Urgent robotic hybrid coronary revascularization in patient with high STS score. A case report.

INTRODUCTION: Robotic-assisted coronary artery bypass grafting (CABG) outcomes in patients with a high society of thoracic surgery (STS) score in urgent settings remain hindered. PRESENTATION OF CASE: A high-risk female patient presented with dyspnea and low ejection fraction (EF = 15%) and was diagnosed with pulmonary edema post myocardial infarction. She was medically stabilized with intraaortic balloon pump and the heart-team decided to intervene with off-pump robotic hybrid coronary revascularization (HCR). The patient had the planned with left internal mammary artery (LITA) anastomosis to the left anterior descending artery (LAD) and the postoperative recovery was uneventful and patients discharged after few days at home. DISCUSSION: CABG has proven to be superior to percutaneous coronary intervention (PCI) even when guided by fractional flow rate and using the last generation stents according to fractional flow reserve versus angiography for multivessel evaluation 3 clinical trial. In moderate SYNTAX score patients that have been historically (SYNTAX trial) treated with multivessels PCI, robotic CABG has been shown to offer the advantage of LITA-LAD in combination with stent for non-LAD territory. CONCLUSION: High-risk, fragile patients, with low EF and high STS score that undergo urgent CABG can benefit from heart-team collaboration, and HCR is an important tool in the armamentarium.

Comparison of minimally invasive versus conventional thoracic aortic operations: Early and midterm results in a series of 624 patients.

OBJECTIVE: Despite minimally invasive techniques having gained wider application in cardiac surgery, current evidence on minithoracic aortic surgery is still limited. The aim of this study was to compare early and midterm outcomes of patients undergoing operations of the proximal thoracic aorta through ministernotomy (MS) versus full sternotomy (FS). METHODS: Data from 624 consecutive patients who underwent proximal aortic repair through MS (n = 214, 34.3%) and FS (n = 410, 65.7%) at two aortic centers were analyzed. Treatment selection bias was addressed using propensity score matching (MS vs. FS). After matching, two well-balanced groups of 202 patients each were created. RESULTS: Median cardiopulmonary bypass and cross-clamp times were 88 and 68 min, respectively, with no difference between groups. Overall, 30-day mortality was 1% (n = 2) in MS and 0.5% (n = 1) in FS (p = .6). No difference was found in the rates of stroke (MS n = 5, 2.5%; FS n = 5, 2.5%), dialysis (MS n = 1, 0.5%; FS n = 4, 2%), bleeding (MS n = 7, 3.5%; FS n = 7, 3.5%), and blood transfusions (MS n = 67, 33.3%; FS n = 57, 28.4%). Patients receiving MS showed a lower incidence of respiratory insufficiency compared with FS (0% vs. 2.5%, p = .04). Intensive care unit and hospital stays were similar between groups. Two-year survival rate was 97.2% in MS and 96.5% in FS (p = .9). CONCLUSIONS: Mini proximal aortic operations can be performed successfully without compromising the proven efficacy and safety of conventional access. In selected patients, MS was associated with very low mortality and morbidity rates. Additionally, MS demonstrated superior clinical outcomes as regards respiratory adverse events, when compared with FS.

Pearls, pitfalls, and surgical indications of the Intuity TM heart valve: A rapid deployment bioprosthesis. A systematic review of the literature.

OBJECTIVES: To highlight short- and long-term clinical outcomes of the Intuity TM rapid deployment prosthesis for surgical aortic valve replacement. METHODS: We reviewed on PubMed/MEDLINE, Embase, SciELO, LILACS, CCTR/CENTRAL, and Google Scholar for clinical trials, retrospective clinical studies, meta-analysis, and gray literature. RESULTS: Fourty-five clinical studies with 12.714 patients were included in the analysis. Thirty-day mortality ranged from 3.8% for Intuity and 3.9% for transcatheter aortic valve replacement (TAVR). The incidence of paravalvular leak (PVL) (Intuity 0% and TAVR 2.17%), permanent pacemaker implantation (Intuity 11.11% and TAVR 12.5%), stroke (Intuity 2.2% and TAVR 2.6%), myocardial infarction (MI) (Intuity 0% and TAVR 1%), were all higher in the TAVR group. Compared to other sutured bioprosthesis (SB), mortality ranged from 0% to 3.9% for Intuity and 0%-6.9% for SB. Long-term cardiac mortality ranged from 0.9% to 1.55% for Intuity and 1.4%-3.3% for the Perceval valve. The incidence of PVL (Intuity 0.24%-0.7% and Perceval 0%-1%), endocarditis (Intuity 0.2%-0.7% and Perceval 1.6%-6.6%), stroke (Intuity 0.36%-1.4% and Perceval 0%-0.8%), MI (Intuity 0.07%-0.26%), and SVD (Intuity 0.12%-0.7% and Perceval 0%) were comparable. Compared to standard full sternotomy (SFS), minimally invasive surgery (MINV) mortality ranged from 0% to 4.3% for MINV and 0%-2.1% for SFS. Hospital costs outcomes ranged from $37,187-$44,368 for the Intuity, $69,389 for TAVR, and $13,543 for SB. Intuity short-term mortality ranged between 0.9% and 12.4% while long-term mortality ranged between 2.6% and 20%. CONCLUSIONS: This manuscript provides a 360° overview of the current rapid deployments, sutureless, and TAVR prosthesis.

Off-Pump Coronary Artery Bypass Reduces Cardiac Death in Patients with Peripheral Arteriopathy.

OBJECTIVE: The aim of this study was to investigate whether the use of off-pump coronary artery bypass (OPCAB) may enhance early outcomes in subjects with peripheral artery disease (PAD) undergoing coronary artery bypass grafting (CABG). METHODS: We employed a propensity-score (PS) method to compare early postoperative results of OPCAB and on-pump CABG patients with associated PAD. The study population consisted of 1,961 patients: 284 in the OPCAB and 1,677 in the on-pump CABG group. The inverse probability of treatment weighting was used as PS method. RESULTS: The incidence of death (1.2% [95% confidence interval, CI: -0.9 to 3.3%], p = 0.262), stroke (2.2% [95% CI: -1.4 to 5.7%], p = 0.235), acute kidney disease (1.5% [95% CI: -3.8 to 6.8%], p = 0.586), limb ischemia (3.2% [95% CI: -0.6 to 7.0%], p = 0.315), and low output syndrome (1.2% [95% CI: -0.9 to 3.3%], p = 0.262) did not differ between the two groups. On the other hand, the rate of cardiac death (1.2% [95% CI: -0.1 to 2.3%], p = 0.038) was significantly higher in on-pump CABG group. CONCLUSIONS: The OPCAB procedure considerably reduced the occurrence of cardiac death after coronary revascularization. This finding might suggest that the OPCAB procedure should be considered as the first option in patients with higher cardiovascular risk scores. Further research is warranted.

Early and Midterm Clinical Outcomes of Transcatheter Valve-in-Valve Implantation Versus Redo Surgical Aortic Valve Replacement for Aortic Bioprosthetic Valve Degeneration: Two Faces of the Same Medal.

OBJECTIVE: To compare early and midterm outcomes of transcatheter valve-in-valve implantation (ViV-TAVI) and redo surgical aortic valve replacement (re-SAVR) for aortic bioprosthetic valve degeneration. DESIGN: Patients who underwent ViV-TAVI and re-SAVR for aortic bioprosthetic valve degeneration between January 2010 and October 2018 were retrospectively analyzed. Mean follow-up was 3.0 years. SETTING: In-hospital, early, and mid-term outcomes. PARTICIPANTS: Eighty-eight patients were included in the analysis. INTERVENTIONS: Thirty-one patients (37.3%) had ViV-TAVI, and 57 patients (62.7%) had re-SAVR. MEASUREMENTS AND MAIN RESULTS: In the ViV-TAVI group, patients were older (79.1 ± 7.4 v 67.2 ± 14.1, p < 0.01). The total operative time, intubation time, intensive care unit length of stay, total hospital length of stay, inotropes infusion, intubation >24 hours, total amount of chest tube losses, red blood cell transfusions, plasma transfusions, and reoperation for bleeding were significantly higher in the re-SAVR cohort (p < 0.01). There was no difference regarding in-hospital permanent pacemaker implantation (ViV-TAVI = 3.2% v re-SAVR = 8.8%, p = 0.27), patient-prosthesis mismatch (ViV-TAVI = 12 patients [mean 0.53 ± 0.07] and re-SAVR = ten patients [mean 0.56 ± 0.08], p = 0.4), stroke (ViV-TAVI = 3.2% v re-SAVR = 7%, p = 0.43), acute kidney injury (ViV-TAVI = 9.7% v re-SAVR = 15.8%, p = 0.1), and all-cause infections (ViV-TAVI = 0% v re-SAVR = 8.8%, p = 0.02), between the two groups. In-hospital mortality was 0% and 7% for ViV-TAVI and re-SAVR, respectively (p = 0.08). At three-years' follow-up, the incidence of pacemaker implantation was higher in the re-SAVR group (ViV-TAVI = 0 v re-SAVR = 13.4%, p < 0.01). There were no differences in reintervention (ViV-TAVI = 3.8% v re-SAVR = 0%, p = 0.32) and survival (ViV-TAVI = 83.9% v re-SAVR = 93%, p = 0.10) between the two cohorts. CONCLUSIONS: ViV-TAVI is a safe, feasible, and reliable procedure.

Learning curve predictors for minimally invasive mitral valve surgery; how far should the rabbit hole go?

OBJECTIVE: To analyze predictors that influence the learning curve of minimally invasive mitral valve surgery (MIMVS). METHODS: Patients who underwent MIMVS between March 2010 to March 2015 were retrospectively analyzed. Predictive factors that influence the learning curve were analyzed. RESULTS: One hundred and five patients were included in the analysis. Cardiopulmonary bypass (CPB) time in minutes was 158.72 ± 40.98 and the aortic cross-clamp (ACC) time in minutes was 114.48 ± 27.29. There were three operative mortalities, one stroke and five >2+ mitral regurgitation. ACC time in minutes was higher in the low logistic Euroscore II (LES) group (LES < 5% = 118.42 ± 27.94) versus (LES ≥ 5 = 88.66 ± 22.26), P < .05 while creatinine clearance in µmol/L was higher in the LES < 5% group (LES < 5% = 84.32 ± 33.7) versus (LES ≥ 5% = 41.66 ± 17.14), (P < .05). One patient from each group required chest tube insertion for pleural effusion P < .05. The cumulative sum analysis (CUSUM) for the first 25 patients had CPB and ACC times that reached the upper limits. Between 25 to 64 patients the curve remained stable while with the introduction of reoperations and complex surgical procedures the CUSUM reached the upper limits. CONCLUSIONS: The learning curve is affected by many factors but this should not desist surgeons from approaching this technique. The introduction of high-risk patients in clinical practice should be carefully measured based on surgeon experience.

Is Peripheral Artery Disease an Independent Predictor of Isolated Coronary Artery Bypass Outcome?

AIM: The aim was to use a propensity score-based analysis to determine the impact of peripheral artery disease (PAD) on early outcomes after coronary artery bypass surgery grafting (CABG) in patients with PAD. METHOD: We conducted a multicentre retrospective analysis of 11,311 consecutive patients who underwent CABG between 1997 and 2017. Patients with previous or concomitant vascular surgery were excluded. The main endpoints were death, stroke, and limb ischaemia requiring percutaneous or surgical revascularisation. Subgroup analyses were performed to test the interaction of PAD with concomitant factors. RESULTS: There was no difference in mortality in patients with and without PAD (p=0.06 and p=0.179, respectively). Patients with PAD had a greater incidence of stroke (p=0.04), acute kidney disease (p=0.003), and limb ischaemia requiring interventions (p<0.001) than those without PAD. The use of off-pump or no-touch aortic techniques did not influence the effect of PAD on the outcomes. Early mortality rate increased in patients with PAD when associated with long cardiopulmonary bypass, cross-clamp times (both p<0.001), and postoperative low cardiac output (p=0.01). CONCLUSIONS: The presence of PAD is associated, independently of other factors, with greater incidence of stroke, acute kidney disease, and limb ischaemia following CABG, irrespective of the technique employed. Operative mortality was greater in patients with PAD only when associated with long cardiopulmonary bypass and aortic cross-clamp times, and low cardiac output.

Comparison between three different equations for the estimation of glomerular filtration rate in predicting mortality after coronary artery bypass.

BACKGROUND: This study was undertaken to compare the accuracy of chronic kidney disease-epidemiology collaboration (eGFRCKD-EPI) to modification of diet in renal disease (eGFRMDRD) and the Cockcroft-Gault formulas of Creatinine clearance (CCG) equations in predicting post coronary artery bypass grafting (CABG) mortality. METHODS: Data from 4408 patients who underwent isolated CABG over a 11-year period were retrieved from one institutional database. Discriminatory power was assessed using the c-index and comparison between the scores' performance was performed with DeLong, bootstrap, and Venkatraman methods. Calibration was evaluated with calibration curves and associated statistics. RESULTS: The discriminatory power was higher in eGFRCKD-EPI than eGFRMDRD and CCG (Area under Curve [AUC]:0.77, 0.55 and 0.52, respectively). Furthermore, eGFRCKD-EPI performed worse in patients with an eGFR ≤29 ml/min/1.73m2 (AUC: 0.53) while it was not influenced by higher eGFRs, age, and body size. In contrast, the MDRD equation was accurate only in women (calibration statistics p = 0.72), elderly patients (p = 0.53) and subjects with severe impairment of renal function (p = 0.06) whereas CCG was not significantly biased only in patients between 40 and 59 years (p = 0.6) and with eGFR 45-59 ml/min/1.73m2 (p = 0.32) or ≥ 60 ml/min/1.73m2 (p = 0.48). CONCLUSIONS: In general, CKD-EPI gives the best prediction of death after CABG with unsatisfactory accuracy and calibration only in patients with severe kidney disease. In contrast, the CG and MDRD equations were inaccurate in a clinically significant proportion of patients.

Early outcomes following isolated coronary artery bypass surgery: Influence of peripheral artery disease.

BACKGROUND: We carried out a propensity score-based analysis on early outcomes after coronary artery bypass grafting (CABG) in patients with and without peripheral artery disease (PAD). MATERIALS AND METHODS: A total of 11 311 patients undergoing isolated CABG between 1997 and 2017 were included in the study. Patients were divided into two groups based on whether they were affected (n = 1961) or not affected (n = 9350) by PAD. Inverse probability of treatment weighting was employed to reduce confounding preoperative and operative variables. The main endpoints were death, cardiac death, stroke, and limb ischemia requiring percutaneous or surgical revascularization. RESULTS: The excellent balance was obtained, and the groups were very similar. For death and cardiac death, there were no differences between patients with and without PAD (P = .06 and P = .179, respectively). In contrast, PAD patients showed a higher incidence of stroke (P = .04), acute kidney disease (AKD) (P = .003) and limb ischemia requiring intervention (P < .001) than patients without PAD. CONCLUSIONS: The presence of peripheral arterial disease increases the incidence of postoperative stroke, AKD and limb ischemia requiring intervention, independent of patient characteristics, concomitant risk factors, surgical approaches, and techniques. Further larger studies are necessary to confirm our findings.

Vascular complications following intra-aortic balloon pump implantation: an updated review.

BACKGROUND: The use of the intra-aortic balloon pump (IABP) as a support device remains controversial due to the fact that a number of studies have shown no benefit in end mortality whilst using this device. One of the reasons for this could be the increase in vascular complications when using the pump. Therefore, the aim of the present review was to assess the current literature available with regards to IABP vascular complications during the clinical situation. METHODS: A literature search was performed, searching for IABP complications in adult human studies between 1990 and 2016. RESULTS: A total of 20 reports were identified as fitting the criteria of this study. The majority of vascular complications were limb ischemia, bleeding or mesenteric ischemia. The overall incidence of vascular complications ranged from 0.94% to 31.1%. Diabetes, peripheral vascular disease and hypertension, as well as smoking were all identified as risk factors for complications following IABP. Furthermore, studies supported the use of sheathless balloon insertion to reduce the risk of complications. CONCLUSION: Major vascular complications, including limb and mesenteric ischemia as well as bleeding and hemorrhage, have been associated with IABP. However, the incidence of these complications was generally low. Further studies are still required to truly understand the risk/benefit associated with the use of IABP.

Early and Mid-term Outcome of the St. Jude Medical Regent 19-mm Aortic Valve Mechanical Prosthesis. Functional and Haemodynamic Evaluation.

BACKGROUND AND OBJECTIVES: The aim of the present study is to report the early and mid-term clinical and haemodynamic results of the St Jude Medical Regent 19-mm aortic mechanical prothesis (SJMR-19). MATERIALS AND METHODS: Between January 2002 and January 2012, 265 patients with aortic valve disease underwent AVR (Aortic Valve Replacement) with a SJMR-19 (St Jude Medical Regent Nr.19). There were 51 males. Mean age was 67.5±12.72years and mean body surface area (BSA) was 1.67±0.14m2. Thirty-six patients required annulus enlargement. The mean follow-up was 34.5±18.8months (range 6-60 months). All patients underwent echocardiographic examination at discharge and within 1 year after surgery. RESULTS: There were 14 (5.3%) hospital deaths. Six of the hospital deaths were identified in patients undergoing reoperation, significantly higher than patients undergoing first time operation (p=0.0001). Also the postoperative mortality was significantly higher in patients undergoing annulus enlargement versus patients not requiring annulus enlargement (p=0.02). The mean transprosthesis gradient at discharge was 19±9mmHg. At 6 months follow-up the mean NYHA FC class was 1.6±0.5 significantly lower than preoperatively 2.4±0.75 (p <0.0001). The M-TPG was 15.2±6.5mmHg within 1 year after surgery. Left ventricular mass (LVM) and indexed left ventricular mass (LVMi) were significantly lower than preoperatively The actuarial survival and cumulative freedom from reoperation at 1, 2 and 3 years follow-up were 99.5%, 97.5%, 96.7% and 99.2%, 96.5%, 94.5% respectively. The cumulative actuarial free-events survival at 4 years was 92%. The Cox model identified age (p=0.015), LVEF≤35% (p=0.043), reoperation (p=0.031), combined surgery (p=0.00002), and annulus enlargement (p=0.015) as strong predictors for poor actuarial free-major events survival. CONCLUSIONS: The SJMR-19 offers excellent postoperative clinical, haemodynamic outcome and LVMi reduction in patients with small aortic annulus. These data demonstrate that the modern St Jude small mechanical protheses do not influence the intermediate free-reoperation survival.

Extracorporeal membrane oxygenation support for life-threatening acute severe status asthmaticus.

INTRODUCTION: Status asthmaticus is a life-threatening condition characterized by progressive respiratory failure due to asthma that is unresponsive to standard therapeutic measures. We used extracorporeal membrane oxygenation (ECMO) to treat patients with near-fatal status asthamticus who did not respond to aggressive medical therapies and mechanical ventilation under controlled permissive hypercapnia. MATERIALS AND METHODS: Between January 2011 and October 2015, we treated 16 adult patients with status asthmaticus (8 women, 8 men, mean age: 50.5±10.6years) with veno-venous ECMO (13 patients) or veno-arterial (3 patients). Patients failed to respond to conventional therapies despite receiving the most aggressive therapies, including maximal medical treatments, mechanical ventilation under controlled permissive hypercapnia and general anesthetics. RESULTS: Mean time spent on ECMO was 300±11.8 hours (range 36-384 hours). PaO2, PaCO2 and pH showed significant improvement promptly after ECMO initiation p=0.014, 0.001 and <0.001, respectively, and such values remained significantly improved after ECMO, p=0.004 and 0.001 and <0.001, respectively. The mean time of ventilation after decannulation until extubation was 175±145.66 hours and the median time to intensive care unit discharge after decannulation was 234±110.30 hours. All 16 patients survived without neurological sequelae. CONCLUSIONS: ECMO could provide adjunctive pulmonary support for intubated asthmatic patients who remain severely acidotic and hypercarbic despite aggressive conventional therapy. ECMO should be considered as an early treatment in patients with status asthmaticus whose gas exchange cannot be satisfactorily maintained by conventional therapy for providing adequate gas change and preventing lung injury from the ventilation.

Low Blood Arterial Oxygenation During Venovenous Extracorporeal Membrane Oxygenation: Proposal for a Rational Algorithm-Based Management.

PURPOSE: Venovenous extracorporeal membrane oxygenation (VV-ECMO) is a therapeutic option in the management of the most severe forms of acute respiratory distress syndrome. Oxygenation during VV-ECMO depends on many parameters, and its management is complex. The management of ECMO is still not completely codified. The aim of this study was to rationalize the management of hypoxemia during VV-ECMO. METHODS: To build a comprehensive flow diagram for management of hypoxemia during VV-ECMO, we considered (1) relationship between O2 arterial saturation and its determinants; (2) analysis of physiopathology of oxygenation under VV-ECMO; and (3) main guidelines and recommendations recapitulated in troubleshooting charts. RESULTS: We propose a stepwise approach that could guide specific intervention to improve oxygenation during VV-ECMO. The first step is to obtain adequate pump flow, the main determinant of oxygenation, by eliminating a mechanical problem or inadequate venous drainage. Second, if hypoxemia persists, algorithm considers multiple reasons for inadequate oxygenation, namely: (1) excessive recirculation, (2) excessive cardiac output (decrease of ratio pump flow/cardiac output), (3) decrease in SvO2 (oxygen saturation in mixed venous blood), (4) malfunction of oxygenator, and (5) deterioration of residual lung function. Finally, for each modification of oxygenation parameters, specific measures are proposed to restore an adequate oxygenation by extracorporeal membrane oxygenation. CONCLUSION: If hypoxemia occurs during VV-ECMO, collecting oxygenation parameters and a clear step-by-step algorithm could guide specific intervention to improve oxygenation. This flow diagram is in accordance with current recommendations recapitulated in guidelines or troubleshooting chart but more accurate and complete. Although rational and appealing, it remains to be tested together with a number of still unsolved issues.

A numerical model of blood oxygenation during veno-venous ECMO: analysis of the interplay between blood oxygenation and its delivery parameters.

Veno-venous extracorporeal membrane oxygenation (VV-ECMO) is an important tool in the management of most severe forms of acute respiratory failure. The determinants and management of oxygen delivery in patients treated with VV-ECMO is a complex topic. The physiological principles of oxygenation on VV-ECMO are reviewed in many textbooks. However a numerical model is an additional instrument to be used in understanding and exploring this intricate subject matter. We present a numerical model of blood oxygenation during VV-ECMO. Using this model we examined the role and impact of each determinant on blood oxygenation. The numerical analysis of variation and interplay between each oxygenation determinants during VV-ECMO is presented in graphical form. These results corroborate all the findings of previous studies. The proposed numerical model facilitates understanding of oxygenation physiology during VV-ECMO; it can be used for a medical simulation system and for teaching the principles of oxygenation during VV-ECMO.

Does the St. Jude Regent 17-mm Offer Better Outcomes Than the Hemodynamic Plus 17-mm Aortic Valve Mechanical Prothesis?

OBJECTIVE: The aim of the present study is to report the early and mid-term clinical and hemodynamic results of a prospective trial investigating the clinical performance of the St. Jude Medical Regent 17 mm (SJMR-17) versus St. Jude Medical Hemodynamic Plus 17 mm (SJMHP-17). MATERIALS AND METHODS: Between January 2000 and August 2013, 20 patients (Group I) with aortic valve (AV) stenosis underwent first time AV replacement with a SJMR-17 and nine patients (Group II) underwent AV replacement with a SJMHP-17. The mean follow-up was 58 ± 31 months. RESULTS: There was one death in Group I. The end-diastolic IVS thickness and end-systolic posterior left ventricle (LV) wall thickness was reduced significantly in boths groups (p = 0.001 and p = 0.006 in Group I and p = 0.007 and p = 0.011 in Group II). The peak and mean transprosthesis gradients (P-TPG and M-TPG) were 29 ± 6.8 mmHg and 17.5 ± 4.5 mmHg in Group I, significantly lower than in Group II (55.2 ± 19.7 mmHg and 28.8 ± 7.7 mmHg). The postoperative left ventricular mass (LVM) and indexed left ventricular mass (LVMi) were reduced significantly in both groups versus the preoperative values. The postoperative LVMi was 114.5 ± 10.6 g/m(2) in Group I versus 127 ± 8 g/m(2) in Group II (p = 0.01). With dobutamine, heart rate, left ventricular ejection fraction, cardiac output, transprosthesis peak, and mean gradients increased significantly in both groups, however, the P-TPG and M-TPG were significantly higher in Group II (p = 0.026 and p = 0.022) despite a non-significant increase of the indexed effective orifice area. CONCLUSIONS: The SJMR-17 can be employed with satisfactory postoperative clinical and hemodynamic outcomes in patients with small aortic annulus, especially in elderly patients offering better outcome than SJMHP-17.

Early and mid-term functional and hemodynamic evaluation of the St. Jude Medical Regent 17 mm aortic valve mechanical prosthesis.

BACKGROUND AND AIM OF THE STUDY: The study aim was to report the early and mid-term clinical and hemodynamic results of a prospective trial investigating the clinical performance of the St. Jude Medical Regent 17 mm mechanical aortic valve prosthesis (SJMR-17). METHODS: Between January 2001 and January 2009, 20 patients (18 females, two males; mean age 69.2 +/- 7.3 years) with aortic valve stenosis underwent first-time aortic valve replacement (AVR) with the SJMR-17. The mean body surface area (BSA) was 1.68 +/- 0.2 m2, and the mean follow up was 18.7 +/- 9.2 months (range: 10-32 months). All patients were monitored with serial echocardiography; the first study was performed preoperatively, while subsequent controls were at two and six months, and within one year, respectively. All survivors underwent dobutamine stress testing (DSE) at one year after surgery. RESULTS: There was one death. At the six-month follow up the mean NYHA class was 1.3 +/- 0.6, and was significantly lower than preoperatively 2.75 +/- 0.86 (p < 0.0001). The peak and mean transprosthetic gradient (TPG) was 29 +/- 6.8 and 17.5 +/- 4.5 mmHg respectively, significantly lower than preoperatively. The left ventricular mass (LVM; g) and indexed left ventricular mass (LVMi; g/m2) were 191.0 +/- 22.6 g and 114.5 +/- 10.6 g/m2, respectively, and were significantly lower than preoperative values (258.0 +/- 40.0 g, p < 0.0001; and 157.0 +/- 26.0 g/m2, p = 0.00002). The mean TPG correlated well with the LVMi reduction (p = 0.033). During DSE, the peak and mean TPGs were increased significantly to 73.8 +/- 17.7 mmHg and 37 +/- 10.7 mmHg, respectively, significantly higher than at the basal (resting) state. Multivariate regression analysis identified the effective orifice area index, BSA, age and postoperative LVMi as strong predictors for a higher mean TPG. CONCLUSION: The SJMR-17 prosthesis might be employed with satisfactory postoperative clinical and hemodynamic outcome in patients with a small aortic annulus, especially in elderly patients, as an alternative to other valves, or to other surgical strategies such as annulus enlargement.