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Percutaneous Aortic Valve Implantation Retrograde From the Femoral Artery
Abstract
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.
... Transcatheter aortic valve replacement (TAVR) has emerged as a viable alternative procedure for treating individuals with severe aortic stenosis who are deemed unsuitable for surgery [1]. TAVR has exhibited favorable outcomes in both the short and medium term [2]. The diseased aortic valve is replaced with bioprosthetic valves using catheters, either through the transfemoral route [2] or the transapical route [3]. ...
... TAVR has exhibited favorable outcomes in both the short and medium term [2]. The diseased aortic valve is replaced with bioprosthetic valves using catheters, either through the transfemoral route [2] or the transapical route [3]. Collectively, the data indicates that the minimally invasive transapical approach is a viable option for patients who are not suitable candidates for open heart surgery due to infeasibility or high risk [4]. ...
Background: Despite recent advancements in techniques, peri- and post-procedural complications still pose a significant challenge in the high-risk transcatheter aortic valve replacement (TAVR) patient population. This study aims to investigate and assess the prevalence of acute kidney injury (AKI) following TAVR, and to identify the risk factors associated with its occurrence.
Methods: We conducted the study at King Abdulaziz Medical City, Riyadh, Saudi Arabia from January 2016 to December 2022. We extracted data from electronic medical records. We categorized and compared patients based on their diagnosis of AKI+ following TAVR, or their absence of AKI- after the procedure.
Results: The study included a total of 344 patients who underwent TAVR. The mean age of the patients was 77.8 ± 8.9 years, 61.8% were male, and the average body mass index was 30.5±7.0. In terms of comorbidities, 70.8% of the patients had diabetes mellitus, 80.5% had hypertension, 8.7% had hypothyroidism, 2.0% had hematological disorders, 23.6% had congestive heart disease, 20.4% had cerebrovascular disease, 4.1% had peripheral vascular disease, 7.3% had cancer, and 34.4% had other comorbidities. The prevalence of AKI was 60 (17.50%) following the procedure. Cerebrovascular diseases showed a significant association with AKI (OR= 3.381, 95% CI, 1.65-6.91, p = 0.001). Chronic kidney disease has a significant effect on AKI (OR = 2.56, 95%CI, 1.02-6.39, p = 0.044). The creatinine level on Day 0 has a significant association with AKI (OR = 1.01, 95%CI, 1.006-1.017, p = 0.0001).
Conclusions: These findings highlight the importance of assessing and managing these risk factors (cerebrovascular diseases, chronic kidney disease, and creatinine level on Day 0) in TAVR patients to mitigate the occurrence and severity of AKI. By understanding and addressing these factors, healthcare providers can potentially improve patient outcomes and reduce the incidence of AKI-associated TAVR procedures.
... The developments in the material technology allowed for miniaturization of the introducer systems so that, as envisioned by Anderson back in 1989, the retrograde approach was widely adopted with the advent of the trans-femoral procedure in 2005. John G. Webb [79,80] refined the retrograde technique in cooperation with Edwards and performed the implantation of the 23 mm and 26 mm Edwards SAPIEN valve (initially the Cribier-Edwards valve) through femoral access over a 22-/24-F pusher sheath with a deflectable Retroflex catheter. ...
... Despite the slightly reduced sheath diameter of 22-F for the 23 mm valve, the incidence of small femoral access and the high degree of vessels' calcification and tortuosity required further improvements in equipment and technique for a wider application of a transfemoral TAVI (TF-TAVI) [79,80]. ...
Aortic valve stenosis (AVS) is the most frequent valvular heart disease in industrialized countries, presenting with very high mortality if left untreated. While drug treatment can sometimes alleviate symptoms, it fails to stop progression or cure the underlying disease. Until the first decade of this millennium, surgical aortic valve replacement (SAVR) remained the only available therapy option with a positive impact on mortality and morbidity. Even though several studies reported highly positive effects of SAVR regarding the improved quality of life and better physical performance, SAVR remained an intervention that, due to its remarkable complexity and the need for heart-lung machine and cardioplegia, was limited by the patients’ comorbid profile. While unsatisfying hemodynamic results after transcatheter aortic balloon valvuloplasty in high-risk surgical patients limited its adoption as an alternative treatment, it provided the impetus for further interventional approaches to the therapy of AVS. This review considers the invention and development of transcatheter aortic valve implantation (TAVI), which established itself as a catheter-based, minimally invasive procedure over the past decade, and has become an equivalent treatment method for high-risk surgical patients. For that matter, early TAVI concepts, their amendments, and the associated pioneers are recognized for paving the way to a revolutionary diversification in AVS treatment.
... Although coronary artery obstruction after TAVR procedure occurs rarely with the reported incidences of 0.34%− 4.1%, the consequences are devastating with a mortality rate of 50% [3,9,14,15]. Since the first case report of coronary artery obstruction after TAVR in humans was described by Webb et al. in 2006, it has still been challenging to predict the risk [16]. Several characteristics have been suggested as relevant risk factors such as low lying coronary ostium, shallow SOV, bulky calcification on the leaflet, long leaflet length, women, ViV procedure or certain types of surgical bioprosthesis (Mitroflow and Trifecta), balloonexpandable valve, and oversized THV [6,7,14,17,18]. ...
... Although coronary artery obstruction after TAVR procedure occurs rarely with the reported incidences of 0.34%− 4.1%, the consequences are devastating with a mortality rate of 50% [3,9,14,15]. Since the first case report of coronary artery obstruction after TAVR in humans was described by Webb et al. in 2006, it has still been challenging to predict the risk [16]. Several characteristics have been suggested as relevant risk factors such as low lying coronary ostium, shallow SOV, bulky calcification on the leaflet, long leaflet length, women, ViV procedure or certain types of surgical bioprosthesis (Mitroflow and Trifecta), balloonexpandable valve, and oversized THV [6,7,14,17,18]. ...
Background
The aim of this study was to evaluate the role of the distance between the aortic valve in projected position to the coronary ostium to determine risk of coronary artery obstruction after transcatheter aortic valve replacement (TAVR).
Methods
An Expected Leaflet-to-ostium Distance (ELOD) was obtained on pre-TAVR planning computed tomography by subtracting leaflet thickness and the distances from the center to the annular rim at annulus level and from the center to the coronary ostium at mid-ostial level. Variables were compared between patients with and without coronary obstruction and the level of association between variables was assessed using log odds ratio (OR).
Results
A total of 177 patients with 353 coronary arteries was analyzed. Mean annulus diameters (22.8 ± 2.8 mm and 23.4 ± 1.0 mm, p > 0.05) and mean sinus of Valsalva (SOV) diameters (31.2 ± 3.6 mm and 31.9 ± 3.6 mm, p > 0.05) were similar between patients with lower and higher coronary heights, respectively. There were three coronary obstruction cases. ELOD ≤ 2 mm in combination with leaflet length longer than mid-ostial height allowed for discrimination of cases with and without coronary obstruction. There was a significant association between coronary obstruction event and ELOD ≤ 2 mm (log OR = 6.180, p < 0.001).
Conclusions
Our study showed that a combination of ELOD < 2 mm and a longer leaflet length than mid-ostial height may be associated with increased risk for coronary obstruction during TAVR.
... The procedure was very complex and demanding and required extensive experience with cardiac catheterization and therefore complications were common. Consequently, the antegrade approach was largely abandoned with the advent of the transfemoral procedure in 2005 (19). Femoral, subclavian/transaxillary and transaortic access was developed (19)(20)(21)(22)(23)(24). ...
... Consequently, the antegrade approach was largely abandoned with the advent of the transfemoral procedure in 2005 (19). Femoral, subclavian/transaxillary and transaortic access was developed (19)(20)(21)(22)(23)(24). The first apical implantation in an animal was performed in 2000 by Professor John Webb in Vancouver, Canada (25,26). ...
This story is about the invention of transcatheter aortic valve implantation (TAVI), and the people who transformed it from a concept and primitive device to a breakthrough lifesaving treatment for hundreds of thousands of patients with aortic valve stenosis. It is an inspirational example of a new disruptive technology that began with an idea most dismissed. The story describes the ups and downs from idea, design, construction, animal testing, proof-of-concept, scientific publication hurdles, a patent, license agreement, cooperation with several companies, fighting in patent courts in Europe and USA and finally how multinational companies financially bypassed the inventor. It is also a story about the struggles and battles the inventor experienced when injected into a world of lawyers and patent fights. I hope my personal story and journey can provide an inspiration and word of caution for new inventors.
... However, this procedure is still associated with complications such as conduction defects, vascular complications, thromboembolic events and paravalvular leakage. CO after TAVR procedure is a rare life-threatening complication and was was described by Webb et al's study (6) . CO is more common in LMCA than RCA due to the higher localization of the right coronary ostium (7) . ...
... This complication usually develops acutely after the TAVR procedure and malposition of the device or natural valve leaflets protrusion or plaque migration in natural valve during the procedure may obliterate the coronary ostia (8) due to anatomic factors such as shallow sinuses of valsalva (<30 mm), low localization of coronary ostium (<12 mm), narrow aortic root, presence of plaque in LMCA and serious calcification of aortic valve cusps. In addition advanced age, female sex, co-existing coronary artery disease, balloon-expandable valves and valve-invalve implantation increase the risk of CO (6,7,9) . DCO is the late occlusion of the coronary ostia after the successful TAVR procedure. ...
Transcatheter aortic valve replacement (TAVR) is an effective procedure in selected patients with symptomatic severe aortic stenosis. However, the complications associated with TAVR are still an important problem today. One of the life-threatening complications associated with TAVR is coronary occlusion, which requires immediate diagnosis and intervention. This serious complication also leads to poor prognosis and mortality. In this case, we aimed to present the late coronary artery occlusion due to thrombus after TAVR and to emphasize the uncertainties and complexities in antithrombotic treatment in patients with TAVR, which may lead to catastrophic outcomes, especially in patients with atrial fibrillation.
... Over the last decade, transcatheter aortic valve implantation (TAVI) has become an established alternative to surgical aortic valve replacement (SAVR) for patients with severe symptomatic aortic stenosis who are at a prohibitive or high risk for cardiac surgery [1,2]. More recent trials have even highlighted the role of TAVI as a valuable alternative to surgery in intermediate [3] and low-surgical-risk patients [4,5]. ...
The expansion of transcatheter aortic valve implantation (TAVI) to low-risk and younger patients has increased the relevance of the long-term durability of transcatheter heart valves (THV). The present study aims to assess the 10-year durability, hemodynamic performance, and clinical outcomes after TAVI using the CoreValve system.
An analysis from a prospective registry with predefined clinical and echocardiographic follow-up included 302 patients who underwent TAVI with the CoreValve system between 2007 and 2015. Bioprosthetic valve failure (BVF) was defined as any bioprosthetic valve dysfunction-related death, re-intervention, or severe hemodynamic valve deterioration.
At the time of TAVI, the mean age was 80.41 ± 7.01 years, and the Society of Thoracic Surgeons (STS) score was 6.13 ± 5.23%. At latest follow-up (median [IQR]: 5 [2–7] years), cumulative all-cause mortality rates at 3, 5, 7, and 10 years was 23.7%, 40%, 65.8%, and 89.8%, respectively. Mean aortic valve area and transvalvular gradient post-TAVI and at 5, 7, and 10 years were 1.94, 1.87, 1.69, and 1.98 cm2 (p = 0.236) and 8.3, 9.0, 8.2, and 10.1 mmHg (p = 0.796), respectively. Overall, 11 patients had BVF, of whom six had structural valve deterioration (SVD). The 10-year actual and actuarial freedom from BVF was 96.1% and 78.8%, and from SVD was 97.9% and 80.9%, respectively. Three patients developed significant non-SVD due to severe paravalvular leakage, and two patients were diagnosed with infective endocarditis.
Using an early-generation self-expanding bioprosthesis, we documented durable hemodynamic performance and low rates of BVF and SVD up to 10 years after TAVI.
... With the advent of transcatheter aortic valve implantation procedures, 24-26 closed chest imaging becomes even more important, regarding value sizing, and accurate positioning of the prosthesis, to avoid coronary obstruction. 25,26 Currently used angiography is limited by its two-dimensional character. 15,19,20 Similar to advanced ultrasound imaging, MDCT can provide three-dimensional images with a high spatial resolution for detailed information on the anatomy of the aortic root and the relation of the annulus to coronary ostia. ...
Aims
Aortic root motion is suspected to contribute to proximal aortic dissection. While motion of the aorta in four dimensions can be traced with real-time imaging, displacement and rotation in quantitative terms remain unknown. The hypothesis was to show feasibility of quantification of three-dimensional aortic root motion from dynamic CT imaging.
Methods and results
Dynamic CT images of 40 patients for coronary assessment were acquired using a dynamic protocol. Scans were ECG-triggered and segmented in 10 time-stepped phases (0–90%) per cardiac cycle. With identification of the sinotubular junction (STJ), a patient-specific co-ordinate system was created with the z-axis (out-of-plane) parallel to longitudinal direction. The left and right coronary ostia were traced at each time-step to quantify downward motion in reference to the STJ plane, motion within the STJ plane (in-plane), and the degree of rotation. Enrolled individuals had an age of 65 ± 12, and 14 were male (35%). The out-of-plane motion was recorded with the largest displacement of 10.26 ± 2.20 and 8.67 ± 1.69 mm referenced by left and right coronary ostia, respectively. The mean downward movement of aortic root was 9.13 ± 1.86 mm. The largest in-plane motion was recorded at 9.17 ± 2.33 mm and 6.51 ± 1.75 mm referenced by left and right coronary ostia, respectively. The largest STJ in-plane motion was 7.37 ± 1.96 mm, and rotation of the aortic root was 11.8 ± 4.60°.
Conclusion
In vivo spatial and temporal displacement of the aortic root can be identified and quantified from multiphase ECG-gated contrast-enhanced CT images. Knowledge of normal 4D motion of the aortic root may help understand its biomechanical impact in patients with aortopathy and pre- and post-surgical or transcatheter aortic valve replacement.
... This becomes particularly problematic when attempting to distinguish between mild obstructions resulting from pathological changes and those caused by prosthetic-patient mismatch (PPM). Moreover, the presence of shielding and various artifacts further complicates insonation, making the assessment of the valve and regurgitant jets associated with it even more difficult (3)(4)(5)(6). Transesophageal echocardiography (TEE) has evolved from one-dimensional imaging using a probe with a single-crystal, M-mode transducer to two-dimensional (2D) imaging with phased-array transducers and now three-dimensional (3D) imaging with matrix array transducers is also available. Recent probes of 3D imaging are extremely superior to the previous multiplane TEE imaging technique to reconstruct 3D images (7). ...
Objective: The advent of 3D transesophageal echocardiography (TEE) was supposed to facilitate more accurate etiological diagnosis of prosthetic valve dysfunction as compared to 2D TEE; however, data to support the same is sparse especially in Asian Indians.
Methods: This was a prospective, open- label study of 50 consecutive patients with prosthetic valve dysfunction who were eligible for the study. All patients underwent both 2D and 3D TEE for assessment of prosthetic valve dysfunction apart from their demographics, clinical evaluation, laboratory assessment and fluoroscopy.
Results: Of 50 patients, 12 had aortic valve prosthetic dysfunction and 38 patients had mitral valve prosthesis dysfunction. Of these, 10 were male and remaining 40 were female patients. Overall, 41 (82%) patients had subtherapeutic prothrombin time at the time of presentation. Thrombus in situ was visualized in 34% of patients with 3D TEE as compared to 2D TEE (4%) (p=0.004). Pannus formation was observed in 20% of patients with 3D TEE as compared to 2D TEE, which could not identify pannus formation in any patient (p=0.03). In 34% of patients, normal motion of leaflets could be seen using 3D TEE as compared to 30% of patients by 2D TEE.
Conclusion: Compared to 2D TEE, 3D TEE imaging offers superior capabilities in assessing prosthetic valve dysfunction, particularly when evaluating thrombus and pannus formation. Additionally, both modalities show nearly similar effectiveness in assessing leaflet motion.
... This was the beginning of what has become the firstline and most common access route for TAVI. 9 Since these first-in-human procedures, the interest of the scientific community in AV transcatheter treatment has grown exponentially, making it the most studied and intervened-upon heart valve. ...
... The transfemoral procedures were performed under sedation, while the transapical procedures (n = 7) were performed under general anesthesia, as previously described. 11,12 The final decision on the implanted valve size was at the discretion of the invasive cardiologist performing the TAVR. circumference/π), and minor and major orthogonal AA diameters were obtained in mid-systolic frame by multiplanar reconstruction of the 3D ECHO dataset after adjustment of three orthogonal planes, using dedicated software (Qlab, Intellispace Cardiovascular, Philips) on-cart or off-line as previously published. ...
Aims:
Transcatheter aortic valve replacement (TAVR) has become the standard of care for selected patients with severe aortic stenosis. Multidetector computed tomography (MDCT) and transoesophageal 2D/3D (two-dimensional/three-dimensional) echocardiography (ECHO) are used for aortic annulus (AA) sizing. The aim of this study was to compare the accuracy of AA sizing by ECHO versus MDCT for Edwards Sapien balloon expandable valve in a single center.
Methods and results:
Data from 145 consecutive patients with TAVR (Sapien XT or Sapien S3) were analyzed retrospectively. A total of 139 (96%) patients had favorable outcomes after TAVR (at most mild aortic regurgitation and only one valve implanted). The 3D ECHO AA area and area-derived diameter were smaller than the corresponding MDCT parameters (464 ± 99 vs. 479 ± 88 mm2 , p < .001, and 24.2 ± 2.7 vs. 25.0 ± 5.5 mm, p = .002, respectively). The 2D ECHO annulus measurement was smaller than both the MDCT and 3D ECHO area-derived diameters (22.6 ± 2.9 vs. 25.0 ± 5.5 mm, p = .013, and 22.6 ± 2.9 vs. 24.2 ± 2.7 mm, p < .001, respectively) but larger than the minor axis diameter of the AA derived from MDCT and 3D ECHO by multiplanar reconstruction (p < .001). The 3D ECHO circumference-derived diameter was also smaller than the MDCT circumference-derived diameter (24.3 ± 2.5 vs. 25.0 ± 2.3, p = .007). The sphericity index by 3D ECHO was smaller than that by MDCT (1.2 ± .1 vs. 1.3 ± .1, p < .001). In up to 1/3 of the patients, 3D ECHO measurements would have predicted different (generally smaller) valve size than was the valve size implanted with favorable result. The concordance of the implanted valve size with the recommended size based on preprocedural MDCT and 3D ECHO AA area was 79.4% versus 61% (p = .001), and for the area-derived diameter, the concordance was 80.1% versus 61.7% (p = .001). 2D ECHO diameter concordance was similar to MDCT (78.7%); however, MDCT AA area derived diameter extrapolated from 2D ECHO measurement would have led to the different valve size selection in additional 33% of the patients.
Conclusions:
3D ECHO AA measurements are smaller than MDCT measurements. If 3D ECHO-based parameters alone are used to size the Edwards Sapien balloon expandable valve, then the selected valve size would have been smaller than the valve size implanted with favorable result in 1/3 of the patients. MDCT preprocedural TAVR assessment should be the preferred method over 3D ECHO in routine clinical practice to determine Edwards Sapien valve size.
... Details on the TAVR procedure are provided elsewhere. 15 Patients were implanted with a balloon-expandable SAPIEN valve (Edwards Lifesciences, Irvine, CA, USA) or selfexpandable Evolut™ valve (Medtronic, Minneapolis, MN, USA). After the procedure, all patients were managed in a general high-care unit for ≥1 day. ...
Ventricular-demand leadless pacemakers (VVI-LPMs) have often been used as an alternative to atrioventricular (AV) synchronous transvenous pacemakers (DDD-TPMs) in patients with high-grade AV block following transcatheter aortic valve replacement (TAVR). However, the clinical outcomes of this unusual usage are not elucidated. Patients who received permanent pacemakers (PPMs) owing to new-onset high-grade AV block after TAVR from September 2017 to August 2020 at a high-volume center in Japan were included in the analysis, and the clinical courses of VVI-LPM and DDD-TPM implants through 2 years of follow-up were compared retrospectively. Out of 413 consecutive patients who underwent TAVR, 51 (12%) patients received a PPM. After excluding 8 patients with chronic atrial fibrillation (AF), 3 with sick sinus syndrome, and 1 with incomplete data, 17 VVI-LPMs and 22 DDD-TPMs were included in our final cohort. The VVI-LPM group had lower serum albumin levels (3.2 ± 0.5 vs. 3.9 ± 0.4 g/dL, P < .01) than the DDD-TPM group. Follow-up revealed no significant differences between the 2 groups in terms of the incidence of late device-related adverse events (0% vs. 5%, log-rank P = .38) and new-onset AF (6% vs. 9%, log-rank P = .75); however, there were increases in the rates of all-cause death (41% vs. 5%, log-rank P < .01) and heart failure rehospitalization (24% vs. 0%, log-rank P = .01) in the VVI-LPM group. This small retrospective study reveals favorable post-procedural complication rates but higher all-cause mortality with VVI-LPM compared to DDD-TPM therapy for high-grade AV block after TAVR at 2 years of follow-up.
... This success has been primarily due to the relative ease of access to the aortic valve through the retrograde, or transfemoral approach, and due to the early success of Edwards Lifesciences (Irvine, CA) in navigating the aortic arch with endovascular approaches. 97 Aortic stenosis (AS), if untreated, is a fatal diagnosis, with a prognosis of 2-5 years depending on symptom severity. 98 Although aortic valve replacement (AVR) is the only effective therapy, approximately one quarter to one third of patients with AS are not offered surgical treatment options due to their poor surgical candidacy, secondary to comorbidities or underlying cardiac function. ...
... This success has been primarily due to the relative ease of access to the aortic valve through the retrograde, or transfemoral approach, and due to the early success of Edwards Lifesciences (Irvine, CA) in navigating the aortic arch with endovascular approaches. 97 Aortic stenosis (AS), if untreated, is a fatal diagnosis, with a prognosis of 2-5 years depending on symptom severity. 98 Although aortic valve replacement (AVR) is the only effective therapy, approximately one quarter to one third of patients with AS are not offered surgical treatment options due to their poor surgical candidacy, secondary to comorbidities or underlying cardiac function. ...
... 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.
... TAVR implantation procedures: TAVR patients were selected by our local heart team, which comprised interventional cardiologists, cardiac surgeons, and cardiovascular anesthesiologists. TAVR was performed by a multidisciplinary heart team in a hybrid operating room using the standard technique [20,21] with patients under conscious sedation [22][23][24][25] and percutaneous femoral artery access and closure. One of the two bioprostheses with a current Conformité Européenne mark approval (SAPIEN S3 (Edwards Lifesciences, Irvine, CA, USA) and CoreValve Evolut R (Medtronic Inc., Minneapolis, MN, USA)) were implanted. ...
Background and Objectives: Permanent pacemaker implantation (PPI) is frequently required following transcatheter aortic valve replacement (TAVR). Dual antiplatelet therapy (DAPT) or oral anticoagulation therapy (OAK) is often necessary in these patients since they are at higher risk of thromboembolic events due to TAVR implantation, high incidence of coronary artery diseases (CAD) with the necessity of coronary intervention, and high rate of atrial fibrillation with the need of stroke prevention. We sought to evaluate the safety, efficiency, and clinical outcomes of early PPI following TAVR using the PlasmaBlade™ (Medtronic Inc., Minneapolis, MN, USA) pulsed electron avalanche knife (PEAK) for bleeding control in patients under DAPT or OAK. Materials and Methods: This retrospective single-center study included patients who underwent PPI after transfemoral TAVR (TF) at our center between December 2015 and May 2020. All PPI were performed using the PlasmaBlade™ Device. Results: The overall PPI rate was 14.1% (83 of 587 patients; 82.5 ± 4.6 years; 45.8% male). The PPI procedures were used to treat high-grade atrioventricular block (81.9%), severe sinus node dysfunction (13.3%), and alternating bundle branch block (4.8%). At the time of the procedure, 35 (42.2%) patients received DAPT, and 48 (57.8%) patients received OAK (50% with vitamin K antagonist (VKA) and 50% with novel oral anticoagulants (NOAK)). One device-pocket hematoma treated conservatively occurred in a patient (1.2%) receiving NOAK. Two re-operations were necessary in patients due to immediate lead dislocation (2.4%). Conclusions: The results of this study illustrate that the use of PlasmaBlade™ for PPI in patients after a TAVR who require antithrombotic treatment is feasible and might result into lower rates of severe bleeding complications compared to rates reported in the literature. Use of the PlasmaBlade device may be considered in this specific group of patients because of their high risk of bleeding.
... [15] In a Medicine meta-analysis of randomized clinical trials, the mortality rate for patients who underwent TF-TAVR was lower than for those who underwent SAVR, and TF-TAVR yielded lower risks of stroke, major bleeding, and atrial fibrillation, as well as a shorter hospital stay. [16] Many approaches for TAVR have been introduced, including transfemoral, [17] transapical, [18] transaortic, [19] and transsubclavian routes. [20] Among them, the transfemoral approach is the current gold standard for TAVR and is used for first-line access. ...
Rationale:
Although the transfemoral approach is the gold standard for transcatheter aortic valve replacement (TAVR), it is not feasible in a considerable number of patients. We report a case of successful transsubclavian TAVR (TS-TAVR) in a patient with severe aortic stenosis (AS) who was ineligible for transfemoral TAVR because she was a kidney transplant recipient.
Patient concerns:
A 72-year-old Korean woman, who had previously undergone kidney transplantation in the right iliac fossa for end-stage kidney disease, was admitted to our center with dyspnea. Upon auscultation, grade IV systolic murmurs were detected in both upper sternal borders and the left lower sternal border, suggestive of valvular heart disease.
Diagnosis:
Two-dimensional transthoracic echocardiography revealed heavy calcification of the aortic valve with a high peak velocity (4.54 m/s) and mean pressure gradient (48.49 mm Hg), indicative of severe AS.
Interventions:
TS-TAVR was performed by a heart team comprised of interventional cardiologists, cardiac surgeons, and anesthesiologists. A self-expandable valve prosthesis (CoreValveTM Evolut RTM, Medtronic Inc., Minneapolis, MN) was successfully deployed via the left subclavian artery.
Outcomes:
Post-TAVR 2-dimensional transthoracic echocardiography demonstrated a well-functioning valve with mild paravalvular leakage. The peak velocity had declined from 4.54 m/s to 2.22 to 2.24 m/s, and the mean pressure gradient had declined from 48.49 to 8.57-9.61 mmHg. The patient was discharged successfully and uneventfully.
Lessons:
Because kidney transplant recipients with severe AS are considered poor candidates for transfemoral TAVR, TS-TAVR is a suitable alternative to consider.
... Fortunately, percutaneous AvR (PAvR) is rapidly developing as a potential alternative to standard surgical AvR. 40 Pioneered by Cribier and Webb,41,42 this technique has received approval for use of two different valves (edwards SAPIen and Medtronic Core valve) in europe, where it is estimated that more than 10,000 valves have been implanted already. trials are well underway in the united States, and general availability is probably imminent. ...
... The pericardium was pre-treated in order to decrease calcification following implantation. This new design was available in two sizes, 23 mm and 26 mm, to allow for more accurate fitment in different sized patients [15,20]. ...
Aims
A review was conducted on the composition, advantages and limitations of available aortic valve prototypes to create an ideal valve for percutaneous implantation.
Patients
Patients with multiple comorbidities who cannot withstand the risks of open cardiac surgery.
Methodology
The search was performed using online databases and textbooks. Articles were excluded based on specific criterion.
Results
Ten prototypes created between 2006 and 2019 were found and reviewed. The prototypes had a set of advantages and limitations with their characteristics coinciding at times.
Conclusions
The ideal percutaneously implantable aortic valve should have minimum coaptation height, zero folds in the leaflets, minimum valve height, minimum leaflet flexion and three leaflets. It can be composed of biological or synthetic material, as long as it provides minimal risk of thrombosis. However, more studies are needed to ensure other ideal parameters.
... Studies have reported that afterload reduction after TAVR results in marked hemodynamic improvement. This reduction in afterload markedly improves aortic valve area from 0.6 to 1.8cm2 and reduced mean pressure gradient from 60 to 8.3 mmHg, thus, leading to a significant reduction in NYHA class by a mean of 1.8 grades with immediate symptomatic relief with similar hemodynamic performance as SAVR [16][17][18][19]. ...
Introduction: Since the approval of transcatheter aortic valve replacement (TAVR), nonagenarian group patients are being increasingly considered for TAVR. Therefore, we compared the clinical outcomes of surgical aortic valve replacement (SAVR) vs TAVR in nonagenarians with severe aortic stenosis.
Methods: A literature search was performed using MEDLINE, Embase, Web of Science, Cochrane, and Clinicaltrials.gov for studies reporting the comparative outcomes of TAVR versus SAVR in nonagenarians. The primary endpoint was short-term mortality. Secondary endpoints were post-operative incidences of stroke or transient ischemic attack (TIA), vascular complications, acute kidney injury (AKI), transfusion requirement, and length of hospital stay.
Results: Four retrospective studies qualified for inclusion with a total of 8,389 patients (TAVR = 3,112, SAVR = 5,277). Short-term mortality was similar between the two groups [RR = 0.91 (95% CI: 0.76–1.10), p = 0.318]. The average length of hospital stay was shorter by 3 days in the TAVR group (p = 0.037). TAVR was associated with a significantly lower risk of AKI [RR = 0.72 (95% CI: 0.62–0.83), p < 0.001] and a lower risk of transfusion [RR = 0.71 (95% CI: 0.62–0.81), p < 0.001]. There was no difference in risk of stroke/TIA[RR = 1.01 (95% CI: 0.70–1.45), p = 0.957]. The risk of vascular complications was significantly higher in the TAVR group [RR = 3.39 (95% CI: 2.65–4.333), p < 0.001].
Conclusion: In this high-risk population, TAVR compared to SAVR has similar short-term mortality benefit but has lower risks of perioperative complications and a higher number of patients being discharged to home.
... John Webb of Canada collaborated with Edwards to develop retrograde arterial implantation. The technique has a deflectable sheath that can easily pass through the aortic arch and the narrowed valve orifice [10]. John Webb and his colleagues also performed the first transapical valve implantation [11]. ...
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.
... In all patients, a multidisciplinary, institutional heart team decided on eligibility for TAVI, procedural feasibility, the preferred access route, prosthesis type and size [12]. Valves were implanted either via a transfemoral or transapical access in accordance with well-described standard techniques [13]. Each of the treating interventionalists had an experience of at least 100 or more TAVI procedures. ...
Background
Low prosthesis position after transcatheter aortic valve implantation (TAVI) is associated with higher rates of new onset conduction disturbances and permanent pacemaker implantations. Purpose of this study was to investigate possible predictors of a low prosthesis position of the SAPIEN 3 (Edwards Lifesciences, Irvine, California, USA) valve type using fusion imaging of pre- and post-procedural computed tomography angiography (CTA).MethodsCTA fusion imaging was performed in 120 TAVI-patients with 3D-reconstruction of the transcatheter heart valve (THV) position within the device landing zone. A low implantation position was defined according to the manufacturer’s recommendations as > 30% of the prosthesis below the native annulus plane.ResultsA low THV position was found in 17 patients (14%). Patients with low THV position had less calcification of the annulus region and a smaller annulus size compared to patients with a normal or high THV position (P = 0.003 and 0.041, respectively). The only independent predictor of a low THV position in multivariate logistic regression analysis was the extent of calcification of the cusp region (odds ratio [CI] 0.842 [0.727–0.976], P = 0.022).Conclusions
Fusion imaging of pre-and post-procedural CTA identified reduced calcification of the cusp region as an independent predictor of a low THV position of the SAPIEN 3. This should be considered when planning the TAVI procedure.Graphic abstractCorrelation of cusp region calcification and prosthesis position after TAVI
... Details on the TAVI procedure are provided elsewhere. 13 Patients were implanted with balloon-expandable SAPIEN (Edwards Lifesciences, Irvine, CA, USA) or self-expandable Evolut TM valves (Medtronic Inc., Minneapolis, MN, USA). During the procedure, 100 UI/kg unfractionated heparin was administered to achieve an activated clotting time of over 250 s. ...
Background:Although left bundle-branch block (LBBB) is a known conduction disorder that occurs after transcatheter aortic valve implantation (TAVI), its clinical impact in the Japanese population remains unclear.
Methods and Results:Of the 298 consecutive patients who underwent TAVI from January 2016 to December 2018 in a high-volume center in Japan, 68 with prior or periprocedural permanent pacemaker implantation (PPI), pre-existing LBBB, death during hospitalization, aborted procedure, or incomplete data were excluded. Among the final cohort of 230 patients, new-onset LBBB occurred in 90 (39%) after TAVI and persisted at 1-month follow up in 29 patients (13%; persistent new-onset LBBB, PN-LBBB). On multivariable analysis, self-expandable valve (SEV) use was found to be the only predictor of PN-LBBB (odds ratio: 4.39, 95% confidence interval: 1.69–11.41, P=0.002). There were no differences between patients with and without PN-LBBB in terms of overall mortality (18.8% vs. 26.0%, log-rank P=0.90) or need for late PPI (4.0% vs. 3.5%, log-rank P=0.74), yet there was an increased re-admission rate for heart failure (HF) in the PN-LBBB group (15.6% vs. 8.0%, log-rank P=0.046) at a median follow up of 431 (interquartile range, 271–733) days.
Conclusions:PN-LBBB following TAVI was not associated with mortality or late PPI, but with a higher incidence of HF-related re-hospitalization at the mid-term follow up.
... Over the past 5 years, the development of minimally invasive transcatheter valve implantation has been explored. [2][3][4][5][6][7][8][9][10][11][12][13] Transarterial and transapical transcatheter aortic valve implantation (AVI) has been explored by cardiologists and cardiac surgeons worldwide. Many reports have shown favorable early clinical and echocardiographic outcomes with transarterial or transapical AVI. ...
We performed the first human case of successful transapical transcatheter aortic valve implantation on a beating heart in October 2005, and therefore we have the longest follow-up on transapical aortic valve implantation in humans. We now report clinical and echocardiographic outcomes of transapical aortic valve implantation in 71 patients.
Between October 2005 and February 2009, 71 patients (44 female) underwent transcatheter transapical aortic valve implantation with either 23- or 26-mm Edwards Lifesciences transcatheter bioprostheses. All patients with symptomatic aortic stenosis were declined for conventional aortic valve replacement owing to unacceptable operative risks and were not candidates for transfemoral aortic valve implantation because of poor arterial access. Clinical and echocardiographic follow-ups were performed before discharge, at 1 and 6 months, and then yearly. The mean follow-up was 12.9 +/- 11.5 months with a total of 917.3 months of follow-up.
Mean age was 80.0 +/- 8.1 years and predicted operative mortality was 34.5% +/- 20.4% by logistic EuroSCORE and 12.1% +/- 7.7% by The Society of Thoracic Surgeons Risk Calculator. Valves were successfully implanted in all patients. Twelve patients died within 30 days (30-day mortality: 16.9% in all patients, 33% in the first 15 patients, and 12.5% in the remainder), and 10 patients died subsequently. Overall survival at 24 and 36 months was 66.3% +/- 6.4% and 58.0% +/- 9.5%, respectively. Among 59 patients who survived at least 30 days, 24- and 36-month survivals were 79.8% +/- 6.4% and 69.8% +/- 10.9%, respectively. Late valve-related complications were rare. New York Heart Association functional class improved significantly from preoperative 3.3 +/- 0.8 to 1.8 +/- 0.8 at 24 months. The aortic valve area and mean gradient remained stable at 24 months (1.6 +/- 0.3 cm(2) and 10.3 +/- 5.9 mm Hg, respectively).
Our outcome suggests that transapical transcatheter aortic valve implantation provides sustained clinical and hemodynamic benefits for up to 36 months in selected high-risk patients with symptomatic severe aortic stenosis.
Objective
The aim of this study was to validate the use of a new resection device in patient candidates for surgical aortic valve replacement. We evaluated the efficacy of this new circular blade to resect the aortic valve and the efficacy to collect the debris during the resection.
Methods
For this study, a single size instrument was used, with an external diameter of 22 mm, and patients were selected on the basis of the preoperative assessment of the aortic diameters.
Results
From October 2018 to June 2019, 10 patient candidates for surgical aortic valve replacement were selected to undergo native aortic valve resection using a new device, before surgical valve implantation. The mean age of the patients was 74 ± 7.6 years, and 8 of 10 were male. The mean aortic annulus diameter, measured before the procedure, was 25.7 ± 1.57 mm. The resection was complete in 9 (90%) patients. In 1 patient, due to an imprecise positioning of the device, the valve resection was partial. None of the patients showed signs or symptoms due to debris embolism. In all patients, the postoperative course was uneventful.
Conclusions
These preliminary results show that resection of the aortic valve using a circular foldable blade is feasible. This prototype, used during conventional surgery even through a small incision, provided an efficient tool to easily resect the valve without debris release.
In just over a decade, there have been paradigm shifts globally in the catheter-based therapies available for the management of patients with severe aortic stenosis. The use of transcatheter aortic valve replacement (TAVR) has been a crucial turning point in the field of cardiology as it granted an option for a minimally invasive method to replace a valve for patients who may or may not be suitable for cardiac surgery. In this chapter, we discuss the current practices and considerations as well as the ongoing evolution of catheter-based approaches for TAVR. The predominant focus of the chapter will be on aortic valve device modifications, prototypes of valves, device delivery systems, and the various techniques. However, discussions on indications/contraindications, proper work-up, preparation, equipment and personnel , complications, and post-procedural management & surveillance will also be reviewed.
Aortic valve replacement is the mainstay of treatment for symptomatic severe aortic stenosis. In this setting, the rapidly evolving field of transcatheter aortic valve implantation (TAVI) is currently considered a safe alternative to surgical aortic valve replacement in patients with severe aortic stenosis who are considered inoperable or at high surgical risk. This review will focus on recent changes in the field of TAVI, describing patient selection, valve types, procedural approaches, short and long-term outcomes, and complications. The rapid evolution of TAVI procedures supported by solid evidence will, in the near future, probably extend the indications to a wider portion of patients with aortic stenosis.
Transcatheter aortic valve replacement (TAVR) is an alternative treatment for selected patients with severe aortic valve stenosis who are at high risk for conventional surgery. Critical stenosis of left main coronary artery as a late complication after TAVR is quite rare.
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.
During the last decade, transcatheter aortic valve implantation (TAVI) has become a revolution in the treatment of high-risk severe aortic stenosis (AS). Current guidelines provide a Class I indication for TAVI in inoperable AS and Class IIa indication for TAVI as an alternative to surgical repair in high-risk patients. A large amount of retrospective, prospective, and randomised data has been published covering almost every angle of the procedure. Improved patient evaluation and selection, new devices, and technical refinements will reduce procedural complications and improve long-term outcomes. With a growing elderly population segment in the Western countries, the procedure has a bright perspective. The purpose of this review is to summarise the state of the art of TAVI procedures, including current indications, and describe procedural characteristics, as well as short and long-term outcomes. Controversial issues such as paravalvular regurgitation and stroke are discussed, as well as off-label indications. A shift towards intermediate risk AS patients, approval of some of the off-label indications, and device versus device competition are some of the future directions of the technique.
Objective: The optimal risk assessment of coronary obstruction (CO) during balloon-expandable transcatheter aortic valve replacement (TAVR) has not been established in patients with severe aortic stenosis of native aortic valve. We aimed to retrospectively determine the anatomical features of native aortic valve associated with CO during balloon-expandable TAVR.
Methods: Between June 2010 and December 2019, 279 consecutive patients with symptomatic severe aortic stenosis of native aortic valve were treated with a SAPIEN XT or SAPIEN 3 valve. Coronary angiography was performed in patients with suspected CO on aortograms or transesophageal echocardiograms. Subsequently, intravascular ultrasound was performed to confirm the presence of CO. In patients whom preprocedural contrast-enhanced computed tomography (CT) measurements were obtained, we compared the anatomical parameters between those with and without CO.
Results: Four patients (1.4%) had significant stenosis at the left coronary artery (LCA) ostium and underwent stent deployment, and 7 patients (2.5%) had mild stenosis at the LCA ostium and underwent conservative treatment. Preprocedural contrast-enhanced CT measurements were obtained in 234 patients (83.9%), showing that the incidence of CO was not significantly different between patients with both left coronary height <12 mm and left sinuses of Valsalva diameter <30 mm and the remaining patients (4.4% [2/45 patients] vs. 4.8% [9/189 patients], P >0.99), but was significantly higher in patients with both the left leaflet length to coronary distance ratio (LCR) >1 and the left projected virtual transcatheter valve to coronary ostium distance (p-VTC) <4 mm than in the remaining patients (31.8% [7/22 patients] vs. 1.9% [4/212 patients], P <0.001).
Conclusion: The left LCR >1 and the left p-VTC <4 mm may be associated with CO during balloon-expandable TAVR.
Background:
Early hypoattenuated leaflet thickening (HALT) occurs in at least 10% of all transcatheter aortic valve replacement (TAVR) patients. The long-term prognostic impact of HALT is uncertain.
Objectives:
The aim of this study was to assess the long-term risk of early HALT post-TAVR.
Methods:
We report outcome data from our prospective observational registry with post-TAVR computed tomography angiography performed between May 2012 and December 2017. The outcomes were survival, cardiovascular mortality, ischemic cerebrovascular events, and symptomatic hemodynamic valve deterioration.
Results:
Early HALT was diagnosed in 115 (16.0%) of 804 patients. During a median follow-up of 3.25 years, survival rates did not differ significantly between patients with and without HALT (Kaplan-Meier 3-year estimates for survival 70.1% vs 74.0%, P = 0.597). The 3-year cardiovascular mortality rate was 13.2% versus 11.3% (with vs without HALT, P = 0.733). The 3-year event rate for cerebrovascular events was 2.0% versus 4.4% (with vs without HALT, P = 0.246), and the 3-year event rate of symptomatic hemodynamic valve deterioration was 9.4% versus 1.5% (with vs without HALT, P < 0.001). Multivariable analysis revealed the following predictors of symptomatic hemodynamic valve deterioration: HALT (HR: 6.10; 95% CI: 2.59-14.29; P < 0.001), the mixed valve-type group (HR: 6.51; 95% CI: 2.38-17.81; P < 0.001), and prosthesis diameter (HR valve size per 3 mm [HR: 0.37; 95% CI: 0.17-0.79]; P = 0.011).
Conclusions:
During a median follow-up of more than 3 years, HALT was not associated with mortality or cerebrovascular events. However, we observed an association of HALT with symptomatic hemodynamic valve deterioration.
Transcatheter aortic valve implantation (TAVI) is a breakthrough technology to replace the aortic valve in patients with severe aortic stenosis using simple cardiac catheterization instead of thoracic surgery. Initiated 20 years ago by my colleagues and me, TAVI has been performed in >1.5 million patients globally and has profoundly altered the landscape of cardiovascular medicine.
Background
Coronary obstruction during transcatheter aortic valve replacement (TAVR) is a rare, yet life-threatening, complication. The routine use of left main (LM) protection with or without stent placement in high-risk patients remains controversial. The aim of this study was to evaluate the outcomes of LM protection during TAVR and identify anatomic factors associated with need for stent placement.
Methods
We retrospectively reviewed all TAVR cases (native and valve-in-valve) performed in our institution between 2014 and 2019 and identified patients who underwent LM protection with a coronary wire, balloon, and/or stent during the procedure. We compared the pre-TAVR computed tomography aortic root characteristics, procedural data, short-, and long-term outcomes among the patients who eventually received an LM stent and those who did not.
Results
Among 1925 TAVR patients, 41 (2.1%) underwent LM protection, and 10 of them (25%) had eventually a stent placed in the LM for threatened obstruction after valve deployment. In the native TAVR group (n = 35), 8 patients underwent LM stenting. A larger TAVR prosthesis, larger annular circumference (83.8 vs 76.1 mm, P = .038), lower ratio of sinotubular junction diameter to prosthesis size (1.02 vs 1.11; P = .032), and longer left coronary cusp (15.1 vs 13.9 mm, P = .18) were associated with higher incidence of LM stenting. In the valve-in-valve TAVR group (n = 6), 5 patients had a valve-to-coronary distance of less than 4 mm, and 2 of them received an LM stent. Both stent and nonstent groups had excellent outcomes with no major adverse cardiovascular events or coronary obstruction at 30 days. After a median follow-up of 351 days, 4 patients died (9.7%) (1 in the stent and 3 in the nonstent group), without any cases of late coronary obstruction or percutaneous coronary intervention in either group.
Conclusions
LM protection with a coronary guidewire, balloon, or stent is a safe and effective method of coronary protection during TAVR in appropriately selected high-risk patients. Annular circumference, prosthesis size, left coronary cusp length, LM ostial height, and ratio of sinotubular junction to prosthesis size are important predictors of stent deployment.
Objective
General anesthesia is associated with inherent risks that can be avoided by the use of lesser invasive anesthetic strategies. We hypothesize that examine and compare the use of local or regional anesthesia (LRA to general anesthesia (GA) in patients undergoing thoracic endovascular aortic repair (TEVAR).
Methods
Patients undergoing TEVAR between 2010-2020 in the Vascular Quality Initiative were analyzed. Exclusion criteria included receipt of branched or physician modified endografts and devices extending distally beyond Zone 5. Patients were categorized as receiving LRA or GA. Center volume was reported by quartile according to annualized TEVAR volume and operative outcomes were compared using appropriate frequentists tests. Univariable and multivariable regression models for anesthesia type and operative outcomes were created to compare unadjusted and adjusted rates of each outcome. Long-term survival was estimated using a Kaplan-Meier survival estimator, while adjusted survival analysis was performed using a Cox proportional-hazards model.
Results
Of the 17,099 patients who underwent TEVAR, 7,299 met the inclusion and exclusion criteria. Of these, 3.8% received LRA. There were no significant differences in the annual proportion of patients who received LRA from 2011 to 2020 (p = 0.49, Chi-square test for trend). Only 18.8% of patients who received LRA were treated at the highest quartile volume centers. Patients who received LRA were older and more comorbid compared to those who received GA. There were no differences in in-hospital mortality (OR = 0.79, 95% CI 0.42 to 1.38, p = 0.44) or composite of any complication (OR = 0.79, 95% CI 0.54 to 1.14, p = 0.22) between patients who received LRA compared to GA. This also applied to patients presenting with rupture. Receipt of LRA was associated with lower odds of post-operative congestive heart failure (OR = 0.19, 95% CI 0.01 to 0.89, p = 0.01) as well as decreased length of ICU (OR = 0.54, 95% CI 0.40 to 0.72, p < 0.01) and hospital length of stay (OR = 0.64, 95% CI 0.46 to 0.84, p < 0.01). LRA was not associated with decreased long-term survival compared to GA (HR 0.95, 95% CI 0.72 to 1.25, p = 0.72).
Conclusion
Despite a greater number of baseline comorbidities, patients undergoing TEVAR with LRA experienced shorter ICU and post-operative lengths of stay, with similar operative outcomes and long-term survival compared to patients who received GA.. Similar findings were found amongst the rupture cohort. LRA should be considered more frequently in select patients undergoing TEVAR.
Transfemoral is the most widely used access to perform transcatheter aortic valve replacement (TAVR). However, alternative access is needed in up to 21% of patients with TAVR because of a myriad of factors. The authors provide a comprehensive review on alternative access for TAVR, discussing the relevant data and providing the pros and cons of each access route.
Background
The use of transcatheter aortic valve replacement (TAVR) in cancer survivors and patients with active cancer (AC) in cancer survivors and patients with active cancer (AC) is expanding, suggesting a need to adjust the indications and risk assessment pre-TAVR.
Objectives
The purpose of this study was to determine the impact of cancer on peri-procedural complications and survival in a long-term, single-center cohort of patients treated with TAVR.
Methods
Patients treated with TAVR between January 2006 and December 2018 were grouped as follows: controls (patients without cancer), stable cancer (SC), and AC. The primary endpoints were peri-procedural complications and 30-day survival. A secondary endpoint was 10-year survival.
Results
A total of 1,088 patients (age 81 ± 5 years, 46.6% men) treated with transfemoral TAVR were selected: 839 controls, 196 SC, and 53 AC. Predominant malignancies were breast, gastrointestinal, and prostate cancer. No differences were observed between patients with cancer and controls regarding peri-procedural complications. Patients with AC had similar 30-day survival compared with controls and SC (94.3% vs. 93.3% vs. 96.9%, p = 0.161), but as expected, reduced 10-year survival. AC was associated with a 1.47 (95% CI 1.16 to 1.87) fold increased risk of all-cause 10-year mortality in multivariable adjusted models.
Conclusions
TAVR should be performed in patients with cancer when indicated, considering that patients with cancer have similar periprocedural complications and short-term survival compared with control patients. However, patients with AC have worse 10-year survival. Future studies are needed to define cancer-specific determinants of worse long-term survival.
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.
Background
Transcatheter aortic-valve implantation (TAVI) has become an essential alternative to surgical aortic-valve replacement in the treatment of symptomatic severe aortic stenosis, and this procedure requires technical expertise. The aim of this study was to identify prospective studies on TAVI from the past 10 years, and then to analyze the quality of information reported about the learning curve.
Materials and methods
A systematic review of articles published between 2007 and 2017 was performed using PubMed and the EMBASE database. Prospective studies regarding TAVI were included. The quality of information reported about the learning curve was evaluated using the following criteria: mention of the learning curve, the description of a roll-in phase, the involvement of a proctor, and the number of patients suggested to maintain skills.
Results
A total of sixty-eight studies met the selection criteria and were suitable for analysis. The learning curve was addressed in approximately half of the articles ( n = 37, 54 percent). However, the roll-in period was mentioned by only eight studies (12 percent) and with very few details. Furthermore, a proctorship was disclosed in three articles (4 percent) whereas twenty-five studies (37 percent) included authors that were proctors for manufacturers of TAVI.
Conclusion
Many prospective studies on TAVI over the past 10 years mention learning curves as a core component of successful TAVI procedures. However, the quality of information reported about the learning curve is relatively poor, and uniform guidance on how to properly assess the learning curve is still missing.
Aims:
The purpose of this registry was to determine the long-term outcomes in patients with asymptomatic contained annulus rupture (CR) as a rare complication of transcatheter aortic valve implantation (TAVI).
Methods and results:
The ENCORE-registry is a multicenter registry (6 centers across Europe) of patients with CR diagnosed on post-TAVI computed tomography angiography (CTA) or transoesophageal echocardiography (TEE). A total of 21 patients (mean age 81.9±4.1 years, 81% balloon-expandable TAVI-prostheses) were diagnosed with CR (mean size of lesions was 15.3±6.9 x 8.5±3.3 x 8.5±2.3 mm). Seventeen were diagnosed among a total of 1602 consecutive routine post-TAVI CTA (incidence 1.1%), two in TEE and two in post-TAVI CTA (each conducted due to suspicion of peri-interventional complications). During a mean follow-up of 2.3±1.7 years (cumulative 48.6 patient years) nine patients (43%) died from non-cardiac causes. None of the patients exhibited symptoms or underwent interventional treatment related to the CR, no sudden cardiac death occurred. A follow-up CTA, performed in eleven patients 240±176 days post-TAVI, revealed stable CR findings in seven, regression in one, and remission in three patients.
Conclusions:
The results of our international multicenter registry demonstrate favourable long-term outcomes of CR after TAVI supporting a watch-and-wait strategy in these patients.
Die Aortenklappenstenose als häufigste Herzklappenerkrankung des älteren Menschen wird bei zunehmender Lebenserwartung der Bevölkerung eine steigende Prävalenz zeigen. Die einzig kausale Therapie besteht im Ersatz der Aortenklappe, wobei ca. 30% der Patienten auf Grund von Komorbiditäten der chirurgische Aortenklappenersatz verwehrt bleibt. Die kathetergestützte Aortenklappenimplantation als risikoärmere Therapiealternative zum konventionellen Klappenersatz wird immer mehr an Bedeutung gewinnen und wurde bereits durch umfangreiche Studien bei Hochrisiko-Patienten und Patienten mit mittlerem Operationsrisiko als ebenbürtiges Verfahren hinsichtlich Outcome und Mortalität validiert. Die postprozedurale Klappenfunktion und somit der langfristige Operationserfolg wird durch diverse Faktoren beeinflusst. Ziel dieser Studie war die Evaluation der postinterventionellen Exzentrizität der implantierten Prothese. Hierbei wurde der Einfluss der präinterventionellen Geometrie des Aortenannulus, der Einfluss des Prothesentyps (ballonexpandierbar vs. selbstexpandierend) sowie der Einfluss der Verkalkung des Aortenklappenapparats auf die Exzentrizität der implantierten Prothese untersucht. Dazu wurden die CT-Datensätze von insgesamt 80 Patienten, welche auf Grund einer hochgradigen Aortenklappenstenose der kathetergestützten Aortenklappenimplantation zugeführt wurden, an zwei Studienorten prä- und postinterventionell hinsichtlich der Geometrie des Aortenannulus bzw. Prothesenrings und Grad der Verkalkung des nativen Aortenannulus ausgewertet. Die Messung der Dimensionen des Aortenannulus erfolgte nach multiplanarer Rekonstruktion durch zwei unabhängige Untersucher. Der Grad der Verkalkung wurde quantitativ mittels Agatston-Score bestimmt, die Verteilung der Verkalkung wurde semiquantitativ mittels visuellen Analogskalen bewertet. Es zeigte sich ein signifikanter Unterschied in der postinterventionellen Exzentrizität zwischen der ballonexpandierenden und der selbstexpandierenden Prothese, wobei nach Implantation einer ballonexpandierbaren Prothese die Exzentrizität deutlich geringer war. Insgesamt verringerte sich jedoch bei allen Patienten die Exzentrizität postinterventionell signifikant. Der Grad der Verkalkung, quantitativ gemessen mittels Agatston-Score, hatte einen signifikanten Einfluss auf die postinterventionelle Exzentrizität. Insbesondere bei Verwendung der selbstexpandierenden Prothese zeigte sich hierbei eine positive Korrelation zwischen hoher Kalklast und hoher Exzentrizität. Bei Patienten, welche eine ballonexpandierbare Prothese erhielten, zeigte sich eine geringere Exzentrizität der implantierten Prothese als bei Patienten, welche eine selbstexpandierende Prothese erhielten. Das Ausmaß der Verkalkung des nativen Aortenannulus beeinflusst die Exzentrizität der implantierten Prothese signifikant. In wie fern ein exzentrisches Prothesengerüst langfristig ausschlaggebend für das Auftreten einer postinterventionellen Aortenklappeninsuffizienz ist, bleibt in prospektiven Studien zu klären.
Importance
Medically treated symptomatic severe aortic stenosis has poor outcomes, and in the past 6 decades, it has successfully been treated with surgical aortic valve replacement (SAVR). However, one-third of patients with indications for SAVR are not offered surgery because of the high risk of complications. Transcatheter aortic valve replacement (TAVR), initially developed as a less invasive treatment for inoperable patients, has successfully been used in healthier patient cohorts. In 2017, TAVR became the most common approach for aortic valve replacement in the United States.
Observations
During the past decade, the Placement of Aortic Transcatheter Valve (PARTNER) trials (for balloon-expandable valves) and the CoreValve trials (for self-expandable valves) investigated the performance of TAVR in progressively lower-risk patient cohorts. The initial trials demonstrated TAVR to be superior (PARTNER B) and noninferior (CoreValve Extreme Risk) to optimal medical therapy in inoperable patients. Subsequent trials showed both balloon-expandable and self-expandable valves to have good results in high-risk, medium-risk, and low-risk surgical patients when compared with SAVR. However, owing to the fundamentally different nature of the procedure, some complications have been more prevalent with TAVR, most notably moderate or severe paravalvular leak, conduction abnormalities necessitating permanent pacemaker placement, and vascular complications. When present, these complications have been associated with worse outcomes.
Conclusions and Relevance
The results of the groundbreaking TAVR trials from the past decade have led to a revolution in the treatment of aortic stenosis. There are now 3 US Food and Drug Administration–approved TAVR devices, and with the encouraging results from the latest low-risk trials, TAVR is likely going to become the dominant treatment for symptomatic severe aortic stenosis. New devices on the horizon are looking to improve the complication rates of TAVR, and ongoing trials are looking to further expand the indications of TAVR and answer 1 of the main remaining questions, ie, long-term durability of percutaneously placed devices.
Aims:
To critically review the available transcatheter aortic valve implantation techniques and their results, as well as propose recommendations for their use and development.
Methods and results:
A committee of experts including European Association of Cardio-Thoracic Surgery and European Society of Cardiology representatives met to reach a consensus based on the analysis of the available data obtained with transcatheter aortic valve implantation and their own experience. The evidence suggests that this technique is feasible and provides haemodynamic and clinical improvement for up to 2 years in patients with severe symptomatic aortic stenosis at high risk or with contraindications for surgery. Questions remain mainly concerning safety and long-term durability, which have to be assessed. Surgeons and cardiologists working as a team should select candidates, perform the procedure, and assess the results. Today, the use of this technique should be restricted to high-risk patients or those with contraindications for surgery. However, this may be extended to lower risk patients if the initial promise holds to be true after careful evaluation.
Conclusion:
Transcatheter aortic valve implantation is a promising technique, which may offer an alternative to conventional surgery for high-risk patients with aortic stenosis. Today, careful evaluation is needed to avoid the risk of uncontrolled diffusion.
To construct a scoring system for the prediction of early mortality in cardiac surgical patients in Europe on the basis of objective risk factors.
The EuroSCORE database was divided into developmental and validation subsets. In the former, risk factors deemed to be objective, credible, obtainable and difficult to falsify were weighted on the basis of regression analysis. An additive score of predicted mortality was constructed. Its calibration and discrimination characteristics were assessed in the validation dataset. Thresholds were defined to distinguish low, moderate and high risk groups.
The developmental dataset had 13,302 patients, calibration by Hosmer Lemeshow Chi square was (8) = 8.26 (P < 0.40) and discrimination by area under ROC curve was 0.79. The validation dataset had 1479 patients, calibration Chi square (10) = 7.5, P < 0.68 and the area under the ROC curve was 0.76. The scoring system identified three groups of risk factors with their weights (additive % predicted mortality) in brackets. Patient-related factors were age over 60 (one per 5 years or part thereof), female (1), chronic pulmonary disease (1), extracardiac arteriopathy (2), neurological dysfunction (2), previous cardiac surgery (3), serum creatinine >200 micromol/l (2), active endocarditis (3) and critical preoperative state (3). Cardiac factors were unstable angina on intravenous nitrates (2), reduced left ventricular ejection fraction (30-50%: 1, <30%: 3), recent (<90 days) myocardial infarction (2) and pulmonary systolic pressure >60 mmHg (2). Operation-related factors were emergency (2), other than isolated coronary surgery (2), thoracic aorta surgery (3) and surgery for postinfarct septal rupture (4). The scoring system was then applied to three risk groups. The low risk group (EuroSCORE 1-2) had 4529 patients with 36 deaths (0.8%), 95% confidence limits for observed mortality (0.56-1.10) and for expected mortality (1.27-1.29). The medium risk group (EuroSCORE 3-5) had 5977 patients with 182 deaths (3%), observed mortality (2.62-3.51), predicted (2.90-2.94). The high risk group (EuroSCORE 6 plus) had 4293 patients with 480 deaths (11.2%) observed mortality (10.25-12.16), predicted (10.93-11.54). Overall, there were 698 deaths in 14,799 patients (4.7%), observed mortality (4.37-5.06), predicted (4.72-4.95).
EuroSCORE is a simple, objective and up-to-date system for assessing heart surgery, soundly based on one of the largest, most complete and accurate databases in European cardiac surgical history. We recommend its widespread use.
Background —The optimal management of aortic valve disease in patients >80 years old depends on functional outcome as well as operative risks and late survival.
Methods and Results —We retrospectively identified 133 patients (62 men, 71 women) aged 80 to 91 years (mean 84±3 years) who underwent aortic valve replacement alone or in combination with another procedure between January 1, 1993, and April 31, 1998. Demographics included hypertension 68%, diabetes mellitus 17%, and history of stroke 11%. Operative (30 day) mortality rate was 11%. Urgent or emergent surgery, aortic insufficiency, and perioperative stroke or renal dysfunction were risk factors for operative death by multivariable analysis. Intensive care unit and total hospital length of stay were prolonged at 6.2 and 14.7 days, respectively. Late follow-up between July 1, 1998, and November 1, 1999, was 98% complete. Actuarial survival at 1 and 5 years was 80% and 55%, respectively. Predictors of late mortality were preoperative or perioperative stroke, chronic obstructive pulmonary disease, aortic stenosis, and postoperative renal dysfunction. The mean New York Heart Association functional class for 65 long-term survivors improved from 3.1 to 1.7. Quality of life assessed with the Medical Outcomes Study Short Form-36 was comparable to that predicted for the general population >75 years old.
Conclusions —Functional outcome after aortic valve replacement in patients >80 years old is excellent, the operative risk is acceptable, and the late survival rate is good. Surgery should not be withheld from the elderly on the basis of age alone.
The color Doppler echocardiographic studies and aortic angiograms of all patients who had these procedures performed within 2 weeks of each other between October 1984 and August 1985 were reviewed to determine whether any parameters of the regurgitant jet visualized by color Doppler study predicted the severity of aortic insufficiency as assessed by angiographic grading. Patients with an aortic valve prosthesis were excluded. Twenty-nine patients had aortic insufficiency and had adequate color Doppler studies for analysis. The mean time between color Doppler examination and angiography was 2.3 days (range 0 to 12).The maximal length and area of the regurgitant jet were poorly predictive of the angiographic grade of aortic insufficiency. The short-axis area of the regurgitant jet from the parasternal short-axis view at the level of the high left ventricular outflow tract relative to the short-axis area of the left ventricular outflow tract at the same location best predicted angiographic grade, correctly classifying 23 of 24 patients. However, the jet could be seen from this view in only 24 of the 29 patients. The height of the regurgitant jet relative to left ventricular outflow tract height measured from the parasternal long-axis view just beneath the aortic valve correctly classified 23 of the 29 patients. Mitral stenosis or valve prosthesis, which was present in 10 patients, did not interfere with the diagnosis or quantitation of aortic insufficiency by these methods.The thickness of the regurgitant stream at its origin relative to the size of the left ventricular outflow tract is a better predictor of the severity of aortic insufficiency as judged by angiographic grading than is the area of the regurgitant jet or the depth to which the jet extends in the left ventricle.
Porcine bioprostheses have been recommended and used for cardiac valve replacement in the elderly. A review of 1,984 patients with 2,042 operations, performed between 1975 and 1992, has afforded a detailed evaluation of clinical performance by valve positions and age groups within the elderly population. The numbers of operations performed by age groups were 65 to 69 years, 719; 70 to 74 years, 745; 75 to 79 years, 431; 80 to 84 years, 119; and 85 years or older, 28. The early mortality rate overall was 9.5% (195 patients), range 6.9% to 17.8% by age groups (p < 0.05), and 11.9% with concomitant procedures and 7.6% without (p < 0.05). The total cumulative follow-up was 10,060 patient-years (mean, 4.9 years). The late mortality rate was 7.0%/patient-year (for age groups, 5.8% to 13.4%/patient-year) (p = not significant). The patient survival at 15 years ranged from 25% +/- 4% for 65 to 69 years to 9% +/- 5% for 75 to 79 years (p < 0.05). The freedom from valve-related complications and composites at 10 years revealed differences (p < 0.05) by age groups only for structural valve deterioration: 85% +/- 2% for 65 to 69 years versus 98% +/- 2% for 80 to 84 years. The overall freedom from structural valve deterioration at 10 years for aortic valve replacement was 98% +/- 1%; for mitral valve replacement, 79% +/- 3%; and for multiple replacement, 86% +/- 7% (p < 0.05, aortic valve replacement > mitral valve replacement).(ABSTRACT TRUNCATED AT 250 WORDS)
A new artificial aortic valve prosthesis was developed for implantation by the transluminal catheter technique without thoracotomy or extracorporal circulation. The new heart valve was prepared by mounting a porcine aortic valve into an expandable stent. Before implantation, the stent-valve was mounted on a balloon catheter and compressed around the deflated balloon. The stent-valve mounted balloon catheter was then advanced retrogradely to the ascending aorta or the aortic root in anaesthetized pigs. Implantation was performed by balloon inflation which expanded the stent-valve to a diameter exceeding the internal diameter of the vessel--thus ensuring a stable fixation against the vessel wall. A total of nine implantations were performed in seven 70 kg closed chest pigs. Sub- and supracoronary implantation was performed in two and three pigs, respectively, while implantation in both positions was done in two. Angiographic and haemodynamic evaluation after implantation revealed no significant stenosis (less than or equal to 16 mmHg) in any of the nine valves and trivial regurgitation in only two. Complications were associated with restriction of the coronary blood flow in three animals. This preliminary study indicates that artificial aortic valves can be implanted in closed chest animals by transluminal catheter technique.
Percutaneous balloon aortic valvuloplasty was used to prospectively treat 492 elderly, symptomatic, nonsurgical patients suffering from severe aortic stenosis in 27 centers in North America and Europe. At 1 year the overall survival rate was 64% and the event-free survival rate (survival free of valve replacement or repeat valvuloplasty) was 43%. Clinical, catheterization and procedural variables were assessed to define prognostic variables. Univariate analysis revealed that patients who survived had a lesser frequency of previous myocardial infarction (2% versus 6%, p less than 0.005), lower incidence of severe ventricular dysfunction (22% versus 48%, p less than 0.001) and lower incidence of symptoms of heart failure (60% versus 75%, p less than 0.02). History of angina (56% versus 45%, p = NS) and syncope (23% versus 16%, p = NS) were similar for both groups. Values obtained at cardiac catheterization that differed in survivors and nonsurvivors included lower pulmonary artery systolic pressure (43 +/- 1 versus 54 +/- 2 mm Hg, p less than 0.001), lower mean pulmonary artery pressure (28 +/- 1.0 versus 36 +/- 1.0 mm Hg, p less than 0.001) and larger initial valve area (0.52 +/- 0.01 versus 0.47 +/- 0.02 cm2, p = 0.006). Discriminate function analysis was performed to identify variables that independently predicted improved probability of survival. Eight variables were significantly and independently predictive. These included age, initial cardiac output, initial left ventricular systolic pressures, initial left ventricular end-diastolic pressures, presence of coronary artery disease, New York Heart Association dyspnea classification, number of balloon inflations and final valve area.(ABSTRACT TRUNCATED AT 250 WORDS)
Percutaneous balloon aortic valvuloplasty has been accompanied by significant early periprocedural morbidity and mortality. Identification of factors associated with increased mortality might allow for improved selection of patients. The Mansfield Scientific Balloon Aortic Valvuloplasty Registry was analyzed to identify the frequency of in-hospital death and the factors associated with it. Of 492 patients undergoing the procedure, 37 (7.5%) died during the hospital stay in which valvuloplasty was performed. Twenty-four of these patients died within the first 24 h and the remainder died within 7 days after the procedure. There were significant differences in baseline clinical and hemodynamic characteristics as well as procedural and postprocedural variables between patients dying and those surviving the in-hospital period. Multivariate analysis identified four factors associated with increased mortality: 1) the occurrence of a procedure-related complication, 2) a lower initial left ventricular systolic pressure, 3) a smaller final aortic valve area, and 4) a lower baseline cardiac output. Thus, baseline hemodynamic, procedural and postprocedural variables and complications can be identified that are associated with increased mortality.
Balloon aortic valvuloplasty was developed as an alternative to aortic-valve replacement in selected elderly patients with aortic stenosis. The use of this procedure is limited, however, by a high incidence of restenosis.
Between December 1985 and April 1989, valvuloplasty was performed in 205 patients. We evaluated 40 demographic and hemodynamic variables as univariate predictors of event-free survival by Cox regression analysis and identified independent predictors of event-free survival by stepwise multivariate analysis.
Early hemodynamic results indicated a decrease in the peak transaortic-valve pressure gradient from 67 +/- 28 to 33 +/- 15 mm Hg after valvuloplasty and an increase in aortic-valve area from 0.6 +/- 0.2 to 0.9 +/- 0.3 cm2 (P less than 0.001 for both comparisons). The rate of event-free survival (defined as survival without recurrent symptoms, repeated valvuloplasty, or aortic-valve replacement) was 18 percent over the mean (+/- SD) follow-up period of 24 +/- 12 months (range, 1 to 47). Significant predictors of event-free survival included the left ventricular ejection fraction and the left ventricular and aortic systolic pressure before valvuloplasty, and the percent reduction in the aortic-valve pressure gradient; the pulmonary-capillary wedge pressure was inversely associated with event-free survival. Although the predicted event-free survival rate for the entire patient group was 50 percent at one year (95 percent confidence interval, 43 to 57 percent) and 25 percent at two years (95 percent confidence interval, 19 to 31 percent), the probability of event-free survival at one year varied between 23 and 65 percent when patients were stratified according to three independent predictors: the aortic systolic pressure, the pulmonary-capillary wedge pressure, and the percent reduction in the peak aortic-valve gradient.
The most important predictors of event-free survival after balloon aortic valvuloplasty were related to base-line left ventricular performance. The best long-term results after valvuloplasty were observed among patients who would also have been expected to have excellent long-term results after aortic-valve replacement.
Aortic regurgitation and mitral stenosis are hemodynamically similar, insofar as both result in passive ventricular filling across a narrow orifice driven by a declining pressure gradient. Because mitral stenosis is successfully characterized by Doppler ultrasound determination of the velocity half-time, or time constant, aortic regurgitation might be quantified in an analogous fashion. Eighty-six patients with diverse causes of aortic regurgitation underwent continuous wave Doppler examination before cardiac catheterization or urgent aortic valve replacement. The Doppler velocity half-time was defined as the time required for the diastolic aortic regurgitation velocity profile to decay by 29%, whereas catheterization pressure half-time was calculated as the time required for transvalvular pressure to decay by 50%. Doppler velocity and catheterization pressure half-times were linearly related (r = 0.91). Doppler velocity half-times were inversely related to regurgitant fraction (r = -0.88). Angiographic severity (1+ = mild to 4+ = severe) was also inversely related to pressure and velocity half-time; a Doppler half-time threshold of 400 ms separated mild (1+, 2+) from significant (3+, 4+) aortic regurgitation with high specificity (0.92) and predictive value (0.90). The Doppler velocity half-time was independent of pulse pressure, mean arterial pressure, ejection fraction and left ventricular end-diastolic pressure. Estimation of transvalvular aortic pressure half-time utilizing continuous wave Doppler ultrasound is a reliable and accurate method for the noninvasive evaluation of the severity of aortic regurgitation.
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.
To identify predictors of long-term outcome after balloon aortic valvuloplasty, we analyzed data on 674 adults (mean age, 78 +/- 9 years; 56% were women) undergoing this procedure at 24 clinical centers who had a mean initial increase in aortic valve area of 0.3 cm2.
Baseline data included clinical, echocardiographic, and catheterization variables. Follow-up data included mortality, cause of death, rehospitalization, 6-month echocardiography, and functional status. Kaplan-Meier curves and log-rank tests were used to evaluate survival in subgroups. Multivariate Cox regression models were used to identify independent predictors of survival. Overall survival was 55% at 1 year, 35% at 2 years, and 23% at 3 years, with the majority of deaths (70%) classified as cardiac by an independent review committee. Rehospitalization was common (64%), although 61% of survivors at 2 years reported improved symptoms. Echocardiography at 6 months (n = 115) showed restenosis from the postprocedural valve area of 0.78 +/- 0.31 cm2 to 0.65 +/- 0.25 cm2 (P < .0001). With stepwise multivariate analysis, sequentially adding clinical, echocardiographic, and catheterization variables, the overall model identified independent predictors of survival as baseline functional status, baseline cardiac output, renal function, cachexia, female gender, left ventricular systolic function, and mitral regurgitation. Baseline and postprocedural variables were examined to identify which subgroup of patients has the best outcome after aortic valvuloplasty. A "lower-risk" subgroup (28% of the study population), defined by normal left ventricular systolic function and mild clinical functional limitation, had a 3-year survival of 36% compared with 17% in the remainder of the study group.
Long-term survival after balloon aortic valvuloplasty is poor with 1- and 3-year survival rates of 55% and 23%, respectively. Although survivors report fewer symptoms, early restenosis and recurrent hospitalization are common.
Over the past 30 years there have been experimental efforts at catheter-based management of aortic valve regurgitation with the idea of extending treatment to nonsurgical candidates. A new catheter-based aortic valve design is described.
The new catheter-delivered valve consists of a stent-based valve cage with locking mechanism and a prosthetic flexible tilting valve disc. The valve cage is delivered first followed by deployment and locking of the disc. In acute experiments, valve implantation was done in four dogs.
Valve implantation was successful in all four animals. The implanted valve functioned well for the duration of the experiments (up to 3 hr).
The study showed the implantation feasibility and short-term function of the tested catheter-based aortic disc valve. Further experimental studies are warranted.
The optimal management of aortic valve disease in patients >80 years old depends on functional outcome as well as operative risks and late survival.
We retrospectively identified 133 patients (62 men, 71 women) aged 80 to 91 years (mean 84+/-3 years) who underwent aortic valve replacement alone or in combination with another procedure between January 1, 1993, and April 31, 1998. Demographics included hypertension 68%, diabetes mellitus 17%, and history of stroke 11%. Operative (30 day) mortality rate was 11%. Urgent or emergent surgery, aortic insufficiency, and perioperative stroke or renal dysfunction were risk factors for operative death by multivariable analysis. Intensive care unit and total hospital length of stay were prolonged at 6.2 and 14.7 days, respectively. Late follow-up between July 1, 1998, and November 1, 1999, was 98% complete. Actuarial survival at 1 and 5 years was 80% and 55%, respectively. Predictors of late mortality were preoperative or perioperative stroke, chronic obstructive pulmonary disease, aortic stenosis, and postoperative renal dysfunction. The mean New York Heart Association functional class for 65 long-term survivors improved from 3.1 to 1.7. Quality of life assessed with the Medical Outcomes Study Short Form-36 was comparable to that predicted for the general population >75 years old.
Functional outcome after aortic valve replacement in patients >80 years old is excellent, the operative risk is acceptable, and the late survival rate is good. Surgery should not be withheld from the elderly on the basis of age alone.
As the population ages, aortic valve replacement, particularly for aortic stenosis, has become more common. Although many patients have considerable coexisting morbidity, almost all symptomatic patients are candidates for surgery. Once symptoms develop, surgery should not be unduly delayed, because the operative mortality clearly increases in the presence of poor left ventricular function, heart failure, and New York Heart Association Class III or IV symptoms. Operative difficulties often are related to fragile tissues, a small aortic annulus, and extensive calcification of the aortic annulus and root. In the author's experience, approximately 10% of these patients undergo aortic annulus and root enlargement using pericardium. A tissue valve is the preferred prosthesis. Operative mortality for elective surgery in patients older than 80 years of age is 4-10%, depending on whether associated procedures are required (eg, coronary artery bypass grafting) or whether the patient has had previous surgery. Postoperative neurologic events are important complications that are more common in the elderly. Outcome after successful surgery is excellent, with a 5-year survival of approximately 60%. The vast majority of patients have an improved symptomatic status.
Aortic valve replacement is a common procedure in elderly patients. There has been a great deal of controversy about the risks associated with early mortality. Uncertainty of the risk associated with a small valve continues to remain controversial. This study was designed to identify the risk factors influencing early mortality and establish an accurate model for the prediction of in-hospital mortality.
One hundred eighty septuagenarians and octogenarians (58% women; mean age, 76 +/- 4.7 years) underwent primary isolated aortic valve replacement between 1986 and 1997. There was an overall mortality of 16.7% (n = 180). Patients with a body surface area less than 1.8 m2 had an in-hospital mortality of 23.2% (n = 95) compared with 8.1% (n = 74; p = 0.009) for patients with a body surface area of 1.8 m2 or more. Patients with a cardiopulmonary bypass time of less than 100 minutes experienced an early mortality of 8.9% (n = 56) compared with a 10.2% (n = 59) early mortality for patients on bypass time between 100 and 124 minutes and a 29.6% (n = 64) early mortality in patients with a pump time longer than 124 minutes (p = 0.040).
Multivariate logistic regression analysis identified small body surface area and long cardiopulmonary bypass time as independent risk factors. A higher mortality was seen in female patients and patients receiving smaller valves. However, there was a strong correlation between small body surface area, small valve size, and female gender.
Small body surface area and long cardiopulmonary bypass time are two independent risk factors in early mortality for elderly patients undergoing primary isolated aortic valve replacement. The use of small valves does not influence early mortality.
Because the elderly are increasingly referred for operation, we reviewed the results of cardiac surgery in patients of 80 years or older.
Records of 182 consecutive octogenarians who had had cardiac operations between 1992 and 1998 were reviewed. Follow-up was 100% complete. Seventy patients had coronary grafting (CABG), 70 aortic valve replacement, 30 aortic valve replacement+CABG, and 12 mitral valve repair/replacement. Rates of hospital death, stroke, and prolonged stay (>14 days) were as follows: CABG: 7 (10%), 2 (2.8%) and 41 (58%); aortic valve replacement: 6 (8.5%), 2 (2.8%) and 32 (45.7%); aortic valve replacement+CABG: 8 (26.5%), 1 (3.8%) and 14 (46.6%); mitral valve repair/replacement: 3 (25%), 1 (8.3%) and 5 (41.6%). Multivariate predictors (P<0.05) of hospital death were New York Heart Association functional class, urgent procedure, prolonged cardiopulmonary bypass time, and, after aortic valve replacement, previous percutaneous aortic valvuloplasty. Ascending aortic atheromatous disease was predictive of stroke, while pre-operative myocardial infarction was predictive of prolonged hospital stay. Actuarial 5-year survival was as follows: CABG, 65.8+/-8.8%; aortic valve replacement, 63.6+/-7.1%; aortic valve replacement+CABG, 62.4+/-6.8%; mitral valve repair/replacement, 57.1+/-5.6%; and total, 63.0+/-5.6%. Multivariate predictors of late death were pre-operative myocardial infarction, and urgent procedure. Ninety percent of long-term survivors were in New York Heart Association class I or II, and 87% believed having a heart operation after age 80 years was a good choice.
Cardiac operations are successful in most octogenarians with increased hospital mortality, and longer hospital stay. Long-term survival and quality of life are good.
To date, the surgical approach is the only option to replace the aortic valve. Percutaneous pulmonary valve replacement has recently opened new perspectives on transcatheter replacement of cardiac valves. We report our experience of aortic valve replacement through a percutaneous technique in lambs.
A bovine jugular vein containing a valve was dissected and sutured into a stent. Twelve lambs were divided into 3 groups. In the first, a valved stent was implanted in the descending aorta after creation of an aortic insufficiency. In the second, the valve was implanted in the native position. In the third, we inserted a valved stent in the native position using an orientation mechanism. All valves were successfully delivered and functioned perfectly in short-term evaluation. All experiments in group 2 failed: 1 valve obstructed the coronary artery orifices, 1 stent was responsible for a major mitral valve insufficiency, and the third implant migrated prematurely. A paraprosthetic leak occurred in the last animal in this group. Animals in group 3 had successful implantation of the valved stent. The orientation mechanism allowed perfect alignment of the device without any damage to the coronary circulation or to mitral valve function.
Nonsurgical implantation of an aortic valve is possible in lambs in the descending aorta and in the native position. An orientation mechanism is obviously needed to avoid obstruction of the coronary orifices. With further improvements, this technique should be feasible in humans.
The purpose of this preliminary study was to devise a new surgical procedure for minimally invasive aortic valve implantation with a transluminal technique.
The new collapsible heart valve was prepared by mounting a porcine aortic valve, taken from a freshly slaughtered pig, into a self-expandable nitinol stent by means of a suture technique. The outer diameter of the valved stent ranged from 15 to 23 mm, and the length ranged from 21 to 28 mm. Before implantation in vivo, these valved stents were tested in an in vitro circulatory system. Only in vitro-tested valved stents with a pressure gradient of less than 7 mm Hg and regurgitation of I degrees or less were used for transluminal aortic valve implantation in vivo. Six of these valved stents were implanted in the descending aorta and 8 in the ascending aorta of anesthetized pigs. The catheter delivery system (22F) was extraperitoneally inserted through the left iliac artery or the infrarenal aorta. Measurements for transvalvular gradient, valvular opening and closure, blood-flow characteristics, regurgitation, and macroscopic analysis were performed at baseline and after the observation period (164 +/- 48 minutes).
This preliminary study contained 14 animals. One animal died of ventricular fibrillation. Technical failure occurred in 2 pigs as a result of stent twisting. At the end of the observation period, the 11 successfully implanted valved stents demonstrated low transvalvular gradients (mean end-systolic Deltarho(max) of 5.4 +/- 3.3 mm Hg for the descending aorta group, 5.4 +/- 1.2 mm Hg for the supracoronary group, and 5.4 +/- 1.1 mm Hg for the subcoronary group), which did not differ from their in vitro gradients. Two-dimensional echocardiography demonstrated complete valvular closure and opening in 5 of 5 cases. Angiography indicated only a physiologic jet of regurgitation (0 degrees ) in 8 animals and mild (I degrees ) regurgitation in 3 animals. Color Doppler ultrasonography indicated no regurgitation in 5 of 5 cases and minor paravalvular leakage in 1 case.
Aortic valved stents can be successfully implanted without thoracotomy by using a transluminal catheter technique. Long-term function of the valves remains to be established.
We assessed the feasibility of percutaneous implantation of a valve in the descending aorta and its function in systemic pressures.
A biological valve harvested from a bovine jugular vein was sutured into a stent. After the creation of aortic insufficiency, the valved stent was percutaneously implanted into eight lambs divided into two groups depending on the severity of the insufficiency created. Haemodynamic and angiographic evaluations were carried out. Anatomical evaluation was finally performed. Aortic insufficiency was created: four lambs had mild insufficiency and four massive insufficiency. A valve was successfully implanted in all and were functioning perfectly in the early follow-up. Despite this competence, animals with massive insufficiency died within 24 h following implantation. None of the animals with mild insufficiency died. The valve was functioning perfectly in the first 2 months following the implantation, but became incompetent after spontaneous healing of the wound of the aortic valve.
Percutaneously implanted valves in the descending aorta of lambs with aortic insufficiency function well in the early follow-up. This technique might become an interesting alternative to the standard approach in patients in whom perioperative risk is high.
To assess the performance of the European System for Cardiac Operative Risk Evaluation (EuroSCORE) when applied in a North American cardiac surgical population.
The simple additive EuroSCORE model was applied to predict operative mortality (in-hospital or 30-day) in 401684 patients undergoing coronary or valve surgery in 1998 and 1999 as well as in 188913 patients undergoing surgery in 1995 in the Society of Thoracic Surgeons (STS) database.
The proportion of isolated coronary artery bypass grafting (CABG) was greater in STS patients (84%) than in Europe (65%). STS patients were also older (mean age 65.3 versus 62.5), and had more diabetes (30 versus 17%) and prior cardiac surgery (11 versus 7%). Other comorbidity was also significantly more prevalent in STS patients. EuroSCORE predicted overall mortality was virtually identical to the observed mortality (1998/1999: predicted 3.994%, observed 3.992%; 1995: observed and predicted 4.156%). Predicted mortality also closely matched observed mortality across the risk groups. Discrimination was good to very good for the population overall and for isolated CABG in both time periods, with the area under the receiver operating characteristic curve between 0.75 and 0.78.
Despite substantial demographic differences between Europe and North America, EuroSCORE performs very well in the STS database, and can be recommended as a simple, additive risk stratification system on both sides of the Atlantic.
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 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 objective of this study was to develop a prosthetic cardiac valve designed for percutaneous transcatheter implantation. Percutaneous catheter-based therapies play a limited role in the management of cardiac valve disease. Surgical implantation of prosthetic valves usually requires thoracotomy and cardiopulmonary bypass. The stent-valve is constructed of a rolled sheet of heat-treated nitinol. Although malleable when cooled, once released from a restraining sheath at body temperature the stent unrolls, becomes rigid, and assumes its predetermined cylindrical conformation. A ratcheting lock-out mechanism prevents recoil and external protrusions facilitate anchoring. Valve leaflets are constructed of bovine pericardium. The feasibility of catheter implantation, prosthetic valve function, and survival were investigated in an animal model. In vitro and pulse duplicator testing documented valve durability. Endovascular delivery of the prototype stent-valve to the aortic or pulmonary position was feasible. Accurate positioning was required to ensure exclusion of the native valve leaflets and, in the case of the aortic valve, to avoid compromise of the coronary ostia or mitral apparatus. Oversizing of the stent in relation to the valve annulus was desirable to facilitate anchoring and prevent paravalvular insufficiency. Stent-valve implantation proved feasible and compatible with survival in an animal model. Transcatheter implantation of prosthetic valves is possible. Further evolution of this technology will involve lower-profile devices with design features that facilitate vascular delivery, visualization, positioning, deployment, and valvular function.
Percutaneous balloon aortic valvuloplasty (BAV) has been limited predominantly to a palliative treatment for poor surgical candidates with critical aortic stenosis and multiple high-risk or comorbid conditions. The most commonly used technique for BAV is the retrograde approach, in which the balloon is passed via the femoral artery using 12-14 Fr sheaths. We compared an antegrade transseptal approach using the Inoue balloon vs. the retrograde transarterial approach using conventional balloons. The antegrade group had an improved acute hemodynamic outcome, including 20% additional increase of aortic valve area and 20% greater reduction of transaortic valve gradient compared to the retrograde approach. Preclosure with the Perclose device was used for the 14 Fr venous access sites, resulting in immediate hemostasis, minimizing the need for transfusion, and diminishing the period of bed rest. The improved acute efficacy and relative ease of venous access for the antegrade approach facilitate BAV by eliminating the need for large-caliber arterial access sheaths. The antegrade approach also incorporates technical elements necessary for percutaneous aortic valve replacement and may have expanded applications as an adjunct to this developing therapy. The impact of improved acute results on the long-term clinical outcome for this patient group will require further study.
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.
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