Transcatheter Aortic Valve Insertion Research Articles

Clinical Outcomes After Transapical and Transfemoral Transcatheter Aortic Valve Insertion: An Evolving Experience

Prior publications note increased adverse events after transapical compared with transfemoral access transcatheter aortic valve insertion (TAVI). We reviewed our TAVI experience to understand the differences in baseline patient characteristics and outcomes associated with the two access methods. The records were reviewed of 567 patients who underwent transfemoral (n= 351, 61.9%) and transapical (n= 216, 38.1%) TAVI from November 2008 through July2015. Compared with patients who underwent transfemoral access, the patients who underwent transapical access were older (82.0 ± 7.5 versus 79.6 ± 9.7 years; p= 0.006), had more peripheral vascular disease (78.2% versus 54.7%; p < 0.001), more previous coronary artery bypass graft operations (50.9% versus 32.5%; p < 0.001), and higher Society of Thoracic Surgeons predicted risk ofmortality (9.4% ± 5.4% versus 8.8% ± 6.5%; p= 0.032). In-hospital and 30-day mortality rates, however, were similar between the two groups (transapical, n= 7, 3.2%; transfemoral, n= 13, 3.7%; p= 0.772). Follow-up echocardiography in 547 (100.0%) surviving patients at a median of 182 days (interquartile range, 35 to 420) demonstrated less paravalvular regurgitation grade of moderate or greater in patients who underwent transapical access (transapical, n= 6, 2.9%; transfemoral, n=35, 10.4%; p= 0.001) but similar ejection fraction in the two groups (transapical, 55.4% ± 12.2%; transfemoral, 55.9% ± 13.0%; p= 0.419). Mortality rates at 1 year (transapical, 19.2% ± 3.0%; transfemoral,14.7% ± 3.2%) and 4 years (transapical, 47.4% ± 6.4%; transfemoral, 42.7% ± 4.9%) were also similar between the two groups (p= 0.342). Transapical and transfemoral transcatheter aortic valve insertions result in similar operative and longer term mortality rates, despite differences in baseline patient risk. The findings support the concept that access does not influence treatment-related mortality rates.

Transfemoral transcatheter aortic valve insertion-related intraoperative morbidity: Implications of the minimalist approach

ObjectivesTransfemoral transcatheter aortic valve insertion may be performed in a catheterization laboratory (ie, the minimalist approach). It seems reasonable when considering this approach to avoid it in patients at risk for intraoperative morbidity that would require surgical intervention. We hypothesized that it would be possible to associate baseline characteristics with such morbidity, which would help heart teams select patients for the minimalist approach. MethodsWe reviewed the records of 215 consecutive patients who underwent transfemoral transcatheter aortic valve insertion with a current commercially available device from November 2008 through July 2015. Demographic characteristics of the patients included a mean age of 78.9 ± 10.6 years, female sex in 73 patients (34.0%), and a mean Society of Thoracic Surgeons predicted risk of mortality of 8.7% ± 5.4%. Valve prostheses were balloon-expandable in 126 patients (58.6%) and self-expanding in 89 patients (41.4%). ResultsSignificant intraoperative morbidity occurred in 22 patients (10.2%) and included major vascular injury in 12 patients (5.6%), hemodynamic compromise requiring cardiopulmonary bypass support in 4 patients (1.9%), cardiac tamponade requiring intervention in 3 patients (1.4%), ventricular valve embolization in 2 patients (0.9%), and inability to obtain percutaneous access requiring open vascular access in 1 patient (0.5%). Intraoperative morbidity was similarly distributed across all valve types (P = .556) and sheath sizes (P = .369). There were no baseline patient characteristics predictive of intraoperative morbidity. ConclusionsPatient and valve characteristics are not predictive of significant intraoperative morbidity during transfemoral transcatheter aortic valve insertion. The finding has implications for patient selection for the minimalist approach.

Transcatheter aortic valve insertion in the nonagenarian patient

Transcatheter aortic valve insertion in the nonagenarian patient

Aborted episode of sudden death due to delayed heart block after transcatheter aortic valve insertion

Aborted episode of sudden death due to delayed heart block after transcatheter aortic valve insertion

COST-ANALYSIS OF TAVI: A SYSTEMATIC REVIEW

BackgroundAortic Stenosis is a disease that requires surgical intervention in its later stages in order to prevent mortality. Traditionally this has been done through a surgical aortic valve replacement (AVR) approach. New and innovative technologies allow for the insertion of prosthetic aortic valves through a transcatheter approach. While the clinical utility of this procedure has been demonstrated, the cost and cost-effectiveness of transcatheter aortic valve insertion (TAVI) has not been established. Our objective in this study is to synthesize the current estimates of cost and cost-effectiveness of TAVI compared to AVR or medical management (MM).MethodsA systematic review was completed. Six databases (EBM Reviews - Cochrane Central Register of Controlled Trials, Ovid MEDLINE, Embase, NHS Economic Evaluation Database, EBM Reviews - Health Technology Assessment, and Scopus) were searched from 1950 to Jan 2013 using broad search terms for TAVI and economic outcomes. Articles were accepted if they included patients undergoing TAVI, reported the cost of procedure and hospital stay or follow-up costs or reported the findings of a cost-effectiveness study.ResultsOf the 198 citations identified, 74 abstracts were included. Of those, 63 were excluded during full-text review. The remaining 11 were included in the final analysis. 4 reported costs while 7 reported cost-effectiveness. Only 1 reported in a Canadian healthcare context. These 11 journal articles were critically appraised independently from three sources using the Drummond checklist. The cost per QALY gained with TAVI compared to AVR ranges from $52,733 to €750,000. The cost per QALY gained with TAVI compared to MM ranges from £16,100 to $61 889.Conclusion BackgroundAortic Stenosis is a disease that requires surgical intervention in its later stages in order to prevent mortality. Traditionally this has been done through a surgical aortic valve replacement (AVR) approach. New and innovative technologies allow for the insertion of prosthetic aortic valves through a transcatheter approach. While the clinical utility of this procedure has been demonstrated, the cost and cost-effectiveness of transcatheter aortic valve insertion (TAVI) has not been established. Our objective in this study is to synthesize the current estimates of cost and cost-effectiveness of TAVI compared to AVR or medical management (MM). Aortic Stenosis is a disease that requires surgical intervention in its later stages in order to prevent mortality. Traditionally this has been done through a surgical aortic valve replacement (AVR) approach. New and innovative technologies allow for the insertion of prosthetic aortic valves through a transcatheter approach. While the clinical utility of this procedure has been demonstrated, the cost and cost-effectiveness of transcatheter aortic valve insertion (TAVI) has not been established. Our objective in this study is to synthesize the current estimates of cost and cost-effectiveness of TAVI compared to AVR or medical management (MM). MethodsA systematic review was completed. Six databases (EBM Reviews - Cochrane Central Register of Controlled Trials, Ovid MEDLINE, Embase, NHS Economic Evaluation Database, EBM Reviews - Health Technology Assessment, and Scopus) were searched from 1950 to Jan 2013 using broad search terms for TAVI and economic outcomes. Articles were accepted if they included patients undergoing TAVI, reported the cost of procedure and hospital stay or follow-up costs or reported the findings of a cost-effectiveness study. A systematic review was completed. Six databases (EBM Reviews - Cochrane Central Register of Controlled Trials, Ovid MEDLINE, Embase, NHS Economic Evaluation Database, EBM Reviews - Health Technology Assessment, and Scopus) were searched from 1950 to Jan 2013 using broad search terms for TAVI and economic outcomes. Articles were accepted if they included patients undergoing TAVI, reported the cost of procedure and hospital stay or follow-up costs or reported the findings of a cost-effectiveness study. ResultsOf the 198 citations identified, 74 abstracts were included. Of those, 63 were excluded during full-text review. The remaining 11 were included in the final analysis. 4 reported costs while 7 reported cost-effectiveness. Only 1 reported in a Canadian healthcare context. These 11 journal articles were critically appraised independently from three sources using the Drummond checklist. The cost per QALY gained with TAVI compared to AVR ranges from $52,733 to €750,000. The cost per QALY gained with TAVI compared to MM ranges from £16,100 to $61 889. Of the 198 citations identified, 74 abstracts were included. Of those, 63 were excluded during full-text review. The remaining 11 were included in the final analysis. 4 reported costs while 7 reported cost-effectiveness. Only 1 reported in a Canadian healthcare context. These 11 journal articles were critically appraised independently from three sources using the Drummond checklist. The cost per QALY gained with TAVI compared to AVR ranges from $52,733 to €750,000. The cost per QALY gained with TAVI compared to MM ranges from £16,100 to $61 889. Conclusion

Implementation of transcatheter aortic valve insertion (TAVI) in clinical practice: An ethical analysis

Objective The objective of this article is to provide an ethical analysis of a high-risk, advanced treatment case where the patient received transcatheter aortic valve insertion (TAVI), for aortic valve stenosis. Particular emphasis will be placed upon the significance of evidence and the implications for priority setting. Method One paradigmatic case involving a TAVI patient from a large university hospital in Norway is described and analysed. The method used was ethical case analysis modified after Kymlicka by Miljeteig et al. Perioperative mortality risk was estimated using the Euroscore risk-logarithm and the Society of Thoracic Surgeons’ risk model, STS. These predict the risk of operative mortality and morbidity associated with adult cardiac surgery. GRADE, the Grading of Recommendations Assessment, Development and Evaluation, was used to evaluate the evidence. Results In the case analysis, we found that it would be ethically justifiable not to recommend TAVI treatment for this patient. Although the patient had a severe condition in need of treatment, the expected improvement was marginal, the quality of evidence was low and the opportunity costs for other patients and society were higher than usually deemed appropriate. Conclusions Decision-making in the absence of high quality evidence from randomized trials is a complex process involving difficult ethical judgments. Novel high-risk devices often enter the European market with limited clinical evidence. Transparency and improved clinical evaluation are required so patient safety is not jeopardized. We argue that implementation of high risk, high cost interventions should be better regulated at a national level. Background All clinical decisions imply priority setting and therefore indirectly affect other patients and other patient groups. The use of expensive, innovative health technologies has an affect on individual patients as well as on other patient groups competing for the same resources.

Transcatheter aortic valve insertion (TAVI): a review

The introduction of transcatheter aortic valve insertion (TAVI) has transformed the care provided for patients with severe aortic stenosis. The uptake of this procedure is increasing rapidly, and clinicians from all disciplines are likely to increasingly encounter patients being assessed for or having undergone this intervention. Successful TAVI heavily relies on careful and comprehensive imaging assessment, before, during and after the procedure, using a range of modalities. This review outlines the background and development of TAVI, describes the nature of the procedure and considers the contribution of imaging techniques, both to successful intervention and to potential complications.

Outcomes of surgical aortic valve replacement in moderate risk patients: Implications for determination of equipoise in the transcatheter era

To determine the contemporary outcomes of surgical aortic valve replacement (SAVR) in a moderate surgical risk population. We studied 502 consecutive adults who had undergone isolated SAVR from January 2002 to June 2011 for severe aortic valve stenosis with a Society of Thoracic Surgery predicted risk of mortality of 4% to 8%. We included concomitant coronary artery bypass and aortic annular enlargement but not other concomitant procedures. The updated Valve Academic Research Consortium definitions were used, as appropriate. The median age was 80 years (range, 49-96), 323 (64.3%) had New York Heart Association class III-IV symptoms, and 101 (20.1%) had undergone previous coronary artery bypass grafting. The mean predicted risk of mortality was 5.6%. Concomitant coronary artery bypass grafting was performed in 270 (53.8%). Re-exploration for bleeding occurred in 29 (5.8%), stroke in 9 (1.8%), and vascular complications in 2(0.4%). In the cohort, 14 early deaths (2.8%) occurred. During follow-up (1174 days), 175 patients died. Using multivariate logistic regression analysis, the significant independent predictors of mid-term death included chronic pulmonary disease (hazard ratio, 2.00, 95% confidence interval, 1.41-2.84; P<.001), peripheral vascular disease (hazard ratio, 1.58; 95% confidence interval, 1.05-2.37; P=.029), and atrial fibrillation (hazard ratio, 1.75; 95% confidence interval, 1.16-2.65; P=.008). SAVR in moderate-risk patients is currently performed with one half of the early predicted risk (2.8%) and a low likelihood of complications, including a 1.8% incidence of stroke. Patients counseled for randomization to transcatheter aortic valve insertion should be informed of the excellent early to mid-term outcomes of SAVR, particularly those without pulmonary impairment, peripheral vascular disease, or atrial fibrillation.

Vascular Access Site Injury After Transfemoral Transcatheter Aortic Valve Insertion

Vascular complications associated with transfemoral transcatheter aortic valve insertion (TAVI) are a frequent untoward consequence of arterial sheath insertion. We report the prevalence of anatomic arterial injury with open artery access TAVI. This review consisted of 53 consecutive patients who received transfemoral Sapien 23 or 26 mm TAVI via the 22- or 24-French sheath through open artery access from November 2008. The median age of the patients was 83 years (range, 59 to 94), and there were 31 males (58%). All arteries were examined to determine the optimal point of access and then explored after removal of the sheath to document injury. The accessed artery had a minimal lumen diameter of 8.9 mm (7.2 to 14.7) and a sheath-to-artery ratio of 1.0 (0.6 to 1.2). The point of access was the common femoral artery in 33 patients (62%) and the external iliac artery in 20 (38%). Exploration of the artery demonstrated localized arterial injury in 22 patients (42%). Female gender was predictive of injury (p = 0.03), but arterial access site location, presence of arterial access calcification, sheath-to-artery ratio, and sheath size were not. Techniques of artery repair included primary closure in 34 patients (64%), pericardial patch angioplasty in 15 (28%), and graft interposition in 4 (8%). There was one minor groin wound complication. Open artery access allows for direct examination and optimal access site choice of the vessel during transfemoral TAVI. Localized arterial injury was commonly encountered after 22- and 24-French sheath insertion, but the associated artery repair complication rate was low.

Transcatheter Aortic Valve Insertion Catastrophe in Inoperable Patients: Should Aortic Valve Replacement Be Denied?

This paper reports the outcomes of patients initially deemed inoperable for standard aortic valve replacement who received transcatheter aortic valve insertion. Each patient experienced a transcatheter valve insertion complication and was then subsequently reconsidered for urgent standard valve replacement. We review the outcomes of these inoperable patients and discuss recommendations for managing this complication.

Early Transcatheter Aortic Valve Thrombosis

Early valve thrombosis is uncommon after pericardial aortic valve replacement. In this report, we describe such a complication after transcatheter aortic valve insertion.

Endovascular Abdominal Aortic Aneurysm Repair to Facilitate Access for Transcatheter Aortic Valve Implantation

Transcatheter aortic valve insertion is an accepted treatment for select patients at high-risk for standard aortic valve insertion. Constraints imposed by the Food and Drug Administration, Centers for Medicare and Medicaid Services, and the PARTNER Trial Executive Committee require a transfemoral approach in certain patients. The presence of aortoiliac aneurysms, occlusive disease, and excessive vessel tortuosity may create difficulties for safe transfemoral access. We report a case in which the limitation of severe iliac artery occlusive disease was overcome by placement of an abdominal aortic endovascular graft that subsequently allowed successful transfemoral access and transcatheter aortic valve implantation.

Down the yellow brick road: Transcatheter aortic valve insertion and patient risk

Catheterization and Cardiovascular InterventionsVolume 79, Issue 1 p. 141-142 Valvular and Structural Heart Diseases Down the yellow brick road: Transcatheter aortic valve insertion and patient risk† Larry S. Dean MD, FSCAI, Corresponding Author Larry S. Dean MD, FSCAI lsdean@uw.edu Department of Medicine/Division of Cardiology, University of Washington School of Medicine, Seattle, WashingtonProfessor of Medicine and Surgery, University of Washington School of Medicine, Seattle, WashingtonSearch for more papers by this author Larry S. Dean MD, FSCAI, Corresponding Author Larry S. Dean MD, FSCAI lsdean@uw.edu Department of Medicine/Division of Cardiology, University of Washington School of Medicine, Seattle, WashingtonProfessor of Medicine and Surgery, University of Washington School of Medicine, Seattle, WashingtonSearch for more papers by this author First published: 06 March 2012 https://doi.org/10.1002/ccd.23495 † Conflict of interest: Reports research support from Edwards Lifesciences. Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat No abstract is available for this article. Volume79, Issue11 January 2012Pages 141-142 SCAI Member Sign in RelatedInformation

Treatment of a degenerative stenosed CoreValve® aortic bioprosthesis by transcatheter valve‐in‐valve insertion

Transcatheter aortic valve insertion (TAVI) is an emerging therapy in patients at high risk for open heart surgery. The long-term durability of the bioprosthesis is unknown. This is the first report of a severely degeneratively stenosed 2nd generation 26 mm CoreValve(®) aortic bioprosthesis which occurred five and a half years after TAVI. A 92-year-old patient presented with decompensated heart failure NYHA class IV, pulmonary edema, and severe pulmonary hypertension. Echocardiography revealed critical AV-stenosis due to heavily calcified bioprosthetic valve leaflets. Due to high surgical risk with an EuroSCORE of 64.97% and a STS-mortality score of 27.0%, we decided to attempt a valve-in-valve insertion of a 3rd generation CoreValve(®) prosthesis of the same size. Following the delicate retrograde passage of the calcified valve with a preformed stiff wire, balloon valvuloplasty of the severely stenosed CoreValve(®) prosthesis under rapid right ventricular pacing was complicated by two balloon catheter ruptures. Insertion of the 3rd generation CoreValve(®) prosthesis of the same size was quite complex but finally it was successfully completed. There was mild periprosthetic regurgitation and significant decrease in transaortic pressure without residual transvalvular gradient immediately after TAVI. Echocardiography and clinical follow-up at 72 hr after TAVI confirmed excellent valve function with a decrease in systolic pulmonary artery pressure from 70 mm Hg to 35 mm Hg, increase in LV-EF from 35% to 45%, and improvement of functional status from NYHA IV to NYHA II. The patient was discharged in good medical conditions at day eight. Degenerative stenosis of a CoreValve(®) bioprothesis may be observed during long-term follow-up after successful TAVI for the treatment of severe aortic valve stenosis. A second valve-in-valve insertion appears feasible but may require particular interventional approaches.

Clinical trial experience with transcatheter aortic valve insertion

Surgical aortic valve replacement has long been considered the standard of care for patients with severe symptomatic aortic stenosis, however, an aging population with increasing complex comorbidities now represents a growing population of patients that is often considered inoperable for a traditional surgical approach. Transcatheter aortic valve implantation is a developing technology that offers an alternative treatment modality for these very high risk patients. This manuscript will review the currently available clinical trial data with transcatheter aortic valve implantation and offer perspective as to the future of this novel technology.

Why do patients with aortic stenosis and unobstructed coronary arteries suffer from angina? insights from transcatheter aortic valve insertion (TAVI)

Why do patients with aortic stenosis and unobstructed coronary arteries suffer from angina? insights from transcatheter aortic valve insertion (TAVI)

One Year Experience With Transcatheter Aortic Valve Insertion [Tavi] Via Transarterial Approach In A New Zealand Public Hospital

Background: Transcatheter aortic valves have been implanted in New Zealand since August 2008 for severe, symptomatic aortic stenosis in patients considered high risk for traditional surgical valve replacement. The self expanding Medtronic CoreValveTM (MCV) and balloon expandable Edwards SepianTM valve (ESV) were used. We describe our experience in Waikato public hospital.

One-Year Experience with Transcatheter Aortic Valve Insertion [TAVI] via Transarterial Approach in a New Zealand Public Hospital

One-Year Experience with Transcatheter Aortic Valve Insertion [TAVI] via Transarterial Approach in a New Zealand Public Hospital

Balloon Aortic Valvuloplasty (BAV) for Severe Symptomatic Aortic Stenosis (AS) in the Current ERA

Background: BAV fell out of favour due to poor survival benefit, perceived procedural complexity and the need for repeat procedure in short duration. It has been used as a bridge to aortic valve replacement (AVR) or transcatheter aortic valve insertion (TAVI) and as a palliative procedure for patients who have been denied valve replacement.

Redo in aortic homograft replacement: Transcatheter aortic valve as a valid alternative to surgical replacement

CLINICAL SUMMARY A 48-year-old woman was referred to our hospital with symptoms of ingravescent severe dyspnea. Fifteen years earlier, she had undergone placement of a 21-mm aortic valve Bravo 400 stentless xenograft (Cryolife International, Atlanta, Ga). Four years later, she underwent a valve replacement with a 21-mm mechanical prosthesis (Carbomedics, Austin, Tex) for valve degeneration, and subsequently, she received a homograft for aortic valve endocarditis. The echocardiographic control, performed during the last 15 years, showed progressive calcific valve degeneration with a peak transvascular pressure gradient of 41 mm Hg and aortic valve area of 0.5 cm. Preoperative computed tomographic angiographic analysis showed diffuse aortic root