Outcomes after SynCardia® temporary total artificial heart implantation: A 20-year single-center experience in 196 patients.

BACKGROUND: The SynCardia® temporary total artificial heart (TAH) serves as a mechanical circulatory support device for patients suffering from irreversible biventricular failure. METHODS: This retrospective study analyzed 196 consecutive patients who underwent TAH implantation at our center from 2001 to 2021. We assessed survival rates and all-cause mortality during TAH support, including survival post-heart transplantation. RESULTS: The median age of patients was 55 years, with 88% being male. The primary diagnoses included cardiomyopathy (43.9%), acute myocardial infarction (26.5%), and postcardiotomy heart failure (15.5%). At implantation, 87.2% of patients were classified as INTERMACS Profile 1. The median duration of support was 96 days (IQR: 23-227). Survival rates at 1, 6, and 12 months were 72%, 41%, and 34%, respectively. Postoperative rethoracotomy was necessary in 44.4% of patients; 39.3% experienced neurological events and 24.6% developed gastrointestinal bleeding. Overall, 64.8% of patients died while on support, primarily due to multiple organ failure (55.9%). Factors such as older age, higher bilirubin levels, postcardiotomy and specific underlying diagnoses were independent predictors of mortality during TAH support. On a positive note, 35.2% of patients underwent successful heart transplants, with 1-, 5-, and 10-year posttransplant survival rates of 65%, 58%, and 51%, respectively. CONCLUSIONS: While high mortality rates persist among patients with biventricular failure, the SynCardia® TAH offers a viable interim solution for critically ill patients, particularly those who can be successfully bridged to heart transplantation.

Impact of calorie intake and weight gain after Norwood procedure on the outcome of stage II palliation.

BACKGROUND: This study aimed to assess the impact of caloric intake and weight-for-age-Z-score after the Norwood procedure on the outcome of bidirectional cavopulmonary shunt. METHODS: A total of 153 neonates who underwent the Norwood procedure between 2012 and 2020 were surveyed. Postoperative daily caloric intake and weight-for-age-Z-score up to five months were calculated, and their impact on outcome after bidirectional cavopulmonary shunt was analysed. RESULTS: Median age and weight at the Norwood procedure were 9 days and 3.2 kg, respectively. Modified Blalock-Taussig shunt was used in 95 patients and right ventricle to pulmonary artery conduit in 58. Postoperatively, total caloric intake gradually increased, whereas weight-for-age-Z-score constantly decreased. Early and inter-stage mortality before stage II correlated with low caloric intake. Older age (p = 0.023) at Norwood, lower weight (p < 0.001) at Norwood, and longer intubation (p = 0.004) were correlated with low weight-for-age-Z-score (< -3.0) at 2 months of age. Patients with weight-for-age-Z-score < -3.0 at 2 months of age had lower survival after stage II compared to those with weight-for-age-Z-score of -3.0 or more (85.3 versus 92.9% at 3 years after stage II, p = 0.017). There was no difference between inter-stage weight gain and survival after bidirectional cavopulmonary shunt between the shunt types. CONCLUSION: Weight-for-age-Z-score decreased continuously throughout the first 5 months after the Norwood procedure. Age and weight at Norwood and intubation time were associated with weight gain. Inter-stage low weight gain (Z-score < -3) was a risk for survival after stage II.

Development of Weight and Height Age z-Score after Total Cavopulmonary Connection.

OBJECTIVE: We aimed to analyze somatic growth of patients after total cavopulmonary connection (TCPC) as well as to identify factors influencing postoperative catch-up growth. METHODS: A total of 309 patients undergoing TCPC at 4 years old or less between 1994 and 2021 were included. Weight for age z-score (WAZ) and height for age-z-score (HAZ) at TCPC and at postoperative time between 1 and 3 years were calculated. Factors influencing somatic growth were analyzed. RESULTS: Most frequent diagnosis and initial palliation were hypoplastic left heart syndrome (HLHS) (34%) and the Norwood procedure (51%), respectively. Median age and weight at TCPC were 2.0 (IQR: 1.7-2.5) years and 11.3 (10.5-12.7) kg, respectively. Median 519 days after TCPC, a significant increase in WAZ (-0.4 to -0.2, p < 0.001) was observed, but not in HAZ (-0.6 to -0.6, p = 0.38). Older age at TCPC (p < 0.001, odds ratio [OR]: 2.6) and HLHS (p = 0.007, OR: 2.2) were risks for low WAZ after TCPC. Older age at TCPC (p = 0.009, OR: 1.9) and previous Norwood procedure (p = 0.021, OR: 2.0) were risks for low HAZ after TCPC. Previous bidirectional cavopulmonary shunt (BCPS) was a protective factor for both WAZ (p = 0.012, OR: 0.06) and HAZ (p = 0.028, OR: 0.30) at TCPC. CONCLUSION: In patients undergoing TCPC at the age of 4 years or less, a significant catch-up growth was observed in WAZ after TCPC, but not in HAZ. Previous BCPS resulted to be a protective factor for a better somatic development at TCPC. HLHSs undergoing Norwood were considered as risks for somatic development after TCPC.

Propensity matched analysis of vascular complications using integrated or expandable sheaths for TAVR.

OBJECTIVES: Vascular access site complications increase morbidity and mortality in transcatheter aortic valve replacement (TAVR). BACKGROUND: Medtronic's EnVeo PRO® low-profile sheath concept and Edwards' expandable eSheath® aim to lower vascular trauma and access site complications. This study aims to compare Valve Academic Research Consortium (VARC)-3 defined access-related vascular complications using the two different transcatheter heart valve (THV) delivery concepts. METHODS: We performed a retrospective, propensity-matched study to compare access site vascular complications in 756 consecutive patients who underwent a transfemoral TAVR using a Medtronic Evolut-R®/Evolut-PRO® or an Edwards Sapien3®/Sapien3ultra® THV. RESULTS: Propensity score matching resulted in 275 patient pairs. The primary endpoint of major VARC-3 vascular complication was 7.6% in the Medtronic group and 12.7% in the Edwards group (p = 0.066). Minor VARC-3 vascular complications were 9.1% and 8%, respectively (p = 0.76). VARC-3 bleeding complications (8.4% vs. 12.7%, p = 0.129) length of hospital stay (7.6 + 5.4 vs. 7.5 + 3.7 days, p = 0.783) and in-hospital mortality (1.1% vs. 0.4%, p = 0.624) were comparable between both groups. CONCLUSIONS: In a propensity-matched TAVR population, patients treated with the integrated sheath showed a trend towards fewer major vascular complications than patients treated with an expandable sheath, however, the difference was not statistically significant.

Stroke after transcatheter aortic valve replacement: A severe complication with low predictability.

OBJECTIVES: We aimed to describe stroke and transient ischemic attacks (TIAs) after transcatheter aortic valve replacement (TAVR) and to identify associated risk factors. BACKGROUND: Stroke/TIA after TAVR is a major complication. METHODS: A total of 1919 concomitant patients underwent TAVR in a single center from 2007 to 2017. Pre-, intra-, and postprocedural data were collected prospectively in a database and analyzed retrospectively. Stroke and TIA were documented according to the Valve Academic Research Consortium-II criteria. Logistic regression was used to determine risk factors for stroke after TAVR. RESULTS: Mean age was 79.5 ± 6.8 years, mean logistic EuroScore was 17.6% ± 12.8%, and 51.8% (n = 994) of the patients were female. Stroke/TIA occurred in 76 patients (3.9%), 1.9% were disabling, and 1.6% nondisabling. The predominant type of stroke were territorial ischemic lesions (82.4%), with primary bleeding in 4.4% and border zone infarctions in 4.4%. Left-sided lesions were more common (45.6% left sided vs. 25% right sided) and 13.2% of the lesions were bilateral (4.4% no finding and 11.8% missing data). In multivariate logistic regression, prior stroke (odds ratio [OR] = 1.83, p = 0.046) and initial experience (first 300 TAVR implanted at our center) were identified as independent risk factors for stroke/TIA during the first 30 days (OR = 1.95, p = 0.045). Overall, the occurrence of stroke had a highly significant impact on a 30-day mortality (13.2% vs. 4.9% in patients without stroke (p = 0.005). CONCLUSION: Stroke within the first 30 days after TAVR severely impairs 30-day survival. We identified prior stroke and initial experience as significant independent risk factors for the occurrence of stroke after TAVR.

Surgical Cutdown Avoids Vascular Complications in Transcatheter Aortic Valve Replacement in Calcified and Small Femoral Arteries.

BACKGROUND: Third-generation transcatheter heart valves (THV) are predominantly implanted through a percutaneous, transfemoral access. To reduce vascular complications, we selectively performed surgical vascular access (cutdown) in patients with particular calcified or small femoral arteries. We aim to review our experience with this approach. METHODS: All patients who underwent transfemoral transcatheter aortic valve replacement (TAVR) with a third-generation THV at our institution between March 2014 and April 2019 were included in the study. All available computerized tomography studies were reassessed for access vessel diameter and visual graduation of calcifications. Vascular complications are reported according to Valve Academic Research Consortium-2 criteria. RESULTS: A total of 944 patients were included. Among them, 879 patients underwent a percutaneous access and 65 patients underwent surgical cutdown. Also, 459 Evolut R/PRO and 420 Sapien 3/ultra were implanted percutaneously and 40 Evolut R/PRO and 25 Sapien 3 were implanted with a surgical cutdown. Patients with surgical cutdown were older (80.0 ± 7.5 vs. 83.8 ± 7.5 years, p < 0.001), had smaller femoral arteries (8.0 ± 1.6 vs. 7.6 ± 1.6 mm, p = 0.034) and more severe vessel calcifications (17.5 vs. 1.0%, p < 0.001). Procedure time was similar for cutdown and percutaneous access (64.0 vs. 64.5 minutes, p = 0.879). With percutaneous access, 80 major vascular complications (10%) occurred, whereas with surgical cutdown, no major vascular complications occurred (p < 0.005). No wound infection occurred after surgical cutdown. The mean length of stay was 8 days in both groups. CONCLUSION: Surgical cutdown for vascular access avoids vascular complications in patients with small or severely calcified femoral arteries.

Hemodynamic Comparison between the Avalus and the Perimount Magna Ease Aortic Bioprosthesis up to 5 Years.

BACKGROUND: We aimed to compare hemodynamic performance of the Avalus (Medtronic) and the Perimount Magna Ease (PME, Edwards Lifesciences) bioprosthesis up to 5 years by serial echocardiographic examinations. METHODS: In patients undergoing aortic valve replacement, 58 received PME prostheses between October 2007 and October 2008, and another 60 received Avalus prostheses between October 2014 and November 2015. To ensure similar baseline characteristics, we performed a propensity score matching based on left ventricular ejection fraction, age, body surface area, and aortic annulus diameter measured by intraoperative transesophageal echocardiography. Thereafter, 48 patients remained in each group. Mean age at operation was 67 ± 6 years and mean EuroSCORE-II was 1.7 ± 1.1. Both values did not differ significantly between the two groups. RESULTS: At 1 year the mean pressure gradient (MPG) was 15.4 ± 4.3 mm Hg in the PME group and 14.7 ± 5.1 mm Hg in the Avalus group (p = 0.32). The effective orifice area (EOA) was 1.65 ± 0.45 cm2 in the PME group and 1.62 ± 0.45 cm2 in the Avalus group (p = 0.79). At 5 years the MPG was 16.6 ± 5.1 mm Hg in the PME group and 14.7 ± 7.1 mm Hg in the Avalus group (p = 0.20). The EOA was 1.60 ± 0.49 cm2 in the PME group and 1.51 ± 0.40 cm2 in the Avalus group (p = 0.38). Five-year survival was 88% in the PME group and 91% in the Avalus group (p = 0.5). In the PME group, there were no reoperations on the aortic valve, whereas in the Avalus group three patients required a reoperation due to endocarditis. CONCLUSION: Both bioprostheses exhibit similar hemodynamic performance during a 5-year follow-up.

Surgical treatment of isolated tricuspid valve endocarditis: Midterm data.

BACKGROUND: Isolated tricuspid valve endocarditis (TVE) is a rare disease which is managed medically in most patients. Only in specific cases, surgical intervention becomes necessary. Hence, data about surgical outcomes are sparse. This study reports on the operative experience in patients with isolated TVE over a period of 20 years. METHODS: We retrospectively analyzed 32 patients with isolated TVE who underwent surgery from February 2001 to June 2021 at the German Heart Centre Munich. RESULTS: Thirty-day mortality was 3.1%. Overall survival was 89.9± 5.5% at 1 year and 76.9 ± 8.5% at 5 years. Cumulative incidence for reoperation was 11.1 ± 6.0% at 5 years. Four patients (12.5%) were treated for recurrent endocarditis. Tricuspid valve repair (TVr) was achieved in 16 patients (50%). If the subvalvular apparatus (n = 10) was involved, tricuspid valve replacement was performed more frequently. CONCLUSIONS: Mortality in patients with isolated TVE undergoing cardiac surgery is high. In half of the cases, TVr was achieved but was less likely in patients with affected subvalvular apparatus.

Access site related vascular complications with third generation transcatheter heart valve systems.

OBJECTIVES: This study examines the impact of anatomical and procedural factors on Valve Academic Research Consortium-2-defined vascular complications at the femoral access site in transcatheter aortic valve replacement (TAVR) with third generation transcatheter heart valve (THV)-systems. BACKGROUND: Randomized clinical trials reported on vascular complications with current THV-systems. However, clinical presentation and consequences of these events are not well studied. METHODS: All patients who underwent a transfemoral TAVR using an Edwards Sapien3®/Sapien3ultra® or a Medtronic Evolut-R®/Evolut-PRO® have been identified from our institutional database. Only procedures utilizing the PerClose-ProGlide® vascular closure device were included. Risk factors for vascular complications were analyzed with a logistic regression model. Preoperative and procedural data were collected. The postoperative course of patients with and without vascular complications was compared. RESULTS: A total of 878 patients met the inclusion criteria. Of these, 152 patients (17.3%) had an access-site related vascular complication (87 major complications, 9.9%). Sheath-to-femoral-artery-ratio (SFAR) (OR per 0.1 increase = 1.35, p < .001) and more than 2 vessel entries with large bore sheaths (OR = 1.76, p = .029) were independent risk factors for vascular complications. Female gender (OR = 1.44, p = .07) and two vessel entries with large bore sheaths (OR = 1.2, p = .53) increased the risk, although no statistical significance was shown. Age (OR = 1.07, p = .62), body mass index (OR = 1.1 per 5 points, p = .32) and vessel wall calcification at puncture site (OR = 0.93, p = .7) had no influence on vascular complications. Patients with vascular complications had a higher need for blood transfusion (p < .001) and a higher in-hospital mortality (2.6 vs. 0.4%, p = .019). CONCLUSIONS: Procedural risk assessment should include SFAR calculation and consider the need for large bore sheath exchange. This might reduce the vascular trauma, lower vascular complication rates and improve the clinical outcome after TAVR.

Mitral valve repair with the edge-to-edge technique: A 20 years single-center experience.

OBJECTIVES: For tailored treatment of primary mitral regurgitation (MR), surgeons developed different repair techniques. One of them, the edge-to-edge repair has recently seen a revival, especially for Barlow's disease. METHODS: This study was designed to assess the outcomes of the edge-to-edge technique in mitral valve (MV) repair. Preoperative, periprocedural, and postoperative data were prospectively collected in a dedicated database and analyzed retrospectively. RESULTS: Between March 1999 and July 2019, a total of 152 patients (mean age: 60 ± 13) received an edge-to-edge repair combined with annuloplasty for degenerative MR at our institution. MR resulted from posterior leaflet prolapse in 23 patients (15.1%), anterior leaflet prolapse in 19 (12.5%), and bileaflet prolapse in 110 (72.4%). Of those who had a bileaflet prolapse, 91 (82.7%) had Barlow's disease. Follow-up was complete in 97.4% (6.4 ± 5.7 years). Echocardiographic assessment was achieved in 85.5% (5.1 ± 5.6 years). Overall survival after 10 years was 73.7 ± 5.0%. Twelve patients required valve-related reoperations due to ring dehiscence (n = 2), leaflet suture dehiscence (n = 2), progression of native valve disease (n = 6), or due to device failure (ring fracture) (n = 2). The cumulative incidence of valve-related reoperation at 10 years was 8.4 ± 3.0% (5.2 ± 4.1% in patients with Barlow's disease). At latest follow-up, echocardiography revealed excellent valve function with no or mild MR in 93 patients (88.6%). The mean gradient was 2.9 ± 1.3 mmHg at discharge and decreased to 2.4 ± 1.3 mmHg. Three patients (2.8%) had more than moderate MR. CONCLUSION: Edge-to-edge MV repair is a simple method with excellent results in terms of valvular function and durability especially in patients with Barlow's disease.

Anatomical reasons for failure of dual-filter cerebral embolic protection application in TAVR: A CT-based analysis.

BACKGROUND: The dual-filter Sentinel™ Cerebral Protection System (Sentinel-CPS) is increasingly used during transcatheter aortic valve replacement (TAVR). However, complex vascular anatomy may challenge Sentinel-CPS deployment. AIM OF THE STUDY: We sought to investigate the impact of anatomic features of the aortic arch and the supra-aortic arteries on technical device failure of Sentinel-CPS application. METHODS: Analysis of the multislice computed tomography pre-TAVR aortograms of all patients undergoing TAVR with Sentinel-CPS between 2016 and 2020 (n = 92) was performed. We investigated the impact of aortic arch anatomy, configuration, and the angles of the supra-aortic arteries, including the determination of vascular tortuosity index on device failure of Sentinel-CPS application. RESULTS: The Sentinel-CPS was applied successfully in 83 patients (90.2%). Device failure in nine patients (9.8%) was due to the infeasibility to perform correct deployment of both filters (n = 7) and to obtain peripheral radial access (n = 2). Patients with a failure of Sentinel-CPS application had a higher right subclavian tortuosity index (217 [92-324] vs. 150 [42-252], p = .046), a higher brachiocephalic tortuosity index (27 [5-51] vs. 10 [0-102], p = 0.033) and a larger angulation of the brachiocephalic artery (59° [22-80] vs. 39° [7-104], p = .014) compared with patients with successful application. A brachiocephalic angle more than 59° was predictive for device failure. No differences in aortic arch anatomy or common carotid artery tortuosity were detected between the groups. CONCLUSIONS: Brachiocephalic tortuosity was found to be associated with failure of Sentinel-CPS application. Filter-based usage should be avoided in TAVR patients with a brachiocephalic angle more than 59°.

Flow Dynamics of Bilateral Superior Cavopulomonary Shunts Influence Outcomes After Fontan Completion.

Bilateral superior vena cava (SVC), which occurs following bilateral bidirectional cavopulmonary shunt (BCPS), is an anomaly marked by unique hemodynamics. This study aimed to determine its effects on outcomes after Fontan completion. Among 405 patients who underwent BCPS and total cavopulmonary connection (TCPC) between 1997 and 2017, 40 required a bilateral-BCPS. The dominant SVC prior to TCPC was identified according to the direction of blood flow in the central pulmonary artery, and its relationship to the inferior vena cava (IVC) was classified as a concordant or discordant relationship. Preoperative factors were analyzed to identify the risk factors for specific adverse outcomes. The length of intensive care unit (ICU) stay after TCPC was longer in the 40 patients who underwent bilateral-BCPS than in those who underwent unilateral BCPS (p = 0.024), and the survival rate was lower in the former group than in the latter group (p = 0.004). In the patients who underwent bilateral-BCPS, the dominant SVC was concordant with the IVC in 30 patients and discordant in 10 patients. With regard to whether certain morphological, hemodynamic, and flow dynamics-related variables were risk factors for adverse outcomes following TCPC, a discordant relationship between dominant SVC and IVC was identified as an independent risk factor for both a longer ICU stay (p = 0.037, HR 2.370) and worse survival (p = 0.019, HR 13.880). Therefore, in patients with a bilateral SVC who have previously undergone bilateral-BCPS, a discordant relationship between dominant SVC and IVC might contribute to worse outcomes following TCPC.

TAVR in Patients on Hemodialysis: Outcome of A High-Risk Patient Group.

BACKGROUND: Perioperative mortality is high and long-term survival is poor for patients on hemodialysis undergoing surgical aortic valve replacement (SAVR). Transcatheter aortic valve replacement (TAVR) offers a safe and effective therapy for high-risk patients suffering from aortic valve stenosis. However, in patients on hemodialysis only limited information is available on the outcome following TAVR. METHODS: Of the 2613 consecutive patients in our single-center TAVR registry, all hemodialysis patients, were identified. Demographics, procedural details, clinical outcomes, mortality, and complications were evaluated. RESULTS: Forty-two hemodialysis patients with a mean age of 75.2±8.2 years, a mean STS predicted risk of mortality of 11.1±9.5% and a mean logEuroScore of 27.9±18.8% underwent TAVR. Mean duration on hemodialysis prior to intervention was 62.8±49.6 months. A transfemoral access was chosen in 24 patients, a transapical in 16, and a transaxillary and a transaortic in one patient, respectively. Estimated survival at 30 days, one, three and five years was 83.3%, 68.3%, 37.7% and 18.9%, respectively. Estimated median survival was 1.8±0.4 years. VARC-2 defined perioperative complications included stroke in 7.1% (3/42), major bleeding in 16.7% (7/42), and vascular complications in 7.1% (3/42). In two patients, echocardiographic examination at three and four years, respectively, showed evidence for structural valve deterioration. CONCLUSION: A high number of patients with ESRD undergoing TAVR require a non-transfemoral access. Predominantly, bleeding events contribute to the perioperative morbidity. An estimated median survival of less than two years after TAVR allows only limited assessment of valve prosthesis durability. Cardiovascular and non-cardiovascular mortality contribute equally to the causes of death beyond the first year after TAVR.

Incidence and Risk Factors for Right Ventricular Outflow Tract Obstruction after the Arterial Switch Operation.

BACKGROUND: The aim of this study was to evaluate the incidence and risk factors for the development of right ventricular outflow tract obstruction (RVOTO) after the arterial switch operation (ASO). METHODS: Between 1983 and 2014, a total of 688 patients underwent ASO. RVOTO was defined as any obstruction of the right ventricular outflow tract (RVOT) requiring reintervention. RESULTS: RVOTO developed in 79 patients (11%) at a median time of 3.8 years (range, 1 day-23.6 years) after ASO. Freedom from RVOT reintervention was 96 ± 1, 89 ± 1, and 83 ± 2% at 1, 10, and 25 years, respectively. Independent risk factors for the development of RVOTO in a Cox's regression model were side-by-side great arteries (p < 0.001), aortic arch anomalies (p < 0.001), use of a pericardial patch for augmentation of the coronary buttons (p < 0.001), and a peak gradient more than 20 mm Hg over the RVOT at discharge (p < 0.001). CONCLUSION: The incidence of RVOTO after ASO is not negligible. Complex morphology, such as side-by-side great arteries and aortic arch anomalies influences the development of RVOTO.

Surgical Treatment of Ebstein's Anomaly.

Surgical repair of the tricuspid valve is a milestone in the medical history of patients with Ebstein's anomaly. The timely alleviation of the insufficiency has an important impact on the prognosis. In this review, we describe features of the disease relevant to surgical correction and the evolution of surgical techniques over six decades. We compare the results of different repair and replacement techniques. Additionally, we discuss concomitant antiarrhythmic surgery and bailout strategies for postoperative right ventricular failure. Finally, we review the surgical options in symptomatic neonates with Ebstein's disease.

Conversion to Total Cavopulmonary Connection Improves Functional Status Even in Older Patients with Failing Fontan Circulation.

BACKGROUND: Facing longer follow-up of patients after Fontan operation, Fontan conversion was proposed to treat failing Fontan circulation. We reviewed our patients who reached up to 42 years of age. METHODS: Fifteen consecutive patients underwent Fontan conversion to extracardiac conduit combined with biatrial maze procedure between October 2006 and January 2014. Mean age at conversion was 30.9 ± 5.6 years and mean interval from primary Fontan palliation to conversion was 23.2 ± 3.3 years. RESULTS: There was one early death. Ten of 14 survivors were extubated within 24 hours, and 11 were discharged from intensive care unit (ICU) within 7 days. The impaired left ventricular function, presented in four patients prior to surgery, improved from EF 43.8 to 54.8% (p = 0.02). During follow-up time of 3.6 ± 2.3 years after conversion, there was no late death and no reoperation. Two patients developed recurrent atrial arrhythmia. Older age at Fontan procedure, lower left ventricular function, higher New York Heart Association (NYHA) class, and anatomy other than tricuspid atresia emerged as risk factors for longer ICU stay. CONCLUSION: Fontan conversion improved the functional status in almost all patients. A concomitant maze procedure effectively eliminated atrial arrhythmia. This procedure provides a benefit even for older patients if all additional cardiac pathologies are addressed.

Midterm results after aortic valve neocuspidization.

Objectives: Aortic valve neocuspidization with autologous pericardium is gaining increasing attention as a surgical treatment option for aortic valve disease. However, little is known about midterm durability and valve-related events. Methods: Patients undergoing aortic valve neocuspidization between 2016 and 2021 were included. Transthoracic echocardiography was performed before the operation, at discharge, and annually thereafter. Data were analyzed for incidences of structural valve deterioration, bioprosthetic valve failure, survival, freedom from reoperation, and hemodynamic performance. Results: A total of 162 patients underwent aortic valve neocuspidization (mean age, 52.6 ± 16.6 years; range, 13-78 years); 114 (70.4%) were male. A total of 132 patients presented with a bicuspid aortic valve (81.5%) and 126 patients presented with aortic valve stenosis (77.8%). Concomitant procedures were performed in 63 patients (38.9%). Mean follow-up was 3.5 ± 1.2 years. At discharge, peak and mean pressure gradients were 15.6 ± 7.2 mm Hg and 8.4 ± 3.7 mm Hg, respectively, with a mean effective orifice area of 2.4 ± 0.8 cm2. After 5 years, peak and mean pressure gradients were 14.5 ± 4.6 mm Hg and 7.5 ± 2.2 mm Hg, respectively, with a mean effective orifice area of 2.3 ± 0.8 cm2. At 5 years, cumulative incidences of moderate and severe structural valve deterioration and bioprosthetic valve failure were 9.82% ± 3.87%, 6.96% ± 3.71%, and 12.1% ± 4.12%, respectively. Survival was 97.3% ± 1.4%, and freedom from reoperation was 91.3% ± 2.4%. Conclusions: Aortic valve neocuspidization accomplishes low pressure gradients early after initial surgery and during follow-up. Survival in this young patient population is excellent. The main reason for reoperation is endocarditis, and rates for structural valve degeneration are low.

Early outcomes of transapical mitral valve implantation versus surgical replacement in matched elderly patients at intermediate surgical risk.

BACKGROUND: Data comparing transcatheter mitral valve implantation (TMVI) with surgical mitral valve replacement (SMVR) are lacking. AIMS: This study sought to compare the 30-day Valve Academic Research Consortium (VARC)-3 device success of TMVI with that of SMVR. METHODS: Matching protocol combined exact matching (sex, atrial fibrillation, previous surgical aortic valve replacement [SAVR] or coronary artery bypass grafting [CABG]), coarsened exact matching (age) and propensity score matching (body mass index, mitral valve pathology and concomitant tricuspid regurgitation). RESULTS: A total of 40 Tendyne TMVI and 80 SMVR patients with similar baseline characteristics were analysed (TMVI vs SMVR): age (78 years [interquartile range [{IQR} 75; 80] vs 78 years [IQR 73; 80]; p=0.8), female (60% vs 60%; p=1.0), atrial fibrillation (67.5% vs 63.7%; p=0.8), previous SAVR (12.5% vs 10.0%; p=0.8), previous CABG (20.0% vs 16.2%; p=0.8), body mass index (25.54 kg/m² vs 25.24 kg/m²; p=0.7) and valve pathology (mitral regurgitation: 70.0% vs 73.8%, mitral stenosis: 7.5% vs 3.8%, and mixed disease: 22.5% vs 22.5%; p=0.6). Most baseline characteristics not included in the matching model were balanced among the TMVI/SMVR cohorts: European System for Cardiac Operative Risk Evaluation (EuroSCORE) II (5.8% [IQR 2.9; 7.5] vs 4.2% [IQR 2.4; 6.8]; p=0.3) and Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score (5.2% [IQR 3.2; 8.6] vs 4.1% [IQR 3.3; 6.1]; p=0.076). Coronary artery disease (67.5% vs 32.5%; p<0.001) and previous percutaneous coronary intervention (47.5% vs 25.0%; p=0.023) differed among groups. Mitral VARC (MVARC) device success at 30 days was achieved in 82.5% of patients after TMVI and 57.5% of patients after SMVR (p=0.04). MVARC procedural success at 30 days was 75.0% after TMVI versus 52.5% after SMVR (p=0.07). Thirty-day mortality (2.5% vs 3.8%; p=0.47), technical success (97.5% vs 97.5%; p=1.0), major bleeding (17.5% vs 18.7%; p=0.087), stroke (5.0% vs 4.9%; p=1.0) and postoperative haemodialysis (7.5% vs 5.2%; p=0.4) were similar in both groups. CONCLUSIONS: Patients with intermediate surgical risk, according to STS-PROM and EuroSCORE II, demonstrated higher rates of MVARC device at 30 days after TMVI compared to 30 days after SMVR. Rates of survival and procedural success, neurological, renal and bleeding complications were similar. Transfusion count and length of stay were lower after TMVI. For elderly patients at intermediate risk, a TMVI eligibility assessment may be considered.

Functional Mitral Valve Regurgitation: Mitral Valve Repair or Replacement? Our "Road Map" for the Appropriate Strategy.

Objectives: The optimal surgical approach for the treatment of functional mitral regurgitation (FMR) remains controversial. Current guidelines suggest that the surgical approach has to be tailored to the individual patient. The aim of the present study was to clarify further aspects of this tailored treatment. Methods: From 01/2006 to 12/2015, 390 patients underwent mitral valve (MV) surgery for FMR (ischemic n = 241, non-ischemic n = 149) at our institution. A regression analysis was used to determine the effect of MV repair or replacement on survival. The patients were analyzed according to the etiology of the MR (ischemic or non-ischemic), different age groups (<65 years, 65-75 years, and >75 years), LV function, and LV dimensions, as well as the underlying heart rhythm. Results: The overall survival rates for the repair group at 1, 5, and 8 years were 86.1 ± 1.9%, 70.6 ± 2.6%, and 55.1 ± 3.1%, respectively. For the same intervals, the survival rates in patients who underwent MV replacement were 75.9 ± 4.5%, 58.6 ± 5.4%, and 40.9 ± 6.4%, respectively (p = 0.003). Patients younger than 65 years, with an ischemic etiology of FMR, poor ejection fraction (<30%), severe dilatation of left ventricle (LVEDD > 60mm), and presence of atrial fibrillation had significantly higher mortality rates after MV replacement (HR, 3.0; CI, 1.3-6.9; p = 0.007). Patients between 65 and 75 years of age had a higher risk of death when undergoing mitral valve replacement (HR, 1.7; CI, 1.0-2.8; p = 0.04). In patients older than 75 years, the surgical approach (MV repair or replacement) had no effect on postoperative survival (HR, 0.8; CI, 0.4-1.3; p = 0.003). Conclusions: Our data demonstrate that, in patients younger than 65 years, the treatment of choice for FMR should be MV repair. This advantage was even more evident in patients with an ischemic origin of MR, a poor ejection fraction, a severe LV dilatation, and atrial fibrillation.

Self-expanding vs. balloon-expandable transcatheter heart valves in small aortic annuli.

Background: Clinical consequences of prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR) is currently in the focus of clinical research. Patients with small aortic annulus are at higher risk to display PPM. Data on incidence and clinical consequences of PPM after TAVR with either balloon-expandable (BEV) or self-expanding (SEV) transcatheter heart valves in small aortic annulus are sparse. Methods: Patients with small aortic annulus (perimeter < 72 mm or aortic annulus area < 400 mm2) who underwent BEV or SEV with contemporary transcatheter heart valve types were identified from the institutional TAVR database. Propensity score matching was applied for imbalanced baseline characteristics between patients undergoing BEV or SEV. Echocardiography and clinical follow-up beyond 3 years was reported following VARC-3 recommendations. Primary endpoint was the incidence of pre-discharge PPM and its association with 3-year mortality. Results: From a total of 507 patients with small aortic annulus, 192 matched patient pairs with SEV or BEV were identified. Mean age was 81 ± 7 (SEV) vs. 81 ± 6 (BEV) years (p = 0.5), aortic annulus perimeter was 69 ± 3 vs.69 ± 3 mm, (p = 0.8), annulus area was 357 ± 27 vs.357 ± 27 mm2 (p = 0.8), and EuroScore II was 5.8 ± 6.6 vs.5.7 ± 7.2 (p = 0.9). SEV resulted in less moderate (20% vs. 31%, p < 0.001) and severe pre-discharge PPM (9% vs.18%, p < 0.001) compared to BEV. At discharge (7 ± 4 vs. 12 ± 9 mmHg, p = 0.003) and at 1-year follow-up (7 ± 5 vs.13 ± 3 mmHg, p < 0.001), SEV displayed lower mean gradients compared to BEV. Estimated survival after SEV was 85% (95% confidence interval (CI): 80%-90%) at 1 year, 80% (95% CI: 75%-86%) at 2 years, and 71% (95% CI: 65%-78%) at 3 years; estimated survival after BEV was 87% (95% CI: 82%-92%) at 1 year, 81% (95% CI: 75%-86%) at 2 years, and 72% (95% CI: 66%-79%) at 3 years, with no significant difference among the groups (p = 0.9) Body surface area (OR: 1.35, p < 0.001), implantation of BEV (odds ratio (OR): 3.32, p < 0.001), and the absence of postdilatation (OR: 2.16, p < 0.001) were independent risk factors for any PPM. At 3 years, patients without PPM had a higher 3-year survival compared with patients with ≥moderate PPM (77% vs. 67%, p = 0.03). Conclusion: BEV implantation in patients with small annulus was associated with a twofold higher incidence of pre-discharge severe PPM compared to SEV implantation. Survival at 3 years after TAVR was similar after BEV and SEV. However, patients with the absence of pre-discharge PPM had a higher 3-year survival compared to patients with ≥moderate PPM.