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.

[Perioperative use of levosimendan in cardiac surgery. Hungarian recommendation]. / A levoszimendán perioperatív alkalmazása a szívsebészetben. Magyar ajánlás.

Low output syndrome significantly increases morbidity and mortality of cardiac surgery and lengthens the durations of intensive care unit and hospital stays. Its treatment by catecholamines can lead to undesirable systemic and cardiac complications. Levosimendan is a calcium sensitiser and adenosine triphosphate (ATP)-sensitive potassium channel (IK,ATP) opener agent. Due to these effects, it improves myocardium performance, does not influence adversely the balance between O2 supply and demand, and possesses cardioprotective and organ protective properties as well. Based on the scientific literature and experts' opinions, a European recommendation was published on the perioperative use of levosimendan in cardiac surgery in 2015. Along this line, and also taking into consideration cardiac surgeon, anaesthesiologist and cardiologist representatives of the seven Hungarian heart centres and the children heart centre, the Hungarian recommendation has been formulated that is based on two pillars: literature evidence and Hungarian expert opinions. The reviewed fields are: coronary and valvular surgery, assist device implantation, heart transplantation both in adult and pediatric cardiologic practice. Orv Hetil. 2018; 159(22): 870-877.

[Pathology and diagnostic opportunities of lower limb compartment syndrome]. / Az alsó végtagi compartment-syndroma kórtana és diagnosztikai lehetoségei.

BACKGROUND: The indication for the surgical treatment of lower limb compartment syndrome mostly depends on the clinical signs, which can be uncertain and often delayed, resulting in a late and insufficient intervention. AIM: In this study, the progression of compartment syndrome was monitored with the measurement of intracompartmental pressure and tissue oxygen saturation. MATERIALS AND METHODS: 16 patients (12 male and 4 female; mean age: 62,7 years) underwent acute lower limb revascularization surgery due to critical (more than 4 hour) limb ischaemia. The indications were the following: 5 iliac artery embolisms and 11 femoral artery occlusions. After revascularization, significant lower limb oedema and swelling were detected. To monitor the elevated intracompartmental pressure (ICP), KODIAG pressure meter was used. Tissue oxygen saturation (StO2) was measured with near-infrared-spectroscopy. RESULTS: In 12 cases the IPC exceeded the critical 40 mmHg. In these patients, StO2 was 50-53%, in spite of the successful re-canalisation. An urgent, semi-open fasciotomy was performed in these cases. In four patients, the clinical picture suggested compartment syndrome. However, the measured parameters did not indicate surgical intervention (ICP: 25-35 mmHg, StO2: normal). SUMMARY: In addition to the empirical guidelines, we describe an evidence based surgical intervention strategy for lower limb compartment syndrome. Our results and advised parameter intervals help the clinicians to decide between conservative and operative treatment of the disease.

[Treatment of large, esophageal perforations and mediastinitis with a covered, removable metallic endoprosthesis and mediastinal drainage]. / Nagy nyelocso-perforatio és mediastinitis kezelése eltávolítható, bevont fémprotézissel és mediastinalis drenázzsal.

The application of covered metallic stents in the treatment of benign strictures and perforations is still in the early stages, because their removal is difficult and may cause tissue proliferation. The therapeutic effect and the efficiency of a new method for the extraction of a removable metallic stent were examined in three patients treated for oesophageal perforation. Two of the three patients were dilated with a balloon catheter because of corrosive oesophageal stenosis, and the oesophagus was perforated. In one patient mediastinal drainage, and jejunostomy and in the other primary suturing and drainage were performed. Sepsis and mediastinitis developed due to the oesophageal perforation and the fistula caused by the mediastinal drain in the first patient, and the insufficiency of the suture in the second patient. The oesophageal defects were sealed on day 8 and 10 after the perforation, and surgery by a covered stent. In the third patient, the oesophageal rupture caused by the dilatation and the attempt to stent a malignant obstruction was sealed with a covered stent within 2 hours. Parenteral nutrition and broad-spectrum antibiotic therapy were started. Three days after the interventions, swallowing tests with water-soluble contrast medium (Gastrografin) did not reveal any extravasations. Feeding via a nasogastric tube, and later oral feeding was started. After transient mediastinal drainage, the stents were removed on day 35 and 74 after implantation. Both openings healed completely. Restenoses above the stents were dilated again. The rupture of the malignant oesophagus in the third patient, following early, permanent stenting, healed without drainage and with no complications. Even with mediastinitis and concomitant sepsis, large oesophageal perforations can be treated successfully with removable, covered metallic stents and adequate mediastinal drainage.