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.

The Mortality Burden of Untreated Aortic Stenosis.

BACKGROUND: The American College of Cardiology/American Heart Association guidelines recommend the assessment and grading of severity of aortic stenosis (AS) as mild, moderate, or severe, per echocardiogram, and recommend aortic valve replacement (AVR) when the AS is severe. OBJECTIVES: The authors sought to describe mortality rates across the entire spectrum of untreated AS from a contemporary, large, real-world database. METHODS: We analyzed a deidentified real-world data set including 1,669,536 echocardiographic reports (1,085,850 patients) from 24 U.S. hospitals (egnite Database, egnite). Patients >18 years of age were classified by diagnosed AS severity. Untreated mortality and treatment rates were examined with Kaplan-Meier (KM) estimates, with results compared using the log-rank test. Multivariate hazards analysis was performed to assess associations with all-cause mortality. RESULTS: Among 595,120 patients with available AS severity assessment, the KM-estimated 4-year unadjusted, untreated, all-cause mortality associated with AS diagnosis of none, mild, mild-to-moderate, moderate, moderate-to-severe, or severe was 13.5% (95% CI: 13.3%-13.7%), 25.0% (95% CI: 23.8%-26.1%), 29.7% (95% CI: 26.8%-32.5%), 33.5% (95% CI: 31.0%-35.8%), 45.7% (95% CI: 37.4%-52.8%), and 44.9% (95% CI: 39.9%-49.6%), respectively. Results were similar when adjusted for informative censoring caused by treatment. KM-estimated 4-year observed treatment rates were 0.2% (95% CI: 0.2%-0.2%), 1.0% (95% CI: 0.7%-1.3%), 4.2% (95% CI: 2.0%-6.3%), 11.4% (95% CI: 9.5%-13.3%), 36.7% (95% CI: 31.8%-41.2%), and 60.7% (95% CI: 58.0%-63.3%), respectively. After adjustment, all degrees of AS severity were associated with increased mortality. CONCLUSIONS: Patients with AS have high mortality risk across all levels of untreated AS severity. Aortic valve replacement rates remain low for patients with severe AS, suggesting that more research is needed to understand barriers to diagnosis and appropriate approach and timing for aortic valve replacement.

A Reproducible and Effective Technique for Coronary Sinus Injury Repair.

Objective: Coronary sinus injury related to the use of a retrograde cardioplegia catheter is a rare but potentially life-threatening complication with mortality reported as high as 20%. We present a series of iatrogenic coronary sinus injuries as well as an effective method of repair without any ensuing mortality. Methods: There were 3,004 cases that utilized retrograde cardioplegia at our institution from 2007 to 2018. Of these, 15 patients suffered a coronary sinus injury, an incidence of 0.49%. A pericardial roof repair was performed in 14 cases in which autologous pericardium was sutured circumferentially to normal epicardium around the injury with purified bovine serum albumin and glutaraldehyde injected into the newly created space as a sealant. Incidence of perioperative morbidity and mortality, operative time, and length of stay were collected. Results: In our series, there were no intraoperative or perioperative mortalities. Procedure types included coronary artery bypass grafting (CABG), valve replacement and repair, or combined CABG and valve procedures. Median (interquartile range) cross-clamp time was 100 (88 to 131) minutes, cardiopulmonary bypass duration was 133 (114 to 176) minutes, and length of stay was 6 (4 to 8) days. None of the patients returned to the operating room for hemorrhage, and there were no complications associated with the repair of a coronary sinus injury when using the pericardial roof technique. Conclusions: Coronary sinus injuries can result in difficult to manage perioperative bleeding and potentially lethal consequences from cardiac manipulation. Our series supports the pericardial roof technique as an effective solution to a challenging intraoperative complication.

Three-year outcomes of the postapproval study of the AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation Trial.

OBJECTIVES: The Cox Maze IV operation is commonly performed concomitant with other cardiac operations and effectively reduces the burden of atrial fibrillation. Prospective randomized trials have reported outcomes early and at 12 months, but only single-center late durability results are available. As part of the postapproval process for a bipolar radiofrequency ablation system, we sought to determine early and midterm outcomes of patients undergoing the Cox Maze IV operation. METHODS: A prospective, multicenter, single-arm study of 363 patients (mean age, 70 years, 82% valve surgery) with nonparoxysmal atrial fibrillation (mean duration, 60 months, 94% Congestive heart failure, Hypertension, Age ≥ 75, Diabetes, Stroke, VAScular disease, Age 65-74, Sex category ≥2) undergoing concomitant Maze IV atrial fibrillation ablation at 40 sites with 70 surgeons was performed between June 2010 and October 2014. Compliance with the study lesion set was 94.5%, and 99% had left atrial appendage closure. Freedom from atrial fibrillation was determined by extended monitoring, with a 48-hour Holter monitor minimum. RESULTS: There were no device-related complications. Freedom from atrial fibrillation off antiarrhythmic medications at 1, 2, and 3 years was 66%, 65%, and 64%, respectively, and including those using antiarrhythmics was 80%, 78%, and 76%, respectively. Warfarin was used in 49%, 44%, and 40%, respectively. CONCLUSIONS: In patients with nonparoxysmal atrial fibrillation, compliance with the protocol was high, and freedom from atrial fibrillation off antiarrhythmics was high and sustained to 3 years. The safety and effectiveness of the system and Cox Maze IV procedure support the Class I guideline recommendation for concomitant atrial fibrillation ablation in patients undergoing cardiac surgery.

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.

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.

The economic value of rapid deployment aortic valve replacement via full sternotomy.

AIM: To compare the economic value of EDWARDS INTUITY Elite™ (EIE) valve system for rapid-deployment aortic valve replacement (RDAVR) in a full sternotomy (FS) approach (EIE-FS-RDAVR) versus FS-AVR using conventional stented bioprosthesis. DATA & METHODS: A simulation model to compare each treatment's 30-day inpatient utilization and complication rates utilized: clinical end points obtained from the TRANSFORM trial patient subset (EIE-FS-RDAVR) and a best evidence review of the published literature (FS-AVR); and costs from the Premier database and published literature. RESULTS: EIE-FS-RDAVR costs $800 less than FS-AVR per surgery episode attributable to lowered complication rates and utilization. Combined with the lower mortality, EIE-FS-RDAVR was a superior (dominant) technology versus FS-AVR. CONCLUSION: This preliminary investigation of EIE-FS-RDAVR versus conventional FS-AVR found the EIE valve offered superior economic value over a 30-day period. Real-world analyses with additional long-term follow-up are needed to evaluate if this result can be replicated over a longer timeframe.

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.

Current Clinical Evidence on Rapid Deployment Aortic Valve Replacement: Sutureless Aortic Bioprostheses.

Aortic stenosis is the most common valvular heart disease in the Western world. It is caused primarily by age-related degeneration and progressive calcification typically detected in patients 65 years and older. In patients presenting with symptoms of heart failure, the average survival rate is only 2 years without appropriate treatment. Approximately one half of all patients die within the first 2 to 3 years of symptom onset. In addition, the age of the patients presenting for aortic valve replacement (AVR) is increased along with the demographic changes. The Society of Thoracic Surgeons (STS) database shows that the number of patients older than 80 years has increased from 12% to 24% during the past 20 years. At the same time, the percentage of candidates requiring AVR as well as concomitant coronary bypass surgery has increased from 5% to 25%. Surgical AVR continues to be the criterion standard for treatment of aortic stenosis, improving survival and quality of life. Recent advances in prosthetic valve technology, such as transcatheter AVR, have expanded the indication for AVR to the extreme high-risk population, and the most recent surgical innovation, rapid deployment AVR, provides an additional tool to the surgeons' armamentarium.

The economic value of INTUITY in aortic valve replacement.

OBJECTIVE: The recent development of the EDWARDS INTUITY Elite™ (EIE) valve system enables the rapid deployment of a prosthetic surgical heart valve in an aortic valve replacement (AVR) procedure via both the minimally invasive (MISAVR) and conventional (CAVR) approaches. In order to understand its economic value, this study performed a cost evaluation of the EIE valve system used in a MIS rapid-deployment approach (MIS-RDAVR) vs MISAVR and CAVR, respectively, compared to standard prosthetic aortic valves. METHODS: A simulation model was developed using TreeAge (and validated with MS Excel) to compare the inpatient utilization and complication costs for each treatment arm. Thirty-day clinical end-points for the MIS-RDAVR (mortality and complications) were taken from the TRANSFORM trial; and a best evidence review of the published literature was used for the MISAVR and CAVR approaches. Studies were pooled and parameter estimates were weighted by sample size in order to compare the TRANSFORM patients. Cost data (2016 USD) were taken from the Premier database. Incremental cost and cost-effectiveness was assessed and one-way/probabilistic sensitivity analyses performed to gauge the robustness of the results. RESULTS: MIS-RDAVR costs $2,621 less than CAVR and had lower mortality rates, making it a superior (dominant) technology relative to CAVR. MIS-RDAVR costs $4,560 more than MISAVR, but was associated with an additional 0.20 life years-per-patient. This implies a cost-effectiveness ratio of $22,903 per-life-year-gained. Thus, MIS-RDAVR is cost-effective compared to MISAVR. CONCLUSIONS: The EIE valve system deployed in a MIS approach appears to be a cost-effective technology compared to MISAVR and CAVR. When compared to CAVR it may achieve cost savings as well. These results suggest that MIS-RDAVR confers superior economic value compared to both standard MISAVR and CAVR via lowered key complication rates (re-operation, renal complications, wound infection, TIA, endocarditis) and utilization (cross-clamp time, hospital ward days).

Minimally Invasive Mitral Valve Surgery III: Training and Robotic-Assisted Approaches.

Minimally invasive mitral valve operations are increasingly common in the United States, but robotic-assisted approaches have not been widely adopted for a variety of reasons. This expert opinion reviews the state of the art and defines best practices, training, and techniques for developing a successful robotics program.

Minimally Invasive Mitral Valve Surgery I: Patient Selection, Evaluation, and Planning.

Widespread adoption of minimally invasive mitral valve repair and replacement may be fostered by practice consensus and standardization. This expert opinion, first of a 3-part series, outlines current best practices in patient evaluation and selection for minimally invasive mitral valve procedures, and discusses preoperative planning for cannulation and myocardial protection.

Minimally Invasive Mitral Valve Surgery II: Surgical Technique and Postoperative Management.

Techniques for minimally invasive mitral valve repair and replacement continue to evolve. This expert opinion, the second of a 3-part series, outlines current best practices for nonrobotic, minimally invasive mitral valve procedures, and for postoperative care after minimally invasive mitral valve surgery.

The role of computed tomography angiography in patients undergoing evaluation for minimally invasive cardiac surgery: an early program experience.

OBJECTIVE: An increasing number of patients are undergoing surgical procedures using minimally invasive cardiac surgery (MICS). These techniques use conventional or retrograde arterial perfusion with direct aortic cross-clamping or endoballoon occlusion. Precise knowledge of the arterial tree is required to avoid complications and to plan for the operation. We examined the role of computed tomography angiography (CTA) in evaluating patients for MICS. METHODS: We reviewed all consecutive candidates undergoing CTA during preoperative evaluation for MICS aortic, mitral, tricuspid, Maze, atrial septal defect, or myxoma procedures between February 2008 and May 2010. The CTA findings of patients excluded from MICS were compared against those successfully undergoing MICS. RESULTS: One hundred eleven MICS candidates underwent preoperative CTA. Thirty-five (32%) had single or multiple CTA findings precluding MICS and underwent sternotomy. Seventy-six (68%) had favorable CTA findings and underwent MICS. The MICS group had a mean age of 62 years, with 29 women (39%); the non-MICS group had a mean age of 68 years, with 17 women (48%). Of the patients excluded from MICS, two (6%) had diminished or absent lower extremity pulses. All MICS patients (except for aortic) had successful use of the endoballoon. There were no perfusion or peripheral vascular complications. There was one stroke, one lymphocele, and one death (chronic obstructive pulmonary disease exacerbation). CONCLUSIONS: Computed tomography angiography is of fundamental importance in evaluating patients for MICS. It can identify calcified regions that make for threatening catheter passage with subsequent retrograde arterial perfusion. Abnormalities of the arterial tree are identified. The use of CTA-guided patient selection can thus avoid major perioperative complications.

Current era minimally invasive aortic valve replacement: techniques and practice.

BACKGROUND: Since the first aortic valve replacement through a right thoracotomy was reported in 1993, upper hemisternotomy and right anterior thoracotomy have become the predominant approaches for minimally invasive aortic valve replacement. Clinical studies have documented equivalent operative mortality, less bleeding, and reduced intensive care/hospital stay compared with conventional sternotomy despite longer procedure times. However, comparative trials face challenges due to patient preference, surgeon bias, and the lack of a standardized minimally invasive surgical approach. METHODS: Twenty cardiothoracic surgeons from 19 institutions across the United States, with a combined experience of nearly 5000 minimally invasive aortic valve replacement operations, formed a working group to develop a basis for a standardized approach to patient evaluation, operative technique, and postoperative care. In addition, a stepwise learning program for surgeons was outlined. RESULTS: Improved cosmesis, less pain and narcotic use, and faster recovery have been reported and generally accepted by patients and by surgeons performing minimally invasive aortic valve replacement. These benefits are more likely to be verified with standardization of the procedure itself, which will greatly facilitate the design and implementation of future clinical studies. CONCLUSIONS: Surgeons interested in learning and performing minimally invasive aortic valve replacement must have expertise in conventional aortic valve replacement at centers with adequate case volumes. A team approach that coordinates efforts of the surgeon, anesthesiologist, perfusionist, and nurses is required to achieve the best clinical outcomes. By first developing fundamental minimally invasive skills using specialized cannulation techniques, neck lines, and long-shafted instruments in the setting of conventional full sternotomy, the safest operative environment is afforded to patients.