Minimally invasive epicardial surgical left atrial appendage exclusion for atrial fibrillation patients at high risk for stroke and for bleeding.

BACKGROUND: Atrial fibrillation (AF) patients at high risk for stroke and for bleeding may be unsuitable for either oral anticoagulation or endocardial left atrial appendage (LAA) occlusion. However, minimally invasive, epicardial left atrial appendage exclusion (LAAE) may be an option. OBJECTIVE: The purpose of this study was to evaluate outcomes of LAAE in high-risk AF patients not receiving oral anticoagulation. METHODS: A retrospective analysis of Medicare claims data was conducted to evaluate thromboembolic events in AF patients who underwent LAAE compared to a 1:4 propensity score-matched group of patients who did not receive LAAE (control). Neither group was receiving any oral anticoagulation at baseline or follow-up. Fine-Gray models estimated hazard ratios and evaluated between-group differences. Bootstrapping was applied to generate 95% confidence intervals (CIs). RESULTS: The LAAE group (n = 243) was 61% male (mean age 75 years). AF was nonparoxysmal in 70% (mean CHA2DS2-VASc score 5.4; mean HAS-BLED score 4.2). The matched control group (n = 972) had statistically similar characteristics. One-year adjusted estimates of thromboembolic events were 7.3% (95% CI 4.3%-11.1%) in the LAAE group and 12.1% (95% CI 9.5%-14.8%) in the control group. Absolute risk reduction was 4.8% (95% CI 0.6%-8.9%; P = .028). Adjusted hazard ratio for thromboembolic events for LAAE vs non-LAAE was 0.672 (95% CI 0.394-1.146). CONCLUSION: In AF patients not taking oral anticoagulation who are at high risk for stroke and for bleeding, minimally invasive, thoracoscopic, epicardial LAAE was associated with a lower rate of thromboembolic events.

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.

Myocardial Protection and Financial Considerations of Custodiol Cardioplegia in Minimally Invasive and Open Valve Surgery.

OBJECTIVE: Single-dose antegrade crystalloid cardioplegia with Custodiol-HTK (histidine-tryptophan-ketoglutarate) has been used for many years. Its safety and efficacy were established in experimental and clinical studies. It is beneficial in complex valve surgery because it provides a long period of myocardial protection with a single dose. Thus, valve procedures (minimally invasive or open) can be performed with limited interruption. The aim of this study is to compare the use of Custodiol-HTK cardioplegia with traditional blood cardioplegia in patients undergoing minimally invasive and open valve surgery. METHODS: A single-institution, retrospective case-control review was performed on patients who underwent valve surgery in Lee Memorial Health System at either HealthPark Medical Center or Gulf Coast Medical Center from July 1, 2011, through March 7, 2015. A total of 181 valve cases (aortic or mitral) performed using Custodiol-HTK cardioplegia were compared with 181 cases performed with traditional blood cardioplegia. Each group had an equal distribution of minimally invasive and open valve cases. Right chest thoracotomy or partial sternotomy was performed on minimally invasive valve cases. Demographics, perioperative data, clinical outcomes, and financial data were collected and analyzed. RESULTS: Patient outcomes were superior in the Custodiol-HTK cardioplegia group for blood transfusion, stroke, and hospital readmission within 30 days (P < 0.05). No statistical differences were observed in the other outcomes categories. Hospital charges were reduced on average by $3013 per patient when using Custodiol-HTK cardioplegia. CONCLUSIONS: Use of Custodiol-HTK cardioplegia is safe and cost-effective when compared with traditional repetitive blood cardioplegia in patients undergoing minimally invasive and open valve surgery.

Differences in mitral valve disease presentation and surgical treatment outcome between Hispanic and non-Hispanic patients.

OBJECTIVES: This study analyzed the differences in clinical presentation, etiology, and hospital outcome between Hispanic and non-Hispanic patients who underwent surgical correction of mitral valve disease at a large urban medical center. DESIGN: All adult patients undergoing isolated mitral valve repair or replacement surgery at two hospitals between 1993 and 2003 were studied. Patients were grouped according to ethnicity as reported to the New York State Cardiac Surgery Reporting System. Preoperative variables compared included age, congestive heart failure (CHF), etiology, and pertinent medical and surgical histories, while perioperative variables included type of operation, mortality, and hospital complications. RESULTS: A total of 1683 patients (135 Hispanic,1548 non-Hispanic) underwent mitral valve surgery. Hispanic patients were younger (48.3+/-16.0 vs 59.7+/-15.9 years, P<.001) and had higher incidences of CHF (48.9% vs 35.3%, P=.002), endocarditis (8.9% vs 5.0%, P=.05), and rheumatic disease (12.6% vs 5.4%, P<.001). Non-Hispanic patients had a higher incidence of degenerative disease (68.0% vs 54.8%, P<.01). No differences in hospital mortality (Hispanic 5.9% vs 5.3%, P=.76) or perioperative complications were observed between the two groups, although Hispanic patients were less likely to undergo mitral valve repair than mitral valve replacement (35.6% vs 61.2%, P<.001). CONCLUSIONS: In the urban population studied, Hispanic patients presented for mitral valve surgery at a younger age and with a higher prevalence of CHF and rheumatic disease. Public health strategies to prevent rheumatic fever among Hispanics are needed, and improved screening might facilitate earlier referral for Hispanic patients, increasing the potential for benefitting from mitral valve repair.

Mitral valve disease presentation and surgical outcome in African-American patients compared with white patients.

BACKGROUND: Disparities associated with race, particularly African-American race, in access to medical and surgical care for patients with cardiac disease have previously been documented. The purpose of this study was to determine the presentation, etiology, and hospital outcome differences between African-American patients and white patients with regard to surgically corrected mitral valve disease. METHODS: All 1,425 adult patients who underwent first time, isolated mitral valvuloplasty or mitral valve replacement by the same group of surgeons at New York University Medical Center and Bellevue Hospital Center between 1993 and 2003 were studied. RESULTS: African Americans (n = 123, 8.6%) were significantly younger (45.6 +/- 14.4 versus 60.5 +/- 15.3 years) and had significantly higher incidences of diabetes mellitus, renal failure, congestive heart failure, endocarditis, and rheumatic mitral disease; whereas whites (n = 1,302, 91.4%) more commonly had degenerative mitral disease. African Americans were less likely to undergo mitral valvuloplasty. There were no significant differences in the incidences of postoperative complications or hospital mortality (2.4% African American versus 5.1% white, p = 0.19). CONCLUSIONS: African Americans present for mitral valve surgery at a significantly younger age than whites and with higher incidences of many risk factors. Whether presentation at a significantly earlier age in African Americans is a result of failures in primary care or an enhanced susceptibility to the process of mitral disease and comorbidities remains to be determined. African Americans were less likely to undergo mitral valvuloplasty, which may have an effect on long-term outcome. Improved screening in this racial group will facilitate earlier referral, increasing the potential for mitral valvuloplasty.

Impact of moderate functional mitral insufficiency in patients undergoing surgical revascularization.

BACKGROUND: Mild and moderate functional ischemic mitral insufficiency present at the time of surgical revascularization present clinical uncertainty. It is unclear whether the relatively poor outcomes in this cohort are dependent on valvular function or related to left ventricular dysfunction. The purpose of this study was to examine the early and late outcomes in patients with less-than-severe functional ischemic mitral insufficiency at the time of isolated coronary artery bypass grafting (CABG). METHODS AND RESULTS: From 1996 through 2004, 2242 consecutive patients undergoing isolated CABG were identified as having none to moderate mitral regurgitation (MR) and no valve leaflet pathology. All of the patients at this single institution routinely had an intraoperative transesophageal echocardiography, prospectively quantified MR, and ejection fraction (EF). The New York State Cardiac Surgery Reporting System infrastructure was used to prospectively collect in-hospital patient variables and outcomes. Social Security Death Benefit Index was used to determine long-term survival. Odds ratio and significance (P value) are presented for each determined risk factor. There were 841 patients (37.5%) with no MR, 1137 (50.7%) with mild MR, and 264 (11.8%) with moderate MR. The patients with moderate MR were more likely to be older, female, and have more renal disease, previous MI, congestive heart failure, previous cardiac surgery, and lower EFs. Hospital mortality was independently and significantly associated with renal disease, decreasing EF, increasing age, previous cardiac operation, and cerebral vascular disease. Multivariable analysis revealed decreased survival with increasing age, previous operation, congestive heart failure, diabetes, nonelective operation, decreasing EF, and the presence of moderate MR (expbeta = 1.49; P=0.007) and mild MR (expbeta = 1.34; P=0.033). CONCLUSIONS: Independent of ventricular function, mild and moderate functional mitral insufficiency are associated with significantly decreased survival in patients undergoing CABG. Whether correction of moderate functional MR at the time of CABG improves outcome still needs to be determined.

Heart transplant and left ventricular assist device costs.

BACKGROUND: With the increasing clinical success of left ventricular assist devices (LVADs), physicians need to measure device cost efficacy to determine the societal value of this technology. Today's large clinical volume allows comparison of the costs of this innovation as compared with orthotopic heart transplant (OHT). METHODS: We evaluated hospital cost and reimbursement for patients who were discharged after LVAD implantation and returned to the hospital for OHT. To control for patient-specific variables, LVAD therapy and OHT therapy were compared in the same patient; that is, only those patients who received an LVAD were discharged, and returned for OHT were studied. Length of stay (LOS), re-admissions and outpatient services were analyzed, including their respective total actual hospital cost (TAHC) and net revenue (NR). Time periods analyzed were the same for LVAD and OHT. RESULTS: From the LVAD population at Columbia-Presbyterian Medical Center, 36 patients were discharged following HeartMate vented electric (VE) implantation and re-admitted for OHT between December 1996 and June 2000. Mean pre-LVAD implantation LOS was 21.3 +/- 24.1 days. Post-LVAD LOS was 36.8 +/- 22.2 days vs 18.2 +/- 12.2 days post-OHT (p < 0.001). Mean length of LVAD support was 123.4 +/- 77.7 days. Overall total costs for LVADs exceeded that of OHT, whereas revenue was relatively lower. TAHC post-LVAD averaged $197,957 +/- 77,291, whereas TAHC post-OHT averaged $151,646 +/-53,909 (p = 0.005). NR averaged $144,756 +/- 96,656 post-LVAD vs $178,562 +/- 68,571 post-OHT (p = 0.09). LVAD patients had more re-admissions compared with OHT: 1.2/123 days (+/- 1.7) vs 0.3/123 days (+/- 0.6), respectively (p = 0.005). The average LOS during a re-admission was similar between the 2 groups (LVAD 5.6 days [+/- 10.6] vs OHT 9.6 days [+/- 8.2]; p = 0.18). OHT was associated with a significantly greater number of outpatient services compared with LVAD (9.7 [+/- 6.1] vs 3.0 [+/- 4.7]; p < 0.001). In contrast to OHT, revenues did not match the costs of LVAD therapy. CONCLUSIONS: LVAD implantation is associated with longer LOS and higher cost for initial hospitalization compared with OHT. LVAD patients have higher re-admission rates compared with OHT but similar costs and LOS. OHT is associated with a greater number of outpatient services. Reimbursements for LVAD therapy are relatively low, resulting in significant lost revenue. If LVAD therapy is to become a viable alternative, improvements in both cost-effectiveness and reimbursement will be necessary.

In vitro characterization of aortic retrograde and antegrade flow from pulsatile and non-pulsatile ventricular assist devices.

BACKGROUND: Many advances have been made in left ventricular assist device (LVAD) development including the introduction of smaller, non-pulsatile pumps. However, controversy exists over the potential significance of non-pulsatile blood flow. In addition, some newer LVADs incorporate descending aortic anastomosis (and therefore retrograde ascending aortic flow) for outflow rather than the traditional ascending aortic anastomosis. This, combined with non-pulsatile flow, may significantly increase the risks of ascending aortic thrombus formation, especially if native cardiac function is negligible and the aortic valve remains closed. The purpose of this study was to compare pulsatile and non-pulsatile flow generated by LVADs with outflow to the ascending aorta and descending aorta. METHODS: An in vitro mock circulatory loop, driven by either a pulsatile or a non-pulsatile LVAD, was anastomosed to transparent aortic models at either the ascending or descending aortic position. The aortic valve was kept closed, modeling no native cardiac output. Normal saline was used as a blood analog. Methylene blue dye was injected into the ascending aorta and aortic arch to demonstrate flow patterns. Dye washout time (in seconds) was used as a marker of flow stagnation and potential thrombogenicity. LVAD flow, rate, after-load and coronary flow were measured. RESULTS: Dye washout times at a flow rate of 5 liters/min were 1.7 +/- 0.75, 2.1 +/- 0.71, 4.7 +/- 0.82 and 9.9 +/- 4.4 seconds for pulsatile ascending (PA), non-pulsatile ascending (NPA), pulsatile descending (PD) and non-pulsatile descending flow (NPD), respectively. Coronary flow averaged 294 ml/min over all set-ups. Dye washout times at a flow rate of 4-liters/min were 3.0 +/- 1.0, 3.0 +/- 0.8, 14.0 +/- 3.8 and 25.0 +/- 9.1 seconds for PA, NPA, PD and NPD, respectively. Coronary flow averaged 227 ml/min over all set-ups. Ascending aortic anastomoses were associated with shorter dye washout times compared with descending aortic anastomoses, regardless of flow type (p < 0.001). There was no difference in washout time between pulsatile and non-pulsatile flow in the ascending aortic position (p = 0.23 and 0.12 for 5 and 4 liters/min, respectively). Pulsatile flow in the descending aorta had shorter washout times than non-pulsatile flow in the descending aorta (p < 0.001 and p = 0.004 for 5 and 4 liters/min, respectively). CONCLUSIONS: LVAD descending aortic anastomosis and retrograde aortic flow is associated with increased flow stagnation in the ascending aorta. This may increase the risk for thrombus formation in patients relying solely on retrograde aortic flow, especially if cardiac function and antegrade blood flow returns.