Conventional Surgical Aortic Valve Replacement Research Articles

IMPROVED EARLY OUTCOMES IN WOMEN UNDERGOING AORTIC VALVE INTERVENTIONS

Abstract Surgical aortic valve replacement (SAVR) in female patients has been associated with higher mortality (up to 3.3–8.9%) and postoperative complication rates when compared with their male counterparts. In recent years, TAVI has been shown to provide a greater benefit than SAVR in women. We sought to assess the early outcomes of the contemporary aortic valve intervention practice (surgical and transcatheter) in patients referred to our cardiac surgery unit. The data of consecutive patients who underwent isolated aortic valve intervention for aortic valve stenosis during the 2018–2022 period were retrieved from our internal database. Several preoperative, intraoperative, and postoperative variables were analyzed, including the predicted risk of a prosthesis–patient mismatch. Nine hundred and fifty–five consecutive patients—514 women and 441 men—were included. Among them, 480 patients—276 female and 204 male—received a transcatheter procedure, and 475—238 women and 237 men—had conventional SAVR. The women were older and had higher EuroSCORE II, while the male patients presented a higher incidence of cardiovascular comorbidities. There was no difference in mortality or major postoperative complication rates after either the surgical or transcatheter procedures between the female and male populations. The availability and targeted use of different techniques and technologies have enabled the safe and effective treatment of female patients treated for severe symptomatic aortic valve stenosis with similar results when compared with their male counterparts.

Postoperative quality of life and pain after upper hemisternotomy and conventional median sternotomy for aortic valve replacement: results of a randomized clinical trial.

Surgical aortic valve replacement through conventional sternotomy yields excellent results. Minimally invasive techniques are deemed equally safe and serve as a viable and less traumatic alternative. However, it is unclear how both surgical techniques affect patient-reported outcomes. The objective of this trial is to compare postoperative cardiac-related quality of life and postoperative pain after upper hemisternotomy and conventional surgical aortic valve replacement. In this single-centre, open-label, investigator-initiated randomized clinical trial, patients were randomized to upper hemisternotomy or conventional full median sternotomy. Patients unable to undergo randomization were monitored prospectively (registry group). Primary outcome was cardiac-specific quality of life, measured with the Kansas City Cardiomyopathy Questionnaire up to 1 year postoperatively. Patients undergoing upper hemisternotomy had a significantly higher physical limitation domain score across all postoperative time points than patients undergoing conventional surgical aortic valve replacement (estimated mean difference 2.12 points; P = 0.014). Patients undergoing upper hemisternotomy were more likely to have a pain score <30 the first 2 days postoperatively than patients undergoing conventional surgical aortic valve replacement (odds ratio 2.63; P = 0.007). This was associated with reduced opioid analgesic intake. Postoperative surgical outcome did not differ between both groups. Surgical aortic valve replacement through both conventional sternotomy and upper hemisternotomy resulted in clinically similar and important improvements in quality of life, with a small advantage for upper hemisternotomy, while there was no compromise in safety.

TransCatheter aortic valve implantation and fractional flow reserve-guided percutaneous coronary intervention versus conventional surgical aortic valve replacement and coronary bypass grafting for treatment of patients with aortic valve stenosis and multivessel or advanced coronary disease: The transcatheter valve and vessels trial (TCW trial): Design and rationale

Background: Patients with severe aortic stenosis (AS) frequently present with concomitant obstructive coronary artery disease (CAD). In those, current guidelines recommend combined coronary artery bypass grafting (CABG) and surgical aortic valve replacement (SAVR) as the preferred treatment option, although this surgical approach is associated with a high rate of clinical events. Combined transcatheter aortic valve implantation (TAVI) and percutaneous coronary intervention (PCI) with or without FFR have evolved as a valid alternative for cardiac surgery in patients with AS and multivessel or advanced CAD. To date, no dedicated trial has prospectively evaluated the outcomes of a percutaneous versus surgical treatment for patients with both severe AS and CAD. Aims: To investigate whether fractional-flow reserve (FFR)-guided PCI and TAVI is non-inferior to combined CABG and SAVR for the treatment of severe AS and multivessel or advanced CAD. Methods: The Transcatheter Valve and Vessels (TCW) trial (clinicaltrial.gov: NCT03424941) is a prospective, randomized, controlled, open label, international trial. Patients ≥ 70 years with severe AS and multivessel (≥ 2 vessels) or advanced CAD, deemed feasible by the heart team for both; a full percutaneous or surgical treatment, will be randomised in a 1:1 fashion to either FFR-guided PCI followed by TAVI (intervention arm) vs. CABG and SAVR (control arm). The primary endpoint is a patient-oriented composite of all-cause mortality, myocardial infarction, disabling stroke, unscheduled clinically-driven target vessel revascularization, valve re-intervention, and life threatening or disabling bleeding at one year. The TCW trial is powered for non-inferiority, and if met, superiority will be tested. Assuming a primary endpoint rate of 30% in the CABG-SAVR arm, with a significance level α of 5%, a non-inferiority limit delta of 15% and a loss to follow-up of 2%, a total of 328 patients are needed to obtain a power of 90%. The primary endpoint analysis is performed on an intention-to-treat basis. Summary: The TCW Trial is the first prospective randomized trial that will study if a less invasive percutaneous treatment for severe AS and concomitant advanced CAD (i.e., FFR-guided PCI - TAVI) is non-inferior to the guidelines recommended approach (CABG-SAVR).

Improved Early Outcomes in Women Undergoing Aortic Valve Interventions.

Surgical aortic valve replacement (SAVR) in female patients has been associated with higher mortality (up to 3.3-8.9%) and postoperative complication rates when compared with their male counterparts. In recent years, TAVI has been shown to provide a greater benefit than SAVR in women. We sought to assess the early outcomes of the contemporary aortic valve intervention practice (surgical and transcatheter) in patients referred to our cardiac surgery unit. The data of consecutive patients who underwent isolated aortic valve intervention for aortic valve stenosis during the 2018-2022 period were retrieved from our internal database. Several preoperative, intraoperative, and postoperative variables were analyzed, including the predicted risk of a prosthesis-patient mismatch. Nine hundred and fifty-five consecutive patients-514 women and 441 men-were included. Among them, 480 patients-276 female and 204 male-received a transcatheter procedure, and 475-238 women and 237 men-had conventional SAVR. The women were older and had higher EuroSCORE II, while the male patients presented a higher incidence of cardiovascular comorbidities. There was no difference in mortality or major postoperative complication rates after either the surgical or transcatheter procedures between the female and male populations. The availability and targeted use of different techniques and technologies have enabled the safe and effective treatment of female patients treated for severe symptomatic aortic valve stenosis with similar results when compared with their male counterparts.

Clinical and hemodynamic outcomes of the Perceval sutureless aortic valve from a real-world registry.

Perceval sutureless valve has been in clinical use for >15 years. The aim of this study is to report the real-word clinical and haemodynamic performance from the SURE-aortic valve replacement international prospective registry in patients who underwent aortic valve replacement with Perceval valve. From 2011 to 2021, patients from 55 institutions received a Perceval valve. Postoperative, follow-up, and echocardiographic outcomes were analysed. A total of 1652 patients were included; mean age was 75.3 ± 7.0 years (53.9% female); mean EuroSCORE II was 4.1 ± 6.3. Minimally invasive approach was performed in 45.3% of patients; concomitant procedures were done in 35.9% of cases. Within 30 days, 0.3 and 0.7% valve-related reinterventions were reported. Transient ischaemic attack, disabling and non-disabling strokes were limited (0.4%, 0.4% and 0.7%, respectively). Pacemaker implant was required in 5.7% of patients. Intra-prosthetic regurgitation ≥2 was present in 0.2% of cases, while paravalvular leak ≥2 in only 0.1%. At a maximum follow-up of 8 years, 1.9% of cardiovascular deaths and 0.8% of valve-related reintervention occurred. Among the 10 cases of structural valve deterioration (mean 5.6 ± 1.4 years after implant; range: 2.6-7.3 years), 9 were treated with a transcatheter vale-in-valve implantation and 1 with explant. Mean pressure gradient decreased from 45.8 ± 16.5 mmHg preoperatively to 13.3 ± 5.2 mmHg at discharge and remained stable during follow-up. This experience represents the largest prospective real-world cohort of patients treated with Perceval showing that Perceval is a safe and effective alternative to conventional surgical aortic valve replacement, providing favourable clinical and haemodynamic results also at mid-term follow-up.

Network Meta-Analysis Comparing Transcatheter, Minimally Invasive, and Conventional Surgical Aortic Valve Replacement

The landscape of aortic valve replacement (AVR) has evolved dramatically over the years, but time-varying outcomes have yet to be comprehensively explored. This study aimed to compare the all-cause mortality among 3 AVR techniques: transcatheter (TAVI), minimally invasive (MIAVR), and conventional AVR (CAVR). An electronic literature search was performed for randomized controlled trials (RCTs) comparing TAVI with CAVR and RCTs or propensity score-matched (PSM) studies comparing MIAVR with CAVR or MIAVR to TAVI. Individual patient data for all-cause mortality were derived from graphical reconstruction of Kaplan-Meier curves. Pairwise comparisons and network meta-analysis were conducted. Sensitivity analyses were performed in the TAVI arm for high risk and low/intermediate risk, as well as patients who underwent transfemoral (TF) TAVI. A total of 27 studies with 16,554 patients were included. In the pairwise comparisons, TAVI showed superior mortality to CAVR until 37.5months, beyond which there was no significant difference. When restricted to TF TAVI versus CAVR, a consistent mortality benefit favoring TF TAVI was seen (shared frailty hazard ratio [HR] = 0.86, 95% confidence interval [CI] = 0.76 to 0.98, p = 0.024). In the network meta-analysis involving majority PSM data, MIAVR demonstrated significantly lower mortality than TAVI (HR = 0.70, 95% CI = 0.59 to 0.82) and CAVR (HR = 0.69, 95% CI = 0.59 to 0.80); this association remained compared with TF TAVI but with a lower extent of benefit (HR = 0.80, 95% CI = 0.65 to 0.99). In conclusion, the initial short- to medium-term mortality benefit for TAVI over CAVR was attenuated over the longer term. In the subset of patients who underwent TF TAVI, a consistent benefit was found. Among majority PSM data, MIAVR showed improved mortality compared with TAVI and CAVR but less than the TF TAVI subset, which requires validation by robust RCTs.

Conventional Biological versus Sutureless Aortic Valve Prostheses in Combined Aortic and Mitral Valve Replacement.

Sutureless aortic valve prostheses have proven to provide a significant decrease in procedural, cardiopulmonary bypass and cross-clamp time, leading to a significant reduction in mortality risk in elderly high-risk cohorts. In this study, we sought to review our institutional experience on the sutureless aortic valve replacement (SU-AVR) and the concomitant mitral valve replacement (SMVR), comparing the combined conventional surgical aortic valve replacement (SAVR) with SMVR. Between March 2018 and July 2022, 114 consecutive patients underwent a combined aortic and mitral valve replacement at our institution. We stratified the patients according to the operative procedures into two groups and matched them 1:2: Group 1 underwent a combined conventional SAVR and SMVR (n = 46), and Group 2 included combined SU-AVR with Perceval prosthesis and SMVR (n = 23). No significant differences in the preoperative characteristics were present. SU-AVR combined with SMVR demonstrated excellent haemodynamic performance, comparable to that of SAVR plus SMVR, with median postoperative gradients over the aortic valve of 4 mmHg (IQR 3.0-4.0) in Group 1 and 4 mmHg (IQR 3.0-4.0) in Group 2 (p = 0.67). There was no significant difference in the occurrence of postoperative major adverse events such as death, stroke, myocardial infarction and kidney failure between the groups. There was also no significant difference in the permanent pacemaker implantation rate, paravalvular leakage or valve dislocation. We also could not detect any significant difference in postoperative mortality between the groups. SU-AVR has proven to be a reliable alternative to conventional valve prostheses in patients with multivalve disease undergoing combined aortic and mitral valve replacement, offering shorter procedural time and outstanding hemodynamic performance compared to the conventional surgical method.

Comparison of transcatheter, minimally invasive and conventional surgical aortic valve replacement: a systematic review and network meta-analysis

Abstract Funding Acknowledgements Type of funding sources: None. Background/Introduction The landscape of aortic valve replacement (AVR) has evolved dramatically over the years, but long-term outcomes have yet to be comprehensively explored. Purpose To compare long-term mortality among three AVR techniques: transcatheter (TAVI), minimally invasive (MIAVR), and conventional surgical AVR (CAVR). Methods An electronic literature search was performed for randomized controlled trials (RCTs) comparing TAVI to CAVR, and RCTs or propensity score-matched (PSM) studies comparing MIAVR to CAVR or MIAVR to TAVI. Individual patient data for all-cause mortality was derived from graphical reconstruction of digitized Kaplan-Meier curves. Pairwise comparisons followed by network meta-analysis were conducted. Sensitivity analyses were performed in the TAVI arm for high risk and low/intermediate risk as well as transfemoral (TF-TAVI) patients. Results A total of 27 studies involving 16,554 patients were included. In the pairwise comparison of TAVI versus CAVR, TAVI showed superior mortality to CAVR until 39.5 months, beyond which there was no significant difference in longer term mortality. When restricted to TF-TAVI versus CAVR, consistent mortality benefit favoring TAVI was seen (shared-frailty hazard ratio [HR]=1.17, 95%CI=1.03-1.33, p=0.016). In the network meta-analysis involving majority PSM data, MIAVR was associated with significantly lower mortality than TAVI (HR=0.69, 95%CI=0.59-0.82) and CAVR (HR=0.68, 95%CI=0.58-0.80); this significant association was not seen when compared to TF-TAVI patients. Conclusions An initial short-medium term mortality benefit for TAVI over CAVR was noted but this benefit was attenuated over the longer term. In the subset of TF-TAVI patients, this long-term mortality benefit persisted, suggesting that non-TF techniques are associated with higher mortality. Amongst majority PSM data, MIAVR showed improved mortality compared to TAVI and CAVR but this was not seen in the TF-TAVI subset. This suggests that MIAVR may have a role in treating patients who are ineligible for TF-TAVI in experienced centers, and future RCTs are needed to conclusively validate this.

194 THROMBOEMBOLIC ACUTE ST ELEVATION MYOCARDIAL INFARCTION AFTER TRANSCATHETER VALVE IMPLANTATION

Abstract Transcatheter aortic valve implantation (TAVI) is an established treatment of severe symptomatic aortic valve stenosis and is an effective and less invasive treatment option compared with conventional surgical aortic valve replacement (SAVR) for patients considered inoperable or at high surgical risk. Thromboembolic and bleeding complications negatively impact recovery and survival after TAVI. This case describes one of the few reported TAVI-associated myocardial infarction due to thrombosis of the prosthetic aortic valve. A 82-years-old woman, suffering from severe symptomatic aortic stenosis, underwent TAVI. Before the procedure, coronary artery disease was excluded by invasive coronary angiography. Since the time of the discharge the patient didn't assume any therapy with aspirin or other antithrombotic drugs. A month after TAVI she complained persistent epigastric pain and was admitted to our department for anterior ST elevation myocardial infarction. Coronary angiography highlighted a monovascular coronary artery disease with thrombotic occlusion of the first diagonal and of the distal left anterior descending coronary artery. In consideration of the thrombotic load thyrofiban was started and it was performed a chest contrast CT which confirmed the diagnostic suspicion of bioprosthetic valve thrombosis. She was first treated with unfractionated heparin (UFH) and then oral anticoagulant therapy with warfarin was started. Echocardiograms (echo) showed a severely reduced systolic function (EF 25%) and high trans-prosthetic gradients (mean transprosthetic pressure gradient of 30 mmHg). On the 8th day after hospitalization she complained chest pain with evidence of moderate pericardial effusion. Epistenocardica pericarditis was therefore diagnosed and the patient started acetylsalicylic acid therapy with progressive clinical, instrumental and laboratory improvement. After 10 days of anticoagulation therapy, she underwent a transesophageal echocardiogram which turned out negative for bioprosthetic valve thrombosis. The predischarge transthoracic echocardiography showed severely reduced systolic function (EF 30%) with a mean transprothesic gradient of 12 mmHg; the circumferential pericardial effusion was mild-moderate but not haemodynamically significative. Therapy at discharged included warfarin and aspirin. Ten days after an echo showed a reduction of the pericardial effusion, an improved systolic function (EF 42%) and mean transprothesic gradient not changed significantly since discharge. Prosthetic valve thrombosis has been reported in up to 40% of patients after TAVI and this case hightlights the importance of antithrombotic therapy after this procedure. Therapeutic anticoagulation appears to be the only non-invasive treatment for resolving valve thrombosis but it is not clear how long this therapy should last for the prevention of prosthetic valve thrombosis.

Results of a Multimodal Approach for the Launch of a Ross Program

BackgroundThere has been renewed interest in the Ross procedure in young patients with aortic valve disease. We describe the details and results of a systematic strategy to launch a new Ross program. MethodsOur department developed a multidisciplinary educational program that involved all practitioners involved in the care of potential Ross patients. A core group of surgeons underwent extensive hands-on technical preparation. Selection of patients was reviewed by a multidisciplinary team. Patient characteristics, operative details, and postoperative outcomes were analyzed. ResultsBetween March 2021 and March 2022, 22 consecutive patients underwent Ross procedure at our institution. The mean age of the patients at time of operation was 40.4 ± 10.2 years, and most patients had no medical comorbidities (12/22). The most common indication for operation was aortic stenosis (13/22), followed by mixed aortic stenosis and aortic insufficiency (7/22). There were no deaths. Postoperatively, no patient required blood transfusion or reexploration for hemorrhage. All patients were discharged home on mean hospital day 5.9 ± 1.1. On predischarge echocardiography, there was a significant reduction in mean aortic gradients preoperatively to postoperatively (49 ± 20 mm Hg vs 4 ± 1 mm Hg; P < .01) without aortic insufficiency or a change in left or right ventricular function. ConclusionsWe demonstrate that with multidisciplinary education and extensive hands-on surgical preparation under proctored supervision, a Ross program can be initiated safely with excellent short-term results and perioperative risk that mimics that of conventional surgical aortic valve replacement.

Biomechanics of Transcatheter Aortic Valve Implant.

Transcatheter aortic valve implantation (TAVI) has grown exponentially within the cardiology and cardiac surgical spheres. It has now become a routine approach for treating aortic stenosis. Several concerns have been raised about TAVI in comparison to conventional surgical aortic valve replacement (SAVR). The primary concerns regard the longevity of the valves. Several factors have been identified which may predict poor outcomes following TAVI. To this end, the lesser-used finite element analysis (FEA) was used to quantify the properties of calcifications which affect TAVI valves. This method can also be used in conjunction with other integrated software to ascertain the functionality of these valves. Other imaging modalities such as multi-detector row computed tomography (MDCT) are now widely available, which can accurately size aortic valve annuli. This may help reduce the incidence of paravalvular leaks and regurgitation which may necessitate further intervention. Structural valve degeneration (SVD) remains a key factor, with varying results from current studies. The true incidence of SVD in TAVI compared to SAVR remains unclear due to the lack of long-term data. It is now widely accepted that both are part of the armamentarium and are not mutually exclusive. Decision making in terms of appropriate interventions should be undertaken via shared decision making involving heart teams.

Cost-Utility Analysis of Transcatheter Aortic Valve Implantation versus Surgery in High-Risk Severe Aortic Stenosis Patients in Thailand.

BackgroundTranscatheter aortic valve implantation (TAVI) has been shown to be effective in treating patients with severe symptomatic AS who are high-risk population for conventional surgical aortic valve replacement (SAVR). This study aimed to evaluate the cost–utility of TAVI compared with SAVR for severe aortic stenosis with high surgical risk in Thailand.MethodsLifetime costs and quality-adjusted life years (QALYs) from societal and healthcare perspectives were estimated using a two-part constructed model. The study population consisted of 80-year-old severe AS patients with high surgical risk. Mortality and complication rates were obtained from landmark trials. All cost–related and utility data were based on Thai population. Costs and QALYs were discounted at a rate of 3% annually and presented as 2021 values. Incremental cost-effectiveness ratios (ICERs) were computed. Sensitivity analyses were performed both deterministically and probabilistically.ResultsThe findings from a societal perspective revealed that TAVI treatment was associated with higher cost (THB 1,551,895 [USD 47,371.64] vs THB 548,438 [USD 16,741.09] and higher QALYs than SAVR treatment (3.15 vs 2.31 QALYs). The estimated ICER was THB 1,196,191/QALY (USD 36,513.78 QALY). For the healthcare system perspective, TAVI treatment resulted in a higher total cost than SAVR treatment (THB 1,451,317 [USD 44,301.49] vs THB 432,398 [USD 13,198.95]) with comparable gains in LY and QALYs from a societal perspective. The ICER was calculated to be THB 1,214,624/QALY (USD 37,076.42/QALY). TAVI was not cost-effective at the Thai willingness to pay (WTP) threshold of THB 160,000/QALY (USD 4884/QALY). The model was the most sensitive to changes in TAVI valve cost and TAVI or SAVR treatment utilities.ConclusionTAVI is not a cost-effective strategy in patients with severe AS who are at high surgical risk when compared to SAVR at the WTP of THB 160,000/QALY (USD 4884/QALY) from the perspectives of society and the healthcare system.

Non-Inferiority of Sutureless Aortic Valve Replacement in the TAVR Era: David versus Goliath.

Background: The rapid development of transcatheter treatment methods has made transcatheter aortic valve replacement (TAVR) a feasible alternative to conventional surgical aortic valve replacement (SAVR). Recently, indications for TAVR have been expanded to intermediate- and low-risk patients, although there still remains a portion of ineligible patients. We sought to evaluate and compare our experience with sutureless SAVR and transapical TAVR in the “grey-area” of patients unsuitable for transfemoral access. Methods: Between April 2018 and June 2021, 248 consecutive patients underwent a sutureless SAVR (SU-SAVR) or TA-TAVR at our institution. We performed a pair-matched analysis and identified 56 patient pairs based on the EuroSCORE II. All transcatheter procedures were performed using SAPIEN XT/3™ prostheses, while all surgical procedures deployed the Perceval (LivaNova) aortic valve. Results: All patients presented with multiple comorbidities as reflected by the median EuroSCORE-II of 3.1% (IQR 1.9–5.3). Thirty-four patients from the surgical group (60.7%) underwent a concomitant myocardial revascularization. There was no significant difference in major adverse events, pacemaker implantation or postoperative mortality during follow-up. Both interventions demonstrated technical success with similar mean postoperative pressure gradients at follow-up and no cases of paravalvular leakage. Conclusions: Sutureless aortic valve replacement constitutes a feasible treatment alternative for patients with aortic valve disease who are ineligible for transfemoral access route and/or require concomitant coronary revascularization. With its excellent hemodynamic performance, similar survival compared to TA-TAVR, and high cost-efficiency without compromising the postoperative outcomes and in-hospital length of stay SU-AVR might be considered for patients in the “grey-area” between TAVR and SAVR.

Transcatheter aortic valve implantation via transaortic surgical access

We report a case of an 80-years&amp;ndash;old patient with a severe, symptomatic aortic valve stenosis and history of ischemic heart disease, previously treated by coronary artery bypass graft surgery. The patient was contraindicated for conventional surgical aortic valve replacement (SAVR) due to advanced age and underlying comorbidity, therefore transcatheter aortic valve implantation (TAVI) has been offered. The access options for the procedure were restricted by the underlying generalized atherosclerosis process causing peripheral vessel disease. We have chosen transaortic access for the patient which in that case was the only possible option. The transaortic valve implantation was successful with satisfactory hemodynamic results, improvement in functional class heart failure of the patient and preserving the function and anatomy of the coronary artery bypass graft. This case report demonstrates that the lack of favorable transfemoral access for TAVI should not be a limitation by itself for the procedure, rather than be stimulus for searching and using new and alternative access for it.

Relationship between the serum GDF-15 concentration and muscle function in female patients receiving aortic valve replacement (TAVR, SAVR): Comparison with healthy elderly female subjects.

PurposeSarcopenia is closely associated with postoperative prognosis in patients undergoing cardiovascular surgery. Growth differentiation factor (GDF)-15 is involved in the pathogenesis of cardiovascular disease. We examined the relationship between the serum GDF-15 concentration and muscle function in patients receiving aortic valve replacement and healthy elderly subjects.MethodsForty-three female patients undergoing aortic valve surgery (79.9 ± 6.4 years; transcatheter aortic valve replacement [TAVR] n = 19, conventional surgical aortic valve replacement [SAVR] n = 24) and 64 healthy elderly female subjects (75.9 ± 6.1 years) were included. Walking speed, grip strength, and skeletal muscle mass index (SMI) by a multifrequency bioelectrical impedance analyzer were measured to determine the presence of sarcopenia. Preoperative serum GDF-15 concentration was measured by enzyme-linked immunosorbent assay.ResultsThe GDF-15 level was higher in patients receiving aortic valve replacement than in healthy elderly subjects (aortic valve replacement: 1624 ± 1186 pg/mL vs. healthy: 955 ± 368 pg/mL, p < 0.001). Multivariate linear regression analysis showed that the serum GDF-15 level determined grip strength independently of the high-sensitivity C-reactive protein level and eGFR, even after adjusting for age (β = -0.318, p = 0.025). Sarcopenia was found in 12.5% of healthy elderly subjects, 83.3% of patients with TAVR, and 64.3% of patients with SAVR. The GDF-15 concentration that defined sarcopenia was 1109 pg/mL in subjects including patients receiving aortic valve replacement.ConclusionsThe preoperative serum GDF-15 concentration, which was higher in female patients receiving aortic valve replacement than in healthy elderly subjects, may be a serum marker of sarcopenia.

Preliminary clinical experience of the novel transcatheter aortic valve system Prizvalve® for the treatment of severe aortic stenosis

Objective: To evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) with the novel Prizvalve® system in treating severe aortic stenosis. Methods: This is a single-center, prospective, single-arm, observational study. A total of 11 patients with severe aortic stenosis with high risk or inappropriate for conventional surgical aortic valve replacement (SAVR) were included, and TAVI was achieved with the Prizvalve® system between March 2021 and May 2021 in West China Hospital. Transthoracic echocardiography (TTE) was performed immediately after prosthesis implantation to evaluate mean transaortic gradient and maximal transaortic velocity. The device success rate was calculated, which was defined as (1) the device being delivered via the access, deployed, implanted and withdrawn, (2) mean transaortic gradient<20 mmHg (1 mmHg=0.133 kPa) or a maximal transaortic velocity<3 m/s post TAVI, and without severe aortic regurgitation or paravalvular leak post TAVI. TTE was performed at 30 days after the surgery, and all-cause mortality as well as the major cardiovascular adverse events (including acute myocardial infarction, disabling hemorrhagic or ischemic stroke) up to 30 days post TAVI were analyzed. Results: The age of 11 included patients were (78.1±6.3) years, with 8 males. A total of 10 patients were with NYHA functional class Ⅲ or Ⅳ. Devices were delivered via the access, deployed, implanted and withdrawn successfully in all patients. Post-implant mean transaortic gradient was (7.55±4.08) mmHg and maximal transaortic velocity was (1.78±0.44) m/s, and both decreased significantly as compared to baseline levels (both P<0.05). No severe aortic regurgitation or paravalvular leak was observed post TAVI. Device success was achieved in all the 11 patients. No patient died or experienced major cardiovascular adverse events up to 30 days post TAVI. Mean transaortic gradient was (9.45±5.07) mmHg and maximal transaortic velocity was (2.05±0.42) m/s at 30 days post TAVI, which were similar as the values measured immediately post TAVI (both P>0.05). Conclusions: TAVI with the Prizvalve® system is a feasible and relatively safe procedure for patients with severe aortic stenosis and at high risk or inappropriate for SAVR. Further clinical studies could be launched to obtain more clinical experience with Prizvalve® system.

Is It Reasonable to Perform Isolated SAVR by Residents in the TAVI Era?

The role of conventional surgical aortic valve replacement (SAVR) is increasingly questioned since the indication for transcatheter aortic valve implantations (TAVIs) is currently extended. While the number of patients referred to SAVR decreases, it is unclear if SAVR should be performed by junior resident surgeons in the course of a heart surgeons training. Patients with isolated aortic valve replacement (AVR) were analyzed with respect to the surgeon's qualification. AVR performed by resident surgeons was compared with AVR by senior surgeons. The collective was analyzed with respect to clinical short-term outcomes comparing full sternotomy (FS) with minimally invasive surgery and ministernotomy (MS) with right anterior thoracotomy (RAT) after a 1:1 propensity score matching. The 30-day all-cause mortality was 2.3 and 3.4% for resident versus senior AVR groups, cerebrovascular event rates were 1.1 versus 2.6%, and no cases of significant paravalvular leak were detected. Clinical short-term outcomes between FS and minimally invasive access, as well after MS and RAT were comparable. Our current data show feasibility and safety of conventional SAVR procedure performed by resident surgeons in the era of TAVI. Minimally invasive surgery should be trained and performed in higher volumes early in the educational process as it is a safe treatment option.

Robotic Aortic Valve Replacement: First 50 Cases

BackgroundExisting management challenges in selecting transcatheter vs surgical aortic valve replacement (SAVR) include bicuspid stenosis, low clinical risk, horizontal valve position, aortic insufficiency (AI), and need for concomitant procedures or mechanical valves. To address these gaps, we present our early experience with fully robotic-assisted aortic valve replacement (RAVR). MethodsBetween January 2020 and February 2021, 50 consecutive RAVR operations were performed using a 3- to 4-cm lateral mini-thoracotomy 3-port technique with transthoracic aortic clamping, similar to our robotic mitral platform. Conventional SAVR prostheses were implanted with interrupted braided sutures in all cases. ResultsThe 50 patients were a median age of 67.5 years, body mass index was 29 kg/m2, calcified bicuspid disease was present in 28 (56%), and severe AI in 8 (16%). Ejection fraction was 0.55 ± 0.08 (mean ± SD), and The Society of Thoracic Surgeons predicted risk of mortality was 1.54% ± 0.7%. Mechanical prostheses were used in 16 of 50 (32%), and 7 required concomitant procedures, including Cox maze in 3, aortic root enlargement in 2, and left atrial appendage clipping, mitral repair, and left atrial myxoma excision in 1 each. Median times (minutes) were 166 for cardiopulmonary bypass, 117 for cross-clamp, 4 for valvectomy, 20 for annular sutures, and 31 for aortotomy closure. All times plateaued after the initial 5 cases. Extubation occurred in 42 of 50 patients (84%) in the operating room, and within 4 hours in the remaining 8 (16%). There was no 30-day operative mortality or stroke. All had 30-day echocardiography demonstrating no valvular or perivalvular abnormalities. ConclusionsRAVR appears to have procedural safety and short-term outcomes to rival alternatives. Incremental experience may facilitate the safe performance of concomitant procedures as deemed necessary.

Advancements in Transcatheter Aortic Valve Implantation: A Focused Update.

Transcatheter aortic valve implantation (TAVI) has become the leading technique for aortic valve replacement in symptomatic patients with severe aortic stenosis with conventional surgical aortic valve replacement (SAVR) now limited to patients younger than 65–75 years due to a combination of unsuitable anatomies (calcified raphae in bicuspid valves, coexistent aneurysm of the ascending aorta) and concerns on the absence of long-term data on TAVI durability. This incredible rise is linked to technological evolutions combined with increased operator experience, which led to procedural refinements and, accordingly, to better outcomes. The article describes the main and newest technical improvements, allowing an extension of the indications (valve-in-valve procedures, intravascular lithotripsy for severely calcified iliac vessels), and a reduction of complications (stroke, pacemaker implantation, aortic regurgitation).

Comparing Quality of Life and Postoperative Pain After Limited Access and Conventional Aortic Valve Replacement: A Randomized Clinical Trial

Objective: Limited access aortic valve replacement (LA-AVR) yields excellent results as an alternative to conventional surgical aortic valve replacement by full median sternotomy (C-AVR). However, robust data on quality of life (QoL) improvements and the differences in postoperative QoL and pain compared to C-AVR are lacking. We report the one-year results of the LImited access Aortic valve Replacement (LIAR) Trial. Methods: The LIAR-Trial is an investigator initiated, Dutch government sponsored, single center, randomized controlled trial comparing postoperative QoL and pain in patients undergoing LA-AVR through partial upper hemisternotomy (UHS) and C-AVR for symptomatic severe aortic valve stenosis. All patients were intended to have their native aortic valve replaced by a rapid deployment stented bioprosthesis (RDSBP). Primary outcome was cardiac related QoL, measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) at one, three, six and twelve months postoperatively. Secondary outcomes included generic QoL, postoperative pain, analgesic use and postoperative Complications. Results: A total of 161 patients were randomized. Per protocol analysis demonstrated significant differences in the primary outcome measures: estimated mean differences of both the Physical Limitations domain (2.22 points; 95%CI, 0.96 - 3.28; p=0.01) and the Total Symptom Score of the KCCQ (3.31 points; 95%CI, 0.30 - 6.31; p=0.031) demonstrated significantly increase improvement after LA-AVR compared to C-AVR. Regarding the secondary outcome measures: LA-AVR was associated with a significant increased improvement in the Overall Summary Score and Social Limitation domain of the KCCQ, Mental Health of the Short Form-36 and reduced postoperative pain. Operative times were significantly longer in the LA-AVR group. No significant differences were found regarding 30-day complication rate. Conclusions: LA-AVR through UHS with the use of a RDSBP is associated with an increased improvement in cardiac related QoL and reduced postoperative pain compared to C-AVR.