Jean-Bernard Masson

Transcatheter Aortic Valve Implantation: Review of the Nature, Management, and Avoidance of Procedural Complications

Transcatheter aortic valve implantation (TAVI) is becoming a reality in the management of patients with severe aortic stenosis and high or prohibitive risk for standard surgical management. Current understanding of the potential adverse events associated with this procedure is limited. Risks associated with TAVI differ from those related to surgical valve replacement and include vascular injury; stroke; cardiac injury such as heart block, coronary obstruction, and cardiac perforation; paravalvular leak; and valve misplacement. The clinical experience of multiple centers experience with different valve implantation systems and techniques was reviewed. Awareness of how complications occur might help in their avoidance, recognition, and management. Ultimately, improved understanding of the potential complications associated with TAVI might help improve outcomes and allow wider application of this therapy.

Acute kidney injury following transcatheter aortic valve implantation : predictive factors, prognostic value, and comparison with surgical aortic valve replacement

Aims Very few data exist on the occurrence of acute kidney injury (AKI) associated with transcatheter aortic valve implantation (TAVI). The objectives of the present study were (i) to determine the incidence, predictive factors, and prognostic value of AKI following TAVI, and (ii) to compare the occurrence of AKI in TAVI vs. surgical aortic valve replacement (SAVR) in patients with pre-procedural chronic kidney disease (CKD). Methods and results A total of 213 patients (mean age 82 ± 8 years) undergoing TAVI for the treatment of severe aortic stenosis were included in the study. Acute kidney injury was defined as a reduction of >25% in estimated glomerular filtration rate (eGFR) within 48 h following the procedure or the need for haemodialysis during index hospitalization. Those patients with pre-procedural CKD (eGFR <60 mL/min/1.73 m2, n = 119) were compared with 104 contemporary patients with CKD who underwent isolated SAVR. The incidence of AKI following TAVI was 11.7%, with 1.4% of the patients requiring haemodialysis. Predictive factors of AKI were hypertension (OR: 4.66; 95% CI: 1.04–20.87), chronic obstructive pulmonary disease (OR: 2.64, 95% CI: 1.10–6.36), and peri-operative blood transfusion (OR: 3.47, 95% CI: 1.30–9.29). Twenty-one patients (9.8%) died during index hospitalization, and the logistic EuroSCORE (OR: 1.03 for each increase of 1%; 95% CI: 1.01–1.06) and occurrence of AKI (OR: 4.14, 95% CI: 1.42–12.13) were identified as independent predictors of postoperative mortality. Patients with CKD who underwent TAVI were older, had a higher logistic EuroSCORE and lower pre-procedural eGFR values compared with those who underwent SAVR (P < 0.0001 for all). The incidence of AKI was lower (P = 0.001; P = 0.014 after propensity score adjustment) in CKD patients who underwent TAVI (9.2%, need for haemodialysis: 2.5%) compared with those who underwent SAVR (25.9%, need for haemodialysis: 8.7%). Conclusion Acute kidney injury occurred in 11.7% of the patients following TAVI and was associated with a greater than four-fold increase in the risk of postoperative mortality. Hypertension, chronic obstructive pulmonary disease, and blood transfusion were predictive factors of AKI. In those patients with pre-procedural CKD, TAVI was associated with a significant reduction of AKI compared with SAVR.

Comparison of the hemodynamic performance of percutaneous and surgical bioprostheses for the treatment of severe aortic stenosis.

OBJECTIVES This study was undertaken to compare the hemodynamic performance of a percutaneous bioprosthesis to that of surgically implanted (stented and stentless) bioprostheses for the treatment of severe aortic stenosis. METHODS Fifty patients who underwent percutaneous aortic valve implantation (PAVI) with the Cribier-Edwards or Edwards SAPIEN bioprosthetic valve (Edwards Lifesciences, Inc., Irvine, California) were matched 1:1 for sex, aortic annulus diameter, left ventricular ejection fraction, body surface area, and body mass index, with 2 groups of 50 patients who underwent surgical aortic valve replacement (SAVR) with a stented valve (Edwards Perimount Magna [SAVR-ST group]), or a stentless valve (Medtronic Freestyle, Medtronic, Minneapolis, Minnesota [SAVR-SL group]). Doppler echocardiographic data were prospectively obtained before the intervention, at discharge, and at 6- to 12-month follow-up. RESULTS Mean transprosthetic gradient at discharge was lower (p < 0.001) in the PAVI group (10 +/- 4 mm Hg) compared with the SAVR-ST (13 +/- 5 mm Hg) and SAVR-SL (14 +/- 6 mm Hg) groups. Aortic regurgitation (AR) occurred more frequently in the PAVI group (mild: 42%, moderate: 8%) compared with the SAVR-ST (mild: 10%, moderate: 0%) and SAVR-SL (mild: 12%, moderate: 0%) groups (p < 0.0001). At follow-up, the mean gradient in the PAVI group remained lower (p < 0.001) than that of the SAVR-ST group, but was similar to that of the SAVR-SL group. The incidence of severe prosthesis-patient mismatch was significantly lower (p = 0.007) in the PAVI group (6%) compared with the SAVR-ST (28%) and SAVR-SL (20%) groups. However, the incidence of AR remained higher (p < 0.0001) in the PAVI group compared with the 2 other groups. CONCLUSIONS PAVI provided superior hemodynamic performance compared with the surgical bioprostheses in terms of transprosthetic gradient and prevention of severe prosthesis-patient mismatch, but was associated with a higher incidence of AR.

Comparison Between Transcatheter and Surgical Prosthetic Valve Implantation in Patients With Severe Aortic Stenosis and Reduced Left Ventricular Ejection Fraction

Background— Patients with severe aortic stenosis and reduced left ventricular ejection fraction (LVEF) have a poor prognosis with conservative therapy but a high operative mortality when treated surgically. Recently, transcatheter aortic valve implantation (TAVI) has emerged as an alternative to surgical aortic valve replacement (SAVR) for patients considered at high or prohibitive operative risk. The objective of this study was to compare TAVI and SAVR with respect to postoperative recovery of LVEF in patients with severe aortic stenosis and reduced LV systolic function. Methods and Results— Echocardiographic data were prospectively collected before and after the procedure in 200 patients undergoing SAVR and 83 patients undergoing TAVI for severe aortic stenosis (aortic valve area ≤1 cm2) with reduced LV systolic function (LVEF ≤50%). TAVI patients were significantly older (81±8 versus 70±10 years; P<0.0001) and had more comorbidities compared with SAVR patients. Despite similar baseline LVEF (34±11% versus 34±10%), TAVI patients had better recovery of LVEF compared with SAVR patients (&Dgr;LVEF, 14±15% versus 7±11%; P=0.005). At the 1-year follow-up, 58% of TAVI patients had a normalization of LVEF (>50%) as opposed to 20% in the SAVR group. On multivariable analysis, female gender (P=0.004), lower LVEF at baseline (P=0.005), absence of atrial fibrillation (P=0.01), TAVI (P=0.007), and larger increase in aortic valve area after the procedure (P=0.01) were independently associated with better recovery of LVEF. Conclusion— In patients with severe aortic stenosis and depressed LV systolic function, TAVI is associated with better LVEF recovery compared with SAVR. TAVI may provide an interesting alternative to SAVR in patients with depressed LV systolic function considered at high surgical risk.

Transapical transcatheter aortic valve implantation: follow-up to 3 years.

BACKGROUND 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. METHODS 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. RESULTS 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). CONCLUSION 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.

Impact of coronary artery disease on outcomes after transcatheter aortic valve implantation

Background: Coronary artery disease (CAD) negatively impacts prognosis of patients undergoing surgical aortic valve replacement and revascularization is generally recommended at the time of surgery. Implications of CAD and preprocedural revascularization in the setting of transcatheter aortic valve implantation (TAVI) are not known. Method: Patients who underwent successful TAVI from January 2005 to December 2007 were retrospectively divided into five groups according to the extent of CAD assessed with the Duke Myocardial Jeopardy Score: no CAD, CAD with DMJS 0, 2, 4, and ≥6. Study endpoints included 30‐day and 1‐year survival, evolution of symptoms, left ventricular ejection fraction (LVEF), and mitral regurgitation (MR) and need of revascularization during follow‐up. Results: One hundred and thirty‐six patients were included, among which 104 (76.5%) had coexisting CAD. Thirty‐day mortality in the five study groups was respectively 6.3, 14.6, 7.1, 5.6, and 17.7% with no statistically significant difference between groups (P = 0.56). Overall survival rate at one year was 77.9% (95% CL: 70.9, 84.9) with no difference between groups (P = 0.63). Symptoms, LVEF, and MR all significantly improved in the first month after TAVI, but the extent of improvement did not differ between groups (P > 0.08). Revascularization after TAVI was uncommon. Conclusion: The presence of CAD or nonrevascularized myocardium was not associated with an increased risk of adverse events in this initial cohort. On the basis of these early results, complete revascularization may not constitute a prerequisite of TAVI. This conclusion will require re‐assessment as experience accrues in patients with extensive CAD.

A New Transcatheter Aortic Valve and Percutaneous Valve Delivery System

OBJECTIVES We describe procedural and clinical outcomes in a high-risk cohort undergoing transcatheter aortic valve replacement with early next-generation transcatheter valve and delivery systems. BACKGROUND Percutaneous aortic valve replacement is gaining acceptance as a viable option in patients at high surgical risk. Broader application will require further advances in valve and delivery system technology. METHODS Transarterial aortic valve replacement was attempted in 25 patients (mean age 85 years) determined to be at high surgical risk due to comorbidities. A new delivery catheter system (RetroFlex 2, Edwards Lifesciences, Irving, California) was utilized in combination with either a balloon-expandable SAPIEN (Edwards Lifesciences) valve or a next-generation low-profile cobalt-chromium bovine pericardial SAPIEN XT (Edwards Lifesciences) valve. RESULTS Percutaneous valve replacement was successful in all 25 high-risk patients. Aortic valve area increased from 0.59 +/- 0.15 cm(2) to 1.60 +/- 0.27 cm(2). In this high-risk cohort (Society of Thoracic Surgeons and logistic EuroSCORE estimates of surgical mortality were 8.9% and 21.0%, respectively), 30-day mortality was 0%. CONCLUSIONS Technical and procedural advances in catheter systems and prosthetic valves designed for percutaneous aortic valve delivery may contribute to increased procedural success and improved clinical outcomes.

Transapical transcatheter aortic valve implantation: 1-year outcome in 26 patients

BACKGROUND We reported the first case of successful transapical transcatheter aortic valve implantation in a human subject in 2005 and have now completed a 12-month follow-up on our first 26 patients. This is, to date, the longest follow-up of patients undergoing transapical aortic valve implantation. METHODS Between October 2005 and January 2007, 26 patients (13 female) underwent transcatheter transapical aortic valve implantation with either 23- or 26-mm Edwards Lifesciences transcatheter bioprostheses. All patients with symptomatic aortic stenosis were declined for conventional aortic valve replacement because of unacceptable operative risks and were not candidates for transfemoral aortic valve implantation because of poor arterial access. Clinical and echocardiographic follow-up was performed before discharge and at 1, 6, and 12 months. Data from the 17 patients who survived over 12 months were used for comparisons of the baseline and follow-up results. RESULTS The mean age was 80 +/- 9 years, and the predicted operative mortality was 37% +/- 20% by using logistic EuroSCORE and 11% +/- 6% by using the Society of Thoracic Surgeons Risk Calculator. Valves were successfully implanted in all patients. Six patients died within 30 days (30-day mortality, 23%), and 3 patients died from noncardiovascular causes after 30 days (late mortality, 12%). Among patients who survived at least 30 days, 12-month survival was 85%. There were no late valve-related complications. New York Heart Association functional class improved significantly. The aortic valve area and mean gradient remained stable at 12 months (1.6 +/- 0.3 cm(2) and 9.6 +/- 4.8 mm Hg, respectively). CONCLUSION Our 1-year clinical and echocardiographic outcomes suggest that transapical transcatheter aortic valve implantation is a viable alternative to conventional aortic valve replacement in selected high-risk patients.

Prevention and management of transcatheter balloon-expandable aortic valve malposition†

Early clinical outcomes in selected high‐risk patients undergoing catheter‐based aortic valve replacement (AVR) compare favorably with conventional surgical AVR. Improved understanding of the mechanisms of success and failure of transcatheter AVR will likely improve outcomes further. To this end, we examined our experience during the developmental phases of transcatheter AVR and describe the causes and management of prosthetic valve malposition.

Transapical Transcatheter Mitral Valve-in-Valve Implantation in a Human

We describe a human transcatheter transapical mitral valve implant within a mitral bioprosthesis (valve-in-valve). A high-risk, 80-year-old man with symptomatic bioprosthetic mitral stenosis was positioned for anterior minithoracotomy. Left ventricular apical access was obtained. After balloon valvuloplasty, a cuffed, 26-mm Cribier-Edwards transcatheter valve (Edwards Lifesciences LLC, Irvine, CA) was deployed within the mitral xenograft, using rapid ventricular pacing. The transcatheter valve functioned properly postoperatively; however, the patient died of multiple organ dysfunction.