Learning Curve for Starting a Successful Single-Centre TAVR Programme with Multiple Devices: Early and Mid-Term Follow-Up.

Aims: We report 30-day, 1-year, and 3-year outcomes for a new TAVR programme that used five different transcatheter heart valve (THV) systems. Methods: From 2014 to 2020, 122 consecutive patients with severe aortic stenosis (AS) received TAVR based on the Heart Team decision. Outcomes were analysed for the whole study population and in addition the first 63 patients (Cohort A, 2014 to 2019) were compared to the last 59 patients (Cohort B, 2019 to 2020). Outcomes included VARC-2 definitions and device performance assessed via transthoracic echocardiography by independent high-volume investigators. Results: The mean patient age was 77.9 ± 6.1 years old, and 48 (39.3%) were male. The mean logistic Euroscore II was 4.2 ± 4.5, and the mean STS score was 6.9 ± 4.68. The systems used were as follows: Medtronic Corevalve Evolute R/PRO (82 patients-67.2%); Abbott Portico (13-10.6%); Boston Scientific Lotus (10-8.2%); Meril Myval (11-9%); and Boston Scientific Neo Accurate (6-5%). Access was transfemoral (95.9% of patients); surgical cut down (18% vs. percutaneous 77.8%); subclavian (n = 2); trans-axillary (n = 2); and direct aorta (n = 1). VARC-2 outcomes were as follows: device success rate 97.5%; stroke rate 1.6%; major vascular complication 3.3%; permanent pacemaker implantation 12.4%. At discharge, the incidences of grade I and II aortic regurgitation were 39.95 and 55.5%, respectively. At one year, all-cause mortality was 7.4% without admissions for valve-related dysfunction. The 3-year all-cause mortality and all-stroke rates were 22.9% and 4.1%, respectively. Between the 1-year and 3-year follow-ups, valve-related dysfunction was detected in three patients; one had THV system endocarditis that led to death. There was a remarkable but statistically non-significant decrease in mortality from Cohort A to Cohort B [four (6.3%) vs. one patient (1.7%), p = 0.195] and major vascular complications occurred at a significantly higher rate in the Cohort B [zero (0%) vs. four (6.8% patient, p = 0.036)]. Overall, we found that using multiple devices was safe and allowed for a learning team to achieve a high device success rate from the beginning (97.5%). Conclusions: TAVR with different THV systems showed acceptable early and mid-term outcomes for survival, technical success, and valve-related adverse events in high-risk patients with significant AS, even in the learning curve phase.

Single-Center Experience with the Balloon-Expandable Myval Transcatheter Aortic Valve System in Patients with Bicuspid Anatomy: Procedural and 30-Day Follow-Up.

Aims: To report our single-center data regarding the initial 52 consecutive patients with a bicuspid aortic valve who underwent a Transcatheter Aortic Valve Implantation (TAVI) procedure using the new balloon-expandable MYVAL system. The focus is on reporting procedural details and outcomes over the 30-day postoperative period. Methods: From December 2019 to July 2023, 52 consecutive patients underwent a TAVI procedure with bicuspid anatomy. All patients had moderate to-high surgical risk or were unsuitable for surgical aortic valve replacement based on the Heart Team's decision. Outcomes were analyzed according to the VARC-2 criteria. The results of bicuspid patients were compared to patients with tricuspid anatomy in the overall study group, and further analysis involved a comparison between 52 pairs after propensity score matching. The device performance was evaluated using transthoracic echocardiography. Data collection was allowed by the Local Ethical Committee. Results: The mean age was 71 ± 7.1 years, and 65.4% were male. The mean Euroscore II and STS score were 3.3 ± 3.2 and 5.2 ± 3.3, respectively. Baseline characteristics and echocardiographic parameters were well balanced even in the unmatched comparison. Procedures were significantly longer in the bicuspid group and resulted in a significantly higher ARI index. All relevant anatomic dimensions based on the CT scans were significantly higher in bicuspid anatomy, including a higher implantation angulation, a higher rate of horizontal aorta and a higher proportion of patients with aortopathy. In the unmatched bicuspid vs. tricuspid comparison, postprocedural outcomes were as follows: in-hospital mortality 0% vs. 1.4% (p = 0.394), device success 100% vs. 99.1% (p = 0.487), TIA 1.9% vs. 0% (p = 0.041), stroke 1.9% vs. 0.9% (p = 0.537), major vascular complication 3.8% vs. 2.3% (p = 0.530), permanent pacemaker implantation 34% vs. 30.4% (p = 0.429), and cardiac tamponade 0% vs. 0.5% (p = 0.624). In the propensity-matched bicuspid vs. tricuspid comparison, postprocedural outcomes were as follows: in-hospital mortality 0% vs. 0%, device success 100% vs. 100%, TIA 1.9% vs. 0% (p = 0.315), stroke 1.9% vs. 0.9% (p = 0.315), major vascular complication 3.8% vs. 0% (p = 0.475), permanent pacemaker implantation 34% vs. 24% (p = 0.274), and cardiac tamponade 0% vs. 0%. There was no annular rupture nor need for second valve or severe aortic regurgitation in both the unmatched and matched comparison. The peak and mean aortic gradients did not differ at discharge and at 30-day follow-up between the two groups regardless of whether the comparison was unmatched or matched. There were no paravalvular leakages (moderate or above) in the bicuspid patients. Intermediate and extra sizes of the Myval THV system used a significantly higher proportion in bicuspid anatomy with a significantly higher oversize percentage in tricuspid anatomy. Conclusions: The TAVI procedure using the Myval THV system in patients with significant aortic stenosis and bicuspid aortic valve anatomy is safe and effective. Hemodynamic parameters do not differ between tricuspid and bicuspid patients. However, the permanent pacemaker implantation rate is higher than expected; its relevance on long-term survival is controversial.

Single center experience with the balloon-expandable Myval transcatheter aortic valve system with the first 100 patients: 30-day and 1-year follow-up.

AIMS: To report our single-center data, regarding the first 100 patients who underwent TAVR procedure with the new balloon-expandable MYVAL system. We report 30-day and 1-year outcomes in low to high-risk TAVR patient population. METHODS: From November 2019 to July 2021, 100 consecutive patients underwent TAVR procedure. Patient outcome was classified according to the VARC-2 definitions. The device performance was assessed using transthoracic echocardiography. Data collection was allowed by the Local Ethical Committee. RESULTS: The mean age was 74.7 years, 63 (63%) were male. The mean Euroscore II and STS score were 4.8 ± 4.9 and 5.6 ± 3.9, respectively. Transfemoral access was the most frequent (surgical vs. percutaneous 2% vs. 97%) and in one patient surgical subclavian access was used. VARC-2 outcomes were as follows: device success 99%, STROKE 1%, major and minor vascular complication was 1% and 11%, respectively, the rate of new permanent pacemaker implantation was 30.7%. At discharge, the incidence of grade I, grade II aortic regurgitation was 39% and 1%, respectively, without relevant PVL. In-hospital mortality was only 1%. These results included a high proportion (17%) of patients with bicuspid aortic valves. At 1 year, the all-cause mortality rate was 7% (only two due to cardiac event) and only a single patient had valve-related dysfunction requiring surgical aortic replacement. CONCLUSIONS: TAVR procedure with MYVAL transcatheter heart valve system shows excellent 30-day and 1-year outcomes regarding patient survival, technical success, and valve-related adverse events. The limitations of our study comprise a single-center study with retrospective data collection.

Aortabillentyu-beültetés antifoszfolipid szindrómában.

Esetismertetés: Egy 44 éves férfi betegnél endokarditisz talaján kialakult súlyos aortabillentyu-elégtelenség tett szükségessé szívsebészeti beavatkozást. A kevesebb mint egy év alatt bekövetkezett többszöri trombotikus esemény felvetette antifoszfolipid szindróma lehetoségét. A lupus antikoaguláns pozitivitás és az említett klinikai kép ezt igazolta. Megbeszélés: Betegünk fiatal életkora és a biológiai mubillentyu korlátozott élettartama ellenére biológiai mubillentyu beültetése mellett döntöttünk. Választásunkat azzal indokoljuk, hogy tanulmányok bizonyítják antifoszfolipid szindrómás betegeknél a mechanikus mubillentyuvel összefüggésbe hozható thromboembolia viszonylag gyakori elofordulását. A mutétet szövodménymentesen elvégeztük, aktivált parciális thromboplastin idovel kontrollált Na-heparin korai adása mellett állítottuk be az orális antikoaguláns terápiát 3,0 INR célértékkel a mutét utáni ötödik napra. A mutét során eltávolított billentyubol korokozó nem tenyészett ki. A kórszövettani vizsgálat abakteriális endokarditiszt véleményezett, nem kizárva a korábbi fertozést. Biológiai mubillentyu implantáció után három hónapig ajánlott aszpirin vagy K-vitamin antagonista adása, betegünk esetében viszont élethosszig tartó antikoaguláns kezelés szükséges, tekintettel rendszerbetegségére. Következtetés: Halmozódó tromboembóliás események kapcsán gondolni kell antifoszfolipid szindrómára, mely igazolása adott esetben meghatározhatja a választható mubillentyu fajtáját. Az ajánlások legtöbbször csak általánosságban fedik le a ritka társbetegségeket, ezért a kapcsolódó szakirodalom áttekintése is szükséges az optimális, betegre szabott döntéshez.

Effectiveness of Preoperative Chest Physiotherapy in Patients Undergoing Elective Cardiac Surgery, a Systematic Review and Meta-Analysis.

Background and Objectives: Patients undergoing cardiac surgery are particularly vulnerable for developing postoperative pulmonary complications (PPCs). This systematic review and meta-analysis aimed to evaluate the role of preoperative chest physiotherapy in such patients. Materials and Methods: All original articles that assessed patients undergoing elective cardiac surgery, with preoperative chest physiotherapy, and compared them to patients undergoing elective cardiac surgery, without preoperative chest physiotherapy, were included. Animal studies, studies conducted prior to the year 2000, commentaries, or general discussion papers whose authors did not present original data were excluded. Studies assessing physiotherapy regimens other than chest physiotherapy were also excluded. The search was performed using the following electronic resources: the Cochrane Central Register of Controlled Trials, the PubMed central database, and Embase. The included studies were assessed for potential bias using the Cochrane Collaboration's tool for assessing the risk of bias. Each article was read carefully, and any relevant data were extracted. The extracted data were registered, tabulated, and analyzed using Review Manager software. Results: A total of 10 articles investigating 1458 patients were included in the study. The studies were published from 2006 to 2019. The populations were patients scheduled for elective CABG/cardiac surgery, and they were classified into two groups: the interventional (I) group, involving 651 patients, and the control (C) group, involving 807 patients. The meta-analysis demonstrated no significant differences between the interventional and control groups in surgery time and ICU duration, but a significant difference was found in the time of mechanical ventilation and the length of hospital stay, favoring the interventional group. A significant difference was shown in the forced expiratory volume in 1s (FEV1% predicted), forced vital capacity (FVC% predicted), and maximum inspiratory pressure (Pi-max), favoring the interventional group. Conclusions: This study is limited by the fact that one of the included ten studies was not an RCT. Moreover, due to lack of the assessment of certain variables in some studies, the highest number of studies included in a meta-analysis was the hospital stay length (eight studies), and the other variables were analyzed in a fewer number of studies. The data obtained can be considered as initial results until more inclusive RCTs are conducted involving a larger meta-analysis. However, in the present study, the intervention was proved to be protective against the occurrence of PPCs. The current work concluded that preoperative chest physiotherapy can yield better outcomes in patients undergoing elective cardiac surgery.

Determination of frail state and association of frailty with inflammatory markers among cardiac surgery patients in a Central European patient population.

INTRODUCTION: With the aging of the population, the screening of frail patients, especially before high-risk surgery, come to the fore. The background of the frail state is not totally clear, most likely inflammatory processes are involved in the development. METHODS: Our survey of patients over age of 65 who were on cardiac surgery were performed with Edmonton Frail Scale (EFS). Patients' demographic, perioperative data, incidence of complications and correlations of inflammatory laboratory parameters were studied with the severity of the frail state. RESULTS: On the basis of EFS, 313 patients were divided into non-frail (NF,163,52%), pre-frail (PF,89,28.5%) and frail (F,61,19.5%) groups. Number of complications in the three groups were different (NF:0.67/patient, PF:0.76/patient, F:1.08/patient). We showed significant difference between NF and F in both intensive care and hospital stay, but there was no statistical difference between the groups in hospital deaths (NF:5/163, PF:3/89, F:5/61). We also found a significant difference between NF and F patients in preoperative fibrinogen-, CRP- and white blood cell count levels. CONCLUSIONS: We first present the incidence of frailty in patients with heart surgery in a Central-European population. According to our results, inflammatory processes are likely to play a role in the development of the frail state.

Outcomes of minimally invasive lung transplantation in a single centre: the routine approach for the future or do we still need clamshell incision?

OBJECTIVES: Minimally invasive lung transplantation (MILT) via bilateral anterior thoracotomies has emerged as a novel surgical strategy with potential patient benefits when compared with transverse thoracosternotomy (clamshell incision, CS). The aim of this study is to compare MILT with CS by focusing on operative characteristics, postoperative organ function and support and mid-term clinical outcomes at Harefield Hospital. METHODS: It was a retrospective observational study evaluating all bilateral sequential lung transplants between April 2010 and November 2013. RESULTS: CS was performed in 124 patients and MILT in 70 patients. Skin-to-skin surgical time was less in the MILT group [285 (265, 339) min] compared with CS [380 (306, 565) min] and MILT-cardiopulmonary bypass [426 (360, 478) min]. Ischaemic time was significantly longer (502 ± 116 vs 395 ± 145 min) in the MILT group compared with CS (P < 0.01). Early postoperative physiological variables were similar between groups. Patients in the MILT group required less blood [2 (0, 4) vs 3 (1, 5) units, P = 0.16] and platelet transfusion [0 (0, 1) vs 1 (0, 2) units, P < 0.01]. The median duration of mechanical ventilation was shorter (26 vs 44 h, P < 0.01) and intensive therapy unit stay was 2 days shorter (5 vs 7) in the MILT group. While overall survival was similar, fraction of expired volume in 1 s (FEV1) and forced vital capacity (FVC) were consistently higher in the MILT group compared with CS during mid-term follow-up after transplantation. Specifically, FEV1 and FVC were, respectively, 86 ± 21 and 88 ± 18% predicted in the MILT group compared with 74 ± 21 and 74 ± 19% predicted in the CS group (P < 0.01) at the 6-month follow-up. CONCLUSIONS: MILT was successfully introduced at our centre as a novel operative strategy. Despite longer ischaemic times and a more complex operation and management, MILT appears to offer early postoperative and mid-term clinical benefits compared with our traditional approach of clamshell operations. These observations warrant larger definite studies to further evaluate the impact of MILT on physiological, clinical and patient-reported outcomes.

Real-time monitoring of endogenous lipid peroxidation by exhaled ethylene in patients undergoing cardiac surgery.

Pulmonary and systemic organ injury produced by oxidative stress including lipid peroxidation is a fundamental tenet of ischemia-reperfusion injury, inflammatory response to cardiac surgery, and cardiopulmonary bypass (CPB) but is not routinely measured in a surgically relevant time frame. To initiate a paradigm shift toward noninvasive and real-time monitoring of endogenous lipid peroxidation, we have explored pulmonary excretion and dynamism of exhaled breath ethylene during cardiac surgery to test the hypothesis that surgical technique and ischemia-reperfusion triggers lipid peroxidation. We have employed laser photoacoustic spectroscopy to measure real-time trace concentrations of ethylene from the patient breath and from the CPB machine. Patients undergoing aortic or mitral valve surgery-requiring CPB (n = 15) or off-pump coronary artery bypass surgery (OPCAB) (n = 7) were studied. Skin and tissue incision by diathermy caused striking (> 30-fold) increases in exhaled ethylene resulting in elevated levels until CPB. Gaseous ethylene in the CPB circuit was raised upon the establishment of CPB (> 10-fold) and decreased over time. Reperfusion of myocardium and lungs did not appear to enhance ethylene levels significantly. During OPCAB surgery, we have observed increased ethylene in 16 of 30 documented reperfusion events associated with coronary and aortic anastomoses. Therefore, novel real-time monitoring of endogenous lipid peroxidation in the intraoperative setting provides unparalleled detail of endogenous and surgery-triggered production of ethylene. Diathermy and unprotected regional myocardial ischemia and reperfusion are the most significant contributors to increased ethylene.

[Pumpless extracorporeal lung assist]. / A minimalizált extracorporális tüdôtámogatás.

The recently introduced pumpless extracorporeal lung assist (PECLA) is a remarkable alternative to the conventional extracorporeal membrane oxygenation in case of severe lung failure. By establishing a shunt between femoral artery and vein using the arterio-venous pressure gradient as a driving force through a low-resistance membrane oxygenator, PECLA provides highly effective gas-exchange by preserved cardiac function. Due to its closed system, reduced priming volume and low heparin demand, the unfavourable effects of extracorporeal membrane oxygenation can be effectively diminished. Hence the small technical, financial and personal input, the PECLA can be ideally used in district hospitals and during transport as well. Our short summary demonstrates the advantages and safety of the system proven over 123 cases.