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Transapical Minimally Invasive Aortic Valve Implantation: Multicenter Experience
Abstract
To evaluate initial multicenter results with minimally invasive transapical aortic valve implantation (TAP-AVI) for high risk patients with aortic stenosis.
TAP-AVI was performed via a small anterolateral minithoracotomy with or without femoro-femoral extracorporeal circulation (ECC) on the beating heart. A pericardial xenograft fixed within a stainless steel, balloon expandable stent (Edwards SAPIEN THV, Edwards Lifesciences) was used. Fifty-nine consecutive patients (81+/-6 years, 44 female) were operated on from 02/06 until 10/06 at 4 centers using fluoroscopic and echocardiographic visualization. Average EuroSCORE predicted risk for mortality was 27+/-14%. TAP valve positioning was performed successfully in 53 patients, 4 required early conversion to sternotomy. Implantation (23-mm valves in 19 and 26-mm valves in 40 patients) was performed on the beating heart during brief periods of rapid ventricular pacing. Thirty-one patients were operated on without cardiopulmonary bypass. Neither coronary artery obstruction nor migration of the prosthesis was observed, and all valves had good hemodynamic function. Echocardiography revealed minor paravalvular leakage in 26 patients (trace in 11, mild in 12, and severe in 3). Eight patients died in-hospital (13.6%) without any valve dysfunction. Actuarial survival was 75.7+/-5.9% at a follow-up interval of 110+/-77 days (range 1 to 255 days).
TAP-AVI can be performed safely with good early results in high risk patients. Long-term valve performance as well as broader based applications of this promising approach will need to be studied.
... The transapical approach expands the population for which TAVR is indicated as an alternative means to access to the periphery due to anatomy or disease [9]. Although the transapical approach is more damaging than other peripheral approaches, many studies have validated its effectiveness and safety [10][11][12]. There is still a general consensus that aortic regurgitation is not on-label for TAVR, by either transfemoral or transapical 2 of 10 approach [13]. ...
... The results showed that the two groups exhibited significant differences in length of hospital stay, ICU stay, and incidence of paravalvular leakage before and after propensity score matching. It has been demonstrated in earlier studies of TA-TAVR that transapical interventions can also effectively reduce the ICU length of stay and total length of hospital stay in patients compared to surgical procedures [11,25], and the findings of this study are similar to the above studies. The difference between the TAVR group and the SAVR group in terms of paravalvular leakage was mainly in the mild paravalvular leakage, which did not have a significant impact on the overall survival or quality of life in terms of short-term outcomes [26]. ...
Background: We aimed to analyze the short-term clinical outcomes of transapical aortic valve replacement (TA-TAVR) compared with surgical aortic valve replacement (SAVR) in symptomatic aortic regurgitation (AR) patients to draw preliminary conclusions about the advantages and disadvantages of TA-TAVR compared with SAVR and to provide evidence for future use of TA-TAVR in AR patients. Method: From September 2016 to September 2021, 69 patients undergoing TA-TAVR with J-valve implantation and 42 patients undergoing SAVR at the Second Hospital of Zhejiang University School of Medicine were analyzed for clinical data and 30-day follow-up outcomes to analyze and compare the differences in clinical endpoints between the two procedures. Results: At 30-day follow-up, there were no significant differences in mortality or neurological events between the two groups before and after the PSM. In secondary endpoints there were significant differences between the pre-match TAVR and SAVR groups, such as the incidence of paravalvular leaks (33.8% vs. 4.8%, p < 0.05), which also remained after the PSM (37.5% vs. 0, p < 0.05). In addition, the incidence of major bleeding was 7.4% in the TAVR group and 26.2% in the SAVR group before matching (p < 0.05). After matching, the statistical difference still remained. In longitudinal comparison, significant improvements in postoperative cardiac ultrasound indices and NYHA classification occurred in both groups. Conclusion: The TA-TAVR approach is safe and reliable, with similar clinical efficacy to SAVR, and has advantages in bleeding rate and speed of recovery.
... 30 Similar findings were observed in European experiences in transapical AVI with 30-day mortality of 8% to 13.6% and survival of 71.4% at 1 year. 28,29 Interim follow-up results from the precommercial transapical PARTNER EU registry including 67 transapical patients (logistic EuroSCORE 33.5%) showed a 30-day survival of 82% and a 6-month survival of 56%. A 30-day survival for transapically treated patients in SOUREC was 88.4% (mean logistic EuroSCORE 30%)(Heatwire at www. medscape.com). ...
... However, cumulative experience does not support this concept. Reported incidences of stroke were approximately 4%. 24,29,30,36 It has been suggested that the incidence of stroke may be lower with transapical approach because of less manipulation in the aortic arch compared with transarterial approach, but this remains to be confirmed by a randomized trial or with a large database. The cause of early stroke is most likely as a result of thromboembolism from the calcified native valve, diseased aortic arch/ascending aorta, clots on catheters, or air. ...
... 12,13 More invasive access routes, such as transapical TAVI, may be used in the case of poor vascular access. 14 For any access route, the TAVI device used can be either self-expandable or balloon-expandable (whereby a balloon catheter is inserted into the device and inflated to expand and situate the new valve). 11 Originally, TAVI was only available for patients who either received MM due to being unsuitable for surgery, or who received SAVR and were at high surgical risk. ...
Objective
Transcatheter aortic valve implantation (TAVI) is a disruptive technology recommended for patients with symptomatic severe aortic stenosis (sSAS). Despite being available for over 15 years in Europe, with an extensive volume of clinical and economic evaluations across all surgical risk groups, there is little evidence on the identification of the key drivers of TAVI’s cost-effectiveness. This study sought to identify these factors and quantify their role.
Methods
A systematic literature review was conducted to identify published economic evaluations of TAVI. This was supplemented by health technology assessment reports. The primary outcome was the likelihood of TAVI being found cost-effective. Secondary outcomes of TAVI being dominant, and the incremental health benefits of TAVI were also explored.
Results
Forty-two studies, reporting 65 unique analyses, were identified. TAVI was found to be cost-effective and dominant in 74% and 20% of analyses, respectively. The latest generation balloon-expandable TAVI device (SAPIEN 3) was more likely to be found cost-effective, as was TAVI use in low-risk populations and when performed via transfemoral access route. There was heterogeneity in the approach taken to economic modelling, which may also influence estimates of cost-effectiveness. Analyses that found TAVI to be dominant always compared it to surgery and usually considered the latest generation balloon-expandable TAVI device. Largest health benefits were observed for the inoperable risk group.
Conclusion
For patients with sSAS, TAVI is typically a cost-effective treatment option. There are important differences by device generation, risk group and access route. It is crucial to consider these differences when appraising the health economic evidence-base for TAVI.
... Transapical transcatheter aortic valve implantation (TA-TAVI) is a minimally invasive procedure used to treat aortic stenosis in individuals at high risk for cardiac surgery. 54 Cox by near-infrared spectroscopy offers the possibility of non-invasively determining cerebral oxygen balance, which recent data suggests may even reflect complete oxygen balance. 12 A variety of clinical conditions that are often seen during cardiac catheterization have the potential to disrupt the balance between cerebral oxygen supply and demand. ...
Near-infrared Spectroscopy (NIRS) has a well-established role in cardiovascular and thoracic anaesthesia, and its use is increasing in popularity. Regional cerebral oxygen saturation monitoring may be helpful for patients who are at risk for cerebral ischemia. During cardiac induction, there is a risk of developing complications like arrhythmias, hypotension, cardiac arrest, ST-segment changes, acute low cardiac output, pulmonary hypertension, diastolic dysfunction, valve dysfunction, residual shunts, or residual obstruction of ventricular outflow tracts, brain injuries, etc; where cerebral oxygen saturation is affected. These complications are multifactorial due to the use of heartlung machines as a result of the issues of aorto-pulmonary shunts, pathophysiological changes in the cardiovascular system, hypothermia, circulatory arrest (DHA), prolonged CPB time, specific surgical technique, anaesthesia, and different medications. The non-invasive, compact, continuous measurement technology known as NIRS tracks oxygenation in the brain, muscle, and other organs. In real time, it senses small changes in tissue oxygenation. We hypothesized that NIRS would be a useful technique for detecting increased susceptibility to ischemic neurologic harm. It could be a helpful technique for tracking brain oxygenation when jugular bulb oxygen saturation monitoring is not an option. NIRS is a useful tool for predicting critical events and figuring out how to handle them for a better outcome and faster discharge.
... A preoperative multislice computed tomography scan (MSCT) is generally performed to assess the valve complex, define the access site, and avoid complications [6,7] (Figure 1). So far, several alternative access routes for antegrade or retrograde TAVI procedures have been described, namely the transfemoral, transaortic, transapical, transcarotid and transaxillary access routes [8][9][10][11]. The transfemoral (TF) access route is considered the gold standard approach for TAVI; however, it can be precluded by unfavorable anatomical characteristics such as calcification, tortuosity, and peripheral artificial graft. The TF approach is usually unsuitable in 10-15% of patients who are candidates for TAVI [12]. ...
Background: The aim of our study was to determine the feasibility and efficacy of transaxillary (TAX) TAVI in patients not eligible for the transfemoral route. Methods: This is a retrospective study of a single center. We analysed 262 patients treated with TAVI. In 17 patients (6.5%), the procedure was performed with the TAX approach. Procedural and hospital data, 30-day safety, and clinical efficacy were assessed and compared between the transfemoral and TAX groups. Results: In the TAX groups, we found a higher prevalence of men (p = 0.001), smokers (p = 0.033), and previous strokes (p = 0.02). The EUROSCORE II was higher in the TAX group (p = 0.014). The success rate of the device was 100%. TAX was associated with a longer procedure time (p = 0.001) and shorter median device time (p = 0.034) in minutes. Patients treated with TAX had a longer hospital stay (p = 0.005) and higher overall bleeding rate (p = 0.001). Peripheral neurological complications were more frequent with TAX (p = 0.001), which almost completely resolved by 30 days. Conclusions: TAX TAVI is safe and effective and should be considered as a second choice when transfemoral TAVI is not feasible due to severe comorbidities.
... Prolonged mechanical ventilation time, intensive care unit (ICU) and hospital stays, and risk of deep and superficial sternal wound infections and sternal dehiscence increase with the degree of obesity [2,3] . Alternative treatment methods with more reasonable mortality and morbidity rates have recently emerged, including minimally invasive aortic valve replacement (mini-AVR) via thoracotomy and transcatheter aortic valve implantation (TAVI) [4,5] . However, TAVI is not feasible in all patients, perioperative and postoperative complications are common, and long-term durability is controversial [1] . ...
Introduction:
The minimally invasive implantation of aortic valve prosthesis via thoracotomy has numerous advantages and is comfortable, especially during the early postoperative period. Disadvantages of this method include peripheral vessel complications and groin infections. Central cannulation (direct aortic cannulation with superior vena cava cannulation) eliminates these drawbacks. In this report, we evaluated this method of treatment in patients with obesity.
Methods:
We retrospectively analyzed the medical records of 21 obese patients with severe aortic stenosis who underwent minimally invasive aortic valve implantation via thoracotomy and central cannulation with a bovine pericardial aortic prosthesis between 2017 and 2021. We compared these records with the medical records of 27 obese patients with severe aortic stenosis who underwent conventional aortic valve surgery.
Results:
Mean cross-clamp and cardiopulmonary bypass times were similar in both groups. Operating time was significantly longer in the minimally invasive group (P <0.05). In the minimally invasive group, acute renal failure occurred in 2 patients. In terms of postoperative complications, deep sternal wound infection/sternal instability was much higher in the conventional group. This was not statistically significant (P=0.090). Minimally invasive operated patients had a comfortable early postoperative period, with a mean visual analog scale for pain of 1.10±0.83 (no pain-mild pain). When we assessed patient satisfaction with the postoperative period, 13 patients were extremely satisfied, 7 patients were satisfied, and 1 patient was quite satisfied.
Conclusion:
Minimally invasive aortic valve implantation via thoracotomy and central cannulation is a safe and effective treatment for obese patients.
... In addition to standard monitoring, which includes ECG, oximetry, and capnography, catheterization of an artery is utilized, before or immediately after induction to anesthesia, for continuous measurement of blood pressure. Intraoperative monitoring of arterial blood gas (ABG) and activated clotting time (ACT) are necessary during these operations as ACT is used to direct heparin anticoagulation [22,23]. ...
Aortic valvular stenosis remains the most common weakening valvular heart lesion. Many high-risk patients cannot tolerate surgery. Transcatheter aortic valve implantation (TAVI) is an emergent alternative technique. General and local anesthesia plus sedation are both valid alternative techniques that can be titrated according to patient characteristics. Hemodynamic management is the main concern of intraoperative anesthesiological management. Preprocedural, multidisciplinary assessment of the patient is essential prior to TAVI and should include a full anesthetic evaluation. TAVI offers a number of advantages to patients and medical teams, but there are still accompanying important complications and anesthesiological risks.
... Vgl.Cribier et al. (2002) sowieWalther et al. (2007). 12Vgl. ...
... Moreover, the risk of obstructing the coronary ostium increases. Implantation techniques to mitigate such risks, including the BASILICA technique, the high implantation technique and bioprosthetic valve fracture/remodeling have shown good results (5)(6)(7)(8)(9)(10). However, there are other complications of ViV-TAVI which are not as easily mitigated. ...
Objective
: To compare early and midterm outcomes of transcatheter valve-in-valve (ViV-TAVI) and redo surgical aortic valve replacement (re-SAVR) for aortic bioprosthetic valve degeneration.
Design
: Patients who underwent ViV-TAVI and re-SAVR for aortic bioprosthetic valve degeneration between January 2010 and October 2018 were retrospectively analyzed. Mean follow-up was 3.0 years.
Setting
: In-hospital, early and mid-term outcomes.
Participants
: 88 patients were included in the analysis.
Interventions
: 31 (37.3%) patients had ViV-TAVI and 57 patients had (62.7%) re-SAVR.
Measurements and main results
: In the ViV-TAVI group, patients were older (79.1 ± 7.4 vs 67.2 ± 14.1, p<0.01). The total operative time, the intubation time, intensive care unit length of stay, total hospital length of stay, inotropes infusion, intubation > 24 hours, total amount of chest tube losses, red blood cells transfusions, plasma transfusions and reoperation for bleeding were significantly higher in the re-SAVR cohort (p<0.01). There was no difference regarding in-hospital permanent pacemaker implantation (ViV-TAVI=3.2% vs re-SAVR=8.8%,p=0.27), patient-prosthesis mismatch [ViV-TAVI=12 patients (mean 0.53 ± 0.07) and re-SAVR=10 patients (mean 0.56 ± 0.08), p=0.4], stroke (ViV-TAVI=3.2% vs re-SAVR=7%, p=0.43, acute kidney injury (ViV-TAVI=9.7% vs re-SAVR=15.8%, p=0.1), all cause infections (ViV-TAVI=0% vs re-SAVR=8.8%, p=0.02), between the two groups. In-
... 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
... Incidence of primary and secondary end points was stratified according to the following variables: age group, gender, baseline left ventricular ejection fraction (LVEF) and logistic EuroSCORE equal or greater than 20% [6,7]. Two separate analyses were conducted, those undergoing isolated SAVR and those undergoing combined SAVR and CABG. ...
OBJECTIVES
Continuous improvement in the management of patients undergoing surgical aortic valve replacement (SAVR) may have considerably enhanced surgical outcomes including in-hospital mortality and perioperative complications. We aimed to analyse in-hospital mortality and morbidity trends in patients undergoing SAVR in a single centre to provide insights for future benchmarking for transcatheter aortic valve implantation indications.
METHODS
This was a retrospective study of prospectively collected data from patients undergoing either isolated SAVR or combined with coronary artery bypass grafting (CABG) at the Bristol Heart Institute, UK, from January 2000 to December 2017. Baseline characteristics were extracted and analysed across 3 different eras (2000–2005, 2006–2011 and 2012–2017). Risk-adjusted time trend was obtained from univariate and multivariate logistic regression including all baseline characteristics.
RESULTS
A total of 2719 patients (63.2%) underwent isolated SAVR, and 1581 (36.8%) underwent combined CABG and SAVR during the study period. For patients undergoing SAVR, in-hospital mortality decreased from 2.9% in 2000–2005 to 0.7% in 2012–2017 (risk-adjusted time trend 0.0001). Hospital mortality in patients aged 75–79 and ≥80 years decreased from 5.6% and 5.3% to 0.4% and 2.2%, respectively. Mortality after combined SAVR and CABG did not significantly decrease (from 3.9% in 2000–2005 to 3.5% in 2012–2017; risk-adjusted time trend = 0.62). However, in patients aged ≥80 years, index hospitalization mortality showed a decreasing non-significant trend from 9.8% to 4.8%.
CONCLUSIONS
Our findings support the hypothesis that mortality and morbidity rates following SAVR have significantly improved over the years, including for patients at high risk.
... All current guidelines consider TAVI the preferred intervention, rather than surgery, for patients who are inoperable or frail and/or patients with high surgical risk (evaluated by the STS and EuroSCORE II scores). [99][100][101][102][103][104][105][106][107][108][109][110][111][112][113] However, following the publication of American and European guidelines, 4 studies comparing TAVI and surgery in patients with low surgical risk were published. Meta-analysis of these studies demonstrated reduced 1-year mortality in transfemoral TAVI. ...
... John Webb and his colleagues also performed the first transapical valve implantation [11]. Walther et al. promoted the number of cases of TAVI via Edwards' apical approach as an easier way to implant the valve [12]. ...
Since the successful application of transcatheter aortic valve implantation (TAVI) in 2002, the interventional treatment of valvular heart disease has developed rapidly. The interventional treatment of aortic valve stenosis or insufficiency has been more mature, and many new-generation TAVI valves have been developed. The recommended level of TAVI technology in the European and American heart valve disease guidelines has increased year by year. In 2019, the multi-center randomized controlled study on patients with low-risk aortic stenosis and conventional aortic valve replacement also showed the advantages of interventional treatment technology, such as small trauma, fast recovery and less complications, and better hemodynamics, which greatly promoted the development of TAVI technology.
... We reported the first successful transcatheter transapical AVI through a left minithoracotomy and the apex of the left ventricle without CPB in humans, 11,12 followed by our early clinical experience with transapical transcatheter AVI without CPB. [14][15][16] Our early experience and that of others 17 have shown that transapical transcatheter AVI definitely relieves aortic stenosis and significantly improves valve-related symptoms. We now report clinical and echocardiographic outcomes of transapical AVI in our first 71 patients. ...
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.
... Transapical approach (TA) approach was the first alternate method to be described when the TF was not feasible, especially when there was significant iliofemoral disease. TA method is the only TAVR method that is anterograde and provides easy valve crossing due to the anatomical approach and avoids cardiopulmonary bypass and sternotomy (26)(27)(28)(29). The procedure involves exposing the apex of the left ventricle by performing a mini-thoracotomy and placing purse string sutures. ...
Valve replacement in high-risk patients with severe aortic stenosis has undergone a huge paradigm shift in the recent years in terms of procedural details and vascular access site for patients who have poor peripheral access. Carotid artery is one of the more promising access sites which has been proven to provide a good alternative site with comparable outcomes to transfemoral approach. In this manuscript, we will provide a review of the current literature on transaortic, transapical, transaxillary and transcarotid approaches to transcatheter aortic valve replacement (TAVR) while focusing on the transcarotid approach.
... The main advantages of TAVI is that the micro-invasive TAVI procedures have diminished invasiveness compared to minimally-invasive procedures, and can be performed on the live, beating heart without the need for extracorporeal circulation or cardiopulmonary bypass nor aortic cross clamp. This renders TAVI favorable than MHV and BHV prostheses as it overcomes the requirement for temporary cardiac arrest, and improves patient recovery time (20). Another advantage of TAVI is that the micro-invasive procedures (commonly the transfemoral approach) can be conducted in a completely percutaneous fashion and with local anesthesia only, whereas minimally invasive approaches (such as mini-sternotomy or mini-thoracotomy) for conventional heart valve prostheses necessitate skin incision and general anesthesia (17). ...
... Poznatky můžeme čerpat pouze ze dvou registrů -REVIVAL II (40 pacientů), TRAVERCE (168 pacientů). 9 Výkon byl prováděn u pacientů s logistickým EuroSCORE 27-36 %. Periprocedurální úspěšnost se v těchto registrech pohybovala mezi 88 a 93 %, konverze na sternotomii byla provedena v 7 %, 30denní mortalita byla 13-15 % a dvouleté přežití 60-70 %. ...
... Následně je vodičem překlenuta stenotická aortální chlopeň, po vodiči je provedena BAV a za kontroly rentgenu a jícnové echokardiografie je implantována chlopeň. (23,24) Po jejím uvolnění následuje vytažení katetru, sutura hrotu a thorakotomie. Nemocný poté zůstává 24 hodin na jednotce intenzivní péče a dalších několik dnů v nemocnici za účelem monitorování hemodynamiky, místa vpichu, poruch rytmu a ledvinných funkcí. ...
... The main advantages of TAVI is that the micro-invasive TAVI procedures have diminished invasiveness compared to minimally-invasive procedures, and can be performed on the live, beating heart without the need for extracorporeal circulation or cardiopulmonary bypass nor aortic cross clamp. This renders TAVI favorable than MHV and BHV prostheses as it overcomes the requirement for temporary cardiac arrest, and improves patient recovery time (20). Another advantage of TAVI is that the micro-invasive procedures (commonly the transfemoral approach) can be conducted in a completely percutaneous fashion and with local anesthesia only, whereas minimally invasive approaches (such as mini-sternotomy or mini-thoracotomy) for conventional heart valve prostheses necessitate skin incision and general anesthesia (17). ...
Prosthetic heart valves have been commonly used to address the increasing prevalence of valvular heart disease. The ideal prosthetic heart valve substitute should closely mimic the characteristics of a normal native heart valve. Despite the development of various interventions, an exemplary valve replacement does not exist. This review provides an overview of the novel engineering valve designs and explores emergent immunologic insights into age-dependent structural valve degeneration (SVD).
... 4 Thus, PVR is usually present immediately after the THV expansion between the THV and the native calcified AV and annulus. Overall, mild PVR is a common finding after TAVR, ranging from 20% to 80%, depending on the grading scheme, 5,6 whereas moderate and severe PVR occurs in 5% to 22% 7,8 of cases according to the type of THV. There is a dramatic decrease in the incidence of moderate or greater PVR with latest generation THVs. ...
Paravalvular regurgitation is a frequent complication after transcatheter aortic valve replacement and its association with worse outcomes depends on the degree of its severity. Despite substantial improvement in transcatheter heart valve design, sizing and implantation technique, moderate or severe paravalvular regurgitation still occurs in 2% to 7% of patients and is associated with a more than 2-fold increase in mortality. This review provides a state-of-the-art approach to (i) paravalvular regurgitation prevention by optimizing patient selection, valve sizing, and positioning and (ii) the detection, quantitation and management of paravalvular regurgitation during and after valve implantation.
... This allows a correct sizing and the selecion of the beter prosthesis. Angio CT-scan of aorto-iliac and femoral arteries is important for choosing the opimal vascular access (igure 4), i.e, femoral route or alternaive, such as the trans-axillary/subclavian access, which consisted in a surgical exposure of the proximal part of the transaxillary artery, showing clear advantage in hosile vessel anatomies [20][21][22][23] ; the trans-apical with surgical exposure of the let ventricular apex using customized introducer, balloon and device; and the last described approach, which is the trans-aoric one, requiring surgical access of the ascend- Figure 2. Muliplanar reconstrucion of a cardiac MSCT. The three planes are examined. ...
... The incidence of stroke varies and rate ranges from 0% to 10% in the published reports as the consequence of the learning curve, the evolution in technique, and equipment but also the completeness of neurologic assessment 6, 19-22 . Some authors have suggested that stroke risk might be lower with transapical access due to less manipulation within the aortic arch, but this has not been a universal finding 6,21 . In our series of transapical patients, we did not observe any stoke comparing to 3 cases (2 %) in the transfemoral group. ...
... The very first transapical TAVI, employing a 23-mm balloon-expandable device, the Edwards Sapien, was performed by Thomas Walther at the Leipzig Heart Center in December of 2004, and soon after was followed by a case in Frankfurt, Germany, both of which were fraught with sizing issues. The first successful series was then accomplished in Leipzig beginning in February 2006, its success owing to the availability of the 26-mm prosthesis [4], and was continued in a multicentre experience [5]. Further iterations of this promising concept included first-in-man implantations of THV in degenerated xenografts [6] and in redo patients [7]. ...
Over the past years, there has been a tremendous evolution of transcatheter aortic valve implantation (TAVI) that turned a novel revolutionary approach to a mature concept. Peri-procedural complications and mortality rates have markedly decreased; hence, TAVI became an integral component of the treatment strategy for patients with severe aortic stenosis and now is the preferred therapy in elderly patients with moderate to high or prohibitive operative risk. This successful development would not have been possible without the joint efforts of clinicians, scientists, engineers, and many others from around the world. In this context, Germany has been one of the forerunners in implanting transcatheter heart valves, as evidenced not only by the high numbers of procedures, but in particular by some individual pioneering achievements. Here, we picture German contributions in the field of TAVI that had impact on clinical practice, including first-in-man experience, CE mark trials, randomized studies, large registries, and other procedurally relevant aspects.
Background and aim of study
Transcatheter aortic valve replacement is established as the standard treatment for severe aortic stenosis. Many approaches have been described, including the suprasternal technique, an alternative for patients with unsuitable femoral arteries. We now describe a trocar‐free technique for the Suprasternal approach.
Methods and Results
Under endotracheal anesthesia, an incision is made above the manubrium and dissection is carried down to the innominate artery with adequate exposure for cannulation. Access site is closed with purse‐string suture. The Suprasternal approach has relatively few contraindications.
Conclusion
Our trocar‐free technique is a safe and easily reproducible technique for TAVRs in patients with poor femoral access.
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.
Background
Transcatheter aortic valve replacement (TAVR) is now an established treatment option for patients with severe aortic stenosis. The most utilized approach remains transfemoral. In patients with difficult femoral access a variety of alternate approaches have been used. Recently, suprasternal access has emerged as a viable alternate approach in patients with very complex vascular access. We describe our 30‐day outcomes of patients who underwent suprasternal transcatheter aortic valve replacement (suprasternal [SS]‐TAVR), which constitutes the largest single‐center cohort to date.
Methods
From May 2016 to September 2021, 658 patients underwent TAVR at our institution. Of which 29 underwent SS‐TAVR. We performed a retrospective analysis to evaluate early (30 days) outcomes of this procedure. Main outcomes evaluated included 30‐day mortality, stroke and pacemaker rates, length of stay, readmission, and valvular function.
Results
All patients were alive 30 days after the procedure. The median hospital length‐of‐stay was 2 days. Two patients (6.9%) had a stroke on the contra‐lateral side of access. Two patients (6.90%) had significant cardiac arrhythmias requiring pacemaker placement. In 30 days, one patient was readmitted (3.45%).
Conclusions
Our data confirm the SS‐TAVR as a feasible and safe alternative with comparable results to established approaches in patients who are unsuitable for femoral artery access and offers clinicians another access site in patients with very complex anatomy.
The collaborative interaction between pediatric interventional cardiologists and congenital heart surgeons has lead to the development of hybrid treatment strategies to optimize options and outcomes for the management of congenital heart defects. Percutaneous access to specific lesions is often limited and the hybrid approach allows for innovative access options to lesions which could otherwise not be managed via transcatheter techniques. In this chapter we summarize novel hybrid access approaches, ranging from arterial surgical cutdown to direct-intraoperative cardiac access, applied to neonates and adults with congenital heart disease.
Hypertension and diabetes are two of the leading causes of morbidity and mortality in the current world population, especially in Western societies. These two pathological conditions are key risk factors for the onset and progression of many cardiovascular diseases such as stroke, atherosclerosis, pulmonary hypertension, thrombosis, and heart failure. In general, hypertension and diabetes mellitus coexist in most patients with metabolic disorders. Both pathologies usually develop concomitantly or consecutively in the same individual due to different underlying pathophysiologic mechanisms that are shared between them. Some of these mechanisms include inadequate renin-angiotensin-aldosterone system activation, insulin resistance, dysfunctional immune response, inflammation, oxidative stress, abnormal sodium renal management, exacerbated sympathetic nervous system activation, and endothelial dysfunction, among others.
Paravalvular leak (PVL) has been shown to be a major complication of TAVR procedure. Recent studies have shown that moderate to severe PVL after TAVR significantly affects patients’ prognosis in a negative manner, and even mild PVL might be associated with increased long-term mortality. Therefore, in order to reduce the incidence of PVL during TAVR procedure, preoperative patient selection and preprocedural planning become very important. Most of the research has proven that some risk factors are highly correlated with PVL post-TAVR. Therefore, this chapter mainly introduces the predictive factors of PVL after TAVR and discusses how to apply recent novel techniques such as machine learning and deep learning to this issue, to help scientific researchers focus on the current situation of topic and future tendency.
Despite the evolution of device technology and increasing operator experience, vascular and bleeding complications remain a major source of perioperative morbidity and mortality, particularly in patients with peripheral arterial disease. These complications may be compounded with the use of large bore access sheaths for mechanical support, which may be required to be left in the vessels for a prolonged period of time. Through this article, the authors demonstrate the importance of assessment for peripheral arterial disease before insertion of large bore sheaths. They also describe various strategies to manage occlusive sheaths for distal reperfusion and percutaneous axillary artery access as an alternate option.
Objectives
Balloon postdilation (BPD) is one strategy for decreasing paravalvular leakage, but its effect on long-term mortality remains unclear. The authors sought to clarify whether BPD influences long-term mortality of patients with transcatheter aortic valve replacement (TAVR).
Design
Single-center retrospective study.
Setting
National heart center; single institution.
Participants
Participants were patients who underwent TAVR in the authors’ hospital from January 2014 to December 2016. A balloon-expandable Sapien XT or Sapien3, or self-expandable CoreValve or Evolute R, was implanted according to the decision of the surgeon considering degree of calcification of the aortic valve.
Interventions
No interventions.
Measurements and Main Results
Multivariate Cox regression analysis and inverse probability weighted estimation were performed using a propensity score to examine whether BPD influenced six-year mortality. Ultimately, 180 patients were analyzed. During the follow-up period, with a median of 1104 (interquartile range: 730-1463) days, 41 patients died and cumulative incidence of mortality at six years was 22.8%. Society of Thoracic Surgeons score (odds ratio [OR]: 2.257, 95% CI: 1.213-4.197, p = 0.010)], BPD (OR: 0.306, 95% CI: 0.098-0.953, p = 0.041), and paravalvular regurgitation of at least moderate-to-mild severity after deploying (OR: 5.407, 95% CI: 1.626-17.978, p = 0.006) were significant factors of mortality.
Conclusions
BPD is associated with reduced six-year mortality.
The ability of 3-D reconstruction has been a key element for the modern use of cardiovascular CT. Importantly, complex image reconstruction is performed by several users, including imaging specialist/radiologist and clinical interventionalist/surgeon. Imaging and image review/reconstruction are increasingly part of a stepwise decision-making process, transforming traditional single-observer reading and reporting to a process involving a team of interdisciplinary clinical specialists. This trend is observed in several subspecialties including oncology and cardiovascular medicine. These developments require a new level of data accessibility and performance of imaging systems, including ability to share data within large healthcare systems. It is supported by novel developments of IT architecture, allowing sharing of a centrally stored dataset between multiple peripheral workstations. Connection of scanners and workstations into a network or “cloud” with integration into the entire electronic health record (EHR) allows exchange of information across healthcare systems and supports multidisciplinary teams working on defined clinical workflows. These “cloud” systems are transforming clinical workflows, exemplified by the examples of acute aortic syndromes (AAS) and transcatheter aortic valve replacement (TAVR), where CT imaging has a central role. However, experience is limited, and further evaluation of the appropriate infrastructure including requirement for reliable patient identification between provider organizations and data safety is critical. Eventually the potential clinical impact needs to be evaluated in clinical trials.
Valvular heart disease is a major cause of morbidity and mortality worldwide. Surgical valve repair or replacement has been the standard of care for patients with valvular heart disease for many decades, but transcatheter heart valve therapy has revolutionized the field in the past 15 years. However, despite the tremendous technical evolution of transcatheter heart valves, to date, the clinically available heart valve prostheses for surgical and transcatheter replacement have considerable limitations. The design of next-generation tissue-engineered heart valves (TEHVs) with repair, remodelling and regenerative capacity can address these limitations, and TEHVs could become a promising therapeutic alternative for patients with valvular disease. In this Review, we present a comprehensive overview of current clinically adopted heart valve replacement options, with a focus on transcatheter prostheses. We discuss the various concepts of heart valve tissue engineering underlying the design of next-generation TEHVs, focusing on off-the-shelf technologies. We also summarize the latest preclinical and clinical evidence for the use of these TEHVs and describe the current scientific, regulatory and clinical challenges associated with the safe and broad clinical translation of this technology.
Introduction
The establishment of transcatheter aortic valve implantation (TAVI) has revolutionized the treatment of severe aortic stenosis. However, with TAVI being approved for low-risk patients, valve durability is becoming of central importance. Here, we summarize how tissue engineered heart valves (TEHVs) may provide a clinically-relevant durable valve replacement compatible with TAVI.
Areas covered
Since its introduction, TAVI prostheses have advanced in design and development. However, TAVI bioprostheses are based on fixed xenogeneic materials prone to progressive degeneration. Transcatheter TEHVs may have the potential to overcome the drawbacks of current TAVI bioprostheses, with their remodeling, self-repair, and growth capacities. So far, performance and remodeling of transcatheter TEHV with in-situ regenerative potential were demonstrated in the low-pressure system, with acute performance proved in the systemic circulation. However, several challenges remain to be solved to ensure a safe clinical translation of TEHVs for TAVI approaches.
Expert opinion
With TAVI rapidly evolving, the establishment of long-term valve durability represents the top priority to reduce the rate of patient re-interventions, remove the associated risks and adverse events, and improve patients’ life quality worldwide. With long-term performance and remodeling proved, TEHVs may represent the next-generation technology for a life-long TAVI prosthesis.
Background
No reports to date have assessed the procedural patterns of high-intensity transient signals (HITS) by monitoring blood flow in cervical arteries. The aim of this study was to examine the sequential distribution of HITS in each procedural phase and predictive factors for HITS during transcatheter aortic valve implantation (TAVI) by monitoring blood flow in the common carotid artery.
Methods
This prospective observational study included 73 patients who underwent TAVI via the transfemoral artery approach. We continuously evaluated and analyzed HITS from administration of heparin to valve implantation.
Results
HITS peaked during balloon valvuloplasty (BAV), amounting to almost 30% of the total HITS count, followed by valve implantation [BAV 141 (73–186) and valve implantation 86 (64–126), respectively]. In univariate and multivariate analysis, the Agatston score of the aortic valve and low-density lipoprotein were confirmed as independent predictors of HITS frequency with logarithmically converted coefficients of 0.00015 (p < 0.001) and 0.0032 (p = 0.027), respectively.
Conclusions
These results provide the first evidence that micro-emboli deriving from calcified burden were scattered primally during BAV, followed by valve implantation. The Agatston score may be a predictor for the amount of HITS.
Initially, transcatheter aortic valve replacement (TAVR) was only used in patients with severe symptomatic aortic stenosis and prohibitive risk for surgical aortic valve replacement. Subsequently, TAVR was extended to patients with high and intermediate surgical risk. Recently, the results of randomized trials in low-surgical-risk patients showed superiority or noninferiority of TAVR versus surgical aortic valve replacement in this population. Procedural outcomes have been improved. Long-term durability of transcatheter heart valves remains to be confirmed. This article presents the evolution and current status of TAVR, with respect to the different types of devices and procedures as well as its outcomes.
Background:
In patients who are not suitable for traditional access routes for transcatheter aortic valve replacement (TAVR) due to severe peripheral vascular disease (PVD) or prohibitive surgical risk, carotid artery (CA) access is an emerging route for TAVR. This study represents the most up to date on outcomes of carotid access TAVR.
Methods:
A systematic review was conducted as per the Preferred Reporting Instructions for Systematic Reviews and Meta-analysis (PRISMA). We performed a thorough electronic search through Pubmed, SCOPUS and Embase databases. Statistical analyses were performed using SPSS version 24 (IBM Corporation, Armonk, New York, USA).
Results:
A total of 15 non-randomized studies were included in this systematic review comprising of patients that received TAVR via 4 vascular access sites, transcarotid (TC) (N = 1035), transfemoral (TF) (N = 1116), transapical (TAP) (N = 307), transaortic (TAO) (N = 176) and transaxillary (TAX) (N = 90). In the Transcarotid cases, device success was achieved in 95.6% of patients (n = 748). The 30-day and 1-yr mortality was 4.2% and 10.5% respectively. 15.3% of patients required new pacemaker implantation. In-hospital stroke or TIA occurred in 4% of cases. 30-day stroke or TIA occurred in 5% of cases. There were no hemorrhagic strokes. 30-day Mortality was significantly higher in the Transaortic group (12.1%) compared to the Transcarotid group (2.6%) [RR = 2.93 95% CI = 1.15-7.58; p = 0.027]. There were no differences in outcomes between the Transcarotid group and the Transapical or Transaxillary groups.
Conclusion:
The most contemporary data on Carotid access TAVR shows impressive device success, low rates of stroke and pacemaker implantation and an acceptable 30-day and 1-year mortality. 30-day mortality was significantly lower in TC compared to TAO patients.
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.
In the early and mid-1990s the idea of transcatheter aortic valve implantation (TAVI) was mooted by several scientists. Anderson and Cribier developed balloon-expandable TAVI systems, and Figulla and Laborde later developed self-expandable systems, because it had become evident that aortic balloon valvuloplasty did not create durable results. Skeptical views of these systems by surgical colleagues and the industry delayed the rapid development of this disruptive new therapy until 2002, when Alain Cribier demonstrated, for the first time, the proof of his concept of TAVI. However, bulky devices and paravalvular leaks in compassionate patients resulted in high mortality rates, and from 2005 onwards clinical trials of more sophisticated devices were able to demonstrate less patient risk, showing that the TAVI technology was equivalent to surgical aortic valve replacement. The employment of the transapical access route initiated the heart team approach with surgical colleagues; however, this access route is no longer common, owing to its greater trauma compared with ?. The need to also treat aortic regurgitation is addressed by the “clipping technology” of the JenaValve, and ongoing clinical trials are investigating extended indications for TAVI at an earlier stage of aortic stenosis or in patients with a reduced ejection fraction, and the safety and efficiency of TAVI for these indications is being compared with ? in low-surgical-risk patients.
In the early 1990s, the idea of Transcatheter Aortic Valve Implantation (TAVI) emerged from clinicians by the insight that the long-term hemodynamic and clinical results of aortic balloon valvuloplasty to treat aortic stenonosis were not satisfying. Thus, Anderson and Cribier developed the balloon-expandable and Figulla and Laborde the self-expendable TAVI systems. Sceptical views by the surgical colleagues and the industry delayed the rapid development of this disruptive new therapy until 2002, when Alain Cribier demonstrated for the first time the proof of his concept. Bulky devices and paravalvular leakages in patients treated in terms of compassionate care resulted in high mortality rates. From 2005 onwards, the treatment of patients not at highest risk using smoother devices in clinical trials could demonstrate that the technology was equivalent to surgical aortic valve replacement. The transapical access route initiated the heart team approach with the surgical colleagues, however, this access route is presently expiring due to its greater trauma. The need to treat also aortic regurgitation is addressed by the "clipping technology" of JenaValve™. Ongoing clinical trials investigate an extended indication for TAVI at an earlier stage of aortic stenosis, or in reduced ejection fraction, and just demonstrated the safety and efficiency even in low surgical risk patients.
Femoral and radial artery access continue to be the standard of care for percutaneous coronary interventions. Cardiac catheterization has progressed to encompass a wide range of diagnostic and interventional procedures including coronary, peripheral, endovascular, and structural heart disease interventions. Despite advanced technology to make these procedures safe, bleeding, and vascular complications continue to be a substantial source of morbidity, especially in patients undergoing large‐bore access procedures. New variations of percutaneous devices have reduced complications associated with these procedures. However, safe vascular access with effective hemostasis requires special techniques which have not been well described in the literature. Large‐bore femoral artery access is feasible, safe, and associated with low complication rates when a protocol is implemented. Wayne State University, Detroit Medical Center Heart Hospital is a tertiary care, high‐volume center for endovascular, structural heart and complex high risk indicated procedures with more 150 procedures involving mechanical circulatory support (MCS) devices per year. In this manuscript, we describe our approach to femoral artery large‐bore sheath insertion and management. Our protocol includes proper identification of the puncture site, device selection, insertion, assessment of limb perfusion while on prolong MCS support, and hemostasis techniques after sheath removal.
Aim:
The aim of our study is to show the importance of multislice computed tomography (CT) assessment in the overall management and diagnostic framework of transcatheter aortic valve replacement (TAVI) procedure candidates.
Methods:
Between June 2015 and April 2017, 200 patients with severe aortic stenosis, not eligible for surgery, were enrolled, as defined by EuroSCORE; they were submitted to TAVI at the interventional cardiology department of the Tor Vergata Polyclinic. CT studies were performed using a 64-slice scanner.
Results:
The reports and datasets produced during the pre-TAVI CT evaluation were retrospectively evaluated.
Discussion:
In TAVI candidates, accurate aortic valve shape and dimensions evaluation is crucial for the proper deployment of the prosthetic valve and in order to reduce postprocedural complications. ECG retrospective gated cardiac CT gives the clinician three-dimensional images of the heart, with high spatial resolution and multiplanar reconstructions allowing accurate visualization of the aortic annulus and coronary ostia to be obtained, and the evaluation of arterial calcifications. Furthermore, CT can provide data on the suitability of peripheral vascular accesses. Moreover, this technique can point out the presence of clinically relevant extracardiac findings. Therefore, CT evaluation assures a safe, reliable and prognostically relevant method for TAVI preprocedural planning.
Conclusion:
Our study remarks the importance of CT assessment in the overall management and diagnostic framework of TAVI candidates; the information provided is essential in order to minimize possible complications and to improve the quality of the therapeutic planning.
The review provides the current state and benefits of the computational fluid dynamics (CFD) applications in cardiovascular surgery. The review covers the milestones of CFD and novel achievements in the development of both numerical algorithms and computational models. Basic methods of flow modeling, including immersed-boundary methods and finite-difference methods, allow solving most core tasks, even using commercially available software packages. Future research prospects of CFD are associated with detailed modeling of the pathological processes affecting functional properties of medical devices, namely thrombus formation and embolism. However, current computational and mathematical systems are limited to address fully all these processes.
Ein Hybrid-OP ermöglicht es, differenzierte radiologische Diagnostik und minimalinvasive Interventionen mit den Optionen klassischer offener Chirurgie zu kombinieren. Dazu ist ein Hybrid-OP mit einer Angiographieanlage sowie weiteren bildgebenden Großgeräten ausgestattet. Der Standort eines Hybrid-OP befindet sich häufig außerhalb bzw. am Rand des eigentlichen OP-Bereichs. Die Möglichkeit, im gleichen OP sowohl minimalinvasiv, interventionell als auch klassisch offen operieren zu können, führt dazu, dass beide chirurgischen Verfahren zu einem Hybrideingriff kombiniert werden. Typische Einsatzgebiete eines Hybrid-OP sind neben Kardio‑, Thorax- und Gefäßchirurgie auch Neurochirurgie und Neuroradiologie sowie Orthopädie und Traumatologie. Der kathetergestützte Ersatz der Aortenklappe (TAVI) ist ein deutlich weniger invasives Verfahren als der herkömmliche, klassisch-chirurgische Ersatz der Aortenklappe und eignet sich besonders für ältere Patienten jenseits von 75 Jahren mit entsprechend ausgeprägter Komorbidität. Viele gefäßchirurgische Eingriffe, die früher konventionell chirurgisch durchgeführt wurden, können mittlerweile komplett oder teilweise durch endovaskuläre, kathetergestützte Eingriffe versorgt werden. Als besonders vorteilhaft für die endovaskuläre Versorgung von thorakalen oder abdominalen Aneurysmen hat sich die Möglichkeit erwiesen, unter Lokalanästhesie den proximal des Aneurysmas liegenden Teil der Aorta mit einem Dilatationsballon blockieren zu können und so die Blutungsgefahr kontrollieren zu können. Fortschritte in der Bildfusion und intraoperativen Navigation erhöhen zunehmend die Akzeptanz von Hybrid-OP in den Bereichen Orthopädie/Traumatologie. Die komplexe Versorgung von Hochrisikopatienten an einem dezentralen Standort stellt eine besondere Herausforderung an die Anästhesie dar.
The Hancock II bioprosthesis (HII) has several design features designed to increase its durability. The study aim was to determine very long-term outcomes for the HII valve in a large patient population.
Long-term follow up was obtained by mail and/or telephone questionnaire of patients undergoing HII valve replacement surgery between 1982 and 2001 (n = 1,569). Follow up was complete on 1,568 patients (99.9%), and ranged from 0 to 250 months.
Isolated aortic valve replacement (AVR) was performed in 1,010 patients and mitral valve replacement (MVR) in 559. The average (+/- SD) age of patients was 67 +/- 11 years, and 65% were males. Long-term death occurred in 445 AVR patients and 275 MVR patients, of which 11% and 17%, respectively, were valve-related. Twenty-year freedom from thromboembolism (all results actuarial) was 79 +/- 3% after AVR and 83 +/- 3% after MVR; freedom from endocarditis was 91 +/- 5% and 85 +/- 5%, respectively. Twenty-year freedom from structural valve deterioration (SVD) was 73 +/- 16% and 39 +/- 9% in AVR patients aged > or = 65 years and < 65 years, respectively. Similarly, 20-year freedom from SVD was 59 +/- 11% and 27 +/- 9% in MVR patients aged > or = 65 years and < 65 years, respectively. When actual statistical techniques were applied (cumulative incidence), 20-year actual risk of SVD was 18 +/- 3% in all AVR patients and 23 +/- 3% in all MVR patients. Reoperation was required in 72 AVR patients, and was valve-related in 60. A total of 49 MVR patients underwent reoperation; 48 of these were valve-related.
The Hancock II bioprosthesis continues to show very good long-term results and durability, particularly in patients aged over 65 years.
The aim of this study was to assess the influence of valve substitute (homograft vs prosthetic valve) on the long-term survival and late valve-related complication rates following aortic valve replacement in patients with aortic valve disease and congestive heart failure.
The effect of choice of valve substitute on outcome after aortic valve replacement in patients with pre-operative heart failure is unknown. The superior haemodynamic profile of homografts may be of particular benefit.
We retrospectively analysed pre-operative, operative and follow-up data on 518 adults in functional classes III and IV, who, over the 25 years 1969-1993, had their initial aortic valve replacement at Harefield hospital. Follow-up conducted during 1996 to April 1997 and totalling 4439 patient-years was 96.1% complete. Using multivariate analysis, independent risk factors for different complications and mortality were defined.
Overall 5-, 10- and 20-year survival was 80+/-2%, 62+/-2% and 30+/-3%, respectively, with no significant difference between valve types. However, homografts (n=381) independently reduced the rate of serious complications and cardiac death, whereas mechanical valves were an independent adverse risk factor for late mortality. The rates of anticoagulant-related bleeding and thromboembolism were increased by mechanical valves, whereas primary tissue failure was the main complication of homografts.
Long-term outcome of homograft aortic valve replacement in patients with congestive heart failure is acceptable, with a reduced rate of serious complications and cardiac death. Further improvements would be expected if the rate of primary tissue failure could be reduced.
Long-term stability of the hemodynamic performance of commercially available Carpentier-Edwards stented bovine pericardial aortic bioprostheses (Perimount RSR) is unknown. To anticipate the fate of this bioprosthesis, we examined its hemodynamic performance up to 17 years using echocardiographic studies in a Premarket Approval cohort.
Of 267 patients at four institutions in the Premarket Approval cohort, 85 had a total of 168 echocardiographic studies during a 17-year period of yearly follow-up examinations. These were reviewed and quantified in a core echocardiographic facility. Longitudinal data analysis was used to account for repeated, censored data.
Mean transvalvular gradient was inversely related to prosthesis size (p = 0.01), and possibly (p = 0.06) increased somewhat during the first 10 years of follow-up, then stabilized. Effective orifice area was larger in larger valve sizes (p = 0.01), declined somewhat during the first 10 years, and then began to increase again. Ejection fraction declined minimally (p = 0.2). In contrast to the rather stable hemodynamics, aortic regurgitation steadily increased from none to 1 to 2+ (p = 0.005), but rarely (< 10% at 17 years) progressed to 3+ or 4+.
The Carpentier-Edwards aortic pericardial bioprosthesis can be anticipated to have an acceptable long-term transvalvular gradient and effective orifice size that will change trivially up to 17 years after implantation. Mild aortic regurgitation will develop progressively. This anticipated hemodynamic resilience supports continued clinical use of the Perimount Carpentier-Edwards bovine pericardial stented bioprosthesis.
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.
This study was undertaken to quantify the relationship between prosthesis size adjusted for patient size (prosthesis-patient size) and long-term survival after aortic valve replacement.
Data from nine representative sources on 13,258 aortic valve replacements provided 69,780 patient-years of follow-up (mean 5.3 +/- 4.7 years), with reliable survival estimates to 15 years. Prostheses included 5757 stented porcine xenografts, 3198 stented bovine pericardial xenografts, 3583 mechanical valves, and 720 allografts. Manufacturers' labeled prosthesis size was 19 mm or smaller in 1109 patients. Expressions of prosthesis-patient size assessed were indexed internal prosthesis orifice area (in centimeters squared per square meter of body surface area) and standardized internal prosthesis orifice size (Z, the number of SDs from mean normal native aortic valve size). Multivariable hazard domain analysis with balancing score and risk factor adjustment quantified the association of prosthesis-patient size with survival.
Prosthesis-patient size down to at least 1.1 cm(2)/m(2) or -3 Z did not adversely affect intermediate- or long-term survival (P >.2). However, 30-day mortality increased 1% to 2% when indexed orifice area fell below 1.2 cm(2)/m(2) (P =.002) or standardized orifice size fell below -2.5 Z (P =.0003). The increased early risk affected fewer than 1% of patients receiving bioprostheses but about 25% of those receiving mechanical devices.
Aortic prosthesis-patient size down to 1.1 cm(2)/m(2) or -3 Z did not reduce intermediate- or long-term survival after aortic valve replacement. However, patient-prosthesis size under 1.2 cm(2)/m(2) or -2.5 Z was associated with a 1% to 2% increase in 30-day mortality. Prosthesis-patient sizes this small or smaller were rarely implanted in patients receiving bioprostheses.
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 aim of the present study is to evaluate a new self-expanding valved stent design for minimal invasive aortic valve implantation and its interference with coronary flow.
An equine pericardial valve mounted onto a self-expanding nitinol stent (3F Therapeutics trade mark, CA, USA), outer diameter 23 mm, was evaluated (A) in vitro in a dynamic pulsatile mock loop and (B) in vivo in six calves (75+/-2.5 kg). In four animals valve stents were implanted on-pump and in two animals off-pump after induction of ventricular fibrillation. Target site for deployment was the orthotopic aorta, over the native valves. In vivo assessment was performed with intracardiac (AcuNav) and intravascular ultrasound including leaflet motion, planimetric valve orifice and residual-coronary\sinus-stent-index (RCSSI, distance stent to aortic wall/coronary diameter) calculations, coronary blood flow characteristics, transvalvular gradient, regurgitation and paravalvular leaking, in combination with continuous cardiac output measures. Macroscopic analysis was performed at necropsy.
Two-dimensional intracardiac ultrasound showed good leaflet motion, with full valvular opening and closing in five of six valves. Planimetric valve orifice was 1.75+/-0.4 cm(2). There were no signs of coronary flow impairment with an RCSSI of 1.8+/-1.2. The implanted valved stents showed a low transvalvular gradient of 5.3+/-3.9 mmHg (mean, peak-to-peak) on invasive measurements and 4.7+/-2.5 mmHg in two-dimensional intracardiac sonography. One of six valves showed mild to moderate regurgitation and one of six valves a minor to moderate paravalvular leak due to size mismatch.
This new self-expanding valved stent design allows for on- and off-pump aortic valve implantation in the orthotopic aorta, over the native valves without interference of the coronary blood flow and excellent acute valve function in properly sized devices.
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.
To validate the use of simultaneous intracardiac and intravascular ultrasound (IVUS) guidance for periprocedural dimension assessment, Residual-Coronary/Sinus-Stent Index (RCSSI) estimation, target site identification, deployment monitoring, and quality control of off-pump aortic Valved Stent implantation.
Five pigs (56+/-5 kg) underwent off-pump orthotopic aortic valve implantation using a custom-made self-expanding Valved Stent. Intracardiac ultrasound (AcuNav) was introduced via the right femoral vein. After left-sided thoracotomy, pursestring sutures were placed on the left ventricular apex. Following heparinization, a guidewire was inserted through the apex and advanced over the aortic valve under fluoroscopy. A wire-guided IVUS catheter transducer (6-F, 12.5-MHz) was inserted and the aortic target site identified. IVUS probe location was tracked with AcuNav, and measures of the aortic root were taken by both. After removal of the IVUS, the Valved Stent delivery system was introduced over the guidewire under fluoroscopy and AcuNav monitoring; the Valved Stent was deployed over the native valves. In vivo assessment included leaflet motion, planimetric valve orifice and RCSSI (stent to aortic wall distance/coronary diameter) calculations, coronary blood flow characteristics, transvalvular gradient, regurgitation, and paravalvular leaking in combination with continuous cardiac output measures. Macroscopic analysis was performed at necropsy.
IVUS dimensions of the aortic root were equal to AcuNav and necropsy dimensions. Both tools showed good valvular function, with full valvular opening and closing in 3 of 5 valves. At necropsy, the 3 aortic Valved Stents were safely anchored. One Valved Stent was placed supra-annularly; 2 dislodged into the left ventricle because of size mismatch. One Valved Stent showed a moderate to severe paravalvular leak.
Simultaneous intracardiac and intravascular ultrasound-guided off-pump orthotopic aortic Valved Stent implantation via left sided thoracotomy is feasible in an animal model. IVUS and intracardiac ultrasound allow adequate aortic dimension assessment and Valved Stent delivery monitoring, as well as postimplantation coronary flow evaluation.
Bioprostheses in heart surgery have been investigated in recent years to reduce the long-term anticoagulant administration associated with mechanical devices. Positive results have been achieved, particularly in elderly patients who have a supposed delayed fibrocalcification and reduced life expectancy. Herein are reported 17-year data on the ongoing long-term study of the Biocor porcine prosthetic heart valve, an improved bioprosthesis with reduced stiffness and improved flexibility of the valve cusps designed to resolve issues of reduced lifespan of previous biological valves.
Data were presented for 1,455 patients who underwent aortic valve replacement (AVR) or mitral valve replacement (MVR) in Sweden with glutaraldehyde-preserved Biocor bioprostheses between 1983 and 2000. Follow up after surgery was evaluated on alternate years using hospital records, interviews, questionnaires and the Cox regression model of multivariate analysis.
At 17 years, the cumulative follow up was 6,540 and 989 patient-years (pt-yr) for AVR and MVR, respectively. Late mortality accounted for 357 (28%) and 65 (38%) patients, respectively, and actuarial survival was 28.2% and 35.4%, respectively. Thromboembolic events occurred in 82 AVR (1.25%/pt-yr) and 18 MVR (1.82%/pt-yr) patients, respectively, with freedom from thromboembolism decreasing with age; 181 AVR and 44 MVR patients received anticoagulants. Reoperations due to structural valve deterioration (SVD) were required in 63 AVR and nine MVR patients. Freedom from reoperation due to SVD increased with age in both groups; actuarial freedom from reoperation was 73.9% and 81.3%, respectively.
Seventeen-year data confirm the low incidence of valve-related complications and improved valve durability reported at the 15-year follow up after both AVR and MVR using Biocor porcine bioprostheses.
Percutaneous aortic valve implantation has been performed in patients with severe aortic stenosis judged as nonsurgical candidates. We evaluated a facilitated transapical antegrade approach for potential use in surgical high-risk patients.
A pericardial xenograft fixed within a 23-mm stent (Cribier-Edwards aortic prosthesis, Edwards Inc., Irvine, CA, USA) was implanted using a transapical approach in fifteen 35-45 kg pigs. A limited or a full sternotomy was used to transapically introduce a crimped valve through a 24-F sheath. Deployments were performed on the beating heart either with ventricular unloading using femoro-femoral cardiopulmonary bypass (CPB) or rapid ventricular pacing (RVP), all under fluoroscopic and echocardiographic visualization.
All valves were successfully deployed at the target site with acceptable visualization of the noncalcified annulus. Valve migration occurred in six procedures (three distal and three retrograde) secondary to inadequate reduction of ventricular output, unfavorable annular anatomy, excessive crimping of the valve, and dislodgement by the delivery balloon. Exact positioning of the valve into the target area was confirmed by autopsy at the end of the procedures. Paravalvular leak was noted in five implants.
The transapical approach provides a safe, accurate, and effective route for facilitated antegrade delivery of a stent-fixed valve. Advanced stent design will lead to better stability of the implant and may minimize the risk of paravalvular leakage in future. Identifying the appropriate population for human feasibility trials remains a challenge.
The number of octogenarians is increasing in industrialized societies, and many patients aged over 80 years have heart valve disease which is amenable to surgical treatment. The perioperative outcomes and long-term results in very elderly patients undergoing valve surgery were evaluated.
A retrospective analysis was conducted of 2,791 patients with long-term follow up, who underwent valve surgery between 1990 and 2002. Of these patients, 132 (68 males, 64 females) were aged over 80 years (mean age 82 +/- 2 years; range: 80-94 years).
Ninety-five patients (71.9%) underwent aortic valve replacement, 36 (27.3%) mitral surgery, and one patient had double-valve surgery. Sixty-five patients (49.2%) required concomitant coronary artery bypass grafting. There were 11 (8.3%) redo procedures. Patients aged over 80 years were significantly more symptomatic preoperatively than their younger counterparts (NYHA class III-IV 90.9% versus 69.0%, p < 0.001), with more congestive cardiac failure, hypertension, peripheral vascular disease, obstructive pulmonary disease, and renal failure (all p < 0.05). Perioperative mortality did not, however, differ significantly between groups (< 80 years versus > or = 80 years, 2.9% versus 4.6%, p = 0.10). There was also no difference in the composite end point of in-hospital death, renal failure, stroke, low output state, myocardial infarction, or sternal wound infection (< 80 years versus > or = 80 years, 10.5% versus 11.4%, p = 0.8). The mean follow up period was 66 +/- 44 months (< 80 years) versus 61 +/- 37 (> or = 80 years). Late mortality was higher in the elderly group (10-year survival 37.9% versus 68.2%, p < 0.001) and preoperative atrial fibrillation (RR 2.75; CI: 1.44-5.23), coronary artery disease (RR 1.98; CI 1.12-3.52) and congestive cardiac failure (RR 2.13; CI: 1.10-4.11) were independent predictors of late mortality. The groups did not differ with respect to long-term valve-related events, with the exception of fewer reoperations among elderly patients.
Valve surgery in selected octogenarians is associated with low morbidity and mortality. The outlook after surgery is very good, and surgery should not be denied to this group on the basis of age alone.
The aim of this study was to evaluate the impact of patient prosthesis mismatch (PPM) and additional risk factors on outcome after aortic valve replacement (AVR).
Four thousand one hundred and thirty-one patients who were operated between May 1996 and April 2004 were evaluated. One thousand eight hundred and fifty-six patients received bileaflet mechanical AVR and 2275 stented xenograft AVR. PPM was defined as severe if manufacturers effective orifice area (EOA) divided by body surface area (BSA) was <0.65 cm(2)/m(2) and as moderate in the range of 0.65-0.85 cm(2)/m(2). PPM, age, gender, EOA index, emergency indication for surgery (within 24h), EuroSCORE as well as requirement for additional procedures were tested. Univariate (Fisher's exact test) and multivariate logistic regression analysis as well as survival analysis (Kaplan-Meier) were performed.
Severe PPM was present in 97 (2.4%) and moderate PPM in 1103 (26.7%) patients. PPM occurs more frequently with xenograft AVR. In-hospital mortality was 5.2% for severe, 10.6% for moderate and 6.9% with no PPM (p=0.018, OR 1.4). Moderate PPM was independently predictive for short- and long-term mortality. Further analysis revealed patient age >70 years (n=1589, p=0.002, OR 1.85), emergency indication (n=374, p<0.001, OR 4.4), EuroSCORE >10 (n=494, p<0.001, OR 4.7) and additional cardiac procedures (n=2049, p<0.001, OR 2.0) as predictors for adverse outcome after AVR.
Severe PPM is rare; moderate PPM is present in a quarter of patients. PPM has a significant impact on short- and long-term mortality after AVR.
Percutaneous aortic valve implantation has recently been performed in nonsurgical patients with severe aortic stenosis. Retrograde valve delivery has been problematic because of the size of the delivery system and concomitant peripheral vascular disease. We investigated a minimally invasive approach through the left ventricular apex for antegrade placement of a device-deliverable valve.
Transapical aortic valve implantation was performed using a 23-mm equine valve mounted on a stainless steel stent in 24 swine (weight range, 35 to 45 kg). A limited or full sternotomy approach was used to access the apex of the heart. The crimped valve was introduced through a sheath in the left ventricular apex. Fluoroscopy and echocardiography were used for guidance. Deployments were performed on the beating heart either with ventricular unloading using femoral extracorporeal circulation or rapid ventricular pacing.
All valves were successfully delivered at the selected target site with acceptable visualization of the noncalcified aortic annulus. Valve migration occurred during eight deployments (two distal and six retrograde) secondary to persistent cardiac output, unfavorable annular anatomy, and dislodgement by the delivery catheter. Exact positioning of the nonmigrated valves at the aortic annulus was examined by necropsy of all animals at the end of the procedures. Paravalvular leak was noted in 14 of 18 (77.8%) valves remaining in situ.
The transapical approach was used for the successful antegrade placement of a stented valve, obviating the technical problems associated with a large delivery system transiting the peripheral vascular system. Stent design contributing to paravalvular leak remains problematic.
Aortic valve replacement with cardiopulmonary bypass is currently the treatment of choice for symptomatic aortic stenosis but carries a significant risk of morbidity and mortality, particularly in patients with comorbidities. Recently, percutaneous transfemoral aortic valve implantation has been proposed as a viable alternative in selected patients. We describe our experience with a new, minimally invasive, catheter-based approach to aortic valve implantation via left ventricular apical puncture without cardiopulmonary bypass or sternotomy.
A left anterolateral intercostal incision is used to expose the left ventricular apex. Direct needle puncture of the apex allows introduction of a hemostatic sheath into the left ventricle. The valve prosthesis, constructed from a stainless steel stent with an attached trileaflet equine pericardial valve, is crimped onto a valvuloplasty balloon. The prosthetic valve and balloon catheter are passed over a wire into the left ventricle. Positioning within the aortic annulus is confirmed by fluoroscopy, aortography, and echocardiography. Rapid ventricular pacing is used to reduce cardiac output while the balloon is inflated, deploying the prosthesis within the annulus. Transapical aortic valve implantation was successfully performed in 7 patients in whom surgical risk was deemed excessive because of comorbidities. Echocardiographic median aortic valve area increased from 0.7 +/- 0.1 cm2 (interquartile range) to 1.8 +/- 0.8 cm2 (interquartile range). There were no intraprocedural deaths. At a follow up of 87 +/- 56 days, 6 of 7 patients remain alive and well.
This initial experience suggests that transapical aortic valve implantation without cardiopulmonary bypass is feasible in selected patients with aortic stenosis.
The percutaneous treatment of valvular heart disease is rapidly progressing through clinical trials. For one valvular lesion, critical aortic stenosis, recent advances in technology and percutaneous techniques may potentially change the way in which we manage this disease in the most frail and elderly patients. Some of these new techniques blur the distinction between surgical and nonsurgical treatments. In this issue of Circulation , Lichtenstein and colleagues report the first series of patients to have an aortic valve implanted via a thoracotomy to expose the left ventricular apex, for subsequent sheath insertion, over-the-wire delivery system advancement, and image-guided implantation of a stent mounted equine crimped on a delivery balloon.1 This article is seminal in defining 2 major emerging issues: valvular heart disease treatments that are hybrids of surgical and catheter-based techniques and the challenges inherent in determining what treatment modalities are best in the growing problem of aortic stenosis in mature, ie, elderly, adults. This report adds to the recently published report from the St. Paul’s Hospital group in Vancouver using the retrograde percutaneous aortic valve (PAV) implantation technique.2
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Which patients will be appropriate for these new approaches to the treatment of aortic stenosis in the mature adult population? Timely assessment of the efficacy and safety of these techniques will be critical for patients, care providers, regulatory agencies, and insurers to evaluate for patient-specific decision making and healthcare policy.
The morbidity and mortality of surgical aortic valve replacement are increased in elderly patients with multiple high-risk comorbid conditions. Therefore, a prospective, single-center, nonrandomized study was performed in high-risk patients with aortic valve disease to evaluate the feasibility and safety of percutaneous implantation of a novel self-expanding aortic valve bioprosthesis (CoreValve).
Symptomatic high-risk patients with an aortic valve area <1 cm2 were considered for enrollment. CoreValve implantation was performed under general anesthesia with extracorporeal support using the retrograde approach. Clinical follow-up and transthoracic echocardiography were performed after the procedure and at days 15 and 30 after device implantation to evaluate short-term patient and device outcomes. A total of 25 patients with symptomatic aortic valve stenosis (mean gradient before implantation, 44.2+/-10.8 mm Hg) and multiple comorbidities (median logistic EuroScore, 11.0%) were enrolled. Device success and procedural success were achieved in 22 (88%) and 21 (84%) patients, respectively. Successful device implantation resulted in a marked reduction in the aortic valve gradients (mean gradient after implantation, 12.4+/-3.0 mm Hg; P<0.0001). The mean aortic regurgitation grade was unchanged. Major in-hospital cardiovascular and cerebral events occurred in 8 patients (32%), including mortality in 5 patients (20%). Among 18 patients with device success surviving to discharge, no adverse events occurred within 30 days after leaving the hospital.
Percutaneous implantation of the self-expanding CoreValve aortic valve prosthesis in high-risk patients with aortic stenosis with or without aortic regurgitation is feasible and, when successful, results in marked hemodynamic and clinical improvement.
To evaluate the feasibility of minimally invasive transapical beating heart aortic valve implantation (TAP-AVI) for high-risk patients with aortic stenosis.
TAP-AVI was performed via a small anterolateral minithoracotomy with or without femoral extracorporeal circulation (ECC) on the beating heart. A pericardial xenograft fixed within a stainless steel, balloon expandable stent (Cribier-Edwards, Edwards Lifesciences, Irvine, CA, USA) was used. Thirty consecutive patients (82 +/- 5.1 years, 21 (70%) female) were operated from 02/06 until 09/06 at one center using fluoroscopic and echocardiographic visualization. Average EuroSCORE predicted risk for mortality was 27 +/- 12%.
Valve positioning was successful in 29 patients and one required early conversion to full sternotomy. Implantation (8 mm x 23 mm and 22 mm x 26 mm valves) was performed on the beating heart during brief periods of rapid ventricular pacing. ECC was applied in 13 patients. Neither coronary artery obstruction nor migration of the prosthesis was observed and all valves displayed good hemodynamic function. Echocardiography revealed minor paravalvular leakage in 14 patients (trace in three, mild in nine and moderate in two). Three patients (10%) died, one on postoperative day (POD) three secondary to preoperative global myocardial failure and two on POD 18 and 86 due to abdominal complications.
Minimally invasive beating heart TAP-AVI is feasible. Initial results are encouraging in view of the high-risk profile of the patients. Long-term studies as well as randomized protocols are required.