
Medically treated symptomatic severe aortic stenosis has poor outcomes, and in the past 6 decades, it has successfully been treated with surgical aortic valve replacement (SAVR). However, one-third of patients with indications for SAVR are not offered surgery because of the high risk of complications. Transcatheter aortic valve replacement (TAVR), initially developed as a less invasive treatment for inoperable patients, has successfully been used in healthier patient cohorts. In 2017, TAVR became the most common approach for aortic valve replacement in the United States.
Observations
During the past decade, the Placement of Aortic Transcatheter Valve (PARTNER) trials (for balloon-expandable valves) and the CoreValve trials (for self-expandable valves) investigated the performance of TAVR in progressively lower-risk patient cohorts. The initial trials demonstrated TAVR to be superior (PARTNER B) and noninferior (CoreValve Extreme Risk) to optimal medical therapy in inoperable patients. Subsequent trials showed both balloon-expandable and self-expandable valves to have good results in high-risk, medium-risk, and low-risk surgical patients when compared with SAVR. However, owing to the fundamentally different nature of the procedure, some complications have been more prevalent with TAVR, most notably moderate or severe paravalvular leak, conduction abnormalities necessitating permanent pacemaker placement, and vascular complications. When present, these complications have been associated with worse outcomes.
Conclusions and Relevance
The results of the groundbreaking TAVR trials from the past decade have led to a revolution in the treatment of aortic stenosis. There are now 3 US Food and Drug Administration–approved TAVR devices, and with the encouraging results from the latest low-risk trials, TAVR is likely going to become the dominant treatment for symptomatic severe aortic stenosis. New devices on the horizon are looking to improve the complication rates of TAVR, and ongoing trials are looking to further expand the indications of TAVR and answer 1 of the main remaining questions, ie, long-term durability of percutaneously placed devices.
Aims:
To critically review the available transcatheter aortic valve implantation techniques and their results, as well as propose recommendations for their use and development.
Methods and results:
A committee of experts including European Association of Cardio-Thoracic Surgery and European Society of Cardiology representatives met to reach a consensus based on the analysis of the available data obtained with transcatheter aortic valve implantation and their own experience. The evidence suggests that this technique is feasible and provides haemodynamic and clinical improvement for up to 2 years in patients with severe symptomatic aortic stenosis at high risk or with contraindications for surgery. Questions remain mainly concerning safety and long-term durability, which have to be assessed. Surgeons and cardiologists working as a team should select candidates, perform the procedure, and assess the results. Today, the use of this technique should be restricted to high-risk patients or those with contraindications for surgery. However, this may be extended to lower risk patients if the initial promise holds to be true after careful evaluation.
Conclusion:
Transcatheter aortic valve implantation is a promising technique, which may offer an alternative to conventional surgery for high-risk patients with aortic stenosis. Today, careful evaluation is needed to avoid the risk of uncontrolled diffusion.
Aortic stenosis (AS) is the most common form of valvular heart disease in the elderly. As this patient population continues to increase, anesthesiologists more often will encounter these patients in the perioperative setting for noncardiac surgical procedures. Cardiac risk during noncardiac surgery in the patient with AS appears to have decreased significantly compared with previous reports that shaped current practice guidelines for perioperative management. In addition, these guidelines preceded the publication of current data supporting the continually expanding role for transcatheter aortic valve replacement in the treatment of AS. In this review, the authors highlight the most recent evidence suggesting that an update of these guidelines is warranted. In addition, the accumulating evidence supporting the role for transcatheter aortic valve replacement to treat AS since the publication of guidelines is reviewed.
Objective
Transcatheter aortic valve replacement is a safe, minimally invasive treatment for severe aortic stenosis in patients with moderate-to-high surgical risk. Monitored anesthesia is administered by an anesthesiologist. This study compares transcatheter aortic valve outcomes under monitored anesthesia vs general anesthesia.
Methods
Data were prospectively collected for 286 patients undergoing transcatheter aortic valve replacement at a single academic hospital from March 2012 to August 2016. The patients were grouped by type of anesthesia: monitored vs general. A propensity score match was performed to compare intraoperative and post-operative outcomes between groups.
Results
General anesthesia was used in 102 patients and moderate sedation in 184. Propensity score matching produced 80 pairs. Compared to procedures under general anesthesia, patients receiving monitored anesthesia had shorter procedure (1.6 [1.4, 2.0] vs 2.0 [1.6, 2.5] hours;P < 0.001) and fluoroscopy times (17 [14.5, 22.5] vs 25 [17.9, 30.3] minutes;P < 0.001) and shorter hospital length-of-stay (3 [2.0, 4.0] vs 5 [3.0, 7.0] days;P < 0.001) but no difference in intensive care unit length-of-stay. Blood transfusion was more common in patients undergoing general anesthesia, but there was no difference in stroke, renal failure, postoperative atrial fibrillation, or need for permanent pacemaker. More patients were discharged to home after monitored anesthesia (90% vs 64%;P < 0.001). There was no difference in 30-day mortality (0% vs 3%;P = 0.15).
Conclusions
Transcatheter aortic valve replacement under monitored anesthesia provides the safety of anesthesia-led sedation without intubation and general anesthetic. We found no compromise in patient safety or clinical outcomes.
Purpose:
In the current case series, we present our experience with the self-expanding CoreValve or Evolut R (Medtronic Inc.) in patients with severe symptomatic aortic valve stenosis and concomitant mitral valve prosthesis.
Methods:
Twelve patients with previous mitral valve prosthesis underwent transcatheter aortic valve replacement for severe symptomatic aortic valve stenosis and/or aortic valve regurgitation. All patients underwent evaluation with an echocardiogram, computed tomography and coronary angiogram. After the index intervention and before discharge all patients underwent transthoracic echocardiography. All outcomes were defined according to the Valve Academic Research Consortium-2 criteria.
Results:
Eleven patients underwent transcatheter aortic valve replacement for severe symptomatic aortic valve stenosis and one patient for severe aortic valve regurgitation. There was immediate improvement of patients' hemodynamic status; no cases of procedural death, stroke, myocardial infarction, or urgent cardiac surgery occurred. There was no 30-day mortality and all patients improved, with 91.6% in functional New York Heart Association class I-II.
Conclusion:
The current study demonstrates that in patients with severe aortic valve stenosis or regurgitation and mitral valve prosthesis, the implantation of a self-expanding aortic valve via the transfemoral route is safe and feasible, with maintained long-term results.
Background:
Transcatheter aortic valve implantation (TAVI) is currently recommended for patients with severe aortic stenosis at intermediate or high surgical risk. The decision process during TAVI evaluation includes a thorough benefit-risk assessment, and knowledge about long-term benefits and outcomes may improve patients' expectation management.
Objective:
To evaluate patients' perceived health status and self-reported long-term outcome more than 5 years after TAVI.
Methods and results:
Demographic and procedure data were obtained from all patients treated with TAVI at our institution from 2006 to 2012. A cross-sectional survey was conducted on the patients alive, measuring health status, including the EQ-5D-5L questionnaire, and clinical outcomes. 103 patients (22.8%) were alive at a median follow-up period of 7 years (5.4-9.8). 99 (96%) of the 103 patients were included in the final analysis. The mean age at follow-up was 86.5 years ± 8.0 years, and 56.6% were female. Almost all patients (93.9%) described an improvement of their quality of life after receiving TAVI. At late follow-up, the mean utility index and EQ-VAS score were 0.80 ± 0.20 and 58.49 ± 11.49, respectively. Mobility was found to be the most frequently reported limitation (85.4%), while anxiety/depression was the least frequently reported limitation (19.8%). With respect to functional class, 64.7% were in New York Heart Association (NYHA) class III or IV, compared to 67.0% prior to TAVI (p=0.51). Self-reported long-term outcomes revealed mainly low long-term complication rates. 74 total hospitalizations were reported after TAVI, and among those 43% for cardiovascular reasons. Within cardiovascular rehospitalizations, new pacemaker implantations were the most frequently reported (18.9%), followed by cardiac decompensation and coronary heart disease (15.6%).
Conclusion:
The majority of the patients described an improvement of health status after TAVI. More than five years after TAVI, the patients' perceived health status was satisfactory, and the incidence of clinical events and hospitalizations was very low.
To construct a scoring system for the prediction of early mortality in cardiac surgical patients in Europe on the basis of objective risk factors.
The EuroSCORE database was divided into developmental and validation subsets. In the former, risk factors deemed to be objective, credible, obtainable and difficult to falsify were weighted on the basis of regression analysis. An additive score of predicted mortality was constructed. Its calibration and discrimination characteristics were assessed in the validation dataset. Thresholds were defined to distinguish low, moderate and high risk groups.
The developmental dataset had 13,302 patients, calibration by Hosmer Lemeshow Chi square was (8) = 8.26 (P < 0.40) and discrimination by area under ROC curve was 0.79. The validation dataset had 1479 patients, calibration Chi square (10) = 7.5, P < 0.68 and the area under the ROC curve was 0.76. The scoring system identified three groups of risk factors with their weights (additive % predicted mortality) in brackets. Patient-related factors were age over 60 (one per 5 years or part thereof), female (1), chronic pulmonary disease (1), extracardiac arteriopathy (2), neurological dysfunction (2), previous cardiac surgery (3), serum creatinine >200 micromol/l (2), active endocarditis (3) and critical preoperative state (3). Cardiac factors were unstable angina on intravenous nitrates (2), reduced left ventricular ejection fraction (30-50%: 1, <30%: 3), recent (<90 days) myocardial infarction (2) and pulmonary systolic pressure >60 mmHg (2). Operation-related factors were emergency (2), other than isolated coronary surgery (2), thoracic aorta surgery (3) and surgery for postinfarct septal rupture (4). The scoring system was then applied to three risk groups. The low risk group (EuroSCORE 1-2) had 4529 patients with 36 deaths (0.8%), 95% confidence limits for observed mortality (0.56-1.10) and for expected mortality (1.27-1.29). The medium risk group (EuroSCORE 3-5) had 5977 patients with 182 deaths (3%), observed mortality (2.62-3.51), predicted (2.90-2.94). The high risk group (EuroSCORE 6 plus) had 4293 patients with 480 deaths (11.2%) observed mortality (10.25-12.16), predicted (10.93-11.54). Overall, there were 698 deaths in 14,799 patients (4.7%), observed mortality (4.37-5.06), predicted (4.72-4.95).
EuroSCORE is a simple, objective and up-to-date system for assessing heart surgery, soundly based on one of the largest, most complete and accurate databases in European cardiac surgical history. We recommend its widespread use.
Background— The design of a percutaneous implantable prosthetic heart valve has become an important area for investigation. A percutaneously implanted heart valve (PHV) composed of 3 bovine pericardial leaflets mounted within a balloon-expandable stent was developed. After ex vivo testing and animal implantation studies, the first human implantation was performed in a 57-year-old man with calcific aortic stenosis, cardiogenic shock, subacute leg ischemia, and other associated noncardiac diseases. Valve replacement had been declined for this patient, and balloon valvuloplasty had been performed with nonsustained results.
Methods and Results— With the use of an antegrade transseptal approach, the PHV was successfully implanted within the diseased native aortic valve, with accurate and stable PHV positioning, no impairment of the coronary artery blood flow or of the mitral valve function, and a mild paravalvular aortic regurgitation. Immediately and at 48 hours after implantation, valve function was excellent, resulting in marked hemodynamic improvement. Over a follow-up period of 4 months, the valvular function remained satisfactory as assessed by sequential transesophageal echocardiography, and there was no recurrence of heart failure. However, severe noncardiac complications occurred, including a progressive worsening of the leg ischemia, leading to leg amputation with lack of healing, infection, and death 17 weeks after PHV implantation.
Conclusions— Nonsurgical implantation of a prosthetic heart valve can be successfully achieved with immediate and midterm hemodynamic and clinical improvement. After further device modifications, additional durability tests, and confirmatory clinical implantations, PHV might become an important therapeutic alternative for the treatment of selected patients with nonsurgical aortic stenosis.
Received September 5, 2002; revision received October 18, 2002; accepted October 20, 2002.
A new artificial aortic valve prosthesis was developed for implantation by the transluminal catheter technique without thoracotomy or extracorporal circulation. The new heart valve was prepared by mounting a porcine aortic valve into an expandable stent. Before implantation, the stent-valve was mounted on a balloon catheter and compressed around the deflated balloon. The stent-valve mounted balloon catheter was then advanced retrogradely to the ascending aorta or the aortic root in anaesthetized pigs. Implantation was performed by balloon inflation which expanded the stent-valve to a diameter exceeding the internal diameter of the vessel--thus ensuring a stable fixation against the vessel wall. A total of nine implantations were performed in seven 70 kg closed chest pigs. Sub- and supracoronary implantation was performed in two and three pigs, respectively, while implantation in both positions was done in two. Angiographic and haemodynamic evaluation after implantation revealed no significant stenosis (less than or equal to 16 mmHg) in any of the nine valves and trivial regurgitation in only two. Complications were associated with restriction of the coronary blood flow in three animals. This preliminary study indicates that artificial aortic valves can be implanted in closed chest animals by transluminal catheter technique.
To evaluate the restenosis rate after successful balloon aortic valvuloplasty, clinical evaluation and repeat catheterization were performed in 96 patients who had undergone balloon dilatation 7 +/- 5 months earlier. Restenosis, defined as a loss of greater than 50% of the benefit in aortic valve area obtained after balloon valvuloplasty, was observed in 48% of the patients. Actuarial analysis showed that the restenosis rate was time dependent and was 80% at 15 months. However, functional improvement was observed in most of the patients with or without restenosis. The restenosis rate was not correlated with the degree of enlargement of the aortic orifice produced by the valvuloplasty procedure. Because of the high incidence of restenosis, balloon aortic valvuloplasty should be limited to patients who have a contraindication to surgery or are at high risk for surgery, or as a bridge to surgery.
Percutaneous transluminal balloon catheter aortic valvuloplasty (PTAV) was carried out in three elderly patients with acquired severe aortic valve stenosis. Transvalvular systolic pressure gradient was considerably decreased at the end of the procedure, during which there were no complications. Increased valve opening was confirmed by angiography and echocardiography. Subsequent clinical course showed a pronounced functional improvement. PTAV is recommended as a simple alternative to aortic valve replacement in elderly and/or high-risk patients.
Three types of catheter-mounted aortic valve were tested in a mock circulation system, and two of them were further tested in anesthetized dogs that had traumatic aortic regurgitation. The valves proved to reduce regurgitation effectively. The umbrella-shaped valve was further tested by phonocardiographic, cineangiographic, and pressure-flow curve studies. A nonsignificant decrease in coronary flow was found to be caused by this prosthetic valve. Since it can be easily inserted through an artery, the umbrella valve may be useful in patients in whom a thoracotomy for valve replacement is contraindicated.
We sought to evaluate the effects of a number of factors that can potentially determine the optimal time for aortic valve replacement (AVR) and the observed and relative survival after the operation.
Aortic valve replacement is performed in patients within a wide age span, but the proportion of elderly patients is increasing. In survival analyses, adjustment for the effects of age is therefore essential. Analysis of relative survival provides additional information on excess or disease-specific mortality and its risk factors.
Survival was analyzed in 2,359 patients (1,442 without and 917 with concomitant coronary artery bypass graft surgery) undergoing their first AVR. By relating observed survival to that expected among the general Swedish population stratified by age, gender and five-year calendar period, the relative survival and disease-specific survival were estimated.
Early mortality after AVR (death within 30 days) was 5.6%. Relative survival rates (excluding early deaths) after 5, 10 and 15 years were 94.6%, 84.7% and 74.9%, respectively. There was an excess risk of dying during the entire follow-up period. Advanced New York Heart Association functional class, preoperative atrial fibrillation and pure aortic regurgitation were independent risk factors for observed and relative survival. Patients in the oldest age group showed decreased observed survival but excellent relative survival.
Old age was not a risk factor for excess mortality after AVR, whereas atrial fibrillation decreased relative survival substantially.
Because the elderly are increasingly referred for operation, we reviewed the results of cardiac surgery in patients of 80 years or older.
Records of 182 consecutive octogenarians who had had cardiac operations between 1992 and 1998 were reviewed. Follow-up was 100% complete. Seventy patients had coronary grafting (CABG), 70 aortic valve replacement, 30 aortic valve replacement+CABG, and 12 mitral valve repair/replacement. Rates of hospital death, stroke, and prolonged stay (>14 days) were as follows: CABG: 7 (10%), 2 (2.8%) and 41 (58%); aortic valve replacement: 6 (8.5%), 2 (2.8%) and 32 (45.7%); aortic valve replacement+CABG: 8 (26.5%), 1 (3.8%) and 14 (46.6%); mitral valve repair/replacement: 3 (25%), 1 (8.3%) and 5 (41.6%). Multivariate predictors (P<0.05) of hospital death were New York Heart Association functional class, urgent procedure, prolonged cardiopulmonary bypass time, and, after aortic valve replacement, previous percutaneous aortic valvuloplasty. Ascending aortic atheromatous disease was predictive of stroke, while pre-operative myocardial infarction was predictive of prolonged hospital stay. Actuarial 5-year survival was as follows: CABG, 65.8+/-8.8%; aortic valve replacement, 63.6+/-7.1%; aortic valve replacement+CABG, 62.4+/-6.8%; mitral valve repair/replacement, 57.1+/-5.6%; and total, 63.0+/-5.6%. Multivariate predictors of late death were pre-operative myocardial infarction, and urgent procedure. Ninety percent of long-term survivors were in New York Heart Association class I or II, and 87% believed having a heart operation after age 80 years was a good choice.
Cardiac operations are successful in most octogenarians with increased hospital mortality, and longer hospital stay. Long-term survival and quality of life are good.
Percutaneous aortic valvuloplasty produces acute hemodynamic and clinical improvement in patients with aortic stenosis who are poor candidates for surgical valve replacement. The benefits of this procedure are mitigated by the high restenosis rates and 1--2 year mortality, in addition to significant vascular complications associated with the large arterial puncture necessary for retrograde arterial approaches. We describe the use of suture closure techniques to reduce the vascular morbidity associated with this procedure. We reviewed 31 consecutive patients who underwent percutaneous aortic valvuloplasty and suture closure with the Perclose device between April 1998 and September 2000. After diagnostic catheterization using 6--8 French (Fr) sheaths, an 8 or 10 Fr Perclose device was preloaded into the artery and the untied sutures left in place. A 12.5 or 14 Fr sheath was passed over the wire, through the sutures. The sutures were tied at the conclusion of the procedure, in conjunction with sheath removal. Twenty-seven out of 31 patients (87%) had successful suture closure of the arteriotomy and did not require prolonged bed rest, manual compression or a compression device. There were 4 failures of percutaneous suture closure, requiring conventional manual compression and bed rest for hemostasis. No patient required surgical repair of the arteriotomy, nor were there any limb complications. Compared to 39 consecutive prior patients who had their arterial puncture managed with manual compression, length of stay was shorter (2.2 days versus 5.3 days) and fewer patients received blood transfusions (0% versus 29%). Preloaded suture closure of the arterial puncture is a useful technique for achieving hemostasis after removal of the large sheaths used for percutaneous valvuloplasty, and reduces the post-procedure patient discomfort and prolonged bed rest associated with this procedure.
Our purpose was to compare the performance of risk stratification model between Parsonnet and European System for Cardiac Operative Risk Evaluation (EuroSCORE) in our patient database.
From August 1994 to December 2000, 803 consecutive patients have undergone heart and thoracic aorta surgery using cardiopulmonary bypass and scored according to Parsonnet and EuroSCORE algorithm. The population was divided into five clinically relevant risk categories. We compared correlation of predicted mortality and observed mortality between these two models. Score validity was assessed by calculating the area under the receiver operating characteristic (ROC) curve.
Overall hospital mortality was 4.5%. In Parsonnet model, predicted mortality was 2.4% for 0-4% risk, 6.7% for 5-9% risk, 12% for 10-14% risk, 17% for 15-19% risk, 25% for 20% plus risk, and 10.4% for overall patients. Observed mortality was 2.4, 0.4, 5.9, 8.7, 11, and 4.5%, respectively. The thoracic aorta and valve cohort indicated poor correlation between predicted and observed mortality compared to coronary cohort. In the EuroSCORE model, predicted mortality was 1.4% for 0-2% risk, 4.0% for 3-5% risk, 6.7% for 6-8% risk, 9.7% for 9-11% risk, 13% for 12% plus risk, and 5.3% for overall patients. Actual mortality was 0, 1.5, 6.8, 11, 21, and 4.5%, respectively. Each of the thoracic aorta, valve, and coronary cohort indicated good correlation between predicted and observed mortality. Areas under the ROC curves were 0.72 in Parsonnet and 0.82 in EuroSCORE.
The EuroSCORE additive model yielded good predictive value for hospital mortality of Japanese patients undergoing not only cardiac but also thoracic aortic surgery.
The design of a percutaneous implantable prosthetic heart valve has become an important area for investigation. A percutaneously implanted heart valve (PHV) composed of 3 bovine pericardial leaflets mounted within a balloon-expandable stent was developed. After ex vivo testing and animal implantation studies, the first human implantation was performed in a 57-year-old man with calcific aortic stenosis, cardiogenic shock, subacute leg ischemia, and other associated noncardiac diseases. Valve replacement had been declined for this patient, and balloon valvuloplasty had been performed with nonsustained results.
With the use of an antegrade transseptal approach, the PHV was successfully implanted within the diseased native aortic valve, with accurate and stable PHV positioning, no impairment of the coronary artery blood flow or of the mitral valve function, and a mild paravalvular aortic regurgitation. Immediately and at 48 hours after implantation, valve function was excellent, resulting in marked hemodynamic improvement. Over a follow-up period of 4 months, the valvular function remained satisfactory as assessed by sequential transesophageal echocardiography, and there was no recurrence of heart failure. However, severe noncardiac complications occurred, including a progressive worsening of the leg ischemia, leading to leg amputation with lack of healing, infection, and death 17 weeks after PHV implantation.
Nonsurgical implantation of a prosthetic heart valve can be successfully achieved with immediate and midterm hemodynamic and clinical improvement. After further device modifications, additional durability tests, and confirmatory clinical implantations, PHV might become an important therapeutic alternative for the treatment of selected patients with nonsurgical aortic stenosis.
To identify the characteristics, treatment, and outcomes of contemporary patients with valvular heart disease (VHD) in Europe, and to examine adherence to guidelines.
The Euro Heart Survey on VHD was conducted from April to July 2001 in 92 centres from 25 countries; it included prospectively 5001 adults with moderate to severe native VHD, infective endocarditis, or previous valve intervention. VHD was native in 71.9% of patients and 28.1% had had a previous intervention. Mean age was 64+/-14 years. Degenerative aetiologies were the most frequent in aortic VHD and mitral regurgitation while most cases of mitral stenosis were of rheumatic origin. Coronary angiography was used in 85.2% of patients before intervention. Of the 1269 patients who underwent intervention, prosthetic replacement was performed in 99.0% of aortic VHD, percutaneous dilatation in 33.9% of mitral stenosis, and valve repair in 46.5% of mitral regurgitation; 31.7% of patients had > or =1 associated procedure. Of patients with severe, symptomatic, single VHD, 31.8% did not undergo intervention, most frequently because of comorbidities. In asymptomatic patients, accordance with guidelines ranged between 66.0 and 78.5%. Operative mortality was <5% for single VHD.
This survey provides unique contemporary data on characteristics and management of patients with VHD. Adherence to guidelines is globally satisfying as regards investigations and interventions.
In April 2002, after extensive ex-vivo and animal implantation studies, we performed the first successful implantation of a new percutaneous aortic valve in a patient with endstage aortic stenosis. The purpose of this article is to give a detailed description of the technique of percutaneous implantation of aortic valve bioprosthesis in patients with severe calcific aortic stenosis. Antegrade transeptal approach was used under local anesthesia and mild sedation. (J Interven Cardiol 2003;16:515–521)
The influence of left ventricular (LV) dysfunction on survival of patients with severe aortic stenosis is poorly characterized. Few data are available about preoperative predictors of cardiac mortality and LV function recovery after aortic valve replacement of such patients. The aim of our study was to examine the outcome and the preoperative predictors of postoperative cardiac death and of LV function recovery in these patients.
We evaluated 85 consecutive patients with severe aortic stenosis (aortic valve area <1 cm(2)) and severe depression of LV ejection fraction (EF) <35% at cardiac catheterization. Among them, 52 underwent aortic valve replacement and they were compared to patients who were not operated on. All patients had a mean clinical follow-up of 53 months and 94% of them had a mean echocardiographic follow-up of 14 months after aortic valve replacement.
The mean baseline characteristics included: LVEF 28+/-6%, peak-to-peak transvalvular gradient 51+/-29 mmHg, aortic valve area 0.63+/-0.25 cm(2). Thirty-three patients did not undergo aortic valve replacement: 32 of them died within 3 years. Fifty-two patients underwent aortic valve replacement and 16 had a concomitant coronary bypass surgery. In-hospital mortality was 8%. Postoperative NYHA functional class changed from 2.84+/-0.67 to 1.43+/-0.44 (P<0.001) and LVEF from 29+/-6% to 43+/-10% (P<0.001). At follow-up 10 patients died of heart disease. By multivariate analysis, preoperative LV end-systolic volume index (ESVI) was the only covariate of cardiac death (LVESVI/10 ml/m(2), OR 1.3, CI 1.1-1.8, P<0.028). By using a receiver operating characteristic curve, LVESVI< or =90 ml/m(2) was the best cut-off value (sensitivity and specificity 78%) to fit with a better survival (93% vs. 63%, P<0.01) and with LVEF recovery after aortic valve replacement (EF improved by 15+/-10% vs. 8+/-5%, P<0.001).
Despite LV dysfunction, aortic valve replacement appears to change drastically the natural history of severe aortic stenosis. Preoperative LV levels predict different postoperative survival rate and LVEF recovery.
This study was done to assess the results of percutaneous heart valve (PHV) implantation in non-surgical patients with end-stage calcific aortic stenosis.
Replacement of PHV has been shown to be feasible in animals and humans. We developed a PHV composed of three pericardial leaflets inserted within a balloon-expandable stainless steel stent. We report the acute and early follow-up results of the initial six PHV implantations.
An anterograde approach was used in all cases. The PHV, crimped over a 22-mm diameter balloon, was advanced through a 24-F sheath from the femoral vein to the aortic valve and delivered by balloon inflation. Clinical, hemodynamic, and echocardiographic outcomes were assessed serially.
All patients were in New York Heart Association functional class IV. The PHV was successfully delivered in five patients. Early migration with subsequent death occurred in one patient who presented with a torn native valve. Acute hemodynamic and angiographic results showed no residual gradient, mild (three patients) or severe (two patients) aortic regurgitation, and patent coronary arteries. On echocardiography, the aortic valve area was increased from 0.5 +/- 0.1 cm(2) to 1.70 +/- 0.03 cm(2) and the aortic regurgitation was paravalvular. Marked and sustained hemodynamic and clinical improvement was observed after successful PHV implants. The first three patients died of a non-cardiac cause at 18, 4, and 2 weeks, respectively, and the other patients are alive at 8 weeks with no signs of heart failure.
Implantation of the PHV can be achieved in patients with end-stage calcific aortic stenosis and might become an important therapeutic option for patients not amenable to surgical valve replacement.
The newly developed percutaneous heart valve (PHV) implantation technique decreases transaortic pressure gradient in patients with aortic stenosis. PHV replacement effects on left ventricular (LV) global and regional systolic function are currently unknown.
Eight patients with severe aortic stenosis had 2D echocardiography at baseline and 24 hours after PHV implantation to evaluate changes in LV volume and LV ejection fraction. Regional function, ie, both peak systolic anterior and posterior wall tissue velocity, as well as strain and strain rate imaging, were measured by tissue Doppler imaging from a short-axis view. At 24 hours, a significant reduction in transaortic mean pressure gradient (from 46+/-15 to 8+/-3 mm Hg; P<0.0001) was accompanied by an increase in aortic valve area (from 0.59+/-0.11 to 1.69+/-0.11 cm2; P<0.0001). LV end-diastolic volume remained unchanged (102+/-36 to 101+/-12 mL; P=NS), whereas LV ejection fraction increased (48+/-18% to 57+/-12%; P<0.01). Improvement in posterior wall displacement (posterior wall tissue velocity increased from 2.2+/-0.5 to 4.4+/-1.0 cm/s(-1); P=0.0003) and deformation (strain rate imaging increased from 1.0+/-0.3 to 1.9+/-0.7 s(-1), P=0.009, and strain increased from 11+/-5% to 17+/-9%; P=0.02) were observed.
Immediately after PHV replacement, improvement of LV global and regional systolic function was evidenced by tissue Doppler imaging.