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Closed heart surgery: back to the future. J Thorac Cardiovasc Surg
... Over the past 5 years, the development of minimally invasive transcatheter valve implantation has been explored. [2][3][4][5][6][7][8][9][10][11][12][13] Transarterial and transapical transcatheter aortic valve implantation (AVI) has been explored by cardiologists and cardiac surgeons worldwide. Many reports have shown favorable early clinical and echocardiographic outcomes with transarterial or transapical AVI. ...
... Many reports have shown favorable early clinical and echocardiographic outcomes with transarterial or transapical AVI. 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 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.
... Therapeutic options for these patients are limited, and neither medical therapy nor balloon valvuloplasty offers survival benefit (9). Minimally-invasive transcatheter aortic valve implantation (TAVI) has therefore been developed as a treatment alternative for this cohort of patients (10)(11)(12)(13)(14)(15)(16). Since the first reports of transfemoral TAVI (14) and the first successful transapical TAVI without CPB using the Cribier-Edwards balloon expandable valve (Edwards Lifesciences, Irvine, California, USA) in humans were reported in 2006 (15,16), there have been dramatic advances in TAVI technology and procedure (17)(18)(19)(20)(21)(22)(23)(24). ...
... Minimally-invasive transcatheter aortic valve implantation (TAVI) has therefore been developed as a treatment alternative for this cohort of patients (10)(11)(12)(13)(14)(15)(16). Since the first reports of transfemoral TAVI (14) and the first successful transapical TAVI without CPB using the Cribier-Edwards balloon expandable valve (Edwards Lifesciences, Irvine, California, USA) in humans were reported in 2006 (15,16), there have been dramatic advances in TAVI technology and procedure (17)(18)(19)(20)(21)(22)(23)(24). The clinical application of TAVI has also significantly broadened. ...
... În 1912 celebrul chirurg Theodore Tuffier (1857-1929), asistat de Carrel, a efectuat prima intervenţie pentru SAo: după toracotomie, au constatat că peretele aortei era foarte subţire; a invaginat peretele anterior al aortei, transvalvular, efectuând astfel, prima divulsie digitală a valvulei aortice, pe cord închis, pacientul supravieţuind peste 20 ani [9,10]. ...
... De asemenea, în aceeaşi perioadă W. Bigelow şi McQuiston studiază efectul hipotermiei în cursul intervenţiilor cardiace [7], iar Clarence Crafoord (1899-1984) publică în 1945 primele cazuri operate de coarctaţie de aortă [24]. Trebuie amintite şi intervenţiile pe cord de extragere a şrapnelelor şi proiectilelor ale medicului militar Dwight Harken, care raportează 134 de astfel de cazuri rezolvate cu succes [9,11,12]. ...
... 12 Recently, we reported a case in which the transarterial delivery system was used to implant an aortic valve via the apex of the left ventricle. 19,20 The present study describes our clinical experience and technique of prosthetic aortic valve implantation by direct left ventricular access using a beatingheart, catheter-based approach in humans. ...
... 12 It was anticipated that in such individuals aortic valve implantation using a left ventricular apical approach would have advantages. 19,20 Obviously, optimal positioning of the prosthetic valve is critical. In our early percutaneous implantation experience, we sought to position the midpoint of the prosthesis adjacent to the major leaflet calcification. ...
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.
... However, the severe disadvantages include a long and tortuous route from the femoral vein to the aortic valve, necessity to cross and dilate the atrial septum and the need to cross the mitral valve with the potential to induce acute mitral insufficiency by pushing against the anterior mitral leaflet. In high-risk patients the latter is often associated with severe reduction in cardiac output due to the creation of a high-grade mitral valve insufficiency [6]. ...
... The retrograde arterial approach requires retrograde crossing of the stenotic aortic valve and is limited to a lowprofile system (24F in diameter). Frequently it results in vascular trauma [6], especially in older patients with their high incidence of peripheral artery as well as atherosclerotic disease in the thoracic and abdominal aorta. ...
... In high-risk patients the latter is often associated with severe reduction in cardiac output due to the creation of a high-grade mitral valve insufficiency. 20 ...
... The retrograde arterial approach requires retrograde crossing of the stenotic aortic valve and is limited to a lowprofile system (24 F in diameter). Frequently it results in vascular trauma, 20 especially in older patients with their high incidence of peripheral artery as well as atherosclerotic disease in the thoracic and abdominal aorta. ...
Modern surgical treatment for aortic valve disease has undergone significant improvements in all areas of this procedure. Successful treatment strategies for cardiovascular diseases have often been initiated and driven by surgeons. Radical excision of diseased tissue, repair and replacement strategies lead to long-term successful treatment of the underlying diseases and clearly improved patient outcome. In highly developed nations, valve surgery will be increasing applied in older people, with more co-morbidities and a higher incidence of concomitant coronary artery disease. Cardiovascular surgeons will be facing increased competition from the catheter-based procedures; these are already applied clinically, and their numbers will rise in near future. Right now interventional cardiologists supported by some cardiac surgeons are on their way to transform some conventional open surgical procedures into catheter-based less invasive interventions, such as valve repair and replacement. Cardiovascular surgery is undergoing a rapid transformation; socio-economic factors and recent advances in medical technology contribute to these changes. Further developments will come, and surgeons with all their expertise in the treatment of valvular heart disease need to be part of it. Cardiovascular surgeons have to adapt the exciting new approaches of transapical and transfemoral transcatheter valve implantation techniques.
... Coronary artery disease (CAD) is one of the main causes of human mortality in the world and coronary artery bypass grafting (CABG) is the mainstay treatment method for CAD (1). Over the past 50 years, cardiopulmonary bypass (CPB) and open heart surgery have led to significant advances in surgical methods throughout the world (2). Although CABG with the help of CPB is a common method for treating CAD, this procedure causes multiple complications after surgery. ...
Implications of this study include 1) Reducing the length of stay of kidney patients undergoing heart surgery in the intensive care unit; 2) Satisfaction of kidney patients, especially those undergoing heart surgery; and 3) Reducing hospital costs and improve the quality of life of kidney patients undergoing heart surgery. Please cite this paper as: Alavi SM, Shahidi E, Sanadgol H , Ziyaeifard M , Bayesh SS, Foroutan M, Saberian M. The relationship between fluid balance and the incidence of post-operative acute kidney injury during and 24 hours after coronary artery bypass graft surgery. J Renal Inj Prev. 2021; 10(2): e11.
... 10,[17][18][19][20] However, it was not until a decade after it was initially proposed that the feasibility of percutaneous AVI was demonstrated in humans by Cribier et al 12,21 using a transvenous, transseptal approach. Subsequently, we described a retrograde procedure using percutaneous femoral artery access for transcatheter AVI. 14 We then further reported the first successful transcatheter, transapical AVI through a left minithoracotomy and the apex of the left ventricle without CPB in humans in 2006, 15,16 and our accumulated experience of transapical transcatheter AVI without CPB. [22][23][24] ...
... Our group's initial animal developmental work utilized direct balloon catheter implantation of an aortic valve through the left ventricular apex [12]. Recently, we reported the first successful case in which the transarterial delivery system was utilized to implant an aortic valve via the apex of the left ventricle without CPB in human [19,20]. Subsequently, we have reported our 1-month follow-up data in seven patients who underwent transapical transcatheter aortic valve implantation [21]. ...
The current treatment of choice for symptomatic aortic stenosis is aortic valve replacement (AVR) with cardiopulmonary bypass (CPB), but AVR is associated with significant operative morbidity and mortality in elderly patients with multiple co-morbid conditions. We recently reported the first successful aortic valve implantation procedure (AVI) via a mini-thoracotomy and left ventricular apical puncture without cardiopulmonary bypass. We now report 6-month follow-up in our initial seven patients.
Seven patients (77+/-10 years old) with symptomatic aortic stenosis were deemed to be non-surgical candidates for AVR and not suitable for a transfemoral percutaneous heart valve implantation due to aorto-iliac disease. The predicted 30-day operative mortality was 31+/-23% according to logistic Euroscore. Patients underwent minimally invasive transapical AVI. With the guidance of fluoroscopy and transesophageal echocardiography, balloon predilation was followed by deployment of a 26mm Cribier-Edwardstrade mark valve (Edwards Lifesciences Inc., Irvine, CA) during rapid ventricular pacing to reduce forward flow and cardiac motion.
Valve implantation was successful in all seven patients. There were no intra-procedural mortalities or complications. Thirty-day operative mortality was 14%. One patient died at day 12 due to pneumonia. Two patients died from non-cardiac diseases at day 51 and 85. The remaining four patients completed 6-month follow-up. The aortic valve area increased from 0.7+/-0.3 to 1.8+/-0.7 and 1.5+/-0.5cm(2) at 1 and 6 months, respectively. The mean transaortic gradient was reduced from 32+/-8 to 10+/-5 and 11+/-8mmHg at 1 and 6 months, respectively. Following AVI, none or trivial, mild, and moderate aortic regurgitation was observed in 4, 2, and 1 patients, respectively. There were no valve-related complications during the follow-up.
Aortic valve implantation can successfully be performed via a minimally invasive apical approach without the need for cardiopulmonary bypass. The early results in this initial series are encouraging. This initial experience suggests that the minimally invasive transapical approach is a viable alternative for patients in whom open-heart surgery is not feasible or poses unacceptable risks.
... In the pulmonary position, access is typically gained via the femoral vein [195], although transventricular pulmonary placement [205] has been advised in senescent patients when the RVOT is large and the valve and catheter size precludes traditional percutaneous placement. In the aortic position, the initial antegrade transseptal procedure via the femoral vein [206] was technically demanding encountering difficulties in accurately seating and deploying the device via this tortuous route (via an atrial septostomy, through the mitral valve and having to negotiate an acute curvature in the left ventricle). Therefore , the transseptal approach was subsequently abandoned for retrograde arterial placement [202,207]. ...
Prosthetic heart valves epitomize both the triumphant advance of cardiac surgery in its early days and its stagnation into a retrospective, exclusive first world discipline of late. Fifty-two years after the first diseased heart valve was replaced in a patient, prostheses largely represent the concepts of the 1960s with many of their design-inherent complications. While the sophisticated medical systems of the developed world may be able to cope with sub-optimal replacements, these valves are poorly suited to the developing world (where the overwhelming majority of potential valve recipients reside), due to differences in age profiles and socio-economic circumstances. Therefore, it is the latter group which suffered most from the sluggish pace of developments. While it previously took less than 7 years for mechanical heart valves to develop from the first commercially available ball-in-cage valve to the tilting pyrolytic-carbon disc valve, and another 10 years to arrive at the all-carbon bi-leaflet design, only small incremental improvements have been achieved since 1977. Similarly, bioprosthetic valves saw their last major break-through development in the late 1960s when formalin fixation was replaced by glutaraldehyde cross linking. Since then, poorly understood so-called 'anti-calcification' treatments were added and the homograft concept rediscovered under the catch-phrase 'stentless'. Still, tissue valves continue to degenerate fast in younger patients, making them unsuitable for developing countries. Yet, catheter-delivered prostheses almost exclusively use bioprosthetic tissue, thereby reducing one of the most promising developments for patients of the developing world into a fringe product for the few first world recipients. With tissue-engineered valves aiming at the narrow niche of congenital malformations and synthetic flexible leaflet valves being in their fifth decade of low-key development, heart valve prostheses seem to be destined to remain an unsatisfying and exclusive first world solution for a long time to come.
Aortic valve stenosis (AS) is the most common heart valve disease with a prevalence up to 3% of adults over the age of 75 years (Nkomo et al. 2006). One-third of US adults ≥65 years has aortic valve sclerosis and of these at least one-third will develop some degree of AS within 5 years (Faggiano et al. 2003; Otto et al. 1999). The natural history, diagnosis, and cellular mechanisms of this disease process have evolved over the past several decades. Over the last 10 years, the scientific progress in the field of calcific aortic valve stenosis has increased exponentially. A critical discovery in our understanding of calcification as the end-stage pathogenesis of a congenital bicuspid or normal tricuspid aortic valve is the osteogenic process (Rajamannan et al. 2003; Otto 2006; Rosenhek et al. 2000a). Progressive calcification of the leaflets usually leads to severe narrowing of the aortic valve orifice and fibrosis of the left ventricular wall, finally resulting in left ventricular outflow tract obstruction and severe aortic stenosis. After a prolonged asymptomatic period with low morbidity and mortality, the development of the classic triad of symptoms including: angina, syncope, or heart failure marks the critical point in the natural history of aortic valve disease. AS is a progressive disease and without intervening treatment associated with high morbidity and mortality rates within a few years of diagnosis (Horstkotte and Loogen 1988). Survival declines when a patient with AS develops angina or syncope, and is even more limited when the patient develops congestive heart failure. Because AS is a disease of the elderly, it can be difficult to distinguish the gradual decrease in physical functioning attributed to advanced age and multiple co-morbidities such as frailty, lung disease, neurological disease, and symptoms from the worsening AS disease. It is not uncommon that patients will lower their activity level below their symptom threshold, to accommodate to the progressive left ventricular outflow tract obstruction. This chapter will outline the studies in the field of diagnosis and the impact of the evolving science of clinical risk factors for calcific aortic valve disease to further understand the complexity of monitoring this disease process in this patient population.
Objective: To discuss the feasibility of balloon-dilated endovascular replacement of aortic valve for the treatment of severe aortic stenosis. Methods: Five patients with severe aortic stenosis were selected for this study. Preoperative evaluation of these patients' clinical conditions indicated that these five patients were unable to tolerate a traditional open cardiovascular surgery. Via femoral artery access balloon - dilated endovascular replacement of aortic valve was carried out in all the five patients. The results were analyzed. Results: The procedure was accomplished via femoral artery access in all the five patients. In one patient the operation was successfully finished with the auxiliary help of trans - cardiac apex puncturing. Technical success was achieved in all the five patients. After the operation the functioning of the aortic valve was greatly improved. Neither complications nor death occurred in all patients. Conclusion: Balloon-dilated endovascular replacement of aortic valve can be safely used for the treatment of severe aortic stenosis in Chinese patients, although more strict preoperative preparation, precise evaluation and careful management during operation are demanded.
A large number of scientific inventions evolved from research in different fields of interest. Only a few people with a visionary mind are able to see the future practical implications that transform a good idea into revolutionary process. For over 30 years the surgical replacement of a diseased aortic valve represented the golden standard of curative treatment for severe symptomatic aortic valve stenosis and significant regurgitation. Only recently has the operative risk declined crucially and the functional results are excellent. Long-term survival is very satisfactory, even for patients >80 years of age and has become close to that of non-operated patients of the same age. Despite these excellent results, surgery was found to be practiced preferentially in patients in good condition, whereas a substantial proportion of patients were not referred to surgery because the perioperative risk was estimated to be high owing to advanced age or significant comorbidities [1]. These patients would need an alternative technique to replace the diseased valve in order to re-establish normal valvular function. Recently, the development of two new techniques has changed the approach of patients considered to be at high risk of being refused conventional intervention: the insertion of a sutureless prosthesis and thus reducing substantially the surgery time and the transcatheter technique known as transcatheter aortic valve implantation (TAVI) allowing a tremendous decrease in the invasiveness of surgery. This new concept could profit from the already well-established method of cardiac catheterization.
Objective To discuss the feasibility of treating patients with severe aortic valve stenosis by aortic valve replacement via transfemoral balloon dilation. Methods Three patients with severe aortic valve stenosis, who could not tolerate traditional open surgery, were chosen to receive aortic valve replacement via transfemoral balloon dilation. Results All the three operations were successfully done by transfemoral approach, including one assisted by transapical puncture. The aortic valve function of patients was improved, and there was no related complication or death. Conclusion Aortic valve replacement via transfemoral balloon dilation can be used for treatment of Chinese patients with severe aortic valve stenosis; but which demands more detailed preoperative preparation, evaluation, and surgical manipulation.
Die Versorgung von degenerierten Herzklappen erlebt zurzeit in mehrfacher Hinsicht einen Wandel: Einerseits lässt die wachsende
Zahl von kardiovaskulären Erkrankungen, verbunden mit dem Altern der Bevölkerung, die Zahl der erkrankten Herzklappen ansteigen.
Andererseits erwächst mit der neuen Aufsehen erregenden Methode der Katheter gestützten Klappenimplantation am schlagenden
Herzen, deren vielversprechender Einsatz im Rahmen verschiedener klinischen Studien zur Zeit untersucht wird, eine Alternative
zur traditionellen offenen Herzklappenchirurgie. Offensichtlich stehen wir ganz am Anfang dieser grundlegenden Veränderungen.
Das vorliegende Kapitel will die Entwicklung der Katheter gestützten Aortenklappenimplantation bis zum heutigen Tag skizzieren,
eine Momentaufnahme aktueller Bestrebungen vermitteln und einen Ausblick wagen, durchaus im Bewusstsein, dass alle diesbezüglichen
Ideen, Meinungen und Entwicklungen gegenwärtig im Fluss sind.
There has been significant improvement in device designs, operative techniques, and early clinical outcomes in <5 years. Presently, there are two catheter-based bioprostheses (balloon expandable or self-expandable), which have been widely used in humans and are undergoing clinical investigations. Three approaches, including transvenous, transarterial, and transapical have been used for delivery of the catheter-based bioprostheses, and transarterial and transapical approaches have been adopted by cardiologists and cardiac surgeons worldwide. The most recent clinical results have been very encouraging and promising. With experience, 30-day operative mortality with either balloon-expandable or self-expandable bioprosthesis was reduced significantly to approximately 10% in high-risk patients. In vivo long-term durability of catheter-based bioprostheses remains unknown, and presently transcatheter procedure is limited to the cohort of high-risk patients. Expanding this new technology to low-risk patients should be done with extreme caution because conventional aortic valve replacement still provides the best long-term outcome with minimal operative mortality and morbidity in low-risk patients. Ongoing clinical trials will address many unanswered questions, such as patient selection, long-term in vivo durability, preoperative assessment, and the role of the procedures in management of valvular diseases.
Transcatheter aortic valve implantation (TAVI) has developed in less than 2 decades to be a viable procedure, carving out a niche position in our armamentarium to treat high-risk patients with aortic valve disease. Rapid advances are occurring in prosthesis design, catheter delivery system, imaging, and the hybrid operating room.
The PARTNER (Placement of AoRTic traNscathetER valve) randomized trial, cohort B confirms the superiority of the transfemoral TAVI compared with standard medical therapy with regard to overall survival and cardiac functional status. Major stroke and vascular complications, however, remain higher in the transfemoral TAVI group. Large European registries of both the transapical and transfemoral TAVI are reporting improved procedural success and early survival. The CoreValve and SAPIEN valves remain the forerunners, with accumulating evidence for use, and published 3-year prosthesis durability data for the latter.
Evidence is accumulating in support of TAVI for high-risk nonoperative aortic stenosis. Even before the PARTNER cohort A results, comparing TAVI and conventional aortic valve replacement, become available, the next generation devices and technological improvements are well underway to make the procedure even more reproducible.
We reported the first case of successful transapical transcatheter aortic valve implantation in a human subject in 2005 and have now completed a 12-month follow-up on our first 26 patients. This is, to date, the longest follow-up of patients undergoing transapical aortic valve implantation.
Between October 2005 and January 2007, 26 patients (13 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 because of unacceptable operative risks and were not candidates for transfemoral aortic valve implantation because of poor arterial access. Clinical and echocardiographic follow-up was performed before discharge and at 1, 6, and 12 months. Data from the 17 patients who survived over 12 months were used for comparisons of the baseline and follow-up results.
The mean age was 80 +/- 9 years, and the predicted operative mortality was 37% +/- 20% by using logistic EuroSCORE and 11% +/- 6% by using the Society of Thoracic Surgeons Risk Calculator. Valves were successfully implanted in all patients. Six patients died within 30 days (30-day mortality, 23%), and 3 patients died from noncardiovascular causes after 30 days (late mortality, 12%). Among patients who survived at least 30 days, 12-month survival was 85%. There were no late valve-related complications. New York Heart Association functional class improved significantly. The aortic valve area and mean gradient remained stable at 12 months (1.6 +/- 0.3 cm(2) and 9.6 +/- 4.8 mm Hg, respectively).
Our 1-year clinical and echocardiographic outcomes suggest that transapical transcatheter aortic valve implantation is a viable alternative to conventional aortic valve replacement in selected high-risk patients.
(J Card Surg 2007;22:18-19)
The incidence of valvular heart disease is expected to increase over the next several decades as a large proportion of the US demographic advances into the later decades of life. At the same time, the next several years can be anticipated to bring a broad transition of surgical therapy to minimally invasive (minithoracotomy and small port) access and the more gradual introduction of percutaneous approaches for the correction of valvular heart disease. Broad acceptance of these technologies will require careful and sometimes perplexing comparisons of the outcomes of these new technologies with existing standards of care. The validation of percutaneous techniques, in particular, will require the collaboration of cardiologists and cardiac surgeons in centers with excellent surgical and catheter experience and a commitment to trial participation. For the near term, percutaneous techniques will likely remain investigational and will be limited in use to patients considered to be high risk or to inoperable surgical candidates. Although current-generation devices and techniques require significant modification before widespread clinical use can be adopted, it must be expected that less invasive and even percutaneous valve therapies will likely have a major impact on the management of patients with valvular heart disease over the next several years.
Among 646 patients with pure aortic stenosis who underwent valve replacement at our institution between 1981 and 1985, the three most frequent causes were calcification of congenitally bicuspid aortic valves (38%), degenerative (senile) calcification of tricuspid aortic valves (33%), and postinflammatory (presumably rheumatic) calcification and fibrosis (24%). Among the 324 patients younger than 70 years of age, calcified bicuspid valves were observed in 50%. In contrast, among 322 patients 70 years of age or older, degenerative calcification accounted for 48% of the stenotic aortic valves. During the 5 years of the study, the relative frequency of postinflammatory disease decreased from 30% to 18%, and that of bicuspid valves decreased from 37% to 33%. In contrast, the relative frequency of degenerative calcification increased from 30% to 46%. Consequently, degenerative (senile) calcification is currently the most common cause of aortic stenosis among patients undergoing valve replacement at our institution. This finding may be related to changes in life expectancy in the general population, alterations in patient referral practices, and an increased willingness of surgeons to operate on older patients. Regardless of cause, the observed temporal changes in etiologic factors for aortic stenosis may indicate a potential source of increasing health-care costs among the elderly population.
Atherosclerotic disease of the aortic arch has been suspected to be a potential source of cerebral emboli. We conducted a study to quantify the risk of ischemic stroke associated with atherosclerotic disease of the aortic arch.
Using transesophageal echocardiography, we performed a prospective case-control study of the frequency and thickness of atherosclerotic plaques in the ascending aorta and proximal arch in 250 consecutive patients admitted to the hospital with ischemic stroke and 250 consecutive controls, all over the age of 60 years.
Atherosclerotic plaques > or = mm in thickness were found in 14.4 percent of the patients but in only 2 percent of the controls. After adjustment for atherosclerotic risk factors, the odds ratio for ischemic stroke among patients with such plaques was 9.1 (95 percent confidence interval, 3.3 to 25.2; P < 0.001). Among the 78 patients who had brain infarcts with no obvious cause, 28.2 percent had plaques > or = 4 mm in thickness, as compared with 8.1 percent of the 172 patients who had infarcts whose possible or likely causes were known (odds ratio, 4.7; 95 percent confidence interval, 2.2 to 10.1; P < 0.001). Plaques of > or = 4 mm in the aortic arch were not associated with the presence of atrial fibrillation or stenosis of the extracranial internal carotid artery. In contrast, plaques that were 1 to 3.9 mm thick were frequently associated with carotid stenosis of > or = 70 percent.
These results indicate a strong, independent association between atherosclerotic disease of the aortic arch and the risk of ischemic stroke. The association was particularly strong with thick plaques. Atherosclerotic disease of the aortic arch should be regarded as a risk factor for ischemic stroke and as a possible source of cerebral emboli.
Background: The aim of the present study was to evaluate the feasibility of minimally invasive transapical beating heart aortic valve implantation (TAP-AVI) for high-risk patients with aortic stenosis. Methods: TAP-AVI was performed via a small anterolateral minithoracotomy with (n = 13) or without (n = 17) femoral cardiopulmonary bypass 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 February 2006 to September 2006 at one center using fluoroscopic and echocardiographic visualization. Average EuroSCORE predicted risk for mortality was 27 ± 12%. Results: Valve-positioning was successful in 29 patients and one required early conversion to full sternotomy. Implantation (8 x 23 mm and 22 x 26 mm valves) was performed on the beating heart during brief periods of rapid ventricular pacing. 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 3, mild in 9 and moderate in 2). Three patients (10%) died, one on postoperative day (POD) 3 secondary to preoperative global myocardial failure, and two on POD 18 and 86 due to abdominal complications. Conclusions: Minimally invasive beating heart TAP-AVI is feasible. Initial results are excellent in view of the high-risk profile of the patients. Longer-term studies as well as randomized protocols are required.
Background— The design of a percutaneous implantable prosthetic heart valve has become an important area for investigation. A percutaneously implanted heart valve (PHV) composed of 3 bovine pericardial leaflets mounted within a balloon-expandable stent was developed. After ex vivo testing and animal implantation studies, the first human implantation was performed in a 57-year-old man with calcific aortic stenosis, cardiogenic shock, subacute leg ischemia, and other associated noncardiac diseases. Valve replacement had been declined for this patient, and balloon valvuloplasty had been performed with nonsustained results.
Methods and Results— With the use of an antegrade transseptal approach, the PHV was successfully implanted within the diseased native aortic valve, with accurate and stable PHV positioning, no impairment of the coronary artery blood flow or of the mitral valve function, and a mild paravalvular aortic regurgitation. Immediately and at 48 hours after implantation, valve function was excellent, resulting in marked hemodynamic improvement. Over a follow-up period of 4 months, the valvular function remained satisfactory as assessed by sequential transesophageal echocardiography, and there was no recurrence of heart failure. However, severe noncardiac complications occurred, including a progressive worsening of the leg ischemia, leading to leg amputation with lack of healing, infection, and death 17 weeks after PHV implantation.
Conclusions— Nonsurgical implantation of a prosthetic heart valve can be successfully achieved with immediate and midterm hemodynamic and clinical improvement. After further device modifications, additional durability tests, and confirmatory clinical implantations, PHV might become an important therapeutic alternative for the treatment of selected patients with nonsurgical aortic stenosis.
Received September 5, 2002; revision received October 18, 2002; accepted October 20, 2002.
After the development of general anesthetics such as ether and chloroform during the middle of the nineteenth century, investigators
began to study techniques to repair heart wounds in the animal laboratory. Soon, simple operations in humans for heart wounds
were reported.
A prosthetic caged-ball aortic valve that can be placed with transcatheter techniques was designed, constructed, and initially evaluated in 12 adult mongrel dogs. The prosthesis consisted of a ring, cage, and ball. The ring was made of stainless steel wire coiled in a springlike configuration and covered with an expandable nylon mesh. The cage consisted of a self-expanding Gianturco stent with flat stainless steel wires attached across the cranial end. The ball was a detachable latex balloon filled with a radiopaque silicone prepolymer system. The self-expanding valve was easily passed through an 11- or 12-F Teflon sheath and was placed in the ascending aorta by means of the carotid approach. The stability and efficacy of the prosthesis were evaluated radiographically for as long as the valve remained functional (1-3 hours). The competency of the valve and the patency of the coronary arteries were determined angiographically over the same period. The results of these studies indicate that development and transcatheter placement of a prosthetic aortic valve are feasible.
A new artificial aortic valve prosthesis was developed for implantation by the transluminal catheter technique without thoracotomy or extracorporal circulation. The new heart valve was prepared by mounting a porcine aortic valve into an expandable stent. Before implantation, the stent-valve was mounted on a balloon catheter and compressed around the deflated balloon. The stent-valve mounted balloon catheter was then advanced retrogradely to the ascending aorta or the aortic root in anaesthetized pigs. Implantation was performed by balloon inflation which expanded the stent-valve to a diameter exceeding the internal diameter of the vessel--thus ensuring a stable fixation against the vessel wall. A total of nine implantations were performed in seven 70 kg closed chest pigs. Sub- and supracoronary implantation was performed in two and three pigs, respectively, while implantation in both positions was done in two. Angiographic and haemodynamic evaluation after implantation revealed no significant stenosis (less than or equal to 16 mmHg) in any of the nine valves and trivial regurgitation in only two. Complications were associated with restriction of the coronary blood flow in three animals. This preliminary study indicates that artificial aortic valves can be implanted in closed chest animals by transluminal catheter technique.
To assess the feasibility of percutaneous mitral commissurotomy, we undertook dilatation of mitral stenosis in 26 adults. The procedure was unsuccessful in six patients (hemopericardium in one, and five failures). In 20 patients (mean age: 41 +/- 13 years) the procedure was successful. We used a single balloon (Trefoil 3 X 12 mm) in eight patients and two balloons in 12 (Trefoil 3 X 10 mm + 19 mm). After valvuloplasty, valve function was improved: the mean transvalvular gradient decreased from 14 +/- 4 mm Hg to 7 +/- 2 mm Hg (P less than 0.001) and valve area increased from 1.1 +/- 0.2 cm2 to 2.2 +/- 0.4 cm2 (P less than 0.01). In a patient with severe valvular and subvalvular disease, mitral regurgitation increased from grade I to grade III. From this preliminary series, we conclude firstly that percutaneous valvuloplasty is feasible in adults with mitral stenosis, and secondly, that it results in a significant improvement in valve function with a low incidence of complications.
A study is reported of an annual follow up over a 15 to 20 year period of the survivors of the first 1,000 patients undergoing closed mitral valvuloplasty for mitral stenosis. In addition to a report of the status of the patients at each year of follow up, a detailed analysis has been made of the factors influencing results of surgery 15 years after operation. The most important factor adversely influencing long term results is significant mitral valve calcification. This is true regardless of age, sex, preoperative status, concomitant mitral insufficiency or minor degrees of aortic valve disease. A beneficial effect of younger age (below 40 years at surgery) or lack of associated mitral insufficiency is apparent only in Group III patients with noncalcific valves, and in these two subgroups the results were 41 and 37% improved, respectively. These figures do not include the large number of patients who have again been improved following a second or even third operation. Late systemic embolization occurs infrequently after such surgery (1.1% per patient year of follow up). In patients without significant valvular calcification and without substantial mitral incompetence or significant associated valvular disease, closed mitral valvuloplasty is the operation of choice. The indications for closed versus open operation for mitral stenosis are discussed in detail.
An investigation was carried out to quantitatively evaluate left ventricular volume flow rate, momentum, force and impulse derived from application of conservation principles for mass and momentum of blood within the ventricle during the ejection phase. An automated digital image processing system was developed and applied to left ventricular angiograms which are computer processed and analyzed frame by frame to determine the dynamical relations by numerical methods. Our initial experience with force and impulse has indicated that neither quantity seemed to be a sensitive indicator of coronary artery disease as evaluated by qualitative angiography for the particular patient group studied. Utilization of the dynamical relations in evaluating human left ventricular performance requires improved means of measurement and interpretation of clinical studies.
This study sought to determine the long-term outcome of adult patients undergoing percutaneous balloon aortic valvuloplasty.
Percutaneous balloon aortic valvuloplasty has been offered as an alternative to aortic valve replacement for selected patients with valvular aortic stenosis. Although balloon aortic valvuloplasty produces an immediate reduction in the transvalvular aortic gradient, a high incidence of restenosis frequently leads to recurrent symptoms. Therefore, it is unclear whether balloon aortic valvuloplasty impacts on the long-term outcome of these patients.
Clinical, hemodynamic and echocardiographic data were collected at baseline in 165 patients undergoing balloon aortic valvuloplasty and examined for their ability to predict long-term outcome.
The median duration follow-up was 3.9 years (range 1 to 6). Ninety-nine percent follow-up was achieved. During this 6-year period, 152 patients (93%) died or underwent aortic valve replacement, and 99 (60%) died of cardiac-related causes. The probability of event-free survival (freedom from death, aortic valve replacement or repeat balloon aortic valvuloplasty) 1, 2 and 3 years after valvuloplasty was 40%, 19% and 6%, respectively. In contrast, the probability of survival 3 years after balloon aortic valvuloplasty in a subset of 42 patients who underwent subsequent aortic valve replacement was 84%. Survival after aortic valvuloplasty was poor regardless of the presenting symptom, but patients with New York Heart Association functional class IV congestive heart failure had events earliest. Univariable predictors of decreased event-free survival were younger age, advanced congestive heart failure symptoms, lower ejection fraction, elevated left ventricular end-diastolic pressure, presence of coronary artery disease and increased left ventricular internal diastolic diameter. Stepwise multivariable logistic regression analysis found that only younger age and a lower left ventricular ejection fraction contributed independent adverse prognostic information (chi-square 14.89, p = 0.0006).
Long-term event-free and actuarial survival after balloon aortic valvuloplasty is dismal and resembles the natural history of untreated aortic stenosis. Aortic valve replacement may be performed in selected subjects with good results. However, the prognosis for the remainder of patients who are not candidates for aortic valve replacement is particularly poor.
The cause of cerebral and peripheral embolism remains undetermined in a significant number of patients. An atherosclerotic thoracic aorta has thus far been considered to be an uncommon one.
To define the potential role of the ascending thoracic aorta as an embolic source, intraoperative ultrasonic aortic imaging was performed in 1200 of 1334 consecutive patients aged 50 years and older who were undergoing cardiac surgery. Patients were divided into two groups according to the results of the ultrasound study in terms of presence or absence of atherosclerotic disease. The prevalence of previous neurological events in the two groups was characterized and compared.
Ascending aortic atherosclerosis was present in 231 (19.3%) of the patients studied. Patients in this category were older (P < .0001). A higher percentage of them were smokers (P < .0001) compared with patients with less severe disease. Coronary artery disease was more extensive (P = .012), and a higher percentage of these patients had a history of peripheral vascular disease (P < .0001). Univariate analysis of the subjects with (n = 158) and without (n = 1042) previous neurological events indicated that age, body mass index, atrial fibrillation, hypertension, and atherosclerosis of the ascending aorta were associated significantly with previous occurrence of a cerebrovascular accident. For the group as a whole, multiple logistic regression analysis demonstrated that hypertension (odds ratio, 1.81; P = .002), atherosclerosis of the ascending aorta (odds ratio, 1.65; P = .013), and atrial fibrillation (odds ratio, 1.54; P = .060) were significantly and independently associated with the occurrence of previous neurological events.
Atherosclerosis of the ascending aorta is an independent risk factor for cerebrovascular events. An atherosclerotic ascending aorta may represent a potential source of emboli or may be a marker of generalized atherosclerosis.
To assess the age- and sex-specific prevalence of peripheral arterial disease (PAD) and intermittent claudication (IC) in an elderly population, we performed a population-based study in 7715 subjects (40% men, 60% women) aged 55 years and over. The presence of PAD and IC was determined by measuring the ankle-arm systolic blood pressure index (AAI) and by means of the World Health Organization/Rose questionnaire, respectively. PAD was considered present when the AAI was <0.90 in either leg. The prevalence of PAD was 19.1% (95% confidence interval, 18.1% to 20.0%): 16.9% in men and 20.5% in women. Symptoms of IC were reported by 1.6% (95% confidence interval, 1.3% to 1.9%) of the study population (2.2% in men, 1.2% in women). Of those with PAD, 6.3% reported symptoms of IC (8.7% in men, 4.9% in women), whereas in 68.9% of those with IC an AAI below 0.90 was found. Subjects with an AAI <0.90 were more likely to be smokers, to have hypertension, and to have symptomatic or asymptomatic cardiovascular disease compared with subjects with an AAI of 0.90 or higher. The authors conclude that the prevalence of PAD in the elderly is high whereas the prevalence of IC is rather low, although both prevalences clearly increase with advancing age. The vast majority of PAD patients reports no symptoms of IC.
Thoracic aortic plaque identified by transesophageal echocardiography heightens the risk of stroke associated with atrial fibrillation (AF). We sought to identify the prevalence, predictors, and implications of aortic plaque in patients with nonvalvular AF.
Thoracic aortic plaque was prospectively sought in 770 persons with AF with the use of transesophageal echocardiography and classified as simple or complex on the basis of thickness >/=4 mm, ulceration, or mobility. Clinical and echocardiographic features of thromboembolism were correlated by multivariate analysis.
Aortic plaque was detected in 57% of the cohort, and complex plaque was detected in 25%. Both were found more frequently in the descending than in the proximal aorta. Potentially etiologic patient characteristics independently associated with complex plaque included advanced age, history of hypertension, diabetes, and past or present tobacco use. Comorbidities associated with aortic plaque were prior thromboembolism, increased pulse pressure, ischemic heart disease, stenosis or sclerosis of the aortic valve, mitral annular calcification (>10%), elevated serum creatinine concentration, spontaneous echo contrast in the left atrium or appendage, and left atrial appendage thrombus. The prevalence of complex plaque in patients aged <70 years with <10% mitral annular calcification, without ischemic heart disease, or without pulse pressure >/=65 mm Hg was 4% (95% CI, 1% to 6%).
Aortic plaque is prevalent in patients with AF and is associated with atherosclerosis risk factors and with left atrial stasis or thrombosis, which are themselves independent stroke risk factors. Since the predominant location of complex plaque was in the descending aorta, the role of aortic plaque as a source of embolism in AF is uncertain.
Although aortic-valve stenosis is clearly associated with adverse cardiovascular outcomes, it is unclear whether valve sclerosis increases the risk of cardiovascular events.
We assessed echocardiograms obtained at base line from 5621 men and women 65 years of age or older who were enrolled in a population-based prospective study. On echocardiography, the aortic valve was normal in 70 percent (3919 subjects), sclerotic without outflow obstruction in 29 percent (1610), and stenotic in 2 percent (92). The subjects were followed for a mean of 5.0 years to assess the risk of death from any cause and of death from cardiovascular causes. Cardiovascular morbidity was defined as new episodes of myocardial infarction, angina pectoris, congestive heart failure, or stroke.
There was a stepwise increase in deaths from any cause (P for trend, <0.001) and deaths from cardiovascular causes (P for trend, <0.001) with increasing aortic-valve abnormality; the respective rates were 14.9 and 6.1 percent in the group with normal aortic valves, 21.9 and 10.1 percent in the group with aortic sclerosis, and 41.3 and 19.6 percent in the group with aortic stenosis. The relative risk of death from cardiovascular causes among subjects without coronary heart disease at base line was 1.66 (95 percent confidence interval, 1.23 to 2.23) for those with sclerotic valves as compared with those with normal valves, after adjustment for age and sex. The relative risk remained elevated after further adjustment for clinical factors associated with sclerosis (relative risk, 1.52; 95 percent confidence interval, 1.12 to 2.05). The relative risk of myocardial infarction was 1.40 (95 percent confidence interval, 1.07 to 1.83) among subjects with aortic sclerosis, as compared with those with normal aortic valves.
Aortic sclerosis is common in the elderly and is associated with an increase of approximately 50 percent in the risk of death from cardiovascular causes and the risk of myocardial infarction, even in the absence of hemodynamically significant obstruction of left ventricular outflow.
We sought to evaluate the effects of a number of factors that can potentially determine the optimal time for aortic valve replacement (AVR) and the observed and relative survival after the operation.
Aortic valve replacement is performed in patients within a wide age span, but the proportion of elderly patients is increasing. In survival analyses, adjustment for the effects of age is therefore essential. Analysis of relative survival provides additional information on excess or disease-specific mortality and its risk factors.
Survival was analyzed in 2,359 patients (1,442 without and 917 with concomitant coronary artery bypass graft surgery) undergoing their first AVR. By relating observed survival to that expected among the general Swedish population stratified by age, gender and five-year calendar period, the relative survival and disease-specific survival were estimated.
Early mortality after AVR (death within 30 days) was 5.6%. Relative survival rates (excluding early deaths) after 5, 10 and 15 years were 94.6%, 84.7% and 74.9%, respectively. There was an excess risk of dying during the entire follow-up period. Advanced New York Heart Association functional class, preoperative atrial fibrillation and pure aortic regurgitation were independent risk factors for observed and relative survival. Patients in the oldest age group showed decreased observed survival but excellent relative survival.
Old age was not a risk factor for excess mortality after AVR, whereas atrial fibrillation decreased relative survival substantially.
The purpose of this study was to evaluate characteristics and outcomes of patients age > or =80 undergoing cardiac surgery.
Prior single-institution series have found high mortality rates in octogenarians after cardiac surgery. However, the major preoperative risk factors in this age group have not been identified. In addition, the additive risks in the elderly of valve replacement surgery at the time of bypass are unknown.
We report in-hospital morbidity and mortality in 67,764 patients (4,743 octogenarians) undergoing cardiac surgery at 22 centers in the National Cardiovascular Network. We examine the predictors of in-hospital mortality in octogenarians compared with those predictors in younger patients.
Octogenarians undergoing cardiac surgery had fewer comorbid illnesses but higher disease severity and surgical urgency than younger patients. Octogenarians had significantly higher in-hospital mortality after cardiac surgery than younger patients: coronary artery bypass grafting (CABG) only (8.1% vs. 3.0%), CABG/aortic valve (10.1% vs. 7.9%), CABG/mitral valve (19.6% vs. 12.2%). In addition, they had twice the incidence of postoperative stroke and renal failure. The preoperative clinical factors predicting CABG mortality in the very elderly were quite similar to those for younger patients with age, emergency surgery and prior CABG being the powerful predictors of outcome in both age categories. Of note, elderly patients without significant comorbidity had in-hospital mortality rates of 4.2% after CABG, 7% after CABG with aortic valve replacement (CABG/AVR), and 18.2% after CABG with mitral valve replacement (CABG/MVR).
Risks for octogenarians undergoing cardiac surgery are less than previously reported, especially for CABG only or CABG/AVR. In selected octogenarians without significant comorbidity, mortality approaches that seen in younger patients.
The outcome of aortic valve replacement for severe aortic stenosis is worse in patients with impaired left ventricular function. Such dysfunction in aortic stenosis may be reversible if caused by afterload mismatch, but not if it is caused by superimposed myocardial infarction.
From our echocardiography database, 55 patients with severe aortic stenosis (valve area < or =0.75 cm2) and ejection fractions of 30% or lower who subsequently underwent aortic valve replacement were included. The operative mortality and clinical follow-up were detailed.
There were 10 perioperative deaths (operative mortality, 18%). Twenty (36%) of the 55 patients had a prior myocardial infarction. In the 35 patients without prior myocardial infarction, there was only 1 death (3%). In contrast, 9 of 20 patients with prior myocardial infarction died (mortality rate, 45%; P< or =.001). The factors significantly associated with perioperative death on univariate analysis (functional class, mean aortic gradient, and prior myocardial infarction) were entered into a model for stepwise logistic regression. This multivariate analysis showed that only prior myocardial infarction was independently associated with perioperative death (odds ratio, 14.9; 95% confidence interval, 2.4-92.1; P = .004).
The risk of aortic valve replacement in patients with severe aortic stenosis and severely reduced left ventricular systolic function is extremely high if the patients have had a prior myocardial infarction. This information should be factored into the risk-benefit analysis that is done preoperatively for these patients, and it may preclude operation for some.
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.
Recently, a prosthetic aortic valve has been implanted percutaneously in several patients using an antegrade transseptal approach. This has been shown to be feasible and associated with dramatic hemodynamic improvement. We report a retrograde implantation of a percutaneous heart valve (PHV) in an 84-year-old man with critical aortic stenosis and refractory congestive heart failure after difficulties encountered with an initial antegrade approach. While attempting antegrade transseptal implantation of a PHV, the anterior leaflet of the mitral valve was tethered by the guidewire resulting in severe mitral regurgitation and pulseless electrical activity. Cardiac resuscitation was successful. Utilizing a retrograde approach, the PHV was successfully implanted in a stable position below the coronary ostia and well above the mitral valve leaflets. The aortic valve area increased from 0.55 to 1.7 cm2 with only mild paravalvular aortic regurgitation. Despite marked improvement in aortic valve function, the patient died secondary to guidewire-induced mitral valve anterior leaflet laceration, severe mitral regurgitation, and cardiogenic shock. Retrograde implantation of a PHV can be successfully performed with substantial increase in aortic valve area and an acceptable degree of aortic regurgitation. Although the retrograde approach may be associated with greater risk of vascular access site complications, it may be considerably safer by avoiding potential guidewire injury to the mitral valve. Further refinements in technique may establish the retrograde approach as the preferred means of PHV implantation in nonsurgical patients with critical aortic stenosis.
Calcific aortic stenosis has many characteristics in common with atherosclerosis, including hypercholesterolemia. We hypothesized that intensive lipid-lowering therapy would halt the progression of calcific aortic stenosis or induce its regression.
In this double-blind, placebo-controlled trial, patients with calcific aortic stenosis were randomly assigned to receive either 80 mg of atorvastatin daily or a matched placebo. Aortic-valve stenosis and calcification were assessed with the use of Doppler echocardiography and helical computed tomography, respectively. The primary end points were change in aortic-jet velocity and aortic-valve calcium score.
Seventy-seven patients were assigned to atorvastatin and 78 to placebo, with a median follow-up of 25 months (range, 7 to 36). Serum low-density lipoprotein cholesterol concentrations remained at 130+/-30 mg per deciliter in the placebo group and fell to 63+/-23 mg per deciliter in the atorvastatin group (P<0.001). Increases in aortic-jet velocity were 0.199+/-0.210 m per second per year in the atorvastatin group and 0.203+/-0.208 m per second per year in the placebo group (P=0.95; adjusted mean difference, 0.002; 95 percent confidence interval, -0.066 to 0.070 m per second per year). Progression in valvular calcification was 22.3+/-21.0 percent per year in the atorvastatin group, and 21.7+/-19.8 percent per year in the placebo group (P=0.93; ratio of post-treatment aortic-valve calcium score, 0.998; 95 percent confidence interval, 0.947 to 1.050).
Intensive lipid-lowering therapy does not halt the progression of calcific aortic stenosis or induce its regression. This study cannot exclude a small reduction in the rate of disease progression or a significant reduction in major clinical end points. Long-term, large-scale, randomized, controlled trials are needed to establish the role of statin therapy in patients with calcific aortic stenosis.
Percutaneous aortic valve implantation by an antegrade transvenous approach has been described but is problematic. Retrograde prosthetic aortic valve implantation via the femoral artery has potential advantages. Percutaneous prosthetic aortic valve implantation via the femoral arterial approach is described and the initial experience reported.
The valve prosthesis is constructed from a stainless steel stent with an attached trileaflet equine pericardial valve and a fabric cuff. After routine aortic balloon valvuloplasty, a 22F or 24F sheath is advanced from the femoral artery to the aorta. A steerable, deflectable catheter facilitates manipulation of the prosthesis around the aortic arch and through the stenotic valve. Rapid ventricular pacing is used to reduce cardiac output while the delivery balloon is inflated to deploy the prosthesis within the annulus. Percutaneous aortic prosthetic valve implantation was attempted in 18 patients (aged 81+/-6 years) in whom surgical risk was deemed excessive because of comorbidities. Iliac arterial injury, seen in the first 2 patients, did not recur after improvement in screening and access site management. Implantation was successful in 14 patients. After successful implantation, the aortic valve area increased from 0.6+/-0.2 to 1.6+/-0.4 cm2. There were no intraprocedural deaths. At follow-up of 75+/-55 days, 16 patients (89%) remained alive.
This initial experience suggests that percutaneous transarterial aortic valve implantation is feasible in selected high-risk patients with satisfactory short-term outcomes.
The present case demonstrates the percutaneous implantation of a bioprosthetic valve in a patient with severe aortic stenosis. An 85-year-old man with significant comorbidities was determined to be at unacceptable risk with traditional surgical valve replacement. Percutaneous aortic valve implantation was performed, was successful and uncomplicated, with significant clinical and hemodynamic improvement. Currently, this procedure is an option only for symptomatic patients who are not appropriate candidates for surgical valve replacement.
15-20 year study of 1,000 patients undergoing closed mitral valvuloplasty
- Ellis Lb Jb Singh
- Morales Dd Harkrn
- Fr
Ellis LB, Singh JB, Morales DD, Harkrn FR. 15-20 year study of 1,000 patients undergoing closed mitral valvuloplasty. Circulation. 1973;48: 357-64.
Temporal changes and the causes of aortic stenosis
- Passik
Outcomes of cardiac surgery in patients age > 80 years
- Alexander