Abstract

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BACKGROUND:

Computational finite element models of the aortic root have previously used material properties of the ascending aorta to describe both aortic sinuses and ascending aorta. We have previously demonstrated significant material property differences between ascending aorta and sinuses in pigs. However, it is unknown whether these regional material property differences exist in humans. The main objective of this study was to investigate biomechanics of fresh human ascending aorta and aortic sinuses and compare nonlinear material properties of these regions.

METHODS:

Fresh human aortic root specimens obtained from the California Transplant Donor Network (Oakland, CA) were subjected to displacement-controlled equibiaxial stretch testing within 24 hours of harvest. Stress-strain data recorded were used to derive strain energy functions for each region. Tissue behavior was quantified by tissue stiffness and a direct comparison was made between different regions of aortic root at physiologic stress levels.

RESULTS:

All regions demonstrated a nonlinear response to strain during stretch testing in both circumferential and longitudinal directions. No significant difference in tissue stiffness was found between anterior and posterior regions of the ascending aorta or among the three sinuses in both directions. However, our results demonstrated that human ascending aorta is significantly more compliant than aortic sinuses in both circumferential and longitudinal directions within the physiologic stress range.

CONCLUSIONS:

Significant material and structural differences were observed between human ascending aorta and aortic sinuses. Regionally specific material properties should be employed in computational models used to assess treatments of structural aortic root disease.

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Abstract

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OBJECTIVES:

This study examined the clinical course of patients with asymptomatic severe aortic stenosis (AS) according to the new proposed aortic valve stenosis grading classification.

BACKGROUND:

The management of patients with asymptomatic severe AS remains controversial. Moreover, under the same denomination of severe AS, several entities might be identified according to transvalvular flow rates and pressure gradients, resulting in 4 flow-gradient patterns.

METHODS:

Transthoracic echocardiography and measurement of B-type natriuretic peptide level from venous blood sample were performed in 150 consecutive patients with asymptomatic severe AS and normal exercise test. Patients were classified in 4 groups, depending on left ventricular flow state (normal flow [NF] vs. low flow [LF]: 35 ml/m²) and pressure gradient levels (low gradient [LG] vs. high gradient [HG]: 40 mm Hg).

RESULTS:

Patients with NF/LG had significantly lower B-type natriuretic peptide than those with LF/HG and LF/LG. The mean follow-up was 27 ± 12 months. At 2 years, cardiac event-free survival was 83 ± 6%, 44 ± 6%, 30 ± 12%, and 27 ± 13% in NF/LG, NF/HG, LF/HG, and LF/LG groups, respectively (p < 0.0001). On multivariable analysis, LF/LG (hazard ratio [HR]: 5.26, 95% confidence interval [CI]: 2.04 to 14.3, p = 0.045) and LF/HG (HR: 2.38, 95% CI: 1.02 to 5.55, p = 0.001) were identified as strong independent determinants of poor prognosis as compared with NF/HG. By limiting the multivariable analysis to patients with LF, LF/LG was an independent predictor of markedly reduced cardiac event-free survival when compared with LF/HG (HR: 5.4, 95% CI: 1.03 to 28.6, p = 0.046).

CONCLUSIONS:

The use of the new proposed AS grading classification integrating valve area and flow-gradient patterns allows a better characterization of the clinical outcome of patients with asymptomatic severe AS.

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Abstract

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OBJECTIVES:

The purpose of this study was to assess deformation dynamics and in vivo mechanical properties of the aortic annulus throughout the cardiac cycle.

BACKGROUND:

Understanding dynamic aspects of functional aortic valve anatomy is important for beating-heart transcatheter aortic valve implantation.

METHODS:

Thirty-five patients with aortic stenosis and 11 normal subjects underwent 256-slice computed tomography. The aortic annulus plane was reconstructed in 10% increments over the cardiac cycle. For each phase, minimum diameter, ellipticity index, cross-sectional area (CSA), and perimeter (Perim) were measured. In a subset of 10 patients, Young's elastic module was calculated from the stress-strain relationship of the annulus.

RESULTS:

In both subjects with normal and with calcified aortic valves, minimum diameter increased in systole (12.3 ± 7.3% and 9.8 ± 3.4%, respectively; p < 0.001), and ellipticity index decreased (12.7 ± 8.8% and 10.3 ± 2.7%, respectively; p < 0.001). The CSA increased by 11.2 ± 5.4% and 6.2 ± 4.8%, respectively (p < 0.001). Perim increase was negligible in patients with calcified valves (0.56 ± 0.85%; p < 0.001) and small even in normal subjects (2.2 ± 2.2%; p = 0.01). Accordingly, relative percentage differences between maximum and minimum values were significantly smallest for Perim compared with all other parameters. Young's modulus was calculated as 22.6 ± 9.2 MPa in patients and 13.8 ± 6.4 MPa in normal subjects.

CONCLUSIONS:

The aortic annulus, generally elliptic, assumes a more round shape in systole, thus increasing CSA without substantial change in perimeter. Perimeter changes are negligible in patients with calcified valves, because tissue properties allow very little expansion. Aortic annulus perimeter appears therefore ideally suited for accurate sizing in transcatheter aortic valve implantation.

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Abstract

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OBJECTIVES:

Transcatheter aortic valve implantation (TAVI) has recently been advocated to decrease perioperative risk in high-risk patients. In this propensity-score analysis we compared outcomes after TAVI to those after surgical aortic valve replacement (AVR).

METHODS:

From June 2009 through June 2010, 82 consecutive patients underwent TAVI via a transapical (n = 60) or transfemoral (n = 22) approach using the Edwards Sapien prosthesis (Edwards Lifesciences, Irvine, Calif). Mean patient age was 81.9 ± 5.2 years, 64.6% were women. Logistic EuroSCORE was 23.6% ± 1.4% and Society of Thoracic Surgeons score was 8.7% ± 1.3%. A group of 82 patients after surgical AVR was retrieved from our database, yielding a control group that was matched to the cases with respect to baseline demographics and typical risk factors.

RESULTS:

Overall mortality did not differ significantly between TAVI and AVR groups at 30 days (7.3% vs 8.6%), 90 days (13.6% vs 11.1%), or 180 days (17.8% vs 16.9%; P = .889). Conversion to surgery was necessary in 2 (2.4%) TAVI cases. Perioperative stroke occurred in 2 (2.4%) cases per group. Pacemakers were implanted for new-onset heart block in 3.7% and 2.4% in the TAVI and AVR groups, respectively (P = 1.0). TAVI resulted in shorter operative times (P < .001), shorter ventilation times (P < .001), and shorter length of stay in the intensive care unit (P = .008). Duration of hospital stay, however, was not significantly different (P = .11).

CONCLUSIONS:

In our experience, mortality rates are similar after both types of procedure. Patients receiving TAVI benefit from faster postoperative recovery. Until more clinical data become available, the optimal procedure has to be determined for each patient according to individual risk factors.

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Abstract

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OBJECTIVES:

The aim of this study was to evaluate vascular complications in a consecutive patient population undergoing transfemoral percutaneous aortic valve replacement (PAVR) applying current Valve Academic Research Consortium definitions.

BACKGROUND:

Vascular complications have been the major cause of mortality and morbidity associated with PAVR. Both open surgical and fully percutaneous access site strategies have been advocated.

METHODS:

All patients undergoing transfemoral PAVR during fiscal years 2009 and 2010 were prospectively evaluated at baseline, after the procedure, and at 30 days.

RESULTS:

PAVR was performed in 137 consecutive patients. All but 1 patient underwent planned arteriotomy closure using a percutaneous pre-closure technique. Smaller sheaths, rigorous angiographic and computed tomographic screening and patient selection, and percutaneous vascular repair techniques were increasingly used over this period. From 2009 to 2010, major vascular complications decreased from 8% to 1% (p = 0.06), minor vascular complications decreased from 24% to 8% (p < 0.01), major bleeds fell from 14% to 1% (p < 0.01), and unplanned surgery decreased from 28% to 2% (p < 0.01). A minimal artery diameter smaller than the external sheath diameter, moderate or severe calcification, and peripheral vascular disease were associated with higher vascular complication rates.

CONCLUSIONS:

Vascular complications occur more often if the minimal artery diameter is smaller than the external sheath diameter, in the presence of moderate or severe calcification, and in patients with peripheral vascular disease. With careful patient selection, advanced interventional techniques, and a fully percutaneous procedure, marked reductions in vascular and bleeding complications can be achieved.

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Abstract

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BACKGROUND:

Congenital bicuspid aortic valves (BAVs) result from fusion of 2 valve cusps, resulting in leftnoncoronary (L-N), right-left (R-L), and right-noncoronary (R-N) morphologic presentations. BAVs predispose to ascending thoracic aortic aneurysms (ATAAs). This study hypothesized that ATAAs with each BAV morphologic group possess unique signatures of matrix metalloproteinases (MMPs) and endogenous tissue inhibitors of metalloproteinases (TIMPs).

METHODS:

Ascending thoracic aortic aneurysm tissue from 46 patients with BAVs was examined for MMP/ TIMP abundance, and global MMP activity was compared with normal aortic specimens (n = 15). Proteolytic balance was calculated as the ratio of MMP abundance to a composite TIMP score. Results were stratified by valve morphologic group (L-N [n = 6], R-L [n = 31], and R-N [n = 9]).

RESULTS:

The BAV specimens (p < 0.05 versus normal aorta, 100%) displayed elevated global MMP activity (273% ± 63%), MMP-9 (263% ± 47%), and decreased MMP-7 (56% ± 10%), MMP-8 (58% ± 11%), TIMP-1 (63% ± 7%), and TIMP-4 (38% ± 3%). The R-L group showed increased global MMP activity (286% ± 89%) and MMP-9 (267% ± 55%) with reduced MMP-7 (45% ± 7%), MMP-8 (68% ± 15%), TIMP-1 (58% ± 7%), and TIMP-4 (35% ± 3%). The L-N group showed elevated global MMP activity (284% ± 71%) and decreased MMP-8 (37% ± 17%) and TIMP-4 (48% ± 14) activity. In the R-N group, MMP-7 (46% ± 13%) and MMP-8 (36% ± 17%) and TIMP-1 (59% ± 10%) and TIMP-4 (42% ± 5%) were decreased. The R-L group demonstrated an increased proteolytic balance for MMP-1, MMP-9, and MMP-12 relative to L-N and R-N.

CONCLUSIONS:

Each BAV morphologic group possesses a unique signature of MMPs and TIMPs. MMP/TIMPscore ratios suggest that the R-L group may be more aggressive, justifying earlier surgical intervention

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Abstract

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BACKGROUND:

Endocarditis affecting the aortic valve, with abscess formation and root destruction, remains a challenge to treat. Aortic root homografts have been advocated because of a perceived lower risk of infective complications than with other root replacement grafts. However, the theoretical advantage of homografts has not been re-evaluated in the modern era. This report is based on an examination of our results for all aortic root replacements in complex, active endocarditis affecting the aortic valve.

METHODS:

From 2000 to 2010, 134 patients (70.9% male; mean age 58.3 ± 14.8 years) at our institution underwent aortic root replacement for active endocarditis. Ninety of the patients (67.2%) had a previously implanted prosthetic aortic valve. Our findings for these patients included one or more of the following: abscess (n = 110, 82.1%), valve vegetation (n = 98, 73.1%), and pseudoaneurysm or rupture or both (n = 62, 46.3%). We retrospectively reviewed data for the patients from hospital records and the social security data base.

RESULTS:

A mechanical composite graft (MC) was used in 43 of the patients (32.1%), a non-homograft biologic valve conduit (BC) in 55 patients (41.0%), and a homograft (HG) valve in 36 patients (26.9%). There was no significant difference among the groups in the incidence of major complications or in-hospital mortality. During a mean follow-up of 32.1 ± 29.4 months, the rates of readmission, reinfection, and reoperation were similar for the three groups. The mean 5-year survival in the study was 58 ± 9% for the MC group, 62 ± 7% for the BC group, and 58 ± 9% for the HG group, respectively (p = 0.48).

CONCLUSIONS:

Aortic root replacement in the presence of complex active infection is associated with significant morbidity and mortality. We report that the rates of major complications and late mortality were similar among MC, BC, and HG groups in our study.

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Abstract

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OBJECTIVE:

Our objective was to analyze the results of transapical aortic valve implantation in high-risk patients with aortic stenosis at up to 3 years after the procedure.

METHODS:

A total of 299 patients underwent transapical aortic valve implantation from February 2006 until January 2010 using the Edwards SAPIEN transcatheter xenograft. Mean patient age was 82 ± 6 years and 70% were female. Logistic EuroSCORE and Society of Thoracic Surgeons score predicted risks for mortality were 31% ± 16% and 12% ± 8%, respectively. All patients were treated in a hybrid operative theater by a team of anesthetists, cardiologists and cardiac surgeons.

RESULTS:

Successful valve implantation was performed in all patients. Transapical aortic valve implantation was uneventful in 267 patients (89.3%), whereas 32 patients (10.7%) required additional interventions. Such interventions included cardiopulmonary bypass support in 18, implantation of a second SAPIEN valve in 15, coronary intervention in 9, conversion to conventional surgery in 6, and annulus perforation in 3 patients (not mutually exclusive). Intraprocedural stroke was not observed in any patient, although 2 (0.7%) patients had a delayed stroke during their hospital stay. Overall survival was 91% at 30 days, 73% at 1 year, 68% at 2 years, and 58% at 3 years.

CONCLUSIONS:

Transapical aortic valve implantation can be performed with good outcomes in high-risk patients with aortic stenosis. Perioperative complications occur in approximately 10% of patients, and a variety of interventions are required for these events. We believe a team approach is therefore essential for the success of transapical aortic valve implantation.

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Abstract

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OBJECTIVES:

This pilot prospective observational study aimed to evaluate the maternal and fetal outcomes of pregnancies under low-dose oral anticoagulation therapy after aortic mechanical replacement.

BACKGROUND:

Need for valve replacement is still an issue for young women with native valve disease who are planning on future pregnancy. Choice of replacement device is a challenging clinical task.

METHODS:

A comprehensive pre-operative counseling protocol to guide choice of replacement device was developed. The pre-operative anticoagulation trial to determine the warfarin daily dosage needed to reach target international normalized ratio (INR) represented the main stem of such protocol. Pregnancies on low-dose anticoagulation therapy (target INR: 1.5 to 2.5) were allowed in a highly selected subset of mechanical aortic valve recipients.

RESULTS:

Twenty-two patients of 40 originally referred for native valve disease surgery requiring valve replacement, safely underwent the pre-operative anticoagulation challenge. No maternal or fetal complications were detected in 16 pregnancies under low oral anticoagulation. Patterns of warfarin daily dosage and induced INRs were characterized during pregnancy.

CONCLUSIONS:

In this small sample observational study, a pre-operative anticoagulation therapy trial helped young women scheduled for valve replacement to acquire complete information as to the choice of prosthetic device. In selected third-generation mechanical aortic prosthesis recipients, low-dose anticoagulation therapy seems safe and feasible for both mother and fetus. Further studies are needed to validate this approach.

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Abstract

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OBJECTIVE:

Transcatheter valve-in-valve implantation is evolving as an alternative to reoperative valve replacement in high-risk patients with degenerated bioprostheses. Nevertheless, hemodynamic performance is limited by the previously implanted xenograft.We report our experience with patient–prosthesis mismatch (PPM) after valve-in-valve implantation in the aortic position.

METHODS:

Eleven patients (aged 79.3 ± 6.1 years) received transapical implantation of a balloon-expandable pericardial heart valve into a degenerated bioprosthesis (size, 23.9 ± 1.6 mm; range, 21–27 mm) in the aortic position. All patients were considered high risk for surgical valve replacement (logistic European System for Cardiac Operative Risk Evaluation, 31.8% ± 24.1%). Severe PPM was defined as an indexed effective orifice area less than 0.65 cm²/m², determined by discharge echocardiography.

RESULTS:

Severe PPM was evident in 5 patients (group 1) and absent in 6 patients (group 2). Mean transvalvular gradients decreased from 29.2 ± 15.4 mm Hg before implantation to 21.2 ± 9.7 mm Hg at discharge (group 1) and from 28.2 ± 9.0 mm Hg before implantation to 15.2 ± 6.5 mm Hg at discharge (group 2). Indexed effective orifice area increased from 0.5 ± 0.1 cm²/m² to 0.6 ± 0.1 cm²/m² and from 0.6 ± 0.3 cm²/m² to 0.8 ± 0.3 cm²/m². Aortic regurgitation decreased from grade 2.0 ± 1.1 to 0.4 ± 0.5 overall. No differences in New York Heart Association class improvement or survival during follow-up were observed. One patient required reoperation for symptomatic PPM 426 days after implantation.

CONCLUSIONS:

Valve-in-valve implantation can be performed in high-risk surgical patients to avoid reoperation. However, PPM frequently occurs, making adequate patient selection crucial. Small bioprostheses (<23 mm) should be avoided. Implantation into 23-mm xenografts can be recommended only for patients with a body surface area less than 1.8 m². Larger prostheses seem to carry a lower risk for PPM. Although no delay in clinical improvement was seen at short-term, 1 PPM-related surgical intervention raises concern regarding long-term performance.

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Abstract

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OBJECTIVES:

The aim of this study was to provide a simple, reproducible, and point-of-care assessment of peri-prosthetic aortic regurgitation (periAR) during transcatheter aortic valve implantation (TAVI) and to decipher the impact of this peri-procedural parameter on outcome.

BACKGROUND:

Because periAR after TAVI might be associated with adverse outcome, precise quantification of periAR is of paramount importance but remains technically challenging.

METHODS:

The severity of periAR was prospectively evaluated in 146 patients treated with the Medtronic CoreValve (Minneapolis, Minnesota) prosthesis by echocardiography, angiography, and measurement of the aortic regurgitation (AR) index, which is calculated as ratio of the gradient between diastolic blood pressure (DBP) and left ventricular end-diastolic pressure (LVEDP) to systolic blood pressure (SBP): [(DBP - LVEDP)/SBP] X 100.

RESULTS:

After TAVI, 53 patients (36.3%) showed no signs of periAR and 71 patients (48.6%) showed only mild periAR, whereas 18 patients (12.3%) and 4 patients (2.7%) suffered from moderate and severe periAR, respectively. The AR index decreased stepwise from 31.7 ± 10.4 in patients without periAR, to 28.0 ± 8.5 with mild periAR, 19.6 ± 7.6 with moderate periAR, and 7.6 ± 2.6 with severe periAR (p < 0.001), respectively. Patients with AR index <25 had a significantly increased 1-year mortality risk compared with patients with AR index ≥25 (46.0% vs. 16.7%; p < 0.001). The AR index provided additional prognostic information beyond the echocardiographically assessed severity of periAR and independently predicted 1-year mortality (hazard ratio: 2.9, 95% confidence interval: 1.3 to 6.4; p = 0.009).

CONCLUSIONS:

The assessment of the AR index allows a precise judgment of periAR, independently predicts 1-year mortality after TAVI, and provides additional prognostic information that is complementary to the echocardiographically assessed severity of periAR.

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Abstract

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BACKGROUND:

Transcatheter aortic valve implantation (TAVI) has become a viable alternative in maximum risk patients. For those patients requiring aortic valve rereplacement, the "valve-in-valve" concept has been described. We report our experience with transapical valvein-valve implantation in 7 patients with deteriorated aortic bioprosthesis at 1-year follow up.

METHODS:

Since November 2008, 210 patients received transapical TAVI due to severe aortic stenosis. Seven patients presented with deteriorated aortic valve bioprosthesis and received transapical valve-in-valve implantation. Mean age was 78.7 ± 0.8 years. Preoperatively, all patients were at New York Heart Association (NYHA) functional class III. For risk estimation, the Society of Thoracic Surgeons (STS) and European System for Cardiac Operative Risk Evaluation (ES) risk scores were used and predicted high mortality (means ± standard error of the mean: STS_Mortality21.6 ± 2.8%, ES_add 14.9 ± 1.1, ES_log 52.6 ± 9.0%). Mean follow-up time was 517 ± 65 days (range, 280 to 799 days).

RESULTS:

Six patients showed a severely deteriorated bioprosthesis in terms of a stenotic valve (aortic valve area: 0.64 ± 0.04 cm², maximum/mean developed transvalvular pressure gradient: dPmax 63.3 ± 10.9mmHg, dPmean 40.4 ± 5.6 mm Hg). One patient's deteriorated prosthesis was highly insufficient. Procedural success rate was 100%, mean procedure time was 46.7 ± 12.3 minutes. Echocardiography revealed excellent hemodynamics of implanted prosthesis (dPmax 31.1 ± 5.5 mm Hg; dPmean 19.4 ± 4.3 mm Hg). Overall, postoperative course was uneventful. No patient died during follow-up, which ranged up to 26 months. All patients, except 1, remained in NYHA class I or II.

CONCLUSIONS:

Our results demonstrate feasibility and safety of the transapical valve-in-valve approach with excellent hemodynamic and clinical results. Decision making in a multidisciplinary setting is mandatory. Further studies with more patients and longer follow-up are needed to identify candidates benefiting from transapical transcatheter valve-in valve implantation.

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Abstract

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BACKGROUND:

Developed in collabration with the American Heart Association, American Society of Echocardiography, European Association for Cardio-Thoracic Surgery, Heart Failure Society of America, Mended Hearts, Society of Cardiovascular Anesthesiologists, Society of Cardiovascular Computed Tomography, and Society for Cardiovascular Magnetic Resonance

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Abstract

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OBJECTIVES:

The aim of this study was to investigate the impact of bisphosphonates on the progression of aortic stenosis.

BACKGROUND:

Valvular calcification is associated with the development and progression of aortic stenosis. Bisphosphonates have been suggested to slow this progression.

MEDHODS:

Female patients older than the age of 60 years with an aortic valve area (AVA) between 1.0 and 2.0 cm² were identified and studied retrospectively. Only those who had follow-up echocardiograms at least a year apart were included. Primary outcomes were the change in AVA and valvular gradients over time. Mortality and freedom from aortic valve replacement were also studied. A propensity-matching method was applied for the probability of the use of bisphosphonates

RESULTS:

The study included 801 female patients (mean age, 76 ± 7.6 years) with a mean follow-up of 5.1 ± 2.4 years. The mean duration of bisphosphonate use was 3.1 ± 2.6 years. At the time of the initial echocardiogram, 323 patients (38%) were taking bisphosphonates. The mean ejection fraction at baseline was 56.7 ± 9.6% with a mean AVA of 1.32 ± 0.25 cm². Peak and mean gradients were 28.4 ± 11 mm Hg and 15.6 ± 6.8 mm Hg, respectively. Propensity matching was successfully performed for 438 patients. On follow-up, there were no differences in the rate of change in AVA or peak and mean gradients when patients were stratified based on the use of bisphosphonates. Bisphosphonates also had no impact on survival or freedom from aortic valve replacement of the use of bisphosphonates.Bisphosphonates had no impact on survival or freedom from aortic valve replacement.

CONCLUSIONS:

In this retrospective analysis of older female patients, bisphosphonates do not have a significant impact on the hemodynamic or clinical progression of aortic stenosis.

Abstract

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OBJECTIVES:

The goal of this study was to assess serial changes in patient health-related quality of life (HRQOL) over time and identify predictors of patient benefit.

BACKGROUND:

Severe aortic stenosis reduces the length and quality of a patient's life. Transcatheter aortic valve implantation (TAVI) is superior to standard medical therapy and noninferior to surgical aortic valve replacement for 1-year mortality. HRQOL is an important outcome measure for which there is limited evidence in TAVI populations.

METHODS:

A total of 102 patients (mean age 80 ± 0.6 years; 49% male) undergoing TAVI consented to participate. Two HRQOL questionnaires—the social functioning (SF)-12v2 with physical component summaries (PCS) and mental component summaries (MCS) and the EQ-5D (with a visual analog scale [VAS])—were completed at baseline, 30 days, 6 months, and 1 year according to the recommendations of the Valve Academic Research Consortium. A SF-6D utility measure was calculated from the SF-12 survey.

RESULTS:

HRQOL significantly improved over 1 year (PCS p = 0.02; EQ-5D p = 0.02; VAS p = 0.01; SF-6D p = 0.03), becoming similar to age-adjusted U.S. population norms. The greatest change occurred from baseline to 30 days (p < 0.001), with further significant improvements to 6 months (p < 0.01). An insignificant decline occurred between 6 months and 1 year (p > 0.05), but a linear pattern of change remained for PCS, EQ-5D, and VAS (p < 0.05). Male sex (SF-6D p = 0.01) and increased operator experience (PCS, EQ-5D, and VAS p < 0.05) were independent predictors of a greater improvement in HRQOL.

CONCLUSIONS:

HRQOL significantly improved early after TAVI and was maintained out to 1 year. Patient factors, procedural complications, and operator experience are predictors of health benefit at 1 year.

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Abstract

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BACKGROUND

Transcatheter aortic-valve implantation (TAVI) is an emerging intervention for the treatment of high-risk patients with severe aortic stenosis and coexisting illnesses. We report the results of a prospective multicenter study of the French national transcatheter aortic-valve implantation registry, FRANCE 2.

METHODS:

All TAVIs performed in France, as listed in the FRANCE 2 registry, were prospectively included in the study. The primary end point was death from any cause.

RESULTS:

A total of 3195 patients were enrolled between January 2010 and October 2011 at 34 centers. The mean (±SD) age was 82.7±7.2 years; 49% of the patients were women. All patients were highly symptomatic and were at high surgical risk for aortic-valve replacement. Edwards SAPIEN and Medtronic CoreValve devices were implanted in 66.9% and 33.1% of patients, respectively. Approaches were either transarterial (transfemoral, 74.6%; subclavian, 5.8%; and other, 1.8%) or transapical (17.8%). The procedural success rate was 96.9%. Rates of death at 30 days and 1 year were 9.7% and 24.0%, respectively. At 1 year, the incidence of stroke was 4.1%, and the incidence of periprosthetic aortic regurgitation was 64.5%. In a multivariate model, a higher logistic risk score on the European System for Cardiac Operative Risk Evaluation (EuroSCORE), New York Heart Association functional class III or IV symptoms, the use of a transapical TAVI approach, and a higher amount of periprosthetic regurgitation were significantly associated with reduced survival.

CONCLUSIONS:

This prospective registry study reflected real-life TAVI experience in high-risk elderly patients with aortic stenosis, in whom TAVI appeared to be a reasonable option.

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Abstract

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BACKGROUND:

Transcatheter aortic-valve replacement (TAVR) is the recommended therapy for patients with severe aortic stenosis who are not suitable candidates for surgery. The outcomes beyond 1 year in such patients are not known.

METHODS:

We randomly assigned patients to transfemoral TAVR or to standard therapy (which often included balloon aortic valvuloplasty). Data on 2-year outcomes were analyzed.

RESULTS:

A total of 358 patients underwent randomization at 21 centers. The rates of death at 2 years were 43.3% in the TAVR group and 68.0% in the standard-therapy group (P<0.001), and the corresponding rates of cardiac death were 31.0% and 62.4% (P<0.001). The survival advantage associated with TAVR that was seen at 1 year remained significant among patients who survived beyond the first year (hazard ratio, 0.58; 95% confidence interval [CI], 0.36 to 0.92; P=0.02 with the use of the log-rank test). The rate of stroke was higher after TAVR than with standard therapy (13.8% vs. 5.5%, P=0.01), owing, in the first 30 days, to the occurrence of more ischemic events in the TAVR group (6.7% vs. 1.7%, P=0.02) and, beyond 30 days, to the occurrence of more hemorrhagic strokes in the TAVR group (2.2% vs. 0.6%, P=0.16). At 2 years, the rate of rehospitalization was 35.0% in the TAVR group and 72.5% in the standard-therapy group (P<0.001). TAVR, as compared with standard therapy, was also associated with improved functional status (P<0.001). The data suggest that the mortality benefit after TAVR may be limited to patients who do not have extensive coexisting conditions. Echocardiographic analysis showed a sustained increase in aortic-valve area and a decrease in aortic-valve gradient, with no worsening of paravalvular aortic regurgitation.

CONCLUSIONS:

Among appropriately selected patients with severe aortic stenosis who were not suitable candidates for surgery, TAVR reduced the rates of death and hospitalization, with a decrease in symptoms and an improvement in valve hemodynamics that were sustained at 2 years of follow-up. The presence of extensive coexisting conditions may attenuate the survival benefit of TAVR.

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Abstract

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BACKGROUND:

The Placement of Aortic Transcatheter Valves (PARTNER) trial showed that among high-risk patients with aortic stenosis, the 1-year survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical replacement. However, longer-term follow-up is necessary to determine whether TAVR has prolonged benefits

METHODS:

At 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either surgical aortic-valve replacement or TAVR. All patients were followed for at least 2 years, with assessment of clinical outcomes and echocardiographic evaluation.

RESULTS:

The rates of death from any cause were similar in the TAVR and surgery groups (hazard ratio with TAVR, 0.90; 95% confidence interval [CI], 0.71 to 1.15; P=0.41) and at 2 years (Kaplan-Meier analysis) were 33.9% in the TAVR group and 35.0% in the surgery group (P=0.78). The frequency of all strokes during follow-up did not differ significantly between the two groups (hazard ratio, 1.22; 95% CI, 0.67 to 2.23; P=0.52). At 30 days, strokes were more frequent with TAVR than with surgical replacement (4.6% vs. 2.4%, P=0.12); subsequently, there were 8 additional strokes in the TAVR group and 12 in the surgery group. Improvement in valve areas was similar with TAVR and surgical replacement and was maintained for 2 years. Paravalvular regurgitation was more frequent after TAVR (P<0.001), and even mild paravalvular regurgitation was associated with increased late mortality (P<0.001).

CONCLUSIONS:

A 2-year follow-up of patients in the PARTNER trial supports TAVR as an alternative to surgery in high-risk patients. The two treatments were similar with respect to mortality, reduction in symptoms, and improved valve hemodynamics, but paravalvular regurgitation was more frequent after TAVR and was associated with increased late mortality

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Abstract

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OBJECTIVES:

The aim of this study was to evaluate the impact of mitral regurgitation (MR) on outcomes after transcatheter aortic valve replacement (TAVR) and the impact of TAVR on MR.

BACKGROUND:

Little is known of the influence of MR on outcomes after TAVR.

METHODS:

The outcomes of patients with mild or less (n = 319), moderate (n = 89), and severe (n = 43) MR were evaluated after TAVR at 2 Canadian centers.

RESULTS:

Patients with moderate or severe MR had a higher mortality rate than those with mild or less MR during the 30 days after TAVR (adjusted hazard ratio: 2.10; 95% confidence interval: 1.12 to 3.94; p = 0.02). However, the mortality rates after 30 days were similar (adjusted hazard ratio: 0.82; 95% confidence interval: 0.50 to 1.34; p = 0.42). One year after TAVR, moderate MR had improved in 58%, remained moderate in 17%, and worsened to severe in 1%, and 24% of patients had died. Severe MR had improved in 49% and remained severe in 16%, and 35% of patients had died. Multivariate predictors of improved MR at 1 year (vs. unchanged MR, worse MR, or death) were a mean transaortic gradient ≥40 mm Hg, functional (as opposed to structural) MR, the absence of pulmonary hypertension, and the absence of atrial fibrillation.

CONCLUSIONS:

Moderate or severe MR in patients undergoing TAVR is associated with a higher early, but not late, mortality rate. At 1-year follow-up, MR was improved in 55% of patients with moderate or severe MR at baseline. Improvement was more likely in patients with high transaortic gradients, with functional MR, without pulmonary hypertension and without atrial fibrillation.

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Abstract

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OBJECTIVES:

Recent evidence indicated that the use of a bioprosthesis in young patients at first-time aortic valve replacement (AVR) is associated with an increased reoperation risk, but not with an increase in long-term mortality, when compared with the use of a mechanical valve. However, at reoperative AVR, follow-up data by prosthesis type have been lacking from the literature. Therefore, we examined long-term survival and valve-related complications according to the type of prosthesis used at reoperative AVR.

METHODS:

We studied 437 patients who underwent reoperative AVR, at a mean age of 58.6 ± 14.2 years, for failure of a previously implanted aortic valve prosthesis. Thirty-day mortality at reoperative AVR was 6% (n = 27). A bioprosthesis was used in 135 (31%) patients. Patients were subsequently followed up for a mean of 7.6 ± 6.8 years after reoperative AVR.

RESULTS:

The use of a bioprosthesis at reoperative AVR was not associated with impaired survival on adjusted analysis (hazard ratio [HR], 0.8 ± 0.4; P = .6). Freedom from thromboembolism, and endocarditis were similar between valve types (both P > .05); however, late postoperative major hemorrhage occurred only in patients who received a mechanical prosthesis at reoperative AVR. Risk factors for third-time AVR included the use of a bioprosthesis (HR, 14.0) and younger age (HR, 1.05 per decreasing year) at reoperative AVR (both P < .001). Thirty-day mortality of third-time AVR was 4% (n = 1/27).

CONCLUSIONS:

At reoperative AVR, the use of a bioprosthesis is associated with equivalent long-term survival compared with a mechanical prosthesis. Patients who receive a bioprosthesis at reoperative AVR are less likely to experience major hemorrhage but more likely to require third-time AVR, albeit with an acceptable third-time perioperative mortality risk. Therefore, the patient's informed preferences regarding prosthesis choice should prevail, even in a reoperative context.

Abstract

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OBJECTIVES:

The primary analysis estimated the cost-effectiveness of transfemoral transcatheter aortic valve implantation (Edwards SAPIEN heart valve; Edwards Lifesciences LLC, Irvine, Calif) compared with standard management in inoperable patients with severe, symptomatic aortic stenosis. The secondary analysis estimated the cost-effectiveness of transcatheter aortic valve implantation (transfemoral or transapical approaches) (SAPIEN heart valve) compared with surgical aortic valve replacement in operable patients with severe, symptomatic aortic stenosis.

METHODS:

A combined decision tree and Markov model was developed to compare costs, life-years, and quality-adjusted life-years over a 20-year time horizon from the Canadian health-care payer perspective. The Placement of Aortic Transcatheter Valves trial provided rates of postoperative complications and mortality. Costs were derived from the Ontario Case Costing Initiative. Comprehensive sensitivity analyses were used to explore the impact of uncertainty on the cost-effective estimates.

RESULTS:

In the primary analysis, comparing transfemoral transcatheter aortic valve implantation and standard management resulted in incremental cost-effectiveness ratios of $36,458/life-year and $51,324/quality-adjusted life-year. In the secondary analysis, transcatheter aortic valve implantation (transfemoral or transapical) and surgical aortic valve replacement were compared, resulting in an incremental cost-effectiveness ratio of $870,143/life-year and transcatheter aortic valve implantation being dominated by surgical aortic valve replacement when comparing quality-adjusted life-years. Deterministic sensitivity analysis for the primary analysis identified the procedural costs and 1-year mortality rates of both transfemoral transcatheter aortic valve implantation and standard management to be the most sensitive parameters in the model, whereas results from the secondary analysis were largely unchanged. Removal of long-term complications in both analyses led to more favorable incremental cost-effectiveness ratios for transcatheter aortic valve implantation.

CONCLUSION:

This economic evaluation suggested that transfemoral transcatheter aortic valve implantation was a cost-effective option compared with standard management for inoperable patients with severe, symptomatic aortic stenosis, but it might not be a cost-effective treatment compared with surgical aortic valve replacement for operable patients.

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Abstract

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OBJECTIVE:

Patients who require aortic valve replacement are increasingly receiving biologic valves to avoid long-term anticoagulation. The thromboembolic risk of bioprosthetic valves is reportedly low. The study objective was to review the incidence of early valve thrombosis requiring reoperation in patients who received a bioprosthetic valve in the aortic position.

METHODS:

We reviewed all adult patients who had a biologic valve implanted in the aortic position at Mayo Clinic between January 1993 and July 2009. Records were reviewed for all cases of reoperation that occurred less than 2 years postoperatively. Incidences of valve thrombosis were calculated including 95% Poisson confidence intervals.

RESULTS:

During the study interval, 4568 patients received biologic valves for aortic valve replacement. We identified 8 patients who underwent reoperation to replace the aortic prosthesis because of thrombus that resulted in functional aortic stenosis. The median age of patients at the time of reoperation was 77 years (range, 52-86), and the median time to reoperation was 398 days (range, 106-626). All patients with valve thrombosis received a stented porcine valve: St Jude Biocor (St Jude Medical, Inc, St Paul, Minn) in 4 patients, Medtronic Mosaic (Medtronic Inc, Minneapolis, Minn) in 2 patients, and Medtronic Hancock (Medtronic Inc) in 2 patients. The calculated incidence of valve thrombosis was 1.26% (confidence interval, 0.56-1.96) for the Biocor valve, 0.37% (confidence interval, 0.19-0.56) for the Mosaic valve, and 0.84% (confidence interval, 0.42-1.25) for the Hancock valve (P = .34). There were no cases of valve thrombosis in patients who received a pericardial valve (5923 patient-years) or stentless valve (172 patient-years).

CONCLUSIONS:

The incidence of early thrombosis of porcine aortic bioprostheses requiring reoperation was not insignificant. Potential causes and mechanisms for such thrombosis are unknown. Recognition of this unanticipated problem and reoperation resulted in a satisfactory outcome for patients.

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Abstract

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BACKGROUND:

Better understanding of aortic root geometry could improve diagnosis and reconstruction of pathologic aortic valves. In this study, a previous model of hemispheric aortic valve leaflets nested within a cylindrical aorta was refined in humans with normal aortic valves.

METHODS:

Using 1-mm axial slices, high-resolution computed tomographic angiograms from 10 normal aortic roots were used to generate high-density X-, Y-, and Z-coordinates of valve structures using Mathematica software. Three-dimensional least squares regression analyses of leaflet and sinus coordinates were employed to compare multiple geometric models of aortic valve and root geometry. Shapes and dimensions of all root structures were evaluated and compared.

RESULTS:

Aortic valve geometry was roughly hemispherical, but the valve base was elliptical (minor-major diameter ratio = .66). Dimensional fits of the leaflet-sinus complexes also were better using ellipsoidal geometry, with taller leaflets than predicted by hemispheres. The commissure between the left and noncoronary cusps was located uniformly at the posterior junction of the base minor diameter and circumference, with the center of the right coronary cusp opposite. The subcommissural post areas flared outward by 5° to 10°, and the volume of the right coronary leaflet-sinus complex was 12.4% and 10.7% larger than the noncoronary cusps and left cusps, respectively.

CONCLUSION:

The normal human aortic valve is an elliptical structure, and ellipsoidal refinements improve representation of leaflet geometry. The left and noncoronary cusps commissure is located posteriorly; the right coronary cusp is located anteriorly. This model could be useful in quantifying pathologic geometry and in engineering devices for aortic valve reconstruction.

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Abstract

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BACKGROUND:

Following guidelines, aortic valve replacement (AVR) in asymptomatic patients with severe aortic valve stenosis is often postponed until symptoms do occur. Delaying AVR will inevitably lead to progression of left ventricular hypertrophy. We studied the relationship between septum wall thickness indexed for body surface area (SWTI) as a measure for LV hypertrophy and 30-day and late all-cause mortality after AVR.

METHODS:

This study included the data of adult patients who underwent isolated AVR between January 2006 and December 2010 and in whom a reliable measurement of the septum wall thickness could be made. The patients were stratified into three groups according to their SWTI. The SWTI was less than 6 mm/m(2) in 136 patients, between 6 and 8 mm/m(2) in 307 patients, and more than 8 mm/m(2) in 126 patients.

RESULTS:

Death occurred in 10 patients within 30 days (1.8%), and 41 patients died during follow-up (7.2%). Univariate logistic regression analysis revealed only endocarditis as predictor of early mortality. Multivariate Cox regression analyses revealed SWTI as a continuous variable as well as a categorical (group) variable to be a predictor of late mortality. Compared with the group SWTI less than 6 mm/m(2), odds ratio for the group with SWTI 6 to 8 mm/m(2) was 3.4 (p = 0.046), and for the group with SWTI more than 8 mm/m(2), it was 6.0 (p = 0.005).

CONCLUSIONS:

In patients undergoing AVR, the SWTI was a strong predictor of late mortality. Whether avoidance of progression of left ventricular hypertrophy by early AVR leads to better outcome remains to be investigated.

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Abstract

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OBJECTIVE:

For children with congenital aortic stenosis (AS) who are selected for biventricular repair, valvuloplasty can be achieved by surgical aortic valvuloplasty (SAV) or by transcatheter balloon aortic dilation (BAD). A retrospective study was undertaken to compare the effectiveness of BAD versus SAV, evaluating the long-term survival, incidence of aortic valve restenosis or aortic insufficiency (AI) or both, and freedom from reoperation for repeated valve repair or replacement. Neonates less than 2 months of age were excluded from this comparison.

METHODS:

We reviewed the outcomes of children undergoing repair by SAV (n = 89) and BAD (n = 69) at our institution during a recent 20-year period. Clinical and echocardiographic follow-up were analyzed. The patient groups were compared with regard to the persistence or recurrence of postoperative aortic gradients and valve insufficiency and valve-related reintervention, including aortic valve replacement (AVR).

RESULTS:

There was no significant difference between the groups with respect to mean age, body surface area, valve anatomy, sex, and preoperative gradients. Our data demonstrate that gradient reduction, AI, and the need for reintervention were worse for BAD. Aortic gradients at last follow-up were similar in both cohorts, but return of a significant gradient occurred sooner for patients who had BAD. Aortic gradient at discharge was significantly better for the patients who underwent SAV. Kaplan-Meier analysis showed that at 10 years, comparison of SAV and BAD was as follows: freedom from reintervention, 72% versus 53% (p = 0.02) and freedom from AVR, 80% versus 75% (p = 0.32).

CONCLUSION:

BAD yields less gradient reduction, more postprocedural AI, and a shorter interval between initial and subsequent reintervention than does SAV. Our results demonstrate that SAV is safe and effective and that residual gradients and degree of AI are low. After SAV, the need for AVR can usually be delayed until the child is significantly older. The long-term functional stability after SAV is excellent. BAD in comparison is associated with an increased frequency and severity of AI and the need for earlier reintervention and valve replacement. SAV should be offered to all patients beyond the newborn period because it gives superior and longer lasting palliation.

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Abstract

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BACKGROUND:

Transcatheter aortic valve implantation (TAVI) has been designed to treat elderly patients with severe aortic stenosis at high risk for operation; however, these patients are also often affected by severe iliac-femoral arteriopathy that prohibits the transfemoral approach.

METHODS:

From May 2008 to January 2012, 400 patients were evaluated for TAVI at our center; of these, 141 patients (64 men; mean age 81.3±8 years) with severe symptomatic aortic stenosis and no reasonable surgical option due to excessive risk were eligible for CoreValve (137 patients; Medtronic Inc, MN) or Sapien (Edwards Lifesciences, CA) implantation. Twenty-five patients (all affected by severe peripheral vasculopathy, including five re-do procedures), with a mean The Society of Thoracic Surgeons mortality score 11%±6%, underwent CoreValve implantation directly from the ascending aorta through a right anterior minithoracotomy. This case series was reviewed to evaluate the clinical outcomes of these patients. A combined team of cardiologists, cardiac surgeons with expertise in hybrid procedures, and anesthetists performed all the procedures.

RESULTS:

In all patients after valve deployment, the mean aortic gradient immediately dropped to 5 mm Hg or less, and the angiographic grade aortic insufficiency was 1 or less in 22 patients. One patient was converted to the transfemoral approach due to an extremely fragile aortic wall, but the patient died of abdominal aorta aneurysm rupture on postoperative day 1. Procedural success was obtained in the remaining 24 patients. A left ventricle tear in 1 patient was successfully surgically treated. Four patients required a permanent pacemaker implantation. Thirty-day mortality was 8% (2 patients). All discharged patients improved their New York Heart Association functional class and functional capacity, and echocardiograms demonstrated good valve performance up to 2 years (mean valve gradient, 9 mm Hg). During follow-up, 1 patient died of cachexia and another of bone marrow aplasia.

CONCLUSIONS:

TAVI with the direct aortic approach is safe and feasible, offering a new attractive option to treat selected high-risk patients with severe aortic stenosis and peripheral vasculopathy, including those requiring a re-do procedure, and has emerged as a valuable alternative route to transapical access.

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Abstract

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BACKGROUND:

Recent studies emphasized the usefulness of exercise stress echocardiography in asymptomatic patients with aortic stenosis. Nevertheless, the additive value of exercise pulmonary hypertension (Ex-PHT) in such patients remains unexplored. We therefore aimed to identify the determinants and to test the impact on outcome of Ex-PHT in asymptomatic patients with severe aortic stenosis.

METHODS AND RESULTS:

Asymptomatic patients with severe aortic stenosis (n=105; aortic valve area <0.6 cm(2)/m(2); age, 71±9 years; male, 59%) and preserved left ventricular systolic function (ejection fraction ≥55%) were prospectively submitted to exercise stress echocardiography. Resting PHT and Ex-PHT were defined as a systolic pulmonary arterial pressure >50 and >60 mm Hg, respectively. Ex-PHT was more frequent than resting PHT (55% versus 6%; P < 0.0001). On multivariable logistic regression, the independent predictors of Ex-PHT were male sex (odds ratio, 4.3; P=0.002), resting systolic pulmonary arterial pressure (odds ratio, 1.16; P=0.002), exercise indexed left ventricular end-diastolic volume (odds ratio, 1.04; P=0.026), exercise e'-wave velocity (odds ratio, 1.35; P=0.047), and exercise-induced changes in indexed left atrial area (odds ratio, 1.36; P=0.006). Ex-PHT was associated with reduced cardiac event-free survival (at 3 years, 22±7% versus 55±9%; P=0.014). In a multivariable Cox proportional hazards model, Ex-PHT was identified as an independent predictor of cardiac events (hazard ratio, 1.8; 95% confidence interval, 1.0-3.3; P=0.047). When exercise-induced changes in mean aortic pressure gradient were added to the multivariable model, Ex-PHT remained independently associated with reduced cardiac event-free survival (hazard ratio, 2.0; 95% confidence interval, 1.1-3.6; P=0.025).

CONCLUSIONS:

In asymptomatic patients with severe aortic stenosis, the main determinants of Ex-PHT are male sex, resting systolic pulmonary arterial pressure, and exercise parameters of diastolic burden. Moreover, Ex-PHT is associated with a 2-fold increased risk of cardiac events. These results strongly support the use of exercise stress echocardiography in asymptomatic aortic stenosis.

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Abstract

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BACKGROUND:

Sutureless aortic bioprostheses bear the potential of easy implantation, reduced ischemic time, and surgical trauma in aortic valve replacement. We herein show our clinical and echocardiographic results after a 1-year experience with a new sutureless bioprosthesis.

METHODS:

The Perceval S (Sorin Biomedica Cardio Srl, Saluggia, Italy) is a pericardial aortic prosthesis assembled within a super-elastic alloy frame. It is implanted intra-annularly, without the need of suture. As part of a premarketing multicenter study (Cavalier Trial), since March 2010, 83 patients were screened for implantation in our center.

RESULTS:

The patients received a size S (4), M (38), or L (41) prosthesis, either as isolated (57) or combined procedures (26). Fifty-one patients (61.5%) received a "J" sternotomy. Mean logistic European system for cardiac operative risk evaluation was 10.±7.5%, mean aortic cross-clamp time was 43.8±20.8 minutes (36±12.7 minutes for isolated procedures). Mean implantation time was 8±3.8 minutes (range 4 to 28 minutes). In-hospital mortality was 2.4% (1 patient for multiorgan failure and 1 for liver insufficiency); mean hospital stay was 11.5±4.4 days (range 2 to 28 days). We recorded 5 pacemaker implantations (6%). At follow-up, we had 2 deaths (1 patient for congestive heart failure and 1 for gastrointestinal bleeding). At 1 year, mean New York Heart Association functional class was 1.0±0.6. Mean transprosthetic gradients were 13.4±2.8, 12.6±2.3, and 10.8±1.3 mm Hg postoperatively, at 6 months, and at 1 year, respectively.

CONCLUSIONS:

The Perceval S shows satisfactory clinical and hemodynamic results. Due to its simple implantation technique, it represents an alternative especially for minimally invasive surgery. Operative trauma can be minimized by short aortic cross-clamp time.

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Abstract

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OBJECTIVES:

The study objective was to examine the short- and long-term outcomes of reoperative aortic root replacement after a previous aortic root replacement.

METHODS:

From September 1985 to February 2011, 84 consecutive patients underwent reoperative aortic root replacement. The patients' mean age was 46 ± 15 years (range, 19-80 years), and 86% were men. The main indication for reoperation was failed biological or bioprosthetic aortic valve and prosthetic valve endocarditis. Cox proportional hazard regression modeling was performed to identify risk factors that adversely affected overall survival.

RESULTS:

The operative mortality was 6% (5 patients). Perioperative morbidity included myocardial infarction in 2 patients, low cardiac output syndrome in 7 patients, sepsis in 3 patients, pulmonary complications in 7 patients, renal failure in 3 patients, reoperation for bleeding or tamponade in 5 patients, superficial sternal wound infections in 3 patients, permanent transvenous pacemaker in 8 patients, and stroke in 1 patient. Kaplan-Meier estimates for survival at 5, 10, and 12 years were 82.5% ± 4.7%, 72.5% ± 6.4%, and 65.0% ± 7.6%, respectively; the freedom from reoperation was 100%, 92.3% ± 5.2%, 92.3% ± 5.2%, respectively; and valve-related mortality was 93.1% ± 3.4%, 90.8% ± 4.0%, and 86.2% ± 5.8%, respectively. During the follow-up, valve-related deaths occurred in 7 patients. Age by increments of 5 years (hazard ratio, 1.205; 95% confidence interval, 1.036-1.401) and prosthetic valve endocarditis (hazard ratio, 2.662; 95% confidence interval, 1.054-6.724) were independent risk factors for mortality.

CONCLUSION:

Aortic root replacement after a previous aortic root replacement is associated with a relatively low operative mortality and perioperative morbidity, but long-term survival is suboptimal. Increasing age and prosthetic valve endocarditis adversely affect survival.

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Abstract

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BACKGROUND:

No human physiological data exists on whether aspirin only is as effective as warfarin plus aspirin in preventing cerebral microembolization in the early postoperative period after bioprosthetic aortic valve replacement (bAVR).

METHODS AND RESULTS:

We prospectively enrolled 56 patients who had no other indication for oral anticoagulation, who underwent bAVR and received, in an open-label fashion, either daily warfarin (for INR 2.0-3.0) plus 81 mg of aspirin (n=28) or 325 mg of aspirin only (n=28). Cerebral microembolization was quantified at 4 hours (baseline) and at 1 month postoperatively, by recording 1-hour bilateral middle cerebral artery (MCA) microembolic signals (MES). Platelet-function analysis (PFA) of closure times (CT) on collagen was also used as a marker of platelet-dependent activation. Follow-up to 1 year was complete. Preoperative demographics and baseline platelet function were equivalent in both groups. There was no mortality, stroke, or transient ischemic attack at 1 year in either group. No significant differences were found in the proportion of patients with MES among those receiving warfarin plus aspirin versus aspirin only, at baseline (68% versus 82%, respectively; P=0.4) and at 1 month (46% versus 43%; P=1.0) after bAVR. The total MES and PFA were also equivalent between groups, at baseline and follow-up.

CONCLUSIONS:

Early after bAVR, the effects of these 2 antithrombotic regimens on cerebral microembolization and platelet function are equivalent. These data bring new mechanistic support to the premise that aspirin only may safely be used early after bAVR in patients who have no other indication for oral anticoagulation.

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Abstract

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BACKGROUND:

Surgical aortic valve replacement (AVR) remains the standard of care for the treatment of operable, symptomatic aortic valve disease; however, to date, there are limited national data on the contemporary long-term outcomes after AVR in older individuals

METHODS AND RESULTS:

We examined long-term survival among 145 911 AVR patients ≥ 65 years of age undergoing AVR at 1026 centers with participation in the Society of Thoracic Surgeons Adult Cardiac Surgery Database from 1991 to 2007. In-hospital complications and long-term survival were stratified by age, Society of Thoracic Surgeons perioperative risk of mortality, and several comorbidities. The median patient age was 76 years; 16% had chronic lung disease, 6% had preoperative renal failure, 38% had heart failure, and 12% had prior cardiac surgery. The median survival in patients 65 to 69, 70 to 79, and ≥ 80 years of age undergoing isolated AVR was 13, 9, and 6 years, respectively. For AVR plus coronary artery bypass graft procedures, median survival was 10, 8, and 6 years, respectively. Although only 5% of isolated AVR patients had a high Society of Thoracic Surgeons perioperative risk of mortality (≥ 10%), their median survival was 2.5 to 2.7 years. Severe lung disease and renal failure were each associated with a ≥ 50% reduction in median survival among all age groups compared with those who did not have these comorbidities, whereas left ventricular dysfunction and prior cardiac operation were associated with a 25% reduction in median survival.

CONCLUSIONS:

Long-term survival after surgical AVR in the elderly is excellent, although patients with a high Society of Thoracic Surgeons perioperative risk of mortality and those with certain comorbidities carry a particularly poor long-term prognosis.

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Abstract

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OBJECTIVE:

Whether patients with bicuspid aortic valves are susceptible not only to ascending aortic dilatation but also to dilatation of the remaining aorta is uncertain. This study evaluated the possible correlation between ascending aortic dilatation and dilatation of the remaining aorta in patients with bicuspid and tricuspid aortic valves, respectively.

METHODS:

The entire aortas of 97 patients (bicuspid in 62, tricuspid in 35) undergoing replacement of the ascending aorta because of ascending aortic pathology (78 with and 19 without concurrent valve pathology) were preoperatively evaluated using computed tomography scanning.

RESULTS:

Aortic dimensions distal to the ascending aorta were smaller in patients with bicuspid aortic valves than in patients with tricuspid aortic valves (P < .001): proximal arch: 3.20 ± 0.60 cm/3.80 ± 0.68 cm; distal arch: 2.90 ± 0.60 cm/3.40 ± 0.50 cm; isthmus, 2.95 ± 0.60 cm/3.50 ± 0.60 cm; descending aorta: 2.70 ± 0.50 cm/3.20 ± 0.65 cm; suprarenal aorta: 2.30 ± 0.40 cm/2.70 ± 0.43 cm; infrarenal aorta: 1.90 ± 0.48 cm/2.20 ± 0.35 cm, respectively. Concomitant pathologic dilatation of the descending aorta was more common in patients with tricuspid aortic valves (37%) than in patients with bicuspid aortic valves (5%) (P < .001). Neither valvular pathology nor bicuspid aortic valve phenotype influenced the aortic dimensions in the bicuspid group (P > .2).

CONCLUSIONS:

Patients with bicuspid aortic valves and dilatation of the ascending aorta consistently had smaller dimensions of the remaining aorta compared with patients with tricuspid aortic valves. Concomitant dilatation of the descending aorta was predominantly found in patients with tricuspid aortic valves.

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Abstract

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BACKGROUND:

Transcatheter aortic valve implantation (TAVI) is associated with a higher risk of neurological events for both the transfemoral and transapical approach than surgical valve replacement. Cerebral magnetic resonance imaging has revealed more new, albeit clinically silent lesions from procedural embolization, yet the main source and predominant procedural step of emboli remain unclear.

METHODS AND RESULTS:

Eighty-three patients underwent transfemoral (Medtronic CoreValve [MCV(TF)], n=32; Edwards Sapien [ES(TF)], n=26) and transapical (ES(TA): n=25) TAVI. Serial transcranial Doppler examinations before, during, and 3 months after TAVI were used to identify high-intensity transient signals (HITS) as a surrogate for microembolization. Procedural HITS were detected in all patients, predominantly during manipulation of the calcified aortic valve while stent valves were being positioned and implanted. The balloon-expandable ES prosthesis caused significantly more HITS (mean [95% CI]) during positioning (ES(TF), 259.9 [184.8-334.9]; ES(TA), 206.1[162.5-249.7]; MCV(TF), 78.5 [25.3-131.6]; P < 0.001) and the self-expandable MCV prosthesis during implantation (MCV(TF), 397.1 [302.1-492.2]; ES(TF), 88.2 [70.2-106.3]; ES(TA), 110.7 [82.0-139.3]; P < 0.001). Overall, there were no significant differences between transfemoral and transapical TAVI or between the MCV and ES prostheses. No HITS were detected at baseline or 3-month follow-up. There was 1 major procedural stroke that resulted in death and 1 minor procedural stroke with full recovery at 3-month follow-up in the MCV group.

CONCLUSIONS:

Procedural HITS were detected by transcranial Doppler in all patients. Although no difference was observed between the transfemoral and the transapical approach with the balloon-expandable ES stent valve, transfemoral TAVI with the self-expandable MCV prosthesis resulted in the greatest number of HITS, predominantly during implantation.

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Abstract

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BACKGROUND:

Patient selection for transcatheter aortic valve implantation (TAVI) remains highly controversial. Some screened patients subsequently undergo conventional aortic valve replacement (AVR) because they are unsuitable TAVI candidates. This study examined the indications and outcomes for these patients, thereby determining the efficacy of the screening process.

METHODS:

Between January 2006 and December 2010, 79 consecutive patients (49% men), aged older than 75 years with high surgical risk, were screened for TAVI, but subsequently underwent conventional AVR through a partial or complete sternotomy. The indications, demographics, and outcomes of this cohort were studied.

RESULTS:

Mean age was 80.4±3.6 years. Mean left ventricular ejection fraction was 0.55±0.16, and the mean logistic European System for Cardiac Operative Risk Evaluation was 13%±7%. Of the 79 patients, 6 (7.6%) had prior cardiac surgical procedures. Indications for TAVI denial after patient evaluations were a large annulus in 31 (39%), acceptable risk profile for AVR in 24 (30%), need for urgent operation in 11 (14%), and concomitant cardiovascular pathology in 5 (6%). Mean cross-clamp time was 55±14 minutes, and cardiopulmonary bypass time was 81±21 minutes. Concomitant procedures included a Maze in 12 patients (15%). Postoperative morbidity included permanent stroke in 2 (2.5%), respiratory failure in 9 (11%), and pacemaker implantation in 2 (2.5%). Hospital mortality was 1.3% (1 of 79). Cumulative survival at 6, 12, and 36 months was 88.5%, 87.1% and 72.7%, respectively.

CONCLUSIONS:

Our existing patient evaluation process accurately defines an acceptable risk cohort for conventional AVR. The late mortality rate reflects the advanced age and comorbidities of this cohort. The data suggest that overzealous widening of TAVI inclusion criteria may be inappropriate.

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Abstract

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BACKGROUND:

Girls and women with Turner syndrome are at risk for aortic dissection and rupture. However, the size of the aorta and the clinical characteristics among those with Turner syndrome and dissection have received little attention.

METHODS AND RESULTS:

We obtained medical records from 20 individuals who voluntarily participated in the International Turner Syndrome Aortic Dissection Registry. Type A dissections occurred in 17 of 20 (85%) cases, and type B occurred in 3 cases of which 1 occurred after coarctation stent placement. Of those with spontaneous aortic dissections, 18 of 19 (95%) had an associated cardiac malformation that included a bicuspid aortic valve. In 1 individual there was no predisposing finding other than the presence of Turner syndrome. Associated pregnancy was documented in 1 of 19 (5%). More than half (13/19, 68%) came to medical attention >24 hours after the onset of symptoms. For those with type A dissections, the mean ascending aortic size index was 2.7±0.6 cm/m(2) (n=9).

CONCLUSIONS:

Aortic dissection in Turner syndrome occurs in young individuals at smaller aortic diameters than in the general population or other forms of genetically triggered aortopathy. The absence of aortic valve or other cardiac malformations appears to markedly reduce the risk of aortic dissection However, aortic dissection can occur in Turner syndrome without cardiac malformations or hypertension. Individuals with Turner syndrome who are >18 years of age with an ascending aortic size index >2.5 cm/m(2) should be considered for an aortic operation to prevent aortic dissection.

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Abstract

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BACKGROUND:

We evaluate the clinical results of the Carpentier-Edwards supraannular (CE SAV) aortic bioprosthesis at long-term follow-up (over 25 years).

METHODS:

Between 1983 and 1994, 1,002 CE SAV prostheses were implanted. Data were prospectively collected, retrospectively analyzed, and stratified by age groups at the time of surgery (group 1, ≤60 years; group 2, 61 to 70 years; group 3, >70 years), using both the actuarial and the "actual" (cumulative risk) methods.

RESULTS:

The operative mortality was 11.3% (valve-related in 2 cases). Follow-up included 8,164.09 patient-years (average 13.7±6.6 years, up to 26.9 years). Overall survival at 25 years was significantly higher in group 1 (p < 0.001). Freedom from structural valve deterioration (SVD) at 15 years was 85.9% (actuarial) and 94.8% (actual). Freedom from reoperation for SVD was 91.8% (actuarial) and 97% (actual). There were no significant differences in valve-related endpoints among group 2 and group 3. Death was valve-related in 11.3%. Younger age at surgery was associated with higher incidence but not earlier presentation of SVD. Freedom from any valve-related complication at 15 years was 23.6%, 66%, and 68% in groups 1, 2, and 3 (actuarial), and 38.9%, 76.1%, and 81.2%, respectively (actual) (p=0.6 among groups 2 and 3).

CONCLUSIONS:

The CE SAV bioprosthesis provides similar outcomes (SVD and reoperation) in patients aged 61 to 70 years and older individuals. Use of a bioprosthesis is justified in patients older than 60 years. Younger patients may be rightfully informed over the expected durability of the prosthesis.

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Abstract

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BACKGROUND:

Degenerative aortic valve stenosis (AS) is associated with conduction abnormalities. Pacemaker implantation is encountered after surgical aortic valve replacement (SAVR). Not much is known about the pacemaker implantation rate during midterm follow-up after SAVR. Our objectives were to determine the incidence of permanent pacemaker implantation (PPI) in the midterm after SAVR in a tertiary care facility.

METHODS:

We reviewed procedural data of 734 consecutive patients (56% men; mean age, 68.9±9.5 years) with degenerative severe AS who underwent SAVR between January 1, 2003, and December 31, 2008. Perioperative electrocardiograms were assessed for occurrence of conduction abnormalities, and we sought to determine the incidence and indication for PPI with a median follow-up of 3.76 years (interquartile range, 2.44 to 5.59 years). Univariate and multivariate logistic regression models were applied to identify predictors for early (≤30 days) and late (>30 days) PPI.

RESULTS:

Isolated SAVR was performed in 56%, SAVR with coronary artery bypass grafting in 35%, and SAVR with any other valve therapy in 5.8%. Complete bundle branch block (BBB) was present in 7% and first-degree atrioventricular block in 11%. New BBBs were detected in 63 patients (8.6%). Fifteen patients (2.0%) required a PPI within 30 days after SAVR, and 28 (4.0%) underwent PPI more than 30 days after SAVR. The linearized rate of PPI after SAVR was 1.01%±0.37% per patient-year. Patients with BBB at baseline had a higher PPI incidence after SAVR than patients without BBB, both within 30 days (8% vs 1.5%, p=0.001) and after 30 days (10% vs 2.9%, p=0.006). PPI incidence after 30 days was also significantly higher in patients with a new BBB after SAVR (7.8% vs 2.9%, p=0.038). By multivariate logistic regression analysis, BBB and the combination of AS and regurgitation predicted PPI within 30 days after SAVR (hazard ratio [HR], 470; 95% confidence interval [CI], 1.55 to 14.27; and HR, 1.33; 95% CI, 0.03 to 1.73, respectively). BBB (HR, 3.26; 95% CI, 1.41 to 7.54), previous cardiac operation (HR, 3.40; 95% CI, 1.16 to 9.94), and severe left ventricular dysfunction (HR, 9.82; 95% CI, 2.90 to 33.26) were predictors for PPI after 30 days post-SAVR.

CONCLUSIONS:

Patients with severe AS who underwent SAVR have a persistent 1% annual risk for PPI. Postoperative presence of BBB predicted the need for PPI both within 30 days and after 30 days after SAVR.

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Abstract

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OBJECTIVE:

Aortic valve replacement using a tissue valve is controversial for patients younger than 60 years old. The long-term survival in this age group, the expected event rates during long-term follow-up, and valve-related complications are not clearly determined.

METHODS:

From January 2000 to December 2009, overall survival, valve-related events, and echocardiographic outcomes were analyzed in all patients younger than 60 years of age, who underwent biologic aortic valve replacement. Patients who received a Perimount Carpentier-Edwards pericardial tissue valve (n = 103) were selected and compared with a propensity matched group of 103 patients who received aortic valve replacement using a mechanical bileaflet valve. The mean follow-up was 33 ± 24 months (range, 2-120), and the mean age at implantation was 50.6 ± 8.8 years (bioprosthesis, 55 ± 8.9 years; mechanical valve, 50 ± 8.6 years; P = .03).

RESULTS:

Survival was significantly reduced in patients after biologic aortic valve replacement (90.3% vs 98%; P = .038). Freedom from all valve-related complications (bioprosthesis, 54.5%; mechanical valve, 51.6%; P = NS) and freedom from reoperation (bioprostheses, 100%; mechanical valve, 98%; P = NS) were comparable in both groups. The average transvalvular mean (11.2 ± 4.2 mm Hg vs 10.5 ± 6.0 mm Hg, P = .05) and peak (19.9 ± 6.7 mm Hg vs 16.7 ± 8.0 mm Hg, P = .03) gradients were greater after biologic aortic valve replacement. Regression of the left ventricular mass index was more pronounced after mechanical valve replacement (118.5 ± 24.9 g/m(2) vs 126.5 ± 38.5 g/m(2); P = NS). The echocardiographic patient-prosthesis mismatch was greater at follow-up after biological aortic valve replacement (0.876 ± 0.2 cm(2)/m(2) vs 1.11 ± 0.4 cm(2)/m(2); P = .01). Oral anticoagulation was a protective factor for survival among the bioprosthetic valve patients (P = .024).

CONCLUSIONS:

In the present limited cohort of patients younger than 60 years old, biologic aortic valve replacement was associated with reduced mid-term survival compared with survival after mechanical aortic valve replacement. Despite similar valve-related event rates in both groups, the better hemodynamic performance of the mechanical valves and/or protective effect of oral anticoagulation seemed to improve the outcome. The transcatheter valve-in-valve intervention as potential treatment of tissue valve degeneration should not be considered the sole bailout strategy for younger patients because no evidence is available that this would improve the outcome.

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Abstract

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OBJECTIVE:

The aim of this propensity-matched, multicenter study was to compare early clinical and echocardiographic outcomes of patients undergoing transapical aortic valve implantation (TA-TAVI) versus patients undergoing sutureless aortic valve replacement (SU-AVR) for severe symptomatic aortic valve stenosis.

METHODS:

We reviewed 468 TA-TAVIs performed in 20 centers from April 2008 to May 2011, and 51 SU-AVRs performed in 3 centers from March to September 2011. Based on a propensity score analysis, 2 groups with 38 matched pairs were created. Variables used in the propensity analysis were age, sex, body surface area, New York Heart Association class, logistic EuroSCORE, peripheral vascular disease, chronic obstructive pulmonary disease, aortic valve area, mitral regurgitation, and left ventricular ejection fraction.

RESULTS:

Preoperative characteristics of the 2 groups were comparable. Hospital mortality was 5.3% and 0% in the TA-TAVI and SU-AVR groups, respectively (P = .49). We did not observe stroke or acute myocardial infarction in the 2 groups. Permanent pacemaker implantation was needed in 2 patients of each group (5.3%, P = 1.0). Dialysis was required in 2 patients (5.3%) in the SU-AVR group and in 1 patient (2.7%) in the TA-TAVI group (P = 1.0). Predischarge echocardiographic data showed that the incidence of paravalvular leak (at least mild) was greater in the TA-TAVI group (44.7% vs 15.8%, P = .001), but there were no differences in terms of mean transprosthetic gradient (10.3 ± 5 mm Hg vs 11 ± 3.7 mm Hg, P = .59).

CONCLUSIONS:

This preliminary experience showed that, in patients at high risk for conventional surgery, SU-AVR is as safe and effective as TA-TAVI and that it is associated with a lower rate of postprocedural paravalvular leak.

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Abstract

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BACKGROUND:

Transcatheter aortic valve-in-valve implantation is an emerging therapeutic alternative for patients with a failed surgical bioprosthesis and may obviate the need for reoperation. We evaluated the clinical results of this technique using a large, worldwide registry.

METHODS AND RESULTS:

The Global Valve-in-Valve Registry included 202 patients with degenerated bioprosthetic valves (aged 77.7±10.4 years; 52.5% men) from 38 cardiac centers. Bioprosthesis mode of failure was stenosis (n=85; 42%), regurgitation (n=68; 34%), or combined stenosis and regurgitation (n=49; 24%). Implanted devices included CoreValve (n=124) and Edwards SAPIEN (n=78). Procedural success was achieved in 93.1% of cases. Adverse procedural outcomes included initial device malposition in 15.3% of cases and ostial coronary obstruction in 3.5%. After the procedure, valve maximum/mean gradients were 28.4±14.1/15.9±8.6 mm Hg, and 95% of patients had ≤+1 degree of aortic regurgitation. At 30-day follow-up, all-cause mortality was 8.4%, and 84.1% of patients were at New York Heart Association functional class I/II. One-year follow-up was obtained in 87 patients, with 85.8% survival of treated patients.

CONCLUSIONS:

The valve-in-valve procedure is clinically effective in the vast majority of patients with degenerated bioprosthetic valves. Safety and efficacy concerns include device malposition, ostial coronary obstruction, and high gradients after the procedure.

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Abstract

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OBJECTIVE:

Transcatheter aortic valve implantation has been used to treat high-risk patients with bioprosthetic valve degeneration (valve-in-valve). We report our experience with transcatheter aortic valve implantation in the treatment of degenerated biologic aortic valve prostheses and discuss factors that can influence the outcome.

METHODS:

From February 2009 to October 2011, 278 patients underwent transcatheter aortic valve implantation, of whom 23 underwent a valve-in-valve procedure with the Edwards Sapien valve to treat a failing bioprostheses in the aortic position. Eight of these valves were stentless bioprostheses. Thirteen patients had valve failure resulting predominantly from stenosis, and the remaining resulting from regurgitation.

RESULTS:

Mean age was 76.9 ± 14.4 years. The mean logistic EuroSCORE was 31.8% ± 20.3% and the Society of Thoracic Surgeons score was 7.6% ± 5.4%. All patients were New York Heart Association class III or IV. The majority of the operations (21/23) were performed via the transapical route. Procedural success was 100%, although 1 patient with a degenerated homograft needed immediate placement of a second valve because of low placement of the first. The reduction in the mean gradient was 31.2 ± 17.06 mm Hg to 9.13 ± 4.9 mm Hg. In those patients with predominant aortic regurgitation (9/23), reduction in aortic regurgitation was achieved in all. The median length of stay was 11.7 days (range, 3-44 days). In-hospital and/or 30-day mortality was 0%.

CONCLUSIONS:

Valve-in-valve is a safe and feasible alternative to treat high-risk patients with failing aortic bioprostheses. The early results are excellent, with improvement seen in hemodynamics.

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Abstract

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OBJECTIVE:

Ascending aortic aneurysms grow circumferentially and longitudinally. This geometric dislocation with widening, flattening, or loss of the sinotubular junction by aortic dilatation distorts and causes incompetence of even a structurally normal valve. We described a technique of surgical correction of ascending aortic aneurysm and valve incompetence by relocating the displaced aortic annulus plane to its normal anatomic position.

METHODS:

Between 1998 and 2011, 48 patients (median age, 66.5; range, 7 to 82 years) with ascending aortic aneurysm and elongation and severe aortic valve incompetence underwent ascending aortic replacement. The aneurysm was incised longitudinally, and an appropriately sized straight Dacron (DuPont, Wilmington, DE) graft was sutured onto the aorta approximately 5 mm above the commissures, recreating the sinotubular junction. When valve competence was assured, the graft, cut considerably shorter than the original length of the ascending aorta, was anastomosed distally. The valve plane was hence relocated in a more cranial/oblique position, restoring its normal alignment. Perioperative echocardiographic and computed tomography studies were done to document the degree of aortic valve incompetence and the morphology of the aortic root.

RESULTS:

During a mean follow-up of 3.0±2.7 years, aortic insufficiency was absent to trivial in 34, mild in 12, and moderate in 2 patients. Postoperative computed tomography showed considerable aortic shortening, remarkable sinotubular junction narrowing, aortic root diameter reduction, and angular widening between the aortic root plane and longitudinal spinal axis corresponding to aortic incompetence reduction.

CONCLUSIONS:

Aortic relocation technique provided satisfactory results in management of ascending aortic aneurysm and elongation with aortic valve incompetence.

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Abstract

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BACKGROUND:

Stentless porcine bioroots and pericardial composite roots were developed as prostheses that avoid the anticoagulation necessary for mechanical composite roots. Data on the hemodynamics of all root replacements are lacking and questions remain regarding comparative performance.

METHODS:

This study evaluated patients receiving a stentless porcine bioroot, a pericardial, or a mechanical composite root at a single institution from January 2000 to December 2008. All patients underwent preoperative, postoperative and greater than 1-year echocardiograms. All root replacements were performed for aortic insufficiency or aneurysm. Median follow-up was 3.3 years (1 to 8 years).

RESULTS:

There were no significant differences in preoperative left ventricular ejection fraction, aortic valve peak gradient, mean gradient, left ventricular end diastolic diameter, and left ventricular end systolic diameter. Postoperative peak and mean gradients in mechanical composite roots were significantly higher than stentless porcine bioroots. At greater than 1 year, stentless porcine bioroots had significantly lower peak and mean gradients than both mechanical composite roots and pericardial composite roots. The end diastolic diameter was also significantly smaller in stentless porcine bioroots at greater than 1 year than mechanical composite roots.

CONCLUSIONS:

All prostheses resulted in favorable hemodynamic and ventricular remodeling. Stentless porcine bioroots had the lowest gradients at greater than 1 year of all root replacements, with significantly better ventricular remodeling when compared with mechanical composite roots. Pericardial roots also had favorable hemodynamics and ventricular remodeling, suggesting that they are a viable alternative.

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Abstract

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BACKGROUND:

Transcatheter aortic valve replacement (TAVR) offers a new treatment option for patients with aortic stenosis, but costs may play a decisive role in decision making. Current studies are evaluating TAVR in an intermediate-risk population. We assessed the in-hospital and 1-year follow-up costs of patients undergoing TAVR and surgical aortic valve replacement (SAVR) at intermediate operative risk and identified important cost components.

METHODS:

We prospectively collected clinical data on 141 patients undergoing TAVR and 405 undergoing SAVR. Propensity score matching yielded 42 matched pairs at intermediate risk. Costs were assessed using a detailed resource-use approach and compared using bootstrap methods.

RESULTS:

In-hospital costs were higher in TAVR patients than in SAVR patients (€40802 vs €33354, respectively; p=0.010). The total costs at 1 year were €46217 vs €35511, respectively (p=0.009). The TAVR was less costly with regard to blood products, operating room use, and length-of-stay.

CONCLUSIONS:

For intermediate-risk patients with severe aortic stenosis the costs at 1 year are higher for TAVR than for SAVR. The difference was mainly caused by the higher costs of the transcatheter valve and was not compensated by the lower costs for blood products and hospital stay in TAVR patients. Therefore, SAVR remains a clinically and economically attractive treatment option.

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Abstract

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BACKGROUND:

Little information is available regarding the clinical and long-term results of patients with complex prosthetic valve endocarditis (PVE) involving the aortic root who undergo root replacement based on the Cabrol or Bentall procedures.

METHODS

Between January 2007 and December 2011, 148 patients underwent cardiac operations for PVE. The analysis included 31 patients with complex PVE and concomitant destruction of the aortic root. Of these, 13 patients were treated by the Cabrol procedure and 18 patients by the Bentall procedure. The mean EuroSCORE for mortality was 50.7%±3.8%. Mean follow-up was 3.8±0.4 years (range, ≤8.0 years), with a total of 97 patient-years.

RESULTS

The observed 30-day mortality was 12.9% and 5-year survival was 75.3%. The most common cause of death was septic multiple organ failure (42.9%). Independent predictors of mortality in multivariate analyses were terminal renal failure (odds ratio [OR], 4.8; p<0.01), type 2 diabetes mellitus (OR, 4.6; p<0.01), postoperative renal failure (OR, 4.0; p<0.01), and staphylococcal infection (OR, 2.1; p=0.01). The prevalence of freedom from reinfection was 100.0% and that from valve-related events was 93.5%.

CONCLUSIONS:

Complex PVE is associated with quite high mortality and morbidity. Composite aortic root replacement provided good clinical and long-term outcomes as well as a low prevalence of reinfection and valve-related events. These results seem not to be inferior to those reported for noncomplex PVE. If the Bentall "button" technique was not feasible, the Cabrol procedure also provided excellent results.

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Abstract

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OBJECTIVES:

To compare the probability, and modes, of explantation for Carpentier-Edwards pericardial versus porcine valves.

METHODS:

Our porcine series began in 1974 and our pericardial series in 1991, with annual prospective follow-up. We used the Kaplan-Meier method and Cox regression for estimation and analysis of patient mortality, and the cumulative incidence function and competing risks regression for estimation and analysis of valve durability.

RESULTS:

Through the end of 2010, we had implanted 506 porcine and 2449 pericardial aortic valves and 181 porcine and 163 pericardial mitral valves. The corresponding total and maximum follow-up years were 3471 and 24, 11,517 and 18, 864 and 22, and 645 and 9. The corresponding probabilities (cumulative incidence function) of any valve explant were 7%, 8%, 22%, and 8%, and of explant for structural valve deterioration were 4%, 5%, 16%, and 5% at 15 years for the first 3 series and at 8 years for the fourth (pericardial mitral valve) series. Using competing risks regression for structural valve deterioration explant, with age, gender, valve size, and concomitant coronary bypass surgery as covariates, a slight (subhazard ratio, 0.79), but nonsignificant, protective effect was found for the pericardial valve in the aortic position and a greater (subhazard ratio, 0.31) and almost significant (P = .08) protective effect of the pericardial valve in the mitral position. Leaflet tear was responsible for 61% of the structural valve deterioration explants in the porcine series and 46% in the pericardial series.

CONCLUSIONS:

Using competing risks regression, the pericardial valve had a subhazard ratio for structural valve deterioration explant of less than 1 in both positions, approaching statistical significance in the mitral position. The mode of structural valve deterioration was predominantly leaflet tear for porcine valves and fibrosis/calcification for pericardial valves.

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Abstract

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BACKGROUND:

The objective of this study was to evaluate the timing, predictive factors, and prognostic value of cerebrovascular events (CVEs) after transcatheter aortic valve implantation.

METHODS AND RESULTS:

The study included 1061 consecutive patients who underwent transcatheter aortic valve implantation with a balloon-expandable (64%) or self-expandable (36%) valve. CVEs were classified as acute (≤24 hours), subacute (1-30 days), or late (>30 days). CVEs occurred in 54 patients (5.1%; stroke, 4.2%) within 30 days after transcatheter aortic valve implantation (acute in 54% of cases). The predictors of acute CVEs were balloon postdilation of the valve prosthesis (odds ratio, 2.46; 95% confidence interval,1.07-5.67) and valve dislodgment/embolization (odds ratio, 4.36; 95% CI, 1.21-15.69); new-onset atrial fibrillation (odds ratio, 2.76; 95% CI, 1.11-6.83) was a predictor of subacute CVEs. Late CVEs occurred in 35 patients (3.3%; stroke, 2.1%) at a median follow-up of 12 months (3-23 months). The predictors of late CVEs were chronic atrial fibrillation (2.84; 95% CI, 1.46-5.53), peripheral vascular disease (hazard ratio, 2.02; 95% CI, 1.02-3.97), and prior cerebrovascular disease (hazard ratio, 2.04; 95% CI, 1.01-4.15). Major stroke was associated with 30-day (odds ratio, 7.43; 95% CI, 2.45-22.53) and late (hazard ratio, 1.75; 95% CI, 1.01-3.04) mortality.

CONCLUSIONS:

In a large cohort of patients undergoing transcatheter aortic valve implantation, the rates of acute and subacute CVEs were 2.7% and 2.4%, respectively. While balloon postdilation and valve dislodgment/embolization were the predictors of acute CVEs, new-onset atrial fibrillation determined a higher risk for subacute events. Late events were determined mainly by a history of chronic atrial fibrillation and peripheral and cerebrovascular disease. The occurrence of major stroke was associated with increased early and late mortality. These results provide important insights for the implementation of preventive measures for CVEs after transcatheter aortic valve implantation.

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