Abstract

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BACKGROUND:

The use of transcatheter aortic-valve replacement has been shown to reduce mortality among high-risk patients with aortic stenosis who are not candidates for surgical replacement. However, the two procedures have not been compared in a randomized trial involving high-risk patients who are still candidates for surgical replacement.

METHODS:

At 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either transcatheter aortic-valve replacement with a balloon-expandable bovine pericardial valve (either a transfemoral or a transapical approach) or surgical replacement. The primary end point was death from any cause at 1 year. The primary hypothesis was that transcatheter replacement is not inferior to surgical replacement.

RESULTS:

The rates of death from any cause were 3.4% in the transcatheter group and 6.5% in the surgical group at 30 days (P=0.07) and 24.2% and 26.8%, respectively, at 1 year (P=0.44), a reduction of 2.6 percentage points in the transcatheter group (upper limit of the 95% confidence interval, 3.0 percentage points; predefined margin, 7.5 percentage points; P=0.001 for noninferiority). The rates of major stroke were 3.8% in the transcatheter group and 2.1% in the surgical group at 30 days (P=0.20) and 5.1% and 2.4%, respectively, at 1 year (P=0.07). At 30 days, major vascular complications were significantly more frequent with transcatheter replacement (11.0% vs. 3.2%, P<0.001); adverse events that were more frequent after surgical replacement included major bleeding (9.3% vs. 19.5%, P<0.001) and new-onset atrial fibrillation (8.6% vs. 16.0%, P=0.006). More patients undergoing transcatheter replacement had an improvement in symptoms at 30 days, but by 1 year, there was not a significant between-group difference.

CONCLUSIONS:

In high-risk patients with severe aortic stenosis, transcatheter and surgical procedures for aortic-valve replacement were associated with similar rates of survival at 1 year, although there were important differences in periprocedural risks. (Funded by Edwards Lifesciences; Clinical Trials.gov number, NCT00530894.).

Abstract

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AIMS:

Treatment of elderly symptomatic patients with severe aortic stenosis and co-morbidities is challenging. Transcatheter aortic valve interventions [balloon valvuloplasty and transcatheter aortic valve implantation (TAVI)] are evolving as alternative treatment options to surgical valve replacement. We report the first results of the prospective multi-centre German Transcatheter Aortic Valve Interventions-Registry.

METHODS AND RESULTS:

Between January 2009 and December 2009, a total of 697 patients (81.4 ± 6.3 years, 44.2% males, and logistic EuroScore 20.5 ± 13.2%) underwent TAVI. Pre-operative aortic valve area was 0.6 ± 0.2 cm² with a mean transvalvular gradient of 48.7 ± 17.2 mmHg. Transcatheter aortic valve implantation was performed percutaneously in the majority of patients [666 (95.6%)]. Only 31 (4.4%) procedures were done surgically: 26 (3.7%) transapically and 5 (0.7%) transaortically. The Medtronic CoreValve™ prosthesis was used in 84.4%, whereas the Sapien Edwards™ prosthesis was used in the remaining cases. Technical success was achieved in 98.4% with a post-operative mean transaortic pressure gradient of 5.4 ± 6.2 mmHg. Any residual aortic regurgitation was observed in 72.4% of patients, with a significant aortic insufficiency (≥Grade III) in only 16 patients (2.3%). Complications included pericardial tamponade in 1.8% and stroke in 2.8% of patients. Permanent pacemaker implantation after TAVI became necessary in 39.3% of patients. In-hospital death rate was 8.2%, and the 30-day death rate 12.4%.

CONCLUSION:

In this real-world registry of high-risk patients with aortic stenosis, TAVI had a high success rate and was associated with moderate in-hospital complications. However, careful patient selection and continued hospital selection seem crucial to maintain these results.

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Abstract

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BACKGROUND:

Transcatheter aortic valve implantation was developed to provide a therapeutic option for patients considered to be ineligible for, and to mitigate mortality and morbidity associated with, high-risk surgical aortic valve replacement.

METHODS AND RESULTS:

The Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry was designed to assess initial post commercial clinical transcatheter aortic valve implantation results of the Edwards SAPIEN valve in consecutive patients in Europe. Cohort 1 consists of 1038 patients enrolled at 32 centers. One-year outcomes are presented. Patients with the transapical approach (n=575) suffered more comorbidities than transfemoral patients (n=463) with a significantly higher logistic EuroSCORE (29% versus 25.8%; P=0.007). These groups are different; therefore, outcomes cannot be directly compared. Total Kaplan Meier 1-year survival was 76.1% overall, 72.1% for transapical and 81.1% for transfemoral patients, and 73.5% of surviving patients were in New York Heart Association (NYHA) class I or II at 1 year. Combined transapical and transfemoral causes of death were cardiac in 25.1%, noncardiac in 49.2%, and unknown in 25.7%. Pulmonary complications (23.9%), renal failure (12.5%), cancer (11.4%), and stroke (10.2%) were the most frequent noncardiac causes of death. Multivariable analysis identified logistic EuroSCORE, renal disease, liver disease, and smoking as variables with the highest hazard ratios for 1-year mortality whereas carotid artery stenosis, hyperlipidemia, and hypertension were associated with lower mortality.

CONCLUSIONS:

The SOURCE Registry is the largest consecutively enrolled registry for transcatheter aortic valve implantation procedures. It demonstrates that with new transcatheter aortic techniques excellent 1-year survival in high-risk and inoperable patients is achievable and provides a benchmark against which future transcatheter aortic valve implantation cohorts and devices can be measured.

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Abstract

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AIMS:

AIMS: Transcatheter aortic valve implantation is a therapeutic alternative for high-surgical-risk patients with severe symptomatic aortic stenosis. Two models of prosthesis are currently commercialized in France, which can be implanted either via a transarterial or a transapical approach. The aim of the study was to evaluate in a national French registry the early safety and efficacy of transcatheter aortic valve replacement (AVR) using either the Edwards SAPIEN™ or CoreValve™ in high-surgical-risk patients with severe aortic stenosis.

METHODS AND RESULTS:

The multicentre national registry was conducted in 16 centres between February 2009 and June 2009, under the authority of the French Societies of Cardiology and Thoracic and Cardio-Vascular Surgery. The primary endpoint was mortality at 1 month. Two hundred and forty-four high-surgical-risk patients (logistic EuroSCORE =20%, STS =10%, or contra-indication to AVR) were enrolled. Mean age was 82 ± 7 years and 43.9% were female. Edwards SAPIEN and CoreValve were implanted in 68 and 32% of patients, respectively. The approaches used were transarterial (transfemoral: 66%; subclavian: 5%) or transapical in 29%. Device success rate was 98.3% and 30-day mortality was 12.7%. Severe complications included stroke (3.6%), tamponade (2%), acute coronary occlusion (1.2%), and vascular complications (7.3%). Pacemaker was required in 11.8%. At 1 month, 88% of patients were in NYHA class II or less.

CONCLUSION:

This prospective registry reflects the real-life experience of transcatheter aortic valve implantation in high-risk elderly patients in France. The early results are satisfactory in terms of feasibility, short-term haemodynamic and functional improvement, and safety. Longer term follow-up will be further assessed.

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Abstract

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Transcatheter aortic valve implantation (TAVI) with the Cribier-Edwards prosthesis may provide an alternative to conventional aortic valve replacement in high-risk patients with aortic stenosis. Previous studies have indicated that TAVI is feasible in this patient population. Transcatheter implantation of a Cribier-Edwards prosthesis was attempted in 55 patients in a United States Food and Drug Administration-approved prospective observational study.Clinical and echocardiographic outcomes were assessed in hospital and at 30 days, 6 months, and 12 months. Fifty-five patients (55% women, mean age 83 years) with a mean aortic valve area of 0.57 ± 0.14 cm(2) and a mean logistic European System for Cardiac Operative Risk Evaluation score of 33.5 ± 17.0% were enrolled. Transcatheter heart valves were implanted successfully in 48 patients (87%). Mean echocardiographic aortic valve area improved from 0.56 ± 0.14 to 1.6 ± 0.48 cm(2) after the procedure (p <0.0001). Thirty-day all-cause mortality and major adverse cardiac and cerebrovascular events were 7.3% and 20%, respectively. There were also 7 major procedural vascular complications (12.7%). Mortality and major adverse cardiac and cerebrovascular events increased to 23.6% and 32.7%, respectively, at 1 year, with most late events related to underlying co-morbidities. Mean New York Heart Association functional class improved from 3.22 ± 0.66 at baseline to 1.50 ± 0.85 at 1 year follow-up (p <0.001). In conclusion, TAVI in high-risk patients with aortic stenosis was feasible, with sustained clinical benefit at 12 months. Procedural complications and late major adverse cardiac and cerebrovascular events, however, overshadowed the overall clinical benefit of TAVI in this high-risk patient population.

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Abstract

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BACKGROUND:

There is a lack of information on the incidence and predictors of early mortality at 30 days and late mortality between 30 days and 1 year after transcatheter aortic valve implantation (TAVI) with the self-expanding CoreValve Revalving prosthesis.

METHODS AND RESULTS:

A total of 663 consecutive patients (mean age 81.0 ± 7.3 years) underwent TAVI with the third generation 18-Fr CoreValve device in 14 centers. Procedural success and intraprocedural mortality were 98% and 0.9%, respectively. The cumulative incidences of mortality were 5.4% at 30 days, 12.2% at 6 months, and 15.0% at 1 year. The incidence density of mortality was 12.3 per 100 person-year of observation. Clinical and hemodynamic benefits observed acutely after TAVI were sustained at 1 year. Paravalvular leakages were trace to mild in the majority of cases. Conversion to open heart surgery (odds ratio [OR] 38.68), cardiac tamponade (OR 10.97), major access site complications (OR 8.47), left ventricular ejection fraction <40% (OR 3.51), prior balloon valvuloplasty (OR 2.87), and diabetes mellitus (OR 2.66) were independent predictors of mortality at 30 days, whereas prior stroke (hazard ratio [HR] 5.47), postprocedural paravalvular leak = 2+ (HR 3.79), prior acute pulmonary edema (HR 2.70), and chronic kidney disease (HR 2.53) were independent predictors of mortality between 30 days and 1 year.

CONCLUSIONS:

Benefit of TAVI with the CoreValve Revalving System is maintained over time up to 1 year, with acceptable mortality rates at various time points. Although procedural complications are strongly associated with early mortality at 30 days, comorbidities and postprocedural paravalvular aortic regurgitation = 2+ mainly impact late outcomes between 30 days and 1 year.

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Abstract

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BACKGROUND:

Transcatheter aortic valve replacement (TAVR) has been shown to improve survival compared with standard therapy in patients with severe aortic stenosis who cannot have surgery. The effects of TAVR on health-related quality of life have not been reported from a controlled study.

METHODS AND RESULTS:

The Placement of Aortic Transcatheter Valves (PARTNER) trial randomized patients with symptomatic, severe aortic stenosis who were not candidates for surgical valve replacement to TAVR (n=179) or standard therapy (n=179). Health-related quality of life was assessed at baseline and at 1, 6, and 12 months with the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the 12-item Short Form-12 General Health Survey (SF-12). The primary end point was the KCCQ overall summary score (range, 0-100; higher=better). At baseline, mean KCCQ summary scores (35±20) and SF-12 physical summary scores (28±7) were markedly depressed. Although the KCCQ summary score improved from baseline in both groups, the extent of improvement was greater after TAVR compared with control at 1 month (mean between-group difference, 13 points; 95% confidence interval, 8-19; P<0.001) with larger benefits at 6 months (mean difference, 21 points; 95% confidence interval, 15-27; P<0.001) and 12 months (mean difference, 26 points; 95% confidence interval, 19-33; P<0.001). At 12 months, TAVR patients also reported higher SF-12 physical and mental health scores with mean differences compared with standard care of 5.7 and 6.4 points, respectively (P<0.001 for both comparisons).

CONCLUSIONS:

Among inoperable patients with severe aortic stenosis, compared with standard care, TAVR resulted in significant improvements in health-related quality of life that were maintained for at least 1 year. Clinical Trials Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894

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Abstract

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Currently, imaging assessment of patients who undergo transcatheter aortic valve implantation is based mainly on echocardiography and angiography, both limited to provide a 3-dimensional evaluation of the prosthesis within the native valve. This study involved 34 patients who underwent multislice computed tomography (MSCT) after transcatheter aortic valve implantation. Prosthesis expansion and circularity, depth of implantation, apposition degree at the ventriculoaortic junction, and positioning in relation to coronary artery ostia were evaluated. Early clinical events such as aortic regurgitation and periprocedural conduction abnormalities were recorded and correlated with multislice computed tomographic findings. MSCT provided comprehensive 3-dimensional assessments of the prostheses in 31 of 34 of patients (91%). Expansion was excellent (mean expansion ratio 100.0 ± 10.4%) and increased significantly from the ventricular side to the aortic side of the prosthesis. Circular deployment was achieved in most patients and increased from the ventricular to the aortic side. Mean implantation depth was -2.4 ± 2.5 mm, associated with a low rate (12%) of permanent pacemaker implantation. Patients with a new conduction abnormalities had the deepest prosthesis implantation, associated with lesser expansion and circularity. Perfect apposition on MSCT was associated with a low rate of significant aortic regurgitation. :In conclusion, MSCT is able to provide an accurate 3-dimensional evaluation of prosthesis deployment and positioning after transcatheter aortic valve implantation. Moreover, these anatomic findings correlate with the most frequent early complications (i.e., the occurrence of aortic regurgitation and conduction abnormalities).

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Abstract

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Transcatheter aortic valve implantation (TAVI) is a novel treatment for high risk or inoperable patients with symptomatic severe aortic stenosis. However, significant atrioventricular (AV) conduction system abnormalities requiring permanent pacemaker (PPM) implantation might complicate this procedure. We used best subsets logistic regression analysis to identify the independent predictors for the development of high-degree AV block (HDAVB) among 70 patients who underwent TAVI at 3 referral centers in Israel from 2008 to 2010. The mean age of the study patients was 83 ± 4.6 years. Of the 70 patients, 28 (40%) developed AV conduction abnormalities requiring PPM implantation within 14 days (median 2) of the procedure. The indications for PPM implantation were HDAVB (n = 25), new-onset left bundle branch block with PR prolongation (n = 2), and slow atrial fibrillation (n = 1). Best subsets logistic regression analysis showed that, among the 15 prespecified clinical, electrocardiographic, and echocardiographic candidate risk factors, only right bundle branch block at baseline (odds ratio 43; p = 0.002) and deep valve implantation (<6 mm from the lower edge of the noncoronary cusp to the ventricular end of the prosthesis, odds ratio 22; p <0.001) were independently associated with the development of periprocedural HDAVB. At 3 months of follow-up, HDAVB was still present in 40% of the patients who received PPM implantation for this indication. In conclusion, 40% of the patients who undergo CoreValve TAVI require PPM implantation after the procedure, with most cases (36%) associated with the development of postprocedural HDAVB. Baseline conduction abnormalities (right bundle branch block) and deep valve implantation (>6 mm) independently predicted the development of HDAVB and the need for PPM implantation after CoreValve TAVI.

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Abstract

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BACKGROUND:

Permanent pacemaker (PPM) requirement is a recognized complication of transcatheter aortic valve implantation. We assessed the UK incidence of permanent pacing within 30 days of CoreValve implantation and formulated an anatomic and electrophysiological model.

METHODS AND RESULTS:

Data from 270 patients at 10 centers in the United Kingdom were examined. Twenty-five patients (8%) had preexisting PPMs; 2 patients had incomplete data. The remaining 243 were 81.3±6.7 years of age; 50.6% were male. QRS duration increased from 105±23 to 135±29 milliseconds (P<0.01). Left bundle-branch block incidence was 13% at baseline and 61% after the procedure (P<0.001). Eighty-one patients (33.3%) required a PPM within 30 days. Rates of pacing according to preexisting ECG abnormalities were as follows: right bundle-branch block, 65.2%; left bundle-branch block, 43.75%; normal QRS, 27.6%. Among patients who required PPM implantation, the median time to insertion was 4.0 days (interquartile range, 2.0 to 7.75 days). Multivariable analysis revealed that periprocedural atrioventricular block (odds ratio, 6.29; 95% confidence interval, 3.55 to 11.15), balloon predilatation (odds ratio, 2.68; 95% confidence interval, 2.00 to 3.47), use of the larger (29 mm) CoreValve prosthesis (odds ratio, 2.50; 95% confidence interval, 1.22 to 5.11), interventricular septum diameter (odds ratio, 1.18; 95% confidence interval, 1.10 to 3.06), and prolonged QRS duration (odds ratio, 3.45; 95% confidence interval, 1.61 to 7.40) were independently associated with the need for PPM.

CONCLUSION:

One third of patients undergoing a CoreValve transcatheter aortic valve implantation procedure require a PPM within 30 days. Periprocedural atrioventricular block, balloon predilatation, use of the larger CoreValve prosthesis, increased interventricular septum diameter and prolonged QRS duration were associated with the need for PPM.

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Abstract

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OBJECTIVE:

Transcatheter aortic valve implantation is an emerging technique for the treatment of aortic valve stenosis in high-risk patients. Detailed knowledge of aortic root anatomy, including specific information on the extent of native cusp calcifications, is required. The aim of this study was to evaluate whether echocardiographic assessment of aortic stenosis using a calcification score is useful to predict outcomes of transcatheter aortic valve implantation in elderly high-risk patients.

METHODS:

Detailed preoperative digitalized transesophageal echocardiographic images were available from 103 patients treated by transapical transcatheter aortic valve implantation between February 2006 and February 2009. On the basis of a previously published study, an index score was developed to describe the extent of valve calcification ranging from 0 to 8 (normal to diffuse calcification).

RESULTS:

The median age of patients was 82.2 ± 5.9 years. The mean logistic European System for Cardiac Operative Risk Evaluation was 33.0% ± 16.3%. Mild paravalvular leak was present in 43 patients (42.2%), and a moderate paravalvular leak was observed in 5 patients (4.9%). Severe regurgitation was not observed in any patient. Logistic regression analysis revealed that the transcatheter aortic valve implantation echocardiographic calcification score is associated with the presence of moderate paravalvular aortic regurgitation (odds ratio, 8.5; 95% confidence interval, 1.2-58.9; P = .0001) and overall moderate aortic regurgitation (odds ratio, 3.6; 95% confidence interval, 1.2-10.4; P = .0006).

CONCLUSIONS:

Transesophageal echocardiography demonstrates detailed anatomic information of the calcification patterns of the aortic valve and root and thus plays an important role in the screening of patients undergoing transcatheter aortic valve implantation. The transcatheter aortic valve implantation echocardiographic calcification score allowed prediction of the risk of postoperative paravalvular and overall aortic regurgitation.

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Abstract

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BACKGROUND:

Transapical aortic valve implantation has evolved to a reproducible therapeutic option for high-risk patients. The aim of the present study was to evaluate our learning experience over 4 years and to analyze outcome-related risk factors.

METHODS AND RESULTS:

A total of 299 patients who received transapical aortic valve implantation between February 2006 and January 2010 with the Edwards SAPIEN transcatheter prosthesis were analyzed according to early experience (EE; patients 1 to 150) and recent experience (RE; patients 151 to 299). Patients consistently demonstrated high risk scores, and major perioperative parameters were comparable between the 2 groups. RE patients had a significantly higher logistic EuroSCORE (RE 33.2 ± 17.2, EE 29.4 ± 14; P=0.039) but a significantly lower STS (Society of Thoracic Surgeons) score (RE 11.4 ± 7.5, EE 13.5 ± 7.8; P=0.019). Use of contrast dye (EE 104 ± 78 mL, RE 93 ± 46 mL) and the need to perform a balloon redilation were significantly reduced in the RE group. Thirty-day mortality decreased from 11.3% to 6.0%, and 1-year mortality improved significantly from 30.7% (EE) to 21.5% in the RE patients (P=0.047). Multivariate logistic regression analysis revealed reduced vital capacity (<70%) and concomitant preoperative mitral regurgitation >1+ as the only independent predictors of 30-day mortality. Classic variables such as age, logistic EuroSCORE >30%, and STS score >15% failed to predict mortality.

CONCLUSIONS:

Recent results with transapical aortic valve implantation indicate a progressive improvement in outcomes despite an unchanged patient risk profile, which reflects a significant learning curve that includes a better understanding of optimal patient selection. Classic surgical risk factors fail to predict outcome, which indicates the need for new transapical aortic valve implantation-specific risk scores.

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Abstract

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OBJECTIVE:

Risk-stratifying algorithms are currently used to determine which patients may be at prohibitive risk for surgical aortic valve replacement, and thus candidates for transcatheter aortic valve implantation. Minimally invasive surgical approaches have been successful in reducing morbidity and improving survival after aortic valve replacement, especially in octogenarians. We documented outcomes after minimally invasive aortic valve replacement in high-risk octogenarians who may be considered candidates for percutaneous/transapical aortic valve replacement.

METHODS:

From 1996 to 2009, minimally invasive aortic valve replacement was performed in 249 consecutive octogenarians. We used the modified European System for Cardiac Operative Risk Evaluation and Society of Thoracic Surgeons score to risk-stratify patients and characterize all early and late results.

RESULTS:

The mean age at operation was 84±3 (range 80-95) years, and 111 patients (45%) were male. Twenty-one percent (n=52) had previous cardiac surgery. Operative mortality was 3% (n=8/249). The median modified European System for Cardiac Operative Risk Evaluation (11%; interquartile range, 6-14) and Society of Thoracic Surgeons score (10.5%; interquartile range, 7-17) were not predictive of 30-day mortality in this cohort of patients (European System for Cardiac Operative Risk Evaluation c-index=0.527, P=.74, Society of Thoracic Surgeons score c-index=0.67, P=.18). Despite their poor predictive power, the Society of Thoracic Surgeons score and European System for Cardiac Operative Risk Evaluation were correlated with each other (r=0.40, P<.0001). Postoperative complications included stroke in 10 patients (4%), pneumonia in 3 patients (1%), renal failure requiring dialysis in 2 patients (1%), cardiac arrest in 2 patients (1%), pulmonary embolism in 1 patient (1%), and sepsis in 1 patient (1%). Follow-up was available for 238 patients (96%) and extended up to 12 years. Overall, long-term survival after minimally invasive aortic valve replacement at 1, 5, and 10 years was 93%, 77%, and 56%, respectively. There was no significant difference in long-term survival compared with that of a US age- and gender-matched population (standardized mortality ratio, 1.01; 95% confidence interval, 0.76-1.37; P=.88). A multivariate Cox-proportional hazards model indicated that increasing age (hazard ratio, 1.10; P=.008) and severe chronic obstructive pulmonary disease (hazard ratio, 2.52; P<.007) were significant predictors of survival. By using these factors, a clinical prediction model (P=.02) was developed and demonstrated that low-risk patients (first quartile prediction score) had 1-, 5-, and 8-year survival of 94%, 84%, and 67%, whereas high-risk patients (third quartile prediction score) had 1-, 5-, and 8-year survival of 89%, 74%, and 49%, respectively.

CONCLUSIONS:

Patients thought to be high-risk candidates for surgical aortic valve replacement have excellent outcomes after minimally invasive surgery with long-term survival that is no different than that of an age- and gender-matched US population. These data provide a benchmark against which outcomes of transcatheter aortic valve implantation could be compared.

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Abstract

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BACKGROUND:

Few data exist on long-term outcomes of elderly patients after aortic valve replacement. We evaluated latest follow-up information for patients =70 years of age after aortic valve replacement.

METHODS AND RESULTS:

Late overall survival of 2890 consecutive patients =70 years of age who underwent aortic valve replacement between January 1993 and December 2007 was reviewed retrospectively, analyzed, and stratified by preoperative and intraoperative variables. Observed 5-, 10-, and 15-year late postoperative survival was lower than generally expected (68%, 34%, and 8% versus 70%, 42%, and 20%, respectively; P<0.001). Independent predictors of late death included older age, renal failure, diabetes mellitus, stroke, myocardial infarction, immunosuppression, prior coronary artery bypass grafting, implanted pacemaker, lower ejection fraction, hypertension, and New York Heart Association class III or IV. After stratification by age-comorbidity risk score, 10-year survival for the lowest-risk group (n=946 [33%]) was similar to expected survival (55% versus 55%; P=0.50), but for the highest-risk group (n=564 [20%]), survival was significantly lower than expected (9% versus 26%; P<0.001). For 229 pairs of propensity-matched patients with mechanical or biological prostheses, survival was not significantly different (67%, 40%, and 19% versus 71%, 45%, and 7% at 5, 10, and 15 years, respectively; P=0.81). Structural deterioration of bioprostheses occurred in 64 patients (2.4%).

CONCLUSIONS:

Survival of elderly patients after aortic valve replacement is influenced by age and preoperative comorbidities; 33% at lowest risk had overall survival similar to that of an age- and sex-matched general population. There was no sufficient evidence that valve type affected survival. Structural deterioration of aortic bioprostheses was rare.

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Abstract

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BACKGROUND:

There is debate concerning whether an aneurysmal ascending aorta should be replaced when associated with a dysfunctioning aortic valve that is to be replaced. To examine this issue, we divided the patients by type of aortic valve dysfunction-either aortic stenosis (AS) or pure aortic regurgitation (AR)-something not previously undertaken.

METHODS AND RESULTS:

Of 122 patients with ascending aortic aneurysm (unassociated with aortitis or acute dissection), the aortic valve was congenitally malformed (unicuspid or bicuspid) in 58 (98%) of the 59 AS patients, and in 38 (60%) of the 63 pure AR patients. Ascending aortic medial elastic fiber loss (EFL) (graded 0 to 4+) was zero or 1+ in 53 (90%) of the AS patients, in 20 (53%) of the 38 AR patients with bicuspid valves, and in all 12 AR patients with tricuspid valves unassociated with the Marfan syndrome. An unadjusted analysis showed that, among the 96 patients with congenitally malformed valves, the 38 AR patients had a significantly higher likelihood of 2+ to 4+ EFL than the 58 AS patients (crude odds ratio: 8.78; 95% confidence interval: 2.95, 28.13).

CONCLUSIONS:

These data strongly suggest that the type of aortic valve dysfunction-AS versus pure AR-is very helpful in predicting loss of aortic medial elastic fibers in patients with ascending aortic aneurysms and aortic valve disease.

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Abstract

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CONTEXT:

Bicuspid aortic valve (BAV), the most common congenital heart defect, has been thought to cause frequent and severe aortic complications; however, long-term, population-based data are lacking.

OBJECTIVE:

To determine the incidence of aortic complications in patients with BAV in a community cohort and in the general population.

DESIGN, SETTING, AND PARTICIPANTS:

In this retrospective cohort study, we conducted comprehensive assessment of aortic complications of patients with BAV living in a population-based setting in Olmsted County, Minnesota. We analyzed long-term follow-up of a cohort of all Olmsted County residents diagnosed with definite BAV by echocardiography from 1980 to 1999 and searched for aortic complications of patients whose bicuspid valves had gone undiagnosed. The last year of follow-up was 2008-2009.

MAIN OUTCOME MEASURE:

Thoracic aortic dissection, ascending aortic aneurysm, and aortic surgery.

RESULTS:

The cohort included 416 consecutive patients with definite BAV diagnosed by echocardiography, mean (SD) follow-up of 16 (7) years (6530 patient-years). Aortic dissection occurred in 2 of 416 patients; incidence of 3.1 (95% CI, 0.5-9.5) cases per 10,000 patient-years, age-adjusted relative-risk 8.4 (95% CI, 2.1-33.5; P = .003) compared with the county's general population. Aortic dissection incidences for patients 50 years or older at baseline and bearers of aortic aneurysms at baseline were 17.4 (95% CI, 2.9-53.6) and 44.9 (95% CI, 7.5-138.5) cases per 10,000 patient-years, respectively. Comprehensive search for aortic dissections in undiagnosed bicuspid valves revealed 2 additional patients, allowing estimation of aortic dissection incidence in bicuspid valve patients irrespective of diagnosis status (1.5; 95% CI, 0.4-3.8 cases per 10,000 patient-years), which was similar to the diagnosed cohort. Of 384 patients without baseline aneurysms, 49 developed aneurysms at follow-up, incidence of 84.9 (95% CI, 63.3-110.9) cases per 10,000 patient-years and an age-adjusted relative risk 86.2 (95% CI, 65.1-114; P <.001 compared with the general population). The 25-year rate of aortic surgery was 25% (95% CI, 17.2%-32.8%).

CONCLUSIONS:

In the population of patients with BAV, the incidence of aortic dissection over a mean of 16 years of follow-up was low but significantly higher than in the general population.

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