Implementation of an innovative ERAS protocol in cardiac surgery: A qualitative evaluation from patients' perspective.

OBJECTIVE: Enhanced recovery after surgery (ERAS) protocols aim to optimize the recovery process for patients after surgical interventions and focus on patient-centered care. In cardiac surgery, the ERAS concept is still in its early stages. Our university hospital has implemented an innovative ERAS protocol for minimally invasive heart valve surgery since 2021. Therefore, our study aimed to comprehensively assess the patient experience within this newly established ERAS protocol and focused on exploring and understanding the nuances of optimal healthcare delivery under the ERAS framework from the unique perspective of the patients undergoing cardiac surgery. METHODS: Qualitative research was conducted using semi-structured interviews. Data was analyzed using Kuckartz´s qualitative content analysis. RESULTS: The following main themes emerged from the 12 completed patient interviews: 1) information and communication flow, 2) perioperative patient care, and 3) rehabilitation. Patients found the pre-operative patient education and preconditioning very helpful. Patients were satisfied with the flow of information throughout the whole perioperative care process. Most patients expressed a need for more information about the course of surgery. The intensity of care provided by different professions was perceived as optimal. The support and inclusion of relatives in perioperative care were considered crucial. Patients appreciated the direct transfer to the rehabilitation and mainly were able to cope with daily life tasks afterward. CONCLUSION: In summary, all patients experienced the ERAS protocol positively, and their healthcare process was well established. Active inclusion and education of patients in their treatment can improve patient empowerment. Two further aspects that deserve major consideration in the healthcare process are the inclusion of relatives and interprofessional cooperation.

Minimally-Invasive Approach in the Setting of a Malignant Primary Cardiac Tumor.

A 71-year-old man with dilated cardiomyopathy without clinical complaints revealed a suspicious finding in checkup. After a multimodality cardiac imaging, the suspicion of a malignant primary cardiac tumor in the left ventricle was substantiated and the patient underwent minimally-invasive cardiac surgery for tumor resection. Postoperative chemotherapy with multiple cycles of liposomal doxorubicin was established and supported by proton beam radiotherapy. Two-year follow-up revealed no disease recurrence.

Interdisciplinary and cross-sectoral perioperative care model in cardiac surgery: implementation in the setting of minimally invasive heart valve surgery (INCREASE)-study protocol for a randomized controlled trial.

BACKGROUND: Valvular heart diseases are frequent and increasing in prevalence. Minimally invasive heart valve surgery embedded in an interdisciplinary enhanced recovery after surgery (ERAS) program may have potential benefits with regard to reduced length of stay and improved patient reported outcomes. However, no prospective randomized data exist regarding the superiority of ERAS program for the patients' outcome. METHODS: We aim to randomize (1:1) a total of 186 eligible patients with minimally invasive heart valve surgery to an ERAS program vs. standard treatment at two centers including the University Medical Center Hamburg-Eppendorf, Germany, and the University Hospital Augsburg, Germany. The intervention is composed out of pre-, peri-, and postoperative components. The preoperative protocol aims at better preparation for the operation with regard to physical activity, nutrition, and psychological preparedness. Intraoperative anesthesiologic and surgical management are trimmed to enable an early extubation. Patients will be transferred to a specialized postoperative anesthesia care unit, where first mobilization occurs 3 h after surgery. Transfer to low care ward will be at the next day and discharge at the fifth day. Participants in the control group will receive treatment as usual. Primary endpoints include functional discharge at discharge and duration of in-hospital care during the first 12 months after index surgery. Secondary outcomes include health-related quality of life, health literacy, and level of physical activity. DISCUSSION: This is the first randomized controlled trial evaluating the effectiveness of an ERAS process after minimally invasive heart valve surgery. Interprofessional approach is the key factor of the ERAS process and includes in particular surgical, anesthesiological, physiotherapeutic, advanced nursing, and psychosocial components. A clinical implication guideline will be developed facilitating the adoption of ERAS model in other heart teams. TRIAL REGISTRATION: The study has been registered in ClinicalTrials.gov ( NCT04977362 assigned July 27, 2021).

Bicuspid aortic valve related aortopathy.

Bicuspid aortic valve related aortopathy is known to significantly increase the risk for catastrophic aortic events and, therefore, represents a considerable health burden. Albeit of ongoing research in this field including genetic, molecular, hemodynamic and morphologic aspects, bicuspid aortic valve related aortopathy still represents an imperfectly understood disorder. This lack in knowledge results in a lack of consistency considering different therapeutic approaches. Recent studies have provided new insights into the etiology and clinical impacts of bicuspid aortic valve related aortopathy in different clinical settings, leading to a growing body of opinion towards a more individualized surgical approach than currently provided by the guidelines. Especially valvular hemodynamics-stenosis and regurgitation-seem to have significant impact on the development of bicuspid aortic valve related aortopathy. In this context, there is evidence that regurgitation of bicuspid aortic valves is the more fatal pathomechanism. Furthermore, "age" represents an aspect that should be taken into account when deciding whether to replace the aorta or not, because the diameter depends mainly on a patients age. The same diameter of the aorta in a 70-year old and a 20-year old patient has to be interpreted differently and should, therefore, result in different therapeutic strategies.

New Device for the Treatment of Functional Ischemic Mitral Regurgitation: Proof of Concept in an In Vitro Model.

BACKGROUND: Optimal surgical treatment of functional ischemic mitral regurgitation (FIMR) is still controversy. Due to the underlying pathophysiology, stand-alone ring annuloplasty is assumed with a high recurrence rate of mitral regurgitation, thus additional subvalvular repair techniques might improve the results. This in vitro study introduces a new device for subvalvular mitral valve repair. METHODS: We developed a new device for subvalvular mitral valve repair, consisting of two frames for papillary muscle (PM) attachment, which are connected with two holding bars serving for fixation of the device on an annuloplasty ring. In the first experimental run, porcine mitral valves including the chordae tendineae and PMs were fixated on a holding device, consisting of a holding ring simulating mitral annulus dilation and height-adjustable frames for PM attachment simulating leaflet tethering. In vitro regurgitant volume was determined in a pulse duplicator. Afterward, the frames for PM attachment were replaced by our newly developed device and the measurements were repeated. RESULTS: In the model simulating FIMR, the regurgitant volume was 44.3 ± 12.38 mL/stroke. After subvalvular reconstruction with our new device, the regurgitant volume was significantly reduced to 33.1 ± 11.68 mL/stroke (p = 0.009). CONCLUSION: In this specific in vitro model, our new device for subvalvular mitral valve reconstruction led to a significant reduction of the regurgitant volume, thus representing a promising technique to potentially improve the results of mitral reconstruction in ischemic functional mitral valve regurgitation. Additional studies are required to further investigate and improve our device.

A matter of thrombosis: different thrombus-like formations in balloon-expandable transcatheter aortic valve prostheses.

OBJECTIVES: Transcatheter aortic valve implantation is a treatment strategy for degenerated aortic valve prostheses, but there is some concern regarding valve thrombosis. The optimal anticoagulation strategy for implantation of a transcatheter aortic valve prosthesis remains unclear. METHODS: Aortic root models with the Sapien-XT and S3 prostheses (sizes 23 and 26) fixed in a Perimount Magna Ease bioprosthesis (sizes 23 and 25) were constructed. The haemodynamics of the left ventricle were imitated in a proved in vitro model. Milk was used for coagulation after 90s. Different areas of the leaflets (W: wall coagulation, C: commissure coagulation left/right and S: sinus coagulation) were examined and the number of thrombus-like formations was counted. RESULTS: A total of 54% of the thrombus-like formations were found in the sinus, 28% at the wall area, 13% at the right commissure and 10% at the left commissure. Significant differences were detected at the wall area. S3 prostheses had significantly more thrombus-like formations than the XT prostheses. Additionally, in the S3 prostheses, the thrombus-like formation resembled a film whereas in the XT prostheses, the thrombus-like formation was like the crumbs of a cake. We noted exactly the same pattern in explanted prostheses from patients. CONCLUSIONS: The Sapien prostheses tend to form thromboses due to their flow properties. More than half of the thrombus-like formations were seen in the sinus. The S3 prostheses had significantly more thrombus-like formations than the XT prostheses in the wall area. There are different patterns of thrombus-like formations in XT and S3 prostheses used for transcatheter aortic valve implantation both in vivo and in vitro.

Survival and reoperation pattern after 20 years of experience with aortic valve-sparing root replacement in patients with tricuspid and bicuspid valves.

OBJECTIVE: Remodeling or reimplantation are established operative techniques of aortic valve-sparing root replacement. Long-term follow-up is necessary comparing tricuspid and bicuspid aortic valves. METHODS: A total of 315 patients (tricuspid, n = 225, bicuspid, n = 89, quadricuspid, n = 1; remodeling, n = 101, reimplantation, n = 214) were evaluated. Mean follow-up was 10.1 ± 5.6 and 6.4 ± 4.2 years for the remodeling and reimplantation group, respectively. Longest follow-up was 21.9 years with 99.2% completeness. Mean age of the patients was 55.9 ± 14.3 for the remodeling group and 48.9 ± 14.5 years for the reimplantation group. RESULTS: There was no significant difference in survival between the remodeling and reimplantation group (P = .11). Survival was comparable with the normal population in the reimplantation group (P = .33). Risk factors for late death were age, diabetes, and a greater New York Heart Association classification. Cumulative incidence of reoperation at 10 years was 5.8% for the reimplantation and 11.7% for the remodeling group (P = .65). Overall, there was no difference in the cumulative incidence of reoperation between tricuspid and bicuspid aortic valve patients (P = .13); however, a landmark analysis showed that in the second decade, the cumulative incidence of reoperation was greater in bicuspid aortic valve patients (P < .001). A total of 10 of 11 reoperated bicuspid aortic valves were degenerated. CONCLUSIONS: The remodeling and reimplantation aortic valve-sparing root replacement techniques provided excellent long-term survival. Although the number of patients was relatively small, we provide some hints that in the second decade after the operation, especially in bicuspid aortic valve patients, the risk of reoperation may be increased, needing further evaluation.

Mitral valve replacement with the novel TRIBIO and an established stented bioprosthesis in a sheep model.

OBJECTIVES: Heart valve replacement with a bioprosthesis is one of the most frequently performed procedures in cardiac surgery and represents a highly effective therapy to relieve diseased heart valves. Nevertheless, as postoperatively elevated transvalvular gradients and prosthesis-patient mismatch are reported as shortcomings of the procedure or of the currently used devices, there is a need for novel bioprostheses with improved haemodynamics. This study presents preclinical haemodynamic results after mitral valve replacement with the novel TRIBIO bioprosthesis (TRIBIO) compared with an established bioprosthesis in a sheep model. METHODS: Six female sheep had their mitral valves replaced with the TRIBIO and 3 with the Carpentier-Edwards Perimount, both sized 19 mm. The TRIBIO consists of a flexible valve-bearing crown, a force-decoupled interface and an intra-annular base ring. Mean and peak transvalvular gradients as well as an effective orifice area were monitored in both groups using transthoracic echocardiography over the course of the 90-day study. RESULTS: In both groups, haemodynamic performance diminished over time. The TRIBIO demonstrated overall superior haemodynamics, i.e. lower transvalvular gradients and a larger effective orifice area, although the results were not statistically significant. On Day 90, the mean values for the mean and peak transvalvular gradients and the effective orifice area were 6 mmHg, 10.2 mmHg and 1.2 cm2 for the TRIBIO and 10 mmHg, 15.8 mmHg and 0.8 cm2 for the Carpentier-Edwards Perimount, respectively. CONCLUSIONS: This study demonstrates a trend towards improved preclinical haemodynamic performance following mitral valve replacement with the TRIBIO compared to that with an established bioprosthesis in a sheep model.

Ex vivo hydrodynamics after central and paracommissural edge-to-edge technique: A further step toward transcatheter tricuspid repair?

OBJECTIVES: Transcatheter approaches in heart valve disease became tremendously important and are currently established in the aortic position, but transcatheter tricuspid repair is still in its beginning and remains challenging. Replicating the surgical edge-to-edge technique, for example, with the MitraClip System (Abbott Vascular, Santa Clara, Calif), represents a promising option and has been reported successfully in small numbers of cases. However, up to now, few data considering the edge-to-edge technique as a transcatheter approach are available. This study aims to determine the ex vivo hydrodynamics after the central and paracommissural edge-to-edge technique in different pathologies. METHODS: Because of basal or apical dislocation of papillary muscles, leaflet prolapse or tethering was simulated in porcine tricuspid valves mounted on a flexible holding device. Central and paracommissural edge-to-edge techniques were evaluated successively in these pathologies. Regurgitant volume and mean transvalvular gradient were determined in a pulse duplicator. RESULTS: In this ex vivo model, the isolated edge-to-edge technique reduced tricuspid regurgitation. In the prolapse model, regurgitant volume decreased significantly after central edge-to-edge technique (from 49.4 ± 13.6 mL/stroke to 39.3 ± 14.1 mL/stroke). In the tethering model, both the central and the paracommissural edge-to-edge techniques led to a significant decrease (from 48.7 ± 13.9 to 43.6 ± 15.6 and to 41.1 ± 13.8 mL/stroke). In all cases, the reduction of regurgitant volume was achieved at the cost of significantly increased mean transvalvular gradient. CONCLUSIONS: This study provides a reduction of tricuspid regurgitation after the edge-to-edge technique in the specific experimental setup. Whether this reduction is sufficient to treat tricuspid regurgitation successfully in clinical practice remains to be established. Transcatheter approaches need to be evaluated further, probably with regard to concomitant annuloplasty for higher reduction of tricuspid regurgitation.

Rest and exercise haemodynamics in patients with one of two stented bioprostheses and in healthy controls with small aortic annuli.

OBJECTIVES: Because bioprosthetic aortic valve replacement remains one of the most frequent cardiac surgical procedures, it is necessary to study patient haemodynamics in more detail. Until now, a few studies assessed haemodynamics during exercise, but none with special regard to small aortic annuli. We compared patients who had the differently designed bioprostheses, Trifecta and Perimount Magna Ease (PME), size ≤ 23 mm, and a healthy control group during rest and exercise. METHODS: We determined the mean transvalvular gradient, the effective orifice area (EOA) and the EOA index during rest and exercise using transthoracic echocardiography in 35 patients with the Trifecta (mean age 71.4 years, follow-up 1 year, labelled valve size 21.7 mm), in 16 patients with the PME (mean age 66.2 years, follow-up 2.6 years, labelled valve size 21.6 mm) and in 25 healthy persons. The parameters derived were summarized in a simplified Valve Academic Research Consortium-2 classification to determine prosthetic valve dysfunction. RESULTS: When we compared the Trifecta and the PME, a significant superiority of the Trifecta was seen at rest in mean transvalvular gradient (7.96 vs 12.19 mmHg) and EOA (1.57 vs 1.48 cm2), during exercise in all parameters (mean transvalvular gradient 11.06 vs 19.2 mmHg, EOA 1.77 vs 1.26 cm2, EOA index 0.96 vs 0.67 cm2/m2). The Trifecta showed a physiological increase in the EOA index during exercise. Exercise led to a shift to better simplified Valve Academic Research Consortium-2 categories in the Trifecta and to worse in the PME group. CONCLUSIONS: This study reveals the haemodynamic superiority of the Trifecta to the PME. Especially in small aortic annuli, this difference might have some relevance for clinical and research issues.

Longer-term results, z scores, and decision nomograms for treatment of the ascending aorta in 1693 bicuspid aortic valve operations.

OBJECTIVE: This study aims to fine-tune the decision making for ascending aorta treatment in bicuspid aortic valve surgery. METHODS: A total of 1693 patients with a primary indication for aortic valve surgery were investigated retrospectively with respect to a multifactorial decision-making policy including the z score and the clinical outcome in relation to different techniques for ascending aorta treatment (no intervention n = 1116; intervention n = 577 either by ascending aorta replacement n = 404 or aortoplasty n = 173). Follow-up was 99.5% complete (mean 7.0 ± 4.4 years, range 0-17.7 years, 11,895 patient-years). RESULTS: Hospital mortality was 1.2% for the no-intervention group and 0.9% for the intervention group and was not different between groups (P = .629). Survival compared with the adjusted normal population was lower for both groups (no intervention: P < .001) but not by such a great margin for the intervention group (P = .27). Determinants for death were not related to the ascending aorta treatment. Aortoplasty led to significantly more reoperations (P = .002). The z score thresholds for intervention on the ascending aorta were greater for younger patients, intervention was more liberal in young age, depicted in nomograms. CONCLUSIONS: In our study, ascending aorta intervention could be performed with low hospital mortality and obviously did not add to the overall mortality compared with no intervention. Ascending aorta replacement was the most definite intervention. The multifactorial decision for ascending aorta intervention including the z score of the ascending aorta was more liberal in younger patients compared to the simple aortic size guidelines and provided excellent results. However, generalizability needs further data.

HeartMate III Left Ventricular Assist Device Thrombosis Triggered by an Automatic Implantable Cardioverter-Defibrillator Shock.

We report the case of an HeartMate III left ventricular assist device (LVAD) thrombosis triggered by a shock from an automatic implantable cardioverter defibrillator, releasing a left ventricular thrombus sucked in the LVAD inflow cannula. With LVAD low flow only the increase in motor temperature gave a hint of the thrombosis and a computer tomography scan confirmed the diagnosis. Pump exchange was performed with an uneventful outcome.

First ex vivo and preliminary sheep model results of the new TRIBIO aortic valve bioprosthesis in small aortic annuli.

OBJECTIVES: Small aortic annuli are challenging in aortic valve replacement. Prosthesis-patient mismatch, accompanied by high transvalvular gradients and small orifice area, is an often faced problem impairing postoperative outcome. The new TRIBIO bioprosthesis aims to enable enhanced haemodynamics, being increasingly important with decreasing annular size. This study compares ex vivo hydrodynamics of TRIBIO with 2 established bioprostheses in small annuli at different stroke volumes, simulating 'rest' and 'exercise', and evaluates haemodynamics of TRIBIO in a sheep model. METHODS: Ex vivo: Porcine aortic roots were hardened with glutaraldehyde, approaching the stiffness of decalcified roots. Each bioprosthesis (TRIBIO, Trifecta™, Perimount® Magna Ease), size 19 mm, was implanted in each aortic root and inserted into a pulse duplicator, determining hydrodynamics and geometric orifice area at different stroke volumes (74, 90, 104 ml). Sheep model: Postoperative transvalvular gradients were assessed after implantation of 19 mm TRIBIO in aortic position. RESULTS: Ex vivo: Mean transvalvular gradients were lowest in TRIBIO (7.3, 8.7, 10.2 mmHg at 74, 90, 104 ml) with significant difference to Perimount® Magna Ease. Geometric orifice area in TRIBIO was 2.7 cm2 and significantly larger compared to Perimount® Magna Ease and Trifecta™. Opening of TRIBIO was uniform and apparently complete, whereas leaflet's outward movement was restricted particularly in Perimount® Magna Ease. Sheep model: TRIBIO presented with low transvalvular gradients (δpmean 4.1 ± 2 mmHg, δpmax 7.8 ± 4.6 mmHg), unimpaired leaflet motion and no central or paravalvular leakage. CONCLUSIONS: Ex vivo, the TRIBIO achieved superior hydrodynamics compared to latest generation bioprostheses. These excellent data are supported by very low transvalvular gradients in a preliminary sheep model.

In vitro coronary flow after transcatheter aortic valve-in-valve implantation: A comparison of 2 valves.

BACKGROUND: Transcatheter aortic valve-in-valve implantation (TAVI-ViV) is an evolving treatment strategy for degenerated surgical aortic valve bioprostheses (SAVBs). However, there is some concern regarding coronary obstruction, especially after TAVI-ViV in calcified SAVBs with externally mounted leaflets. We investigated in vitro coronary flow and hydrodynamics after TAVI-ViV using 2 modern SAVBs with externally and internally mounted leaflets. METHODS: Aortic root models including known risk factors for coronary obstruction served for the implantation of SAVBs with either externally mounted leaflets (St Jude Trifecta, size 25) or internally mounted leaflets (Edwards Perimount Magna Ease, size 25). Left and right coronary flow, as well as hydrodynamic parameters, were measured before and after TAVI-ViV with an Edwards Sapien XT transcatheter heart valve, size 23. After the first experimental run, the SAVB leaflets were artificially "calcified," and the measurements were repeated. RESULTS: In both models, noncalcified and calcified, there was no significant reduction in coronary flow with either the Trifecta or the Perimount Magna Ease SAVB. After TAVI-ViV, in the noncalcified model, the mean pressure gradient was increased (Trifecta, P = .0001; Perimount Magna Ease, P = .006) and the geometric orifice area was decreased (P < .001 for both), whereas in the calcified model, the mean pressure gradient was decreased (P < .001 for both) and the geometric orifice area was increased (P < .001 for both). CONCLUSIONS: In our specific model, in noncalcified as well as calcified conditions, TAVI-ViV is feasible with either SAVB (Trifecta or Perimount Magna Ease) without an increased risk of coronary obstruction. Nevertheless, before clinical application of these results, thorough preoperative assessment, considering the different limitations of this model, is mandatory.

Long-Term (up to 21 Years) Follow Up after Biological and Mechanical Aortic Valve Replacement in Younger Patients.

BACKGROUND: Despite the limited durability of biological aortic valves, increasing numbers of younger patients are choosing to receive them, due mainly to the lack of a need for permanent anticoagulation. Few data exist, however, regarding the outcomes of valve replacement in patients aged <55 years, and additional data are required in this patient population. METHODS: Between 1993 and 2014, at the authors' institution, a total of 448 patients (237 males, 101 females; mean age 45.8 ± 8.0 years) underwent aortic valve replacement (AVR) with either a mechanical prosthesis (M1 group, n = 318) or a biological prosthesis (B1 group, n = 130). The mean follow up was 8.5 ± 5.8 years (range: 4 days to 20.8 years) in the M1 group, and 4.9 ± 4.6 years (range: 2 days to 21 years) in the B1 group. The entire collective (EC) (n = 448 patients) was compared and analyzed with a selective collective (SC) (n = 109 patients) after exclusion of patients with concomitant procedures or comorbidities (M2 group, n = 74; B2 group, n = 35). RESULTS: Early mortality was greater after biological AVR in the EC (6.1% versus 1.9%), but in the SC no early deaths were observed after both primary and redo procedures. The reoperation rate was greater after biological AVR in both collectives. The late mortality, survival and endocarditis rates were comparable in both collectives. Bleeding occurred more often in the EC after mechanical AVR. CONCLUSIONS: Biological AVR in patients aged <55 years provides satisfactory outcomes, whereas reoperations were performed less commonly in patients with mechanical valve substitutes. In selective patients, AVR can be performed with zero mortality.

Does Undersizing of Transcatheter Aortic Valve Bioprostheses during Valve-in-Valve Implantation Avoid Coronary Obstruction? An In Vitro Study.

Background The transcatheter aortic valve-in-valve implantation (TAViVI) is an evolving treatment strategy for degenerated surgical aortic valve bioprostheses (SAVBs) in patients with high operative risk. Although hemodynamics is excellent, there is some concern regarding coronary obstruction, especially in SAVB with externally mounted leaflet tissue, such as the Trifecta (St. Jude Medical Inc., St. Paul, Minnesota, United States). We investigated coronary flow and hydrodynamics before and after TAViVI in a SAVB with externally mounted leaflet tissue (St. Jude Medical, Trifecta) with an undersized transcatheter aortic valve bioprosthesis (Edwards Sapien XT; Edwards Lifesciences LLC, Irvine, California, United States) in an in vitro study. Materials and Methods An aortic root model was constructed incorporating geometric dimensions known as risk factors for coronary obstruction. Investigating the validity of this model, we primarily performed recommended TAViVI with the Sapien XT (size 26 mm) in a Trifecta (size 25 mm) in a mock circulation. Thereafter, hydrodynamic performance and coronary flow (left/right coronary diastolic flow [lCF/rCF]) after TAViVI with an undersized Sapien XT (size 23 mm) in a Trifecta (size 25 mm) were investigated at two different coronary ostia heights (COHs, 8 and 10 mm). Results Validation of the model led to significant coronary obstruction (p < 0.001). Undersized TAViVI showed no significant reduction with respect to coronary flow (lCF: COH 8 mm, 0.90-0.87 mL/stroke; COH 10 mm, 0.89-0.82 mL/stroke and rCF: COH 8 mm, 0.64-0.60 mL/stroke; COH 10 mm, 0.62-0.58 mL/stroke). Mean transvalvular gradients (4-5 mm Hg, p < 0.001) increased significantly after TAViVI. Conclusions In our in vitro model, undersized TAViVI with the balloon-expandable Sapien XT into a modern generation SAVB (Trifecta) successfully avoided coronary flow obstruction.