Early and Late Results after Surgical Mitral Valve Repair: A High-Volume Center Experience.

BACKGROUND: Surgical mitral valve repair is the gold standard treatment of severe primary mitral regurgitation (MR). In the light of rapidly evolving percutaneous technologies, current surgical outcome data are essential to support heart-team-based decision-making. METHODS: This retrospective, high-volume, single-center study analyzed in 1779 patients with primary MR early morbidity and mortality, postoperative valve function, and long-term survival after mitral valve (MV) repair. Surgeries were performed between 2009 and 2022. Surgical approaches included full sternotomy (FS) and right-sided minithoracotomy (minimally invasive cardiac [MIC] surgery). RESULTS: Of the surgeries (mean age: 59.9 [standard deviation:11.4] years; 71.5% males), 85.6% (n = 1,527) were minithoracotomies. Concomitant procedures were performed in 849 patients (47.7%), including tricuspid valve and/or atrial septal defect repair, cryoablation, and atrial appendage closure. The majority of patients did not need erythrocyte concentrates. Mediastinitis and rethoracotomy for bleeding rates were 0.1 and 4.3%, respectively. Reoperation before discharge for failed repair was necessary in 12 patients (0.7%). Freedom from more than moderate MR was > 99%. Thirty-day mortality was 0.2% and did not differ significantly between groups (p = 0.37). Median follow-up was 48.2 months with a completeness of 95.9%. Long-term survival was similar between groups (p = 0.21). In the FS and MIC groups, 1-, 5-, and 10-year survival rates were 98.8 and 98.8%, 92.9 and 94.4%, and 87.4 and 83.1%, respectively. CONCLUSION: MV surgery, both minimally invasive and via sternotomy, is associated with high repair rates, excellent perioperative outcomes, and long-term survival. Data underscore the effectiveness of surgical repair in managing MR, even in the era of advancing interventional techniques.

Aortic Valve Repair Results in Better 1-Year Survival Than Replacement: Results From German Aortic Valve Registry.

BACKGROUND: Aortic valve (AV) repair is an evolving surgical strategy in the treatment of nonelderly adults with aortic regurgitation. We aimed to determine the 1-year outcome after AV repair vs surgical AV replacement (sAVR) using real-world data from the German Aortic Valve Registry. METHODS: A total of 8076 aortic regurgitation patients (mean age, 59.1 ± 15.0 years; 76% men; mean The Society of Thoracic Surgeons score, 1.3 ± 1.1), who underwent AV surgical procedures between 2011 and 2015, were identified from German Aortic Valve Registry. The AV was repaired in 2327 patients (29%), and the remaining 5749 patients (71%) underwent sAVR. A weighted propensity score model, including the variables of age, sex, and The Society of Thoracic Surgeons score, was used to correct for baseline differences between AV repair and sAVR cohorts. The primary end point was 1-year survival after AV repair vs sAVR. Secondary end points were freedom from cardiac events and AV reinterventions. RESULTS: Survival at 1 year was 97.7% (95% CI, 97.0%-98.5%) in the AV repair cohort vs 96.4% (95% CI, 95.9%-96.9%) in the propensity score-weighted sAVR cohort (log-rank P < .001). Cox regression revealed a significant advantage of AV repair vs sAVR (hazard ratio, 0.68; 95% CI, 0.51-0.90; P < .0001) on 1-year survival, which was independent of age. Cardiac event-free survival at 1 year was 85.7% (95% CI, 483.8%-87.7%) in the AV repair group vs 81.7% (95% CI, 80.7%-82.9%) in the sAVR group (log-rank P < .001). AV reintervention was required in 38 AV repair patients (1.6%) compared with 1.6% in the sAVR cohort (P = .59). CONCLUSIONS: AV repair surgery, whenever intraoperatively feasible, is associated with a significantly better 1-year survival and 1-year cardiac event-free survival compared with sAVR.

Outcomes After Transcatheter Mitral Valve Replacement According to Regurgitation Etiology.

BACKGROUND: Whether transcatheter mitral valve replacement (TMVR) devices perform similarly with respect to the underlying mitral regurgitation (MR) etiology remains unknown. The aim of the present analysis was to assess outcomes of TMVR according to the MR underlying etiology among the CHoice of OptImal transCatheter trEatment for Mitral Insufficiency (CHOICE-MI) registry. METHODS: Of 746 patients, 229 patients (30.7%) underwent TMVR. The study population was subdivided according to primary, secondary, or mixed MR. Patients with mitral annular calcification were excluded. The primary study endpoint was a composite endpoint of all-cause mortality or hospitalization for heart failure at 1 year. Secondary study endpoints were all-cause and cardiovascular mortality at 1 year, New York Heart Association functional class, and residual MR, both at discharge and 1 year. RESULTS: The predominant MR etiology was secondary MR (58.4%), followed by primary MR (28.7%) and mixed MR (12.9%). Technical success and procedural mortality were similar according to MR etiology. Discharge echocardiography revealed residual MR 2+ in 11.3%, 3.7%, and 5.3% of patients with primary, secondary, and mixed MR, respectively (P = .1). MR elimination was similar in all groups up to the 1-year follow-up. There was no difference in terms of primary combined outcome occurrence according to MR etiology. One-year all-cause mortality was reported in 28.8%, 24.2%, and 32.1% of patients with primary, secondary, and mixed MR, respectively (P = .07). CONCLUSIONS: In our study we did not find differences in short-term and 1-year outcomes after TMVR according to MR etiology.

Structure of multidisciplinary heart teams, a survey-based heart team study.

OBJECTIVES: Multidisciplinary approach is well established in various disciplines, with evidence highlighting improved patient outcomes. The objective of this survey was to determine the real-world practice of heart teams across Europe. METHODS: The survey was drafted after a consensus opinion from the authors. The survey was sent to cardiac surgeons and cardiologists identified through electronic search. The survey link and the information sheet were sent through email followed by survey completion reminders. The survey responses were cumulated and analysed. RESULTS: Among 2188 invited clinicians, 220 clinicians from 26 countries took part in the survey (response rate 10%). The completion rate for the survey questions was 85%. A total of 140 (64%) were cardiac surgeons and 80 (36%) were cardiologists. The heart team meeting frequency was weekly according to 104 (55%) respondents. This was conducted face to face according to 139 (73%) of the responses. Eighty-seven (56%) of the respondents reported 10-20% of patients undergoing percutaneous coronary intervention were discussed at the heart team meeting. Seventy-nine (47%) respondents had ad hoc percutaneous coronary intervention institutional guidelines. Fifty-four (32%) respondents reported an audit process for the heart team decisions. CONCLUSIONS: This survey suggests that there is marked variability in the infra-structure and execution of heart teams in different institutions. The results of the survey suggest a need to formulate guidelines on the composition and execution of heart teams which may result in an increase in transparency of decision-making within different institutions in reporting and comparing outcomes.

Transcatheter interventions for left-sided valvular heart disease complicated by cardiogenic shock: a consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) in collaboration with the Association for Acute Cardiovascular Care (ACVC) and the ESC Working Group on Cardiovascular Surgery.

Valvular heart disease (VHD) is one of the most frequent causes of heart failure (HF) and is associated with poor prognosis, particularly among patients with conservative management. The development and improvement of catheter-based VHD interventions have broadened the indications for transcatheter valve interventions from inoperable/high-risk patients to younger/lower-risk patients. Cardiogenic shock (CS) associated with severe VHD is a clinical condition with a very high risk of mortality for which surgical treatment is often deemed a prohibitive risk. Transcatheter valve interventions might be a promising alternative in this setting given that they are less invasive. However, supportive scientific evidence is scarce and often limited to small case series. Current guidelines on VHD do not contain specific recommendations on how to manage patients with both VHD and CS. The purpose of this clinical consensus statement, developed by a group of international experts invited by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) Scientific Documents and Initiatives Committee, is to perform a review of the available scientific evidence on the management of CS associated with left-sided VHD and to provide a rationale and practical approach for the application of transcatheter valve interventions in this specific clinical setting.

Transcatheter Aortic Valve Replacement for Isolated Aortic Regurgitation Using a New Self-Expanding TAVR System.

BACKGROUND: Patients with severe aortic regurgitation (AR) are often not considered for surgery because of increased surgical risk. Because of unique anatomical characteristics among patients with AR, interventional treatment options are limited, and implantation results are inconsistent compared with those among patients with aortic stenosis. OBJECTIVES: The authors describe the initial commercial experience of the first Conformité Européenne-marked transfemoral transcatheter aortic valve replacement system (JenaValve Trilogy [JV]) for the treatment of patients with AR. METHODS: This multicenter registry included 58 consecutive patients from 6 centers across Germany. Transcatheter aortic valve replacement was performed with the JV system for isolated severe and symptomatic AR. Patient characteristics, primary implantation outcomes, and valve performance up to 30 days were analyzed using Valve Academic Research Consortium 3 definitions. RESULTS: The mean patient age was 76.5 ± 9 years, with a mean Society of Thoracic Surgeons score of 4.2% ± 4.3%. Device success was achieved in 98% of patients. The mean gradient was 4.3 ± 1.6 mm Hg, and no moderate or severe paravalvular regurgitation occurred. No conversion to open heart surgery or valve embolization was reported. There were no major vascular complications or bleeding events. The rate of new permanent pacemaker implantation was 19.6%. At 30 days, 92% of the patients were in NYHA functional class I or II, and the 30-day mortality rate was 1.7%. CONCLUSIONS: Treatment of patients with severe symptomatic AR using the transfemoral JV system is safe and effective. Given its favorable hemodynamic performance and low complication rates, this system may offer a new treatment option for patients with AR not suitable for surgery.

A case report: transfemoral transcatheter aortic valve replacement with a dedicated valve system for severe aortic regurgitation in a patient with a left ventricular assist device.

Background: Up to 30% of patients with the left ventricular assist device (LVAD) develop moderate to severe aortic regurgitation (AR) within the first year. Surgical aortic valve replacement (SAVR) is the treatment of choice in patients with native AR. However, the high perioperative risk in patients with LVAD might prohibit surgery and choice of therapy is challenging. Case summary: We report on a 55-year-old female patient with a severe AR 15 months after implantation of LVAD due to advanced heart failure (HF) as a consequence of ischaemic cardiomyopathy. Surgical aortic valve replacement was discarded due to high surgical risk. Thus, the decision was made to evaluate a transcatheter aortic valve replacement (TAVR) with the TrilogyXTä prothesis (JenaValve Technology, Inc., CA, USA). Echocardiographic and fluoroscopic control showed an optimal valve position with no evidence of valvular or paravalvular regurgitation. The patient was discharged 6 days later in a good general condition. At the 3-month follow-up, the patient showed noteworthy symptomatic improvement with no sign of HF. Discussion: Aortic regurgitation is a common complication among advanced HF patients treated with LVADSystems and associated with a deterioration in the quality of life and worsen clinical prognosis. The treatment options are limited to percutaneous occluder devices, SAVR, off-label TAVR, and heart transplantation. With the approval of the TrilogyXT JenaValve system, a novel dedicated TF-TAVR option is now available. Our experience demonstrates the technical feasibility and safety of this system in patients with LVAD and AR resulting in effective elimination of AR.

High Efficacy and Low Early Mortality in High-Volume Center Tricuspid Valve Surgery.

BACKGROUND: Isolated tricuspid valve surgery has been associated with early mortality rates of up to 10%. With rapidly emerging interventional catheter-based options, the question arises whether current technical and perioperative protocols in cardiac surgery translate into lower than previously expected mortality rates, especially when looking at data from high-volume centers. METHODS: We performed a retrospective single-center analysis in 369 patients undergoing isolated tricuspid valve repair (n = 256) or replacement (n = 113) between 2009 and 2021. Surgical approaches included full sternotomy, as well as right-sided minithoracotomy. According to a recently introduced clinical risk score, patients were divided into scoring groups, and observed (O) versus expected (E) early mortality were compared. Pre- and postoperative tricuspid valve function was also analyzed. RESULTS: Overall, 30-day mortality was 4.1%, ranging from 0% (scoring group 0-1 points) to 8.7% (scoring group ≥ 10 points), which was substantially lower than the expected early mortality (2% in the lowest to 34% in the highest scoring group). Preoperative tricuspid regurgitation was severe in 71.3% (n = 263), moderate to severe in 14.9% (n = 55), and mild or less in 6.5% (n = 24). The corresponding postoperative values were 0% (n = 0), 1.4% (n = 5), and 81.6% (n = 301). CONCLUSION: Our high-volume center data indicate substantially lower than predicted 30-day mortality in different cardiac surgical risk scoring groups. The majority of patients had zero to minimal residual tricuspid valve insufficiency postoperatively. Randomized controlled trials are needed to compare tricuspid valve functional results and long-term outcomes of surgical versus interventional procedures in patients undergoing isolated tricuspid valve procedures.

Transcatheter aortic valve implantation with different self-expanding devices-a propensity score-matched multicenter comparison.

OBJECTIVE: Several supra-annular self-expanding transcatheter systems are commercially available for transcatheter aortic valve implantation (TAVI). Comparative data in large-scale multicenter studies are scant. METHODS: This study included a total of 5175 patients with severe aortic stenosis undergoing TAVI with the ACURATE neo (n = 1095), Evolut R (n = 3365), or Evolut PRO (n = 715) by a transfemoral approach at five high-volume centers. Propensity score matching resulted in 654 triplets. Outcomes are reported according to the Valve Academic Research Consortium-3 (VARC-3) consensus. RESULTS: Moderate or severe paravalvular regurgitation (PVR) occurred significantly more often in the ACURATE neo group (5.2%) than in the Evolut R (1.8%) and Evolut PRO (3.3%) groups (p = 0.003). The rates of major vascular-/access-related complications (4.6%, 3.8%, and 5.0%; p = 0.56), type 3 or 4 bleeding (3.2%, 2.1%, and 4.1%; p = 0.12), and 30-day mortality (2.4%, 2.6%, and 3.7%; p = 0.40) were comparable. The rate of new permanent pacemaker implantation (PPI) was significantly lower in the ACURATE neo group (9.5%, 17.6%, and 16.8%; p < 0.001). Independent predictors for 2-year survival were a Society of Thoracic Surgeons (STS) risk score ≥5%, diabetes mellitus, a glomerular filtration rate <30 ml/min, baseline mean transvalvular gradient ≤ 30 mm Hg, treating center, and relevant PVR. CONCLUSION: In this multicenter study, TAVI with the ACURATE neo, Evolut R, or Evolut PRO was feasible and safe. The rate of relevant PVR was more frequent after the ACURATE neo implantation, with, however, lower rates of PPI. Two-year survival was mainly driven by baseline comorbidities.

Right coronary artery deformation and injury following tricuspid valve surgery.

Background: Due to its close anatomical proximity to the annular plane of the tricuspid valve (TV), the right coronary artery (RCA) is at risk of injury and distortion during surgical and interventional repair. Recently, reversible, non-flow limiting, purse-string like deformations of the RCA following percutaneous TV annuloplasty have been described. In contrast, there are only anecdotal reports on RCA deformation following conventional TV surgery. Materials and methods: A retrospective analysis of all patients undergoing TV surgery in our hospital between 2009 and 2019 was performed including all patients who received a post-operative coronary angiography (POCA). Angiographic footage was reviewed for RCA affections. Results: A total of 1,383 patients underwent TV surgery (replacement and repair) for tricuspid regurgitation in our center. TV repair was performed in 1,248 (90.2%) patients and 135 (9.8%) patients underwent isolated TV surgery. Sixty-five patients (4.7%) underwent POCA within 48 h after surgery due to suspected myocardial ischemia, representing the final study population. Mean age was 70.3 ± 11.3 years, 56.3% were female. Mean EuroSCORE II was 9.8 ± 11.6%. Patients with the need for POCA due to suspected myocardial injury suffered from a higher mortality compared to event-free patients over the long-term follow up period (median 2.9 years) regardless of the observed coronary status. RCA affections were observed in 24 (36.9%) patients. A new RCA deformation without flow-impairment or vascular damage was found in 16 (24.6%) of the cases and was managed conservatively. There was no significantly worse outcome observed as compared to patients without RCA affections. Six (9.2%) patients showed an RCA deformation accompanied by subtotal occlusion. A complete RCA-occlusion was observed in 2 (3.1%) patients. Revascularization by percutaneous coronary intervention could be successfully performed in these patients. RCA deformation occurred exclusively after TV repair while no cases were observed after TV replacement. Conclusion: Right coronary artery deformation without flow-limitation following surgical TV repair is a specific/typical phenomenon which might not impair patients' outcome and could be managed conservatively in most of the cases. RCA injury indicating further interventional therapy is a rare complication of TV surgery. However, the need for immediate POCA in general appears to be associated with a worsened intermediate-term outcome.

Propensity matched comparison of TAVI and SAVR in intermediate-risk patients with severe aortic stenosis and moderate-to-severe chronic kidney disease: a subgroup analysis from the German Aortic Valve Registry.

OBJECTIVE: We compared TAVI vs. SAVR in patients with moderate-to-severe chronic kidney disease (eGFR 15-60 ml/min/1.73 m2) for whom both procedures could possibly be considered (age ≤ 80 years, STS-score 4-8). BACKGROUND: According to both ACC/AHA and ESC/EACTS recent guidelines, aortic stenosis may be treated with either transcatheter (TAVI) or surgical (SAVR) aortic valve replacement in a subgroup of patients. A shared therapeutic decision is made by a heart team based on individual factors, including chronic kidney disease (CKD). METHODS: Data from the large nationwide German Aortic Valve Registry were used. A propensity score method was used to select 704 TAVI and 374 SAVR matched patients. Primary endpoint was 1-year survival. Secondary endpoints were clinical complications, including pacemaker implantation, vascular complications, myocardial infarction, bleeding, and the need for new-onset dialysis. RESULTS: One-year survival was similar (HR [95% CI] for TAVI 1.271 [0.795, 2.031], p = 0.316), with no divergence in Kaplan-Meier curves. In spite of post-procedural short-term survival being numerically higher for TAVI patients and 1-year survival being numerically higher for SAVR patients, such differences did not reach statistical significance (96.4% vs. 94.2%, p = 0.199, and 86.2% vs. 81.2%, p = 0.316, respectively). In weighted analyses, pacemaker implantation, vascular complications, and were significantly more common with TAVI; whereas myocardial infarction, bleeding requiring transfusion, and longer ICU-stay and overall hospitalization were higher with SAVR. Temporary dialysis was more common with SAVR (p < 0.0001); however, a probable need for chronic dialysis was rare and similar in both groups. CONCLUSION: Both TAVI and SAVR led to comparable and excellent results in patients with moderate-to-severe CKD in an intermediate-risk population of patients with symptomatic severe aortic stenosis for whom both therapies could possibly be considered.

Outcomes of aortic valve repair: early results from the German Aortic Valve Registry.

OBJECTIVES: Aortic valve (AV) repair is an evolving surgical strategy in the treatment of young patients with aortic regurgitation (AR) and/or aortic root aneurysm. We aimed to determine the clinical outcome following AV repair/AV-sparing root surgery using real-world data from the German Aortic Valve Registry. METHODS: A total of 2327 patients with AR (mean age 55.2 ± 15.0 years, 76% men), who underwent AV repair/AV-sparing root surgery between 2011 and 2015 (i.e. 5% of 42 868 AV surgery patients enrolled in the German Aortic Valve Registry during the same period) were included. Study cohort was subdivided according to the technique of AV repair: isolated AV repair without root surgery (group I) (n = 914), AV-sparing root surgery (i.e. reimplantation or remodelling) without cusp repair (group II) (n = 1077) and AV-sparing root surgery (i.e. reimplantation or remodelling) with simultaneous cusp repair (group III) (n = 336). Primary end point was 1-year survival after AV repair/AV-sparing root surgery. Secondary end points were freedom from cardiac adverse events and freedom from AV reinterventions at 1-year follow-up. RESULTS: Thirty-day mortality was 19 (0.8%) in the whole study cohort without significant differences in the 3 subgroups [4 (0.4%) patients in group I vs 14 (1.3%) patients in group II vs 1 (0.3%) patient in group III (P = 0.054)]. Postoperatively, 1445 (74%) patients had no residual AR, 474 (24%) patients had mild AR and 40 (2%) patients had moderate/severe AR at the time of hospital discharge. One-year survival (95% confidence interval) was 97.7% (97.1-98.3) in the whole study cohort and without significant difference among the 3 subgroups. One-year cardiac adverse event-free survival (95% confidence interval) was 85.7% (84.2-87.1) and was similar in all 3 study groups in propensity score-weighted analysis. A total of 38 (1.6%) patients required AV reintervention during a 1-year follow-up, without significant difference among subgroups (P = 0.11). CONCLUSIONS: AV repair/AV-sparing root surgery is performed in 5% of patients requiring AV surgery in Germany. Our data demonstrate very satisfactory periprocedural and 1-year survival and cardiac event-free survival after AV repair surgery. Implementation of specific surgical techniques during the index procedure seems to result in comparable outcomes.

Surgical aortic valve replacement in patients aged 50-69 years-insights from the German Aortic Valve Registry (GARY).

OBJECTIVES: The aim of this study was to analyse the outcome of patients between 50 and 69 years of age undergoing biological or mechanical aortic valve replacement. METHODS: Data were collected from the German Aortic Valve Registry. Data were analysed regarding baseline characteristics and outcome parameters such as 5-year survival, stroke and reintervention. RESULTS: In total.3046 patients undergoing isolated surgical aortic valve replacement between 2011 and 2012 were investigated and a propensity score matching was performed. Within this period, 2239 patients received a biological prostheses, while 807 patients received a mechanical prosthesis. Mean age in the biological group was 63.07 (±5.11) and 57.34 (±4.67) in the mechanical group (standardized mean difference 1.172). In the overall cohort, there were more female patients in the biological group (32.7% vs 28.4%) and log EuroSCORE I was higher (5.41% vs 4.26%). After propensity matching (610 pairs), there was no difference in the mortality at 5-year follow-up (12.1% biological vs 9.2% mechanical P = 0.05) nor for reoperation/reintervention (2.5% biological vs 2.0% mechanical, P = 0.546). Patients undergoing mechanical aortic valve replacement suffered from a higher stroke rate 3.3% vs 1.5% (P = 0.04) at 5-year follow-up. CONCLUSIONS: Aortic valve replacement with biological or mechanical prostheses showed similar 5-year outcomes for survival and reoperation in a propensity-matched cohort, but significantly increased stroke rate after mechanical aortic valve replacement. This could influence the choice of a mechanical valve in younger patients.

Large thrombus in transit in a COVID-19 patient.

The course of COVID-19 patients may be complicated by thromboembolic events. We report on a 48-year-old female COVID-19 patient who underwent surgical removal of a large intracardiac thrombus. As per our centre protocol, critically ill COVID-19 patients are anticoagulated by the direct thrombin inhibitor Argatroban with close monitoring of anti-IIa activity. An intra-atrial thrombus formation fixed in a patent foramen ovale but also large mobile portions in both atria was diagnosed 4 days after weaning and removal of the jugular and femoral extracorporeal membrane oxygenation cannulas. The thrombus was removed surgically via median sternotomy and on cardiopulmonary bypass. The thrombus had a bizarre appearance with several finger-like appendices, and histological analysis revealed a mixed picture of acute and chronic thrombus portions. This case highlights the risk of life-threatening thrombus formation in COVID-19 patients despite therapeutic thrombin inhibition.

Characteristics and outcomes of patients screened for transcatheter mitral valve implantation: 1-year results from the CHOICE-MI registry.

AIMS: Transcatheter mitral valve implantation (TMVI) represents a novel treatment option for patients with mitral regurgitation (MR) unsuitable for established therapies. The CHOICE-MI registry aimed to investigate outcomes of patients undergoing screening for TMVI. METHODS AND RESULTS: From May 2014 to March 2021, patients with MR considered suboptimal candidates for transcatheter edge-to-edge repair (TEER) and at high risk for mitral valve surgery underwent TMVI screening at 26 centres. Characteristics and outcomes were investigated for patients undergoing TMVI and for TMVI-ineligible patients referred to bailout-TEER, high-risk surgery or medical therapy (MT). The primary composite endpoint was all-cause mortality or heart failure hospitalization after 1 year. Among 746 patients included (78.5 years, interquartile range [IQR] 72.0-83.0, EuroSCORE II 4.7% [IQR 2.7-9.7]), 229 patients (30.7%) underwent TMVI with 10 different dedicated devices. At 1 year, residual MR ≤1+ was present in 95.2% and the primary endpoint occurred in 39.2% of patients treated with TMVI. In TMVI-ineligible patients (n = 517, 69.3%), rates of residual MR ≤1+ were 37.2%, 100.0% and 2.4% after bailout-TEER, high-risk surgery and MT, respectively. The primary endpoint at 1 year occurred in 28.8% of patients referred to bailout-TEER, in 42.9% of patients undergoing high-risk surgery and in 47.9% of patients remaining on MT. CONCLUSION: This registry included the largest number of patients treated with TMVI to date. TMVI with 10 dedicated devices resulted in predictable MR elimination and sustained functional improvement at 1 year. In TMVI-ineligible patients, bailout-TEER and high-risk surgery represented reasonable alternatives, while MT was associated with poor clinical and functional outcomes.

Transapical mitral valve implantation for treatment of symptomatic mitral valve disease: a real-world multicentre experience.

AIMS: Transcatheter mitral valve implantation (TMVI) is a new treatment option for patients with symptomatic mitral valve (MV) disease. Real-world data have not yet been reported. This study aimed to assess procedural and 30-day outcomes of TMVI in a real-world patient cohort. METHOD AND RESULTS: All consecutive patients undergoing implantation of a transapically delivered self-expanding valve at 26 European centres from January 2020 to April 2021 were included in this retrospective observational registry. Among 108 surgical high-risk patients included (43% female, mean age 75 ± 7 years, mean STS-PROM 7.2 ± 5.3%), 25% was treated for an off-label indication (e.g. previous MV intervention or surgery, mitral stenosis, mitral annular calcification). Patients were highly symptomatic (New York Heart Association [NYHA] functional class III/IV in 86%) and mitral regurgitation (MR) was graded 3+/4+ in 95% (38% primary, 37% secondary, and 25% mixed aetiology). Technical success rate was 96%, and MR reduction to ≤1+ was achieved in all patients with successful implantation. There were two procedural deaths and 30-day all-cause mortality was 12%. At early clinical follow-up, MR reduction was sustained and there were significant reductions of pulmonary pressure (systolic pulmonary artery pressure 52 vs. 42 mmHg, p < 0.001), and tricuspid regurgitation severity (p = 0.013). Heart failure symptoms improved significantly (73% in NYHA class I/II, p < 0.001). Procedural success rate according to MVARC criteria was 80% and was not different in patients treated for an off-label indication (74% vs. 81% for off- vs. on-label, p = 0.41). CONCLUSION: In a real-world patient population, TMVI has a high technical and procedural success rate with efficient and durable MR reduction and symptomatic improvement.

Long-Term Clinical Outcome in Elderly Patients Undergoing Mitral Valve Repair.

BACKGROUND: Long-term data on patients over 75 years undergoing mitral valve (MV) repair are scarce. At our high-volume institution, we, therefore, aimed to evaluate mortality, stroke risk, and reoperation rates in these patients. METHODS: We investigated clinical outcomes in 372 patients undergoing MV repair with (n = 115) or without (n = 257) tricuspid valve repair. The primary endpoint was the probability of survival up to a maximum follow-up of 9 years. Secondary clinical endpoints were stroke and reoperation of the MV during follow-up. Univariate and multivariable Cox regression analysis was performed to assess independent predictors of mortality. Mortality was also compared with the age- and sex-adjusted general population. RESULTS: During a median follow-up period of 37 months (range: 0.1-108 months), 90 patients died. The following parameters were independently associated with mortality: double valve repair (hazard ratio, confidence interval [HR, 95% CI]: 2.15, 1.37-3.36), advanced age (HR: 1.07, CI: 1.01-1.14 per year), diabetes (HR: 1.97, CI: 1.13-3.43), preoperative New York Heart Association (NYHA) functional class (HR: 1.41, CI: 1.01-1.97 per class), and operative creatininemax levels (HR: 1.32, CI: 1.13-1.55 per mg/dL). The risk of stroke in the isolated MV and double valve repair groups at postoperative year 5 was 5.0 and 4.1%, respectively (p = 0.65). The corresponding values for the risk of reoperation were 4.0 and 7.0%, respectively (p = 0.36). Nine-year survival was comparable with the general population (53.2 vs. 53.1%). CONCLUSION: Various independent risk factors for mortality in elderly MV repair patients could be identified, but overall survival rates were similar to those of the general population. Consequently, our data indicates that repairing the MV in elderly patients represents a suitable and safe surgical approach.

Final 3-year clinical outcomes following transcatheter aortic valve implantation with a supra-annular self-expanding repositionable valve in a real-world setting: Results from the multicenter FORWARD study.

OBJECTIVES: The Evolut R FORWARD study confirmed safety and effectivenesss of the Evolut R THV in routine clinical practice out to 1 year. Herein, we report the final 3-year clinical follow up of the FORWARD study. BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a proven alternative to surgery in elderly patients with symptomatic severe aortic stenosis. Long-term clinical outcome data with the Evolut R platform are scarce. METHODS: FORWARD is a prospective multicenter observational study that evaluated the Evolut R system in routine clinical practice at 53 centres. Eligible patients had symptomatic native aortic valve stenosis or failed surgical aortic bioprosthesis and elevated operative risk per Heart-Team assessment. TAVR was attempted in 1039 patients. RESULTS: Mean age was 81.8 ± 6.2 years, 64.9% were women, STS score was 5.5 ± 4.5% and 34.2% were frail. Rates of all-cause mortality and disabling stroke were 24.8% and 4.8% at 3 years. Early need for a new pacemaker implantation after TAVR (all-cause mortality: with new PPI; 21.0% vs. without; 22.8%, p = 0.55) and the presence of > trace paravalvular regurgitation (all-cause mortality: no or trace; 22.0% vs. ≥ mild; 25.5%, p = 0.29) did not affect survival. Between 1 and 3 years incidence rates of valve related intervention, endocarditis and clinically relevant valve thrombosis were low. CONCLUSIONS: The Evolut R valve maintained a favorable safety profile through 3 years in routine clinical practice. Rates of transcatheter heart valve-related adverse events were low.

Prognosis and Clinical Results after Coronary Artery Bypass Operation in Young Patients Aged <45 Years: Chances and Limitations of a New Therapy Option.

Coronary artery bypass grafting (CABG) is the recommended type of revascularization procedure in patients with left main or three-vessel disease and is considered an alternative when percutaneous coronary intervention is not feasible. We evaluated registry data to obtain long-term outcome data.All patients ≤45 years in whom CABG was performed between 2009 and 2019 were selected from the Heart and Diabetes Center NRW, Germany. Cox regression analysis was applied to estimate the incidence risk of events after surgery.A total of 209 patients (81.8% male) were included. Mean (standard deviation) follow-up duration was 5.8 (3.1) years. The combined outcome of death, stroke, myocardial infarction, or repeated revascularization occurred in 31 patients (14.8%). Estimated mean time to event was 8.5 (standard error: 0.22) years. By the end of the follow-up period, 8 patients (3.8%) had died, among whom 2 (1.0%) died within 1 month after surgery, 1 (0.5%) within 1 year, 1 (0.5%) within 2 years, and 4 (1.9%) after 2 years.Risk factors independently associated with postsurgery events were angina pectoris CCS (Canadian Cardiovascular Society) class IV (adjusted hazard ratio [HR]: 4.954; 95% confidence interval [CI]: 1.322-18.563; p = 0.018) and STS (Society of Thoracic Surgeons) score (adjusted HR: 1.152 per scoring point; 95% CI: 1.040-1.276; p = 0.007).After performing CABG in patients ≤45 years, event-free long-term outcomes were observed in the majority of patients. Presence of angina pectoris CCS class IV and higher STS scores were independently associated with adverse postsurgery events.