Decreasing pacemaker implantation rates with Evolut supra-annular transcatheter aortic valves in a large real-world registry.

BACKGROUND: Permanent pacemaker implantation (PPI) rates following transcatheter aortic valve replacement (TAVR) remain a concern. We assessed the PPI rates over time in patients implanted with an Evolut supra-annular, self-expanding transcatheter valve from the US STS/ACC TVT Registry. METHODS: Patients who underwent TAVR with an Evolut R, Evolut PRO or Evolut PRO+ valve between July 2018 (Q3) and June 2021 (Q2) were included. PPI rates were reported by calendar quarter. In-hospital PPI rates were reported as proportions and 30-day rates as Kaplan-Meier estimates. A Cox regression model was used to determine potential predictors of a new PPI within 30 days of the TAVR procedure. RESULTS: From July 2018 to June 2021, 54,014 TAVR procedures were performed using Evolut valves. Mean age was 79.3 ± 8.8 years and 49.2 % were male. The 30-day PPI rate was 16.6 % in 2018 (Q3) and 10.8 % in 2021 (Q2, 34.9 % decrease, p < 0.001 for trend across all quarters). The in-hospital PPI rate decreased by 40.1 %; from 14.7 % in 2018 (Q3) to 8.8 % in 2021 (Q2) (p < 0.001 for trend across all quarters). Significant predictors of a new PPI within 30 days included a baseline conduction defect, history of atrial fibrillation, home oxygen, and diabetes mellitus. CONCLUSION: From 2018 to 2021, TAVR with an Evolut transcatheter heart valve in over 50,000 patients showed a significant decreasing trend in the rates of in-hospital and 30-day PPI, representing the lowest rate of PPI in any large real-world registry of Evolut. During the same evaluated period, high device success and shorter length of stay was also observed.

Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus.

BACKGROUND: Patients with severe aortic stenosis and a small aortic annulus are at risk for impaired valvular hemodynamic performance and associated adverse cardiovascular clinical outcomes after transcatheter aortic-valve replacement (TAVR). METHODS: We randomly assigned patients with symptomatic severe aortic stenosis and an aortic-valve annulus area of 430 mm2 or less in a 1:1 ratio to undergo TAVR with either a self-expanding supraannular valve or a balloon-expandable valve. The coprimary end points, each assessed through 12 months, were a composite of death, disabling stroke, or rehospitalization for heart failure (tested for noninferiority) and a composite end point measuring bioprosthetic-valve dysfunction (tested for superiority). RESULTS: A total of 716 patients were treated at 83 sites in 13 countries (mean age, 80 years; 87% women; mean Society of Thoracic Surgeons Predicted Risk of Mortality, 3.3%). The Kaplan-Meier estimate of the percentage of patients who died, had a disabling stroke, or were rehospitalized for heart failure through 12 months was 9.4% with the self-expanding valve and 10.6% with the balloon-expandable valve (difference, -1.2 percentage points; 90% confidence interval [CI], -4.9 to 2.5; P<0.001 for noninferiority). The Kaplan-Meier estimate of the percentage of patients with bioprosthetic-valve dysfunction through 12 months was 9.4% with the self-expanding valve and 41.6% with the balloon-expandable valve (difference, -32.2 percentage points; 95% CI, -38.7 to -25.6; P<0.001 for superiority). The aortic-valve mean gradient at 12 months was 7.7 mm Hg with the self-expanding valve and 15.7 mm Hg with the balloon-expandable valve, and the corresponding values for additional secondary end points through 12 months were as follows: mean effective orifice area, 1.99 cm2 and 1.50 cm2; percentage of patients with hemodynamic structural valve dysfunction, 3.5% and 32.8%; and percentage of women with bioprosthetic-valve dysfunction, 10.2% and 43.3% (all P<0.001). Moderate or severe prosthesis-patient mismatch at 30 days was found in 11.2% of the patients in the self-expanding valve group and 35.3% of those in the balloon-expandable valve group (P<0.001). Major safety end points appeared to be similar in the two groups. CONCLUSIONS: Among patients with severe aortic stenosis and a small aortic annulus who underwent TAVR, a self-expanding supraannular valve was noninferior to a balloon-expandable valve with respect to clinical outcomes and was superior with respect to bioprosthetic-valve dysfunction through 12 months. (Funded by Medtronic; SMART ClinicalTrials.gov number, NCT04722250.).

Clinical Impact of Standardized TAVR Technique and Care Pathway: Insights From the Optimize PRO Study.

BACKGROUND: Procedural success and clinical outcomes after transcatheter aortic valve replacement (TAVR) have improved, but residual aortic regurgitation (AR) and new permanent pacemaker implantation (PPI) rates remain variable because of a lack of uniform periprocedural management and implantation. OBJECTIVES: The Optimize PRO study evaluates valve performance and procedural outcomes using an "optimized" TAVR care pathway and the cusp overlap technique (COT) in patients receiving the Evolut PRO/PRO+ (Medtronic) self-expanding valves. METHODS: Optimize PRO, a nonrandomized, prospective, postmarket study conducted in the United States, Canada, Europe, Middle East, and Australia, is enrolling patients with severe symptomatic aortic stenosis and no pre-existing pacemaker. Sites follow a standardized TAVR care pathway, including early discharge and a conduction disturbance management algorithm, and transfemoral deployment using the COT. RESULTS: A total of 400 attempted implants from the United States and Canada comprised the main cohort of this second interim analysis. The mean age was 78.7 ± 6.6 years, and the mean Society of Thoracic Surgeons predictive risk of mortality was 3.0 ± 2.4. The median length of stay was 1 day. There were no instances of moderate or severe AR at discharge. At 30 days, all-cause mortality or stroke was 3.8%, all-cause mortality was 0.8%, disabling stroke was 0.7%, hospital readmission was 10.1%, and cardiovascular rehospitalization was 6.1%. The new PPI rate was 9.8%, 5.8% with 4-step COT compliance. In the multivariable model, right bundle branch block and the depth of the implant increased the risk of PPI, whereas using the 4-step COT lowered 30-day PPI. CONCLUSIONS: The use of the TAVR care pathway and COT resulted in favorable clinical outcomes with no moderate or severe AR and low PPI rates at 30 days while facilitating early discharge and reproducible outcomes across various sites and operators. (Optimize PRO; NCT04091048).

Structural Valve Deterioration After Self-Expanding Transcatheter or Surgical Aortic Valve Implantation in Patients at Intermediate or High Risk.

Importance: The frequency and clinical importance of structural valve deterioration (SVD) in patients undergoing self-expanding transcatheter aortic valve implantation (TAVI) or surgery is poorly understood. Objective: To evaluate the 5-year incidence, clinical outcomes, and predictors of hemodynamic SVD in patients undergoing self-expanding TAVI or surgery. Design, Setting, and Participants: This post hoc analysis pooled data from the CoreValve US High Risk Pivotal (n = 615) and SURTAVI (n = 1484) randomized clinical trials (RCTs); it was supplemented by the CoreValve Extreme Risk Pivotal trial (n = 485) and CoreValve Continued Access Study (n = 2178). Patients with severe aortic valve stenosis deemed to be at intermediate or increased risk of 30-day surgical mortality were included. Data were collected from December 2010 to June 2016, and data were analyzed from December 2021 to October 2022. Interventions: Patients were randomized to self-expanding TAVI or surgery in the RCTs or underwent self-expanding TAVI for clinical indications in the nonrandomized studies. Main Outcomes and Measures: The primary end point was the incidence of SVD through 5 years (from the RCTs). Factors associated with SVD and its association with clinical outcomes were evaluated for the pooled RCT and non-RCT population. SVD was defined as (1) an increase in mean gradient of 10 mm Hg or greater from discharge or at 30 days to last echocardiography with a final mean gradient of 20 mm Hg or greater or (2) new-onset moderate or severe intraprosthetic aortic regurgitation or an increase of 1 grade or more. Results: Of 4762 included patients, 2605 (54.7%) were male, and the mean (SD) age was 82.1 (7.4) years. A total of 2099 RCT patients, including 1128 who received TAVI and 971 who received surgery, and 2663 non-RCT patients who received TAVI were included. The cumulative incidence of SVD treating death as a competing risk was lower in patients undergoing TAVI than surgery (TAVI, 2.20%; surgery, 4.38%; hazard ratio [HR], 0.46; 95% CI, 0.27-0.78; P = .004). This lower risk was most pronounced in patients with smaller annuli (23 mm diameter or smaller; TAVI, 1.32%; surgery, 5.84%; HR, 0.21; 95% CI, 0.06-0.73; P = .02). SVD was associated with increased 5-year all-cause mortality (HR, 2.03; 95% CI, 1.46-2.82; P < .001), cardiovascular mortality (HR, 1.86; 95% CI, 1.20-2.90; P = .006), and valve disease or worsening heart failure hospitalizations (HR, 2.17; 95% CI, 1.23-3.84; P = .008). Predictors of SVD were developed from multivariate analysis. Conclusions and Relevance: This study found a lower rate of SVD in patients undergoing self-expanding TAVI vs surgery at 5 years. Doppler echocardiography was a valuable tool to detect SVD, which was associated with worse clinical outcomes. Trial Registration: ClinicalTrials.gov Identifiers: NCT01240902, NCT01586910, and NCT01531374.

2-Year Outcomes After Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients.

BACKGROUND: The Evolut Low Risk Trial (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients) showed that transcatheter aortic valve replacement (TAVR) with a supra-annular, self-expanding valve was noninferior to surgery for the primary endpoint of all-cause mortality or disabling stroke at 2 years. This finding was based on a Bayesian analysis performed after 850 patients had reached 1 year of follow-up. OBJECTIVES: The goal of this study was to report the full 2-year clinical and echocardiographic outcomes for patients enrolled in the Evolut Low Risk Trial. METHODS: A total of 1,414 low-surgical risk patients with severe aortic stenosis were randomized to receive TAVR or surgical AVR. An independent clinical events committee adjudicated adverse events, and a central echocardiographic core laboratory assessed hemodynamic endpoints. RESULTS: An attempted implant was performed in 730 TAVR and 684 surgical patients from March 2016 to May 2019. The Kaplan-Meier rates for the complete 2-year primary endpoint of death or disabling stroke were 4.3% in the TAVR group and 6.3% in the surgery group (P = 0.084). These rates were comparable to the interim Bayesian rates of 5.3% with TAVR and 6.7% with surgery (difference: -1.4%; 95% Bayesian credible interval: -4.9% to 2.1%). All-cause mortality rates were 3.5% vs 4.4% (P = 0.366), and disabling stroke rates were 1.5% vs 2.7% (P = 0.119), respectively. Between years 1 and 2, there was no convergence of the primary outcome curves. CONCLUSIONS: The complete 2-year follow-up from the Evolut Low Risk Trial found that TAVR is noninferior to surgery for the primary endpoint of all-cause mortality or disabling stroke, with event rates that were slightly better than those predicted by using the Bayesian analysis. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients [Evolut Low Risk Trial]; NCT02701283).

Five-Year Outcomes From the United States Pivotal Trial of Valiant Captivia Stent Graft for Blunt Aortic Injury.

BACKGROUND: The Clinical PeRformancE of the Valiant Thoracic Stent Graft with Capitvia Delivery System for the EndovaSCUlar treatment of Blunt Thoracic Aortic Injuries (RESCUE) study evaluating thoracic endovascular repair using the Valiant Captivia endograft for blunt thoracic aortic injury reported promising 30-day outcomes. We now describe 5 years of follow-up of this cohort. METHODS: Fifty patients (mean age 40.7 ± 17.4 years, 76% male, mean injury severity score 38 ± 14.4) were treated for blunt thoracic aortic injury (2010 to 2012) with this endograft. Seventy percent (n = 35) of blunt thoracic aortic injury extent was grade III or higher. Extent of arch repair required full (40%) or partial (18%) left subclavian artery coverage. At 5 years, clinical and imaging compliance was 90.3% (28 of 31) and 67.7% (21 of 31), respectively. RESULTS: Thirty-day mortality was 8%. Three additional patients died of non-device-related causes (respiratory failure, infection, metastatic cancer) through 5-year follow-up, yielding a Kaplan-Meier survival of 85.2% through 5 years. Neither stroke nor spinal cord ischemia was observed at 5 years. Two type II endoleaks seen at 30 days resolved spontaneously, and no additional endoleaks were described in the study cohort through 5 years. No secondary endovascular procedures or conversion to open surgery were reported through 5 years. Four subjects underwent left subclavian revascularization for symptomatic indications. Finally, complete exclusion of the traumatic injury was maintained with no incidences of stent graft kinking, fracture, loss of patency, or migration through 5 years in all patients. CONCLUSIONS: This multicenter clinical trial describes excellent 5-year outcomes and durable exclusion of blunt thoracic aortic injury using a novel stent graft system. Thoracic endovascular repair with this endograft appears to be a safe and effective treatment option for patients with blunt thoracic aortic injury.

Bioprosthetic valve fracture: Technical insights from a multicenter study.

OBJECTIVE: Valve-in-valve transcatheter aortic valve replacement (VIV TAVR) can result in high residual gradients that are associated with increased mortality. Bioprosthetic valve fracture (BVF) has been shown to improve residual gradients following VIV TAVR; however, factors influencing the results of BVF have not been studied. METHODS: BVF was performed in 75 patients at 21 centers. Hierarchical multiple linear regression was performed to identify variables that were associated with lower final transvalvular gradient. RESULTS: Surgical valves with a median true internal diameter of 18.5 mm (interquartile range, 17.0-20.5 mm) were treated with VIV TAVR in conjunction with BVF using balloon-expandable (n = 43) or self-expanding (n = 32) transcatheter heart valves with a median size of 23 mm (interquartile range, 23-23 mm). There were no aortic root disruptions, coronary occlusions, or new pacemakers; in-hospital or 30-day mortality was 2.6% (2 out of 75). Final mean transvalvular gradient was 9.2 ± 6.3 mm Hg, but was significantly lower when BVF was performed after VIV TAVR compared with BVF first (8.1 ± 4.8 mm Hg vs 16.9 ± 10.1 mm Hg; P < .001). After adjusting for timing of BVF (ie, before or after VIV TAVR), transcatheter heart valve size/type, surgical valve mode of failure, true internal diameter, and baseline gradient and BVF balloon size, performing BVF after VIV TAVR (P < .001) and using a larger BVF balloon (P = .038) were the only independent predictors of lower final mean gradient. CONCLUSIONS: BVF can be performed safely and results in reduced residual transvalvular gradients. Performing BVF after VIV TAVR and using larger balloon appears to achieve the best hemodynamic results.

Two-Year Outcomes After Transcatheter Aortic Valve Replacement With Mechanical vs Self-expanding Valves: The REPRISE III Randomized Clinical Trial.

Importance: To our knowledge, REPRISE III is the first large randomized comparison of 2 different transcatheter aortic valve replacement platforms: the mechanically expanded Lotus valve (Boston Scientific) and self-expanding CoreValve (Medtronic). Objective: To evaluate outcomes of Lotus vs CoreValve after 2 years. Design, Setting, and Participants: A total of 912 patients with high/extreme risk and severe, symptomatic aortic stenosis enrolled between September 22, 2014, and December 24, 2015, were randomized 2:1 to receive Lotus (607 [66.6%]) or CoreValve (305 [33.4%] at 55 centers in North America, Europe, and Australia. The first 2-year visit occurred on October 17, 2016, and the last was conducted on April 12, 2018. Clinical and echocardiographic assessments are complete through 2 years and will continue annually through 5 years. Main Outcomes and Measures: All-cause mortality and all-cause mortality or disabling stroke at 2 years. Other clinical factors included overall stroke, disabling stroke, repeated procedures, rehospitalization, valve thrombosis, and pacemaker implantation. Echocardiographic analyses included effective orifice area, mean gradient, and paravalvular leaks (PVLs). Results: Of 912 participants, the mean (SD) age was 82.8 (7.3) years, 465 (51%) were women, and the mean (SD) Society of Thoracic Surgeons predicted risk of mortality was 6.8% (4.0%). At 2 years, all-cause death was 21.3% with Lotus vs 22.5% with CoreValve (hazard ratio [HR], 0.94; 95% CI, 0.69-1.26; P = .67) and all-cause mortality or disabling stroke was 22.8% with Lotus and 27.0% with CoreValve (HR, 0.81; 95% CI, 0.61-1.07; P = .14). Overall stroke was 8.4% vs 11.4% (HR, 0.75; 95% CI, 0.48-1.17; P = .21); disabling stroke was more frequent with CoreValve vs Lotus (4.7% Lotus vs 8.6% CoreValve; HR, 0.53; 95% CI, 0.31-0.93; P = .02). More Lotus patients received a new permanent pacemaker (41.7% vs 26.1%; HR, 1.87; 95% CI, 1.41-2.49; P < .01) or had a valve thrombosis (3.0% vs 0.0%; P < .01) compared with CoreValve. More patients who received CoreValve experienced a repeated procedure (0.6% Lotus vs 2.9% CoreValve; HR, 0.19; 95% CI, 0.05-0.70; P < .01), valve migration (0.0% vs 0.7%; P = .05), or embolization (0.0% vs 2.0%; P < .01) than Lotus. Valve areas remained significantly larger and the mean gradient was lower with CoreValve than Lotus (valve area, mean [SD]: Lotus, 1.53 [0.49] cm2 vs CoreValve, 1.76 [0.51] cm2; P < .01; valve gradient, mean [SD]: Lotus, 13.0 [6.7] mm Hg vs 8.1 [3.7] mm Hg; P < .01). Moderate or greater PVL was more frequent with CoreValve (0.3% Lotus vs 3.8% CoreValve; P < .01) at 2 years. Larger improvements in New York Heart Association (NYHA) functional class were observed with Lotus compared with CoreValve (improved by ≥1 NYHA class: Lotus, 338 of 402 [84.1%] vs CoreValve, 143 of 189 [75.7%]; P = .01; improved by ≥2 NYHA classes: 122 of 402 [37.3%] vs 65 of 305 [21.3%]). Conclusions and Relevance: After 2 years, all-cause mortality rates, mortality or disabling stroke were similar between Lotus and CoreValve. Disabling stroke, functional class, valve migration, and PVL favored the Lotus arm whereas valve hemodynamics, thrombosis, and new pacemaker implantation favored the CoreValve arm. Trial Registration: clinicaltrials.gov Identifier: NCT02202434.

Effect of Mechanically Expanded vs Self-Expanding Transcatheter Aortic Valve Replacement on Mortality and Major Adverse Clinical Events in High-Risk Patients With Aortic Stenosis: The REPRISE III Randomized Clinical Trial.

Importance: Transcatheter aortic valve replacement (TAVR) is established for selected patients with severe aortic stenosis. However, limitations such as suboptimal deployment, conduction disturbances, and paravalvular leak occur. Objective: To evaluate if a mechanically expanded valve (MEV) is noninferior to an approved self-expanding valve (SEV) in high-risk patients with aortic stenosis undergoing TAVR. Design, Setting, and Participants: The REPRISE III trial was conducted in 912 patients with high or extreme risk and severe, symptomatic aortic stenosis at 55 centers in North America, Europe, and Australia between September 22, 2014, and December 24, 2015, with final follow-up on March 8, 2017. Interventions: Participants were randomized in a 2:1 ratio to receive either an MEV (n = 607) or an SEV (n = 305). Main Outcomes and Measures: The primary safety end point was the 30-day composite of all-cause mortality, stroke, life-threatening or major bleeding, stage 2/3 acute kidney injury, and major vascular complications tested for noninferiority (margin, 10.5%). The primary effectiveness end point was the 1-year composite of all-cause mortality, disabling stroke, and moderate or greater paravalvular leak tested for noninferiority (margin, 9.5%). If noninferiority criteria were met, the secondary end point of 1-year moderate or greater paravalvular leak was tested for superiority in the full analysis data set. Results: Among 912 randomized patients (mean age, 82.8 [SD, 7.3] years; 463 [51%] women; predicted risk of mortality, 6.8%), 874 (96%) were evaluable at 1 year. The primary safety composite end point at 30 days occurred in 20.3% of MEV patients and 17.2% of SEV patients (difference, 3.1%; Farrington-Manning 97.5% CI, -∞ to 8.3%; P = .003 for noninferiority). At 1 year, the primary effectiveness composite end point occurred in 15.4% with the MEV and 25.5% with the SEV (difference, -10.1%; Farrington-Manning 97.5% CI, -∞ to -4.4%; P<.001 for noninferiority). The 1-year rates of moderate or severe paravalvular leak were 0.9% for the MEV and 6.8% for the SEV (difference, -6.1%; 95% CI, -9.6% to -2.6%; P < .001). The superiority analysis for primary effectiveness was statistically significant (difference, -10.2%; 95% CI, -16.3% to -4.0%; P < .001). The MEV had higher rates of new pacemaker implants (35.5% vs 19.6%; P < .001) and valve thrombosis (1.5% vs 0%) but lower rates of repeat procedures (0.2% vs 2.0%), valve-in-valve deployments (0% vs 3.7%), and valve malpositioning (0% vs 2.7%). Conclusions and Relevance: Among high-risk patients with aortic stenosis, use of the MEV compared with the SEV did not result in inferior outcomes for the primary safety end point or the primary effectiveness end point. These findings suggest that the MEV may be a useful addition for TAVR in high-risk patients. Trial Registration: ClinicalTrials.gov Identifier: NCT02202434.

Comparison of thoracic aortic diameter changes after endograft placement in patients with traumatic and aneurysmal disease.

OBJECTIVE: The purpose of this study was to evaluate acute changes in aortic size before and after endograft placement for traumatic injury and aneurysmal disease. We hypothesize that there are inherent differences between trauma and aneurysm populations undergoing thoracic endovascular aortic repair (TEVAR) and that these factors may affect device choice and sizing for each group. METHODS: This retrospective study evaluated the existing digital imaging of traumatic injury and aneurysmal patients enrolled in the 0802 and 0803 multi-site trials that received the GORE Conformable TAG thoracic device. Pre- and post-treatment imaging was available for 70 traumatic injury and 54 aneurysmal patients. Post-treatment imaging was defined as being complete within 30 days of treatment. A standardized protocol was used to complete measurements of the proximal and distal maximum neck diameters through the use of the orthogonal view before imaging and at 30-day imaging. The resultant changes in diameter for each group were analyzed by means of t-tests. RESULTS: Mean increases in proximal (3.0 mm vs 2.0 mm; P < .05) and distal neck diameters (2.9 mm vs 0.7 mm; P < .01) after TEVAR are significantly greater in traumatic injury patients than in aneurysm patients between pretreatment and 30-day imaging. In both study populations, smaller pretreatment aortic neck diameters showed a larger change in neck diameter than did larger pretreatment aortic diameters. Aneurysm patients were oversized significantly more than were trauma patients at the proximal neck (9.1% vs 4.5%; P < .05). However, at the distal neck, the trauma patients were oversized more than were the aneurysm patients (17.5% vs 13.6%; P = .06). A strong correlation was found between the percentage of oversizing and change in the distal neck diameter after TEVAR in both patient groups. CONCLUSIONS: The results suggest that there are differences between trauma and aneurysm populations. Careful device selection may contribute to the avoidance of complications related to both undersized and oversized devices. Short-term analysis shows that TEVAR can be successfully accomplished in both trauma and aneurysm groups over a wide sizing range. Further data regarding long-term device complications are needed to better characterize this relationship.

Noninferiority of closely monitored mechanical valves to bioprostheses overshadowed by early mortality benefit in younger patients.

BACKGROUND: Confidence in bioprosthetic durability without anticoagulation has led to a contemporary trend of offering tissue valves to younger patients. Close monitoring of mechanical valve patients at lower international normalized ratio (INR) thresholds may reduce anticoagulation morbidity. We prospectively compared results of bioprostheses (BP) and a bileaflet mechanical prosthesis (MP) monitored at low INR thresholds. METHODS: Patients received an isolated Carpentier-Edwards bovine or Medtronic porcine BP or the On-X MP. INR targets were 2.0 for MP recipients undergoing aortic valve replacement and 2.5 for mitral valve replacement, using point-of-care home monitoring. Operations consecutively performed between September 2003 and August 2007 were propensity matched using logistic regression by preoperative covariates of age, sex, valve position, New York Heart Association class, ejection fraction, atrial fibrillation, and creatinine. RESULTS: Of 469 operations consecutively performed, 172 patients were matched for analysis. Mean age was 56.2±9.6 years (range, 24 to 72 years). Median follow-up was 4.0 years (total follow-up, 667.0 patient-years). No late bleeding events occurred. The thromboembolic complication rates per patient-year were 0.77% for MP and 0.78% for BP (p=0.67). There were 9 BP deaths vs 4 MP (2.35% vs 1.41%/patient-year; BP hazard ratio, 0.60; 95% confidence interval, 0.13 to 2.15). Postoperative linearized mortality benefit of MP was observed as early as 5 years, reaching significance at 7.5 years (p=0.04). CONCLUSIONS: Patients aged 65 years or younger with MP and closely monitored anticoagulation display noninferiority to BP from bleeding and thromboembolic complications. MP valves begin to confer mortality benefit over BP as early as 7.5 years postoperatively. Because this predates the timeline of typical structural valve degeneration, equipoise is suggested when choosing a BP in a young patient with future expectations of valve-in-valve intervention.

Left atrial reduction enhances outcomes of modified maze procedure for permanent atrial fibrillation during concomitant mitral surgery.

BACKGROUND: Success of the maze procedure after mitral operations with large left atria and permanent atrial fibrillation remains suboptimal. Current technique variations tend to obscure the decision-making algorithm in these patients. A single energy-source approach for the surgical management of patients with large left atria and permanent atrial fibrillation is presented. METHODS: From January 2003 to July 2005, 71 consecutive drug-resistant patients with permanent atrial fibrillation and left atrial enlargement who required mitral valve surgery underwent aggressive left atrial reduction combined with left-sided only irrigated radiofrequency unipolar maze. Left atrial dimensions were measured by transesophageal echo anterior-to-posterior leading edge-to-edge standardized protocol. There were 39 men (54.9%) and 32 women (45.1%), and their mean age was 71.9 +/- 9.5 years. Mean duration of atrial fibrillation was 49.3 +/- 58.0 months. RESULTS: All patients underwent left atrial reduction with identical Cox-maze III pulmonary vein and appendage isolation including mitral annular connection, followed by appendage suture closure. Left atrial size was reduced from 6.7 +/- 1.2 cm to 4.3 +/- 0.6 cm (p = 0.001). Mitral valve repair was performed in 55 patients (76.1%) and replacement in 17 (23.9%). The 30-day mortality was 4.2% (3/71). Postoperative length of stay was 8.8 +/- 5.7 days, with 56 (82.4%) of 68 patients discharged in normal sinus rhythm. P-wave sinus rhythm was 93.8% between 7 and 12 months and 92.0% for patients with 1 year or more of follow-up. CONCLUSIONS: Left atrial reduction combined with a left atrial only single energy-source radiofrequency maze procedure is an effective treatment for patients with permanent atrial fibrillation undergoing concomitant mitral operations.

Expression of focal adhesion kinase in normal and pathologic human prostate tissues.

BACKGROUND: Focal adhesion kinase (FAK) regulates multiple cellular processes including growth, differentiation, adhesion, motility, and apoptosis. In tumor cells, including prostate adenocarcinoma, FAK overexpression has been linked to cancer progression. METHODS: By using immunohistochemistry, FAK expression was investigated in human prostate specimens. RESULTS: FAK was expressed predominantly in the basal layer of normal prostate epithelium but not in secretory epithelium. FAK was expressed at similar levels in all stages of prostate tumorigenesis, including preinvasive carcinoma and metastatic disease. Elevated FAK expression was observed at the earliest stages of transformation and expression continued during cancer progression. CONCLUSION: Given the established role for FAK in the regulation of integrin signaling, we suggest that the sustained elevated levels of FAK expression during prostate tumor cell progression is consistent with a role for FAK in the development and maintenance of prostate carcinoma.