Francis G. Duhay

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.

Five-year clinical and economic outcomes among patients with medically managed severe aortic stenosis: results from a Medicare claims analysis.

Background—Patients with severe, symptomatic aortic stenosis, who do not undergo valve replacement surgery have a poor long-term prognosis. Limited data exist on the medical resource utilization and costs during the final stages of the disease. Methods and Results—We used data from the 2003 Medicare 5% standard analytic files to identify patients with aortic stenosis and a recent hospitalization for heart failure, who did not undergo valve replacement surgery within the ensuing 2 calendar quarters. These patients (n=2150) were considered to have medically managed severe aortic stenosis and were tracked over 5 years to measure clinical outcomes, medical resource use, and costs (from the perspective of the Medicare Program). The mean age of the cohort was 82 years, 64% were female, and the estimated logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) (a measure of predicted mortality with cardiac surgery) was 17%. During 5 years of follow-up, overall mortality was 88.4% with a mean survival duration of 1.8 years. During this time period, patients experienced an average of 4.4 hospital admissions, 52% were admitted to skilled nursing care, and 28% were admitted to hospice care. The total 5-year costs were

Three-year hemodynamic performance, left ventricular mass regression, and prosthetic-patient mismatch after rapid deployment aortic valve replacement in 287 patients

63 844 per patient, whereas mean annual follow-up costs (excluding the index quarter) per year alive were

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

29 278. Conclusions—Elderly patients with severe aortic stenosis undergoing medical management have limited long-term survival and incur substantial costs to the Medicare Program. These results have important implications for policy makers interested in better understanding the cost-effectiveness of emerging treatment options such as transcatheter aortic valve replacement.

Clinical and economic outcomes after surgical aortic valve replacement in Medicare patients

OBJECTIVE Superior aortic valve hemodynamic performance can accelerate left ventricular mass regression and enhance survival and functional status after surgical aortic valve replacement. This can be achieved by rapid deployment aortic valve replacement using a subannular balloon-expandable stent frame, which functionally widens and reshapes the left ventricular outflow tract, to ensure a larger effective orifice area compared with conventional surgical valves. We report the intermediate-term follow-up data from a large series of patients enrolled in the Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve (TRITON) trial. METHODS In a prospective, multicenter (6 European hospitals), single-arm study, 287 patients with aortic stenosis underwent rapid deployment aortic valve replacement using a stented trileaflet bovine pericardial bioprosthesis. Core laboratory echocardiography was performed at baseline, discharge, and 3 months, 1 year, and 3 years after rapid deployment aortic valve replacement. RESULTS The mean patient age was 75.7 ± 6.7 years (range, 45-93; 49.1% women). The mean aortic valve gradient significantly decreased from discharge to 3 years of follow-up. The mean effective orifice area remained stable from discharge to 3 years. At 1 year, the left ventricular mass index had decreased by 14% (P < .0001) and at 3 years by 16% (P < .0001) compared with at discharge. The prevalence of severe patient-prosthesis mismatch was 3% at discharge and remained stable during the follow-up period. CONCLUSIONS In a large series of elderly patients with symptomatic severe aortic stenosis, rapid deployment aortic valve replacement using a subannular balloon-expandable stent frame demonstrated excellent hemodynamic performance and significant left ventricular mass regression. With continued follow-up, future studies will establish whether these favorable structural changes correlate with improvement in long-term survival and functional status.

FIVE-YEAR CLINICAL AND ECONOMIC OUTCOMES IN PATIENTS WITH MEDICALLY MANAGED SEVERE AORTIC STENOSIS: RESULTS FROM A MEDICARE CLAIMS ANALYSIS

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.

System and Method for Locating Medical Devices in Vivo Using Ultrasound Doppler Mode

Background: Aortic valve replacement (AVR) is the standard of care for patients with severe, symptomatic aortic stenosis who are suitable surgical candidates, benefiting both non-high-risk and high-risk patients. The purpose of this study was to report long-term medical resource use and costs for patients following AVR and validate our assumption that high-risk patients have worse outcomes and are more costly than non-high-risk patients in this population. Methods: Patients with aortic stenosis who underwent AVR were identified in the 2003 Medicare 5% Standard Analytic Files and tracked over 5 years to measure clinical outcomes, medical resource use, and costs. An approximation to the logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) based on administrative data was used to assess surgical risk, with a computed logistic EuroSCORE > 20% considered high-risk. Results: We identified 1474 patients with aortic stenosis who underwent AVR, of whom 1222 (82.9%) were non-high-risk and 252 (17.1%) were high-risk. Among those who were non-high-risk, the mean age was 73.3 years, 464 (38.2%) were women, and the mean logistic EuroSCORE was 7%, whereas in those who were high-risk, the mean age was 77.6 years, 134 (52.8%) were women, and the mean logistic EuroSCORE was 37%. All-cause mortality was 33.2% for non-high-risk and 66.7% for high-risk patients at 5 years. Over this time period, non-high-risk patients experienced an average of 3.9 inpatient hospitalizations and total costs of

Haemodynamic benefits of rapid deployment aortic valve replacement via a minimally invasive approach: 1-year results of a prospective multicentre randomized controlled trial

106,277 per patient versus 4.7 hospitalizations and total costs of

Early outcomes after isolated aortic valve replacement with rapid deployment aortic valve

144,183 for high-risk patients. Conclusion: Among elderly patients undergoing AVR, long-term mortality and costs are substantially greater for high-risk than for non-high-risk individuals. These findings indicate that further research is needed to understand whether newer approaches to aortic valve replacement such as transcatheter AVR may be a lower cost, clinically valuable alternative.

Intracardiac sheath stabilizer

BACKGROUND Patients with severe, symptomatic aortic stenosis, who do not undergo valve replacement surgery have a poor long-term prognosis. Limited data exist on the medical resource utilization and costs during the final stages of the disease. METHODS AND RESULTS We used data from the 2003 Medicare 5% standard analytic files to identify patients with aortic stenosis and a recent hospitalization for heart failure, who did not undergo valve replacement surgery within the ensuing 2 calendar quarters. These patients (n=2150) were considered to have medically managed severe aortic stenosis and were tracked over 5 years to measure clinical outcomes, medical resource use, and costs (from the perspective of the Medicare Program). The mean age of the cohort was 82 years, 64% were female, and the estimated logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) (a measure of predicted mortality with cardiac surgery) was 17%. During 5 years of follow-up, overall mortality was 88.4% with a mean survival duration of 1.8 years. During this time period, patients experienced an average of 4.4 hospital admissions, 52% were admitted to skilled nursing care, and 28% were admitted to hospice care. The total 5-year costs were