No full-text available
To read the full-text of this research,
you can request a copy directly from the authors.
Early experience with percutaneous transcatheter implantation of heart valve prosthesis for the treatment of end-stage inoperable patients with calcific aortic stenosis
Abstract
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.
... In 2001, Alain Cribier reported his experience with balloon implanted valves in sheep (11), and in 2002 he performed the FIM implantation in an adult patient with a severely calcified aortic stenosis (12). 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). ...
... 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.
... Soon after, other clinicians began experimenting with transapical and transfemoral TAVR approaches, although many of these experiences were accompanied by fairly high mortality and stroke rates. 84 Initial data from the Initial Registry of Endovascular Implantation Of Valve in Europe (I-REVIVE) and Registry of Endovascular Critical Aortic Stenosis Treatment trial (RECAST) registries, as well as the Edwards Revascularization after Transcatheter Valve Implantation (REVIVAL) trial, demonstrated feasibility for transcatheter valvular procedures and laid the groundwork for larger subsequent trials and technological advancements. 84 (2017). ...
... 84 Initial data from the Initial Registry of Endovascular Implantation Of Valve in Europe (I-REVIVE) and Registry of Endovascular Critical Aortic Stenosis Treatment trial (RECAST) registries, as well as the Edwards Revascularization after Transcatheter Valve Implantation (REVIVAL) trial, demonstrated feasibility for transcatheter valvular procedures and laid the groundwork for larger subsequent trials and technological advancements. 84 (2017). 95 , 96 The most significant technological advancements and largest clinical successes with transcatheter therapies have been observed with transcatheter treatment of AS. ...
... Soon after, other clinicians began experimenting with transapical and transfemoral TAVR approaches, although many of these experiences were accompanied by fairly high mortality and stroke rates. 84 Initial data from the Initial Registry of Endovascular Implantation Of Valve in Europe (I-REVIVE) and Registry of Endovascular Critical Aortic Stenosis Treatment trial (RECAST) registries, as well as the Edwards Revascularization after Transcatheter Valve Implantation (REVIVAL) trial, demonstrated feasibility for transcatheter valvular procedures and laid the groundwork for larger subsequent trials and technological advancements. 84 (2017). ...
... 84 Initial data from the Initial Registry of Endovascular Implantation Of Valve in Europe (I-REVIVE) and Registry of Endovascular Critical Aortic Stenosis Treatment trial (RECAST) registries, as well as the Edwards Revascularization after Transcatheter Valve Implantation (REVIVAL) trial, demonstrated feasibility for transcatheter valvular procedures and laid the groundwork for larger subsequent trials and technological advancements. 84 (2017). 95 , 96 The most significant technological advancements and largest clinical successes with transcatheter therapies have been observed with transcatheter treatment of AS. ...
... Following its first successful human application, feasibility trials on the Cribier design were restricted to compassionate use [15,19]. For these trials, the valve structure was modified again, to utilise an equine pericardium material. ...
... For these trials, the valve structure was modified again, to utilise an equine pericardium material. These early trials confirmed the feasibility of the anterograde trans-septal approach for transcatheter atrial valve replacement [15,19]. ...
Aims
A review was conducted on the composition, advantages and limitations of available aortic valve prototypes to create an ideal valve for percutaneous implantation.
Patients
Patients with multiple comorbidities who cannot withstand the risks of open cardiac surgery.
Methodology
The search was performed using online databases and textbooks. Articles were excluded based on specific criterion.
Results
Ten prototypes created between 2006 and 2019 were found and reviewed. The prototypes had a set of advantages and limitations with their characteristics coinciding at times.
Conclusions
The ideal percutaneously implantable aortic valve should have minimum coaptation height, zero folds in the leaflets, minimum valve height, minimum leaflet flexion and three leaflets. It can be composed of biological or synthetic material, as long as it provides minimal risk of thrombosis. However, more studies are needed to ensure other ideal parameters.
... Transkateter aort kapak implantasyonu ile ilgili ilk deneyimlerden birisi olan Cribier ve arkadaşlarının [17] yaptığı bir çalışmada ortalama işlem süresi 134±23 dk olarak bildirilmiştir. Aynı araştırmacının yer aldığı 2015 yılında yayınlanan başka bir çalışmada ise ortalama işlem süresi 102±46 dk olarak bulunmuştur [18]. ...
... Transkateter aort kapak implantasyonu işleminde girişim yeri komplikasyonları 24-25 Fr kılıfların kullanıldığı dönemde daha sık görülürken, günümüzde daha küçük çaplı kılıflar (16)(17)(18) ve kapama cihazlarının kullanılması sonucu daha az görülmeye başlanmıştır. Van Mieghem ve arkadaşlarının [21] yaptığı bir çalışmada majör vasküler girişim yeri komplikasyonu gelişme riski %10'un üzerinde bulunmuş, arteriyel kılıf boyutu ve kadın cinsiyetin önemli belirleyiciler olduğu gösterilmiştir. ...
... Early TAVR experience used 2-dimensional (2D) transthoracic echocardiography (TTE) for sizing of the valve (11). However, the incidence of paravalvular leak (PVL) led to the use of MDCT for preoperative TAVR sizing (12,13). ...
... Transcatheter aortic valve replacement (TAVR) or transcatheter aortic valve implantation (TAVI) was first performed via a transseptal approach by Cribier in a critically ill patient with severe aortic stenosis in 2002. 1 Since this first-in-man case, TAVR was considered to be an alternative treatment option for patients with severe aortic stenosis at high surgical risk, as surgical aortic valve replacement (SAVR) was considered to have an unacceptably elevated risk of complications or death. [2][3][4][5] Continuous advances in TAVR technology have created different types of access, such as classical transfemoral, transcaval, trans-subclavian, transaxillary, transcarotid, transaortic and transapical. [6][7][8] In addition, ongoing improvements in devices and techniques also decreased the composite adverse events and mortality. ...
Introduction
Transcatheter aortic valve replacement (TAVR) has become an important treatment in patients with aortic valve disease with the continuous advancement of technology and the improvement of outcomes. However, TAVR-related complications still increase patient morbidity and mortality. Remote ischaemic preconditioning (RIPC) is a simple procedure that provides perioperative protection for many vital organs. However, the efficiency of RIPC on TAVR remains unclear based on inconsistent conclusions from different clinical studies. Therefore, we will perform a protocol for a systematic review and meta-analysis to identify the efficiency of RIPC on TAVR.
Methods and analysis
English databases (PubMed, Web of Science, Ovid Medline, Embase and Cochrane Library), Chinese electronic databases (Wanfang Database, VIP Database and China National Knowledge Infrastructure) and trial registry databases will be searched from inception to December 2023 to identify randomised controlled trials of RIPC on TAVR. We will calculate mean differences or standardised mean differences with 95% CIs for continuous data, and the risk ratio (RR) with 95% CIs for dichotomous data by Review Manager version 5.4. Fixed-effects model or random-effects model will be used according to the degree of statistical heterogeneity assessed by the I-square test. We will evaluate the risk of bias using the Cochrane risk-of-bias tool 2 and assess the evidence quality of each outcome by the Grading of Recommendations Assessment, Development and Evaluation. The robustness of outcomes will be evaluated by trial sequential analysis. In addition, we will evaluate the publication bias of outcomes by Funnel plots and Egger’s regression test.
Ethics and dissemination
Ethical approval was not required for this systematic review protocol. The results will be disseminated through peer-reviewed publications.
PROSPERO registration number
CRD42023462926
... 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]. ...
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.
... With continued advancements in medical technology, transcatheter aortic valve implantation (TAVI) has emerged as a potential alternative to surgical AVR [4] and its application has now been extended to the low surgical risk group [5,6]. The emergence of TAVI has led to an increased interest in sternal-sparing approaches but there are no large randomized trials directly comparing the outcomes of RAT AVR with TAVI. ...
Purpose
This study aims to evaluate the perioperative outcomes of aortic valve replacement (AVR) via right anterior minithoracotomy (RAT) during the learning curve.
Methods
It was a retrospective, observational, cohort study of patients who underwent RAT AVR from June 2015 to April 2022. Primary outcomes measured were 30-day morbidity and mortality.
Results
A total of 107 consecutive patients underwent elective RAT AVR. Our patients were mostly male (78.5%), elderly (mean 68.7 years), and obese (34.6%). A majority of the patients (93.5%) were of low operative risk. Median cross-clamp and bypass times were 95 and 123 minutes respectively. There was a statistically significant correlation between increase in number of cases and decrease in operative time. All patients had no paravalvular leak at discharge. There were no operative cardiovascular mortality or major morbidity including stroke, myocardial infarction, renal failure requiring dialysis, or vascular complication. No patient required intraoperative conversion to full sternotomy for completion of AVR.
Conclusion
Our study demonstrated that RAT AVR can be safely introduced. The learning curve required in performing RAT AVR can be safely negotiated through training, previous experience in minimally invasive surgery, careful patient selection including use of preoperative computed tomography of the aorta, and introduction of sutureless/rapid deployment valves.
... This becomes particularly problematic when attempting to distinguish between mild obstructions resulting from pathological changes and those caused by prosthetic-patient mismatch (PPM). Moreover, the presence of shielding and various artifacts further complicates insonation, making the assessment of the valve and regurgitant jets associated with it even more difficult (3)(4)(5)(6). Transesophageal echocardiography (TEE) has evolved from one-dimensional imaging using a probe with a single-crystal, M-mode transducer to two-dimensional (2D) imaging with phased-array transducers and now three-dimensional (3D) imaging with matrix array transducers is also available. Recent probes of 3D imaging are extremely superior to the previous multiplane TEE imaging technique to reconstruct 3D images (7). ...
Objective: The advent of 3D transesophageal echocardiography (TEE) was supposed to facilitate more accurate etiological diagnosis of prosthetic valve dysfunction as compared to 2D TEE; however, data to support the same is sparse especially in Asian Indians.
Methods: This was a prospective, open- label study of 50 consecutive patients with prosthetic valve dysfunction who were eligible for the study. All patients underwent both 2D and 3D TEE for assessment of prosthetic valve dysfunction apart from their demographics, clinical evaluation, laboratory assessment and fluoroscopy.
Results: Of 50 patients, 12 had aortic valve prosthetic dysfunction and 38 patients had mitral valve prosthesis dysfunction. Of these, 10 were male and remaining 40 were female patients. Overall, 41 (82%) patients had subtherapeutic prothrombin time at the time of presentation. Thrombus in situ was visualized in 34% of patients with 3D TEE as compared to 2D TEE (4%) (p=0.004). Pannus formation was observed in 20% of patients with 3D TEE as compared to 2D TEE, which could not identify pannus formation in any patient (p=0.03). In 34% of patients, normal motion of leaflets could be seen using 3D TEE as compared to 30% of patients by 2D TEE.
Conclusion: Compared to 2D TEE, 3D TEE imaging offers superior capabilities in assessing prosthetic valve dysfunction, particularly when evaluating thrombus and pannus formation. Additionally, both modalities show nearly similar effectiveness in assessing leaflet motion.
... Transcatheter aortic valve implantation (TAVI) was initially limited to patients with symptomatic severe aortic stenosis (AS) who were considered to be at prohibitive risk for surgical aortic valve replacement (SAVR) due to their age, health condition, or other factors (1). However, as TAVI has been studied more, it has been shown to be effective in patients with high, intermediate, and even low surgical risks (2)(3)(4). ...
Background
The novel Vienna TAVI system is repositionable and retrievable, already pre-mounted on the delivery system, eliminating the need for assembly and crimping of the device prior to valve implantation.
Aims
The purpose of this first-in-human feasibility study was to determine the safety, feasibility, clinical and hemodynamic performance of the Vienna TAVI system at 6-month follow-up. (ClinicalTrials.gov identifier NCT04861805).
Methods
This is a prospective, non-randomized, single-arm, single-center, first-stage FIH feasibility study, which is followed by a second-stage pivotal, multicenter, multinational study in symptomatic patients with severe aortic stenosis (SAS). The first-stage FIH study evaluated the safety and feasibility, clinical and hemodynamic performance of the device in 10 patients with SAS based on recommendations by the VARC-2.
Results
All patients were alive at 3-month follow-up. 1 non-cardiovascular mortality was reported 5 months after implantation. There were no new cerebrovascular events, life-threatening bleeding or conduction disturbances observed at 6-month follow-up. The mean AV gradient significantly decreased from 48.7 ± 10.8 to 7.32 ± 2.0 mmHg and mean AVA increased from 0.75 ± 0.18 to 2.16 ± 0.42 cm ² ( p < 0.00001). There was no incidence of moderate or severe total AR observed. In the QoL questionnaires, the patients reported a significant improvement from the baseline 12-KCCQ mean score 58 ± 15 to 76 ± 20. NYHA functional class improved in two patients, remained unchanged in one patient. There was an increase in mean 6-min-walk distance from baseline 285 ± 97 to 347 ± 57 m.
Conclusions
This study demonstrates that using Vienna TAVI system has favourable and sustained 6-month safety and performance outcomes in patients with symptomatic severe aortic stenosis.
... 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.
... In parallel, continuous development in the management and techniques of SAVR has constantly improved the outcome of patients with severe aortic valve stenosis. Nevertheless, the PARTNER trials have proven the efficacy and safety in high-and moderate-risk patients receiving TAVI without the need for cardiopulmonary bypass [5][6][7][8]. ...
Transapical transcatheter aortic valve implantation (TA-TAVI) is generally considered to be associated with increased morbidity and mortality compared with transfemoral transcatheter aortic valve implantation TAVI (TF-TAVI). We aimed to compare different patient risk profiles, access-related complications, and long-term survival using inverse probability treatment weighting. This is a retrospective, single-center analysis of 925 consecutive patients with aortic valve stenosis undergoing TF-TAVI (n = 802) or TA-TAVI (n = 123) at the University Hospital Basel, Switzerland, as a single procedure between September 2011 and August 2020. Baseline characteristics revealed a higher perioperative risk as reflected in the EuroSCORE II (geometric mean 2.3 (95% confidence interval (CI) 2.2 to 2.4) vs. 3.7 (CI 3.1 to 4.5); before inverse probability of treatment weighting (IPTW) p < 0.001) in the transfemoral than in the transapical group, respectively. After 30 days, TF-TAVI patients had a higher incidence of any bleeding than TA-TAVI patients (TF-TAVI n = 146 vs. TA-TAVI n = 15; weighted hazard ratio (HR) 0.52 (0.29 to 0.95); p = 0.032). After 5 years, all-cause mortality did not differ between the two groups (TF-TAVI n = 162 vs. TA-TAVI n = 45; weighted HR 1.31, (0.92 to 1.88); p = 0.138). With regard to our data, we could demonstrate, despite a higher perioperative risk, the short- and long-term safety and efficacy of the transapical approach for TAVI therapies. Though at higher perioperative risk, transapically treated patients suffered from less bleeding or vascular complications than transfemorally treated patients. It is of utmost interest that 5-year mortality did not differ between the groups.
... Cribier used both antegrade and retrograde approaches and achieved exceptional success considering the patients' high frailty and comorbidities and the technique's sophistication as reported in 2004 (I-REVIVE trial) [77]. The implantations were performed using mild sedation, without rapid right ventricular pacing or extracorporeal circulation. ...
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.
... Even though the initial improvement in left ventricular function and clinical status following consolation of the aortic valve blockage was unaffected by paravalvular aortic regurgitation, severe paravalvular aortic regurgitation may have a deteriorating effect on long-term clinical outcomes succeeding PHV implantation. Future developments in stent design, such as larger maximal stent diameters, may lessen the frequency and graveness of paravalvular aortic regurgitation [30,31]. ...
Since the first pacemaker was implanted, nearly 60 years have passed. Since then, pacemaker technology has made major advancements that have increased both its safety and effectiveness in treating people with bradyarrhythmias. The repeated stimulation of cells in specialized "pacemaker" regions of the mammalian heart and the transmission of stimulus via the ventricles serve as evidence that the electrical function of the mammalian heart is necessary for a regular mechanical (pump) role. The development of action potentials in individual cardiac cells is linked to myocardial electrical activity and the heart's regular cooperative electrical functioning. A container or pulse initiator that houses the battery and electronics, as well as lines that connect to the myocardium to deliver a depolarizing pulse and detect intrinsic cardiac stimulation, are all parts of a pacemaker. Defibrillators could be used with artificial hearts that have electrical pacemakers integrated into them in order to treat arrhythmia, heart failure, and cardiac arrest. Modern pacemakers have units for supporting patients with other disorders like "heart failure," which happens when the heart does not pump as forcefully as it should. While many pacemakers are effective in treating different types of arrhythmias (irregular heartbeats), they also have units for treating them.
... Transcatheter aortic valve replacement (TAVR) was initially restricted to patients with severe symptomatic aortic stenosis (AS) deemed at prohibitive risk for surgical aortic valve replacement (SAVR) [1]. One randomized trial at a time, TAVR showed its efficacy in high, intermediate and, recently, low surgical-risk patients for the management of severe degenerative AS [2][3][4][5][6][7]. ...
Indications for transcatheter aortic valve replacement (TAVR) have steadily increased over the last decade since the first trials including inoperable or very high risk patients. Thus, TAVR is now the most common treatment of aortic valve stenosis in elderly patients (vs. surgical aortic valve replacement -SAVR-). In this review, we summarize the current indications of TAVR and explore future directions in which TAVR indications can expand.
... Therefore, accurate and contemporary data on the prevalence of structural heart disease including left ventricular systolic dysfunction (LVSD) and diastolic dysfunction (LVDD) in middle-aged individuals are required by health economists to allocate funding and resources for early diagnosis and intervention, particularly in the era of percutaneous technology. [9][10][11] The aim of this study was to develop a prospective registry to assess the burden and significance of cardiac abnormalities found on echocardiography in patients presenting with cardiac symptoms who were referred from primary care to an open access echocardiography service. ...
Purpose
To evaluate the prevalence and incidence of significant structural heart disease in targeted patients with cardiac symptoms referred by general practitioners (GPs) using open access echocardiography, without prior clinical evaluation by a cardiologist.
Design
Data were derived from 488 subjects who underwent transthoracic echocardiography between January and April 2018. Patients were referred directly by GPs in East Berkshire, South England, through an online platform. Echocardiography was performed within 4–6 weeks of referral and all reports were assessed by a consultant cardiologist with expedited follow-up facilitated pro re nata. Results were analysed to determine the frequency of detection of structural abnormalities, particularly of the left ventricle and cardiac valves.
Results
Echocardiography was prospectively performed in consecutive subjects (50% male, mean (±SD) age 68.5±22 years; 50% female; mean (±SD) 64.6 (±19.1)). At least one abnormality likely to change management was found in 133 (27.3%) of all open access echocardiograms. Clinical heart failure with left ventricular systolic dysfunction (LVSD) and diastolic dysfunction was confirmed in 46 (9%) and 69 (14%), respectively. Of the 46 patients with LVSD, 33 were new diagnoses. Significant cardiac valve disease was found in 42 (8.6%) patients. 12 of these had known valvular disease or previous valvular surgery, and 30 were new diagnoses.
Conclusion
Major structural and functional cardiac abnormalities are common in late middle-aged patients who present to GPs with cardiac symptoms and signs. Reported, unrestricted open access echocardiography enables early detection of significant cardiac pathology and timely intervention may improve cardiovascular outcomes.
... While approximately 15,000 isolated aortic valve procedures were performed in Germany in 2010, nearly 25,000 were performed in 2019 [1]. For decades, the gold standard for the treatment of symptomatic aortic valve stenosis was conventional surgical aortic valve replacement (SAVR) alone [2]. Since 2006, transcatheter aortic valve implantation (TAVI) has been considered a well-established alternative technique [3]. ...
Objectives:
The number of transcatheter aortic valve implantations (TAVI) has increased enormously in recent decades. Transcatheter valve prosthesis failure and the requirement of conventional surgical replacement are expected to attract more focus in the near future. Indeed, given the scarcity of research in this field, the next decade will likely represent the beginning of a period of meaningful exploration of the degenerative changes that occur with transcatheter valves. The current study represents-through a series of consecutive cases-one of the first analyses of the underlying causes of TAVI failure, i.e., degenerative, functional and infective, followed by surgical aortic valve replacement (SAVR) and postoperative outcome.
Methods:
Between October 2008 and March 2021, 2098 TAVI procedures, including 1423 with transfemoral, 309 with transapical, and 366 with transaortic access, were performed in our institution. Among these, 0.5% (number(n) = 11) required acute SAVR (n = 6) within 7 days (n = 3) or later (n = 2), and were included in the study.
Results:
Valve stent dislocation was the most common cause of replacement (83%). Causes of replacement within 7 days after TAVI were multifactorial. In the later course, endocarditis was the sole indication for SAVR after TAVI. TAVI with transapical or transaortal approach had a higher EuroSCORE II (10.9 (7.2-35.3) vs. 3.5 (1.8-7.8)). Their 30-day mortality after surgical conversion was higher (67% vs. 20%), when compared to those who underwent a transfemoral procedure. The longest documented survival beyond 30 days was 58 months.
Conclusions:
The causes of SAVR after TAVI failure are multifactorial, and include biological, physical and infectious factors. An acceptable midterm prognosis may be expected in patients with physical causes when dislocation of the catheter prosthesis is observed; in such cases, emergency conversion is required. Conversion due to infection, as in cases of endocarditis, had the worst outcome. Prognosis after conversion due to degeneration is still problematic, due to a lack of autopsies and the recent history of prosthetic implantations.
... The introduction of transcatheter aortic valve implantation (TAVI) in 2002, as an alternative to treat patients with severe aortic valve stenosis who previously had only surgery as an intervention option, represented a huge mark in the structural heart disease management revolution [1]. ...
Transcatheter aortic valve implantation (TAVI) to manage structural bioprosthetic valve deterioration has been successful in mitigating the risk of a redo cardiac surgery. However, TAVI-in-TAVI is a complex intervention, potentially associated with feared complications such as coronary artery obstruction. Coronary obstruction risk is especially high when the previously implanted prosthesis had supra-annular leaflets and/or the distance between the prosthesis and the coronary ostia is short. The BASILICA technique (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction) was developed to prevent coronary obstruction during native or valve-in-valve interventions but has now also been considered for TAVI-in-TAVI interventions. Despite its utility, the technique requires a not so widely available toolbox. Herein, we discuss the TAVI-in-TAVI BASILICA technique and how to perform it using more widely available tools, which could spread its use.
... TAVI was first introduced in 2002, initially being performed in high risk inoperable patients. 3 The original Placement of Aortic Transcatheter Valves (PARTNER) ...
Objectives
To date the reported outcomes of surgical aortic valve replacement (SAVR) are mainly in the settings of trials comparing it with evolving transcatheter aortic valve implantation. We set out to examine characteristics and outcomes in people who underwent SAVR reflecting a national cohort and therefore ‘real-world’ practice.
Design
Retrospective analysis of prospectively collected data of consecutive people who underwent SAVR with or without coronary artery bypass graft (CABG) surgery between April 2013 and March 2018 in the UK. This included elective, urgent and emergency operations. Participants’ demographics, preoperative risk factors, operative data, in-hospital mortality, postoperative complications and effect of the addition of CABG to SAVR were analysed.
Setting
27 (90%) tertiary cardiac surgical centres in the UK submitted their data for analysis.
Participants
31 277 people with AVR were identified. 19 670 (62.9%) had only SAVR and 11 607 (37.1%) had AVR+CABG.
Results
In-hospital mortality for isolated SAVR was 1.9% (95% CI 1.6% to 2.1%) and was 2.4% for AVR+CABG. Mortality by age category for SAVR only were: <60 years=2.0%, 60–75 years=1.5%, >75 years=2.2%. For SAVR+CABG these were; 2.2%, 1.8% and 3.1%. For different categories of EuroSCORE, mortality for SAVR in low risk people was 1.3%, in intermediate risk 1% and for high risk 3.9%. 74.3% of the operations were elective, 24% urgent and 1.7% emergency/salvage. The incidences of resternotomy for bleeding and stroke were 3.9% and 1.1%, respectively. Multivariable analyses provided no evidence that concomitant CABG influenced outcome. However, urgency of the operation, poor ventricular function, higher EuroSCORE and longer cross clamp and cardiopulmonary bypass times adversely affected outcomes.
Conclusions
Surgical SAVR±CABG has low mortality risk and a low level of complications in the UK in people of all ages and risk factors. These results should inform consideration of treatment options in people with aortic valve disease.
... Transfemoral aortic valve implantation (TAVI) represents an outstanding success story in interventional cardiology in recent years. Since the first implantation by Cribier et al. (1), there has been an enormous increase in clinical and scientific experience, and the method now represents an indispensable standard therapy (1)(2)(3)(4). ...
Aims: To compare intermediate performance and mortality rates in patients, who underwent transcatheter aortic valve implantation (TAVI) with two different types of prostheses: Edwards Sapien 3 (ES3) and Direct Flow Medical (DFM).
Methods and Results: 42 consecutive patients implanted with a DFM prosthesis for severe aortic stenosis were matched 1:1 with an equal number of patients, who received an ES3 during the same period. Primary endpoint was mortality. MACE, as a composite of all-cause death, stroke, and re-do-procedure (valve-in-valve), was defined as secondary endpoint. Moreover, we compared NYHA class, NT-proBNP-levels and the extent of restenosis. Patients were followed for 2 years. DFM patients showed echocardiographic elevated mean pressure gradients compared to ES3 patients before discharge (11.2 mmHg ± 5.3 vs. 3.5 mmHg ± 2.7; p < 0.001) and upon 6-months follow-up (20.3 mmHg ± 8.8 vs. 12.3 mmHg ± 4.4; p < 0.001). ES3 candidates showed superior NYHA class at follow-up ( p = 0.001). Kaplan-Meier analysis revealed significantly worse survival in patients receiving a DFM prosthesis compared to ES3 (Breslow p = 0.020). MACE occurred more often in DFM patients compared to ES3 (Breslow p = 0.006).
Conclusions: Patients receiving DFM valve prostheses showed worse survival and higher rates in MACE compared to ES3. Prosthesis performance regarding mean pressure gradients and patients' NYHA class also favored ES3.
... In 2002, Alain Cribier performed pioneering percutaneous heart valve implantation on a human being using the anterograde transseptal approach. However, using this first-generation device and challenging access route was associated with high mortality and stroke rates [3]. A transapical technique was simultaneously proposed, with experimental applications in vivo and then in patients [4][5][6]. ...
Transcatheter aortic valve implantation (TAVI) is a safe and beneficial treatment for patients with severe symptomatic aortic stenosis at high and intermediate surgical risk. The safety of the procedure continues to improve thanks to more refined procedural approaches and devices but, also and above all, to the accrual of the procedural knowledge and expertise by the operators. The diversification of the approaches and the possibility to tailor the treatment on the individual needs and anatomical features of the patients allows a rapid learning curve in the management of even complications. Indeed, there are several approaches with which TAVI can be carried out: transfemoral arterial, subclavian, transcarotid, transaortic, transaxillary, transapical, and through right anterior thoracotomy. Although transfemoral venous TAVI is less common, it has already have been carried out using caval-aortic punctures. This field is rapidly evolving, and it will be of paramount importance for interventional cardiologists and cardiothoracic surgeons to keep up to date with further developments. This review intends to give an in-depth and update overview of both conventional and innovative TAVI approaches, with the scope to highlight the relevant advantages, major disadvantages, safety aspects and techniques.
... 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.
... During the early experience, TAVR was exclusively reserved for patients considered to be inoperable or at prohibitive risk for surgical aortic valve replacement (7,8). In this setting, the randomized controlled PARTNER [Placement of AoRTic TraNscathetER Valve] and the non-randomized CoreValve Extreme Risk trial were performed. ...
Degenerative heart valve disease is associated with significant morbidity and mortality and healthcare expenditures. Transcatheter heart valve repair and replacement has introduced a fundamental change in the therapeutic management and transcatheter aortic valve replacement (TAVR) has gained substantial popularity. Favorable results from randomized trials and large real world registries lead to TAVR being considered a standard procedure with high rates of procedural success and low rates of peri-procedural complications. This article aims to review the past evolution, summarize the available evidence, discuss current indications and limitations and venture a glimpse into the future of percutaneous interventions for aortic valve disease.
... 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.
Transcatheter aortic valve replacement (TAVR) has emerged as a ground‐breaking, minimally invasive alternative to traditional open‐heart surgery, primarily designed for elderly patients initially considered unsuitable for surgical intervention due to severe aortic stenosis. As a result of successful large‐scale trials, TAVR is now being routinely applied to a broader spectrum of patients. In deciding between TAVR and surgical aortic valve replacement, clinicians evaluate various factors, including patient suitability and anatomy through preprocedural imaging, which guides prosthetic valve sizing and access site selection. Patient surgical risk is a pivotal consideration, with a multidisciplinary team making the ultimate decision in the patient's best interest. Periprocedural imaging aids real‐time visualization but is influenced by anaesthesia choices. A comprehensive postprocedural assessment is critical due to potential TAVR‐related complications. Numerous trials have demonstrated that TAVR matches or surpasses surgery for patients with diverse surgical risk profiles, ranging from extreme to low risk. However, long‐term follow‐up data, particularly in low‐risk cases, remains limited, and the applicability of published results to younger patients is uncertain. This review delves into key TAVR studies, pinpointing areas for potential improvement while delving into the future of this innovative procedure. Furthermore, it explores the expanding role of TAVR technology in addressing other heart valve replacement procedures.
Different methodologies have been used to assess the role of AV calcification (AVC) on TAVI outcomes. This systematic review aims to describe the burden of AVC, synthesize the different methods of calcium score quantification, and evaluate the impact of AVC on outcomes after TAVI. We included studies of TAVI patients who had reported AV calcium scoring by contrast-enhanced multidetector CT and the Agatston method. The impact of calcification on TAVI outcomes without restrictions on follow-up time or outcome type was evaluated. Results were reported descriptively, and a meta-analysis was conducted when feasible. Sixty-eight articles were included, with sample sizes ranging from 23 to 1425 patients. Contrast-enhanced calcium scoring was reported in 30 studies, calcium volume score in 28 studies, and unique scoring methods in two. All studies with calcium volume scores had variable protocols, but most utilized a modified Agatston method with variable attenuation threshold values of 300-850 HU. Eight studies used the Agatston method, with the overall mean AV calcium score in studies published from 2010 to 2012 of 3342.9 AU [95%CI: 3150.4; 3535.4, I2 = 0%]. The overall mean score was lower and heterogenous in studies published from 2014 to 2020 (2658.9 AU [95% CI: 2517.3; 2800.5, I2 = 79%]. Most studies reported a positive association between calcium burden and increased risk of adverse outcomes, including implantation of permanent pacemaker (7/8 studies), paravalvular leak (13/13 studies), and risk of aortic rupture (2/2 studies). AVC quantification methodology with contrast-enhanced CT is still variable. AVC negatively impacts TAVI outcomes independently of the quantification method.
Valvular heart disease remains as a major cause of morbidity and mortality in the aging population around the world. For patients with advanced, symptomatic disease, surgical open-heart valve replacement or repair remains the standard treatment with both excellent short- and long-term outcomes. However, there are many older patients that are not considered surgical candidates, especially those with comorbidities. Often medical management alone is not enough for these high-risk patients; thus, less-invasive transcatheter approaches for valve repair/implantation have been developed and are growing in use. This chapter will discuss advanced 3D imaging in such patients during the applications of such procedures.
Over the last 20 years, transcatheter aortic valve replacement (TAVR) has revolutionized the management of aortic stenosis and has become the standard of care across the entire spectrum of surgical risk. Expansion of TAVR in treating younger, lower-risk patients with longer life expectancies, and treating earlier in the disease process, has seen a continuous evolution in device technology, with several next-generation transcatheter heart valves developed to minimize procedural complications and improve patient outcomes. This review provides an update on the latest advances in transcatheter delivery systems, devices, and leaflet technology.
Aortic valve stenosis ( AS ) is the most common acquired valve disease in developed countries. Surgical aortic valve replacement ( SAVR ) was the only effective treatment option for patients with AS until the introduction of transcatheter aortic valve replacement ( TAVR ). TAVR has become a cornerstone in the management of patients with AS, and in the last few years, the total number of annual TAVR procedures has exceeded the number of SAVR procedures in the United States. TAVR valves have undergone substantial modifications to improve their performance. As TAVR technologies continue to evolve, new devices differing in their design will become available to fit more clinical needs of patients. Although the majority of patients can be successfully treated with any one of a number of devices, currently there is no one ideal valve that can fit all patients. Therefore, a multitude of factors should be considered when selecting a TAVR device for your patient, to obtain the best results. This chapter will summarize different types of TAVR devices available or under investigation and what patient, anatomic, or device‐specific factors should be considered when selecting among TAVR devices.
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.
In this report, we present a patient with ventricular septal defect (VSD) that was detected at follow-up one month after transcatheter aortic valve implantation (TAVI) and successfully closed percutaneously. Before the procedure, a 29 mm Portico self-expanding aortic valve prosthesis was placed in the heavy calcific aortic valve position, and then the balloon was dilated due to aortic insufficiency and excellent results were obtained. One month after TAVI, the patient complained of shortness of breath at rest, and on physical examination a pansystolic murmur was detected. Transthoracic echocardiography (TTE) revealed a well-functioning prosthetic aortic valve; however, a VSD was detected causing left-to-right shunt in the interventricular septum. Later, we performed the interventional treatment of the defect using the Amplatzer muscular VSD occluder device with the transfemoral approach. Currently, five months after the combined procedure, the patient showed a significant improvement in symptoms and no significant shunt was observed.
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.
Transfemoral is the most widely used access to perform transcatheter aortic valve replacement (TAVR). However, alternative access is needed in up to 21% of patients with TAVR because of a myriad of factors. The authors provide a comprehensive review on alternative access for TAVR, discussing the relevant data and providing the pros and cons of each access route.
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.
Purpose
Transcatheter aortic valve replacement (tAVR) has emerged as a less-invasive alternative to traditional surgical aortic valve replacement. The purpose of this study was to examine the effect of a novel clinical pathway with an emphasis on early physical therapy and occupational therapy on patients undergoing tAVR in the acute care setting.
Methods
A retrospective study was conducted involving 189 patients who underwent tAVR. The control group (n = 74) included patients who underwent tAVR prior to the implementation of the pathway. The intervention group (n = 115) included patients who underwent tAVR following the implementation of the pathway. Inpatient length of stay and discharge disposition were measured.
Results
No differences in demographics or clinical variables were found; for example, mean age was 79.5 ± 11.2 years, with 57% male in the control group versus 81.6 ± 8.4 years and 59% male in the intervention group. Length of stay was significantly lower in the intervention group (control 6.9 ± 5.4 days, intervention 4.8 ± 5.4 days, P = .009) and significantly shorter length of stay postprocedure (control 4.8 ± 2.9 days, intervention 3.5 ± 4.0, P = .015). The incidence of the patient's discharge disposition to home increased from 77% of patients in the control group to 86% of patients in the intervention group but was not statistically significant ( P = .118).
Conclusions
A clinical pathway specific to patients post-tAVR provided early mobility, targeted education, individualized functional goals, and discharge disposition recommendations. Patients in the intervention group experienced reduced hospital length of stay.
Background:
Transcatheter aortic valve implantation (TAVI) is a valuable treatment option for patients with reduced left ventricular ejection fraction (LVEF) and low-flow/low-gradient (LF/LG) aortic stenosis (AS). According to current literature, the presence of severe AS is unlikely in case of severely reduced LVEF and mean pressure gradient (meanPG) below 30 mmHg. However, a considerable number of patients presenting with typical clinical symptoms of severe AS, show gradients below 30 mmHg. We hypothesized, that these patients undergoing TAVI do have a measurable clinical benefit and an improved LVEF.
Methods:
In this single center retrospective cohort study, data from 1,199 patients undergoing TAVI between 2013 and 2017 was analyzed. A 6-month follow-up was performed to assess changes in NT-proBNP, NYHA-class, and LVEF.
Results:
30 patients presented with LVEF <35%, an aortic valve area (AVA <1 cm2), and a meanPG below 30 mmHg. Mean logistic EuroSCORE II was 24.05 ± 10.9. The majority of patients (56 %) showed improved NYHA-class upon follow-up. NT-proBNP-levels decreased from 3,901pg/ml IQR 10,880 to 1,491 pg/ml IQR 2,245 (p < 0.001). LVEF increased from 30 % IQR 6,25 to 40 % IQR 15 (p < 0.001).
Conclusions:
Based on our findings TAVI represents a valuable treatment option even in patients with LF/LG AS and PGmean below 30mmHg.
Objective:
The aim of this study was to provide an economic assessment of interventional vs. surgical aortic valve replacement in the context of cost-effectiveness.
Background:
Aortic stenosis represents the most common form of degenerative valvular heart diseases. As life expectancy increases, an even emerging prevalence is expected. Over decades, surgical replacement was considered as the method of choice. Up to one third of the patients were not eligible for surgery, as their estimated peri- operative risk was too high. In the early 2000s a catheter-based technique has been developed, being an alternative treatment option for patients, considered to be inoperable. Recently the Food and Drug Association (FDA) approved transcatheter replacement (TAVR) in the low risk setting. Nevertheless, concerns on the higher price remain.
Methods:
We performed an analysis of current literature on aortic stenosis and economic aspects. Out of 322 screened publications, 7 studies were found eligible by expert hand selection.
Results:
Based on the predefined payment readiness of the analyzed healthcare system, TAVR appeared to have a slightly better cost effectiveness. Initial results within the early era seemed to be inconsistent. Recent publications showed, TAVR might be of more cost effectiveness when using the newest generation devices and a profound clinical experience is guaranteed.
Conclusions:
We assume, that TAVR will not only be the method of choice for the treatment of aortic stenosis in many patients. As the valves are getting cheaper, TAVR might even be superior to conventional heart surgery from an economic point of view.
This study aimed to compare incidence of IE between BE and SE valves by performing a systematic review and meta-analysis of the literature. We comprehensively searched the databases of MEDLINE and EMBASE from inception to November 2019. Included studies were published observational studies that compared the risk of IE among patients undergoing TAVR employing BE versus SE valves, using the random-effects to calculate risk ratios and 95% confidence intervals (CIs).Ten cohort studies from April 2013 to November 2019 were included in this meta-analysis involving 13,478 subjects (6289 SE and 7189 BE types). Our study showed no statistical difference in IE rates between each type of valves (pooled OR 0.96, 95% CI: 0.68–1.35, p = 0.801 with I2 = 14.7%). There was no difference in IE rate between BE and SE valves following TAVR. Further studies are warranted to confirm our findings.
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.
The role of cardiac surgeons in the treatment of aortic valve disease is changing with the expansion of transcatheter aortic valve replacement (TAVR). Recent trials in patients at low surgical risk will further this paradigm-shift, and the future cardiac surgeons in this space remains uncertain. In this Viewpoint article, we discuss the role that surgeons can play in the future of structural heart medicine. We examine the potential effects of the low-risk TAVR trials on overall operative volumes and how these effects may be limited through structured training programs and strong collaboration within the heart team. Finally, future considerations and cautions for the cardiac surgical community are discussed. The coming era presents an opportunity for growth, leadership and strong inter-disciplinary collaboration for the cardiac surgery community.
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.
This study reports clinical (84 patients) and catheterization (15 patients) follow-up of the first 90 patients who underwent percutaneous balloon aortic valvuloplasty (PBAV) at Massachusetts General Hospital. Eight patients died within 1 week inhospital; 1 patient was lost to follow-up. Mean age of the group was 79 ± 1 year (range 52 to 95). Before PBAV 25% of the patients were in New York Heart Association class III and 73% were in class IV. Endpoints were aortic valve surgery, death, second PBAV or interview. Mean follow-up was 5.5 ± 0.3 months after PBAV. Although all patients improved symptomatically immediately after PBAV, at follow-up 16% were in New York Heart Association class I, 20% were in class II, 11% were in class III and 25% were in class IV. Twentythree (28%) patients died during the follow-up period. A second PBAV was performed in 15 patients who had repeat catheterization. All had restenosis but only 13 of 15 had recurrent symptoms. Repeat PBAV produced results similar to the first PBAV despite the use of larger or double balloons. Although PBAV improves most patients' symptoms, recurrence of clinical symptoms and a high mortality within 6 months should limit the procedure to selected patients.
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.
Percutaneous balloon aortic valvuloplasty has been accompanied by significant early periprocedural morbidity and mortality. Identification of factors associated with increased mortality might allow for improved selection of patients. The Mansfield Scientific Balloon Aortic Valvuloplasty Registry was analyzed to identify the frequency of in-hospital death and the factors associated with it. Of 492 patients undergoing the procedure, 37 (7.5%) died during the hospital stay in which valvuloplasty was performed. Twenty-four of these patients died within the first 24 h and the remainder died within 7 days after the procedure. There were significant differences in baseline clinical and hemodynamic characteristics as well as procedural and postprocedural variables between patients dying and those surviving the in-hospital period. Multivariate analysis identified four factors associated with increased mortality: 1) the occurrence of a procedure-related complication, 2) a lower initial left ventricular systolic pressure, 3) a smaller final aortic valve area, and 4) a lower baseline cardiac output. Thus, baseline hemodynamic, procedural and postprocedural variables and complications can be identified that are associated with increased mortality.
Between December 1, 1986 and October 30, 1987, balloon aortic valvuloplasty was performed in 492 patients with aortic stenosis (mean age 79 +/- 8.4 years) enrolled in the Mansfield Scientific Aortic Valvuloplasty Registry. All procedures were performed from a femoral approach (92%), brachial approach (6%) or transseptal approach (2%) and utilized either a single balloon technique (72%) or a double balloon technique (28%). Valvuloplasty resulted in a significant improvement in aortic valve area (0.50 +/- 0.18 cm2 to 0.82 +/- 0.30 cm2), mean aortic valve gradient (60 +/- 23 mm Hg to 30 +/- 13 mm Hg) and cardiac output (3.86 +/- 1.26 to 4.05 +/- 1.31 liters/min). Serial aortography demonstrated a moderate or severe increase in aortic insufficiency in only 2.1% of patients. Statistical analysis of the procedural factors affecting acute valvuloplasty results demonstrated significant correlations of single versus double balloon technique, total number of balloon inflations and total number of balloon exchanges with respect to the absolute change in mean aortic valve gradient occurring during the valvuloplasty procedure. In addition, there was a significant correlation between the maximal time of valvuloplasty balloon inflation with aortic valve area measured after valvuloplasty, and there were significant correlations of the total number of balloon inflations and total number of balloon exchanges with the aortic valve mean gradient measured after valvuloplasty. The overall complication rate for the procedure was 20.5%, including vascular injury in 11%, embolic phenomenon in 2.2%, ventricular perforation resulting in tamponade in 1.8%, massive aortic insufficiency in 1%, nonfatal arrhythmia in 0.8% and myocardial infarction in 0.2%.(ABSTRACT TRUNCATED AT 250 WORDS)
Seventy-one patients aged greater than or equal to 80 years (mean +/- standard deviation 82 +/- 2) with aortic stenosis or mixed stenosis and regurgitation underwent aortic valve replacement alone (n = 35, group 1) or in combination with a coronary artery bypass procedure without any other valve procedure (n = 36, group 2). Preoperatively, 91% had severe cardiac limitations (New York Heart Association class III or IV). Hospital mortality was 12.7% overall (9 of 71), 5.7% (2 of 35) for group 1 and 19.4% (7 of 36) for group 2. Perioperatively, 1 patient (1.4%) had a stroke. Survival from late cardiac death at 1 and 3 years was 98.2 and 95.5%, respectively, for all patients, 100% for patients who underwent isolated aortic valve replacement, and 96.3 and 91.2%, respectively, for patients who underwent aortic valve replacement plus coronary artery bypass. Eighty-three percent of surviving patients had marked symptomatic improvement. Freedom from all valve-related complications (thromboembolism, anticoagulant, endocarditis, reoperation or prosthetic failure) was 93.3 and 80.4% at 1 and 3 years, respectively. Thus, short- and long-term morbidity and mortality after aortic valve replacement for aortic stenosis in patients aged greater than or equal to 80 years are encouragingly low, although the addition of coronary artery bypass grafting increases short- and long-term mortality.
Percutaneous transluminal balloon valvuloplasty was attempted in 92 adult patients with severe calcific aortic stenosis. The mean age was 75 +/- 11 years (range 38 to 91) and 35 patients were more than 80 years old. Most of the patients were severely disabled; 66 were in New York Heart Association functional class III or IV, 27 had syncopal attacks and 21 had severe angina pectoris. Because of unacceptably high surgical risk or contraindication to thoracic surgery, 42 patients could not be considered for valve replacement. Other patients either were in a category of high operative risk or refused the surgical intervention. Valvuloplasty was performed by way of the femoral route (82 patients) or the brachial route (10 patients). Catheters of size 15, 18 and 20 mm were successively placed across the aortic valve and three inflations were usually done with each of them, lasting 80 seconds on average, until a decrease in peak to peak systolic pressure gradient to 40 mm Hg or less was attained, a result considered satisfactory. The inflated balloons were not totally occlusive in most cases and clinical tolerance of inflation was good. Valvuloplasty resulted in a reduction of mean systolic gradient from 75 +/- 26 to 30 +/- 13 mm Hg (p less than 0.001); the final gradient was less than 40 mm Hg in 78 patients. Mean calculated aortic valve area increased from 0.49 +/- 0.17 to 0.93 +/- 0.36 cm2 (p less than 0.001). Immediately after the procedure, ejection fraction increased from 48 +/- 16 to 51 +/- 16% (p less than 0.01).(ABSTRACT TRUNCATED AT 250 WORDS)
This study reports clinical (84 patients) and catheterization (15 patients) follow-up of the first 90 patients who underwent percutaneous balloon aortic valvuloplasty (PBAV) at Massachusetts General Hospital. Eight patients died within 1 week in-hospital; 1 patient was lost to follow-up. Mean age of the group was 79 +/- 1 year (range 52 to 95). Before PBAV 25% of the patients were in New York Heart Association class III and 73% were in class IV. Endpoints were aortic valve surgery, death, second PBAV or interview. Mean follow-up was 5.5 +/- 0.3 months after PBAV. Although all patients improved symptomatically immediately after PBAV, at follow-up 16% were in New York Heart Association class I, 20% were in class II, 11% were in class III and 25% were in class IV. Twenty-three (28%) patients died during the follow-up period. A second PBAV was performed in 15 patients who had repeat catheterization. All had restenosis but only 13 of 15 had recurrent symptoms. Repeat PBAV produced results similar to the first PBAV despite the use of larger or double balloons. Although PBAV improves most patients' symptoms, recurrence of clinical symptoms and a high mortality within 6 months should limit the procedure to selected patients.
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.
Pulmonary regurgitation can lead to severe right ventricular dysfunction, which is a delicate postoperative problem in the long-term follow-up of patients who had surgery for congenital heart diseases. Clinical conditions of patients suffering from pulmonary valve incompetence are improved by valve replacement with a prosthetic valve. To date, the surgical approach is the only option to replace a pulmonary valve. We report the first experience of percutaneous pulmonary valve implantation.
A fresh bovine jugular vein containing a native valve was sutured into a vascular stent and then cross-linked with a 0.6% glutaraldehyde solution for 36 hours. After being hand-crimped onto a balloon catheter, the device was inserted percutaneously according to standard stent-placing techniques. The valved stent was finally deployed in the position of the native pulmonary valve of the lamb. Hemodynamic evaluation was carried out before and 2 months after implantation. Anatomic evaluation was finally performed. Percutaneous pulmonary valve replacement was successful in 5 lambs. No complications were noted. Early and late angiographic and hemodynamic studies confirmed a good position of the stents with a competent valve at the end of the protocol. One stent was slightly stenotic, with macroscopically visible calcifications.
Nonsurgical implantation of pulmonary valves is possible in the lamb. This new technique is similar to standard stent implantation. Thus, it should be feasible in humans, in whom it will lead to a significant reduction of reoperations in patients in need of pulmonary valve replacement.
Valved conduits from the right ventricle to the pulmonary artery are frequently used in paediatric cardiac surgery. However, stenosis and insufficiency of the conduit usually occur in the follow-up and lead to reoperations. Conduit stenting can delay surgical replacement, but it aggravates pulmonary insufficiency. We developed an innovative system for percutaneous stent implantation combined with valve replacement.
A 12-year-old boy with stenosis and insufficiency of a prosthetic conduit from the right ventricle to the pulmonary artery underwent percutaneous implantation of a bovine jugular valve in the conduit.
Angiography, haemodynamic assessment, and echocardiography after the procedure showed no insufficiency of the implanted valve, and partial relief of the conduit stenosis. There were no complications after 1 month of follow-up, and the patient is presently in good physical condition.
We have shown that percutaneous valve replacement in the pulmonary position is possible. With further technical improvements, this new technique might also be used for valve replacement in other cardiac and non-cardiac positions.
Over the past 30 years there have been experimental efforts at catheter-based management of aortic valve regurgitation with the idea of extending treatment to nonsurgical candidates. A new catheter-based aortic valve design is described.
The new catheter-delivered valve consists of a stent-based valve cage with locking mechanism and a prosthetic flexible tilting valve disc. The valve cage is delivered first followed by deployment and locking of the disc. In acute experiments, valve implantation was done in four dogs.
Valve implantation was successful in all four animals. The implanted valve functioned well for the duration of the experiments (up to 3 hr).
The study showed the implantation feasibility and short-term function of the tested catheter-based aortic disc valve. Further experimental studies are warranted.
To date, the surgical approach is the only option to replace the aortic valve. Percutaneous pulmonary valve replacement has recently opened new perspectives on transcatheter replacement of cardiac valves. We report our experience of aortic valve replacement through a percutaneous technique in lambs.
A bovine jugular vein containing a valve was dissected and sutured into a stent. Twelve lambs were divided into 3 groups. In the first, a valved stent was implanted in the descending aorta after creation of an aortic insufficiency. In the second, the valve was implanted in the native position. In the third, we inserted a valved stent in the native position using an orientation mechanism. All valves were successfully delivered and functioned perfectly in short-term evaluation. All experiments in group 2 failed: 1 valve obstructed the coronary artery orifices, 1 stent was responsible for a major mitral valve insufficiency, and the third implant migrated prematurely. A paraprosthetic leak occurred in the last animal in this group. Animals in group 3 had successful implantation of the valved stent. The orientation mechanism allowed perfect alignment of the device without any damage to the coronary circulation or to mitral valve function.
Nonsurgical implantation of an aortic valve is possible in lambs in the descending aorta and in the native position. An orientation mechanism is obviously needed to avoid obstruction of the coronary orifices. With further improvements, this technique should be feasible in humans.
We report our experience of percutaneous valve insertion in pulmonary position in humans.
Over the past 40 years, prosthetic conduits have been developed to surgically establish continuity between the right ventricle and the pulmonary artery. However, stenosis and insufficiency of the conduit due to valvular degeneration or panus ingrowth frequently occur, limiting patients' lifespan. Percutaneous stenting of conduits has recently emerged as a technique for delaying surgical replacement, but it creates a pulmonary regurgitation when crossing the valve.
Seven children and one adult with stenosis and/or insufficiency of the pulmonary graft underwent percutaneous implantation of a bovine jugular valve in pulmonary position.
Percutaneous pulmonary valve (PV) replacement was successful in all patients. No complications occurred in early follow-up. Angiography, hemodynamic studies and echocardiography after the procedure showed no significant regurgitation of the implanted valve. Implantation was effective in relieving the obstruction in five patients. All patients showed improvement in their clinical status at the latest follow-up (mean 10.1 months).
Non-surgical insertion of the PV is possible without any major complications. This new technique may have an important role in the management of conduit obstructions and pulmonary regurgitation.
We assessed the feasibility of percutaneous implantation of a valve in the descending aorta and its function in systemic pressures.
A biological valve harvested from a bovine jugular vein was sutured into a stent. After the creation of aortic insufficiency, the valved stent was percutaneously implanted into eight lambs divided into two groups depending on the severity of the insufficiency created. Haemodynamic and angiographic evaluations were carried out. Anatomical evaluation was finally performed. Aortic insufficiency was created: four lambs had mild insufficiency and four massive insufficiency. A valve was successfully implanted in all and were functioning perfectly in the early follow-up. Despite this competence, animals with massive insufficiency died within 24 h following implantation. None of the animals with mild insufficiency died. The valve was functioning perfectly in the first 2 months following the implantation, but became incompetent after spontaneous healing of the wound of the aortic valve.
Percutaneously implanted valves in the descending aorta of lambs with aortic insufficiency function well in the early follow-up. This technique might become an interesting alternative to the standard approach in patients in whom perioperative risk is high.
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.
Aortic valve replacement for aortic stenosis in persons aged 80 years and over McKay RG. The Mansfield Scientific Aortic Valvuloplasty Registry: overview of acute hemodynamic results and procedural complications
- At Culliford
- Ac Galloway
- Colvin
- Sb
Culliford AT, Galloway AC, Colvin SB, et al. Aortic valve replacement for aortic stenosis in persons aged 80 years and over. Am J Cardiol 1991;67:1256 –60. 3. McKay RG. The Mansfield Scientific Aortic Valvuloplasty Registry: overview of acute hemodynamic results and procedural complications. J Am Coll Cardiol 1991;17:189 –92.
Transcatheter implantation of balloon expandable prosthetic heart valves: early results in an animal model (abstr)
- A Cribier
- H Eltchaninoff
- N Borenstein
Cribier A, Eltchaninoff H, Borenstein N, et al. Transcatheter implantation of balloon expandable prosthetic heart valves: early results in an
animal model (abstr). Circulation 2001;104 Suppl II:II552.
- Cribier
JACC Vol. 43, No. 4, 2004
Cribier et al.
February 18, 2004:698–703
Percutaneous Heart Valve in Aortic Stenosis
Transluminal implantation of artificial heart valves
- Andersen
Transcatheter implantation of balloon expandable prosthetic heart valves
- Cribier
The Mansfield Scientific Aortic Valvuloplasty Registry
- McKay