First Experiences with MANTA Vascular Closure Device in Minimally Invasive Valve Surgery.

BACKGROUND: To more minimize the minimally invasive valve surgeries, percutaneous vascular access and closure has been used for the establishment of extracorporeal circulation. This study investigates early clinical outcomes of patients who received MANTA for femoral artery closure as first experiences in minimally invasive valve surgery. METHODS: Between January 2019 and July 2019, 103 consecutive patients (mean age: 58 ± 11 years) underwent video-assisted minimally invasive valve surgery through right anterior minithoracotomy at two cardiac surgery referral centers in Germany. Percutaneous cannulation for cardiopulmonary bypass and femoral artery closure with MANTA were performed in all patients: 18-F and 14-F MANTA were used in 88 (85.4%) and 15 (14.6%) patient, respectively. Mitral, aortic, tricuspid, and double valve surgeries were performed in 51 (49.5%), 39 (37.9%), 7 (6.8%), and 6 (5.8%), patients, respectively. Clinical data were prospectively entered into our institutional database. RESULTS: Cardiopulmonary bypass time and cross-clamping time were 69 ± 23 and 38 ± 14 minutes, respectively. Except for two patients with late pseudoaneurysm on 15th and 23th postoperative day, neither major nor minor vascular complications nor vascular closure device failure according to the Valve Academic Research Consortium-2 definition criteria was observed. Additionally, no wound healing disorders or conversion to surgical closure was observed. CONCLUSIONS: MANTA as percutaneous femoral artery closure after decannulation of cardiopulmonary bypass is a safe, feasible, and effective approach and yields excellent early outcomes. Larger size studies are needed to evaluate more the efficacy and safety of MANTA.

Totally endoscopic micro-invasive aortic valve replacement.

Micro-invasive totally endoscopic aortic valve replacement surgery is a minimally invasive cardiac procedure that can be performed with the help of several techniques and technologies that employ the latest innovations in instrumentation and technological advances in the field, thereby greatly limiting the overall invasiveness of the procedure. With the help of a 3-dimensional camera, long instruments, a very small thoracotomy and a soft-tissue retractor without any rib retractor, the aortic valve can be easily and safely accessed for replacement. The other main features of these techniques are extracorporeal circulation that is achieved through peripheral percutaneous cannulation of the femoral vessels, antegrade cardioplegia, the use of automated devices for suturing the valvular ring and the prosthetic suture cuff, namely the RAM device, the Sew-Easy device and the Cor-Knot Mini device. Additionally, an automated vascular closure device such as the MANTA device is later used to close the femoral artery following decannulation.

Totally Endoscopic Replacement of the Ascending Aorta and the Aortic Root including the Aortic Valve via Right Mini-Thoracotomy: A Multicenter Study.

Background: Recently, minimally invasive access via right anterolateral mini-thoracotomy (RAMT) has been gaining popularity in cardiac surgery. This approach is also an option for surgeons performing aortic surgery. The aim of this study is to present our surgical method, highlighting the total endoscopic minimally invasive approach via RAMT for replacement of the ascending aorta (AAR) with or without involvement of the aortic root and the aortic valve. Methods: Clinical data of 44 patients from three participating institutions with AAR with or without involvement of the aortic valve or aortic root via RAMT between April 2017 and February 2024 were retrospectively analyzed. According to surgical procedure, patients were divided into two groups, in the AAR and in the Wheat/Bentall group with concomitant valve or root replacement. Operative time, length of ventilation, perioperative outcome, length of intensive care unit (ICU) as well as postoperative hospital stay, and mid- and long-term results were retrospectively analyzed. Results: Mean age was 61.4 ± 10.7 years old with a frequency of male gender of 63.6%. Mean cardiopulmonary bypass (CBP) time and aortic cross-clamping time was 94.9 ± 32.5 min and 63.8 ± 25.9 min, respectively. CPB and aortic clamp time were significantly lower in AAR group. In the first 24 h, the mean drainage volume was 790.3 ± 423.6 mL. Re-thoracotomy due to bleeding was zero. Sternotomy was able to be avoided in all patients. Patients stayed 35.9 ± 23.5 h at ICU and were discharged 7.8 ± 3.0 days following surgery from hospital. Mean ventilation time was 5.8 ± 7.6 h. All patients survived and 30-day mortality was 0.0%. At a median follow-up time of 18.2 months, all patients were alive. The results were similar in both groups. Conclusions: The full endoscopic RAMT approach with 3D visualization is a safe, feasible and promising technique that can be transferred in the field of aortic surgery without compromising surgical quality, postoperative outcomes, or patient safety when performed by an experienced team in a high-volume center.

Extracorporeal membrane oxygenation for influenza-associated acute respiratory distress syndrome.

BACKGROUND: Extracorporeal membrane oxygenation (ECMO) therapy for patients with influenza A (H1N1)-related acute respiratory distress syndrome (ARDS) has been described once all other therapeutic options have been exhausted. The current report reviews our institutional experience and lessons learned in 18 consecutive patients. METHODS: Between December 2009 and March 2011, 18 patients underwent ECMO therapy for severe H1N1-related ARDS. Mean age was 40 ± 18 years (range 4-67 years). Ten patients (56%) received venoarterial cannulation (v-a ECMO) while venovenous cannulation (v-v ECMO) was initiated in the remaining patients (n = 8, 44%). To identify risk factors of adverse outcome, univariate analysis was performed for clinical parameters. RESULTS: Successful ECMO weaning was possible in 44% (n = 8) of patients and overall mortality was 61% (n = 11). Seven of the eight patients who could be successfully weaned from ECMO support fully recovered. Survival within the v-a ECMO group (60%) was superior to the v-v ECMO group (13%; p = 0.06). Two patients (11%) required re-exploration of the axillary artery cannulation site. No further adverse events associated with ECMO implantation occurred. Outcome was better when the time of severe deoxygenation (Pao2 < 70 mm Hg) despite maximally invasive respiratory support to ECMO implantation was less than 6 hours (odds ratio: 2.4; p = 0.05). CONCLUSIONS: ARDS associated with H1N1 remains a devastating clinical picture. In our hands, ECMO support offered survival to 40% of patients with otherwise fatal prognosis. While v-v ECMO remains the method of choice for patients suffering an isolated ARDS in the setting of stable hemodynamic conditions, v-a ECMO may be considered if the clinical picture of ARDS is aggravated by systemic inflammatory response syndrome with the requirement of high dose vasopressor support.

Simple and controlled method to avoid hyperperfusion of the right arm following axillary artery cannulation for extracorporeal membrane oxygenator support.

The right axillary artery has become the cannulation site of choice for establishment of extracorporeal membrane oxygenator support in many centers. Dissection and cannulation of this vessel are simple and safe in the majority of patients. Typically, a side graft is used to avoid malperfusion of the right arm. Although this protocol offers many advantages, a common complication is the critical hyperperfusion of the right arm. Subsequent compartment syndrome and decline of antegrade inflow of oxygenated blood, especially into the brain and coronary arteries, can be life threatening in such critical patients. We describe herein a simple yet effective and controlled technique to avoid this particular problem.

Femoral or Axillary Cannulation for Extracorporeal Circulation during Minimally Invasive Heart Valve Surgery (FAMI): Protocol for a Multi-Center Prospective Randomized Trial.

BACKGROUND: Minimally invasive heart valve surgery via anterolateral mini-thoracotomy with full endoscopic 3D visualization (MIS) has become the standard treatment of patients with valvular heart disease and low operative risk over the past two decades. It requires extracorporeal circulation and cardioplegic arrest. The most established form of arterial cannulation for MIS is through the femoral artery and is used by most surgeons, but it is suspected to increase the risk of stroke through retrograde blood flow. An alternative route of cannulation is the axillary artery, producing antegrade blood flow during extracorporeal circulation. METHODS: Femoral or axillary cannulation for extracorporeal circulation during minimally invasive heart valve surgery (FAMI) is a multicenter randomized controlled trial designed to determine whether axillary cannulation is superior to femoral cannulation for the outcome of a manifest stroke within 7 days postoperatively. The target sample size was 848 participants. Patients ≥ 18 years of age, with valvular regurgitation or stenosis scheduled for minimally invasive surgery via anterolateral mini-thoracotomy, were randomized to axillary cannulation (treatment group) or to femoral cannulation (standard care). Patients were followed up for seven days postoperatively. A CT scan was performed pre-operatively to screen patients for vascular calcifications and to assess the safety of femoral cannulation. The standard of care is femoral artery cannulation, but is performed only in patients without significant vascular calcifications or severe kinking of the iliac arteries and in patients with sufficient vessel diameter. The cannulation is performed via Seldinger's technique, and the vessel closed percutaneously using a plug-based vascular closure device. Only patients without significant vascular calcifications are considered for femoral cannulation, as an increased risk of stroke is assumed. In patients with vascular calcifications, axillary cannulation is the standard of care to avoid these risks. Retrospective studies have hinted that, even in patients without vascular calcifications, there may be a lower stroke risk with axillary cannulation compared to femoral cannulation. We present a protocol for a multi-center randomized trial to investigate this hypothesis. DISCUSSION: To date, evidence on the best access for peripheral artery cannulation during minimally invasive heart valve surgery has been scarce. Patients may benefit from axillary cannulation for extracorporeal circulation in terms of stroke risk and other neurological and vascular complications, though femoral cannulation is the gold standard. The aim of this study is to determine the risks of peri-operative stroke in a prospective randomized comparison of femoral vs. axillary cannulation.

The Long-Term Outcome and Quality of Life after Replacement of the Ascending Aorta.

(1) Background: Despite optimal surgical therapy, replacement of the ascending aorta leads to a significant reduction in the quality of life (QoL). However, an optimal result includes maintaining and improving the QoL. The aim of our study was to evaluate the long-term outcome and the QoL in patients with aneurysms in the ascending aorta; (2) Methods: Between 2014 and 2020, 121 consecutive patients who underwent replacement of the ascending aorta were included in this study. Acute aortic pathologies were excluded. A standard short form (SF)-36 questionnaire was sent to the 112 survivors. According to the surgical procedure, patients were divided into two groups (A: supracoronary replacement of the aorta, n = 35 and B: Wheat-, David- or Bentall-procedures, n = 86). The QoL was compared within these groups and to the normal population, including myocardial infarction (MI), coronary artery disease (CAD) and cancer (CAN) patients; (3) Results: 83 patients were males (68.6%) with a mean age of 62.0 ± 12.5 years. Early postoperative outcomes showed comparable results between groups A and B, with a higher re-thoracotomy rate in B (A: 0.0% vs. B: 22.1%, p = 0.002). The 30-day mortality was zero. Overall, mortality during the follow-up was 7.4%. The SF-36 showed a significant decay in both the Physical (PCS) and Mental Component Summary (MCS) in comparison to the normal population (PCS: 41.1 vs. 48.4, p < 0.001; MCS: 42.1 vs. 50.9, p < 0.001) but without significant difference between both groups. Compared to the MI and CAD patients, significantly higher PCS but lower MCS scores were detected (p < 0.05); (4) Conclusions: Replacement of the ascending aorta shows low risk regarding the operative and postoperative outcomes with satisfying long-term results in the QoL. The extent of the surgical procedure does not influence the postoperative QoL.

Impact of pre-existing comorbidities on outcomes of patients undergoing surgical aortic valve replacement - rationale and design of the international IMPACT registry.

BACKGROUND: Degenerative aortic valve disease accounts for 10-20% of all cardiac surgical procedures. The impact of pre-existing comorbidities on the outcome of patients undergoing surgical aortic valve replacement (SAVR) needs further research. METHODS: The IMPACT registry is a non-interventional, prospective, open-label, multicenter, international registry with a follow-up of 5 years to assess the impact of pre-existing comorbidities of patients undergoing SAVR with the INSPIRIS RESILIA aortic valve on outcomes. IMPACT will be conducted across 25 sites in Austria, Germany, The Netherlands and Switzerland and intends to enroll approximately 500 patients. Patients will be included if they are at least 18 years of age and are scheduled to undergo SAVR with the INSPIRIS RESILIA Aortic Valve with or without concomitant ascending aortic root replacement and/or coronary bypass surgery. The primary objective is to determine all-cause mortality at 1, 3, and 5 years post SAVR. Secondary objectives include cardiac-related and valve-related mortality and structural valve deterioration including hemodynamics and durability, valve performance and further clinical outcomes in the overall study population and in specific patient subgroups characterized by the presence of chronic kidney disease, hypertension, metabolic syndrome and/or chronic inflammation. DISCUSSION: IMPACT is a prospective, multicenter European registry, which will provide much-needed data on the impact of pre-existing comorbidities on patient outcomes and prosthetic valve performance, and in particular the performance of the INSPIRIS RESILIA, in a real-world setting. The findings of this study may help to support and expand appropriate patient selection for treatment with bioprostheses. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04053088 .

The role of extracellular and intracellular proteolytic systems in aneurysms of the ascending aorta.

Aneurysms of the ascending aorta are an outstanding challenge to clinicians as they may persist asymptomatic until they present with dissection or rupture. Intensive research is performed to reveal the molecular mechanisms causing aneurysm formation. Calpains are ubiquitous non-lysosomal cysteine proteases which are classically activated by calcium signaling. The two major forms of the calpain-family are calpain-I and calpain-II. Calpastatin specifically inhibits the proteolytic activity of calpain-I and -II. Recently it has been demonstrated in aneurysm tissues from ascending aortas obtained from Marfan syndrome patients that calpain-II expression is increased and calpastatin expression is decreased. Thus, we were interested in the probable role of calpains in aneurysms of ascending aorta in non-Marfan patients. Therefore, ascending aortic samples of dilated and non-dilated aortas were analyzed according to their calpain-I, -II and calpastatin content as well as the expression levels of MMPs and elastin as well as the infiltration of inflammatory cells. We have found significant differences in calpain-I and calpastatin protein expression and serum levels in patients with aneurysm of the ascending aorta. Furthermore, MMP-1 and MMP-3 expression levels correlate with calpain-I protein levels. Due to our findings we conclude that calpain-1 seems to be related to fibrotic alteration in aortic aneurysm tissue in our experimental group. The change in calpain-1 modulates the structure of aortic tissue causing alteration in elastin structure, thus enabling macrophage infiltration and elevation of MMP levels. Circulating levels of calpain-1 may be used as a prognostic marker in the future if further correlation analyses are done.