Factor Xa Inhibitors for Patients after Mechanical Heart Valve Replacement?

Patients with a mechanical heart valve need a lifelong anticoagulation due to the increased risk of valve thrombosis and thrombo-embolism. Currently, vitamin K antagonists (VKA) are the only approved class of oral anticoagulants, but relevant interactions and side effects lead to a large number of patients not achieving the optimal therapeutic target international normalized ration (INR). Therefore, steady measurements of the INR are imperative to ensure potent anticoagulation within a distinctive range. Direct oral anticoagulants (DOACs) with newer agents could serve as a possible alternative to VKAs in this patient cohort. DOACs are approved for several indications, e.g., atrial fibrillation (AF). They only have a minor interaction potential, which is why monitoring is not needed. Thereby, DOACs improve the livability of patients in need of chronical anticoagulation compared with VKAs. In contrast to dual platelet inhibition using aspirin in combination with an ADP receptor antagonist and the direct thrombin inhibitor dabigatran, the oral factor Xa inhibitors apixaban and rivaroxaban show promising results according to current evidence. In small-scale studies, factor Xa inhibitors were able to prevent thrombosis and thrombo-embolic events in patients with mechanical heart valves. Finally, DOACs seem to represent a feasible treatment option in patients with mechanical heart valves, but further studies are needed to evaluate clinical safety. In addition to the ongoing PROACT Xa trial with apixaban in patients after aortic On-X valve implantation, studies in an all-comer collective with rivaroxaban could be promising.

Implanting Impella 5.5 under Local Anesthesia.

BACKGROUND: Surgically implanted Impella 5.5. delivers full cardiac support and left ventricular unloading for patients with heart failure. So far, the Impella device is implanted under general anesthesia (GA). MATERIAL AND METHODS: A total of n = 3 critically ill patients presented with acute heart failure in need of cardiac support. All patients suffered cardiogenic shock of varying etiology. Due to hemodynamically unstable conditions, GA was avoided. All implantations were performed solely under local anesthesia (LAS) without any regional anesthesia. RESULTS: All implantations were performed successfully under LAS with 60 mL of mepivacaine of 2% solution and ropivacaine of 1% solution (50:50 ratio). All devices were placed from the right axillary artery. One patient needed hematoma evacuation several days after surgery. No other Impella-related complication was observed. CONCLUSION: A surgical implantation of the Impella 5.5 device under LAS is feasible and safe. Despite the small number of cases, no disadvantage can be described at the present moment. Our series should encourage physicians to perform the procedure under LAS.

Outcomes and Characteristics of Patients with Intraprocedural Cardiopulmonary Resuscitation during TAVR.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has become an established alternative to surgical aortic valve replacement (AVR) for higher risk patients. Periprocedural TAVR complications decreased with a growing expertise of implanters. Yet, TAVR can be accompanied by life-threatening adverse events such as intraprocedural cardiopulmonary resuscitation (CPR). This study retrospectively analyzed predictors and outcomes in a cohort of patients from a high-volume center undergoing periprocedural CPR during TAVR. METHODS: A total of 729 patients undergoing TAVR, including 59 with intraprocedural CPR, were analyzed with respect to peri- and postprocedural outcomes. RESULTS: Patients undergoing CPR showed a significantly lower left ventricular ejection fraction (LVEF) and lower baseline transvalvular mean and peak pressure gradients. The systolic blood pressure measured directly preoperatively was significantly lower in the CPR cohort. CPR patients were in a higher need for intraprocedural defibrillation, heart-lung circulatory support, and conversion to open heart surgery. Further, they showed a higher incidence of atrioventricular block grade III , valve malpositioning, and pericardial tamponade. The in-hospital mortality was significantly higher after intraprocedural CPR, accompanied by a higher incidence of disabling stroke, new pacemaker implantation, more red blood cell transfusion, and longer stay in intensive care unit. CONCLUSION: Impaired preoperative LVEF and instable hemodynamics before valve deployment are independent risk factors for CPR and are associated with compromised outcomes. Heart rhythm disturbances, malpositioning of the prosthesis, and pericardial tamponade are main causes of the high mortality of 17% reported in the CPR group. Nevertheless, mechanical circulatory support and conversion to open heart surgery reduce mortality rates of CPR patients.

Ten-Year Long-Term Analysis of Mechanical and Biological Aortic Valve Replacement.

BACKGROUND: For patients undergoing aortic valve replacement (AVR), structural valve deterioration (SVD) of a bioprosthesis (BP) is substantially accelerated in younger patients and valve-in-valve implantation is not always a considerable option. The risk-benefit assessment between SVD versus the risk of bleeding and thromboembolic events in patients with a mechanical prosthesis (MP) resulted in an age limit shift irrespective of inconsistent results reported in literature. METHOD: This retrospective single-center study compared 10-year long-term outcomes in patients undergoing isolated AVR with MP or BP. The risk-adjusted comparison of patients undergoing isolated AVR (n = 121) was performed after 1:1 propensity score matching (PSM) for age, sex, endocarditis, and chronic renal impairment (caliper of 0.2) leading to 29 pairs. Short- and long-term outcomes with respect to reoperation, major bleeding, stroke, all-cause and cardiovascular mortality, and overall survival at 10 years were analyzed. RESULTS: After PSM, groups were comparable with respect to preoperative characteristics, including patients with a mean age of 65 ± 3 years (MP) and 66 ± 4 years (BP) and an incidence rate of 6.9% for infective endocarditis in both cohorts. Short-term outcomes (transient neurologic disorder = 0.0 vs. 6.9%; stroke = 0.0%; in-hospital mortality = 3.4%) and in-hospital stays were comparable between MP and BP. CONCLUSION: After isolated AVR with MP and BP, 10-year long-term outcomes were comparable in the reported single-center cohort. MP can still be implanted safely without a disadvantage as regards long-term survival.

Preoperative Statin Therapy for Atrial Fibrillation and Renal Failure after Cardiac Surgery.

BACKGROUND: Performing cardiac surgery in patients with cardiovascular risk factors incorporates a steady risk for the development of postoperative complications. Perioperative statin intake was associated with an improvement of perioperative outcomes in these patients. However, the European Association for Cardio-Thoracic Surgery guidelines regarding the perioperative statin treatment were changed recently due to large studies reporting about relevant adverse effects related to statin therapy. METHODS: All relevant databases were searched including the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, and the metaRegister of Controlled Trials. Various registries were screened (National Research Register, the ClinicalTrials.gov, and gray literature) with search on online conference indices of relevant scientific meetings. No language restrictions were applied. RESULTS: We identified 10 randomized controlled studies summarizing 3,468 participants undergoing various kinds of cardiac surgical procedures. All included studies presented with marked differences regarding study design. Pooled analysis indicated that statin pretreatment was associated with a formally reduced incidence of postoperative atrial fibrillation (AF) (odds ratio [OR] 0.63, 95% confidence interval [CI] 0.39-1.00; p = 0.05) but with an increased incidence of renal failure (OR 1.20, 95% CI 1.01-1.44; p = 0.04) compared with control. Substantial heterogeneity was observed among studies reporting about AF. CONCLUSION: Current but sparse evidence reveals that statin pretreatment is associated with a higher rate of postoperative renal failure compared with control therapy but is ineffective to substantially reduce postoperative AF. Given the relevant heterogeneity among included studies, statin pretreatment cannot be generally recommended.

Experimental Studies for Small Diameter Grafts in an In Vivo Sheep Model-Techniques and Pitfalls.

BACKGROUND: Scientific attempts to create the "ideal" small diameter vascular graft have been compared with the "search of the holy grail." Prosthetic material as expanded polytetrafluoroethylene or Dacron shows acceptable patency rates to large caliber vessels, while small diameter (< 6 mm) prosthetic conduits present unacceptably poor patency rates. Vascular tissue engineering represents a promising option to address this problem. MATERIAL AND METHODS: Thirty-two female Texel-sheep aged 6 months to 2 years underwent surgical common carotid artery (CCA) interposition using different tissue-engineered vascular substitutes. Explantation of the grafts was performed 12 (n = 12) and 36 (n = 20) weeks after surgery. Ultrasound was performed on postoperative day 1 and thereafter every 4 weeks to evaluate the graft patency. RESULTS: The average length of implanted substitutes was 10.3 ± 2.2 cm. Anesthesia and surgical procedure could be performed without major surgical complications in all cases.The grafts showed a systolic blood flow velocity (BFV) of 28.24 ± 13.5 cm/s, a diastolic BFV of 9.25 ± 4.53 cm/s, and a mean BFV of 17.85 ± 9.25 cm/s. Native vessels did not differ relevantly in hemodynamic measurements (systolic: 29.77 cm/s; diastolic: 7.99 cm/s ± 5.35; mean 15.87 ± 10.75). There was no incidence of neurologic complications or subsequent postoperative occlusion. Perioperative morbidity was low and implantation of conduits was generally well tolerated. CONCLUSION: This article aims to give a precise overview of in vivo experiments in sheep for the evaluation of small diameter vascular grafts performing CCA interposition, especially with regard to pitfalls and possible perioperative complications and to discuss advantages and disadvantages of this approach.

Major Bleeding after Surgical Revascularization with Dual Antiplatelet Therapy.

OBJECTIVE: Patients with acute coronary syndrome are treated with dual antiplatelet therapy containing acetylsalicylic acid (ASA) and P2Y12 antagonists. In case of urgent coronary artery bypass grafting this might be associated with increasing risks of bleeding complications. METHODS: Data from 1200 consecutive urgent operations between 2010 and 2018 were obtained from our institutional patient database. For this study off-pump surgery was excluded. The primary composite end point major bleeding consisted of at least one end point: transfusion ≥ 5 packed red blood cells within 24 hours, rethoracotomy due to bleeding, chest tube output >2000 mL within 24 hours. Demographic data, peri-, and postoperative variables and outcomes were compared between patients treated with mono antiplatelet therapy, ASA + clopidogrel (ASA-C) +ticagrelor (ASA-T) or +prasugrel (ASA-P) < 72 hours before surgery. Furthermore, we compared patients with dual antiplatelet therapy with ASA monotherapy. RESULTS: From 1,086 patients, 475 (44%) received dual antiplatelet therapy. Three-hundred seventy-two received ASA-C (77.7%), 72 ASA-T (15%), and 31 ASA-P (6.5%). Major bleeding (44 vs. 23%, p < 0.0001) was more frequently in patients receiving dual therapy with higher rates of massive drainage loss within 24 hours (23 vs. 11%, p < 0.0001) of mass transfusion (34 vs. 16%, p < 0.0001) and rethoracotomy (10 vs. 5%, p = 0.002) when compared with ASA. In this analysis, ASA-T and ASA-P were not associated with higher bleeding complications compared with ASA-C. CONCLUSION: Dual antiplatelet therapy is associated with higher rates of major bleeding. Further studies should examine the difference in the prevalence of major bleeding complications in the different dual antiplatelet therapy regimes in patients requiring urgent surgery.

"Vascular Outlining": Augmented Imaging for Transfemoral Access-A Preclinical Investigation.

BACKGROUND: Advanced visualization software tools have been used in clinics to improve the safety and accuracy of transcatheter procedure. Imaging techniques have greatly evolved during the era of transcatheter aortic valve implantation (TAVI). In a retrospective analysis, we investigated the feasibility of augmented fluoroscopy for iliofemoral access using a novel "Vascular Outlining" roadmapping technology. METHODS: The Vascular Outlining prototype device (Philips Healthcare) application was used with iliofemoral angiography of 10 patients undergoing transfemoral TAVI. The software processes any conventional angiographic sequences, extracting the static outline of vessels and projecting the two-dimensional vessel margins as a roadmap on live fluoroscopy. Post-processed results were clinically assessed to determine whether the technical performance of the tool is sufficient. RESULTS: Augmented imaging was possible in all investigated angiography sequences. The analysis of software-generated images showed accurate projection of the two-dimensional outline of the iliofemoral vessels as an overlay on the live fluoroscopy image in most cases. Overlay inaccuracy was only observed in cases with low contrast or patient movement. CONCLUSION: In static and contrasted angiography sequences, "Vascular Outlining" showed accurate image overlay. We identified that the quality of the vascular outline is dependent on the opacification of the contrast injection and the stability of the patient on the table. With further development. this application might increase the accuracy of femoral puncture and reduce the incidence of vascular complications. Clinical trials are needed to confirm these hypotheses.

SAVR versus TAVI: What about the Hemodynamic Performance? An In Vivo and In Vitro Analysis.

BACKGROUND: Surgical aortic valve replacement (SAVR) is nowadays discussed whether it remains the gold standard of treatment. In the last decade, there has been a tremendous increase in transcatheter aortic valve implantation (TAVI) due to the growing expertise and excellent results of the catheter-based approach. We, therefore, retrospectively compared the rapid deployment valve (RDV), the Edwards Intuity valve (IEV), with the Edwards Sapien 3 (S3V) with regard to post-procedural hemodynamics. METHODS: A total of 246 patients treated with TAVI or SAVR between February 2009 and November 2015 were included. One-hundred twenty-five patients were analyzed in the SAVR group and compared with 121 patients undergoing TAVI. Transvalvular pressure gradients (PGs) and the incidence and extent of aortic regurgitation (AR) were compared post-procedurally by echocardiography for each valve size. In vitro hemodynamics were analyzed by placing both valves into an aortic silicone phantom connected to a pulsatile flow pump and measured using phase-contrast magnetic resonance imaging (4D flow MRI). RESULTS: Post-procedurally, mean transvalvular PGs for the 23 mm valves were 9 (7;11.5) versus 13 (9;18) (p < 0.001), whereas maximum PGs were 16.5 (14;22) versus 25.5 mm Hg (17.5;34) (p < 0.001) in IEV and S3V patients, respectively. The 21 mm IEV showed significantly lower transvalvular PGs compared with the 23 mm S3V: mean PGs: 11 (8;13) versus 13 (9;18) (p < 0.05); maximum PG: 19.5 (13;24) versus 25.5 (18;34) mm Hg (p < 0.05). Analysis revealed significantly lower post-procedural transvalvular PGs for larger valves sizes. With respect to AR, the incidence of AR was significantly lower in IEV group (p < 0.05). In vitro velocities and turbulent kinetic energy values showed similar results between both valves. CONCLUSION: Implanted RDVs presented a lower incidence of paravalvular regurgitation and were associated with significantly lower post-procedural transvalvular PGs, especially for small valve sizes. Our data might support the application of rapid deployment aortic valves in patients with small aortic annulus in the TAVI era.

Levosimendan Reduces Mortality and Low Cardiac Output Syndrome in Cardiac Surgery.

BACKGROUND: There has been conflicting evidence concerning the effect of levosimendan on clinical outcomes in patients undergoing cardiac surgery. Therefore, we performed a systematic review and conducted this meta-analysis to provide evidence for/against the administration of levosimendan in cardiac surgery patients. METHODS: We performed a meta-analysis from literature search in PubMed, EMBASE, and Cochrane Library. Only randomized controlled trials comparing the administration of levosimendan in cardiac surgery patients with a control group (other inotrope, standard therapy/placebo, or an intra-aortic balloon pump) were included. In addition, at least one clinical outcome had to be mentioned: mortality, myocardial infarction, low cardiac output syndrome (LCOS), acute kidney injury, renal replacement therapy, atrial fibrillation, prolonged inotropic support, length of intensive care unit, and hospital stay. The pooled treatment effects (odds ratio [OR], 95% confidence intervals [CI]) were assessed using a fixed or random effects model. RESULTS: The literature search retrieved 27 randomized, controlled trials involving a total of 3,198 patients. Levosimendan led to a significant reduction in mortality (OR: 0.67; 95% CI: 0.49-0.91; p = 0.0087). Furthermore, the incidence of LCOS (OR: 0.56, 95% CI: 0.42-0.75; p < 0.0001), acute kidney injury (OR: 0.63; 95% CI: 0.46-0.86; p = 0.0039), and renal replacement therapy (OR: 0.70; 95% CI: 0.50-0.98; p = 0.0332) was significantly decreased in the levosimendan group. CONCLUSION: Our meta-analysis suggests beneficial effects for the prophylactic use of levosimendan in patients with severely impaired left ventricular function undergoing cardiac surgery. The administration of levosimendan was associated with a reduced mortality, less LCOS, and restored adequate organ perfusion reflected in less acute kidney injury.

Latest Generation of Balloon-Expandable Valve, the Edwards Sapien 3 Valve: Less Paravalvular Regurgitation but Higher Transvalvular Pressure Gradients.

BACKGROUND: The latest generation of balloon-expandable valve, the Edwards Sapien 3 valve (S3V), was designed to reduce paravalvular regurgitation (PVR). We retrospectively compared S3V with Edwards Sapien XT valve (SXTV) with regard to postprocedural transvalvular pressure gradients (PGs). METHODS: Analysis of 152 patients receiving SXTV and 125 patients receiving S3V between February 2009 and April 2015 was performed. Transvalvular PGs and the incidence and extent of aortic regurgitation (AR) were compared postprocedurally by echocardiography for each valve size. RESULTS: Postprocedurally, mean PGs for the 23 mm valves were 10.9 ± 5.3 versus 13.9 ± 5.1 (p = 0.017), whereas maximum PGs were 19.9 ± 8.3 versus 26.1 ± 10.4 mm Hg (p = 0.005) in SXTV and S3V patients, respectively. For the 26 mm valves, gradients were also significantly higher in S3V patients (mean PG: 11.6 ± 4.9 vs. 9.2 ± 4.2 [p = 0.004]; maximum PG: 23.0 ± 10.1 vs. 17.2 ± 7.4 mm Hg [p < 0.001]). Analysis revealed no significant differences in postprocedural transvalvular PGs for 29 mm valves (mean PG of 9.3 ± 3.9 and 11.2 ± 4.3 mm Hg [p = ns] and maximum PG of 17.5 ± 7.2 vs. 20.9 ± 6.8 mm Hg [p = ns]) between SXTV and S3V groups, respectively. With respect to PVR, the incidence of AR was significantly lower in S3V group (p = 0.001). CONCLUSION: S3V shows lower incidence of PVR; however, it is associated with significantly higher postprocedural transvalvular PGs for 23 and 26 mm valve sizes. These data might contribute to the scientific discussion, especially with respect to prosthesis selection in individual patients with small annular dimension.

Buckberg versus Calafiore Cardioplegia in Patients with Acute Coronary Syndromes.

BACKGROUND: Choice of cardioplegic solution plays a pivotal role in special subgroups of patients referred for on-pump cardiac surgery. This retrospective analysis aimed to assess the impact of intermittent warm (Calafiore, Cala) versus intermittent cold blood cardioplegia (Buckberg, Buck) in patients referred to coronary artery bypass graft (CABG) surgery due to acute coronary syndromes (ACS). METHODS: From 2008 to 2015, all consecutive patients undergoing urgent on-pump CABG surgery due to ACS (n = 950) were retrospectively analyzed. Intraoperative cardiac arrest was achieved using Buck (n = 273) or Cala (n = 677). Patients were compared regarding clinical outcomes and perioperative myocardial injury (PMI). Propensity score matching was performed to control for differences in preoperative patient characteristics. RESULTS: Prevalences of left main stenosis >50%, COPD, and advanced New York Heart Association (NYHA) class were higher for intermittent warm blood cardioplegia (IWC)-patients while more Buck-patients had preoperative intra-aortic balloon pump (IABP) and redo procedures. Buck-patients needed more intraoperative defibrillations and showed longer cardiopulmonary bypass (CPB) and aortic clamping times. 30-day all-cause mortality (10.6 versus 9.3%), major adverse cardiac events (MACE) (52.7 versus 48.6%), and PMI (50.5 versus 55.7%; all p > 0.05) rates were comparable for Buck- and Cala-patients. Propensity score matching resulted in equal group sizes (n = 212 each) and balanced distribution of preoperative covariates. Although more Buck-patients still needed inotropic support >24 hours postoperatively (25.7 versus 14.7%; p = 0.005) compared with Cala-group, outcome variables of interest did not differ between treatment groups (30-day mortality: 7.5 versus 9.0%; MACE: 49.5 versus 40.6%; PMI: 48.1 versus 37.3%; all p > 0.05). CONCLUSION: Buckberg and Calafiore cardioplegia offer comparable myocardial protection and similar postoperative results in patients undergoing CABG surgery due to ACS.

Localization of Exogenous Mesenchymal Stem Cells in a Pig Model of Lung Transplantation.

BACKGROUND: Mesenchymal stem cells (MSCs) have a great potential for the treatment of acute lung injury. This study provides a detailed immunohistochemical and stereological analysis of the localization and distribution of exogenous MSC in a pig model of lung transplantation after intravascular or endobronchial application. METHODS: MSC derived from human bone marrow were labeled by DiI and administered intravascularly or endobronchially to the lungs of donor pigs after a period of 3 hours warm and 3 hours cold ischemia. The left lung was transplanted to a recipient pig and reperfused for 4 hours before fixation. The right donor lung was fixed for microscopic analysis directly after the ischemia time. RESULTS: After both administration routes, a similar number of exogenous MSC was found in the lungs. Within each animal, the heterogeneity of MSC distribution was high both with respect to left and right lung as well as to the different lobes of each lung. After endobronchial application, MSC were found in alveolar and bronchial/bronchiolar lumen, whereas after intravascular administration, they were mainly observed in blood vessels. CONCLUSION: Although the administration of exogenous MSC is possible by endobronchial or intravascular application, it yields a heterogeneous distribution in the lungs which may warrant strategies to improve a more homogeneous distribution.

Rapid Deployment Valve Implantation using the EDWARDS Intuity Valve System: A Word of Caution regarding Sizing in Calcified Sinotubular Junctions.

In aortic valve replacement, severe calcification of the sinotubular junction is a limitation in the application of the rapid deployment Edwards Intuity valve system. This is illustrated by a case presentation in which discrepancies of shape and diameter between sizer and valve mounted on the deployment system resulted in discarding the prosthesis and performing a biocomposite root replacement instead. Modification of the valve sizer will allow for safer sizing because the sizing process will mimic the implantation process more accurately.

Impact of device landing zone calcification patterns on paravalvular regurgitation after transcatheter aortic valve replacement with different next-generation devices.

OBJECTIVE: Residual paravalvular regurgitation (PVR) has been associated to adverse outcomes after transcatheter aortic valve replacement (TAVR). This study sought to evaluate the impact of device landing zone (DLZ) calcification on residual PVR after TAVR with different next-generation transcatheter heart valves. METHODS: 642 patients underwent TAVR with a SAPIEN 3 (S3; n=292), ACURATE neo (NEO; n=166), Evolut R (ER; n=132) or Lotus (n=52). Extent, location and asymmetry of DLZ calcification were assessed from contrast-enhanced CT imaging and correlated to PVR at discharge. RESULTS: PVR was ≥moderate in 0.7% of S3 patients, 9.6% of NEO patients, 9.8% of ER patients and 0% of Lotus patients (p<0.001), and these differences remained after matching for total DLZ calcium volume. The amount of DLZ calcium was significantly related to the degree of PVR in patients treated with S3 (p=0.045), NEO (p=0.004) and ER (p<0.001), but not in Lotus patients (p=0.698). The incidence of PVR ≥moderate increased significantly over the tertiles of DLZ calcium volume (p=0.046). On multivariable analysis, calcification of the aortic valve cusps, LVOT calcification and the use of self-expanding transcatheter aortic valve implantation (TAVI) prostheses emerged as predictors of PVR. CONCLUSIONS: The susceptibility to PVR depending on the amount of calcium was mainly observed in self-expanding TAVI prostheses. Thus, DLZ calcification is an important factor to be considered in prosthesis selection for each individual patient, keeping in mind the trade-off between PVR reduction, risk of new pacemaker implantation and unfavourable valve ha emodynamics.

Intracardiac Metastasis from a Large Cell Neuroendocrine Lung Carcinoma.

Primary malignant tumors of the heart are rare; the biggest group is sarcomas. Cardiac metastases make up the biggest group of secondary cardiac tumors. We present a rare case of cardiac metastasis (3.1 × 3.2 × 2.8 cm) localized in the right atrium, originating from a large cell neuroendocrine lung carcinoma, with close contact to the tricuspid valve and inferior cava vein.

Outcomes of a Rapid Deployment Aortic Valve Versus Its Conventional Counterpart: A Propensity-Matched Analysis.

OBJECTIVE: The aim of this study was to compare outcomes after rapid-deployment aortic valve replacement (RDAVR) and conventional aortic valve replacement (AVR) from two studies. METHODS: Patients who underwent RDAVR (INTUITY valve) in the prospective, 5-year, single-arm multicenter TRITON study, or conventional AVR (Perimount Magna Ease valve) in the prospective Perimount Magna Ease postmarket study, were propensity score matched and compared for procedural, hemodynamic, safety, and clinical outcomes. RESULTS: Matched RDAVR (n = 106) and conventional AVR (n = 106) patients had similar baseline characteristics (mean ± SD age, 72.8 ± 7.6 vs 72.5 ± 7.4 years; male 59.4% vs 61.3%) and procedures (concomitant procedures: 41.5% vs 50.9%). Mean ± SD aortic cross-clamp time was significantly shorter in RDAVR than AVR patients (51.8 ± 20.9 vs 73.9 ± 33.2 minutes; P < 0.001), as was mean cardiopulmonary bypass time (82.8 ± 34.2 vs 102.4 ± 41.7 minutes; P < 0.001). At 1 year, RDAVR patients showed significantly lower mean ± SD and peak aortic valve gradients (9.0 ± 3.4 and 17.0 ± 6.2 mm Hg, respectively) than conventional AVR patients (13.4 ± 5.5 and 24.2 ± 10.8 mm Hg, respectively; all P < 0.001). Patient-prosthesis mismatch was significantly less common with RDAVR than with AVR [overall: 16/66 (24.2%) vs 46/76 (60.5%); P = 0.007; severe: 2/66 (3.0%) vs 13/76 (17.1%)]. There were no significant differences between the RDAVR and AVR groups regarding 30-day safety endpoints. Survival rates in the RDAVR and conventional AVR groups were, respectively, 99.1% and 100.0% at 30 days, 97.1% and 95.1% at 1 year, and 93.3% and 94.1% at 3 years (P = nonsignificant). CONCLUSIONS: In this retrospective study with matched populations, the RDAVR with the INTUITY valve system provided superior procedural and hemodynamic outcomes than a standard bioprosthesis without compromising safety.

Long-term outcomes of a rapid deployment aortic valve: data up to 5 years.

OBJECTIVES: Rapid deployment aortic valve replacement (AVR) has been developed to facilitate minimally invasive approaches for cardiac surgery and shorten procedural times. TRITON is a prospectively designed study to assess safety and efficacy of rapid deployment AVR with Edwards INTUITY valve system. This report presents the 5-year outcomes of the TRITON trial. METHODS: A total of 295 patients with aortic valve stenosis were enrolled in the TRITON trial and 287 patients received the study valve. Procedural, early (≤30 days) and late (>30 days) outcomes were collected. Valve haemodynamic performance was evaluated at specified time points by an independent Echocardiography Core Laboratory and clinical events adjudicated by an independent Clinical Events Committee. RESULTS: Mean age was 75.3 ± 6.7 years. A total of 158 patients underwent isolated AVR and 129 patients underwent AVR with concomitant procedures. The 5-year survival rates were 85.7 ± 3.4% and 75.2 ± 4.9% for isolated AVR and concomitant AVR, respectively. Overall, freedom from valve-related death at 5 years was 98.2 ± 0.8%. At 5 years, the valve effective orifice area was 1.6 ± 0.3 cm 2 , mean gradient was 10.5 ± 5.4 mmHg and peak gradient was 18.9 ± 9.3 mmHg. CONCLUSIONS: The 5-year outcomes of the TRITON trial demonstrate acceptable long-term safety and excellent haemodynamic performance of rapid deployment AVR with the Edwards INTUITY valve system. CLINICALTRIALS.GOV: NCT01445171.

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

OBJECTIVE: Minimal access aortic valve replacement is associated with favorable clinical outcomes; however, several meta-analyses have reported significantly longer crossclamp times compared with a full sternotomy. We examined the procedural and early safety outcomes after isolated rapid deployment aortic valve replacement by surgical approach in patients enrolled in the Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve trial. METHODS: The Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve trial was a prospective, multicenter, single-arm study, with successful implants in 287 patients with aortic valve stenosis who underwent rapid deployment aortic valve replacement using the EDWARDS INTUITY Valve System (Edwards Lifesciences, Irvine, Calif). Patients were evaluated perioperatively for procedural times and technical success rates; at discharge, for hospital length of stay; and, at 30 days, for early adverse events. RESULTS: A total of 158 patients underwent isolated aortic valve replacement through a full sternotomy (n = 71), upper hemisternotomy (n = 77), or right anterior thoracotomy (n = 10). Mean age at baseline was 75.7 ± 7.2 years. Mean aortic crossclamp and cardiopulmonary bypass times (minutes) were similar for full sternotomy and upper hemisternotomy, 43.5 ± 32.5/71.6 ± 41.8 and 43.1 ± 13.1/69.6 ± 19.1, respectively, and significantly longer for right anterior thoracotomy, 88.3 ± 18.6/122.2 ± 22.1 (P < .000). Early adverse event rates were similar, and in-hospital mortality rates were low regardless of surgical approach. CONCLUSIONS: These data suggest that isolated rapid deployment aortic valve replacement through an upper hemisternotomy can lead to shorter crossclamp times than has been reported historically in the literature. This may facilitate minimal access aortic valve replacement by eliminating the issue of prolonged crossclamp times. Further, low in-hospital mortality and new permanent pacemaker implant rates were observed regardless of surgical approach.

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