Midterm outcomes of aortic valve replacement using a rapid-deployment valve for aortic stenosis: TRANSFORM trial.

Background: The use of rapid-deployment valves (RDVs) has been shown to reduce the operative time for surgical aortic valve replacement (AVR). Long-term core laboratory-adjudicated data are scarce, however. Here we report final 7-year data on RDV use. Methods: TRANSFORM was a prospective, nonrandomized, multicenter, single-arm trial implanting a stented bovine pericardial valve with an incorporated balloon-expandable sealing frame. A prior published 1-year analysis included 839 patients from 29 centers. An additional 46 patients were enrolled and implanted, for a total of 885 patients. Annual clinical and core laboratory-adjudicated echocardiographic outcomes were collected through 8 years. Primary endpoints were structural valve deterioration (SVD), all-cause reintervention, all-cause valve explantation, and all-cause mortality. Secondary endpoints included hemodynamic performance assessed by echocardiography. The mean duration of follow-up was 5.0 ± 2.0 years. Results: The mean patient age was 73.3 ± 8.2 years. Isolated AVR was performed in 62.1% of the patients, and AVR with concomitant procedures was performed in 37.9%. Freedom from all-cause mortality at 7 years was 76.0% for isolated AVR and 68.2% for concomitant AVR. Freedom from SVD, all-cause reintervention, and valve explantation at 7 years was 97.5%, 95.7%, and 97.8%, respectively. The mean gradient and effective orifice area at 7 years were 11.1 ± 5.3 mm Hg and 1.6 ± 0.3 cm2, respectively. Paravalvular leak at 7 years was none/trace in 88.6% and mild in 11.4%. In patients undergoing isolated AVR, the cumulative probability of pacemaker implantation was 13.9% at 30 days, 15.5% at 1 year, and 21.8% at 7 years. Conclusions: AVR for aortic stenosis using an RDV is associated with low rates of late adverse events. This surgical pericardial tissue platform provides excellent and stable hemodynamic performance through 7 years.

Five-Year Outcomes After Bicuspid Aortic Valve Replacement With a Novel Tissue Bioprosthesis.

BACKGROUND: This study investigated the safety and effectiveness of surgical aortic valve replacement with RESILIA tissue (Edwards Lifesciences) through 5 years in patients with native bicuspid aortic valves. Outcomes were compared with those for patients with tricuspid aortic valves. METHODS: Of 689 patients from the COMMENCE (ProspeCtive, nOn-randoMized, MulticENter) trial who received the study valve, 645 had documented native valve morphology and core laboratory-evaluable echocardiograms from any postoperative visit, which were used to model hemodynamic outcomes over 5 years. Linear mixed-effects models were used to estimate longitudinal changes in mean gradient and effective orifice area. RESULTS: Patients with native bicuspid aortic valves (n = 214) were more than a decade younger than those with tricuspid aortic valves (n = 458; 59.8 ± 12.4 years vs 70.2 ± 9.5 years; P < .001). The bicuspid aortic valve cohort exhibited no structural valve deterioration over 5 years, and rates of paravalvular leak and transvalvular regurgitation were low (0.7% and 2.9%, respectively [all mild] at 5 years). These outcomes mirrored those in patients with native tricuspid aortic valves. The model-estimated postoperative mean gradient and effective orifice area, as well as the rate of change of these outcomes, adjusted for age, body surface area, and bioprosthesis size, did not differ between the 2 cohorts. CONCLUSIONS: Among patients with bicuspid aortic valves, RESILIA tissue valves demonstrated excellent outcomes to 5 years, including no structural valve deterioration and very low rates of paravalvular and transvalvular regurgitation. These results are encouraging for RESILIA tissue durability in young patients.

Mid-term outcomes of the COMMENCE trial investigating mitral valve replacement using a bioprosthesis with a novel tissue.

Objective: Novel tissue leaflets (RESILIA tissue) may improve durability of bioprosthetic heart valves. The COMMENCE trial is an ongoing prospective study to evaluate valve replacement using RESILIA tissue. This report describes mid-term outcomes in the mitral cohort of COMMENCE. Methods: Adult patients requiring mitral valve replacement were enrolled in a prospective, single-arm trial at 17 sites in the United States and Canada. An independent clinical events committee adjudicated safety events using definitions from established guidelines, and hemodynamic performance was evaluated by an independent echocardiographic core laboratory. Results: Eighty-two patients (median age 70 years) successfully underwent mitral valve replacement with the study valve. Five-year event-free probabilities for all-cause mortality, structural valve deterioration, and reoperation were 79.9%, 98.7%, and 97.1%, respectively. Hemodynamic valve function measurements were stable through the 5-year follow-up period; valvular leaks were infrequently observed and primarily clinically insignificant/mild. Conclusions: Mitral valve replacement patients implanted with a RESILIA tissue bioprosthesis had a good safety profile and clinically stable hemodynamic performance.

3-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis.

BACKGROUND: Randomized data comparing outcomes of transcatheter aortic valve replacement (TAVR) with surgery in low-surgical risk patients at time points beyond 2 years is limited. This presents an unknown for physicians striving to educate patients as part of a shared decision-making process. OBJECTIVES: The authors evaluated 3-year clinical and echocardiographic outcomes from the Evolut Low Risk trial. METHODS: Low-risk patients were randomized to TAVR with a self-expanding, supra-annular valve or surgery. The primary endpoint of all-cause mortality or disabling stroke and several secondary endpoints were assessed at 3 years. RESULTS: There were 1,414 attempted implantations (730 TAVR; 684 surgery). Patients had a mean age of 74 years and 35% were women. At 3 years, the primary endpoint occurred in 7.4% of TAVR patients and 10.4% of surgery patients (HR: 0.70; 95% CI: 0.49-1.00; P = 0.051). The difference between treatment arms for all-cause mortality or disabling stroke remained broadly consistent over time: -1.8% at year 1; -2.0% at year 2; and -2.9% at year 3. The incidence of mild paravalvular regurgitation (20.3% TAVR vs 2.5% surgery) and pacemaker placement (23.2% TAVR vs 9.1% surgery; P < 0.001) were lower in the surgery group. Rates of moderate or greater paravalvular regurgitation for both groups were <1% and not significantly different. Patients who underwent TAVR had significantly improved valve hemodynamics (mean gradient 9.1 mm Hg TAVR vs 12.1 mm Hg surgery; P < 0.001) at 3 years. CONCLUSIONS: Within the Evolut Low Risk study, TAVR at 3 years showed durable benefits compared with surgery with respect to all-cause mortality or disabling stroke. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283).

Five-year Outcomes of the COMMENCE Trial Investigating Aortic Valve Replacement With RESILIA Tissue.

BACKGROUND: The COMMENCE trial was conducted to evaluate the safety and effectiveness of aortic valve replacement using a bioprosthesis with novel RESILIA tissue (Edwards Lifesciences). RESILIA tissue is incorporated in the INSPIRIS RESILIA aortic valve (Edwards Lifesciences). METHODS: Patients underwent clinically indicated surgical aortic valve replacement with a bovine pericardial bioprosthesis (model 11000A; Edwards Lifesciences) in a prospective, multinational, multicenter (n = 27), US Food and Drug Administration Investigational Device Exemption trial. Events were adjudicated by an independent clinical events committee, and echocardiograms were analyzed by an independent core laboratory. Outcomes through an observational period of 5 years are reported. RESULTS: Between January 2013 and March 2016, 689 patients received the study valve. Mean patient age was 66.9 ± 11.6 years; Society of Thoracic Surgeons Predicted Risk of Mortality was 2.0% ± 1.8%; and 23.8%, 49.9%, and 24.4% of patients were New York Heart Association functional class I, II, and III at baseline, respectively. Through December 11, 2020 the follow-up duration was 4.3 ± 1.4 years, and the completeness of follow-up over the observational period was 95.5%. Early (<30 days) all-cause mortality was 1.2%, stroke 1.6%, and major paravalvular leak 0.1%. Five-year actuarial freedom from all-cause mortality, structural valve deterioration, and all-cause reintervention were 89.2%, 100%, and 98.7%, respectively. At 5 years the effective orifice area was 1.6 ± 0.5 cm2, mean gradient was 11.5 ± 6.0 mm Hg, 97.8% of patients were class I/II, and 97.8% and 96.3% of patients had none/trace paravalvular and transvalvular regurgitation, respectively. CONCLUSIONS: The safety and hemodynamic performance of this aortic bioprosthesis with RESILIA tissue through 5 years are encouraging, with clinically stable hemodynamics, minimal regurgitation, and no evidence of structural valve deterioration.

Prophylactic Left Atrial Appendage Exclusion in Cardiac Surgery Patients With Elevated CHA2DS2-VASc Score: Results of the Randomized ATLAS Trial.

OBJECTIVE: Patients with elevated CHA2DS2-VASc scores are at high risk for atrial fibrillation (AF) and thromboembolic events (TE) after cardiac surgery. Left atrial appendage exclusion (LAAE) is a permanent, continuous approach to stroke prevention in AF, overcoming limitations of oral anticoagulation (OAC). We report ATLAS trial results focused on LAAE technical success and perioperative safety and TE rates with and without LAAE in cardiac surgery patients who developed postoperative AF (POAF). METHODS: ATLAS (NCT02701062) was a prospective, multicenter, feasibility trial. Patients age ≥18 years, undergoing structural heart procedure, with no preoperative AF, CHA2DS2-VASc ≥2, and HAS-BLED ≥2 were randomized 2:1 to LAAE or no LAAE. Patients who developed POAF and/or received LAAE were followed for 1 year. LAAE was evaluated with intraoperative transesophageal echocardiography. RESULTS: A total of 562 patients were randomized to LAAE (n = 376) or no LAAE (n = 186). Mean CHA2DS2-VASc (3.4 vs 3.4) and HAS-BLED (2.8 vs 2.9) scores were similar for LAAE and no LAAE groups. LAAE success (no flow nor residual stump >10 mm) was 99%. One LAAE-related serious adverse event (0.27%) occurred and was resolved without sequelae. There were 44.3% of patients who developed POAF. Through 1 year, 3.4% of LAAE patients and 5.6% of no LAAE patients had TE. OAC was used by 32.5% of POAF patients. Bleeding was higher with OAC than without (16.1% vs 5.4%, P = 0.008). CONCLUSIONS: ATLAS demonstrated a high rate of successful LAAE with low LAAE-related serious adverse events in cardiac surgery patients. Study results should be considered in future trial design to further evaluate prophylactic LAAE for stroke prevention in cardiac surgery patients with elevated stroke risk.

Standardized Aortic Valve Neocuspidization for Treatment of Aortic Valve Diseases.

BACKGROUND: Aortic valve replacement is the traditional surgical treatment for aortic valve diseases, yet standardized aortic valve neocuspidization (AVNeo) is a promising alternative that is gaining popularity. The purpose of this article is to review the available published literature of AVNeo using glutaraldehyde-treated autologous pericardium, also known as the Ozaki procedure, including indications, outcomes, potential benefits, and modes of failure for the reconstructed valve. METHODS: A comprehensive literature search was performed using keywords related to aortic valve repair, AVNeo, or Ozaki procedure. All articles describing performance of AVNeo were reviewed. RESULTS: Reported early mortality after AVNeo varies from 0% to 5.88%. The largest cohort of patients in the literature includes 850 patients with an inhospital mortality rate of 1.88%. Cumulative incidence of aortic valve reoperation was 4.2% in the largest series. Reoperation was uncommon and mainly due to infective endocarditis or degeneration of the reconstructed valve (most commonly due to aortic valve regurgitation, rather than stenosis). CONCLUSIONS: Aortic valve neocuspidization is a versatile and standardized alternative to aortic valve replacement with a biological prosthesis. Early to midterm outcomes from a number of centers are excellent and demonstrate the safety and durability of the procedure. Long-term outcomes and clinical trial data are necessary to determine which patients benefit the most from this procedure.

Best Practices of Aortic Valve Replacement With the Edwards Intuity Elite Valve.

PURPOSE: The Edwards Intuity Elite (EIE; Edwards Lifesciences, Irvine, CA) valve system is a recent surgical aortic valve designed to expedite implantation, facilitate minimally invasive approaches, and provide low gradients, particularly in smaller valve sizes. The report reviews various best practices learned through experience with the EIE valve system. DESCRIPTION: With its sealing frame designed to anchor and seal the valve after resection of the diseased native aortic valve, EIE use differs from that of conventional sutured valves. EVALUATION: Critical technical aspects include patient selection, aortotomy and debridement, valve sizing, guiding suture technique and valve seating and deployment. In addition, special anatomic and pathologic conditions are considered, as well as intraoperative transesophageal echocardiography and postimplantation cardiac rhythm monitoring. CONCLUSIONS: These best practices simplify and standardize the use of the EIE valve system and may benefit surgeons adopting this valve.

Should All Low-risk Patients Now Be Considered for TAVR? Operative Risk, Clinical, and Anatomic Considerations.

PURPOSE OF REVIEW: This article reviews the current data on TAVR in low-risk patients with severe, symptomatic aortic stenosis, highlights the results of the recently published Medtronic Low Risk Randomized Study and PARTNER 3 trials, and describes specific clinical, anatomic, and procedural considerations regarding the optimal treatment choice in this population. RECENT FINDINGS: In low-risk patients, the Medtronic Low Risk Randomized Study demonstrated TAVR to be non-inferior to surgery with respect to the composite endpoint of death or disabling stroke while PARTNER 3 trial proved TAVR to be superior to surgery with regard to the composite endpoint of death, stroke, or rehospitalization. Recent trials demonstrate the safety and efficacy of TAVR in low-risk patients and have led to an FDA indication for the use of TAVR in these patients. However, the lack of long-term data on the rate of transcatheter valve deterioration in the younger population, higher incidence of paravalvular leak and pacemaker implantation following TAVR, along with certain intrinsic anatomic factors remain potential challenges to generalize TAVR in all low surgical risk patients. We describe specific clinical, anatomic, and procedural considerations regarding the optimal treatment choice for low-risk patients with severe, symptomatic AS.

Preventing Respiratory Failure After Cardiac Surgery Using Post-extubation Bilevel Positive Airway Pressure Therapy.

OBJECTIVE: Our study aimed to evaluate if an extubation protocol for all post-operative cardiac patients in the cardiothoracic intensive care unit using intermittent bilevel positive airway pressure (BiPAP) could reduce the rate of re-intubation. METHODS: A total of 1,718 patients undergoing cardiac surgery from May 2012 to April 2016 were analyzed. Patients from May 2014 to April 2016 were included in a post-extubation BiPAP therapy protocol that included one hour of BiPAP followed by three hours of a nasal cannula for 24 hours after extubation in the cardiothoracic intensive care unit. The protocol cohort was retrospectively compared to a control group (nasal cannula only) from May 2012 to April 2014. All demographic and outcome data were analyzed from our institution's Society of Thoracic Surgeons (STS) Cardiac Database. RESULTS: There was no statistical difference in the rate of re-intubation between the BiPAP group (n = 35; 4.07%) and the control group (n = 34; 3.96%; p = 0.9022). Sub-group analysis of the 69 re-intubated patients identified several significant risk factors: prior valve surgery (p = 0.028), chronic lung disease (p = 0.0343), emergent operation (p = 0.0016), longer operating room time (p = 0.0109), cardiopulmonary bypass time (p = 0.0086), higher STS predicted risk of mortality score (p = 0.0015). Re-intubation was associated with higher 30-day mortality rates (p = 0.0026), prolonged cardiothoracic intensive care unit length of stay (p < 0.0001), and hospital length of stay (p < 0.0001). CONCLUSION: While a BiPAP protocol did not show a significant difference in re-intubation rates after cardiac surgery, the subgroup analysis of re-intubated patients showed several significant risk factors for re-intubation. Early identification of these risk factors when considering extubation may help teams avoid associated morbidity and mortality outcomes.

Permanent Pacemaker Implantation After Rapid Deployment Aortic Valve Replacement.

BACKGROUND: Expandable, rapid deployment aortic valves may interfere with the cardiac conduction system, which can lead to permanent pacemaker implantation (PPI). We sought to characterize PPI after rapid deployment aortic valve replacement with the Edwards Intuity valve system (Edwards Lifesciences, Irvine, CA) and investigate associated factors. METHODS: We analyzed 708 patients from 29 centers in the Multicenter Experience With Rapid Deployment Edwards Intuity Valve System for Aortic Valve Replacement (TRANSFORM) trial undergoing rapid deployment aortic valve replacement with or without coronary artery bypass graft surgery without preexisting pacemakers. Intrinsic conduction status was recorded as well as PPI incidence through 1 year. The PPI indications were categorized based on expert review of patient PPI source documents. Multivariate analysis was conducted to identify characteristics associated with PPI. RESULTS: After rapid deployment aortic valve replacement, the PPI incidence through 30 days (PPI30) was 13.6%, with 10.9% due to atrioventricular block. In the 423 of 708 patients (59.7%) without any baseline conduction abnormalities, all-cause PPI30 was 8%, 5% for atrioventricular block. For PPIs inserted before discharge, the median time to PPI was 5 days, with 22% placed within 48 hours. Independent predictors of PPI30 were baseline right bundle branch block (odds ratio 7.35, p < 0.0001), female gender (2.62, p = 0.004), larger valve size (1.20, p = 0.016), and atrioventricular block (1.80, p = 0.062). Subset analysis revealed a greater than twofold difference in PPI30 among the largest enrolling centers. CONCLUSIONS: Patient factors associated with PPI after rapid deployment aortic valve replacement were right bundle branch block, atrioventricular block, female gender, and larger valve size. Interestingly, a strong center-level effect was associated with PPI. This effect may reflect differences in practice patterns, such as postoperative drug management or timing to PPI. These findings provide a deeper understanding of PPI after rapid deployment aortic valve replacement and help guide clinical practice and patient management.

Step-by-Step Aortic Valve Replacement With a New Rapid Deployment Valve.

PURPOSE: Rapid deployment/sutureless aortic valve replacement is aimed at minimizing the invasiveness of surgical aortic valve replacement. We describe the implantation techniques of a new rapid deployment aortic valve, focusing on its unique and challenging features. DESCRIPTION: The EDWARDS INTUITY Elite aortic valve (Edwards Lifesciences, Irvine, CA) represents a hybrid between the surgical PERIMOUNT Magna Ease (Edwards Lifesciences) pericardial valve, but with advanced features of the percutaneous SAPIEN valve system (Edwards Lifesciences). A flexible delivery system, with a balloon-expandable subannular frame, facilitates insertion. Important implantation steps include an extended oblique "hockey-stick" aortotomy, symmetrical annular debridement, intra-annular and supra-annular sizing, guiding suture placement, and balloon expansion of the subannular valve frame. EVALUATION: Although this valve provides advantages over conventional aortic valves, its implantation is unique, and special operative considerations must be heeded for optimal outcomes. Implantation requires minimal suturing, enabling smaller incisions. Also, the intra-annular inflow frame may promote improved hemodynamics. CONCLUSIONS: The INTUITY Elite system represents a significant innovation in bioprosthesis technology. It has been shown to be safe and effective, but its implantation requires detailed attention to several unique operative steps.

The COMMENCE trial: 2-year outcomes with an aortic bioprosthesis with RESILIA tissue.

OBJECTIVES: The COMMENCE trial was conducted to evaluate the safety and effectiveness of a novel bioprosthetic tissue for surgical aortic valve replacement (AVR). METHODS: Patients underwent clinically indicated surgical AVR with the Carpentier-Edwards PERIMOUNT™ Magna Ease™ aortic valve with RESILIA™ tissue (Model 11000A) in a prospective, multinational, multicentre (n = 27), single-arm, FDA Investigational Device Exemption trial. Events were adjudicated by an independent Clinical Events Committee; echocardiograms were analysed by an independent Core Laboratory. RESULTS: Between January 2013 and February 2016, 689 patients received the study valve. Mean age was 67.0 ± 11.6 years; 71.8% were male; 26.3% were New York Heart Association Class III/IV. Mean STS PROM was 2.0 ± 1.8 (0.3-17.5). Isolated AVR was performed in 59.1% of patients; others had additional concomitant procedures, usually CABG. Thirty-day outcomes for all patients included all-cause mortality 1.2%, thromboembolism 2.2%, bleeding 0.9%, major paravalvular leak 0.1% and permanent pacemaker implantation 4.7%. Median intensive care unit and hospital length of stay were 2 (range: 0.2-66) and 7 days (3.0-121.0), respectively. At 2 years, New York Heart Association class improved in 65.7%, effective orifice area was 1.6 ± 0.5 cm2; mean gradient was 10.1 ± 4.3 mmHg; and paravalvular leak was none/trivial in 94.5%, mild in 4.9%, moderate in 0.5% and severe in 0.0%. One-year actuarial freedom from all-cause mortality for isolated AVR and for all patients was 98.2% and 97.6%, respectively. Two-year actuarial freedom from mortality in these groups was 95.3% and 94.3%, respectively. CONCLUSIONS: These data demonstrate excellent early safety and effectiveness of aortic valve replacement with a novel bioprosthetic tissue (RESILIA™). CLINICAL TRIAL REGISTRATION: clinicaltrials.gov: NCT01757665.

TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) US clinical trial: Performance of a rapid deployment aortic valve.

BACKGROUND: The TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) trial (NCT01700439) evaluated the performance of the INTUITY rapid deployment aortic valve replacement (RDAVR) system in patients with severe aortic stenosis. METHODS: TRANSFORM was a prospective, nonrandomized, multicenter (n = 29), single-arm trial. INTUITY is comprised of a cloth-covered balloon-expandable frame attached to a Carpentier-Edwards PERIMOUNT Magna Ease aortic valve. Primary and effectiveness endpoints were evaluated at 1 year. RESULTS: Between 2012 and 2015, 839 patients underwent RDAVR. Mean age was 73.5 ± 8.3 years. Full sternotomy (FS) was used in 59% and minimally invasive surgical incisions in 41%. Technical success rate was 95%. For isolated RDAVR, mean crossclamp and cardiopulmonary bypass times for FS were 49.3 ± 26.9 minutes and 69.2 ± 34.7 minutes, respectively, and for minimally invasive surgical 63.1 ± 25.4 minutes and 84.6 ± 33.5 minutes, respectively. These times were favorable compared with Society of Thoracic Surgeons database comparators for FS: 76.3 minutes and 104.2 minutes, respectively, and for minimally invasive surgical, 82.9 minutes and 111.4 minutes, respectively (P < .001). At 30 days, all-cause mortality was 0.8%; valve explant, 0.1%; thromboembolism, 3.5%; and major bleeding, 1.3%. In patients with isolated aortic valve replacement, the rate of permanent pacemaker implantation was 11.9%. At 1 year, mean effective orifice area was 1.7 cm2; mean gradient, 10.3 mm Hg; and moderate and severe paravalvular leak, 1.2% and 0.4%, respectively. CONCLUSIONS: INTUITY RDAVR performed effectively in this North American trial. It may lead to a relative reduction in aortic crossclamp time and cardiopulmonary bypass time and has excellent hemodynamic performance. Pacemaker implantation rate observed was somewhat greater than European trials and requires further investigation.

Health Status After Transcatheter or Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Increased Surgical Risk: Results From the CoreValve US Pivotal Trial.

OBJECTIVES: This study sought to compare the health status outcomes for patients treated with either self-expanding transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (AVR). BACKGROUND: In patients at increased surgical risk, TAVR with a self-expanding bioprosthesis is associated with improved 1-year survival compared with AVR. However, elderly patients may be just as concerned with quality-of-life improvement as with prolonged survival as a goal of treatment. METHODS: Between 2011 and 2012, 795 patients with severe aortic stenosis at increased surgical risk were randomized to TAVR or AVR in the CoreValve US Pivotal Trial. Health status was assessed at baseline, 1 month, 6 months, and 1 year using the Kansas City Cardiomyopathy Questionnaire, Medical Outcomes Study Short-Form 12 Questionnaire, and EuroQOL 5-dimension questionnaire; growth curve models were used to examine changes over time. RESULTS: Over the 1-year follow-up period, disease-specific and generic health status improved substantially for both treatment groups. At 1 month, there was a significant interaction between the benefit of TAVR over AVR and access site. Among surviving patients eligible for iliofemoral (IF) access, there was a clinically relevant early benefit with TAVR across all disease-specific and generic health status measures. Among the non-IF cohort, however, most health status measures were similar for TAVR and AVR, although there was a trend toward early benefit with TAVR on the Short-Form 12 Questionnaire's physical health scale. There were no consistent differences in health status between TAVR and AVR at the later time points. CONCLUSIONS: Health status improved substantially in surviving patients with increased surgical risk who were treated with either self-expanding TAVR or AVR. TAVR via the IF route was associated with better early health status compared with AVR, but there was no early health status benefit with non-IF TAVR compared with AVR. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).

Minimally invasive surgery using bipolar radiofrequency energy is effective treatment for refractory atrial fibrillation.

BACKGROUND: A web-based registry was used to prospectively study patients after minimally invasive surgery with monitoring to determine freedom from atrial fibrillation (AF) (clinicaltrials.gov/ct2/show/NCT00747838). This is a report showing the utility and feasibility of the registry. METHODS: All patients had symptomatic AF refractory to medical treatment. Surgical ablation was performed using bipolar radiofrequency (RF) energy with a clamp around pulmonary veins and additional RF was delivered to ablate ganglionic plexi and create linear lesions. After a 3-month blanking period, prolonged electrocardiogram monitoring was done at 6 months, 1 year, and 2 years. Success was defined as no episodes of AF and atrial tachyarrhythmias greater than 30 seconds by monitoring. RESULTS: A total of 118 patients were studied from 4 institutions from June 2006 to February 2011. Seventy-two patients were male (61%). The mean age was 64±9 years. CHADS2 (Congestive heart failure, Hypertension, age greater than 75, Diabetes and Stroke score for risk of thromboembolic events in patients with atrial fibrillation) was 1.3. Warfarin was used in 92 (78%), antiarrhythmic medications in 108 (92%), and 35 (30%) had previous catheter ablation. Paroxysmal AF was present in 80 (68%), persistent AF present in 35 (30%), and long-standing persistent present in 3 (2%). The mean left atrial size was 4.4 cm. The surgical approach was bilateral minithoracotomy in 69 (58%) and totally thoracoscopic in 49 (42%). The left atrial appendage was excluded or excised in 112 (95%) patients. There were no deaths related to the procedure. Only 5 (4%) patients required ventilation greater than 24 hours; permanent pacemaker was needed in 3 (2%) patients. Mean length of hospital stay was 5 days. At a mean follow-up of 16.5 months, 80% of patients were free of AF off antiarrhythmic medications with long-term monitoring. Quality of life data showed significant improvement at 6 and 12 months. CONCLUSIONS: The STAR (stable angina in practice) registry is an effective web-based tool for long-term follow-up of patients after surgery for AF. Minimally invasive surgery with lesions created by bipolar RF energy is an effective treatment for AF in carefully selected patients.

Does use of a right internal thoracic artery increase deep wound infection and risk after previous use of a left internal thoracic artery?

OBJECTIVE: To determine whether adding right internal thoracic artery to previous left internal thoracic artery bypass at reoperation increases deep sternal wound infection and hospital mortality, particularly in diabetic patients. METHODS: Reoperations (n = 2875; 2381 men) in patients with previous left internal thoracic artery bypass were performed between January 1990 and January 2003; 1939 (67%) had no repeat internal thoracic artery grafting, 923 (32%) received an additional right internal thoracic artery graft, and 13 (0.5%) had bilateral internal thoracic artery grafting with reuse of the left internal thoracic artery. Of the patients, 352 (12%) were insulin-treated and 590 (21%) non-insulin-treated diabetics. Multivariable logistic regression analysis was used to identify preoperative variables associated with right versus non-right internal thoracic artery use in diabetics and nondiabetics and to formulate propensity models. Propensity scores were used for matching and adjusted multivariable analyses of deep wound infection and hospital mortality. RESULTS: Deep wound infection occurred in 3.0% (7/230) of diabetics receiving right internal thoracic artery grafts, 2.2% (5/230) of propensity-matched diabetics receiving non-right internal thoracic artery grafts (P = .6), in 1.1% (6/538) of nondiabetics receiving right internal thoracic artery grafts, and in 1.0% (5/538) of matched non-diabetic patients receiving non-right internal thoracic artery grafts (P = .8). Corresponding hospital mortality in these matched groups was 1.7% (4/230) versus 6.1% (14/230) for diabetics (P = .02) and 2.6% (14/538) versus 3.5% (19/538) for nondiabetics (P = .4). Risk factors for deep wound infection included higher weight (P = .0003), higher New York Heart Association functional class (P = .03), and less severe left anterior descending disease (P = .03). Risk factors for death were (P < .02) emergency operation, mitral valve replacement, and greater number of saphenous vein grafts. CONCLUSIONS: Use of the right internal thoracic artery for reoperations does not increase the risk of deep wound infections in diabetics or nondiabetics and does not increase mortality.