Effect of Transcatheter Aortic Valve Implantation vs Surgical Aortic Valve Replacement on All-Cause Mortality in Patients With Aortic Stenosis: A Randomized Clinical Trial.

Importance: Transcatheter aortic valve implantation (TAVI) is a less invasive alternative to surgical aortic valve replacement and is the treatment of choice for patients at high operative risk. The role of TAVI in patients at lower risk is unclear. Objective: To determine whether TAVI is noninferior to surgery in patients at moderately increased operative risk. Design, Setting, and Participants: In this randomized clinical trial conducted at 34 UK centers, 913 patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk due to age or comorbidity were enrolled between April 2014 and April 2018 and followed up through April 2019. Interventions: TAVI using any valve with a CE mark (indicating conformity of the valve with all legal and safety requirements for sale throughout the European Economic Area) and any access route (n = 458) or surgical aortic valve replacement (surgery; n = 455). Main Outcomes and Measures: The primary outcome was all-cause mortality at 1 year. The primary hypothesis was that TAVI was noninferior to surgery, with a noninferiority margin of 5% for the upper limit of the 1-sided 97.5% CI for the absolute between-group difference in mortality. There were 36 secondary outcomes (30 reported herein), including duration of hospital stay, major bleeding events, vascular complications, conduction disturbance requiring pacemaker implantation, and aortic regurgitation. Results: Among 913 patients randomized (median age, 81 years [IQR, 78 to 84 years]; 424 [46%] were female; median Society of Thoracic Surgeons mortality risk score, 2.6% [IQR, 2.0% to 3.4%]), 912 (99.9%) completed follow-up and were included in the noninferiority analysis. At 1 year, there were 21 deaths (4.6%) in the TAVI group and 30 deaths (6.6%) in the surgery group, with an adjusted absolute risk difference of -2.0% (1-sided 97.5% CI, -∞ to 1.2%; P < .001 for noninferiority). Of 30 prespecified secondary outcomes reported herein, 24 showed no significant difference at 1 year. TAVI was associated with significantly shorter postprocedural hospitalization (median of 3 days [IQR, 2 to 5 days] vs 8 days [IQR, 6 to 13 days] in the surgery group). At 1 year, there were significantly fewer major bleeding events after TAVI compared with surgery (7.2% vs 20.2%, respectively; adjusted hazard ratio [HR], 0.33 [95% CI, 0.24 to 0.45]) but significantly more vascular complications (10.3% vs 2.4%; adjusted HR, 4.42 [95% CI, 2.54 to 7.71]), conduction disturbances requiring pacemaker implantation (14.2% vs 7.3%; adjusted HR, 2.05 [95% CI, 1.43 to 2.94]), and mild (38.3% vs 11.7%) or moderate (2.3% vs 0.6%) aortic regurgitation (adjusted odds ratio for mild, moderate, or severe [no instance of severe reported] aortic regurgitation combined vs none, 4.89 [95% CI, 3.08 to 7.75]). Conclusions and Relevance: Among patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk, TAVI was noninferior to surgery with respect to all-cause mortality at 1 year. Trial Registration: isrctn.com Identifier: ISRCTN57819173.

Transcatheter aortic valve implantation in the United Kingdom: temporal trends, predictors of outcome, and 6-year follow-up: a report from the UK Transcatheter Aortic Valve Implantation (TAVI) Registry, 2007 to 2012.

BACKGROUND: We assessed trends in the performance of transcatheter aortic valve implantation in the United Kingdom from the first case in 2007 to the end of 2012. We analyzed changes in case mix, complications, outcomes to 6 years, and predictors of mortality. METHODS AND RESULTS: Annual cohorts were examined. Mortality outcomes were analyzed in the 92% of patients from England and Wales for whom independent mortality tracking was available. A total of 3980 transcatheter aortic valve implantation procedures were performed. In successive years, there was an increase in frequency of impaired left ventricular function, but there was no change in Logistic EuroSCORE. Overall 30-day mortality was 6.3%; it was highest in the first cohort (2007-2008), after which there were no further significant changes. One-year survival was 81.7%, falling to 37.3% at 6 years. Discharge by day 5 rose from 16.7% in 2007 and 2008 to 28% in 2012. The only multivariate preprocedural predictor of 30-day mortality was Logistic EuroSCORE ≥40. During long-term follow-up, multivariate predictors of mortality were preprocedural atrial fibrillation, chronic obstructive pulmonary disease, creatinine >200 µmol/L, diabetes mellitus, and coronary artery disease. The strongest independent procedural predictor of long-term mortality was periprocedural stroke (hazard ratio=3.00; P<0.0001). Nonfemoral access and postprocedural aortic regurgitation were also significant predictors of adverse outcome. CONCLUSIONS: We analyzed transcatheter aortic valve implantation in an entire country, with follow-up over 6 years. Although clinical profiles of enrolled patients remained unchanged, longer-term outcomes improved, and patients were discharged earlier. Periprocedural stroke, nonfemoral access, and postprocedural aortic regurgitation are predictors of adverse outcome, along with intrinsic patient risk factors.

Real-world 6-month outcomes of minimally invasive aortic valve replacement with the EDWARDS INTUITY Elite valve system.

OBJECTIVES: We report on real-world safety and performance outcomes of minimally invasive rapid-deployment aortic valve replacement using the EDWARDS INTUITY Elite aortic valve system. METHODS: The study valve system was used in a European, prospective, multicentre post-market study. Various procedural, haemodynamic and clinical outcomes were evaluated through 6 months of post-implant. RESULTS: A total of 276 patients out of 280 (98.6%) enrolments were successfully implanted with the study valve using a minimally invasive approach between February 2016 and April 2017. Of these 276 patients, 240 (87%) underwent partial sternotomy and 36 (13%) patients underwent right thoracotomy. Mean cross-clamp time was 51.9 [standard deviation (SD): 16.0] min. From baseline to 6 months, the mean effective orifice area increased from 0.8 (SD: 0.3) to 1.8 (SD: 0.6) cm2 and the mean systolic gradient decreased from 46.0 (SD: 14.1) to 8.8 (SD: 3.7) mmHg. After 6 months, 70.7% and 26.4% of patients were in New York Heart Association class I and II, respectively. Freedom from death, major bleeding, major paravalvular leak, reoperation and device explant at 6 months were 96.0%, 98.5%, 98.8%, 99.2% and 99.2%, respectively. CONCLUSIONS: These results demonstrate that the study valve is a safe and effective choice for patients undergoing aortic valve replacement via minimally invasive surgery. NAME AND REGISTRATION OF REGISTRY: MISSION (Assessing clinical outcomes using the EDWARDS INTUITY Elite Valve System in isolated AVR using Minimally InvaSive Surgery In a EurOpean multi-ceNter, active, post-market registry). clinicaltrials.gov ID #NCT02907463.

The Impact of a Dedicated Chronic Total Occlusion PCI Program on Heart Team Decision Making.

BACKGROUND: Guidelines endorse a heart team (HT) approach to standardize the decision-making process for patients with complex coronary artery disease (CAD). With percutaneous treatment options for complex CAD increasing, we hypothesized that practice had changed over the past decade-and that more individuals, previously deemed too high risk for intervention, would now be referred for either surgical or percutaneous revascularization. METHODS: This observational study was conducted at St Thomas' Hospital (London, United Kingdom). All patients discussed at HT meetings were recorded and treatment recommendations audited. A subset of historic cases was selected for blinded, repeat discussion. RESULTS: From April 2018 to 2019, a total of 52 HT meetings discussing 375 cases were held. Patients tended to be male, with a majority demonstrating multivessel CAD in the context of preserved left ventricular function. SYNTAX scores were balanced across the tertiles. Thirty-five percent of patients had at least 1 chronic total occlusion (mean J-CTO, 3 [interquartile range, 2-3]), affecting the right coronary artery in 60%. Fifteen historic patients with isolated CTOs were re-presented an average of 8 years later; only 3 patients received the same outcome, with 80% now receiving a recommendation for revascularization over medical therapy. CONCLUSIONS: A dedicated program supporting complex coronary intervention is associated with a change in treatment recommendations issued by the local HT. In line with international guidelines, this might indicate that any complex or multivessel CAD should be discussed at HT meetings with, ideally, the presence of CTO operators.

Long-Term Outcomes Following Heart Team Revascularization Recommendations in Complex Coronary Artery Disease.

Background The Heart Team ( HT ) comprises integrated interdisciplinary decision making. Current guidelines assign a Class Ic recommendation for an HT approach to complex coronary artery disease ( CAD ). However, there remains a paucity of data in regard to hard clinical end points. The aim was to determine characteristics and outcomes in patients with complex CAD following HT discussion. Methods and Results This observational study was conducted at St Thomas' Hospital (London, UK). Case mixture included unprotected left main, 2-vessel (including proximal left anterior descending artery) CAD , 3-vessel CAD , or anatomical and/or clinical equipoise. HT strategy was defined as optimal medical therapy ( OMT ) alone, OMT +percutaneous coronary intervention ( PCI ), or OMT +coronary artery bypass grafting. From April 2012 to 2013, 51 HT meetings were held and 398 cases were discussed. Patients tended to have multivessel CAD (74.1%), high SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery) scores (median, 30; interquartile range, 23-39), and average age 69±11 years. Multinomial logistic regression analysis performed to determine variables associated with HT strategy demonstrated decreased likelihood of undergoing PCI compared with OMT in older patients with chronic kidney disease and peripheral vascular disease. The odds of undergoing coronary artery bypass grafting compared with OMT decreased in the presence of cardiogenic shock and left ventricular dysfunction and increased in younger patients with 3-vessel CAD . Three-year survival was 60.8% (84 of 137) in the OMT cohort, 84.3% (107 of 127) in the OMT + PCI cohort, and 90.2% in the OMT +coronary artery bypass grafting cohort (92 of 102). Conclusions In our experience, the HT approach involved a careful selection process resulting in appropriate patient-specific decision making and good long-term outcomes in patients with complex CAD .

Outcomes of minimally invasive aortic valve replacement surgery.

Minimally invasive aortic valve replacement has been used for more than 20 years, but its uptake has been limited. The volumes have increased steadily over the last 10 years, but it is still not regarded as a mainstream procedure. The issue, to some extent, is due to the lack of perceived evidence that minimal access incisions confer any benefit other than cosmetic appearance. In this article, the current literature on minimally invasive aortic valve replacement is reviewed, and it is concluded that benefits are demonstrable, particularly in higher risk, comorbid settings.

Minimally Invasive Versus Conventional Aortic Valve Replacement: A Propensity-Matched Study From the UK National Data.

OBJECTIVE: Minimally invasive aortic valve replacement (MIAVR) has been demonstrated as a safe and effective option but remains underused. We aimed to evaluate outcomes of isolated MIAVR compared with conventional aortic valve replacement (CAVR). METHODS: Data from The National Institute for Cardiovascular Outcomes Research (NICOR) were analyzed at seven volunteer centers (2006-2012). Primary outcomes were in-hospital mortality and midterm survival. Secondary outcomes were postoperative length of stay as well as cumulative bypass and cross-clamp times. Propensity modeling with matched cohort analysis was used. RESULTS: Of 307 consecutive MIAVR patients, 151 (49%) were performed during the last 2 years of study with a continued increase in numbers. The 307 MIAVR patients were matched on a 1:1 ratio. In the matched CAVR group, there was no statistically significant difference in in-hospital mortality [MIAVR, 4/307,(1.3%); 95% confidence interval (CI), 0.4%-3.4% vs CAVR, 6/307 (2.0%); 95% CI, 0.8%-4.3%; P = 0.752]. One-year survival rates in the MIAVR and CAVR groups were 94.4% and 94.6%, respectively. There was no statistically significant difference in midterm survival (P = 0.677; hazard ratio, 0.90; 95% CI, 0.56-1.46). Median postoperative length of stay was lower in the MIAVR patients by 1 day (P = 0.009). The mean cumulative bypass time (94.8 vs 91.3 minutes; P = 0.333) and cross-clamp time (74.6 vs 68.4 minutes; P = 0.006) were longer in the MIAVR group; however, this was significant only in the cross-clamp time comparison. CONCLUSIONS: Minimally invasive aortic valve replacement is a safe alternative to CAVR with respect to operative and 1-year mortality and is associated with a shorter postoperative stay. Further studies are required in high-risk (logistic EuroSCORE > 10) patients to define the role of MIAVR.

The effect of coronary artery disease defined by quantitative coronary angiography and SYNTAX score upon outcome after transcatheter aortic valve implantation (TAVI) using the Edwards bioprosthesis.

AIMS: We sought to evaluate the effects of significant coronary artery disease (CAD) upon outcome after transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: We performed a retrospective study of 271 consecutive patients undergoing TAVI using either the Edwards SAPIEN or Edwards SAPIEN XT valve. Pre-procedural coronary angiograms were analysed by quantitative coronary angiography (defining significant CAD as a stenosis of ≥70% or ≥50% if in the left main stem or a vein graft). Ninety-three out of 271 patients had significant CAD. There was no difference in mortality at 30 days or 12 months between the two groups (6.7% vs. 7.5% and 21.5% vs. 23.7%; log-rank p=0.805). A secondary analysis using the SYNTAX algorithm of coronary anatomy complexity was performed on 189 patients. Those in the high SYNTAX score (>33) group had higher mortality at 30 days and 12 months (14.3% and 57.1%) than the low (5.2% and 23.3%) and intermediate-risk groups (11.1% and 22.2%; log-rank p=0.007). ROC analysis identified a SYNTAX score of >9 at the time of TAVI as the optimal cut-off, with an independent association with mortality (HR 1.95 [95% CI: 1.21-3.13]; p=0.006). Patients with a SYNTAX score >9 had greater 30-day, 12-month and overall mortalities than those with a SYNTAX score <9 (3.7% vs. 11.3% and 20.7% vs. 34.3%; log-rank p=0.005). CONCLUSIONS: Significant CAD, as defined using "real-world" QCA margins, did not have a significant effect upon mortality after TAVI for severe aortic stenosis. However, higher-risk SYNTAX groups, including those with a score >9, had increased mortality.

Endoluminal repair of aneurysms associated with coarctation.

BACKGROUND: Late aneurysm formation is a well-recognized complication of surgery for aortic coarctation. Open surgery to repair these aneurysms is associated with significant morbidity and mortality. Endoluminal repair is an attractive alternative to open surgery. METHODS: Data were collected prospectively on consecutive patients who presented with aneurysms associated with coarctation RESULTS: Between June 1999 and October 2001, 5 patients underwent elective endoluminal repair for coarctation aneurysms. All procedures were technically successful and no patients died. Four patients previously had open surgery to repair aortic coarctation, and 1 presented with an aneurysm associated with a previously unrecognized coarctation. The median follow-up was 7 months (range, 3 to 29 months), and to date, all aneurysms remain excluded. CONCLUSIONS: Endoluminal repair is a promising alternative to redo open surgery for thoracic aneurysms associated with previous surgery for aortic coarctation. Long-term follow-up is required to assess the durability of the stent grafts.

Direct TAVI using a balloon-expandable system: a novel technique to eliminate pre-deployment balloon aortic valvuloplasty.

AIMS: Transcatheter aortic valve implantation (TAVI) is now the therapy of choice for those patients with severe symptomatic aortic stenosis who are considered to be at too high risk for conventional surgery. Balloon aortic valvuloplasty (BAV) is routinely performed to allow placement of the balloon-expandable valve during the procedure. Instrumentation of the valve has been linked to procedural stroke risk, with the associated runs of rapid pacing risking haemodynamic compromise. We outline a novel technique to eliminate BAV prior to transcatheter valve placement. METHODS AND RESULTS: We illustrate a clinical case that outlines the problems encountered in transcatheter valve placement despite a prior BAV. The solution used in this case involved the partial inflation of the distal section of the balloon allowing easy passage of the SAPIEN XT valve from the transaortic route. After bench testing, we report a series of patients who have undergone this "direct TAVI" procedure from both the transaortic and the transfemoral routes. CONCLUSIONS: In a limited series within a single centre, "direct TAVI" has been shown to be effective in allowing accurate placement of a balloon-expandable device without the need for prior BAV.

What is the best timing of surgery in patients with post-infarct ventricular septal rupture?

A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was 'in which patients with a post-infarct ventricular septal rupture (PIVSR) might immediate surgery give better results than delayed surgery in terms of mortality'? Altogether, 88 papers were found using the reported search criteria, of which 6 represented the best evidence to answer the clinical question. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. The recommendations are based on outcomes from 3238 patients undergoing surgery for PIVSR. Mean age was 67.5 ± 8.8 (40-88 years). Left ventricular function was compromised in most patients with mean ejection fraction of 40%. All papers carried out univariate and/or multivariate analyses of variables that contributed to different in-hospital mortalities. Early surgery, i.e. from >3 days to within 4 weeks after MI, had an overall in-hospital mortality of 52.4%; delayed surgery, typically from 1 week to after 4 weeks post-myocardial infarction, had an overall operative in-hospital mortality of 7.56%. Most authors observe that a shorter time between rupture and surgery is an unfavourable predictor of outcome independent of haemodynamic status. The consensus was that nearly all patients with PIVSR, particularly if >15 mm diameter with a significant shunt and resultant haemodynamic deterioration, should undergo early surgical repair. The precise timing of surgery depends on patients' haemodynamic status. Exclusion from surgery should be considered if life expectancy or quality is severely limited by another limiting underlying pathology. If the patient is in cardiogenic shock, due to pulmonary to systemic blood flow ratio shunt rather than infarct size, immediate surgery should follow resuscitation measures and cardiac support. If the patient is haemodynamically stable, surgery could be performed after 3-4 weeks of medical optimization with inotropic and mechanical cardiac support. If there is clinical deterioration, immediate surgery is indicated.

The effects of VARC-defined acute kidney injury after transcatheter aortic valve implantation (TAVI) using the Edwards bioprosthesis.

AIMS: The aim of this study was to identify the incidence and risk factors for acute kidney injury (AKI) after TAVI, a potentially serious complication of transcatheter aortic valve implantation (TAVI) that has been redefined by the Valve Academic Research Consortium (VARC). METHODS AND RESULTS: We performed a retrospective analysis of 248 patients undergoing TAVI. AKI was defined as a VARC-modified Risk, Injury, Failure, Loss, and End-stage (RIFLE) kidney disease score ≥ 2. Eighty-nine patients suffered AKI (35.9%) and demonstrated increased mortality at 30 days (13.5% vs. 3.8%) and one year (31.5% vs. 15.0%) (p<0.001). Multivariate regression analysis identified diabetes mellitus (p<0.001), peripheral vascular disease (p=0.007), chronic kidney disease stage (p=0.010) as independently associated risk factors for AKI. CONCLUSIONS: More than one third of patients sustain AKI after TAVI using the Edwards bioprosthesis, as defined by the VARC-modified RIFLE score. AKI increased the mortality at both 30 days and at one year. A history of diabetes mellitus, peripheral vascular disease and higher chronic kidney disease stage had the strongest independent associations with post-TAVI AKI.

Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry.

OBJECTIVES: The objective was to define the characteristics of a real-world patient population treated with transcatheter aortic valve implantation (TAVI), regardless of technology or access route, and to evaluate their clinical outcome over the mid to long term. BACKGROUND: Although a substantial body of data exists in relation to early clinical outcomes after TAVI, there are few data on outcomes beyond 1 year in any notable number of patients. METHODS: The U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry was established to report outcomes of all TAVI procedures performed within the United Kingdom. Data were collected prospectively on 870 patients undergoing 877 TAVI procedures up until December 31, 2009. Mortality tracking was achieved in 100% of patients with mortality status reported as of December 2010. RESULTS: Survival at 30 days was 92.9%, and it was 78.6% and 73.7% at 1 year and 2 years, respectively. There was a marked attrition in survival between 30 days and 1 year. In a univariate model, survival was significantly adversely affected by renal dysfunction, the presence of coronary artery disease, and a nontransfemoral approach; whereas left ventricular function (ejection fraction <30%), the presence of moderate/severe aortic regurgitation, and chronic obstructive pulmonary disease remained the only independent predictors of mortality in the multivariate model. CONCLUSIONS: Midterm to long-term survival after TAVI was encouraging in this high-risk patient population, although a substantial proportion of patients died within the first year.

Is it safe to perform endoscopic vein harvest?

A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was: in [patients undergoing coronary revascularisation] is [endoscopic vein harvest] superior to [open harvest] in improving [clinical outcome and cost effectiveness]? Altogether >166 papers were found using the reported search, of which eight represented the best evidence to answer the clinical question. All papers agree that endoscopic vein harvesting (EVH) reduces the level of postoperative pain (pain score for EVH=0.52+/-0.95; open technique=1.02+/-1.51; P=0.03) and wound complications (range from 3 to 7.4% for EVH and 13 to 19.4% for conventional technique). These clinical benefits were associated with a high level of patient satisfaction. On average, four papers found that the length of hospital stay was reduced in the EVH group [weighted mean difference (WMD) -1.04 to -0.85; confidence interval (CI) -1.92 to -0.16; P=0.02]. The overall occlusion rates of venous grafts after six months were 21.7% for EVH and 17.6% for open technique. There were no differences in the six months occlusion and disease rates between EVH and conventional vein harvest (CVH), as determined by means of univariate analysis (P=0.584). However, some papers (PREVENT-IV sub-analysis and Yun et al.) called into question EVH by reporting high vein occlusion rates. At six months, this was 21.7% for EVH and 17.6% for open technique rising to 46.7% vs. 38.0% (P<0.001) at 12-18 months. At three years, endoscopic harvesting was also associated with higher rates of death, myocardial infarction, or repeat revascularisation (20.2% vs. 17.4%; P=0.04), death or myocardial infarction (9.3% vs. 7.6%; P=0.01), and death (7.4% vs. 5.8%; P=0.005). We conclude that EVH reduces the level of postoperative pain and wound complication, with a high-level of patient satisfaction but a sub-analysis of a large RCT has recently called into question the medium- to long-term patency of grafts endoscopically harvested.

Does intermittent cross-clamp fibrillation provide equivalent myocardial protection compared to cardioplegia in patients undergoing bypass graft revascularisation?

A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was: does intermittent cross-clamp fibrillation provide equivalent myocardial protection compared to cardioplegia in patients undergoing bypass graft revascularisation? Altogether, 58 papers were found using the reported search, of which 13 represented the best evidence to answer the clinical question. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. We identified 13 studies, of which eight were randomised prospective trials. None of these studies found increased mortality, seven analyzed serum cardiac enzymes and showed that intermittent ischemic arrest provides equal or better protection compared to cardioplegic techniques. Two studies found an increased usage of inotropes and intra aortic balloon pump (IABP) in the intermittent ischemic arrest group. We conclude that intermittent cross-clamp fibrillation is a versatile and cost-effective method of myocardial protection, with the immediate postoperative outcome comparable to cardioplegic arrest in first-time coronary artery bypass graft (CABG). The ischaemic duration associated with intermittent cross-clamp fibrillation is invariably shorter than that associated with cardioplegic arrest, and this may be one explanation for the comparable outcomes. There may also be an element of preconditioning protection during the intermittent cross-clamp fibrillation method, as has been shown experimentally. During elective CABG in patients with no clinical evidence of aortic or cerebro-vascular disease, the incidence of peri-operative microemboli (ME) and postoperative neuropsychological disturbances are shown to be comparable with both techniques of myocardial preservation.

Bovine pericardial versus porcine stented replacement aortic valves: early results of a randomized comparison of the Perimount and the Mosaic valves.

OBJECTIVE: A stented bovine pericardial valve might be less obstructive than a stented porcine valve. This study compared early hemodynamic function in a prospective series of 99 patients randomized to receive either a Mosaic or Perimount replacement aortic valve. METHODS: Echocardiography was performed early after surgery and at 1 year after surgery. Patients also filled in psychologic questionnaires and underwent a 6-minute walk. RESULTS: The groups were matched demographically. The Perimount valve was significantly less obstructive in terms of mean pressure difference (11 +/- 5 vs 17 +/- 7 mm Hg; P < .0001), with a trend in favor of a larger effective orifice area (1.47 +/- 0.45 vs 1.28 +/- 0.46 cm(2); P = .05) postoperatively. There were no differences in left ventricular mass regression, aortic regurgitation, 6-minute walk, psychologic questionnaires, or mortality and clinical events. CONCLUSION: The stented bovine pericardial valve was less obstructive than the stented porcine valve. Both valves were associated with similar and significant improvements in quality of life, exercise ability, and regression of left ventricular mass.